FujiFilm VAL Serie Manual Del Usuario página 3

Instructions for use
Intended use
The VAL series biopsy valves are used to close the working channel of endoscopes.
The VAL series air/water endoscope valves are used to control the insufflation and
rinsing functions of an endoscope for gastrointestinal examinations.
The VAL series suction endoscope valves are used to control the suction function of
an endoscope for gastrointestinal examinations.
Product features
Figure 1:
Air/water endoscope valve
Figure 2: Positioning of the suction endoscope valve
Direction mark
Qualification of user
Use of these instruments requires comprehensive knowledge of the technical princip-
les, clinical applications and risks of gastrointestinal endoscopy. The instruments
should only be used by or under the supervision of physicians who are adequately
trained and experienced in endoscopic techniques.
General instructions
Use this instrument only and exclusively for the purposes described in these instruc-
tions.
ATTENTION! Instruments marked with this symbol are intended for single use
only and are sterilised with ethylene oxide.
Sterile instruments can be used immediately. Before use, check the "Use by" date on
the packaging, as sterile instruments are only allowed to be used up to this date.
Do NOT use the instrument if the sterile packaging has tears or perforations, sealing is
not ensured or moisture has penetrated. All medwork instruments should be stored in
a dry place that is protected from light. Keep all instructions for use in a safe and
easily accessible place.
medwork instruments that are labelled as intended for single use only must not be
reprocessed, resterilised or reused. Reuse, reprocessing or resterilisation can alter
product properties, resulting in functional failure that can endanger the patient's health
or lead to disease, injury or death. Reuse, reprocessing or resterilisation furthermore
entails the risk of contamination of the patient or the instrument, as well as the risk of
cross contamination, including the transmission of infectious diseases. Contamination
Push button
Retainer ring
Suction endoscope valve
Biopsy valve
of the instrument can result in illness, injury or death of the patient.
Contraindications
The contraindications for the VAL series correspond to the specific contraindications
for oesophageal gastroduodenoscopy, colonoscopy, sigmoidoscopy, rectoscopy and
endoscopic retrograde cholangiopancreatography.
Possible complications
Infection.
Precautions
After removal from the packaging, check the instruments for correct function, kinks,
fractures, rough surfaces, sharp edges and protrusions. If you discover any damage or
malfunction on the instruments, do NOT use them and inform your responsible field
service contact or our branch office.
Any person who markets or uses medical devices is required to report any serious
incident that has occured in relation to the device to the manufacturer and the compe-
tent authority of the Member State in which the user and/or patient is established.
Attention! The air/water and suction endoscope valves are intended exclusively for
use with FUJIFILM ® gastrointestinal endoscopes from the series 700 and the en-
doscope EI-580BT.
The VAL series biopsy valves are intended for use with FUJIFILM
gastrointestinal endoscopes.
Instructions for use
Position the biopsy valve (green) onto the working channel inlet valve of the endosco-
pe.
Lock the air/water endoscope valve (blue) in the cylinder of the endoscope handle.
Check that the valve is tightly seated and that there is no gap between the retainer
ring and the endoscope. Before starting the examination check the operation of the
valve by pressing the push button.
Lock the suction endoscope valve (orange) in the cylinder of the endoscope handle.
Make sure that the valve is correctly oriented to the cutout. The direction mark on the
push button indicates the insertion position (direction mark offset 90° to the endosco-
pe handle, see Figure 2).
Check that the valve is tightly seated and that there is no gap between the retainer
ring and the endoscope. Before starting the examination check the operation of the
valve by pressing the push button.
After the examination remove the air/water and suction valve by pulling at the retainer
ring (see product features)
Hold the biopsy valve close to the endoscope to pull it from the working channel.
After completion of the surgical procedure
Instruments intended for single use, including packaging, must be disposed of in
accordance with the relevant applicable hospital and administrative guidelines and in
accordance with the relevant applicable legal regulations.
List of all icons used on medwork products
Date of manufacture
Follow the instructions
for use
Applied part Type BF
Batch code
Item number
Packaging unit
Do not reuse
Sterilised using
ethylene oxide
Non-sterile
Manufacturer
Sterile barrier system
English
® and OLYMPUS ®
Use by
Caution near pacemakers
Do not use if packaging
is damaged
Not suitable for lithotripsy
Contains natural rubber
latex
Gastroscopy
Colonoscopy
Enteroscopy
ERCP
Medical device