Twin Stim Plus 3 Edition Instruction Manual: Combo Stimulator
Twin Stim Plus 3 Edition Instruction Manual: Combo Stimulator
Twin Stim Plus 3 Edition Instruction Manual: Combo Stimulator
Combo Stimulator
INSTRUCTION MANUAL
This manual is valid for the
Twin Stim® Plus 3rd Edition Combo Stimulator
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.
Declaration of conformity:
Roscoe Medical, Inc. declares that the device complies with following
normative documents:
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TABLE OF CONTENTS
Chapter 2: INTRODUCTION........................................................................ 5
Chapter 4: CONSTRUCTION....................................................................12
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Chapter 1: GENERAL DESCRIPTION
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.
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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.
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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.
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.
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Chapter 3:
IMPORTANT SAFETY INFORMATION
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.
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:
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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
2b 2c
2a 2d
12
11
9 4
8 5
7 6
12
13
14
15
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
6
3
7
4
5 8
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Chapter 5: TECHNICAL SPECIFICATIONS
The technical specification details of Twin Stim® Plus 3rd Edition Combo
stimulator are as follows:
06 Size 13.8cm(L)x7.8cm(W)x2.8cm(H)
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Two adjustable timers, from 1 to 60 minutes or
Continuous. Adjustable in 1 minute each step
13 Treatment time from 1 to 15 minutes, and 5 minutes each step
from 15 to 60 minutes. Treatment time
countdown automatically.
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Chapter 6:
THERAPY PROGRAM AND WAVEFORMS
TENS PROGRAM
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seconds. Pulse rate (2~150Hz) and pulse
width (50~300μs) are fully adjustable.
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
Strength-Duration
06 70% while the pulse width is increased by
program (SD2)
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
Burst Frequency
2. Normal
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3. Modulation
Cycle time
4. Strength-Duration
EMS PROGRAM
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The stimulation of the CH2 will occur after the
1st contraction of CH1 is completed. In this
mode, the setting of ON time should be no less
Alternate
04 than two times of the “Ramp” time. The OFF
program (A)
time should be equal or more than the ON time.
ON time ≥Ramp up + Ramp down
OFF time ≥ON time
EMS WAVEFORMS
Constant (C)
Synchronous (S)
CH1
CH2
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Alternate (A)
CH1
CH2
IF (Interferential) PROGRAM
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The pulse rates of the CH1 and CH3 is fixed
in 4000Hz; The pulse rates of CH2 and CH4
are based on the interference frequencies and
fixed frequency (4000Hz), means that pulse
Modulation
04 rate = 4000Hz+Interference frequency. The
program (M1)
interference frequencies are adjustable from
80Hz to 150Hz.
The pulse rates of CH2 and CH4 are modulated
between setting value and 4080Hz in 10 seconds.
IF (Interferential) WAVEFORM
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Burst frequency is decreased from the setting
value to 20Hz in 10 seconds, and then
Modulation
04 increased from 20Hz to the setting value in
program (M1)
next 10 seconds. In this program, the burst
frequency is adjustable from 20Hz to 80Hz.
RUSSIAN WAVEFORM
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Chapter 7: ACCESSORIES
Twin Stim® Plus 3rd Edition Combo Stimulator comes complete with
standard accessories as below:
No DESCRIPTION QTY’
1 50 X 50 mm Adhesive Electrodes 8PCS
3 AA Battery 4PCS
6 AC Adapter 1PC
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Chapter 8: OPERATING INSTRUCTIONS
Caution:
► Remove the batteries if the device is not in use for long periods of time.
► Do not mix old and new batteries or difference type of batteries.
► Warning: If batteries leak and come into contact with the skin or eyes,
wash immediately with copious amounts of water.
► Batteries must be handled by an adult. Keep batteries out of the reach
of children.
► Remove exhausted batteries from the unit.
► Dispose of batteries safety according to local regulation.
Caution:
Always use the electrodes with CE mark,
or which are legally marketed in the US
under 510(K) procedure. Connection Cables
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8.3 Connect lead wires to device
1) Before proceeding to this step, be sure the device is completely
turned OFF.
2) Insert the lead wires into the lead connectors on top of the device.
PLUG
LEAD CONECTOR
Caution:
Do not insert the plug of the patient lead wire into any AC power
supply socket.
8.4 Electrode
8.4.1 Electrode options
The electrodes are disposable and should be routinely replaced when
they start to lose their adhesive nature. If you are unsure of your electrode
adhesive properties, order replacement electrodes. Replacement electrodes
should be re-ordered through or on the advice of your physician to ensure
proper quality. Follow application procedures outlined in electrode packing,
to maintain optimal stimulation and to prevent skin irritation.
