Factory Direct Medical PAINLESS TENS User manual

PAINLESS TENS ™
Wireless
Rechargeable
Instruction Manual

Contents
Introduction 2
Indications for Use 2
Parts 3
Safety Warnings 4
Specifications/Battery Information 7
Operating Instructions 8
Recommended Use 0
Recommended Electrode Placements 0
Cleaning and Storage
Troubleshooting
Introduction
The wireless PAINLESS TENS is a single-channel transcutaneous electrical nerve
stimulator (TENS) for over-the-counter (No prescription is required) use of pain relief.
The device generates small pulses of electrical current and delivers the pulses to the
user’s skin through adhesive gel electrode pads such that the underlying nerves are
activated and the pain associated with sore and aching muscles is relieved.
The PAINLESS TENS is portable, compact, rechargeable and stylish in design. It
may help relieve pain in various areas of body, such as the lower back, shoulders, arms
and legs.
Indications for Use
To be used for relief of pain associated with sore and aching muscles in the shoulder,
waist, back, arm, and leg due to strain from exercise or normal household and work
activities.
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Parts Included
PAINLESS TENS ™
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Safety Warnings
Contraindications:
Do not use this device if you have a cardiac pacemaker, implanted defibrillator, or other
implanted metallic or electronic device. Such use could cause electric shock, burns,
electrical interference, or death.
Warnings:
. If you are in the care of a physician, consult with your physician before using
this device;
2. If you have had medical or physical treatment for your pain, consult with your
physician before using this device;
3. If your pain does not improve, becomes more than mild, or continues for more
than five days, stop using the device and consult with your physician;
4. Do not apply stimulation over your neck because this could cause severe muscle
spasms resulting in closure of your airway, difficulty in breathing, or adverse
effects on heart rhythm or blood pressure;
5. Do not apply stimulation across your chest because the introduction of electrical
current into the chest may cause rhythm disturbances to your heart, which could
be lethal;
6. Do not apply stimulation over open wounds or rashes, or over swollen, red,
infected, or inflamed areas or skin eruptions (e.g., phlebitis, thrombophlebitis,
varicose veins);
7. Do not apply stimulation over, or in proximity to, cancerous lesions;
8. Do not apply stimulation in the presence of electronic monitoring equipment
(e.g., cardiac monitors, ECG alarms), which may not operate properly when the
electrical stimulation device is in use;
9. Do not apply stimulation when in the bath or shower;
0. Do not apply stimulation while sleeping;
. Do not apply stimulation while driving, operating machinery, or during any
activity in which electrical stimulation can put you at risk of injury;
2. Do not use the device on children, if it has not been evaluated for pediatric use;
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3. Consult with your physician before using this device, because the device may
cause lethal rhythm disturbances to the heart in susceptible individuals;
4. Apply stimulation only to normal, intact, clean, healthy skin.
5. Using stimulation electrodes that are too small or incorrectly applied could
result in discomfort or skin burns.
Precautions:
. TENS is not effective for pain of central origin, including headache.
2. TENS is not a substitute for pain medications and other pain management
therapies.
3. TENS devices have no curative value.
4. TENS is a symptomatic treatment and, as such, suppresses the sensation of pain
that would otherwise serve as a protective mechanism. Effectiveness is highly
dependent upon patient selection by a practitioner qualified in the management
of pain patients.
5. The long-term effects of electrical stimulation are unknown.
6. Since the effects of stimulation of the brain are unknown, stimulation should not
be applied across your head, and electrodes should not be placed on opposite
sides of your head.
7. The safety of electrical stimulation during pregnancy has not been established.
8. You may experience skin irritation or hypersensitivity due to the electrical
stimulation or electrical conductive medium (gel).
9. If you have suspected or diagnosed heart disease, you should follow precautions
recommended by your physician.
0. If you have suspected or diagnosed epilepsy, you should follow precautions
recommended by your physician.
