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.
7. Direction for Use
7.1 General Operation Guidance
1) The Pch Life TENS & PMS unit needs to be charged for up to 10 hours before the
first use.
2) Connect the electrode cables to the output sockets at the bottom of the unit.
3) Connect the pads to the cables by snapping them on.
4) Use a damp towel to wipe the skin where you intend to put the pads, so as to
remove any body oil, cosmetic or dirt. Remove the protective film and place the pads
on the area making sure that both pads are on the skin and not overlapping.
Warning:
To avoid an electrical short, never put two electrode pads together.
5) Turn on the unit by sliding the On/Off switch from Off to On.
Warning:
Do not move pads or touch them with your hands during use, it may cause
strong stimulation.
6) When you have turned on the unit, the LCD display will automatically show Mode
1. The “T” (Timer) will automatically choose the time duration of 20 minutes.
7) To change the modes, press the M (Mode) button. Once you have selected a mode,
gradually increase the intensity by pressing the + button, and to decrease the intensity
by pressing the – button. The chosen power output depends on your comfort level. At
the precondition of acceptance, the intensity should be chosen as high as possible for
the best effect but still feel comfortable.
8) To set the time of use, press the T button. The auto time set is 20 minutes. Each
press of the T button increases the time by 10 minutes. After the time runs out the
device turns off automatically, and it can be restarted if treatment is needed to be
continued.
9) Sit back and enjoy the deep soothing sensations!
Notes: The Pch Life TENS & PMS unit is very safe, the output intensity increases
only by pushing the + key. Even if the intensity is increased to the maximum, it is
within the safe range, but may feel uncomfortable. When the user switches the mode,
the intensity will automatically go down to the minimum for safety reasons.
10) Press the Pause key (“►II” button) to lock the LCD display, the “MODE” display
will blink.The device will not work no matter what key you press on the control
panel,it is locked.To unlock press the Pause key again.
11) If you need to turn off the device during stimulation, slide the On/Off switch to
“OFF”.
12) Before storing the TENS & PMS use the protective film to cover the electrode
pads.
Notes:
①
Never connects this product with a common headphone.
②
Please do not touch the USB port when using the device. The USB port is only
used to connect the charger, do not connect other devices.
③
The charger supplied by the manufacturer must in compliance with IEC/EN
60601-1, the use of unauthorized chargers can impair the safety.
④
The battery needs to be charged for up to 10 hours before the first use.
7.2 Electrode guidelines
1) Use only the electrodes supplied by the manufacturer; other electrodes may
present a risk of unsuitable electrical characteristics with your stimulator.
2) Do not use the electrodes on different people, otherwise, skin reaction or cross
contamination may occur.
3) Always turn power off before removing or repositioning the electrodes.
4) Wash skin thoroughly, and then dry it before applying the electrodes.
5) Apply the whole surface of the electrodes firmly to the skin. Do not use electrodes
that do not stick properly to the skin or only partially stick to the skin.
6) In case of skin redness under the electrodes after a stimulation session, do not start
a new session in the same place if skin redness is still evident.
7.3 Regular TENS Application principles
1) Find the exact pain point or the area where the muscles ache most. For best
relief of pain, place the electrode pair from one channel on either side of the pain.
(See Figure 1: Twin mode) or you may place one electrode on the painful site and
the other near the site of pain.
2) Intensity: The intensity can be gradually increased up to the point when it
becomes uncomfortable. Always stay below that point of discomfort.
3) Recommended application duration and Mode selection:
When starting out,
choose Mode 1 at a low Intensity level for 10 minutes up
to 3 times a day. You may increase the intensity and time after you have
become familiar with the device and the feel for the stimulation. Stay with
Mode 1 for a few days before trying any of the other Modes and intensity
settings. Remember, the modes to be used for pain relief are Modes 1, 2,3, 4, 5
and 6.
It is difficult to recommend a particular mode for a specific type of pain and it
is usually determined by the user’s feel of relief.
However, if you do not feel any relief of pain after having tried different
modes and intensities it is recommended that you consult with your physician.
4) If the stimulation sensation becomes weaker or disappears, you may
increase the intensity by pressing the up key (+) to a point when the stimulation
becomes uncomfortable, but if the sensation does become uncomfortable, press
the down key (-) to decrease the intensity. Always stay under the point of
discomfort!
5) If you experience an adverse reaction (skin irritation/redness/burns /other
painful sensation), or if you feel unusual discomfort, stop using the device
immediately.
6) There are two ways to place the pads, in twin or opposed modes.
Fix the two pads from one channel on either side of the pain area, or one
electrode on the painful site and the other near the site of pain, but on the same
side of body. If you want to use both channels at the same time, make sure that
the second pair of electrodes is also fixed near the side of pain on the same side
of the body (right under or over the first pair)
Fixing the two or four pads respectively on the opposite sides of the
body is not recommended and provides little benefit.
7.4 Regular TENS Application Methods
Use the device 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.
Users can choose Mode 1, 2, 3, 4, 5 or 6 for temporary relief of pain.
* Many people experience immediate relief from muscle pain, while others require
several days of regular use to feel the benefits. The results vary and will depend
upon your underlying conditions and how often you use the device.
If your pain does not improve, you can try to increase the intensity and time or
change the mode.
Note:
The charts below are merely a suggestion for where to place the electrodes, what
Mode to choose and how long to stimulate, but only after the user has gone
through the starting procedure (above) and is familiar with the device.
8
9
Mode 1
Mode 4
Mode 6
Mode 5
Mode 2
Mode 3
