Welch Allyn Cardioperfect Workstation, Software Version 1.6.5 - Installation Guide - Manual (Page 6)

CardioPerfect Workstation
DIR 80013928, Ver. F 6 / 56
1. Safety summary
Introduction
We at Welch Allyn are dedicated to provide safe products to ou r customers. It is the user’s responsibility to
follow the rules of safety as established for their protection and for the protection of their patients as
described in this manual.
The hospital’s Biomedical/IT support staff shall require primary skills including disciplines related to
maintenance and servicing computer controls/platforms.
Please take note of all safety precautions and warnings provided with the devices before using the devices
and the accompanying software.
WARNING: The CardioPerfect family of devices is 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 (non-medical electrical equipment) shall be situated outside the patient
environment (reference IEC 60601-1-1).

The personal computer used should adhere to the appropriate safety standard for non-medical
electrical equipment (IEC 60950, or its national variants), and use of an isolation transformer is
recommended.

Normal isolation transformer does not fulfill the IEC601-1-1 standard and its supplement EEE
requirements for transformer unit. To maintain operator and patient safety, consider the
requirements of IEC 60601-1-1. Measure the leakage currents to confirm that no electric shock
hazard exists.

The personal computer used should adhere to the appropriate electromagnetic compatibility
(EMC) standard for non-medical electrical equipment (CISPR 22/24 - FCC Part 15 - CE, or
related national variants).
If it is required for the personal computer to be situated within the patient environment, it is the
responsibility of the user to ensure that the system provides a level of safety in compliance with
IEC 60601-1-1.
Note: On computers that you plan to use for clinical procedures, disable automatic installation of
Windows updates.