Overview; Overall Regulatory Standard Compliance; Electromagnetic Compatibility (Emc - Dräger Infinity Delta Instructions For Use Manual

Overview

This appendix contains technical specifications for the physical and functional aspects
of the patient monitoring system. These specifications apply to adult, pediatric, and
neonatal patients.
Upon request, Dräger makes any technical information required to perform
maintenance and/or calibration of serviceable items available to qualified technical
personnel.

Overall Regulatory Standard Compliance

IEC 60601-1 and applicable collateral and particular standards
IEC 60601-1-2

Electromagnetic Compatibility (EMC)

This section is intended to provide information with regard to electromagnetic
compatibility for the Dräger Delta series of patent monitors (hereafter referred to as
'equipment'). It supplements the information that already exists elsewhere in the
instructions for use.
Much of the information below is derived from requirements specified in the
electromagnetic compatibility standard for medical electrical equipment IEC 60601-1-
2: 2001/A1:2004 published by the International Electrotechnical Commission and,
available from a variety of sources. While primarily aimed at device manufacturers
this contains a large amount of information that may be useful to interested users of
medical equipment.
The information contained in this section (such as separation distances) is in general
specifically written with regard to the Dräger patient monitors specified above. The
numbers provided will not guarantee, but should provide reasonable assurance of,
faultless operation. This information may not be applicable to other medical electrical
equipment, older equipment may be particularly susceptible to interference.
NOTE:
Medical electrical equipment needs special precautions regarding
electromagnetic compatibility (EMC) and must be installed and put into service
according to the EMC information provided in this section and the instructions
for use which accompanied your monitor.
Portable and mobile RF communications equipment can affect medical
electrical equipment.
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