Performa
™
Professional Series
- 6 -
DANGER
THIS STIMULATOR MUST NOT BE USED IN COMBINATION
WITH THE FOLLOWING MEDICAL DEVICES:
1. Internally transplanted electronic medical devices,
such as a pacemaker.
2. Electronic life support equipment, such as respirators.
3. Electronic medical devices attached to the body,
such as electrocardiographs.
Using this stimulator with other electronic medical devices may cause
erroneous operation of those devices.
Do not use other RF equipment near the Performa
™
Professional
Series.
Do not use RFID systems near the Performa
™
Professional Series.
Do not use electrical stimulation in conjunction with high frequency
surgical equipment or microwave or shortwave therapy systems.
This device needs special precautions regarding EMC and
needs to be installed and put into service according to the
EMC information provided on pages 57 – 59.
These devices are contraindicated for use in an MRI
environment and should be removed prior to an MRI exam
or MRI exposure. Keep the device away from strong magnetic fields.
These devices are MR unsafe .
WARNING
DO NOT USE THIS DEVICE UNDER THESE CONDITIONS:
• If a patient has a cardiac pacemaker, implanted defibrillator, or other
implanted metallic or electronic device. Such use could cause electric
shock, burns, electrical interference, or death.
• Together with a life-supporting medical electronic device such as an
artificial heart or lung or respirator.
• In the presence of electronic monitoring equipment (e.g., cardiac
monitors, ECG alarms), which may not operate properly when the
electrical stimulation device is in use.
• On open wounds or rashes, or over swollen, red, infected, or inflamed
areas or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins);
or on top of, or in proximity to, cancerous lesions.
• Over areas of skin that lack normal sensation.
• Do not use while patient is in bath or shower.
• Do not use while patient is sleeping.
• Patients with arterial or venous thrombosis or thrombophlebitis are at risk
of developing embolisms when electrical stimulation is applied over or
adjacent to the vessels containing the thrombus. If a patient has a history
of deep vein thrombosis, even many years past, the affected area should
not be stimulated.
• Fresh fractures should not be stimulated in order to avoid unwanted
motion.
• Stimulation should not be applied immediately following trauma or
to tissues susceptible to hemorrhage.
Safety Precautions
