36 Specifications
395
Monitor Mounting Precautions
Mount the monitor using either the Philips Quick Mount or Fix Mount solution or another approved
mounting solution. Select the mounting equipment and the mounting position so that no patient,
operator or other person can be harmed by a monitor removed intentionally or released accidentally
from the mount. When using the Quick Mount, be aware of the danger of accidental activation of the
Quick Mount release button when lifting or moving items located under the monitor, such as pole
mounts, etc. If in doubt, use the Philips Fix Mount solution to avoid such situations. Refer to the
respective IntelliVue Monitor Service Manual, Installation Instructions chapter, for more details.
Altitude Setting
Altitude affects tcGas and CO
2
measurements. The monitor must be configured at installation to the
correct altitude.
Monitor Safety Specifications
The monitors, together with the Multi-Measurement Modules (M3001A/M3002A), and the Flexible
Module Rack (M8048A), all modules and MMS extensions, comply with the Medical Device Directive
93/42/EEC.
185-0145-PH Aspect BISx, 185-0111 Aspect BIS Engine and 185-0124 Aspect DSC comply with the
requirements of the Council Directive 93/42/EEC of 14 June 1993 (Medical Device Directive).
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 +Suppl. No. 1-94 + Am. 2; IEC 60601-1-1:2000; EN 60601-1-1:2001;
IEC 60601-1-2:2001 + A1:2004; EN 60601-1-2:2001 + A1:2006.
The possibility of hazards arising from software errors was minimized in compliance with ISO
14971:2007, EN60601-1-4:1996 + A1:1999 and IEC 60601-1-4:1996 + A1:1999.
Classification (according to IEC 60601-1): Class 1, Type CF, Continuous Operation. The BIS
measurement uses a Type BF applied part.
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.
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