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User Manual

Dual Channel TENS


Prescription Strength Pain Relief

• Quick and Easy Set-Up


• 20 Minute Treatment Timer
• 12 Preset Modes
• 100 Intensity Levels
• Treatment Record Log
• Auto Shut-Off

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This manual is valid for the InTENSity at Home™ Dual Channel TENS E200-6R.

This instruction manual is published by Compass Health Brands Corp.

Compass Health Brands reserves the right to improve and amend this manual at any time without prior
notice. Amendments may however be published in new editions of this manual.

All Rights Reserved. Rev. V2.0 © 2017

Please Note:
Compass Health Brands recommends consulting a physician before using
a TENS unit to verify any possible contraindications.

Conformity to safety standards.

Compass Health Brands declares that the device complies with the following normative documents:

IEC60601-1, IEC60601-1-2, I EC60601-2-10,


IEC62366, IEC60601-1-11, ISO10993-5, ISO10993-10,
ISO10993-1, ISO7010

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TABLE OF CONTENTS
Introduction.......................................................... 4 Electrode Positioning ......................................... 26
Important Safety Precautions and Warnings.......... 6 Cleaning and Storage......................................... 29
• Safety Symbols............................................... 6 • Cleaning the Unit.......................................... 29
Package Contents.............................................. 13 • Cleaning the Electrodes................................ 29
Know Your Device............................................... 14 • Washing the Electrodes................................ 29
Battery Information ............................................ 16 • Storage........................................................ 31
• Disposal of Batteries..................................... 16 Technical Information.......................................... 32
Treatment Setup................................................. 17 Technical Specifications...................................... 32
• Connect Electrodes and Lead Wires............. 17 Troubleshooting.................................................. 33
• Electrode Placement..................................... 18 Disposal............................................................. 36
• Select Body Part and Program...................... 19 Glossary of Symbols........................................... 36
• Therapeutic Programs.................................. 20 Important Information Regarding
• Intensity Adjustment..................................... 22 Electromagnetic Compatibility (EMC)................... 37
• Start Treatment............................................. 22 Warranty............................................................. 44
• Pause or Stop Treatment.............................. 23
Other Important Features.................................... 24
• Safety Lock.................................................. 24
• Treatment Record Log.................................. 25
3

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INTRODUCTION

Thank you for purchasing the InTENSity at Home™ How does TENS work?
Dual Channel TENS (Model E200-6R) for your pain Scientific theory suggests that electrical stimulation
relief solution. therapy may work in several ways:
Please read the complete manual carefully before • The gentle electrical pulses move through the skin
using the device for the first time, and keep this to nerves nearby the source of pain, shutting out
instruction manual in a convenient place or store with the pain message from ever reaching the brain.
the device for future reference.
• The gentle electrical pulses increase the
What is TENS? production of endorphins, the body’s natural
TENS stands for Transcutaneous Electrical Nerve pain killer.
Stimulation. It is a noninvasive, drug-free method of
controlling pain. TENS uses tiny electrical impulses
sent through the skin to the nerves to modify pain
perception. TENS does not cure any physiological
problem. It only helps control the pain. TENS does
not work for everyone. However, in most patients,
it is effective in reducing or eliminating the pain,
allowing for a return to normal activity.

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INTRODUCTION (CONT’D)

What conditions can TENS help relieve? either side of the pain area. PLEASE NOTE: Never
TENS provides pain relief for a number of different place the electrodes on the head, throat, face, heart,
pain conditions associated with exercise, normal chest area, eyes, oral cavity, sexual organs or over
work and household activities. This product is the spine or bony premises.
designed for temporary relief of pain associated with How long can I use the TENS unit?
sore and aching muscles in the: You may use the TENS unit no more than 20 minutes
• Neck • Waist a session, up to 2 times per day for each area of
• Shoulders • Upper Extremities (arms) your body, or muscles in that region may become
• Back • Lower Extremities (legs) exhausted and sore.
The
 InTENSity at Home™ Dual Channel PLEASE NOTE: The electrodes are designed for
TENS should be applied to normal, healthy, temporary use for approximately 10 treatments.
clean and dry skin of adult patients.
What can I treat? Package Contents:
The InTENSity at Home™ Dual Channel TENS can • 1 x TENS Device • 4 x “AAA” Batteries
treat many different types of pain. Refer to diagrams • 4 x Electrodes • 2 x Lead Wires
on pages 26 – 28 for the ideal locations to place
• 1 x User Manual
the electrodes to treat the most common forms of
pain. For other areas of pain, place the electrodes on

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IMPORTANT SAFETY PRECAUTIONS AND WARNINGS
It is important that you read all the warning and precautions included in this manual because
they are intended to keep you safe, prevent injury and avoid a situation that could result in
serious injury and equipment damage.

