Bard Magnum Instrucciones De Uso página 5

2. Positioning:
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a) With the B
(cocked) instrument. Align the holes on the needle hubs with the posts of the instrument carrier sleds.
Partially close the cover to maintain the position of the needle hubs. Compress the ends of the spacer
to release and remove (see Figure 3). Close the cover. Introduce the needle, under imaging control
where appropriate, through the incision until the needle point is proximal to the area to be biopsied.
OR
b) With ONLY the B
spacer attached under imaging control through the incision until the needle point is proximal to the
area to be biopsied. When the position is confirmed, attach the energized (cocked) B
biopsy Instrument. Taking care to maintain the needle orientation, align the holes on the needle hubs
with the posts of the instrument carrier sleds. Partially close the cover to maintain the position of the
needle hubs. Compress the ends of the spacer to release and remove (see Figure 3). Close the
cover.
3. While maintaining the instrument position and needle orientation, move the safety lever from "S" (Safe)
to "F" (Fire, Ready). Depress the trigger button to cause both the stylet and cannula to automatically
advance.
4. Remove the instrument and needle from the patient.
Note: It is not necessary to take the needle out of the instrument to retrieve the core tissue
specimen.
5. Expose the sample by pulling back the white cocking slide ONCE. Notice the status indicator is one-half
silver, one-half red and the sample notch is exposed. Remove the sample.
6. Energize (cock) the instrument by pulling back the white cocking slide one more time. The status indicator
is now red. Take additional biopsies if required. If additional biopsies are NOT being taken, then remove
and discard the needle, release the safety and fire the instrument. The status indicator is now silver
indicating the instrument is not energized.
Note: If collecting multiple samples, inspect the needle for damaged point, bent shaft or other
imperfections after each sample is collected. Do not use the needle if any imperfection is noted.
Bard recommends the M
sterilize the instrument after each cleaning and lubrication.
J. Directions for Reprocessing M
Risk assessment and classification of medical devices before preparation:
The nature and extent of the reprocessing depends on the application of the medical device. Therefore,
the operator is responsible for the correct classification of the device, per the local requirements, and thus
for determining the nature and extent of the reprocessing. Based on this user-dependent classification, the
operator can specify which of the below listed reprocessing steps under Section J.1 must be carried out.
• DO NOT use 2% glutaraldehyde or other bactericidal solutions.
• DO NOT use highly alkaline or highly acidic cleaners.
• DO NOT clean with concentrated chlorhexidine gluconate or any other agent containing alcohol.
• DO NOT sterilize by irradiation.
• USE appropriate personal protective equipment as dictated by facility protocol.
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Biopsy Instrument and Biopsy Needle: Open the cover of the energized
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M
Biopsy Needle with Spacer: Introduce the needle with the unique
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Instrument be cleaned and lubricated prior to every use. End-users may
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Figure 3
Instrument:
3
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