Product Description - natus OBM00042 Instrucciones De Uso

Standards
Symbol
Reference
ISO 15223-1
Symbol 5.4.3
ISO 60601-1
Table D.1 #11
ISO 15223-1
Symbol 5.4.4
ISO 60601-1
Table D.1 #10
ISO 60601-1
Table D.2 #2
ISO 15223-1
Symbol 5.1.4
ISO 15223-1
Symbol 5.2.8
ISO 15223-1
Symbol 5.3.7
ISO 15223-1
Symbol 5.3.8
ISO 15223-1
Symbol 5.4.2
ISO 15223-1
Symbol 5.4.5
LATEX
(Reference Annex
B for the general
prohibition symbol)
2012/19/EU
ISO 15223-1
Symbol 5.3.2
Product Part Numbers
OBM00042
CZA00037
Français
Description :
Les capteurs de néonatologie à l'hydrogel pour OBM sont des électrodes de surface à
usage unique qui s'utilisent pour conduire des signaux électriques de manière non-invasive
entre un patient et l'Olympic Brainz Monitor ou d'autres amplificateurs destinés à effectuer
des tests d'EEG, de PSG, de potentiels évoqués ou d'EMG.
Utilisation prévue :
On utilise les électrodes d'enregistrement de surface à usage unique pour stimuler ou
enregistrer l'activité électrique de muscles ou de nerfs moteurs ou sensoriels dans le cadre
d'études de conduction nerveuse, de potentiels évoqués ou en monitorage peropératoire.
Utilisateurs prévus et groupe de patients cible :
Ce produit est conçu pour être utilisé sur des patients de néonatologie ou sur des
nourrissons (âgés de 0 à 28 jours et dont l'âge post-conception est compris entre 24 et
46 semaines), sous supervision d'un médecin.
Standard Title of Symbol
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.
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.
Waste Electrical and Electronic Equipment
(WEEE)
Medical devices — Symbols to be used
with medical device labels, labelling and
information to be supplied.

Product Description

101.6cm (40") lead, (1.5mm DIN), 12 x 5/pkg
305mm (12") lead, (1.5mm DIN), 12 x 5/pkg
Symbol Title as per
Explanation
Reference Standard
Consult instructions for Indicates the need for the user to consult the instructions for use.
use
Operating instructions
Caution: Read Indicates the need for the user to consult the instructions for use for
all warnings and important cautionary information such as warnings and precautions that
precautions in cannot, for a variety of reasons, be presented on the medical device
instructions for use itself.
General warning sign Indicates a hazard of potential personal injury to patient or operator.
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.
Do not use if package Indicates a medical device that should not be used if the package has
is damaged been damaged or opened.
Temperature limit Indicates the (storage) temperature limits to which the medical device
can be safely exposed.
Humidity limitation Indicates the range of (storage) humidity to which the medical device can
be safely exposed.
Do not re-use Indicates a medical device that is intended for one use, or for use on a
single patient during a single procedure.
Not made with Natural Indicates a medical device that is not made with natural rubber latex.
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.
Keep away from Indicates a medical device that needs protection.
sunlight
Avantages cliniques :
Facilite l'enregistrement des études d'EEG/PSG pour détecter les anomalies indicatives
d'atteintes cérébrales ou de troubles du sommeil.
Contre-indications et effets secondaires :
Aucune contre-indication ni aucun effet secondaire n'a été signalé dans le cadre des
procédures réalisées avec les capteurs de néonatologie à l'hydrogel de Natus. Consultez les
avertissements et les précautions présentés ci-dessous.
Instructions d'utilisation :
• Ouvrez le sachet juste avant l'utilisation.
• Nettoyez et séchez la peau avant d'appliquer le capteur.
• Décollez l'électrode de sa pellicule protectrice au dos.
• Collez-la sur le patient, en vous assurant que la pression d'adhésion soit uniforme sur
l'ensemble de sa surface.
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