FOR THE
INSTRUCTION MANUAL
INSTRUCTION MANUAL
Twin Stim Plus
R
FDA 510K
DIGITAL TENS/EMS
Distributed by:
V1.0
PDF created with FinePrint pdfFactory trial version http://www.pdffactory.com
1
INDEX
1. General Description .............................................. 2
2. Introduction ........................................................... 2
3. Cautions................................................................. 4
4. Warnings ................................................................ 6
5. Contraindications.................................................. 6
6. Adverse Reactions ................................................ 6
7. Construction.......................................................... 7
8. Technical Specifications ....................................... 9
9. Replaceable Parts ................................................. 13
10 Accessories .......................................................... 13
11. Graphic Symbols ................................................... 14
12. Operating Instructions ......................................... 14
13. Parameter Controls.............................................. 15
14. Attachment of Electrode Lead Wires .................. 18
15. Lead Wire Maintenance ........................................ 18
16. Electrode Options ................................................. 19
17. Electrode Placement............................................. 19
18. Tips for Skin Care ................................................. 20
19. Application of Reusable self
adhesive electrodes ............................................. 20
20. Adjusting the Controls ......................................... 22
21. Battery Information............................................... 30
22. Maintenance, Transportation, and
Storage of the Device ........................................... 31
23. Safety-Technical Controls .................................... 32
24. Malfunctions.......................................................... 32
25. Conformity to Safety Standards .......................... 33
26. Warranty................................................................. 33
Chapter Contents Page
PDF created with FinePrint pdfFactory trial version http://www.pdffactory.com
32
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 discuss
this with your physician or therapist.
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® 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
1. Relaxation of muscle spasms
2. Prevention or retardation of disuse atrophy
3. Increasing local blood circulation
4. Muscle re-education
5. Immediate post-surgical stimulation of calf muscles to prevent
venous thrombosis
6. Maintaining or increasing range of motion
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
Chapter 1: GENERAL DESCRIPTION
The Twin Stim® Plus Digital TENS/EMS is a battery operated pulse
generator that sends electrical impulses electrodes to the body and
reach the nerves and underlying muscle group. This unit is a
combination stimulator of TENS and EMS which can be used for
muscle stimulation and pain relief. The device is provided with two
controllable output channels, each independent of each other. An
electrode pair can be connected to each output channel. The intensity
controls are protected by a cap to avoid accidental touch. The settings
are controlled by press buttons.
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, drugfree 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.
PDF created with FinePrint pdfFactory trial version http://www.pdffactory.com
54
8. 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.
9. Turn the TENS off before applying or removing electrodes.
10.Isolated cases of skin irritation may occur at the site of electrode
placement following long term application. If this occurs,
discontinue use and consult your physician.
11. If TENS therapy becomes ineffective or unpleasant, stimulation
should be discontinued until its use is re-evaluated by a physician
12.Keep this device out of the reach of children.
13.The device has no AP/APG protection.
Do not use it in the presence of explosive atmosphere and
flammable mixture.
EMS
1. Federal law (USA) restricts this device to sale by or on the order
of a physician
2. Safety of powered muscle stimulators for use during pregnancy
has not been established.
3. Caution should be used for patients with suspected or diagnosed
heart problems.
4. Caution should be used for patients with suspected or diagnosed
epilepsy.
5. Caution should be used in the presence of the following:
a. When there is a tendency to hemorrhage following acute trauma
or fracture;
b. Following recent surgical procedures when muscle
contraction may disrupt the healing process;
c. Over the menstruating or pregnant uterus; and
d. Over areas of the skin which lack normal sensation.
6. Some patients may experience skin irritation or hypersensitivity
due to the electrical stimulation or electrical conductive medium.
The irritation can usually be reduced by using an alternate
conductive medium, or alternate electrode placement.
7. Electrode placement and stimulation settings should be based on
the guidance of the prescribing practitioner.
8. Powered muscle stimulators should be kept out of the reach of
children.
9. Powered muscle stimulators should be used only with the leads
and electrodes recommended for use by the manufacturer.
