SPINALSENSA SS170 Biofeedback System

Operating Instructions

Metron Medical Australia Pty Ltd ACN 050 240 527 P.O. Box 2164, 57 Aster Avenue, Carrum Downs, Victoria, Australia 3201 Int Tel: (613) 9775 1234 Int Fax: (613) 9775 1990 Tel: (03) 9775 1234 Fax: (03) 9775 1990 Prepared by: David Mitchell, Metron Medical Australia, Rev 1V1, Jan 2008

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1 CONTENTS 1 CONTENTS ......................................................................................................................................................................... 2

2 INTRODUCTION............................................................................................................................................................... 4

3 OPERATING WARNINGS .............................................................................................................................................. 5 3.1 INDICATIONS FOR USE............................................................................................................................................... 5 3.2 CONTRAINDICATIONS ................................................................................................................................................ 5 3.3 PRECAUTIONS.............................................................................................................................................................. 5 3.4 ELECTROMAGNETIC INTERFERENCE ...................................................................................................................... 5 3.5 INFLAMMABLE GASES AND ANAESTHETICS ......................................................................................................... 6 3.6 OPEN WOUNDS OR BROKEN TISSUE ....................................................................................................................... 6 3.7 PREVENTION OF CROSS INFECTION ........................................................................................................................ 6 3.8 HANDLING OF USB CABLE (PATIENT LEAD) ......................................................................................................... 6 3.9 DAMAGE TO THE SPINALSENSA............................................................................................................................... 6 3.10 QUALITY ASSURANCE ............................................................................................................................................. 6

4 OPERATIONAL – CONTROLS & DISPLAYS ........................................................................................................... 8 4.1 FRONT PANEL - CONTROLS AND INDICATORS...................................................................................................... 8 4.2 PRACTITIONER UNIT FRONT PANEL - FUNCTIONS OF CONTROLS AND INDICATORS.................................... 9

4.2.1 Power On Button................................................................................................................................................... 9 4.2.2 Selection Dial ........................................................................................................................................................ 9 4.2.3 Set (Enter) Button.................................................................................................................................................. 9 4.2.4 Back (Undo) Button .............................................................................................................................................. 9 4.2.5 Sensor Status (Green LED) ................................................................................................................................ 10 4.2.6 Sensor Status (Red LED) .................................................................................................................................... 10 4.2.7 Treatment Parameters List ................................................................................................................................. 10 4.2.8 Spinal Position Real Time Display .................................................................................................................... 10 4.2.9 Logged Data Display .......................................................................................................................................... 11

4.3 PATIENT SENSOR CONTROLS AND NOMENCLATURE ........................................................................................ 11 4.3.1 Sensor Tip ............................................................................................................................................................ 11 4.3.2 Flexible Molding ................................................................................................................................................. 12 4.3.3 Curvature Sensing Strip...................................................................................................................................... 12 4.3.4 Start Button.......................................................................................................................................................... 12 4.3.5 Electronics Enclosure ......................................................................................................................................... 12 4.3.6 Cable Connection Socket.................................................................................................................................... 12 4.3.7 Charging LED ..................................................................................................................................................... 12 4.3.8 Finger Notch........................................................................................................................................................ 12 4.3.9 Adhesive Patch ................................................................................................................................................... 13

5 SYMBOLS.......................................................................................................................................................................... 13

6 ABBREVIATIONS ........................................................................................................................................................... 14

7 REAR PANEL ................................................................................................................................................................... 14 7.1 MAINS INLET CONNECTOR ..................................................................................................................................... 14 7.2 MAINS FUSES ............................................................................................................................................................. 14 7.3 MAINS LABEL ............................................................................................................................................................ 15 7.4 EQUIPMENT IDENTIFICATION LABEL.................................................................................................................... 15

8 OPERATIONAL PROCEDURES ................................................................................................................................. 16 8.1 SETTING UP ................................................................................................................................................................ 16 8.2 USING THE SPINALSENSA SYSTEM........................................................................................................................ 17

8.2.1 Setting Treatment Parameters............................................................................................................................ 17 8.2.2 Real-time Display................................................................................................................................................ 19

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8.2.3 Vibration and Audio Feedback .......................................................................................................................... 19 8.3 GUIDELINES TO TREATMENT USING THE SPINALSENSA SYSTEM................................................................... 20

8.3.1 General Procedure.............................................................................................................................................. 20 8.3.2 Attaching Sensor to Patient ................................................................................................................................ 21 8.3.3 Placement of the Patient Sensor ........................................................................................................................ 22 8.3.4 Consistently Positioning the Sensor for Further Treatments........................................................................... 23 8.3.5 Patient Sheet - Sensor Positioning..................................................................................................................... 25 8.3.6 Real-time Display Training ................................................................................................................................ 26 8.3.7 Home Training with the Spinalsensa Patient Sensor........................................................................................ 27 8.3.8 Treatment Review - Downloading Patient Data ............................................................................................... 27

9 CLEANING & PREVENTATIVE MAINTENANCE................................................................................................ 28 9.1 CLEANING UNIT ........................................................................................................................................................ 28 9.2 PREVENTATIVE MAINTENANCE............................................................................................................................. 28 9.3 BATTERY REPLACEMENT........................................................................................................................................ 28 9.4 DECOMMISSIONING AND BATTERY DISPOSAL ................................................................................................... 28

10 SPECIFICATIONS......................................................................................................................................................... 29

11 ABOUT US....................................................................................................................................................................... 32

12 WARRANTY STATEMENT........................................................................................................................................ 33

13 EC DECLARATION...................................................................................................................................................... 34

14 CE MARK........................................................................................................................................................................ 35

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2 INTRODUCTION The Metron Medical SS170 Spinalsensa is a biofeedback system intended to be used by medical practitioners, in particular physiotherapists, chiropractors, occupational therapists and physicians. The Spinalsensa system is split into two units - the Practitioner Unit and the Patient Sensor Unit. The Practitioner Unit is used to display and set the treatment parameters of the Patient Sensor Unit. The Patient Sensor Unit performs the measurement, datalogging functions and patient feedback. Once the Practitioner has setup the treatment parameters in the Clinic, the Patient can take the Patient Sensor Unit back home (or to work) and by following the Practitioners directions for use, can use the Spinalsensa for biofeedback training away from the clinic. The Patient can return to the clinic several days or a week or so later, for the Practitioner to check progress and change the treatment parameters, as the patient progresses through the treatment. The downloaded Patient Sensor data, shows how compliant the patient has been in performing the desired number of training sessions, and how compliant in keeping within the desired ranges of spinal curvature. In the clinic the Practitioner Unit can be used as a real time display of spinal curvature, which then can be used for biofeedback training within the Clinic. The Spinalsensa measurements are performed using a flexible load cell strip contained in the soft molding of the Patient Sensor Unit. The Patient Sensor Unit is attached to the patient via a one-time use, disposable, two sided adhesive patch. This manual, the SS170 Operators Instructions describes the Setup and Operation of the SS170 Spinalsensa, as well as information on the care, maintenance and safety.

