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INSTRUCTIONS FOR USE
ENDOTUBE FOR WASH BOTTLE WITH CO2
TUBING
CAUTION
TEMPERATURE LIMITS
KEEP AWAY FROM
DIRECT SUNLIGHT
PROTECT FROM
MOISTURE
LOT
LOT CODE
QTY
QUANTITY
EXPIRY
DO NOT USE IF
PACKAGING IS DAMAGED
MD
MEDICAL DEVICE
• Using the tubing for more than 24 hours
can cause bacteria to develop in the
stagnant water within tubing
• Before using this device, please read the
instructions for the endoscope you will be
using, as well as for any accessories that
will be used.
HS.NisshaMedical.com
Nissha Medical Technologies SAS
25 Boulevard de la Paix
95800 Cergy
France
+33 1 39 72 66 66
DISPOSE OF AFTER
24h
24 HOURS OF USE
NON-STERILE
NON
STERILE
MANUFACTURER
LATEX
LATEX FREE
Not made with
natural rubber latex
PHT FREE
PHT
READ INSTRUCTIONS
FOR USE
REF
REFERENCE
EC ACCORDING TO
DIRECTIVE 93/42/EEC
0197
AND UPDATE
2007/47/EC
COMMDOCU200/004
Rev C Date: 2021-05-07
ENGLISH
EN
ENDOTUBE FOR WASH BOTTLE WITH CO2 TUBING
Please read the following information carefully.
Failure to use the product as intended may have harmful consequences for
the patient.
Important reminder:
This document contains instructions for using the "ENDOtube for Wash
Bottle CO2 Insufflation," tubing for endoscopes. It contains no references
to particular medical procedures. The manufacturer will not be held liable
for any problems caused by improper use of the device.
I. INTENDED PURPOSE / COMPATIBILITY
ENDOtube for Wash Bottle CO2 Insufflation is designed to supply
an endoscope with air or carbon dioxide (CO2) and water during
gastrointestinal endoscopy procedures and contains a tube with a filter
designed to deliver carbon dioxide (CO2) to an endoscope via a CO2
insufflator. ENDOtube for Wash Bottle CO2 Insufflation must be used
within 24 hours of opening.
There are eight models of the ENDOtube for Wash Bottle CO2
Insufflation available:
• FLOCO2LUER is compatible with Olympus endoscopes and insufflators
fitted with a female Luer lock fitting.
• FLPCO2LUER is compatible with Pentax endoscopes and insufflators
fitted with a female Luer lock fitting.
• FLFCO2LUER is compatible with FUJIFILM 600 and earlier endoscopes
and insufflators fitted with a female Luer lock fitting.
• FLF7CO2LUER is compatible with FUJIFILM 700 endoscopes and
insufflators fitted with a female Luer lock fitting.
• FLOCO2FUJI is compatible with Olympus endoscopes and insufflators
fitted with a special Luer lock fitting.
• FLPCO2FUJI is compatible with Pentax endoscopes and insufflators fitted
with a special Luer lock fitting.
• FLFCO2FUJI is compatible with FUJIFILM 600 and earlier endoscopes and
insufflators fitted with a special Luer lock fitting.
• FLF7CO2FUJI is compatible with FUJIFILM 700 endoscopes and
insufflators fitted with a special Luer lock fitting.
Part no.
Description
1
Tube
2
Tube
3
Cap
4
Tube
5
Tube Clamp
6
Valve
7
Cap
CONTRAINDICATIONS:
The contraindications are those particular to any endoscopy procedure.
HS.NisshaMedical.com
Part no.
Description
8
Pentax Connector
9
O-ring
10
Metal Cap
11
Pentax Connector
12
O-ring
13
O-ring
14
Olympus Connector
1/15
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Sommaire des Matières pour NISSHA MEDICAL ENDOduo ENDOTUBE
- Page 1 Valve O-ring Olympus Connector CONTRAINDICATIONS: The contraindications are those particular to any endoscopy procedure. HS.NisshaMedical.com 1/15 Nissha Medical Technologies SAS 25 Boulevard de la Paix 95800 Cergy France COMMDOCU200/004 +33 1 39 72 66 66 HS.NisshaMedical.com Rev C Date: 2021-05-07...
- Page 2 ENGLISH II. STORAGE / PACKAGING STORAGE: • Room temperature: +10°C to +50°C • Expiry date: 2 years (see on the label) PACKAGING: ENDOtube for Wash Bottle CO2 Insufflation, is packaged individually in boxes of 10. Once removed from its packaging, the tubing must be used within 24 hours of opening. III.
- Page 3 ENGLISH 13. Once the procedure is complete, clamp and unplug the ENDOtube for Wash Bottle CO2 Insufflation system. 14. You can then turn off the processor and insufflator once you have unplugged the ENDOtube for Wash Bottle CO2 Insufflation. 15. Make sure that the device is properly disposed of within 24 hours of opening the packaging. A traceability label is provided for this purpose.
