CareFusion Alaris 8015 User Manual page 437

The Alaris System has been assessed and complies with the
following standards:
PC unit and overall System: CAN/CSA C22.2 No.
60601-1-1 (3.0 Edition 2014), IEC 60601–1 (3.1 Edition
2012), 60601-1-2 (2007), 60601-1-8 (2012)
Auto-ID module: IEC 60825–1 (Edition 3.0 2014) (LEDs
used in Auto-ID module are not regulated by FDA in the
United States; however, they are classified as a CLASS 1
LED PRODUCT in other countries under this standard.)
Compact Flash Wireless Networking Module: Class B
digital device limits pursuant to Parts 15 (RF Devices and
Computing Devices 2015) and 18 (Medical Devices) of the
FCC Rules and Regulations 2015. To comply with FCC
and Industry Canada exposure requirements, the CF
Wireless Module is approved for operation when there is
more than 20 cm between the antenna and the user's or
patient's body.
EtCO module: ISO 80601-2-55 (2011), IEC 60601-2-49
2
(2011)
PCA, Pump and Syringe modules: IEC 60601-2-24
(Edition 2.0 2012), ANSI/ AAMI ID26 (2013)
Appendix Section
Alaris System User Manual – with v9.33 Model 8015
Compliance (Continued)
Standards
Regulations and Standards
A-43