intensity TWIN STIM III User manual

INSTRUCTION MANUAL

This manual is valid for the InT E NSityTM Twin Stim III
TENS/EMS Combo Stimulator
This user manual is published by Current Solutions™, LLC
Current Solutions™, LLC 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.V1.2 © 2012
: United States Federal Law restricts this device to sale by
or on the order of a physician or licensed practitioner
Declaration of conformity:
Current Solutions™, LLC declares that the device complies
with following normative documents:
IEC60601-1, IEC60601-1-2, I EC60601-2-10, IEC60601-1-4,
ISO10993-5, ISO10993-10, ISO10993-1

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Table of Contents
1. SAFETY INFORMATION……………………………………………4
1.1 General description
1.2 Medical background
1.3 Indication for use
1.4 Contraindications
1.5 Warnings, Cautions, Adverse Reactions
2. PRESENTATION……………………………………………………12
2.1 Front and Rear panel
2.2 LCD display
3. SPECIFICATION……………………………………………………15
3.1 Accessories
3.2 Technical information
3.3 The waveforms of the stimulation programs
4. INSTRUCTIONS FOR USE ....................................................... 20
4.1 Battery
4.2 Connect electrodes to lead wires
4.3 Connect lead wires to device
4.4 Electrodes
4.5 Turn ON
4.6 Select the Therapeutic Mode
4.7 Steps to set a new program
4.8 Adjust Channel Intensity
4.9 Safety lock feature
4.10 Stop the treatment
4.11 Turn OFF
4.12 Low battery indicator
5. PROGRAM................................................................................. 28
6. CLEANING AND CARE ............................................................. 29
6.1 Tips for skin care
6.2 Cleaning the device
6.3 Electrodes
6.4 Cleaning the Electrode cords
6.5 Maintenance
7. TROUBLES HOOTING.............................................................. 32
8. STORAGE.................................................................................. 34
9. DISPOSAL ................................................................................. 34
10. ELECTROMAGNETIC COMPATIBILITY (EMC)TABLES .......... 34
11. GLOSSARY OF SYMBOLS ....................................................... 39
12. WARRANTY............................................................................... 40

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1. SAFETY INFORMATION
1.1 General
InTENSityTM Twin Stim~ Ill is a portable electrotherapy device featuring
two therapeutic modes: Transcutaneous Electrical Nerve Stimulator
(TENS) and Electrical Muscle Stimulation (EMS), 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 a warning system and the body’s method of telling us that
something is wrong. Pain is important; without it abnormal conditions
may go undetected, causing damage or injury to vital parts of our
bodies. Even though pain is a necessary warning signal of trauma or
malfunction in the body, nature may have gone too far in its design.
Aside from its value in diagnosis, long-lasting persistent pain serves
no useful purpose. Pain does not begin until the coded message
travels to the brain where it is decoded, analyzed, and then reacted to.
The pain message travels from the injured area along the small
nerves leading to the spinal cord. Here the message is switched to
different nerves that travel up the spinal cord to the brain. The pain
message is then interpreted, referred back and the pain is felt.
EXPLANATION OF TENS
Transcutaneous Electrical Nerve Stimulation (TENS) is a non
invasive, drug free method of controlling pain. TENS uses tiny
electrical impulses sent through the skin to nerves to modify your
pain perception. TENS does not cure any physiological problem;
it only helps control the pain. TENS does not work for everyone;

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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 modied while stimulation actually
occurs. You may discuss this with your physician or therapist.
EXPLANATION OF EMS
Electrical Muscle Stimulation (EMS) 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. This device 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 exes as in

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physical exercise. Then when the pulse ceases, the muscle
relaxes and the cycle is repeated. 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. EMS works similarly but uses an external source
(the stimulator)with electrodes attached to the skin for transmitting
electrical impulses into the body. The impulses stimulate the
nerves to send signals to a specically targeted muscle, which
reacts by contracting, just as it does with normal muscular activity.
1.3 Indication for use
InTENSityTM Twin Stim~ Ill Stimulator may be used for the following
conditions:
For Transcutaneous Electrical Nerve Stimulator therapeutic
modes (TENS):
1) Symptomatic relief of chronic intractable pain.
2) Post traumatic pain.
3) Post surgical pain.
For Electrical Muscle Stimulation I Neuromuscular Stimulation
therapeutic mode (EMS):
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.
IMPORTANT SAFETY INFORMATION!
Read the 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.

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1.4 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,
inamed 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 ow through the carotid sinus region
(anterior neck) or transcerebrally (through the head).
5) Do not use this device if the patient has a demand-type
cardiac pacemaker or any implanted debrillator.
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.
1.5 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.
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, such
as headache.

