Richmar InTENSity 10 User manual

INSTRUCTION MANUAL
INTENSITY™ 10
INTENSITYINTENSITY 10

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This manual is valid for the
InTENSity™ 10 TENS Stimulator
This user manual is published by Compass Health Brands.
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.
All Right Reserved. Rev. C © 2023
United States Federal Law restricts this device to sale by or
on the order of a physician or licensed practitioner
Conformity to safety standards
Compass Health Brands declares that the device complies
with following normative documents:
IEC60601-1, IEC60601-1-2, IEC60601-2- 10,
ISO10993-5, ISO10993-10, ISO10993-1

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TABLE OF CONTENTS
1. GENERAL INFORMATION _______________________________ 4
1.1 Device Information
1.2 Medical Background
1.3 Indication for Use
2. IMPORTANT SAFETY INFORMATION ______________________ 5
2.1 Contraindications
2.2 Warnings, Cautions, Adverse Reactions
3. PRESENTATION _______________________________________ 10
3.1 Front and Rear Panel
3.2 LCD Display
4. SPECIFICATION _______________________________________ 12
4.1 Accessories
4.2 Technical Information
4.3 The Waveforms of the Stimulation Programs
5. INSTRUCTIONS FOR USE _______________________________ 14
5.1 Battery
5.2 Connect Electrodes to Lead Wires
5.3 Connect Lead Wires to Device
5.4 Electrode Options
5.5 Turn ON
5.6 Select the Therapeutic Program
5.7 Select the Treatment Time
5.8 Adjust Channel Intensity
5.9 Safety Lock Feature
5.10 Turn OFF
5.11 Low Battery Indicator
6. PROGRAM ___________________________________________ 20
7. CLEANING AND CARE _________________________________ 21
7.1 Tips for Skin Care
7.2 Cleaning the Device
7.3 Electrodes
7.4 Cleaning the Electrodes Cords
7.5 Maintenance
8. TROUBLESHOOTING ___________________________________ 24
9. STORAGE ____________________________________________ 26
10. DISPOSAL ___________________________________________ 26
11. ELECTROMAGNETIC COMPATIBILITY (EMC) TABLES ________ 27
12. GLOSSARY OF SYMBOLS ______________________________ 31
13. WARRANTY _________________________________________ 32

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1. GENERAL INFORMATION
1.1 Device Information
InTENSity™ 10 TENS stimulator is a portable electro-therapy device
featuring Transcutaneous Electrical Nerve Stimulation (TENS), which
is used for pain relief and electrical muscle stimulation. The stimulator
sends a gentle electrical current to underlying nerves and muscle
group via electrodes applied on the skin. The parameters of the device
are controlled by the buttons on the front panel. The intensity level is
adjustable according to the needs of the individual patient.
1.2 Medical Background
EXPLANATION OF PAIN
Pain is a warning system and the body’s method of telling us that
something is wrong. Pain is important; without it abnormal conditions
may go undetected, causing damage or injury to vital parts of our
bodies. Even though pain is a necessary warning signal of trauma or
malfunction in the body, nature may have gone too far in its design.
Aside from its value in diagnosis, long-lasting persistent pain serves no
useful purpose. Pain does not begin until the coded message travels to
the brain where it is decoded, analyzed, and then reacted to. The pain
message travels from the injured area along the small nerves leading
to the spinal cord. Here the message is switched to dierent nerves
that travel up the spinal cord to the brain. The pain message is then
interpreted, referred back and the pain is felt.
EXPLANATION OF TENS
Transcutaneous Electrical Nerve Stimulation (TENS) is a non-invasive,
drug free method of controlling pain. TENS uses tiny electrical
impulses sent through the skin to nerves to modify your 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 eective in reducing or eliminating the pain,
allowing for a return to normal activity.

