Welch Allyn Cardioperfect PRO ECG Recorder - User Manual - Manual (Page 3)

CardioPerfect
PRO ECG Recorder - User Manual
DIR 80012763 Ver. F 3 / 26
Safety and Precautions
Caution
Radio Frequency (RF) interference between the PRO ECG Recorder or
cardiograph and any existing RF transmitting or receiving equipment at
the installation site, including electrosurgical equipment, in close
proximity to the cardiograph should be evaluated before the equipment is
operated as they may seriously degrade performance.
The CardioPerfect Cardiograph is susceptible to interference from RF
energy sources (lowered RF immunity) which exceed the IEC 60601-1-2
limits, such as power line bursts, other medical devices, cellular products,
information technology equipment and radio/television transmission.
To reduce EMC interference the cardiograph shall be separated from the
emitting source as much as possible. If assistance is needed, call your
local Welch Allyn service representative.
Artifact on the ECG caused by electromagnetic interference should be
evaluated by a physician or physician authorized personnel to determine
if it will negatively impact patient diagnosis or treatment.
Like all electronic devices, this cardiograph is susceptible to electrostatic
discharge (ESD). Electrostatic discharge typically occurs when
electrostatic energy is transferred to the patient, the electrodes, or the
cardiograph. ESD may result in ECG artifact that may appear as narrow
spikes on the cardiograph display or on the printed report. When ESD
occurs, the cardiograph’s ECG interpretation may be inconsistent with
the physician’s interpretation.
Welch Allyn assumes no liability for failures resulting from RF
interference between Welch Allyn medical electronics and any radio
frequency generating equipment when these levels exceed those
established by applicable standards.
Patient cables and PC connection cables are intended to be inserted and
removed from the Pro-Recorder in a push / pull motion. Do not twist the
cables. Damage to the cables and the Pro-Recorder will occur.
Medical Device Directive
The CardioPerfect Pro cardiograph complies with the requirements of the Medical Device
Directive 93/42/EEC and carries the 0297 mark accordingly.