Roscoe Medical InTENSity 5000 Hybrid User manual

INSTRUCTION MANUAL

This manual is valid for the
InTENSity
TM 5000 Hybrid 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.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
following normative documents:
IEC60601-1, IEC60601-1-2, I EC60601-2-10, IEC60601-1-4,
ISO10993-5, ISO10993-10, ISO10993-1

TABLE OF CONTENTS
1. SAFETY INFORMATION 4
1.1 General
1.2 Medical background
2. PARTS 6
3. GENERAL WARNINGS AND SAFETY 8
4. INSTRUCTIONS FOR USE 10
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 the pulse width and the pulse rate
4.8 Select therapy time
4.9 Adjust channel intensity
4.10 Safety lock feature
4.11 Turn the device off
5. SPECIFICATION 16
5.1 Technical Information
5.2 The waveforms of the stimulation programs
6. PROGRAM 19
7. CLEANING AND CARE 19
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 23
9. MAINTENANCE AND CAUTIONS 15
10. STORAGE 25
11. DISPOSAL 25
12. GLOSSARY OF SYMBOLS 26
13. WARRANTY 27

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1. SAFETY INFORMATION
1.1 General
The InTENSity™ 5000 Hybrid is a battery operated TENS device that
sends electrical impulses through electrodes to the body and
reaches the nerves causing pain. The device is provided with two
controllable output channels, each independent of each other. A pair
of electrodes can be connected to one output channel.
The electronics of the InTENSity™ 5000 Hybrid create electrical
impulses whose intensity, duration, number per second and
modulation may be altered with the controls/switches. These buttons
are very easy to use and the LED display shows the exact mode,
time and intensity. Values of parameters are very convenient and
easy to adjust 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.

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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.
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.

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2. PARTS
About the InTENSity™ 5000 Hybrid
5000 Your InTENSity Hybrid contains:
NO. DESCRIPTION QUANTITY
A InTENSity™ 5000 Hybrid unit 1 PCS
B Electrode pads 4 PCS
C Cable 2 PCS
D User Manual 1 PCS
E 9 V battery, type 6F22 1 PCS
F Carrying case 1 PCS
Main Unit Parts
1. Intensity output indicator (channel 1)
2. Intensity output indicator (channel 2)
3. Increases the output intensity of channel 1
4. Decreases the output intensity of channel 1
5. Increases the output intensity of channel 2
6. Decreases the output intensity of channel 2
7. Key-press cover
8. Therapy mode LED indicator
15 16
1 2
3
46
7
5
8
9
11
13 12
14
17
18
19
10

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9. Use to set the therapy mode
10. Use to set the therapy time
11. Therapy time LED indicator
12. Use to set and adjust the pulse width
13. Use to set and adjust the pulse rate
14. ON/OFF button
15. Output socket: electric signal output after connection of the cable
with adhesive electrodes on channel 1
16. Output socket: electric signal output after connection of the cable
with adhesive electrodes on channel 2
17. Belt clip
18. Battery compartment cover
19. AC Adapter connection point

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3. GENERAL WARNINGS AND SAFETY
Before you start
Please carefully read and understand the following warnings and
cautions to ensure the safe and correct use of this device and to
prevent injury.
•Make sure the batteries are installed correctly.
•Connect the cable to the electrode pads and then
connect to the unit.
•Attach the electrode pads to the area of pain.
•Do not use the electrode pads if any of them are
scratched or damaged in any way.
Contraindications
Do not use this device if you have a cardiac pacemaker, implanted
defibrillator, or other implanted metallic or electronic device. Such
use could cause electric shock, burns electrical interference, or
death.
Warnings
1. If you are under the care of a physician, consult with your
physician before using this device.
2. If you have had any medical or physical treatment for your pain,
consult with your physician before using this device.
3. If your pain does not improve, becomes more than mild, or
continues for more than five days, stop using the device and
consult your physician.
4. Do not apply stimulation over painful areas. Consult with your
physician before using this device.
5. Do not apply stimulation over your neck because this could
cause severe muscle spasms resulting in closure of your
airway, difficulty in breathing, or adverse effects on your heart
rhythm or blood pressure.
6. Do not apply stimulation across your chest because the
introduction of electrical current into the chest may cause
rhythm disturbances to your heart, which could be fatal.
7. This is a class II medical device and available only through a
prescription from a physician.

