medwork BAS Serie Manual Del Usuario página 4

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
Figure 1: E.g.: BAS2-A2-30-23-200
Tube
Luer lock connector
Figure 2: Disassembly and assembly
Pulling rod
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.
All instruments labelled as unsterile must be prepared in accordance with the appli-
cable medwork preparation instructions before use for the first time.
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.
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.
Stone extraction basket
Handle
Rubber seal
Screw cap
Handle
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.
ATTENTION! For stone extraction baskets of the BAS series, only system components 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 clamping grip.
extracted by pulling back the catheter via the papilla. Slowly pull the instrument out of
the endoscope to prevent contamination of the patient and user with blood and other
body fluids, and an associated risk of infection.
Attention! If the stone cannot pass through the papilla, the basket must be prepared
for mechanical lithotripsy.
Non-endoscopic mechanical lithotripsy under radiological
control:
Screw on the clamping grip and pull it from the pulling rod. Unscrew the screw cap
and remove the rubber seal. Carefully pull the tube out of the endoscope over the
traction cable. Then remove the endoscope and the tube.
Use the lead line of the stone extraction basket to slide the flexible emergency spiral
(LIT1-N4-38-090) forward to the stone. Make sure that the basket is continuously
under tension if possible.
Insert the traction cable into the lithotriptor handle (LIT2-D-HAN) and attach the
emergency spring to the handle with a light rotary movement (see also the LIT2-D-
HAN instructions for use).
Fix the lead line centred in the chuck.
Make sure that the emergency sleeve is outside the chuck (proximal).
Now, slowly increase the pressure on the stone by turning the tension screw. If the
emergency spiral is under tension, we recommend that you wait a few seconds after
each complete rotation of the tension screw before continuing. This allows the force to
build up continuously to control how the stone is crushed.
ATTENTION! The stone extraction baskets of the BAS series suitable for lithotripsy are
equipped with a defined rated break point. Once crushing has been completed, the
basket with the emergency spring is carefully removed from the duct. The stone
concretions can be retrieved out of the duct with a balloon catheter or a small stone
extraction basket.
English
icon.
Small stones can be