SENSIA® SED01Dual chamber pacemaker (DDD)

Implant Manual

0123

2005

The following are trademarks of Medtronic:Capture Management, Intrinsic, Medtronic, Search AV, Sensia

Contents1 Description 52 Indications 53 Contraindications 54 Warnings and precautions 6

4.1 Warnings 64.2 Precautions 7

5 Potential adverse events 105.1 Patient-related potential adverse events 115.2 Device system-related potential adverse events 11

6 Implant procedure 116.1 Verify lead and connector compatibility 126.2 Test the lead system 126.3 Connect the lead to the device 126.4 Test the device operation 136.5 Position and secure the device 146.6 Program the device 146.7 Replace a device 14

7 Magnet operation and Recommended Replacement Time (RRT/ERI) 158 Measuring methods 159 Product specifications 17

9.1 Shipping, nominal, and electrical reset parameters 179.2 Programmable parameters 219.3 Automatic and clinician-selectable diagnostics 26

10 Physical characteristics, battery longevity 2810.1 Electrical characteristics 28

11 Declaration of conformity 2812 Medtronic limited warranty 2913 Packaging symbols 29

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1 DescriptionAbout this manual – This document is primarily an implant manual. Regular patient follow-up sessions shouldbe scheduled after implant. Follow-up procedures such as monitoring battery measurements and confirmingtherapy parameters are described in the product documentation that is included with the software that supportsthis device. To obtain additional copies of product documentation, contact a Medtronic representative.This manual describes the Medtronic Sensia D dual chamber, multiprogrammable, implantable pulse generator(IPG) bipolar/unipolar Model SED01.Single chamber rate response – Single chamber rate response is controlled through an activity-based sensor.Programmer and software – Use the appropriate Medtronic programmer and software to program this device.Programmers from other manufacturers are not compatible with Medtronic devices but will not damage Medtronicdevices.Contents of sterile package – The package contains one implantable pulse generator and one torque wrench.

2 IndicationsThese Medtronic Sensia implantable pulse generators (IPGs) are indicated for use to improve cardiac output,prevent symptoms, or protect against arrhythmias related to cardiac impulse formation or conduction disorders.These devices are indicated for use in patients who are experiencing exercise intolerance or exercise restrictionsrelated to an arrhythmia. Using rate response modes may restore heart rate variablility and improve cardiacoutput.Sensia D Series implantable pulse generators are indicated for single use only.

3 ContraindicationsThere are no known contraindications for the use of pacing as a therapy to control heart rate. The patient’s ageand medical condition may influence the selection of the pacing system, the mode of operation, and the implanttechnique used by the physician.Medtronic Sensia D Series implantable pulse generators (IPGs) are contraindicated for the following applications:

● Use of an implantable cardioverter defibrillator (ICD) with a unipolar-only IPG or in those cases in whichunipolar leads are implanted for the other models described. Pacing in the unipolar configuration may causethe ICD to deliver inappropriate therapy or to withhold appropriate therapy.

● Dual chamber pacing in patients with chronic or persistent supraventricular tachycardias, including atrialfibrillation or flutter.

● VDD mode operation in patients with sinus disorders.● Single chamber atrial pacing in patients with AV conduction disturbance.● Asynchronous pacing where the presence or likelihood of spontaneous rhythms may cause competitive

pacing.

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4 Warnings and precautions4.1 Warnings4.1.1 Device operationCrosstalk – Crosstalk may cause the device to self-inhibit, which results in no pacing. Program Ventricular SafetyPacing to On to prevent inhibition due to crosstalk.Lead compatibility – Do not use another manufacturer’s leads without demonstrated compatibility withMedtronic devices. If a lead is not compatible with a Medtronic device, the result may be undersensing of cardiacactivity, failure to deliver necessary therapy, or a leaking or intermittent electrical connection.Lead connection – Consider the following information when connecting the lead and device:

● Cap abandoned leads to avoid transmitting electrical signals.● Plug any unused lead ports to protect the device.● Verify lead connections. Loose lead connections may result in inappropriate sensing and failure to deliver

arrhythmia therapy.Rate responsive modes – Do not program rate responsive modes for patients who cannot tolerate rates abovethe programmed Lower Rate. Rate responsive modes may cause discomfort for those patients.Single chamber atrial modes – Do not program single chamber atrial modes for patients with impaired AVnodal conduction. Ventricular pacing will not occur.4.1.2 Pacemaker-dependent patientsInhibit function – Use caution when using the programmer to inhibit pacing. The patient is without pacing supportwhen pacing is inhibited.Pacemaker-dependent patients – Always program Ventricular Safety Pacing (VSP) to On forpacemaker-dependent patients. Ventricular Safety Pacing prevents ventricular asystole due to inappropriateinhibition of ventricular pacing caused by oversensing.Polarity override – Do not override the polarity verification prompt with bipolar polarity when a unipolar lead isconnected. Overriding the polarity verification prompt results in no pacing output.Threshold Margin Test (TMT) and loss of capture – Be aware that loss of capture during a TMT at a 20%reduction in amplitude indicates an inadequate stimulation safety margin.4.1.3 Medical therapy hazardsDiathermy – People with metal implants such as pacemakers, implantable cardioverter defibrillators (ICDs), andaccompanying leads should not receive diathermy treatment. The interaction between the implant and diathermycan cause tissue damage, fibrillation, or damage to the device components, which could result in serious injury,loss of therapy, and/or the need to reprogram or replace the device.Electrosurgical cautery – Electrosurgical cautery may induce ventricular arrhythmias and fibrillation or maycause device malfunction or damage. If electrosurgical cautery cannot be avoided, observe the followingprecautions to minimize complications:

● Keep temporary pacing and defibrillation equipment available.● Use a bipolar electrocautery system if possible.● Use short, intermittent, and irregular bursts at the lowest clinically appropriate energy levels.● Avoid direct contact with the implanted device or leads. If unipolar cautery is used, position the ground plate

so the current pathway does not pass through or near the device and lead system. The current pathwayshould be a minimum of 15 cm away from the device and lead system.

● Program the device to an asynchronous pacing mode for pacemaker-dependent patients.

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External defibrillation – External defibrillation may damage the implanted device. External defibrillation mayalso temporarily or permanently elevate pacing thresholds or temporarily or permanently damage the myocardiumat the electrode tissue interface. Current flow through the device and lead may be minimized by following theseprecautions:

● Use the lowest clinically appropriate defibrillation energy.● Position the defibrillation patches or paddles a minimum of 15 cm away from the device.● Position the defibrillation patches or paddles perpendicular to the device and lead system.

