Current Solutions InTENSity Select Combo User manual

TENSPros
SELECT Combo
INSTRUCTION MANUAL

TENSPros
This manual is valid for the InTENSity Select
Combo
TENS/IF/MIC/EMS 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. V1.1 © 2010
: United States Federal Law restricts this device to sale by
or on the order of a physician or licensed practitioner
Conformity to safety standards
Current Solutions™, LLC declares that the device complies with
following normative document:
IEC60601-1, IEC60601-1-2, IEC60601-2-10,IEC60601-1-4,
ISO10993-5, ISO10993-10, ISO10993-1
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Table of Contents
1．
．
SAFETY INFORMATION…..…………………………................
1.1 General description
1.2 Medical background
1.3 Indication for use
1.4 Contraindications
1.5 Warnings, Cautions, Adverse Reactions
2 PRESENTATION…………………………………………………..
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 Safety 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 cables
6.5 Maintenance
7．TROUBLESHOOTING………………………………….…………
8．STORAGE……………………………………………................…
9．DISPOSAL………………………………………………….........…
10．ELECTROMAGNETIC COMPATIBILITY(EMC)TABLES........
11．GLOSSARY OF SYMBOLS …..............................................
12．WARRANTY…………………..................................................
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1. Safety information
1.1 General
Combo is a portable electrotherapy device
featuring four therapeutic modes : Transcutaneous Electrical Nerve
Stimulation (T
pain relief and electrical muscle stimulation. The stimulator sends
gentle electrical current to underlying nerves and muscle groups
via electrodes applied on the skin. The parameters of the 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
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only helps control the pain. TENS does not work for everyone;
however, in most patients it is effective in reducing or eliminating
the pain, allowing for a return to normal activity.
HOW TENS WORKS
There is nothing “magic” about Transcutaneous Electrical Nerve
Stimulation (TENS). TENS is intended to be used to relieve pain.
The TENS unit sends comfortable impulses through the skin that
stimulate the nerve (or nerves) in the treatment area. In many
cases, this stimulation will greatly reduce or eliminate the pain
sensation the patient feels. Pain relief varies by individual patient,
mode selected for therapy, and the type of pain. In many patients,
the reduction or elimination of pain lasts longer than the actual
period of stimulation (sometimes as much as three to four times
longer). In others, pain is only modified while stimulation actually
Occurs. You may 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 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.
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HOW EMS WORKS
The EMS units send comfortable impulses through the skin that
stimulate the nerves in the treatment area. When the muscle
receives this signal it contracts as if the brain has sent the signal
itself. As the signal strength increases, the muscle flexes as in
physical exercise. Then when the pulse ceases, the muscle relaxes
and the cycle 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.
WHAT IS IF?
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
4,100 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 stimulate muscle nerves to achieve the
symptomatic relief of chronic intractable pain, post-traumatic pain,
and post-surgical pain.
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WHAT IS MICROCURRENT?
Microcurrent stimulation is a type of therapy in which very low
current is sent into the cells of the body. Microcurrent is a very faint
current that is so small it is measured in millionths of an amp
(Microamps). Human cells generate a current that is in the micro
amp range which is why you can’t feel it - the current is so low it
doesn’t stimulate the sensory nerves.
Microcurrent is a physiological electric modality that increases ATP
(energy) production in the cells of your body. This dramatically
increases the tissue’s healing rate. The immediate response to the
correct microcurrent frequency suggests that other mechanisms
are involved as well. The exact effects or changes in the tissue are
unmistakable; scars will often suddenly soften; trigger points often
become less painful within minutes when the “correct” frequency is
applied. In many situations the changes seen seem to be long
lasting and in many cases permanent.
1.3 Indication for use
Combo TENS/EMS/IF/MIC Stimulator may be
used for the following conditions:
For Transcutaneous Electrical Nerve Stimulator / Interferential/
Microcurrent therapeutic modes (TENS/IF/MIC)
1)
2)
3)
Symptomatic relief of chronic pain
Post traumatic pain
Post surgical pain
For Electrical Muscle Stimulation / Neuromuscular Stimulation
therapeutic mode (EMS)
1)
2)
3)
4)
5)
6)
Relaxation of muscle spasms
Increase of blood flow circulation
Prevention of disuse atrophy
Muscle re-education
Maintaining or increasing range of motion
Immediate post-surgical stimulation of lower leg muscles to
prevent venous thrombosis
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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.
1.4 Contraindications

