FujiFilm medwork BAL Serie Manual Del Usuario página 3

Instructions for use
Intended use
The BAL series instruments are used for endoscopic extraction of stones and sludge
from the bile duct and pancreatic duct and to clear an occlusion of pancreatic duct
after administration of contrast agent.
Product features
Tube
Guide wire connection
Contrast agent connection
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
of the instrument can result in illness, injury or death of the patient.
Indications
Choledocholithiasis.
Contraindications
The contraindications for the BAL series are the same as the specific contraindications
for endoscopic retrograde cholangiopancreatography.
Possible complications
Pancreatitis, cholangitis, perforation, haemorrhage, aspiration, infection, sepsis,
allergic reaction in particular to laytex, hypertension, hypotension, respiratory depres-
sion or arrest, cardiac dysrhythmia or arrest. Additional possible complications in
conjunction with balloon stone extraction include impaction of the stone to be extrac-
tion, local inflammation or pressure necroses.
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.
Balloon
Air connection
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! When using stone extraction balloons that are compatible with guide wires,
observe the guide wire diameter recommended on the product label.
Instructions for use
Insert the balloon catheter into the working channel of the endoscope and gradually
slide the catheter forward until the tip is visible in the endoscopic image. Before using
a guide wire, we recommend you rinse the guide wire lumen with sterile saline solution
to make sliding easier. For double lumen balloon catheters, the mandrin must be
removed before placement. Probe the bile system until behind the stone. Fit the
included disposable syringe to the marked connector and under radiological guidance
fill the balloon with air, sterile saline solution or Aqua Dest. Please observe the
maximum defined filling capacity (ml) on the marked connector for the product.
Carefully pull the disposable stone extraction balloon toward the papilla. Strong
resistance can point to a stone that is too large or impacted. There is a risk of dama-
ging the balloon. Deflate the balloon before passing the papilla. Pull the instrument out
of the endoscope slowly to avoid contaminating the patient and handler with blood and
other bodily fluids and subsequent 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 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