CODMAN VAL-10-001-CHPV-proc-guide
CODMAN VAL-10-001-CHPV-proc-guide
CODMAN VAL-10-001-CHPV-proc-guide
Codman ® Hakim ®
Programmable Valve System for Hydrocephalus
The programmability of the valve may allow for the develop- 3. Place the transmitter head over the valve such
that the feet of the transmitter head straddle
ment of specialized treatment regimens. The setting of the
the valve mechanism and the arrows on the
Codman Hakim Programmable Valve is changed through
transmitter head align with the direction of CSF
the use of an externally applied, codified magnetic field. The flow through the valve.
spring in the ball-spring mechanism of the valve sits atop a
rotating spiral cam which contains a stepper motor. applying 4. Press and release the start button on the trans-
a specific magnetic field to the stepper motor will cause the mitter head while holding the transmitter head
cam to turn slightly, increasing or decreasing the tension on in place. The instruction light illuminates and
the pressure selector buttons sequentially light
the spring, and changing the opening pressure of the valve. The
until the valve is finished being programmed.
Codman Hakim Programmable Valve is available in eight
basic configurations. 5. Hold the transmitter head in place until the
programmer beeps indicating that program-
ming has been completed (approximately 3-5
seconds). The instruction light will briefly illu-
minate at the end of the programming cycle.
Transmitter Head
CSF Flow
Valves are supplied without a specific it is acceptable to prime the valve by filling it with lint-free
setting and must be programmed prior sterile saline or an appropriate antibiotic solution prior to implan-
to use. after choosing the desired initial tation. if the valve housing includes SiPHonGUaRd, priming the
setting, the valve can be programmed in system must be reduced to a rate of approximately .5cc/minute.
its packaging by placing the four feet of The valve mechanism should be placed over a bony region and
the transmitter head in the four blister not over an area with an excessive amount of soft tissue. The
depressions over the valve mechanism
valve could become embedded in the soft tissue, making it dif-
and aligning the arrows on the transmitter
ficult to program postoperatively.
head with the arrows on the package.
Frontal Approach
Transmitter Head
Occipital Approach
Packaging Blister
2
POSTOPERATIVE PROGRAMMING
The new setting of the valve should be determined taking The position of the valve mechanism may
into account all of the patient’s clinical symptoms and the be marked by your fingertip. Place the trans-
surgeon’s own experience. it is advisable not to increase the mitter head over that fingertip so that it
setting of the valve by more than 40 mm H2o in a 24-hour is centered directly under the transmitter
period. Palpate the scalp to locate the implanted valve, then head. The feet of the transmitter head should
straddle the valve mechanism and touch the
locate the valve mechanism based on the type of housing
patient’s skin. The transmitter head has an
that has been implanted.
arrow on it indicating the direction of CSF
flow, which must align with the CSF flow
through the valve.
Micro Valve
Right Angle
3 Valve Mechanism
Pressure Setting Verification
Radiograph Plate
OPERATING PROCEDURES FOR VALVE POSITIONING VERFICATION The CODMAN VPV™ system has two modes of opera-
(VPV™) SYSTEM #82-3192 tion: packaged valve mode and implanted valve mode.
Valve Adjustment: Implanted Valve Mode
Implanted Valve Mode
1. Turn on the VPV Programmer Unit. The implanted
The implanted valve mode is used when
valve icon illuminates.
adjusting the setting of a valve post-
2. The program unit beeps and the LEd panel displays operatively when the patient’s scalp is
the following message: imPLanTEd VaLVE PLEaSE implanted intact. When the implanted valve mode
Valve icon
SELECT PRESSURE. is selected, the acoustic monitoring fea-
ture is active.
