COMPASS HEALTH TENS 7000 Rechargeable TENS Unit Device User Manual

: June 12, 2024
: COMPASS HEALTH

COMPASS HEALTH TENS 7000 Rechargeable TENS Unit Device

COMPASS HEALTH TENS 7000 Rechargeable TENS Unit Device

This manual is valid for the TENS 7000® Rechargeable Device

This user manual is published by Compass Health Brands Corp.

Compass Health Brands does not guarantee its contents and reserves the right to improve and amend it at any time without prior notice. Amendments may however be published in new editions of this manual.

This device complies with Part 18 of the FCC Rules

LEGAL NOTICE

Distribution, reproduction and translation of the software and its documentation (or excepts thereof) are prohibited without the prior consent of Compass Health Brands Corp.

Compass Health Brands Corp reserves the right to change the software and associated data without notice. All other rights reserved.

For questions about your TENS 7000® Rechargeable Device:

Compass Health Brands Corp
6753 Engle Road
Middleburg Heights, OH 44130
Tech Support:888-549-4945, Option 2
Email: techcsr@compasshealthbrands.com

LIMITED WARRANTY

Congratulations on the purchase of your TENS 7000® Rechargeable Device.

Compass Health Brands Corp, warrants that your TENS 7000® Rechargeable Device is free of defects in material and workmanship. This warranty shall remain in effect for one (1) year* from the date of the original end user purchase. If this Product fails to function during the warranty period due to a defect in materials or workmanship, Compass will repair or replace the respective Product without charge. Compass’ sole obligation in the case of any breach of its warranty set forth in the manual shall be, at Compass’ option, to replace the Product without charge to Compass’ purchaser, or to refund the purchase price. It is at the discretion of Compass’ purchaser, if they will refund their customer and/or end user. If the Product is requested to be returned and product plus accessories is unopened/unused it can be returned minus a 25% restock fee, to the customer who purchased the Product from Compass. Any repairs or modifications to this Product performed by any unauthorized centers or groups will void this warranty.

COMPASS HEALTH BRANDS SHALL RESERVE THE RIGHT TO REQUEST PROOF OF PURCHASE FROM THE END-USER TO VALIDATE THE WARRANTY PERIOD.

This warranty does not cover:

Replacement parts not provided by the manufacturer.
Defects or damage caused by labor furnished by someone other than the manufacturer.
Any malfunction in the Product caused by product misuse, including, but not limited to, the failure to provide reasonable and required maintenance or any use that is inconsistent with the Product’s Manual. COMPASS HEALTH BRANDS SHALL NOT BE LIABLE IN ANY EVENT FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES. Some locations DO NOT allow the exclusion or limitation of incidental or consequential damages, so the above limitation or exclusion may not apply to you.

***** The device warranty only applies to the device and does not include any accessories. All accessories have a 6 month warranty, except the electrodes. Damages to the device or accessories due to non-adherence with the Instruction Manual and its warning and cautions will exclude the warranty.

To obtain replacement parts, service or a replacement device under this warranty:

A claim must be made within the warranty period directly to Compass or the company from whom you purchased the device.
An RMA number must be obtained from Compass in order to receive replacements parts and/or return defective product under the warranty.
To contact Compass’ Tech Support Department for troubleshooting and/or replacement request, please call: 888-549-4549, Option 2.

This warranty gives you specific legal rights and you may also have other rights which vary from location to location. Any representative or agreement not contained in the warranty shall be void.

Information in this document is subject to change without prior notice. The manufacturer of the equipment may have patents, patent applications, trademarks, or copyrights covering material in this document. This document does not grant license to any of these intellectual property rights. The manufacturer shall not be liable for any errors and/or omissions for incidental or consequential damages in connection with the performance, or use of this material. All rights reserved. Without limiting the rights under copyright law, no part of this document may be reproduced, stored in or introduced into a retrieval system, or transmitted in any way without the express written permission of the manufacturer.