If an external defibrillation is delivered within 15 cm of the device, contact a Medtronic representative.Medical treatment influencing device operation – The electrophysiological characteristics of a patient’s heartcan change over time, especially if the patient’s medications have changed. As a result of the changes,programmed therapies may become ineffective and possibly dangerous to the patient.4.1.4 Hospital and medical environmentsExternal defibrillation equipment – Keep external defibrillation equipment nearby for immediate use wheneverarrhythmias are possible or intentionally induced during device testing, implant procedures, or post-implanttesting.External pacing instrument – Keep an external pacing instrument available for immediate use. When the leadis disconnected, pacemaker-dependent patients are without pacing support.4.2 Precautions4.2.1 Handling and storage instructionsFollow these guidelines when handling or storing the device.Checking and opening the package – Before opening the sterile package tray, visually check for any signs ofdamage that might invalidate the sterility of the package contents.If the package is damaged – The device packaging consists of an outer tray and inner tray. Do not use thedevice or accessories if the outer packaging tray is wet, punctured, opened, or damaged. Return the device toMedtronic because the integrity of the sterile packaging or the device functionality may be compromised. Thisdevice is not intended to be resterilized.Dropped device – Do not implant the device if it has been dropped on a hard surface from a height of 30 cm ormore after it is removed from its packaging.Use by date – Do not implant the device after the “Use by” date on the package label. Battery longevity may bereduced.For single use only – Do not resterilize and reimplant an explanted device that has been contaminated by contactwith body fluids.Sterilization – Medtronic has sterilized the package contents with ethylene oxide before shipment. This deviceis for single use only and is not intended to be resterilized.Device storage – Store the device in a clean area, away from magnets, kits containing magnets, and sourcesof electromagnetic interference. Exposing the device to magnets or electromagnetic interference may damagethe device.Temperature limits – Store and transport the package between –18 °C and +55 °C. Electrical reset may occurat temperatures below –18 °C. Device longevity may decrease and performance may be affected at temperaturesabove +55 °C.Device temperature – Allow the device to reach room temperature before it is programmed or implanted. Devicetemperature above or below room temperature may affect initial device function.

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4.2.2 Explant and disposalConsider the following information related to device explant and disposal:

● Explant the implantable device postmortem. In some countries, explanting battery-operated implantabledevices is mandatory because of environmental concerns; please check the local regulations. In addition, ifsubjected to incineration or cremation temperatures, the device may explode.

● Medtronic implantable devices are intended for single use only. Do not resterilize and reimplant explanteddevices.

● Please return explanted devices to Medtronic for analysis and disposal. See the back cover for mailingaddresses.

4.2.3 Device operationAccessories – Use this device only with accessories, parts subject to wear, and disposable items that have beentested to technical standards and found safe by an approved testing agency.Atrial Capture Management – Atrial Capture Management does not program atrial outputs above 5.0 V or1.0 ms. If the patient needs a pacing output higher than 5.0 V or 1.0 ms, manually program the Amplitude andPulse Width. If a lead dislodges partially or completely, Atrial Capture Management may not preventloss-of-capture.Continuous myopotentials – Continuous myopotentials can cause reversion to asynchronous operation inunipolar pacing. Sensing of myopotentials is more likely to occur when sensitivity settings of 0.5 mV through1.4 mV are programmed.Device status indicators – If any of the device status indicators (examples include RRT/ERI and ElectricalReset) are displayed on the programmer after interrogating the device, inform a Medtronic representativeimmediately. If these device status indicators are displayed, therapies may not be available to the patient.Electrical reset – Electrical reset can be caused by exposure to temperatures below –18 °C or strongelectromagnetic fields. Advise patients to avoid strong electromagnetic fields. Observe temperature storage limitsto avoid exposure of the device to cold temperatures. If a partial reset occurs, pacing resumes in the programmedmode with many of the programmed settings retained. If a full reset occurs, the device operates in VVI mode at65 min-1. Electrical reset is indicated by a programmer warning message that is displayed immediately uponinterrogation. To restore the device to its previous operation, it must be reprogrammed. See the device implantmanual for a complete list of preserved and changed partial and full reset parameters.Epicardial leads – Epicardial leads have not been determined appropriate for use with the Ventricular CaptureManagement feature. Program Ventricular Capture Management to Off if implanting an epicardial lead.False bipolar pathway with unipolar lead – When implanting a unipolar lead, ensure that the tip and ringsetscrews are properly engaged and that all electrical contacts are sealed to prevent electrical leakage betweenthe tip and ring contacts. Electrical leakage may cause the device to inappropriately identify a unipolar lead asbipolar, resulting in loss of output.Hex wrench – Do not use a blue-handled or right-angled hex wrench. These wrenches have torque capabilitiesgreater than the lead connector can tolerate. The setscrews may be damaged by excessive torque.Muscle stimulation – Muscle stimulation (for example, due to high-output unipolar pacing) may result in pacingat rates up to the Upper Sensor rate in rate responsive modes.Pacing and sensing safety margins – Consider lead maturation when selecting pacing amplitudes, pacingpulse widths, and sensing levels. Loss of capture may occur if lead maturation is not considered when selectingsettings.PMT intervention – Even with the feature turned to On, PMTs may still require clinical intervention such aspacemaker reprogramming, magnet application, drug therapy, or lead evaluation.Programmers – Use only Medtronic programmers and application software to communicate with the device.Programmers and software from other manufacturers are not compatible with Medtronic devices.

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Shipping values – Do not use shipping values or nominal values for pacing amplitude and sensitivity withoutverifying that the values provide adequate safety margins for the patient.Slow retrograde conduction – Slow retrograde conduction may induce pacemaker-mediated tachycardia(PMT) when the VA conduction time is greater than 400 ms. Programming PMT intervention may help preventPMT when the VA conduction time is less than 400 ms.Tip and ring contacts – When implanting a device, ensure that the tip and ring setscrews are properly engagedand all electrical contacts are sealed to prevent possible electrical leakage between the tip and ring contacts.Also, ensure that electrical contacts are sealed when using lead extenders or adaptors with bipolar models.Electrical leakage may cause a loss of output.Twiddler’s syndrome – Twiddler’s syndrome, i.e., patient manipulation of the device after implant, may causethe pacing rate to increase temporarily if the pacemaker is programmed to a rate responsive mode.Ventricular Capture Management – Ventricular Capture Management does not program ventricular outputsabove 5.0 V or 1.0 ms. If the patient needs a pacing output higher than 5.0 V or 1.0 ms, manually programAmplitude and Pulse Width. If a lead dislodges partially or completely, Ventricular Capture Management may notprevent loss-of-capture.4.2.4 Pacemaker-dependent patientsDiagnostic modes – Do not program diagnostic modes (ODO, OVO, and OAO) for pacemaker-dependentpatients. Instead, use the programmer’s inhibit function for brief interruption of outputs.4.2.5 Medical therapy hazardsCo-implantation with an implantable cardioverter defibrillator (ICD) – An ICD may be implanted at the sametime as an implantable pulse generator (IPG) with bipolar leads. Follow the implant instructions in the leadtechnical manual to place the lead. Observe the following precautions to avoid using pulse generator featuresthat trigger unipolar polarity in patients with ICDs:

● Disable the IPG’s Automatic Polarity Configuration feature, and manually program pacing lead polarities tobipolar configuration. For complete instructions, refer to the Pacemaker Reference Guide for this product.