SAFETY SYMBOLS USED IN DANGER


THIS MANUAL This stimulator must not be used in combination
with the following medical devices:
Indicates a potentially hazardous situation • Internally transplanted electronic
which, if not avoided, could result in medical devices, such as pacemakers.
death or serious injury.
• Electronic life-support equipment, such
Indicates a potentially hazardous situation as respirators.
which, if not avoided, could result in
serious injury and equipment damage. • Electronic medical devices attached to the body,
such as electrocardiographs.
Indicates a potentially hazardous situation
which, if not avoided, may result in minor Using this stimulator with other electronic medical
or moderate injury to the user, or damage devices may cause erroneous operation of those
to the device or other property. devices.

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IMPORTANT SAFETY PRECAUTIONS AND WARNINGS (CONT’D)

WARNING • On open wounds or rashes, over swollen, red,


infected, inflamed areas, or skin eruptions (e.g.,
Consult with your physician before using this phlebitis, thrombophlebitis, varicose veins); or on
device, because the device may cause lethal rhythm top of, or in proximity to, cancerous lesions.
disturbances in certain susceptible individuals.
• Over areas of skin that lack normal sensation.
DO NOT USE THIS DEVICE UNDER • On the opposite sides of your head since the
THESE CONDITIONS: effects of stimulation of the brain are unknown.
• If you have a cardiac pacemaker, implanted
defibrillator, or other implanted metallic or DO NOT USE ON THESE INDIVIDUALS:
electronic device. Such use could cause electric • Pregnant women, because the safety of
shock, burns, electrical interference, or death. electrical stimulation during pregnancy has not
• Together with a life-supporting medical electronic been established.
device such as an artificial heart, lung or respirator. • Children or infants, because the device has not
• In the presence of electronic monitoring equipment been evaluated for pediatric use.
(e.g., cardiac monitors, ECG alarms), which may • Persons incapable of expressing their thoughts
not operate properly when the electrical stimulation or intentions.
device is in use.
• If there are any underlying skin conditions (i.e.
erythema, psoriasis, eczema, etc.)
7

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IMPORTANT SAFETY PRECAUTIONS AND WARNINGS (CONT’D)
DO NOT USE THIS DEVICE DURING illness, consult your physician in order to confirm
THESE ACTIVITIES: that it is advisable for you to use this TENS unit.
• Bathing or showering • Consult a physician if you are on any pain
• Sleeping medications as they may decrease your normal
level of sensation, causing possible adverse
• Driving, operating machinery or any activity in which
reactions not to be felt.
electrical stimulation can put you at risk for injury.
WARNING AND PRECAUTIONS
PAIN MANAGEMENT WARNINGS
REGARDING THE ELECTRODES
• If you have had medical or physical treatment for
• Apply electrodes to normal, healthy, clean, dry
your pain, consult with your physician before using
skin (of adult patients) because it may otherwise
this device.
disrupt the healing process.
• If your pain does not improve, becomes seriously
• If you experience any skin irritation or redness
chronic or severe, or continues for more than five
after a session, do not continue stimulation in that
days, stop using the device and consult with
area of the skin.
your physician.
• The mere existence of pain functions as a very NEVER APPLY THE ELECTRODES TO:
important warning telling us that something • The head or any area of the face.
is wrong. Therefore, if you suffer from any serious

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IMPORTANT SAFETY PRECAUTIONS AND WARNINGS (CONT’D)
• The neck or any area of the throat • The electrode is already pre-gelled and will adhere
because this can cause severe muscle to your skin.
spasms resulting in closure of the airway, • To avoid damage to the adhesive surface of the
difficulty breathing, or adverse effects on heart electrode, put the electrodes only on the skin or
rhythm or blood pressure. on the plastic film provided.
• Both sides of the thorax simultaneously • Place electrodes anywhere from 2”-6” apart from
(lateral or front and back), or across your each other on your skin.
chest because the introduction of
electrical current may cause rhythm disturbances, • Always place clean electrodes in accordance with
which could be lethal. the illustrations provided (Refer to pages 26 – 28
for electrode placement).
WARNING AND PRECAUTIONS
REGARDING THE ELECTRODE DO NOT USE YOUR ELECTRODES THIS WAY:
• Do not bend or fold because the electrode may • Do not place on your spine or backbone.
not function properly. Place the electrode onto the • Electrodes should not touch any metal object,
plastic film and then store in the sealed container such as a belt buckle, necklace or other jewelry
when not in use. made from metal.
• Do not apply ointment or any solvent to the
electrodes or to your skin because it will keep
the electrode from functioning properly.
9