FOREWORD

This manual has been written for the owners and operators of the TENS 7000® Rechargeable. It contains general information on the instructions for safety, intended use, working principle, operation, maintenance, trouble shooting, and warranty. In order to maximize the use, efficiency, and working life of your unit, please read this manual thoroughly and become familiar with the controls, as well as the accessories, before operating the unit.

INDICATIONS FOR USE

The TENS 7000® Rechargeable is intended for use by medical specialists and by an end user. Users must have the basic physical and cognitive prerequisites such as vision, hearing, and literacy. The TENS 7000® Rechargeable is intended to be used for:

Temporary relief of pain due to exercise or normal household work activities.
Sore and aching muscle pain in the upper and lower extremities
Minor aches and acute pain.

SYMBOLS

Symbols on the device and throughout the manual:

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Manufactured for:

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Correct Disposal of This Product (Waste Electrical & Electronic Equipment) Statement: Contact the local authorities to determine the proper method of disposal of potentially bio-hazardous parts and accessories.

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Type BF applied part complying with IEC 60601-1

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This symbol indicates that this device is a Class II equipment according to IEC 60601-1 (when charging)

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Refer to instruction manual/ booklet

Symbols on the package

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This side up
The transportation package must be vertical and straight up during transportation.

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Fragile, handle with care
The product inside the packaging could be easily damaged if dropped or handled without care and attention.

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Keep away from rain
The product package should keep out of the rain and not to store it in damp conditions

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Temperature limitation

The product package should be stored at a temperature between -4° F and 131°F (-20°C and 55°C).

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Upper limit of humidity
The product package should be stored at a humidity less than 93%.

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Atmospheric pressure limitation The product package should be stored at an atmospheric pressure between 86kPa and 106kPa.

PRECAUTIONARY DEFINITIONS

The precautionary instructions found in this section and throughout this manual are indicated by specific symbols. Understand these symbols and their definitions before operating this equipment.

The definition of these symbols is as follows:

CAUTION

Text with a “CAUTION” indicator will explain possible safety infractions that could have the potential to cause minor to moderate injury or damage to equipment.

WARNING

Text with a “WARNING” indicator will explain possible safety infractions that will potentially cause serious injury and equipment damage.

Refer to Instruction Manual/Booklet

NOTE: Throughout this manual, “NOTE” may be found. These Notes are helpful information to aid in the particular area or function being described.

Type BF applied part

Accessories are considered a BF applied part.

WARNINGS AND CAUTIONS

Please read the user manual entirely before using the TENS 7000® Rechargeable and take care of what follows:

WARNING

Read, understand, and practice the precautionary operating instructions. Know the limitations and hazards associated with using the TENS 7000® Rechargeable. Observe the precautionary and operational decals placed on the unit.