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.
IMPORTANT SAFETY INFORMATION
Read instruction manual before operation. Be sure to comply with all
“CAUTIONS” and “WARNINGS” in the manual. Failure to follow
instructions can cause harm to user or device.
Chapter 3 : CAUTIONS
TENS
1. Federal law (USA) restricts this device to sale by or on the order
of a physician.
2. Do not use this device for undiagnosed pain syndromes until
consulting a physician.
3. Patients with an implanted electronic device, such as a cardiac
pacemaker, implanted defibrillator, or any other metallic or electronic
device should not undergo TENS treatment without first consulting
a doctor.
4. Patients with heart disease, epilepsy, cancer or any other health
condition should not undergo TENS treatment without first
consulting a physician.
5. 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.
6. 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.
7. Do not place electrodes on your head or at any sites that may
cause the electrical current to flow transcerebrally (through the
head).
PDF created with FinePrint pdfFactory trial version http://www.pdffactory.com
76
Chapter 7 : CONSTRUCTION
FRONT
(1)LEAD CONNECTOR
(2)PANEL COVER
(3)LIQUID CRYSTAL DISPLAY
(4)INTENSITY INCREASE CONTROL
(5)INTENSITY DECREASE CONTROL
(6)MODE CONTROL
(7)SET CONTROL
(8)INCREMENT CONTROL
(9)DECREMENT CONTROL
(10)LED
10.Portable powered muscle stimulators should not be used while
driving, operating machinery, or during any activity in which
involuntary muscle contractions may put the user at undue risk of
injury.
Chapter 4 : WARNINGS
1. The long-term effects of chronic electrical stimulation are
unknown.
2. Stimulation should not be applied over the carotid sinus nerves,
particularly in patients with a known sensitivity to the carotid
sinus reflex.
3. Stimulation should not be applied over the 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.
4. Stimulation should not be applied transthoracically in that the
introduction of electrical current into the heart may cause cardiac
arrhythmias.
5. Stimulation should not be applied transcerebrally.
6. Stimulation should not be applied over swollen, infected, or inflamed
areas or skin eruptions, e.g., phlebitis, thrombophlebitis, varicose
veins, etc.
7. Stimulation should not be applied over, or in proximity to, cancerous
lesions.
Chapter 5: CONTRAINDICATION
Electrical stimulators should not be used on patients with cardiac
demand pacemakers.
Chapter 6: ADVERSE REACTIONS
Skin irritation and burns beneath the electrodes have been reported
with the use of electrical stimulators. If irritation occurs, discontinue
use and consult your physician.
PDF created with FinePrint pdfFactory trial version http://www.pdffactory.com
98
Chapter 8 : TECHNICAL SPECIFICATIONS
The technical specification details of Twin Stim® Plus are as follows:
MECHANISM TECHNICAL DESCRIPTION
01 Channel Four, isolated between channels
02 Pulse Amplitude Adjustable, 0-100 mA peak into 500 ohm
load each channel.
03 Wave Form Asymmetrical Bi-Phasic Square Pulse
04 Voltage 0 to 50V (Load: 500 ohm)
05 Power source Four AA batteries
06 Size 13.8cm(L) x 7.8cm(W) x 2.8cm(H)
07 Weight 425 grams with battery.
08 Pulse Rate Adjustable, from 2 to 150 Hz, 1 Hz/step
09 Pulse Width Adjustable, from 50 to 300 microseconds,
10 µs/step
10 On Time Adjustable, 2~90 seconds , 1 Sec./ step
11 Off Time Adjustable, 0~90 seconds , 1 Sec./ step
12 Ramp Time Adjustable, 1~8 seconds, 1 Sec./ step, The
“On” time will increase and decrease in the
setting value.
13 Mode Five TENS Modes: B(Burst), N(Normal),M
(Modulation),SD1( Strength Duration), SD2
Three EMS Modes:C(Constant) S
(Synchronous), A(Alternate)
14 Burst Mode Burst rate: Adjustable, 0.5 ~ 5Hz
Pulse width adjustable, 50~300µs
Frequency fixed = 100 Hz
15 Normal Mode The pulse rate and pulse width are
adjustable. It generates continuous
stimulation based on the setting value.
