Welch Allyn Cardioperfect PRO ECG Recorder - User Manual - Manual (Page 4)

CardioPerfect
PRO ECG Recorder - User Manual
DIR 80012763 Ver. F 4 / 26
Warnings
CardioPerfect devices are an integral part of a personal computer
based diagnostic system. The user shall adhere to warnings in order
to ensure safe and reliable performance of the system.
The personal computer, computer peripheral and all accessories (non-
medical electrical equipment) connected to the ECG shall be situated
outside the patient environment and the system shall meet the
requirements of IEC 60601-1-1.
The personal computer used should be approved to the
appropriate safety standard for non-medical electrical equipment
(IEC 60950, or its national variants). Also, the use of an additional
protective earth ground or an isolation transformer is required for
the electric power circuit to which the CardioPerfect system is
connected in order to satisfy the IEC 60601-1-1 safety standard.
Power strips (multiple portable socket outlets) are not allowed for
use in connecting the medical electrical equipment or any
accessories to ground unless used in concert with a medical
approved isolation transformer.
Additional equipment that is added to the system may pose a
safety hazard. Use of an additional protective earth ground or an
isolation transformer is required to meet IEC 60601-1-1.
During defibrillation, the ECG signals displayed may show waveform
artifacts and cannot be relied on as a true indication of the patient’s
physical condition.
Accessible metal parts, such as electrode terminations, should not
come in contact with other electrically conductive parts, including earth
ground.
Welch Allyn provides a number of high quality patient leads in varying
termination styles. Use of these approved patient leads is required for
electrical protection of the patient during cardiac defibrillation.
CardioPerfect devices are not intended for direct cardiac application.
An inoperable or damaged electrocardiograph can be identified by
abnormal signals on the ECG waveforms. Abnormal signals are
characterized by flat lines, excess noise, square waves or other non
typical anomalies that appear on the ECG waveform. The
electrocardiograph can be periodically tested by connecting the
CardioPerfect to an ECG simu
lator. Follow manufacturer’s
instructions.
If there is a requirement for equipment to be connected to a personal
computer or other non-medical rated equipment, it is the responsibility
of the user to ensure that the electric power circuit to which the
CardioPerfect system is connected includes an additional protective
earth ground or an isolation transformer in order to satisfy the IEC
60601-1-1 safety standard.
Other medical equipment —including but not limited to defibrillators,
ultrasound machines, pacemakers, and other stimulators —may be
used simultaneously with the electrocardiograph. However, such