Patient Sensor Unit Practitioner Unit

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3 OPERATING WARNINGS 3.1 Indications For Use - Postural training 3.2 Contraindications - Suffering acute or severe back pain - Spinal fracture within the past 3 months - Spondylolisthesis - History of surgery to the back in the last 6 months (ie spinal fusion) - Dermatological conditions (e.g. eczema, dermatitis). - Allergy to the adhesive material (gel). - Patients who are unable to understand or respond to the instructions of the

practitioner. - Patients with pacemakers. Although not directly affected by the Spinalsensa

system, the pacemaker may be susceptible to electromagnetic fields in the clinical environment. It is advisable to check with the appropriate authorities.

3.3 Precautions - The adhesive patch should not be placed over the eyes or other sensitive tissues. - The Spinalsensa is designed for qualified practitioners. - Care should be taken when plugging leads into the unit. Avoid forcing plugs into

sockets as this may damage the electrical integrity of the leads and the unit. - The Spinalsensa patient sensor should not be worn when operating vehicles or

playing sports, as the sensor contains a small metal cantilever strip, which could cause injury in extreme physical situations.

- The Spinalsensa patient sensor should not be worn in the shower. - The Spinalsensa patient sensor should not submerged in water for cleaning.

3.4 Electromagnetic Interference The Spinalsensa has been designed to comply with IEC 60601-1-2: 2002 but this does not guarantee that other equipment in the vicinity will not be affected by the electromagnetic emissions from this unit. Similarly, other equipment in the vicinity may effect the operation of the Spinalsensa. Cell/Mobile Phone Interference and other radiative emissions may effect the sensing of curvature by inducing ‘spikes’ or rapid changes in the measured Spinal Position when it is obvious the patient is not moving. It is important to have Cell/Mobile Phones well away from the Patient Sensor unit when the unit is operating. Other possible sources of ‘spikes’ may be other instruments or appliances in the clinic (or next room), if the noise is substantial it may be advantageous to move the Patient Sensor to a different location away from the offending noise source.

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USB Cable/Leads can create problems if they have intermittent breaks in continuity, this can lead to what appears as noise - jumpy signals being displayed, or if the break in continuity is a longer duration it can appear as a loss in signal or corrupt data. This can be avoided by taping the USB Cable to the patient so the leads don’t pull out of the Patient Sensor connections. It is recommended that all equipment used near this unit complies with the relevant electromagnetic compatibility requirements for that equipment and to check before use that no interference is evident or disruptive. 3.5 Inflammable Gases and Anaesthetics The Spinalsensa is NOT SUITABLE for use in the presence of inflammable gases and anaesthetics. 3.6 Open Wounds or Broken Tissue The Spinalsensa adhesive patches have not been designed to be used on open wounds or broken skin. Use in the presence of these conditions is not recommended and is not an intended use of the device. 3.7 Prevention of Cross Infection The Spinalsensa is designed to be used with one time use disposable adhesive patches. These disposable adhesive patches are not designed for repeated usage, nor are they designed for use between patients as this may lead to patient cross infection as the patches contact the skin surface. 3.8 Handling of USB Cable (patient lead) The USB Cable may be compromised by rough handling, dropping or by stepping on top of. Handling of the cable in these ways may adversely affect the performance of the Spinalsensa system. Careful handling of the USB Cable will prolong the cables life and preserve its electrical and mechanical characteristics. 3.9 Damage to the Spinalsensa If when the unit is unpacked, or if it is mishandled at any stage of its life, and there appears to be physical damage to the machine, it should not be used. Use should only commence or continue after it has been thoroughly checked by an appropriately qualified technician to ensure its functional and safety performance has not been impaired. 3.10 Quality Assurance It is recommended that a program of regular and appropriate quality assurance including verification/calibration and electrical safety inspections be instituted for this equipment. Calibration should be performed at 12 month intervals. Information on the type and frequency of electrical safety testing may be obtained from locally published Standards. In Australia, the relevant Standards published by the Standards Australia are:

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AS 2500 (1986) - Guide to the Safe Use of Electricity in Patient Care EN60601.1 (1998) Approval and Test Specification Medical Electrical Equipment Part 1: General

Requirements AS 3551 (1988) - Acceptance Testing and In-Service Testing, Electromedical Equipment A hospital Biomedical Engineering Department or a third party service organization nominated by the manufacturer or distributor should be capable of performing the necessary calibration, testing and documentation. A program of electrical safety inspections is recommended to confirm continued operator and patient safety. Local statutory requirements for electrical safety inspections may also apply. Notes about the device: 1) Practitioner Unit is a Class I Electrical Device - 3 Pin mains connection (Active, Neutral and Ground). 2) Both the Screws fastening the IEC socket to the Practitioner Unit enclosure are grounded and can be used as accessible metal parts for testing ground continuity. 3) The Spinalsensa System is a Class IIa Medical Device as defined by the MDD 93/42/EEC. 4) The Spinalsensa Patient Sensor has no electrically conductive parts connected to the patient. The sensor is physically adhered to the patient via a patch that is adhered to the non-conductive flexible molding. 5) Practitioner Unit has no MOV's (Metal Oxide Varistors) across the mains connection IEC socket. 6) Practitioner Unit does not have a filtered mains IEC socket.

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4 OPERATIONAL – CONTROLS & DISPLAYS 4.1 Front Panel - Controls and Indicators

1 2 3 4 5 6 7 8 9 Controls and displays located on the top panel:

1. Treatment Parameters List 6. Power On/Off Button 2. Selection Dial 7. Set (Enter) Button 3. Sensor Status (Green = Ok) 8. Spinal Position Real Time Display 4. Sensor Status (Red = Failure) 9. Logged Data Display 5. Back (undo) Button

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4.2 Practitioner Unit Front Panel - Functions of Controls and Indicators

4.2.1 Power On Button

The mains power cord should be connected to mains power outlet and the outlet turned on. To switch the unit on, press the 'Power Button', the LCD display backlight will illuminate indicating the unit is ready for use. Also the unit can be switched off by pressing the

'Power Button'. To completely isolate the Spinalsensa Practitioner Unit from the mains supply the detachable power cord must be removed from the socket located on the rear panel. This would be necessary for example to open the enclosure to perform service work.

4.2.2 Selection Dial The 'Selection Dial' is located on the lower left hand side of the panel, it is a rotary control used to (a) Select one of the eight treatment parameters or (b) Change the value of a 'Treatment Parameter' - for example the numeric value of 'Session Time' in minutes. Rotating the Dial Clockwise increases a value, or by rotating the Dial Counterclockwise decreases a value. The 'Selection Dial' is indented, so it feels like when rotating the Dial it makes small 'bumps', these small 'bumps' are a tactile feedback that indicate a parameter or value has changed by one unit.

