Safety Guidelines - PowerDot PD-02 Operator Instructions Manual

Do NOT use PowerDot PD-02 for the patients with the following conditions:

Cardiac stimulator (pacemaker), implanted defibrillator or other implanted electronic device. Such use
could cause electric shock, burns, electrical interference or death.

Body-worn electro mechanical medical devices, i.e. insulin pump.

Serious arterial circulation problems in lower limbs.

Abdominal or inguinal hernia

Symptomatic local pain relief unless etiology is established or pain syndrome has been diagnosed

Cardiac arrhythmia (do not use on chest)

Use caution for patients with suspected or diagnosed heart problems

Use caution for patients with suspected or diagnosed epilepsy

Use caution in the presence of the following:
- when there is a tendency to hemorrhage following acute trauma or fracture
- following recent surgical procedure when muscle contraction may disrupt the healing process
- over a menstruating or pregnant uterus
- over the skin areas which lack normal sensation

Depending on the judgement of the responsible physician, the device may only be applied under supervision and with
the parameters defined by the responsible physician. Otherwise the exercise may be too strenuous for the patients with:
- hypertension (> stage 2), ischemic heart disease and cerebrovascular diseases
- cardiovascular diseases
- pregnancy. Safety of powered muscle stimulators for use during pregnancy has not been established.
- under 16 years of age

Proceed with caution after recent surgery

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
- Skin irritation and burns beneath the electrodes have been reported with the use of powered muscle stimulators.
- Potential adverse effects with TENS are skin irritation and electrode burns.

Read all instructions for operation before treating a patient.

The long-term effects of chronic electrical stimulation are unknown.

TENS is not effective for pain of central origin (including headache).

Safety Guidelines

1. Counter-indications
2. Additional Precautions
3. Adverse Effects
4. General Safety Measures
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