Specifications
52
Affinity® Three Birthing Bed and Affinity® Four Birthing Bed User Manual
(USR025 REV 6)
Table 8-1. Applied Parts (in accordance with IEC 60601-1)
Nurse Call Connection Requirements
Table 9. Classification and Standards
The Affinity® Three Birthing Bed and Affinity® Four Birthing Bed are designed and manufactured according to
equipment classifications and the following standards.
Siderails
Headboard
Foot section—lift-off and Stow n Go
Labor grips
Mattress
Labor bar
Attached calf support
Detachable telescopic calf support
Detachable non-telescopic calf support
Detachable telescopic leg support
Detachable non-telescopic leg support
Armboard
For information about the Nurse Call connection requirements, refer to the
SideCom®
Communication System Design and Application Manual
(DS059).
Technical and Quality Assurance Standards
EN 60601-1 and amendments, 2nd Edition (A through D
model beds)
EN 60601-1 3rd Edition (E model and newer beds)
UL 60601-1
CSA® C22.2 No. 601.1
IEC 60601-2-38 (A through D model beds)
IEC 60601-2-52 (E model and newer beds)
IEC 60601-1-2
ISO 13485
Equipment Classifications per EN 60601-1
Class
I
equipment, internally powered equipment
Degree of Protection Against Electric Shock of the
Applied Part
Type B
Classification according to Directive 93/42/EEC
Class
I
Degree of Protection Against Ingress of Water
IPX2, A through D model beds
IPX4, E model and newer beds
Degree of Protection Against the Presence of
Flammable Anaesthetic Mixtures
Not for use with flammable anesthetics
Mode of Operation
Continuous operation with intermittent loading, 3 minutes
ON/27 minutes OFF
Summary of Contents for Affinity Four Birthing Bed
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