Richmar Tens 3000 User manual

INSTRUCTION MANUAL
Tens 3000
TENS 3000
TENS 3000

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This manual is valid for the
TENS 3000 Stimulator
This user manual is published by Richmar.
Richmar 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. V2 © 2019
United States Federal Law restricts this device to sale by or
on the order of a physician or licensed practitioner
Conformity to safety standards
Richmar declares that the device complies with following
normative documents:
IEC60601-1, IEC60601-1-2, IEC60601-2- 10, IEC60601-1-4,
ISO10993-5, ISO10993-10, ISO10993-1

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TABLE OF CONTENTS
1. GENERAL INFORMATION _______________________________ 4
1.1 General Description
1.2 Medical Background
1.3 Indication for Use
2. SAFETY INFORMATION _________________________________ 6
2.1 Contraindications
2.2 Warnings, Cautions, Adverse Reactions
3. PRESENTATION _______________________________________ 11
3.1 Device Features
4. SPECIFICATIONS ______________________________________ 11
4.1 Device Contents
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 Electrode Options
5.4 Adjusting the Controls
5.5 Turn ON
6. CLEANING AND CARE _________________________________ 19
6.1 Tips for Skin Care
6.2 Cleaning the Device
6.3 Cleaning Electrodes
6.4 Cleaning the Lead Wires
6.5 Maintenance
7. TROUBLESHOOTING ___________________________________ 21
8. STORAGE ____________________________________________ 23
9. DISPOSAL ___________________________________________ 23
10. ELECTROMAGNETIC COMPATIBILITY (EMC) TABLES ________ 24
11. GLOSSARY OF SYMBOLS _______________________________ 28
12. WARRANTY _________________________________________ 29

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1. GENERAL INFORMATION
1.1 General Description
The TENS 3000 is a battery operated pulse generator that sends
electrical impulses electrodes to the body and reach the nerves
causing pain. The device is provided with two controllable output
channels, each independent of each other.
The electronics of the TENS 3000 create electrical impulses whose
Intensity, duration, number per second and modulation may be
altered with the controls or switches. Dial controls are very easy to
use and the slide cover prevents accidental changes in the setting.
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
TENS 3000 Stimulator may be used for the following conditions:
TENS:
1. Symptomatic relief of chronic intractable pain.
2. Acute post-traumatic pain.
3. Acute post-surgical pain.

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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.
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.
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.

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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.
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.

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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.
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 Laryngeal and
Pharyngeal muscle spasms 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.

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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.
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.
29. DO NOT pull on the electrode wire as that may damage the wire and
electrode.
30. DO NOT apply to broken skin.
31. The electrodes should be discarded when they are no longer
adhering to the skin.
32. The electrodes are intended for single patient use only.
33. If irritation occurs, discontinue use and consult your clinician.
34. Read the instructions for use of self-adhesive electrodes before
application.
35. Always use the electrodes with the requirements of the IEC/
EN60601-1, ISO10993-1/-5/-10 and IEC/EN60601-1-2, such as with
CE mark, or are legally marketed in the U.S. under 510(K)
procedures.

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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.
2. If the stimulation levels are uncomfortable, reduce the stimulation
intensity to a comfortable level and contact your physician if any
problems persist.

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3. PRESENTATION
3.1 Device Features
4. Specifications
4.1 Device Contents
NO DESCRIPTION QTY
1 TENS Device (Item: DT3002) 1 each
2 Pair of Lead wires (Item: WW3005) 2/pk
32” x 2” Self-Adhesive electrodes
(Item: EP2020WC2-INTM) 4/pk
4 9V Battery, Type 6F22 (Item: TA9050-I) 1 each
5 Instruction manual 1 each
6 Carrying case (Item: CC3001) 1 each
BATTERY STRIPBATTERY STRIP
BATTERY COMPARTMENT

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4.2 Technical Information
Channel Dual, isolated between channels
Power supply One 9 volt battery, (alkaline or nickel-cadmium rechargeable)
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 50°C (14°F to 122°F) with a relative humidity of
10%-90%,atmospheric pressure from 700 to 1060 Hpa
Dimensions 3.75” x 2.60” x 1.0” (LxWxH
Weight 4 ounces.(With battery)
Tolerance There may be a ±5% tolerance of all setting and ±10% tolerance of
output of intensity.
Timer 15,30 minutes or continuous
Technical Specifications for Transcutaneous Electrical Nerve
Stimulator (TENS) Mode
Waveform Asymmetrical Biphasic Square Pulse
Pulse Amplitude Adjustable, 0 ~ 80mA at 500 ohm
Load each channel, 1mA/Step.
Pulse Width Adjustable from 30-260μs
Pulse Rate Adjustable from 2 to 150 Hz, 1 Hz/step
Burst Burst occurs twice every second, Pulse width(adjustable)
Frequency Fixed = 100 Hz
Modulation
The pulse width is automatically varied in a cyclic pattern over
an interval of nominally 10 seconds, (in max 150Hz) Pulse rate
decreases linearly over a period of 4 seconds from the control
setting value to a value which is 40% less. The lower pulse
rate will continue for 1 second. Then increase linearly over a 4
seconds period to its original value. The original pulse rate will
continue for 1 second. The cycle is then repeated.
Normal Normal stimulation based on setting value. Only pulse width,
pulse rate and timer are adjustable in this mode.

