USER MANUAL

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

All Right Reserved. Rev. A © 2022

Conformity to safety standards

Compass Health Brand Corp. declares that the device
complies with following normative documents:
IEC60601-1, IEC60601-1-2, ISO10993-5,
ISO10993-10, ISO10993-1

2
TABLE OF CONTENTS

Legal Notice_______________________________________________________ 4
Limited Warranty___________________________________________________ 5
Foreword__________________________________________________________ 7
Indications for Use__________________________________________________ 7
Symbols __________________________________________________________ 8
Precautionary Definitions____________________________________________ 9
Warnings and Cautions______________________________________________ 10
Product Description_________________________________________________ 14
Contraindications___________________________________________________ 14
Technical Specifications______________________________________________ 15
Mode Description / Parameters ______________________________________ 16
Device Inspection___________________________________________________ 17
Device Construction________________________________________________ 17
Accessories________________________________________________________ 18
Charging the Battery _______________________________________________ 18
Set Up Instructions__________________________________________________ 19
Prepping the Treatment Area_____________________________________ 19
Placement of the Electrodes______________________________________ 19
Setting Treatment_______________________________________________ 20
Selecting the Mode______________________________________________ 20
Selecting the Treatment Time_____________________________________ 20
Adjusting Therapy Intensity Level and Start Treatment _______________ 21
Special Features________________________________________________ 21
Turning off the Device____________________________________________ 21
Maintenance and Storage____________________________________________ 22
Alterations and Repairs__________________________________________ 22
Cleaning and Maintenance_______________________________________ 22
Storage________________________________________________________ 23
Technical Checks________________________________________________ 24
Troubleshooting____________________________________________________ 25
Electromagnetic Compatibility_______________________________________ 26
3
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: [email protected]

4
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:

1. Replacement parts not provided by the manufacturer.
2. Defects or damage caused by labor furnished by someone other than
the manufacturer.
3. 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.

5
To obtain replacement parts, service or a replacement device under this
warranty:
1. A claim must be made within the warranty period directly to Compass
or the company from whom you purchased the device.
2. An RMA number must be obtained from Compass in order to receive
replacements parts and/or return defective product under the
warranty.
3. 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.

6
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:

1. Temporary relief of pain due to exercise or normal household

work activities
2. Sore and aching muscle pain in the upper and lower extremities
3. Minor aches and acute pain.

7
SYMBOLS

Symbols on the device and throughout the manual:

Manufactured for:

Correct Disposal of This Product (Waste Electrical & Electronic Equipment)

Statement: Contact the local authorities to determine the proper method of
Medical Device
disposal of potentially bio-hazardous parts and accessories.
Medical Device

Type BF applied part complying with IEC 60601-1

This symbol indicates that this device is a Class II equipment according to

IEC 60601-1 (when charging)

Refer to instruction manual/ booklet

Medical Device

Symbols on the package

This side up
The transportation package must be Medical
verticalDevice
and straight up during
transportation.
Medical Device
Fragile, handle with care
Medical Device
The product inside the packaging could be easily damaged if dropped or
handled without care and attention.

Keep away from rain

The product package should Medical
keep out of the rain and not to store it in damp
Device

conditions
+55° C Temperature limitation
The product package should be stored at a temperature between
-20° C
-4° F and 131°F (-20°C and 55°C).
93%
Upper limit of humidity
Medical Device
The product package should be stored at a humidity less than 93%.

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

Medical Device

8
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. Medical Device

WARNING

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

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.

Medical Device

Medical Device

9
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 Medical
operational
Device
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.

10
• 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 mis 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.

11
• 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.
Medical Device

• 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.

12
• 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.

13
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:

o Acute infections
o Acute inflammations with participation of pathogen agents
o Active tuberculosis
o Acute venous disease (untreated trhomoses)
o Untreated malignant processes
o Erysipelas
o Patients with cardiac pacemakers and other
electronic implants
o Untreated heart disorders and diseases, especially cardiac
insufficiency, decompensated cardiac edema, and
cardiac arrhythmia
o Pregnancy
o Infectious skin diseases
o Vertebrobasilar insufficiency (VBI)

14
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

Adjustable, from 10-90 mins or Continuous. Adjustable in 5

Timer min increments from 10-55 minutes and 10 min increments
from 60-90 minutes. Treatment time counts down automatically

Patient Compliance Unit can store up to 60 sets of records, total recorded

Meter time is 999 mins

A low battery indicator will show up on the LCD screen,

in the upper right hand corner, to let you know when it’s
Low Battery Indicator
getting low. It is recommended to charge the batter if there
are only 1 bars on the low battery indicator and it's flashing

