DePuy Synthes Codman Neuro Mode D'emploi page 4

50 °C
Temperature limitations
0 °C
85%
Humidity limitations
15%
Date of manufacture
Caution
Double insulation
Type BF applied part
Manufacturer
Catalogue number
Quantity
Serial number
Underwriters' Laboratories
Electrical and electronic equipment. Return waste to
collection system or treatment and recycling facilities.
Applicable in the EU. Follow disinfection instructions
before return.
Protection against vertically falling water drops
MR Unsafe
Fragile, handle with care
Keep dry
Made In
Instructions for Use
Materials Required
DirectLink Module
Patient Monitor
DirectLink Patient Monitor Interface Cable (compatible with Patient
Monitor)
CODMAN MICROSENSOR ICP Transducer (in unopened sterile
package)
DirectLink ICP Extension Cable
A. Connect the DirectLink Module to the
Patient Monitor
1. Select the DirectLink Patient Monitor Interface Cable that
is compatible with the patient monitor that will be used.
2.
Visually inspect the cable, connectors, and connector
pins for signs of damage. Do not use if damaged. Make
sure that the connector pins and internal portions of the
connector are dry and free of visible debris prior to use.
3. Attach the interface cable to the DirectLink and then to an
available invasive pressure input channel on the patient
monitor, as outlined in Steps 3.1 through 3.3:
3.1.
Hold the module with its front panel facing up. Align
the cable's connector so that the "fin" of the strain
relief points downward. Align the cable to the signal
output receptacle on the module, marked with the
symbol (see Detail "D" in Figure 2).
3.2. Firmly push the cable connector into the receptacle
until it fully engages and locks in place.
All manuals and user guides at all-guides.com
CAUTION: Align the "fin" of the strain relief of the
interface cable with the receptacle on the module
as outlined in Step 3.1 before pushing these
parts together. DO NOT twist the connector after
pushing it in part way. Twisting the connector in
this manner will damage the pins and can lead to
product malfunction.
3.3. Attach the other end of the interface cable to the
available invasive pressure input channel connector
of the patient monitor. Refer to the manual for your
patient monitor. Use the cable management strap to
reduce any excessive length of interface cable.
4.
The DirectLink Module self-test will run automatically; LEDs
will switch on and off sequentially. At the end of the self-
test, the amber LED alone will remain illuminated, indicating
that the module is ready for the next step. Proceed to
Section B. Calibrate the Patient Monitor.
CAUTIONS:
• Do not press any buttons during the DirectLink self-test
or the self-test will incorrectly detect a failure condition.
• If the amber LED does not illuminate, do not use the
DirectLink Module; contact your local Codman Neuro
Representative for a replacement module.
Note: Whenever the amber status LED is steady, the DirectLink
Module sends a full scale signal greater than 250 mmHg to the
patient monitor to indicate that a zeroed ICP sensor is not yet
connected to the system. Some patient monitors might display an
"over range" pressure message.
B. Calibrate the Patient Monitor
1. Press the  button ONE TIME to send a 0 mmHg reference
signal to the patient monitor. The green reference LED
marked "0 mmHg" will illuminate and the amber status LED
at the bottom of the front panel will turn off.
Note: If the LED marked "0 mmHg" is not illuminated,
repeatedly press the  button until the correct LED is
illuminated.
2.
Zero the patient monitor following its manual. Verify that the
0 mmHg signal is shown on the patient monitor.
CAUTION: If the patient monitor does not display
"0 mmHg" at this point, consider that the patient
monitor may not be compatible.
3. Press the  button a second time to send a 100 mmHg
reference signal to the patient monitor. The green status
LED marked "100 mmHg" will illuminate. Note: If the LED
marked "100 mmHg" is not illuminated, press the  button
until the correct LED is illuminated.
4. Verify that the 100 mmHg signal is shown on the patient
monitor. If the ICP pressure reading on the patient monitor
does not show "100," follow the patient monitor manual to
adjust the monitor gain until it displays "100."
CAUTION: If the reading is significantly different from
100mmHg and if the patient monitor does not allow
adjusting the gain, consider that the patient monitor
may not be compatible.
5.
Press the  button a third time to exit the calibration mode.
The amber status LED at the bottom of the front panel will
illuminate.
6. Proceed to Section C. Zero the ICP Sensor.
Note: Steps 1 through 5 can be repeated at any time for
assurance that the patient monitor is correctly calibrated.
Note: Whenever the amber status LED remains steadily
illuminated, the DirectLink Module sends a signal greater than
250 mmHg to the patient monitor. Some patient monitors
might display an "over range" pressure message.
C. Zero the ICP Sensor
WARNING: The zeroing steps must be performed before the
sensor is implanted. Zeroing sensor after it is implanted will
result in incorrect pressure readings.
1. Follow sterile technique to open the ICP sensor sterile
package and place the contents on a sterile surface.
2. To attach the ICP sensor to the extension cable and then
connect the cable to the DirectLink module, follow Steps
2.1 through 2.3:
2.1. Pass the connector of the ICP sensor out of
the sterile field and connect it to the ICP sensor
extension cable.
4