3. Press the appropriate setting selection key. The program unit beeps; the
corresponding LEd illuminates. at the same time, the display changes to:
imPLanTEd VaLVE, PoSiTion TRanSmiTTER HEad, and PRESS STaRT. Acoustic Monitoring
When the implanted valve mode is
4. Palpate the scalp to locate the shunt and the implanted valve. Gently palpate selected, a sensor contained within the
the valve to locate the hard inlet portion, approximately 10mm long. Place CENTER ROD
transmitter detects valve vibration as
your fingertip on the scalp directly over the inlet portion.
the setting of the valve is changed.
5. Part any hair with fingertips. apply a pea-sized amount of ultrasound gel, T I F I
approximately 2mm thick, to the patient’s scalp. alternate method: apply Packaged Valve Mode
E
C E
ultrasound gel to the entire bottom surface of the center rod to a thickness of The packaged valve mode is used when
D
approximately 2mm. adjusting the setting of a valve in the
C
H P V
package before implantation and when
6. Before placing transmitter on the scalp, ensure that the arrow on the trans-
adjusting the setting of a recently
mitter is in line with the direction of fluid flow through the shunt.
implanted valve when the patient skin
7. Place the transmitter on the scalp so the center rod is directly over the hard integrity requires a sterile barrier. When
inlet portion of the valve and the transmitter’s feet contact the patient’s the packaged valve mode is selected,
scalp. The center rod may recede slightly and the gel will compress. Hold the acoustic monitoring feature is not
Transmitter in place until adjustment is complete (approximately 3 seconds). active.
Eliminate or minimize ambient noise. Excessive noise can interfere with the
acoustic monitoring process.
This technique guide is not intended to
8. Press the transmitter’s blue start button. The program unit beeps once and replace the “Instructions for Use” for
the LCd display changes to: adJUSTinG VaLVE PLEaSE WaiT. the CODMAN VPV System. Refer to
I.F.U. for further instructions if needed.
9. during the adjustment, the setting selection keys light sequentially and the
program unit emits a series of clicks until the selected setting command has
been issued to the valve.
Transmitter Head (side)
10. When the adjustment is complete (approximately 3 seconds), the pro-
gram unit emits on long beep and the display changes to: adJUSTmEnT
ComPLETE PRESS a kEY.
5
pressure settings Inverted Valve Adjustment: codMAN HAKIM PROGRAMMER
#82-3192
An inverted valve can be diagnosed on x-ray: the white
marker appears on the left side of the valve, instead of the
right side. When an inverted valve has been diagnosed, use
the inverted valve adjustment cycle to adjust the valve to
any of the 18 settings. This optional command is in effect for
one adjustment cycle only. Follow the steps below to enable
this feature.
1. If the program unit power is on, turn it off. Turn power on. The title screen
displays for 3 seconds. The display changes to: CODMAN VPV VERSION 1.27
(or other).
While the title screen is displayed, press the “70” key on the program unit front
panel. The display changes to: ADJUST INVERTED VALVE? 30 = YES 40 =
NO.
2. Press the “30” key to set the next adjustment cycle for an inverted valve, or press
“40” to exit. When you press “30,” the display changes to: ADJUST INVERTED
VALVE? PLEASE CONFIRM 80 = YES 40 = NO.
3. To confirm that the next adjustment cycle is for an inverted valve, press “80”;
or press “40” to cancel and exit. When you press “80,” the display changes to:
IMPLANTED VALVE INVERTED VALVE PLEASE SELECT PRESSURE.
6
The Codman® Hakim® Programmable Valve is considered to be "MRI Conditional" according to ASTM F2503. The valve
demonstrates no known hazards when an MRI is performed under the following conditions:
In non-clinical testing, the CHPV produced a temperature rise of 0.4°C at a maximum whole body averaged specific
absorption rate (SAR) of 3.0W/kg for 15 minutes of MR scanning in a 3-Tesla Excite® General Electric MR scanner.
CODMAN® , BACTISEAL®, RICKHAM®, SIPHONGUARD® and the Codman logo are registered
trademarks of Codman & Shurtleff, Inc. HAKIM® is a registered trademark of Medos S.A. VAL-10-001 LKS/QP 12/06