Roscoe Medical Twin Stim Plus 3rd Edition User manual

TENSPros
Twin Stim®Plus 3rd Edition
Combo Stimulator
INSTRUCTION MANUAL

TENSPros

TENSPros
This manual is valid for the
Twin Stim®Plus 3rd Edition Combo Stimulator
This user manual is published by Roscoe Medical, Inc.
Roscoe Medical, Inc. 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.V1.0 © 2013, 20130719
United States Federal Law restricts this device to sale by or
on the order of a physician or licensed practitioner.
Declaration of conformity:
Roscoe Medical, Inc. declares that the device complies with following
normative documents:
IEC60601-1, IEC60601-1-2, IEC60601-1-11, IEC60601-2-10,
ISO10993-1, ISO10993-5, ISO10993-10, ISO14971
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TABLE OF CONTENTS
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Chapter 1: GENERAL DESCRIPTION...................................................
Chapter 2: INTRODUCTION........................................................................
Chapter 3: IMPORTANT SAFETY INFORMATION.........................
Chapter 4: CONSTRUCTION....................................................................
Chapter 5: TECHNICAL SPECIFICATIONS.......................................
Chapter 6: THERAPY PROGRAM AND WAVEFORMS.............
Chapter 7: UNIT AND ACCESSORIES...............................................
Chapter 8: OPERATING INSTRUCTIONS........................................
Chapter 9: PARAMETER CONTROLS................................................
Chapter 10: PATIENT COMPLIANCE METER..................................
Chapter 11: MAINTENANCE AND STORAGE...................................
Chapter 12: TROUBLESHOOTING.........................................................
Chapter 13: NORMALIZED SYMBOLS.................................................
Chapter 14: WARRANTY..............................................................................

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The Twin Stim®Plus 3rd Edition Combo Stimulator is a battery operated
pulse generator that sends electrical impulses electrodes to the body and
reaches the nerves and underlying muscle group. This unit is a combination
stimulator of TENS, EMS, IF (Interferential) and RUSSIAN which can be
used for muscle stimulation and pain relief. The device is provided with four
controllable output channels, each independent of each other. An electrode
pair can be connected to each output channel. The intensity level is
controlled by press buttons.
Chapter 1: GENERAL DESCRIPTION

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Chapter 2: INTRODUCTION
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 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 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 Stimulation
(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
want to discuss this therapy option with your physician or therapist to see
if it will benefit your pain management needs.

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EXPLANATION OF EMS
Electrical Muscle Stimulation 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.
It is a product derived from the square waveform, originally invented by
John Faraday in 1831. Through the square wave pattern it is able to work
directly on muscle motor neurons. The Twin Stim®Plus 3rd Edition Combo
Stimulator has low frequency and this in conjunction with the square wave
pattern allows direct work on muscle groupings. 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.
HOW EMS WORKS
The EMS units send comfortable impulses through the skin that stimulate
the nerves in the treatment area. When the muscle receives this signal it
contracts as if the brain has sent the signal itself. As the signal strength
increases, the muscle flexes as in physical exercise. Then when the pulse
ceases, the muscle relaxes and the cycle starts over again, (Stimulation,
Contraction and Relaxation.) Powered muscle stimulators should only be
used under medical supervision for adjunctive therapy for the treatment
of medical diseases and conditions.
EXPLANATION OF IF (Interferential)
Interferential Stimulation (IF) is an anti-inflammatory based treatment
modality. Interferential stimulation is characterized by two alternating-
current sine waves or square waves of differing frequencies that “work”
together to produce an interferential current that is also known as a beat
pulse or alternating modulation frequency. One of the two currents is
usually held at 4,000 Hz, and the other can be held constant or varied
over a range of 4,001 to 4,150 Hz. Because of the frequency, the
interferential wave meets low impedance when crossing the skin to enter
deep into soft tissues. The interferential currents reportedly can stimulate
sensory, motor, and pain fibers. These large impulse fibers interfere with
the transmission of pain messages at the spinal cord level. This deep
tissue penetration stimulates parasympathetic nerve fibers for increased
blood flow and edema reduction. It utilizes the low electric-current to

