Cardinal Health PRO Patient User Manual page 21

Standard/Law
Symbol
Reference
21 CFR Part
801.1(c)(1)(i)F
21 CFR Part
801.109
Directive 93/42/
EEC Articles 4, 11,
12, 17 Annex 12
Directive 93/68/
EEC
IEC 60417-5172
Section 7.2.6
ISO 7000-2616
ISO 7000-5008
ISO 7000-5007
ISO 7000-5417
Standard/Law Title
Labeling - Medical devices; prominence
of required label statements
Labeling - Prescription devices
Council Directive 93/42/EEC of 14 June
1993 concerning medical devices
CE Marking
Class II equipment
External cord connected
OFF (power)
ON (power)
Programmable duration
Symbol Title/
Explanatory Text
Text Reference
Prescription Use Only Requires prescription for
sale in the United States
and is used in place of the
statement below:
CAUTION: Federal law
restricts this device to sale
by or on the order of a
physician, dentist or
licensed practitioner.
The requirements for Signifies European
accreditation technical conformity.
and market
surveillance relating
to the marketing of
products; Medical
Device Directive.
Marking Power adaptor meets the
Requirements for safety requirements
Class II Equipment specified for Class II
equipment according to
IEC 61140.
External Cord Con- Indicates that device is
nected connected to an external
power source.
OFF (Power) To indicate disconnection
from power.
ON (Power) To indicate connection to
power.
Programmable To identify the control of a
Duration programmable timer to start
an operation at a specific
point in time and to stop the
operation at a specific point
in time or after a specific
duration; or to identify a
display of the programmed
or to-be-programmed
duration.
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