Temperature: -50˚F~185˚F
Operating Conditions Relative Humidity: <80%
Atmosphere Pressure: 750hPa

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

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

Tolerance intensity and voltage
15
MODE DESCRIPTION/PARAMETERS
Pulse Width and Pulse Rate are
1) Timing: adjustable. This mode creates
10~90 minutes continuous stimulation based on the
setting value.
Normal 2) Frequency:
Mode 2-150Hz

3) Pulse width:
50-300μS

Burst Rate: Adjustable from 0.5-5Hz

Pulse Width: 50-300us
1) Timing: Frequency fixed: When 0.5-1hz, adjust
10~90 minutes 0.1hz each time, when 1-5hz, adjust 1hz
each time.
2) Pulse train frequency:
Burst Mode 10 pulses
0.5-5Hz per burst

3) Pulse width:
50-300μS 0.5 -5 bursts
per second

Modulation mode is a combination of

1) Timing: pulse width and pulse rate modulation.
10~90 minutes Continuous stimulation, from 50% set of
width to 50% set of rate.
Modulation 2) Pulse train frequency:
Mode 2-150Hz

3) Pulse width: 0.5 sec 0.5 sec

50-300μS 50% of
Set Width
50% of
Set Rate

SD1 (Strength-Duration) consists of

1) Timing:
10~90 minutes automatic modulation of 10 seconds
intermittent stimulation.
2) Pulse train frequency:
SD1 Mode 2-150Hz

3) Pulse width:
10 seconds
50-300μS

SD2 (Strength-Duration) consists of

1) Timing: automatic modulation of 10 seconds
10~90 minutes intermittent stimulation.
2) Pulse train frequency:
SD2 Mode 2-150Hz

3) Pulse width:
10 seconds
50-300μS

16
DEVICE INSPECTION

Item Description Item # QTY UOM

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

1 2

9
8

3
5 6
4 7

1. Channel 1 Port 6. Increase/Decrease CH 2

2. Channel 2 Port 7. Set Button — Change
3. Type C Charging Port Parameters
4. On/Off/Play/Pause 8. Mode Button — Change Mode
5. Increase/Decrease CH 1 9. Belt Clip

17
ACCESSORIES

125mm 125mm

2.0mm plug lead wires (2/pk) USB Charging Cord

Intended Use 3. Avoid electrodes from being exposed to
Electrodes are intended for use as a direct sunlight or extreme humidity.
disposable, conductive adhesive interface Recommended storage conditions:
between the patient’s skin and the electrical 41º – 86º, Relative Humidity: 40 – 70%
stimulator. 4. DO NOT leave the electrodes uncovered
in air as this will decrease the viscosity
and performance of the product.
Directions For Use
Caution
Application 1. Read instructions carefully prior to use.
1. Clean skin thoroughly prior to each 2. The electrodes are intended for single
application of electrodes. Electrodes do patient use only.
not stick well if any lotion, oil, make-up, 3. DO NOT apply to broken skin. Should
dirt, etc. is left on skin. skin rash occur, discontinue use and
• 2”x2” Square – White Cloth Electrode 2. Insert the pins of the lead wire from the contact your physician. DO NOT use
while driving a motorized vehicle or
device into the electrode wire
• Self-Adhesive Electrode Gel connectors. while operating machinery.
• Premium Quality 3. Remove the electrodes from the 4. DO NOT disassemble or alter electrodes.
protective liner and apply firmly to 5. For use with TENS and EMS type
• Reliable & Reusable
160mm • Flexible
the skin. Adhesion improves when
electrodes reach skin temperature. 6.
devices only.
DO NOT use on children or infants.
These electrodes have not been
• 4 Electrodes Per Package Removal evaluated for pediatric use.
1. Make sure device is turned off. Lift at the
edge of electrodes and peel. DO NOT For questions or comments regarding
pull on the lead wires when removing product, please contact 800-376-7263.
electrodes from the release liner or skin.
You may damage the electrodes if you Exp Date: YYYY-MM-DD
do so. Lot #:
Size: 2”x2” White Cloth
2. Place the electrodes on the liner and Shape: Square
remove the lead wire by twisting and Qty: 4/pk
pulling at the same time.
Manufactured for: Compass Health Brands Corp.
Care and Storage Middleburg Heights, OH 44130

SAMPLE UDI
1. Between uses, store the electrodes in the
resealable bag in a cool, dry place.
2. The life of the electrodes varies (01)000922371617595(10)TR11150101(17)20161030
depending on skin conditions, storage, Made in China
amount of use, type of stimulation and 2050.19.04.A ©2019 Compass Health Brands Corp.
stimulation site. Electrode life may be NOT FOR INDIVIDUAL RESALE
extended by carefully following the
application instructions above and
below.