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1.5 Warnings, Cautions and Adverse Reactions
WARNINGS:
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CAUTIONS:
1) Federal law (USA) restricts this device to sale by or on the
order of a physician.
2) For single patient use only.
3) Keep yourself informed of the contraindications.
4) This stimulator not intended for unattended, personal use by
patients who have noncompliant, emotionally disturbed,
dementia, or low IQ.
5) Read, understand, and practice the warnings, cautions and
operating instructions. Know the limitations and hazards
associated with using any device. Observe the 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 defibrillator, or any other metallic or
electronic device should not use this device without first
consulting a doctor.
9) Stimulation delivered by this device may be sufficient to cause
electrocution. Electrical current of this magnitude must not flow
through the thorax or across the chest because it may cause a
cardiac arrhythmia.
10) Do not place electrodes on the front of the throat as spasm of
the Laryngeal and Pharyngeal muscle may occur. Stimulation
over the carotid sinus (neck region) may close the airways,
make breathing difficult, and may have adverse effects on the
heart rhythm or blood pressure.
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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.
14) Electrode placement and stimulation settings should be based
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Adverse Reactions:
1) 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.
2) If the stimulation levels are uncomfortable, reduce the
stimulation Intensity to a comfortable level and contact your
physician if any problems persist.
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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 on channel 1.
2) Output socket: electric signal output after connection of the
cable with adhesive electrodes on channel 2.
3) Increasing the output intensity of channel 1 [▲]. Use to set
the application program and the parameter of the waveform in
the setting state.
4) Decreasing the output intensity of channel 1 [▼]. 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 [▲]. 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 [▼]. Use to set
the application program and the parameter of the waveform
in the setting state. Use 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
[▲] and [▼].
10) Press [ ] to turn ON. Press [ ] button and hold for
approximately 3 seconds to turn off the device.
11) Belt Clip.
12) The battery compartment cover for user access.
13) Adapter Receptacle.
2.2 LCD display
1) Displays therapeutic mode.
2) Displays therapeutic program for TENS and EMS therapeutic
mode.
3) Displays therapeutic program for IF and MIC therapeutic mode
or displays the cycle time for TENS, IF and MIC therapeutic
mode 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 1 (CH1); Display of
waveform pulse width or EMS waveform of contraction
(working) time in setting state.

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3. Specification
3.1 Accessories
3.2 Technical information
Channel Dual, isolated between channels
Power supply 9.0 V Alkaline DC -1 *6LR61 battery
A
da
p
ter out
p
ut: 9.0Vdc
,
800mA(optional)
Operating conditions
5°C to 40°C （41℉to 104℉）with a relative
humidit
y
of
Storage conditions
-10°C to 50°C （14℉to 122℉）with a relative
humidity of
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%
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.
Adjusts in 1 minute steps. Treatment time
countdown is automatic.

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Technical specifications for Transcutaneous Electrical Nerve
Stimulator (TENS) mode
Waveform Mono-
p
hase s
q
ua
r
e
p
ulse wave
Pulse amplitude Adjustable, 0~105mA peak at 1000 ohm Load
each channel, 1mA/Step.
Pulse Width
A
d
j
ustable
,
f
r
om 50 to300us microseconds
,
Pulse Rate
A
d
j
ustable
,
f
r
om 1 to 150 Hz
,
1 Hz/ste
p
Burst (B) Burst rate: Adjustable, 0.5 ~ 5Hz
Pulse width adjustable, 50~300μS
=dexifycneuqerF
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.
10μS/step
100 Hz
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Technical specifications for Electrical Muscle Stimulation
(EMS) mode
Waveform: Mono-
p
hase s
q
ua
r
e
p
ulse wave
Pulse amplitude Adjustable, 0~105mA peak at 1000 ohm Load
each channel, 1mA/Step.
Pulse Width Adjustable, from 50 to 300μS microseconds,
10
μ
S/ste
p
.
Pulse Rate Adjustable, from 1 to 150 Hz, 1 Hz/step
Contraction time Adjustable, 1~60 seconds , 1 Sec./ step
Relaxation (OFF) 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
dow
Alternate (A) The Stimulation of the CH2 will occur after the
1st working 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
Ti
TI Ramp down
OFF TIME≥ON TIME
Delay (D) The Stimulation of the CH2 will occur after the
1st operation of CH1 is started+ Delay Time. 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 + Delay Time.
ON TIME=Contraction + Ramp up + Ramp
down

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Technical specifications for Interferential (IF) mode
Waveform Bi-phase square pulse
Pulse amplitude Adjustable, 0~70mA peak to peak at 1000 ohm Load
Pulse Rate Channel 1 – Fundamental frequency: 4000 Hz fixed
Channel 2 – Selectable frequency: 4001 to 4150 Hz
Interference frequency: 1 to 150 Hz.
Phase Width 125μS
Technical specifications for Microcurrent (MIC) mode
Waveform Mono-phase square pulse wave
Pulse amplitude Adjustable, 0~0.7mA peak at 1000 ohm Load each
channel
,
0.01mA/Step
Pulse Width (P.W.) Adjustable, from 2 to 200ms, 1ms/step
Pulse Rate (P.R.) Adjustable, from 1 to 150 Hz, 1 Hz/step
Constant(P1) Constant stimulation based on setting value. Only
pulse width, pulse rate and timer are adjustable in
this program. “Constant” is equal to the “Normal”
mode of a TENS therapeutic mode
Pulse Width
Modulation (P2)
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 (2 to 200ms) and cycle time (5 to
30 sec) are fully adjustable.
Pulse Rate
Modulation (P3)
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 (2
to 200ms) and cycle time (5 to 30 sec) are fully
adjustable.
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