Cardinal Health Alaris 8000 Series, Directions For Use Manual

Page: 373 / 378

Regulations and Standards
A-11 Alaris
®
System Directions for Use
Appendix Section
NOTES:
€
Compliance levels raised by
IEC 60601-2-24
.

Performed at the minimum and maximum rated input voltage.
‚
U
T
is the
AC
mains voltage prior to application of the test level.
ƒ
At
80 MH
z and
800 MH
z, the higher frequency range applies.
„
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
The compliance levels in the
ISM
frequency bands between
150
kHz and
80 MH
z, and in the frequency
range
80 MH
z -
2.5 GH
z, are intended to decrease the likelihood that mobile/portable communications
equipment could cause interference if inadvertently brought into patient areas. For this reason, an
additional factor of
10
/
3
is used in calculating the recommended separation distance for transmitters in
these frequency ranges.
†
Field strengths from fixed transmitters [such as base stations for radio (cellular/cordless) telephones and
mobile radios, amateur radio,
AM
/
FM
radio broadcast,
TV
broadcast] cannot be predicted theoretically with
accuracy. To assess the electromagnetic environment due to fixed
RF
transmitters, an electromagnetic site
survey should be considered. If the measured field strength in the location in which the Alaris
®
System is
used exceeds the applicable
RF
compliance level, the Alaris
®
System should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating the Alaris
®
System.
‡
Over the frequency range
150
kHz -
80 MH
z, field strengths should be less than [
V
1
]
V
/m.
ˆ
The
ISM
(Industrial, Scientific and Medical) bands between
150
kHz and
80 MH
z are
6.765
-
6.795 MH
z,
13.553
-
13.567 MH
z,
26.957
-
27.283 MH
z, and
40.66
-
40.70 MH
z.
Communications Interface Board Accessory
The CI Board contains a radio frequency
IEEE 802.11
b,
wireless, local-area network interface (
RF
card). The
RF
card
allows the Alaris
®
System to communicate with the Alaris
®
Server connected to the hospital information system. The
RF
card is compliant with the rules and regulations in the
locations where the CI Board is sold, and is labeled as
required. The United States Federal Communications
Commission (
FCC
) and Canadian Department of
Communications (
DOC
) identification numbers are visible
through the CI Board’s clear plastic cover. If an international
country approval stamp is required, it is placed adjacent to the
identification numbers in the area provided.
Compliance (Continued)
Alaris
®
System (Continued)
Electromagnetic Environment (Continued)