Please reference the EMC Guidance at the end of the manual regarding special precautions and electromagnetic environment needed when using the device.
Improper installation, operation, or maintenance of the TENS 7000® Rechargeable may result in malfunctions of this unit or other devices.
DO NOT use the device in the presence of a flammable anesthetic mixture with air or oxygen, or nitrous oxide.
In case of device failure or other obvious defects, turn the unit off immediately, and notify the company you purchased the device from.
DO NOT use on persons with implanted demand type cardiac pacemakers or defibrillators.
DO NOT use on persons with severe heart failure or arrhythmia.
DO NOT apply pulsed electrostatic fields over areas in which symptoms of existing thrombosis or thrombophlebitis are present.
DO NOT apply pulsed electrostatic fields over, or in proximity to, cancerous lesions.
DO NOT apply pulsed electrostatic fields over swollen, red, or inflamed areas or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins).
DO NOT apply pulsed electrostatic fields when the patient is in the bath or shower.
DO NOT apply pulsed electrostatic fields while the patient is driving, operating machinery, or during any activity in which pulsed electrostatic fields can put the patient at risk of injury.
DO NOT use this device if you have a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device. Such use could cause electric shock, burns, electrical interference, or death.
DO NOT use this unit for purposes other than treatment indicated in this manual.
DO NOT use the TENS 7000® Rechargeable with high frequency surgical equipment on the patient. It will cause unstable output when the unit is close to the high frequency equipment (in the same room and without shield).
DO NOT use this device simultaneously with other therapeutic device (such as microwave, shortwave), to avoid miss operation. Operation in close proximity (e.g. 3 ft) to a shortwave or microwave therapy device may produce instability in the device output.
Be sure to use only the specified battery provided by the manufacturer and listed in this manual under Technical Specifications. If there are issues with the battery (based on the low battery indicator) please contact your distributor or the manufacturer.
Please stop using the battery when it appears abnormal, such as bulging, cracked housing, or any shape changes.
NEVER perform unauthorized service work.
Please dispose of the equipment and other accessories according to local regulations. DO NOT treat them as household waste.
DO NOT put the device in fire or water. If the batteries are not properly disposed, it may cause a battery explosion.
If the unit is not functioning properly or you feel discomfort, immediately stop using the unit. If you feel any discomfort with your body or skin, consult the doctor and follow his/her instructions.
The adhesive electrodes are for single patient use only, DO NOT use on another patient, to prevent infection.
If the adhesive electrodes loses viscosity, please replace the electrode in order to maintain good electrical connection and to avoid potential injury.
DO NOT secure electrodes with none or little viscosity, using any other adhesive method such as, tape, Band-Aid, wraps, etc. Electrodes MUST be replaced if not attached completely to the treatment area, including lifting edges.
Patients with suspected or diagnosed heart disease should follow precautions recommended by their physicians before using this device.
Keep this device out of the reach of children.
DO NOT use this device while sleeping. The main device may malfunction or overheat, or the electrodes may move to an unexpected region or potentially disconnect and cause harm to the patient.

CAUTION

This is a Class II medical device but Federal law allows these devices to be sold over-the-counter (no prescription needed).
ALWAYS check the device and the accessories for damage before use.
Take care not to allow water to enter the device. Liquid penetration could damage the device.
DO NOT use volatile liquids, such as paint thinner or benzene, because they may damage the plastic casing.
Ensure that the connectors are fully dry before connecting to the device.
Use this device only with the accessories recommended by the manufacturer.
Handle the device with care. DO NOT drop, knock, or shake the device. Rough handling can damage internal circuit boards.
DO NOT press, bend or damage the electric cable.
Please charge the device at least every three months during long-term storage.
DO NOT use this device while driving.
DO NOT use this device in areas with high humidity.

PRODUCT DESCRIPTION

The TENS 7000® Rechargeable device is a powerful non-invasive alternative for safe and effective pain relief. It was designed with 5 different advanced modes to relieve your pain when you need it the most. All the parameters are adjustable on the easy to read large digital display screen, that uses tiny electrical pulses through electrodes attached to the skin, to decrease the perception of pain.

CONTRAINDICATIONS

DO NOT use the device over carotid sinus (neck) region.
TENS devices can affect the operation of demand type cardiac pacemakers and is suggested to consult with your physician before using.
DO NOT use if you have heart disease, without consulting a physician.
DO NOT stimulate on any site that may cause current to flow transcerebrally (through the head).
DO NOT apply TENS on undiagnosed pain syndromes until etiology is established.
DO NOT use if you have any of the following diseases:
- Acute infections
- Acute inflammations with participation of pathogen agents
- Active tuberculosis
- Acute venous disease (untreated trhomoses)
- Untreated malignant processes
- Erysipelas
- Patients with cardiac pacemakers and other electronic implants
- Untreated heart disorders and diseases, especially cardiac insufficiency, decompensated cardiac edema, and cardiac arrhythmia
- Pregnancy
- Infectious skin diseases
- Vertebrobasilar insufficiency (VBI)

