FujiFilm medwork SPE Serie Instrucciones De Uso página 4

Instructions for use
Intended use
The SPE1-Y series products are accessories used with endoscopic instruments to fix
guide wires during the procedure.
Product features
Biopsy valve
Fixing mechanism
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.
Contraindications
The contraindications for the SPE1-Y7 series are the same as the specific contraindi-
cations for endoscopic retrograde cholangiopancreatography.
Possible complications
Pancreatitis, cholangitis, cholecystitis, perforation, haemorrhage, aspiration, infection,
sepsis, allergic reactions to contrast agents or medicines, hypertension, respiratory
depression or arrest, cardiac arrhythmia or arrest.
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 kinks, fractures, rough
surfaces, sharp edges and protrusions. Should you discover any damages on the
instruments, do NOT use them, and please inform your responsible field service
contact person 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.
Fixing fork
Handle for instruments
Instructions for use
Placement of the SPE1-Y7 series on the endoscope
Push the easyCure adapter laterally onto the working channel inlet valve of the
endoscope.
Placement of the guide wire
Insert the flexible tip of the guide wire at the proximal guide wire port of the ERCP
catheter or papillotome into the guide wire lumen.Push the guide wire towards the
distal tip until it is flush with it. Guide the instrument into the applicable duct in ac-
cordance with the operating instructions. Release the guide wire from the proximal
guide wire port to the easyCure adapter from the slotted guide wire lumen. Fix the
guide wire by wrapping it around the fixing fork of the easyCure adapter.
Placement of instruments
Introduce the placed and fixed guide wire at the distal tip of the easyCure instrument.
The guide wire comes out at the distal guide wire port by bending the catheter
slightly. Release the easyCure fixation while having the assistant holding it in position.
Introduce the instrument through the easyCure adapter up to the distal guide wire port
and fix the guide wire. Position the easyCure instrument over the fixed guide wire in
short steps. Pull the instrument slowly and evenly out of the endoscope after the
procedure. Make sure that the guide wire is fixed by the easyCure adapter.
Disconnecting the guide wire
Position the guide wire and the instrument in the duct system as securely as possible
under radiological control (release the guide wire fixation if necessary). Hold the
instrument is the same location and pull the guide wire back under radiological control
until it exits the distal guide wire port. Position the guide wire for further procedures
and secure its position with the guide wire fixation. Remove the instrument.
Figure no. 1: Lateral attachment of the SPE1-Y7 to the working channel inlet valve of the endoscope:
Figure no. 2: Introduction of the instruments
through the medial sealing lips of the SPE1-Y7:
English
Figure no. 3: Fixation of guide wires by wrapping
the guide wire around the fixing fork: