v
other adverse reactions. Electrodes are intended for short term use and should be removed from the patient
promptly following testing.
·
FCC Warning (Part 15.21): Changes or modifications not expressly approved by the party responsible for
compliance could void the user’s authority to operate the device.
·
A possible explosion hazard exists. Do not use the device in the presence of a flammable anesthetic mixture.
·
The device has not been designed for use with high-frequency (HF) surgical equipment and does not provide a
protective means against hazards to the patient.
·
The quality of the signal produced by the device may be adversely affected by the use of other medical
equipment, including but not limited to defibrillators and ultrasound machines.
·
There is no known safety hazard if other equipment, such as pacemakers or other stimulators, is used
simultaneously with the device; however, disturbance to the signal may occur.
·
Operations may be affected in the presence of strong electromagnetic sources such as electrosurgery
equipment.
·
The battery operated device transmits data reflecting a patient’s physiological condition to a receiving device.
During operation failure, data transmission and LCD information will cease to occur. In mission critical
conditions, it is advisable to have a backup device available.
·
Use only recommended battery cells. Use of other cells may present a risk of fire or explosion.
