intensity IF COMBO DI4738 User manual

TENSPros
if combo
INSTRUCTION MANUAL

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This manual is valid for the InTENSityTM IF
Combo TENS and IF 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 INFORMATIO 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………
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．INSTRUCTION FOR U
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……………………………………………………….……23
6．…………………………………….……...24
6.1 Tips for skin care
6.2 Cleaning the device
6.3 Electrodes
6.4 Cleaning the Electrode cords
6.5 Maintenance
7．TROUBLESHOOTIN
8．STORAGE…………………………
9．
10．ELECTROMAGNETIC COMPATIB
11．GLOSSARY OF SYMBLOS

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1. Safety information
1.1 General
InTENSityT M
IF Combo stimulator is a portable electrotherapy device
featuring two therapeutic modes: Transcutaneous Electrical Nerve
Stimulation (TENS) and Interferential (IF), which are used for pain
relief. 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 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
HOW TENS WORKS
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;
however, in most patients it is effective in reducing or eliminating the
pain, allowing for a return to normal activity.
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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,

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EXPLANATION OF 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.
1.3 Indication for use
InTENSityT M IF Combo Stimulator may be used for the Symptomatic
relief of chronic intractable pain, acute post traumatic pain or acute
post surgical pain.
IMPORTANT SAFETY INFORMATION!
Read 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
1This device should not be used for symptomatic local pain relief
unless etiology is established or unless a pain syndrome has
been diagnosed.
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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.

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1.5 Warnings, Cautions and Adverse Reactions
WARNINGS:
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.
6) Electronic monitoring equipment (such as ECG monitors and
ECG alarms) may not operate properly when electrical stimulation
is in use.
7) Stimulation should not be applied over the carotid sinus nerves,
particularly in patients with a known sensitivity to the carotid sinus
reflex.
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This device should not be used on patients with epilepsy.
This device should not be used on patients with serious arterial
circulatory problems in the lower limbs
This device should not be used on patients with abdominal or
inguinal hernia

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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.

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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)
1)
2)
This device has no AP/APG protection. Do not use it in the
presence of explosive atmosphere and flammable mixture.
Adverse Reactions:
Skin irritation from the electrode gel and electrode burns are
potential adverse reactions. If skin irritation occurs, discontinue
use and consult your physician.
If the stimulation levels are uncomfortable, reduce the stimulation
Note: Always use electrodes that are legally marketed and sold in
the United States under 510K guidelines.
Intensity to a comfortable level and contact your physician if
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 channel 1.
2) Output socket: electric signal output after connection of the cable
with adhesive electrodes channel 2.
3) Therapeutic mode selection (M). Stop the treatment. Exit setting
mode to the user interface.
4) Increasing the output intensity of channel 1 [▲]. To set the
application program and the parameter of the waveform in the
setting state.
5) Decreasing the output intensity of channel 1 [▼]. To set the
application program and the parameter of the waveform in the
setting state. To unlock the current treatment program.
6) LCD display: Shows the operating state of the device.
7) Parameter Selection (S): press the button to enter setting state;
you can select the difference parameters in conjunction with [▲]
and [▼].

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▲]. To set the
] button and hold for
▼]. To set the
2.2 LCD display

