Roscoe Medical InTENSity Twin Stim IV User manual

Twin Stim IV
INSTRUCTION MANUAL
www.roscoemedical.com

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This manual is valid for the
Twin Stim IV
This instruction manual is published by Roscoe Medical Inc.
Roscoe Medical Inc. 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.V1.0 © 2015, 20150211
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,
IEC62366, IEC60601-1-11, ISO10993-5, ISO10993-10,
ISO10993-1, ISO7010

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Table of Contents
1. Introduction ........................................4
1.1 General
1.2 Medical Background
1.3 Indication for use
2. Important Safety Precautions and Warnings............6
3. Package Contents .................................13
3.1 Front And Rear Panel
3.2 LCD Display
4. Specification ......................................16
4.1 Technical Information
4.2 Program Parameters
4.3 Waveform Information
5. Instruction For Use.................................20
5.1 Battery
5.2 Connecting Electrodes
5.3 Connecting Lead Wires
5.4 Turn On The Device
5.5 Setting a New Program
5.6 Start Treatment
5.7 Other Important Functions
Safety Lock Feature
Low Battery Indicator
Charging The Battery
5.8 Other Important Functions
5.9 Patient Compliance Meter
6. Cleaning And Storage ..............................31
6.1 Cleaning The Unit
6.2 Cleaning The Electrode Pads
6.3 Storing The Electrode Pads And Lead Wires
6.4 Storing The Unit
7. Troubleshooting ...................................33
8. Disposal ..........................................35
9. Glossary Of Symbols ...............................35
10. Electromagnetic Compatibility (EMC) Tables ..........36
11. Warranty ..........................................42

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1. INTRODUCTION
1.1 General
The InTENSity Twin Stim IV is a portable electrotherapy device
featuring two therapeutic modes: Transcutaneous Electrical Nerve
Stimulator (TENS) and Neuromuscular Electrical Stimulation (NMES),
which are used for pain relief and electrical muscle stimulation.
The stimulator sends 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 patients.
1.2 Medical Background
Explanation of pain
Pain is an unpleasant sensation that can serve a useful purpose by
alerting us to a possible injury or disease. When the body is functioning
normally, pain serves as a warning system that something is not right.
Without pain a person would not know when to avoid danger or seek
medical help. Pain becomes a problem when it continues after treatment
has started or long after an injury is healed.
There are two types of pain:
Acute — Limited in duration. Examples include but are not limited to:
• Sprains • Incisional pain • Muscle strain
Chronic — Long-lasting, persistent pain that ceases to serve
as a warning system and becomes a problem.
Examples include but are not limited to:
• Low back pain • Pinched Nerves
• Bursitis • Joint Pain
The Twin Stim IV was developed to help relieve some types
of chronic and acute pain.

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How does TENS work?
There is nothing “magic” about Transcutaneous Electrical Nerve
Stimulation (TENS). TENS is intended to help relieve pain. The TENS unit
sends comfortable impulses through the skin to 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 patients, 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 discuss this with your physician or therapist.
How NMES works
Neuromuscular Electrical Stimulation (NMES) is an internationally
accepted and proven way of treating muscular injuries. It works by
sending electronic pulses to the muscle needing treatment; this causes
the muscle to exercise passively. This device is low frequency and in
conjunction with the square wave pattern allows the stimulation to
work directly on the muscle groups. This is being widely used in
hospitals and sports clinics for the treatment of muscular injuries and
for the re-education of paralyzed muscles, to prevent atrophy in affected
muscles and improving muscle tone and blood circulation.
The goal of electrical muscle stimulation is to achieve contractions or
vibrations in the muscles. Normal muscular activity is controlled by the
central and peripheral nervous systems, which transmit electrical signals
to the muscles. NMES works similarly but uses an external source (the
stimulator) with electrodes attached to the skin for transmitting electrical
pulses into the body. The pulses stimulate the nerves to send signals to a
specically targeted muscle, which reacts by contracting, just as it does
with normal muscular activity