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IMPORTANT SAFETY PRECAUTIONS AND WARNINGS (CONT’D)

DO NOT USE YOUR ELECTRODES THIS WAY (CONT’D) • Do not use for any other purpose except as
• Do not share electrodes with another person. This may described in this manual.
cause a skin irritation or infection. Electrodes are • Do not insert the electrode plug into any place
intended for use by one person. other than the output socket on the main unit.
• Do not place or relocate the electrodes while the • Do not mix Alkaline and Manganese batteries as
device is on. this will shorten the battery life.
• Always turn the power off before removing or • Do not pull on the electrode cord during
changing the electrode location. treatment.
• Do not leave electrodes attached to the skin • Do not use the TENS device while wearing
after treatment. electronic devices such as watches as this may
• Electrodes should not be placed on the soles of damage the device.
both feet at the same time. • Do not use near a cell phone as this may cause
• Electrodes should not be placed on the calves of the stimulator to malfunction.
both legs at the same time. • Do not bend or pull the end of the cord.
• When pulling out the cord from the device, hold
CAUTION WHILE USING THE TENS UNIT
the plug and pull.
• If the TENS unit is not functioning properly or you
feel discomfort, immediately stop using the device. • Replace the cord when broken or damaged.

10

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IMPORTANT SAFETY PRECAUTIONS AND WARNINGS (CONT’D)
• Do not throw the batteries into a fire. • TENS is not a substitute for pain medications and
The batteries may explode. other pain management therapies.
• Dispose of the device and components according • TENS devices do not cure diseases or injuries.
to applicable legal regulations. Unlawful disposal • TENS is a symptomatic treatment and, as such,
may cause environmental pollution. suppresses the sensation of pain that would
• Using electrodes that are too small or incorrectly otherwise serve as a protective mechanism.
applied, could result in discomfort or skin burns. • Effectiveness is highly dependent upon patient
• Always use electrodes that are legally marked and selection by a practitioner qualified in the
sold in the United States for over-the-counter (OTC) management of pain patients.
use only (InTENSity at Home™ Electrodes – E201-6R). • You may experience skin irritation or hypersensitivity
due to the electrical stimulation or electrical
GENERAL PRECAUTIONS conductive medium (gel) on the electrodes.
• The long-term effects of electrical stimulation
• If you have suspected or diagnosed heart disease,
are unknown.
you should follow precautions recommended by
• Apply stimulation to only normal, intact, clean, your physician.
dry, and healthy skin.
• If you have suspected or diagnosed epilepsy,
• TENS is not effective in treating the original source you should follow precautions recommended by
or cause of the pain, including headache. your physician.

11

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IMPORTANT SAFETY PRECAUTIONS AND WARNINGS (CONT’D)

GENERAL PRECAUTIONS (CONT’D) POSSIBLE ADVERSE REACTIONS


• Use caution if you have a tendency to bleed • Do not use the device to treat one region for
internally, such as following an injury or fracture. extended periods of time (more than 20 minutes
• Consult with your physician prior to using the a session, up to 2 times/day) or muscles in that
device after a recent surgical procedure, because region may become exhausted and sore.
stimulation may disrupt the healing process. • You may experience skin irritation and burns
• This stimulation should not be applied over the beneath the stimulation electrodes applied to your
menstruating or pregnant uterus. skin.
• This stimulation should not be applied over areas • You should stop using the device and consult with
of skin that lack normal sensation. your physician if you experience adverse reactions
from using the device.
• Keep unit away from young children.
The unit contains small pieces that may
be swallowed. Contact your physician
immediately if ingested.
• Use this device only with the InTENSity at Home™
brand electrodes (E201-6R).

12

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PACKAGE CONTENTS

E200-6R Unit (2) Lead Wires (4) “AAA” Batteries

Instruction Manual (4) 2” x 2” Electrodes

13

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KNOW YOUR DEVICE
1. LCD Display: Operating state of the device
2. Program Buttons: Select body part and treatment
program.
3. CH 1 Output Intensity: Increase or decrease
CH1 CH 2

8 channel 1 intensity.
4. CH 2 Output Intensity: Increase or decrease
channel 2 intensity.
5. Pause Button: Pause/resumes treatment.
7 6. Treatment Records: To check treatment records
1
9 and usage history.
7. Power: Press to turn on the device. Press and
hold for 3 seconds to turn off the device.
3 4 8. Output Sockets: Lead wire output sockets
9. Belt Clip
5 6 10
10. Battery Cover
2

14

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KNOW YOUR DEVICE (CONT’D)
1. Home
2. Treatment Mode
1 2 3 4 5 3. Treatment Records
4. Electrode Load Indicator: Alerts user of
a bad connection between the lead wires,
electrodes and skin.
6 12 5. Low-Battery Indicator
11 6. Output Display: Start, pause or lock
7. Hour Indicator: For treatment records only
7 8. Channel Intensity: Graphic display (CH1 & CH2)
8 8 9. Channel Intensity: Numeric display (CH1 & CH2)
10. Therapeutic Body Part: Displays selection
9 9
11. Treatment Time: Displays time remaining for
10 selected treatment.
12. Timer Indicator: Will blink while treatment is in
progress and stay solid when paused or stopped.