. Use caution if you have a tendency to bleed internally, such as following an
injury or fracture.
2. Consult with your physician prior to using the device after a recent surgical
procedure, because stimulation may disrupt the healing process.
3. Use caution if stimulation is applied over the menstruating or pregnant uterus.
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4. Use caution if stimulation is applied over areas of skin that lack normal
sensation;
5. Keep this device out of the reach of children.
6. Use this device only with the leads, electrodes, and accessories recommended by
the manufacturer.
Adverse Reactions:
. You may experience skin irritation and burns beneath the stimulation electrodes
applied to your skin.
2. You may experience headache and other painful sensations during or following
the application of electrical stimulation near your eyes and to your head and
face.
3. You should stop using the device and should consult with your physician if you
experience adverse reactions from the device.
4. Medical Electrical Equipment needs special precautions regarding
electromagnetic compatibility (EMC) and needs to be installed and put into
service according to the EMC information provided. Portable and mobile radio
frequency (RF) communication equipment can affect Medical Electrical
Equipment.
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Specifications:
•Size: 5.6 x 4.4 x .4 cm
•Weight: 20 g
•Power supply: DC 3.7V Lithium Rechargeable battery
•Channels: Single channel
•Waveform: Asymmetric biphasic pulse
•Intensity- 0-80 mA (500 ohms)
•Pulse width: 00μS
•Frequency: -60 Hz
•Timer: Continuous for 3 hour time duration period - then it shuts Off. Battery
holds charge for 2 hours on charge at Constant Intensity level of 0.
•Intensity: 20 levels/adjustable
•Mode: 3 pulse modes (modulations) automatically adjusts
•Operating condition: 5 oC to 40 oC（4 oF to 04 oF） with a relative humidity
of 35% ~ 75%, atmospheric pressure from 700 to 060 Hpa.
•Storage condition: - 0 oC to 50 oC（4 oF to 22 oF） with a relative humidity
of 0% ~ 90%, atmospheric pressure from 700 to 060 Hpa.
Safety Standards: IEC IEC6060 - , IEC6060 - -2: 993
European Conformity
European Directive 2002/96/EC 93/42/EEC
Battery Information:
LED Battery Indicator/Function
. When the light becomes red, the unit needs to be recharged.
2. When charging is finished the light goes green.
3. The unit can be recharged with the USB cable and AC adapter in the package, the
USB plugged into a computer and also with other approved 5V adapters.
Charging the Battery
. To charge the unit, it will take about .5 hour to complete a full charge.
2. The battery can last for 2 hours at Intensity level 0, used constantly - this is 50% of
the maximum Intensity level of 20.
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Operating Instructions
PAINLESS TENS ™
Control Unit
On/Off Power (Middle Circle Button)
+ Intensity Increase (Right Button)
- Intensity Decrease (Left Button)
On/Off LED Light Indicator (Top Green or Red Light)
Instructions for Use:
. Before using the system charge th e PAINLESS TENS with the enclosed USB
cable and adapter or connect the unit by the USB cable to a computer.
2. Make sure both (2) inputs of the PAINLESS TENS unit are connected into the
snap-pin connectors of the gel electrode pad.
Note: The unit comes with Butterfly shaped electrode pad so you use just
electrode pad with its 2 snap-pin connectors to attach to the 2 input connectors of
the TENS unit.
3. Peel off the plastic film from the opposite side of the gel electrode pad.
4. Place the PAINLESS TENS attached to the gel electrode pad onto the treatment
areas. Press down firmly and ensure a full and firm contact is made with the skin.
5. Press the On/Off power button to turn On the unit as indicated by the LED light
being green.
6. If the light is red the unit needs to be charged.
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7. When the unit is turned On and the LED is green the device will start an
automatically timed program set for a 3 hour treatment once you set the Intensity
level past 0 by pushing the “+” button.
