USER’S MANUAL IN ENGLISH

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Manage your pain when active or at rest

READ INSTRUCTIONS

OPERAT INGB E F O R E

1 INTRODUCTION BEFORE USING THE STIMULATOR1.1 Electro-Medic: A Solid Culture, a Therapeutic Alternative, Devices Conceived from the Finest Technology 31.2 Medical Context: Usage and Benefits of Neurostimulation 4 1.3 Safety Measures: Medical Indications, Contraindications, Precautions, Caution 5-7

2 INTRODUCING THE DEVICE2.1 Equipment and Accessories 82.2 Electrical Specifications, and Pre-Programmed Settings 9 2.3 Keypad Functions 102.4 LCD Screen Indicators 11

3 ASSEMBLY INSTRUCTIONS3.1 Electrodes: Assembly, Application, Connection, and Engagement 123.2 Settings: Modifying a program, Locking/Unlocking, Modifying Treatment Time 133.3 Adjusting Intensity Level 143.4 Ceasing Stimulation 143.5 List of Stimulation Modes 153.6 Table of Programs, Configurations and Customization 16-173.7 Battery Maintenance: First Charge, Battery Status, Replacement, Battery Charger 18-203.8 Troubleshooting 20

4 MAINTENANCE AND CLEANING 21

5 WARRANTY 21

6 DOCUMENTATION HISTORY

22

7 CHOOSING APPROPRIATE ELECTRODES, FUNCTIONS 26-28

2 page 1

2 BEFORE USING THE STIMULATOR

A CONCEPT ACCESSIBLE TO ALL

INTRODUCTION1.1

3 page1 Electro-Medic is the proud

Canadian manufacturer of -TENS-, safe and efficient neurostimulator devices. They are compact electrical devices that are therapeutic and portable, offering :

A SOLID CULTURE IN ELECTROTHERAPY: Our devices are carefully conceived to allow for noticeable reductions in pain -- including, but not limited to: acute, chronic, sports-related, post-operative, and post-traumatic pain. They provide a therapeutic option that is medically recognized -- and applicable within a clinical environment, at home, and even while engaging in everyday activities! Our model is technologically refined -- yet light, compact, and user-friendly. We’ve pursued thorough and consistent collaboration with healthcare providers and their patients, in order to develop a device that is capable of serving an expanded range of patients’ needs.

MANAGE YOUR PAIN WHEN ACTIVE OR AT RESTMEDICAL CONTEXTUTILIZATION OF NEUROSTIMULATIONELECTROTHERAPY/NEUROSTIMULATION WAS DEVELOPED BY THE PHYSIOLOGIST, PATRICK WALL, AND IS SCIENTIFICALLY-PROVEN AND PRESCRIBED BY MEDICAL PROFESSIONALSElectrotherapy or neurostimulation -TENS- is transferred via electrodes placed upon the body near the treatment area. Electrical vibrations emanate from the -TENS- through the electrodes, and support the body’s natural tendency toward healing and pain management.

TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR – SENSORY IMPRESSIONSUsers should expect to experience a light tingling sensation beneath the electrodes at the skin’s surface. This indicates that the device is working to provoke a natural analgesic reaction to alleviate pain.

AN EXCELLENT ALTERNATIVE TO OVERMEDICATIONNeurostimulation is used in cases of post-operative and post-traumatic acute sharp pain, and also for muscular relaxation. It helps to alleviate pain in cases where even heavy medication couldn’t.

ACCESSIBLE TO ALL-TENS- gives users the chance to choose the most appropriate program for their specific type of pain, which is both non-surgical and non-medicative. It is a highly efficient solution -- much more than just a complement to traditional treatment. -TENS- Helps to manage pain when active or at rest

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1.2 THET E N S

1.3 SAFETY MEASURESMEDICAL INDICATIONS, CONTRAINDICATIONS, PRECAUTIONS, CAUTION-TENS- answers each user’s specific needs. Without the use of pharmaceuticals and aggressive procedures, this technique is safe and recognized for its lack of side effects, when administered properly. It is moderately-priced, compact, and extremely easy to use. Compact and lightweight the -TENS- can be worn at waist or slipped into a pocket which facilitates daily activities.

