Pulse™ Product Reference Manual

Product Reference Manual

Pulse Product Reference Manual 9513658 L 1

Contents Pulse System ......................................................................................................................... 2

Pulse IOM, C-Arm and iGA ................................................................................................... 55

Pulse Bendini ..................................................................................................................... 115

Pulse Navigation ............................................................................................................... 142

Pulse LessRay .................................................................................................................... 208


Pulse System


Pulse is a spine technology platform with multiple applications inclusive of:

• Neuromonitoring (IOM)

• 3D Navigation

• Radiation Reduction Technology (LessRay)

• Rod Bending Technology (Bendini)

• Spinal measurements (IGA)

Refer to the Indications for use for each country to confirm which modalities and applications are permitted for

use under the FDA, or CE mark, respectively.

Please note that the Pulse Navigation application has been cleared and/or approved for the following indications:

FDA The Pulse System is a medical device comprised of Pulse NVM5, Pulse LessRay, and Pulse Navigation. Pulse NVM5 is intended for intraoperative neurophysiologic monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremities. The device provides information directly to the surgeon, to help assess a patient’s neurophysiologic status. The Pulse NVM5 provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), motor evoked potential (MEP) or somatosensory evoked potential (SSEP) responses of nerves. The System also integrates Bendini® software used to locate spinal implant instrumentation for the placement of spinal rods. • XLIF (Detection) – The XLIF (Detection) function allows the surgeon to locate and evaluate spinal nerves, and is used as a nerve avoidance tool. • Basic & Dynamic Screw Test – The Screw Test functions allow the surgeon to locate and evaluate spinal nerves by providing proximity information before, during or after bone preparation and placement of bone screws. • Free Run EMG – The Free Run EMG function identifies spontaneous EMG activity of spinal nerves by continually displaying a live stream waveform of any mechanically induced myotome contractions. • Twitch Test (Train of Four) – The Twitch Test Function allows the surgeon to assess moderate degrees of neuromuscular block in effect by evaluating muscle contraction following a train of four stimulation pulses. • MEP – Transcranial or lumbar (i.e., conus in region of L1-L2) stimulation techniques for motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract and peripheral nerves. The MEP function provides an adjunctive method to allow the surgeon to monitor spinal cord and motor pathway integrity during procedures with a risk of surgically induced motor injury. • SSEP – The SSEP function allows the surgeon to assess sensory spinal cord function in surgical procedures during which the spinal cord is at risk. • Remote Access - The remote monitoring and local wireless control provides real-time capabilities to the Pulse System • Bendini – The Bendini Spinal Rod Bending function is used to locate spinal implant system instrumentation (screws, hooks) to determine their relative location to one another to generate bend instructions to shape a spinal rod. A surgeon is able to use those instructions and bend a rod using the Bendini Bender, a mechanical rod bender. Pulse LessRay is intended for use in any application where a fluoroscope is incorporated to aid in diagnosis and treatment of disease. Pulse Navigation is intended as an intraoperative image-guided localization system in either open or minimally invasive spinal surgical procedures. Instruments and implants tracked by a passive marker sensor system are virtually displayed on a patient's 3D radiographic image data. The system enables computer-assisted navigation for spinal surgical procedures in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure can be identified relative to the acquired image of the anatomy. This may include the


following spinal implant procedures: - Pedicle Screw Placement (cervical, thoracic, lumbar) - Iliosacral screw placement

CE

Navigation. Pulse NVM5 is intended for intraoperative neurophysiologic monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremities. The device provides information directly to the surgeon, to help assess a patient’s neurophysiologic status. The Pulse NVM5 provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), motor evoked potential (MEP) or somatosensory evoked potential (SSEP) responses of nerves. The System also integrates Bendini software used to locate spinal implant instrumentation for the placement of spinal rods. • XLIF (Detection) – The XLIF (Detection) function allows the surgeon to locate and evaluate spinal nerves, and is used as a nerve avoidance tool. • Basic & Dynamic Screw Test – The Screw Test functions allow the surgeon to locate and evaluate spinal nerves by providing proximity information before, during or after bone preparation and placement of bone screws. • Free Run EMG – The Free Run EMG function identifies spontaneous EMG activity of spinal nerves by continually displaying a live stream waveform of any mechanically induced myotome contractions. • Twitch Test (Train of Four) – The Twitch Test Function allows the surgeon to assess moderate degrees of neuromuscular block in effect by evaluating muscle contraction following a train of four stimulation pulses. • MEP – Transcranial or lumbar (i.e., conus in region of L1-L2) stimulation techniques for motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract and peripheral nerves. The MEP function provides an adjunctive method to allow the surgeon to monitor spinal cord and motor pathway integrity during procedures with a risk of surgically induced motor injury. • SSEP – The SSEP function allows the surgeon to assess sensory spinal cord function in surgical procedures during which the spinal cord is at risk. • Remote Access – The remote monitoring and local wireless control provides real-time capabilities to the Pulse System • Bendini – The Bendini Spinal Rod Bending function is used to locate spinal implant system instrumentation (screws, hooks) to determine their relative location to one another to generate bend instructions to shape a spinal rod. A surgeon is able to use those instructions and bend a rod using the Bendini Bender, a mechanical rod bender. Pulse LessRay is intended for use in any application where a fluoroscope is incorporated to aid in diagnosis and treatment of disease. Pulse Navigation is intended as an intraoperative image-guided localization system in either open or minimally-invasive spinal surgical procedures. Instruments and implants tracked by a passive marker sensor system are virtually displayed on a patient's 3D radiographic image data. The system enables computer-assisted navigation for spinal surgical procedures in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure can be identified relative to the acquired image of the anatomy. This may include the following spinal implant procedures: • Pedicle Screw Placement (3D Navigation in Sacral and Thoracolumbar Spine).


Pulse Description

The Pulse System provides surgeon-driven neurophysiologic electromyography (EMG), Motor Evoked Potential

(MEP), and Somatosensory Evoked Potential (SSEP) monitoring to nerve roots during spinal procedures. NuvaMap

O.R. is a real-time intraoperative assessment of various patient anatomical parameters through the use of

fluoroscopic images.

Bendini is the Rod Bending System used to bend rods for spinal surgery applications. The system is comprised of a

camera and digitizer to register implant locations, software to calculate bend angles between each implant and

generate bend instructions, and a mechanical bender to manually bend the rod to implant specific contours.

Pulse Navigation is an application within Pulse System. It is a stereotactic surgical application intended as an aid for

precisely locating anatomical structures in either open or percutaneous procedures. It consists of Camera,

computer, spinous process clamps and hip pins, passive reflective arrays, Pulse Navigation instruments, tablet, and

a computer interface for communication between the User and the device. It is intended for intraoperative image-

guided localization which allows for surgical instruments to be tracked in three-dimensional space. The device

provides real-time information directly to the surgeon, enabling the surgeon to evaluate the instrument depth and

trajectory for computer-assisted navigation during spine surgery. Instruments are tracked in three-dimensional

space with an Infrared (IR) Camera, being virtually displayed and superimposed on registered radiographic images.

Radiographic images can be either 3D fluoroscopic images (C-arm) or 3D intraoperative scan (CT or Cone Beam CT).

NuVasive Navigation Instruments are intended to be used with fixation screws from NuVasive’s Reline and

VuePoint sets.

Pulse LessRay is intended for use with a standard C-arm or fluoroscope during a surgical or interventional

procedure. When used in connection with the low-dose and/or pulse setting on the fluoroscope, the user may

improve the quality (clarity, contrast, noise level, and usability) of a noisy (low-quality) image. By using this system,

some or much of the graininess of low-radiation dose images may be eliminated, allowing for greater utility of low-

dose imaging in the O.R. LessRay works by combining (or in some cases alternating) the current image being taken

with a prior “learned” image of the same anatomy. The initial image, taken at full radiation dose settings, serves as

the “baseline” to which images taken at lower dose radiation settings are compared to and enhanced.


Important Labeling Information

Indications for Use (OUS)

Navigation. Pulse NVM5 is intended for intraoperative neurophysiologic monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremities. The device provides information directly to the surgeon, to help assess a patient’s neurophysiologic status. The Pulse NVM5 provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), motor evoked potential (MEP) or somatosensory evoked potential (SSEP) responses of nerves. The System also integrates Bendini software used to locate spinal implant instrumentation for the placement of spinal rods. • XLIF (Detection) – The XLIF (Detection) function allows the surgeon to locate and evaluate spinal nerves, and is used as a nerve avoidance tool. • Basic & Dynamic Screw Test – The Screw Test functions allow the surgeon to locate and evaluate spinal nerves by providing proximity information before, during or after bone preparation and placement of bone screws. • Free Run EMG – The Free Run EMG function identifies spontaneous EMG activity of spinal nerves by continually displaying a live stream waveform of any mechanically induced myotome contractions. • Twitch Test (Train of Four) – The Twitch Test Function allows the surgeon to assess moderate degrees of neuromuscular block in effect by evaluating muscle contraction following a train of four stimulation pulses. • MEP – Transcranial or lumbar (i.e., conus in region of L1-L2) stimulation techniques for motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract and peripheral nerves. The MEP function provides an adjunctive method to allow the surgeon to monitor spinal cord and motor pathway integrity during procedures with a risk of surgically induced motor injury. • SSEP – The SSEP function allows the surgeon to assess sensory spinal cord function in surgical procedures during which the spinal cord is at risk. • Remote Access – The remote monitoring and local wireless control provides real-time capabilities to the Pulse System • Bendini – The Bendini Spinal Rod Bending function is used to locate spinal implant system instrumentation (screws, hooks) to determine their relative location to one another to generate bend instructions to shape a spinal rod. A surgeon is able to use those instructions and bend a rod using the Bendini Bender, a mechanical rod bender. Pulse LessRay is intended for use in any application where a fluoroscope is incorporated to aid in diagnosis and treatment of disease. Pulse Navigation is intended as an intraoperative image-guided localization system in either open or minimally-invasive spinal surgical procedures. Instruments and implants tracked by a passive marker sensor system are virtually displayed on a patient's 3D radiographic image data. The system enables computer-assisted navigation for spinal surgical procedures in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure can be identified relative to the acquired image of the anatomy. This may include the following spinal implant procedures: • Pedicle Screw Placement (3D Navigation in Sacral and Thoracolumbar Spine).


Indications for Use (US)

The Pulse System is a medical device comprised of Pulse NVM5, Pulse LessRay, and Pulse Navigation. Pulse NVM5 is intended for intraoperative neurophysiologic monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremities. The device provides information directly to the surgeon, to help assess a patient’s neurophysiologic status. The Pulse NVM5 provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), motor evoked potential (MEP) or somatosensory evoked potential (SSEP) responses of nerves. The System also integrates Bendini® software used to locate spinal implant instrumentation for the placement of spinal rods. • XLIF (Detection) – The XLIF (Detection) function allows the surgeon to locate and evaluate spinal nerves, and is used as a nerve avoidance tool. • Basic & Dynamic Screw Test – The Screw Test functions allow the surgeon to locate and evaluate spinal nerves by providing proximity information before, during or after bone preparation and placement of bone screws. • Free Run EMG – The Free Run EMG function identifies spontaneous EMG activity of spinal nerves by continually displaying a live stream waveform of any mechanically induced myotome contractions. • Twitch Test (Train of Four) – The Twitch Test Function allows the surgeon to assess moderate degrees of neuromuscular block in effect by evaluating muscle contraction following a train of four stimulation pulses. • MEP – Transcranial or lumbar (i.e., conus in region of L1-L2) stimulation techniques for motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract and peripheral nerves. The MEP function provides an adjunctive method to allow the surgeon to monitor spinal cord and motor pathway integrity during procedures with a risk of surgically induced motor injury. • SSEP – The SSEP function allows the surgeon to assess sensory spinal cord function in surgical procedures during which the spinal cord is at risk. • Remote Access - The remote monitoring and local wireless control provides real-time capabilities to the Pulse System • Bendini – The Bendini Spinal Rod Bending function is used to locate spinal implant system instrumentation (screws, hooks) to determine their relative location to one another to generate bend instructions to shape a spinal rod. A surgeon is able to use those instructions and bend a rod using the Bendini Bender, a mechanical rod bender. Pulse LessRay is intended for use in any application where a fluoroscope is incorporated to aid in diagnosis and treatment of disease. Pulse Navigation is intended as an intraoperative image-guided localization system in either open or minimally invasive spinal surgical procedures. Instruments and implants tracked by a passive marker sensor system are virtually displayed on a patient's 3D radiographic image data. The system enables computer-assisted navigation for spinal surgical procedures in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure can be identified relative to the acquired image of the anatomy. This may include the following spinal implant procedures: - Pedicle Screw Placement (cervical, thoracic, lumbar) - Iliosacral screw placement


Important Labeling Information (continued)

Contraindications

Contraindications include, but are not limited to:

1. Infection, local to the operative site.

2. Signs of local inflammation.

3. Patients who unwilling to restrict activities or follow medical advice.

4. Patients with physical or medical conditions that would prohibit beneficial surgical outcome.

5. Use with components of other systems, unless otherwise specified.

6. Medical conditions which contraindicate the use of a computer-assisted surgery system and its associated

applications including any medical conditions which may contraindicate the medical procedure itself.

7. The Pulse Navigation System is contraindicated in any spine surgery where radiographic images are

inadequate to accurately determine the instrument or implants relative location to the patient’s anatomy.

8. Pulse LessRay is intended to be used for aiding a treatment professional in viewing images obtained from

a fluoroscopic X-ray device or C-arm. Its use with any other device has not been evaluated.

9. For contraindications and additional information related to the screw system used with NuVasive

Navigation Instruments, refer to the respective NuVasive screw system Instructions for Use (IFU) and

associated labeling documents.

The Pulse System may not be effective, and is not intended for use, when neuromuscular block or epidural blocks

have been used for, or in conjunction with, anesthesia. Contraindications to use of Motor Evoked Potential (MEP)

monitoring include epilepsy, cortical lesions, convexity skull defects, raised intracranial pressure, cardiac disease,

proconvulsant medications or anesthetics, intracranial electrodes, vascular clips or shunts, and cardiac pacemakers

or other implanted biomedical devices. Otherwise unexplained intraoperative seizures and possibly arrhythmias

are indications to abort MEP.

Neuromuscular Block or paralytics should not be in effect during the use of Pulse EMG as they might interfere with

the electromyography readings.

Do not use the Pulse System in conjunction with high frequency electromagnetic diathermy devices. Failure to do

so may result in patient burns at the electrode sites.

Use of MEPs is contraindicated in patients with a history of head injury, cerebral aneurysm, stroke, seizures, other

neurological impairments, or patients with metal plates or fragments in their head.

Do not attempt to use this device when using paralyzing agents on the patient, as nerve surveillance may be

compromised.

Do not use cutaneous electrodes for stimulation (stimulation electrodes) if the patient has a cardiac pacemaker,

implanted defibrillator, or other implanted metallic or electronic device. Such use could cause electric shock,

burns, electrical interference, or death.



Minimize coupling with electrosurgical equipment when setting up the Pulse System. Some actions that may help

reduce electrical coupling include: locate the electrosurgical patient return pad as close to the surgical site as

practical; route the monopolar and bipolar electrosurgical wiring together and away from any other patient

connected leads and electrodes; minimize the activation of electrosurgical instruments while they are not in

patient contact; plug the electrosurgical generator equipment into a separate power outlet from any other

patient-connected electrical device; and use the lowest electrosurgical power setting that achieves the surgical

requirement.

Pulse electrodes (surface, corkscrew, and needle electrodes) are not intended to come into contact with the central nervous system (CNS) or dural sac. These electrodes should only be placed on the surface of the skin of the patient or sub-dermally. To avoid incorrect use of Pulse electrodes, no Pulse electrodes should ever be placed within the surgical site.

Potential Adverse Events and Complications

As with any major surgical procedures, there are risks involved in orthopedic surgery. Infrequent operative and

postoperative complications include:

• Tissue or nerve damage, including due to improper positioning and placement of implants or instruments

• Sensory or motor deficits

• Post-operative change in spinal curvature, loss of correction, height, or reduction, including due to anchor

failure; such changes may result in permanent deformity and/or pain

• Non-union (or pseudarthrosis), delayed union, or mal-union

• Dural tears, pseudomeningocele, fistula, persistent CSF leakage, meningitis

• Cauda equina syndrome, neuropathy, neurological deficits (transient or permanent), paraplegia,

paraparesis, reflex deficits, irritation, arachnoiditis, muscle loss

• Scar formation possibly causing neurological compromise or compression around nerves or pain.

• Loss of or increase in spinal mobility or function

• Inability to perform the activities of daily living

• Hemorrhage, hematoma, occlusion, seroma, edema, hypertension, embolism, stroke, excessive bleeding,

phlebitis, wound necrosis, wound dehiscence, damage to blood vessels, vascular injury, visceral injury, or

other types of cardiovascular system compromise

• Development of respiratory problems (e.g. pulmonary embolism, atelectasis, bronchitis, pneumonia, etc.)

• Extended exposure to anesthesia

• Foreign body (allergic) reaction to implants, debris, corrosion products (from crevice, fretting, or general

corrosion) including metallosis, staining, tumor formation, or autoimmune disease

• Pain, skin irritation, rash, sensitization, local inflammatory response, immunological response, systemic

reaction, cell death, fever, or infection remains due to the risk of exposure to toxins, allergens, pyrogens,

microbial contaminants, or other non-biocompatible materials

• Cardiotoxicity, neurotoxicity, or cancer due to long-term exposure to non-biocompatible materials.

• Infection

• User or patient injury may occur due to blunt force trauma, including tissue damage or bone fracture

• Burns (1st, 2nd, or 3rd degree) or lesions

• Lens, cornea, or retinal damage including cataracts, corneal ulcers, retinal burns, or permanent loss of eye

function due to exposure to infrared or laser radiation



• Risks due to exposure to leakage current or current shunting, including respiratory or skin irritation, pain,

burns, tissue damage, nerve damage, ventricular fibrillation, cord damage with the potential for

permanent loss of function, brain damage, and death

• Skin or lung irritation, burns and/or inhalation of hazardous gas or smoke due to battery malfunction

• Increased exposure to radiation

• Oral injuries, including tongue and lip lacerations, tooth fractures, and mandibular fractures

• Recurrent Laryngeal Nerve Injury, airway obstruction, and/or damage/injury to the trachea

• Stall or malfunction of an active implantable

• Urinary retention or loss of bladder control or other types of urological system compromise.

• Sexual dysfunction, including impotence

• Death

Note: additional surgery may be necessary to correct some of these potential adverse events.

Potential Pulse System failures include the following, which can cause serious or critical patient injury, including

many of the adverse events noted above:

• Neurophysiologic response failures or inaccuracies, including false positives, false negatives and/or missed

neurophysiologic responses or alerts

• Navigational failures/inaccuracies, or system failures preventing the use of navigated guidance

• Malfunctions and errors in the use of the Bendini application may result in inaccurate rod bends

• Inaccurate or flawed image display using the LessRay System

• Inaccurate planning, instrumentation recommendations, and/or spinal parameter measurements

Warnings, Cautions, and Precautions

Read all instructions and understand all warnings and cautions before using the Pulse System and accessories.

Failure to do so may lead to serious medical consequences. Refer to the Instructions for Use accompanying other

NuVasive devices before use with the Pulse System to confirm proper use of these devices.

Patients with implanted electronic devices, such as cardiac pacemakers, should not be subjected to electrical

stimulation unless specialist medical opinion has first been obtained. The MEP modality is capable of generating

outputs exceeding 2mA RMS/cm² in every stimulation current (from 200 to 1500mA)/pulse (1 to 8) combination

except for the 100mA/1 pulse combination. Prolonged stimulation at outputs greater than 2mA RMS/cm² may

result in skin burns.

Chronically compressed nerves, or severely compressed nerves in an acute setting, are known to be less sensitive

to depolarization currents (i.e., have significantly higher depolarization current values). They are also less likely to

demonstrate significant changes in their threshold depolarization current values immediately following nerve

decompression. Under such circumstances, exercise caution in interpreting displayed data.

The Pulse System contains no user serviceable parts inside, and servicing (other than that explicitly defined

elsewhere in this manual) must be performed by the manufacturer or its authorized agent.



Do not use the Pulse System in the presence of explosive gases. The device is not explosion proof.

To minimize the risk of electric shock, always connect the Patient Module cable to the Control Unit before

connecting the Patient Module to the patient EMG leads. Also, always disconnect the patient EMG leads before

removing the Patient Module cable from the Control Unit.

If system navigation seems inaccurate and re-registration steps to restore accuracy are not successful, abort use of

the system.

Minimize coupling with electrosurgical equipment when setting up the Pulse System. Some actions that may help

reduce electrical coupling include: locate the electrosurgical patient return pad as close to the surgical site as

practical; route the monopolar and bipolar electrosurgical wiring together and away from any other patient

connected leads and electrodes; minimize the activation of electrosurgical instruments while they are not in

patient contact; plug the electrosurgical generator equipment into a separate power outlet from any other

patient-connected electrical device; and use the lowest electrosurgical power setting that achieves the surgical

requirement.

Assess navigational accuracy repeatedly throughout a procedure when using a surgical navigation system.

a. Reconfirm accuracy by positioning the navigated instrument tip on an identifiable anatomical

landmark and comparing the actual tip location to that displayed by the system.

b. If the stereotaxic navigation system does not appear to be accurate despite troubleshooting (e.g.,

resetting the system; checking the spheres on the arrays and ensuring they are clean and

securely fixed) then do not rely on the navigation system.

If data acquisition seems inaccurate, software application does not initiate or malfunctions during use, and

recommended steps to restore the system are not successful – abort use of the system.

The Pulse Navigation System has been successfully tested against the requirements of IEC 60601-1-2. However,

radio frequency (RF) interference could hamper its operation or the operation of other nearby electrical devices. If

you suspect either of these conditions, move the conflicting equipment farther apart, separate the equipment with

a RF barrier, or discontinue use of the system.

Movement of the patient during 3D radiographic image acquisition may result in inaccurate measurements. Efforts

to immobilize the patient during data acquisition should be taken to restrict patient movement. If patient

movement during data acquisition is observed or suspected, re-start the data acquisition process to ensure

accurate image.

Scans from only calibrated intraoperative 3D imaging systems must be used for Pulse navigation. Use of scans from

uncalibrated imaging systems may lead to navigation error.

Only patients that meet the criteria described in the indications should be selected. Patient condition and/or

predispositions such as those addressed in the aforementioned contraindications should be avoided.

Only use instruments that are compatible with the Pulse navigation system.



The methods of use for the instruments are to be determined by the user’s experience and training in surgical

procedures.

Do not use instruments for any action for which it was not intended such as hammering, prying, or lifting.

Instruments should be treated as any precision instrument and should be carefully placed on trays, cleaned after

each use, and stored, according to generally accepted hospital methods and practices.

Instruments should be protected during storage and from corrosive environments.

Some surgeries require the use of instruments which incorporate a measuring function. Ensure that these are not

worn and that any surface markings are clearly visible.

NuVasive does not and cannot warrant the use of instruments nor any of the component parts upon which repairs

have been made or attempted except as performed by NuVasive or an authorized NuVasive repair representative.

Do not use the Pulse System in the presence of explosive gases. The device is not explosion proof.

MEP scalp stimulation electrodes can deliver a high voltage shock. To avoid shock, never handle both electrodes at

the same time. Confirm both electrodes are securely and properly attached to the patient before initiating any

test.

MEP stimulation may introduce additional hazards to the patient through use. Examples of these hazards include:

tongue or lip laceration, mandibular fracture, seizure, cardiac arrhythmia, and scalp burn.

A Red Channel may indicate a disconnected or separated electrode or poor electrode impedance. If a failed

channel or channel that has been disabled is accepted, responses from this channel will not be detected during

stimulation. This could lead to a false-negative result if the myotome is innervated by the spinal level under test.

Free Run events on this channel will not be detected.

To avoid trans-thoracic stimulation, confirm both MEP electrodes are properly attached to the patient’s scalp or

abdomen before initiating any test.

To avoid bite injuries, the patient must be fitted with a bite block before initiating transcranial MEP testing. MEP

stimulation may induce violent muscle contractions throughout the patient’s body. Secure physical restraints

should be used, and surgical operations should be discontinued before and during MEP stimulation. Confirm the

surgeon is well notified prior to any MEP testing.

Only use electrodes supplied with the Pulse System. Use of other electrodes may adversely affect results.

Do not place stimulation electrodes over the patient’s neck because this could cause severe muscle spasms

resulting in closure of the patient’s airway, difficulty in breathing, or adverse effects on heart rhythm or blood

pressure.

Do not place stimulation electrodes across the patient’s chest because the introduction of electrical current into

the chest may cause rhythm disturbances to the patient’s heart, which could be lethal.



Do not place stimulation electrodes over open wounds or rashes, or over swollen, red, infected, or inflamed areas

or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins).

Do not place stimulation electrodes over, or in proximity to, cancerous lesions.

Electrodes should be applied only to normal, intact, clean, healthy skin.

The size, shape, and type of electrodes may affect the safety and effectiveness of electrical stimulation and

recording.

Using stimulation electrodes that are too small or incorrectly applied could result in discomfort or skin burns.

Use caution if electrodes are applied over areas of skin that lack normal sensation.

Keep electrodes out of the reach of children.

Replace self-adhesive electrodes if they no longer stick firmly to the patient’s skin.

The patient may experience skin irritation and burns beneath the stimulation electrodes applied to their skin.

The patient may experience headache and other painful sensations during or following the application of electrical

stimulation near their eyes and to their head and face.

Do not perform a spinal assessment within NuVaMap O.R. while stimulation is active as the assessment screen

may cause neuromonitoring related content and/ or alerts to not be displayed.

Setting Free Run threshold too high may result in missed free run alert.

The Pulse Disposable Accessories are single-use devices supplied sterile. Sterile, single-use only products should

NOT be re-sterilized. Do not use if package is opened or damaged. Do not use after the expiration date specified on

the product label. Do not use if the product is damaged in any way.

The Pulse Reusable Accessories are supplied non-sterile. Do not use if the product is damaged in any way.

The Pulse Disposable Accessories and Pulse Reusable Accessories may ONLY be used with the NuVasive Pulse

System.

If system data acquisition seems inaccurate or if the software application does not initiate or malfunctions during

use, and recommended steps to restore the system are not successful, abort use of the system.

Do not use the Pulse System in flammable environments. The system is not suitable for use in the presence of a

flammable, anesthetic mixture with air or oxygen or nitrous oxide.



Avoid wagging the C-arm, adjusting the angle of the surgical table, or rotating the fluoro image between each

fluoro shot. This may cause inaccuracy in angle measurements.

Confirm a compatible C-arm with low-res, video-out BNC connection is used. Image transmission may result in an

image that is not identical to the C-arm display.

NuVasive does not endorse, recommend or validate any third party software or equipment for use with NuVasive

products, NuVasive services or software apps unless otherwise included in the product verification, validation, and

regulatory submission. Any use by you of any such third party software or equipment is at your sole risk. We have

no responsibility or liability arising from your use of such third party software or equipment. Such as damage to

your NuVasive products, or problems, inaccuracies or malfunctions in NuVasive products, NuVasive services or

software apps arising from such use. NuVasive Pulse Navigation System has been tested for compatibility with

following third party instruments:

The long-term effects of cutaneous electrodes for electrical stimulation and/or recording are unknown.

Improperly placed corkscrews may result in poor responses or no responses, even with high electrical current

stimulus.

Proper handling, insertion and placement of electrodes is critical for monitoring. Needles should be at least 1”

apart. Please follow your hospital’s medical waste ‘sharps’ guidelines for proper disposal of needle electrodes.

Inspect all system components and packaging for damage before use. Do not use sterile components if packaging

is opened or damaged. If components are visibly damaged, do not use the system.

Note the STERILE expiry date. Devices with elapsed STERILE expiry dates have to be considered as nonsterile and

may not be used.



Do not use alcohol to clean the Touch Screen on the Control Unit.

Do not allow liquids to enter the Control Unit or Patient Module or camera, as this may result in damage or

malfunction of the Pulse System.

Avoid dripping any fluids into any Pulse Navigation equipment. Disconnect the power and allow the system to dry

if you suspect fluids may have entered any part of the System.

The Pulse System is not protected against the effects of defibrillation. Do not use in conjunction with a

defibrillator.

While the Pulse System is designed to assist in the electromyographic location of spinal nerves in proximity to the

surgical site, it is not intended to take the place of thorough knowledge of spinal anatomy and appropriate surgical

technique, nor should the information provided by the system be construed as definitive indicators of nerve

location. Such factors as the distance from the nerve, the position and placement of electrodes, individual muscle

and/or nerve responses, the proximity and strength of sources of electrical interference, and other patient and

environmental factors, may influence the operation. If, in the judgment of the clinician, this resistance is sufficient

to preclude proper placement of instruments, the procedure should be suspended.

To avoid trans-thoracic stimulation, the Stimulation Anode should not be located on the chest or upper back. Place

this electrode on the lower abdomen, gluteus, or upper flank.

To optimize accuracy of EMG recording, the EMG Common electrode should be located between the site of

stimulation and the recording electrodes (e.g., on the flank).

The Pulse System contains sensitive electronic components which may be damaged by electrostatic discharge

(ESD). Normal precautions should be taken to avoid causing ESD impulses to occur directly on the EMG input

electrodes. For example, it is recommended that before touching the EMG electrodes, the operator should touch

the barrel of the main cable connector between the Control Unit and the Patient Module to reduce any

accumulated charge on the operator.

Prior foraminal or extraforaminal surgery may leave scar tissue at the site of surgery which can result in undue

resistance to instrument insertion. Exercise care in inserting instrumentation in such circumstances to prevent the

application of excessive force that can damage internal structures.

The Pulse System is to be used only as an adjunct to medical judgment and appropriate surgical practices.

Instrument insertion and advancement should be conducted only after careful analysis of radiographic images of

the operative target area. Do not advance instruments until all available data has been considered.

Avoid contact between any of the Pulse System’s electrical connections and any other conductive parts, including

those connected to protective earth/ground.



Do not connect the Pulse System to unapproved devices. Connection of the Pulse System to unapproved

equipment may result in dangerous levels of patient leakage currents. Use only approved NuVasive accessories

with the Pulse System. Do not use cables or accessories other than those provided with the system.

Do not attempt to bypass the grounding prong on the power cord by using a three-prong to two prong adapter.

The system must be properly grounded.

Do not exceed the recommended electrical ratings for the system. Exceeding the ratings could damage the system.

The system mouse, camera, and keyboard are not designed for sterilization, and may be damaged if sterilization is attempted.

Safety precautions must always be exercised when using electrical equipment to prevent operator/patient shock,

fire hazard, or equipment damage.

Avoid contaminating the IR passive reflective markers on the Passive Reflective Arrays with any liquid or solid

materials to ensure the proper functioning of the Pulse Navigation System. Contaminated or damaged markers

must be replaced.

Do not use any solvent to clean the Pulse Navigation System. Solvents may damage the finish and remove

lettering.

To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.

Only use the system components as delivered by NuVasive. Do not modify the system in any way. Altering the

system or using it outside of its intended use may result in severe harm to the patient, user or third-party.

Before moving the system cart(s), shut down and stow all components, remove any loose items from the top of

the cart(s).

Confirm Pulse X-ray image is consistent with X-ray image on C-arm monitor.