8. There are 20 different Intensity levels of -20 adjusted by the “+” and “-” controls.
Push the “+” to begin a treatment cycle and adjust the intensity to a comfortable
level.
9. When you press “+” or “-” button on the unit, you can hear buzzer, which means
t h e intensity level is increasing or decreasing by level at a time. When the
Intensity level is increased to the highest level or decreased to the lowest level there
is no buzzer sound.
0. For every 30 minute treatment the unit goes through a cycle of 4 pre-programmed
modes at the Intensity level you adjust it to.
. When the pre-program timer of On for the 3 hour time duration is over, the unit will
automatically turn Off. If you want another 3 hour treatment cycle simply push the
On button and set the Intensity level again.
2. You can usually get about 0 treatments on re-charge of the battery.
3. The unit can also be turned Off by pressing the On/Off button. The LED light will
go out.
Note: When the electrode pad is not placed securely on the skin the condition will
be different as follows:
•Press “+” button, you can hear 3 buzzers, the green light will flash for 3
seconds which means the device is still Off, the intensity cannot be
increased. In this case, the pads should be repositioned firmly on the skin.
•If the Off state continues for minute or the Intensity level is 0 for minute,
the device will turn Off automatically.
Note: To conserve battery and prevent unexpected Intensity impulses, the device will
automatically power Off when not in use or when the electrodes are not attached
properly. If this occurs the green light will go Off.
If the LED light becomes blurry and/or the stimulation Intensity becomes weaker, it
means the battery power charge is low. It is time to recharge the device. After fully
charging the device the LED green light will show the unit is On.
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Accessories:
Accessories to this unit can be purchased separately. These are smaller 2 inch round
and 2x3 inch rectangular electrodes with snap-pin connector pin on each
electrode. If you choose these, you use 2 of the smaller pads to connect to the 2
input connectors of the TENS unit. Use ONLY PAINLESS TENS electrodes with
this unit as other electrodes ma not work properl .
Recommended Use
•Start from the lowest Intensity and gradually adjust to the most comfortable
Intensity level from to 20.
•Be sure the area to be treated is free of perspiration, dirt and abrasions.
•Good skin care is important for a comfortable use of device. Be sure the
treatment site is clean of dirt and body lotion, and wipe with an alcohol pad if
needed.
•Keep gel electrode pad(s) covered with the plastic film after use. Keeping the
pad(s) clean will extend their lifespan, which will vary and depend on the
frequency of use. The average expected life of a gel electrode pad is 30 days
with normal use.
•You should ONLY use PAINLESS TENS gel electrodes with this unit. Other
gel electrode pads ma affect the proper use and effectiveness of this unit.
•The gel electrode pads should be replaced when they lose their adhesiveness. To
purchase additional pads, please contact the seller.
•Make sure the gel electrode pad is connected to both input pins on the
PAINLESS TENS unit.
Recommended Electrode Placement Points
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Cleaning and Storage
. Turn Off the device before cleaning.
2. The electrode pad of the device can be cleaned with a soft and wet cloth.
3. Never use excessive water or cleaning agents to clean the device.
4. The gel electrode pad can remain on the control unit between uses, and are
covered by the plastic film to avoid getting dirty and dry.
5. Avoid exposure to extreme moisture or temperature.
Troubleshooting
If your device is not operating properly, please check below for common problems and
suggested solutions. If the recommended action does not solve the problem, please
contact the seller.
Stimulation is weak or non-existent
•Be sure skin is clean and gel electrode pads are firmly attached to skin.
•The battery is low and needs to be charged.
•The gel electrode pad needs to be replaced.
Device does not turn on
•Check if battery is low and needs to be recharged.
Electrode pads are not sticky
•The gel electrode pads will lose adhesiveness over times of uses. Please contact
the seller for replacements.
Skin turns red
•Stop and treat another area.
•If problem persists, contact your physician.
Distributed by:
Factory Direct Medical
34 Futurity Gate, Unit 5
Concord, Ontario
L4K S6