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stimulate muscle nerves to achieve the symptomatic relief of chronic
intractable pain, post-traumatic pain, and post-surgical pain.
EXPLANATION OF RUSSIAN
Russian stimulation uses medium frequencies to provide electrical stimulation
to muscle groups and is used to reduce muscle spasms as well as for muscle
strengthening. Russian stimulation is a specific form of electro-stimulation
with a Symmetrical Biphasic Square waveform produced by dividing a
2500Hz carrier frequency into 20～80Hz packets. This method was claimed
by its author (Kots) to produce maximal muscle strengthening effects
without significant discomfort to the patient.
INDICATION FOR USE
For TENS and IF (Interferential):
► Symptomatic relief of chronic intractable pain;
► Reduction of inflammation;
► Post-traumatic acute pain and edema;
► Post-surgical acute pain and edema.
For EMS and Russian:
► Relaxation of Muscle spasms and edema reduction;
► Prevention or retardation of disuse atrophy;
► Increasing local blood circulation;
► Muscle re-education;
► Maintaining or increasing range of motion;
► Immediate postsurgical stimulation of calf muscles to prevent venous
thrombosis.

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Chapter 3:
IMPORTANT SAFETY INFORMATION
Read instruction manual before operation. Be sure to comply with all
“Contraindications”, “Warnings”, “Cautions” and “Adverse reactions” in the
manual. Failure to follow instructions can cause harm to user or device.
3.1 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.
3.2 Warnings, cautions and adverse reactions
Warnings
1) This device should be used only under the continued supervision of
a licensed physician.
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.
6) Electronic 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 anterior neck or mouth.
Severe spasm of the laryngeal and pharyngeal muscles may occur
and the contractions may be strong enough to close the airway or
cause difficulty in breathing.
9) Stimulation should not be applied transthoracically in that the 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), but above all not 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.
18) Keep electrodes separate during treatment, electrodes in contact with
other could result in improper stimulation or skin burns.
19) Keep the stimulator out of reach of children.
20) Consult your doctor if you are in any doubt whatsoever.

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Cautions:
1) Federal law (USA) restricts this device to sale by or on the order of a
physician.
2) For single patient use only.
3) Keep yourself informed of the contraindications.
4) This stimulator is not intended for unattended, personal use by patients
who have noncompliant, emotionally disturbed, dementia, or low IQ.
5) Read, understand, and practice the warnings, cautions and operating
instructions. Know the limitations and hazards associated with using
any device. Observe the precautionary 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 not 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 a 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
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 patient selection by a person
qualified in the management of pain afflicted patients.

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16) Isolated cases of skin irritation may occur 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 of 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 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 and flammable mixture.
Adverse reactions:
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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Chapter 4: CONSTRUCTION
PANEL
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®
Twin Stim Plus 3rd Edition

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Supply Voltage: DC 9V/0.8A adaptor or 4XAA 1.5V batteries
Caution: Federal law (USA) restricts this
device to sale by or on the order of a physician
Manufacturer for Roscoe Medical, Inc.
21973 Commerce Parkway, Strongsville, Ohio 44149
www.roscoemedical.com
®
Model: Twin Stim Plus 3rd
Edition Combo Stimulator
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1) Lead connector
2) Channel 1, Channel 2, Channel 3 and Channel 4
3) Liquid crystal display
4) Panel cover
5) Mode control
6) Power on/off control
7) AC Adapter
8) Set control
9) Increment control – for Pulse Rate, Pulse Width and time indicators,
interference frequency
10) Decrement control – for Pulse Rate, Pulse Width and time indicators,
interference frequency
11) Intensity decrease control
12) Intensity increase control
13) Belt clip
14) Battery case
15) Battery cover

