Hologic ThinPrep - Page 52

INTRODUCTION
1.12 ThinPrep
®
Integrated Imager Operator’s Manual
1
Symbols Used on the Instrument
The following symbols are used on this instrument:
Symbol Title Description Standard information
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 Medical
devices—Symbols to be used
with medical device labeling
and information to be supplied,
Section 5.4.4
In vitro diagnostic
medical device
Indicates a medical device that is
intended to used as an in vitro
diagnostic medical device
ISO 15223-1 Medical
devices—Symbols to be used
with medical device labeling
and information to be supplied,
Section 5.5.1
Authorized
Representative in
the European
Community
Indicates the Authorized
Representative in the European
Community
ISO 15223-1 Medical
devices—Symbols to be used
with medical device labeling
and information to be supplied,
Section 5.1.2
Serial number Indicates the manufacturer’s serial
number so that a specific medical
device can be identified
ISO 15223-1 Medical
devices—Symbols to be used
with medical device labeling
and information to be supplied,
Section 5.1.7
Catalogue
Number
Indicates the manufacturer's
catalogue number so that the
medical device can be identified
ISO 15223-1 Medical
devices—Symbols to be used
with medical device labeling
and information to be supplied,
Section 5.1.6
Manufacturer Indicates the medical device
manufacturer, as defined in the EU
Directives 90/385/EEC, 93/42/EEC
and 98/79/EC
ISO 15223-1 Medical
devices—Symbols to be used
with medical device labeling
and information to be supplied,
Section 5.1.1
Date of
manufacture
Indicates the date when the
medical device was manufactured.
ISO 15223-1 Medical
devices—Symbols to be used
with medical device labeling
and information to be supplied,
Section 5.1.3