- Page 4 Bouchon Connecteur Olympus CONTRE INDICATIONS: Les contre-indications sont celles spécifiques à toute intervention endoscopique. HS.NisshaMedical.com 4/15 Nissha Medical Technologies SAS 25 Boulevard de la Paix 95800 Cergy France COMMDOCU200/004 +33 1 39 72 66 66 HS.NisshaMedical.com Rev C Date: 2021-05-07...
- Page 5 FRANÇAIS II. STOCKAGE / CONDITIONNEMENT STOCKAGE: • Température ambiante : +10 à +50 °C • Date de péremption : 2 ans (voir sur l’étiquette) CONDITIONNEMENT: Les tubulures pour flacon de lavage pour endoscope sont conditionnées unitairement puis par carton de 10. Une fois sortie de son emballage la tubulure doit être utilisée dans les 24 heures.
- Page 6 FRANÇAIS la bonne connexion des tubulures aux différents appareils. 11. Si pendant l’intervention, vous voulez changer la source d’insufflation (air ou CO2) reporté vous au point 9 ou 10. 12. Si le flacon d’eau doit être remplacé, utiliser les techniques appropriées à ce changement. 13.
- Page 7 Junta tórica Tapón Conector Olympus CONTRAINDICACIONES: Las contraindicaciones son las específicas para cualquier intervención endoscópica. HS.NisshaMedical.com 7/15 Nissha Medical Technologies SAS 25 Boulevard de la Paix 95800 Cergy France COMMDOCU200/004 +33 1 39 72 66 66 HS.NisshaMedical.com Rev C Date: 2021-05-07...
- Page 8 ESPAÑOL II. ALMACENAMIENTO / PRESENTACIÓN ALMACENAMIENTO: • Temperatura ambiente: +10 a +50 ºC • Fecha de caducidad: 2 años (ver en la etiqueta) PRESENTACIÓN: Los tubos para frasco lavador de endoscopio están disponibles de forma individual dentro de cajas de 10 unidades. Una vez abierto el embalaje, el tubo debe utilizarse dentro de 24 horas.
- Page 9 ESPAÑOL botella de agua y que los tubos estén bien conectados a los diferentes aparatos. 11. Si durante la intervención, desea cambiar la fuente de insuflación (aire o CO2) remítase a los puntos 8 o 9. 12. Si debe reemplazar el frasco de agua, utilice las técnicas adecuadas para realizar el cambio. 13.
- Page 10 Stopfen Olympus-Ansatz GEGENANZEIGEN: Die Gegenanzeigen umfassen die für jedes endoskopische Verfahren geltenden spezifischen Gegenanzeigen. HS.NisshaMedical.com 10/15 Nissha Medical Technologies SAS ZA des Boutries 12 rue des Cayennes 78700 Conflans Sainte Honorine COMMDOCU200/004 France HS.NisshaMedical.com +33 1 39 72 66 66...
- Page 11 DEUTSCH II. LAGERUNG / VERPACKUNG LAGERUNG: • Umgebungstemperatur: +10 °C bis +50 °C • Verfallsdatum: 2 Jahre (siehe auf dem Etikett) VERPACKUNG: Die Anschlussschläuche für Endoskop-Spülflaschen sind einzeln verpackt in Schachteln zu 10 Stück gepackt. Nach der Entnahme aus der Verpackung müssen die Anschlussschläuche innerhalb von 24 Stunden verwendet werden. III.
- Page 12 DEUTSCH 10. Vor Beginn des Eingriffs und unabhängig vom verwendeten Verfahren (Punkt 8 oder 9) ist die ordnungsgemäße Funktion zu überprüfen, indem der Luft/Wasser- oder Luft/CO2-Kanal am Endoskop angesaugt wird. Bei einer Fehlfunktion ist die Wasserflasche auf Dichtheit und der ordnungsgemäße Anschluss der verschiedenen Schläuche zu überprüfen. 11.
- Page 13 O-ring Tappo Connettore Olympus CONTROINDICAZIONI: Le controindicazioni sono quelle particolari per ogni procedura endoscopica. HS.NisshaMedical.com 13/15 Nissha Medical Technologies SAS 25 Boulevard de la Paix 95800 Cergy France COMMDOCU200/004 +33 1 39 72 66 66 HS.NisshaMedical.com Rev C Date: 2021-05-07...
- Page 14 ITALIANO II. MAGAZZINAGGIO / CONFEZIONE MAGAZZINAGGIO: • Temperatura ambiente: +10 a +50 ºC • Data di scadenza: 2 anni (vedere sulla etichetta) CONFEZIONE: L’ENDOtube per Insufflazione di CO2 è confezionato individualmente in scatole di 10 pezzi. Una volta che è rimosso dalla sua confezione, il tubo deve essere usato entro 24 ore dall’apertura.
- Page 15 ITALIANO 11. Se desiderate cambiare la sorgente di insufflazione (aria o CO2) durante la procedura, vedere i punti 9 e 10. 12. Se dovete sostituire la bottiglia di acqua, usate le tecniche adatte. 13. Una volta che la procedura è completata, afferrare e staccare la spina dell’ENDOtube per sistema bottiglia di lavaggio + insufflazione di CO2.