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SAFETY SYMBOLS USED IN THIS MANUAL
DANGER
Indicates a potentially hazardous situation which, if not
avoided, could result in death or serious injury.
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.
1.3 Indication for Use
Twin Stim IV Stimulator may be used for the following conditions:
1) Symptomatic relief of chronic intractable pain.
2) Post traumatic pain.
3) Post surgical pain.
For Neuromuscular Electrical Stimulation Therapeutic Mode (NMES):
1) Relaxation of muscle spasm.
2) Increase of blood ow circulation.
3) Prevention of disuse atrophy.
4) Muscle re-education.
5) Maintaining or increasing range of motion.
6) Immediate post-surgical stimulation of lower leg muscles
to prevent venous thrombosis.
2. IMPORTANT SAFETY PRECAUTIONS
AND WARNINGS
It is important that you read all the warning and
precautions included in this manual because they are
intended to keep you safe, prevent injury and avoid a
situation that could result in damage to the device.

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DANGER
This stimulator must not be used in combination with the following medical
devices:
• Internally transplanted electronic medical devices,
such as a pacemaker.
• Electronic life support equipment, such as respirators.
• Electronic medical devices attached to the body,
such as electrocardiographs.
Using this stimulator with other electronic medical devices may cause errone-
ous operation of those devices.
WARNING
DO NOT USE THIS DEVICE UNDER THESE CONDITIONS
• Consult with your physician before using this device, because the device
may cause lethal rhythm disturbances in certain susceptible individuals.
• If you have a cardiac pacemaker, implanted debrillator, or other implanted
metallic or electronic device. Such use could cause electric shock, burns,
electrical interference, or death.
• Together with a life-supporting medical electronic device such as an articial
heart or lung or respirator.
• In the presence of electronic monitoring equipment (e.g., cardiac monitors,
ECG alarms), which may not operate properly when the electrical stimulation
device is in use.
• On open wounds or rashes, or over swollen, red, infected, or inamed areas
or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins); or on top
of, or in proximity to, cancerous lesions.
• Over areas of skin that lack normal sensation.
• On the opposite sides of your head since the effects of stimulation
of the brain are unknown.
DO NOT USE ON THESE INDIVIDUALS
• Pregnant women, because the safety of electrical stimulation during
pregnancy has not been established.
• Children or infants, because the device has not been evaluated for
pediatric use.
• Persons incapable of expressing their thoughts or intentions.

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WARNING (CONTINUED)
DO NOT USE THIS DEVICE DURING THESE ACTIVITIES
• When in the bath or shower
• While sleeping
While driving, operating machinery, or during any activity in which electrical
stimulation can put you at risk for injury.
PAIN MANAGEMENT WARNINGS
• If you have had medical or physical treatment for your pain, consult with your
physician before using this device.
• If your pain does not improve, becomes seriously chronic or severe, or
continues for more than ve days, stop using the device and consult with your
physician.
• The mere existence of pain functions as a very important warning telling us
that something is wrong. Therefore, if you suffer from any serious illness,
consult your physician in order to conrm that it is advisable for you to use
this TENS Stimulator.
WARNINGS AND PRECAUTIONS REGARDING THE PADS
• Apply pads to normal, healthy, dry, clean skin (of adult patients) because it
may otherwise disrupt the healing process.
• If you experience any skin irritation or redness after a session, do not continue
stimulation in that area of the skin.
NEVER APPLY THE PADS TO:
• The head or any area of the face.
• Any area of the throat because this could cause severe muscle
spasms resulting in closure of the airway, difculty in breathing,
or adverse effects on heart rhythm or blood pressure.
•
• Both sides of the thorax simultaneously (lateral or front and
back), or across your chest because the introduction of electrical
current may cause rhythm disturbances which could be lethal.

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CAUTION
WARNINGS AND PRECAUTIONS REGARDING THE PADS
• United States Federal Law restricts this device to sale by or on the order of a
physician or licensed practitioner
• Do not bend or fold because the pad may not function properly. Place the
pads onto the plastic lm and then store into the sealed package when not in
use.
• Do not apply ointment or any solvent to the pads or to your skin because it
will disrupt the pads from functioning properly.
• The pads are already pre-gelled and will adhere to your skin.
• To avoid damage to the adhesive surface of the pads, put the pads only on
the skin or on the plastic lm provided.
• Place the pads at least 1 inch apart on your skin. The pads should never
touch each other.
• Make sure the components are connected well and the pads are xed on the
part of the body you wish to treat or the therapy may not be effective.
DO NOT USE YOUR PADS THIS WAY
• Pads should not touch each other when placed onto your skin.
• Do not place on your spine or backbone.
• Pad should not touch any metal object, such as a belt buckle or necklace.
• Pads should not be placed simultaneously on the soles of both feet.
• Pads should not be placed simultaneously on the calves of both legs.
• Do not share pads with another person. This may cause a skin irritation or
infection. Pads are intended for use by one person.
• Do not place or relocate the pads while the device is on.
• Always turn the power off before removing or changing the pad location.
• Do not leave pads attached to the skin after treatment.

