Medi-Globe ENDO-FLEX ZB0100 User manual

GA-0353 - Vers. 1.0 (2019-10)
Instruction for Use – Biopsy Valves SU
ENDO-FLEX GmbH ° Alte Hünxer Str. 115 ° D-46562 Voerde ° Germany °  (0049) - (0)281 – 9 44 00 – 0 ° FAX: (0049) - (0)281 – 9 44 00 – 11
Email: [e-mail] ° www.endo-flex.de
Attention
:
This medical device may only be purchased by specialists, doctors
and medical personnel and may only be used in accordance with
these instructions for use and the defined area of application.
Description / Versions
The biopsy valves offered by ENDO-FLEX are made of an elastic and non-
slip plastic, which facilitates handling especially with protective gloves.
Coloured undershields (red and blue) almost rule out confusion with com-
patible endoscope types. The detachable cap also allows the use of instru-
ments with larger outside diameters.
Products
This user manual is valid for the products listed below:
• ZB0100
• ZB0120
Important Note
Please ensure you read this user manual carefully before each use and
keep it somewhere that is easily accessible for users and/or appropriate
specialist staff.
Ensure you carefully read through the warnings. Patients, users or third
parties may suffer serious injury as a result of the improper use of the
products.
Content and Packaging
1 outer box
100 Biopsy Valves SU (Single Use) individually non-sterile packed
1 Instruction for use
1. Scope of Application
The products listed above must only be used by physicians with appropri-
ate specialist training in gastroenterology. The products are intended
solely for the medical sector as illustrated below and must therefore be
used within an operating environment suitable for this purpose. It is es-
sential that both the user as well as the appropriate specialist staff famil-
iarize themselves with the instruments before the user makes use of
them.
2. Application Period
These instruments are intended to be used uninterrupted for a period of
less than 60 minutes under normal conditions (MDD 93/42 EEC).
3. Intended Use
The biopsy valve is used to cover the opening to the biopsy/suction chan-
nel inlet of a gastrointestinal endoscope. The biopsy valve provides
• access for endoscopic device passage and exchange,
• helps maintain insufflation and
• minimizes leakage of biomaterial from the biopsy port throughout the
gastrointestinal endoscopic procedure.
Indications
• safe passage of flexible endoscopic instruments
Contraindications
• Not known
4. Complications / Side Effects / Cross-reactions
Sedation during endoscopic examination increases the risk of hypoxemia,
hypercapnia, hypotension, arrhythmias and aspiration due to reduced
protective reflexes. Hypoxemia also occurs without sedation during endo-
scopic examinations due to the feed of the endoscope. Possible injuries in
connection with endoscopic examinations can be: perforations, bleeding,
infections such as acute pancreatitis.
5. Warnings / Precautions
These instructions must be followed, as well as instructions from compat-
ible components and hospital regulations for infection prevention, safe
use, cleaning and sterilization. Failure to do so may result in serious injury
to the patient and/or the user.
The following applies to the product:
• All components should be carefully checked for compatibility and integ-
rity before use. Do not use defective instruments! If defects occur, dis-
pose of the instrument and replace it with a new one.
• Never use the product outside the recommended technical specifica-
tions (intended use).
• Never tamper with the structural conditions of the instrument, avoid
kinks and other damage, and immediately discontinue use in the event
of a malfunction!
• Wear protective clothing (gloves, goggles, gown, etc.) is absolutely nec-
essary!
•
6. Compatibility
ZB0100 - OLYMPUS- / FUJIFILM-Endoscopes (Blue)
ZB0120 - PENTAX-Endoscopes (Red)
7. Function Test
The medical devices must be checked with regard to the following as-
pects prior to use:
• Undamaged packaging
• Damage on the product (cracks, bending, deformation)
Inspect products for immaculate surfaces, correct assembly and func-
tionality.
8. Preparation / Application
• Check the instrument for reliable function and irregularities before the
procedure.
• ! If you notice any irregularities, replace the instrument with a new
one.
Application
• Open package and remove the biopsy valve from packaging.
• Securely place the biopsy valve with closed cap onto the biopsy/suction
channel opening of the gastrointestinal endoscope.
• After use, dispose the instrument according to legal requirements and
your facility’s infection control protocols
9. Reprocessing and Sterilisation
These instruments are delivered in non-sterile condition and CANNOT EF-
FECTIVELY be cleaned, disinfected and sterilised after single use on ac-
count of the design which can no longer be removed and must be dis-
posed of after single use.
10. Liability and Warranty
As the manufacturer here, ENDO-FLEX shall not be liable for any damage
or consequential damage arising from improper use or handling. This shall
in particular apply to any use not in line with the defined purpose or fail-
ure to observe the preparation and sterilisation instructions and warn-
ings. This shall also apply to repairs or modifications to the product made
by individuals who are not authorised to do so by the manufacturer.
11. Service
Do not carry out any modifications to the product. If you have any con-
cerns, complaints or comments regarding our products, please get in
touch with us.

GA-0353 - Vers. 1.0 (2019-10)
Instruction for Use – Biopsy Valves SU
ENDO-FLEX GmbH ° Alte Hünxer Str. 115 ° D-46562 Voerde ° Germany °  (0049) - (0)281 – 9 44 00 – 0 ° FAX: (0049) - (0)281 – 9 44 00 – 11
Email: [e-mail] ° www.endo-flex.de
12. Transport and Storage Conditions
• Products may only be transported and stored in the packaging provided
for this purpose.
• Products must be stored dry and protected from sunlight at room tem-
perature.
• Do not place any objects on the storage packaging and the sterile bar-
rier system!
• Do not store near aggressive chemicals.
13. Disposal
After use, this product may present a biological hazard. Handling and dis-
posal must be carried out according to recognised medical procedures
and in accordance with applicable legal requirements
14. Symbols used
Symbol for “Item Number”
Symbol for “Batch code”
Symbol for “Manufacturer”
Symbol for “Date of manufacture”
Symbol for “keep dry”
Symbol for “protect from sunlight”
Symbol for “Observe instructions for use”
Symbol for “single use only”
Symbol for “non-sterile”
Symbol for “Caution”
Symbol for “Do not use if packaging is damaged”