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8. Do not apply stimulation over, or in proximity to, cancerous
lesions.
9. Do not apply stimulation over open wounds or rashes, or over
swollen, red, infected, or inflamed areas or skin eruptions (e.g.,
phlebitis, thrombophlebitis, varicose veins).
10. Do not apply stimulation in the presence of electronic
monitoring equipment (e.g., cardiac monitors, ECG alarms), as
they may not operate properly when the electrical stimulation
device is in use.
11. Do not apply stimulation when in the bath or shower.
12. Do not apply stimulation while sleeping.
13. Do not apply stimulation while driving, operating machinery, or
during any activity in which electrical stimulation can put you at
risk for injury.
14. Do not use the device on children. It has not been evaluated
for pediatric use.
15. Consult with your physician before using this device, because
the device may cause lethal rhythm disturbances to the heart
in susceptible individuals.
16. Apply stimulation only to normal, intact, clean, healthy skin.
Precautions
1. You may experience skin irritation or hypersensitivity due to
the electrode pads.
2. If you have suspected or diagnosed heart disease, you should
follow precautions recommended by your physician.
3. If you have suspected or diagnosed epilepsy, you should
follow precautions recommended by your physician.
4. Use caution if you have a tendency to bleed internally, such as
following an injury or fracture.
5. Consult with your physician prior to using this device, because
stimulation may disrupt the healing process.
6. Use caution if stimulation is applied over the menstruating
abdomen.
7. Use caution if stimulation is applied over areas of skin that lack
normal sensation.
8. Keep this device out of the reach of children.
9. Use this device only with electrode pads supplied by the
manufacturer or distributor.
10. Please stop using the device and consult your physician if you

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experience any adverse reactions form this device, e.g. skin
irritation.
Adverse Reactions
1. You may experience skin irritation and burns beneath
stimulation electrodes applied to your skin.
2. You may experience headache and other painful sensations
during or following the application of electrical stimulation near
your eyes and to your head and face.
3. You should stop using the device immediately and consult with
your physician if you experience any adverse reactions.
4. INSTRUCTIONS FOR USE
4 .1 Battery
4.1.1 Check/Replace the battery
Over time, in order to ensure the functional safety of device,
changing the battery is necessary.
1. To remove the battery cover, press and pull
down following the direction of the arrow
indicated on the battery cover.
2. Remove the battery from the compartment.
3. Insert the 9V HD battery into the battery
compartment.
4. Ensure 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.
5. Replace the battery compartment cover and
press to close.
9V 6F22

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4.1.2 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 spent batteries appropriately.
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 fire 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.
Transparent Film
Connection Cables

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CAUTION:
Always use the electrodes with CE mark, or which are legally
marketed in the U.S. under 510(K) procedure.
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 Electrodes 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.
CAUTION:
4.4.3 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.
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.

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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
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 first 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!
In order to turn on the device, press ON/OFF button, mode LED
indicator and timer LED indicator will light up.
4.6 Select the therapeutic part program
InTENSity™ 5000 Hybrid supplies 5 therapeutic modes for you to
select from. Press MODE button, the appropriate mode LED
indicator will illuminate. Press MODE button to select the therapy
mode circularly.
There are 5 therapeutic modes available: B (Burst), N (Normal),
M1 (Pulse Width Modulation), M2 (Pulse Rate Modulation), SD
(Strength Duration). Stimulator 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.
4.7 Adjust the pulse width and pulse rate
By turning the [P. W.] knob clockwise to select pulse width, the
pulse width is adjustable from 30 µs to 260 µs.
By turning the [P. R.] knob clockwise to select pulse rate, the pulse
rate is adjustable from 2 Hz to 150 Hz.