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CAUTION (CONTINUED)
CAUTION WHILE USING THE STIMULATOR
• If the stimulator is not functioning properly or you feel discomfort,
immediately stop using the device.
• Do not use for any other purpose except for what it is intended for.
• Do not insert the electrode plug into any place other than the jack
on the main unit.
• Do not mix Alkaline and Manganese batteries as this will shorten
the battery life.
• Do not pull on the electrode cord during treatment.
• Do not use the device while wearing electronic devices such as
watches as this may damage the device.
• Do not use near a cell phone as this may cause the stimulator to malfunction.
• Do not bend or pull the end of the cord.
• When pulling out the cord from the device, hold the plug and pull.
• Replace the cord when broken or damaged.
• Do not throw the batteries into a re. The batteries may explode.
• Dispose of the device, batteries, and components according to applicable
legal regulations. Unlawful disposal may cause environmental pollution.
• The size, shape and type of pads may affect the safety and effectiveness
of electrical stimulation.
• The electrical performance characteristics of pads may affect the safety
and effectiveness of electrical stimulation.
• Using pads that are too small or incorrectly applied, could result in
discomfort or skin burns.

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GENERAL PRECAUTIONS
• The long-term effects of electrical stimulation are unknown.
• Apply stimulation to only normal, intact, clean, dry, and healthy skin.
• TENS is not effective in treating the original source or cause of the pain,
including headache.
• TENS is not a substitute for pain medications and other
pain management therapies.
• TENS devices do not cure disease or injuries.
• TENS is a symptomatic treatment and, as such, suppresses the sensation
of pain that would otherwise serve as a protective mechanism.
• Effectiveness is highly dependent upon patient selection by a practitioner
qualied in the management of pain patients.
• You may experience skin irritation or hypersensitivity due to the electrical
stimulation or electrical conductive medium (gel).
• If you have suspected or diagnosed heart disease, you should follow
precautions recommended by your physician.
• If you have suspected or diagnosed epilepsy, you should follow precautions
recommended by your physician.
• Use caution if you have a tendency to bleed internally, such as following
an injury or fracture.
• Consult with your physician prior to using the device after a recent surgical
procedure, because stimulation may disrupt the healing process.
• Use caution if stimulation is applied over the menstruating or pregnant uterus.
• Use caution if stimulation is applied over areas of skin that lack
normal sensation.
• Keep unit away from young children. The unit contains small pieces
that may be swallowed. The electrode cord can cause strangulation.
Immediately contact your physician should any of these things occur.
• Use this device only with the leads, electrodes, and accessories
recommended by the manufacturer.
• Keep unit out of the reach of young children.

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Note: Always use electrodes that are legally marked and sold
in the United States under 510K guidelines.
POSSIBLE ADVERSE REACTIONS
• Do not use to treat one region for extended periods of time (more than 30
minutes a session, up to 2 times/day) or muscles in that region may become
exhausted and sore.
• You may experience skin irritation and burns beneath the stimulation
electrodes applied to your skin.
• You should stop using the device and consult with your physician if you
experience adverse reactions from the device.