4.2.3 Set (Enter) Button

The 'Set Button' is located on the lower right hand side of the panel, it is a tactile membrane button that is used to Set or Enter the selection/value made by 'Selection Dial'. For example to modify the 'Session Time' parameter, the 'Selection Dial' is rotated until the 'Session Time' is highlighted in the 'Treatment Parameter' portion

the of LCD screen, the 'Set Button' is pressed - enabling the 'Session Time' to be modified - rotating the 'Selection Dial' will now change the numerical value of 'Session Time'. To store the new numerical value, press the 'Set Button', the new value for 'Session Time' is now stored. And the 'Selection Dial' now again goes back to highlighting/selecting a 'Treatment Parameter'.

4.2.4 Back (Undo) Button The 'Back Button' is located on the lower centre of the panel, it is a tactile membrane button that is used to go Back or Undo the selection/value made by 'Selection Dial'. For example the 'Session Time' parameter is highlighted in the 'Treatment Parameter' portion the of LCD screen, the 'Set Button' is pressed - enabling the

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'Session Time' to be modified, if this was a slip/mistake the 'Back Button' can be pressed to go back one step. Conversely, if a numerical value is changed, pressing the 'Back Button' will revert a numerical value back to its original value.

4.2.5 Sensor Status (Green LED)

The 'Sensor Status' window at the bottom of the panel has Two LEDs positioned behind the tinted slot window. The Green LED positioned on the left hand side of the tinted window, indicates (a)

If flashing, that Data Transfer is being established between the Practitioner Unit and Patient Sensor Unit, (b) If steady, that there is error free Data Transfer taking place.

4.2.6 Sensor Status (Red LED)

The 'Sensor Status' window at the bottom of the panel has Two LEDs positioned behind the tinted slot window. The Red LED positioned on the Right hand side of the tinted window, indicates

that Data Communications has failed, or a communication error has occurred - for example if the Patient Sensor Unit is disconnected abruptly, without switching the Practitioner Unit Off first.

4.2.7 Treatment Parameters List The 'Treatment Parameters' are located on the left hand portion of the LCD screen. It is a list of eight variables which can be modified by the practitioner. The 'Selection Dial' highlights these parameters for selection and modification. There are five posture settings: (1) Neutral Position, (2) Flexion Feedback, (3) Extension Feedback, (4) Flexion Maximum, (5) Extension Maximum. The three remaining settings are timing settings: (6) Feedback Delay, (7) Inactivity Time and (8) Session Time.

4.2.8 Spinal Position Real Time Display

The 'Spinal Position' portion of the screen is located on the bottom right hand side of the LCD screen. On either side it shows two pictograms, on the left a person in Spinal Flexion and on the right a person in Spinal Extension. In between the Flexion and Extension figures is a stylised bargraph which looks like seven vertebrae stacked on top of each other. When displaying the patients neutral posture the bargraph is positioned in the centre of

the display with all the vertebrae stacked vertically, however if the displayed posture goes toward Flexion the bargraph moves toward the Flexion figure AND the vertebrae curves over stylistically ' ) ' like the vertebrae in a person in Flexion. If the displayed posture goes

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toward Extension the bargraph moves toward the Extension figure AND the vertebrae curves over stylistically ' ( ' like the vertebrae in a person in Extension.

4.2.9 Logged Data Display

The 'Logged Data' Display is located on the top right hand side on the LCD screen. It shows the associated numerical values and state of the selected parameter.

4.3 Patient Sensor Controls and Nomenclature

Sensor Tip

Curvature Sensing Strip

Flexible Molding

Start Button

Electronics Enclosure

Cable Connection Socket

Charging LED Finger Notch

Adhesive Patch

4.3.1 Sensor Tip The sensor tip is located at the top of the picture above, the tip has a small oval 'bump' on the topside surface of the tip. This 'bump' is useful to hold between the index finger and thumb when testing the Spinalsensa for the first time, as outlined in the Setup section of this manual.

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4.3.2 Flexible Molding The main body of the Spinalsensa is a soft flexible molding. The molding protects the Curvature Sensing Strip, and creates a larger area for the Adhesive Patch to stick to. The elastic material is sensitive to aggressive solvents so care must be taken when cleaning the sensor that the Alcohol wipes or mild detergents are only used.

4.3.3 Curvature Sensing Strip Inside the Flexible Molding is a thin metallic strip that is used to sense the curvature of the patients spine. This metallic strip has sensitive measuring gauges that detect the bending of the metallic strip, either backwards or forwards. The thin metallic strip can only curve so far before the metal bends and kinks - for this reason it is recommended that the Spinalsensa should not be manually flexed back and forth except gently for the first time it used to confirm correct operation.

4.3.4 Start Button The 'Start Button' is a tactile switch used to start the training session. By pressing the 'Start Button' the Patient Sensor powers up and will go through the three stage sequence for a session - [1] initializing to neutral position, [2] the training session and [3] session completion (power down).

4.3.5 Electronics Enclosure The electronics enclosure is a translucent blue plastic compartment that holds the Patient Sensors battery and electronics.

4.3.6 Cable Connection Socket At the left hand side of the electronics enclosure is a mini-USB socket, this socket enables charging of the battery and data communications when connected with the Practitioner Unit. The USB cable plugs into the mini-USB socket in one orientation only, so care must be taken not to force the plug into the Patient Sensor, the connections should slide together smoothly without too much effort.

4.3.7 Charging LED Located inside the electronics enclosure just above the Finger Notch is a small blue LED, this LED will be illuminated whenever connected to the USB charger or the Practitioner Unit.

4.3.8 Finger Notch The Finger Notch is a small cut-away at bottom of the Flexible Molding. The Finger Notch enables the patient to grasp the tag on the Adhesive Patch and peel it away from the Patient Sensor after a training session.

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4.3.9 Adhesive Patch The adhesive patch's primary function is to attach the Patient Sensor Unit to the Patients skin. The Patch has a gel adhesive on both sides, the side with the 'crack back' (split backing) is a strong adhesive for attaching the Patch to the Sensor Unit, the other side of the Patch (single backing - labeled "on") has a less aggressive adhesive for attaching the Patient Sensor / Patch combination to the patients skin. The Adhesive Patch is a single use device - this ensures the adhesive characteristics are consistent each time the Patient Sensor is used and the measurements performed by the sensor are consistent also. 5 Symbols Several symbols are used on the enclosure of the Spinalsensa which are defined as follows:

On/Off (standby) button: Pressing the On/Off button switches the device on or conversely off.

Set (Enter) parameter button: Pressing the Set button either Stores the current posture position or loads the new parameter value selected by the Selection Dial.

