Current Solutions Intensity IF Combo User Manual
if combo
INSTRUCTION MANUAL
This manual is valid for the InTENSity
TM
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
Table of Contents
1．SAFETY INFORMATIO
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
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5．PROGRAM……………………………………………………….……23
6．
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
…………………………………….……...24
1. Safety information
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1.1 General
InTENSity
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.
TM
IF Combo stimulator is a portable electrotherapy device
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
Transcutaneous Electrical Nerve Stimulation (TENS) is a noninvasive, 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.
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,
5
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 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 electriccurrent 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
InTENSity
T 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
This device should not be used for symptomatic local pain relief
1
unless etiology is established or unless a pain syndrome has
been diagnosed.
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
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.
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.
17) The electrodes are only to be placed on healthy skin. Avoid
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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.
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
problems persist.
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 [▼].
▲]. To set the
] button and hold for
▼]. To set the
2.2 LCD display
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