Remove the Pulse Camera and place the Pulse Camera Cart into its transport position before moving.

Do not use un-calibrated equipment.

Check if the camera is ready to be used prior to tracking/navigation.

Do not use damaged components for tracking.

In addition, periodically inspect the instruments for wear and tear, such as corrosion or discoloration. For instruments that are no longer functional, or exhibit excessive wear and tear, please return instruments to NuVasive

Navigation instruments must be confirmed before using for navigation as unconfirmed instruments may lead to

navigation error.

Do not use dirty or damaged spheres for navigation.

Surgical grade instrument lubrication should be applied to all moving components during the wash and sterilization

cycle to ensure proper functionality.

Instruments should not be bent or altered in any way. If damage is observed, the instrument should not be used

and returned to NuVasive.



The Pedicle Access Kit components are designed for use only when fully assembled. Make sure that the handle,

needle, and cannula are assembled and that the cannula is securely locked in place.

Needles are sharp, and extreme care must be taken during handling.

If an instrument is disassembled and re-assembled, re-confirm the device before navigating.

Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient.

The physician should take precautions against putting undue stress on the spinal area with instruments. Any

surgical technique should be carefully followed.

It is important that the surgeon exercise extreme caution when working in close proximity to vital organs, nerves,

or vessels, and that the force applied to the instrumentation is not excessive, to prevent potential injury to the

patient.

The physical characteristics required for many instruments do not permit them to be manufactured from

implantable materials. If any broken fragments of instruments remain in the body of a patient, they could cause

allergic reactions or infections. If an instrument breaks in surgery and fragments go into the patient, these pieces

should be removed prior to closure and should not be implanted.

If instrument confirmation failure occurs, check that no other instrument is in the view of the camera except the

instrument being registered.

User must confirm that screw selected for treatment matches screw option selected in the navigation software.

If using Pulse with the Siemens CIOS Spin 3D scanner:

a. Do not remove the Pulse Cios array from the C-arm

b. Do not disassemble the Cios array

c. Confirm the Siemens Cios is calibrated with the Pulse system prior to using NaviLink.

d. The Siemens CIOS NaviLink calibration is good for 1 year of service and service date is labeled on

the Siemens CIOS Spin system array.

Do not obstruct the normal flow of air around the Camera (for example, draping or bagging the Camera). Doing so

will affect the Camera’s operational environment, possibly beyond its recommended thresholds. Reliance on data

provided by a Camera that is outside of recommended thresholds may lead to inaccurate measurements.

Do not obstruct the normal flow of air around the Pulse Cart (for example draping or bagging the Pulse Cart). Doing

so will affect Pulse’s operational environment possibly beyond its recommended thresholds.

Do not simultaneously touch the Pulse system and patient.

Do not touch the tracking camera lens or LEDs. These components can become hot during normal operation.

Reliance on data provided by a Camera with an interrupted optical path may lead to inaccurate measurements.



Do not use the NuVasive Pulse Camera without inspecting it for cleanliness and damage both before and during

the procedure. Do not use the camera with a dirty camera lens cover. Reliance on data provided by an unclean or

damaged Camera may lead to inaccurate measurements.

Do not use if the camera lens is damaged. Do not use damaged camera lens for tracking.

Only use IR passive reflective markers supplied with the system. Use of other markers may lead to inaccurate

measurements.

Draping patient reference array/s and the CIOS system array during navigation registration can cause inaccuracies. Follow hospital’s infection control guidelines in order to safely drape around these arrays during registration with Pulse.

Remove the navigation arrays from navigation instruments before cleaning and sterilization. Remove the passive

reflective markers from the confirmation tool and flat arrays before cleaning and sterilization. The navigation

patient reference arrays, hip pins, and passive reflective markers are single use and should be disposed after each

use.

Federal (U.S.) law restricts this device to sale, distribution, or use by, or on the order of, a physician.

Hip pin should only be used in the lumbar and sacral regions of the spine.

Dilator insertion and advancement should be conducted only after careful analysis of radiographic images of the

operative target area. While a positive EMG detection by the Pulse System can be associated with a high level of

certainty that a nerve is in close proximity to the Dilator tip, the absence of such an EMG detection cannot be

construed as a certain indication that no nerves are close to the Dilator tip. Do not advance Dilator probes until all

available data have been considered.

Do not advance the Dilator faster than the rate of update of Detection data.

A thorough cleaning and preparation of the dermal surface prior to placement of recording electrodes is required

for proper adherence and sensitivity of the electrodes. It is recommended to apply sufficient skin preparation to

achieve acceptable electrode impedance. Caution should be exercised during skin preparation and electrode

removal. Excessive preparation and/or sudden removal may lead to skin reaction and abrasion.

In preparing the sites for EMG Electrode placement, patient sensitivity to disinfecting and sterilizing agents (e.g.,

alcohol, povidine, etc.), electrode materials, and adhesive tapes and electrode backings should be considered to

prevent skin reactions.

Using the provided electrode placement instructions, extreme care should be taken to confirm that the recording

electrodes have been placed on the correct muscle groups, and on the correct side of the patient, before plugging

the EMG Harness into the Patient Module. Failure to follow these instructions may result in the display of

inadequate information necessary for data interpretation.

There may be a noticeable muscle twitch in either or both legs during the stimulation. This will subside after a few

seconds. Do not attempt to restrain the legs to prevent them from twitching, as this will interfere with the EMG

signals.



If the patient moves, or is moved, during the course of surgery, electrode positions may be disturbed. In such

instances, electrode positions should be re-examined to confirm proper location, adequacy of contact, and security

of connections. Run electrode test to affirm adequacy of EMG electrode contact.

If the intended level of surgery changes intraoperatively, EMG Recording Electrode placement may no longer be

appropriate for monitoring one or more of the nerves at or near the operative site. In such an event, the EMG

Recording Electrode placement should be altered, commensurate with change.

Movement of the patient during stimulation can cause excessive electrical “noise” and/or false EMG (noise)

artifacts.

The use of electrosurgical equipment near the Pulse System’s EMG Electrodes may damage the Patient Module or

Control Unit.

Over-abrading can cause serious topical reaction to the patient. Always apply using the preferred patient

preparation technique.

Do not touch the electrode sites with your fingers/skin as this may compromise the conductivity between the

patient’s skin and electrode.

Connection of a patient to electrosurgical equipment and to the Pulse System simultaneously may result in burns

at the site of the electrodes and possibly damage the Pulse System circuitry.

Operation of the Pulse System in close proximity to shortwave or microwave therapy equipment may produce

instability in the electrical stimulator output.

Do not attempt to repair the Pulse System. Any malfunction which does not respond to remedies identified in this

Guide (see ‘TROUBLESHOOTING’ section in the Product Reference Manual) can only be addressed by

manufacturer’s service. We require that the device be returned to NuVasive for any such inspection, service, or

repair.

Improperly placed or bent needles increase the risk of needle breaking off in the patient.

Do not attempt to straighten bent needles because this may cause stress and weaken the needle causing it to

break off in the patient.

Needles are sharp and extreme care must be taken during handling.

Do not allow liquids to enter the Stimulation Probe or Stimulation Clip/Activator, as this may result in damage or

malfunction of the Pulse System.

Do not use saline irrigation in the vicinity of the Stimulation Electrodes while operating the System. Saline solutions

may lead to shunting of the stimulation current resulting in improper operation.



Avoid fluid contact with all cable connections.

Avoid contact between any of the Pulse System’s electrical connections and any other conductive parts, including

those connected to protective earth/ground.

Remain alert for audible indications of EMG-like activity as an indicator of nerve trauma. Lack of audible feedback

may indicate speaker system malfunction.

The Pulse System will not be able to reliably detect EMG impulses on channels degraded by noise. If an Impedance

Test Error occurs, immediate attention should be directed toward correcting the problem by checking the

electrode placement, securing the electrodes with tape, and eliminating any other sources of the noise. If

excessive ambient noise persists or if a noise error message appears, check the position of all leads and electrodes,

and position them as far away from other electronic equipment as possible. Observe the EMG signals using the

free run, or evoked potentials display to determine the nature of the noise.

Poor electrode impedance may create susceptibility to electrical interference, which can adversely affect system

performance.

Do not connect the Pulse System to unapproved devices. Connection of the Pulse System to unapproved

equipment may result in dangerous levels of patient leakage currents. Use only approved NuVasive accessories

with the Pulse System. Do not use cables or accessories other than those provided with the system.

Audible alert notification of spontaneous EMG events will not be generated when the Pulse System is used with

the “Mute” setting activated. To receive all possible audible alerts when using the Pulse System, confirm that the

“Mute” setting is not activated.

Placement of recording electrodes within close proximity of one another (less than one inch) may prevent the

Pulse System from recording differential responses. To confirm differential responses can be recorded, position

the recording electrodes at least 1 inch from each other.

Do not push or pull connectors in constricted areas. Doing so may damage the connectors.

Do not put heavy objects on cable connectors. Doing so may damage the connectors.

Pull cable connections apart by gripping the connector. Do not pull them apart by tugging on the cable as this can

damage the connecting cable. Never force a connection or a disconnection.

Switch off power to the system before cleaning it.

Do not use aerosol sprays near the equipment as these sprays can damage circuitry.

Do not attempt to bypass the grounding prong on the power cord by using a three-prong to two prong adapter.

The system must be properly grounded.



Do not exceed the recommended electrical ratings for the system. Exceeding the ratings could damage the system.

The system mouse, camera, and keyboard are not designed for sterilization, and may be damaged if sterilization is

attempted.

System components are fragile. Use care when handling system components.

Federal (U.S.) law restricts this device to sale, distribution, or use by, or on the order of, a physician.

Exercise caution when increasing max stimulation. Higher stimulation may result in increased patient movement,

which may impact retractor position.

Safety precautions must always be exercised when using electrical equipment to prevent operator/patient shock,

fire hazard, or equipment damage.

Do not allow liquids to enter the Pulse Computer or Camera as this may result in damage or malfunction of the

System.

Avoid contaminating the IR passive reflective markers on the Passive Reflective Arrays with any liquid or solid

materials to ensure the proper functioning of the Pulse Navigation System. Contaminated or damaged markers

must be replaced.

Instrument insertion and advancement should be conducted only after careful analysis of radiographic images of

the operative target area. Do not advance instruments until all available data has been considered.

Operation of the Pulse Navigation System in close proximity to shortwave or microwave therapy equipment may

lead to inaccurate measurements.

Do not use alcohol to clean the Touch Screen on the Pulse Computer.

Applying excessive force to the instrument arrays when tracking their locations can result in inaccurate

measurements due to deflection of the instrument, do not apply excessive force to the instrument arrays.

The accuracy of data acquisition can be influenced by the rotation of the passive reflective array relative to

the Camera. Cameras should be placed such that a direct line of sight to the operative area is established.

Do not use any solvent to clean the Pulse Navigation System. Solvents may damage the finish and remove

lettering.

Do not autoclave any of the Pulse Navigation System components except for the Pulse Navigation Instruments, Flat

Arrays, and Spinous Process Clamp. Autoclaving any other components will damage the system.

To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.



Do not attempt to repair the Pulse Navigation System. NuVasive requires that the device be returned for any

inspection, service, or repair.

Use only 70% isopropanol and a lens cleaning solution formulated for multi-coated lenses to clean the Camera.

Other fluids may cause damage to the illuminator filters. Do not use any paper products for cleaning. Paper

products may cause scratches on the illuminator filters.

Verify that all relevant instrumentation has been properly cleaned and sterilized before surgery. Only use the

system components as delivered by NuVasive. Do not modify the system in any way. Altering the system or using it

outside of its intended use may result in severe harm to the patient, user or third party.

Before moving the system cart(s), shut down and stow all components, remove any loose items from the top of

the cart(s).


Remove the Pulse Camera and place the Pulse Camera Cart into its transport position before moving.

Do not use if the camera lens is damaged. Do not use damaged camera lens for tracking.

Do not use un-calibrated equipment.

Check if the camera is ready to be used prior to tracking/navigation.

Do not use damaged components for tracking.

In addition, periodically inspect the instruments for wear and tear, such as corrosion or discoloration. For

instruments that are no longer functional, or exhibit excessive wear and tear, please return instruments to

NuVasive

The Patient Reference array needs to be fully secured on the Patient Reference fixation device for tracking. All the

instruments must be confirmed before using for navigation as not doing so can lead to navigation error.

Do not use dirty or damaged spheres for tracking.

Cybersecurity Considerations: Confirm a secure web browser connection by checking for the secure connection

indicator in the browser by ensuring the URL begins with HTTPS in addition to the lock icon. All data are encrypted

using secure HTTPS communication channels established through the use of validated security certificates.

The application includes data integrity checks to ensure corrupted data is not used.

Patient Education: Preoperative instructions to the patient are essential. The patient should be made aware of the

potential risks of the surgery.



Single Use/Do Not Re-Use: Reuse of a single use device that has come in contact with blood, bone, tissue or other

body fluids may lead to patient or user injury. Possible risks associated with reuse of a single use device include,

but are not limited to, mechanical failure, material degradation, potential leachables, and transmission of

infectious agents.

MRI Safety Information: Do not use the Pulse System in conjunction with, or in the presence of magnetic

resonance (MR) devices. The Pulse System is not compatible with the magnetic fields associated with magnetic

resonance (MR) devices.

Compatibility: Do not use the Pulse System with components of other systems. Unless stated otherwise, NuVasive

devices are not to be combined with the components of another system.

Do Not Implant the Instruments: Complications to the patient may include, but are not limited to:

• Nerve damage, paralysis, pain, or damage to soft tissue, visceral organ, or joints.

• Dural leak in cases of excessive load application or impingement of close vessels, nerves, and/or organs by

slippage or misplacement of the instrument.

• Bony fracture, especially in the case of deformed spine or weak bone.

• Infection, if instruments are not properly cleaned and sterilized.

• Breakage of the device, which could make necessary removal difficult or sometimes impossible, with

possible consequences of late infection and migration. Breakage could cause injury to the patient.

• Pain, discomfort, or abnormal sensations due to the presence of the device.

Complications to the hospital staff may include, but are not limited to:

• Cutting of skin.

• Physical injury that may result from the disassembly of multi-component instruments occurring during

surgery.

• Injury that may result from instrument breakage, slippage, misuse, or mishandling.

If too much underlying anatomy is blocked by surgical instruments, the Pulse LessRay System should not be used.

If the fluoroscope has been oriented to an angle that does not have a corresponding learned image, or the

anatomy which is being imaged has been altered by the physician or changed its orientation in space, learn a new

image or cease using the Pulse LessRay System.

If any significant distortion, manipulation, or deformation of the anatomy has taken place since the image was

learned, learn a new image.

If the fluoroscope has been pitched or its position altered and a learned image hasn’t been learned at that

orientation, do not use a prior learned image, learn a new image.

If there is any question to the correctness or validity of the image alignment, consider using alternate mode to

evaluate the Pulse LessRay System’s assumption about the underlying anatomy, or consider taking a full-dose or

higher-dose image.



Pulse LessRay must not be used as an alternative to sound medical judgment.

The C-arm model must be selected prior to starting a session. Selecting the incorrect C-arm model/ type may result

in incorrect tracking or detection of X-ray images.

Once a learned image has been set, if either the patient or C-arm moves significantly, the Pulse LessRay algorithm

will not align images to improve the subsequent image quality. At this point a new image should be learned (if

more images are needed in this new location) or the fluoroscope should be re-centered back to the desired

location.

Only equipment and accessories complying with IEC 60601-1 , IEC 60950-1, or IEC 62368-1 and approved for use

with the NuVasive Pulse system may be connected.

Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in

improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify

that they are operating normally.

Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this

equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this

equipment and result in improper operation.

Only authorized USB devices should be connected to the system to ensure data integrity and reduce risk of

malware.

If metal is not visible in low-dose image, metal boost should not be used.

The LessRay table array should not be moved. If it is moved, new baselines should be taken.

Pulse LessRay is an accessory to a fluoroscopic device. The C-arm monitor should always remain in the direct line of

sight of the physician so that the unenhanced images can be referred back to at any time.

Pulse LessRay cannot improve the quality of poor-quality learned images. If the learned image is not clear, do not

attempt to try to improve this with the Pulse LessRay System.

If the new image taken is very poor quality, do not attempt to try to improve it with Pulse LessRay.

If the surgical tool or instrument/implant is not clear relative to the underlying anatomy and the quality of the

image is not adequate to perform the procedure, consider using alternate mode to allow greater clarity of the

underlying anatomy without the blocking instruments.

Pulse LessRay cannot substitute for sound medical judgment. If the merged image displayed is not of sufficient

quality, do not attempt to perform the procedure using this image.

Always take a confirmatory X-ray prior to proceeding with the intervention.



The use of sterile drapes that are not fully transparent and clear may interfere with the Pulse LessRay Camera’s

ability to properly detect the table and C-arm collar Arrays and the ability to determine the position of the C-arm

relative to the patient table.

Please consult the C-arm or fluoroscope’s user instructions to properly decrease the radiation settings for that

particular unit prior to use of Pulse LessRay.

Pulse LessRay is not intended for use with or for diagnostic interpretation of mammography images.

Place clear transparent sterile drapes over the C-arm collar and table Array before using in a sterile field.

Although the entire image is being used by LessRay to compare the new to the learned image, zooming the image

may cause information at the top and bottom of the image to be obscured from view. Do not use this feature if

losing this information would be detrimental.

If the system is unplugged before being shut down completely, it may cause the system to not boot properly which

will require servicing.

Ensure all monitors are connected prior to plugging in and turning on the computer.

For LessRay tablet, incorrect replacement of batteries could result in excessive temperatures, fire or explosion. Do

not use damaged batteries.

Pre-Operative Warnings

The Pulse Navigation System contains no user serviceable parts inside and servicing (other than that explicitly

defined elsewhere in this manual) must be performed by the manufacturer or its authorized agent.

Only use instruments that are compatible with the Pulse Navigation System.

The method of use for the instruments are to be determined by the user’s experience and training in surgical

procedures.

The instruments should be carefully examined prior to use for functionality, excessive wear, or damage. A

damaged instrument should not be used as this may increase the risk of malfunction and potential patient injury.

NuVasive does not and cannot warrant the use of instruments nor any of the component parts upon which repairs

have been made or attempted except as performed by NuVasive or an authorized NuVasive repair representative.

Patient condition and/or predispositions such as those addressed in the aforementioned contraindications should

be avoided.

Instruments should be protected during storage and from corrosive environments.



All non-sterile parts should be cleaned and sterilized before use. The mutimodality harness, SSEP pod, and surface

electrodes should not be sterilized.

Inspect all components for damage before use.

Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient.

Do not use these instruments for any action for which it was not intended such as hammering, prying, or lifting.

The instruments should be treated as any precision instrument and should be carefully placed on trays, cleaned

after each use, and stored, according to generally accepted hospital methods and practices.

Some surgeries require the use of instruments which incorporate a measuring function. Ensure that these are not

worn and that any surface markings are clearly visible.

Surgical grade instrument lubrication should be applied to all moving components during the wash and sterilization

cycle to ensure proper functionality.

Only patients that meet the criteria described in the indications should be selected.

Refer to Cleaning and Sterilization Instructions below for all non-sterile parts.

Remove the navigation arrays from navigation instruments before cleaning and sterilization. Remove the passive

reflective markers from Instrument calibration tool and flat arrays before cleaning and sterilization.

The patient reference arrays, hip pins, and passive reflective markers are single use and should be disposed after

each use.

The NuVasive Instruments should not be bent or altered in any way. If damage is observed, the instrument should

not be used and returned to NuVasive.

Intra-Operative Warnings

The physician should take precautions against putting undue stress on the spinal area with instruments.

Any surgical technique should be carefully followed.

It is important that the surgeon exercise extreme caution when working in close proximity to vital organs, nerves,

or vessels, and that the force applied to the instrumentation is not excessive, to prevent potential injury to the

patient.



The physical characteristics required for many instruments do not permit them to be manufactured from

implantable materials. If any broken fragments of instruments remain in the body of a patient, they could cause

allergic reactions or infections. If an instrument breaks in surgery and fragments go into the patient, these pieces

should be removed prior to closure and should not be implanted.

Assess navigational accuracy repeatedly throughout a procedure when using a surgical navigation system.

1. Reconfirm accuracy by positioning the navigated instrument tip on an identifiable anatomical landmark

and comparing the actual tip location to that displayed by the system.

2. If the stereotaxic navigation system does not appear to be accurate despite troubleshooting (e.g.,

resetting the system), do not rely on the navigation system.

If system data acquisition seems inaccurate or if the software application does not initiate or malfunctions during

use, and recommended steps to restore the system are not successful, abort use of the system.

If system navigation seems inaccurate and re-registration steps to restore accuracy are not successful, abort use of

the system.

The Pulse System has been successfully tested against the requirements of IEC 60601-1-2. However, radio

frequency (RF) interference could hamper its operation or the operation of other nearby electrical devices. If you

suspect either of these conditions, move the conflicting equipment farther apart, separate the equipment with a

RF barrier, or discontinue use of the system.

Movement of the patient during the course of 3D radiographic image acquisition may result in inaccurate

measurements. Efforts to immobilize the patient during data acquisition should be taken to restrict patient

movement. If patient movement during data acquisition is observed or suspected, re-start the data acquisition

process in order to ensure accurate image.

Scans from only calibrated intraoperative 3D imaging systems must be used for Pulse navigation. Use of scans from

un-calibrated imaging systems may lead to navigation error.

Navigation instruments must be confirmed before using for navigation as unconfirmed instruments may lead to

navigation error.

If instrument registration failure occurs, check that no other instrument is in the view of the camera except the

instrument being registered.

User must confirm that screw selected for treatment matches screw option selected in the navigation software.

Do not obstruct the normal flow of air around the Camera (for example, draping or bagging the Camera). Doing so

will affect the Camera’s operational environment, possibly beyond its recommended thresholds.

Reliance on data provided by a Camera that is outside of recommended thresholds may lead to inaccurate

measurements.



Do not obstruct the normal flow of air around the Pulse Cart (for example, draping or bagging the Pulse Cart).

Doing so will affect Pulse’s operational environment, possibly beyond its recommended thresholds.

Do not simultaneously touch the Pulse system and patient.

Do not touch the tracking camera lens or LEDs. These components can become hot during normal operation.

Reliance on data provided by a Camera with an interrupted optical path may lead to inaccurate measurements.

Do not use the NuVasive Pulse Camera without inspecting it for cleanliness and damage both before and during

the procedure. Do not use the camera with a dirty camera lens cover. Reliance on data provided by an unclean or

damaged Camera may lead to inaccurate measurements.

Only use IR passive reflective markers supplied with the system. Use of other markers may lead to inaccurate

measurements.

Capturing the patient reference arrays for registration can happen before you drape or after you remove the drape

from the patient reference arrays during 3D image acquisition for navigation. Make sure to gently drape over the

patient reference arrays, ensuring the arrays are not bumped or moved in this process. Any movement of the

arrays during this process could require a re-capture of the arrays, or even re-scan of the patient if the registration

accuracy is not adequate.

Confirm Cios is calibrated prior to using NaviLink.

Do not remove Cios array from C-arm.


The Pedicle Access Kit components are designed for use only when fully assembled. Make sure that the handle,

needle, and cannula are assembled together and that the cannula is securely locked in place.

If an instrument is disassembled and re-assembled, re-confirm the device before navigating.

Post-Operative Warnings

During the postoperative phase it is of particular importance that the physician keeps the patient well informed of

all procedures and treatments.

Precautions and place the Pulse Camera Cart into its transport position before moving. See warning on P Inspect all system components and packaging for damage before use. Do not use sterile components if packaging

is opened or damaged. If components are visibly damaged, do not use the system. Sterile components with

elapsed sterile expiry dates must be considered as non-sterile.



Do not allow liquids to enter the Pulse Computer or Camera as this may result in damage or malfunction of the

System. Avoid dripping any fluids into any Pulse® Navigation equipment. Disconnect the power and allow the

system to dry if you suspect fluids may have entered any part of the System.

Do not use the Pulse Navigation System in conjunction with, or in the presence of magnetic resonance (MR)

devices. The Pulse Navigation System is not compatible with the magnetic fields associated with magnetic

resonance (MR) devices.

Operation of the Pulse Navigation System in close proximity to shortwave or microwave therapy equipment may

lead to inaccurate measurements.

Do not attempt to repair the Pulse Navigation System. NuVasive requires that the device be returned for any

inspection, service, or repair.

Avoid fluid contact with all cable connections.

Applying excessive force to the instrument arrays when tracking their locations can result in inaccurate

measurements due to deflection of the instrument, do not apply excessive force to the instrument arrays.

The accuracy of data acquisition can be influenced by the rotation of the passive reflective array relative to the

Camera. Cameras should be placed such that a direct line of sight to the operative area is established.

The Patient Reference array needs to be fully secured on the Patient Reference fixation device for tracking.

Switch off power to the system before cleaning it.

Do not use aerosol sprays near the equipment as these sprays can damage circuitry.

Do not autoclave any of the Pulse Navigation System components except for the Pulse Navigation Instruments, Flat

Arrays, and Spinous Process Clamp. Autoclaving any other components will damage the system.

Use only 70% isopropanol and a lens cleaning solution formulated for multi-coated lenses to clean the Camera.

Other fluids may cause damage to the illuminator filters. Do not use any paper products for cleaning. Paper

products may cause scratches on the illuminator filters.

Verify that all relevant instrumentation has been properly cleaned and sterilized before surgery.

The system mouse and keyboard are not designed for sterilization and may be damaged if

sterilization is attempted.

System components are fragile. Use care when handling system components.



Before moving the Pulse Navigation System, shut down and stow all components, remove any loose items from

the top of the Pulse Navigation System.

Do not attempt to repair the Pulse System. Any malfunction which does not respond to remedies identified in this

Guide (see ‘TROUBLESHOOTING’ section in the Quick Reference Manual) can only be addressed by manufacturer’s

service. We require that the device be returned to NuVasive for any such inspection, service, or repair.

Method of Use

Please refer to the Pulse System Reference Manual for use of the entire system (software and accessories). Refer

to the Instructions for Use accompanying other NuVasive devices for proper use of these devices.

Packaging

Packages for each of the components should be intact upon receipt.

Devices should be carefully examined for completeness, and for lack of damage, prior to use. Damaged packages

or products should not be used, and should be returned to NuVasive.

The Pulse Disposable Accessories are single-use devices supplied sterile.

Sterile, single-use only products should NOT be re-sterilized. Do not use if package is opened or damaged.

Do not use if the product is damaged in any way.

Do not use after the expiration date specified on the product label. Discard after use.



Cleaning and Decontamination

The Pulse Control Unit, Patient Module, harnesses, keyboard, mouse, Cios array, table array, and C-arm collar

arrays are not intended for sterilization. If necessary, they may be cleaned with a soft towel or wipe dampened

with a mild detergent and water solution according to standard hospital practices.

Pulse Navigation System Cleaning and Decontamination

To clean the Camera, unplug it and proceed as follows:

1. Remove dust from each illuminator filter and lens, using a photographic lens duster (brush).

Gently wipe the surface in one direction only, by pulling the brush across the surface.

2. Gently wipe the illuminator filters and lenses with disinfectant wipes containing 70% isopropanol.

Continue cleaning the remainder of the Camera, taking care not to wipe debris from the Camera case

onto the illuminator filters or lenses. Avoid prolonged contact between the wipes and the Camera.

3. Clean the illuminator filters and lenses, using a commercial lens cleaning solution formulated for multi-

coated lenses (for example, AR66) and a clean knitted microfiber optical cleaning cloth (for example,

Hitecloth). Avoid prolonged contact between the lens cleaner and the illuminator filters and lenses.

Pulse Computer, Camera Cart, and Pulse Cios 3D Spin arrays cleaning and decontamination

The Pulse Computer and Camera Cart components are not intended for sterilization. If necessary, the camera filter

and lens may be dusted via a photographic lens duster (brush) by wiping the surface in one direction only. Wipe

the filter, lens, and remainder of the camera via disinfectant wipes containing 70% isopropanol. Clean filter and

lens via commercials lens cleaning solution formulated for multicoated lens (for example, AR66) and a clean

knitted microfiber optical cleaning cloth (for example, Hitecloth).



Pulse Navigation accessories

The following accessories are available within Pulse Navigation System:

Component Sterility Sterilization Method

Patient Reference Array Sterile, single use EO

Hip Pin Sterile, single use EO

Passive Marker Spheres Sterile, single use EO

Pedicle Access Kit Sterile, single use EO

Spinous Process Clamp Non-Sterile, reusable Steam

Slap Hammer Non-Sterile, reusable Steam

Pin Cap Non-Sterile, reusable Steam

Pointer Non-Sterile, reusable Steam

Hardware Inserter Non-Sterile, reusable Steam

Driver Non-Sterile, reusable Steam

Drill Guide Non-Sterile, reusable Steam

Drill Guide Handle Non-Sterile, reusable Steam

Drills Non-Sterile, single use Steam

Patient Reference Array Inserter Non-Sterile, reusable Steam

Instrument Array Non-Sterile, reusable Steam

Confirmation Block Non-Sterile, reusable Steam

Cleaning and sterilization of reusable accessories

These cleaning and sterilization instructions apply to all Pulse Navigation accessories listed above and Nav.S

instruments. Remove instrument arrays from navigation instruments before cleaning and sterilization. Remove and

discard the passive reflective markers from the instrument confirmation block, instrument flat arrays, drill guide,

and pointer before cleaning and sterilization. The patient reference arrays, Hip pins, passive reflective markers,

and drills are single use and should be disposed after each use. Assemble new reflective spheres to confirmation

block, instrument arrays, pointer, and drill guide after steam sterilization and prior to use in surgery.

Cleaning and decontamination

All Pulse Navigation accessories listed above and Nav.S instruments must first be thoroughly cleaned using the

validated methods described below before sterilization and introduction into a sterile surgical field. Contaminated

instruments should be wiped clean of visible soil at the point of use, prior to transfer for full processing. Cleaning

instructions for the instruments are as follows:

1. Prior to soaking the device in an enzymatic cleaning solution, rinse the device under cool running tap

water and wipe off any residual soil or debris with a disposable towel. Ensure to flush out any lumens,

cracks or crevices while rinsing under running cool tap water.



2. Prepare an enzymatic cleaning solution per manufacturer’s recommendations using warm tap

water. Place the device in the solution in the open position (as appropriate) and soak for 50

seconds. While soaking, actuate the device through a full range of motion to allow complete penetration

of the cleaning solution.

3. After the 50 seconds soak time, remove the device and wipe any soil or debris using a disposable

towel. Then place the device into a fresh batch of an enzymatic cleaning solution using warm tap water.

Brush the entire surface of the instrument with a soft bristle brush. Actuate the device while brushing and

ensure to brush all hard to reach areas. Use a sterile syringe and lumen brush to clean hard to reach areas

and flush each end of the device with a total of 60 ml.

4. Remove the device from the detergent and rinse by agitating and actuating in RO/DI water for 30

seconds. Flush all hard to reach areas with a sterile syringe at each end of the device with a total of 60 ml.

5. Use a low foaming, neutral pH, phosphate-free cleaning solution and prepare per manufacturer’s

recommendations using warm tap water in a sonication unit. Allow the device to sonicate for 10 minutes.

