3
CAUTION
Jelly Tab Sensors: Potential skin irritation or tissue breakdown
• Do not prepare skin or apply electrodes to damaged or compromised tissue or to
babies with marked jaundice.
• Do not leave electrodes on a patient for prolonged periods. If the patient
perspires under an electrode that has not been removed, irritation may develop.
Jelly Tab Sensors: Material Damage to the Device
• Do not touch the underside of the sensor, as the entire surface is conductive.
Environmental Specifications:
Operating Conditions:
• Temperature: 5°C to 40°C (41°F to 104°F)
• Relative Humidity: 5% to 90% non-condensing
• Altitude: 700 hPa to 1060 hPa
Storage Conditions:
• Temperature: -30°C to 55°C (-22°F to 131°F)
• Relative Humidity: 5% to 90% non-condensing
• Altitude: 230 hPa to 1060 hPa
Compliance Standards:
• ISO 10993-1: 2018 Biological evaluation of medical devices — Part 1: Evaluation and
testing within a risk management process
• ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers
and Systems for Vibration
Disposal Instructions:
Following use, properly dispose of adhesive Flexicoupler electrodes with waste.
Disclaimer:
Natus Medical Incorporated is not responsible for injury, infection, or other damage
resulting from the use of this product.
Any serious incident that has occurred in relation to the device should be reported
to Natus Medical Incorporated and the competent authority of the Member State in
which the user and/or patient is established.
Refer to the Natus website for an electronic copy of this document.
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.
Search for “Flexicoupler and Jelly Tab Combo Pack IFU” (refer to the Product Part
Numbers) 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).
Glossary of Symbols:
Symbol
Standard Reference
Standard Title
Symbol Title
Explanation
Medical Device Not applicable
Not applicable
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.
ISO 15223-1
Symbol 5.4.5
(Reference Annex B for the
general prohibition symbol)
Medical devices – Symbols to be used
with medical device labels, labelling
and information to be supplied.
Not made with Natural Rubber
Latex
Indicates a medical device that is not made with natural
rubber latex.
ISO 15223-1
Symbol 5.1.1
Medical devices – Symbols to be used
with medical device labels, labelling
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, labelling
and information to be supplied.
Authorized representative in the
European Community
Indicates the Authorized representative in the European
Community.
ISO 15223-1
Symbol 5.1.5
Medical devices – Symbols to be used
with medical device labels, labelling
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, labelling
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
Annex A #A.15
Medical devices – Symbols to be used
with medical device labels, labelling
and information to be supplied.
Consult instructions for use
Indicates an instruction to consult an electronic
instructions for use (eIFU).
ISO 15223-1
Symbol 5.4.4
Medical devices – Symbols to be used
with medical device labels, labelling
and information to be supplied.
Caution: Read all warnings and
precautions in instructions for
use
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.
IEC 60601-1
Table D.1 #10
Medical electrical equipment – Part 1:
General requirements for basic safety
and essential performance.
MDR 2017/745
EU Medical Device Regulation
CE marking
Signifies European technical conformity.
ISO 15223-1
Symbol 5.1.4
Medical devices – Symbols to be used
with medical device labels, labelling
and information to be supplied.
Use-by date
Indicates the date after which the medical device is not to
be used.
Note: This symbol shall be accompanied by a date to
indicate that the medical device should not be used after
the end of the year, month or day shown.
ISO 15223-1
Symbol 5.2.8
Medical devices – Symbols to be used
with medical device labels, labelling
and information to be supplied.
Do not use if package is
damaged
Indicates a medical device that should not be used if the
package has been damaged or opened.
ISO 15223-1
Symbol 5.3.7
Medical devices – Symbols to be used
with medical device labels, labelling
and information to be supplied.
Temperature limit
Indicates the (storage) temperature limits to which the
medical device can be safely exposed.
ISO 15223-1
Symbol 5.3.8
Medical devices – Symbols to be used
with medical device labels, labelling
and information to be supplied.
Humidity limitation
Indicates the range of (storage) humidity to which the
medical device can be safely exposed.
