Integra Codman HAKIM Manual De Instrucciones página 8

EN – ENGLISH
HAKIM
®
Programmer and Transmitter
IMPORTANT INFORMATION
Please Read Before Use
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 O in increments of 10 mm H
2 2
Pa).
The transmitter (Figure 2) provides the programming signal to the valve.
Reordering Information
Catalog No Description
823190R 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
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 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.
The HAKIM Programmer can be used only with supplied transmitter and cord. Use of
accessories other than those supplied may result in increased emissions or decreased
immunity of the equipment.
The HAKIM Programmer must be used by a trained medical professional
in a healthcare setting.
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
(392 Pa) in a 24-hour period. Patients whose 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).
Use caution not to obstruct cord connections during programmer use.
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.
Follow the instructions for programmer installation per electromagnetic compatibility
(EMC) Table I -IV.
Do not stack the HAKIM Programmer with other equipment to avoid interference.
Mobile RF communication equipment can affect functionality of the HAKIM Programmer.
O (from 294 Pa to 1960 Pa in increments of 98
2
WARNING: Portable RF communication equipment (including peripherals such as
antennas) should be used no closer than 30 cm (12 inches) to any part of the HAKIM
Programmer) Otherwise, degradation of the performance of this equipment could
result
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
100/120 VAC
220/240 VAC
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:
O
2
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:
2
Fuse Type
T5AL 5 x 20 mm
T2AL 5 x 20 mm
CODMAN HAKIM
PROGRAMMER VER 5.0
LANGUAGE
30 = ENGLISH
MORE = 200