FujiFilm Medwork Koala TRP1 Serie Instrucciones De Uso página 3

Instructions for use
Intended use
The TRP series products are used to retrieve endoscopically resected polyps by
aspiration.
Product features
Figure 1:
Aspiration unit tubing port
Lid
Strainer drawer 2
Inspection window
Figure 2: TRP1-S4 additional strainer drawers, grey
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.
The instrument can be used immediately. Before use, check the "Use by" date on the
packaging, as the instruments are only allowed to be used up to this date.
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, sterilised or reused. Reuse, reprocessing or sterilisation can alter
product properties, resulting in functional failure. Reuse, reprocessing or sterilisation
furthermore entails the risk of contamination, as well as the risk of cross contaminati-
on, including the transmission of infectious diseases.
Contraindications
The contraindications for the Koala series are the same as the specific contraindica-
tions for oesophagogastroduodenoscopy, colonoscopy, sigmoidoscopy, rectoscopy
and endoscopic retrograde cholangiopancreatography.
Possible complications
No precautions required.
Endoscope suction tubing
Inspection window
Strainer drawer 1
Body
Precautions
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
After removing the polyp trap from the packaging, check it for kinks and breaks. Make
sure the inspection window with the suction tubing is engaged in the strainer drawer 1
position. Connect the top end of the suction tubing of the polyp trap to the suction port
on the endoscope. Connect the tubing of the aspiration unit to the port on the polyp
trap. Aspirate the resected polyp via the working channel of the endoscope until it is
enclosed in the strainer drawer. Turn the body of the polyp trap towards strainer
drawer 2 until the inspection window with the suction tubing is engaged. Remove the
strainer drawer and prepare the polyp for pathological examination. Then place the
strainer drawer back in the special slot on the polyp trap.
The white pre-installed strainer drawers can be swapped for the enclosed grey screen
drawers (see figure 2) and used for removing further adenoids when the TRP1-S4
product is used.
Evacuate other polyps via the strainer drawers, if necessary alternately. Having
removed all the polyps disconnect the polyp trap from the suction port on the endosco-
pe and from the aspiration unit.
Attention! If the inspection window with the suction tubing is in the flow-through
position (viewing window outside a strainer drawer), biomaterial is conveyed directly
into the aspiration unit. Remember that the strainer drawers have to be engaged in the
body of the polyp trap during the surgical intervention in order to make it possible for a
necessary vacuum to build up.
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