BENEFICIAL EFFECTS OF NEUROSTIMULATION pain management • a return to a normal, active life • improved mobility • accelerated healing after a traumatic injury

TENS INDICATIONS FOR PAIN RELIEF• acute, subacute or chronic pain • pain following a trauma • relieves pre and post surgery

FUNCTIONAL REHABILITATION : 5 page

• Sprain• Neck, back and lower back pain (acute or chronic)• Tendinitis, epicondylitis, bursitis, capsulitis• Rheumatism (osteoarthritis, arthritis)• Tension headache• Diabetic neuropathy• Facial neuralgia• Shingles• Fibromyalgia• Phantom member• Complex regional pain syndrome• Post stroke or spastic pain

• Multiple sclerosis• Related to cancer, under interdisciplinary supervision (doctor, physiotherapist) ***prohibited: Presence of metastasis or in the case of circulatory leukemia***• Angina pain• Labour/delivery• Dysmenorrhea• Intermittent lameness• Perineal pain• Interstitial cystitis• Urinary and/or fecal incontinence

Better autonomy in daily activities

6 LOCAL CONTRAINDICATIONS DO NOT APPLY ON THESE REGIONS• Transcranial application: the risks of applying the electrodes in a transcranial way are unknown.• Anterior region of the neck, carotid sinus (throat): risk of stimulation of the vagus nerve, phrenic, pharyngeal muscles or carotid sinuses.• Eyes: the risks of treating this area are unknown.• Various infections: risk of expending infection.• Skin disorder: psoriasis, eczema… Caution near open wound or healing scar.• Undiagnosed pain.

LOCAL CONTRAINDICATIONS

MUST BE USED UNDER INTERDISCIPLINARY OR MEDICAL SUPERVISION• Cancer - absolute contraindication: presence of metastasis or in the case of circulatory leukemia. - local contraindication: for other types of cancer, must be used under interdisciplinary supervision.• Transthoracic application and Anterior surface of the cardiac region.• Electronic implant: risk of interference with the operation of the implant.• Cardiac stimulator: absolute or local contraindication, to be used under interdisciplinary supervision with authorization from treating cardiologist.• Heart disease: risk of the heart having difficulty compensating for high metabolic demand.• Pregnancy: abdominal and lumbar region during pregnancy. It is possible to use the -TENS- at the lumbar level during labour/delivery.• Skin sensorial disorder, loss of sensitivity: risk that the patient does not adequately sense the current, which increases the risk of burns or skin irritation.• Genitals: proper training required.• DVT / phlebitis / embolism: risk of displacement of the thrombus in the bloodstream.• Bleeding: risk of increasing bleeding.• Epilepsy: local contraindication: head and neck (cervical region). Precaution at the level of the trunk and limbs. Electrical stimulation could trigger epileptic seizure.• Tuberculosis: during the active phase, electrical stimulation may extend the infection area.

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6 7 page

PRECAUTIONS

• Circulatory disorder: stimulation increases the metabolic demand and the demand can therefore exceed the oxygen supply, thereby aggravating the pain. Can even lead to tissue ischemia or necrosis.• Skin disorder: the resistance is decreased, increasing the risk of burns.• Active epiphysis patch: may affect bone growth.• Chest, heart and abdominal region: may affect normal heart function.• Communication disorder: risk of injury, misunderstanding of use. Must be used under interdisciplinary supervision.

CAUTION

• Children: keep out of reach of children.• When driving a vehicle: never handle the -TENS- or move the electrodes while driving.• Risk of skin damage: when using the carbon electrodes, always use conductive gel. Adhesive tape may cause skin damage.

