Johnson & Johnson Codman HAKIM Mode D'emploi page 2

ENGLISH
IMPORTANT INFORMATION
Please Read Before Use
HAKIM ® Programmer and Transmitter
The HAKIM Programmer and Transmitter were designed and developed in conjunction
with Carlos Hakim, Ph.D. and Salomon Hakim, M.D.
Description
The programming system consists of two parts: the programmer and
the transmitter.
The programmer (Figure 1) is an electronic module that houses the power
and control circuits. The control panel on the front of the programmer
features a programming information display panel and a representation of the
programmable portion of the valve as it appears when x-rayed. The control
panel also contains the buttons used to program the pressure setting of the
valve and choose the language for the display. The pressure settings range
from 30 mm H O to 200 mm H
2 2
to 1960 Pa in increments of 98 Pa).
The transmitter (Figure 2) provides the programming signal to the valve.
Reordering Information
Catalog No. Description
82-3190 Programmer, complete, 100–240 VAC supplied with carrying
case, transmitter and cord. Not sterile.
Indications and Usage
The HAKIM Programmer and Transmitter are designed for use only with
CODMAN ® HAKIM Programmable Valves in the treatment of hydrocephalus
when shunting cerebrospinal fluid (CSF) from the ventricles of the brain.
PRECAUTIONS
CODMAN HAKIM Programmable Valves are supplied without a specific
programmed pressure setting and must be programmed prior to use.
Carefully read the instruction manual packaged with the CODMAN HAKIM
Programmable Valve before programming or implanting the valve.
Do not use the programmer in a magnetic resonance imaging (MRI) suite.
Do not allow the programmer or the transmitter to remain in
environmental extremes.
After exposure to environmental extremes, such as those found in transport
or storage, allow the programmer and the transmitter to come to room
temperature before operating.
Do not program the valve on a metal surface, such as a Mayo stand.
While becoming familiar with valve programming, it is recommended that
the pressure setting of the implanted valve be changed in increments of
no more than 40 mm H O (392 Pa) in a 24-hour period. Patients whose
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pressure setting has been changed must be carefully monitored during the
first 24 hours postprogramming. It is recommended that x-rays be taken to
confirm the changes made to valve pressure setting.
Before use, check the programmer and transmitter connections, settings,
and function (see "Preimplantation Programming Familiarization Procedure"
in this manual).
Unauthorized modifications to the programmer or the transmitter can cause
a malfunction that could result in serious patient injury or death.
Electrical shock hazard: Do not open the programmer or transmitter. Refer
servicing to qualified service personnel.
Explosion hazard: Do not use the programmer in the presence of flammable
material; i.e., anesthetics, solvents, cleaning agents, and endogenous gases.
Before turning on the programmer, verify that the correct fuse is installed.
Do not move the transmitter during programming.
Do not sterilize the programmer or the transmitter or immerse them in
any liquid.
205181-001-E.indd 2 205181-001-E.indd 2
O in increments of 10 mm H O (from 294 Pa
2
Programming the Valve
Programmer Information
Programming must be performed prior to implantation through nonsterile
outer package. Perform programming postoperatively as needed.
The programmer control panel (see Figure 1) features a display panel and a
representation of the programmable portion of the valve as it appears when
x-rayed. This representation also incorporates the 18 pressure selection
buttons. Eighteen LEDs, corresponding to the position of the valve pressure
indicator when viewed on x-ray, confirm the pressure setting chosen.
Transmitter Information
The transmitter (Figure 2) incorporates an illuminated center hole and
directional arrows to aid in proper positioning over the valve. It connects to
the programming unit via a pronged plug and is activated by a start button.
X-rayed Valve Information (Figures 3 & 4)
The white marker on the valve indicates the right hand side of the valve. The
pressure indicator on the white ring indicates the chosen pressure setting.
There is a direct correlation between the position of the pressure selector
buttons on the programming unit's control panel and the positions of the
pressure indicator on the valve as seen when x-rayed. Note that when the
valve is programmed to 70, 120, or 170, the pressure indicator aligns with
the "X" in the center of the valve.
After depressing the desired pressure selector button, a blue LED lights in
the programmer, corresponding exactly with the position of the pressure
indicator on the valve. The transmitter then emits a sequentially coded
electromagnetic signal. The stepper motor of the valve detects the signal and
rotates the cam assembly, which in turn adjusts the tension of the spring to
the selected pressure setting.
Programmer Initialization and Language Selection Procedure
Before first use of the programmer on a valve, perform the following steps to
set up the programmer for operation and to set the display language.
1. Verify that the correct fuse is installed in the programmer for the power
supply voltage to be used:
Supply Voltage Fuse Type
100/120 VAC T5AL 5 x 20 mm
220/240 VAC T2AL 5 x 20 mm
2. Insert the plug from the transmitter into the receptacle at the back of
the programmer.
3. Plug the socket end of the programmer power cord into the receptacle on
the programmer. Insert the plug end of the power cord into an appropriate
power source.
4. Set the rear panel programmer power switch to ON. After completing
the self test procedure, the LCD panel on the front of the programmer will
illuminate and display the following title screen:
CODMAN HAKIM
PROGRAMMER VER 3.01
NOTE: The software version number displayed may be different than the one
shown above.
5. As soon as the message above is displayed, press the "30" pressure
selection button on the front panel. The display will change to:
LANGUAGE
30 = ENGLISH
MORE = 200
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