● Do not program the Lead Monitor to Adaptive because the monitor automatically reprograms the selectedlead to unipolar polarity when an out-of-range lead impedance is detected.

● Do not program the Transtelephonic Monitor to On because the pacing polarity is temporarily set to unipolarwhen the magnet is applied.

● If a full electrical reset occurs, the IPG resets bipolar devices to the Implant Detection feature and to theAutomatic Polarity Configuration feature.

Computed tomographic x-ray (CT scan) – If the patient undergoes a CT scan procedure and the device is notdirectly in the CT scan beam, the device is not affected.If the device is directly in the CT scan beam, oversensing may occur for the duration of time the device is in thebeam. Additionally, if the device is operating in a rate responsive pacing mode, a minor increase in pacing ratemay occur during the CT scan procedure.If the device will be in the beam for more than 4 s, take appropriate measures for the patient, such as enablingan asynchronous mode for pacemaker-dependent patients or enabling a nonpacing mode fornonpacemaker-dependent patients. These measures prevent false inhibition and false tracking. After completingthe CT scan procedure, restore device parameters.High-energy radiation – Do not direct high-energy radiation sources such as cobalt 60 or gamma radiation atthe device. High-energy radiation may damage the device, however, the damage may not be immediatelydetectable. If a patient requires radiation therapy near the device, radiation exposure to the device should notexceed 500 rads. However, diagnostic x-ray and fluoroscopic radiation should not adversely affect the device.Lithotripsy – Lithotripsy may permanently damage the device if the device is at the focal point of the lithotripterbeam. If lithotripsy must be performed, take the following precautions:

● Keep the focal point of the lithotripter beam a minimum of 2.5 cm away from the implanted device.

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● For pacemaker-dependent patients, program the implanted device to an asynchronous pacing mode or to asingle chamber mode without rate response before treatment.

Magnetic resonance imaging (MRI) – Do not use magnetic resonance imaging (MRI) on patients who have animplanted device. MRI can induce currents on implanted leads, potentially causing tissue damage and theinduction of tachyarrhythmias. MRI may also cause damage to the device.Radio frequency (RF) ablation – An RF ablation procedure may cause device malfunction or damage. Radiofrequency ablation risks may be minimized by observing the following precautions:

● Keep temporary pacing and defibrillation equipment available.● Avoid direct contact between the ablation catheter and the implanted system.● Position the ground plate so the current pathway does not pass through or near the device and lead system.

The current pathway should be a minimum of 15 cm away from the device and lead system.● Program the device to an asynchronous pacing mode for pacemaker-dependent patients.

Therapeutic ultrasound – Do not expose the device to therapeutic ultrasound. Therapeutic ultrasound maypermanently damage the device.4.2.6 Home and occupational environmentsCellular phones – This device contains a filter that prevents most cellular phone transmissions from interactingwith device operation. To further minimize the possibility of interaction, observe these cautions:

● Maintain a minimum separation of 15 cm between the device and the cellular phone, even if the cellular phoneis not on.

● Maintain a minimum separation of 30 cm between the device and any antenna transmitting above 3 W.● Hold the cellular phone to the ear farthest from the device.

This device has been tested to the frequency ranges used by common cellular phone transmission technologies.Based on this testing, the device should not be affected by the normal operation of cellular phones using suchtechnologies.Electromagnetic interference (EMI) – Instruct patients to avoid devices that generate strong EMI.Electromagnetic interference may cause device malfunction or damage such as prevention of programming,detection, or therapy delivery. The patient should move away from the EMI source or turn off the source becausethis usually allows the device to return to its normal mode of operation. EMI may be emitted from these sources:

● high-voltage power lines● communication equipment such as microwave transmitters, linear power amplifiers, or high-powered amateur

transmitters● commercial electrical equipment such as arc welders, induction furnaces, or resistance welders

Home appliances that are in good working order and properly grounded do not usually produce enough EMI tointerfere with device operation. There are reports of temporary disturbances caused by electric hand tools orelectric razors used directly over the implant site.Electronic article surveillance (EAS) – Electronic article surveillance equipment, such as retail theft preventionsystems, may interact with devices and result in inappropriate therapy delivery. Advise patients to walk directlythrough an EAS system and not remain near an EAS system longer than necessary.Static magnetic fields – Patients should avoid equipment or situations where they would be exposed to staticmagnetic fields greater than 10 gauss or 1 mT. Static magnetic fields may cause the device to operateasynchronously. Sources of static magnetic fields include, but are not limited to, stereo speakers, bingo wands,extractor wands, magnetic badges, or magnetic therapy products.

5 Potential adverse eventsPotential adverse events associated with the use of a device system (defined as the device and leads) include,but are not limited to, the following. The potential adverse events are listed in random order.

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5.1 Patient-related potential adverse events● Air embolism● Bleeding● Body rejection phenomena including local tissue rejection● Cardiac dissection● Cardiac perforation● Cardiac tamponade● Chronic nerve damage● Death● Embolism● Endocarditis● Excessive fibrosis● Fibrillation or other arrhythmias● Fluid accumulation● Formation of cysts● Heart block● Heart wall rupture● Hematoma/seroma● Infection● Keloid formation● Muscle and nerve stimulation● Myocardial damage● Myocardial irritability● Myopotential sensing● Pericardial effusion● Pericardial rub● Pneumothorax● Thromboemboli● Thrombosis● Venous occlusion● Venous perforation● Vein wall rupture

5.2 Device system-related potential adverse events● Erosion of the device and lead through the skin● Extrusion● Inappropriate acceleration of arrhythmias● Lead abrasion and discontinuity● Lead migration/dislodgment● Threshold elevation● Transvenous lead-related thrombosis● Valve damage (particularly in fragile hearts)

6 Implant procedureProper surgical procedures and sterile techniques are the responsibility of the physician. The followingprocedures are provided for information only. Each physician must apply the information in these proceduresaccording to professional medical training and experience.The implant procedure includes the following steps:

● Verify lead and connector compatibility.● Test the lead system.

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● Connect the lead to the device.● Test the device operation.● Position and secure the device.● Program the device.● Replace a device.

6.1 Verify lead and connector compatibilityWarning: Verify lead and connector compatibility before using a lead with this device. Using an incompatiblelead may damage the connector, result in electrical current leakage, or result in an intermittent electricalconnection.Select a compatible lead. Refer to the following table.

Table 1. Lead and connector compatibilityModel Polarity Primary leads Lead adaptorSED01 Bipolar/Unipolar IS-1 BIa 5866-24M for bifurcated bipolar lead

a IS-1 refers to the International Connector Standard (see Document No. ISO 5841-3) whereby pulse generatorsand leads so designated are assured of meeting the electrical and mechanical parameters specified in theIS-1 International Standard.