TECHNICAL SPECIFICATIONS

GENERAL

Product Name

| TENS 7000® Rechargeable
Product Model|

DT7303

Device Dimensions

| 110 x 62 x 20 mm
Screen Size|

44 x 48 mm

PERFORMANCE

Channels|

2

Output Waveform

| Symmetrical Biphasic Pulse
Output Voltage|

Adjustable, 0-100mA(p-p), at 1000 ohm load

Device Intensity

| 50 levels
Pulse Width|

Adjustable, 5-300 us, 10 microseconds/step

Pulse Rate

| Adjustable, 2-150 Hz, 1/step
Power Source (Battery)|

500mAh lithium battery

Modes

| Five Modes: Normal , Burst, Modulation, SD1 & SD1
Timer|

Adjustable, from 10-90 mins or Continuous. Adjustable in 5 min increments from 10-55 minutes and 10 min increments from 60-90 minutes. Treatment time counts down automatically

Patient Compliance Meter

| Unit can store up to 60 sets of records, total recorded time is 999 mins

Low Battery Indicator

|

A low battery indicator will show up on the LCD screen, in the upper right hand corner, to let you know when it’s getting low. It is recommended to charge the batter if there are only 1 bars on the low battery indicator and it’s flashing

**** Operating Conditions

| Temperature: -50˚F~185˚F Relative Humidity: <80% Atmosphere Pressure: 750hPa
**** Storage & Transport Conditions|

Temperature: -50˚F~185˚F Relative Humidity: <80% Atmosphere Pressure: 75-106KPa

Tolerance

| There may be a +/- 20% of all parameters and +/- 10% of intensity and voltage

MODE DESCRIPTION/PARAMETERS

**** Normal Mode

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Timing: 10~90 minutes
Frequency: 2-150Hz
Pulse width: 50-300μS

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Pulse Width and Pulse Rate are adjustable. This mode creates continuous stimulation based on the setting value.

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**** Burst Mode

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**** Timing: 10~90 minutes
Pulse train frequency: 0.5-5Hz
Pulse width: 50-300μS

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Burst Rate: Adjustable from 0.5-5Hz Pulse Width: 50-300us
Frequency fixed: When 0.5-1hz, adjust 0.1hz each time, when 1-5hz, adjust 1hz each time.

**** Modulation Mode

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Timing: 10~90 minutes
Pulse train frequency: 2-150Hz
Pulse width: 50-300μS

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Modulation mode is a combination of pulse width and pulse rate modulation. Continuous stimulation, from 50% set of width to 50% set of rate.

**** SD1 Mode

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Timing:10~90 minutes
Pulse train frequency: 2-150Hz
Pulse width: 50-300μS

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SD1 (Strength-Duration) consists of automatic modulation of 10 seconds intermittent stimulation.

**** SD2 Mode

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Timing: 10~90 minutes
Pulse train frequency: 2-150Hz
Pulse width: 50-300μS

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SD2 (Strength-Duration) consists of automatic modulation of 10 seconds intermittent stimulation.

DEVICE INSPECTION

Item Description

| Item #| QTY|

UOM

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TENS 7000® Rechargeable device

| DT7303| 1| Each
Black Carrying Case| CC7303| 1|

Each

45” Black lead wires

| WW3005| 2| Pack
USB Charging Cord| DT7303X| 1|

Each

TENS 7000® Electrodes (2”x 2” White Cloth)

| DT7202-PK1| 4| Pack
Instruction Manual| N/A| 1|

Each

DEVICE CONSTRUCTION

Device Construction

Channel 1 Port
Channel 2 Port
Type C Charging Port
On/Off/Play/Pause
Increase/Decrease CH 1
Increase/Decrease CH 2
Set Button — Change Parameters
Mode Button — Change Mode
Belt Clip

ACCESSORIES

2.0mm plug lead wires (2/pk)
USB Charging Cord
2”x 2” White Cloth Electrodes (4/pk)
Carrying Case

Charging the Battery

When the device is turned on, check the low battery indicator. The low battery indicator is located in the upper right hand corner of the device.
When the battery is low and the battery indicator blinks stating that the battery needs to charge. Turn off the unit.
The Lithium battery can be recharged by connecting the USB side of the charger to a computer or a wall adapter charging box and then connecting the other side of the cord to the bottom of the device.