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HOW TENS WORKS
There is nothing "magic" about Transcutaneous Electrical Nerve
Stimulations (TENS). TENS is intended to be used to relieve pain.
The TENS unit sends comfortable impulses through the skin that
stimulate the nerve (or nerves) in the treatment area. In many cases,
this stimulation will greatly reduce or eliminate the pain sensation the
patient feels. Pain relief varies by individual patient, mode selected
for therapy, and the type of pain. In many patients, the reduction or
elimination of pain lasts longer than the actual period of stimulation
(sometimes as much as three to four times longer). In others, pain
is only modified while stimulation actually occurs. You may wish
to discuss this method of pain management treatment with your
physician or therapist.
1.3 Indication For Use
InTENSity™ 10 TENS Stimulator may be used for the following
conditions:
TENS:
1. Symptomatic relief of chronic intractable pain.
2. Post-traumatic pain.
3. Post-surgical pain.
2. SAFETY INFORMATION
Read instruction manual before operating. Be sure to comply with all
“Contraindications”, Warnings”, “Cautions” and “Adverse reactions”
in the manual. Failure to follow instructions may cause harm to user
or device.
Safety Symbols Used in this Manual
WARNING
Indicates a potentially hazardous situation which, if not
avoided, could result in serious injury and equipment
damage.
CAUTION
Indicates a potentially hazardous
situation which, if not avoided, may result in minor or
moderate injury to the user or patient or damage to the
device or other property.

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2.1 Contraindications
1. This device should not be used for symptomatic local pain relief
unless etiology is established or unless a pain syndrome has been
diagnosed.
2. This device should not be used when cancerous lesions are present
in the treatment area.
3. Stimulation should not be applied over swollen, infected, inflamed
areas or skin eruptions (e.g. phlebitis, thrombophlebitis, varicose
veins, etc.).
4. Electrodes must not be applied to sites that might cause current/
stimulation to flow through the carotid sinus region (anterior neck)
or trans-cerebrally (through the head).
5. DO NOT use this device if the patient has a demand-type cardiac
pacemaker or any implanted defibrillator or other implanted
metallic or electronic devices as they can cause electric shock,
burns, electrical interference or death.
6. This device should not be used over poorly enervated areas.
7. This device should not be used on patients with epilepsy.
8. This device should not be used on patients with serious
arterial circulatory problems in the lower limbs.
9. This device should not be used on patients with abdominal or
inguinal hernia.
10. DO NOT use this device if you have heart disease without
consulting your physician.
2.2 Warnings, Cautions and Adverse Reactions
WARNINGS:
1. This device should be used only under the continued supervision
of a licensed physician or practitioner.
2. The long-term eects of chronic electrical stimulation are
unknown. Electrical stimulation devices DO NOT have any curative value.
3. TENS is a symptomatic treatment and, as such, suppresses the
sensation of pain, which would otherwise serve as a protective
mechanism.
4. Safety has not been established for the use of therapeutic
electrical stimulation during pregnancy. DO NOT use during
pregnancy unless directed by your physician.
5. Electrical stimulation is not eective for pain of central origin, such
as a headache.
6. Electrical monitoring equipment (such as ECG monitors and ECG
alarms) may not operate properly when electrical stimulation is in use.