6. Remove the device from the detergent and rinse by agitating and actuating in ambient RO/DI water for 30

seconds. Actuate through a full range of motion while rinsing and flush all hard to reach areas with a

sterile syringe at each end of the device with a total of 60 ml.

7. Transfer the device into the washer for processing. Position the device to allow for proper drainage.

Below is the validated and recommended cycle:

Phase Recirculation time Water temperature Detergent type & concentration

(if applicable)

Pre-wash 2 minutes Cold Tap Water N/A

Enzyme Wash 2 minutes Hot Tap Water MetriZyme, 1 oz/gallon or Equivalent

(per Manufacture’s recommendation)

Wash 2 minutes 65.5o C (set point) MetriZyme, 1 oz/gallon or Equivalent


PURW Rinse 1 minute 43o C N/A

Drying 15 minutes 90o C N/A

8. Dry the instruments using a clean non-linting cloth.



9. Visually inspect the instruments following performance of the cleaning instructions prescribed above. Ensure there is no visual contamination of the instruments prior to proceeding with sterilization. If possible, contamination is present at visual inspection, repeat the cleaning steps above. Otherwise, contact your NuVasive representative – contaminated instruments should not be used, and should be returned to NuVasive.

10. All instrument moving parts should be well lubricated. Be careful to use surgical lubricants and not industrial oils.

Note: Certain cleaning solutions such as those containing bleach or formalin may damage some devices

and must not be used.

Contact your local representative or NuVasive directly for any additional information related to cleaning of

NuVasive surgical instruments. The Pulse System is rated IPX0



Sterilization

The steam serializable components of the Pulse System are to be packaged in an FDA-cleared sterilization wrap

prior to placement in an autoclave.

In a properly functioning and calibrated steam sterilizer, effective sterilization may be achieved using the

parameters prescribed in the NuVasive Cleaning and Sterilization Instructions (doc #9400896).

All Pulse Navigation accessories listed above and Nav.S instruments are provided non-sterile and must be sterilized

prior to use. All non-sterile instruments provided in sterilization trays are sterilizable by steam autoclave using

standard hospital practices. Sterilization of the instruments may be accomplished effectively by means of vacuum

steam cycles described below. Remove the passive reflective markers from the confirmation block and instrument

flat arrays before autoclaving. Failure to do so will damage the System and results in inaccurate measurements.

The steam sterilizable components of the Pulse System are to be packaged in an FDA-cleared sterilization wrap

prior to placement in an autoclave. In a properly functioning and calibrated steam sterilizer, effective sterilization

may be achieved using the following parameters:

Method: Steam

Cycle: Pre-Vacuum

Temperature: 270°F (132°C)

Exposure Time: 4 minutes

Minimum Dry Time: 30 minutes

Minimum Cool Down Time: 40 minutes

Always sterilize the instruments in the disassembled, open, unlocked position. Avoid sudden cooling of the device

components. Ensure that all functions are unimpaired before use.

Before proceeding with surgery, verify that all devices are correctly assembled and that all instruments are

undamaged. Assemble new reflective spheres to confirmation block and instrument flat arrays after steam

sterilization of the confirmation block and instrument flat arrays.

Sterile components

Hip pins, patient reference arrays, and passive reflective marker spheres are Ethylene Oxide sterilized, single use and

disposable. Do not attempt to reprocess sterile single use components.



All non-sterile instruments must first be thoroughly cleaned using the validated methods prescribed in the

NuVasive Cleaning and Sterilization Instructions (doc #9400896) before sterilization and introduction into a sterile

surgical field. Contaminated instruments should be wiped clean of visible soil at the point of use, prior to transfer

to a central processing unit for cleaning and sterilization. The validated cleaning methods include both manual and

automated cleaning. Visually inspect the instruments following performance of the cleaning instructions to ensure

there is no visual contamination of the instruments prior to proceeding with sterilization. If possible contamination

is present at visual inspection, repeat the cleaning steps.

Contaminated instruments should not be used, and should be returned to NuVasive.

Instruments with a “D” prefix part number (e.g. DXXXXXXX) may be disassembled. Please refer to the additional

disassembly instructions for these instruments.


Technical Specification

Control Unit Requirements

Voltage: 100 - 120V/220 - 240V

Frequency: 50/60Hz

Current: 5A/2.5A

Classifications

• The NuVasive® Pulse System and its components are classified Class I Equipment with respect to the

type/degree of protection against electric shock.

• The Pulse Patient Module is classified as a Type BF Applied Part device with respect to protection against electric shock.

• The NuVasive® Pulse System and its components are NOT protected against ingress of water (IPX0)

• The NuVasive® Pulse System and its components shall be cleaned and/or disinfected following the instructions

found in this document’s Cleaning and Decontamination section.

• Do not use the Pulse System in a flammable environment. The NuVasive® Pulse System and its components

are NOT suitable for use in the presence of a Flammable Anesthetic Mixture with Air or in the presence of a

Flammable Anesthetic Mixture with Oxygen or

Nitrous Oxide.

• The NuVasive® Pulse System and its components are suitable for continuous use.

• Only equipment and accessories complying with EN 60601-1 and approved for use with the Pulse System may be connected. When interconnecting to other equipment or accessories always verify equipment complies with the requirements of 60601-1 with attention to clause 16 (medical system).


Technical Specifications (cont.)

Ambient Operating Conditions

Temperature: +10o C to +35o C

Humidity: 30% to 75% Relative Humidity

Atmospheric Pressure: 700 hPa to 1,013 hPa (525 mmHg to 760 mmHg)

Non-Operating Conditions

Temperature: +10o C to +40o C

Humidity: 30% to 75% Relative Humidity


Shock: 5 cm drop height

Transportation and Storage Conditions

Temperature: -20o C to +60o C

Humidity: 15% to 90% Relative Humidity (non-condensing)


Shock and Vibration Per ASTM D4169

Physical Size

Control Unit: 17” x 18” x 10”D (43 x 46 x 25 cm)

Patient Module 8.7” x 7.4” x 4.9” or ( 222.1mm x 187.5mm x 125.2mm)

Monitor 25.4”W x 2.6”Dx15.3”H (64.5 cm x 6.7 cm x 38.7 cm)

Cart with Monitor (Min) 26.0”W x 25.4”D x 58.5”H (66.0 cm x 64.5 cm x 148.6 cm)

Cart with Monitor (Max) 26.0”W x 25.4”D x 78.1”H(66.0 cm x 64.5 cm x 198.4cm)

Camera cart (min): 22.0” W x 22.0” D x 66.0” H (55.8 cm x 55.8 cm x 167.64 cm)

Camera cart (max): 29.0” W x 22.0” D x 85.0” H (73.66 cm x 55.8 cm x 215.9 cm)

Weight

Control Unit: 24 lbs (10.9 kg)

Patient Module 10 lbs (4.5 kg)

Monitor: 16.3 lbs, 7.3kg

Cart with Monitor 241.6 lbs , 109.59kg

Camera cart: 98.0 lbs., 44.5 kg

Pulse camera: 4.6 lbs., 2.1 kg



Guidance and manufacturer’s declaration—electromagnetic emissions

The Pulse System is intended for use in the electromagnetic environment specified below. The customer or

the user of the Pulse System should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment—guidance

RF emissions

CISPR 11 Group 1

The Pulse System uses RF energy only for its internal function.

Therefore, its RF emissions are very low and are not likely to

cause any interference in nearby electronic equipment.

RF emissions

CISPR 11 Class A

The Pulse System uses RF energy only for its internal function.

Therefore, its RF emissions are very low and are not likely to

cause any interference in nearby electronic equipment.

Harmonic emissions

IEC 61000-3-2 Class A

Voltage fluctuations/

flicker emissions

IEC 61000-3-3

Complies

Guidance and manufacturer’s declaration—electromagnetic immunity

The Pulse System is intended for use in the electromagnetic environment specified below. The customer or the

user of the Pulse System should assure that it is used in such an environment.

Immunity test IEC 60601-1-2

test level Compliance level

Electromagnetic

environment—guidance

Electrostatic

Discharge (ESD) IEC

61000-4-2

±8 kV contact

±15 kV air

±8 kV contact

±15 kV air

Floors should be wood, concrete, or

ceramic tile. If floors are covered

with synthetic material, the relative

humidity should be at least 30%

Electrical fast

Transient/burst IEC

61000-4-4

±2 kV for power

supply lines

±1kV for

input/output lines

±2 kV for power

supply lines

±1kV for

input/output lines

Mains power quality should be that

of a typical commercial or hospital

environment.

Surge IEC 1000-4-5

±1 kV differential

mode

±2 kV common

mode

±1 kV differential

mode

±2 kV common

mode

Mains power quality should be that

of a typical commercial or hospital

environment.

Note: UT is the a.c. mains voltage prior to application of the test level.






Immunity test IEC 60601-1-2 test

level Compliance level

Electromagnetic


Voltage dips, short

Interruptions and

voltage variations on

power supply Input

lines IEC 61000-4-11

0 % UT (100% dip in

UT) for 0.5 cycles

At 0°, 45°, 90°, 135°,

180°, 225° and 135°

0 % UT (100% dip in

UT) for 1 cycle at 0°

70 % UT (30% dip in

UT) for 25/30 cycle

at 0°

0 % UT (100% dip in

UT) for 250/300

cycle

0 % UT (100% dip

in UT) for 0.5 cycle

At 0°, 45°, 90°, 135°,

180°, 225° and 135°

0 % UT (100% dip in

UT) for 1 cycle at 0°

70 % UT (30% dip in

UT) for 25/30 cycle

at 0°

0 % UT (100% dip in

UT) for 250/300

cycle

Mains power quality should be that of a

typical commercial or hospital

environment. If the user of the Pulse

requires continued operation during

power mains interruptions, it is

recommended that the Pulse be

powered from an uninterruptible power

supply or a battery.

Power frequency

(50/60 Hz) magnetic

field IEC 61000-4-8

30 A/m 30 A/m

If image distortion occurs, it may be

necessary to position the Pulse further

from sources of power frequency

magnetic fields or to install magnetic

shielding. The power frequency

magnetic field should be measured in

the intended installation location to

assure that it is sufficiently low.

Note: UT is the a.c. mains voltage prior to application of the test level.






Immunity test IEC 60601-1-2 test

level Compliance level

Electromagnetic


Conducted RF

IEC 61000-4-6

3 Vrms

150 kHz to 80

MHz

3 Vrms

Portable and Mobile RF

communications equipment should

be used no closer to any of the Pulse

system, including cables, than the

recommended separation distance

calculated from the equation

applicable to the frequency

transmitter

Recommended separation distance:

d = 1.2√P

d = 1.2√P 80 MHz to 800 MHz

d = 2.3√P 800 MHz to 2.5 GHz

where P is the maximum output

power rating of the transmitter in

watts (W) according to the

transmitter manufacturer and d is

the recommended separation

distance in meters (m).

Field strengths from fixed RF

transmitters, as determined by an

electromagnetic site survey, a should

be less than the compliance level in

each frequency range. b

Interference may occur in the

vicinity of equipment marked with

the following symbol:

Radiated RF

IEC 61000-4-3

3 V/m

80 MHz to 2.7 GHz

3 V/mc


Note: At 80 MHz and 800 MHz, the higher frequency range applies.

Note: These guidelines may not apply to all situations. Electromagnetic propagation is affected by absorption

and reflection from structures, objects, and people.

References

a. Field strengths from fixed transmitters, such as base stations for radio (cellular/ cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength outside the shielded location in which the system is used exceeds the applicable RF compliance level above, the equipment should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as relocating the equipment.

b. Over the frequency range of 150 KHz to 80 MHz field strengths should be less than 3 V/m.



Recommended separation distances between portable and mobile RF communications equipment and the

Pulse System

The Pulse System is intended for use in the electromagnetic environment in which radiated RF disturbances are

controlled. The customer or the user of the Pulse System can help prevent electromagnetic interference by

maintaining a minimum distance between portable and mobile RF communications equipment (transmitters)

and the Pulse system as recommended below, according to maximum output power of the communications

equipment.

Rated maximum output

power of transmitter W

Separation distance according to frequency of transmitter m

150 MHz to 80 MHz

d = 1.2√P

80 MHz to 800 MHz

d = 1.2√P

80 MHz to 800 MHz

d = 2.3√P

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

For transmitters rated at maximum output power not listed above, the recommended separation distance d in

meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the

maximum output power rating of the transmitter is watts (W) according to the transmitter manufacturer.

Note: At 80 MHz and 800 MHz, the higher frequency range applies.

Note: These guidelines may not apply to all situations. Electromagnetic propagation is affected by absorption

and reflection from structures, objects, and people.


Wireless Coexistence

Warning: Portable RF communications equipment (including peripherals such as antenna cables and

external antennas) should be used no closer than 30 cm (12 inches) to any part of the NuVasive Pulse

System, including cables specified by the manufacturer. Otherwise, degradation of the performance of this

equipment could result.

If this wireless medical system is to be operated within proximity of other wireless devices, the following tables

may be used to determine the minimum separation distances between this device and nearby transmitters. The

summary tables below are based on the worst-case separation distances as it relates to the threshold of

communication levels found during testing.

Nearby Transmitter’s EIRP (W) Wi-Fi Co-Channel (2437MHz)

Minimum Separation (m)

Wi-Fi 2.4GHz Band Adjacent-

Channel

Minimum Separation (m)

10 980.61 73.45

1 310.10 23.23

0.1 98.06 7.35

0.01 31.01 2.32

Graphical Symbols

For Symbols Glossary, please refer to https://www.nuvasive.com/eifu/symbols-glossary


System Setup

Pre-Case Inspection

Pulse is installed and qualified on site by a certified NuVasive technician. Prior to each use, the system should be

inspected and tested as follows:

Control Unit Inspection

• Inspect the screens for damage and confirm that all labels are legible and in good condition.

• Confirm that the power cord insulation is in good condition and that there are no exposed wires.

• If any damage is observed, the device must be taken out of service and returned to NuVasive®.

• If the application freezes during use, restart the machine by going to the windows Start menu and selecting

“Restart”.

Patient Module Inspection

• Insert the Patient Module cable connector into the corresponding Control Unit receptacle and confirm that it

seats fully.

• Confirm that the cable insulation and Patient Module housing are in good condition and that there are no

exposed wires.

• If any damage is observed, the device must be taken out of service and returned to NuVasive.

Camera and Camera Cart Inspection

• Inspect the camera for damage and confirm that all labels are legible and in good condition.

• Confirm the Ethernet cable is in good condition and that there is no damage to the cord.

• Inspect the camera cart for damage and make sure telescope pole can go up and down and lock into position.

• Remove the Pulse Camera and place the Pulse Camera Cart into its transport position before moving.


System Setup (continued)

Equipment Setup

• Attach the Patient Module to the Control Unit prior to power-up of the Pulse System. See the O.R. setup in

the IOM section for more detail.

• Plug Control Unit into wall outlet; confirm power is clean and grounded.

• Press the Power switch on the Control Unit. It is located on the back of the Control Unit.

• Confirm Camera is properly set up and allows visualization of all Arrays (Navigation, LessRay and Bendini).

• Attach the Ethernet cable for the camera to one of the Ethernet ports on the Pulse system.

• Attach the other end of the Ethernet cable to the camera port located on the backside of the camera.

• A green led light will illuminate, and an audible sound will confirm connection when the Pulse system is

turned on and the Pulse software has been booted.

Reviewing System Settings

After pressing the Power button, the screen will show the software version number and will show the different

modules as they are loading.

If you are having any devices connect to Pulse wirelessly, click the Wi-Fi icon to display the instructions to connect

a remote device. (See Section on “Connecting a Remote Client)

Select the appropriate user role for the local wireless client (Neurophysiologist, C-arm Tech, or Sales Rep).

Select the appropriate anatomies and approaches for the surgery and press Start.

On the next screen, confirm that all the needed modalities are selected and that all appropriate devices are

connected.

Depending on the anatomies and approaches selected, the pre-surgery workflow will differ.

Pulse Camera and camera cart Pulse System (Control Unit)

Camera

Connection

On/Off

button

Pulse I/O and Power

Patient Module

Connection


System Start Up (continued)


Press the menu icon in the upper left-hand corner of the screen

to access the Pulse System menu. Pressing the “Labeling” button

will open the PRM.

Press the “X” to return to the session

Connecting to the internet

Once Pulse has booted up to the start screen, these are the

steps for connecting the Pulse Unit to the Internet:

If connecting by Ethernet cable,

1. Connect one end of the Ethernet cable to the appropriate active wall port.

2. Connect the other end of the Ethernet cable to the back of the Pulse Unit

If connecting by Wireless Internet access:

1. Press the Main Menu button at the upper left-hand corner of the Pulse screen.

2. Select the network settings option 3. Select the Wi-Fi tab 4. Press the button labeled “Turn Wi-Fi On” 5. Use the dropdown list to select the appropriate Wi-Fi

connection. 6. If there is additional authentication necessary, it will appear

in the embedded browser window.


System Start Up (continued)

Connecting Wireless Local Client

If you are going to be using a local client with the Pulse System, the following steps will allow for the connection of

a Local Client to the pulse system.

Click on the Connect Devices icon.

The Connect devices icon can be found on the main Pulse screen before a session is started or within the devices

panel of Pulse when a session is in progress.

Local Wireless Client Profiles

There are three local wireless client profiles a user may select from for use with Navigation application:

• Neurophysiologist (NP)

• Sales Representative (Rep)

• and C-arm Technician (C-Arm Tech)

Depending on the profile chosen, the user may be restricted from performing certain functions in Pulse as noted in

Table 5. The NP and Sales Rep profiles have full access to Navigation functionality.

Select the appropriate user role for the local wireless client (Neurophysiologist, C-arm Tech, or Sales Rep).

CORE-Element/Action User Profiles

Rep NP C-Arm Tech

Select Anatomy Yes Yes Yes

Select Approach Yes Yes Yes

Start Session Yes Yes Yes

View Device Connection Status Yes Yes Yes

Select Pulse Workflow Tabs Yes Yes No

Select/Deselect Applications Yes Yes No

Read/Write Annotations Yes Yes No

Access to reporting Yes Yes No

View/Control NAV application Yes Yes No Table 5- Pulse Core Permission by Local Client User Profile

• Neurophysiologist

o The neurophysiologist profile has access to all navigation functionality.

• Sales Representative

o The sales representative profile has access to all navigation functionality.


• C-arm Technician

o The C-arm technician profile is limited to C-arm view with no abilities to perform navigation

functionality including changing settings.

Pulse will then provide the user with the instructions for connecting a local wireless client via a tablet for using

features of the Navigation application. The instructions provide:

1. The local wireless client pre-connection steps 2. The name of the Pulse Wireless Network to which to connect. 3. The password for the Pulse Wireless Network 4. The web browser address needed to connect the Local Wireless Client to the Pulse System 5. The daily code (changes every 24 hours) for connecting the local wireless client to the Pulse system 6. The option to select the type of access needed by local wireless client user that is connecting to the system

(C-arm Tech, Sales Representative, Neurophysiologist).


Software end session and shutdown

Step 1: End session

• On Pulse display: Pulse controls select end tab.

Pulse Navigation Display 1: Pulse Controls select End tab (to continue st

• Select proceed to continue steps to end session.

• ChoChoose to export reports, log files, screen shots, diagnostics or end procedure. Selecting end procedure

will end your current session.

Selecting end to close software and end procedure

End tab

End procedure End procedure


Software end session and shutdown (continued)

Known Defect

Pulse will give you an error during the export if the USB being used is full and does not have room . If this error

occurs use an empty USB stick and re-export the images.

• Confirm end procedure.

Step 2: Shutdown

• On Pulse Navigation display 1: Pulse controls select menu icon.

Confirm end procedure

Menu Icon

Menu icon


Software end session and shutdown (continued)

• Select shutdown from the menu. This will close the Pulse app and shutdown windows.

• Pulse system can be turned off, unplugged, and moved to storage.

Software Restore Session

Step 1: Restore Session

• If Pulse is accidently shutdown during a session Restore Session in the main menu bar on Pulse Display 1 can be used to restore the state of all Pulse applications before the session was closed.

Shutdown pulse

Restore

Session

Restore Session


Maintenance

Service and Repair

The Pulse System has no user serviceable parts. Servicing and repair are to be performed only by NuVasive or its

authorized agent.

Pulse System Components

Set Configuration Description

PULSESYS Pulse System including computer, cart, monitors, wireless connectivity, I/O ports and shipping containers

PULSEIOM Pulse IOM Set including Patient Module, Power and Data Cables, SSEP Pod, IOM Harness and shipping container

PULSECAM Pulse Camera Set including camera, data and power cables, and shipping container

PULSECAMCART Pulse Camera Cart Set including camera stand and shipping container

PULSELRBED Pulse LessRay Bed Set including bed rail clamps, table array and shipping container

Preventative Maintenance

It is recommended that the Pulse System undergo factory inspection and maintenance every 6 months. A NuVasive

service technician will perform routine system maintenance at the customer site for customers with Pulse

Technical Service contracts.

This may include but not be limited to:

• Software upgrades – any applicable software patches will be installed

• Hardware upgrades – any applicable hardware reworks will be implemented

• Full system test

o Camera accuracy test(s), monitor testing (touchscreen and display), imaging equipment tracking test,

patient module operational test, Radix lens inspection, mains cable inspection, and video in/out test.

• Repairs to any nonfunctional hardware (excludes hardware damage due to negligence or unapproved use or

storage)

• Electrical safety test per IEC 60601-1 or IEC 62353

Customers that do not have a Pulse Technical Service contract will need to contact NuVasive Customer Service at

1 (800) 475-9131 to arrange preventive maintenance.

Electrical Safety Test

Upon initial receipt, and annually thereafter, the Pulse System should be inspected and an Electrical Safety Test

should be performed, including leakage current, to assure that the device continues to comply with applicable

electrical safety standards for hospital grade medical devices.


Maintenance (continued)

Camera Calibration

Confirm the Pulse cameras are calibrated within the service dates before the start of any case. Refer to the service

label on the camera to determine calibration due date. Contact NuVasive Customer Service at 1 (800) 475-9131 if

the calibration date has expired to schedule a camera calibration.

Service Life Pulse System service life is 6 months.

Disposal of Pulse Electronic Hardware

The Pulse System components such as Control Unit, Patient Module, Camera, Keyboard, and associated electronics

are not disposable. Contact NuVasive for assistance on proper disposition of non-disposable components.


Pulse Camera

To clean the Camera, unplug it and proceed as follows:

4. Remove dust from each illuminator filter and lens, using a photographic lens duster or lint free non

scarring cloth.. Gently wipe the surface in one direction only, by pulling the brush or cloth across the

surface.

5. Gently wipe the illuminator filters and lenses with disinfectant wipes containing 70% isopropanol.

Continue cleaning the remainder of the Camera, taking care not to wipe debris from the Camera case

onto the illuminator filters or lenses. Avoid prolonged contact between the wipes and the Camera.

6. Clean the illuminator filters and lenses, using a commercial lens cleaning solution formulated for multi-

coated lenses (for example, AR66) and a clean knitted microfiber optical cleaning cloth (for example,

Hitecloth). Avoid prolonged contact between the lens cleaner and the illuminator filters and lenses.

Pulse Computer, Monitor, Camera Cart and Patient Module

The Pulse Computer, Monitor, Camera Cart and Patient Module components are not intended for sterilization. If

necessary, they may be cleaned with a soft towel or wipe dampened with a mild detergent and water solution

according to standard hospital practices. Monitor touchscreen, vents, or other openings into the devices should

not be directly sprayed.

Precaution: Do not use alcohol to clean the Touch Screen.

Precaution: Do not allow liquids to enter the Control Unit or Patient Module, as this may result in damage

or malfunction of the Pulse System.


Pulse IOM, C-Arm and iGA


Pulse IOM, C-Arm and iGA

Modality Overviews

IOM on the Pulse System provides surgeon-driven neurophysiologic electromyography (EMG), motor evoked

potential (MEP), and somatosensory evoked potential (SSEP), trans-abdominal muscle action potential (TMAP) for

real-time assessments of the functional health of nerve root and spinal cord during spinal procedures.

iGA on the Pulse System, is a real-time intraoperative assessment of various patient anatomical parameters using

lateral fluoroscopic images. Intuitive software displays the comparison of intraoperative anatomical values to

preoperative and planned patient measurements.

The system also includes a live display of C-arm images as they are captured.

The purpose of this manual is to provide setup, operation, troubleshooting, and technical guidance for the Pulse

System. This manual should be used for quick reference. Early setup and testing are recommended to assist in

proper operation of the system during surgery. Care and maintenance of the system is recommended for a

dependable life of all components.

For assistance or technical support, please call the Pulse Technical Support Team at (877) 963-8768 or contact

NuVasive customer service at (800) 475-9131.


Glossary

Anterior cervical discectomy and fusion (ACDF): A procedure to remove a damaged disc (discectomy) through the

front (anterior) of the neck (cervical). After the disc is removed, the spine may be stabilized using a cervical plate

and screws and the fusion of two or more vertebrae.

Control Unit: Any compatible computer, supplied by NuVasive, meeting the minimum technical specifications,

running the Pulse application to control the Patient Module.

Current Shunting: When electrical current is leaking out and being dispersed around a large area resulting in

reduced accuracy of the system readings. For stimulation response to be accurate, it is important that insulated

instruments are used so the electrical current is focused directly on the desired area and not dispersed around

surrounding tissue area. An insulating sheath for use with non-insulated instruments is available through NuVasive

customer service.

Decompression: Procedure designed to remove tissues that are causing pressure on a nerve.

Dilator: A small tube used for placement of percutaneous screws.

Dynamic Stimulation Clip (DSC): The clip that attaches to surgical instruments and through which electrical current

is passed to the instrument to stimulate the nerve and elicit a response.

Electromyography (EMG): The measurement of electrical signals from muscle contractions. In standard EMG, the

technician manually increases or decreases current and interprets the resulting waveform responses to determine

the nerve threshold. With Pulse, the system increases or decreases the current to calculate and display the

threshold reading. The Pulse system provides threshold information to the surgeon in four ways:

• Through a numerical threshold calculation.

• Through color-coding (green, yellow, and red) to assist in interpreting the likelihood that a nerve is compromised or not.

• Through an audible sound that is different for each level of response; and

• Through EMG waveform display.

Harness: Refers to the collection of insulated wires that connect the recording electrodes to the PULSE™ Patient

Module.

Free Run EMG: A passive monitoring mode where the Pulse system listens for signals produced by mechanical

disturbance of neural tissue and displays them as EMG waveforms for interpretation by the surgeon. The Pulse

screen includes an onscreen control for setting the sensitivity threshold. Free Run events that exceed the

sensitivity threshold are captured, temporarily displayed, and logged into the patient report.

Innervate - To supply nerves to a muscle or muscle group. Pulse monitors nerve activity by monitoring the

response in the myotomes (muscle groups) that are innervated by specific nerves.


Glossary (Cont.)

I-PAS Insulated Pedicle Access System: Insulated instrument used for pilot hole formation and tapping required

for screw placement. The instrument can be electrified for continuous stimulation and monitoring by the Pulse

system.

K-wire: A guide wire used during percutaneous pedicle screw placement to guide other accessories, such as the

tap, insulators, and screws.

Lumbar interbody fusion: The surgical fusion of two or more vertebrae in the lumbar region for remedial

immobilization of the spine. There are several acronyms for this type of surgery that indicate the angle of

approach:

• ALIF (anterior lumbar Interbody fusion): approaching from the front of the body through an incision in the abdomen

• PLIF (posterior lumbar interbody fusion): approaching from the back of the body

• TLIF (transforaminal lumbar interbody fusion): approaching from the side of the spine through a small incision in the back

• XLIF (eXtreme Lateral Interbody Fusion): the XLIF procedure enables access to the spine via a direct lateral, retroperitoneal approach. The surgeon uses Pulse™ to aid in avoiding the nerves of the lumbar plexus.

Motor evoked potential (MEP): A modality used to monitor spinal cord integrity or peripheral nerves during spinal

surgery. For monitoring of spinal cord integrity, this method involves transcranial stimulation of the motor cortex

through the cranium while recording the resulting muscle responses via electrodes placed on upper and/or lower

limb muscles. For monitoring of peripheral nerves in the lumbosacral region, see glossary term "TMAP™" (also

referred to as lumbar MEP). The presence and strength of the responses helps the surgeon assess the functional

continuity of the spinal cord and motor pathways. MEP monitoring is available in Pulse for cervical and

thoracolumbar procedures.

Myotome: Muscle group supplied by specific spinal nerves. Pulse monitors nerve activity by monitoring the

response in the myotomes that are innervated by specific nerves.

Posterior cervical fusion (PCF): The procedure to fuse two or more vertebrae in the cervical region through the

back of the neck.

Recording Electrodes: The electrodes placed on the patient to record Electromyography (EMG) and motor

evoked potential (MEP) responses to electrical or mechanical stimulus.

Remote Monitoring: A feature that allows a medical doctor or other specialist to access and view a session from a

remote location. Once connected, the remote user can see the Pulse system data in real-time during surgery and

can communicate in real-time.


Glossary (Cont.)

Somatosensory evoked potentials (SSEPs): A modality that monitors the ascending sensory pathways

predominately located in the dorsal columns. SSEPs use evoked stimulation of peripheral nerves, and monitor

latency and amplitude of this signal along the sensory pathway.

Stimulated EMG: A monitoring modality in Pulse where signals are produced by electrical stimulation of neural

tissue. The Pulse System calculates a threshold value based on how much stimulus was applied before a response

from the corresponding myotomes was received.

The Dynamic mode allows for continuous stimulation to be applied through the instruments used by the surgeon

during the procedure, for continuous real-time monitoring of nerve responses.

Surgeon-directed: The ability to get real-time feedback when the surgeon intuitively wants to know. Pulse is

designed to provide intraoperative monitoring feedback directly to the operative surgeon with the ability to

control stimulation from the surgical field.

Threshold: The point at which a physiological effect begins to be produced, such as the degree of stimulation

applied to a nerve to produce a response from the muscles it supplies.

Trans-abdominal muscle action potential (TMAP): TMAP (or lumbar MEP) is a modality used to monitor the motor

pathway of the lumbosacral peripheral nerve roots during spinal surgery. This method involves lumbar stimulation

of the conus medullaris near the L1-L2 region, while recording the resulting muscle responses via electrodes placed

on the lower extremity myotomes. TMAP is available on Pulse™ for lumbar procedures.

Twitch Test: Test performed to aid in assessment of the effects of neuromuscular blocking agents. The Pulse™

Twitch Test applies four quick pulses and evaluates the response from each pulse.

Neuromuscular blocking agents must not be in effect during use of the Pulse system. This includes Stimulated

EMG, Free Run EMG, TMAP, and MEP function


Technical Specification

Display Accuracy and Precision

• Display resolution: 1920x1080 pixels, 16-bit color

EMG Monitor

Number of Channels: 24

Frequency Response: 30Hz to 1.5kHz

A/D Converter: 16-bit resolution

Full Scale Span: +/- 10mV

A/D Sampling Rate: 6000 Hx

Common Mode Rejection Ratio: Greater than 90dB

EMG Stimulation Output

Waveform: Rectangular, Monophasic Pulse

Polarity: Cathodic

Output Regulation: Constant Current

Pulse Width: 200 microseconds +- 2%

Current Pulse Amplitude: 1 – 90mA (dependent upon electrode impedance)

Stimulation Current Display Accuracy: the greater of 1mA or 10%

Load Impedance: 200 to 8,000 ohms, 200 to 10,000 ohms

Stim Rate: Up to 5Hz

Maximum Voltage: 300V

TMAP Stimulation Output


Polarity: Cathodic


Pulse Width: 50 microseconds

Current Pulse Amplitude: 0 to 1500mA

Pulse Rate: 1Hz



Technical Specification (cont.)