15

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BATTERY INFORMATION
Check/Replace the battery DISPOSAL OF BATTERIES
• Remove the belt clip and battery cover Depleted batteries do not belong in the
• Insert 4 “AAA” batteries, as shown. household waste. Dispose of the batteries
according to your federal, state and local
• Replace the battery cover and belt clip.
regulations. As a consumer, you are obligated
by law to properly dispose depleted batteries.

CAUTION
• Keep the batteries and TENS unit out of the reach
of children.
• Do not dismantle, throw into fire or short-circuit
batteries.
• Do not expose the batteries to excess heat.
• Remove the batteries from the TENS unit if it is not
going to be used for a long period of time.
• Always replace with the same type of battery.

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TREATMENT SETUP
Step 1 Step 3
Cleaning the Skin Connect Lead Wires to the Device
Clip excess hair from the treatment area. Wash area 1. Make sure the device is turned OFF.
with soap and water, and dry completely. 2. Holding the insulated portion, push the plug end
of the lead wire into CH1 output socket. If using
Step 2 all 4 electrodes, repeat for CH2.
Connect Electrodes to Lead Wires
Take the electrodes out of the sealed package and
insert the pin end of the lead wire into each pigtail
connection of the electrodes you plan to use.
Make sure there is no bare metal exposed from the pins.

NOTE: This device has two output sockets called


channels. You may use one or both channels with
a pair of lead wires on each. Using both channels
gives you the advantage of stimulating two different
areas at the same time. If using just one channel,
NOTE: You must use at least 2 electrode pads. only connect to CH1 and leave CH2 empty.
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TREATMENT SETUP (CONT’D)

Step 4 WARNING
Electrode Placement
1. Ensure skin is clean and thoroughly dry before Before using the device for the first time, you
applying the electrodes. are strongly advised to take careful note of the
2. Remove the electrodes from the plastic film and contraindications and safety measures detailed on
position them on your body — pressing firmly to pages 6 – 12 of this manual. This is a powerful piece
ensure good contact. of equipment and is neither a toy nor a gadget!

Note: Electrode placement suggestions can be


found on pages 26 –28.
18

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TREATMENT SETUP (CONT’D)
Step 5 Step 6
Turn the Power On Select the Therapeutic Body Part and Program
1. Press the " " button on the top right side 1. T here are 6 therapeutic body part buttons
to turn the unit on. This will be indicated by available: neck, shoulder, hand, low back,
the LED screen lighting up blue and an audible knee and foot.
quick chirp sound. 2. Each therapeutic body part has 2 programs
2. The device will not start treatment until a channel (12 total programs) — P1 and P2. You can
intensity is increased. toggle between them by pressing the body
part button repeatedly.
3. P1 is for acute pain and P2 is for chronic pain.

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TREATMENT SETUP (CONT’D)

Body Part Program Treatment Time Frequency Pulse Width Cycle Time

P1 20 Min. 80 – 100Hz 100 – 150µs 10 Sec

Neck P2 20 Min. 4Hz 150 – 200µs 20 Sec

P1 20 Min. 80 – 100Hz 100µs 10 Sec

Shoulder P2 20 Min. 10Hz 220 – 260µs 20 Sec

P1 20 Min. 100Hz 100µs Fixed

Hand P2 20 Min. 1 – 10Hz 150µs 20 Sec

20

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TREATMENT SETUP (CONT’D)

Body Part Program Treatment Time Frequency Pulse Width Cycle Time

P1 20 Min. 80 – 100Hz 120µs 10 Sec

Low back P2 20 Min. 4Hz 200 – 260µs 20 Sec

P1 20 Min. 120Hz 100 - 120µs 10 Sec

Knee P2 20 Min. 1 – 10Hz 150 – 200µs 20 Sec

P1 20 Min. 80 – 120Hz 100 – 120µs 10 Sec

Foot P2 20 Min. 1 – 10Hz 200µs 20 Sec

21

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TREATMENT SETUP (CONT’D)
Step 7 CAUTION
Adjust Intensity and Start Treatment
1. If the electrodes are not placed firmly on the skin
1. T o start treatment, press [CH1+] or [CH2+]. or the device is not connected to the electrodes
2. The intensity output will start at 1. Repeatedly and the output intensity level is equal to 10mA or
press the [CH1+] or [CH2+] buttons to increase greater, the intensity will stop automatically.
the output intensity to the desired level. 2. If the stimulation levels are uncomfortable or
3. Press [CH1–] or [CH2–] to decrease the output become uncomfortable, reduce the stimulation
intensity. intensity to a comfortable level and contact your
medical practitioner if problems persist.