16 Modulation Mode Modulation mode is a combination of pulse
rate and pulse width modulation. The pulse
BACK
BACK
(11) BATTERY CASE
(12) BELT CLIP
SIDE
PDF created with FinePrint pdfFactory trial version http://www.pdffactory.com
1110
20 Synchronous Stimulation of both channels occurs
Mode (S) synchronously. The “ON” time including
“Ramp Up” and “Ramp Down” time.
Therefore, the setting of ON Time should be
no less than two times of the “Ramp” time in
this mode.
ON TIME ≥ Ramp up + Ramp down
21 Alternate The stimulation of the CH2 will occur after
Mode(A) the 1st contraction of CH1 is completed. In
this mode, the setting of ON Time should be
no less than two times of the “Ramp” time.
The OFF Time should be equal or more than
the ON Time.
ON TIME ≥Ramp up + Ramp down
OFF TIME ≥ON TIME
22 Timer 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.
23 Patient This unit can store 60 sets of operation
Compliance Meter records. Total recorded time is 999 hours.
24 Low Battery A low battery indicator will show up when
Indicator the battery is low.
25 Operating Temperature:0°~40°C
Condition Relative Humidity: 30%~75%
Atmosphere Pressure : 700Hpa~1060Hpa
26 Remark There may be up to a +/-5% tolerance of all
parameters and +/-20% tolerance of
amplitude & voltage.
rate and width are automatically varied in a
cycle pattern. The pulse width is decreased
by 50% from its original setting in 0.5 second,
then the pulse rate is decreased by 50%
from its original setting in 0.5 second.Total
cycle time is 1 second. In this mode, pulse
rate(2-150Hz) and pulse width(50-300 µs)
are fully adjustable.
17 SD1 Mode 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
seconds. Pulse rate ( 2~150Hz) and pulse width
(50~300µs) are fully adjustable.
18 SD2 Mode 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.
19 Constant Constant stimulation based on setting value.
Mode (C) Only pulse width, pulse rate and timer are
adjustable in this mode. “Constant” is equal
to the “Normal” mode of a TENS unit.
PDF created with FinePrint pdfFactory trial version http://www.pdffactory.com
1312
Chapter 9 : REPLACEABLE PARTS
The replaceable parts and accessories of Twin Stim® Plus Digital
TENS/EMS devices are as given below –
Except leads, electrodes, battery and battery case cover, please do
not try to replace the other parts of a device.
PARTS
01 LEAD WIRES
02 ELECTRODES
03 1.5 BATTERY, TYPE AA
04 BELT CLIP
05 BATTERY CASE COVER
06 LEAD CONNECTOR
07 MAIN PCB
08 INTENSITY KNOB
09 LCD COVER
10 INTENSITY CONTROL COVER
Chapter 10 : ACCESSORIES
Each Twin Stim® Plus Digital TENS/EMS comes complete with standard
accessories and the standard labels as given below:
I. Accessories
REF. NO. DESCRIPTION Q’ TY
1. TKS4040 40 X 40 mm Adhesive Electrodes 8 pieces
2. KE-26 Electrodes Leads 4 pieces
3. AA Battery 4 piece
4. Instruction Manual 1 piece
5. Carrying Case 1 piece
The waveforms of the TENS modes are as follows.
1. Burst
2. Normal
3. Modulation
4. SD1 (Strength-Duration)
5. SD2 (Strength-Duration)
PDF created with FinePrint pdfFactory trial version http://www.pdffactory.com
1514
6) Select the mode and settings as directed by your physician.
7) 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. (Please put a picture of them) Press the up arrow button
to increase intensity and press the down arrow button to decrease
intensity.
8) After treatment, turn the device off by pressing the (ON/OFF
button)
Chapter 13 : PARAMETER CONTROLS
PULSE DURATION
Wider pulse duration settings will deliver stronger stimulation for any
given intensity setting. As mentioned in the Controls section, by
using a combination of intensity and pulse duration, it is felt that
various pulse widths are capable of stimulating different groups of
nerve fibres.