6.2 Test the lead systemFor lead testing procedures, refer to the technical manual supplied with the implant support instrument.6.3 Connect the lead to the deviceWarning: Verify that the lead connections are secure. Loose lead connections may result in inappropriatesensing, which can cause inappropriate arrhythmia therapy or a failure to deliver arrhythmia therapy.Caution: Use only the wrench supplied with the device. The wrench is designed to prevent damage to the devicefrom overtightening a setscrew.Connect the lead to the device by performing the following steps:

1. Insert the wrench into a grommet on the connector port.a. Check that the setscrew is retracted from the connector port. If the connector port is obstructed, retract

the setscrew to clear it. Do not disengage the setscrew from the connector block, see Figure 1.

Figure 1. Preparing the connector port setscrew

1

2

1 Connector port, A2 Connector port, V

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b. Leave the wrench in the grommet until the lead is secure. This allows a pathway for venting trapped airwhen the lead is inserted, see Figure 2.

Figure 2. Wrench in the grommet

2. Push the lead connector pin into the connector port until the connector pin is visible in the lead viewing area.

Sterile water may be used as a lubricant. Sealant is not required.

Figure 3. Inserting a lead into the device

1 The lead pin is visible at the end of the viewing area.

3. Tighten the setscrew by turning the wrench to the right until the wrench clicks.4. Repeat these steps for each lead.5. Gently pull on the lead to confirm the connection.

6.4 Test the device operationWarning: Keep an external pacing instrument available for immediate use. When the lead is disconnected,pacemaker-dependent patients are without pacing support.Verify device operation by reviewing an ECG. If pacing and sensing are not adequate, perform one or more ofthe following tasks:

● Verify the connection of the lead to the device. Confirm that the lead connector pin appears in the viewingarea.

● Disconnect the lead from the device. Visually inspect the lead connector and lead. Replace the lead ifnecessary.

● Retest the lead. Inadequate electrical signals may indicate lead dislodgment. If necessary, reposition orreplace the lead.

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6.5 Position and secure the deviceWarning: Electrosurgical cautery may induce ventricular arrhythmias or may cause device malfunction ordamage. If electrosurgical cautery cannot be avoided, observe the following precautions to minimizecomplications:

● Keep temporary pacing and defibrillation equipment available.● Use a bipolar electrocautery system if possible.● Use short, intermittent, and irregular bursts at the lowest appropriate energy levels.● Avoid direct contact with the device or leads. If unipolar cautery is used, position the ground plate so the

current pathway does not pass through or near the device and lead. The current pathway should be a minimumof 15 cm away from the device and lead.

● Program the device to an asynchronous pacing mode for pacemaker-dependent patients.Note: Proper device placement can facilitate lead wrap and prevent muscle stimulation and device migration.The device may be implanted in right or left pectoral sites. Either side of the device may face the skin to facilitateexcess lead wrap.Note: Implant the device within 5 cm of the surface of the skin to optimize post-implant ambulatory monitoring.

1. Verify that each lead connector pin or plug is fully inserted into the connector port and that all setscrews aretight.

2. To prevent twisting of the lead body, rotate the device to loosely wrap the excess lead length. Do not kinkthe lead body.

3. Place the device and leads into the surgical pocket.4. Suture the device securely within the pocket. Use non-absorbable sutures. Secure the device to minimize

post-implant rotation and migration. Use a surgical needle to penetrate the suture hole on the device.5. Suture the pocket incision closed.

6.6 Program the deviceIf the patient experiences muscle stimulation while being paced in the unipolar configuration, reduce the amplitudeor narrow the pulse width. Maintain adequate stimulation safety margins.6.7 Replace a deviceWarning: Keep an external pacing instrument available for immediate use. When the lead is disconnected,pacemaker-dependent patients are without pacing support.See Section 6.5, “Position and secure the device”, page 14, for additional warnings.If you are replacing a previously implanted device, perform the following steps:

1. Program the device to a non-rate responsive mode to avoid potential rate increases while handling thedevice.

2. Dissect the lead and the device free from the surgical pocket. Do not nick or breach the lead insulation.3. Use a wrench to loosen the setscrews in the connector port.4. Gently pull the lead out of the connector port.5. Evaluate the condition of the lead. Replace the lead if the electrical integrity is not acceptable or if the lead

connector pin is pitted or corroded. Return the explanted lead to Medtronic for analysis and disposal.6. Connect the lead to the replacement device.

Note: A lead adaptor may be needed to connect the lead to the replacement device (see Section 6.1,“Verify lead and connector compatibility”, page 12). Contact a Medtronic representative for questions aboutlead adaptor compatibility.

7. Use the replacement device to evaluate stimulation thresholds and sensing potentials.8. After confirming acceptable electrical measurements, place the device in the surgical pocket and suture the

pocket incision closed.

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9. Return the explanted device to Medtronic for analysis and disposal.

7 Magnet operation and Recommended Replacement Time (RRT/ERI)Table 2. Magnet operation and Recommended Replacement Time (RRT/ERI) status

Magnet operation Indicators of RRT/ERI statusWithout magnet With magnet Without magnet With magnetDDD DOO at 85 min-1 VVI at 65 min-1 VOO at 65 min-1

VDD VOO at 85 min-1 VVI at 65 min-1 VOO at 65 min-1

VVI/AAI VOO/AOO at 85 min-1 VVI at 65 min-1 VOO at 65 min-1

Note: The device does not respond to the application of a magnet for one hour after the use of a programmerunless the session is ended with the command option to immediately clear data collected in the device. Thedefault command for ending a session allows the device to retain collected data for one hour.

8 Measuring methodsImportant parameters such as pulse duration, pulse amplitude and sensitivity are factory measured at thestandard conditions of 37 °C; 60 min-1; 3.5 V; 0.4 ms; nominal sensitivity; at three load levels per EN 45502–2–1.Pulse duration – Pulse duration is measured at 1/3 peak voltage levels according to standard EN 45502-2-1.See Figure 4.Amplitude – The pulse amplitude is calculated per standard EN 45502-2-1.Sensitivity – The atrial and ventricular sensitivity are defined as the voltage amplitude of a standard EN 45502-2-1test signal that is just sufficient to be sensed by the device. See Figure 6.Notes:

● When measuring the pacing and sensing parameters with pacing system analyzers, considerable differencesmay be observed with the specifications presented in this manual, because the measuring methods employedby such systems may differ from those described above.

● Lead impedance measurement results may be distorted by electrocardiogram monitoring equipment.

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Figure 4. Measurement of pulse duration

V

ms

1 Maximum amplitude2 1/3 maximum amplitude3 Pulse duration

Figure 5. Measurement of pulse amplitude

A =

ms

D

F

D

F

Figure 6. Measurement of sensitivity

2 ms

15 ms

1

1 Amplitude

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9 Product specifications9.1 Shipping, nominal, and electrical reset parametersNotes:

● “Unchanged” indicates that the programmed setting is unaffected by nominal programming or an electricalreset event. “Adaptive” indicates that the parameter is adapted during operation.

● The shipping parameters for some features are not applied until the 30-minute Implant Detection period iscomplete.