MEP Stimulation Output


Polarity: Polarity Selectable


Pulse Width: 50 microseconds

Pulse Intervals 0.5 to 4 milliseconds

Current Pulse Amplitude: 1 to 1500mA

Pulse Rate: 1 Hz


Multipulse: 1-8 Pulses



As shown in the graph, MEP Stimulation is limited to 125 mJ/sec. The graph allows the user to estimate the

number of pulses permitted given a current voltage (based on an impedance of 1 kΩ)

Note: Transcranial MEP stimulation exceeds 2 mA rms/cm2. Confirm that the corkscrew electrodes are secure prior

to starting stimulation.

SSEP Stimulation Output


Polarity: Polarity Selectable


Pulse Width: 50-500 microseconds

Current Pulse Amplitude: 1 to 100mA (Dependent on electrode impedance)

Stim Rate: 1.7 to 8 Hz


SSEP Monitor

Number of Channels 7

Frequency Response: 30 Hz to 500 Hz

A/D Converter 16 Bit Resolution

Full Scale Span: +- 2,048 microvolts

A/D Sampling Rate: 6000Hz

Common Mode Rejection Ratio: Greater than 74dB


Pulse Monitoring Accessories

Patient Preparation

Dual Surface Electrodes Dual Needle Electrodes

MEP Stimulation Electrodes (Corkscrew Electrodes) TMAP Stimulation Electrodes

MEP/ EMG Harness SSEP Harness Cranial Array


Pulse Surgical Accessories

Dynamic Stimulation Clip and Inline Activator Probe

I-PAS Needle TMAP Activator

XLIF Dilators

XLIF Stimulating Electrode

Insulating Sheath


Pulse Compatible Stimulation, Dissection Instruments

and Accessories

MaXcess Retractor

Taps/Drills

Pedicle Probe (in combination with Insulating Sheath)

Screw Drivers

Insulated Dilators


Anesthesia Recommendations

Electromyography (EMG) Monitoring

Contraindication: Neuromuscular blocking agents should not be in effect during the use of Pulse EMG as they

might interfere with the electromyography readings.

Trans-Abdominal Muscle Action Potential (TMAP) Monitoring

Neuromuscular blocking agents should not be in effect during the use of Pulse TMAP monitoring. Volatile

inhalation agents, however, may be used.

Motor Evoked Potential (MEP) Monitoring

It is recommended that during use of MEP monitoring, the anesthesiologist should perform total intravenous

anesthesia (TIVA) and avoid neuromuscular blocking agents, post-induction.

Anesthesia Recommendations for MEP Monitoring

• Use a bite-block and/or other means to protect from potential bite injury1

• Limit paralytics to induction dose only2

• No volatile inhalation agents throughout procedure3-5

• TIVA utilizing narcotic is optimal6

• Administration of IV agents (except for induction) should be performed via a constant infusion and NOT bolus administration to prevent transient depression in MEP amplitudes7

• Although in many patients it may be possible to obtain MEP responses with low levels of volatile inhalation agents and/or nitrous oxide, multiple studies have shown the use of such agents reduces or even eliminates reliable responses8-10 (particularly in patients with pre-existing neurological deficits)

Somatosensory Evoked Potential (SSEP) Monitoring

• Volatile inhalation agents reduce amplitude and increase latency in a dose-dependent fashion11

• If used, volatile inhalation agents should be kept at less than 0.5 MAC (mean alveolar concentration)12

• Nitrous oxide reduces amplitude and increases latency in a dose-dependent fashion greater than equipotent concentrations of volatile inhalation agents12

• If used, nitrous oxide must be kept at less than 50%13

• When combined, nitrous oxide and volatile inhalation agents produce more depression of signals than when used individually12,14

• Administration of IV agents (except for induction) should be performed via a constant infusion and NOT bolus administration to prevent transient depression of responses14


Anesthesia Recommendations (Cont.)

References

1. MacDonald DB. Safety of intraoperative transcranial electrical stimulation motor evoked potential monitoring.

J Cli Neurophysiol 2002;19(5):416-29.

2. Calancie B, Harris W, Brindle GF, et al. Threshold-level repetitive transcranial electrical stimulation for

intraoperative monitoring of central motor conduction. J Neurosurg 2001;95(2 Suppl):161-8.

3. Zhou HH, Zhu C. Comparison of isoflurane effects on motor evoked potential and F wave. Anesthesiology

2000;93(1):32-8.

4. Pechstein U, Nadstawek J, Zentner J, et al. Isoflurane plus nitrous oxide versus propofol for recording of motor

evoked potentials after high frequency repetitive electrical stimulation. Electroencephalogr Clin Neurophysiol

1998;108(2):175-81.

5. Kawaguchi M, Inoue S, Kakimoto M, et al. The effect of sevoflurane on myogenic motor-evoked potentials

induced by single and paired transcranial electrical stimulation of the motor cortex during nitrous

oxide/ketamine/fentanyl anesthesia. J Neurosurg Anesthesiol 1998;10(3):131-6.

6. Scheufler KM, Zentner J. Total intravenous anesthesia for intraoperative monitoring of the motor pathways:

an integral view combining clinical and experimental data. J Neurosurg 2002;96(3):571-9.

7. Lotto ML, Banoub M, Schubert A. Effects of anesthetic agents and physiological changes on intraoperative

motor evoked potentials. J Neurosurg Anesthesiol 2002;16(1):32-42.

8. van Dongen EP, ter Beek HT, Schepens MA, et al. The influence of nitrous oxide to supplement fentanyl/low-

dose propofol anesthesia on transcranial myogenic motor-evoked potentials during thoracic aortic surgery. J

Cardiothorac Vasc Anesth 1999;13(1):30-4.

9. Kunisawa T, Nagata O, Nomura M, et al. A comparison of the absolute amplitude of motor evoked potentials

among groups of patients with various concentrations of nitrous oxide. J Anesth 2004;18:181-4.

10. Osburn L. A guide to the performance of transcranial electrical motor evoked potentials. Part 1. Basic

concepts, recording parameters, special considerations, and application. Am J of Electroneurodiagnosic

Technol 2006;46:98 158.

11. Zouridakis G, Papanicolaou AC. A concise guide to intraoperative monitoring. Boca Raton: CRC Press;2001.

12. Toleikis JR, American Society of Neurophysiological Monitoring. Intraoperative monitoring using

somatosensory evoked potentials. A position statement by the American Society of Neurophysiological

Monitoring. J Clin Monit Comput 2005;19(3):241-58.

13. Banoczi W. Update on anesthetic and metabolic effects during intraoperative neurophysiological, monitoring

(IONM). Am J of Electroneurodiagnosic Technol 2005;45:225-39.

14. Sloan TB, Heyer EJ. Anesthesia for intraoperative neurophysiologic monitoring of the spinal cord.J Clin

Neurophysiol 2002;19(5):430-43.


Patient Preparation

1. Prep the electrode sites.

a. Mark (see note below)

b. Clean with skin prep pad, if required

c. Dry with gauze

d. Shave

e. Abrade with pumice pad - 5 swipes maximum with light pressure

f. Place electrodes

2. After all electrodes are placed, confirm acceptable impedance by testing with the

Impedance Meter. Readings below 10 kOhms indicate adequate skin prep.

3. Connect electrodes to the Harness according to color- code instructions.

4. Confirm acceptable impedance if repositioning is necessary

Precaution: Over-abrading can cause serious topical reaction to the patient. Always

apply using the preferred patient preparation technique as described above.

Precaution: Do not touch the electrode sites with your fingers/skin as this may

compromise the conductivity between the patient's skin and electrode.

Needle Electrode Preparation and Placement

1. Prep the electrode sites.

a. Mark (see note)

b. Clean with skin prep pad, if required

c. Insert needle electrodes sub dermally at a shallow angle and no less than 1" apart over the appropriate

muscle groups

d. Secure electrodes with tape

2. (*OPTIONAL) After all electrodes are placed, confirm acceptable impedance by testing with the Impedance

Meter. Readings below 10 kOhms indicate adequate skin prep.

3. Connect electrodes to the EMG or EMG/MEP Harness according to color-code instructions.

Precaution: Improperly placed corkscrews may result in poor responses or no responses, even with high electrical

current stimulus.

Precaution: Proper handling, insertion and placement of electrodes is

critical for EMG monitoring. Needles should be at least 1" apart. Please

follow your hospital's medical waste “sharps” guidelines for proper and

safe disposal of needle electrodes.


Electrode Placement

EMG Lumbar Electrode Placement

Place electrodes as indicated in the diagram.

EMG Cervical Electrode Placement Place electrodes as indicated in the diagram.


Electrode Placement (cont.)

MEP Cervical Electrode Placement


MEP Thoracolumbar

Electrode Placement Place electrodes as indicated in the diagram.



SSEP Electrode Placement




TMAP Stimulation Electrode Preparation

and Placement

Unlike the recording surface electrodes, the TMAP stimulating electrodes do not

require the clean, dry, shave or abrade preparation steps.

1. Prep the electrode site:

a. Mark skin

b. Place electrodes

The posterior stim electrode (circle) should be placed midline as close to the L1-L2

disc space as possible. The anterior stim electrode (square) should be placed

superior to the umbilicus, aligned with the posterior stim electrode. For patients

with higher BMI, this may require placing the anterior stim electrode biased

towards the approach side.

2. After electrodes are placed, connect the EMG/MEP harness according to

the color code instructions.

Note: The TMAP simulating electrodes should be placed after the patient is in the

lateral decubitus position.

Note: The TMAP stim electrodes are radiolucent and should not interfere with

C-arm fluoroscopy images.


OR Setup

Product Positioning

Note: Set-up of the Pulse System is required by trained NuVasive personnel only, with assistance by hospital OR

personnel. System set-up requires training, and knowledge of environmental restrictions on locations of use.

• Position the Patient Module on the bed rail such that the

harness reaches the furthest desired location without

tension.

• Position the Pulse System and all components away from

other electrical equipment to reduce the possibility of

electrical interference.

• Position all connecting cables so as not to interfere with

the intended motions of the C-arm during the procedure.

• Plug the Control Unit into a dedicated grounded AC power

outlet not shared with other electrical equipment.

Connecting the Patient Module (PM) to the Pulse System

• Plug the PM cable into I/O panel of the Pulse Cart and into the PM Connection on the Patient Module.

• Push connector in firmly until completely seated

I/O panel on the rear of Pulse system


OR Setup (cont.)

Connecting the Harness to the Patient Module

Plug the Harness Connector into the respective

Harness receptacle on the Patient Module.

Prior to patient draping, follow system Power Up

and Operation Procedures to run Impedance Test.

Refer to the Impedance Test section for further

information. It is also recommended to check the

Free Run EMG waveforms at this point to confirm

noise-free baseline EMGs.*

Harness cables and Twitch Test lead should be

routed superiorly out of compression stockings. The

Anode lead should be routed anterior, in the

direction of the Patient Module. Confirm that no

surgical accessories (e.g., leg compression devices)

will move, tension, or interfere with the leads

during the surgical procedure.

Plug the Stimulation Probe into one of the accessory ports on the Patient Module, or into the hub on the Dynamic

Stimulation Clip.

Plug the Dynamic Stimulation Clip into one of the accessory ports on the Patient Module.

*Prior to anesthetic induction, EMGs associated with voluntary patient movement or pre-existing nerve compression/irritation may appear on

the Free Run EMG screen.


System Start Up


If cervical is selected, the pre-surgery workflow steps will be:

1. Twitch Test 2. Set MEP Baseline 3. Set SSEP Baseline 4. View C-arm

If Thoracic is selected, the pre-surgery workflow steps will be:

1. Twitch Test 2. Set MEP Baseline 3. Set SSEP Baseline 4. View C-arm 5. Measure PI 6. Measure LL

If Lumbar is selected, the pre-surgery workflow steps will be:

1. Twitch Test 2. Set SSEP Baseline 3. View C-arm 4. Measure PI 5. Measure LL

During intra-op, select the appropriate modality from the drop-down list on the right side.

When the surgery is complete, select “End”.

Once the surgery has ended, the user will be prompted to export a report and/ or log files. There is also an option

to end the case without exporting a report or log files.


Select the applications that will be needed for the surgery

(Active applications will be purple, inactive will be grey.

Press the button to toggle between active and inactive).

Attach a patient harness. Press “Run Electrode Test”

This performs the impedance test. Review results and

remedy as necessary.

Turn off recording channels as necessary by pressing

the button corresponding to the channel.


System Start Up (cont.)

Impedance Results

EMG/SSEP Peripheral Recording electrode test impedance indicator.

The impedance ranges for passing or failing electrode test is defined in patinetmodule.xml file from PM module

and are based on the type of the electrode.

EMG Recording electrode channels

1. GREEN = Pass = The electrode calculated impedance greater than or equal to, ( ≥), 300Ω and less than or

equal to, (≤), 30kΩ.

2. YELLOW = Marginally (passes) = The electrode measured impedance greater than, (>), 30kΩ and less than or equal to, (≤), 60kΩ, or less than (<), 300Ω.

3. RED = Fail = The electrode calculated impedance is greater than, (>), 60kΩ * Impedance calculation accuracy is +/- 100 ohms from 0 to 1000 and +/- 10% from 1001 to 60000 due to the resolution of the values provided

by the PM

Recording SSEP electrode channels


equal to, (≤), 10kΩ

2. RED = Fail = The electrode calculated impedance is less than, (<), 100Ω or greater than, (>), 10kΩ * Impedance calculation accuracy is +/- 100 ohms from 0 to 1000 and +/- 10% from 1001 to 10000 due to the resolution of the values

provided by the PM

Stimulating EMG (TT, Dynamic, Basic, XLIF) and SSEP Electrode Channels

1. GREEN = Pass = = The electrode calculated impedance less than or equal, (≤), 10kΩ*

2. RED = Fail = The electrode calculated impedance is greater than, (>), 10kΩ* *Stimulation Electrode Impedance calculation accuracy is +/- 20 ohms due to the resolution of the values provided by the PM

Stimulating MEP cranial electrode channels


equal to, (≤), 10kΩ

2. RED = Fail = The electrode calculated impedance is less than, (<), 100Ω or greater than, (>), 10kΩ *Stimulation Electrode Impedance calculation accuracy is +/- 20 ohms due to the resolution of the values provided by the PM

Pass, marginal pass, and failed electrode will be illustrated on the IOM figure in the appropriate color. The

corresponding color will be reflected in the electrode test panel.

Vastus Medialis 31kΩ

Tibialis Anterior 0.8kΩ

Biceps Femoris 0.8kΩ

Medial Gastroc 0.8kΩ

APB – ADM >60kΩ

Pop Fossa 0.8kΩ

PTN 0.8kΩ


System Start Up (cont.)

Quick Access Menu

You can also make adjustments from the IOM

screen by opening the Quick Access Menu located

in the gear icon at the bottom right side of the

screen, under the myotome man.


IOM Software Use

Select Mode

After the impedance test, the system displays the IOM screen. Verify the date and time are correct. Review other

system settings and modify as desired. For details, see the System Settings section in Setup. Press OK when done.

Next, select the desired mode. Note that you have the following options:

• The XLIF mode provides stimulated EMG feedback for nerve avoidance during minimally disruptive surgery.

• The Dynamic Stim EMG mode provides real-time, continuous stimulation and threshold monitoring. It may be used during pilot hole formation, tapping, and screw placement.

• The Free Run EMG mode provides real-time, continuous monitoring of free-run myotome response. It may be used during procedures to detect nerve responses not due to active stimulation by Pulse.

• Waveforms can be turned on or off by pressing the Waveforms button.

MEP

Motor Evoked Potential (MEP) monitoring involves either transcranial stimulation of the motor cortex through the

cranium or lumbar stimulation (i.e., conus in region of L1-L2) while recording the resulting muscle responses via

electrodes placed on upper and/or lower limb muscles.

SSEP

During SSEPs, a peripheral nerve is electrically stimulated, and the response is measured along the pathway,

through the spinal cord, and into the sensory cortex of the brain. SSEPs enable the detection of potential neural

compromise during spinal surgeries.

TMAP

TMAP (or lumbar MEP) is a modality used to actively monitor the motor pathway of the lumbosacral peripheral

nerve roots during spinal surgery. This method involves lumbar stimulation of the conus medullaris near the L1-L2

region, while recording the resulting muscle responses via electrodes placed on the lower extremity myotomes.

TMAP is available on Pulse™ for lumbar procedures.


IOM Software Use (cont.)

Twitch Test

The presence of neuromuscular blocking agents can be investigated using the Twitch Test mode on the Pulse

System. This is done by applying a series of four quick stimulations to the patient and recording the response.

Stimulation can be applied to the patient utilizing one of the following methods:

• Peripheral Stimulation - Stimulation is applied to a peripheral nerve root via a separate electrode and the response is recorded in the corresponding myotome. Requires application of the Twitch Test electrode prior to patient draping. (See Electrode Placement in the Setup and Pre-op section of the manual for details.)

• Direct Stimulation - Stimulation is applied to the tissue of the surgical site using the Ball Tip Probe. No additional patient preparation is necessary.

Twitch Test Results

Results for the Twitch Test are displayed as a ratio in the middle of the screen.

The ratio represents a relative measurement of the response from the first stimulus and the response from the

last. The results are color coded as follows:

Color Result Comments

Red 0% - 29% Little or no muscle response

Yellow 30% - 74% Marginal muscle response

Green 75% - 100% Acceptable muscle response



Twitch Test Parameter Adjustments

Parameter adjustments can be made from the Twitch Test Settings menu in the Setup or Pre-surgery sections. To

access the Twitch Test Settings menu in the setup screen, press the gear icon on the twitch test Application button.

To access the Twitch Test Settings menu in the pre-surgery screen, select the Twitch Test application and press the

gear icon underneath the myotome man.

From the Twitch Test Settings menu, the following

parameter adjustments can be made for Twitch

Test:

a. Stimulation Mode b. Max stimulation c. Polarity selection

Twitch Test stimulation can be initiated by pressing the start

Stim button at the top right-hand corner of the screen.

Twitch Test can be run in manual or auto mode (Selectable

from the TT Settings Menu found in the gear icon at the

bottom of the page.

Manual: User sets stimulation current, and the system runs

the TOF at the designated current.

Auto: User sets the Maximum current, and the system

threshold stimulates up to the maximum current if the

response is not detected prior to reaching the maximum

current.

Peripheral: Stimulation is delivered at a distal stimulating site.

Direct: Stimulation is delivered in the surgical field by way of

an accessory.



Dynamic Stimulated EMG

Dynamic Testing

The Dynamic Stimulated EMG mode provides real-

time continuous stimulation and threshold

monitoring. It may be used during pilot hole

formation, tapping and screw placement. This

mode may be used during traditional "open" and

percutaneous procedures.

During setup, select 'Dynamic' Screw Test Mode.

Place the Insulating Sheath over the pedicular instrument (e.g., Pedicle Finder, Awl, etc.) to insulate the instrument

from soft tissue and fluids and to reduce current shunting. The Insulating Sheath is not needed when using the

I-PAS Insulated Pedicle Access System.

Attach the Dynamic Stimulation Clip to the pedicular instrument. Place Clip proximal to sheath in direct metallic

contact with the instrument. With I-PAS, attach the Clip on the metal post embedded in the handle.

Press stim button on the stimulation clip's inline activator. (Do not hold the button down; it should be pressed and

released.) Alternatively, stimulation may be initiated by pressing the Start Stim button on the screen.

An amber stimulation bar indicates stimulation current level during testing.

Results are displayed in the large round Dynamic Threshold display in the middle of the screen. The results are

updated in real-time as the threshold changes.

Stimulation may be manually stopped by pressing the DSC stim button or by pressing the Stop Stim button on the

screen.

Note: The Dynamic Stimulated EMG results are accompanied by audible tones. See the next section on Dynamic

Stimulated EMG Results for a description of the audio feedback.

In Dynamic mode, if electrical contact is lost with the patient, the message "Incomplete stim path" will appear on

the message bar. The stimulation will automatically stop.



Dynamic Stimulated EMG Results

Numeric reading Color correspondence Audio feedback

numeric reading of the threshold ≥ 11mA Green Slow, low pitch

7mA ≤ numeric reading of the threshold ≤ 10mA Yellow Faster, higher pitch

numeric reading of the threshold < 7 mA Red Fastest, highest pitch

Peer-reviewed publications suggest that the failure to evoke myogenic responses from stimulation of a hole or

screw at intensities of > 10mA excludes bony pedicular perforation.15 Because the reported threshold criterion

varies anywhere from 7 to 10mA, it is advisable to consider a response in the yellow range questionable and

investigate screw placement more carefully.

EMG Parameter Adjustments

From the Dynamic Settings, adjustments to

Maximum Stimulation for the EMG test can be

made.

References

15. Toleikis JP, Skelly JP, Carlvin AO, et al. The usefulness of electrical stimulation for assessing pedicle screw placements. J Spinal Disord Tech 2000;13(4):283-9.



XLIF

XLIF Operation

The XLIF mode provides stimulated EMG feedback

for nerve avoidance during minimally disruptive

surgery.

Attach the Dynamic Stimulation Clip to the XLIF

Dilator.

Press stim button on the DSC inline activator. Do

not hold the button down; it should be pressed

and released. Alternatively, stimulation may be

initiated by pressing the Stim On screen button if only one stimulation source is plugged in.

A stimulation bar indicates stimulation current level during testing.

Results are displayed in the large oval detection Threshold display. Results are updated in real-time as the

threshold changes.

Stimulation may be manually stopped by pressing the stim button on the DSC or by pressing the Stop Stim button

on the screen.

Note: The XLIF mode results are accompanied by audible tones.

Note: In XLIF mode, if electrical contact is lost with the patient, the message "Incomplete Stim Path" will appear on

the message bar. The stimulation will stop.

Note: XLIF mode shows stimulated results (as described above) plus waveforms for stimulated and Free Run events,

when Waveforms button is selected.



XLIF Detection Results

Numeric reading Color

correspondence

Audio

feedback Interpretation

numeric reading of the threshold ≥ 11mA Green Slow, low pitch Nerve in close

proximity

5 mA ≤ numeric reading of the threshold ≤ 10mA Yellow Faster, higher pitch Nerve in close

proximity

numeric reading of the threshold < 5 mA Red Fastest, highest

pitch

Nerve in very close

proximity

Observations made from direct nerve stimulation during instrumentation procedures have found that clinically

normal nerves elicit an EMG response under an applied stimulus ranging from 1-5mA, with an average of about

2mA.16 Therefore, the closer the proximity of the nerve, the lower the threshold. In an investigation of stimulated

EMG proximity testing during routine clinical discography, insulated discography needles were used as the stimulus

source at varying distances from the disc space (and therefore the exiting spinal nerve).17 In general, there was a

decreasing EMG threshold with decreasing distance from the disc, with an average threshold of about 3mA in the

neural foramen (i.e., very close to the nerve), about 5mA just outside the neural foramen, about 12mA at the level

of the pars, and greater than 16mA posterior to the lamina.18

As always with stimulated EMG monitoring, care should be taken to consider the clinical health of the nerve(s)

being monitored. Chronic nerve injury may require higher stimulus intensities to elicit the same EMG response as a

normal nerve.19 If nerve health is in question, the threshold scale should be elevated such that only higher values

are acceptable.

References

16. Calancie B, Madsen P, Lebwohl N. Stimulus-evoked EMG monitoring during transpedicular lumbosacral spine instrumentation: Initial clinical results. Spine

1994;19(24):2780-6.

17. Maguire J, Wallace S, Madiga R, et al. Evaluation of interpedicular screw position using intraoperative evoked electromyography. Spine 1995;20(9):1068-1074.

18. Peloza J. Validation of neurophysiological monitoring of posterolateral approach to the spine via discogram procedure. 9th International Meeting on Advanced

Spine Techniques, Montreux, Switzerland, May 2002.

19. Holland NR, Lukaczyk TA, Riley LH, et al. Higher electrical stimulus intensities are required to activate chronically compressed nerve roots. Spine 1998;23(2):

224-7.



MEP

MEP Testing

MEP can be used to monitor the integrity of the motor pathways of the spinal cord. Stimulation is applied to the

motor cortex through the cranium and the "motor evoked potential" responses are recorded via the recording

electrodes. In MEP, the user manually sets the stimulation current utilizing the Stimulator box. Stimulation current

may be adjusted from 50mA to 1500mA.

Any current that exceeds the maximum stimulation will result in an audible alert and a GREATER THAN (>)

MAX STIM CURRENT alert message (e.g. >1500 mA).

Thresholds that remain within 100mA of baseline are color-coded green. Changes greater than 100mA but less

than 200mA from baseline are color-coded yellow. Changes greater than 200mA are color-coded red.20

Change from baseline Color code Audio feedback

0 to 100mA Green Slow, low pitch

>100 to <200mA Yellow Faster, high pitch

200mA or more Red Fastest, highest pitch

References

20. Calancie B. Alarm criteria for motor-evoked potentials: What's wrong with the "presence-or-absence" approach? Spine 2008;33(4):406-414.



Navigating to MEPs

Select MEP from the Modality dropdown menu on the right side of the screen.

MEP Stimulation

With MEPs, you manually set the stimulation current utilizing the MEP Settings. Stimulation current may be

adjusted from 200mA to 1500mA.



MEP Stimulation Parameter Adjustments

Parameter adjustments can be made from the MEP Settings menu.

The following parameter adjustments can be made for MEP stimulation:

a. Stimulation current (adjust from settings menu)

b. Number of pulses

c. Interpulse interval

d. Response threshold

e. MEP stimulation Polarity

f. Remote client access

g. MEP Display parameter menu

MEP Display Parameters

Display Scaling/Gain can be adjusted under the options of the Display Menu.

a

b

c

d

e

f

g



MEP Testing

When stimulation is initiated, the system performs

a single stimulation at the requested current.

1. Press the Start Stim button on the right side of

the screen.***

2. Responses are indicated in the Waveform

area of the screen

The tabs on each myotome will change color to

indicate whether or not a response was detected.

• A green Alert indicates a response was detected.

• A red Alert indicates a response was not detected.

***Stimulation may only be initiated through the main Pulse System, unless local wireless clients are granted permission through an option in

the MEP Stimulation Settings Menu

MEP Baselines can be set by pressing the Baseline

button located on the right side of the screen.

Baselines can be set at any point throughout the

procedure. A confirmation dialogue appears

before any changes are made to the baseline.



Free Run EMG

Free Run EMG waveforms are available in multiple views. It is available in Dynamic, Twitch Test, Dynamic, XLIF,

MEP, and SSEP. There is also an Independent Free Run EMG view.

Turning On Full Screen View

To turn on full screen view for Free Run EMG, navigate

to modality select menu on the right side of the

screen and Select Free Run.



SSEP

Modality Overview

SSEPs can be used to monitor the integrity of the sensory pathways

of the spinal cord. Stimulation is applied to a peripheral nerve

(usually the posterior tibial nerve just posterior to the medial

malleolus and/or the ulnar nerve over the anterior/ulnar aspect of

the wrist) and SSEP responses are recorded from the sensory

pathway. For each peripheral nerve stimulated, responses are

recorded at a peripheral, sub-cortical, and cortical location.

The time it takes for a response to get to the recording electrode

(latency) and the strength of the response (amplitude) is measured

by placing markers on the response waveforms. Once a baseline

amplitude and latency are recorded, and markers are placed,

subsequent tests are compared back to the baseline.

SSEP Menus

All adjustments for SSEPs can be made in the

settings menu on the SSEP screen. The SSEP

settings menu can be launched by clicking the

Gear Icon in the lower right-hand corner of the

screen.

Currently, there are three settings Menus that can

be adjusted:

• Stimulation settings

• Display settings

• Recording settings



SSEP Stimulation Parameters that can be Adjusted from this menu:

1. Artifact Reject Threshold 2. Powerline Frequency (50Hz/60Hz) 3. Stimulation Rate 4. Stimulation Count 5. Polarity 6. Current 7. Pulse Width

*Powerline Frequency (50Hz - International, 60Hz - U.S)

You can navigate to the Display and Recording Menu’s by selecting them at the

bottom of the screen.

SSEP Display Parameters:

1. Waveform Mode

2. Recording site Selection

3. Historical Waveforms Displayed

4. Global and individual Recording site Display Gain

SSEP Recording Menu Parameters:

• Delete Historical Waveform



Starting and Stopping Stimulation

1. Press Start Stim to initiate SSEP stimulation.

2. To stop stimulation prior to the completion of

an epoch, press Stop Stim.

Setting Baselines

Baselines can be set for all SSEP stimulation sites

simultaneously.

Press the Set Baseline button to set all baselines

simultaneously.



Adjusting Waveform Scaling (Gain)

The waveform display scaling can be adjusted for (1) all waveforms and

also (2) individually by waveform group.

1. Adjust All Waveforms: Adjust all Cortical, Subcortical or Peripheral waveforms at the same time by selecting the desired waveform group and using the + and – icons to adjust size.

2. Adjust Individual Waveform Groups: Select the desired column/quadrant and recording channel, then use the + and – icons to adjust size.

View Settings

By default, the SSEP screen will be split to display

both SSEPs and Free Run EMG data

simultaneously. There is also the option to

minimize the Free Run EMG screen and display

SSEPs only.

Click the down area on Free run to minimize the

Free Run EMG window and allow the SSEP window

to expand into the available space.


IOM Software Use (cont.) TMAP

TMAP Testing

TMAP (lumbar MEP) can be used to actively

monitor the motor pathway of the lumbosacral

nerve roots. Stimulation is applied to the conus

medullaris near the L1-L2 region and the evoked

responses are recorded via the recording

electrodes in the lower extremity myotomes.

In TMAP Threshold mode, the system increases stimulation current to determine the threshold value for each

enabled channel. Stimulation is issued at a rate of five times per second until a response on all channels is received

or the maximum stimulation level is reached.

The TMAP mode will default to a preoperative

data view, which can be used to find the baseline

threshold values for each myotome, using the

"Baseline" button at the top of the Pulse screen.

As subsequent tests are completed, the resulting

thresholds are compared back to baseline and

accompanied by a color code and audible tone.

After baselines have been captured and the TMAP

Activator is connected, the user can alternate

between the data and graphic views.

TMAP Threshold stimulation is initiated by pressing the Find Baseline button (if it is the

first stimulation), and then pressing the start Stim button on subsequent stimulations,

to initiate the TMAP Threshold stimulation process.

To set a new baseline, press the “Find Baseline” button. When “Find Baseline” is

selected, a prompt is given advising that a new baseline will be set.

Users are able to switch between TMAP Alert and TMAP Threshold modes, adjust Stim

Current/Max Stim Current, enable timers, and control remote access via the TMAP

Settings window (accessible through the gear icon and the bottom of the window).



TMAP Threshold Results

Change from baseline Color code Audio feedback

0 to 100mA Green Slow, low pitch

>100 Yellow Faster, higher pitch

No response Red Fastest, highest pitch

Any current that exceeds the maximum stimulation will result in an audible alert and a GREATER THAN (>)

MAX STIM CURRENT alert message (e.g. >1500 mA).