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7. Stimulation should not be applied over the carotid sinus nerves,
particularly in patients with a known sensitivity to the carotid
sinus reflex.
8. Stimulation should not be applied over the neck or mouth. Severe
spasm of the laryngeal and pharyngeal muscles may occur and the
contraction may be strong enough to close the airway or cause
diculty in breathing.
9. Stimulation should not be applied transthoracically. Introduction of
electrical current into the heart may cause cardiac arrhythmias.
10. Stimulation should not take place while the user is connected to
high-frequency surgical equipment, it may cause burn injuries on
the skin under the electrodes, as well as problems with the stimulator.
11. DO NOT use the stimulator in the vicinity of shortwave or microwave
therapy equipment, since this may aect the output power of the
stimulator.
12. NEVER use in environments with high humidity such as in the
bathroom or when having a bath or shower.
13. Caution should be used in applying electrical stimulation to
patients suspected of having heart disease. Further clinical data is
needed to show there are no adverse results.
14. NEVER use near the heart. Stimulation electrodes should NEVER be
placed anywhere on the front of the thorax (marked by ribs and
breastbone), take extreme caution not to place near or on the
two large pectoral muscles. Here it can increase the risk of
ventricular fibrillation and lead to cardiac arrest.
15. Electrodes should not be placed over the eyes, in the mouth, near
the genitals or internally.
16. NEVER use on the areas of the skin which lack normal sensation.
17. Apply the electrodes to clean, dry, and unbroken skin only.
18. Keep electrodes separate during treatment, electrodes in contact
with each other could result in improper stimulation or skin burns.
19. Keep the stimulator out of reach of children.
20. Consult your doctor if you have any questions or concerns before
using this device.

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CAUTIONS:
1. Federal law (USA) restricts this device to sale by or on the order of
a physician.
2. This device is for single patient use only.
3. Keep yourself informed of the contraindications.
4. This device is not intended for use on an unattended patient who is
non-compliant, emotionally disturbed, has dementia, or low IQ.
5. Read, understand, and practice the warnings, cautions and operating
instructions. Know the limitations and hazards associated with using
this device. Observe the cautionary and operational decals placed
on the unit. Always follow the operating instructions prescribed by
your healthcare practitioner.
6. The instruction of use was listed; any improper use may be dangerous.
7. Do no use this device for undiagnosed pain syndromes until
consulting a physician.
8. Patients with an implanted electronic device, such as a cardiac
pacemaker, implanted defibrillator, or any other metallic or
electronic device should not use this device without first consulting
a doctor.
9. Stimulation delivered by this device may be sucient to cause
electrocution. Electrical current of this magnitude must not flow
through the thorax or across the chest because it may cause
cardiac arrhythmia.
10. DO NOT place electrodes on the front of the throat as spasm of the
Laryngeal and Pharyngeal muscle may occur. Stimulation over the
carotid sinus (neck region) may close the airways, make breathing
dicult, and may have adverse eects on the heart rhythm or
blood pressure.
11. DO NOT place electrodes on your head or at any sites that may
cause the electrical current to flow transcerebrally (through the head).
12. Patients with heart disease, epilepsy, cancer or any other health
condition should not use this device without first consulting a physician.
13. Some patients may experience skin irritation or hypersensitivity
due to the electrical stimulation or silicone rubber. If rash develops
or pain persists, discontinue use and consult a doctor.
14. Electrode placement and stimulation settings should be based on
the guidance of prescribing practitioner.
15. Eectiveness is highly dependent upon the patient and the
selection of therapy by a person qualified in the management of pain.
16. Isolated cases of skin irritation have occurred at the site of the
electrode placement following long-term application. If this occurs,
discontinue use and consult your physician.

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17. The electrodes are only to be placed on healthy skin. Avoid
skin irritation by ensuring that good contact is achieved between
electrodes and skin.
18. If the stimulation levels are uncomfortable or become
uncomfortable, reduce the stimulation intensity to a comfortable
level and contact your physician if problems persist.
19. This device should not be used while driving, operating machinery,
close to water or during any activity in which involuntary muscle
contractions may put the user at undue risk for injury.
20. NEVER use the device in rooms where aerosols (sprays) are used or
pure oxygen is being administered.
21. DO NOT use it near any highly flammable substances, gases or explosives.
22. DO NOT use this device at the same time as other equipment which
sends electrical pulses to your body.
23. DO NOT confuse the electrode cables and contacts with your
headphones or other devices, and DO NOT connect the electrodes
to other devices.
24. DO NOT use sharp objects such as pencil point or ballpoint pen to
operate the buttons on the control panel.
25. Inspect applicator cables and associated connectors before each use.
26. Turn the device o before applying or removing the electrodes.
27. Electrical stimulator should be used only with the leads and
electrodes recommended for use by the manufacturer.
28. This device has no AP/APG protection. DO NOT use it in the
presence of explosive atmosphere of flammable mixture.
2. If the stimulation levels are uncomfortable, reduce the stimulation
intensity to a comfortable level and contact your physician if any
problems persist.
ADVERSE REACTIONS:
1. Skin irritation from the electrode gel and electrode burns are
potential adverse reactions. If skin irritation occurs, discontinue use
and consult your physician.
Note: Always use electrodes that are legally marketed and sold in the
United States under 510K guidelines.