2”x 2” White Cloth Carrying Case

Electrodes (4/pk)

Charging the Battery

1. 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.

2. When the battery is low and the battery indicator blinks stating that
the battery needs to charge. Turn off the unit.

3. 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.
18
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:

1. Determine the placement sites for the electrodes. You must use a
minimum of 2 electrodes.

2. Wash the area with mild soap and water (DO NOT use alcohol). Rinse
and dry thoroughly.

3. 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

1. Connect the lead wires to the

electrodes before applying
them to the treatment area.

2. Connect the lead wires to

the output sockets at the
top of the unit.

3. 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.
Medical Device
19
Setting Treatment

NOTE: DO NOT turn the unit on until all electrodes (2 or 4) and lead wires are
properly attached.
1. 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.
1. Press the until there is a border around the desired
mode as shown.
2. 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.

20
Adjusting Therapy Intensity Level and Start Treatment

1. 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

1. 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.
2. Automatic Shut off
The device automatically turns off when the time for your therapy
session has elapsed.
3. 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

1. The device turns off automatically after the therapy session time
has elapsed.
2. To turn the unit off manually, press and hold the On/Off switch. The
display will go blank and the device will turn off.
3. 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:
1. Never connect this product with a common headphone.
2. 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.
3. Only use a charger that has been obtained from the manufacturer of
the TENS 7000® Rechargeable device.
4. The battery needs to be charged for up to 10 hours before the first use.

21
MAINTENANCE AND STORAGE INSTRUCTIONS

1. Alterations and repairs

1. 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.
2. 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.
3. 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.

2. Cleaning and maintenance

For the device:

1. 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.
2. DO NOT use or store the device where there are magnetic fields or
electric waves (near TV set or speakers).
3. DO NOT place the devices in areas of high temperature, high
humidity, or under direct sunlight.
4. Keep the device out of reach of children.
5. All worn accessories should be disposed of according to your local
regulations.

For electrodes:

Refer to the following suggestions:

1. 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.
2. 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.

22
 3. 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.
4. 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.
5. 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

1. Disconnect the cables from the stimulator and

Medical Deviceelectrodes.

2. DO NOT pull on the cables; only pull on the connectors attached to

the ends of the cables.
3. Store the stimulator with the cables in a clean, dry place.

3. Storage

CAUTION

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

• 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

23
4. Technical checks

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

These include:

1. Checking the device for completeness.

2. Visual check:
• for mechanical damage
• or damage to all cables and connections

5. 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.

24
TROUBLESHOOTING
Problem Possible Causes Try this Solution

One pad feels This is normal. Different areas of Nothing needs to be done. Make sure
stronger than your body will react differently. the pads are sticky and are making good
the other. contact.

The intensity Pads are not attached to the Attach both pads firmly to the skin.
is not felt. Very body firmly.
weak intensity
level. The transparent films are still Peel off film on the adhesive surface of
stuck to the pads. pads.

The pads stacked together or Do not stack pads together or overlap

overlap. pads.

The cord is not properly Connect cord correctly into the jack.
connected to the unit.

The intensity setting is getting weak. Increase the intensity level.

The battery capacity is low. Charge the battery.

The skin turns The adapter is not connected Check to ensure the adapter is properly
red or the skin properly. connected to the device. Check if the
feels irritated. adapter is connected to an electrical outlet.

No power The battery capacity is Charge the battery.

source; no depleted.
display in LCD

Power cut off The battery is weak. Charge the battery.

during use.
The cord is broken. Replace the cord.

It is difficult to Have you removed the Peel off film on the adhesive surface of
attach the pad transparent film from the pad? pads.
to the skin.
Was the pad applied Dry the pad.
immediately after washing?

Is the adhesive surface of the Replace the pad.

pad damaged?

Adhesive Are you using pad when Use when not perspiring, in a cool room.
surface of pad perspiring?
is not sticky.
Were the pads stored under Replace the pad.
high temperature, high
humidity, or direct sunshine?

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

25
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,
Medical Device
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.

26
There is no guarantee that interference will not occur in a particular
installation. Radiated or conducted electromagnetic signals can cause:

1) 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.

2) 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.

27
 Manufactured for:
Compass Health Brands Corp.
6753 Engle Road, Middleburg Heights, OH 44130
Ph: 800-376-7263
www.compasshealthbrands.com
Made in China

3571.22.08.A ©2022 Compass Health Brands Corp.