Specifications
48 Affinity® 4 Birthing Bed Instructions for Use (USR025 REV 13)
Applied Parts (in accordance with IEC 60601-1)
Nurse Call Connection Requirements
Classification and Standards
The P3700 Affinity® 4 Birthing Bed is 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 Directive 93/42/EEC until May 25, 2020
Regulation (EU) 2017/745 regulation from
May 26, 2020
WEEE Directive 2012/19/EU
RoHS Directive 2011/65/EU
ISO and EN ISO 13485
ISO and EN ISO 14971
REACH Directive 1907/2006
Serial Numbers after H297AA4665 and up to
Serial Numbers beginning with O218AA
IEC and EN 60601-1 (2
nd
Edition)
UL 60601-1: 2006
IEC and EN 60601-2-38 + A1
CAN/CSA C22.2 No. 601.1-M90 + A1 and A2
– Serial Numbers before O079AA
IEC and EN 60601-1-2 (2
nd
Edition)
CAN/CSA-C22.2 No. 60601-1-2:03 + A1
– Serial Numbers after O078AA
IEC and EN 60601-1-2 (3
rd
Edition)
CAN/CSA-C22.2 No. 60601-1-2:2007
P3700E beds with Serial Numbers between
those beginning with O219AA and S360AA
IEC and EN 60601-1 (Edition 3.0)
IEC and EN 60601-2-52
IEC and EN 60601-1-2 (3
rd
Edition)
IEC and EN 60601-1-6: 2010
IEC and EN 62366
CAN/CSA C22.2 No. 60601.1: 2008
P3700E beds with Serial Numbers after those
that begin with S361AA
IEC and EN 60601-1 (Edition 3.1)
IEC and EN 60601-2-52 + Amendment 1
IEC and EN 60601-1-6: 2010 + Amendment 1
IEC and EN 62366 + Amendment 1
CAN/CSA C22.2 No. 60601.1-14
– Up to Serial Numbers beginning
with T242AA
IEC and EN 60601-1-2 (3
rd
Edition)
CAN/CSA-C22.2 No. 60601-1-2-08
– After Serial Numbers beginning
with T242AA
IEC and EN 60601-1-2 (4
th
Edition)
CAN/CSA-C22.2 No. 60601-1-2:16
Equipment Classifications per EN 60601-1 Class I equipment, internally powered equipment
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