P rocedure G uide

Codman ® Hakim ®
Programmable Valve System for Hydrocephalus

Utilizing the CODMAN HAKIM Programmer or

CODMAN Valve Positioning Verification (VPV™) System
 CODMAN® HAKIM® PROGRAMMABLE VALVE FUNDAMENTALS OPERATING CODMAN HAKIM PROGRAMMER

The Codman Hakim Programmable Valve offers the PROGRAMMER #82-3190

ability to optimize the opening pressure of a shunt system To program the valve:
before and after implantation. a shunted patient’s condition will
1. Turn on the programmer unit. The instruction
often change over the course of their treatment making pres-
light on the programmer panel will illuminate.
sure changes necessary. The programmable valve allows a sur-
geon to non-invasively change the opening pressure between 2. Choose the desired pressure on the program-
30 mm H2o and 200 mm H2o in 18 steps; negating the need mer panel by pressing the corresponding raised
for revision surgery to alter the valve pressure. button. The instruction light will come on.

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.

Programmer Unit #82-3190

Transmitter Head

CSF Flow

In-Line Valve with

1 SIPHONGUARD® Anti-Siphon Device
PREOPERATIVE PROGRAMMING VALVE IMPLANTATION

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.

The valve must be oriented with the valve mechanism facing up

towards the scalp and in the correct direction for CSF flow.
The MIcro Valve, in-Line, and Right angle housings have a flat
bottom that should rest against the skull, insuring that the
mechanIsm Is facIng up.
m

Frontal Approach

Programming Unit #82-3190

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.

It is imperative that the transmitter head

remain centered over the valve mechanism
CSF Flow with the feet of the transmitter head touch-
ing the scalp during the entire programming
cycle. If the transmitter head is not aligned
properly with the valve, or if it moves during
the programming cycle, incorrect program-
ming will occur.
Standard Valve

Valve with Prechamber

Micro Valve

Micro Valve with RICKHAM® Reservoir

In-Line with Reservoir

Right Angle

In-Line with SIPHONGUARD

Right Angle with SIPHONGUARD

3 Valve Mechanism
Pressure Setting Verification

It is advisable to x-ray the complete system Radiopaque Marker

immediately after implantation to have a Central Marker Correct
permanent record of component place-
Implanted Valve
ment and to verify valve pressure. It is Valve "x"
also advisable to x-ray the valve whenever
valve pressure is reprogrammed or if the
patient undergoes an MRI.

A proper radiograph will be generated

when the film is shot perpendicular to the
plane of the valve with the non-implanted Cam Position
Indicator Implanted Valve
side of the patient’s head resting on the
plate. The film must be taken in relation to
Incorrect
the valve and not the patient’s anatomy.

Radiograph Plate

The setting of the valve can be deter-

Central Marker
mined by comparing the position of the
radiopaque maker on the valve cam to Valve "x" Radiopaque Marker
the fixed position of the radiopaque right-
hand side indicator on the base plate of
the valve.

Comparing the patient radiographs to the

diagram on the programming unit panel
will indicate the valve setting. Note that
settings of 70, 120 and 170 mm H2O align
with the cross in the center of the valve.

Note: Remember to verify valve pressure setting after an MRI.

4
 POSTOPERATIVE PROGRAMMING PROGRAMMER UNIT MODE SELECTIONS

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.

noTE: if the acoustic monitoring feature did not receive an expected

response, the program unit will emit three beeps and one of the two mes-
sages will be displayed.

REPEaT adJUSTmEnT or no SiGnaL REPEaT adJUSTmEnT PRESS a

kEY.
Transmitter Head (bottom)
after the “adJUSTmEnT ComPLETE” message is displayed press any key
to clear. The LCd panel will change to the original message: imPLanTEd
VaLVE PLEaSE SELECT PRESSURE.

The VPV Programmer provides confirmation of the valve adjustment without

the need for radiographic imaging when the "ADJUSTMENT COMPLETED"
message is displayed.

5
pressure settings Inverted Valve Adjustment: codMAN HAKIM PROGRAMMER

To Obtain this Program this #82-3190

Pressure in the Pressure on the
Inverted System Pressure Formula Programmer Prior to following the procedure to perform
adjustment of an inverted valve, review the section
30 mm H2O 210 - 30 = 180 180 mm H2O on setting verfications in the Instructions for Use to
40 mm H2O 210 - 40 = 170 170 mm H2O insure that the radiographs were taken and read in
50 mm H2O 210 - 50 = 160 160 mm H2O the proper orientation.
60 mm H2O 210 - 60 = 150 150 mm H2O An inverted valve can be diagnosed on x-ray; the white marker will appear on the left
70 mm H2O 210 - 70 = 140 140 mm H2O side of the valve instead of the right side. Programming the inverted valve requires a
80 mm H2O 210 - 80 = 130 130 mm H2O "double programming" to obtain the desired setting.
90 mm H2O 210 - 90 = 120 120 mm H2O
1. Program the valve with the valve programmer (82-3190) at the 200 valve
100 mm H2O 210 - 100= 110 110 mm H2O pressure setting.
110 mm H2O 210 - 110 = 100 100 mm H2O
120 mm H2O 210 -120 = 90 90 mm H2O
2. Calculate the following: 210 (constant) minus the desired pressure setting
equals the programming pressure setting. For example, where 70 is the desired
130 mm H2O 210 - 130 = 80 80 mm H2O pressure setting: 210 - 70 = 140.
140 mm H2O 210 - 140 = 70 70 mm H2O
150 mm H2O 210 - 150= 60 60 mm H2O 3. Push the button for the programming pressure setting (in this example, 140)
on the programmer; hold the transmitter in place for approximately 5 seconds
160 mm H2O 210 - 160= 50 50 mm H2O
until the confirmation tone is heard. If the surgeon is unsure whether the
170 mm H2O 210 -170 = 40 40 mm H2O reprogramming took place, he or she must repeat the complete process, Steps
180 mm H2O 210 - 180 = 30 30 mm H2O 1-3, otherwise the programming will be incorrect.
190 mm H2O N/A N/A
Note: When the valve is inverted, pressure settings of 190 and 200 are not possible
200 mm H2O N/A N/A to program with 82-3190. See instructions for 82-3192 below.

Inverted Valve Adjustment & confirmation: VPV 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.

The VPV Programmer provides confirmation of the valve adjustment without

the need for radiographic imaging when the "ADJUSTMENT COMPLETED"
message is displayed.

Proceed as usual, following the steps in Valve Adjustment: Implanted Valve

Mode. At the end of the adjustment cycle, the program unit returns to the normal
adjustment cycle.

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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:

• MRI can be performed at any time after implantation

• Use an MRI System with a static magnetic field of 3 tesla or less
• Use an MRI System with a spatial gradient of 720 Guass/cm or less
• Limit the exposure to RF energy to a whole-body-averaged specific absorption rate (SAR) of W/kg for 15 minutes
• Verify the valve setting after the MRI procedure (see 'Programming the Valve')

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.

For more information, contact your Codman Sales Representative

325 Paramount Drive, Raynham, MA 02767 • (508) 880-8100

For product information, call (800) 225-0460 • www.codman.com
©2006 Codman & Shurtleff, Inc. All rights reserved.

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