A green light shows that it is charging. The charging process will can take up to two hours to complete a full charge.

NOTE: Only charge the unit when battery is completely drained the first 2 times. Unplug the charger from power outlet when charging is complete. When stimulation intensity decreases, it indicates that the device needs charging. DO NOT use the device while charging.

SET UP INSTRUCTIONS

Prepping the Treatment Area

Proper preparation of the treatment area, covered by the electrodes, allows more stimulation to reach targeted tissues, prolongs electrode life, and reduces the risk of skin irritation. After connecting the lead wire(s) to the stimulator, use the following steps to prepare your skin at the electrode placement sites:

Determine the placement sites for the electrodes. You must use a minimum of 2 electrodes.
Wash the area with mild soap and water (DO NOT use alcohol). Rinse and dry thoroughly.
When removing electrodes, ALWAYS remove by pulling from the electrode surface (not the attached wire) in the direction of hair growth.

Placement of the Electrodes

Connect the lead wires to the electrodes before applying them to the treatment area.
Connect the lead wires to the output sockets at the top of the unit.
Remove the protective from the electrodes from the plastic liner before placing onto the treatment area.

WARNING

To avoid an electrical short, NEVER put two electrode pads together. They must be at least 2” but not more than 6” apart.

Setting Treatment

NOTE: DO NOT turn the unit on until all electrodes (2 or 4) and lead wires are properly attached.

Turn on the unit by pressing the

Selecting the Mode

This device includes five treatment modes to choose from:

Burst
Normal
Modulation
SD1 (Strength-Duration 1)
SD1 (Strength-Duration 2)

For the specifics on how each mode delivers stimulation, please refer to the Technical Specifications Table located at the front of the of manual.

Press the until there is a border around the desired mode as shown .
To change the parameters (such as pulse width, pulse rate, etc), press the and the number for pulse width will blink.
2a To increase or decrease the pulse width, to your desired setting, press either the until desired number is reached.
2b To change the next parameter, press again and the next parameter (such as pulse rate) will blink. Refer to 2a, above to increase or decrease the parameter to the desired setting.

Selecting the Treatment Time

Press until the time under the clock is blinking. To increase or decrease the timer, press until desired time is reached. Treatment time ranges from 10 – 90 mins and Continuous, as indicated by the — instead of a number.

NOTE: If you change modes during the course of a therapy session, the treatment time will not reset unless you manually reset it by performing the steps described above.

NOTE: It is recommended to treat 10 mins per day and gradually increase either the length of your treatment or the number of 10 min treatments per day (not to exceed 30 mins total). After a period of adaptation, it is okay to try other Modes and increase time and intensity.

Adjusting Therapy Intensity Level and Start Treatment

Once all the parameters have been set, gradually increase the intensity on CH1 by pressing the + button for the corresponding lead wire and electrode connected, at the top of the device, until a comfortable stimulation is felt. If using CH2, do the same for that channel. Once the intensity is adjusted, the treatment starts and the timer counts down.

Special Features

Lock Function
If in an emergency, or you want to reposition the pads, press the Pause key (“►II” button) to lock the device, the “MODE” display will blink. The device will not work no matter what key you press on the control panel, it is locked. To unlock press the Pause key again.
Automatic Shut off
The device automatically turns off when the time for your therapy session has elapsed.
Low Battery Status Indicator

NOTE: When the battery is low and the LCD screen blinks, it indicates that the battery needs to charge. Turn off the device, and charge the battery.

Turning off the Device

The device turns off automatically after the therapy session time has elapsed.
To turn the unit off manually, press and hold the On/Off switch. The display will go blank and the device will turn off.
In an emergency you may also pull the connector(s) from the device and then remove the electrode pads.

NOTE: To prevent unpleasant electric shocks, never remove the pads while it is still turned on.