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4.7 Select therapy time
There are 4 therapy times (15, 30, 60, C) for you to select. Press
the [TIMER] button, the appropriate time LED indicator will be lit.
Press [TIMER] button cycle to select the therapy time.
4.9 Adjust channel intensity
Press the intensity control button [▲] and [▼] to control the
intensity output and you will hear a “beep” sound. Slowly press the
intensity button control until you reach the setting recommended by
your physician or therapist. Repeat for the other channel, if both
channels are used.
CAUTION:
1. The maximum output intensity level is 20.
2. The therapy mode and therapy time LED
indicator will flash in this state.
4.10 Safety Lock Feature
The Safety Lock Feature automatically activates after there is no
operation in the panel for 20 seconds by locking out the ability to
press the buttons (except the pulse width and pulse rate knobs).
This is a safety feature to prevent accidental changes to your
settings and to prevent accidental increases to the intensity levels.
After the device locks, you will hear three “beep” sounds when you
press other buttons (except the [▼] button of channel 1). Press the
[▼] button of channel 1 to unlock the device and you will hear a
“D1” sound.
4.11 Turn the device off
Press the ON/OFF button to turn off the device.

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5. PECIFICATIONS
5.1 Technical information
Mechanism
Technical description
01 Channel
Dual, isolated between channels
02
Power Supply
One 9 Volt Battery
03
Pulse AmplitudeAdjustable,0-80 mA
peak into 500 ohm load each channel
04 Pulse Rate
Adjustable, from 2 to 150 Hz
Burst rate: 0.5Hz (Burst mode)
05 Pulse WidthAdjustable,
from 30 to 260 microseconds
06
Voltage
0 to 40 V (Load : 500 ohm)
07 Wave Form
Mono-phase square pulse wave
08
Size
11.7cm(L) x 6.6cm(W) x 28.5cm(H)
09
Weight
94 g (without battery)
10
Timer
15, 30,60 minutes or Continue
11
Burst (B)Bursts occur twice very second.
Pulse width(adjustable), pulse
rate = 100 Hz, Burst rate=0.5Hz
12
Normal Mode
(N)The pulse rate and pulse width are
adjustable. It generates continuous
stimulation based on the settingvalue
.
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Modulation 1
mode (M1)
Modulation 1 mode is a pulse width
modulation. The pulse width is
automatically varied in a cycle
pattern over an interval of nominally
10 Seconds. Pulse width increase
over a period of 5 seconds from 30
us to the control setting value, then
decreases over a 5 seconds period
to its original value (30 us). The cycl
e
is then repeated.

17
14
Modulation 2
mode (M2)
Modulation 2 mode is a pulse rate
modulation. The pulse rate is
automatically varied in a cycle patter
n
over an interval of nominally 10
seconds. Pulse rate decreases over
a period of 5 seconds from the control
setting value to a value which is 40%
less, then increase over a 5 seconds
period to its original value. The cycle
is then repeated.
15
SD mode (SD)
The SD (Strength-Duration) mode
consists of automatic modulation
intensity and pulse width in 70%
range. The intensity is always
increasing while the pulse width is
decreasing and vice versa. The
intensity is decreased by 70%
while the pulse width is increased
by 70% in 5 seconds. In the next 5
seconds, the intensity is increased
by 70% while the pulse width is
decreased by 70%. Total cycle
time is 10 seconds. Pulse rate
(2~150Hz) and pulse width (30 ~
260μS) are fully adjustable.

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5.2 The waveforms of the stimulation programs
Burst(B)
2 Burstper second 10pulsesperBurst
Normal (N)
Pulse Width Modulation
Pulse Rate Modulation
Cycle time
SD (Strength-Duration)
10
seconds

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6. PROGRAM
Mode
Program
Modulation
Method
Frequency
Pulse
Width
Treatment
Time
TENS
B Burst 100 Hz
Burst: 0.5 Hz
30-260µs
15,30,60 min,
continuous
N Continuous 2-150 Hz 30-260µs
15,30,60 min,
continuous
M1
Pulse Width
Modulation
2-150 Hz 30-260µs
15,30,60 min,
continuous
M2
Pulse Rate
Modulation
2-150 Hz 30-260µs
15,30,60 min,
continuous
SD
Strength-
Duration
2-150 Hz 30-260µs
15,30,60 min,
continuous
7. CLEANING AND CARE
7.1 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.

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7.2 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.
7.3 Electrodes
1. Use this device only with the leads and electrodes provided
by the manufacturer. Use only the electrode placements and
stimulation settings prescribed by your physician or therapist.
2. It is recommended, at minimum, 1.5” x 1.5” self-adhering
electrodes be used at the treatment area.
3. 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.
Reusable, Self-adhering electrodes
Reusable, Self-adhering electrodes