Indications; Contraindications; Product Description; Function And Intended Application - Johnson & Johnson Codman VPV System Mode D'emploi

ENGLISH
IMPORTANT INFORMATION
Please Read Before Use
CODMAN ® VPV ® System

Indications

The CODMAN VPV System is indicated for use only with CODMAN
treatment of hydrocephalus when shunting cerebrospinal fluid from the ventricles of the brain. It is used to adjust
the CODMAN HAKIM Programmable Valve to the selected pressure and provides valve adjustment confirmation
without the need for radiographic imaging.

Contraindications

There are no known contraindications for the use of the CODMAN VPV System.

Product Description

The CODMAN VPV System (catalog no. 82-3192) is comprised of the program unit, the transmitter unit, a power
cord, and ultrasound gel in a carrying case (see Figures 1 through 3).

Function and Intended Application

The CODMAN VPV System is intended for adjusting CODMAN HAKIM Programmable Valves in the treatment
of hydrocephalus.

The Program Unit

The program unit (Figure 2) is an electronic module that houses the power and control logic circuits. The front
panel of the program unit contains the following features:
A. Liquid crystal display (LCD) screen
B. Mode selection key
C. Packaged valve mode icon and light emitting diode (LED)
D. Implanted valve mode icon and LED indicator lamp
E. A partial representation of the valve as it appears when x-rayed
F. Pressure selection keys and their corresponding LEDs
G. Receptacle for transmitter cord
H.
Receptacle for power cord
I. Fuse holder
J. Power switch
The pressure selection keys (F in Figure 2) range from 30 mm H
(from 294 Pascals [Pa] to 1960 Pa in increments of 98 Pa).

The Transmitter

The transmitter (Figure 3) connects to the program unit with a cord. The transmitter generates the electromagnetic
field that changes the setting of the valve.
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HAKIM Programmable Valves in the
® ®
O to 200 mm H O in increments of 10 mm H O
2 2 2

Program Unit Mode Selection

The CODMAN VPV System has two modes of operation: packaged valve mode and implanted valve mode.

1. The Packaged Valve Mode

The packaged valve mode is used when adjusting the setting of a valve before implantation and
when adjusting the setting of a recently implanted valve when patient skin integrity requires a
sterile barrier. When the packaged valve mode is selected, the acoustic monitoring feature is
Packaged
not active.
Valve Icon
2. The Implanted Valve Mode – with Acoustic Monitoring Feature
The implanted valve mode is used when adjusting the setting of a valve postoperatively when the
patient's scalp is intact. When the implanted valve mode is selected, the acoustic monitoring
feature is active. See The Acoustic Monitoring Feature.
Implanted
Valve Icon

The Acoustic Monitoring Feature

When the implanted valve mode is selected, a sensor contained within the transmitter detects valve vibration
as the setting of the valve is changed. The program unit analyzes the valve vibration to determine instances of
improper placement of the transmitter or an inability to sense valve adjustment.
If confirmation of the valve adjustment is not displayed, the clinician may choose to perform the valve adjustment
steps again. No known adverse effects have been associated with multiple adjustment attempts. See Appendix E:
Clinical Study Summary for further information.

Reordering Information

Catalog No. Description
82-3192 CODMAN VPV System
82-3193 CODMAN VPV Program Unit
82-3194 CODMAN VPV Transmitter Unit
Order replacement ultrasound gel from any supplier of good quality ultrasound gel.

Warnings and Precautions

CODMAN HAKIM Programmable Valves are supplied without a specific setting and must be adjusted
prior to use.
Carefully read the instruction manual packaged with the CODMAN HAKIM Programmable Valve before
implanting or adjusting the valve.
Valve adjustment must be performed prior to implantation through the nonsterile outer package. Perform
adjustments postoperatively as needed.
Do not use the program unit in a magnetic resonance imaging (MRI) suite.
Electromagnetic interference and other types of interference generated by other equipment or medical devices
might affect the operation of the system.
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