Codman Hakim Bedienungsanleitung Seite 14

Priming Adapter (Figure 5)
The priming adapter, provided with the In-line, Right Angle, and Micro
Valves, facilitates preimplantation irrigation to the valve
Straight Connector
The straight connector joins the proximal and distal catheters to the
Cylindrical and Micro Valves
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 REUSE 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, Right Angle with SiphonGuard
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
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
Valve, Right Angle with unitized distal
catheter
Priming Adapter
Right Angle Adapter
Drainage Catheter
Peritoneal Catheter
Ventricular Catheter
Straight Connector
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