Philips Avalon CTS M2720A, Руководство по обслуживанию

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1 General Information Patient Safety
4
Patient Safety
The Telemetry System should only be used by, or under the direct supervision of, a licensed physician or
other health care practitioner who is trained in the use of fetal heart rate monitors and in the
interpretation of fetal heart rate traces. US federal law restricts this device to sale by, or on the order of, a
physician.
The base station is an electrical Class 1 device.
The telemetry system is in conformity with the requirements of the European Medical Devices Directive
93/42/EEC. They are classified into Class IIb according to Annex IX rule 10.
The device complies with the following safety standards:
• EN 60601-1:1990+A1:1993+A2:1995 / IEC 60601-1:1988+ A1:1991+A2:1995
• EN 60601-1-1:2001+A1:2004 (IEC 60601-1-1:2000+A1:2004)
• EN 60601-1-2:2001+A1:2006
• EN 60601-1-4:1996+A1:1999
• EN 60601-1-6:2004
• EN 60601-2-37:2001
Protective Earth Terminal.
This symbol identifies the terminal for connection to an external protective earth system.
Antenna input symbol.
Service socket symbol.
This symbol appears on the device adjacent to the CE marking and defines Class 2 radio
equipment per Radio and telecommunications Terminal Equipment Directive 1995/5/EC.
Antenna symbol on cordless Transducers.
IPX1 Ingress Protection code according to IEC 60529. Base station is rated IP X1 (protection against
vertical water drops only).
IP68 Ingress Protection code according to IEC 60529. All transducers are rated IP 68 (protection
against dust, access to hazardous parts, and the effects of continuous immersion in water to a
depth of 0.5 meter for five hours).
Type CF equipment, not defibrillation proof.
Symbol indicating separate collection for waste electrical and electronic equipment.
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