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3. PRESENTATION
3.1 Front and Rear Panel
1. Output socket: electric signal output of the cable on channel 1 & 2.
2. AC Adaptor connecting port.
3. T(time) and S(therapeutic part) setting buttons.
4. Increases [▲] the output intensity of channel 1.
5. Decreases [▼] the output intensity of channel 1. It is also used to
unlock the current treatment program.
6. LCD display: Shows the operating state of the device.
7. Increases [▲] the output intensity of channel 2.
8. Decreases [▼] the output intensity of channel 2. It is also used to
unlock the current treatment program.
9. Press [ ] to turn ON the device. Press [ ] and hold for
approximately 3 seconds to turn o the device.
10. Belt Clip.
11. Battery compartment cover.

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1. Displays therapeutic mode (TENS).
2. Lock function indicator.
3. Low-battery indicator.
4. Displays the cycle time of the treatment.
5. Timer symbol.
6. Displays the numerical value of the output intensity for channel 1.
7. Displays the numerical value of the output intensity for channel 2.
8. Displays the therapeutic program by body part.
3.2 LCD Display

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4. SPECIFICATIONS
4.1 Accessories
NO DESCRIPTION QTY
1 TENS Stimulator Device (Item: DI1010) 1 each
2 Pair of Lead wires (Item: WW3005) 2/pk
32” x 2” Self Adhesive electrodes
(Item: EP2020WC2-INTM) 4/pk
49V TENScell alkaline battery
(Item: TA5013-I) 1 each
5 Instruction manual 1 each
6 Carrying case (Item: CC5082) 1 each
7 Wall (AC) adapter (Item: DI0001X) 1 each
4.2 Technical Information
Channel Dual, isolated between channels
Power supply 9.0 V Alkaline battery, type: 6LR61
Adapter output:9.0Vdc, 800mA (optional)
Operating
Conditions
5°C to 40°C (41°F to 104°F) with a relative humidity of
30%-75%,atmospheric pressure from 700 to 1060 Hpa
Storage
Conditions
-10°C to 55°C (14°F to 131°F) with a relative humidity of
10%-90%,atmospheric pressure from 700 to 1060 Hpa
Dimensions 4.6 × 2.6 × 0.98 inches (L*W*H)
Weight 0.3 lbs./137 g (With battery)
Tolerance There may be a ±20% tolerance of all settings.
Timer 15, 30, 60 minutes and continuous.
Electrode Detection
Function
The amplitude level will be reset to 0mA when the amplitude
level is 12mA or greater and if an open circuit at either channel
is detected.
Waveform Bi-phase square pulse wave
Pulse Amplitude Adjustable, 0~105mA at 1000 ohm. Load each channel, 1mA/
Step
Pulse Width From 100 to 260μs,
Pulse Rate Adjustable from 50 to 150 Hz

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4.3 The Waveforms of the Stimulation Programs
Normal
Pulse Width Modulation
Pulse Rate Modulation
Modulation (Pulse Width and Pulse Rate)