Back (undo) button: Pressing the Back button disregards the new parameter value selected by the Selection Dial.

+ Increase Parameter Symbol: The Selection Dial when rotated Clock Wise increases the selected parameters value.

- Decrease Parameter Symbol: The Selection Dial when rotated Counter Clock Wise increases the selected parameters value.

Attention Symbol: indicates that the instructions for use should be consulted before operation is attempted.

BF Symbol: indicates that the applied parts (electrodes) of this equipment are rated as Type BF which means that the applied parts are suitable for placement on the external surface of the body.

Fuse rating symbol: indicates the fuse is located adjacent to symbol and to be replaced with a fuse of the stated rating

WEEE symbol: indicates the device should not be disposed in municipal waste, but in an environmentally responsible way (see 8.4)

0805 CE Mark

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6 Abbreviations LED - Light Emitting Diode Nr. - Number SN - Serial Number W - Watts V - Volts A - Amperes 7 Rear Panel

Equipment Identification Label

Mains Label Fuse Drawer Mains Inlet Connector

7.1 Mains Inlet Connector The mains inlet connector is an IEC appliance connection and contains the mains power connector and fuse holder. The mains cable supplied with the Spinalsensa should be fitted with an approved plug suitable for connection to local mains power outlets. Ensure that the mains power outlet is properly earthed. IMPORTANT: It is important that the Spinalsensa be operated from a mains supply

which has a nominal supply voltage equal to that indicated on the mains label on the rear panel. Safety and performance specifications are only valid if these voltages are the same.

7.2 Mains Fuses External mains fuses are installed to protect the Spinalsensa from damage if certain internal faults occur. Fuses do age and sometimes fail unnecessarily. Fuse failure should

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not, however, be interpreted as a fault in the fuse only. If the mains fuses fail, the Spinalsensa should be inspected by a qualified technician. Ensure that mains fuses are replaced with the same type and rating as stated on the mains power label. 7.3 Mains Label This label is located on the back of the unit and provides information on the voltage ratings, frequency, power and the fuse ratings.

7.4 Equipment Identification Label This label is located on the underside of the unit and provides information on the manufacturer, equipment identification and details of the input range.

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8 Operational Procedures 8.1 Setting Up Connection to mains: The mains power cord should be connected to the IEC power socket at the rear of the Spinalsensa Practitioner Unit. The other end of the power cord should then be plugged into the mains power outlet, and the power outlet switched on. Battery Charging: The Spinalsensa Patient Sensor is powered by an internal rechargeable battery. This battery is charged by an external USB charger that is powered by the mains. When charging the Patient Sensor an indicator at the bottom of the Patient Sensor will be illuminated, indicating the charger is connected correctly. The Patient Sensor comes complete with the USB charger, 1 metre USB cable (USB to mini-USB) and Mains adapter connections (USA, UK, EU, AUS). Slide the correct Mains adapter on to the charger module, it will lock in to place with a 'click'. Carefully connect the USB cable to the charger via the larger sized USB plug. Plug the other end of the USB cable - ie the smaller 'mini-USB' plug into the side of the Patient Sensor - carefully observe the orientation of the plug and socket, the connections should slide together easily, and very little force is required. Plug the charger into a mains power outlet, and switch the power outlet on. The Blue LED located at the bottom of the Patient Sensor should be illuminated. The Patient Sensor is now charging. Generally the Patient Sensor will be used daily, so it is recommended to charge the Patient Sensor each day, for example overnight. Cables: The Spinalsensa Practitioner Unit has one USB socket located at the front of the unit, this socket plugs into the 2.9 metre USB cable which is used for connecting to the Patient Sensor Units. Checking Unit: Before using the Spinalsensa system on a patient for the first time, it is advisable to confirm the Spinalsensa system is operating normally. The following checklist can be followed to confirm the correct operation of the displays and controls (once the Patient Sensor Unit has been charged). 1. Press the 'Power Button' – the Practitioner Unit will power up, make a beep sound and illuminate the LCD backlight and display an initialisation message with "Metron", "Spinalsensa" and a software version number on the screen. 2. A few seconds later the screen will show an animation of the "Spinalsensa Patient Sensor with a cable being plugged into it", with the instructions "Connect Sensor!". 3. Connect the Patient Sensor to the Practitioner unit via the 3 metre USB cable. The Blue LED at the bottom of the Patient Sensor should be illuminated. 4. Press the 'Start Button' on the Patient Sensor, the Patient Sensor will confirm with a beep sound, and perform the neutral position acquisition. 5. A few seconds later the screen will show an animation of the "Spinalsensa Patient Sensor sending 1's and 0's down the cable", with the statement "Downloading...". The small

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tinted window 'sensor status' at the bottom of the Practitioner Unit should show a flashing Green LED, indicating data communication is in progress. 6. After Downloading has occurred the 'Spinal Position' section of the screen should show two pictograms, on the left a person in Spinal Flexion and on the right a person in Spinal Extension. In between the Flexion and Extension figures is a stylised bargraph which looks like seven vertebrae stacked on top of each other. The 'sensor status' window at the bottom of the Practitioner Unit should show a illuminated Green LED. 7. Holding the Patient Sensor, slowly and carefully bend the flexible tip of the sensor 10 millimeters (1/2 an inch) upward, the display should show the 'Vertebrae' moving toward the Extension Person, and now move the flexible tip of the sensor 10 millimeters (1/2 an inch) downward, the display should show the 'Vertebrae' moving toward the Flexion Person. 8. The test is now complete, the Patient Sensor is measuring curvature, and the Practitioner Unit is receiving and transmitting data to the Sensor. 9. Press the 'Power Button' – the Practitioner Unit will power down, make a beep sound and the LCD backlight will go dark. It is advisable for the practitioner to familiarize themselves with the operation of the Spinalsensa by testing the Patient Sensor on themselves to gain a feel for the setting of parameters and the capabilities of the system. 8.2 Using the Spinalsensa System

8.2.1 Setting Treatment Parameters The Treatment Parameters can be grouped into two distinct groups. The first group of five Treatment Parameters are the posture thresholds for triggering feedback alerts and alarms. Setting these thresholds is simply a matter of recording the current curvature position of the patient/sensor - this is done by Selecting the desired Parameter with the 'Selection Dial' - for example "Flexion Maximum". In the 'Logged Data' part of the LCD screen it will show "Threshold: Enter", position the patient in posture where the "Flexion Maximum" alarm should occur and press the 'Set Button' to store this posture threshold, the screen will show "Threshold: Stored". If the posture was not quite the correct one, position the patient again and press the 'Set Button' again. The Neutral Position is the optimum posture, it is approximately in the middle of the "Acceptable Posture Range". It is the classical standing straight posture. This position is used as a reference position by the Sensor, and is used for the Real-time display. The Flexion Feedback and Extension Feedback effectively define the "Acceptable Posture Range", if the Patient's posture exceeds either of these two thresholds a quick feedback vibration will be felt by the patient to remind them they have exceeded the recommended range of spinal curvature. When a feedback vibration is given, it is also logged by the Patient Sensor as a transgression. The logged number of transgressions is a metric that can be used to monitor patient improvement and compliance. As the treatment progresses the Practitioner can reduce the "Acceptable Posture Range" as the Patients proprioperception improves with training.

