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Acuity system compliance with safety standards – Welch Allyn Acuity and Mobile Acuity LT Central Monitoring Systems - User Manual User Manual

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Chapter 1 General information

7

Acuity System compliance with safety standards

The CE Mark and Notified Body Registration Number signify that the product meets all essential
requirements of European Medical Device Directive 93/42/EEC.

Table 1. Acuity System compliance with safety standards

Acuity System component(s)

Product category

Organization and
standard

Propaq Encore, Propaq CS, Propaq LT, Welch Allyn
1500 Patient Monitor and Micropaq monitors

Wireless Micropaq, Propaq LT and Propaq CS
monitors

Medical Equipment

EN 60601-1:1990
A1:1992, A2:1995

IEEE 802.11, Wireless
LAN Medium Access
Control (MAC) and
Physical Layer (PHY)
Specifications

IEEE 802.11a, 802.11e,
802.11h, 802.1X, 5 GHz

All components operating together as a system

Electromagnetic compatibility for
Medical Equipment

IEC 60601-1-2:2007

All components operating together as a system

Medical Systems

IEC 60601-1-1:2000

All information systems components

Information Technology Equipment

EN 60950:1994

Acuity System cordless receiver cabinet

Electromagnetic compatibility

FCC Class A

a

a. When the equipment is operated in a commercial environment, Class A limits provide reasonable protection against

harmful interference. The equipment generates, uses and can radiate radio frequency energy; if it is not used in
accordance with this reference guide, or if it is modified from original installation, it might cause harmful interference
to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference, in
which case the user is required to correct the interference at his own expense.