Using An Ite Display; Safety - Philips V24CT User's Reference Manual

Using an ITE Display

Using an ITE Display
The M1167A/77A CMS Patient Monitoring System provides means for
customers to use ITE displays. There are several restrictions associated
with this option. Since the display is used as part of a medical device
within the patient vicinity, there are additional requirements to be
fulfilled in order to be in compliance with the European Council
Directive 93/42/EEC (Medical Device Directive) and with FDA
recognized consensus standards:

Safety

1-38 The CMS and V24 and V26 Patient Monitors
• Safety
• EMC
• Performance Requirements
1. The display must either comply with the requirements of the:
EN60601-1 +A1 +A2 {IEC601-1 +A1 +A2}, or
it must conform to the requirements of an IEC XXX electrical
safety standard and fulfill specific requirements according to the
EN60601-1-1 +A1 {IEC601-1-1 + A1} to provide the same level of
safety as EN60601-1 {IEC601-1}:
– The display must be constructed or protected so that spillage
of liquids does not wet parts of the display which may cause a
safety hazard (IEC601-1; 44.3).
– The ITE display must be used with an isolation transformer
(e.g. Philips M1389A), if the enclosure leakage current
exceeds the requirements of EN60601-1/IEC601-1 (normal
and single fault condition). The power cable must be secured
so that the transformer cannot be disconnected without the
use of a tool.
2. A test of the Enclosure Leakage Current (normal and single fault
condition) of the complete system, including the display, has to be
performed and documented.