Synthes MAXFRAME AUTOSTRUT, User Manual

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50 Physician User Manual • MAXFRAME AUTOSTRUT™ System
7. Symbols Glossary
Following are the symbols and their descriptions used in
the MAXFRAME AUTOSTRUT System:
Symbol Standard Number
and Title Symbol
Number Symbol Title Description
EN ISO 15223-1 5.1.5 Batch code Indicates the manufacturer’s batch code so that
the batch or lot can be identified.
EN ISO 15223-1 5.1.7 Serial number Indicates the manufacturer's serial number so
that a specific medical device can be identified.
ISO 15223-1 5.1.3 Date of manufac-
ture Indicates the date the device was manufac-
tured.
21 CFR 801.109 – Prescription Use
Only Caution: Federal (US) law restricts this device
to sale by or on the order of a physician.
ISO 15223-1 5.4.2 Do not reuse Indicates a medical device that is intended
for one use, or for use on a single user during
a single procedure.
ISO 15223-1 5.4.4 Caution Indicates the need for the user to consult the
instructions for use for important cautionary
information such as warnings and precautions
that cannot, for a variety of reasons,
be presented on the medical device itself.
ISO 15223-1 5.4.3 Consult instructions
for use Indicates the need for the user to consult the
instructions for use.
ISO 15223-1 5.1.6 Catalog number Indicates the manufacturer’s catalog number
so that the medical device can be identified.
ISO 15223-1 5.1.1 Manufacturer Indicates the medical device manufacturer.
ISO 15223-1 5.3.7 Temperature limit Indicates the temperature limits to which the
medical device can be safely exposed.
ISO 15223-1 5.3.9 Atmospheric pres-
sure limitation Indicates the range of atmospheric pressure
to which the medical device can be safely
exposed.
ISO 15223-1 5.2.8 Do not use if pack-
age is damaged Indicates a medical device that should not
be used if the package has been damaged or
opened.
ISO 15223-1 5.7.10 Unique Device
Identifier
(Barcode) Indicates a carrier that contains Unique Device
Identifier information.