Intended Use; Warnings And Precautions - Medivators DEFENDO Gebrauchsanweisung

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Intended Use:

The DEFENDO® Disposable Biopsy Valve is intended for covering the endoscope biopsy port during an endoscopy procedure. The biopsy valve
provides access for endoscopic device passage and exchange, helps maintain sufflation, and minimizes leakage of biomaterial from the biopsy
port throughout the endoscopic procedure.
The DEFENDO® Y-OPSY® Biopsy Valve Irrigator is intended to enable simultaneous irrigation and instrumentation in the endoscope's
biopsy channel.
The DEFENDO™ Disposable Air/Water Valve is intended to be used to control the air/water function on an endoscope during a
GI endoscopic procedure.
The DEFENDO™ Disposable Suction Valve is intended to be used to control the suction function on an endoscope during a
GI endoscopic procedure.

Warnings and Precautions:

Guidelines for Preventing Cross Contamination:
•
DO NOT RESTERILIZE OR REPROCESS.
•
DEFENDO Biopsy Valves, Y-OPSY Biopsy Valve Irrigators, DEFENDO Air/Water Valves, and DEFENDO Suction Valves must be discarded
•
after each procedure.
The appropriate DEFENDO Biopsy Valves, Y-OPSY Biopsy Valve Irrigators, DEFENDO Air/Water Valves, and DEFENDO Suction Valves are to be
•
used with the compatible endoscope, based on scope type/manufacturer.
DEFENDO Biopsy Valves, Y-OPSY Biopsy Valve Irrigators, DEFENDO Air/Water Valves, and DEFENDO Suction Valves should not be refurbished,
•
reprocessed, or resterilized.
DEFENDO Biopsy Valves, Y-OPSY Biopsy Valve Irrigators, DEFENDO Air/Water Valves, and DEFENDO Suction Valves are for single use only.
•
Reuse poses a risk of cross contamination of bodily fluids.
Discard biohazard valves in accordance with local, state, and federal regulations.
•
NOTE: If package is damaged or opened prior to intended use, DEFENDO Biopsy Valves, Y-OPSY Biopsy Valve Irrigators, DEFENDO Air/Water
•
Valves, and DEFENDO Suction Valves must be discarded immediately.
Sterility is not guaranteed if package has been opened or damaged. Do not use if packaging or product is damaged.
•
Contact customer service for assistance.
•
Federal (USA) law restricts the sale of this device by or on the order of a physician.
•
WARNING:
Always wear gloves and other appropriate personal protective equipment while handling such as gown and face mask. After use, these products may be potential
biohazards. Handle and dispose of in accordance with accepted medical practice and applicable local, state, and federal laws and regulations.
Instructions for Use (by product number):
100301
DEFENDO Disposable Biopsy Valve for OLYMPUS® GI Endoscopes and
FUJIFILM™ GI Endoscopes
1. Open the sterile peel pack and remove the DEFENDO Disposable Biopsy Valve.
2. Position the DEFENDO Disposable Biopsy Valve onto the biopsy port of the OLYMPUS or FUJIFILM Endoscope.
3. Always make sure the lid of the biopsy valve is closed.
4. If the diameter of the accessory is >3mm, open the lid for instrumentation.
5. At the end of the procedure, remove and discard the biopsy valve.
100302
DEFENDO Disposable Biopsy Valve for PENTAX® GI Endoscopes
1. Open the sterile peel pack and remove the DEFENDO Disposable Biopsy Valve.
2. Position the DEFENDO Disposable Biopsy Valve onto the biopsy port of the PENTAX Endoscope.
3. Always make sure the lid of the biopsy valve is closed.
4. If the diameter of the accessory is >3mm, open the lid for instrumentation.
5. At the end of the procedure, remove and discard the biopsy valve.
6 IFU-49 REV AM
MODE D'EMPLOI INSTRUCCIONES DE USO
BRUKSANVISNING ИНСТРУКЦИИ ПО ПРИМЕНЕНИЮ
KÄYTTÖOHJE ΟΔΗΓΙΕΣ ΧΡΗΣΗΣ
使用说明 使用說明
ISTRUZIONI PER L'USO GEBRUIKSINSTRUCTIES
INSTRUÇÕES DE USO ИНСТРУКЦИИ ЗА УПОТРЕБА
HASZNÁLATI UTASÍTÁS INSTRUCCIONES DE USO
KULLANIM TALİMATLARI
ONLY
STERILIZED USING
STERILE EO
ETHYLENE OXIDE
STERILIZED USING
STERILE EO
ETHYLENE OXIDE
EN
BRUGSANVISNING
MODE D'EMPLOI
NAUDOJIMO INSTRUKCIJOS
2
DO NOT RESTERILIZE
SINGLE USE ONLY
2
DO NOT RESTERILIZE
SINGLE USE ONLY