BD Alaris - Page 21

Symbols Glossary
BD Alaris
TM
System with Guardrails
TM
Suite MX User Manual 7
Caution: Refer to accompanying
documentation.
Caution PCU and all
modules, PCA
handset,
device labels,
and external
packaging
Ref 0434A
IEC-TR-60878 Graphic
symbols for electrical
equipment used in a
medical practice
IPX1
Degree of particle and water ingress
protection.
Degrees of
ingress
protection
provided by
enclosure
SpO
2
module
device label
Ref. 2: IEC 60601-1,
Table D.3, General
requirements for basic
safety and essential
performance
IPX2
Degree of particle and water ingress
protection.
Degrees of
ingress
protection
provided by
enclosure
PCU, pump
module,
syringe
module, PCA
module, PCA
handset,
EtCO
2
module, and
Auto-ID
module
device labels
Ref. 2: IEC 60601-1,
Table D.
3, General
requirements for basic
safety and essential
performance
IUI Connector: Inter-Unit Interface
connector used to establish power
and communications between PCU
and attached modules.
Input-output PCU, all
modules side
panel
Ref. 5448 IEC-TR-6078
Graphic symbols for
electrical equipment in a
medical practice
Indicates the date on which a product
was manufactured.
Dat
e of
manufacturer
Unique device
identification
(UDI) label
for PCU, and
all modules
Ref. 2497 IEC-TR-6078
Graphic symbols for
electrical equipment in a
medical practice
Indicates generally elevated,
potentially hazardous, levels of non-
ionizing radiation, or to indicate
equipment or systems e.g. in the
medical electrical area that include
RF transmitters or that intentionally
apply RF electromagnetic energy for
diagnosis or treatment.
Non-ionizing
electromagnetic
radiation
PCU front
panel and user
manual
Ref. 5140 IEC-TR-6078
Graphic symbols for
electrical equipment in
medical practice
Federal Law restricts device to sale
by or
on the order of a licensed
health provider.
Prescription use
only
User manual
and external
packaging
21 CFR 801.109
Symbol
(Graphical
Image)
Definition Symbol Title Symbol
Location
Ref. No. Standard
XXXX-XX-XX
nly
O