FujiFilm medwork DIL Serie Manual Del Usuario página 4

Instructions for use
Intended use
The DIL series instruments are used for the endoscopic dilation of strictures in the
gastrointestinal tract.
Product features
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 FUJIFILM 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.
FUJIFILM 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 of the instrument can result in illness, injury or death of the patient.
Indications
Strictures in the upper and lower gastrointestinal tract, gastroenteric anastomotic
strictures, benign biliary strictures, achalasia, Crohn's strictures, biliary and pancreatic
stones.
Contraindications
The contraindications for the DIL series correspond to the specific contraindications
for oesophagogastroduodenoscopy and endoscopic retrograde cholangiopancreato-
graphy.
Possible complications
Allergic reaction to contrast agents, bleeding, perforation, sepsis/infection, pancreatitis,
cholangitis.
Precautions
In order to ensure that the examination proceeds smoothly, the diameter of the
endoscope working channel and the diameter of the instruments must be matched to
one another.
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
Tube
Dilation balloon
Three-way valve
Luer lock connector
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! Only use sterile water, saline or contrast agent solutions for inflation
purposes. Do not use air or gases for inflation purposes, as these reduce the effec-
tiveness of the balloon. Monitor the working pressure during the procedure. The
working pressure may not exceed maximum pressure. Both specifications are
provided on the label on your product. Only use the dilation balloon in combination
with a dilation instrument equipped with an appropriate pressure display. Bear in mind
that the balloon can become damaged during dilation if it comes into contact with
sharp-edged or metal objects.
Attention! Do not expand the balloon with air or liquid before use as this can damage
the endoscope. Before use, remove the protective sheath from the distal end, as well
as the metal wire from the guide wire lumen. Connect a dilation instrument to the
insufflation hub of the dilation balloon. Apply medical grade silicone oil to the balloon
to facilitate forward movement of the balloon in the working channel. Before insufflati-
on, the entire dilation balloon must be pushed fully out of the endoscope, fluoroscopi-
cally identified and positioned. If you are using a guide wire measuring approx. 200 cm
in length, make sure that it exits the guide wire lumen again at the Guide Wire Port.
Loosen the guide wire fixture at the biopsy valve and insert the deflated dilation
balloon into the working channel. Then secure the guide wire again in the fixture
intended for this purpose. If you are working with a guide wire measuring 400 cm or
more in length, the guide wire can exit the guide wire lumen at the Guide Wire Port or
at the distal end of the guide wire hub. Note the following when using the Guide Wire
Port. The proximal black marking indicates that the Guide Wire Port will soon become
visible. The fixation must then be loosened and the dilation balloon removed comple-
tely from the working channel. Secure the guide wire. Stop pulling back the dilation
balloon immediately if you notice any resistance and then remove the instrument from
the patient together with the endoscope. Should pressure suddenly drop or the balloon
burst, the procedure must be stopped immediately. Deflate the balloon and remove
the instrument from the patient together with the endoscope. Then separate the
balloon at the black distal marking. The plastic tubing can now be removed from the
working channel.
Instructions for use
Insert the guide wire at the distal end into the guide wire lumen. Using short nudging
movements, insert the instrument carefully up to the exit portal visible through the
endoscope and into the required dilation position. Ensure that the balloon has fully
exited the endoscope and verify fluoroscopically that the balloon is correctly positioned
within the stricture using the radiopaque markings. Now expand the dilation balloon
fully to the inflation pressure shown on the display by adding fluid. The relevant
working pressure is provided on the label on your product. To remove the instrument,
generate negative pressure using the dilation instrument. The dilatation instrument
indicator should be within vacuum range. Ensure that the balloon is fully deflated and
that the fluid has been removed completely. Slowly remove the fully deflated balloon
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 FUJIFILM 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
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