Merit Medical ACHIEVE Mode D'emploi page 3

hemorrage, infection, adjacent tissue injury, pain, bleeding,
hemoptysis, hemothorax, non-target tissue, organ or vessel
perforation, pneumothorax, and air embolism. Air embolism
is a rare but serious potential complication of lung biopsy
procedures. Rapid deteriorization of neurological status and/
or cardiac arrhythmia may be indicative of air embolism.
Prompt diagnosis and treatment must be considered if the
patient exhibits signs or symptoms of air embolism.
CAUTION
For single use only. Re-use may result in a non-functional
product or contribute to cross contamination.
Do not use if package is damaged.
Do not resterilize. After resterilization, the sterility of the device
is not guaranteed because of an indeterminable degree of
potential pyrogenic or microbial contamination which may
lead to infectious complications. Cleaning, reprossessing
and/or resterilization of the present medical device increases
the probability that the device will malfunction due to the
potential adverse effects on components that are influenced
by thermal and/or mechanical changes.
NOTE: If collecting multiple samples, inspect the needle for a
damaged point, bent shaft or other imperfections after each
sample is taken.
NOTE: After use, this product may be a potential biohazard.
Handle and dispose of in accordance with acceptable
medical practices and applicable local, state, and federal laws
and regulations.
If biasing the device prior to obtaining a sample, take care to
avoid bending the stylet notch.
COAXIAL ACHIEVE PLACEMENT
During the pre-procedure set-up, insert the biopsy device
through the coaxial introducer needle to verify compatibility.
Adjust sliding stopper on coaxial needle to desired
calibration level. Lock in place. Insert coaxial and stylet until
sliding stopper rests on skin surface. Image coaxial needle
to make sure the tip is on the surface of the lesion. Remove
inner stylet.
1.
AUTOMATIC & DELAY MODE
STEP 1: PREPARATION OF ACHIEVE FOR USE
To charge the Achieve biopsy device, simply pull back on the
charging handle and release twice, first to charge the cutting
STYLET
cannula, second to charge the inner stylet. See Figures 2
STILETT
through 4.
STILETTO
ESTILETE
STILET
SPECIMEN NOTCH
ENCOCHE À SPÉCIMEN
PROBEENTNAHMEBEREICH
TACCA PER IL CAMPIONE
PORTAMUESTRAS
2.
RANHURA DA AMOSTRA
MONSTERGROEF
FIGURE 2:
Non-charged and
after firing.
3.
STEP 2: POSITION THE NEEDLE
Position the needle at or near the edge of the region to be
sampled.
CANNULA
CANULE
KANÜLE
CÁNULA
CÂNULA
FIGURE 3:
Pull back the
charging handle
once to retract
the cannula which
exposes the
notched stylet.
3
PLUNGER
PISTON
SPANNVORRICHTUNG
STANTUFFO
ÉMBOLO
ÊMBOLO
ZUIGERSTANG
FIGURE 4:
Pull back the
charging handle
a second time
to retract the
notched stylet.