Roscoe Medical INTENSITY 10 User manual

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Instruction Manual

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This manual is valid for the
InTENSityTM 10 TENS 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.V 2 © 2015
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 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
1.2 Medical background
1.3 Indication for use
1.4 Contraindications
1.5 Warnings, Cautions, Adverse Reactions
2. PRESENTATION ____________________________________ 10
2.1 Front and Rear panel
2.2 LCD display
3. SPECIFICATION ___________________________________ 12
3.1 Accessories
3.2 Technical information
3.3 The waveforms of the stimulation programs
4. INSTRUCTIONS FOR USE ___________________________ 14
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
4.7Adjust Channel Intensity
4.8 Safety Lock Feature
4.9 Turn OFF
4.10 Low battery indicator
5. PROGRAM ________________________________________ 20
6. CLEANING AND CARE ______________________________ 21
6.1 Tips for skin care
6.2 Cleaning the device
6.3 Electrodes
6.4 Cleaning the Electrodes cords
6.5 Maintenance
7. TROUBLESHOOTING _______________________________ 24
8. STORAGE ________________________________________ 26
9. DISPOSAL ________________________________________ 26
10. ELECTROMAGNETIC COMPATIBILITY (EMC) TABLES ___ 27
11. GLOSSARY OF SYMBOLS __________________________ 33
12. WARRANTY ______________________________________ 34

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1. SAFETY INFORMATION
1.1 General
InTENSityTM 10 TENS stimulator is a portable electrotherapy device
featuring Transcutaneous Electrical Nerve Stimulation (TENS)
therapeutic device, which is used for pain relief. The stimulator
sends a gentle electrical current to underlying nerves and muscle
group via electrodes applied on the skin. The parameters of 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- inva-
sive, drug free method of controlling pain. TENS uses tiny electrical
impulses sent through the skin to nerves to modify your pain percep-
tion. 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 modied 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
InTENSityTM 10 TENS Stimulator can be used for the symptomatic
relief of chronic intractable pain, acute post traumatic pain, acute
post-surgical pain and arthritis pain.
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, inamed 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 ow through the carotid sinus region
(anterior neck) or trans-cerebrally (through the head).

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5. Do not use this device if the patient has a demand-type cardiac
pacemaker or any implanted debrillator.
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.
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 reex.
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 dif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

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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 brillation 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.
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.

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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 debrillator, or any other metallic or
electronic device should not use this device without rst
consulting a doctor.
9. Stimulation delivered by this device may be sufcient to cause
electrocution. Electrical current of this magnitude must not ow
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 difcult, 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 ow trans-cerebrally (through the
head).
12. Patients with heart disease, epilepsy, cancer or any other
health condition should not use this device without rst
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 qualied 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.

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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 ammable 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 ammable mixture.
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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2. PRESENTATION
2.1 Front and Rear Panel
1. Output socket: electric signal output after connection of the
cable(s) with adhesive electrodes on Channel 1and/or Channel
2.
2. AC Adapter connection point.
3. Treatment time selection button.
4. Increases [▲] the output intensity of channel 1.
5. Decreases [▼] the output intensity of channel 1 and also
unlocks the current treatment program.
6. LCD display: Shows the operating state of the device
7. Therapeutic mode selection button; it also stops treatment.
8. Increases [▲] the output intensity of channel 2.
9. Decreases [▼] the output intensity of channel 2 and also
unlocks the current treatment program.
10. Press to turn ON the device. Press button and hold for
approximately 3 seconds to turn off the device
11. Belt Clip.
12. Battery compartment cover.

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2.2 LCD Display
1. Displays TENS therapeutic mode.
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.

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3. SPECIFICATIONS
3.1 Accessories
No DESCRIPTION QTY
1 TENS stimulator device 1 piece
2 Electrodes Leads 2 pieces
3 40mm x 40mm adhesive electrodes 4 pieces
4 9V Alkaline Battery, type 6LR61 1 piece
5 Instruction Manual 1 piece
6 Carrying case 1 piece
7 AC Adapter (optional) 1 piece
3.2 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 50°C (14°F to 122°F) with a
relative humidity of 10%-90%,atmospheric
pressure from 700 to 1060 Hpa
Dimensions 4.5 × 2.55 × 0.9 inches (L*W*H)
Weight 0.28 lbs.(With battery)
Tolerance There may be a ±5% tolerance of all
setting and ±10% tolerance of output of
intensity.
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.
Timer 15,30,60 minutes and continuous

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Waveform Mono-phase square pulse wave
Pulse Amplitude Adjustable, 0 ~ 105mA at 1000 ohm
Load each channel, 1mA/Step.
Pulse Width From 100 to 260 microseconds
Pulse Rate From 50 to 150 Hz
3.3 The waveforms of the stimulation programs
Normal
Pulse Width Modulation
Pulse Rate Modulation
Modulation (Pulse Width and Pulse Rate)

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4. INSTRUCTIONS FOR USE
4.1 Battery
4.1.1 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 spent batteries
appropriately.
4.1.2 Disposal of Battery

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CAUTION:
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 affected areas with clear water
immediately and contact a physician immediately.
3. Battery should not be charged, dismantled, thrown into re or
short-circuited.
4. Protect battery from excess heat.
5. Remove batteries from the unit if they are spent 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.
4.2 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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4.3 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 different areas at the same time.
CAUTION:
Do not insert the plug of the patient lead wire into any
AC power supply socket.
4.4 Electrode
4.4.1 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.

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4.4.2 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
rmly to the skin and make good contact between the skin and the
electrodes. Place the electrodes over the skin; attach them properly,
rmly and evenly.
CAUTION:
1. Before applying the self-adhesive electrodes, it is
recommended that you wash, degrease and dry the skin
rst.
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.
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 nd which method best ts the needs of
the individual patient.
Every patient responds to electrical stimulation differently and their
needs may vary from the conventional settings suggested here.
If the initial results are not positive, speak to your physician about
4.4.3 Electrode Placement

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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.
4.5 Turning On the Device
Before using the device for the rst time, you are strongly advised
to take careful note of the contraindications and safety measures
detailed at the beginning of this manual (Safety information), 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.
4.6 Select the therapeutic part program
InTENSity™ TENS 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 ash after you
have selected it. Apply electrodes to the exact site indicated by your
physician or therapist.
4.7 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.
4.8 Adjust channel intensity
Press the intensity control button up [▲] or 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.

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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.
2. If the electrodes are not placed rmly 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.
4.9 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.
4.10 Turn Off
Press and HOLD the [ ] button and for approximately 3 seconds to
turn OFF the device.
CAUTION:
1. 1. If there is no operation in the panel for 2 minutes in the
waiting state, the device will turn off automatically.
2. In shutdown state, keep pressing the channel 2 down [▼]
button rst, and then press the [ ] button at the same time to
restore factory parameter settings.
4.11 Low Battery Indicator
A battery symbol is shown ashing 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.

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5. PROGRAM