(2)
I. Directions for Use:
Bard
®
Max•Core
®
disposable biopsy instrument preparation:
Before using, inspect the needle for damaged point, bent shaft or other imperfections that would prevent proper function. If the needle is damaged
or bent, DO NOT USE. Notify your Bard Sales Representative or Customer Service Representative.
1. Using aseptic technique, remove the Instrument from its package. See Figure 1.
Note:
To remove the protective needle sheath and yellow guard, you must energize (cock) Instrument.
2.
Energize (cock) Instrument by pulling back on the top slide to withdraw the cannula and lock in place. See Figure 2. Then pull back on the bot-
tom slide to withdraw the stylet and lock in place. See Figure 3. Remove protective needle sheath and yellow guard. Instrument is ready to fire
when both slides are locked back.
Recommendation:
For ease of insertion, puncture the skin with a scalpel at the entry site.
Biopsy Procedure:
The biopsy procedure must be performed using appropriate aseptic techniques.
1. Prepare site as required. Adequate anesthesia should be administered prior to incision of the skin.
2. Verify Instrument is energized (cocked). See Figure 3.
Note:
Do not place fingers in front of cocking slides once Instrument is energized (cocked). Impeding cocking slides' movement will impact func-
tionality.
3. Insert tip of needle to the point to be biopsied.
4. While maintaining Instrument's position and the needle orientation, depress the rear actuator button, or push the side actuator forward (direc-
tion of arrow), to cause both stylet and cannula to automatically advance.
5. Remove needle from patient and pull back on the top slide to withdraw the cannula and expose the biopsy specimen (See Figure 2). Remove
the specimen.
6. If additional biopsies are required, pull back on the bottom slide to withdraw the stylet and repeat the procedure.
Figure 1
•
As Packaged (Protective Needle Sheath and Yellow Guard Not Shown)
• Instrument
Not
Energized (Cocked)
•
Not
Ready to Fire
Figure 2
•
Top Slide Locked Back
•
Biopsy Sample Notch Exposed
Figure 3
•
Top Slide and Bottom Slide Locked Back
•
Instrument Energized (Cocked)
•
Ready to Fire
Warranty
Bard Peripheral Vascular warrants to the first purchaser of this product that this product will be free from defects in materials and workmanship for a
period of one year from the date of first purchase and liability under this limited product warranty will be limited to repair or replacement of the defec-
tive product, in Bard Peripheral Vascular’s sole discretion or refunding your net price paid. Wear and tear from normal use or defects resulting from
misuse of this product are not covered by this limited warranty.
TO THE EXTENT ALLOWABLE BY APPLICABLE LAW, THIS LIMITED PRODUCT WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES,
WHETHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS
FOR A PARTICULAR PURPOSE. IN NO EVENT WILL BARD PERIPHERAL VASCULAR BE LIABLE TO YOU FOR ANY INDIRECT,
INCIDENTAL OR CONSEQUENTIAL DAMAGES RESULTING FROM YOUR HANDLING OR USE OF THIS PRODUCT.
Some states/countries do not allow an exclusion of implied warranties, incidental or consequential damages. You may be entitled to additional rem-
edies under the laws of your state/country.
An issue or revision date and revision number for these instructions are included for the user's information on the last page of this booklet. In the
event 36 months have elapsed between this date and product use, the user should contact Bard Peripheral Vascular to see if additional product
information is available.
Assembled in Mexico.
ENGLISH