natus Universal XactTrace, Инструкция пользователя

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Universal XactTrace
®
User Instructions
3
Symbol
Standard
Reference
Standard Title of
Symbol
Symbol Title
as per
Referenced
Standard
Explanation
ISO 15223-1
Symbol
5.1.11
Medical devices
—
Symbols to be used
with information to
be supplied by the
manufacturer
— Part
1: General
requirements
Country of
Origin Indicates the country
of origin.
ISO 15223-1
Symbol 5.1.1
Symbols to be used
with information to
be supplied by the
manufacturer
— Part
1: General
requirements
Legal
Manufactur
er
Indicates the medical
device manufacturer.
UK MDR
2002
UKCA Mark UKCA Mark
Signifies Great Britain
(England, Wales, and
Scotland) conformity.
UK Approved Body
number appears
under symbol.
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
representati
ve in the
European
Community
Indicates the
Authorized
representative in the
European Community.
Swiss
Medical
Device
Ordinance
(MedDO)
Swiss Authorized
Representative
Swiss
authorized
representati
ve Indicates the
Authorized
representative in
Switzerland.
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.
IEC 60601-1
Table D.1
#20
IEC 60417
Symbol 5333
Medical electrical
equipment
— Part 1:
General
requirements for
basic safety and
essential
performance. TYPE BF
APPLIED
PART Identifies a type BF
applied part complying
with IEC 60601-1.
Based on
ISO 15223-1,
Annex B
Negation of
Symbol 5.4.5
Symbols to be used
with information to
be supplied by the
manufacturer
— Part
1: General
requirements
Not made
with natural
rubber latex
Indicates the absence
of natural rubber latex
as a material of
construction within the
medical device or the
packaging of a medical
device.