FujiFilm medwork PAP Serie Manual Del Usuario página 4

Instructions for use
Intended use
The PAP series instruments are used for transendoscopic exploration of the papilla,
visualisation of the duct systems and papillotomy, and may also be used for injection
of contrast media.
Product features
Tube
Guide wire connection
HF connectors
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
The indications correspond to the general indications for endoscopic retrograde
cholangiopancreatography, cholangioscopy and duodenoscopy.
Contraindications
The contraindications for the PAP series are the same as the specific contraindica-
tions for endoscopic retrograde cholangiopancreatography.
Possible complications
Pancreatitis, cholangitis, perforation, haemorrhage, aspiration, infection, sepsis,
allergic reaction, hypertension, hypotension, respiratory depression or arrest, cardiac
arrhythmia or arrest, tissue damage, obstruction of the pancreatic duct, fulguration and
burns, hyperamylasemia, recurrent bile duct stone, papillary stenosis, biliary stricture,
cholecystitis.
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
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.
Cutting wire
Luer-Lock connector
Dual-ring handle
Thumb ring
Attention! AXS_tome+ papillotomes have a stop function that activates at a tension of
approx. 90° to avoid excess tension on the cutting wire (> 90°) in use. The 90°-
tension of the papillotome can be overcome with a small amount of force by pulling the
double ring handle towards the thumb ring. This prevents a tension of > 90° without
impairing the function of the papillotome.
Precautions if using high-frequency current
The instruments are suitable for the use of monopolar HF current. Before using the HF
control unit, familiarise yourself with the device manufacturer's safety procedures and
instructions for use, and in particular check that the earthing and closed circuit (return
electrode) are correct. Observe the relevant HF device manufacturer's recommended
setting parameters before use. The instruments must be used with a Type BF or CF
generator. The peak voltage measured in the "Cutting/Coagulation Mode" is 1,600 V
for PAP Series instruments. If this value is exceeded, an accidental current flow may
occur. Do not use the instruments near flammableliquids, explosive gases or in
oxygen-enriched environments.
During HF application, make sure the instruments do not have any contact with metal
objects such as clips etc. because the contact may cause functional failure or fracture
of instruments.
Instructions for use
Remove the distal shaping wire from the guide wire lumen of the multi-lumen PAP
series papillotome. Carefully inspect the connecting cable for kinks or breaks. Connect
the return electrode and the papillotome to the HF control unit when the latter is
switched off. Make sure the connectors are joined properly. Insert the papillotome into
the working channel of the endoscope and push it forward a little at a time until the tip
is visible on the endoscopic image. The multi-lumen papillotome can be inserted using
a previously positioned guide wire. Flush the lumen with sterile saline solution before
insertion. You can check that the tip of the papillotome is in the correct position by
application of contrast agent through the Luer lock connector. Check the settings of
the HF control unit and switch it on. Perform the endoscopic papillotomy (EPT). You
can change the deflection of the distal instrument tip by operation of the dual-ring
handle. After the EPT switch off the HF control unit and remove the connection cable
from the handle. Slowly pull the instrument out of the endoscope to prevent contami-
nation of the patient and user with blood and other body fluids, and an associated risk
of infection.
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