Manual Compass Tens 7000 - rechargeable (page 10 of 28) (English)

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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

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

TABLE OF CONTENTS

Legal Notice ______________________________________________________ 4

Limited Warranty __________________________________________________ 5

Foreword _________________________________________________________ 7

Indications for Use _________________________________________________ 7

Symbols __________________________________________________________ 8

Precautionary Denitions ___________________________________________ 9

Warnings and Cautions _____________________________________________ 10

Product Description ________________________________________________ 14

Contraindications __________________________________________________ 14

Technical Specications _____________________________________________ 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

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 modications 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.

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 specic 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

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, efciency, 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.

Medical Device

Manufactured for:

Medical Device

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.

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)

Medical Device

Refer to instruction manual/ booklet

SYMBOLS

Symbols on the device and throughout the manual:

Medical Device

This side up

The transportation package must be vertical and straight up during

transportation.

Medical Device

Fragile, handle with care

The product inside the packaging could be easily damaged if dropped or

handled without care and attention.

Medical Device

Keep away from rain

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

conditions

Medical Device

Temperature limitation

The product package should be stored at a temperature between

-4° F and 131°F (-20°C and 55°C).

Medical Device

Upper limit of humidity

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

Medical Device

Atmospheric pressure limitation

The product package should be stored at an atmospheric pressure between

86kPa and 106kPa.

Symbols on the package

+55° C

93%

106kPa

86kPa

-20° C

PRECAUTIONARY DEFINITIONS

The precautionary instructions found in this section and throughout this

manual are indicated by specic symbols. Understand these symbols and

their denitions before operating this equipment.

The denition of these symbols is as follows:

Medical Device

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.

Medical Device

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:

Medical Device

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 ammable 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 debrillators.

• DO NOT use on persons with severe heart failure or arrhythmia.

• DO NOT apply pulsed electrostatic elds over areas in which symptoms of

existing thrombosis or thrombophlebitis are present.

• DO NOT apply pulsed electrostatic elds over, or in proximity to,

cancerous lesions.

• DO NOT apply pulsed electrostatic elds over swollen, red, or inamed

areas or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins).

• DO NOT apply pulsed electrostatic elds when the patient is in the bath

or shower.

• DO NOT apply pulsed electrostatic elds while the patient is driving,

operating machinery, or during any activity in which pulsed electrostatic

elds can put the patient at risk of injury.

• DO NOT use this device if you have a cardiac pacemaker, implanted

debrillator, 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 specied battery provided by the manufacturer

and listed in this manual under Technical Specications. 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 re 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.

Medical Device

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 ow

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 inammations 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

insufciency, decompensated cardiac edema, and

cardiac arrhythmia

o Pregnancy

o Infectious skin diseases

o Vertebrobasilar insufciency (VBI)

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 ashing

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

TECHNICAL SPECIFICATIONS

MODE DESCRIPTION/PARAMETERS

Normal

Mode

1) Timing:

10~90 minutes

2) Frequency:

2-150Hz

3) Pulse width:

50-300μS

Pulse Width and Pulse Rate are

adjustable. This mode creates

continuous stimulation based on the

setting value.

Burst Mode

1) Timing:

10~90 minutes

2) Pulse train frequency:

0.5-5Hz

3) Pulse width:

50-300μS

Burst Rate: Adjustable from 0.5-5Hz

Pulse Width: 50-300us

Frequency xed: When 0.5-1hz, adjust

0.1hz each time, when 1-5hz, adjust 1hz

each time.

Modulation

Mode

1) Timing:

10~90 minutes

2) Pulse train frequency:

2-150Hz

3) Pulse width:

50-300μS

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

1) Timing:

10~90 minutes

2) Pulse train frequency:

2-150Hz

3) Pulse width:

50-300μS

SD1 (Strength-Duration) consists of

automatic modulation of 10 seconds

intermittent stimulation.

SD2 Mode

1) Timing:

10~90 minutes

2) Pulse train frequency:

2-150Hz

3) Pulse width:

50-300μS

SD2 (Strength-Duration) consists of

automatic modulation of 10 seconds

intermittent stimulation.