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The Flexion Maximum and Extension Maximum are thresholds which cause the Patient Sensor to continuously vibrate and emit a beeping sound. These thresholds are primarily for ensuring patient safety rather than feedback training. The five threshold positions are shown diagrammatically below.

The three remaining Treatment Parameters are timing settings. These settings are the Feedback Delay time, the Inactivity Time and the Session Time. The Feedback Delay time defines how long before the Feedback vibration occurs when the Flexion Feedback or Extension Feedback thresholds have been exceeded. Initially the Feedback Delay will be set to Zero time so that the patient is aware they have exceeded the "Acceptable Posture Range" as soon as possible. As the treatment progresses, and the patients proproperception ability improves, the practitioner can allow the patient some extra time to correct their posture before the Feedback vibration occurs. If the patient exceeds the "Acceptable Posture Range" and corrects their posture before the Feedback Delay time, there will be no Feedback vibration and the transgression will not be logged. The Inactivity Time is used to remind the patient that static postures should be avoided also. As the Patient Sensor monitors the spinal curvature, if no significant changes in posture are sensed for the period of the 'Inactivity Time' then a series of vibrations will occur to remind the patient to be more dynamic. The Patient Sensor will also log an Inactivity transgression. Initially it may be too much to expect a patient to maintain a healthy posture and be dynamic, so the Inactivity timer can be set to '0' meaning that it is switched off. However as the treatment progresses the inactivity timer can be set to more realistic values (for example, 5 to 10 minutes). The inactivity timer can also give some indication of patient compliance, for example if the Patient Sensor is not worn and is just started, having high values of Inactivity Time transgressions may be the result. The Session Time is the length of the time the Patient Sensor will operate for, once the 'Start Button' has been pressed. After the Session Time has elapsed the Patient Sensor will automatically power down. Typical Sessions Times will be 20 to 40 minutes.

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8.2.2 Real-time Display At the beginning of treatment it is useful to educate the Patient about the "Acceptable Posture Range" and the Neutral Position. Although the Patient Sensor provides vibration feedback when the "Acceptable Posture Range" has been exceeded, for training a visual feedback device is ideal for illustrating the Neutral Position in the Clinical setting. The 'Spinal Position' display is a 25 position bargraph, that is referenced to at one end of the scale to the Flexion Feedback threshold and at the other end of the scale to the Extension Feedback threshold, the bargraph is effectively an 'expanded scale' device that varies depending on the settings of the Flexion and Extension Feedback thresholds. The Bargraph is displayed as a stylised 'spine' made from 7 vertebrae, as the bargraph moves laterally, the curvature for the spine curves as well. This lateral movement and curvature create an intuitive display, but also a display that has a non-linear feel - larger movements at the ends near the Flexion & Extension Thresholds and finer movements about the Neutral Position. At the Neutral Position the vertebrae change from a solid blue color, to an outline - dramatically illustrating the Neutral Position.

8.2.3 Vibration and Audio Feedback The Vibration from the Patient Sensor provides a simple method of feedback to the patient. The vibration for Biofeedback consists of the following: Flexion Feedback Alert - 2 short vibrations, repeated every 5 seconds. Extension Feedback Alert - 1 short vibration, repeated every 5 seconds. Flexion & Extension Maximum Alarm - 1 long vibration and Beep, repeated every 1 seconds. Inactivity Time Alert - 5 short vibrations. (no repetition)

The vibration signals for Operational Status are: Start Button pressed - 1 short vibration + short low pitch beep and long high pitch beep. Starting Treatment - 1 short vibration + two short high pitch beeps. End of Session - 1 long vibration + long low pitch beep.

Although the Patient Sensor uses audio beeps for conveying alarms and status, the volume level of the sound is designed to be unobtrusive to the patient and others.

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8.3 Guidelines to Treatment using the Spinalsensa System

8.3.1 General Procedure The general procedure for using the Spinalsensa is listed below:

• Assessment: Medical assessment and examination of patients condition, performed by a qualified practitioner.

• Diagnosis: From the assessment and patient history a diagnosis can be formed for

the patients condition. If postural training of the spine is an appropriate treatment for the patients condition the Spinalsensa biofeedback system could be utilized.

• Contraindications: Before prescribing the Spinalsensa as a treatment, confirm no

contraindications exist. • Prescribing the Spinalsensa: The Spinalsensa requires significant patient

compliance, so some consultation with the patient on what the Spinalsensa can do and what is required by the patient for the treatment to have favorable outcomes.

• Sensor Placement: from the assessment and examination of the patients movement

and spinal curvature the sensor placement can be determined. • Sensor Attachment: the sensor can be attached to the patient with a single use

adhesive gel patch. • Clinical Training: In the clinic the patient can be trained using visual feedback from

the Spinalsensa. Instruction on the Neutral Position and how to perform training away from the clinic.

• Instruction on how to attach the Sensor: Using visual and tactile cues and some

simple aids, the patient can be taught how to attach the sensor reliably when not at the clinic.

• Patient Information: The Patient sensor has a small manual with a patient

information sheet that the practitioner can write down information for the patient: these include how many training session are to be performed per day, the next appointment, a drawing of the sensor placement. Also the patient should be encouraged to read the small manual with regards, to sensor care, cleaning and charging the battery.

• Training at Home: The Patient performs training at home, up to 2 weeks between

appointments. • Follow-Up Appointments: Follow up appointments to monitor patient progress,

provide encouragement, refreshing the patient with clinical training and to modify the posture limits and training times as the patients proprioperception abilities improve.

• Final Outcome: The final outcome is the patients posture is significantly improved

and that the patients proprioperception ability helps in avoiding undesirable postures which may lead to pain or other unfavorable outcomes.

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8.3.2 Attaching Sensor to Patient

Inside the Patient Sensor carry case there are several Adhesive Patches - each individually packed in plastic 'EZ-tear' bags. Take the bag and tear the perforated strip from the bag. Carefully remove the Adhesive Patch from the bag. Each side of the Adhesive Patch has a peel off plastic backing, on one side the plastic backing is split in two - this is called the 'crack back' side. The other backing has the word 'no' printed on it. Bend the patch so that the 'crack back' side 'opens' in the middle, and peel off both the crack back's. The two halves of the 'crack back' can be disposed of. Place the Adhesive Patch on a flat surface - like a table, and with the exposed sticky side facing up, carefully place the Patient Sensor down on the Adhesive Patch and apply a small amount of pressure to ensure the Adhesive Patch is firmly stuck on the Patient Sensor. Carefully peel off the 'no' side backing off the Patch/Sensor. The 'no' backing can be disposed of. Attach the Patient Sensor to the Patient. The positioning of the Patient Sensor is critical and will vary from Patient to Patient, to help the Patient perform this task at home, the Patient Sensor comes with basic instructions and a positioning sheet for the Practitioner fill out to assist with the consistent placing of the sensor. The procedure for placement is in the next section. Note: depending on the patients skin type, an alcohol wipe of the patients skin area might be required.

