II. User manual
1. Warnings
1) The long-term effects of chronic electrical stimulation are unknown.
2) Do not use stimulation over the main arteries around your neck.
3) Do not use stimulation over the neck or mouth. Severe spasm of muscles may
occur and the contractions may be strong enough to close the airway or cause
difficulty in breathing.
4) Do not apply stimulation directly to the heart area across the chest or on the chest.
5) Do not use stimulation on your head or across your head.
6) Do not use stimulation over swollen, infected, or inflamed areas or skin eruptions,
e.g., phlebitis, thrombophlebitis,varicose veins.
7) Do not use stimulation over, or in proximity to, cancerous lesions.
8) Do not use stimulation when charging the device.
2. Precautions
1) Do not use the muscle stimulator during pregnancy.
2) Do not use if you have heart problems.
3) Do not use if you have epilepsy.
4) Do not use the device in the presence of the following:
a. When there is a tendency to hemorrhage following acute trauma or fracture;
b. Following recent surgical procedures when muscle contraction may disrupt the
healing process;
c. Over the menstruating or pregnant uterus;
d. Over areas of the skin which lack normal sensation.
5) Do not use the products near the heart, it may cause fast or irregular heartbeat.
6) Some patients may experience skin irritation or hypersensitivity due to the
electrical stimulation or electrical conductive medium. The irritation can usually be
reduced by using an alternate conductive medium (like gel), or alternate electrode
placement.
7) Pch Life TENS & PMS must be kept out of the reach of children.
8) Pch Life TENS &PMS should be used only with the leads and electrodes
recommended for use by the manufacturer.
9) Never apply the pads to your skin with the power on, which will result in sudden
shock. If, during application, you want to move the pads to another body part, please
shut down the device first, and then move the pads to the place that you want to
stimulate.
10) Never use this product near the following devices: pacemakers or any other
embedded electronic medical devices, heart-lung machine and any other life keeping
electronic medical devices, electrocardiograph and any other medical screening and
monitoring devices. Simultaneous use of the Pch Life TENS & PMS and any of the
above devices will cause malfunction and can be very dangerous to the users.
11) Two pads should be used together as a pair. Always peel off the protective film on
the pads before use. To avoid an electrical short, do not connect two pads to each
other.
12) Do not apply pads to the same spot for over 60 minutes at a time.
13) Do not use the Pch Life TENS & PMS while driving, operating machinery, or
during any activity in which involuntary muscle contractions may put the user at
undue risk of injury.
14) Do not use the product in bathroom or a moist environment. Do not use while
bathing.
15) Do not use the product in the condition of air mixed with flammable gases.
16) Never use this product in concurrence with high frequency surgical equipment; it
may result in burns at the site of the stimulator electrodes and possible damage to the
control unit.
17) Never use this product near a microwave oven, or other high frequency
equipment.
18) Never use this product while it is being charged.
19) Do not operate the product in close proximity (e.g. 1m/3ft)) to shortwave
therapy equipment, it may produce instability in stimulator output.
3. Contraindication
1) Do not use this device on patients who have a cardiac pacemaker, implanted
defibrillator, or other implanted metallic or electronic device, because this may
cause electric shock, burns, electrical interference, or death.
2) Do not use this device on patients whose pain syndromes are undiagnosed.
3) Do not use this device during pregnancy.
4) Do not use this device on babies or infants who cannot express themselves.
4. Adverse Reactions
1) Patients may experience skin irritation and burns beneath the stimulation
electrodes applied to the skin;
2) Patients may experience headache and other painful sensations during or
following the application of electrical stimulation.
3) Patients should stop using the device and should consult with their physicians if
they experience adverse reactions from the device.
5. Indications for Use
TENS:
To be used for temporary relief of pain associated with sore and aching muscles in
the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg)
due to strain from exercise or normal household work activities. Choose Mode 1, 2
，
3, 5, 6.
PMS:
It is intended to be used to stimulate healthy muscles in order to improve and
facilitate muscle performance. Choose Mode 1, 4, 5, 6.
6. Description of the Device
6.1 General Description of the Device
Pch Life TENS & PMS is a portable and DC 3.7V battery powered multifunction
device, offering both Transcutaneous Electrical Nerve Stimulation (TENS) and
Powered Muscle Stimulation (PMS) qualities in one device.
Pch Life TENS & PMS has 6 operation modes, which can give certain electrical
pulses through electrode adhesive pads to the suggested area of the body where the
electrodes are placed.
The electronic stimulatory module has the operating elements of an ON/OFF Switch,
Display screen, Mode Selection key, Intensity Modification keys, Timing key, Pause
key, Output socket, and USB port for battery charging.
The display screen can show battery power, selected mode, current intensity, time
remaining of an application mode, and indication of a pause (Page 10, No. 10).
The device is equipped with accessories of electrode pads, electrode cables, a battery
charger, and one USB cable. The electrode cables are used to connect the pads to the
device; the USB cable is used to connect the charger and the built-in lithium battery.
All accessories, including USB cables, electrode pads, electrode cables, chargers can
only be changed or replaced by a qualified person.
The electrodes are interchangeable. The application area of electrode pads must be
larger than the smaller electrode pads. The electrode pads are provided by GMDASZ
Manufacturing Co., Ltd. with 510(k) cleared Number K092546.
6.2 Specifications and Essential performance:
(Essential performance: The values of pulse duration, amplitudes, and repetition
frequencies do not deviate by more than ±30% when measured with an error not
exceeding ±10% into a load resistance (500Ω) within the range specified by the
manufacturer.)
- Power supply: DC 3.7V
- Output voltage: 42V@500Ω
- Output current: 84mA@500Ω
- Consumed current: 40mA
- Pulse width: 100μS
- Frequency: 1~110Hz
- Smallest are of electrode pad: 4cm2
- Timer: 10~60 minutes
- Strength level adjustment: 20 grades
- Charger: Input: 100-240V 50/60Hz 0.18A Max; Output: DC5V 250mA; Class
II, not applied part, not suitable for use in the presence of a flammable gases,
with oxygen or nitrous oxide, or for continuous operation..
6.3 Features
* A large, easy to read LCD display
* Adjustable timer
* 6 Modes
* Rechargeable lithium battery
6.4 Mode Description
We suggested that you initially experiment using each of the 6 modes. The mode that
gives you the most desirable sensations and comfort is the most appropriate one to use
for your current condition.
1) Intensity should be set at a level where you will feel some muscular vibration and
involuntary muscle movements.
It should be set to give a comfortable feeling and should not be painful.
2) Timing of application should be at least 10 to 20 minutes.
3) Frequency of the application should be at least one to three times per day.
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