Maintenance; Service And Repair; Product End Of Life; Warranty - Depuy Synthes CODMAN NEURO DirectLink ICP Module Betriebsanleitung

When the
Device
Behavior Possible cause
behavior
Occurs
Red status During sensor Damaged ICP Extension
LED is reconnection Cable; damaged or faulty
illuminated OR DirectLink Module; or
At any time damaged sensor.
during use
During sensor DirectLink memory may
zeroing be corrupted.
Amber After a zeroing 1. The sensor has
status LED attempt already been
illuminates implanted.
(instead of 2. The sensor vibrated/
green LED was moved/was
illuminating) 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.
After a sensor DirectLink Module has
reconnection not detected a variable
attempt signal from the sensor
that would correspond
to an implanted probe.
DirectLink system will
not allow this step for a
non-implanted probe.

Maintenance

No yearly maintenance or calibration is required for the DirectLink
Module.

Service and Repair

The DirectLink Module and the DirectLink Extension Cable are
not repairable products; please contact your local Codman Neuro
Representative to order a replacement.

Product End of Life

The module contains electrical components. Dispose of the
equipment in accordance with local ordinances.
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 solid amber LED remains lit. If
the red LED returns at this point,
perform a) and b). Then perform
c) with a new extension cable.
d) If the red LED returns, perform
a) and b). Then perform c) with a
new sensor.
e) If the red LED returns, replace the
DirectLink Module.
a) Disconnect all cables from the
ICP Module and the patient
monitor to reset/reboot the
device.
b) Reconnect to patient monitor/
extension cable and make sure
self-test completes successfully.
c) Ensure that sensor is prepared
for zeroing per the proper
technique outlined in the sensor's
instructions for use. Repeat the
zeroing (by following Step 3 in
Section C. Zero the ICP Sensor) or
resume monitoring [by following
Step 3 in Section F. Resume
Monitoring After Temporary
Disconnection (ACKNOWLEDGE
Function)], as applicable.
d) If the red LED returns, replace the
DirectLink Module.
Cause #1: Verify you are working
with an un-implanted probe. Probes
can only be zeroed before they are
implanted.
Causes #2, 3, & 4: To correct the
condition, repeat Step 3 in Section C.
Zero the ICP Sensor. If it fails again,
replace the DirectLink Module. If it
fails yet again, replace the sensor.
Cause #5: Make sure that all cables
connected to the DirectLink Module
are separated away from other
electrical equipment and cables.
Repeat Step 3 in Section C. Zero
ICP Sensor.
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.

Warranty

Codman & Shurtleff, Inc. warrants that this medical device is free from
defects in both materials and workmanship for 1 year from the date of
purchase. THE ABOVE WARRANTIES ARE IN LIEU OF ALL OTHER
WARRANTIES EITHER EXPRESS OR IMPLIED, INCLUDING
ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE. Suitability for use of this medical device
for any surgical procedure shall be determined by the user.
Neither Codman & Shurtleff nor its affiliated companies shall be
liable for incidental or consequential damages of any kind.
™ DirectLink is a trademark of DePuy Synthes Products, Inc.
® CODMAN MICROSENSOR is a registered trademark of
DePuy Synthes Products, Inc.

Appendix A

Electromagnetic compatibility

General Notes

Medical electrical equipment requires special precautions regarding
electromagnetic compatibility (EMC) and needs to be 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.
The equipment should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, the equipment
should be observed to verify normal operation in the configuration in
which it will be used.
Guidance and manufacturer's declaration – electromagnetic emissions
The DirectLink is intended for use in the electromagnetic environment specified below. The
customer or the user of the DirectLink should ensure that it is used in such an environment.
Emissions test Compliance
RF emissions
Group 1
CISPR 11
RF emissions
Class A
CISPR 11
Harmonic emissions
Not Applicable
IEC 61000-3-2
Voltage fluctuations/
flicker emissions Not Applicable
IEC 61000-3-3
Guidance and manufacturer's declaration – electromagnetic immunity
The DirectLink is intended for use in the electromagnetic environment specified below. The
customer or the user of the DirectLink should ensure that it is used in such an environment.
IEC 60601
IMMUNITY test
test level
± 6 kV contact
Electrostatic
discharge (ESD)
± 8 kV air
IEC 61000-4-2
± 2 kV for power
Electrical fast
supply lines
transient/burst
± 1 kV for input/
IEC 61000-4-4
output lines
Surge
Not Applicable
IEC 61000-4-5
7
Table 1
Electromagnetic environment – guidance
The DirectLink uses RF energy only for its internal
function. Therefore, its RF emissions are very low
and are not likely to cause any interference in nearby
electronic equipment.
The DirectLink is suitable for use in all establishments
other than domestic and those directly connected to
the public low-voltage power supply network that
supplies buildings used for domestic purposes.
Table 2
Electromagnetic environment
Compliance level
– guidance
± 6 kV contact Floors should be wood, concrete or
ceramic tile. If floors are covered
± 8 kV air with synthetic material, the relative
humidity should be at least 30 %.
± 2 kV for power
supply lines
Mains power quality should be that
of a typical commercial or hospital
± 1 kV for input/
environment.
output lines
Not Applicable Not Applicable