Altitude Setting; Monitor Safety Specifications; Emc And Radio Regulatory Compliance - Philips IntelliVue X2 Instructions For Use Manual

24 Specifications
• Connecting the ECG sync out to external equipment should only be done by a qualified user. Do
not touch the patient when you have contact to the ECG output connector socket.
• Always connect the ECG sync cable first to the external device and then to the monitor. Wherever
possible, pre-install the cable before the patient is brought into the vicinity of the equipment.

Altitude Setting

Altitude affects CO
altitude.

Monitor Safety Specifications

0366
The monitor complies with the Medical Device Directive 93/42/EEC.
In addition, the product complies with:
IEC 60601-1:1988 + A1:1991 + A2:1995; EN60601-1:1990 + A1:1993 + A2:1995; UL 60601-
1:2003; CAN/CSA C22.2#601.1-M90; JIS T 0601-1:1999; IEC 60601-1-1:2001; EN 60601-1-
1:2001; IEC 60601-1-2:2001; EN 60601-1-2:2001.
Classification (according to IEC 60601-1): Class II, Type CF, Continuous Operation.
The possibility of hazards arising from software errors was minimized in compliance with ISO
14971:2000, EN60601-1-4:1996 + A1:1999 and IEC 60601-1-4:1996 + A1:1999.

EMC And Radio Regulatory Compliance

This ISM device complies with Canadian ICES-001. Cet appareil ISM est conforme a la norme NMB-
001 du Canada.
The X2 including IntelliVue Instrument Telemetry WMTS (US only)
FCC Rules. Operation is subject to the condition that this device does not cause harmful interference
Operation of this equipment requires the prior coordination with a frequency coordinator designated
by the FCC for the Wireless Medical Telemetry Service.
The X2 including IntelliVue Instrument Telemetry ISM (2.4 GHz) - FCC and Industry Canada
Radio Compliance: This device complies with Part 15 of the FCC Rules and RSS-210 of Industry
Canada. Operation is subject to the following two conditions: (1) this device may not cause harmful
interference, and (2) this device must accept any interference received, including interference that may
cause undesired operation. Any changes or modifications to this equipment not expressly approved by
Philips Medical Systems may cause harmful radio frequency interference and void your authority to
operate this equipment.
This product is intended to be connected to the Publicly Available Interfaces (PAI) and used
throughout the EEA.
250
measurements. The monitor must be configured at installation to the correct
2
The radio device used in this product is in compliance with the essential requirements and
other relevant provisions of Directive 1999/5/EC (Radio Equipment and
Telecommunications Terminal Equipment Directive). Class 2 radio equipment. Member
states may apply restrictions on putting this device into service or placing it on the market.
Altitude Setting
complies with part 15 of the
.