natus Nicolet EDX Bedienungsanleitung Seite 3

Instructions to Access the eIFU:
A copy of the Instructions for Use in PDF format is in the associated product area:
• Neurology: https://neuro.natus.com/neuro-support
Search for "Nicolet EDX Amplifier Cables IFU" (refer to the Product Part Numbers) and
Glossary of Symbols:
Symbol Standard
Reference
Not applicable
21 CFR
Part 801.109(b)(1)
ISO 15223-1
Symbol 5.4.5
(Reference
LATEX
Annex B for the
general prohibition
symbol)
2012/19/EU
ISO 15223-1
Symbol 5.1.1
ISO 15223-1
Symbol 5.1.2
ISO 15223-1
Symbol 5.1.3
ISO 15223-1
Symbol 5.1.5
ISO 15223-1
Symbol 5.1.6
ISO 15223-1
Symbol 5.4.3
Annex A #A.15
IEC 60601-1
Table D.2 #10
ISO 15223-1
Symbol 5.4.4
IEC 60601-1
Table D.1 #10
IEC 60601-1
Table D.2 #2
MDR 2017/745
ISO 15223-1
Symbol 5.2.8
Standard Title
Not applicable
Labeling-Prescription devices
Medical devices — Symbols
to be used with medical
device labels, labelling and
information to be supplied
Waste Electrical and Electronic
Equipment (WEEE)
Medical devices — Symbols
to be used with medical
device labels, labelling and
information to be supplied
Medical devices — Symbols
to be used with medical
device labels, labelling and
information to be supplied
Medical devices — Symbols
to be used with medical
device labels, labelling and
information to be supplied
Medical devices — Symbols
to be used with medical
device labels, labelling and
information to be supplied
Medical devices — Symbols
to be used with medical
device labels, labelling and
information to be supplied
Medical devices — Symbols
to be used with medical
device labels, labelling and
information to be supplied
Medical electrical equipment —
Part 1: General requirements
for basic safety and essential
performance
Medical devices — Symbols
to be used with medical
device labels, labelling and
information to be supplied
Medical electrical equipment —
Part 1: General requirements
for basic safety and essential
performance
Medical electrical equipment —
Part 1: General requirements
for basic safety and Essential
performance
EU Medical Device Regulation
Medical devices — Symbols
to be used with medical
device labels, labelling and
information to be supplied
choose the version for your local language for the instructions to use.
The files can be printed, saved, or searched using Adobe Reader. A copy of Adobe Reader
can be downloaded directly from Adobe Systems (www.adobe.com).
Symbol Title
An indication of This product is a medical device.
Medical Device
Prescription only Indicates that the product is authorized for sale by or on the order of a
licensed healthcare practitioner.
Not made with Indicates that the medical device is not made with natural rubber latex.
natural rubber latex
Disposal at end Indicates that electrical and electronic equipment waste should not
of operating life be discarded together with unseparated waste but must be collected
instructions separately.
Manufacturer Indicates the medical device manufacturer.
Authorized Indicates the Authorized representative in the European Community.
representative
in the European
Community
Date of manufacture Indicates the date when the medical device was manufactured.
Batch code Indicates the manufacturer's batch code so that the batch or lot can be
identified.
Catalogue number Indicates the manufacturer's catalogue number so that the medical
device can be identified.
Consult instructions Indicates an instruction to consult an electronic instructions for use
for use (eIFU).
Follow instructions Refer to instruction manual/Booklet.
for use
NOTE on ME EQUIPMENT "Follow instructions for use"
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.
General warning sign Indicates a hazard of potential personal injury to patient or operator.
CE marking Signifies European technical conformity.
Do not use if package Indicates a medical device that should not be used if the package has
is damaged been damaged or opened.
Explanation
3