The wider pulse duration is needed to recruit motor fibres, whereas
the narrow pulse duration is used on the more sensory fibres. The
choice of which pulse duration to use is partially dependent upon the
Treatment Mode and Protocol selected.
PULSE RATE
The Pulse Rate (hertz or pulses per second) chosen depends greatly
upon the type of electrode placement given to the patient.
When using contiguous and dermatome electrode placements (i.e.
stimulating directly through the area of pain or localized enervation),
a quick pulse rate (setting greater than 80Hz on the Pulse Rate
Control) is desired. The patient should not perceive individual pulses
but rather have the sensation of steady continuous stimulation.
When using point treatments, it has been suggested that slow pulses
be utilized (less than 10Hz). With this setting the patient should be
able to slightly perceive individual pulses.
When using multiple electrode placement strategies, such as
combinations of point and contiguous electrode placements, the
quicker pulse rates are suggested.
II. LABEL
The label attached to the back of
device contains important
information about this devicemodel, supply voltage and caution.
Please do not remove.
Chapter 11 : GRAPHIC SYMBOLS
1. Degree of Electrical Protection BF
2. Do not insert the plug into AC power supply socket.
3. Timer
4. Low Battery
5. Increment
6. Decrement
Chapter 12: OPERATING INSTRUCTIONS
1) Insert the AA battery into the device’s battery compartment.
Make sure to remove the plastic seal on the AA battery. Line up
the positive and negative terminals on the battery with their
corresponding terminals in the device.
2) Insert the lead wires into the lead wire sockets on top of the
device.
3) Open the electrode package. Then insert each lead wire pin into
the pig tail of the electrodes
4) Place the electrode on your body as directed by your physician.
5) Press the (ON/OFF button) to turn on the device.
PDF created with FinePrint pdfFactory trial version http://www.pdffactory.com
1716
minutes of such a tetanized muscular contraction will generally break
the spasm. In all cases, if the patient complains that the stimulation is
uncomfortable, reduce intensity and/or cease stimulation.
TIME DURATION
The onset of pain relief should occur shortly after the intensity setting
has been determined. However, in some cases, pain relief may take
as long as 30 minutes to achieve, especially when using point
electrode placements and slow pulse rates.
TENS units are typically operated for long periods of time, with a
minimum of 20 – 30 minutes and in some post-operation protocols, as
long as 36 hours.
In general, pain relief will diminish within 30 minutes of the cessation
of stimulation. Pain relief obtained through point electrode placements
may last longer (perhaps because of the presence of endorphins).
CONTRACTION / RELAXATION
The contraction time and relaxation time of EMS is adjustable.
Stimulation will continue at the setting contraction time and cease
also at the setting relaxation time. Then the cycle starts over again –
Stimulation, Contraction and Relaxation.
RAMP
In order to achieve a comfortable exercise and avoid startle because
of electrical shock, each contraction course may be ramped so that
the signal comes on gradually and smoothly. The intensity of electrical
current will reach the setting level within the Ramp time, however, it
can not reach the expected level if the contraction time is less than
the ramp time.
OUTPUT MODE
The output of both channels are adjustable. It can be in the pattern
of synchronous or alternate. Stimulation of both channels will occur
at the same time when simultaneous pattern is selected. At alternating
mode, the stimulation of the CH2 will occur after the 1st contraction
of CH1 is finished.
Despite above recommendations, these individual patients may
require slight variations of the above settings, according to the nature
of their condition.
TREATMENT MODE
Normal or Conventional TENS offers the practitioners complete control
over all the various treatment parameters of the instrument.
Burst Mode is analogous to the Low Rate TENS technique except the
low frequency individual pulses are replaced by individual “bursts”
of 7-10 individual pulses. It is thus a combination of Conventional
TENS and Low Rate TENS. In Burst Mode, the treatment frequency
is adjustable at the range between 0.5Hz – 5Hz.