● For serial numbers ending with a “B”, initiating a CareLink session while EGM storage is running could resultin a partial electrical reset. The serial number can be found on the patient identification card, the label on theIPG box and engraved on the device.

● After certain serious device errors, the pacemaker will recover as a model SES01. If this occurs, contact aMedtronic representative.

Table 3. Mode and rates

Parameter Shipping Medtronic nominalPartial electri-cal reset

Full electricalreset

Mode and ratesMode DDD DDD Unchanged VVIMode Switch On On Unchanged OffDetect Rate 175 min-1 175 min-1 175 min-1 175 min-1

Detect Duration No Delay No Delay No Delay No DelayBlanked FlutterSearch

On On Unchanged On

Lower Rate 60 min-1 60 min-1 Unchanged 65 min-1

Upper TrackingRate

130 min-1 130 min-1 Unchanged 120 min-1

Upper Sensor Rate 130 min-1 130 min-1 Unchanged 120 min-1

Table 4. Rate response

Parameter ShippingMedtronic nomi-nal

Partial elec-trical reset

Full electricalreset

ADL Rate 95 min-1 95 min-1 Unchanged 95 min-1

Rate Profile Optimization On On Unchanged OffADL Response 3 3 3 3Exertion Response 3 3 3 3ADL Setpoint 15 Unchanged 15 15UR Setpoint 40 Unchanged 40 40

Activity Threshold Medium/Low Unchanged Medium/Low Medium/LowAcceleration 30 s Unchanged 30 s 30 sDeceleration Exercise Unchanged Exercise Exercise

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Table 5. Atrial Lead

Parameter ShippingMedtronicnominal

Partial electri-cal reset Full electrical reset

Amplitudea 3.5 V (Adaptive) 3.5 V (Adap-tiveb)

Unchanged 5.0 V

Pulse Width 0.4 ms (Adap-tive)

0.4 ms(Adaptiveb)

Unchanged 0.4 ms

Sensitivity 0.5 mV (Adap-tive)

0.5 mV(Adaptiveb)

Unchanged 0.5 mV

Sensing Assurance On On Unchanged OffPacing Polarity Configure Unchanged Unchanged Configurec

Sensing Polarity Configure Unchanged Unchanged Configurec

Lead Monitor Configure Unchanged Unchanged ConfigureNotify if < 200 Ω 200 Ω 200 Ω 200 ΩNotify if > 4000 Ω 4000 Ω 4000 Ω 4000 ΩMonitor Sensitivity 8 8 8 8

a Tolerance for amplitudes from 0.5 V through 6.0 V is ±10% and for 7.5 V is -20/+0%. Tolerances are basedon 37 °C and a 500 Ω load. Amplitude is determined 200 µs after the leading edge of the pace.

b Value from which adaptive adjustment begins when nominals are programmed.c Bipolar models revert to Implant Detection during which polarity is automatically configured.

Table 6. Ventricular lead

Parameter ShippingMedtronicnominal

Partial electri-cal reset Full electrical reset

Amplitudea 3.5 V (Adaptive) 3.5 V (Adap-tiveb)

Unchanged 5.0 V

Pulse Width 0.4 ms (Adaptive) 0.4 ms(Adaptiveb)

Unchanged 0.4 ms

Sensitivity 2.8 mV (Adaptive) 2.8 mV(Adaptiveb)

Unchanged 2.8 mV

Sensing Assurance On On Unchanged OffPacing Polarity Configure Unchanged Unchanged Configurec

Sensing Polarity Configure Unchanged Unchanged Configurec

Lead Monitor Configure Unchanged Unchanged ConfigureNotify if < 200 Ω 200 Ω 200 Ω 200 ΩNotify if > 4000 Ω 4000 Ω 4000 Ω 4000 ΩMonitor Sensitivity 8 8 8 8

a Tolerance for amplitudes from 0.5 V through 6.0 V is ±10% and for 7.5 V is -20/+0%. Tolerances are basedon 37 °C and a 500 Ω load. Amplitude is determined 200 µs after the leading edge of the pace.

b Value from which adaptive adjustment begins when nominals are programmed.c Bipolar models revert to Implant Detection during which polarity is automatically configured.

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Table 7. Atrial Capture Management

Parameter ShippingMedtronicnominal

Partial electricalreset Full electrical reset

Atrial Capture Man-agement

Adaptive Adaptive Unchanged Off

Amplitude Margin 2x (times) 2x (times) Unchanged 2x (times)Minimum AdaptedAmplitude

1.5 V 1.5 V Unchanged 1.5 V

Capture Test Fre-quency

Day at … Day at … Day at … Day at …

Capture Test Time 1:00 AM 1:00 AM 1:00 AM 1:00 AMAcute Phase Days Re-maining

112 days Unchanged Unchanged 112 days

Table 8. Ventricular Capture Management

Parameter ShippingMedtronicnominal

Partial electri-cal reset Full electrical reset

Ventricular CaptureManagement

Adaptive Adaptive Unchanged Off

Amplitude Margin 2x (times) 2x (times) Unchanged 2x (times)Minimum AdaptedAmplitude

2.0 V 2.0 V Unchanged 2.0 V

Capture Test Fre-quency

Day at Rest Day at Rest Day at Resta Day at Rest

Capture Test Time None None Nonea NoneAcute Phase Days Re-maining

112 days Unchanged 112 days 112 days

V. Sensing duringSearch

Adaptive Adaptive Adaptive Adaptive

a If values differ from nominal, the Capture Test Time will be set to occur every Day at…12 hours after electricalreset time.

Table 9. Intrinsic Activation and AV Intervals

Parameter ShippingMedtronicnominal

Partial electricalreset

Full electrical re-set

Paced AV (PAV) 150 ms 150 msa 150 msb 150 msSensed AV (SAV) 120 ms 120 msa 120 msb 120 msRAAV Off Off Unchanged OffStart Rate 80 min-1 80 min-1 80 min-1 80 min-1

Stop Rate 120 min-1 120 min-1 120 min-1 120 min-1

Maximum Offset -40 ms -40 ms -40 ms -40 ms

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Table 9. Intrinsic Activation and AV Intervals (continued)

Parameter ShippingMedtronicnominal

Partial electricalreset

Full electrical re-set

Search AV+ On On Unchanged OffMax Increase to AV 170 ms 170 ms Unchanged 110 ms

a Value from which adaptive adjustment begins when nominals are programmed.b Reset value from which adaptive adjustment begins if Search AV+ is On at a partial reset.

Table 10. Refractory/blanking

Parameter ShippingMedtronicnominal

Partial elec-trical reset Full electrical reset

PVARP Auto Auto Unchanged 310 msa

Minimum PVARP 250 ms 250 ms Unchanged NonePVAB 180 ms 180 ms 180 ms 180 msAtrial Refractory Peri-odb

250 ms 250 ms Unchanged 310 ms

Atrial Blanking Periodb 180 ms 180 ms 180 ms 180 msVentricular RefractoryPeriod

230 ms 230 ms 230 ms 230 ms

Ventricular BlankingPeriod (after atrialpace) (PAVB)

28 ms 28 ms 28 ms 28 ms

a Sensor varied PVARP and automatic PVARP are disabled at full electrical reset.b Atrial modes only.

