FujiFilm INJ Serie Manual Del Usuario página 3

Instructions for use
Intended use
The INJ series instruments are used for endoscopic injection in the upper and lower
gastrointestinal tract.
Product features
Tube
Control for injection needle
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 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.
Indications
Ulcer bleeding, varices, Mallory-Weiss syndrome, oesophagitis, gastritis, erosions,
fistulas, polyps, unclear gastrointestinal mucosa lesions.
Contraindications
The contraindications for the INJ series are the same as the specific contraindications
for oesophagogastroduodenoscopy, colonoscopy, sigmoidoscopy, rectoscopy,
enteroscopy and endoscopic retrograde cholangiopancreatography.
Possible complications
Ulcers, oesophageal stenoses/strictures, fever, perforation, haemorrhage, aspiration,
infection, sepsis, allergic reaction to medicines, hypertension, hypotension, respiratory
depression or arrest, cardiac arrhythmia or arrest, pain.
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.
Injection needle
Handle
Luer lock connector
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! The instrument should not be used in endoscopes with side-look optics
because bending via the Albarran lever can cause instrument failure. Observe the
warnings and application instructions of the respective manufacturer when injecting
substances.
Instructions for use
Put a syringe filled with injection solution on the Luer-Lock connector of the injection
needle and flush the air out of the catheter. Insert the retracted injection needle into
the working channel of the endoscope and advance the catheter littel by little until the
catheter tip is visible in the endoscopic image. Make sure that the needle is fully
retracted into the catheter to avoid injuring the patient and damaging the endoscope.
The needle is fully retracted into the catheter as soon as the operating element at the
handle has latched noticeably when pulling back. Do not pull the operating element
back beyond the latching point. Adjust the tip of the endoscope to the injection site.
Extend the needle by pushing the control and perform the injection. After completing
the injection successfully, the needle must be fully retracted into the catheter tip. 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.
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