6
7
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, 3,
4, 5, 6.
PMS:
It is intended to be used to stimulate healthy muscles in order to improve and
facilitate muscle performance. Choose Mode 1, 2, 3, 6.
6.
Description of the Device
6.1
General Description of the Device
Therapeutix 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.
Therapeutix 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.)
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