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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 reex.
8) 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 difculty 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). Take extreme caution not
to place near or on the two large pectoral muscles. Here it
can increase the risk of ventricular brillation 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.

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19) Keep the stimulator out of reach of children.
20) Consult your doctor if you are in any doubt whatsoever.
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 not intended for unattended, personal
use by patients who have noncompliant, emotionally
disturbed, dementia, or low lQ.
5) Read, understand, and practice the warnings, cautions and
operating instructions. Know the limitations and hazards
associated with using any device. Observe the cautionary 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 debrillator, or any other
metallic or electronic device should not use this device without
rst consulting a doctor.
9) Stimulation delivered by this device may be sufcient to
cause electrocution. Electrical current of this magnitude must
not ow 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 difcult, 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 ow transcerebrally (through the
head).
12) Patients with heart disease, epilepsy, cancer or any other
health condition should not use this device without rst
consulting a physician.

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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 qualied in the management of pain aficted patients.
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 ammable 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 ammable mixture.

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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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2. PRESENTATION
2.1 Front and Rear Panel
1) Output socket: electric signal output after connection of the cable
with adhesive electrodes channel 1
2) Output socket: electric signal output after connection of the cable
with adhesive electrodes channel 2
3) Increasing the output intensity of channel 1 [A]. Use to set the
application program and the parameter of the waveform in the
setting state.
4) Decreasing the output intensity of channel 1 [V]. Use to set
the application program and the parameter of the waveform in
the setting state and to unlock the current treatment program.
5) Therapeutic mode selection. Stop the treatment. Exit setting
mode to return to the user interface.
6) LCD display: Shows the operating state of the device.
7) Increasing the output intensity of channel 2 [A]. Use to set the
application program and the parameter of the waveform in the
setting state.

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8) Decreasing the output intensity of channel 2 [V]. Use to set
the application program and the parameter of the waveform in
the setting state and to unlock the current treatment program.
9) Parameter Selection: press the button to enter setting
state; you can select the different parameters in
conjunction with [A] and [V].
10) Press [.b} to turn ON. Press [9] button and hold for
approximately 3 seconds to turn off the device.
11) Belt Clip
12) The battery compartment cover
13) Adapter Receptacle
2~2 LCD display
1) Displays therapeutic mode.
2) Displays therapeutic program.
3) Displays Delay time for EMS or Displays the cycle time for
TENS in setting state.
4) Timer symbol.
5) EMS waveform of ramp up and ramp down time.
6) Display of waveform pulse width.
7) Displays channel 1.
8) Display of the output intensity for channel I (Cl-Il); Display of
waveform pulse width or EMS waveform of contraction
(working) time in setting state.
9) EMS waveform of contraction (working) time.
10) The device is locked indicator.
11) Display of waveform pulse rate.

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12) Display of the output intensity for channel 2 (CH2); Display
of waveform pulse rate or EMS waveform of relaxation time
in setting state.
13) Displays channel 2.
14) EMS waveform of relaxation time.
15) Displays the treatment time or EMS waveform of ramp up and
ramp down time.
16) Low-battery indicator.

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3. Specication
3.1 Accessories
NO DESCRIPCIÓN CANTIDAD
1 Electrical stimulator device 1 piece
2 2 Electrode Leads 2 piecess
3 3 1.5” x 1.5” Adhesive Electrodes 4 piecess
4 4 9V Alkaline Battery, type 6LR61 1 piece
5 5 Instruction Manual 1 piece
6 6 Carrying case 1 piece
77 AC Adapter (optional) 1 piece
3.2 Technical information
Channel Dual, isolated between channels
Power Supply 9.0 V Alkaline DC-Ix6LR61 battery
Adapter output: 9.OVdc, 800mA(optional)
Operating
Conditions
5°C to 40°C ( 41°F – 104°F ) with a relative
humidity of 30% – 75%, atmospheric pressure from
700 – 1060 hPa.
Storage
Conditions
-10°C to 50°C (14°F to 122°F)with a relative
humidity of 10%-90%, atmospheric pressure from
700 – 1060 hPa
Dimensions 4.5 x 2.55 x 0.9 inches(LxWxH)
Weight 0.28 lbs. (With battery)
Tolerance There may be a ±5% tolerance of all setting
and ±10% tolerance of output of intensity.
Timer Adjustable from 1 – 60 minutes or continuous.
Adjusts in 1 minute steps. Treatment time
countdown is automatic.
Electrode
Detection
Function
The amplitude level will be reset to OmA when the
amplitude level is 12mA or greater and an open
circuit at either channel is detected.

