Natus ErgoJust LTM and ErgoJust ICU Cart Information For Use
1-4
July 6, 2020
Labels and symbols
The following labels and symbols may be affixed to the Natus ErgoJust LTM cart and/or Natus Neurology Incorporated system
components. Items marked with “-” are non-standardized symbols.
Symbol
Standard
Reference
Standard Title of
Symbol
Symbol Title as per
Referenced Standard
Explanation
Medical Device
-
-
An indication of Medical
device
This product is a medical
device.
21 CFR Part
801.109(b)(1)
Labeling-Prescription
devices.
Prescription only
Indicates the product is
authorized for sale by or on
the order of a licensed
healthcare practitioner.
2012/19/EU
Waste Electrical and Elec-
tronic Equipment (WEEE)
Disposal at end of operat-
ing life instructions
Indicates that electrical and
electronic equipment waste
should not be discarded
together with unseparated
waste but must be collected
separately.
ISO 15223-1
Symbol 5.1.1
Medical devices — Symbols
to be used with medical
device labels, labeling and
information to be supplied.
Manufacturer
Indicates the medical device
manufacturer.
ISO 15223-1
Symbol 5.1.2
Medical devices — Symbols
to be used with medical
device labels, labeling and
information to be supplied.
Authorized
representative in the
European Community
Indicates the Authorized
representative in the
European Community.
ISO 15223-1
Symbol 5.1.3
Medical devices — Symbols
to be used with medical
device labels, labeling and
information to be supplied.
Date of manufacture
Indicates the date when the
medical device was
manufactured.
ISO 15223-1
Symbol 5.1.5
Medical devices — Symbols
to be used with medical
device labels, labeling and
information to be supplied.
Batch or Lot code
Indicates the manufacturer's
batch code so that the batch
or lot can be identified.
ISO 15223-1
Symbol 5.1.6
Medical devices — Symbols
to be used with medical
device labels, labeling and
information to be supplied.
Catalogue number
Indicates the manufacturer’s
catalogue number so that the
medical device can be
identified.
ISO 15223-1
Symbol 5.4.3
Medical devices — Symbols
to be used with medical
device labels, labeling and
information to be supplied.
Consult instructions for
use
Indicates the need for the
user to consult the
instructions for use.
ISO 60601-1
Table D.1 #11
Medical electrical equip-
ment — Part 1: General
requirements for basic safety
and essential performance.
Operating instructions
ISO 60601-1
Table D.2 #10
Medical electrical equip-
ment — Part 1: General
requirements for basic safety
and essential performance
Follow instructions for
use
Refer to instruction manual/
Booklet.
NOTE on ME EQUIPMENT
"Follow instructions for use”
