Sterilization; Storage; Technical Specifications; Operating Conditions - Depuy Synthes CODMAN NEURO DirectLink ICP Module Betriebsanleitung

4. Visually inspect the module after wiping down to ensure
markings remain. Do not use the module if markings
are compromised. Contact your local Codman Neuro
Representative for a replacement.
5. If required by hospital procedures, sterilize the extension
cable in accordance with its manual.

Sterilization

CAUTION: Do not sterilize the DirectLink Module or the patient
monitor interface cable. Damage will result.
Please refer to the manual for the DirectLink ICP Extension Cable for
sterilization instructions for that component. Remove the bed clip
from the extension cable before sterilization.

Storage

For long term storage of the DirectLink Module and Extension Cable,
ensure that they are protected from dust and kept in a clean, dry
environment with these conditions:
■ Humidity (RH) range: 15% to 85% (non-condensing)
■ Temperature range: 0C to +50C

Technical Specifications

Operating conditions

Operating Temperature Range
(exclusive of transducer)
Operating Humidity Range (exclusive
of transducer)
Storage Temperature Range
(exclusive of transducer)
Storage Humidity Range (exclusive
of transducer)

Output Signal

Output signal range
Output Signal Accuracy (exclusive of
transducer, including extension cable
and Patient Monitor cable)
Output Signal Sensitivity
Output Signal Drift
(exclusive of transducer)
Output Signal Frequency Response
(exclusive of transducer)
Output Signal Resolution

Power Consumption

Power Consumption
(exclusive of transducer)

Transducer Compatibility

Transducer Excitation Voltage
Transducer Zeroing Range
Transducer Output Impedance

Patient Monitor Connection

Input impedance across the
excitation voltage signals
Output Impedance across the sensor
signals

Recommended External Patient Monitor Specifications

The DirectLink ICP Module is compatible with patient monitors that
meet the following specifications:
Transducer excitation voltage range
Zero range
Frequency Response
Isolation
Transducer Sensitivity
Nominal transducer output
impedance
5°C to 40°C
20% to 80% (non-condensing)
0°C to +50°C
15% to 85% (non-condensing)
-50 to 250 mmHg
+ ⁄ - 1.0 mmHg over the pressure range
-50 mmHg to 50 mmHg and + ⁄ - 2%
over the pressure range 50 mmHg to
250 mmHg
5 µV/V/mmHg
<0.1 mmHg/day over 7 days
25 Hz (-3 dB)
0.1 mmHg
<169 mW at 6.5 VDC and <25 mW
at 2.5 VDC
2.5 to 6.5 VDC
+ ⁄ - 50 mmHg
1000 Ohm (nominal)
> 200 Ohm
< 3 kOhm
2.5 to 6.5 VDC
At least + ⁄ - 50 mmHg
At least 10 Hz
Type BF or Type CF
5 uV/Vex/mmHg
1000 Ohm
WARNING: Use ONLY the Patient Monitor Interface Cable
identified with the monitor manufacturer's name and model,
listed in Recommended Accessories and Reordering Information.

Applicable Standards

The DirectLink system has been tested and conforms to the
standards listed below. However, it is not guaranteed that
electromagnetic interference may not occur in a given situation.
Please consult Troubleshooting for more information about resolving
electromagnetic interference, if it occurs.
IEC 60601-1:2005 +A1:2012
IEC 60601-1-2:2007
EN 60601-1:2006 +A1:2013
EN 60601-1-2:2007/AC:2010
ANSI/AAMI ES 60601-1:2005/(R)2012
ANSI/AAMI/IEC 60601-1-2:2007/(R)2012
CAN/CSA-C22.2 NO. 60601-1:14
CAN/CSA-C22.2 NO. 60601-1-2-08 (R2014)
Recommended Accessories and
Reordering Information
The following DirectLink accessories are available separately. Contact
your Codman Neuro Representative or Codman customer service to
place an order.
Description
DirectLink ICP Extension Cable
Patient Monitor Interface Cable, Dräger/Siemens
(10 pin)
Patient Monitor Interface Cable, Philips (12 pin)
Patient Monitor Interface Cable, GE (11 pin)
CODMAN MICROSENSOR Basic Kit, sterile
CODMAN MICROSENSOR Plastic Skull Bolt
Kit, sterile
CODMAN MICROSENSOR Ventricular Catheter
Kit with Tuohy-Borst Adapter, sterile
CODMAN MICROSENSOR Metal Skull Bolt
Kit, sterile
CODMAN MICROSENSOR Ventricular Catheter,
sterile
*Product availability may differ by country; please contact your local
Codman Neuro Representative for information.

Troubleshooting

When the
Device
Behavior
behavior
Occurs
The self-test Immediately Damaged interface
does not after connecting cable.
start interface cable
to the module
and to the
patient monitor
Red status During self-test Button press during
LED is startup OR faulty module.
illuminated
After the Patient monitor may
self-test not be compatible with
DirectLink Module.
6
Catalog Number
82-6840
82-6880
82-6881
82-6882
626631, 626631US, 82-6631*
626632, 626632US, 82-6632*
626633, 626633US, 82-6633*
626638, 626638US, 82-6638*
626653, 626653US, 82-6653*
Possible cause Recommended Solutions
a) Replace the Patient Monitor
Interface Cable. Make sure self-
test completes successfully.
b) If the self-test does not start,
replace the module.
a) Verify buttons are not pressed
while self-test is ongoing.
b) Disconnect the cable from patient
monitor and the ICP module
to reboot.
c) Reconnect interface cable and
patient monitor and make sure
self-test completes successfully.
d) If the red LED returns, replace the
DirectLink module.
Verify the excitation voltage supplied
by the patient monitor is within the
specified operating range: Supply
voltage must be between 2.5 and 6.5
V. An "out of range" voltage supply will
result in the red LED illuminating.