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5. INSTRUCTIONS FOR USE
5.1 Battery
5.1.1 Check/Replace the Battery
Over time, in order to ensure the functional safety of the device,
changing the battery is necessary.
1. Slide the battery compartment
cover to open.
2. Insert the 9V battery into the
battery compartment.
3. Make sure you are installing
the battery properly. Be sure
to match the positive and
negative ends of the battery to
the marking in the battery
compartment of the device.
4. Press and push down the battery following the direction of the
arrow indicated on the photo.
5. Replace the battery compartment cover and press to close.
6. If battery requires replacement, slide the battery compartment
cover to open. Pull up the battery following the directions of the
arrow indicated on the photo and insert a new 9V battery
according to the above steps 2 to 5.
Dispose of used batteries according to the current
federal, state and local regulations. As a consumer,
you are obligated by law to discard depleted
batteries appropriately.
5.1.2 Disposal of Battery
Medical Device

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CAUTION FOR BATTERIES:
CAUTION:
1. Swallowing a battery may be fatal. Keep the battery and the
device out of the reach of children. If a battery is swallowed,
consult a physician immediately.
2. If a battery has leaked, avoid contact with skin, eyes and mucus
membranes. Rinse the aected areas with clear water immediately
and contact a physician immediately.
3. Battery should not be charged, dismantled, thrown into fire or
short-circuited.
4. Protect battery from excess heat.
5. Remove batteries from the unit if they are depleted or if you are not
using the unit for prolonged periods of time. This prevents damage
caused by leaking battery.
6. Always replace with the same type battery.
5.2 Connect Electrode to Lead Wires
Insert the lead wire connector into electrode connector (standard 0.08
inch female connection). Make sure the connectors are completely
pushed together showing no exposed metal of the pins.
Always use the electrodes with CE mark, or which are legally marketed
in the U.S. under 510(K) procedure.

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5.3 Connect Lead Wires to Device
1. Before proceeding to this step,
be sure the device is completely
turned OFF.
2. Insert the wires provided with
the system into the jack sockets
located on top of the device.
3. Holding the insulated portion of the
connector, push the plug end of
the wire into one of the jacks (see
drawing); one or two sets of wires
may be used.
4. This device has two output receptacles controlled by
Channel 1 and Channel 2 at the top of the unit. You may
choose to use one channel with one pair of lead wires or
both channels with two pairs of lead wires. Using both
channels gives the user the advantage of stimulating two
dierent areas at the same time.
CAUTION:
DO NOT insert the plug of the patient lead wire into any AC power
supply socket.
5.4 Electrode Options
The electrodes are disposable and should be routinely replaced before
they start to lose their adhesive nature. Replacement electrodes should
be re-ordered through or on the advice of your physician to ensure
proper quality. Follow application procedures outlined in electrode
package to maintain optimal stimulation and to prevent skin irritation.
Inspect your electrodes before every use. Replace electrodes as
needed. Reusable electrodes can cause slight skin irritation, lose
adhesion properties and deliver less stimulation if overused.
INTENSITY
TWIN STIM III

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5.4.1 Place Electrode on Skin
Apply electrodes to the exact site
indicated by your physician or therapist.
Before applying electrodes, be sure the
skin surface over which electrodes are
placed is thoroughly cleaned and dry.
Make sure the electrodes are pressed
firmly to the skin and make good contact between the skin and
the electrodes. Place the electrodes over the skin; attach them
properly, firmly and evenly. Electrodes should be placed at least
2” but no more than 6” apart, per channel.
CAUTION:
1. Before applying the self-adhesive electrodes, it is recommended
that you wash, degrease and dry the skin first.
2. DO NOT turn on the device when the self-adhesive electrodes
are not positioned on the body.
3. NEVER remove the self-adhesive electrodes from the skin
while the device is turned on. You will feel an uncomfortable
electrical shock.
4. It is recommended to use the specific size provided by
manufacturer or, at a minimum, 1.5” x 1.5” self-adhering, square
electrodes are used at the treatment area, to avoid skin irritations
or burns. For smaller electrodes, the maximum current setting of the
waveform should be appropriately reduced.
5. It is recommended not to exceed a current density of 2mA/ cm 2 , to
avoid skin irritations or burns.
6. Ensure the entire surface of the electrode has good contact with
the skin.
The placement of electrodes can be one of the most important
parameters in achieving success with this therapy. Of utmost
importance is the willingness of the physician to try the various styles
of electrode placement to find which method best fits the needs of
the individual patient.
Every patient responds to electrical stimulation dierently and their
needs may vary from the conventional settings suggested here. If the
initial results are not positive, speak to your physician about alternative
stimulation settings and/or electrode placements. Once an acceptable
location has been achieved, mark down the electrode sites and the
device settings, so the patient can easily continue treatment on their own.
5.4.2 Electrode Placement

