Cardinal Health ALLY TO GO NPWT Patient User Manual page 26

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 Requires prescription for
Only 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 Signifies European technical
for accreditation and conformity.
market surveillance
relating to the
marketing of
products; Medical
Device Directive.
Marking Power adaptor meets the
Requirements for safety requirements specified
Class II Equipment for Class II equipment
according to IEC 61140.
External Cord Indicates that device is
Connected 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.
26