Cardinal Health Alaris 8000 Series, Directions For Use Manual

Page: 375 / 378

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