● Buttocks
Mode 1 for 10-20 minutes, and Mode 6 for
10-20 minutes; twice or 3 times a day.
Apply the device to the points shown to exercise
the muscles.
● Legs
Mode 1 for 10-20 minutes, Mode 2 for 10-20
minutes, and Mode 3 for 10-20 minutes; twice or
3 times a day.
The device can stimulate areas of the legs and
thighs so as to improve the muscles.
20
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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. Battery
8.1 Battery information
Capacity: 110mAh
Voltage: DC 3.7V
Restriction: 4.2V
8.2 Charging the Battery
1) The Lithium battery can be recharged through both AC adaptor and computer
USB input.
2) Turn off the unit.
3) Connect the unit and the charger with USB extension cord. Plug charger into
any power outlet, a green light shows that it is charging. The charging process
will last approximately 1 hour. When charging is finished, the LCD will show a
full battery cell.
4) The battery should be charged for 10 hours or so before first use.
Notes: Only charge the unit when battery is completely drained the first 2
times. Unplug the charger from power outlet when charging is complete. When
stimulation intensity decreases, it indicates that the device needs charging.
Recharge it and then continue to use the device. Do not use the device while
charging.
9. Readjustments, alterations and repairs
1) Do not disassemble, repair or modify the device without authorization, you
will void any warranty on the product.
2) The manufacturer is only responsible for the safety and performance of Pch
Life TENS & PMS when readjustments, alterations and repairs are carried out
by authorized individuals and when the Pch Life TENS & PMS is used in
accordance with the user instructions.
3) Qualified technicians who are familiar with the technical features of the
device have been provided with circuit diagrams, PCB drawings, component
lists and setting instructions by the manufacturer.
10. Cleaning and maintenance
A. For the control unit:
1) To keep the controller clean, use a soft and dry cloth for dust or a soft damp
cloth for any dirt and smudges. Do not use any cleaning solutions to clean the
controller and its pads.
2) Do not use or store the device where there are magnetic fields or electric
waves (near TV set or speakers).
3) Do not place the devices in areas of high temperature, high humidity, or
under direct sunlight.
4) Keep the device out of reach of children.
5) All worn accessories should be disposed of according to your local
regulations.
B. For electrode pads:
* Refer to the user manual of the pads manufacturer (510K092546), or
reference to the following suggestions:
1) Unplug the output cord from the output jack of the controller after each
use. Cover both pads with the protective film before storage. Never fold the
electrode pads.
2) Between uses, store the electrodes in the reusable bag in a shady place.
Stockroom temperature: +5°C~+27°C (41-80°F) and humidity of 30%~80%.
No need to sterilize.
3) Never apply the pads to any other surface other than your skin. If the pads
become soiled or dirty, the adhesive power may decrease. In this case,
moisten the surface of the pads with water and wipe away the dirty portion.
This will allow a temporary restoration of the adhesive power. However, too
much water will result in loss of the adhesive power.
4) The life of the electrodes varies depending on skin conditions, storage,
amount of use, type of stimulation, and stimulation site. Electrode life may be
extended by carefully following this Instruction for Use. The expired
electrodes are to be recycled and do not harm environment.
Warning:
The electrodes are intended for single patient use only!
11. Storage
Caution:
Do not store in a damp area. Dampness may affect the device and
cause rust.
- Normal working ambient temperature: 5°C~40°C (40-104°F)
- Normal working ambient humidity: ≤80%RH
- Store and transport ambient temperature: -20°C~55°C (4° -131° F)
- Store and transport ambient humidity: ≤93%RH
12. Technical checks
Technical checks on the device should be performed every 24 months.
These include:
1. Checking to see whether the user instructions and the medical device book are
included in the accompanying documentation.
2. Checking the equipment for completeness.
3. Visual check:
- for mechanical damage
- for damage to all cables and connections
4. Functional safety
- Checking the output signals with a load resistance of 500Ω real (current and
voltage)
- Checking the frequency
- Checking the pulse width.
These technical checks may only be performed by individuals with appropriate
training. The results must be noted in the medical device book along with the date
and name of the person carrying out the check.