Modulated Mode attempts to prevent nerve accommodation by
continuously cycling the treatment intensity. When using Modulated
Mode increase the intensity only when the unit is at the maximum
intensity of the modulation cycle. If the intensity is increased during
a low intensity period of the cycle, the patient may turn up the control
very slowly, so that they may feel the intensity any higher.
INTENSITY
Each patient responds differently to different levels of intensity, due
to varying degrees of tissue resistance, enervation, skin thickness,
etc. Intensity instructions are therefore limited to the following settings:
Perception – The intensity is increased so that the patient can feel
the stimulation, but there is not any muscular contraction.
Slight Contraction – Intensity is increased to a barely visible muscular
contraction that is not strong enough to move a joint. When using
low pulse rate settings, this will show as individual twitches. At
higher pulse rates there will simply be increased muscle tension.
Strong muscular contraction is typically not used in TENS therapy.
However, muscular contraction may be useful if the pain involves a
cramped or spastic muscle.The TENS can be used as a traditional
muscle stimulator in the circumstances to quickly break the spasm.
Use a quick pulse rate, wide pulse duration and set the intensity to
visible contraction (still within patient tolerance). Twenty or thirty
PDF created with FinePrint pdfFactory trial version http://www.pdffactory.com
1918
Chapter 16 : 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.
Chapter 17: ELECTRODE PLACEMENT
The placement of electrodes can be one of the most important
parameters in achieving success with TENS or EMS 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.
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 placement has been achieved, mark down the
electrodes sites and the settings, so the patient can easily continue
treatment at home.
Chapter 14 : ATTACHMENT OF ELECTRODE LEAD
WIRES
The wires provided with the system insert into the jack sockets
located on top of the device. 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.
After connecting the wires to the stimulator, attach each wire to
an electrode. Use care when you plug and unplug the wires.
Jerking the wire instead of holding the insulated connector body
may cause wire breakage.
CAUTION
Do not insert the plug of the patient lead wire into any AC power
supply socket.
Chapter 15: LEAD WIRE MAINTENANCE
Clean the wires by wiping with a damp cloth. Coating them lightly
with talcum powder will reduce tangling and prolong life.
PDF created with FinePrint pdfFactory trial version http://www.pdffactory.com
2120
Removal
1. Turn off the unit prior to removing the electrodes.
2. Lift at the edge of electrodes and peel; do not pull on the lead
wires because it may damage the electrodes.
3. Place the electrodes on the liner and remove the lead wire by
twisting and pulling at the same time.
Care and Storage
1. Between uses, store the electrodes in the resealable bag in a
cool dry place.
2 . It may be helpful to improve repeated application by spreading a
few drops of cold water over the adhesive and turn the surface
up to air dry. Over Saturation with water will reduce the adhesive
properties.
Imp o r tant
1. Do not apply to broken skin.
2. The electrodes should be discarded and re-ordered from your
physician when they are no longer adhering.
3. The electrodes are intended for single patient use only.
4. If irritation occurs, discontinue use and consult your physician.
5. Read the instructions for use of self-adhesive electrodes before
application.
Chapter 18: TIPS FOR SKIN CARE
To avoid skin irritation, especially if you have sensitive skin, follow
these suggestions:
1. Wash the area of skin where you will be placing the electrodes,
using mild soap and water before applying electrodes, and after
taking them off. Be sure to rinse soap off thoroughly and dry skin
well.
2. Excess hair may be clipped with scissors; do not shave stimulation
area.
3. Wipe the area with the skin preparation your physician 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 centre 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
when not wearing electrodes.
8. Never apply electrodes over irritated or broken skin.
Chapter 19: APPLICATION OF RE-USABLE SELF
ADHESIVE ELECTRODES
Application
1. Clean and dry the skin at the prescribed area thoroughly with
soap and water prior to application of electrodes.
2. Insert the lead wire into the pin connector on the pre-wired
electrodes.
3. Remove the electrodes from the protective liner and apply the
electrodes firmly to the treatment site. Make sure that the unit is
turned off prior to applying the electrodes.
