Cardinal Health Alaris 8000 Series Directions For Use Manual page 375

Federal Aviation Regulations
The following Alaris
®
Compliance with Federal Aviation Regulations for use as a
"Portable Electronic Device Aboard Aircraft". This is pursuant
to the Advisory Circular No.
FAA
Designated Engineering Representative with an
FAA
"Statement of compliance with the Federal Aviation
8110-3,
Regulations".
PC Unit
Pump Module
Syringe Module
The Alaris System has been assessed and complies with the
®
following standards:
PC Unit and overall System:
No. ,
601.1–M90 IEC 60601–1
Auto-ID Module:
Module are not regulated by
however, they are classified as a
other countries under this standard.)
Communications Interface Board Accessory: Class
digital device limits pursuant to Parts
Computing Devices) and
Rules and Regulations. To comply with
Canada exposure requirements, the CI Board is approved
for operation when there is more than
antenna and the user's or patient's body.
t Module:
E CO ISO 9918
2
,
EN 475 EN 864
PCA, Pump and Syringe Modules:
/
ANSI AAMI ID:26
SpO Module:
EN 865
2
Alaris System Directions for Use
®
Appendix Section
Compliance (Continued)
products have received a Statement of
91-21-1A
Standards
UL 60601–1
( s used in Auto-ID
IEC 60825–1 LED
in the United States;
FDA
CLASS 1 LED PRODUCT
15
(Medical Devices) of the
18
,
ASTM F 1456-01
IEC 60601-2-24
and attested by an
form
FAA
, /
CAN CSA C22.2
in
B
( Devices and
RF
FCC
and Industry
FCC
cm between the
20
, ,
ASTM F 1463
,
Regulations and Standards
A-13