10 seconds

0.5 sec

50% of

Set Width

0.5 sec

50% of

Set Rate

0.5 -5 bursts

per second

10 pulses

per burst

DEVICE INSPECTION

DEVICE CONSTRUCTION

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

1. Channel 1 Port

2. Channel 2 Port

3. Type C Charging Port

4. On/Off/Play/Pause

5. Increase/Decrease CH 1

6. Increase/Decrease CH 2

7. Set Button — Change

Parameters

8. Mode Button — Change Mode

9. Belt Clip

1 2

ACCESSORIES

Intended Use

Electrodes are intended for use as a

disposable, conductive adhesive interface

between the patient’s skin and the electrical

stimulator.

Directions For Use

Application

1. Clean skin thoroughly prior to each

application of electrodes. Electrodes do

not stick well if any lotion, oil, make-up,

dirt, etc. is left on skin.

2. Insert the pins of the lead wire from the

device into the electrode wire

connectors.

3. Remove the electrodes from the

protective liner and apply firmly to

the skin. Adhesion improves when

electrodes reach skin temperature.

Removal

1. Make sure device is turned off. Lift at the

edge of electrodes and peel. DO NOT

pull on the lead wires when removing

electrodes from the release liner or skin.

You may damage the electrodes if you

do so.

2. Place the electrodes on the liner and

remove the lead wire by twisting and

pulling at the same time.

Care and Storage

1. Between uses, store the electrodes in the

resealable bag in a cool, dry place.

2. 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 the

application instructions above and

below.

3. Avoid electrodes from being exposed to

direct sunlight or extreme humidity.

Recommended storage conditions:

41º – 86º, Relative Humidity: 40 – 70%

4. DO NOT leave the electrodes uncovered

in air as this will decrease the viscosity

and performance of the product.

Caution

1. Read instructions carefully prior to use.

2. The electrodes are intended for single

patient use only.

3. DO NOT apply to broken skin. Should

skin rash occur, discontinue use and

contact your physician. DO NOT use

while driving a motorized vehicle or

while operating machinery.

4. DO NOT disassemble or alter electrodes.

5. For use with TENS and EMS type

devices only.

6. DO NOT use on children or infants.

These electrodes have not been

evaluated for pediatric use.

For questions or comments regarding

product, please contact 800-376-7263.

Exp Date: YYYY-MM-DD

Lot #:

Size: 2”x2” White Cloth

Shape: Square

Qty: 4/pk

Manufactured for: Compass Health Brands Corp.

Middleburg Heights, OH 44130

• 2”x2” Square – White Cloth Electrode

• Self-Adhesive Electrode Gel

• Premium Quality

• Reliable & Reusable

• Flexible

• 4 Electrodes Per Package

125mm

160mm

125mm

(01)000922371617595(10)TR11150101(17)20161030

SAMPLE UDI

NOT FOR INDIVIDUAL RESALE

Made in China

2.0mm plug lead wires (2/pk)

2”x 2” White Cloth

Electrodes (4/pk)

Carrying Case

USB Charging Cord

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 rst 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:

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.

Medical Device

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.

1. Turn on the unit by pressing the

Selecting the Mode

This device includes ve treatment modes to choose from:

• Burst

• Normal

• Modulation

• SD1 (Strength-Duration 1)

• SD1 (Strength-Duration 2)

For the specics on how each mode delivers stimulation, please refer to the

Technical Specications 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.

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 rst use.

MAINTENANCE AND STORAGE INSTRUCTIONS

1. Alterations and repairs

1. Any repairs or modications to the device, attempted by anyone other

than the manufacturer, will immediately void the warranty. DO NOT

attempt repairs or modications 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. Qualied 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 elds 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.

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 electrodes.

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

Medical Device

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

Medical Device

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.

TROUBLESHOOTING

Problem Possible Causes Try this Solution

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 rmly.

Attach both pads rmly to the skin.

The transparent lms are still

stuck to the pads.

Peel off lm 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

The battery capacity is

depleted.

Charge the battery.

Power cut off

during use.

The battery is weak. Charge the battery.

The cord is broken. Replace the cord.

It is difcult to

attach the pad

to the skin.

Have you removed the

transparent lm from the pad?

Peel off lm 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 denes 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.

Medical Device

CAUTION

• The use of accessories and cables other than those specied 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

elds, 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 conguration 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:

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.

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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