WARNING• Not servicing/maintenance while the Electro-Medic equipment is in use

INTRODUCING THE DEVICE 2.1 EQUIPMENT AND ACCESSORIES MODEL : SOULTHE PORTABLE NEUROSTIMULATOR, -TENS- “SOUL,” COMES WITH THE FOLLOWING ACCESSORIES• 1 case • 1 instruction/application manual • 1 charger with 2 lithium-ion batteries • 2 wires with 1 set of carbon electrodes • 1 Gel tube • 1 Roll of adhesive tape • 1 protective silicone envelope that may be used with 1 included belt clip and 1 elastic band to attach to the body for enhanced convenience and mobility • 1 lanyard so that -TENS- may be worn around the neck

CAUTIONCarefully read the instructions relating to use of electrodes as indicated on the packaging.

Only use accessories that are authorized by Electro-Medic.

2 8 pa

ge

1 855 230 6334 info@electromedic.ca electromedic.ca

L’EXPÉRIENCE DU MOUVEMENTSTIMULE et SOULAGE

650, boul. Industriel Suite 100 Blainville Qc J7C 5Y7

GCAR-4060 4 Rectangle 4 x 6 cm

CCAR-4040 4 Carrée/Square 4 x 4 cm

Modèle / Model Q Forme / Shape Grandeur / Size

No. lot :

Exp :

Carbon Electrodes

Électrodes de carbone

GEL

GELConducteurConductive

Pour électrodes | For electrodes

HypoallergiqueFormule hydrosoluble pour l’électrothérapie

HypoallergenicAqueous ElectromedicalCoupling Agent

2015 - 001

GEL-903 fl. oz.(90ml)

9 page

SPECIFICATIONSELECTRICAL SPECIFICATIONS• 2 Fully independent channels • Weight without battery : 75g• Constant current up to a resistance of 1500Ohms • External Dimension : 110mm x 64mm x 11mm (Each program has a maximum output amplitude of 38V) • Timer : 10-20-30-40-50-60-continuous • Stimulation current/channel: 0-60mA • Pulse width : 40-350Us • Pulse rate :1-160 Hz • Operating environment: 0ºC to 35ºC, 20% to 65 %• Frequency and the impulse length are adjustable on all programs R.H.;700hPa to 1060 hPa• Power : 1 rechargeable 600mAh lithium-ion batter • Storage and transport environment: 0ºC to 55ºC, 10% to 90% R.H,500 • Weight with battery : 92g hPa to 1060 hPa

TENS SAFETY CLASSIFICATIONSINTERNAL POWERED EQUIPMENT, TYPE BF APPLIED PART, NOT SUITABLE FOR : • Use in the presence of : a flammable anaesthetic mixture with air, oxygen, or nitrous oxide• Continuous use

CHOICE OF 10 PRE-PROGRAMMED SETTINGS

Continuous Modulated Width (MW) Modulated Rate (MR) Alternate (ALT) Burst

2.2

12345

Mixed Frequency Stimulate Blood Flow Custom Program 1 Custom Program 2 Custom Program 3

6789

10

1 INCREASE Allows user to increase intensity of left or right channel Caution: Increase carefully and only as prescribed.

2 DECREASE Allows user to decrease the intensity of left or right channel. Deactivates the lock.

3 ON/OFF BUTTON Turns device on and off. Also halts stimulation if device is in an active mode.

4 PROGRAM SELECTION Allows user to safely and efficiently switch between 10 pre-programmed stimulation modes. Ch. #1 See 3.5 STIMULATION MODES.

5 SELECTION Press and hold for 3 seconds to access program personalization mode. Press once more to confirm and save current selection.

6 TIMER Activates a timer to aid user in keeping track of duration of use, up to sixty minutes. User may choose between durations in increments of ten minutes. When held down, C mode is activated, and time counts continuously.

7 PROGRAM SELECTION Allows user to safely and efficiently switch between 10 pre-programmed stimulation modes. Ch. #2 See 3.5 STIMULATION MODES.

8 PAUSE Pauses the device. When pressed again, device gradually returns to the previous intensity level by pressing on the pause button Timer function will also pause when device is paused.