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Technical specications for Transcutaneous Electrical Nerve
Stimulator (TENS) mode
Waveform Mono-phase square pulse wave
Pulse amplitude Adjustable, 0—lO5mA at 1000 ohm Load each
channel, imA/step
Pulse Width Adjustable, from 50 to 300ps, lOps/step.
Pulse Rate Adjustable, from I to 150 Hz, 1 Hz/step
Burst (B) Burst rate: Adjustable, 0.5 – 5Hz
Pulse width adjustable, 50 – 300ps
Frequency xed = 10Hz
Normal (N) The pulse rate and pulse width are adjustable.
It generates continuous stimulation based on
the setting value.
Pulse Width
Modulation (M)
The pulse width is automatically varied in a cycle
time. The pulse width is decreased from its original
setting to 60% in setting cycle time, and then
increased from 60% to its original setting in nest
setting cycle time. In this program, pulse rate
(1 – 150Hz), pulse width (50 – 300ps)
and cycle time (5 – 30 sec) are fully adjustable.
Pulse Rate
Modulation (M1)
The pulse rate is automatically varied in a cycle
time. The pulse rate is decreased from its original
setting to 60% in setting cycle time, and then
increasing from 60% to its original setting in nest
setting cycle time. In this program, pulse rate
(1 – 150Hz), pulse width (50 – 300ps) and cycle
time (5 – 30 sec) are fully adjustable.

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Technical specications for Electrical Muscle Stimulation
(EMS) mode
Waveform Onda de pulso cuadrada monofásica.
Pulse amplitude Adjustable, 0~105 mA at 1,000 ohm Load each
channel, 1 mA/step.
Pulse Width Adjustable, from 50 – 300µs.
Pulse Rate Adjustable, from 1 – 150 Hz, 1 Hz/step.
Contraction time Adjustable, 1—60 seconds, I Sec./step
Relaxation
(OFF) time Adjustable, 0—60 seconds, 1 Sec./step
Ramp time Adjustable, 1 – 6 seconds, I Sec./step,
The “On” time will increase and decrease
in the setting value..
Synchronous (S) Stimulation of both channels occurs
synchronously. The “ON” time including
"Contraction", "Ramp Up" and "Ramp Down" time.
ON TIME = Contraction + Ramp up + Ramp down
Alternate (A) The Stimulation of the CH2 will occur after the
1st operation of CH1 is completed. In this
program, The “ON” time including “Contraction”,
“Ramp Up” and “Ramp Down” time. The OFF
Time should be equal or more than the ON Time
ON TIME = Contraction + Ramp up + Ramp down
OFF TIME ≤ ON TIME
Delay (D) The Stimulation of the CH2 will occur after CH1
is started + Delay Time. In this program, The
“ON” time includes “Contraction”, “Ramp Up” and
Ramp up + Ramp down Time. The OFF Time
should be equal or more than the ON Time +
Delay Time. Time Delay time is adjustable from
1 – 10 seconds in this program.

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3~3 The waveforms of the stimulation programs
Burst (B)
Normal (N)
Pulse Width Modulation
Pulse Rate Modulation
Cycle Time
Cycle Time
Burst Frequency 7 pulses
per burst

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Synchronous(S)
Afternate (A)
De[ay(D)
On Time Off Time
Delay Time

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4. INSTRUCTIONS FOR USE
4 .1 Battery
4.1.1 ChecklReplace the battery
Over time, in order to ensure the
functional safety of device, the battery
must be periodically changed.
1) Slide the battery compartment
cover and open.
2) Insert the 9V battery into the
battery compartment.
3) Make sure you are installing the
battery properly. Be sure to match the positive and negative ends
of the battery to the marking in the battery compartment of the device.
4) Press and pull down following the direction of the arrow
indicated on the photo.
5) Replacing the battery compartment cover and press to close
6) If replacing the battery, you should slide the battery compartment
cover and open. Pull up the battery following the direction of
the arrow indicated on the photo. And insert the 9V battery
according to the above steps 2-5.
4.1.2 Disposal of battery
Spent batteries do not belong in household waste.
Dispose of the battery according to the current federal,
state and local regulations.
Caution:
1) Battery may be fatal if swallowed. Therefore, keep the battery and
the product out of the range of children, if a battery was swallowed,
consult a physician immediately.
2) If a battery has leaked, avoid contact with skin, eyes and mucus
membranes. Rinse the affected spots with clear water immediately
and contact a physician right away.
3) Battery may not be charged, dismantled, thrown into re or
short-circuited.
4) Protect battery from excess heat; Take the battery out of the product
if they are spent or in case you no longer use the article, This
prevents damage caused by leaking
5) Always replace the same type battery