Thresholds that remain within 100mA of baseline are color-coded green. Changes greater than 100mA are

color-coded yellow. Changes resulting in no response are color-coded red.20

References

20. Calancie B. Alarm criteria for motor-evoked potentials: What's wrong with the "presence-or-absence" approach? Spine 2008;33(4):406-14

TMAP Alert

In TMAP Alert mode, the system will stimulate at

the selected stimulation current.

In TMAP Alert, you manually set the stimulation

current utilizing the Stimulation box. Stimulation

current maybe adjusted from 200mA to 1500mA

in 50mA increments.

When stimulation is initiated, the system performs a single stimulation at the requested current. The tabs on each

myotome will change color to alert the surgeon whether or not a response was detected.

A Green Alert indicates a response was detected. A Red Alert indicates a response was not detected.


C-Arm Software Use

Setup

Using a cable and/or adapter, connect the C-arm to Pulse. Pulse

accepts C-arm video in from BNC, VGA, DVI, or ethernet (ethernet

is only available for the Siemens Cios Spin). The cables/adapters

provided with the Pulse system are a BNC cable, ethernet cable,

BNC to DVI dongle, and VGA to DVI dongle. Once the C-arm is

connected, touch the C-arm gear icon under the devices and

connections on the setup page to access the C-arm display setup

menu. The C-arm panel will be red when no C-arm has been

connected manually from the software, and black once a C-arm is

successfully connected.

Using the dropdown menu, select the appropriate C-arm and

confirm connectivity and image quality using the live C-arm view

on the left. Use two finger touch to pan and zoom the image.

Additionally, image controls may be accessed from this view by

tapping the image to display buttons along the bottom of the

image. These buttons are referred to as context controls.

Available context controls from the setup stage are brightness,

contrast, reset, 1:1, and fit to view. Once done with setup, close

the pop-up by selecting the X in the upper righthand corner.

The supported C-arms models are listed below:

• GE OEC 9900/9800 9”

• GE OEC 9900/9800 9” HD

• GE OEC 9900/9800 12”

• GE OEC 9900/9800 12” HD

• Ziehm RFD 3D

• Ziehm RFD 3D HD

• Siemens CIOS Spin


C-Arm Software Use (cont.)

Pre-Surgery

To view live C-arm images in the Pre-Surgery stage, select the

“View C-arm” tab. Available context controls from this stage are

brightness, contrast, reset, 1:1, fit to view, save to image bank,

copy to reference, and dual viewport open/close (available from

the arrow on the right side of the viewport). When selecting

copy to reference or the dual viewport arrow, two image

viewports will be displayed. Historical images may be displayed

in the right hand reference viewport by selecting an image from

the image bank context control button. To close the dual

viewport, select the dual viewport arrow again.

Intra-Op

To view live C-arm images in the Intra-op stage, confirm the C-

arm/IOM application is selected from the upper right hand

teardrop menu. The C-arm image(s) will be displayed to the left

of the IOM man. The context controls available from this stage

are the same as the Pre-Surgery stage. To maximize the C-arm

image viewing space, the IOM man may be minimized using the

minimize button in the top right corner of the IOM man.

Image bank

Users may desire to select images from the image bank that

were taken at an earlier time. To perform this task, select the

image bank icon. This will display images within the image bank.

After you have selected an image, that image will display on the

larger screen. To return to the live view of the fluoroscopy

machine, press the “Return to Live” button that is indicated at

the top of the screen, as demonstrated below.

The icon in the middle of the screen will allow the user to copy

an image from the left to the right. This icon will always be

available in the middle of the screen for ease of use. Displayed

to the right is the dual image display mode. Fluoroscopy images

may be viewed in both single and dual image modes.

Note: when changing from the single to dual state of image

display on one client, other connected clients will see these

changes as well.


C-Arm Software Use (cont.)

Exporting Saved Images:

Images may be exported onto a USB drive after the case has

been completed. If no C-arm images have been captured, this

option will not be enabled. By selecting the case and date

desired, all images captured within this session will be exported

to the USB drive after selecting and pressing “Copy Report to

USB”. USB drive files may also be imported into the Pulse

system.

Note: All content with potential to store PHI shall be removed for

all sessions that are no longer capable of being restored.

Sessions shall expire 12 hours after the last "event" in the

session.

Labels:

In the context menu, users can choose the tag icon to label levels of the

spine. Select the level and then touch the image to tag the spine with

the desired levels.


iGA

iGA allows the user to measure angles of lordosis and kyphosis in fluoroscopic images intraoperatively.

Setup

On the Setup page under Applications, confirm the iGA icon is

purple to indicate that it is turned on and available for use. Also,

confirm that a C-arm has been connected per the C-arm Setup

instructions.

Taking Pre-surgery Measurements

After navigating to the “Pre-surgery” tab, the user can take an

initial measurement for Cervical Lordosis, Lumbar Lordosis, or

Pelvic Incidence, if the user was not able to measure this

preoperatively. The system will automatically recommend the

appropriate measurement based on the initial anatomy selected

from the start screen.

To preview the latest C-arm image, select the “View C-arm” tab.

To measure Pelvic Incidence for example, touch the “Measure PI” tab. Then

import an image from the image bank for assessment. This image should include

the femoral heads and sacral endplate. The user can make a measurements from

either a single image file or two image files by selecting the number of images: 1

or 2.

To take a measurement, follow the wizard on the right panel of the screen and

select next after completing each step:

1. Anterior S1: Touch and drag the image so that the “+” is on the anterior corner of the S1 endplate.

2. Posterior S1: Touch and drag the image so that the “+” is on the posterior corner of the S1 endplate.

3. Femoral Head 1: Touch and drag the image so the circle overlaps with one of the femoral heads

4. Femoral Head 2: Touch and drag the image so the circle overlaps with the other femoral head

5. Select “Done” when completed

1Terran J, Schwab F, Shaffrey CI, et al. The SRS-Schwab adult spinal deformity classification: assessment and clinical correlations based on a

prospective operative and nonoperative cohort. Neurosurg 2013;73(4):559-68.


iGA (continued)

To measure Lumbar Lordosis, touch the “Measure LL” tab. Then select the import icons to import images from the

C-arm. Two images are required, one with the sacral endplate and one with the L1 superior endplate. Follow

prompts to identify the orientation of the image and then identify which image represents the superior anatomy.

To take a measurement, follow the wizard on the right panel of the screen and select “Next” after completing each

step:

1. Anterior S1: Touch and drag the image so that the “+” is on the anterior corner of the S1 endplate.

2. Posterior S1: Touch and drag the image so that the “+” is on the posterior corner of the S1 endplate.

3. Anterior Superior L1: Touch and drag the image so that the “+” is on the anterior corner of the superior

endplate of L1.

4. Posterior Superior L1: Touch and drag the image so that the

“+” is on the posterior corner of the superior endplate of L1.

5. Select “Done” with completed.

For some measurement such as ΔCL and PI-LL, an indicator will be displayed on the screen with the appropriate

calculation. For example, once the user completes both the “Measure PI” and “Measure LL” tab, an indicator will

be displayed showing the Pelvic Incidence minus Lumbar Lordosis calculation. This indicator may be color coded

red, yellow, or green to show how the value corresponds to the suggested value per the literature.1 Green means

that the value is within the recommended range of alignment, yellow means it is slightly malaligned, and red

means that it is severely malaligned.

1Terran J, Schwab F, Shaffrey CI, et al. The SRS-Schwab adult spinal deformity classification: assessment and clinical correlations based on a

prospective operative and nonoperative cohort. Neurosurg 2013;73(4):559-68.


iGA (continued)

Taking Intra-op Measurements

After selecting the “Intra-op” tab, the ΔCL and/or PI-LL

measurement indicators will be displayed on the C-arm/IOM

screen. To complete additional measurements during intra-

op, touch the application icon from the top right corner of the

screen and select “iGA®”.

The user is automatically taken to the iGA chart screen. On

this page, the user can touch to add some pre-op and planned

parameter values.

To configure the chart screen, the user can select “Edit” from

the top left, deselect the row and column headers that should

not be displayed, and then click “Done”.

To measure an intra-op measurement for ΔCL, lumbar

lordosis, thoracic kyphosis, or a segmental angle, click on the

“+” in an intra-op cell (intra-op 1, intra-op 2, intra-op 3, final).

After clicking on a cell, a measurement screen will open.

Similar to the pre-surgery Lumbar Lordosis measurement,

import two images to measure off of and follow the steps on

the right panel to measure the angle. When the

measurement is complete, touch “Done” to return back to

the iGA® chart screen.

To view coronal and sagittal assesments, the user can toggle

between the coronal and sagittal tabs at the top of the chart

screen.

To return to the C-arm view, simply touch the “X” on the

upper right corner of the iGA® chart screen.


iGA (continued)

Coronal Offset Measurements (C7-CSVL)

C7-CSVL assessment is available in the Coronal panel of iGA chart for all anatomies (Cervical, Thoracic and Lumbar).

When the user selects the C7-CSVL assessment for Preop & Plan stages the keypad will appear. Options to select negative/positive values will be available.

Keypad should only allow to enter values in the range of -100cm … +100cm

Numbers entered using keypad will be displayed for all clients and restored on session restore

When the user selects C7-CSVL assessment for any Intraop stages and/or Final stage, the assessment screen with the wizard will appear. The title of the view & wizard will say "C7-CSVL Intra-op #N" (where #N is stage number) C7-CSVL is single image only assessment.

The wizard will have 4 steps:

1. Set distance scale

2. C7 Mid-Body

3. Left Superior S1

4. Right Superior S1

The wizard will have action buttons Reset & Done. The wizard steps and buttons are disabled until user imports the image and specifies the image orientation.User can load an image by selecting image from the image bank menu. Once the image is loaded, the orientation wizard will appear.

Steps:

1. Right (similar to posterior) available on all 4 sides of the image

2. Head (similar to sagittal head) available on remaining 2 sides after Right side selected

Cancel button is always disabled for newly imported image. For existing image, cancel button should cancel any changes to orientation and close the wizard. Reset button should reset any selections for orientation and reset back to step 1. Done button is disabled until both Right & Head orientation steps are completed. Done action should close the orientation wizard and came back to assessment view. There should be an orientation button at the bottom of the assessment view. This button will open orientation wizard any time during the assessment.

Use the icons for Posterior and Anterior options from session start screen. Once image import and orientation are completed, the wizard steps get enabled and first step (Distance Calibration) is pre-selected

Distance Calibration:

1. Visual user interface is the same as ither IGA measurement steps


iGA (continued)

When distance scale step is selected, the small circle will appear on the image. The user will be able to manipulate the image to line up this circle with the distance calibration sphere and click Next

When the user selects a step, the marker for that step will be highlighted on the image. The user can manipulate the image to place the marker in the correct location. (pinch/spread gestures and drag gestures to zoom the image in and out or move it around to align the anatomical landmark with the static point).

When the user moves to the next step, the marker from the previous step becomes fixed relative to the image and changes back to the default un-highlighted color (except for distance calibration). The user can easily navigate between steps (and even out of sequence) by just selecting the step number in the list.

At the top left corner of the screen the assessment Pill should be displayed. Before any measurements taking the Pill is displayed in selected (purple color) with empty values (--). Once user gets to the last step in the wizard (step 3), the C7-CSVL value will be calculated and updated at real time as user is adjusting the marker.

The following graphics will be displayed:

1. Superior endplate

2. Mid-body point

1. C7 mid body line

2. Coronal offset distance line

Reset button swill reset the assessment: reset the assessment pill value, erase all the graphics and markers, distance scale, wizard resets back to step 1. (No confirmation is required). Done button completes the assessment and saves it. Once assessment is completed, its data should be synchronized with all clients, and any connected client should be able to see C7-CSVL value in the chart, and once assessment is opened all data & graphics will be available for other users. When user is attempting to reload a new image from the image bank while an assessment is in progress (or completed), this will reset the entire assessment back to step 1 (confirmation is required).

Note: The C7-CSVL assessment is not available in pre-surgery workflow step of Pulse

TPA Assessment:

TPA assessment will be available in Sagittal panel of iGA chart for all anatomies (Cervical, Thoracic and Lumbar).

TPA assessment will be available on all stages of the chart screen: Pre-op, Intraop 1, Intraop 2, Intraop 3, Final and Plan. When user selects the TPA assessment for Preop & Plan stages the keypad will appear. No option for Kyphosis & Lordosis will be available (no negative values).

Keypad will only allow to enter values in the range of 0 to 180 degrees.


iGA (continued)

Numbers entered using keypad will be displayed for all clients and restored on session restore. When the user selects TPA assessment for any Intraop stages and/or Final stage, the assessment screen with the wizard will appear.

The wizard will have 5 steps:

1. T1 Mid-Body

2. Anterior S1

3. Posterior S1

4. Femoral Head 1

5. Femoral Head 2

When assessment is opened without any loaded image, the image bank context menu will be opened by default and pre-scrolled to the last image. User will be able to load an image by selecting image from the image bank menu. Once image is loaded, the wizard steps get enabled and first step is pre-selected.

When the user selects a step, the marker for that step will be highlighted on the image. The user can manipulate the image to place the marker in the desired location (pinch/spread gestures and drag gestures to zoom the image in and out or move it around to align the anatomical landmark with the static point).

When the user moves to the next step, the marker from the previous step becomes fixed relative to the image and changes back to the default un-highlighted color. The user can easily navigate between steps (and even out of sequence) by just selecting the step number in the list. For the femoral head steps, the software will display a circle, and the user will pan and zoom the image to fit the circle. If the femoral heads are at or near the edge of the image, the software will allow the image to be moved sufficiently to allow at least 1/3 of the femoral head to be in the circle.

At the top left corner of the screen the TPA Pill will be displayed. Before any measurements taking the Pill is displayed in selected (purple color) with empty values (--). Once user gets to the last step in the wizard (step 5), the TPA value and the threshold color will be calculated and updated at real time as user is adjusting the marker.

The following graphics will be displayed:

1. Femoral Head 1 (purple color)

2. Femoral Head 2 (purple color)

3. S1 Superior Endplate (purple color)

4. Femoral Sacral Midpoint Line (purple color)

5. Femoral T1 Midbody Line (purple color)


iGA (continued)

Reset button will reset the assessment: reset the TPA pill value, erase all of the graphics and markers, wizard resets back to step 1. (no confirmation is required). Done button completes the assessment and saves it. After Done button is pressed, the assessment view is closed and navigated back to the chart screen. Once assessment is completed, its data will be synchronized with all clients, and any connected client will be able to see TPA value in the chart, and once assessment is opened all data & graphics will be available for other users. When user is attempting to reload a new image from the image bank while an assessment is in progress (or completed), this will reset the entire assessment back to step 1 (confirmation is required).

Note: TPA assessment is not available in pre-surgery

SVA Assessment

Much like the other measuring assessments within the IGA

functionality of Pulse, the SVA wizard will allow for

measurement from

6. C7 Mid-body to

7. S1 Superior-posterior point

Similar to the steps and capabilities of the functions above,

use the SVA wizard to measure the SVA via the guided steps

as dictated by the wizard.

Cobb Angle Assessment

Much like the other measuring assessments within the iGA

functionality of Pulse, the Cobb Angle wizard will allow for

measurement from

1. Superior Endplate of the Superior Vertebral Body

2. Inferior Endplate of the Inferior Vertebral Body

Similar to the steps and capabilities of the functions above,

use the Cobb Angle wizard to measure the coronal angle

between two vertebral bodies as guided by the wizard.


Patient Reports

Saving Reports

To save a patient report:

• Select the End workflow step

• Insert a USB drive into the USB port on the back of the Pulse

System

• Select Export Reports

• Choose the date of the report(s) you want to copy and press the export button

The system copies Summary reports upon Export, with an option to export both the Full and Summary Reports.

Case Wrap-up

When the procedure is complete:

• Select the End option on the end of the workflow steps.

• Export necessary reports, logs, etc.

• Select End Procedure.

After selecting End Procedure, you will be prompted to confirm that

you want to end the current monitoring session. Confirmation will

navigate you back to the start-up page for procedure approach.

Shutdown

To Properly shutdown the Pulse System:

• Click the Hamburger Menu

• Select “Shut down” from the options.

• Confirm that you want to shut the system down.


Troubleshooting

Screen Message Cause Corrective Action

1. Noise Artifact (One Channel) This is due to any event that is

exceeding the alarm sensitivity

threshold. This can be caused by

inadequate recording electrode

prep or by electrical interference

from a device in the vicinity of the

recording electrodes. This can also

be due to an actual Free Run EMG

event in one or more myotomes.

Examine the EMG waveform display

in Free Run to determine which

channels have a noisy signal. Noisy

signal may look like this:

ONE Channel Noisy:

Check the recording electrodes

corresponding with the noisy

channel and ensure cable snaps are

connected to electrodes. Also, use

the impedance meter to check that

proper electrical contact has been

achieved on the electrodes.

This table is intended to help a PULSE™ user understand the screen messages of the system. In some cases,

corrective action may eliminate the problem. If you need additional assistance, please call the IOS™ Hotline for

immediate technical support at 877 -963 -8768 (toll-free).

This table is intended to help a PULSE user understand the screen messages of the system. In some

cases, corrective action may eliminate the problem. If you need additional assistance, please call the

IOS™ Hotline for immediate technical support at 877 -963 -8768 (toll-free).


1. Noise Artifact (All Channel) This is due to any event that is

exceeding the alarm sensitivity

threshold. This can be caused by

inadequate recording electrode

prep or by electrical interference

from a device in the vicinity of the

recording electrodes. This can also

be due to an actual Free Run EMG

event in one or more myotomes.

ALL Channels Noisy:

Check the EMG reference electrode.

Make sure brown cable snap is

connected to electrode. Ensure

harness is completely seated in the

Patient Module. The surgical table,

Sequential Compression Devices

(SCDs), Bair Hugger®, and shared

electrical outlets may also lead to

interference.

If actual Free Run Event is occurring:

Inform the surgeon of possible nerve

root irritation so that the source can

be identified and eliminated.


Troubleshooting (continued)


2. Stimulation Artifact. • Patient anode electrode may

not be positioned close enough to

the site of stimulation.

• Patient anode electrode may have

poor contact with the patient's skin.

Remove original anode electrode, re-

prep (abrade), and replace with a

new anode electrode. Place new

anode electrode closer to the site of

stimulation. Use needle electrode, if

possible.

For lumbar: Latissimus dorsi (mid-

back) For cervical: Mastoid process

(behind ear)

3. Incomplete Stim Path. Check

probe or clip.

• The probe or stim clip is in poor

contact with the bare nerve, pilot

hole, screw, guidewire, surgical

instrument, etc. during stimulation.

• The probe or stim clip is not

plugged into the Patient Module.

Confirm the probe is making good

electrical contact with screw, pedicle,

or bare nerve root for the duration

of the test. Note: Only the ball tip of

the Screw Test Pedicle Probe is

conductive. If using the Dynamic

Stimulation Clip (DSC), ensure the

clip is in proper contact with the

dilator, retractor, screwdriver, etc.

Verify that the probe or the stim clip

is plugged into the Patient Module

and the corresponding light is

illuminated green. This can also be

verified on the screen: plugged

in/working probes and clips will have

a grey background, while a probe or

clip that is unplugged or not working

will have a red background.




4. Incomplete stim path. Check

anode electrode.

The anode may have poor electrical

contact with the patient's skin or

may be unsnapped from the

corresponding harness wire.

• Ensure the anode electrode is

plugged into the corresponding

harness wire.

• Check the connection between the

anode and the skin with the

impedance test after the electrode is

applied. If the anode impedance is

suspect, re-prep and replace it with a

new electrode.

5. Incomplete stim path. Check MEP

electrodes.

MEP stimulation electrodes are not

properly connected.

Verify corkscrew electrodes are

plugged into the corresponding

harness wires and are firmly in the

patient's scalp.

6. Incomplete stim path. Check

peripheral

Twitch Test electrode.

• The stimulation source (electrode

or Ball Tip Probe) is in poor contact

with the patient's tissue during

stimulation.

• The anode electrode may have

poor electrical contact with the

patient's skin or may be

disconnected.

• In Direct Stimulation Mode, ensure

that the anode is connected and in

good contact with the patient. Ensure

that the Pedicle Probe tip is in good

contact with the patient.

• In Peripheral Stimulation Mode,

ensure the peripheral electrode is

connected to the harness wire and in

good contact with the patient.




7. Free Run EMG freezes up. Patient Anode Electrode may be

positioned too close to Recording

Electrodes. Patient Anode Electrode

may have poor contact.

Remove original Anode Electrode,

re-prep (abrade) and replace a new

(large) Patient Anode Electrode (gray

lead) and place closer to the site of

stimulation (and in the opposite

direction of the Recording

Electrodes).

For lumbar and thoracolumbar:

recommend use Latissimus dorsi.

For cervical: recommend use Mastoid

process.

8. No twitch during Twitch Test. • Poor placement of the stimulation

electrode.

• An insufficient amount of current

was used to stimulate the nerve.

• Neuromuscular blocking agents are

on board.

• In Direct Stimulation Mode, ensure

the Pedicle Probe is in the proper

proximity to the target nerve to

provide stimulation. If using a dilator,

dilate farther down, point the

electrode posteriorly, increase

maximum stimulation to 80mA, and

proceed with stimulation.

• In Peripheral Stimulation Mode,

ensure the peripheral electrode is

placed in the proper location to

provide nerve stimulation. Increase

maximum stimulation to 80mA.

• Consult with the anesthesiologist to

ensure that no neuromuscular

blocking agents are in effect.


Twitch Test Troubleshooting

Placement of lumbar electrodes

Lumbar: peripheral stimulation

For the Lumbar Twitch Test, the stimulation electrode should be placed in a

vertical orientation over the peroneal nerve. Identify the lateral tendon of the

knee and the posterior crease of the knee. Place the electrode just medial to

the lateral tendon, so that the electrode spans the posterior crease.

(Needle electrodes should not be used for stimulation in this area.)

Lumbar: peripheral recording

The recording electrode should be placed on the tibialis anterior muscle, at the

midway point between the knee and the ankle. This is because Pulse™ needs

several milliseconds from the time of stimulation to the time of recording to

assess whether there has been a muscle twitch. If the two electrodes are too

close together, PULSE™ might pick up the end of the stimulation on the

recording electrode and discount any muscle reaction. This is known as "Stim

Artifact" when PULSE™ sees the stimulation where the EMG waveform is meant

to be.

There are two ways to troubleshoot Stim Artifact:

1. Manually decrease stimulation by 5- 10mA on the Twitch Test screen. 2. Move recording electrode distally.

This information is intended to help a PULSE user understand the screen messages of the system. In some cases, corrective action may

eliminate the problem. If you need additional assistance, please call the IOS™ Hotline for immediate technical support at 877-963-8768

(toll -free).

Placement of cervical electrodes

Cervical: peripheral stimulation

For the Cervical Twitch Test, the stimulation electrode should be placed so that

it stimulates the median nerve. For best results, locate the crease that is formed

when the hand is flexed to the shoulder. Place the electrode toward the center

of the arm, in a vertical orientation, so that the electrode spans the crease.

Note: Needle electrodes should not be used for stimulation in this area.


Twitch Test Troubleshooting (continued)

Cervical: peripheral recording

The recording electrode is placed on the abductor pollicis brevis and the

abductor digiti minimi muscles, as shown in the anatomical figure on the

right. A needle electrode may be re quired here, as it is difficult to attain

good impedance on these muscle groups with surface electrodes.


MEP Troubleshooting

Procedural

Situation

Cause

Corrective Action

1. MEP electrodes

aren’t passing

impedance test

This can be caused by poor

electrode impedance, or the

electrode is not plugged in properly.

Verify electrodes are attached to the MEP harness

and are firmly in the patient’s scalp or properly

placed abdominally.

2. Incomplete stim path

while trying to run a

MEP

This can be caused by poor

electrode impedance, or the

electrode is not plugged in properly.

Verify electrodes are attached to the MEP harness

and are firmly in the patient’s scalp or properly

placed abdominally.

3. Getting responses

only in the upper

extremities

• The stimulation from the

corkscrew electrodes is not

adequate to elicit a motor response.

• The patient has a preoperative

motor deficit is a diabetic,

or is obese.

• The corkscrew electrodes are

positioned too laterally.

• Verify corkscrew electrodes are positioned over

the motor cortex at C3 and C4 and move more

medially, if necessary.

• Check with the anesthesiologist to confirm

he/she is using TIVA.

(Inhalation agents have a deleterious effect on

MEPs.)

• Ensure patient has 4 out of 4 twitches. (No

neuromuscular block can be used when running

MEPs.)

4. Getting responses

only on one side

• The stimulation from the

corkscrew electrodes is not

adequate to elicit a motor response.

• The patient has a preoperative

motor deficit is a diabetic or is

obese.

• One of the corkscrew electrodes

is poorly positioned.

Verify corkscrew electrodes are positioned over

the motor cortex at C3 and C4 and reposition the

corkscrew electrode on the side from which

responses are being obtained, if necessary.

This table is intended to help a PULSE™ user correlate results with intraoperative events. In some cases, red

results may be due to factors other than spinal cord or peripheral nerve injury, but the surgeon should

always be aware that a red result is a clinically significant change from baseline and could be indicative of

motor deficit. PULSE™ users, unless qualified to practice medicine, may not understand the results of any

PULSE™ test. Users are encouraged, however, to give surgeons factual information regarding PULSE™ results. If

you need additional assistance, please call the IOS™ Hotline for immediate technical support at 877 -963 -8768

(toll-free).


MEP Troubleshooting (continued)

Procedural Situation Cause

5. Had good results but all/most of

the thresholds have steadily risen

throughout the case

Most likely cause is buildup of anesthesia (Anesthetic Fade), although with

cord ischemia, it can take up to 45 minutes to lose cord function. The surgeon

should be made aware of these possibilities.

6. Had good baselines but a few

thresholds have steadily risen

Yellow responses indicate that the cord's motor function is still intact, but you

should proceed with caution. The cause is usually due to buildup of anesthesia

(Anesthetic Fade).

7. Unable to elicit responses from

myotomes that are innerved at a

level below the point of surgery the

myotomes above the point of

surgery are still present

This may be caused by anesthesia, so check with the anesthesiologist to

confirm nothing has changed with the patient (i.e., volatile gases, large

blood pressure changes, or the presence of neuromuscular blocking

agents). If nothing has changed, then notify the surgeon immediately. This

may be indicative of a spinal cord injury.

8. Unable to elicit responses from

all myotomes (above and below the

point of surgery), which have been

present throughout the case

This may be caused by anesthesia, so check with the anesthesiologist to

confirm nothing has changed with the patient (i.e., volatile gases, large

blood pressure changes, or the presence of neuromuscular blocking

agents). If nothing has changed, then notify the surgeon immediately. This

may be indicative of a spinal cord injury.

9. Unable to elicit responses from a

few myotomes below the point of

surgery, while the remaining

myotomes are still present

The overall motor function of the cord is still intact, but this indicates

possible loss of motor function in those specific myotomes. The surgeon

should be made aware of this possibility.


Pulse Bendini


Pulse Bendini

Modality Overview

The Pulse Bendini Spinal Rod Bending System consists of three main components that are used to accurately bend

a spinal rod for use in spinal surgery applications. The three components include 1) a spatial measurement system

with a Digitizer (to obtain the location of the implants), 2) software (to convert the implant locations to a series of

bend instructions), and 3) a mechanical rod bender (tool used to execute bend instructions).








Bendini Setup

Please refer to the two package inserts for the Spinal Rod Bender, pointer and array for important labeling

information regarding those Bendini System components.

Equipment Setup

Equipment Requirements

• Pulse System

• Pulse camera and camera cart

• Bendini Spinal Rod Bender II (BENDERII) or Bendini Spinal Rod Bender OCT (BENDEROCT)

• Rod Cutter

• Bendini Pointers (see Pointers Selection section below)

Disposable Requirements

• Bendini Array (Sterile)

Case Preparation

• Ensure the Pulse Control Unit is placed outside the sterile field in a location that is easy to view and allows

access to the touch screen by non-sterile personnel for data input and management.

• The System should be plugged into clean power, properly grounded.

• Bendini Rod Bender and Bendini Pointers are autoclave sterilized prior to surgery per the parameters in the IFU.

Follow the entire sterile processing steps required by the facility.

• Bendini Array is sterile-packaged and ready for use.

• The patient will remain on a radiolucent, bendable surgical table in the prone position.


Bendini Setup (continued)

Pointer Selection

BENDERII Pointers

Adjustable Hybrid Pointer (Green)

Select this pointer in percutaneous, open, or hybrid cases. Compatible with Armada®, Precept®, Reline® open, and

MAS® screws. Also, for use with closed tulip screws.

• The adjustable offset feature enables planned screw movement through acquiring a defined offset amount.

Adjustable Open Pointer (Yellow)

Select this pointer in open cases. Compatible with Armada and Reline open screws.

• The adjustable offset feature enables planned screw movement through acquiring a defined offset amount.

• This pointer also has an independent pivoting feature that allows the surgeon to adjust the screw tulip while

keeping the array pointed towards the camera.

Lock Screw Pointer (Blue)

Select this pointer in cases using 3CO racks or when digitizing on top of a temporary rod. Compatible with

Armada® and Reline® lock screws.

Adjacent Segment Fixation (ASF) Pointer (Purple)

Select this pointer in cases using an Adjacent Segment Fixation (ASF) or fixed tulips.



BENDEROCT Pointers

BendiniOCT Hybrid Pointer (Turquoise)

Select this pointer in cases using VuePoint®, VuePoint II, Reline®, Precept®, Armada®, or MAS® PLIF screws. This

pointer can also be used with VuePoint II occipital plates.

BendiniOCT Open Pointer (Yellow)

Select this pointer in cases using VuePoint, VuePoint II, Reline, or Armada open screws.

BendiniOCT Connector Pointer (White)

Select this pointer in cases using VuePoint or VuePoint II 3.5mm connectors or eyelets. Compatible connectors

include offset, in-line rod-to-rod, and lateral offset connectors.

BendiniOCT Lock Screw Pointer (Orange)

Select this pointer when digitizing on top of a temporary rod. Compatible with VuePoint or VuePoint II lock screws.

This pointer can also be used to digitize a VuePoint occipital plate.



Digitizer Assembly

• Using clean gloves, surgical staff will connect the selected sterile Pointer to

the Array to form the assembled Digitizer.

• The Pointer is screwed into the Array until tight. The gold metal on the

Pointer will disappear into the Array once properly assembled.

• If the reflective markers are contaminated with liquid or solid material

during assembly or use, wipe off surface with a piece of wet gauze.

• All Pointers are assembled similarly.

Precaution: When using “Other” screws, user must confirm the distal tip of

the Pointer fits and fully seats in the screw shank. The Hybrid Pointer may

act as an option to use with “Other” Systems, if proper fit is confirmed. User

discretion is advised when using Bendini with “Other” screws.

Array

Assembled

Digitizer

Pointer

Reflective

Markers


Bendini Surgical Workflow

Workflow Steps

The Bendini System will typically be utilized at the end of a posterior fixation surgical procedure after screws

and/or hooks have been placed, prior to rod insertion.