22

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TREATMENT SETUP (CONT’D)
Step 8 Step 9
Pause or Stop Treatment Treatment Timer
1. In case of an emergency or the need to stop 1. A ll 12 presets are set to a 20 minute timer.
treatment immediately, please press the [ I I ] 2. When the timer counts all the way down to
button to pause treatment, the “I I ” will display on zero, the device will stop and return to the
the LCD screen. home screen.
2. Press [ I I ] again to continue treatment, or Step 10
press the [ ] to stop treatment. The device will Turn the Power Off
return to the home screen.
1. Press and hold the [ ] button for 3 seconds.
2. When the screen turns off then the devise is off.

CAUTION
To conserve battery and prevent unexpected shock,
the device will automatically power off when it is
not in use for three (3) minutes (standby mode).
The device will beep and shut off automatically.

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TREATMENT SETUP (CONT’D) OTHER IMPORTANT FUNCTIONS
PLEASE NOTE: Safety Lock
• Be sure not to move the electrode to another part • T
 he lock function automatically activates after
of your body without turning off the power first. there is no operation for 20 seconds in treatment
• Keep the electrodes clean and do not expose to status, the indicator “ “ display on LCD. This is
heat or direct sunlight. a safety feature to prevent accidental changes to
• If the electrodes do not adhere to your body or are your settings and to prevent accidental increases
dirty, replace with a new electrode (item# E201-6R). to the output intensity level. Press [CH1–] or
[CH2–] button to unlock.
• Always use the electrodes with a CE mark, or which
are legally marketed in the US under 510(K) procedure.
• Do not clean the electrode or adhesive gel with
any chemical.
• Place the electrodes on intact skin only. Do not
place on cuts or damaged skin.
• The InTENSity at Home™ Dual Channel TENS is for
single person use. Low Battery Indicator
• Place the electrode on the protective transparent • When the low power indicator “ ” flashes on
film when not in use. the LCD, you should replace all four (4) “AAA”
batteries with new ones as soon as possible.

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OTHER IMPORTANT FUNCTIONS (CONT’D)
Treatment Record Log Check and Delete Accumulative Records
• The treatment record log can store up to • While in the individual records menu, press the
60 treatments. [ II ] button to switch to accumulative records
• The treatment record log can store up to menu.
100 hours of total usage. • Press the [ ] button and hold for 3 seconds.
Check and Delete Individual Records All records stored on the device will be deleted
followed by an audible beeping sound.
• While on the home screen, press the [ ]
button to enter the treatment record log. The LCD CAUTION
will show each of the records and corresponding The records will be permanently deleted and can
treatment times. Press [ + ] and [ – ] buttons to not be restored if you complete the deletion process.
cycle through each record.

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ELECTRODE PLACEMENT GUIDE
• Apply electrodes around the pain site as indicated
and keep them at least 2” but no more than 6”
Shoulder Pain
apart.
• The skin must be clean and dry.
• Press on firmly, making good contact between
the skin and the electrodes.
• Never remove electrodes from the skin while the
device is turned on.

Cervical/Neck Pain

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ELECTRODE PLACEMENT GUIDE (CONT’D)

Carpal Tunnel/ Lower Back/


Knee/Elbow Pain
Wrist Pain Lumbar Pain

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ELECTRODE PLACEMENT GUIDE (CONT’D)

Foot/Calf Pain

Caution:
Do not stimulate
both feet or calves
simultaneously.

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CLEANING AND STORAGE
Cleaning the Unit Washing the Electrode Pads
1. T urn unit off and disconnect the lead wires from • To “wash” the electrodes, place a small drop of
the unit. water on your clean fingertip and rub the water
2. Clean the device after use with a soft, slightly across the entire gel surface. Place the gel
moistened cloth and wipe gently. adhesive face up and let it air dry until the water
• Do not use chemicals (like thinner, benzene). is absorbed and has been reconstituted. Do not
wipe with a tissue paper or cloth. If the electrode
• Do not let water get into the internal area. still does not stick properly, replace them with
NOTE: This device and accessories (including the new electrodes (E201-6R).
electrodes) do not require sterilization.