8.4.2 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 dried. Make sure the electrodes are
placed 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:
1) Before applying the self-adhesive electrodes, it is recommended to wash
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and degrease the skin, and then dry it.
2) Do not turns 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 still turned on.
4) It is recommended that, at a minimum, 4cm x 4cm self-adhering based,
square electrodes are used at the treatment area.
8.5 Turn on
Before using the device for the first time, you are strongly advised to take
careful note of the counter-indications and safety measures detailed at
the beginning of this manual (Safety information), as this powerful
equipment is neither a toy nor a gadget!
Press the [ ] button to turn on the device.
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8.7 Adjust output intensity
There are 4 sets of intensity buttons, which correlate to each of the 4
channels. Slowly increase or decrease the intensity as directed by your
physician by pressing the up or down intensity buttons under the
respective channel.
Press the up arrow [△] button to increase intensity and press the down
arrow [▽] button to decrease intensity.
Caution:
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.
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Chapter 9: PARAMETER CONTROLS
There are 4 therapeutic modes available –TENS, EMS, IF and RUSS. Each
mode’s parameters can be set by pressing [SET] button to enter setting
mode, and then adjust the parameters by pressing [▲] or [▼] button.
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[▲] or [▼] button to adjust the parameter from 1s to 8s.
9.2.3 Set ON time (A or S program)
Press [SET] button again, The “On” indicator displays on LCD, press [▲]
or [▼] button to adjust the parameter from 2s to 90s.
9.2.4 Set OFF time (A or S program)
Press [SET] button again, The “Off” indicator displays on LCD, press [▲]
or [▼] button to adjust the parameter from 2s to 90s.
9.2.5 Set pulse width
Press [SET] button again, the “Width” indicator displays on LCD, press
[▲] or [▼] button to adjust the parameter from 50μs to 300μs.
9.2.6 Set pulse rate
Press [SET] button again, The “Rate” indicator displays on LCD, press
[▲] or [▼] button to adjust the parameter from 2Hz to 150Hz.
9.2.7 Set timer
There are two adjustable timers available. The left timer controlling the
treatment time of CH1 and CH2. The right timer controlling the treatment
time of CH3 and CH4. The treatment time is adjustable from 1 to 60
minutes or C (Continuous). Press [SET] button to enter this menu, then
press [▲] or [▼] button to adjust the setting. Press [▲] button when the
timer shows 60 minutes, it will be switched to continuous stimulation.
Two timers can be set in the same way.
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or C (Continuous). Press [SET] button to enter this menu, then press [▲]
or [▼] button to adjust the setting. Press [▲] button when the timer shows
60 minutes, it will be switched to continuous stimulation. Two timers can
be set in the same way.
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Chapter 10:
PATIENT COMPLIANCE METER
This unit can store 60 sets of operation records. Total treatment time up to
999 hours can be stored.
Check & Delete Individual Record
Press [MODE] button and turn on the power simultaneously. The LCD will
show the number of records and operation time. Press the [▲] or [▼] button
to check each record.
To delete a record, press [SET] button for 3 seconds.
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Chapter 11:
MAINTENANCE AND STORAGE
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Chapter 12: TROUBLESHOOTING
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Electrode active area Replace electrodes with
size is too small large more area
Stimulation is
uncomfortable May not be operating
Please check the manual
the device according
before use.
to the manual.
Improper electrode and Reposition electrode and
Stimulation is applicator placement applicator
ineffective
Unknown Contact Clinician
Re-position the electrodes. If
Use the electrodes on the
at any time you feel pain or
same site every time.
discomfort stop use immediately.
The electrodes aren't
Ensure the electrode is stuck
The skin becomes stuck onto the skin securely on the skin.
red and/or you feel properly.
a stabbing pain Clean the electrode pads with a
The electrodes are dirty. damp, lint free cloth or replace
new electrode pads.
The surface of the
Replace new electrode.
electrode was scratched.
The electrode pads Turn off the device and stick
come off the skin. the electrode pad firmly to
the skin.
Output current
The cable is Turn off the device and connect
stops during
disconnected the cable.
therapy
The power of the Please replace them with
batteries has been new batteries.
exhausted.
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Chapter 13: NORMALIZED SYMBOLS
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Chapter 14: WARRANTY
Twin Stim® Plus 3rd Edition Combo Stimulator carries a warranty of one
year from the date of delivery. The warranty applies to the stimulator only
and covers both parts and labor relating thereto.
The warranty does not apply to damage resulting from failure to follow the
operating instructions, accidents, abuse, alteration or disassembly by
unauthorized personnel.
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Manufacturer for Roscoe Medical, Inc.
21973 Commerce Parkway, Strongsville, Ohio 44149
www.roscoemedical.com