NOTE:

Never connect this product with a common headphone.
Please do not touch the USB port when using the device. The USB port is only used to connect the charger, do not connect other devices.
Only use a charger that has been obtained from the manufacturer of the TENS 7000® Rechargeable device.
The battery needs to be charged for up to 10 hours before the first use.

MAINTENANCE AND STORAGE INSTRUCTIONS

Alterations and repairs

Any repairs or modifications to the device, attempted by anyone other than the manufacturer, will immediately void the warranty. DO NOT attempt repairs or modifications on the the device, as it can negatively affect the safety and performance of the device, as well as cause harm to the individual using the device.
The manufacturer is only responsible for the safety and performance of TENS 7000® Rechargeable when readjustments, alterations and repairs are carried out by authorized individuals and when the TENS 7000® Rechargeable is used in accordance with the user instructions.
Qualified technicians who are familiar with the technical features of the device have been provided with circuit diagrams, PCB drawings, component lists and setting instructions by the manufacturer.

Cleaning and maintenance

For the device:

To keep the device clean, use a soft and dry cloth for dust or a soft damp cloth for any dirt and smudges. DO NOT use any cleaning solutions to clean the device or the electrodes.
DO NOT use or store the device where there are magnetic fields or electric waves (near TV set or speakers).
DO NOT place the devices in areas of high temperature, high humidity, or under direct sunlight.
Keep the device out of reach of children.
All worn accessories should be disposed of according to your local regulations.

For electrodes:

Refer to the following suggestions:

Unplug the output cord from the output socket at the top of the device after each use. Place electrodes on the protective liner for storage. NEVER fold the electrodes.
Between uses, store the electrodes in the reusable bag in a shady place. Storage temperature: +5°C~+27°C (41~86°F) and humidity of 40%~70%. No need to sterilize.
Never apply the electrodes to any other surface other than your skin. If the electrodes become soiled or dirty, the adhesive quality may decrease. In this case, moisten the surface of the electrode with one tiny drop of water and wipe away the dirt. This may allow one additional use of the electrode, only if the electrode is completely adhered to the treatment area with no lifting. If there is any lifting of the edges, replace with a new electrode. If an electrode is used with poor connection to the patient, it could cause a shock or burn. NOTE: Too much water will result in a loss of adhesion on the electrode.
The life of the electrodes varies depending on skin conditions, storage, amount of use, type of stimulation, and stimulation site. Electrode life may be extended by carefully following this Instruction for Use. Expired electrodes are to be disposed of and do not harm environment.
When the electrodes dry out and do not stick, replace with new pads that are OTC 510K cleared and compatible with TENS 7000® Rechargeable, with smallest area of 4cm2.

WARNING: The electrodes are intended for single patient use only!

For Lead wires

Disconnect the cables from the stimulator and electrodes.
DO NOT pull on the cables; only pull on the connectors attached to the ends of the cables.
Store the stimulator with the cables in a clean, dry place.

Storage

CAUTION

DO NOT store in a damp area. Dampness may affect the device and cause rust.

Normal working ambient temperature: -50°F~185°F
Normal working ambient humidity: ≤80%RH
Store and transport ambient temperature: -50°F~185°F
Store and transport ambient humidity: ≤93%RH

Technical checks

Technical checks on the device should be performed every 24 months.
These include:

Checking the device for completeness.
Visual check:
- for mechanical damage
- or damage to all cables and connections

Disposal of the Unit

To dispose of the unit, its accessories and packing materials, take appropriate actions in accordance with the rules and regulations in force in your area to prevent adverse ecological effects.

TROUBLESHOOTING

Problem

| Possible Causes|

Try this Solution

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One pad feels stronger than the other.

| This is normal. Different areas of your body will react differently.|

Nothing needs to be done. Make sure the pads are sticky and are making good contact.

The intensity is not felt. Very weak intensity level.

|

Pads are not attached to the body firmly.

| Attach both pads firmly to the skin.
The transparent films are still stuck to the pads.|

Peel off film on the adhesive surface of pads.

The pads stacked together or overlap.

| Do not stack pads together or overlap pads.
The cord is not properly connected to the unit.|

Connect cord correctly into the jack.

