Directions For Use - Bard MAGNUM Instructions D'utilisation

• Scalpel
• Sample collection container
• Other equipment as necessary
I. Directions for Use:
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Bard Magnum biopsy instrument preparation:
After following the directions for reprocessing (Reference section J):
1. Using aseptic technique, remove the instrument from its package.
2. We suggest cradling the instrument in your palm with your fingers on the white cocking slide (See
Figure 1). Energize (cock) the instrument by pulling back with full pressure on the white cocking slide
twice until both sleds are fully engaged. Notice the status indicator is now red. (See Figures 2A and
2B.)
3. Test the instrument by first moving the safety lever from "S" (Safe) to "F" (Fire, Ready) then depress
the trigger button to actuate the instrument.
4. Re-Energize (cock) the instrument.
WARNING: WHEN THE SAFETY LEVER IS IN THE "F" POSITION, THE INSTRUMENT IS READY TO FIRE.
CARE SHOULD BE TAKEN NOT TO INADVERTENTLY DEPRESS THE TRIGGER AND FIRE THE DEVICE.
5. Select penetration depth of 22mm or 15mm by moving the lever in the rear of the instrument to the
appropriate setting.
Figure 1
Bard Magnum biopsy needle preparation:
The needle has centimeter markings for depth measurement and is packaged with a spacer. The spacer
holds the relative position of the stylet and cannula during insertion either into the patient or into the
Bard Magnum instrument.
Prior to use, determine the appropriate gauge and length of the needle required for the specific biopsy
to be performed. Using aseptic technique, remove the needle from the package and from the protective
sheath.
Precaution: Before using, inspect the needle components for damage. DO NOT USE if the needle com-
ponents are damaged. Note: The tip is made with a slight back bend. This is not a defect.
Biopsy Procedure:
The biopsy procedure must be performed using appropriate aseptic technique.
1. Prepare the site as required. Adequate anesthesia should be administered prior to incision of the skin.
Recommendation: For ease of insertion, puncture the skin with a scalpel at the entry site.
2. Positioning:
a) With the Bard Magnum biopsy instrument and biopsy needle: Open the cover of the energized
(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 Bard Magnum biopsy needle with spacer:
Introduce the needle with the unique 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
Figure 2A
Figure 3
2
Figure 2B