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8.3.3 Placement of the Patient Sensor The Spinalsensa is primarily designed for the lumbar spine, however the sensor could be placed on the cervical or thoracic spine or even across another curving part of the body - such as the top of the shoulder. The problem for positioning the sensor, is the human body varies from person to person and therefore so does the spine, adipose tissue, and muscular tone. These biological variations of the human body make it difficult to prescribe a simple solution to positioning the Patient Sensor. This section outlines a method for positioning the sensor so that it can monitor the relevant body curvature and be positioned consistently for each session. The lumbar spine will be considered in this section, but can be extrapolated for other parts of the body. The patient sensor has two alignment axes, the first axis (vertical) is placed in alignment with the centre of the spine. The second axis (horizontal) is the optimum location for sensing curvature, this axis is situated at the 'waist' (where the flexible molding curves in) or near the #4 dimple (above the electronics enclosure), the curvature sensors are located at this position inside the flexible molding. The positioning of this curvature sensing axis in relation to the patients spine is the key to getting reliable measurements.

All measurement systems have a range and a sensitivity, the Spinalsensa Patient Sensor is no different, there is a maximum range of curvature that the sensor can measure and a minimum sensitivity which defines the smallest amount of curvature the sensor can detect. This why for the best results the sensor should be positioned where there is maximum curvature, so that small changes in curvatures can be sensed accurately.

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The ideal placement for the sensor is where there is (1) maximum changes in curvature for accurate measurement, and (2) close to the clinical region of interest. To find the place where maximum changes in curvature occur, instruct the patient to perform flexion and extension exercises, whilst the patient is performing these exercises, observe the way in which the lumbar spine curves. As no patient back is the same, the curvature will be slightly different for each case. The sensor curvature sensing axis should be located at this curvature position on the patients spine, generally this is the L4-5 interspace. The final positioning variable is how the sensor is oriented, either in the normal vertical position or the inverted position. Generally the sensor is oriented in the normal vertical orientation, however sometimes this orientation may not be ideal - for example if the sensor needs to be positioned low on the patients spine, the wider electronics enclosure end of the patient sensor may be too close to the patients buttocks and may cause discomfort. By inverting the sensor the thin sensing part of the patient sensor will be less intrusive. The sensor can now be attached to the patient.

8.3.4 Consistently Positioning the Sensor for Further Treatments Getting the patient to consistently position the sensor for each treatment is a challenging issue. In some medical treatments where high precision is required, tattooing of reference (fiducial) points on the patient is performed, however this is an extreme measure, and the Spinalsensa does not require that level of precision. For the Spinalsensa some tolerance is allowable, as positioning is 'important' but not 'critical'. For the treatment to be effective the patient much be able to position and attach the sensor in only a few minutes, otherwise the patient will not comply with the treatment. The patient can position the sensor by:

• Visually, by using a mirror reflection. • Making references to other body features: Spinous processes, umbilicus (navel -

belly button), freckles or existing markings such as tattoos. • Using aides: measuring tape, string, marker pen, USB cable! • Using physical reference points on the sensor: Dimples, electronics enclosure and

Battery bump (physical reference points - shown below) • Or a combination of the some of the above.

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Some examples of repositioning are: A) Visual, using USB cable and reference points on sensor. Once the sensor has been positioned on the patients spine, using the USB cable wrapped around the waist of the patient - at the level of the navel, note where the cable lines up on the patient sensor ie: which of the physical reference points (dimples, top of enclosure, battery bump or bottom of enclosure). So at home all the patient has to do is wrap the cable around themselves, line it up with the reference point on the sensor and attach the sensor. B) Visual using a marker pen. As the Spinalsensa may be used several times a day, it can be a good idea to mark the location on the skin with a marker pen the first time it is positioned (for example in the morning) so that when the sensor is used throughout the day it can be simply lined up with the mark.

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8.3.5 Patient Sheet - Sensor Positioning The "Patient Sheet" is the first page of the Patient manual that is packed in the carry case of the Patient Sensor. This sheet is useful for passing on treatment information to the Patient - particularly the sensor placement and orientation, how many training sessions a day to perform, and the next appointment. Any extra instructions or notes to the patient can also be filled in - ie sensor positioning cues or the use of positioning aids.

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8.3.6 Real-time Display Training Real-time training in the clinic is performed by connecting the patient sensor to the Practitioner Unit via the long (2.9 metre) USB cable. The "Spinal Position" section of the Practitioner Unit LCD screen is used by the patient to visualize their own spinal curvature. 1. Press the 'Power Button' – the Practitioner Unit will power up, make a beep sound and illuminate the LCD backlight and display an initialization message with "Metron", "Spinalsensa" and a software version number on the screen. 2. A few seconds later the screen will show an animation of the "Spinalsensa Patient Sensor with a cable being plugged into it", with the instructions "Connect Sensor!". 3. Connect the Patient Sensor to the Practitioner unit via the USB cable. The Blue LED at the bottom of the Patient Sensor should be illuminated. 4. Press the 'Start Button' on the Patient Sensor, the Patient Sensor will confirm with a two tone beep sound, make sure the patient is in the neutral posture, the sensor will beep twice when a stable (static) neutral posture has been acquired. 5. A few seconds later the screen will show an animation of the "Spinalsensa Patient Sensor sending 1's and 0's down the cable", with the statement "Downloading...". The small tinted window 'sensor status' at the bottom of the Practitioner Unit should show a flashing Green LED, indicating data communication is in progress. 6. After Downloading has occurred the 'Spinal Position' section of the screen should show two pictograms, on the left a person in Spinal Flexion and on the right a person in Spinal Extension. In between the Flexion and Extension figures is a stylised bargraph which looks like seven vertebrae stacked on top of each other. The 'sensor status' window at the bottom of the Practitioner Unit should show a illuminated Green LED.

Note: if this is the first time the Patient Sensor has been used, the Neutral Position and Flexion and Extension Feedbacks and Flexion and Extension Maximums will need to be setup at this stage.

