The device has been evaluated to meet general RF exposure requirement. The device can be used in portable
exposure condition without restriction.
Precautions
Safety of powered muscle stimulators for use during pregnancy has not been established.
Caution should be used for patients with suspected or diagnosed heart problems.
Caution should be used for patients with suspected or diagnosed epilepsy.
Caution should be used 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
c.
healing process;
d.
Over the menstruating or pregnant uterus; and
e.
Over areas of the skin which lack normal sensation.
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, or alternate electrode placement.
Electrode placement and stimulation settings should be based on the guidance of the prescribing practitioner.
Powered muscle stimulators should be kept out of the reach of children.
Powered muscle stimulators should be used only with the leads and electrodes recommended for use by the manufacturer.
Powered muscle stimulators should not be used while driving, operating machinery, or during any activity in which
involuntary muscle contractions may put the user at undue risk of injury.
Adverse Reactions
Skin irritation and burns beneath the electrodes have been reported with the use of powered muscle stimulators.
Electromagnetic Compatibility (EMC)
This equipment generates, uses, and radiates radio frequency energy. The equipment may cause radio frequency interference to
other medical or non-medical devices and to radio communications.
If this equipment is found to cause interference, which can be determined by turning on and off the equipment, the operator or
qualified service personnel should take following actions:
Reorient or relocate the affected device;
Increase the distance between the equipment and the affected device;
Power the equipment by another source;
Consult the service engineer for further suggestions.
Caution: it is customer’s responsibility to assure that this equipment and vicinity equipment comply with the contents of
EMC in this manual.
Caution: This section will list the contents described in the YY0505-2012 form. It is the responsibility of the user to
ensure that this equipment and its nearby equipment meet the RF interference parameters indicated in the general safety
requirements.
Caution: do not use any device that might send out RF signals, including cell phone, radio transceiver and radio control
products, which might cause operation parameters beyond the standards. Please shutdown these devices when you are
near the equipment. Operator has the responsibility to warn user or any others to comply with this rule.
Caution: manufacturer will not responsible for any unauthorized actions that cause interference.