PDF created with FinePrint pdfFactory trial version http://www.pdffactory.com
2322
4. Mode Control
There are 5 TENS modes(B, N, M, SD1, SD2) and 2 EMS modes
(S, A) available. The mode can be selected by pressing the “Mode”
control. When a TENS mode is selected, the LCD shows “TENS”
on the top. When EMS mode is selected, the LCD shows “EMS”
on the top.
5. Set Control
By pressing the “Set” control, you may enter the setting you
intend to make adjustment. You may start to set the value by
pressing the “Increment” and “Decrement” controls when the
value is flashing.
6. Increment Control
This button controls the increase of settings. When pressing this
button, the parameter will increase.
7. Decrement Control
This button controls the decrease of parameter. When pressing
this button, the parameter will decrease.
8. Timer
The unit has a timer of 1-60 minutes and Continuous. It can be
adjusted by pressing the “Set” and “Increment” or “Decrement”
controls. The treatment time will countdown automatically in one
minute increments. Its output will be shut off when time is up.
9. Low Battery Indicator
A low battery sign will show up on the liquid crystal display
when it needs to be replaced as soon as possible. The unit may
continue to operate for a few more hours depends on the
setting intensity level.
Chapter 20 : ADJUSTING THE CONTROLS
1. Panel Cover:
A lid covers the controls for selecting mode and adjusting settings.
Your medical professional may wish to set these controls for you
and request that you leave the cover in place.
2. Power On/Off Controls and Intensity Controls:
Power of the unit can be turned on by pressing the power control.
The intensity level can be increased or decreased by pressing the
intensity controls. Intensity level can be adjusted in 100 steps
linearly.
There are 4 leds on the top of unit showing the output of electrical
current. They will be light up when there is output.
3. Lead Connector
Connection of the electrodes is made with the four-lead connector
(lead wires). The device must be switched off before connecting
the cables. Electrodes must be pressed firmly on the skin.
PDF created with FinePrint pdfFactory trial version http://www.pdffactory.com
2524
d. Set Pulse Rate
Pulse rate is adjustable from 2Hz to 150 Hz . Press “SET”
control to enter this menu,then press “Increment” or “Decrement”
to adjust the setting. Unless otherwise instructed, turn the
pulse rate control to the 70-120 Hz range.
e. 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 & CH4.
The treatment time is adjustable from 1 to 60 minutes or C
(Continuous). Press “SET” control to enter this menu, then
press “Increment” or “Decrement” to adjust the setting.
Press “Increment” control when the timer shows 60 minutes,
it will be switched to continuous stimulation. Two timers can
be set in the same way.
11. Steps to Set a EMS Program
The settings can be adjusted according to the following steps.
f. Turn on the Power
After the electrodes are placed firmly on skin and the lead
wires are plugged in the socket of device, press the ON/OFF
Continuous
10. Steps to Set a TENS Program
The settings can be adjusted according to the following steps.
a. Turn on the power
After the electrodes are placed firmly on skin and the lead
wires are plugged in the socket of device, turn the on/off
control clockwise. The menu will reveal on LCD. Notice the
indication of power and function on the LCD.
b. Select a Mode
Select a mode by pressing the “Mode” control. The mode you
selected will show up on the top of liquid crystal display. There
are 5 modes of your option including –B(Burst), M(Normal), M
(Modulation), SD1 and SD2. When a TENS mode is selected, it
shows “TENS” on the top of liquid crystal display.
After a mode is selected, always press “Set” to enter next
setting, and press “Increment or “Decrement” to adjust its value.
c. Set Pulse Width
Pulse Width is adjustable from 50 uS to 300 uS. Press “SET”
control to enter this menu, then press “Increment” or “Decrement”
to adjust the setting. If no instructions regarding the pulse width
are given in therapy, set the control to the suggested
70-120 uS setting.
Right TimerLeft Timer
PDF created with FinePrint pdfFactory trial version http://www.pdffactory.com
2726
i. Set On Time
The On Time controls the time of stimulation. By pressing the
“Set” control, the contraction time can be adjusted. Both
channels’ stimulation is cycled on and off by the contraction
and relaxation settings. The range is adjustable from
2 seconds to 90 seconds.
