natus Xltek EMU40EX, User Manual

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Xltek EMU40EX Battery Pack User Manual
12
GLOSSARY OF SYMBOLS
Symbol
Standard
Reference
Standard Title Symbol Title Explanation
Not applicable Not applicable An indication of
Medical Device This product is a medical device.
21 CFR Part
801.109(b)(1) Labeling-Prescription
devices Prescription only Indicates that the product is
authorized for sale by or on the
order of a licensed healthcare
practitioner.
ISO 15223-1
Symbol 5.4.5
(Reference
Annex B for
the general
prohibition
symbol) Medical devices
—
Symbols to be used with
medical device labels,
labelling and information
to be supplied
Not made with natural
rubber latex Indicates that the medical device is
not made with natural rubber latex.
2012/19/EU Waste Electrical and
Electronic Equipment
(WEEE) Disposal at end of
operating life
instructions Indicates that electrical and
electronic equipment waste should
not be discarded together with
unseparated waste but must be
collected separately.
ISO 15223-1
Symbol 5.1.1 Medical devices
—
Symbols to be used with
medical device labels,
labelling and information
to be supplied
Manufacturer Indicates the medical device
manufacturer.
ISO 15223-1
Symbol 5.1.2 Medical devices
—
Symbols to be used with
medical device labels,
labelling and information
to be supplied
Authorized
representative in the
European Community Indicates the Authorized
representative in the European
Community.
ISO 15223-1
Symbol 5.1.3 Medical devices
—
Symbols to be used with
medical device labels,
labelling and information
to be supplied
Date of manufacture Indicates the date when the
medical device was manufactured.
ISO 15223-1
Symbol 5.1.6 Medical devices
—
Symbols to be used with
medical device labels,
labelling and information
to be supplied
Catalogue number
Indicates the manufacturer’s
catalogue number so that the
medical device can be identified.
ISO 15223-1
Symbol 5.1.7 Medical devices
—
Symbols to be used with
medical device labels,
labelling and information
to be supplied
Serial number Indicates the manufacturer's serial
number so that a specific medical
device can be identified.
ISO 15223-1
Symbol 5.4.3
Annex A
#A.15 Medical devices
—
Symbols to be used with
medical device labels,
labelling and information
to be supplied
Consult instructions for
use Indicates an instruction to consult
an electronic instructions for use
(eIFU).