natus Xltek EMU40EX, Руководство пользователя и обслуживания

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EMU40EX™ User and Service Manual
22
Glossary of Symbols
Symbol
Standard
Reference
Standard Title of
Symbol
Symbol Title
as per
Referenced
Standard
Explanation
ISO 15223-1
Symbol 5.7.7
Medical devices —
Symbols to be used
with information to be
supplied by the
manufacturer — Part 1:
General requirements
An indication of
Medical Device
This product is a
medical device.
Medical Device
Directive
93/42/EEC
or
Medical Device
Regulation
2017/745
as applicable
Council Directive
93/42/EEC
Regulation (EU)
2017/745
CE Marking of
Conformity
Signifies European
technical conformity.
Notified body number
appears under symbol
if applicable.
ISO 15223-1
Symbol 5.1.2
Medical devices —
Symbols to be used
with information to be
supplied by the
manufacturer — Part 1:
General requirements
Authorized
representative
in the European
Community
Indicates the
Authorized
representative in the
European Community.
UK MDR 2002 UKCA Mark UKCA Mark Signifies Great Britain
(England, Wales, and
Scotland) conformity.
UK Approved Body
number appears under
symbol.
Custom
Symbol
Custom Symbol UK Responsible
Person
Indicates the UK
Responsible Person in
Great Britain (England,
Wales, and Scotland).
Swiss Medical
Device
Ordinance
(MedDO)
Swiss Authorized
Representative
Swiss
authorized
representative
Indicates the
Authorized
representative in
Switzerland.
21 CFR
801.109(b)(1)
Labeling-Prescription
devices
Device is
cleared for the
US market as
requiring a
prescription
Indicates that the
product is authorized
for sale by or on the
order of a licensed
healthcare
practitioner.