Service And Repair; Product End Of Life - Integra Codman DirectLink ICP Manual De Instrucciones

EN – ENGLISH
When the
Device
Behavior Possible cause
behavior
Occurs
Red status During sensor Damaged ICP
LED is reconnection Extension Cable;
illuminated OR damaged or faulty
At any time DirectLink Module;
during use or damaged sensor.
During sensor DirectLink memory
zeroing may be corrupted.
Amber After a zeroing 1. The sensor has
status LED attempt already been
illuminates implanted.
(instead of 2. The sensor
green LED vibrated/was
illuminating) moved/was
touched during
the zeroing
process.
3. The module is
damaged and
cannot perform
zeroing.
4. The sensor is
damaged.
5. The Module is
experiencing
electrical
interference from
other equipment.
Recommended Solutions
a) Disconnect all cables
from ICP Module and the
patient monitor.
b) Reconnect Patient
Monitor Interface Cable
to the DirectLink Module
and to the patient
monitor. Verify that
the self-test completes
successfully (solid amber
LED).
c) Connect the ICP
Extension Cable to
the DirectLink Module
without the sensor
attached and ensure the
Maintenance
solid amber LED remains
lit. If the red LED returns
at this point, perform No yearly maintenance or calibration is required for the
a) and b). Then perform
DirectLink Module.
c) with a new extension
cable.

Service and Repair

d) If the red LED returns,
perform a) and b). Then
The DirectLink Module and the DirectLink Extension Cable
perform c) with a new
sensor.
are not repairable products; please contact your local Integra
e) If the red LED returns,
representative to order a replacement.
replace the DirectLink
Module.

Product End of Life

a) Disconnect all cables
from the ICP Module and
The module contains electrical components. Dispose of the
the patient monitor to
reset/reboot the device.
equipment in accordance with local ordinances.
b) Reconnect to patient
monitor/extension cable
PRODUCT INFORMATION DISCLOSURE
and make sure self-test
completes successfully.
INTEGRA LIFESCIENCES CORPORATION ("INTEGRA") HAS
c) Ensure that sensor is
prepared for zeroing per EXERCISED REASONABLE CARE IN THE SELECTION OF
the proper technique
MATERIALS AND THE MANUFACTURE OF THESE PRODUCTS.
outlined in the sensor's
instructions for use.
INTEGRA WARRANTS THAT THESE PRODUCTS SHALL
Repeat the zeroing
CONFORM TO THE PRODUCT LIMITED WARRANTY AS
(by following Step 3
in Section C. Zero the
PROVIDED IN THE PRODUCT LABELING OR APPLICABLE
ICP Sensor) or resume
PRODUCT CATALOG. THIS WARRANTY IS EXCLUSIVE, AND
monitoring [by following
Step 3 in Section F.
INTEGRA DISCLAIMS ALL OTHER WARRANTIES, WHETHER
Resume Monitoring After
EXPRESSED OR IMPLIED, INCLUDING BUT NOT LIMITED
Temporary Disconnection
(ACKNOWLEDGE
TO, ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR
Function)], as applicable.
FITNESS FOR A PARTICULAR PURPOSE. INTEGRA SHALL
d) If the red LED returns,
replace the DirectLink
NOT BE LIABLE FOR ANY INCIDENTAL OR CONSEQUENTIAL
Module.
LOSS, DAMAGE, OR EXPENSE, DIRECTLY OR INDIRECTLY
Cause #1: Verify you are
working with an un- ARISING FROM USE OF THESE PRODUCTS. INTEGRA NEITHER
implanted probe. Probes can
ASSUMES NOR AUTHORIZES ANY PERSON TO ASSUME ANY
only be zeroed before they are
implanted.
OTHER OR ADDITIONAL LIABILITY OR RESPONSIBILITY IN
Causes #2, 3, & 4: To correct
CONNECTION WITH THESE PRODUCTS.
the condition, repeat Step
3 in Section C. Zero the ICP
Sensor. If it fails again, replace
Appendix A
the DirectLink Module. If it
fails yet again, replace the
Electromagnetic compatibility
sensor.
Cause #5: Make sure that
all cables connected to General Notes
the DirectLink Module are
separated away from other
Medical electrical equipment requires special precautions
electrical equipment and
regarding electromagnetic compatibility (EMC) and needs to be
cables. Repeat Step 3 in
Section C. Zero ICP Sensor.
installed and put into service according to the EMC information
provided in this document.
Portable and mobile RF communications equipment can affect
medical electrical equipment. The use of accessories and
cables other than those specified in this document, with the
exception of accessories and cables sold by the Manufacturer
of the medical electrical equipment as replacement parts for
internal components, may result in increased emissions or
decreased immunity of the Medical Electrical Equipment.
8
When the
Device
Behavior Possible cause
behavior
Occurs
Amber After a sensor DirectLink Module
status LED reconnection has not detected a
illuminates attempt variable signal from
(instead of the sensor that
green LED would correspond
illuminating) to an implanted
probe. DirectLink
system will not allow
this step for a non-
implanted probe.
Recommended Solutions
Verify you are working with
an implanted probe and
re-attempt the reconnection
process again, by following
the steps in Section F.
Resume Monitoring After
Temporary Disconnection
(ACKNOWLEDGE Function).
Make sure that the sensor
has not become dislodged or
has moved from the original
placement position in the
patient. Replace sensor if it
has become dislodged.