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3. PACKAGE CONTENTS
Twin Stim IV Unit 2 × Lead wires 4 × Electrode pads
(2"x 2")
1 x Instruction Manual 1 × LI rechargeable 1 × USB Cable
Battery Pack and Wall Charger
1 x Quick Start Guide
INSTRUCTION MANUAL
Twin Stim IV
TM
The purpose of this guide is to assist you in correctly operatingyour Intensity™ 10 unit. This
device should only be used under the continued supervision of a licensed physician.This guide
is not intended to replaceor substitute the Intensity™ 10 I nstruction Manual. PLEASE READ
THE INSTRUCTION MANUALCOMPLETELY BEFORE USING THIS DEVICE. Read, understand
and practice the warnings, cautions and operating instructions. Alwaysfollow the operating
instructions prescribed by your healthcare provider.
QUICK REFERENCE GUIDE PAGE 1
1
2
Top
Side Front Back
3
4
5
6
7
8
9
10
11
Channel1 and 2 sockets
AC/DCadapter receptacle
T(time) and S (therapeutic part)
selectionbuttons
Channel1 intensity increase button
Channel1 intensity decrease button
LCDdisplay
Channel2 intensity increase button
Channel2 intensity decrease button
Poweron/o button
Beltclip
Batterycompar tmentcover
1
2
3
4
5
6
7
8
9
10
11
INTENSITY™10 UNIT
ELECTRODES
(2SE TS)
LEAD WIRES
(2SE TS)
1
2
3
4
5
6
7
8
LCD DISPLAY
TENStherapeutic mode
Lockfunction indicator
Low-batteryindicator
Treatmenttime
Timersymbol
Channel1 intensity level
Channel2 intensity level
Bodypart selec tion
1
2
3
4
5
6
7
8
Formore informationabout your Intensity™ 10 unit, please visit us online at roscoemedical.com or call 1-800-871-7858.
S
CH1CH2

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3.1 Front and Rear Panel
1) LCD Display: Operating state of the device
2) Body Part Buttons: Select body part or treatment program
3) Channel 1 Intensity Buttons: Increase or decrease the output
intensity of channel 1.
4) Set button: Press this button to enter the setting status
5) Power Button: Press once to turn on. Press and hold for 3 seconds to
turn off.
6) Channel 2 Intensity Buttons: Increase or decrease the output
intensity of channel 2.
7) Pause/Mode Button: Press this button to change treatment modes
(TENS or NMES). Press button again to pause active treatment status
8) LED: Charging indicator light.
9) Output Sockets: Lead wire output sockets
10) Battery compartment cover.
11) Belt Clip.
12) USB charging port.
S
M /
CH1CH2
1
12
2
3
46
5
7
8
9
11
10
Twin Stim IV

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3.2 LCD Display
1) Displays waveform mode.
2) Displays home screen
3) Displays set mode
4) Displays output state: start, pause, lock
5) Hour Indicator
6) Contraction, Relaxation & Ramp
7) Displays output intensity of channel 1 , pulse width and pulse rate
8) Displays therapeutic body part: hand, foot, shoulder, arm,
leg and back
9) Displays therapeutic mode: TENS, NMES
10) Low-battery indicator
11) Load indicator
12) Indicates compliance meter mode
13) Displays the treatment time
14) Display output intensity of channel 2
1
2
3
4
5
6
7
12 11
10
13
14
9
8

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4. SPECIFICATIONS
4.1 Technical Information
Channel Dual, isolated between channels
Power Supply 3.7V LI rechargeable battery pack
Charger output: 5.0V DC, 300mA (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 1,060 Hpa
Storage and
Transport Conditions
-10°C to 55°C (14°F to 131°F) with a relative
humidity of 10%-90%,atmospheric pressure
from 700 to 1,060 Hpa
Dimensions 11.7 × 6 × 2.1 cm (L*W*H)
Weight 3.5 oz. (Without battery)
Electrode Detection
Function
The amplitude level will be reset to 0mA when the
amplitude level is 10mA or greater and an open
circuit at either channel is detected.
Technical Specifications (TENS & NMES)
Waveform TENS: Symmetrical bi-phase rectangular wave
NMES: Biphasic rectangular
Pulse Amplitude TENS/NMES: Adjustable, 0 to 100mA at 1,000 ohm
Load each channel, 1mA/Step
Pulse Width TENS: From 50 to 400us microseconds
NMES: From 200 to 400us (microseconds)
Pulse Rate TENS: From 1 to 150Hz
NMES: From 1 to 100Hz
Treatment Time 5 to 90 minutes
Technical Specifications (NMES ONLY)
Contraction Time 5 to 30 seconds
Relaxation Time 5 to 60 seconds
Ramp Up/Down Time 1 to 9 seconds
Treatment Time 5 to 90 minutes

