NeurOptics NPi-300 Pupillometer Gebrauchsanweisung Seite 16

Symbol
Source/Compliance
U.S. 40 CRF 273.2 European
Community Directive Article 21
of 2006/66/EC
Standard: ISO 15223-1
Symbol Reference No: 5.1.1
European Medical Devices
Directive 93/42/EEC of 14 June
1993 (as amended by Directive
2007/47/EC) as described in
Article 17 of the Directive
European Medical Devices
Directive 93/42/EEC of 14 June
1993 (as amended by Directive
2007/47/EC) as described in
Article 17 of the Directive
Standard: ISO 15223-1
Symbol Reference No: 5.1.2
Standard: ISO 15223-1
Symbol Reference No: 5.4.3
Standard: ISO 60878
Symbol Reference No: 5140
ISO 15223-1 Medical Devices –
Symbols To Be Used with
Medical Device Labels,
Labeling, and Information to
be Supplied 5.3.4
ISO 15223-1 Medical Devices –
Symbols To Be Used with
Medical Device Labels,
Labeling, and Information to
be Supplied 5.3.7
ISO 15223-1
Reference No. 5.3.1
NeurOptics® NPi®-300 Pupillometer System—Instructions for Use ©2021 NeurOptics, Inc.
Title of Description of Symbol
Recycle. Battery Dispose of according to local procedures
contains Lithium. containing Ion batteries and products
containing lithium perchlorate.
Manufacturer Indicates the medical device manufacturer,
as defined in EU Directives 90/385/EEC,
93/42/ EEC and 98/79/EC.
Conformité Indicates manufacturer declaration that
Européenne the product complies with the essential
or European requirements of the relevant European
Conformity health, safety and environmental protection
legislation.
Conformité Indicates that the product complies with
Européenne the essential requirements of the relevant
or European European health, safety and environmental
Conformity with protection legislation and that the product is
Identification of listed through TUV SUD as the Notified Body.
Notified Body
Authorized Indicates the authorized representative in
representative the European Community.
in the European
Community
Consult electronic Indicates the need for the user to consult
instructions for use the instructions for use at NeurOptics.com.
Non-ionizing Includes RF Transmitters.
electromagnetis
radiation
Keep Dry Indicates a medical device that needs to be
protected from moisture.
Temperature Indicates the temperature limits to which
Limit the medical device can be safely exposed.
Fragile, handle Indicates a medical device that can be
with care broken or damaged if not handled carefully.
9223 Research Drive
Irvine, CA 92618 | USA
p: 949.250.9792
Toll Free North America: 866.99.PUPIL
info@NeurOptics.com
NeurOptics.com
NPi-300 IFU Rev F (HOMA-BCLLVU)
16