9 CHANNEL #2 INPUT 10 CHANNEL #1 INPUT

1

2

3 4 5 6 7 8

910

SoulP

HzUS

MW CMALT C MXFBMR

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KEYPAD FUNCTIONS 2.3

10

1

2 2

12 11

10

9

3 3

4 4

5 5

6

8

6

7

1 PROGRAM LOCK Program may not be modified.

2 OPEN CIRCUIT Electrode may be disconnected, or other possible problem.

3 PROGRAM NUMBER Shows the currently selected program. • The left side shows program number of ch. #1 • The right side shows program number of ch. #2

4 IMPULSE FREQUENCY INDICATOR • “Up” arrow signifies high frequency • “Down” arrow signifies low frequency

5 INTENSITY Displays independent channel intensity as graduated bar.

6 IMPULSE INTENSITY Displays independent channel intensity in numerical form.

7 INDICATES STIMULATION MODE 8 LOCK Indicates whether the program is locked.

9 TIMER Displays remaining treatment time.

10 Us OR Hz In Selection Mode, displays whether numerical value of program is measured in Us or in Hz.

11 PAUSE MODE ACTIVATED Indicates that pause mode is activated.

12 BATTERY STATUS Indicates the level of battery power remaining.

P

HzUS

ALT C B MXFCMMR MW

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LCDSCREEN

INDICATORS 2.4

See Sections 3.2 to 3.8 for detailed explanations of the following functions.

3 CONNECT EACH WIRE INTO THE APPROPRIATE INPUT

CHANNEL ON TOP OF DEVICE.

C

DEVICE SETUPFor safe and optimal performance, only use accessories provided by Electro-Medic. Gradually and appropriately adjusting the intensity level of the device will ensure comfort, pain relief, and optimal benefits. It is particularly inadvisable to experiment with higher levels too quickly.

The electrodes used with this device should never be smaller than 2.54cm in diameter. WARNING: The smaller the electrodes are, the greater the intensity of stimulation onto the localized area where they are placed. Smaller electrodes are associated with a higher risk of skin irritation. Skin irritation may also occur if the self-adhesive electrodes do not stick properly onto the entire surface of the skin. This is often because of lack of adhesive, and may be avoided by replacing the self-adhesive electrodes after fifteen to twenty uses. Carbon electrodes must be used with conductive gel, in order for current to flow adequately. *Note: Additional application instructions are provided on packaging.

to skin that has been washed, dried, and is not irritated. This will allow for the best adherence and optimal electrode performance...

It is possible to purchase the adhesive for Electro-Medic

electrodes (Sold separately)

To optimize results we recommend that you evaluate your pain level before, during and after each treatment using the following pain rating scale.

B

3.1 ASSEMBLY

A

TURN ON THE DEVICE BY

PRESSING THE ON/OFF KEY

D

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APPLY THE ELECTRODES

CONNECTING THE ELECTRODES TO THE WIRES

PAIN EVALUATOR

No pain at all

More intense and/ormore imaginably

uncomfortable

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The plug/adapter plug pins insulates the device from the main supply.

Do not position the device in a position where it is difficult to disconnect from the supply mains to safely terminate operation of Electromedic equipment..

TO MODIFY A PROGRAM To modify a program, press the PR key for the channel you wish to modify until the desired program shows in region 3 on the LCD screen. If you wish to use the second channel as well, select a program in that channel using the other PR button. All programs may be used in combination with one another, except ALT.Caution: Do not modify program parameters without first consulting your healthcare provider.

TO LOCK/UNLOCK A PROGRAMTo lock or unlock a program, simultaneously press the “DOWN” arrow and the PR button for 3 seconds. You will see the lock symbol, as illustrated above, in the left area of the screen. • To change the lock status: use the “RIGHT” arrow • If the locked program symbol is showing : program is locked• If the locked program symbol is not showing : program is unlocked, the user can then modify the program

TO MODIFY THE TREATMENT TIME (0-60 MINUTES) Press the “TIMER” key. The timer on the screen will flash. Continue holding down this key and then confirm desired timer mode by pressing the S key. • Interval Mode: You may select between treatment durations in increments of ten minutes: 10-20-30-40-50-60 minutes. While in this mode, the timer will count down from your selected interval, and will stop once timer reaches zero. Continue pressing to activate Continuous Mode C• Continuous Mode: With this option, the timer continuously counts, and user must manually stop treatment once the desired time has been reached

