Synthes 82-6828, Manual

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2.2. To connect the other end of the extension cable to
the DirectLink Module, hold the module with its front
panel facing up. Align the extension cable connector
so that the “fin” of the strain relief points downward.
Align the connector to the signal input receptacle on
the module, marked with the symbol (see Detail
“D” of Figure 2).
CAUTION: Align the “fin” of the strain relief of
the extension cable with the receptacle on the
module as outlined in Step 2.2 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.
2.3. Firmly push the cable connector into the receptacle
until it locks into place.
3. Follow the manual packaged with the sensor. Follow the
technique in the sensor manual to lay the tip of the sensor
horizontally on top of a shallow pool of sterile water or
sterile saline. Press and hold the à 0 ß button on the
DirectLink Module for until the amber LED flashes. (This
should take approximately 5 seconds.) The solid green
status LED illuminates. This means that the zeroing process
has finished and the zero reference for that particular
sensor has been saved to the DirectLink Module’s memory.
CAUTION: If the solid amber LED turns on again, it
means that the operation to zero the sensor failed
because of one of these conditions:
a. The sensor vibrated/was moved/was touched
during the zeroing process
b. The sensor is damaged
c. The module is damaged and cannot perform
zeroing
d. The sensor might already be implanted
To correct conditions a through c, repeat Step 3. If it
fails again, use another sensor. If it fails yet again, do
not use the module. Arrange for replacement of the
DirectLink Module.
CAUTION: If the red LED turns on at this stage of
sensor zeroing, see Troubleshooting .
4. Verify that the patient monitor displays 0 mmHg. The sensor
is ready to be implanted and must now only be used with
the DirectLink Module with which it was zeroed. Implant the
sensor in the usual manner, in accordance with its manual.
Use the bed clip on the extension cable to attach any
excessive length of the cable to the bed.
D. Implant the Sensor
WARNING: Do not implant a sensor THAT HAS NOT BEEN
ZEROED in accordance with the instructions in Section C. Zero
the ICP Sensor. Implanting a sensor before it is zeroed will result
in incorrect pressure values being displayed.
Read and follow the manual for the sensor to complete the
implantation procedure.
After implantation, follow the instructions in the applicable section of
this manual:
• Resume Monitoring After Temporary Disconnection
(ACKNOWLEDGE Function)
• Connect an Implanted Sensor to a Different Monitor
E. Disconnect the Sensor During Patient Transport
Prior to some diagnostic procedures or treatments, it might be
required or desirable to disconnect the DirectLink Module and
the Extension Cable. For example, all DirectLink cables and the
DirectLink ICP Module are MR Unsafe and must be removed before
the patient enters an MR environment. Follow the steps in this section
to disconnect the DirectLink system from the patient.
CAUTION: After a temporary disconnection, the patient must be
reconnected to the original DirectLink Module used to zero the
sensor. Failure to reconnect to the original module will result in
loss of the transducer zero baseline, resulting in inaccurate ICP
measurements.
1.
Disconnect the extension cable from the DirectLink Module.
The extension cable can also be disconnected from the
sensor, if necessary. The amber status LED will illuminate;
this indicates that the module is awaiting reconnection.
Note: To disconnect cables from the DirectLink Module,
grasp the connector housing and gently pull backwards
towards the strain relief to release the mechanical lock. The
cable should pull out of the connector freely, as shown in
Detail “E” in Figures 2 and 3.
2. Disconnect the patient monitor interface cable from the
DirectLink Module, if desired.
3. After the patient’s return to the unit, follow the instructions
in the applicable section to resume ICP monitoring:
• Resume Monitoring After Temporary Disconnection
(ACKNOWLEDGE Function)
• Connect an Implanted Sensor to a Different Monitor
F. Resume Monitoring After Temporary Disconnection
(ACKNOWLEDGE Function)
Follow the steps below after the sensor has been zeroed and
implanted
, to reconnect it with the patient monitor and DirectLink
Module previously used.
CAUTION: After a temporary disconnection, the patient must be
reconnected to the original DirectLink Module used to zero the
sensor. Failure to reconnect to the original module will result in
loss of the transducer zero baseline, resulting in inaccurate ICP
measurements.
1. Follow all steps in Section A. Connect the DirectLink
Module to the Patient Monitor .
2.
Follow Steps 1 - 5 in Section B. Calibrate the Patient
Monitor .
WARNING: At this step, do not attempt to zero the probe.
3. To resume monitoring, using the previously stored
zero value, press the

button and the
à
0
ß
button
simultaneously. This is called the ACKNOWLEDGE
FUNCTION. The amber status LED blinks for approximately
4 seconds. Then the green status LED illuminates and the
pressure is displayed on the patient monitor.
Note: if the amber status LED does not turn off and the
green status LED does not illuminate, see Troubleshooting .
WARNING: The two buttons MUST be pressed
simultaneously in order to successfully resume
monitoring. Do not press and hold the
à
0
ß
button
alone as it might re-zero the implanted probe. If the
ICP transducer is zeroed after implantation, incorrect
pressure values will be displayed.
4.
Verify that the patient monitor displays a physiological
waveform.
G. Connect an Implanted Sensor to a Different Monitor
It is possible to use a zeroed, implanted sensor with a different
patient monitor. The sensor MUST remain attached to the
DirectLink Module that was used to zero that sensor. Connect
the appropriate interface cable to the patient monitor. Follow all
steps in Section A. Connect the DirectLink Module to the Patient
Monitor .
H. Discontinue Monitoring ICP / Wipe Down and
Inspect the System
1. Disconnect the extension cable from the DirectLink Module
and the sensor. Explant the sensor from the patient.
Note: To disconnect cables from the DirectLink Module,
grasp the connector housing and gently pull backwards
towards the strain relief to release the mechanical lock. The
cable should pull out of the connector freely, as shown in
Detail “E” in Figures 2 and 3.
2. Disconnect the patient monitor interface cable from the
patient monitor and the DirectLink Module.
3. Wipe down the module and the cables with one of the
following methods:
• combination wipes (Quaternary Ammonium/Isopropyl
Alcohol)
• 70% isopropyl alcohol
CAUTION: Do not immerse the module or cables in any
liquid or allow liquid to enter the receptacles. Do not
sterilize the module.