Cleaning the Electrode Pads


1. T urn the power off and remove the lead wires
from the electrodes.
2. Wash the electrodes when the adhesive surface
becomes dirty and/or the electrodes are difficult
to attach to the skin.

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CLEANING AND STORAGE (CONT’D)

CAUTION • If replacement electrodes are necessary, use only


electrodes that are the same size (2" x 2") as the
• T
 he life of electrodes may vary by the frequency electrodes provided with the TENS.
of washing, skin condition, and storage state.
• Use of electrodes that are larger, may reduce the
• If the electrodes no longer stick to your skin or the effect of the stimulation. Use of electrodes that
electrodes are broken, you should replace with are much smaller than the electrodes provided
new electrodes. with the TENS may increase the chance of skin
• Before applying the self-adhesive electrodes, irritation or burns occurring under the electrodes.
it is recommended to wash and degrease the • Always use the electrodes with a CE mark,
skin, and then dry it. or which are legally marketed in the US under
• Do not turn on the device when the electrodes are 510(K) procedure.
not positioned on the body.
• Never remove the self-adhesive electrodes from
the skin while the device is still turned on.

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CLEANING AND STORAGE (CONT’D)
Storing the Electrode Pads and Lead Wires Storing the Unit
1. T urn the device off and remove the lead wires 1. P lace the unit, electrodes, lead wires and manual
from the unit. back into the retail packaging. Store the box in a
2. Remove the electrodes from your body and cool, dry place, 14°F ~ 122°F; 10% ~ 90%
disconnect the lead wires from the TENS unit. relative humidity.
3. Place the electrodes onto the plastic film and 2. Do not store in places that can be easily reached
then store them and the lead wires in the by children.
sealed package. 3. When not in use for a long period of time,
remove the batteries before storage.

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TECHNICAL INFORMATION TECHNICAL SPECIFICATIONS

Channel Dual, isolated between channels Symmetrical Biphasic


Waveform
Rectangular Wave
Power Supply (4) “AAA” Batteries
Adjustable,
10°C ~ 50°C (50ºF to 122ºF) Pulse 0 ~ 100mA @ 1,000 ohm
Operating
Relative Humidity: 10% – 90% Amplitude Load each channel,
Conditions
Atmospheric Pressure: 700 – 1060 Hpa 1mA/Step.
-10°C ~ 50°C (14ºF to 122ºF) Pulse Width 100µs ~ 260µs
Storage
Relative Humidity: 10% – 90%
Conditions
Atmospheric Pressure: 700 – 1060 Hpa Pulse Rate 1Hz ~ 120Hz

Dimensions 12.0×7.0×2.7cm (4.7"x2.8"x1.1") L*W*H Treatment Time 20 Minutes

Weight 100g (3.5 oz.) Without Battery

The amplitude level will reset to 0mA


Electrode
when the amplitude level is 10mA or
Detection
greater and an open circuit on either
Function
channel is detected.

NOTE: If the unit does not operate after taking these measures, contact your nearest dealer.
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TROUBLESHOOTING

PROBLEM POSSIBLE CAUSES POSSIBLE SOLUTION

Are the batteries depleted? Recharge or replace the batteries.


The Unit Cannot
Power On
Are the batteries installed correctly? Insert the batteries observing the correct polarity.

Electrodes are dried out or dirty. Replace with new electrodes.


Stimulation Weak
Electrodes will not stick to skin. Clean treatment area of dirt and/or oily
Or Cannot Feel
substances (lotion).
Any Stimulation
Lead wires are old/worn/damaged Replace with new lead wires.

Intensity is too high. Decrease intensity.

Electrodes are too close together Reposition the electrodes to be a minimum of


1½" apart.
Stimulation Is
Uncomfortable
Electrode active area size is too small Replace electrodes with ones that have an active
area no less than 25.0cm2 (5cm x 5cm).

May not be operating the device according to the manual. Please check the manual before use.

NOTE: If the unit does not operate after taking these measures, contact your nearest dealer.
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CLEANING AND STORAGE (CONT’D)

PROBLEM POSSIBLE CAUSES POSSIBLE SOLUTION

Verify connection is secure.

Turn down the intensity.

Intermittent Rotate lead wire in the socket 90º. If still


Lead Wires
Output intermittent, replace the lead wire.

If still intermittent after replacing a lead wire, a


component may have failed. Call tech support at
1-800-3-ROSCOE (376-7263).

Improper electrode placement Reposition electrodes.


Stimulation is
Ineffective Unknown Contact tech support at 1-800-3-ROSCOE
(376-7263)

Using the electrode on the same site every time. Re-position the electrode to another area. If at
Skin Becomes any time you feel pain or discomfort stop use
Red And/Or You immediately.
Feel A Stabbing
Pain The electrode is not sticking onto the skin properly. Ensure the electrode is securely placed
on the skin.