3.2 SETTINGSMODIFYING A PROGRAM

13 page

See Section 3.5 STIMULATION MODE and Section 3.6 POSSIBLE PROGRAMS AND CONFIGURATIONS

3.3 ADJUSTING ANDLOCKING INTENSITY LEVEL

ADJUSTINGWhen the “UP”arrow is held down, the intensity increases more rapidly. Similarly, when the “DOWN” arrow is held down, the intensity diminishes more rapidly. Caution: increase intensity in a progressive way.

LOCKINGPress the “UP” or “DOWN” arrow to choose the desired option. The lock symbol appears when the security lock is active: It will appear after 10 seconds once setting the selected intensity.If you would like to increase intensity and the lock symbol is showing, you must first deactivate the security lock by pressing the down arrow .Then you will be able to adjust intensity by pressing up the arrow

STOPTo stop the stimulation, lower the intensity with the down arrow until it returns to zero (0.00), or press the “ON/OFF” key.

PAUSEYou may pause for up to 5 minutes at any time during the treatment. • If the device is locked, unlock before pressing “PAUSE.” • The timer will stop while the device is paused• To continue treatment, press “PAUSE” again 14pa

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3.4 CEASING OR PAUSING THE STIMULATION

STIMULATION MODES C CONTINUOUS MODE In “CONTINUOUS” mode, the impulses are steady; the interval rate and the length of the impulses are fixed

B BURSTIn “BURST” mode, the impulses are delivered at a rate of 2 pulse train per second (2Hz).

MR MODULATED RATE In “MR” mode, the frequency decreases by 160Hz to 65Hz in 9 equal steps, and comes back to the selected value in 9 steps. The total length of the cycle is 6 seconds.

MW MODULATED WIDTHIn “MW” mode, the pulse width ranges from 150Us to 70Us in 9 equals steps, and then returns to the selected value in 9 steps. The total length of the cycle is 6 seconds.

CM COMBINATION MODULATION In “CM” mode the modulated width (MW) and the modulated rate (MR) alternates such that when one parameter decreases, the other increases.

MXF MIXED FREQUENCY In “MXF” mode, the signal alternates between a high frequency and a low frequency for 5 seconds. In this mode the screen indicates • The F and the up arrow signify high frequency • The F and the down arrow signify low frequency

ALT ALTERNATEWhen you’re looking for massage or relief, place the electrodes as if for the high frequency stimulation. Even though we obtain a modulated high fre-quency stimulation, the channels are activated alternately, which produces a massage. Always use 2 channels and 4 electrodes with this program. The program is the same for both channels.

15page

3.5

POSSIBLE PROGRAMS AND CONFIGURATIONS

PROGRAM FREQUENCY (Hz) IMPULSES (Us) TIMER (MIN) MODE FIXED

P1 Continuous 80 150 30 C yesP2 Modulated Width (MD) 80 70-150 30 MW yesP3 Modulated Rate 65-160 150 30 MR yesP4 Alternate (ALT) 80 70-150 30 ALT yesP5 Burst 2 250 20 B yesP6 Mixed Frequency 80-2 180 40 MXF (5sec) yesP7 Activate blood flow 6-15 260 30 MR yesP8 Custom Program (1) 80 150 30 C noP9 Custom Program (2) 80 150 30 C noP10 Custom Program (3) 80 150 30 C no

LEXICONHz :

Hz #1 :Hz #2 :

Us : Us #1 : Us #2 : Timer : Fixed :

Frequency adjustmentFrequency #1 adjustmentFrequency #2 adjustmentImpulse duration adjustmentImpulse #1 duration adjustmentImpulse #2 duration adjustmentsDuration of treatmentIndicates whether the program are fixed or can be modified 16pa

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3.6

PROGRAMS #8, #9 and #10PROCEDURE

CUSTOMIZING & PERSONALIZING FIRST STEPPROGRAMMING CHANNEL #1 Press and hold the S key for 3 seconds. Channel #1 will flash. • Using the “LEFT”, UP or DOWN arrow, scroll through the programs until the one you desire shows on the LCD screen • Choose the type of program desired for channel #1: C, B, MR, MW, CM, MXF • Press S to confirm your chosen program.

