NETWORK MEDICAL Crawford Intubation Set Gebrauchsanweisung

PPRODUCT NAME CRAWFORD INTUBATION SET and CANALICULUS INTUBATION SET
PPRODUCT INFORMATION AND INSTRUCTIONS FOR USE
Symbols Used
GB- Lot GB- Use Until GB- Do Not Re-use
Number Date DE – Nicht
DE – Ch.-B. DE – wiederverwenden
ES - Número de Verwendbar ES - No reutilizar
lote bis FR- Ne pas réutiliser
o
FR- N de lot ES - Usar IT - Non riutilizzare
IT - Numero di antes de la
lotto fecha
FR- Date
limite
d'utilisation
IT - Utilizzare
entro
COR_015
GB- Catalogue GB- Caution GB - Consult
Number DE – Vorsicht Electronic
DE – ES - Instructions for Use
Katalognummer Advertencia DE – Elektronische
ES - Número de FR- Gebrauchsanweisung
catálogo Avertissement beachten
FR- Numéro du IT- Attenzione ES - Consultar
catalogue instrucciones de
IT - Riferimento empleo electrónicas
di catalogo FR - Consulter le
mode d'emploi
électronique
IT - Consultare le
Istruzioni per l'uso
elettroniche
GB - INSTRUCTIONS FOR USE
Description
The NETWORK MEDICAL Crawford Intubation Set and Canaliculus Intubation Set consist of two malleable stainless steel probes attached by a length of silicone tubing. The probes of the Crawford Intubation
Set have olive shaped tips which have been designed to prevent unintentional perforation of the soft tissue and can be located by the hook of the Crawford Retrieval device and used to draw the probe down
through the nose efficiently and safely. Both sets are supplied sterile for SINGLE USE ONLY.
Intended Use
The NETWORK MEDICAL Crawford Intubation and Canaliculus Intubation Sets are intended for silicone intubation procedures. The device provides a means of restoring the patency of the lacrimal system.
CAUTIONS
•
This device is supplied STERILE and ready to use.
•
This device is for SINGLE USE ONLY. Do NOT re-sterilise or re-use.
•
Do not use if the packaging has been opened or damaged.
•
This device is only to be used by a suitably trained or qualified person under the facility approved and recommended conditions.
•
Ease of passage of the probes through the Lachrymal System will vary widely from patient to patient with the placement of the tubes in some patients being quite difficult due to narrow openings in the
lachrymal system, especially at the lower end of the bony canal. Separation of the silicone tubing from the probe may occur when intubating patients with severe blockage or a pronounced bony
prominence.
•
Silicone tubing could be difficult to detect or to remove. Examination under anaesthesia, including nasal endoscopy may be warranted when accidental tube extrusion cannot be reliably confirmed.
•
For safe disposal, the needle should be considered as 'sharp' and must be immediately placed in a secure puncture-resistant bin (conforming to BS7320) which is suitable for incineration. All the
components should be disposed of in accordance with hospital approved procedures.
•
The product comes into contact with bodily fluids, which can be contaminated. Care should be taken in the handling and disposal of the silicone tubing after use to prevent contamination.
•
Do not use for any purposes other than lacrimal surgery.
MRI Compatibility
All tubing is made from Silicone, which is MRI compatible.
Incident Reporting
Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established
Instructions and Surgical Procedure
•
Each punctum should be dilated.
•
The lachrymal system is probed to open up any blockages using a standard lachrymal probe such as a Bowman 00.
•
The Crawford probe is passed through the Upper Punctum and across the Upper Canaliculus and then orientated down through the lachrymal system into the nose approximately 35mm – 40mm.
•
If any difficulties are experienced in locating the probe a Bowman probe may be used to establish metal to metal contact and define the position of the probe. The surgeon must keep lateral tension on the
lid to avoid an accordion type effect of the canaliculus, which increases the risk of perforating the epithelium and creating a false passage.
Network Medical Products Ltd
Coronet House, Kearsley Road, Ripon,
North Yorkshire, HG4 2SG, UK
Tel: +44 (0)1765 609555 Fax: +44 (0)1765 608476
info@networkmedical.co.uk| www.networkmedical.co.uk
GB- Do not use if product is GB- Sterilised
opened or damaged. by Irradiation
DE – Nicht verwenden, wenn die DE – Sterilisiert
Packung bereits offen oder durch
beschädigt ist Bestrahlung
ES - No utilizar si el producto está ES- Esterilizado
abierto o dañado por irradiación
FR- Ne pas utiliser si l'emballage FR- Stérilisé
est ouvert ou endommagé. par irradiation.
IT - Non usare se la confezione è IT- Sterilizzato
aperta o danneggiata a raggi gamma.
only
GB – Caution: US Federal law
restricts this device to sale by or GB- Do not
on the order of a physician resterilise
DE – Vorsicht: Nach dem US- DE – Nicht
amerikanischen Bundesgesetz erneut
darf dieses Medizinprodukt nur sterilisieren
von medizinischen Fachkreisen ES - No
oder auf Anordnung dieser reesterilizar
gekauft werden. FR- Ne pas
ES - Advertencia: las leyes restériliser
federales de Estados Unidos IT - Non
limitan la venta y el uso a un risterilizzare
facultativo (o por prescripción de
este)
FR- Avertissement : La loi fédérale
américaine limite la vente et
l'utilisation aux médecins ou à la
demande d'un médecin
IT - Attenzione: la legge federale
degli Stati Uniti d'America limita
la vendita e l'uso ai medici o su
prescrizione del medico
COR_015 REV 06 11/20
GB – GB – Date of
Manufacturer Manufacture
DE – Hersteller DE –
ES - Fabricante Herstellungsdatum
FR –Fabricant ES - Fecha de
IT – Fabbricante fabricación
FR – Date de
fabrication
IT - Data di
fabbricazione
GB – Medical GB – Unique
Device Device Identifier
DE – DE –
Medizinprodukt Medizinprodukt-
ES - Dispositivo Kennung
medico ES - Identificador
FR – Dispositif único del
médical dispositivo
IT - Dispositivo FR – Identifiant
medico unique du
dispositif
IT - Identificatore
univoco del
dispositivo
1639
Page 1 of 6
GB – EU Authorised Representative
DE – EU-Bevollmächtigter
ES - Representante autorizado de la
UE
FR – Représentant UE autorisé
IT - Mandatario nell'Unione europea
GB - Sterile barrier system with an
additional packaging layer inside
DE – Steriles Barrieresystem mit
zusätzlicher Schicht in der
Verpackung
ES - Sistema de barrera estéril con
una capa de embalaje adicional en
el interior
FR- Système de barrière stérile avec
emballage protecteur
supplémentaire à l'intérieur
IT - Sistema di barriera sterile con
uno strato di confezionamento
aggiuntivo al suo interno
GB - Single sterile barrier system
with protective packaging outside
DE - Einfach-Sterilbarrieresystem
mit schützender Außenverpackung
ES- Sistema de barrera estéril
individual con embalaje protector
en el exterior
FR - Système de barrière stérile
unique avec emballage protecteur
externe
IT - Sistema di barriera singola
sterile con confezionamento
protettivo esterno
Advena Limited
Tower Business Centre,
2nd Floor, Tower Street, Swatar,
BKR 4013, Malta