Step 1: Launch Pulse Control Unit

• Press the Power button

• Follow standard Pulse procedure to connect any devices or tablets

• Select the appropriate Anatomy and Approach based on the type of

case being performed

• Press Start

Step 2: System Setup

• Select the Bendini Application so that it is highlighted purple

• Confirm that the Camera is properly set up and connected under

Devices & Connections

• If desired, set up additional applications and devices

• Once system is fully set up, navigate to the Pre-Surgery workflow step

• If desired, Bendini System Selection workflow can be accessed from

the Setup screen

• Press the ‘gears’ icon on the Bendini application

• Under System Selection, select appropriate case information under

“Hardware Inputs.” Drop down menus include "Bender Type," “Rod

Type,” “Rod Diameter,” and “Rod Material.” Once a Bender and Rod

Type are selected, appropriate rod diameters and materials will

appear in the other setup drop down menus.

o "Bender Type" selections include: BENDER (bend 5.5mm rods),

BENDERII (bend 5.5 or 6.0mm rods), or BENDER OCT (bend 3.5,

5.5, or 3.5-5.5mm rods)

o Types of “Rod Systems” include: Reline® MAS® Core Tray, Reline

MAS Long Tray, Reline Open (Hex), Reline Open (No Hex),

Precept® Core Tray, Precept Long Tray, Armada® Hex, Armada No Hex, SpheRx® EXT, and VuePoint® II, and

VuePoint.

Selecting the type of system will help determine a Prebent rod size or Standard straight rod size from the tray if

that option is available. This would allow the user to potentially not have to cut a rod to length.

“Rod Diameter” selections, depending on the type of rod, include:

For BENDERII: 5.5 and 6.0 (only available when Reline Open or Reline MAS trays are selected)

For BENDER OCT: 3.5, 5.5, 3.5-5.5mm Transition (only when VuePoint II is selected), and 3.5mm Hinged (only

when VuePoint II is selected)

o “Rod Material” selections, depending on rod type, include: Titanium (Ti), Cobalt Chrome (CoCr), Stainless

Steel (Stainless St), and Ultra-Strength Stainless Steel (US Stainless St).

Fig. 13- Pulse Launch Screen

Fig. 14- Pulse Setup Screen

Fig. 15- Pulse Setup Bendini Screen 1


Bendini Surgical Workflow (continued)

• Once user selects appropriate Hardware Inputs, “Insertion Direction” is

enabled. Selections include: “Head to Foot” or “Foot to Head.”

o Note: Insertion direction is disabled for transition and hinged rods,

as it is obvious which direction these rods need to be loaded.

• "Overhang” selection is enabled once an insertion direction is selected.

User selects desired rod overhang that will be added to each end of the

rod independently. Options for superior or inferior overhang each

include: 2.5mm, 5mm, 6mm (only for the inserter end of MAS® rods), 7.5mm, 10mm, 15mm, and 20mm. The

software includes and accommodates for the inserter or hex length within the overhang settings.

o Note: Superior overhang is disabled for hinged rods, as Bendini only measures and bends the inferior portion

of the rod. The user must trim the superior portion of the rod on their own.

Step 3: Pre-Surgery Workflow

Use the Camera Setup tab to confirm the camera can see the digitizer array

Step 4: Intra-Op Workflow

Open Application

• Navigate to the Bendini Application using the button in the top right

of the screen

• Select Bendini

System Selection

• If System Selection not completed in Setup, select appropriate hardware and customization preferences. For full

details see Bendini Surgical Technique Step 2

• Select Done



Orientation

The orientation workflow step provides camera orientation

information to the system so that the rod is displayed and calculated

correctly.

• The camera should be pointed toward the surgical construct and

aligned with the height of the digitizer array when inserted in the

central screw of the construct. You may check alignment using the

Live View mode in Camera Setup

• The surgeons should place the digitizer in the most superior screw

of the construct and capture a point

• The system will provide audial and visual confirmation that the

point was captured

• The surgeon should next place the digitizer in the most inferior

screw of the construct and capture a point

• Upon audial and visual confirmation of point capture, select Done to

proceed

• To redo the Orientation workflow, select Reset

Note: if point capture unsuccessful, check digitizer array icon at the

bottom center of the screen. A green icon indicates the camera is

functioning and can see the array. If red, confirm the camera is

connected and can see the array.

Precaution: Once construct orientation has begun, do not move or

bump the Camera once it is positioned to the surgical site. Moving

the Camera during screw acquisition may require reorientation of

the Camera and reacquisition of the entire construct.

Screw Acquisition

• On the Acquire Screws workflow step, select the side of the

construct that will be digitized first by choosing Left/Right in the

tools panel

• The surgeon may then begin digitizing the construct

o Note: if digitization has begun without selecting a side, a

popup will appear asking which side to start with.

• Screws can be digitized from head to foot, foot to head, or out of

order (non-sequential)



o The order of digitization does not drive the rod insertion

direction. Insertion direction is selected under “Rod Selection”

in Setup

• Confirm the Pointer’s distal tip fits and fully seats in the screw

heads prior to acquiring screws.

o When using the BENDERII Hybrid Pointer or BENDER OCT

Hybrid Pointer, upon proper insertion and to confirm seating,

the green color band will be buried inside the Guide.

• Prior to digitizing, confirm the reflective markers on the array are

facing the camera.

• Confirm there is nothing obstructing the view between the Camera

and the Digitizer when obtaining data points

To record a screw point, squeeze the Array shutter handles together

to uncover the middle reflective marker.

• An audible sound is created, and a circle will appear on the Bendini

Acquire Screws Screen. Release pressure to close the shutter

handles.

• The latest or last acquired point appears darker with a lighter

colored surrounding halo.

• If the Camera is moved after digitizing the first of the two sides,

user must return to Camera Setup screen and confirm Camera

can still visualize the digitizer array prior to digitizing

contralateral side.

o Caution: Do not exert excessive force to the screw with

the Digitizer during screw acquisition as it can result in

inaccurate measurements due to movement of the

patient anatomy

Adjustable Offset Feature on BENDERII Pointers

The Adjustable Hybrid Pointer and the Adjustable Open Pointer

from the BENDERII set give the surgeon the ability to execute

planned sagittal screw movement by a specific amount.

Ultimately this location is where the screw is locked to the rod.

• The surgeon inserts the Digitizer into the screw. Keeping the

distal tip engaged to the screw head, the surgeon selects an

offset amount to be added to the screw.

Color band is buried inside the Guide

Acquire screws screen 1

Acquire screws screen 2



• The surgeon angles the Offset Pointer in the direction he or she

wishes to apply the offset to. The System will acquire a point at

that specific offset amount.

• The System will treat this acquired point like every other acquired

point.

• The rod will be bent to this acquired point.

• Offset options are provided from 0mm to 16mm in 2mm

increments.

• To adjust between offset options, pull the shaft away from the

Array and twist until the pin falls into desired offset slot (right).The

latest or last acquired point appears darker with a lighter colored

surrounding halo.

Rod Diameter Selection on BENDER-OCT Pointers

Before digitizing with the Bendini-OCT Hybrid Pointer and Bendini-

OCT Open Pointer, the surgeon needs to select which diameter rod is

going to be acquired.

• Options include: 3.5mm rod and 5.5mm rod. For transition rods,

this will need to be switched during digitization when the rod

transitions to the other diameter.

• To select the appropriate rod diameter on the pointer, lift on the array and twist until the pin falls in the

appropriate 3.5 or 5.5 rod slot.

Digitizing on Top of a Lock Screw

The BENDERII Lock Screw Pointer gives the surgeon the ability to

digitize on top of lock screws that are holding a temporary rod or

3CO rack in place.

• For a temporary rod, sequentially digitize each lock screw

above the rod.

• For a 3CO rack, use the Adjustable Hybrid or Adjustable Open

Pointer to digitize screws leading up to the 3CO rack and then

switch to the Lock Screw Pointer to digitize lock screws

holding the rack in place. Continue digitizing the rest of the

construct after the rack with the Adjustable Hybrid or Open Pointer.

The Bendini-OCT Lock Screw Pointer also gives the surgeon the ability to digitize on top of lock screws that are

holding a temporary rod in place.

• Confirm that the pointer is set to Lock Screw when acquiring points above a temporary rod.

Adjustable offset pointer function

OCT Rod diameter selector

OCT Lock screw and VP1 Keel plate selector



Digitizing an Adjacent Segment Fixation (ASF)

When digitizing an ASF, the Adjacent Segment Fixation Pointer should be used. Instructions below can be followed

either in order from 1 to 3 when ending digitization with the ASF or from 3 to 1 when beginning digitization with

the ASF.

• Digitize screws leading up to the ASF with the pointer’s foot outside of the tulip.

• Digitize with the foot of the pointer in the tulip and the body of the pointer on the same side of the ASF as the

screws that were digitized leading up to the ASF.

• Digitize again with the body of the pointer in the tulip of the ASF and the pointer’s foot on the side of the ASF

that is the end of the construct.

Digitizing a Cervical Offset Connector

When digitizing offset, in-line rod-to-rod, or lateral offset

connectors, use the Bendini-OCT Connector Pointer to

acquire the 3.5 connector slot.

• First, hold the pointer vertically and insert one prong on

the pointer's distal tip into the 3.5 slot on the

connector. Digitize this point.

• Then, flip the pointer around and insert the other prong

on the pointer's distal tip into the 3.5 slot on the

connector. Digitize this point.

• Digitize again with the body of the pointer in the tulip of

the ASF and the pointer’s foot on the side of the ASF

that is the end of the construct.

Point of digitization on the ASF pointer



How to Digitize When Using a Hinged Rod

When using a hinged rod, use the Bendini-OCT Hybrid

Pointer and Hinged Rod Template to acquire the desired

location for the hinge to fall within the construct.

• First, hold the Bendini-OCT hinge rod template so

the distal tip is in the location of where the surgeon

would like the hinge to be. Then rest the inferior

portion of the hinge rod template into the occipital

plate's tulip, similar to placement of the superior

portion of a hinged rod.

• Use the Bendini-OCT Hybrid pointer to digitize

inside the tulip of the hinged rod template's distal

tip. Use the same pointer to digitize all surrounding

screws.

Digitizing an Occipital Plate

To digitize a VuePoint® II Occipital Plate, use the Bendini-OCT Hybrid Pointer.

• First, hold the pointer vertically and place the distal ball on the pointer's tip into the tulip on the occipital

plate. Digitize this point.

• Next, continue to hold the pointer vertically and move the pointer down so the second ball on the pointer's tip

goes into the tulip. The distal ball on the pointer's tip should be just below the tulip. Digitize this point.

• When skipping C1, it is recommended to hold the pointer where the C1 tulip would have been and acquire this

point. This will create a ghost point that will help the rod transition from the C2 tulip to the occipital plate.

• To digitize a VuePoint Occipital Plate, use the Bendini-OCT Lock Screw Pointer.

• First, confirm the pointer is set to "VPI Keel."

• Hold the pointer vertically and place the distal tip of the pointer into the top of the side-loading tulip. Digitize

this point.

• Next, continuing to hold the pointer vertically, slide the pointer into the side loading connector so that the

distal tip of the pointer falls below the tulip of the connector.

• When skipping C1, it is recommended to hold the pointer where the C1 tulip would have been and acquire this

point. This will create a ghost point that will help the rod transition from the C2 tulip to the occipital plate.



Digitizing for Reline Trauma

To digitize for Reline Trauma, use the Bendini Trauma Pointer.

Note: For assembly of the Digitizer and step-by-step instructions, please

reference the Bendini Technique Guide (9501356 D).

• Attach the Array to the Bendini Trauma Pointer. Once Array is attached,

insert into the most cranial Guide. (This may be a Trauma or Standard

Reline Guide, depending on the length of the construct.)

• If digitizing a polyaxial screw, follow the same instructions outlined in the

Bendini Technique Guide to acquire each screw point keeping the Pointer

in the center inline position (Fig. A)

• If digitizing a fixed screw, the Bendini Trauma Pointer will need to be

adjusted to account for proper overhang in orientation to the fixed screws.

With the Pointer in the most cranial Guide, confirm the Pointer is in the lateral offset position with the top

housing positioned away from the midline of the fracture . Proper depth is

identified when the black laser marked line on the Pointer is flush with the top

of the Trauma Guide. Squeeze the Array shutter handles together to acquire

the screw point.

• Then slide the top housing on the Pointer to offset toward the midline of the

fracture. The Digitizer can be slid into multiple positions but should always be

positioned toward the midline of the fracture site to account for fixed screws.

Digitize this point. Repeat the above instructions for adjacent levels when

Guides are used two or more levels above the fracture

• Move the Bendini Trauma Pointer to the Trauma Guide/fixed screw caudal to

the fracture and digitize with the Pointer in the lateral offset position away

from the midline. Then slide the Pointer toward the midline of the fracture and

digitize this point. Repeat for adjacent levels when Guides are used two or

more levels below the fracture.

Note: When an index screw is used at the fracture level, digitize the index screw

with Pointer in the inline position.

• When no fixation is used at the fracture level and there is only one fixed screw

above and below, digitize one point with the Pointer in the center inline

position and one point with the Pointer in the offset position toward the

midline. Repeat these steps for both fixed screws above and below the fracture

level. Next, add a virtual "ghost point" with the Bendini software’s

• Points Menu directly between the two most medial points on the Acquire

Screws screen. See the Bendini Technique Guide for additional instructions.

• Digitize any remaining polyaxial screws with the Pointer in the center inline position.



Edit Points

• To add a virtual point, select "Add Point" from the "Points" menu in the

tools panel. Touch an area on the screen within the construct to add a

new point.

o Added points are displayed in light blue.

o To undo all added points, select Undo.

• To adjust an individual point, select "Adjust Point" from the "Points"

menu. Touch a point to adjust. Use the arrows in the lower left of the

sagittal view to adjust in the sagittal plane or use the arrows in the lower

right of the coronal view to adjust in the coronal plane.

o To undo all adjustments, select Undo.

• To delete an individual point, open the "Points" menu and press "Remove

Point." Touch the point to remove.

o To undo a removed point, select "Undo"

To clear all points on the screen or bend plan (start over) select "Clear All

Points" from "Points" menu.

• To identify where to place the transition point when a 3.5-5.5 transition

rod is being used, select "Transition Point" from the "Points" menu.

Instructions will direct the user to select the most inferior 3.5mm screw

and the software will place the 3.5-5.5mm transition point in between

that screw and the next screw below it.

o White numbers will appear next to the orange point in both the

sagittal and coronal view to show how many millimeters away the

new point is from the original screw.

• To register a different side, select “Left” or “Right” on Tools Panel to

toggle to that side. Information is not lost when toggling between Left

and Right sides.

o If the system is not registering points when the trigger marker is

revealed, confirm that all markers are not contaminated with material and/or obstructed from being seen

by the Camera. If any markers are contaminated, wipe them clean with a wet cloth in order for the Camera

to register points.



(Optional) iGA :

IGA allows the user to measure angles of lordosis and kyphosis in fluoroscopic images intra-operatively. This

information can then be used to help the surgeon determine how much sagittal or coronal correction to add into

the rod with the Bendini software. For additional information on how to use IGA., please reference the IGA.


• Select the IGA. application

• Follow instructions on the screen to manually input or import via USB Pre-op and/or Plan Parameter values, if

desired.

• Measure intraoperative values in IGA.

• To return to Bendini, touch the Bendini icon under the application button in the top right corner

Sagittal Bending

The Sagittal Bending Feature allows the surgeon to add lordosis or

kyphosis to the rod.

• After the surgeon has digitized the screws, press the “Sagittal

Bending” button above the spine image in the sagittal view.

o Select desired sagittal bending segments to adjust. Options

for thoracolumbar screw systems include:

Lumbar Lordosis (2 points) - for an even distribution of

correction between points

Lumbar Lordosis (Apex Point) – Select an apex point to

bend around

(1/3)(2/3) Lordosis - to add 1/3 of the total correction

to L1-L4 and 2/3 of the total correction to L4-S1

Thoracic Kyphosis - for an even distribution of


o Options for cervical screw systems include:

Lordosis (2 points) - for an even distribution of


Lordosis (Apex Point) - Select an apex point to bend

around

Kyphosis (2 points) - for an even distribution correction of between points

Next, the user must follow the instructions on the

screen to select the superior, inferior, and/or apex

points for the selected sagittal bending segments. The

chosen points will turn pink when touched.

Use the -1° or -5° buttons to add lordosis. Use the +1°

or +5° buttons to add kyphosis. The angular value will

update based on the lordosis or kyphosis adjustments.

If more than one sagittal bending segment was

selected, the user will need to touch the angle symbol

for the segment they would like to adjust first. Then

touch the angle symbol for the second segment.

Sagittal Bending tool step 3





Orange points represent the adjusted location of the

screws. The number adjacent to the orange point

represents the distance in millimeters from the

original digitized point.

As lordosis is adjusted, the number representing the

degree of that segmental parameter is updated.

To clear all adjustments, press “Reset” on the bottom

right of the panel

Coronal Straightening

The Coronal Straightening feature allows the surgeon to

straighten the rod in the Coronal plane. Using the adjustment

feature on the screen, the user can remove or eliminate coronal

bends in the rod.

• After the surgeon has digitized the screws, press the “Coronal

Straightening” section in the tools panel

• Select either Full Construct if straightening the whole

construct or Custom Segment if selecting only a portion of the

construct

o If Full Construct is selected, the first and last points of the

construct will automatically be selected as the desired

segment to straighten.

o If Custom Segment is selected, the user must follow the

workflow instructions to select two digitized points in the

coronal view to define the straightening line. The selected

points will turn pink when touched.

The first point chosen is the starting point of the

straightening line.

The second point chosen defines the direction of the

line.

The straightening line is drawn through the center of

the 2 points.

• Press one of the straightening options in tools panel to

straighten the rod in the coronal plane. Options include: 25%

to line, 50% to line, 75% to line, and 100% straight.

o The orange points represent the adjusted location of the

screws. The number adjacent to the orange point

represents the distance in millimeters from the original

digitized location.

• To clear all adjustments, press the “Undo” button on the

bottom right below the straightening option buttons.

Coronal Straightening tool step 1






Rod Calculation

Once all screws on one side of the construct have been acquired and all rod adjustments have been made, press

“Calculate Rod.”

• The rod can be previewed in the Sagittal and Coronal views.

• The calculated Rod Preview Screen displays one sagittal and coronal orientation line on the rod.

• The white end represents the inserter end or hex end of the rod.

• If the rod was previously calculated, but the surgeon wants to add a point or additional correction, the user can press “Undo Rod.” This will remove the generated line and allow for further point acquisition or rod manipulation.

• Rod System, Diameter, Material, Insertion direction, and Overhang can be adjusted without having to redigitize points.

o Note: Although the rod contour does not change, the bend instructions will change in order to accommodate any adjustments

• Once a rod is calculated, the ‘Rod Options’ tool will open in the tools panel. o All constructs will have the Custom option automatically selected. This is the exact rod that will best fit the

construct. o Most constructs will have a Smoothed option that enables a smoother rod with less sharp bends. o In some constructs a Standard Rod button will appear if a particular length rod is available in the selected

set. o In some constructs, a Prebent Rod button will appear if a prebent rod is available from the selected set.

• To select any of these alternative rod options, press the associated button in the Rod Options tool panel o Note: When choosing a rod other than Custom, additional reduction may be required to seat the rod, as

indicated by the white numbers shown next to the points. o If Prebent or Standard is selected, the Bend Instructions screen will detail the available Prebent or Standard

rod in the selected set. There may be a difference in overhang. If there is a difference, the software will display the new overhang on each end. To bend and cut a custom rod instead, select the Custom rod from the Rod Options tool panel



Bend Instructions

Navigate to the Bend Instructions using the workflow buttons at

the top of the application window. The software will calculate

and present rod bend instructions.

• The green triangle column represents the location of the bend.

• The orange square column represents the rotation required or the plane of the bend.

• The blue circle column represents the degree of the bend.

• A scroll arrow will appear below the last instructions in the event there are more than 8 lines of bend instructions.

• Pressing the screen on each numbered row will highlight that individual row.

• It will also reveal the next available row that can be selected next.

• Depending on the rod diameter used, the instructions will tell the user to press either the 3.5mm, 5.5mm, or 6.0mm button on the bender.

• In some constructs a Standard Rod button will appear first if a rod is available in the selected set.

• In the example to the right, the user is told to press the 5.5mm button on the bender and then cut the rod to 255mm. The next instructions say to load the “Inserter End” of the rod into the Bender with the “Line Up.”

• User will execute the bend instructions from left to right, sequentially starting at “1.”

• User will insert the rod “Head-to-Foot.”

• To move to the other side, user can press the L/R toggle button on the left panel.

Bend Instructions step 1





If the rod required is greater than 300mm but less than or equal to 600mm, bend instructions will inform the user

to “FLIP THE ROD” during bending.

• After releasing and flipping the rod, repeat the posterior line alignment during loading.

On rod trimming and rod orientation, please note:

• After releasing and flipping the rod, repeat the posterior line alignment during loading. The rod bender collet and the short distance ahead of the collet accounts for 20mm of the rod that cannot be bent.

• If a bend is required in this 20mm, the software will account for this distance by adding extra rod length to allow a bend to be placed in this area.

• The user will then be instructed to cut off this defined additional length following completion of all the bends.

• Although the user has the option of selecting the insertion direction, to avoid cutting off any hex/rod inserter features at the end of the rod, orientation may also flip and require the rod to be inserted in the non-preferred direction.

Bending the Rod

Mechanical bender functions



Measure and Cut the Rod

• Select an appropriate length of rod as indicated on the Bend Instructions Screen.

• Measure the rod to the “Cut Rod” length in the software bend instructions. o When a transition rod is used, there will be two different cut instructions for the user to trim both the

3.5mm and 5.5mm ends of the rod.

• The Bender has a “Rod Measurement Slot” that will measure a rod up to 400mm. Drop the rod into the slotted area, lining up the non-cut end at the zero mark.

• Insert the rod into the rod cutter. Trim the rod to the recommended length using the rod cutter as needed.

• Rod must be cut to the exact length detailed in the bend instructions for proper fit in the construct.

Measurement slot on bender

Cut Rod bend instruction



Insert Rod into Bender

• For the BENDERII, press the “5.5” button on the rod diameter switch located on the purple plate to bend a 5.5mm rod, or press “6.0” on the rod diameter switch to bend a 6.0mm rod. o The system can only bend 5.5mm straight rods from

Precept®, Armada®, SpheRx® EXT, or Reline®, and 6.0mm straight rods from Reline.

o Confirm this button is set at the correct rod diameter setting during all bending.

• For the BENDEROCT, press the "3.5" button on the rod diameter switch located on the bend letter plate to bend a 3.5mm rod, or press "5.5" on the rod diameter switch to bend a 5.5mm rod. o The system can only bend 3.5mm rods from VuePoint II,

and VuePoint, 3.5 to 5.5mm straight rods from VuePoint® II or VuePoint, 3.5mm hinged rods from VuePoint II, and 5.5mm rods from Precept, Armada, SpheRx EXT, or Reline.

• In the direction towards the “Rotation Guide,” Push the gold “Rod Engagement Lever” to the “Rotate” position.

• Turn the “Rotation Knob” in the clockwise direction until the “Posterior Line” marking appears on the “Rotation Guide.”

• Once “Posterior Line” is set, pull the gold “Rod Engagement Lever” towards the “Rotation Knob” until it is in the “Lock/Unlock” position.

Bending the Rod • Rotate grey “Rotation Knob” in the counterclockwise position

until the gold “Rod Gripping Collet” is visible.

• Insert the rod into the gold “Rod Gripping Collet” in the direction indicated in the software Bend Instructions.

• Rotate the rod until the desired rod line matches the “Posterior Line” and arrow on the “Rotation Guide”. o For Precept rods, confirm the rod insertion notch is

pointed up. o For rods with 2 lines, mark the preferred line.

Load rod bend instruction

Load rod functions on bender

Posterior line up indicator

Bend instructions



• In the clockwise direction, rotate the purple “Rotation Knob” until firmly tight.

• Push the gold “Rod Engagement Lever” into the “Rotate” position towards the “Rotation Guide”.

• Each set of instructions on the software screen has an orange square, green triangle and blue circle component which corresponds to a like colored section on the bender.

• Match each line of instructions with the corresponding Location, Rotation, and Bend Angle Indicators on the bender. o Start by translating the “Location Slide Mechanism” to

the proper Location number (green “Location Indicator” triangle will point to this number)

o Rotate “Rotation Knob” clockwise or counterclockwise to the proper Rotation number (orange square “Rotation Indicator” window)

• The “Rod Bender Handle” is brought down and a bend is placed in the rod at the set location according to the instructions.

• After each bend is complete return the Bender into a neutral position.

• Enter the next row of instructions into the dials on the Bender and continue to bend the rod.

• Repeat until all bend instructions have been sequentially executed.

• On the last bend pull gold “Rod Engagement Lever” towards the “Rotation Knob” to the “Lock/Unlock” position.

• Rotate the "Rotation Knob" counterclockwise to release the rod from the Bender.

Rod Insertion

• The rod should be placed into the construct in the direction indicated on the screen, with the line or marking on the rod facing up towards the posterior aspect of the patient.

• Confirm through fluoro that both the rod length is appropriate for the construct and the overhang length is acceptable. Trim the rod length if desired.

• The case can proceed as would otherwise, including making final adjustments to the rod using standard rod benders and trimming the length of the rod if necessary. This completes the use of the Bendini System.

Mechanical bender appearance

Example bent rod


Troubleshooting

System is not registering points

• If the system is not registering points when the Trigger Marker is revealed, confirm that all Markers are not contaminated with any material and/or obstructed from being seen by the Tracking System Camera. If any Marker is contaminated, wipe clean with a wet gauze.

• Check that the Array icon is green on the bottom center portion of the Acquire Screws screen

• During introduction of the Digitizer and visualization of the Camera, confirm the Trigger Marker is adequately covered by the shutters.

Bends too severe error

• A red point will appear and inform the user that the System cannot perform the bend angle required, and the maximum bend angle on the bender has been reached.

• The software will provide an option to calculate a rod with the next available solution that is within the Bender’s capability. The Acquire Screws screen will show the user the number of mm away this new solution is from the points acquired. If the user presses “Accept” the new bend solution will appear.

• If the user presses “Decline” the system will inform the user to adjust the screw positions and reacquire points.

• Clear points, align towers or screw heads, and re-digitize to try again.

• Consider keeping the alignment of the Digitizer coaxial to the implant when registering its location to get the best results.


Cleaning and Sterilization

Instrument Cleaning and Decontamination

All instruments must first be thoroughly cleaned using the following validated methods before sterilization and

introduction into a sterile surgical field. Contaminated instruments should be wiped clean of visible soil at the

point of use, prior to transfer for full processing. Cleaning instructions for the Bendini Spinal Rod Bender and

Pointer instruments are as follows:

1. Prior to soaking the instruments in an enzymatic cleaning solution, rinse the instruments under cool running tap water and wipe off any residual soil or debris with a disposable towel. Ensure to flush out any lumens, cracks, or crevices while rinsing under running cool tap water.

2. Prepare an enzymatic cleaning solution, such as MetriZyme, per manufacturer’s recommendations using warm tap water. Place the instruments in the solution in the open position (as appropriate) and allow to soak for a minimum of 50 seconds. While soaking, actuate the instruments through a full range of motion (as appropriate for the specific instrument) to allow complete penetration of the cleaning solution. Instruments that are designed to be disassembled should be disassembled prior to cleaning. Instruments that do not disassemble may require additional soaking.

3. After the 50 seconds soak time, remove the instruments and wipe any soil or debris using a disposable towel. Then, place the instruments into a fresh batch of an enzymatic cleaning solution using warm tap water. Brush the entire surface of the instrument with a soft bristled brush. Actuate the instruments through a full range of motion while brushing and ensure to brush all hard to reach areas. Use a sterile syringe and lumen brush to clean hard to reach areas and flush each end of the instruments with a minimum of 60mL.

4. Remove the instruments from the detergent and rinse by agitating and actuating in RO/DI water for a minimum

of 30 seconds. Flush all hard to reach areas with a sterile syringe at each end of the instrument with a minimum of 60mL.

5. Use a low foaming, neutral pH, phosphate-free cleaning solution and prepare per manufacturer’s recommendations using warm tap water in a sonication unit. Allow the instruments to sonicate for 10 minutes. Instruments should be properly placed to maximize cleaning and to avoid damage or dislodgement of instruments and components.

6. Remove the instruments from the detergent and rinse by agitating and actuating in ambient RO/DI water for a minimum of 30 seconds. Actuate the instruments through a full range of motion while rinsing and flush all hard to reach areas with a sterile syringe at each end of the instruments with a minimum of 60mL.


Cleaning and Sterilization (continued)

7. Transfer the instruments into the washer for processing. Position the instruments to allow for proper drainage. Below is the validated and recommended cycle:

Phase Recirculation Time Water Temperature Detergent Type and Concentration

(if applicable)

Pre-wash 2 minutes Cold tap water N/A

Enzyme Wash 2 minutes Hot tap water MetriZyme, 1 ox/gallon) or equivalent (per

manufacturer’s instruction)

Wash 2 minutes 65.5°C (set point) MetriZyme, 1 ox/gallon) or equivalent (per

manufacturer’s instruction)

PURW Rinse 1 minute 43°C N/A

Drying 15 minutes 90°C N/A

8. Dry the instruments using a clean soft towel.

Visually inspect the instruments following performance of the cleaning instructions prescribed above. Ensure there

is no visual contamination of the instruments prior to proceeding with sterilization. If contamination is present at

visual inspection, repeat the cleaning steps above. Otherwise, contact your NuVasive® representative –

contaminated instruments should not be used, and should be returned to NuVasive.

All instrument moving parts should be well lubricated. Be careful to use surgical lubricants and non-industrial oils.

Note: Certain cleaning solutions such as those containing bleach or formalin may damage some devices and must

not be used.

Contact your NuVasive representative for any additional information related to cleaning and sterilization of

NuVasive surgical instruments.


Cleaning and Sterilization (continued)

Sterilization

These sterilization instructions do not apply to instruments provided sterile.

All instruments and implants are provided non-sterile and must be sterilized prior to use. All components can be

sterilized by steam autoclave using standard hospital practices.

The implants and instruments can be sterilized using the provided standard open cases or Aesculap® closed cases

(standard or PrimeLine™ lid). Small baskets, trays, and other types of accessories, especially with covers or lids, not

provided by NuVasive for a specific system should not be used. Only NuVasive standard open cases, and Aesculap

closed cases (standard or PrimeLine lid) are validated for use with NuVasive products.

For standard open cases, devices are to be packaged in an FDA-cleared sterilization wrap prior to placement in an

autoclave.

For information regarding closed Aesculap cases, please refer to appropriate Instructions for Use provided by

Aesculap. In a properly functioning and calibrated steam sterilizer, effective sterilization may be achieved using the

following parameters:

Method: Steam Method: Steam

Cycle: Pre-Vacuum Cycle: Pre-Vacuum

Temperature 270°C (132°F) Temperature 273°C (134°F)

Exposure Time: 4 minutes Exposure Time: 3 minutes

Minimum Dry Time: 30 minutes Minimum Dry Time: 30 minutes

Minimum Cool Down Time: 40 minutes Minimum Cool Down Time: 40 minutes

Sterile Components

The digitizer array is an Ethylene Oxide sterilized single-use disposable. Packaged individually, the array is

assembled to a steam sterilized pointer in the sterile field. After the Bendini System is used, the array is

unassembled from the pointer and disposed of.

