Applicable Standards - Codman DirectLink ICP Gebrauchsanleitung

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
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
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 6.5VDC and <25 mW
at 2.5VDC
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 25 Hz
Type BF or Type CF
5 uV/Vex/mmHg
1000 Ohm
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 Integra representative 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 Integra representative for information.
Troubleshooting
When the
Device
Behavior
behavior
Occurs
The self-test Immediately Damaged interface
does not after cable.
start connecting
interface
cable to the
module and
to the patient
monitor
Red status During self-test Button press during
LED is startup OR faulty
illuminated module.
After the Patient monitor may
self-test not be compatible
with DirectLink
Module.
7
EN – ENGLISH
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.