For training, visual feedback is ideal for illustrating the Neutral Position. The Neutral Position is shown on the LCD as a vertical spine pictogram - with each of the vertebrae is drawn as an outline. Spinal positions other than Neutral are drawn as solid (filled-in) vertebrae. The patient can be monitored whilst sitting or standing. At the beginning it is useful to educate the Patient about the "Acceptable Posture Range" and the importance of the Neutral posture. The Patient Sensor will provide vibration feedback if the Flexion or Extension Feedback positions has been exceeded. For visual training the Flexion and Extension Alerts can be modified/programmed to enable the LCD screen (spinal position window) to display larger or smaller curvature ranges. Initially the range should be set to a larger range as patient will need to improve proprioperception, as the patient progresses and the patients proprioperception improves the displayed curvature range can be decreased.

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8.3.7 Home Training with the Spinalsensa Patient Sensor The Patient Sensor is supplied in a carry case that protects the Patient Sensor when not in use, and holds the adhesive patches, alcohol wipes (Medi-swab), 1 metre USB cable, USB charger and patient manual. The front page of the patient manual is useful to illustrate the positioning of the sensor and other useful information such as the number of sessions a day, the next appointment and any special exercises. The patient manual also has the sequence of instructions for using the patient sensor, how to clean the sensor, charging the sensor and special warnings. However the most important issue is patient compliance, the patient will need to be educated on the benefits of using the device, shown where and how to position the sensor and the importance of avoiding static postures and the importance of the neutral posture.

8.3.8 Treatment Review - Downloading Patient Data 1. Press the 'Power Button' – the Practitioner Unit will power up, make a beep sound and illuminate the LCD backlight and display an initialization message with "Metron", "Spinalsensa" and a software version number on the screen. 2. A few seconds later the screen will show an animation of the "Spinalsensa Patient Sensor with a cable being plugged into it", with the instructions "Connect Sensor!". For downloading data, the sensor does not need to be attached to the patient. 3. Connect the Patient Sensor to the Practitioner unit via the 3 metre USB cable. The Blue LED at the bottom of the Patient Sensor should be illuminated. 4. Press the 'Start Button' on the Patient Sensor, the Patient Sensor will confirm with a two tone beep sound, several seconds later the sensor will make a two beeps (indicating that neutral position acquired). 5. A few seconds later the screen will show an animation of the "Spinalsensa Patient Sensor sending 1's and 0's down the cable", with the statement "Downloading...". The small tinted window 'sensor status' at the bottom of the Practitioner Unit should show a flashing Green LED, indicating data communication is in progress. 6. After Downloading has occurred the 'Spinal Position' section of the screen should show two pictograms, on the left a person in Spinal Flexion and on the right a person in Spinal Extension. In between the Flexion and Extension figures is a stylised bargraph which looks like seven vertebrae stacked on top of each other. The 'sensor status' window at the bottom of the Practitioner Unit should show a illuminated Green LED. 7. Using only the 'Selection Dial' the downloaded data can be scrolled through. The data can be manually recorded for gauging patient performance and compliance. Note: If the 'Set Button' is pressed at anytime, the sensor will assume that it is being programmed - ie the treatment parameters are being modified, and when the sensor is powered down the sensor will clear all the downloaded data in preparation for the new series of sessions.

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9 Cleaning & Preventative Maintenance 9.1 Cleaning Unit There is no requirement for routine cleaning of the Spinalsensa Practitioner Unit other than to ensure that all ventilation holes are kept clear of debris and any spillage of gels, water etc, particularly on the front of the unit, and near the mains inlet connector on the back of the unit. Any spillage should be cleared as soon as possible. The Patient Sensor will require regular cleaning particularly on the flat application surface that the adhesive patch attaches to. To clean the flat application surface, use the supplied alcohol wipes to clean the surface. No other solvent should be used on the Patient sensor as this may result in the flexible molding deteriorating or dissolving. Do not submerge the Patient Sensor in water or other cleaning fluids, as the Patient Sensor is not sealed and the electronics will be damaged. 9.2 Preventative Maintenance There is no preventative maintenance that needs to be performed on the Spinalsensa System other than occasional cleaning as detailed above. It is however recommended that routine calibration verification and electrical safety testing be carried out on the Spinalsensa Practitioner Unit at least once every twelve months. Information on the type and frequency of electrical safety testing may be obtained from Australian Standard AS 3551 or from relevant locally published standards. 9.3 Battery Replacement Although it is not expected the Ni-MH battery will need replacement within the service life of the Patient Sensor Unit, it is possible to replace the Ni-MH battery to extend the service life of the SS170 Patient Sensor Unit once the battery has failed, this procedure however needs to be performed by a qualified Metron Service Agent as the procedure also involves replacement of the Start Switch and the soldering of electrical connections. 9.4 Decommissioning and Battery Disposal The Spinalsensa contains a 3.6 Volt 150 mAh Ni-MH battery, it is recommended at the time decommissioning/battery disposal the battery be removed from the unit for recycling or disposition in an environmentally responsibly way. The battery removal method is outlined in the SS170 Service Manual. WEEE symbol: The symbol of the doubled crossed wheelie bin shown below indicates the device should not be disposed of in unsorted municipal waste, but in an environmentally responsible way.

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10 Specifications POWER SUPPLY REQUIREMENTS: Practitioner Unit: Voltage 110/220/240 Volts AC Frequency 50/60 Hz Power Max 65 VA Primary Fuse (external) 2 of 2 A 5 x 20 mm DA205 Delay Secondary Fuse (internal) 1 of 1 A 5 x 20 mm M205 Patient Sensor Unit: USB Charger Voltage 100 to 240 Volts AC Frequency 50/60 Hz Power Max 5 VA Internal Battery Type NiMH Voltage 3.6 V Current 150 mAh MAINS STEP-DOWN TRANSFORMER: Integrated switch mode power supply complying with international standard IEC 601-1: 1988 (EN 60601-1) and all subsequent amendments. Secondary voltages 24 Volts @ 2.7A SENSOR INPUT: Sensor: Two Vishay Strain Gauges in Half Bridge arrangement Input Amplifier: Single Ended Input G = 100 Sensor Range: Cantilever Tip deflection +/- 35 mm ADC: 10 bit ADC SENSOR UNIT SETUP PARAMETERS: Curvature Position for Flexion Maximum Alarm (10 bit value). Curvature Position for Flexion Feedback Alert Trigger (10 bit value). Curvature Position for centre Neutral Position (10 bit value). Curvature Position for Extension Feedback Alert Trigger (10 bit value). Curvature Position for Extension Maximum Alarm (10 bit value). Feedback Alert time delay in seconds (0 - 5 seconds).

