System Precautions; Electromagnetic Compatibility Precautions - Dräger Resuscitaire WBR82 Instructions For Use Manual

PROPRIETARY AND CONFIDENTIAL DRAFT 8 Jan 04

System Precautions

Accessory equipment connected to the analog and digital interfaces must be certified according
to the respective IEC standards (e.g. IEC950 for data processing equipment and IEC60601-1
for medical equipment). Furthermore, all configurations must comply with the systems standard
IEC60601-1-1. Any person who connects additional equipment to the signal input or output
configures a medical system, and is therefore responsible for ensuring that the system complies
with the system standard IEC60601-1-1. If in doubt, consult technical service or your local
representative.

Electromagnetic Compatibility Precautions

Information on Electromagnetic Compatibility
General information on electromagnetic compatibility (EMC) according to international EMC standard
IEC 60601-1-2:
Medical electrical equipment is subject to special precautionary measures concerning electromagnetic
compatibility (EMC) and must be installed and put into operation in accordance with the EMC
information provided on page 2-27.
Portable and mobile RF communications equipment can affect medical electrical equipment.
WARNING
Do not connect connectors with an ESD warning symbol and do not touch the pins of such connectors without
implementing ESD protective measures. Such protective measures may include antistatic clothing and shoes,
touching a ground stud before and during connection of the pins, or using electrically insulating and antistatic
gloves. All relevant personnel must be instructed in these ESD protective measures.
WARNING:
This product has been validated with the accessories and options listed in this manual. It is
found to comply with all relevant safety and performance requirements applicable to the device.
It is therefore the responsibility of that person or organization who makes an unauthorized
modification, or incorporates an unapproved attachment to the device, to ensure that the
system still complies with those requirements.
WARNING:
Do not use equipment next to other devices unless verification of normal operation in the
configuration in which it is to be used can be achieved. Patient injury, personal injury, or
equipment damage could occur.
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