4
5
Included in this package:
*
1 controller
* 2 pairs of electrodes [510(k) cleared]
*
2 output electrode cables
* 1 USB cable
*
1 charger
* 1 User’s manual
*
1 plastic holder
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)
Therapeutix TENS&PMS must be kept out of the reach of children.
8)
Therapeutix 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 Therapeutix 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 Therapeutix 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.
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