Table 11. Additional features

Parameter ShippingMedtronicnominal

Partial electri-cal reset Full electrical reset

Sleep Function Off Off Off OffSleep Rate 50 min-1 50 min-1 50 min-1 50 min-1

Bed Time 10:00 PM 10:00 PM 10:00 PM 10:00 PMWake Time 8:00 AM 8:00 AM 8:00 AM 8:00 AM

Non-Competitive AtrialPacing

On On Unchanged Off

Single Chamber Hys-teresis

Off Unchanged Unchanged Off

PMT Intervention Off Off Unchanged OffPVC Response On On Unchanged OnVentricular Safety Pac-ing

On On Unchanged On

Implant Detection On/Restart Unchanged Unchanged On/Restart

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Table 12. Telemetry features

Parameter ShippingMedtronicnominal

Partial elec-trical reset Full electrical reset

Transtelephonic Moni-tor

Off Unchanged Unchanged Off

Extended Telemetry Off Unchanged Off OffExtended Marker Standard Unchanged Standard Standard

9.2 Programmable parametersCaution: When programming Upper Tracking Rates of 190, 200, or 210 min-1, be careful to ensure that theserates are appropriate for the patient. The Upper Tracking Rates of 190, 200, and 210 min-1 are intended primarilyfor use in pediatric patients.Note: In the event of a component failure, the limits for atrial and ventricular rates are held independently to anupper rate limit. This rate limit is automatically disabled with high rate temporary modes. If the Upper TrackingRate is set to 190 min-1 or higher, the atrial and ventricular Rate Limit is 227 min-1 (±17 min-1). Otherwise, theatrial and ventricular Rate Limit is 200 min-1 (±20 min-1).

Table 13. Mode and ratesParameter Settings NotesMode DDD; DDI; DVI; DOO; VDD; VVI; VVT; VOO;

VVIR; VOOR; AAI; AAT; AOO; AAIR; AOOR; VDI;VDIR; ADI; ADIR; ODO; OAO; OVO

Mode Switch On; OffDetect Rate 120; 125; 130 … 200 min-1 (±3 min-1)Detect Duration No Delay; 10; 20 … 60 sBlanked Flutter Search On; Off

Lower Rate 30; 35; 40 … 120 min-1 (except 65 and 85 min-1)(±1 min-1)125; 130; 135 … 170 min-1 (±2 min-1)

Upper Tracking Rate 80; 90; 95 … 180 (except 85 min-1) (±2 min-1)Upper Sensor Rate 80; 90; 95 … 180 min-1 (except 85 min-1)

(±2 min-1)

Table 14. Rate ResponseParameter Settings NotesADL Rate 60; 65; 70 … 120 min-1 (±1 min-1)

125; 130; 135 … 175 min-1(±2 min-1)

Rate Profile Optimiza-tion

On; Off

ADL Response 1; 2; 3; 4; 5Exertion Response 1; 2; 3; 4; 5

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Table 14. Rate Response (continued)Parameter Settings NotesADL Setpoint 5; 6; 7 … 40; 42; 44; 46 … 80 Programmable from the Exercise test onlyUR Setpoint 15; 16; 17 … 40; 42; 44; 46 … 80; 85;

90; 95 … 180Programmable from the Exercise test only

Activity Threshold Low; Medium/Low; Medium/High;High

Acceleration 15 s (+8/–2 s); 30 s (+13/–3 s); 60 s(+19/–3 s)

Deceleration 2.5 min (+0.6/–0.2 min); 5 min(+1.1/–0.5 min); 10 min(+1.1/–1.0 min); Exercise

Table 15. Atrial LeadParameter Settings NotesAmplitudea (with AtrialCapture Management)

0.5; 0.75; 1.0 … 4.0; 4.5; 5.0 V(±10%)

0.625, 0.875, 1.125, 1.375, 1.625, and1.875 V can be set by Capture Manage-ment. Values are displayed but are notselectable.

Amplitudea (without At-rial Capture Manage-ment)

0.5; 0.75; 1.0 … 4.0; 4.5; 5.0; 5.5;6.0 V (±10%)7.5 V (+0/–20%)

Pulse Width (with AtrialCapture Management)

0.12; 0.15 ms (±10 µs)0.21; 0.27; 0.34; 0.40; 0.46; 0.52;0.64; 0.76; 1.00 ms (±25 µs)

Settings lower than 0.40 ms can be pro-grammed, but Capture Management ad-justs them to 0.40 ms.

Pulse Width (without At-rial Capture Manage-ment)

0.12; 0.15 ms (±10 µs)0.21; 0.27; 0.34; 0.40; 0.46; 0.52;0.64; 0.76; 1.00; 1.25; 1.50 ms(±25 µs)

Sensitivity 0.18; 0.25; 0.35 mV (±60%)0.5; 0.7; 1.0; 1.4; 2.0; 2.8; 4.0 mV(±40%)

0.18, 0.25, and 0.35 mV apply to bipolaratrial sensing only.

Sensing Assurance On; OffPacing Polarity Bipolar; Unipolar; Configure Configure is displayed but is not selecta-

ble.Sensing Polarity Bipolar; Unipolar; Configure Configure is displayed but is not selecta-

ble.Lead Monitor Off; Configure; Monitor Only; Adap-

tiveNotify if < (less than) 200 Ω Non-programmable.Notify if > (greater than) 1000; 2000; 3000; 4000 ΩMonitor Sensitivity 2; 3; 4 … 16

a Tolerance for amplitudes from 0.5 V through 6.0 V is ±10% and for 7.5 V is –20/+0%. Tolerances are basedon 37 °C and a 500 Ω load.Amplitude is determined 200 µs after the leading edge of the pace.

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Table 16. Ventricular LeadParameter Settings NotesAmplitudea (with Ven-tricular Capture Man-agement)

0.5; 0.75; 1.0 … 4.0; 4.5; 5.0 V(±10%)

0.625, 0.875, 1.125, 1.375, 1.625, and1.875 V can be set by Ventricular CaptureManagement. Values are displayed butare not selectable.

Amplitudea (withoutVentricular CaptureManagement)

0.5; 0.75; 1.0… 4.0; 4.5; 5.0; 5.5;6.0 V (±10%)7.5 V (+0/–20%)

Pulse Width (with Ven-tricular Capture Man-agement)

0.12; 0.15 ms (±10 µs)0.21; 0.27; 0.34; 0.40; 0.46; 0.52;0.64; 0.76; 1.00 ms (±25 µs)

Settings lower than 0.40 ms can be pro-grammed, but Capture Management ad-justs them to 0.40 ms.