The intensity setting is getting weak.

| Increase the intensity level.
The battery capacity is low.|

Charge the battery.

The skin turns red or the skin feels irritated.

| The adapter is not connected properly.| Check to ensure the adapter is properly connected to the device. Check if the adapter is connected to an electrical outlet.

No power source; no display in LCD

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The battery capacity is depleted.

|

Charge the battery.

Power cut off during use.

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The battery is weak.

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Charge the battery.

The cord is broken.

|

Replace the cord.

It is difficult to attach the pad to the skin.

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Have you removed the transparent film from the pad?

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Peel off film on the adhesive surface of pads.

Was the pad applied immediately after washing?

| Dry the pad.
Is the adhesive surface of the pad damaged?|

Replace the pad.

Adhesive surface of pad is not sticky.

|

Are you using pad when perspiring?

| Use when not perspiring, in a cool room.
Were the pads stored under high temperature, high humidity, or direct sunshine?|

Replace the pad.

If the above measures are not effective, please contact your distributor or Compass Health Brands Tech Support at Tel: 800-376-7263 Option 2; WEB: www.compasshealthbrands.com

Electromagnetic Compatibility

Important information regarding Electro Magnetic Compatibility (EMC)

With the increased number of electronic devices such as PC and mobile (cellular) telephones, radio transceivers, mobile radio transmitters, radio controlled toys, and so on, Medical devices in use may be susceptible to electromagnetic interference from other device. Electromagnetic interference may result in incorrect operation of the medical devices and create a potentially unsafe situation. Medical devices should also not interfere with other devices.

In order to regulate the requirements for EMC (Electro Magnetic Compatibility) with the aim to prevent unsafe product situations, the EN60601-1-2 standard has been implemented. This standard defines the levels of immunity to electromagnetic interference as well as maximum levels of electromagnetic emissions for medical devices.

This unit has been thoroughly tested and inspected to assure proper performance and operation! This product needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided, the following tables recommend minimum separation distances between portable and mobile RF communications equipment and the TENS unit.

CAUTION

The use of accessories and cables other than those specified by TENS 7000® Rechargeable, with the exception of cables sold by TENS 7000® Rechargeable as replacement parts for internal components, may result in increased emission or decreased immunity of the device.
DO NOT use a mobile phone or other devices that emit electromagnetic fields, near the unit. This may result in incorrect operation of the unit.
This device SHOULD NOT be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, this device should be observed to verify normal operation in the configuration in which it will be used.
Refer to further guidance below regarding the EMC environment in which the device should be used.

There is no guarantee that interference will not occur in a particular installation. Radiated or conducted electromagnetic signals can cause:

As to devices:
- Deviation of the values of pulse duration, amplitudes, and repetition frequencies, may impair the unit’s essential performance. The device has passed EMC highest interference level test, and the parameters do not deviate the essential performance requirement.
- The device displays abnormally in LCD.
As to patients:
- The sensitivity of stimulation may be weaker or stronger, but it does not produce safety issues.
- It cannot achieve expected effect.
- If this equipment is found to cause or respond to interference, attempt to correct the problem by one or more of the following measures:
- If feeling too weak or too strong stimulation, adjust the strength level to an acceptable level.
- If the device display is abnormal, power off and restart the device and check whether it shows properly.
- Re-orient or re-locate the affected device.
- Increase the separation between the unit and the affected device.
- Power the equipment from a source other than that of the affected device.
- Consult the service representative for further suggestions.

Customer Support

Manufactured for:
Compass Health Brands Corp.
6753 Engle Road, Middleburg Heights, OH 44130
Ph:800-376-7263
www.compasshealthbrands.com
Made in China

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Documents / Resources

| COMPASS HEALTH TENS 7000 Rechargeable TENS Unit Device [pdf] User Manual
TENS 7000 Rechargeable TENS Unit Device, TENS 7000, Rechargeable TENS Unit Device, TENS Unit Device
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