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