Pulse Width (withoutVentricular CaptureManagement)

0.12; 0.15 ms (±10 µs)0.21; 0.27; 0.34; 0.40; 0.46; 0.52;0.64; 0.76; 1.00; 1.25; 1.50 ms(±25 µs)

Sensitivity 1.0; 1.4; 2.0; 2.8; 4.0; 5.6; 8.0;11.2 mV (±40%)

Sensing Assurance On; OffPacing Polarity Bipolar; Unipolar; Configure Configure is displayed but is not selecta-

ble.Sensing Polarity Bipolar; Unipolar; Configure Configure is displayed but is not selecta-

ble.Lead Monitor Off; Configure; Monitor Only; Adap-

tiveNotify if < (less than) 200 Ω Non-programmable.Notify if > (greater than) 1000; 2000; 3000; 4000 ΩMonitor Sensitivity 2; 3; 4 … 16

a Tolerance for amplitudes from 0.5 V through 6.0 V is ±10% and for 7.5 V is –20/+0%. Tolerances are basedon 37 °C and a 500 Ω load.Amplitude is determined 200 µs after the leading edge of the pace.

Table 17. Atrial Capture ManagementParameter Settings NotesAtrial Capture Manage-ment

Off; Monitor Only; Adaptive

Amplitude Margin 1.5x; 2x; 2.5x; 3x; 4x (times)Minimum Adapted Am-plitude

0.5; 0.75; 1.0 … 3.5 V

Capture Test Frequen-cy

1; 2; 4; 8; 12 hours; Day at rest; Dayat … ; 7 Days at …

For Day(s) at …, next parameter specific-ies the time of day.

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Table 17. Atrial Capture Management (continued)Parameter Settings NotesCapture Test Time 12:00 AM; 1:00 AM … 11:00 PM Applies only for Day(s) at … parameter.Acute Phase Days Re-maininga

Off; 7; 14 … 84; 112; 140; 168; 196;224; 252 days

a If the acute phase is completed, the time and date of completion are indicated below Acute Phase DaysRemaining.

Table 18. Ventricular Capture ManagementParameter Settings NotesVentricular CaptureManagement

Off; Monitor Only; Adaptive

Amplitude Margin 1.5x; 2x; 2.5x; 3x; 4x (times)Minimum Adapted Am-plitude

0.5; 0.75; 1.0 … 3.5 V

Capture Test Frequen-cy

15 min; 30 min; 1 hour; 2 hours; 4hours; 8 hours; 12 hours; Day at rest;Day at…; 7 Days at…

For Day(s) at …, next parameter specifiesthe time of day.

Capture Test Time 12:00 AM; 1:00 AM … 11:00 PM Applies only for Day(s) at … parameter.Acute Phase Days Re-maininga

Off; 7; 14 … 84; 112; 140; 168; 196;224; 252 days

V. Sensing duringSearch

Unipolar; Bipolar; Adaptive

a If the acute phase is completed, the time and date of completion are indicated below Acute Phase DaysRemaining.

Table 19. Intrinsic Activation and AV IntervalsParameter Settings NotesPaced AV (PAV) 30; 40; 50 … 350 ms (±4 ms)Sensed AV (SAV) 30; 40; 50 … 350 ms (+16/–4 ms)RAAV On; OffStart Rate 50; 55; 60 … 175 min-1

Stop Rate 55; 60; 65 … 180 min-1

Maximum Offset -10; -20; -30 … -300 msSearch AV+ On; OffMax Increase to AV 10; 20; 30 … 250 ms

24

Table 20. Refractory/BlankingParameter Settings NotesPVARP Auto; Varied; 150; 160; 170 …

500 ms (±9 ms)Minimum PVARP 150; 160; 170 … 500 ms (±9 ms) Auto PVARP only.

PVAB 130; 140; 150 … 350 ms (±9 ms) Blanking for PVARP.Ventricular RefractoryPeriod

150; 160; 170 … 500 ms (±9 ms)

Atrial Refractory Perioda 180; 190; 200 … 500 ms (±9 ms)Ventricular Blanking Pe-riod

20; 28; 36; 44 ms (+0/–15 ms) After atrial pace.

Atrial Blanking Perioda 130; 140; 150 … 350 ms (±9 ms)a Atrial modes only.

Table 21. Additional featuresParameter Settings NotesSleep Function On; OffSleep Rate 30; 35; 40 … 90 min-1 (except 65 and

85 min-1) (±1 min-1)Bed Time 12:00 AM; 12:15 AM; 12:30 AM …

11:45 PM (±10 min)Wake Time 12:00 AM; 12:15 AM; 12:30 AM …

11:45 PM (±10 min)Non-Competitive AtrialPacing

On; Off

Single Chamber Hyste-resis

Off; 40; 50; 60 min-1 (±1 min-1)

PMT Intervention On; OffPVC Response On; OffVentricular Safety Pac-ing

On; Off

Implant Detection On/Restart; Off/Completea

a If Implant Detection is completed, the time and date of completion are indicated below the Off/Complete setting.

Table 22. Telemetry featuresParameter Settings NotesTranstelphonic Monitor On; OffExtended Telemetry On; OffExtended Markera Standard; Therapy Trace

a Therapy Trace markers cannot be displayed or printed on the programmer.

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Table 23. Status (reset) parametersParameter Settings NotesAtrial Lead Status Reset IndicatorVentricular Lead Status Reset IndicatorRRT/ERI or POR Reset Reset Listed under Additional Features

Table 24. Temporary parametersParameter Settings NotesChamber Atrium; Ventricle Setting determines available modes.Mode DDD; DDI; DOO; VDD; VDI; VVI;

VVT; VOO; AAI; ADI; AAT; AOO;ODO; OVO; OAO

Availability of modes is dependent on pro-grammed mode.

Lower Rate 30; 35; 40 … 120 min-1 (except 65and 85 min-1) (±1 min-1)125; 130; 135 … 180 min-1(±2 min-1)190; 200; 210 … 250 min-1(±3 min-1)260; 270; 280; 300; 310; 320; 330;350; 370; 380; 400 min-1 (±5 min-1)

Rates above 180 min-1 are available byselecting the enable button.

Amplitudea 0.25; 0.375 … 2.0; 2.25; 2.50;2.75 … 4.0; 4.5; 5.0; 5.5; 6.0 V(±10%)7.5 V (+0/–20%)

Pulse Width 0.03; 0.06; 0.09 … 0.15 ms (±10 µs)0.21; 0.27; 0.34; 0.40; 0.46; 0.52;0.64; 0.76; 1.00; 1.25; 1.50 ms(±25 µs)

Atrial Sensitivity 0.18; 0.25; 0.35 mV (±60%)0.5; 0.7; 1.0; 1.4; 2.0; 2.8; 4.0 mV(±40%)

Ventricular Sensitivity 1.0; 1.4; 2.0; 2.8; 4.0; 5.6; 8.0;11.2 mV (±40%)

AV Delay 30; 40; 50 … 350 ms (±4 ms) Selection sets PAV and SAV if pertinent tomode.

a The amplitude values in 0.125 V increments apply only to the Capture Management and Temporary test.

