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CRW™ BiopsyPlus Kit -
Single Use
Description
The CRW™ BiopsyPlus Kit consists of the following
components:
•
1 side window-type cutting needle with depth
markings and depth stop
•
1 long biopsy bushing (90mm)
•
1 short biopsy bushing (60mm)
•
2 nylon thumbscrews
•
1 12” aspiration line
The window at the needle’s tip is opened and closed by
rotating the inner cannula within the outer cannula,
using the upper and lower hubs.
Intended Use
The CRW™ BiopsyPlus Kit is for single patient use in
stereotactic biopsy of brain tumors.
Symbols
*Only the aspiration line contains DEHP.
Cutting Window Use
Open the cutting window by rotating the upper hub
indicator to align with the lower hub indicator. Close
the cutting window by rotating the upper hub indicator
180° away from the lower hub indicator.
Instructions for Use
1.
Set the depth stop to the target marking indicated
by the double line marking. This will place the
center of the 10 mm cutting window at the target
point.
2.
Insert the desired bushing length (60mm or
90mm) into the guide block holder and attach the
thumbscrew. Proper bushing selection should take
into account the head size of the patient while
minimizing needle flexion.
Luer
Upper Hub
Outer Cannula Depth Stop
Cutting Window Indicator
Lower Hub
Depth Markings
Cutting Window
Inner Cannula
Notice
This insert is designed to provide instructions for
use of the CRW™ BiopsyPlus Kit. It is in no way a
reference for stereotactic technique.
Each CRW™ BiopsyPlus Kit is packaged sterile,
and the contents of the package are nonpyrogenic.
The CRW™ BiopsyPlus Kit is designed to be used
with Integra Radionics equipment only. Use with
equipment and components from other
manufacturers is not recommended.
Warning
Do not modify Integra Radionics equipment or
components. Any modifications may
compromise the safety and efficacy of the
device.
The surgeon must decide on the appropriate
use of the device relative to the patient.
The use of biopsy instruments involves the
removal of intracranial materials and entails
some risk of hemorrhage.
Patients or their representatives should be
informed of possible complications associated
with the device.
For single patient use only. The CRW™
BiopsyPlus Kit is designed as a single-use,
disposable product and should not be re-
sterilized or reused.
Re-sterilization may result in impaired function
(e.g. dulling of the cutting window, loss of
vacuum, inaccuracy of bushing) and cross
contamination. Once used, the kit should be
discarded according to hospital policy.
Single use only.
Caution: Federal (USA) law
restricts this device to sale by or
on order of a physician.
Do not use if the product
sterilization barrier or its
packaging is compromised.
Latex free.
Consult instructions for use.
Sterilized using ethylene oxide.
Contains or presence of
phthalates: Bis(2-ethylhexyl)
phthalate (DEHP).*
STERILE EO
