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