9.3 Automatic and clinician-selectable diagnosticsTable 25. Automatic Diagnostics

Parameter SettingsHeart Rate Histogramsa (Short and LongTerm, Atrial and Ventricular)Include Refractory Senses Include; Exclude

26

Table 25. Automatic Diagnostics (continued)Parameter SettingsAV Conduction Histograms (Short andLong Term)Search AV+ HistogramSensor Indicated Rate ProfileAtrial High Rate Episodes (Mode SwitchOn)Collection Delay after Mode Switch 0; 1; 2 … 20; 25; 30 … 60 sCollection Methodb Frozen; Rolling

Atrial High Rate Episodes (Mode SwitchOff)Detection Rate 80; 85; 90 … 180; 200; 220; 240 … 320; 330; 350; 370; 380;

400 min-1

Detection Duration 1; 2; 3 … 20; 25; 30 … 50; 55; 60 sTermination Beats 5; 6; 7 … 20 beatsCollection Methodb Frozen; Rolling

Ventricular High Rate EpisodesDetection Rate 80; 85; 90 … 180; 200; 220; 240 … 320; 330; 350; 370; 380;

400 min-1

Detection Duration 2; 3; 4 … 198; 199; 200 beatsTermination Beats 5; 6; 7 … 20 beatsSVT Filter Off; OnCollection Methodb Frozen; Rolling

Chronic Lead TrendsLead Monitor CountersSensitivity Trends Monitors chambers with Sensing AssuranceCapture Management Trend Based on use of Capture ManagementAtrial Capture ManagementVentricular Capture Management

Key Parameter Historya Heart Rate Histograms can be programmed to include or exclude refractory sensed events.b Collection Method applies to Atrial High Rate Episodes and Ventricular High Rate Episodes.

Table 26. Clinician-Selectable DiagnosticsDiagnostic and parameters Parameter settingsCustom Rate TrendDuration Beat-to-Beat; 1 Hour; 24 hoursCollection Method Frozen; RollingInclude Refractory Senses? Include; Exclude

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Table 26. Clinician-Selectable Diagnostics (continued)Diagnostic and parameters Parameter settingsVentricular Capture Management DetailEGM Collection Off; Atrial; EGM; Ventricular EGM; Summed EGM

Atrial Capture Management DetailEGM Collection Off; Atrial EGM; Ventricular EGM; Summed EGM

High Rate DetailaHigh Rate Type AHR and VHR; AHR; VHREGM Type Off; Atrial EGM; Ventricular EGM; Summed EGMAllocation (Collection Methodb = Frozen,High Rate Type = AHR and VHR)

2 for 12/0; 2 for 0/12; 2 for 6/6; 4 for 0/6; 4 for 6/0; 4 for 3/3(number of episodes for pre-onset s/post onset s collected)

Allocation (Collection Methodb = Frozen,High Rate Type = AHR only or VHR only)

1 for 0/24; 1 for 24/0; 1 for 12/12; 2 for 12/0; 2 for 0/12; 2 for 6/6;4 for 0/6; 4 for 6/0; 4 for 3/3 (number of episodes for pre-on-set s/post onset s collected)

Allocation (Collection Methodb = Rolling,High Rate Type = AHR and VHR)

2 for 8/0; 2 for 4/4; 2 for 0/12; 4 for 4/0; 4 for 2/2; 4 for 0/6 (numberof episodes for pre-onset s/post onset s collected)

Allocation (Collection Methodb = Rolling,High Rate Type = AHR only or VHR only)

1 for 12/0; 1 for 6/6; 1 for 0/24; 2 for 8/0; 2 for 4/4; 2 for 0/12; 4for 4/0; 4 for 2/2; 4 for 0/6 (number of episodes for pre-on-set s/post onset s collected)

Pre-detection Timeout 1; 2; 3 … 12; 14; 16 … 24 weeksa High rate detection rate, detection duration, and termination criteria are set by parameters for the automatic

diagnostic.b Collection Method is set in the High Rate automatic diagnostic.

10 Physical characteristics, battery longevityFor information on the physical dimensions, battery, and longevity, refer to the Pacemaker ProgrammingGuide.10.1 Electrical characteristics10.1.1 Variation with temperatureBasic rate, test pulse rate, pulse duration, and pulse amplitude remain within expected tolerances when the devicetemperature is between 20 °C to 43 °C. Sensitivity at nominal conditions as measured at 37 °C can vary up to±20% from 22 °C to 45 °C.

11 Declaration of conformityMedtronic declares that this product is in conformity with the essential requirements of Directive 1999/5/EC onRadio and Telecommunications Terminal Equipment and Directive 90/385/EEC on Active Implantable MedicalDevices.For additional information, contact Medtronic at the telephone numbers and addresses provided on the backcover.

28

12 Medtronic limited warrantyFor complete warranty information, see the accompanying warranty document.

13 Packaging symbolsRefer to the package label to see which symbols apply to this product.

Table 27. Explanation of symbols on package labelingSymbol Explanation

0123

Conformité Européenne (European Conformity). This symbol means that the de-vice fully complies with AIMD Directive 90/385/EEC (NB 0123) and R&TTEDirective 1999/5/EC.

The use of this device might be subject to individual country licensing regimes inEurope.

Open here

Do not use if package is damaged

Do not reuse

Sterilized using ethylene oxide

Caution: consult accompanying documents

Date of manufacture

Use by

Serial number

29

Table 27. Explanation of symbols on package labeling (continued)Symbol Explanation

Lot number

Temperature limitation

Adaptive

Coated

Package contents

IPG device

Operating instructions

Torque wrench

Atrial amplitude/pulse width

RV amplitude/pulse width

Upper tracking rate/lower rate

A-V interval (paced/sensed)

(PVARP) Post ventricular atrial refractory period

30

Table 27. Explanation of symbols on package labeling (continued)Symbol Explanation

Ventricular refractory period

Pacing polarity

Sensing polarity

Atrial sensitivity

Ventricular sensitivity

Magnet Rate

For your patient file/For your registration card

Implantation date

31

ManufacturerMedtronic, Inc.710 Medtronic ParkwayMinneapolis, MN 55432-5604USAInternet: www.medtronic.comTel. +1-763-514-4000Fax: +1-763-514-4879Medtronic E.C. Authorized Representative/Distributed ByMedtronic B.V.Earl Bakkenstraat 106422 PJ HeerlenThe NetherlandsTel. +31-45-566-8000Fax: +31-45-566-8668

Europe/Africa/Middle East HeadquartersMedtronic International Trading SàrlRoute du Molliau 31Case Postale 84CH-1131 TolochenazSwitzerlandInternet: www.medtronic.comTel. +41-21-802-7000Fax: +41-21-802-7900Technical manuals:www.medtronic.com/manuals

© Medtronic, Inc. 2008M929934A001C2008-01-22

*M929934A001*