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3. Specification
3.1 Accessories
No DESCRIPTION Q’TY
1 Electrical stimulator device 1 piece
2 Electrodes 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
7 AC Adaptor (optional) 1 piece
3.2 Technical information
Channel Dual, isolated between channels
Power supply 9.0 V Alkaline DC -1 *6LR61 battery
Adapter output:9.0Vdc 800mA
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/Step.
Pulse Width Adjustable, from 50 to 300us
microseconds, 10μS/step
Pulse Rate Adjustable, from 1 to 150 Hz, 1
Hz/step
Burst (P1)
Burst rate: Adjustable, 0.5 ~ 5Hz;
0.1Hz/step
Pulse width adjustable, 50~300μS
Frequency fixed = 100 Hz
Normal (P2)
The pulse rate and pulse width are
adjustable. It generates continuous
stimulation based on the setting
value.
Pulse Width Modulation
(P3)
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 (P4)
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 Interferential (IF) mode
Waveform Bi-phase square pulse
Pulse amplitude Adjustable, 0~70mA peak to peak at 1000
ohm Load each channel, 1mA/Step.
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
P1
The pulse rate of the CH1 is fixed in
4000Hz; CH2 pulse rate is increased from
4001Hz to 4010Hz in a cycle time, and then
decreased from 4010Hz to 4001Hz in nest
setting cycle time. In this program, CH2
interference frequency is varied from 1Hz to
10Hz, cycle time (5 to 30 sec) is fully
adjustable.
CH 2 pulse rate=4000Hz+ Interference
frequency
P2
The pulse rate of the CH1 is fixed in
4000Hz; CH2 pulse rate is increased from
4001Hz to 4150Hz in a cycle time, and then
decreased from 4150Hz to 4001Hz in nest
setting cycle time. In this program, CH2
interference frequency is varied from 1Hz to
150Hz, cycle time (5 to 30 sec) is fully
adjustable.
CH 2 pulse rate=4000Hz+ Interference
frequency
P3
The pulse rate of the CH1 is fixed in
4000Hz; CH2 pulse rate is increased from
4080Hz to 4150Hz in a cycle time, and then
decreased from 4150Hz to 4080Hz in nest
setting cycle time. In this program, CH2
interference frequency is varied from 80Hz
to 150Hz, cycle time (5 to 30 sec) is fully
adjustable.
CH 2 pulse rate=4000Hz+ Interference
frequency
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P4
The pulse rate of the CH1 is fixed in
4000Hz; CH2 pulse rate is automatically
varied in a cycle time. Interference
frequency is increased from its original
setting to 60% in setting cycle time, and
then decreased from 60% to its original
setting in nest setting cycle time. In this
program, CH2 interference frequency (2 to
150Hz) and cycle time (5 to 30 sec) are fully
adjustable.
CH 2 pulse rate=4000Hz+ Interference
frequency
3.3 The waveforms of the stimulation programs
Burst
Normal
Pulse Width Modulation
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Pulse Rate Modulation
Interferential
4. Instruction for use
4 .1 Battery
4.1.1 Check/Replace the battery
Over time, in order to ensure the functional
safety of device, changing the battery is
necessary.
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) Replace the battery compartment cover and press to close
6) If replace 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.
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4.1.2 Disposal of battery
Spent batteries do not belong in the 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 electrodes
connector (standard 0.08 inch female
connection). Make sure no bare metal of the
pins is exposed.
Caution:
Always use the electrodes with the requirements of the
IEC/EN60601-1 ，ISO10993-1/-5/-10 and IEC/ EN60601-1-2, such
as with CE mark, or which are legally marketed in the US under
510(K) procedure.
4.3 Connect lead wires to device
1) Before proceeding to this step, be sure the device is completely
turns OFF.
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2) The wires provided with the system insert
into the jack sockets located on top of the
device.
3) 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.
4) This device has two output receptacles controlled by Channel 1
and Channel 2 at the top of the unit. You may choose to use one
channel with one pair of lead wires or both channels with two
pairs of lead wires. Using both channels gives the user the
advantage of stimulating two different areas at the same time.
Caution:
Do not insert the plug of the patient lead wire into any AC power
supply socket.
4.4 Electrode
4.4.1 Electrode options
The electrodes are disposable and should be routinely replaced
when they start to lose their adhesive nature. If you are unsure of
your electrode adhesive properties, order replacement electrodes.
Replacement electrodes should be re-ordered through or on the
advice of your physician to ensure proper quality. Follow application
procedures outlined in electrode packing, to maintain optimal
stimulation and to prevent skin irritation.
4.4.2 Place electrodes on skin
Apply electrodes to the exact site indicated by
your physician or therapist, before applying
electrodes, be sure the skin surface over
which electrodes are placed is thoroughly
cleaned and dried. Make sure the electrodes
are placed firmly to the skin and make good contact between the
skin and the electrodes. Place the electrodes over the skin; attach
them properly, firmly, and evenly.
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Caution:
1) Before applying the self-adhesive electrodes, it is
recommended to wash and degrease the skin, and then dry it.
2) Do not turns on the device when the self-adhesive electrodes
are not positioned on the body.
3) Never remove the self-adhesive electrodes from the skin
while the device is still turns on.
4) It is recommended that, at minimum 1.5" x 1.5" self-adhering
based, square electrodes are used at the treatment area
4.4.3 Electrode placement
The placement of electrodes can be one of the most important
parameters in achieving success with 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.
4.5 Turn on
Before using the device for the first time, you are strongly advised to
take careful note of the contraindications and safety measures
detailed at the beginning of this manual (Safety information), as this
powerful equipment is neither a toy nor a gadget !
In order to turn on the devi
The operation page appears on the screen.
4.6 Select the Therapeutic Mode
There are two therapeutic modes available –TENS and IF. The
therapeutic mode can be selected by pressing the [M] control.

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Caution:
Consult your physician for your suitable therapeutic mode
4.7 Steps to Set a New Program
4.7.1 TENS Setting
Press the [S]button cycle to enter the setting state. The settings can
be adjusted according to the following steps:
1) Set the Therapeutic Program
There are 4 programs in TENS therapeutic mode available –Burst
(P1), Normal (P2), Pulse Width Modulation (P3), and Pulse Rate
Modulation (P4). The therapeutic program
can be selected by pressing the [▲] and [▼]
button.
2) Set Cycle Time (Optional)
Cycle time is adjustable form 5 to 30 seconds.
Only modulation has this parameter setting.
Press [S] button cycle to enter this menu, and then press the [▲] and
[▼] button to adjusting the setting.
3) Set Timer
Press [S] button cycle to enter this setting. The treatment time is
adjustable from 1 to 60 minut
control to adjust setting. You can set the timer to “Continuous” mode
by pressing the [▲] control when it shows 60 minutes. Its output will
be shut off when time is up.
4) Set Pulse Width
Pulse Width is adjustable from 50 us to 300 us. Press [S] button to
enter this menu, then press [▲] or [▼] button to adjust the setting.
5) Set Pulse Rate
Pulse rate is adjustable from 1 Hz to 150 Hz (0, 5 Hz to 5 Hz for
Burst). Press [S] button cycle to enter this menu, and then press [▲]
or [▼] button to adjust the setting.