Do not attempt to clean or reprocess the Array.


Pulse Navigation


Labeling Information

Device Description

Pulse Navigation is an application within Pulse System. It is a stereotactic surgical application intended as an aid for

precisely locating anatomical structures in either open or percutaneous procedures. It consists of Camera, computer,

spinous process clamps and hip pins, passive reflective arrays, Pulse Navigation instruments, tablet, and a computer

interface for communication between the User and the device. It is intended for intraoperative image-guided

localization which allows for surgical instruments to be tracked in three-dimensional space. The device provides real-

time information directly to the surgeon, enabling the surgeon to evaluate the instrument depth and trajectory for

computer-assisted navigation during spine surgery. Instruments are tracked in three-dimensional space with an

Infrared (IR) Camera, being virtually displayed and superimposed on registered radiographic images. Radiographic

images can be either 3D fluoroscopic images (C-arm) or 3D intraoperative scan (CT or Cone Beam CT). NuVasive

Navigation Instruments are intended to be used with fixation screws from NuVasive’s Reline and VuePoint sets.








OR setup

Option 1: Cervical/Thoracic/Lumbar procedures:

System at the Head of the bed and reference array/s attached and angled in the cranial direction

• Patient in prone position

• Attached patient reference array to relevant vertebra

• Monitor and camera at the head of the bed

Option 2: Thoracic/Lumbar/Sacral procedures:

System at the foot of the bed and reference array/s attached and angled in the caudal direction

• Patient in prone position

• Attached patient reference array to relevant vertebra

• Monitor and camera at the foot of the bed


Equipment setup

Equipment requirements re-usable

• Pulse System (Fig. 1)

• Camera and camera cart (Fig. 3)

• Pulse Navigation Instruments

• Pulse Navigation Instrument Arrays

• Confirmation Block

• Hardware Inserter

• Driver

• Spinous Process Clamps

Disposable requirements

• Disposable Marker Spheres

• Hip Pins

• Patient reference arrays Cranial (black) and Caudal (white)

Case preparations

• Ensure the Pulse System is placed outside the sterile field in a location that is easy to view and allows

access to the touch screen by non-sterile personnel for data input and management. The System should

be plugged into clean power and properly grounded.

• Instruments are autoclave sterilized prior to surgery per the parameters in the IFU. Follow the entire

sterile processing steps by the facility (reference appropriate hospital sterilization procedures).

• The Pulse Navigation patient reference arrays are sterile-packaged and ready for use.

• Ensure all Equipment is connected, powered on and functioning properly prior to use.


Equipment setup (cont.)

Step 1: Power on Pulse system

• Plug the Pulse system into the wall

and press Power On/Off button

(Fig.2)

• After pressing the Power button, the screen will show the software version number and will show the

different modules as they are loading.

Camera cart Ethernet

connection

On/Off

button

Fig. 1

Pulse system Fig. 2

Power on system


Equipment setup (cont.)

Step 2: Camera setup

• Attach the Camera’s Ethernet cable to the Ethernet port labeled camera on the Pulse system.

• Attach the other end of the Ethernet cable to the camera port located on the backside of the camera.

• An audible sound and green led light will illuminate to confirm connection when the Pulse system is turned on and the Pulse software has been booted.

Step 3: Pedicle Screw Navigated Instrument Setup

• Secure sterile passive marker spheres onto pointer, drill guide, instrument arrays and confirmation

block posts by press fitting the spheres receptacle onto post.

• Remove the desired Navigation.S Instruments from its sterilization case.

• Remove Instrument Arrays from the sterilization case and attach it to the

Instrument. Fully seat the array so it is flush with the navigation ring (Fig. 4).

• There is a total of five different instrument arrays provided for pedicle screw placement instruments – A,

B, C, D, and E (Fig. 5.). The A,B,C ,D, and E array can be used with any of the navigated instruments. A list

of compatible Pulse Navigated instruments is listed below in Table 1.

Fig. 4 - Instrument with instrument array attached

Fig. 3 Pulse camera and camera card

Array

Seating

Navigation Ring

Fig. 5 - Instrument arrays A-E


Equipment Setup (cont.) Part Number Description Category

11000443 NAV.S RELINE MAS Tap, 4.5mm Cannulated Tap





10001139 NAV.S RELINE Screwdriver, Poly Cann Screwdriver

10001145 NAV S. RELINE Shankdriver, Cann Screwdriver

10001150 NAV S. RELINE MAS Driver, Reduction Cann Screwdriver

10001230 NAV S. RSS/RMM Screwdriver, Poly Cann Screwdriver

11001211 NAV S. RSS Tap, 3.75mm Solid Tap

11001056 NAV.S RELINE Tap, MAS, 4.5mm Consol Tap



11001066 NAV.S Reline Tap, 4.5mm Solid Short Consol Tap



11000425 NAV.S RMM Drill, 4.5mm Drill Bit



10001172 NAV.S Awl Awl

10001173 NAV.S Gearshift, Thoracic Gearshift

10001174 NAV.S Gearshift Lumbar Gearshift

10001175 NAV.S Gearshift Iliac Gearshift

5050180 Pulse Pointer (Biult in Array) Pointer

5050133 Pulse, Pedicle Needle (Disposable) Jamshidi

5050267 Pulse, Navigated Drill Guide (Biult-in Array) Drill Guide

8801611 NAV S VuePoint II Tap, 3.0mm Tap

8801612 NAV S VuePoint II Tap, 3.5mm Tap

8801613 NAV S. S VuePoint II Drill Bit Drill Bit

8977729 NAV S VuePoint II Driver, Threaded Screwdriver

Table 1- Compatible navigation instruments


Equipment Setup (cont.)

Navigated Stealth-Midas Rex EM200N

Indications For Use The Stealth-Midas™ System is indicated for the drilling, burring and removal of hard tissue and bone in spinal surgical procedures. Computer-assisted surgery and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a long bone, or vertebra, can be identified relative to a CT- or MR-based model, fluoroscopic images, or digitized landmarks of the anatomy.

Device description The Stealth-Midas™ is a powered drill that will remove soft tissue, hard tissue, bone, and biomaterials during surgical procedures. The permanently attached tracker will allow for intraoperative navigation of spinal procedures using Pulse Navigation. This device is intended for use by physicians trained in the procedures described

• Pulse is compatible with the navigated Stealth-Midas Rex EM200N electric handpiece along with the below

dissecting tools and attachments Table 2.

• Follow the navigated Electric Stealth-Midas™ System User’s Guide (Document number 175033EN Rev B

https://manuals.medtronic.com/content/dam/emanuals/st/CONTRIB_241245.pdf) to assemble the

handpiece, attachment, and corresponding dissecting tool.

https://manuals.medtronic.com/content/dam/emanuals/st/CONTRIB_241245.pdf



Part Number Description

EM200N Electric Stealth-Midas Motor

AS10 Straight Attachment 10cm, Small Bore

AA10 Angled Attachment 10cm, Small Bore

AS14 Straight Attachment 14cm, Large Bore

AA14 Angled Attachment 14cm, Large Bore



10MH30 Stealth-Midas Rex Match Head Ø3x100mm


14BA40 Stealth-Midas Rex Ball Fluted Ø5x140mm

15MH22 Stealth-Midas Rex Match Head Ø2.2x150mm

SP14MH30T Stealth-Midas Clearview Match Head Ø3x140mm

Table 2- Compatible Medtronic Electric Stealth-Midas attachment and dissecting tools.



• Each of these above dissecting tools with corresponding attachments can be selected in the Array Assignment

section in the Pulse Navigation software (Fig 6). Follow Software-Presurgery step 1 and 2 to confirm setup and

use with Pulse Navigation.

Known Defect It is possible to confirm and navigate more than one Stealth Midas configuration (orientation +dissecting tool) at a time on Pulse. Only one Stealth Midas configuration should be used. If using a second configuration during a session, delete the previous configuration before use. Not deleting the initial configuration can cause the wrong dissecting tool with orientation to be represented when navigating that instrument. Equipment Setup (cont.)

Fig 6. Selecting the Stealth-Midas EM200N with corresponding

attachment position and dissecting tool on Pulse Navigation.



Pulse Navigated Drill Guide Setup

• An optional drill guide handle can be attached to the Pulse navigated drill guide (Fig 7). There are 5 different

angles/ridges for the handle to slide down and attach to the drill guide. Compress the gold button on the

handle and slide the drill guide handle’s shaft down one of the ridges on the drill guide until the button clicks

in place to secure attachment (Fig 7).

Gold Button

Drill Guide

Handle

Drill Guide

Assembled Drill

Guide with Handle

Ridge

Shaft

Fig 7. Pulse Navigation Drill Guide and Assembly

Depth Stop



• Place Spheres on the drill guide array.

• The Pulse navigated drill guide is compatible with 2 different diameter drill sizes 3.0mm and 4.0mm. The 3.0

mm drill can be used for depth 15mm – 45mm long. The 4.0mm drill can be used for drill depths of 60-90mm

long. These drill bits come in 2 different types of attachments, ¼ Square or AO attachment Table 3.

Description Part Number Compatible Drill Depth Length

3.0mm ¼ Square Attachment Drill Bit 5050270 15mm – 45mm

4.0mm ¼ Square Attachment Drill Bit 5050271 60mm – 90mm

3.0 mm AO Attachment Drill Bit 5050272 15mm – 45mm

4.0mm AO Attachment Drill Bit 5050273 60mm – 90mm

Table 3- Compatible Navigated Drill Guide Bits



• Adjust the depth stop by first lifting and turning the actuator clockwise to change between depths from 15-

45mm or depth 60-90mm. Make sure the arrow is lined up from the actuator to the depth stop range (Fig 8).

The 15-45mm depths can only be achieved using the 3.0mm drill bit. The 60-90mm depths can only be

achieved using the 4.0mm drill. A physical stop is built into the depth stop preventing the 4.0mm drill from

being able to fit into the drill guide while in the 15-45mm position.

• Compress the gold button on the depth stop and adjust to the desired depth .

Actuator

Selected Depth

Actuator lined up with

the 15-45mm depth

range

Depth Stop

Fig 8. Depth Stop on Pulse Navigated Drill Guide



Step 4: Available Registration Methods

Single Fiducial Registration – This method uses a single patient array (Caudal) and fiducial marker built into the patient reference fixation device to register the 3-D data set. This method requires the patient reference fixation device to be attached to the anatomy of interest and to be included in the 3D volume of the scan using one of the following validated scanners labeled in Table 4. Dual Fiducial Registration – This method uses two patient reference arrays (Cranial and Caudal) and two fiducial markers built into the patient reference fixation device to register the 3-D data set. This method requires both patient reference fixation devices to be attached to the anatomy of interest and to be included in the 3D volume of the scan using one of the following validated scanners labeled in Table 4. Siemens CIOS Navilink Registration – This method uses a previously calibrated and tested Siemens CIOS 3D spin with an attached NuVasive CIOS system array. This method requires a single patient array (Caudal) and a reference fixation device to be attached to the anatomy of interest (Table 4), however, this registration does not require the fiducials to be included in the 3-D data set to register.

Registration type Compatible Scanners Hardware used Quantity

Dual Fiducial O-arm II, Ziehm 3D, Siemens CIOS 3D

Spinous process clamps only

Spinous process clamp and Hip pin

2

1 of each

Single Fiducial O-arm II, Ziehm 3D, Siemens CIOS 3D

Hip pin or spinous process clamp

1

Siemens CIOS Navilink Siemens CIOS 3D Hip pin or spinous process clamp

1

Table 4- Registration Types, compatible scanners, and required patient reference array fixation hardware

requirements



Step 5: Patient Reference Array Setup-Sterile Field

• Determine the type of registration you’ll use for the case.

• A patient reference fixation and patient reference arrays are required for all types of 3D navigation

registrations. Single or Dual Fiducial registration is required when using an O-arm II or Ziehm 3D scanner. A

Siemens CIOS 3D spin scanner can also be used with single or dual fiducial registration.

• Single Fiducial registration requires either 1 Spinous process clamp or 1 hip pin and needs to be included in the

3D scan volume.

• Dual Fiducial Registration requires either 2 Spinous Process Clamps or 1 spinous process clamp and 1 Hip Pin

at least 10cm apart from each other and requires both patient fixation frames to be in the 3D scan volume.

• The CIOS Navilink registration can only be done on a Siemens CIOS Spin 3D scanner. The patient reference

fixation frame is not required to be in the 3D scan volume.



• When using a Spinous Process Clamp, slide the proximal end of the clamp into the hardware inserter (Fig.

9,10). The hardware inserter will click when fully seated.

• When using a Hip Pin, slide the proximal end of the pin into the pin cap (Fig. 11,12).

Fig. 10 - Spinous Process Clamp Attachment to Hardware Inserter

Connector

Fully Seated

Fig 12. 6DOF Hip Pin with Hip Cap

Fig 11. 6DOF Hip Pin

Fig. 9 Spinous Process Clamp



Step 6: Prepare the patient for the 3D scan

Single Fiducial Registration

• Attach a single Hip Pin or Spinous Process Clamp on to the Pelvis (iliac crest) or Spine respectively.

• Warning: Hip pin should only be used in the lumbar and sacral regions of the spine.

• Secure the Caudal (white) patient reference array to the Hip Pin (Fig. 13) or Spinous Process Clamp using

the hexalobe driver (Fig.14).

• When inserting a Spinous Process Clamp or Hip Pin onto the patient, confirm these devices are inserted

such that the camera has a clear line of sight to the Patient Reference Array.

Dual Fiducial Registration • Insert two Spinous Process Clamps or a single Spinous process clamp

and single Hip Pin onto the operative area making sure they are

within the scan volume of the scanner being used. The clamp that is

closer to the head will be

referred to as the cranial clamp. The

clamp closer to the feet of the patient will be

referred to the caudal clamp.

• Warning: Hip pin should only be used in the lumbar and sacral regions

of the spine.

• Attach Patient Reference Arrays to Spinous Process

Clamp (Fig. 15). The black patient reference array

will attach to the cranial clamp. The white patient

reference array will attach to the caudal clamp.

• When inserting a Spinous Process Clamp or Hip Pin onto

the patient, confirm these devices are inserted

such that the camera has a clear line of sight to the

Patient Reference Array.

Fig. 14 - Caudal Patient Reference Array attach to Spinous Process clamp.

Fig. 15 - Cranial and Caudal Patient Reference Arrays

Fig. 13 - Caudal Patient Reference Array attach to a Hip Pin.



Siemens CIOS Spin NaviLink Registration • Use either a Spinous Process Clamp or Hip Pin for patient reference array fixation. If you are using a Spinous

Process Clamp, attach to the Spinous Process (Fig. 14).

• If you are using the Hip Pin, attach it to the pelvis (Fig. 13).

• Warning: Hip pin should only be used in the lumbar and sacral regions of the spine.

• Attach the Caudal (white) patient reference array to the patient fixation used.

• When inserting a Spinous Process Clamp or Hip Pin onto the patient, ensure these devices are inserted such

that the camera has a clear line of sight to the Patient Reference Array.


Software Startup

Step 1: Start up display

• Pulse software will automatically boot-up after the Pulse System is powered on.

• Pulse has two touchscreen displays. The first display is dedicated for the Pulse controls.

The other display is dedicated for Pulse navigation (Fig. 16).

Fig. 16- Pulse Display Screens. Top image is a dedicated Pulse Control Display; Bottom image is the dedicated Pulse Navigation Display.

Display 1: Pulse controls

Display 2: Pulse navigation display


Software Startup (cont.)

Step 2: Anatomy and approach

• Select the anatomy and approach for the

procedure and press start (Fig. 17).

Fig. 17– Select the approach


Software Setup

Confirm camera connection

• To confirm the camera connection, select the gear icon below the camera (Fig. 20).

• Continue to Pre-Surgery by selecting the Pre-Surgery tab once camera connection has been confirmed. Select

the Proceed button from the warning (Fig. 21).

Fig. 20– Camera Viewer

Fig. 21 – Warning Pop-up when moving to pre-surgery


Software Pre-Surgery

Step 1: Pre-surgery: assign instrument arrays

• From the Pre-surgery menu select the Instrumentation Tab. Select the instruments you plan to

use. Instrument arrays will automatically be assigned from A-E based on the order of instruments

selected. Eg. If your first instrument selected is a screwdriver, pulse will select the A array. If you select

another instrument that will be assigned to the B array and so forth. (Fig. 22).

• If you need to change arrays, select the array symbol and a pop up will appear with a list of instrument

arrays (A,B, C, D, E). Select the correct array to the corresponding instrument. If the array was previously

assigned to another instrument then the previous instrument will need the user to select a new array and

confirm in order to navigate with that instrument again.

• Pulse Pointer, Pulse Navigated Drill Guide, Pedicle Access Needle, and the Stealth-Midas Rex do not need

to have an array assigned. These have built -in arrays on the device itself.

Wifi button

Fig. 22 – Patient array selection


Software Pre-Surgery (cont.)

Step 2: Pre-surgery: confirmation of instrument arrays

• Select the instrument array to be confirmed.

• Place Instrument array onto divot of confirmationblock and aim it towards the camera (Fig. 23). Note: If

you try to confirm an instrument with the wrong assigned instrument array, the software will not be able

to confirm that instrument until the right array is selected correctly or that you reassign the correct array.

Fig. 23 – Confirmation of instrument

using confirmation block


Software Pre-Surgery (cont.)

• Hold instrument in divot until the status bar is filled and audio sound is made signifying the

completion of the confirmation of the instrument (Fig. 24).

• If an error message occurs and the instrument does not confirm then this will signify that either the wrong

instrument, instrument array, un-seated spheres or camera interference occurred during confirmation.

Verify the camera can see the instrument, passive spheres are correctly seated and not damaged nor dirty

and that the correct instrument and array was selected before repeating the steps again.

Fig. 24 – Confirmation of instrument using confirmation block

Wifi button


Software Intra-op

Navigation icons and Features

• All Navigation is displayed on Pulse Display 2: Pulse Navigation Display

Assigned instruments that have been confirmed can be used to navigate with a registered 3D

data set. Use known anatomical landmarks to confirm accuracy (Fig. 25).

• The Patient Reference Array Movement Indicator detects changes between the two patient reference arrays

(Fig. 25) and is only available when using Dual Pin Registration.

Green color array = less than 1 mm change between the two patient reference arrays. Yellow color array = 1 – 2 mm change between the two patient reference arrays. Red color array = a greater than 2mm change between the two patient reference arrays. Grey color array = only 1 patient array is being tracked.

Wifi button

Fig. 25 – Intra-op navigation of a 4.5mm consol tap

Navigation Menu Bar

and Features

Patient reference

array movement

indicator

Patient Registration

Information


Software Intra-op (cont.)

• Menu Bar and Features are accessible through icons in the upper

right corner of the Navigation

screen (Fig. 26).

Array Assignment

Appearance

Camera Setup

Layout Tools

Fig. 26 – Navigation Toolbar and Features

Registration

Tools

Layout and View Types

Open and Close Tool

Bar


Software Intra-op (cont.) Registration

• Select the Registration Icon in the menu bar from the Pulse Navigation Display. (Fig. 27)

• Follow the registration workflow determined in the equipment setup steps.

Single Fiducial registration

• Select New Registration on the summary page in the Registration Menu (Fig. 27).

• Move to the Select Type Folder tab and select Single Fiducial registration. The caudal array (white) will be

selected automatically (Fig. 28).

Fig. 27 – Select New Registration

Fig. 28 – Selecting Single Fiducial Registration


Software Intra-op (cont.) • Assign your patient reference fixation device, (Hip Pin or Spinous Process Clamp) and then the size of the

patient fixation device. For the Hip Pin choose between the 10cm or 15cm length. For the Spinous Process

Clamp choose between the 10cm or 13cm length. (Fig. 29).

• Move to the Capture Array(s) tab. Adjust Pulse Camera and Camera cart to see caudal patient reference array

(star). Select Capture Array(s) before acquiring 3D Scan. (Fig. 30).

Fig. 29 – Selecting Patient Array Fixation Device

Fig. 30 – Capturing Array for Single Fiducial

Registration


Software Intra-op (cont.) • Move to the Load/Register Patient Data Tab. Pulse can load 3D scans through either a USB or network

transfer. (Network transfer via ethernet connection between Pulse and the imaging device needs to be setup

ahead of time by a Pulse Specialist and a hospital PACS administrator). Select the mode of transfer and select

scan checking the name and date (Fig. 31).

• Confirm the scan orientation (Fig. 32 ). Pulse will automatically register the data set, exiting the registration

menu, and proceed into the main navigation screen. The user must check accuracy using anatomical

landmarks before proceeding (Fig. 33).

Fig. 31 – Loading 3D Patient Scan Data

Fig. 32 – Confirm Orientation



Fig. 33 – Confirm Accuracy



Dual fiducial registration


• Move to the Select Type Folder tab and select Dual Fiducial registration. The cranial array (black) and caudal

array (white) will be selected automatically.

• Assign your patient reference fixation devices for both patient arrays. (Hip Pin and/or Spinous Process Clamp)

and then the size of the patient fixation device. (Hip Pin, 10cm or 15cm; Spinous Process Clamp, 10cm or

13cm) (Fig. 35).

Fig. 35 – Dual Fiducial Registration

Fig. 34– Select New Registration


Software Intra-op (cont.) • Move to the Capture Array(s) tab. Adjust Pulse Camera and Camera cart to see both cranial (Diamond) and

caudal (star) patient reference array and select Capture Arrays before acquiring 3D Scan. (Fig. 36).

• Move to the Load/Register Patient Data Tab. Pulse can load 3D scans through either a USB or network

transfer. (Network transfer via ethernet connection between Pulse and the imaging device needs to be setup

ahead of time by a Pulse Specialist and a hospital PACS administrator). Select the mode of transfer and select

scan checking the name and date (Fig. 37).

Fig. 36 –Capture Arrays for Dual Fiducial

Registration

Fig. 37 – Loading 3D Patient Scan Data



• Confirm the scan orientation (Fig. 38 ). Pulse will automatically register the data set if the registration accuracy

is under 1.0mm, exiting the registration menu, and proceed into the main navigation screen. The user must

check accuracy using anatomical landmarks before proceeding (Fig. 39).

Fig. 38 – Confirm Orientation

Fig. 39 – Confirm Accuracy



• If registration is un-successful (Fig. 40) please check that the correct patient name was selected for the 3D

scan and that the correct patient reference array fixation devices were selected in the Select Type step.

Confirm that the assign patient arrays are seated down correctly on the Hip pin and Spinous Process clamp(s).

If not start with Capture Array(s) step:

• Press Re-register and repeat all the steps in Intra-Op Registration.

Fig. 40 – Unsuccessful Registration for Dual Fiducial

Registration


Software Intra-op (cont.) Siemens CIOS Spin Navilink Registration

• Install of the Siemens CIOS Spin 3D System array and calibration of the Navilink registration needs to be

completed ahead of time and done by a Pulse Specialist. Calibration is good for 1 year of service and service

date is labeled on the Siemens CIOS Spin system array. (Fig. 41).

• Connect the Siemens CIOS 3D Spin with the Pulse System using an ethernet cable.


Wifi button

Fig. 42 – Select New Registration

Fig. 41 – Pulse CIOS System array


Software Intra-op (cont.) • Move to the Select Type Folder tab and select CIOS registration. The caudal array (white) will be selected

automatically. The patient reference array fixation device will not need to be selected in this step. The

software does not need to know which pulse patient reference array fixation device is used for this type of

registration (Fig. 43). Proceed to the next step.

• Setup a 3D scan on the Siemens CIOS making sure to select the connection with the Pulse navigation system.

• Adjust cameras on the Pulse system to see both CIOS array and the Caudal patient reference array. A green

banner on top of the array view in the Capture Array(s) step will signal when it can see both arrays and to start

the 3D scan. (Fig. 44).

Fig. 43 – CIOS Registration Selection

Fig. 44 – Capture Array(s) view during a CIOS Navilink registration


Software Intra-op (cont.) • Acquire 3D scan on the Siemens CIOS Spin 3D.

• The software will automatically move to the Load/Register Patient Data tab once the scan has been

acquired. Select the read network folder tab and import study. Network transfer is the only method to

load the 3D patient scan using CIOS Navilink registration. (Fig. 45). (Network transfer via ethernet

connection between Pulse and the imaging device needs to be setup ahead of time by a Pulse Specialist

and a hospital PACS administrator)

• Confirm image orientation (Fig. 46).

Fig. 45 – Import Study

Fig. 46– Confirm image Orientation


Software Intra-op (cont.) • The software will register the Siemens CIOS 3D data set and will automatically open the main Navigation

display.

• Select Confirm and use anatomical landmarks to confirm accuracy (Fig. 47).

Multi Registration

• Pulse Navigation can store up to 8 registrations per session. A User can toggle between registrations in

Registration Overview. Make sure to attach and use the correct patient array(s) and patient reference array

fixation device accordingly to the completed associated registration. Always confirm accuracy using

anatomical landmarks.

• To toggle to between registrations make sure to attach correct array(s) on to the patient referrence array

fixation device that was used during the initial registration.

Fig. 47 – Confirm Navigation Accuracy


Software Intra-op (cont.) • Select the Registration to be used in the overview tab from the Registration menu bar (Fig. 48).

• Press the Select button to proceed and use anatomical landmarks to confirm accuracy (Fig. 49).

Fig. 48 – Select Registration

Fig. 49 – Select Registration


Software Intra-op (cont.) Array assignment

• Array assignment allows users to add, delete, or confirm instrument arrays and patient arrays (Fig. 50).

• Refer to Step 1 Pre-Surgery: Assign Instrument and Arrays; Step 2 Pre-Surgery: Confirmation of Instrument

Arrays to make changes to array assignments for both instrument and patient reference arrays.

Tools

• Tools menu allows the user to control features of navigated instruments during 3D navigation (Fig. 51).

Fig. 50 – Intra-op: Array assignment

Fig. 51 – Intra-op: Tools Menu



• Tools menu allows the user to control features of navigated instruments during 3D navigation (Fig. 52).

Trajectory Line On/Off

Auto Tool Selection

On/Off

Direction of Projection

Type of Projection

Extension On/Off and

Length

Diameter and Length of

Trajectory and Screw

Projections

Add Labels and

Containers

Containers with

Labels

Toggle between

saved Trajectories

or placed screws

Place Screw Save Trajectory

Scroll

Hide/Show All

Screws or

Trajectories

Fig. 52 – Features in the Tools Menu



• Auto Tool Selection On/Off = Software can customize the Tools menu automatically(On) manually (Off)

based on instrument that is currently being navigated (Fig. 53).

• Direction of the Projection = Trajectories can be projected forward of the tip of the instrument or

reverse/backwards from the tip of the instrument (Fig. 54).

Fig. 53 – Auto Tool selected to off. Scroll bar on right used to select instrument.

Fig. 54 – A forward projection of a screw on a navigated instrument.


Software Intra-op (cont.) • Trajectory Line On/Off = Turn On/Off trajectory line from navigated instrument (Fig. 55 and 56).

Fig. 55 – Trajectory Line On

Fig. 56 – Trajectory Line Off



• Type of Projection = Polygon (Fig. 57), line (Fig. 58), and screw (Fig. 54) is the type of projections that can

be selected. The polygon and screw size are projected by the diameter and length selected. The line projection

is based on length only. Forward projection can access polygon, line, and screw. Reverse trajectory can access

polygon and line.

Fig. 57 – Trajectory Line On

Fig. 58 – Trajectory Line Off



• Extension On/Off and Length = Turns on and off the extension line. Length of the extension can be

adjusted from 1mm -200mm (Fig. 59).

Fig. 59 – Extension Line On (Yellow)



• Diameter and Length of the Trajectory and Screw Projection = Select carrot to adjust sizes of the

diameter and length of Trajectories and screw sizes (Fig. 60 and Fig. 61).

Fig. 60 – Changing the diameter of projection or screw.

Fig. 61 – Changing the length of projection or screw.



• Save Trajectory = Saves the trajectory based on the position of the navigated instrument being tracked at

the time it is selected (Fig. 62). • Place Screw = Places the screw in the position of the navigated screwdriver being tracked at the time it is

selected (Fig. 63).

Fig. 62– Saving a Trajectory

Fig. 63 – Placing a screw.



• Hide All/Show All Screws or Trajectories = Hides or shows any of the trajectories or screws that have

been saved or placed respectively (Fig. 64 and Fig. 65).

Fig. 64– Show all screws

Fig. 65 – Hide all screws



• Add levels and Containers with Labels = Allow the user to select the levels of the spine used to label

the trajectories and screws planned and placed throughout a single registration (Fig. 66).

Fig. 66 – Add levels for labeling trajectories and screws



Layouts and View Types

• Saved Layout allows the user to change the navigation layout displayed on the navigation screen (Fig. 67 and

68).

Fig. 67 – Saved : Layout

Fig. 68 – Default 2 window layout



• ep • View Types allow the user to change the views navigation on the navigation screen (Fig. 69 and 70).

• Refer to Pre-Surgery: Assign Patient Arrays; Step 2 Pre-Surgery: Assign Instrument Arrays; Step 3 Pre-Surgery:

Confirmation of Instrument Arrays to make changes to array assignmen

Fig. 69 – View Types

Fig. 70 – Digital Radiographic Reconstruction (DRR) View


Software Intra-op (cont.) Known Defect If the browser on the local wireless client happens to automatically refresh during the process of changing the Layout then that selection of the new layout will not be changed on the local wireless client until the user exit the Layout step and re-enters the Layout menu. This defect does not affect the main Pulse display. Layouts are changed immediately with no issues from the local wireless client.



Appearance

• Appearance menu allows the user to change the display settings on the navigation screen (Fig. 71 and 72).

Fig. 71 – Intra-op: Appearance Navigation Display

Invert the Grey/Black

color scale

Brightness and Contrast

Flip Image

Rotate Image by

90 Degrees

DRR Interaction Mode

Touchscreen Gesture

Selection

2mm Slab

Thickness

On/Off

Reset View

Settings to the

Default Settings

Fig. 72 – Appearance Menu and Features



Camera setup

• Camera setup allows the user to visualize the operative field through an array and live camera view (Fig. 73

and 74).

Fig. 73 – Intra-op: Camera setup array view

Fig. 74 – Camera setup live view



Workflow for Trajectory Planning, Cannulation/Taping, and Screw Placement

Trajectory Planning

1. Attach instrument arrays and confirm instruments you will use to plan, cannulate, tap, and place screw as

described in Equipment setup: Step 3.

2. Attach a patient reference fixation device/s and corresponding patient reference array/s to the

appropriate anatomy of interest such as operative vertebra or PSIS and register the 3-D data set as

described in Equipment Setup: Step 4-6.

3. Make sure to check registration accuracy using anatomical landmarks at every level you navigate.

4. Select the preferred display layout as described in Software intra-op: Layout and View Types.

5. Adjust appearance of display to preference as described in Software intra-op: Appearance.

6. Select the Tools and add operative container levels as described in Software intra-op: Add levels and

Containers with Labels.

7. Plan the screw trajectory using the forward trajectory feature. Use the extension feature if using a

minimally invasive approach. A virtual screw or polygon can be used to template the size, and diameter of

the screw in the pedicle (Fig 75).

Fig. 75 – Forward Projection of a 6.5 mm diamte 45mm length screw


Software Intra-op (cont.) 8. Save the trajectory by selecting the level container and selecting save trajectory button. It will save the

trajectory at the position of the navigated instrument when taken (Fig 76).