NOTE: If the unit does not operate after taking these measures, contact your nearest dealer.
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TROUBLESHOOTING (CONT’D)

PROBLEM POSSIBLE CAUSES POSSIBLE SOLUTION

The electrode is dirty. Clean the electrodes according to the description


Skin Becomes in this manual (page 29) or replace with new
Red And/Or You electrodes.
Feel A Stabbing
The surface of the electrode is scratched. Replace with a new electrode.
Pain
If problems persist. Contact your physician.

The electrode came off the skin or the edges are lifting Turn off the device and reapply the electrodes to
Output Current away from the skin. your skin.
Stops During
The lead wires are disconnected. Turn off the device and reconnect the lead wires.
Therapy
The batteries are depleted. Charge or replace the batteries.

NOTE: If the unit does not operate after taking these measures, contact your nearest dealer.
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DISPOSAL GLOSSARY OF SYMBOLS

Used fully discharged batteries must be disposed  lectrical devices are recyclable material
E
of in a specially labeled collection container, at toxic and should not be disposed of with
waste collection points or through an electrical household waste after their useful life!
retailer. You are under legal obligation to dispose Help us to protect the environment and
of batteries correctly. save resources and take this device to the
appropriate collection points. Please contact
Please dispose of the device in accordance with the the organization which is responsible for
legal obligation. waste disposal in your area if you have any
questions.

Type BF Applied Part

 lease refer to instruction manual because


P
of the higher levels of output.

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IMPORTANT INFORMATION REGARDING ELECTROMAGNETIC COMPATIBILITY (EMC)

With the increased number of electronic Nevertheless, special precautions need to be


devices such as computers and mobile observed:
(cellular) telephones, medical devices in • The use of accessories and cables other than
use may be susceptible to electromagnetic those specified by Compass Health Brands,
interference from other devices. Electromagnetic with the exception of cables sold by Compass
interference may result in incorrect operation of Health Brands as replacement parts, may result
the medical device and create a potentially unsafe in increased emission or decreased immunity of
situation. Medical devices should also not interfere the device.
with other devices.
• The medical devices should not be used adjacent
In order to regulate the requirements for EMC to or stacked with other equipment. In case
(Electromagnetic Compatibility) with the aim to adjacent or stacked use is necessary, the medical
prevent unsafe product situations, the IEC60601- device should be observed to verify normal
1-2 standard has been implemented. This standard operation in the configuration in which it will
defines the levels of immunity to electromagnetic
be used.
interferences as well as maximum levels of
electromagnetic emissions for medical devices. • Refer to further guidance below regarding the
EMC environment in which the device should
Medical devices manufactured for Compass
be used.
Health Brands conform to this IEC60601-1-2:2007
standard for both immunity and emissions.

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TABLE 1:
GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSIONS

InTENSity at Home™ electrical stimulators are intended for use in the electromagnetic environment specified below.
The customer or the user of these electrical stimulators should assure that it is used in such environment.

Emissions test Compliance Electromagnetic environment — guidance

RF emissions Group 1 The device uses RF energy only for its internal function. Therefore, its RF emissions
CISPR 11 are very low and are not likely to cause any interference in nearby electronic
equipment.

RF emissions Class B The device is suitable for use in all establishments including domestic and those
CISPR11 directly connected to the public low-voltage power supply network that supplies
buildings used for domestic purposes.
Harmonic emissions Not applicable
lEC 61000-3-2

Voltage fluctuations/ Not applicable


flicker emissions
lEC 61000-3-3

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TABLE 2:
GUIDANCE AND MANUFACTURER’S DECLARATION — ELECTROMAGNETIC IMMUNITY

InTENSity at Home™ electrical stimulators are intended for use in the electromagnetic environment specified below.
The customer or the user of these electrical stimulators should assure that it is used in such environment.

Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance

Electrostatic ±6 kV contact ±6 kV contact Floors should be wood, concrete or ceramic tile.


discharge (ESD) ±8 kV air ±8 kV air If floors are covered with synthetic material, the
lEC 61000-4-2 relative humidity should be at least 30%.

Electrical fast Not applicable Not applicable Not applicable


transient/burst
IEC 61000-4-4

Surge IEC Not applicable Not applicable Not applicable


61000-4-5

Voltage dips, short Not applicable Not applicable Not applicable


interruptions and voltage
variations on power supply
input lines IEC 61000-4-11

Power frequency 3 A/m 3 A/m Power frequency magnetic fields should be at


(50/60Hz) magnetic field levels characteristic of a typical location in a
IEC 61000-4-8 typical commercial or hospital environment.