As the “ON” time including the ramp up and ramp down time,
the setting of it should be no less than two times of the “Ramp”
time. (ON TIME ≥Ramp up + Ramp down)
j. Set Off Time
The Off Time controls the time of relaxation. By pressing the
“SET” control, the relaxation time can be adjusted. Both
channels’ stimulation is cycled on and off by the contraction
and relaxation settings. The range is adjustable from 0 second
to 90 seconds.
In Alternate mode, the OFF Time should be equal or more than
the ON Time. (OFF TIME ≥ON TIME)
k. Set Pulse Width
button. The menu will reveal on LCD. Notice the indication of
power and function on the LCD.
g. Select Mode
There are three EMS modes of option, C(Constant) S
(Synchronous) or A Alternate). Select a mode by pressing the
“Mode” control. When an EMS mode is selected, the LCD
shows “EMS” on the top.
After a mode is selected, press “SET” control to enter next
setting. You may adjust the setting only when it is flashing.
Then press the “Increment” or “Decrement” control to change
the settings.
h. Set Ramp Time
The ramp time controls the time of output current that increase
from 0 to the setting level, and from the setting value to 0.
When the ramp time is set, each contraction may be ramped
up and down in order that the signals come on and come off
gradually and smoothly. The ramp time is adjustable from
1 to 8 seconds.
PDF created with FinePrint pdfFactory trial version http://www.pdffactory.com
2928
12. 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” control and turn on the power simultaneously.
The LCD will show the number of records and operation time.
Press the “Increment” and “Decrement button to check each
record.
To delete a record, press “SET” control for 3 seconds.
Check & Delete Accumulative Record
At the individual records menu, press “Mode” control to switch
to accumulative record menu. Press the “SET” control first, then
press the “Mode” control simultaneously for 3 seconds and all of
the records will be deleted followed by a beeper sound.
Pulse Width is adjustable from 50 uS to 300 uS. Press “SET”
control to enter this menu, then press “Increment” or
“Decrement” to adjust the setting. If no instructions regarding
the pulse width are given in therapy, set the control to the
suggested 70-120 uS setting.
l. Set Pulse Rate
Pulse rate is adjustable from 2Hz to 150 Hz . Press “SET”
control to enter this menu, then press “Increment” or
“Decrement” to adjust the setting. Unless otherwise instructed,
turn the pulse rate control to the 70-120 Hz range.
m.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 & CH4.
The treatment time is adjustable from 1 to 60 minutes or C
(Continuous). Press “SET” control to enter this menu, then
press “Increment” or “Decrement” to adjust the setting.
Press “Increment” control when the timer shows 60 minutes,
it will be switched to continuous stimulation.
When you use the EMS treatment, the intensity level will flash
when it is at “OFF” time (relaxation). The intensity level can not
be adjusted until it works again at “ON” time.
Continuous
Left Timer RightTimer
PDF created with FinePrint pdfFactory trial version http://www.pdffactory.com
3130
BATTERY CHARGING
(1) Plug the charger into any working 110 or 220/240v mains electrical
outlet. The use of any attachment not supplied with the charger
may result in the risk of fire, electric shock, or injury to persons.
(2) Follow the battery manufacturer’s instructions for charging time.
(3) After the battery manufacturer’s recommended charging time
has been completed, unplug the charger and remove the battery.
(4) Batteries should always be stored in a fully charged state.
To ensure optimum battery performance, follow these guidelines:
(a) Although overcharging the batteries for up to 24 hours will
not damage them, repeated overcharging may decrease
useful battery life.
(b) Always store batteries in their charged condition. After a
battery has been discharged, recharge it as soon as possible.
If the battery is stored more than 60 days, it may need to be
recharged.
(c) Do not short the terminals of the battery. This will cause the
battery to get hot and can cause permanent damage. Avoid
storing the batteries in your pocket or purse where the
terminals may accidentally come into contact with coins,
keys or any metal objects.