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LCD
1) Output intensity from channel 1 to channel 4
2) TENS, EMS, IF (Interferential) and RUSS (Russian) mode
3) Therapy program
4) Time symbol
5) Pulse rate and pulse width indicator
6) Lock symbol
7) Low battery symbol
8) Time indicator
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Chapter 5: TECHNICAL SPECIFICATIONS
The technical specification details of Twin Stim®Plus 3rd Edition Combo
stimulator are as follows:
No. MECHANISM TECHNICAL DESCRIPTION
Channel01 Four, isolated between channels
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08
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Power source DC 6V, 4×AA 1.5V battery, or
AC Adapter output :DC 9V,800mA
06 Size 13.8cm(L)x7.8cm(W)x2.8cm(H)
Pulse Rate
TENS/EMS: 2Hz~150Hz;
IF: 4000Hz~4150 Hz ;
RUSS:
fixed rate:2500 Hz; Burst rate:20Hz~80Hz
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Pulse width
On Time
Off Time
50μs~300μs
Adjustable, 2~90 seconds,1Sec./step
Adjustable, 0~90 seconds,1Sec./step
Ramp Time Adjustable, 1~8 seconds, 1 Sec./ step, The “On” time will increase and decrease in the
setting value.
425 grams with battery.Weight07
Type of protection
against electric
shock Class II Equipment
Output intensity
Waveform
0~40Vpp (at 500 ohm load)
04 Bi-Phasic Square Pulse
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13 Treatment time
Two adjustable timers, from 1 to 60 minutes or
Continuous. Adjustable in 1 minute each step
from 1 to 15 minutes, and 5 minutes each step
from 15 to 60 minutes. Treatment time
countdown automatically.
Patient Compliance
Meter This unit can store 60 sets of operation records. Total recorded time is 999 hours.
15 Low battery symbol A low battery symbol will show up when the
battery is low.
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Operating
conditions
Temperature: 0°C ~40°C
Relative Humidity: 30%~75%
Atmosphere Pressure: 700hPa~1060hPa
Storage conditions Temperature:-10°C~50°C Relative humidity:10%~90%
Atmospheric pressure: 700hPa ~ 1060hPa

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Chapter 6:
THERAPY PROGRAM AND WAVEFORMS
TENS PROGRAM
No. MECHANISM TECHNICAL DESCRIPTION
01 Program Five TENS program: B(Burst), N(Normal), M(Modulation),SD1(Strength Duration 1),
SD2 (Strength Duration 2)
02 Burst program (B) Burst rate: Adjustable, 0.5 ~ 5Hz Pulse width adjustable, 50~300μs
Frequency fixed = 100 Hz
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Normal program
(N)
The pulse rate and pulse width are adjustable.
It generates continuous stimulation based on
the setting value.
Modulation
program (M)
Modulation mode is a combination of pulse rate
and pulse width modulation. The pulse rate and
width are automatically varied in a cycle pattern.
The pulse width is decreased by 50% from its
original setting in 0.5s, and then the pulse rate
is decreased by 50% from its original setting in
0.5 seconds. Total cycle time is 1 second. In
this mode, pulse rate (2~150Hz) and pulse
width (50~300μs) are fully adjustable.
Strength-Duration
program (SD1)
The SD1(Strength-Duration) mode consists of
automatic modulation intensity and pulse width
in 40% range. The intensity is always increasing
while the pulse width is decreasing and vice-
versa. The intensity is decreased by 40% while
the pulse width is increased by 40% in 5
seconds. In the next 5 seconds, the intensity
is increased by 40% while the pulse width is
decreased by 40%. Total cycle time is 10

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seconds. Pulse rate (2~150Hz) and pulse
width (50~300μs) are fully adjustable.
Strength-Duration
program (SD2)
The SD2(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 (50~300μs) are fully adjustable.
TENS WAVEFORMS
1.Burst
2. Normal
Burst Frequency

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No. MECHANISM TECHNICAL DESCRIPTION
01 Program Three EMS Modes:
C(Constant), S(Synchronous), A(Alternate)
02 Constant
program (C)
Constant stimulation based on setting value.
Only pulse width, pulse rate and timer are
adjustable in this mode. “Constant” is equal
to the “Normal” mode in TENS.
03 Synchronous
program (S)
Stimulation of both channels occurs
synchronously. The “ON” time including “Ramp
up” and “Ramp down” time. Therefore, the
setting ON time should be no less than two
times the “Ramp” time in this mode.
ON time≥Ramp up + Ramp down
3. Modulation
4. Strength-Duration
Cycle time
EMS PROGRAM