CareFusion Alaris 8015 User Manual page 438

Standards (Continued)
The Alaris System when upgraded to v9.33 software only
has been assessed and complies with the following
standards:
PC unit and overall System: UL 60601–1 (2003),
CAN/CSA C22.2 No. 601.1-M90 (2.0 Edition 1990), IEC
60601–1 (2.0 Edition 1988)
Auto-ID module: IEC 60825–1 (2007) (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 9918:1993, ASTM F 1456 (2001),
2
ASTM F 1463 (1993), EN 475 (1995), EN 864 (1997)
PCA, Pump and Syringe modules: IEC 60601-2-24 (1.0
Edition (1998), ANSI/ AAMI ID26 (1998)
SpO module: EN 865 (1997)
2
Regulations and Standards
A-44
Compliance (Continued)
Alaris System User Manual – with v9.33 Model 8015
Appendix Section