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4.2 Program Parameters
TENS
Body
Part Program Treatment Time
Pulse
Rate
Pulse
Width
Cycle
Time
Neck
P1 20 Min. 80 – 100Hz 100 – 120µs10 Sec
P2 20 Min. 4Hz 150 – 200µs20 Sec
Shoulder
P1 20 Min. 80 – 100Hz 100µs10 Sec
P2 20 Min. 10Hz 220 – 260µs20 Sec
Hand
P1 20 Min. 100Hz 100µsFixed
P2 20 Min. 1 – 10Hz 200µs20 Sec
Low back
P1 20 Min. 80 – 100Hz 100µs10 Sec
P2 20 Min. 4Hz 200 – 260µs20 Sec
Knee
P1 20 Min. 120Hz 100 – 120µs10 Sec
P2 20 Min. 1 – 10Hz 150 – 200µs20 Sec
Foot
P1 20 Min. 80 – 120Hz 100 – 120µs10 Sec
P2 20 Min. 1 – 10Hz 200µs20 Sec
Body Part Program Treatment
Time
Pulse
Rate
Pulse
Width
All
Therapeutic
Parts
U1 Adjustable
5 – 90 mins
Adjustable
1 – 150 Hz
Adjustable
50 – 400µs

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4.2 Program (Continued)
NMES
Body
Part Program Treatment Time
Pulse
Rate
Pulse
Width
Contract
Time
Relax
Time
Ramp
Up/Down
Neck
P1 20 Min. 40Hz 300µs12 Sec 20 Sec 2 Sec
P2 20 Min. 50Hz 300µs12 Sec 30 Sec 2 Sec
Shoulder
P1 20 Min. 45Hz 300µs12 Sec 20 Sec 2 Sec
P2 20 Min. 55Hz 300µs12 Sec 35 Sec 2 Sec
Hand
P1 20 Min. 10Hz 300µs12 Sec 20 Sec 2 Sec
P2 20 Min. 5Hz 300µs12 Sec 30 Sec 2 Sec
Low back
P1 20 Min. 60Hz 300µs12 Sec 20 Sec 2 Sec
P2 20 Min. 70Hz 300µs12 Sec 30 Sec 2 Sec
Knee
P1 20 Min. 20Hz 300µs12 Sec 30 Sec 2 Sec
P2 20 Min. 25Hz 300µs12 Sec 50 Sec 2 Sec
Foot
P1 20 Min. 30Hz 300µs12 Sec 20 Sec 2 Sec
P2 20 Min. 5Hz 300µs12 Sec 30 Sec 2 Sec
All
Body
Parts
U1
Min:
5 - 90,
Step:
5min
Default:
20Min
1 - 100Hz
Step:
1Hz
Default:
40Hz
200 - 400µs
Step: 5
Default:
300uS
5 - 30s
Step:1s
Default:
12s
5 - 60s
Step:
1s
Default:
20s
1 - 9s
Step: 1s
Default:
2s

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4.3 Waveform Information — TENS
Continuous
Pulse Width Modulation
Pulse Rate Modulation
Modulation (Pulse rate and width modulation)
Waveform Information — NMES
Synchronous
Cycle time
Cycle time
Cycle time
intensity
time
CH1
CH2

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5. INSTRUCTIONS FOR USE
5.1 Battery
Installation of Battery
Push down on the belt clip to release it. Remove the battery cover and
insert the battery, as shown on the diagram. Replace the battery cover
and belt clip. For battery charging instructions, please see page 29.
Disposal of Battery
Depleted batteries do not belong in the household waste.
Dispose of the batteries according to the your federal,
state and local regulations. As a consumer, you are
obligated by law to return depleted batteries.
CAUTION
1) Keep the battery and the product out of the range of children.
2) Battery may not be dismantled, thrown into re or short-circuited.
3) Protect battery from excess heat; Take the battery out of the product if
the product is not used for a long period of time.
4) Always replace with the same type of battery.
5.2 Connecting Electrodes
Take the pads out of the sealed package; insert the pin of the lead wire
into the electrodes pigtail. Make sure there is no bare metal exposed.