Contraindications - FujiFilm medwork SPE Série Mode D'emploi

Instructions for use
Intended use
The SPE1-B6- and SPE1-C6-series instruments are used for application of fluids to
the mucous membrane of the gastrointestinal tract.
The SPE1-B5-series instruments are used for rinsing and suction in the bronchial
tract.
Product features
Tube
SPE1-B6, SPE1-C6,
SPE1-B5-18-120
Luer lock connector
SPE1-B5-21-120
Handle
Qualification of user
The instruments must only be used with comprehensive knowledge of the technical
principles of gastro-intestinal or bronchial endoscopes. 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.
Exit opening
Handle
Mandrel
Tube
Mandrel

Contraindications

The contraindications for the SPE series are the same as the specific contraindica-
tions for oesophagogastroduodenoscopy, colonoscopy, sigmoidoscopy and rectosco-
py and bronchoscopy.
Possible complications
Perforation, haemorrhage, infection, sepsis, allergic reaction 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 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.
Instructions for use
Check that the stylet cap is correctly closed on the Luer lock connector of the spray
catheter. Insert the spray catheter into the working channel of the endoscope and
advance it a little at a time until it is visible at the exit of the endoscope.
After placement of the spray catheter (SPE1-B6 and SPE1-C6), you can apply
colouring agent, contrast agent or medical fluids from the Luer Lock port with the stylet
horizontal. The stylet cap must be closed tightly for this.
After placement of the spray catheter SPE1-B5-18-120, you can suction fluids from
the bronchial tract or rinse it through the Luer-Lock port with the stylet in place. The
stylet cap must be tightly closed for this.
After placement of the spray catheter SPE1-B5-21-120, you can suction fluids from
the bronchial tract or rinse it through the Luer Lock port after removing the stylet.
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