Current Solutions LG SMART TENS User manual

LG SMART TENS
INSTRUCTION MANUAL
'.

This manual is valid for the
LG SMART TENS Stimulator
Conformity to safety standards
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.V1.0 © 2011
: United States Federal Law restricts this device to sale by
or on the order of a physician or licensed practitioner
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

1. SAFETY INFORMATION…..…………………………............…….4
1.1 General
1.2 Medical background
1.3 Indication for use
1.4 Contraindications
1.5 Warnings, Cautions, Adverse Reactions
2. PRESENTATION…………………………….........……............… 10
2.1 Front and Rear panel
2.2 LCD display
3. SPECIFICATION………………………………………............….. 13
3.1 Accessories
3.2 Technical information
3.3 The waveforms of the stimulation programs
4. INSTRUCTION FOR USE …………………………………...........15
4.1 Battery
4.2 Connect electrodes to lead wires
4.3 Connect lead wires to device
4.4 Electrode
4.5 Turn ON
4.6 Select the Therapeutic Program
4.7Adjust Channel Intensity
4.8 Safety Lock Feature
4.9 Turn OFF
4.10 Low battery indicator
5. PROGRAM……………………………………………................… 21
6. CLEANING AND CARE……………………………...............….…22
6.1 Tips for skin care
6.2 Cleaning the device
6.3 Electrodes
6.4 Cleaning the Electrodes cords
6.5 Maintenance
7. TROUBLESHOOTING…………………………………...........…..26
8. STORAGE…………………………………………....................….28
9. DISPOSAL……………………………………………................….28
10. ELECTROMAGNETIC COMPATIBILITY (EMC) TABLES….... 28
11. ………………………….….............34
12. WARRANTY………………………………………..…................. 35
GLOSSARY OF SYMBOLS
TABLE OF CONTENTS
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1. SAFETY INFORMATION
1.1 General
LG SMART TENS stimulator is a portable electrotherapy
device featuring Transcutaneous Electrical Nerve Stimulation
(TENS) therapeutic device, which is used for pain relief. The
stimulator sends a gentle electrical current to underlying nerves
and muscle group via electrodes applied on the skin. The
parameters of device are controlled by the buttons. Its
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 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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5
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
Stimulations
1.3 Indication for use
LG SMART TENS Stimulator should be used for the
Symptomatic relief of chronic intractable pain, acute post
traumatic pain, acute post surgical pain and arthritis pain.
MPORTANT 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
1)
(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
patients, 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.
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,
inflamed 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 flow 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 defibrillator.
6) This device should not be used over poorly enervated areas.
7) Epilepsy
8) Serious arterial circulatory problems in the lower limbs
9) Abdominal or inguinal hernia
10) Do not use this device if you have heart disease without
consulting your physician.
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.
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
1.5 Warnings, Cautions and Adverse Reactions
WARNINGS:
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carotid sinus reflex.
8) Stimulation should not be applied over the anterior 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 difficulty 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), but above all not on the
two large pectoral muscles. Here it can increase the risk of
ventricular fibrillation 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.
19) Keep the stimulator out of reach of children.
20) Consult your doctor if you are in any doubt whatsoever.
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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 precautionary
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.
11) Do not place electrodes on your head or at any sites that
may cause the electrical current to flow transcerebrally
(through the head).
12) Patients with heart disease, epilepsy, cancer or any other
health condition should not use this device without first
consulting a physician.
13) Some patients may experience skin irritation or

9
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.
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.
2) If the stimulation levels are uncomfortable, reduce the
stimulation 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.
2) Adapter Receptacle.
3) LCD display: Shows the operating state of the device.
4) Increasing the output intensity of channel 1.
5) Decreasing the output intensity of channel 1.
6) Select the treatment time from 15 minutes, 30 minutes,
60 minutes and continuous.
7) Increasing the output intensity of channel 2.
8) Decreasing the output intensity of channel 2.
9) Therapeutic part program selection and stop treatment.
10) Turn on or turn off the device.
11) Belt Clip.
12) The battery compartment cover.
)
DC9 V/0. 8A
LG SMART TENS

2.2 LCD Display
1) Display TENS therapeutic mode.
2) Lock function indicator.
3) Low-battery indicator.
4) Display numbers of the treatment time.
5) Timer symbol.
6) Display numbers of the output intensity for channel 1.
7) Display numbers of the output intensity for channel 2.
8) Display therapeutic program by body part.
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3. SPECIFICATION
3.1 Accessories
No DESCRIPTION Q’TY
1 TENS stimulator device 1 piece
2 Electrodes Leads 2 pieces
3 40mm x 40mm 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 supply 9.0 V Alkaline battery, type: 6LR61
Adapter output:9.0Vdc, 800mA (optional)
Operating
conditions
5°C to 40°C (41℉H to 104℉H)with a
relative humidity of 30%-75%,atmospheric
pressure from 700 to 1060 Hpa
Storage
conditions
-10°C to 50°C (14℉H to 122℉H)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 15,30,60 minutes and continuous
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Technical specifications
Waveform Mono-phase square pulse wave
Pulse
amplitude
Adjustable, 0~105mA peak at 1000 ohm
Load each channel, 1mA/Step.
Pulse Width From 100 to 260us microseconds
Pulse Rate From 50 to 150 Hz
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3.3 The waveforms of the stimulation programs
Normal
Pulse Width Modulation
Cycle time
Pulse Rate Modulation
Cycle time
Modulation(Pulse width and Pulse rate)
Cycle time

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 step 2) to 5).
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. As
a consumer, you are obligated by law to return
spent battery.
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.
15

Transparent Film
Connection Cables
CAUTION:
Always use the electrodes with CE mark, or which are
legally marketed in the US under 510(K) procedure.
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.
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4.3 Connect lead wires to device
1) Before proceeding to this step,
be sure the device is
completely turns OFF.
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 new 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.
17
LG SMA RT TENS

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.
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, 40mm x 40mm
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 at home.
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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 device, press the [ ] button and
then the operation page appears on the screen.
4.6 Select the therapeutic part program
LG SMART TENS Stimulator with 10 pre-set programs, the
details please refer to Page 21 <Programs>. The therapeutic
part program can be selected by pressing the [ S ] button control.
The therapeutic part program indicator will flash after you
selected. Apply electrodes to the exact site indicated by your
physician or therapist.
4.7 Select the treatment time
There are 4 choices available for the treatment time-15 min,
30min, 60min and continuous. The treatment time can be
selected by press [ T ] button.
4.8 Adjust channel intensity
Press the intensity control button ([▲] and [▼]) to control the
intensity output. Slowly press the intensity button control until you
reach the setting recommended by your physician or therapist.
Repeat for the other channel, if both channels are to be used.
CAUTION:
1) If the stimulation levels are uncomfortable or become
uncomfortable, reduce the stimulation intensity to a
comfortable level and contact your medical practitioner
if problems persist.
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2) If the electrodes no placed firmly on skin or the device
has not connected on the electrodes, the stimulator's
output intensity surpasses 12mA, the intensity will enulls
automatically.
3) You can press [S] button to stop the treatment if you
want, and the device enter into waiting mode(If the
button is locked, you should press only one of the [▼]
button first)
4.9. Safety Lock Feature
The Safety Lock Feature automatically activates after there is no
operation in the panel for 30 seconds by locking out the ability to
press the buttons. This is a safety feature to prevent accidental
changes to your settings and to prevent accidental increases to
the intensity levels. You can press either one of the [▼] button
to unlock the device.
4.10. Turn OFF
If you want to turn off the device, Press [ ] button is OK.
CAUTION:
If there is no operation in the panel for 2 minutes in the
waiting state, the device will be turns off automatically.
4.11. Low battery indicator
A battery symbol is shown on the display when the battery is
almost empty. As long as the stimulator is working normally you
can continue the treatment. When stimulation feels weaker than
usual or the stimulator turns off, it is time to replace the new
battery.
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