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5.5 Turning On the Device
Before using the device for the first time, you are strongly advised
to take careful note of the contraindications and safety measures
detailed at the beginning of this manual (pages 5-9 and throughout
manual), as this powerful equipment is neither a toy nor a gadget!
To turn on the device, PRESS and RELEASE the ON/OFF
button. The operation page will appear on the LCD screen.
5.6 Select the Therapeutic Part Program
InTENSity™Stimulator is equipped with 10 pre-set programs. For
details on how to program please refer to Section 5 “Programs”. The
therapeutic body part program can be selected by pressing the [S]
button control.
The therapeutic body part program indicator will flash after you
have selected it. Apply electrodes to the exact site indicated by your
physician or therapist.
CAUTION:
Consult your physician for your suitable therapeutic mode.
5.7 Select the Treatment Time
There are 4 choices available for the treatment time: 15 min, 30 min, 60
min and Continuous. The treatment time can be selected by pressing
the [T] button.
5.8 Adjust Channel Intensity
Press the intensity control button up [ ] and down [ ] to control the
intensity output. Slowly press the intensity button up until you reach
the setting recommended by your physician or therapist. Repeat for
the other channel, if both channels are to be used.
CAUTION:
1. If the stimulation levels are uncomfortable or become
uncomfortable, reduce the stimulation intensity to a comfortable
level and contact your medical practitioner if problems persist.

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5.9. Safety Lock Feature
The Safety Lock Feature automatically activates by locking out your
ability to operate the buttons when you have stopped setting the
program or adjusting the intensity for 30 seconds. This is a safety
feature to prevent accidental changes to your settings and to prevent
accidental increases to the intensity levels. You can press either one of
the down [ ] buttons to unlock the device.
5.10 Turn O
If device is locked, the []button must be pressed first to unlock the
device. Then press and hold [ ] button for approximately 3 seconds
to turn o device. If device is not locked, just press and hold [ ]
button for 3 seconds to turn o.
CAUTION:
1. If there is no operation in the panel for 2 minutes in the waiting
state, the device will turn o automatically.
2. In shutdown state, keep pressing the channel 2 down [ ] button
first, and then press the [ ] button at the same
time to restore factory parameter settings.
5.11 Low Battery Indicator
A battery symbol is shown flashing on the display when the battery
is almost empty. The battery should be replaced with a new battery
as soon as possible. However, the unit may continue to operate for an
extended period of time depending on the setting and intensity level.
2. When using the device in active mode, if the electrodes are not
placed firmly on the skin or the device is not connected to the
electrodes and the stimulator’s output intensity surpasses 12mA,
the intensity will automatically reset to 0mA.

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6. PROGRAM
Therapeutic
Part Program
Waveform Frequency
(Hz)
Pulse Wide
(μs)
Treat. time
(Min) default
Neck Modulation 60-100 100-150 30
Shoulder Pulse Rate
modulation
80-100 260 30
Mid Back Pulse Rate
modulation
100-150 100 30
Low Back Frequency
modulation
50-80 260 30
Elbow Continuous 100 100 30
Wrist Continuous 100 260 30
Hip Pulse Rate
modulation
100-150 200 30
Knee Pulse Width
modulation
120 100-150 30
Ankle Continuous 100 100 30
Foot Modulation 60-100 100-160 30