Philips V26CT, V24CT manual Using an ITE Display, Safety, Performance Requirements

The CMS and V24 and V26 Patient Monitors

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
	•	EMC
	•	Performance Requirements
Safety	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.

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