To obtain the frequency in Hz, use the “LEFT”, UP or DOWN arrow until the desired frequency shows on the screen. Press S to confirm your chosen frequency.

Once again using the “LEFT” arrow, program the length of the impulse in Us. Press S to confirm the length of the impulse. Channel #2 will then flash.

YOU ARE NOW READY FOR THE SECOND STEP -- PROGRAMMING CHANNEL #2 PROGRAMMING CHANNEL #2 With the “RIGHT,” UP or DOWN arrow, this time, simply repeat the steps above as for programming channel #1. Once you’ve finished, the screen will return to the starting point and all your chosen parameters for an optimal, personalized and secured treatment, will be saved.

1 2 17page

BATTERY BATTERY STATUSAs shown : 1/3 of the battery 2/3 of the battery 3/3 of the battery

BATTERY REPLACEMENT

LI-ION BATTERY CHARGER SPECIFICATION LED INDICATION• Adapter (Model : JKY36-SP0420650)• Input : 100V-240V~, 50/60HZ,150mA• Output : 4.2V , 650mA• Red light : Battery is charging• Green light : Battery is fully charged or device is plugged in without battery

3.7

18 page

CHARGING STATION• Input : 4.2V • Output : 4.2V • Green light : Battery is fully charged • Green light : Device is plugged in without battery

THE PATIENT IS AN INTENDED OPERATORThe patient can operate the buttons and change battery under normal circumstances and maintain the device and its accessories according to the user manual.

WARNING• Not servicing/maintenance while the Electro-Medic equipment is in use

CAUTION!• Only charge with Electro-Medic Li-ion rechargeable batteries• DO NOT reverse the (+) and (-) terminals at connection or let the batteries contact metals such as necklaces or hairpins • DO NOT charge Li-ion batteries longer than 72 hours>• Only use battery charger in compliance with the requirements of IEC 60601-1• When charging/using, shall not touch charging connector/battery and the patient simultaneously.

SAFETY INSTRUCTIONS• Do not expose product to fire, direct sunlight or other heat sources, as such exposure may result in burning, explosion, and/or generation of toxic gas• Do not store or transport the product with metal objects• Do not disassemble or modify the product• Do not bring the product into contact with water or any other liquid

OPERATION INSTRUCTIONS• Insert 1 Li-ion battery. Align the poles (+) and (-) correctly• Plug the charger into household AC electric outlet• Red LED will light up to indicate proper charging• When fully charged the LED indicator turns green. Remove the charger from the AC outlet, and then remove the battery

CHARGING TIME• Li-ion battery will take 3.5 hours to charge

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Type BF applied part : electrodes

IP22

Continuous operation

Internally powered Electro-Medicequipment

Applied part

Protection against harmful ingress of water

or particulate matter

Mode of operation

Note: Not intended to be sterilized.Not for use in an OXYGEN RICH ENVIRONMENT

Protection against electric shock

The plug/adapter plug pins insulates the device from the main supply. Do not position the device in a position where it is difficult to disconnect from the supply mains to safely terminate operation of me equipment..

SAFETY CLASSIFICATION OF ELECTRO-MEDIC EQUIPMENT

LI-ION BATTERY• Charging Voltage Limited : 4.2V• Rechargeable Li-ion battery : 3.7V/600mAh

CAUTION • Do not short-circuit• Do not expose the battery to high temperatures• Use specified charger only

CHARGER CLASSIFICATIONSCLASS II, NO APPLIED PART, NOT SUITABLE FOR USE IN THE PRESENCE OF : • a flammable anaesthetic mixture with air, oxygen, or nitrous oxide• continuous operation

TROUBLESHOOTINGIF THE OPEN CIRCUIT SYMBOL SHOWS ON THE SCREEN• the electrodes are not connected properly, are experiencing poor contact on the skin, or must be replaced • it may also be the case that the wires are poorly connected or are dysfunctional.