9. If you need to adjust the trajectory, reposition the navigated instrument and select the container label

and select update trajectory (Fig 77).

Fig. 77 – Updating Forward Projection trajectory and length of a 6.5 mm diamte 50mm length screw at L4-L

Fig. 76 – Saved Forward Projection of a 6.5 mm diamte 45mm length screw at L4-L


Software Intra-op (cont.) Cannulation and/or Taping

10. The Tabels below list navigated instruments for cannulation and/or tapping.

Navigation Awl-Taps


11001056 NAV.S RELINE CONSOL CANN TAP 4.5MM



11001061 NAV.S RELINE CONSOL STYLET

11001062 NAV.S RELINE CONSOL RATCHET HANDLE

11001066 NAV.S RELINE CONSOL TAP 4.5MM



11001084 NAV.S RELINE CONSOL SOLID TAP 3.75MM





10001172 Nav.S Reline Awl

10001173 Nav.S Reline Gearshift Probe, Thoracic

10001174 Nav.S Reline Gearshift Probe, Lumbar

10001175 Nav.S Reline Gearshift Probe, Iliac

Table 6- Pulse Navigated Cannulated Aw-Tap Instruments

Navigation Drills


11000425 NAV.S RMM DRILL, 4.5MM





8801610 Navigation.S VuePoint II Drill Bit

Table 7- Pulse Navigated Drill Instruments


Software Intra-op (cont.) 3rd Party instruments

Medtronic Electric Stealth-Midas System


EM200N Electric Stealth-Midas Motor



AS14 Straight Attachment 14cm, Large Bore

AA14 Angled Attachment 14cm, Large Bore





14BA40 Stealth-Midas Rex Ball Fluted Ø5x140mm

15MH22 Stealth-Midas Rex Match Head Ø2.2x150mm

SP14MH30T Stealth-Midas Clearview Match Head Ø3x140mm

Medtronic Pedicle Access Kit


9733498NAV Navigated Pedicle Access Kit Table 8- Pulse Navigated 3rd Party Instruments



Navigation Taps

Part Number Description 11001006 NAV.S RELINE SOLID TAP 3.75MM

11000642 NAV.S RELINE SOLID TAP 4.0MM














11000442 NAV.S RELINE CANN TAP 4.0MM














11001211 Navigation.S RSS Solid Tap, 3.75mm















8801611 Navigation.S VuePoint II Tap Ø3.0mm (Ø3.5mm Screws)

8801612 Navigation.S VuePoint II Tap Ø3.5mm (Ø4.0mm Screws)

Table 9 - Pulse Navigated Tap Instruments



11. Cannulate and/or tap the pedicle by aligning the already confirmed navigated instrument to the saved

plan( Fig 78).

12. Update the plan trajectory by selecting the reverse projection and polygon feature when the navigated

instrument is fully seated at the desired depth of the pedicle (Fig 79).

13. Repeat Steps 11 and 12 if further cannulation or Tapping is required.

Fig. 78 – Aligning tap to saved Forward Projection trajectory at L4-L

Fig. 79 – Updating saved trajectory once the tap is fully seated at the desired depth at L4-L



Screw Placement

14. Table 10 list all navigated screwdrivers.


D1642763 Navigation.S Reline Driver Poly Solid SA

D100001140 Navigation.S Reline Driver Poly Solid

D1642994 Navigation.S Reline Driver Poly Solid Locking SA

D100001141 Navigation.S Reline Driver Poly Solid Locking

10001139 Navigation.S Reline Driver Poly Cannulated

D10001139 Navigation.S Reline Driver Poly Cannulated Dismantlable

D1642776 Navigation.S Reline Driver Closed Iliac Solid SA

D100001142 Navigation.S Reline Driver Closed Iliac Solid

10001146 Navigation.S Reline Shankdriver Solid

10001145 Navigation.S Reline Shankdriver Cannulated

D10001145 Navgiation.S Reline Shankdriver Cannulated Dismantlable

10001155 Navigation.S Reline Shankdriver Low Profile Cannulated

D1642768 Navigation.S Reline Driver Fixed Solid SA

D100001144 Navigation.S Reline Driver Fixed Solid

10001143 Navigation.S Reline Driver Fixed Cannulated

D10001143 Navigation.S Reline Driver Fixed Cannulated Dismantlable

D1874926 Navigation.S RSS/RMM Driver, Poly Solid SA

D11001744 Navigation.S RSS/RMM Driver, Poly Solid

10001230 Navigation.S RSS/RMM Driver, Poly Cannulated

D11001230 Navigation.S RSS/RMM Driver, Poly Cannulated Dismantlable

10001150 Navigation.S Reline Driver, Reduction Cannulated

8977729 Navigation.S VuePoint II Driver, Threaded

Table 10- List of navigated screwdrivers

15. Attach a screw onto the navigated already confirmed screwdriver and adjust diameter and length to

match the screw being placed. Table 8 list all compatible navigated screw diameters and lengths for Reline

and VuePoint II fixation system.

Screw size chart

Fixation System Name

Min Diameter Max Diameter Min Length Max Length

Reline 4.0 mm 12.5 mm 17.5 mm 120 mm

VuePoint II 3.5 mm 5.5 mm 10 mm 40 mm

Table 11 - Compatible Navigated Screws for Reline and VuPoint II Drivers

16. Navigate screw and driver to the saved trajectory (Fig. 80). Perform surgery as indicated by the surgical

technique for the corresponding NuVasive implant system.



Fig. 80 – Navigating a Nav S., Driver with a 6.5mm diameter x 50mm length screw attached to the saved trajectory.

Fig. 81 – Saved 6.5mm diameter and 50mm length screw at L4-L



17. Optional: Save Screw after being placed by selecting the container level and saving the screw (Fig. 81).

18. Repeat steps 3-13 for each additional screw placement.

19. It is recommended to confirm screw placement accuracy with stimulated electromyography (EMG) or

confirmation 2D C-arm, X-ray, or an intra-operative 3D imaging..

IOM Integration

• During Navigation, Pulse can change the instrument color dynamically while stimulating

using the NuVasive IOM software. Based on the threshold colors, the instruments will

change color automatically during stimulation of the instrument in Navigation (Fig. 82 - 85).

Fig. 82 – Standard navigation with

no Pulse IOM stimulation

Fig. 83 – Standard navigation with Pulse

IOM stimulation and a green threshold

map warning


Pulse IOM stimulation and a yellow

threshold map warning


Pulse IOM stimulation and a red threshold

map warning



Pulse Navigation accessories

The following accessories are available within Pulse Navigation System:

Component Sterility Sterilization Method

Patient Reference Array Sterile, single use EO

Hip Pin Sterile, single use EO

Passive Marker Spheres Sterile, single use EO

Pedicle Access Kit Sterile, single use EO

Spinous Process Clamp Non-Sterile, reusable Steam

Slap Hammer Non-Sterile, reusable Steam

Pin Cap Non-Sterile, reusable Steam

Pointer Non-Sterile, reusable Steam

Hardware Inserter Non-Sterile, reusable Steam

Driver Non-Sterile, reusable Steam

Drill Guide Non-Sterile, reusable Steam

Drill Guide Handle Non-Sterile, reusable Steam

Drills Non-Sterile, single use Steam

Patient Reference Array Inserter Non-Sterile, reusable Steam

Cleaning and sterilization of reusable accessories

These cleaning and sterilization instructions apply to all Pulse Navigation accessories listed above and Nav.S

instruments. Remove instrument arrays from navigation instruments before cleaning and sterilization. Remove and

discard the passive reflective markers from the instrument confirmation block, instrument flat arrays, drill guide,

and pointer before cleaning and sterilization. The patient reference arrays, Hip pins, passive reflective markers,

and drills are single use and should be disposed after each use. Assemble new reflective spheres to confirmation

block, instrument arrays, pointer, and drill guide after steam sterilization and prior to use in surgery.

Cleaning and decontamination

All Pulse Navigation accessories listed above and Nav.S instruments must first be thoroughly cleaned using the

validated methods described below before sterilization and introduction into a sterile surgical field. Contaminated

instruments should be wiped clean of visible soil at the point of use, prior to transfer for full processing. Cleaning

instructions for the instruments are as follows:

11. Prior to soaking the device in an enzymatic cleaning solution, rinse the device under cool running tap water

and wipe off any residual soil or debris with a disposable towel. Ensure to flush out any lumens, cracks or

crevices while rinsing under running cool tap water.


Cleaning and Decontamination (continued)

12. Prepare an enzymatic cleaning solution per manufacturer’s recommendations using warm tap water. Place the

device in the solution in the open position (as appropriate) and soak for 50 seconds. While soaking, actuate

the device through a full range of motion to allow complete penetration of the cleaning solution.

13. After the 50 seconds soak time, remove the device and wipe any soil or debris using a disposable towel. Then

place the device into a fresh batch of an enzymatic cleaning solution using warm tap water. Brush the entire

surface of the instrument with a soft bristle brush. Actuate the device while brushing and ensure to brush all

hard to reach areas. Use a sterile syringe and lumen brush to clean hard to reach areas and flush each end of

the device with a total of 60 ml.

14. Remove the device from the detergent and rinse by agitating and actuating in RO/DI water for 30

seconds. Flush all hard to reach areas with a sterile syringe at each end of the device with a total of 60 ml.

15. Use a low foaming, neutral pH, phosphate-free cleaning solution and prepare per manufacturer’s

recommendations using warm tap water in a sonication unit. Allow the device to sonicate for 10 minutes.

16. Remove the device from the detergent and rinse by agitating and actuating in ambient RO/DI water for 30

seconds. Actuate through a full range of motion while rinsing and flush all hard to reach areas with a sterile

syringe at each end of the device with a total of 60 ml.

17. Transfer the device into the washer for processing. Position the device to allow for proper drainage. Below is

the validated and recommended cycle:

Phase Recirculation time Water temperature Detergent type & concentration

(if applicable)

Pre-wash 2 minutes Cold Tap Water N/A

Enzyme Wash 2 minutes Hot Tap Water MetriZyme, 1 oz/gallon or Equivalent


Wash 2 minutes 65.5o C (set point) MetriZyme, 1 oz/gallon or Equivalent


PURW Rinse 1 minute 43o C N/A

Drying 15 minutes 90o C N/A

18. Dry the instruments using a clean non-linting cloth.

19. Visually inspect the instruments following performance of the cleaning instructions prescribed above. Ensure there is no visual contamination of the instruments prior to proceeding with sterilization. If possible, contamination is present at visual inspection, repeat the cleaning steps above. Otherwise, contact your NuVasive representative – contaminated instruments should not be used, and should be returned to NuVasive.

20. All instrument moving parts should be well lubricated. Be careful to use surgical lubricants and not industrial oils.


Cleaning and Decontamination (continued)

Note: Certain cleaning solutions such as those containing bleach or formalin may damage some devices and must

not be used.

Contact your NuVasive representative for any additional information related to cleaning and sterilization of

NuVasive surgical instruments.

Sterilization

All Pulse Navigation accessories listed above and Nav.S instruments are provided non-sterile and must be sterilized

prior to use. All non-sterile instruments provided in sterilization trays are sterilizable by steam autoclave using

standard hospital practices. Sterilization of the instruments may be accomplished effectively by means of vacuum

steam cycles described below. Remove the passive reflective markers from the confirmation block and instrument

flat arrays before autoclaving. Failure to do so will damage the System and results in inaccurate measurements.

The steam sterilizable components of the Pulse System are to be packaged in an FDA-cleared sterilization wrap

prior to placement in an autoclave. In a properly functioning and calibrated steam sterilizer, effective sterilization

may be achieved using the following parameters:

Method: Steam

Cycle: Pre-Vacuum

Temperature: 270°F (132°C)

Exposure Time: 4 minutes

Minimum Dry Time: 30 minutes

Minimum Cool Down Time: 40 minutes

Always sterilize the instruments in the disassembled, open, unlocked position. Avoid sudden cooling of the device

components. Ensure that all functions are unimpaired before use. Before proceeding with surgery, verify that all

devices are correctly assembled and that all instruments are undamaged. Assemble new reflective spheres to

confirmation block and instrument flat arrays after steam sterilization of the confirmation block and instrument

flat arrays.

Sterile components

Hip pins, patient reference arrays, and passive reflective marker spheres are Ethylene Oxide sterilized, single use and

disposable. Do not attempt to reprocess sterile single use components.


Pulse LessRay


LessRay Functional Overview

LessRay works by combining (or in some cases alternating) the current image being taken with a prior “learned”

image of the same anatomy. The initial image, taken at full radiation dose settings, serves as the “baseline” to

which images taken at lower dose radiation settings can be compared and enhanced.

C-arm Tracking

The 3-dimensional (3D) C-arm tracking component adds usability

enhancements to LessRay. By providing a navigational guide for the C-

arm technologist during a procedure, the C-arm Tracking feature may

reduce the number of images needed for relocalization, reduce

fluoroscopy time, and reduce radiation. One of the most prominent

challenges of C-arm use is the difficulty of returning the C-arm to the

position in which a previous image was taken. Tracking helps the C-arm

technologist to move the C-arm back to the position that a learned

image was taken. While moving the C-arm, the display shows where the

C-arm is currently positioned relative to the selected learned image. The

display indicates when the C-arm is correctly positioned to take a new image

to align with the learned image.

X-ray Image Stitching

The stitching feature allows the user to stitch together multiple images to

create a panoramic view of the pertinent anatomy.

Alternate Image

By merging an image containing instruments with the unencumbered learned image,

the radio-dense metallic tools and implants that obscure the underlying anatomy can

be rendered partially translucent in the merged image. In addition, by alternating the

new image with the learned image, the user may potentially make these metallic tools

or implants “disappear from” and “reappear in” the image, displaying the anatomy

blocked by the instruments, thereby aiding the assessment of the instruments relative

to the anatomy of interest.

Angle Grid

By lining up the spinal anatomy to a grid on the LessRay monitor, the C-arm

technologist may find the desired end plate shot in reduced time/or with a

reduced number of images taken.


LessRay Setup

C-arm Model Compatibility

LessRay currently services GE/OEC 9800 and 9900, 9” and 12” models, and Siemens Cios Spin.

• The user interface defaults to the C-arm technologist screen on the Siemens Cios Spin imaging system

• If using a GE C-arm, the C-arm technologist interface can be accessed via the ‘C-arm Tech Profile’ on the

LessRay tablet.

Steps are listed below:

o Client: Turn on the wireless client. o Client: Follow the instructions to set up the wireless connection on the Pulse cart. When

it comes to “Select the type of user being connected” select the C-arm Tech profile. When the verification pop up is present, insert the code supplied in the Connection Instructions on the cart, your name, and then select confirm.

LessRay Hardware Components

The use of LessRay requires the components listed below. All components are provided non-sterile and are not

intended to be used in a sterile field. Clear transparent sterile drapes should be used to cover the C-arm Collar,

Table Array, and Calibration Sphere when in a sterile environment.

1. Pulse System

2. Pulse Camera

3. Pulse Camera Cart

4. C-arm technologist touchscreen monitor on Cios Spin, or LessRay Tablet

1. LessRay tablet comes with C-arm attachment, docking station, power cord, and extra

batteries

5. Pulse Monitor

6. Pulse BNC video cable (to connect the computer to the GE fluoroscopes)F

7. Ethernet cable (to connect the computer to the Cios fluoroscope)

8. C-arm Collar with Arrays

9. Table Array

10. Short table clamp

11. Long table clamp

Note: The LessRay tablet can be stored docking station, or attached to the C-arm.

The tablet should be charged via the docking station or power cord in-between

cases to preserve battery life. The case tablet comes with two sets of external

batteries to prolong the usability of the tablet. These batteries may also be

charged via the docking station. Each battery system will provide the tablet with 8

hours of battery life. These batteries may be switched (one at a time) while

keeping the tablet on and running.

Note: At least one battery must be in the tablet during the battery switch to keep

the device running.


LessRay Setup (continued)

Connecting the LessRay Tablet to the C-arm

Complete the following steps to set up LessRay for use in the operating room:

1. Position the Pulse cart so surgeon monitor can be seen by the physician, and the LessRay Tablet (or Cios

Spin Screen) are at an accessible viewing angle for the C-arm technologist.

2. Cios Spin Set-up

1) Attach table array to surgical table using long or short clamps

This can be placed on the C-arm side, or opposite the C-arm side. When placing,

consider the line of sight to the camera.

2) Plug Ethernet cord into Cios spin and Pulse cart

3) Verify that Cios array is attached to Cios spin

3. GE Set-up

1) Attach table array to surgical table using long or short clamps

2) Plug BNC cable into GE C-arm (far left or middle port)

3) Attach Pulse LessRay tablet to C-arm

4) Attach LessRay Collar (9” or 12”, respectively)

Note: The Pulse Cart must be turned on before turning the LessRay tablet on. If you turn the tablet on without the

initial connection an invalid webpage will be displayed. If you turn ON the pulse cart the tablet will not be able to

establish a connection. The tablet will need to restart to establish a connection

Arrays, C-arm Collar, Keyboard, Remote, and Calibration Sphere

Clean the Table Arrays, C-arm Collar Arrays, C-arm Collar, Keyboard, and Remote with disinfectant wipes

containing 70% isopropanol. Avoid prolonged contact between wipes and Arrays. If the Arrays show damage or

wear, use new Arrays.

The Calibration Sphere should be cleaned using NuVasive instrument cleaning instructions (Doc – 9400896).

Clear transparent sterile drapes must be used to cover C-arm Collar, Table Array, and Calibration Sphere to

maintain the sterile field while using LessRay.

Camera setup/positioning

The Table Array and Collar Array must both be visible to the LessRay Camera for tracking to function properly. To

aid in finding the best position of the camera, select the camera view on the Pulse screen. This will provide a full

view of the camera line of sight which may help in confirming visibility of the C-arm Collar and Table Arrays. Adjust

the camera until both arrays are captured in the field of view. The live view may be used in addition to the array

view to find the optimal position.



The Table Array and C-arm collar arrays are displayed as icons. When these icons turn green, they are within the

camera’s field of view. Position the C-arm over the target anatomy and in the C-arm A/P orientation. If using Pulse

Navigation, please note that the patient array and instrument arrays will not show up as icons in the LessRay

camera viewer.

The recommended position of the camera is at the head or the foot of the bed. If the arrays are all visible to the

camera, the camera positioning is at the discretion of the surgeon. The camera view icon is displayed on the

bottom right hand of the C-arm and pulse view during the intra-op portion of the procedure, and on the main

screen camera view during the set-up. Again, you can use this icon to better understand the camera’s line of sight,

and adjust the camera, or arrays accordingly. In the image below, both icons are green, indicating that the camera

can view both arrays within its scope of view. The icons are displayed as a table (for the table array) and a C-arm

(for the C-arm array).

If the Camera can see the Collar Array and the Table Array, tracking is enabled.

1. Position the C-arm over the target anatomy and in the C-arm A/P orientation.

2. Position the Table Array so that it can be seen by the camera throughout the procedure. Placing it closer

to the camera and not behind the C-arm is recommended to maintain camera visualization.

3. Slide the C-arm up and down the table to verify that the Camera has vision over the necessary range to

perform the surgical procedure.

4. Position the C-arm in the C-arm lateral (cross table) orientation and verify that the Camera still has line of

sight of both the C-arm and the Table Array. Slide the C-arm up and down the table to verify that the

Camera has vision over the necessary range to perform the surgical procedure.



Note: another way to confirm the arrays for the C-arm and

table are within view of the camera is to see that the two

corresponding symbols (highlighted below) are both showing

green.

Cios Spin Note: if LessRay tracking is lost in the lateral C-arm

view, and there is no obstruction blocking the LessRay Radix

lenses, remove the Navilink spheres on the Cios collar.

Opening LR on Pulse screen

On the Pulse setup screen, confirm you have selected LessRay as one of the applications for the case. Once you

have moved from the setup main screen, you will be guided into pre-surgery. After going through the other

workflow items like neuromonitoring and IGA parameters, if selected, you will be guided to the “Setup LR” tab,

which stands for setup LessRay. During the LessRay set up, you may have an option to create a stitch. More detail

about how to perform the setup is in the section below “Setting Up LessRay”. The Pulse screen and surgeon

monitor will display differently than the LessRay tablet/Cios screen. These screens are optimized for the specific

role permissions and display size for the C-arm technologist and the surgeon. The C-arm tech will not have access

to any other Pulse applications from their tablet.

Setting Up LessRay

On the Pulse screen or on the LessRay tablet or Cios Spin screen, navigate to the Setup LR screen.



From here, the C-arm technologist may scout for basic initial positioning over the appropriate anatomy.

Once the LessRay hardware is configured, tracking begins aiding in the localization of the anatomy. This feature,

called “Scouting,” helps in positioning the fluoroscope over the anatomy to be imaged by providing visual cues of

the C-arm movement based on the previous X-ray image taken.

Position the fluoroscope as best as possible over the target anatomy. Take an X-ray image. In the example below,

the image is not centered over the anatomy, and we would like to have a better centered view of L4/L5 as well as

L5/S1.

Move the C-arm left, right, up, down, in, and/or out to center the target anatomy in the Viewfinder circle on the

LessRay screen. Continue taking X-ray images until the desired X-ray image which is centered on the target

anatomy is acquired. In the example below, the next X-ray image taken is centered on L4 and L5.

Once scouting has been used to find an acceptable image of the anatomy, press the “Learn” button to save that

image for both image enhancement and relocalization.



For every learned X-ray image, LessRay helps the C-arm technologist move the C-arm back to the location where

the image was taken. This is accomplished through the “Viewfinder” feature, similar to the scouting feature, where

the learned X-ray image is moved on the screen to match movement of the C-arm.

Once the technologist has ‘learned’ all the X-ray images for the procedure, and the surgeon and staff are prepared

to move forward, they may enter the intra-op portion of the procedure.

Tracking View

The view for the surgeon will show the tracking feature in the bottom left hand corner of the default C-arm/IOM

screen, as displayed below:



The view for the C-arm technologist will remain the same as they experienced during the set-up. The C-arm view is

displayed below:

The alignment bar will show if the image has been aligned. If the image does not align, a banner will indicate that

the alignment has failed. A gray bar indicates an alignment has not been attempted.

LessRay Features

Tracking

After an image had been ‘learned’ the Pulse LessRay system will track to that

image. The user can save multiple ‘learned’ images. All ’learned’ images will

appear in the slide out baseline tray, available from the arrow in the bottom left

hand corner of the screen. Upon learning, they will be given default names;

however, Upon learning, they will be given default names; however, these can be

labeled to give the C-arm tech more information about what anatomy it includes,

or where it is located. To label the baseline, open the baseline list, click the

baseline name, and then click rename.

One of the most prominent challenges of C-arm use is the difficulty of returning

the C-arm to the position in which a previous image was taken. Tracking helps the

C-arm technologist to move the C-arm back to the position that a learned image

was taken. While moving the C-arm, the display shows where the C-arm is

currently positioned relative to the selected learned image. The display indicates

when the C-arm is correctly positioned to take a new image to align with the

learned image.


LessRay Features (continued)

Crosshair

The “Crosshairs” button when selected, displays a crosshair in the center of the Viewfinder to assist with

localization.

Angle Grid

The angle grid is another tool that can be helpful in locating endplates or lining the C-arm up to other anatomy.



Stitching

1. Take an image of the desired anatomy and press “Stitch”.

2. Move the C-arm in the direction required to image more of the anatomy, while keeping the circle green.

3. Take a new image that aligns and stitches to the previous image. Now both X-ray images are considered

“learned” images and are part of Stitch “A.”

4. Continue moving the C-arm and taking images. LessRay will stitch each successful alignment into the Image

Set.

5. When the full view of the patient is captured, press “End Stitch” to exit Stitching Mode. The LessRay will blend

the images together live, as shown above.

X-ray Image Stitch allows a larger view of the anatomy to be viewed at once. Each learned image in the stitch can

be selected by moving the C-arm close to that image in the stitch. Taking a new image while the Viewfinder circle is

green will cause an image enhancement to be attempted between the new image and the closest learned image of

the stitched image set.

Unstitch

If an aligned image is unintentionally added to a stitch, selecting “Unstitch” will remove the most recent

composited image from the selected image set.



Images

Saving images

Images may be saved in several ways. If the user desires to save the entire screen, the camera icon in the top left-

hand corner may be pressed to save everything on the user screen via a screenshot. This can be done on the main

Pulse system cart. *Be aware there may be patient information in the screenshot which should be treated in

compliance with HIPPA.

If the user desires to save the image only, this can be performed by touching the image in the right-side smaller

box, which is the ‘copy to reference’ box. This will navigate to a different screen, with the chosen image moved

into the center of the view. Choose the “Save” icon to save the image. These images can be exported at the end of

the case.

To save an image on the Pulse cart, press the save button from context controls or press copy to reference. To save an image on the LessRay GUI press the save button from the tool panel, or select the live image and press the save button from the context controls or copy to reference.



Image bank

To see saved images; (stitches and baseline images are saved automatically); tap the image to activate context

controls and then press the image bank icon to view the thumbnails of images in the image bank. To view the full-

size image, click the thumbnail. When viewing a reference image in the left/live viewport, select the "return to

live" button at the top of the viewport.

Alternatively, the user may also choose the arrow on the left bottom corner to view images in the image bank.

After pressing the arrow, the image bank will slide across the bottom of the screen, and the user may scroll

through using a side by side finger sweeping motion to view the images.

Low-dose alignment

Low-dose Imaging with Siemens Cios Spin

The Cios Spin has a variety of radiation exposure settings to choose from. Careful selection based on patient

anatomy or other considerations may result in lower radiation levels, and usable images when used in conjunction

with LessRay.

After completing scouting and saving of full-dose fluoroscopy images to establish baseline, the C-arm technologist

may adjust the Cios Spin to take lower dose images. To do this, navigate to the circular “Fluoro” button on the

main Cios Spin touch user interface (TUI). After pressing the Fluoro button you are now in Fluoro image mode. The

user may adjust the dose to low dose choosing the “Dose” square button, located just beneath the Fluoro button,

and pressing “low”. Confirm, if necessary, that the user has also pressed the “Tech lock” square button, to turn off

the “Auto” function. If this stays on, the Cios Spin may adjust the dosage back from the setting it was just placed

into. If the C-arm technologist would like to adjust the dosage further manually, the user may press the “Pulse

rate” square button on the bottom right hand corner of the TUI. This dosage level can be lowered to 0.5p/s.

Low-dose Imaging with GE Fluoroscopes

The GE 9900 and 9800 fluoroscopes have a variety of radiation exposure settings to choose from. Careful selection

may result in lower radiation levels used to achieve usable quality images, especially when used in conjunction

with LessRay.

Automatic Settings

Low-dose - This button will reduce the dosage of radiation used per X-ray exposure.

Pulse Fluoroscopy - Typical non-pulsed fluoroscopy is 30 X-ray images taken per second (30 PPS). The pulse rate

may be set to a variety of pulse rates offered on the C-arm - 1, 2, 4, 8, 15 or continuous (30 PPS). Setting the dose

to 1 may result in 1 X-ray image taken per second as opposed to the standard 30 per second.



Manual Settings

Automatic Brightness Control (ABC) function - This function adjusts the two main controls of the X-ray tube, mAs

(current) and kV (voltage). The kV controls the penetration of the X-ray images. The mAs control the total amount

of X-ray images. The ABC function of the fluoroscope adjusts these two settings at the beginning of each X-ray

exposure to achieve an acceptable image quality.

When mA and kV are manually adjusted, ABC is automatically disabled. Turning down the mAs and adjusting the

kV manually is referred to by LessRay as ultra- low dose imaging. Typically imaging at mAs values lower than the

standard setting “Low Dose” results in unusable images. However, with LessRay, these manual settings may be

usable.

Steps:

1. Navigate back to a learned image.

2. Achieve a successful Image enhancement, then press the “Auto” button on the C-arm to disable ABC.

Verify that Auto Contrast is still enabled on the fluoroscope.

3. Take a new X-ray image.

4. If the next new X-ray image is still usable on the LessRay screen, turn the mA on the fluoroscope down

one notch.

5. As the surgical procedure progresses, continue turning the mA down until the image fails to enhance in

LessRay or becomes unusable by the physician.

6. Once the image quality becomes too low, turn the mA up slightly so that the image is usable.

7. At any point the kV may be adjusted to potentially improve the quality of the image being produced.

If the image becomes unusable or a full dosage X-ray image is required, press the “Auto” button on the

fluoroscope to set the fluoroscope back to 1pps and low dose. Press the “Pulse” and “Low Dose” buttons to set the

fluoroscope back to “Full Dose” imaging.

One final note on ultra-low dose imaging: the fluoroscope has a built-in automatic contrast adjuster. This setting

mostly affects the contrast of the image displayed. When ABC is disabled, auto-contrast is automatically disabled

on some fluoroscopes. Keeping automatic contrast enabled during imaging may help with contrast visualization.



Image Enhancement

LessRay may be used to improve visibility of target anatomy or structures that would otherwise be obstructed by

the presence of radio-dense material (e.g., tools or bones). When an image that includes tools, for example, is

merged with a learned image that does not have a tool, the tool will appear semi-transparent, allowing the

physician to “see behind” the tool or other radio-dense object. The user can adjust the opacity or translucency of

the object using the image enhancement slider. The slider helps add more or less of the baseline image to the

alignment.

Note: For procedures which have small radio-dense objects added into the image which need to be tracked or

monitored, the object may be too faint to visualize adequately at a 30% ratio. LessRay should not be used under

these circumstances.



Metal Boost™

In scenarios where adjusting the base amount slider is not adequate for visibility of radio-dense materials, the

Metal Boost function may be used. Pressing the “Metal Boost” button causes the image to be post-processed

if possible, to boost the visibility of radio-dense materials in the alignment, like instruments or wires. After

selecting, Metal Boost™ will be attempted on all subsequent alignments until the button is disabled again.

Note: In some cases, the new X-ray image will be too low-quality for Metal Boost to be attempted even if the

alignment is successful. In those scenarios, the unboosted alignment will be displayed with an alert notifying the

user that the boost was unsuccessful.

Warning: If metal is not visible in low-dose image, Metal Boost™ should not be used. Note: When using metal boost, if contrast and noise in the image obscure the metal, troubleshoot as follows:

1. Retake an image with the fluoroscope set to a higher radiation dose setting. 2. If the issue persists, turn metal boost off. 3. If necessary, temporarily cease using LessRay and use the fluoroscope per protocol without LessRay.

Note: In some cases, the new X-ray image will be too low-quality for Metal Boost to be attempted even if the

alignment is successful. In those scenarios, the unboosted alignment will be displayed with an alert notifying the

user that the boost was unsuccessful.

Alternate

To alternate an image over the baseline image, press the alternate button when an aligned pair of images is

displayed. This feature will show the latest image alternating over the baseline image. This can be useful to show

how anatomy may have shifted over the surgery, or how things have changed with instrumentation.

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Inc.

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© 2021. NuVasive Inc. All rights reserved. Pulse® Navigation is a registered trademark of NuVasive, Inc. in the United States and may be registered in

other countries. All other third-party marks are the property of the respective owners.

©2021. NuVasive, Inc. All rights reserved. NuVasive, Pulse™, and Pulse Navigation™. are registered trademarks of NuVasive, Inc. in

the United States and may be registered in other countries.

Documents

Pulse™ Product Reference Manual