Current Solutions InTENSity Twin Stim III User manual

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TWIN STIM
®
III
INSTRUCTION MANUAL

TENSPros
This manual is valid for the InTENSityTM Twin Stim III
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.V1.1 © 2010
: 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
TENS/EMS Combo Stimulator

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Table of Contents
1. SAFETY INFORMATION…………………………………………………………………....
noitpircsedlareneG1.1
1.2 Medical background
1.3 Indication for use
1.4 Contraindications
1.5 Warnings, Cautions, Adverse Reactions
NOITATNESERP.2 ………………………………………………………………..………………...
2.1 Front and Rear panel
2.2 LCD display
3. SPECIFICATION……………………………………………………………..…………………....
3.1 Accessories
3.2 Technical information
3.3 The waveforms of the stimulation programs
4. INSTRUCTIONS FOR USE .........………………………..………………………………
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 Safty lock feature
4.10 Stop the treatment
4.11 Turn OFF
4.12 Low battery indicator
5. PROGRAM...........................................................................................................................…
6. CLEANING AND CARE…………………………………………………….………………..
6.1 Tips for skin care
6.2 Cleaning the device
6.3 Electrodes
6.4 Cleaning the Electrode cords
6.5 Maintenance
GNITOOHSELBUORT.7 ....……………………………………………………………………
8. STORAGE…………………………………………………………………………………….............
9. DISPOSAL…………………………………………………………………………………................
10. ELECTROMAGNETIC COMPATIBITY (EMC) TABLES
11. GLOSSARY OF SYMBOLS
……
12. WARRANTY
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1.1 General
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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InTENSityTM Twin Stim III
1.Safety information

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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 modified 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 flexes 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 specifically targeted muscle, which
reacts by contracting, just as it does with normal muscular activity.
1.3 Indication for use
Stimulator may be used for
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 / Neuromuscular Stimulation
therapeutic mode (EMS):
1) Relaxation of muscle spasm.
2) Increase of blood flow circulation.
3) Prevention of disuse atrophy.
4) Muscle re-education.
5) Maintaining or increasing range of motion.
imulation 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.
InTENSityTM Twin Stim III

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1.4 Contraindications
1.5 Warnings, Cautions and Adverse Reactions
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out of reach of children.
you are in any doubt whatsoever.
CAUTIONS:

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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 qualified in the management of pain afflicted 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 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.

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Adverse Reactions:

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2. Presentation
2.1 Front and Rear Panel
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intensity of channel 2 [▼]. Use to set
rameter of the waveform in
the current treatment program.
ss the button to enter setting
▲] and [▼].
Press [ ] button and hold for
cover for user access.
2.2 LCD display
or Displays the cycle time for
y for channel 1 (CH1); Display of
S waveform of contraction
raction (working) time
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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. Specification
3.1 Accessories
No DESCRIPTION Q’TY
1 Electrical stimulator device 1 piece
2 Electrode Leads 2 pieces
3 1.5”x 1.5” Adhesive Electrodes 4 pieces
4 9V Alkaline Battery, type 6LR61 1 piece
5 Instruction Manual 1 piece
6 Carrying case 1 piece
3.2 Technical information
Channel Dual, isolated between channels
Power
l
9.0 V DC-1 Alkaline *6LR61 battery(optional AC Adaptor)
Operating
conditions
5°C to 40°C （41 to 104℉ ℉）with a relative humidity of
30%-75%,atmospheric pressure from 700 to 1060 Hpa
Storage
conditions
-10°C to 50°C （14℉to 122℉）with a relative humidity of
10%-90%,atmospheric pressure from 700 to 1060 Hpa
Dimensions 4.5×2.55×0.9 inches(L*W*H)
Weight 0.28 lbs(With battery)
Tolerance There may be a ±5% tolerance of all setting and ±10%
tolerance of output of intensity.
Electrode
Detection
Function
The amplitude level will be reset to 0mA when the
amplitude level is 12mA or greater and an open circuit at
either channel is detected.
Timer
Adjustable, from 1 to 60 minutes or continuous, Adjustable
in 1minutes each step. Treatment time countdown
automatically.

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Technical specifications for Transcutaneous Electrical Nerve
Stimulator (TENS) mode
Waveform Mono-phase square pulse wave
Pulse amplitude Adjustable, 0~105mA peak at 1000 ohm Load each
channel, 1mA/Ste
p
.
Pulse Width Adjustable, from 50 to 300us microseconds, 10μS/step
Pulse Rate Adjustable, from 1 to 150 Hz, 1 Hz/step
Burst (B)
Burst rate: Adjustable, 0.5 ~ 5Hz
Pulse width adjustable,50-300uS
Frequency fixed=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 to 150Hz), pulse width (50
to 300us) and cycle time (5 to 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 increased from
60% to its original setting in nest setting cycle time. In
this program, pulse rate (1 to 150Hz), pulse width (50
to 300us) and cycle time (5 to 30 sec) are fully
adjustable.

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Technical specifications for Electrical Muscle Stimulation
(EMS) mode
Waveform: Mono-phase square pulse wave
Pulse amplitude Adjustable, 0~105mA peak at 1000 ohm Load each
channel, 1mA/Step.
Pulse Width Adjustable, from 50 to 300μS microseconds,
Pulse Rate Adjustable, from 1 to 150 Hz, 1 Hz/step
Contraction time Adjustable, 1~60 seconds , 1 Sec./ step
Relaxation (OFF) time Adjustable, 0~60 seconds , 1 Sec./ step
Ramp time Adjustable, 1~6 seconds, 1 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 Down”
time. ON TIME = Contraction + 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 to 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

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Synchronous(S)
Alternate (A)
Delay (D)
4. Instruction for use
4 .1 Battery
4.1.1 Check/Replace the 9V ALKALINE battery
Over time, in order to ensure the
functional safety of device, the battery
must be periodically changed.
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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 lots of
clear water immediately and contact a physician right
away.
3) Battery may not be charged, dismantled, thrown into fire
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 battery.
5) Always replace the same type battery.
4.2 Connect electrodes to lead wires
Insert the lead wire connector into
electrode connector (standard 0.08 inch
female connection). Make sure there are
no bare metal pins exposed.
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