(d) WARNINGS:
1. Do not attempt to charge any other types of batteries in
your charger, other than rechargeable batteries made for
your charger. Other types of batteries may leak or burst.
2. Do not incinerate the rechargeable battery as it may explode!
Chapter 22 : MAINTENANCE, TRANSPORTATION
AND STORA GE OF THE DEVICE
1. Non-flammable cleaning solution is suitable for cleaning the device.
Note: Do not smoke or work with open lights (for example, candles,
etc.) when working with flammable liquids.
2. Stains and spots can be removed with a cleaning agent.
13. Check/Replace the Battery:
Over time, in order to ensure the functional
safety of the unit, changing the battery is
necessary.
1. Make sure that both intensity controls are
switched to off position.
2. Slide the battery compartment cover and
open.
3. Remove the battery from the compartment.
4. Insert the battery into the compartment. Note
the polarity indicated on the battery and in
the compartment.
5. Replace the battery compartment cover
and press to close.
Chapter 21: BATTERY INFORMATION
PRECATIONS
1. Remove battery if equipment is not likely to be used for some time.
2. Please recycle the used battery in accordance with domestic
regulation.
3. Do not throw the used battery into fire.
If you use rechargeable batteries, please follow the instructions.
RECHARGEABLE BATTERIES (NOT INCLUDED)
Prior to the use of a new unit, the rechargeable battery should be
charged according to the battery manufacturer’s instructions. Before
using the battery charger, read all instructions and cautionary
markings on the battery and in this instruction manual.
After being stored for 60 days or more, the batteries may lose their
charge. After long periods of storage, batteries should be charged
prior to use.
PDF created with FinePrint pdfFactory trial version http://www.pdffactory.com
3332
3. Do not submerge the device in liquids or expose it to large amounts
of water.
4. Return the device to the carrying box with sponge foam to ensure
that the unit is well-protected before transportation.
5. If the device is not to be used for a long period of time, remove the
batteries from the battery compartment (acid may leak from used
batteries and damage the device). Put the device and
accessories in carrying box and keep it in cool dry place.
6. The packed TENS/ EMS device should be stored and transported
under the temperature range of -20°C ~ + 60°C, relative humidity
20%~ 95%, atmosphere pressure 500 hPa~ 1060 hPa.
Chapter 23: SAFETY-TECHNICAL CONTROLS
For safety reasons, review the following checklist before using
your Twin Stim® Plus Digital TENS/EMS
1.Check the device for external damage.
- deformation of the housing.
- damaged or defective output sockets.
2.Check the device for defective operating elements.
- legibility of inscriptions and labels.
- make sure the inscriptions and labels are not distorted.
3.Check the usability of accessories.
- patient cable undamaged.
- electrodes undamaged.
- Battery is not corroded
Please consult your distributor if there are any problems with device
and accessories.
Chapter 24 : MALFUNCTIONS
Should any malfunctions occur while using the Twin Stim® Plus
Digital TENS/EMS, check
The Twin Stim® Plus Digital TENS/EMS devices are in compliance
with the EN 60601-1-2:2001 and EN 60601-1:1990+A1:1993+A2:
1995+A13:1996 safety standards.
Chapter 26 : WARRANTY
All Twin Stim® Plus Digital TENS/EMS models carry a warranty of
one year from the date of delivery. The warranty applies to the
stimulator only and covers both parts and labour 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.
- whether the parameters are set to the appropriate form of therapy.
Adjust the control correctly.
- whether the cable is correctly connected to the device. The cables
should be inserted completely into the sockets.
- whether the LCD reveals the menu. If necessary, insert a new
battery.
- for possible damage to the cable. Change the cable if any damage
is detected.
* If there is any other problem, please return the device to your
distributor. Do not try to repair a defective device.
Chapter 25: CONFORMITY TO SAFETY
STANDARDS
PDF created with FinePrint pdfFactory trial version http://www.pdffactory.com
PDF created with FinePrint pdfFactory trial version http://www.pdffactory.com
Loading...