BD Alaris - Page 22

Chapter 1—Introduction
8BD Alaris
TM
System with Guardrails
TM
Suite MX User Manual
Signifies European Technical
Conformity
CE marking,
Conformité
Européenne,
Notified Body
2797: BSI
Group, The
Netherlands B.V.
PCU and all
modules
device labels,
(except
EtCO
2
, SpO
2
,
and Auto ID
modules),
PCA handset
device label,
user manual,
and shipping
label
(International
only)
765/2008/EC 768/2008/
EC MDD 93
/42/EEC
Articles 4,11,12,17,
Annex II
Complies with Australian
Communications Requirement
s.
Australian
Communications
Authority
PCU device
label and user
manual
NA
Meets FCC requirements per 21 CFR
Part 15.
Federal
Communication
Au
thority
PCU and all
modules and
device labels
Meets FCC requirements
per 21 CFR Part 15
Plug the PCU into an AC outlet
during storage to ensure
a fully
charged battery. The AC indicator
light () is on when the PCU is
plugged in.
Power plug PCU front
panel
Ref 5334 IEC-TR-60878:
Graphical symbols for
electrical equipment in a
medical practice
Indicates the acceptable upper and
lower lim
its of atmospheric pressure
for transport and storage.
Atmospheric
pressure
limitation
User manual
and shipping
label
Ref 2621 IEC-TR-60878
Graphical symbols for
electrical equipment in a
medical practice
Indicates the acceptable upper and
lower
limits of Relative humidity for
transport and storage.
Humidity
limitation
User manual Ref 2620 IEC-TR-60878
Graphical symbols for
electrical equipment in a
medical practice
Indicates the upper and lower limit of
temperature to which t
he medical
device can be safely exposed.
Temperature
limitation
User manual Ref 5.3.6 ISO 15223-1
Medical Devices-
Symbols to be used with
medical device labels,
labeling and information
to be supplied-Part 1:
General Requirement
Consult Instructions for Use Consult
instructions for
use symbol
Pump
module,
syringe
module, PCA
module, SpO
2
module, and
device labels
Ref 5.4.3 ISO 15223-1
Medical Devices-
Symbols to be used with
medical device labels,
labeling and information
to be supplied-Part 1:
General Requirements
Symbol
(Graphical
Image)
Definition Symbol Title Symbol
Location
Ref. No. Standard