Roscoe Medical InTENSity Micro Combo User manual

INSTRUCTION MANUAL

This manual is valid for the InTENSityTM Micro
Combo TENS/MIC Stimulator
This user manual is published by Roscoe Medical, Inc.
Roscoe Medical 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 Rights Reserved. Rev. V1.1 © 2013
: United States Federal Law restricts this device to sale by or on
the order of a physician or licensed practitioner.
Conformity to safety standards
Roscoe Medical, Inc. declares that the device complies with the
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. SAFETY INFORMATION………………………………………………………… 4
1.1 General Description
1.2 Medical background
1.3 Indication for use
1.4 Contraindications
1.5 Warnings, Cautions, Adverse Reactions
2. PRESENTATION..………………………………………………………………..… 11
2.1 Front and Rear panel
2.2 LCD display
3. SPECIFICATION………………………………………............…..……………….. 14
3.1 Accessories
3.2 Technical information
3.3 The waveforms of the stimulation programs
4. INSTRUCTION FOR USE………………………………………………………......17
4.1 Battery
4.2 Connect electrodes to lead wires
4.3 Connect lead wires to device
4.4 Electrode
4.5 Turn ON
4.6 Select the Therapeutic Program
4.7 Steps to set a new program
4.8 Adjust Channel Intensity
4.9 Safety Lock Feature
4.10 Stop the treatment
4.11 Turn OFF
4.12 Low battery indicator
5. PROGRAM………………………………………………………............................ 27
6. CLEANING AND CARE………………………………………………………......... 28
6.1 Tips for skin care
6.2 Cleaning the device
6.3 Electrodes
6.4 Cleaning the Electrodes cables
6.5 Maintenance
7. TROUBLESHOOTING………………………………………………………...... 31
8. STORAGE………………………………………………………......................... 33
9. DISPOSAL……………………………………………................………………. 33
10. ELECTROMAGNETIC COMPATIBILITY (EMC) TABLES…....………………… 34
11. GLOSSARY OF SYMBOLS………………………….….............…………………. 40
12. WARRANTY………………………………………..….................………………... 41

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1. SAFETY INFORMATION
1.1 General
InTENSityTM Micro Combo is a portable electrotherapy device
featuring two therapeutic modes: Transcutaneous Electrical Nerve
Stimulation (TENS) and Microcurrent (MIC), which are used for pain
relief and electrical muscle stimulation. The stimulator sends gentle
electrical current to underlying nerves and muscle groups 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
different 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 effective 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.
EXPLANATION OF MICROCURRENT
Microcurrent stimulation is a type of therapy in which very low current
is sent into the cells of the body. Microcurrent is a very faint current
that is so small it is measured in millionths of an amp (Microamps).
Human cells generate a current that is in the micro amp range which
is why you can’t feel it – the current is so low it doesn’t stimulate the
sensory nerves.
Microcurrent is a physiological electric modality that increases ATP
(energy) production in the cells of your body. This dramatically
increases the tissue’s healing rate. The immediate response to the
correct microcurrent frequency suggests that other mechanisms are
involved as well. The exact effects or changes in the tissue are
unmistakable; scars will often suddenly soften; trigger points often
become less painful within minutes when the “correct” frequency is
applied. In many situations the changes seen seem to be long lasting
and in many cases permanent.
1.3 Indication for use
InTENSityTM Micro Combo TENS/MIC Stimulator may be used for the
following conditions:
1. Symptomatic relief of chronic pain.
2. Post-traumatic pain.
3. Post-surgical pain.

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IMPORTANT SAFETY INFORMATION!
Read instruction manual before operating. Be sure to comply
with all “Contraindications”, Warnings”, “Cautions” and
“Adverse reactions” outlined in the manual. Failure to follow
these instructions may cause harm to the user or the device.
1.4 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.
1.5 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 effects of chronic electrical stimulation are
unknown. Electrical stimulation devices do not have any curative
value.

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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 effective 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 difficulty 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 affect 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.

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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 noncompliant, emotionally disturbed, has dementia, or a
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 sufficient 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 difficult, and may have adverse effects 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 trans-cerebrally (through the
head).
12. Patients with heart disease, epilepsy, cancer or any other health

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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. Effectiveness 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 off before applying or removing the electrodes.
27. Electrical stimulators 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 or flammable mixture.

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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.