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TABLE 4 :
GUIDANCE AND MANUFACTURER’S DECLARATION — ELECTROMAGNETIC IMMUNITY

InTENSity at Home™ electrical stimulators are intended for use in the electromagnetic environment specified below.
The customer or the user of these electrical stimulators should assure that it is used in such environment.

Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance

Conducted RF Portable and mobile RF Communications equipment should


Not applicable
lEC 61000-4-6 be used no closer to any part of the device, including cables,
than the recommended separation distance calculated from the
equation applicable to the frequency of the transmitter.
Recommended separation distance
d = 1.2 √P
d = 1.2 √P 80 MHz to 800 MHz
d = 2.3 √P 800 MHz to 2.5 GHz
Where P is the maximum output power rating of the transmitter in
Radiated RF 3 V/m watts (W) according to the Transmitter manufacturer and d is the
3 V/m
lEC 61000-4-3 80 MHz to 2.5 GHz recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an
electromagnetic site survey,a should be less than the compliance
level in each frequency range. b
Interference may occur in the vicinity of equipment
marked with the following symbol:

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TABLE 4 (CONT’D):
NOTE I: At 80 MHz ends 800 MHz. the higher frequency range applies.
NOTE 2: T
 hese guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.

a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured
field strength in the location in which the device is used exceeds the applicable RF compliance level above, should be observed
to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or
relocating the device.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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TABLE 6:
RECOMMENDED SEPARATION DISTANCES BETWEEN
PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE DEVICE

The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters) and as recommended below,
according to the maximum output power of the communications equipment.

Separation Distance According To Frequency Of Transmitter In Meter


Output Power of
Transmitter in Watt 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
d = 1.2 √P d = 1.2 √P d = 2.3 √P

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

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TABLE 6 (CONT’D):
For transmitters rated at a maximum output power not listed above, the recommended separation distance (d) in meters (m) can
be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
NOTE I At 80 MHz and 800 MHz. the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.

NOTE: EMC tests conducted including attached electrode cord of 1.5 m length.

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LIMITED ONE YEAR WARRANTY
Limited Consumer Product Warranty (United States)
This InTENSity at Home™ Dual Channel TENS is warranted to the original consumer “the purchaser” to be free from defects
in material and workmanship which are not commercially acceptable for the period of one year from the date of purchase.
Warranty coverage terminates if you sell or otherwise transfer this product to another person. This warranty gives you specific
legal rights and you may also have other rights, which vary by location.

COMPASS HEALTH BRANDS MAKES NO EXPRESS WARRANTY OF ANY KIND REGARDING THIS PRODUCT OTHER
THAN THOSE WARRANTIES SET FORTH HEREIN. ANY IMPLIED WARRANTY, INCLUDING ANY IMPLIED WARRANTY OF
MERCHANTABILITY OR ANY IMPLIED WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE TO THE EXTENT PERMITTED
BY LAW, SHALL BE LIMITED IN DURATION TO A PERIOD OF 120 DAYS FROM THE DATE OF PURCHASE BY THE ORIGINAL
PURCHASER.

In the event that this product is found by Compass Health Brands to not meet the above limited warranty, as purchaser’s sole
and exclusive remedy, Compass Health Brands will repair or at the option of Compass Health Brands, replace this product
without charge for such replacement parts or labor. The purchaser shall bear all expenses related to returning this product to
Compass Health Brands
This warranty does not apply to any part of the product that has been subject to misuse, abuse, or alteration. Improper or
incorrectly performed maintenance or repair voids this warranty. The warranty applies to the device only, accessories are not
included in warranty.

TO THE EXTENT PERMITTED BY LAW, COMPASS HEALTH BRANDS SHALL NOT BE LIABLE FOR ANY INCIDENTAL
OR CONSEQUENTIAL DAMAGES INCLUDING, BUT NOT LIMITED TO, REPLACEMENT COSTS RESULTING FROM THE
BREACH OF ANY WRITTEN OR IMPLIED WARRANTY.

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LIMITED ONE YEAR WARRANTY (CONT’D)
If you wish to make a claim under this warranty, please contact your local DME dealer/retailer where you purchased the unit
from. You will need the following information when making your claim:
• The entire original InTENSity at Home™ product and packaging
• The original receipt showing date of purchase
• Detailed description of the problem
• Serial Number

InTENSity at Home™ Model:____________________________________


Serial Number:________________________________________________
Date of Purchase:_____________________________________________
Distributor:___________________________________________________

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Manufactured for:

Middleburg Heights, OH, 44130


800.376.7263
compasshealthbrands.com
Made in China /Hecho en China

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