Glossary Of Symbols - natus MiniMuffs Manual Del Usuario

Instructions to Access the eIFU:
A copy of the Instructions for Use in PDF format is in the
associated product area:
• Newborn Care:
https://newborncare.natus.com/newborn-care-support

Glossary of Symbols:

Standard
Symbol
Reference
Medical Not applicable
Device
21 CFR Part
801.109(b)(1)
ISO 15223-1
Symbol 5.4.5
(Reference
LATEX
Annex B for
the general
prohibition
symbol)
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 #2
MDR 2017/745
ISO 15223-1
Symbol 5.1.4
ISO 15223-1
Symbol 5.2.8
ISO 15223-1
Symbol 5.4.2
U.S. EPA
Regulation 40
CFR Part 211,
Subpart B
Standard Title
Not applicable
Labeling-Prescription devices
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 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
EU Medical Device Regulation
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
Code of Federal Regulations
Search for "MiniMuffs Neonatal Noise Attenuators IFU" (refer to
the Product Part Number) and 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 Medical
Device
Prescription only
Not made with natural rubber
latex
Manufacturer
Authorized representative in
the European Community
Date of manufacture
Batch code
Catalogue number
Consult instructions for use
General warning sign
CE marking
Use-by date
Do not use if package is
damaged
Do not re-use
U.S. Environmental
Protection Agency logo
Explanation
This product is a medical device.
Indicates that the product is authorized
for sale by or on the order of a licensed
healthcare practitioner.
Indicates that the medical device is not
made with natural rubber latex.
Indicates the medical device
manufacturer.
Indicates the Authorized representative in
the European Community.
Indicates the date when the medical
device was manufactured.
Indicates the manufacturer's batch code
so that the batch or lot can be identified.
Indicates the manufacturer's catalogue
number so that the medical device can be
identified.
Indicates an instruction to consult an
electronic instructions for use (eIFU).
Indicates a hazard of potential personal
injury to patient or operator.
Signifies European technical conformity.
Indicates the date after which the medical
device is not to be used.
Indicates a medical device that should
not be used if the package has been
damaged or opened.
Indicates that the medical device is
intended for one use, or for use on a
single patient during a single procedure.
Products with this logo comply with the
specified EPA regulation.
3