You must test the electrodes and the wires to troubleshoot.

For more information, please contact your authorized distributor.

3.820pa

ge

ADAPTER INPUT • 100-240V 50/60 Hz, 1.2A

The power adapter is a part of the device. 2MOPP of 60601-1-1 The approvals for the unit are only valid if used in combination with this type of adapter we provide.

CAUTION• It is not permitted to connect device to any other type of adapter other than adapter we provide.

45 21pa

ge

WARRANTYElectro-Medic, Fabricant, attests that the product “TENS. SOUL” is without material and workmanship defects at the time of delivery.

Electro-Medic guarantees every -TENS- device for 3 years from the date of purchase.

THE ELECTRO-MEDIC GUARANTEE• only applies to the device itself • does not cover any accessories (wires, electrodes, chargers) • can only be claimed by the original owner of the device and upon presentation of proof of purchase.

Electro-Medic, after verification of the defective device, will replace the product if it is still under warranty.

Any modifications, abuse, misuse, accidental damage, or repairs made by a third party will cancel the current guarantee.

In the case of problems with the device while still under warranty coverage period, it should be expedited to the point of sale. This will ensure the most prompt response to your request.

MAINTENANCE THE DEVICE Maintenance and cleaning of the device is relatively simple • Always store the stimulator and its accessories inside the provided carrying case • Never expose the stimulator to water • Wipe the device with a humid cloth, if needed. • The manufacturer will provide circuit diagrams, component part lists, descriptions, calibration instructions to assist to service personnel in parts repair

ELECTRODES If signs of degradation appear, replace the electrodes, as recommended in Section 3.1. a) Self-adhesives electrodes: If the self-adhesive electrodes no longer adhere properly to the skin, they may be re-humidified. Place a few drops of water onto the pads before placing them back onto their plastic film. Store them inside their bag hermetically until their next use.b) Carbon electrodes: Rinse the electrodes when treatment has finished. Never use soap or cleaning products, as this may considerably diminish the lifetime of the electrodes.

WIRESDisconnect the wires and the connections delicately and adequately.

BATTERY Take the battery out of the device when not in use for pe-riods of longer than 1 month at a time, in order to maintain the battery’s amperage at an optimal level. It is advisable to remove the battery when not in use for periods of time longer than 1 month.

CONCEIVED BY ELECTRO-MEDIC 650 Industriel blvd suite 100 Blainville Qc Canada J7C 5Y71 855 230 6334info@electromedic.ca

For any inquires about usage of -TENS- by Electro-Medic, feel free to contact your authorized distributor.

6 DOCUMENT HISTORY

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RELATIVE INFORMATION TO THE ELECTROMAGNETIC COMPATIBILITYTested and approved within the security standards : IEC 60601-1/ IEC 60601-1-2/ IEC 60601-2-10

Wireless communications equipment such as wireless home network devices, mobile phones, cordless telephones and their base stations, walkie-talkies can affect this equipment and should be kept at least a distance d = 3,3 m away from txuipment.(Note. As indicated in Table 6 of IEC 60601-1-2:2007 for ELECTRO-MEDIC EQUIPMENT, a typical cell phone with a maximum output power of 2 W yields d = 3,3 m at an IMMUNITY LEVEL of 3 V/m).

Full EMC tables are available from Tenscare on application

The SOUL is designed to withstand foreseeable disturbances by electrostatic discharge, magnetic fields from AC power and the receivers/transmitters of radio frequencies such as mobile phones.

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LEGEND Be sure to read the instruction manual before using the stimulator

Type BF Equipment - floating isolated applied part

Please dispose of the device/battery/accessory/packing in accordance with the legal obligation in your area

Class II equipment

Alternating current

Direct current

Ingress protection

Batch code

Serial number

Manufacturer

Manualversion 3.0

SofwareVersion 2.0

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24 25page