Contraindications - FujiFilm BAS-Series Bedienungsanleitung

Instructions for use
Intended use
The BAS series instruments are used for endoscopic removal of stones from the bile
duct and pancreatic duct.
Product features
Tube
CUT marking
Luer lock connector
BAS1-K2
Dual-ring handle
Tube
Luer lock connector
BAS1-K3
Dual-ring handle
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.
twist´n CATCH basket
Thumb ring
Guide wire port
twist´n CATCH basket
Cover cap
Luer lock connector
Thumb ring
Indications
Choledocholithiasis.

Contraindications

The contraindications for the BAS series correspond to the specific contraindications
for oesophageal gastroduodenoscopy, colonoscopy, sigmoidoscopy, rectoscopy and
endoscopic retrograde cholangiopancreatography.
Possible complications
Perforation, cholangitis, haemorrhage, aspiration, infection, sepsis, allergic reaction to
contrast medium or medications, hypertension, hypotension, respiratory depression or
arrest, cardiac arrhythmia or arrest. Additional possible complications when extracting
foreign bodies are the impaction of the foreign body to be extracted, aspiration of the
foreign body, 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.
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.
When using the product, observe the guide wire diameter recommended on the
product label.
When extracting stones from the duct system, it may be necessary to perform a
papillotomy if the stone will not pass the papilla. Observe all safety measures, warning
notices and contraindications when doing this.
ATTENTION! For stone extraction baskets of the BAS series, only system compo-
nents of the LIT series may be used. medwork¨ assumes no product liability if the
product is used with other lithotripsy system components.
All BAS series stone extractors are suitable for mechanical lithotripsy, with the
exception of the stone extractors marked with this
Instructions for use
Insert the retracted basket into the working channel of the endoscope and advance
the stone extraction basket little by little until the catheter tip is visible in the endosco-
pic image. Probe the desired duct system until the basket has passed the stone and
carefully capture the stone under radiological guidance. The stone extractor is
retracted and extended by operation of the dual-ring handle.
Special features for using the BAS1-K3 series products:
If access to the bile duct is already provided via a guide wire, insert the end of the
guide wire into the distal opening of the guide wire lumen and push the instrument
forward using the long-wire technique until the tip of the instrument is visible in the
endoscopic image.
When using the short-wire technique push the guide wire at the guide wire port out of
the tube and push the instrument forward until the tip of the instrument is visible in the
endoscopic image.
If an injection is made into the guide wire lock through the Luer Lock port, the cover
cap must be screwed in beforehand.
Small stones can be extracted by pulling back the catheter via the papilla. The stone
will not pass the papilla, attempt to crush it manually with the basket. If this is unsuc-
cessful, the basket must be prepared for a mechanical lithotripsy. Pull the instrument
out of the endoscope slowly to avoid contamination of the patient and users with blood
and other body fluids and the associated risk of infection.
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