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4.3 The Waveforms of the Stimulation Programs
Burst
Normal
Modulation
10 pulses
per burst

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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 front battery cover down 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 and placing the battery ribbon under
the battery for easy removal later.
4. Press and push down battery snug into the compartment.
5. Slide battery cover back up to lock into place.
6. If battery requires replacement, slide the battery compartment
cover to open. Pull up the battery out of the compartment by
pulling on the battery ribbon to pop out easily and then insert a
new 9V battery according to the above steps 2 to 5.
5.1.2 Disposal of Battery
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.
5.1.3 CAUTION FOR BATTERIES:
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.

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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 (on page 5-9 and throughout
manual), as this powerful equipment is neither a toy nor a gadget!
CAUTION:
5.2 Connect Lead Wires to Electrodes
Ensure the device is in the OFF position before proceeding to this
step. Connection of the electrodes is made with two-lead connector.
Both intensity controls must be at the O position. Electrodes must be
pressed firmly on the skin
5.3 Electrode Options
Your clinician will decide which type of electrode is best for your
condition. Follow application procedures outlined in electrode packing,
to maintain stimulation and prevent skin irritation. Using the legally
marketed TENS electrode is recommended.
CAUTION:
Always use the electrodes with CE mark, or which are legally marketed
in the U.S. under 510(K) procedure.

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5.3.1 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 that, at a minimum, 1.5” x 1.5” self-adhering,
square electrodes are used at the treatment area.
5.3.2 Electrode Placement
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.

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5.4 Adjusting the Controls
5.4.1 Slide Cover:
A slide-on panel cover covers the controls
for Pulse Width, Pulse Rate, Mode
Selector and Modulation Selector. Your
medical professional may wish to set
these controls for you and request that
you leave the cover in place.
5.4.2 Display LED:
Each of the LEDs illuminates green whenever the electronics of the
device create a current impulse. Due to the capacity of the human eye,
the illumination of the lamp can only be recognized up to a frequency
of approximately 30 Hz. At higher frequencies, the lamp will appear to
be constantly illuminated.
5.4.3 Mode Control
Expose the controls by sliding front cover
down from top of unit. This switch has 3
positions: B for Burst stimulation, N for
Constant stimulation, and M for modulation.
Push the Mode Selector until engaged in
position desired.

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5.4.4 Pulse Width Control
This dial adjusts the length of time each
electrical signal is applied through the skin,
which controls the strength and sensation
of the stimulation.
5.4.5 Timer Control
Treatment time of TENS can be preset with
Timer Control. This switch has 3 positions,
15, 30 and C (Continue). Push the Timer
Control until engaged in position desired.
5.5 Turn ON
If both controls are in the o-position
(white markings on the housing match
up with the OFF dot on each control), the device is switched o. By
turning clockwise to hear/feel a click, and then stop, this means the
appropriate channel is switched on and the impulse display led will
illuminate and begin to pulse according to the frequency set.
To increase the current strength, slowly turn the dial clockwise,
waiting about 2-3 seconds between each increase until you feel a
strong but comfortable stimulation.
To reduce the current strength or switch the device o, turn the
controls counter clockwise to the required setting or o-position.

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6. CLEANING AND CARE
6.1 Tips for Skin Care
Follow these suggestions to avoid skin irritation, especially if you have
sensitive skin:
1. Wash the area of skin you will be placing the electrodes on with
soap. Rinse thoroughly and dry the area completely before and
after placing electrodes.
2. Excess hair may be clipped with scissors; DO NOT shave
stimulation area.
3. Wipe the area with the skin preparation your clinician has
recommended. Let this dry. Apply electrodes as directed.
4. Many skin problems arise from the “pulling stress” from adhesive
patches that are excessively stretched across the skin during
application. To prevent this, apply electrodes from center outward;
avoid stretching over the skin.
5. To minimize “pulling stress”, tape extra lengths of lead wires
to the skin in a loop to prevent tugging on electrodes.
6. When removing electrodes, always remove by pulling in the
direction of hair growth.
7. It may be helpful to rub skin lotion on electrode placement area
during treatment down time when you are not wearing electrodes.
8. NEVER apply electrodes over irritated or broken skin.
6.2 Cleaning the Device
1. Remove the battery from the device before you clean the device.
2. Clean the device after use with a soft, slightly moistened cloth.
For hard to clean situations, you can also moisten the cloth
with mild soapy water.
3. DO NOT use any chemical cleaners or abrasive agents for cleaning.

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6.3 Cleaning Electrodes
1. Electrodes cannot be cleaned as they are made with a self-
adhesive gel. Electrodes can be re-used and number of uses vary
from user to user.
2. If electrodes do not stick to the skin completely (including lifting
edges) please replace with new electrodes. DO NOT use smaller
electrodes than were provided by the manufacturer unless directed
specifically by your physician.
TO REMOVE YOUR ELECTRODES:
1. Lift the corner of the electrode and gently remove it from the skin.
2. Between uses, place the electrodes back onto the protective sleeve
and insert them into the resealable bag and store in a cool dry
place.
6.4 Cleaning the Lead Wires
Clean the lead wires by wiping them with a damp cloth. Coating them
lightly with talcum powder will reduce tangles and prolong their life.
6.5 Maintenance
1. Maintenance and all repairs should only be carried out by an
authorized agency. The manufacturer will not be held responsible for
the results of maintenance or repairs by unauthorized persons.
2. The user must not attempt any repairs to the device or
accessories. Please contact the retailer for repair.
3. Opening of the equipment by unauthorized agencies is not allowed
and will terminate any claim to warranty.
4. Check the unit before each use for signs of wear and/or damage.
Replace worn items as required.