Surgical Procedure - Integra LifeSciences CODMAN HAKIM Precision Fixed Pressure Valves Mode D'emploi

Valve Introducer
A disposable polyethylene valve introducer is supplied to aid in passing the
valve and drainage catheter from the burr hole site to a mastoidal incision,
when a two-step passage technique is used. Because of the malleability
of this introducer, it can be preformed to a desired curvature prior to
valve placement.
CODMAN Catheter Passer
Catheter passers [catalog no. 82-1515 or 82-1516] are available separately.
They are recommended for passing the catheter from the abdominal incision
to the scalp incision.
Sterility
The CODMAN HAKIM Precision Fixed Pressure Valve Systems are intended
for SINGLE USE ONLY; DO NOT RESTERILIZE. Use aseptic technique in
all phases of handling. Integra will not be responsible for any product that
is resterilized, nor accept for credit or exchange any product that has been
opened but not used.
Integra single-use devices have not been designed to undergo or withstand
any form of alteration, such as disassembly, cleaning or re-sterilization,
after a single patient use. These devices are intended to come into contact
with the central nervous system and the ability does not currently exist to
destroy possible contaminates such as Creutzfeldt-Jakob Disease. Reuse
can also compromise device performance and any usage beyond the design
intent of this single-use device can result in unpredictable use hazards or
loss of functionality. (THIS STATEMENT APPLIES TO NON-IMPLANTABLE
COMPONENTS ONLY.)
As long as the individual package is not opened or damaged, the product
is sterile.
The following components have been tested and were determined to
be nonpyrogenic:
Valve, Cylindrical
Valve, Cylindrical with Prechamber
Valve, Micro
Valve, Micro with RICKHAM Reservoir
Valve, In-line
Valve, In-line with unitized distal catheter
Valve, In-line with SIPHONGUARD
Valve, Right Angle
Valve, Right Angle with unitized distal catheter
Valve, Right Angle with SIPHONGUARD
Priming Adapter
Right Angle Adapter
Drainage Catheter
Peritoneal Catheter
Ventricular Catheter
Straight Connector
Preimplantation Performance Testing
Each CODMAN HAKIM Precision Fixed Pressure Valve is individually tested
on a component level to ensure conformance to the advertised performance
characteristics. Each valve is calibrated at its prescribed opening pressure
during manufacture.
Performing a manometer test is not recommended, as it is susceptible
to environmental factors. Manometer testing yields a result that is not
physiologic in nature and for which manufacturers do not specify performance
ranges. If the surgeon insists upon performing manometer testing for
confirmation of CODMAN HAKIM Valve closing pressures, it is possible,
but is not recommended. When performed correctly, manometer testing
generates valve closing pressures similar to the CODMAN HAKIM Valve
opening pressure setting. However, closing pressure results will typically
vary noticeably from the opening pressure setting.
For those surgeons who wish to perform functional testing, please see
Preimplantation Performance Testing in the Appendix.

Surgical Procedure

There are a variety of surgical techniques that can be used to place
a CODMAN HAKIM Precision Fixed Pressure Valve. The surgeon must
choose a technique in accordance with his or her own clinical experience
and medical judgment.
Irrigation
Hold the valve vertically with the outlet end pointing upward. Using a syringe,
or the action of the pumping chamber (if applicable), slowly and gently fill
the entire valve system (Figure 6) with pyrogen-free, sterile saline solution
or appropriate antibiotic solution. Note: A priming adapter is provided with
the In-line, Right Angle, and Micro Valve versions to facilitate irrigation
(Cylindrical Valves incorporate a pumping chamber for this purpose).
CAUTION: Do not fill, flush, or pump the valve with fluid in which
cotton, gauze, or other lint-releasing material has been soaked.
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