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Inactivity Alert timer in minutes (0 - none, 1 - 60 minutes). Session time in minutes (1 - 120 minutes). SENSOR UNIT DATA LOGGED PARAMETERS: The total number of Flexion Maximum Alarms recorded. (0 - 99) The total number of Flexion Feedback Alerts recorded. (0 - 9999) The total number of Extension Feedback Alerts recorded. (0 - 9999) The total number of Extension Maximum Alarms recorded. (0 - 99) The total number of sessions completed by Patient. (0 - 99) The total time (accumulated session times) in minutes. The total time (accumulated session times) in hours. (0 - 9999 minutes total). The accumulated time beyond the Flexion Feedback Trigger position in minutes. The accumulated time beyond the Flexion Feedback Trigger position in hours. (0 - 9999 minutes total). The accumulated time beyond the Extension Feedback Trigger position in minutes. The accumulated time beyond the Extension Feedback Trigger position in hours. (0 - 9999 minutes total). Note: Time beyond Feedback Triggers is not directly displayed on device, however percentages are calculated relative to the total time. CONTROLS AND DISPLAYS: On/Off power button: Soft touch power On and Off control. Main Display: 240 x 128 Graphical LCD with White LED backlight Posture Curvature Bargraph: The LCD has a 25 position pictograph of the Spine showing a representative curvature for biofeedback training. Patient Data: Patient logged parameters are numerically displayed in this partition of the LCD. Treatment Parameter: 8 Selectable Treatment Parameters are displayed on the left hand partition of the LCD. Adjust Dial: data entry encoder - rotate clockwise for increase, or conversely for decreasing data. Set button: Enters parameter for data entry. Back button: Reverts to previous parameter value. Sensor Status Indicators: Two indicators (Red and Green) show Sensor communication status. COMMUNICATIONS: Electrical Connection: Mini-USB cable and connectors (but no USB protocol is utilized). Protocol: RS-232 Character Based Protocol. Configuration: 9600 baud, 8 bits, 1 start bit, 1 stop bit, no parity.

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ELECTRICAL SAFETY: Manufactured to International Standards: EN60601.1 (1998) Approval and Test Specification Medical Electrical Equipment Part 1: General Requirements Applied Parts: Patient Sensor Applied Parts Classification: BF Device Classification: Class I Equipment DIMENSIONS & WEIGHT: Width 240 mm Packed 3 Kg Height 120 mm Unpacked 1.5 Kg Depth 250 mm

ENVIRONMENTAL CONDITIONS: Operating: Temperature Range 10 - 40 oC Relative Humidity 30 % - 90 % Transport & Storage: Temperature Range 0 - 70 oC Relative Humidity 10 % - 100 %

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11 About Us Metron Medical Australia - Design and Manufacture

Metron Medical have been designing and manufacturing electrotherapy for over 25 years in Melbourne, Australia. Metron has been successful in Australasia and throughout Europe and the Americas. With the valuable clinical input from Practitioners, University and Research institutes, product development is considered an ongoing process, and we are proud to have been an integral part of the Spinalsensa development and look forward to taking this new technology further in to the future. With a focus and commitment to quality, Metron has achieved various quality standards, including ISO9001, ISO13485, CMDCAS and CE

certification. Also, Metron is regularly audited to maintain FDA clearance and TGA accreditation for the entire range of products. Michael Carter - Inventor

Michael holds a BAppSc & Grad Dip in Industrial Design and an MBA in Innovation and Entrepreneurship. Michael got the inspiration for inventing the Spinalsensa when he was still at University, lying in bed one morning immobilized by back pain, he thought there must some way to avoid this situation happening again. Prescribed a back brace whilst in high school a few years earlier, Michael knew how difficult, both physically and psychologically it was to wear a back brace. He was supposed to wear his back brace for two years, however he could last only two months. Life was too difficult wearing it. Michael researched the concept further and sought opinions from leading researchers and practitioners, the idea of a Spinalsensa type device was well received. The Spinalsensa was taken further and with consultation from Universities, health professionals and private enterprise, the Spinalsensa went from a concept to a reality.

Michael currently lives in Brisbane, Australia with his wife Isabella, son Ned, daughter Milly and pet goldfish Elliot. Apart from taking the family to beach on weekends and playing tennis, he has a keen interest in new technology, innovation, and sustainability.

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12 WARRANTY STATEMENT Metron Medical Australia Pty Ltd., will warrant this device/instrument/appliance (excluding accessories) against defects in manufacture for a period of two years from the date of purchase. Accessories including patient leads, cables and electrodes will be covered under this warranty for a period of three months from the date of purchase.

- PROVIDING - The instrument has not been serviced by persons not authorized by Metron Medical Australia Pty Ltd., and has not been misused or tampered with and has been used on the correct voltage as branded on it.

- THIS WARRANTY EXCLUDES - Parts of the device/instrument/appliance failure of which in the opinion of the dealer of manufacturer is a result of misuses or abuse or any other reason not directly attributed to fault in manufacture. Batteries are excluded from this warranty except where it can be demonstrated that any battery failure was caused by a malfunction in the Spinalsensa. This warranty also excludes glass or ceramic portions.

- IN THE EVENT OF FAILURE - The complete device/instrument/appliance should be returned to the dealer from which it was purchased or to the nearest authorized service agent, together with a full report, freight paid and insured.

- UNDER NO CIRCUMSTANCES - Shall Metron Medical Australia Pty Ltd., or their agents or dealers be liable in any manner whatsoever for any compensation or damages to any person occasioned by this device/instrument/appliance for any loss, injury or any damage occasioned by or as a result of the misuse or abuse of this device/instrument/appliance.

- LOSS IN TRANSIT - The warrantor does not accept any responsibility for loss or damage to the device/instrument/appliance in transit. Any express or applied conditions, statements or warranty, statutory or otherwise (save specifically provided above) is hereby excluded.

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13 EC DECLARATION

Metron Medical Australia Pty Ltd, 57 Aster Avenue, Carrum Downs, Australia, 3201 declares that the medical devices described hereafter: Metron Spinalsensa Biofeedback System Model: SS 170 is in conformity with the harmonised international standard EN 60601-1; 1990 including amendments. is in conformity with the harmonised international standard EN 60601-1-2, 2002. is in conformity with the essential requirements and provisions of Council Directive 93/42/EEC. is subject to the procedure set out in Annex II of Directive 93/42/EEC under the supervision of Notified Body Number 0805,Office of Devices, Blood and Tissues - Therapeutic Goods Administration, PO Box 100, Woden, ACT 2606, Australia. Melbourne, 13th September 2007

Ashley Williams Managing Director Metron Medical Australia Pty Ltd

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14 CE MARK

0805

The Metron Spinalsensa Biofeedback System bears the above marking in accordance with the requirements of Council Directive 93/42/EEC. Should you as the purchaser and/or user of this product wish to make any comment about the product or the manner in which it may be used our Authorized Representative within the European Union may be contacted as follows: Metron Medical c/- Physiomed Services Attention: Kevin Lee 8-11 Glossop Brook Business Park Surrey Street Glossop DERBYSHIRE SK13 91J UNITED KINGDOM

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