Synthes 82-6828, Руководство пользователя

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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)
5°C to 40°C
Operating Humidity Range (exclusive
of transducer)
20% to 80% (non-condensing)
Storage Temperature Range
(exclusive of transducer)
0°C to +50°C
Storage Humidity Range (exclusive
of transducer)
15% to 85% (non-condensing)
Output Signal
Output signal range -50 to 250 mmHg
Output Signal Accuracy (exclusive of
transducer, including extension cable
and Patient Monitor cable)
+⁄- 1.0 mmHg over the pressure range
-50 mmHg to 50 mmHg and +⁄-2%
over the pressure range 50 mmHg to
250 mmHg
Output Signal Sensitivity 5 µV/V/mmHg
Output Signal Drift
(exclusive of transducer)
<0.1 mmHg/day over 7 days
Output Signal Frequency Response
(exclusive of transducer)
25 Hz (-3 dB)
Output Signal Resolution 0.1 mmHg
Power Consumption
Power Consumption
(exclusive of transducer)
<169 mW at 6.5 VDC and <25 mW
at 2.5 VDC
Transducer Compatibility
Transducer Excitation Voltage 2.5 to 6.5 VDC
Transducer Zeroing Range
+⁄- 50 mmHg
Transducer Output Impedance 1000 Ohm (nominal)
Patient Monitor Connection
Input impedance across the
excitation voltage signals
> 200 Ohm
Output Impedance across the sensor
signals
< 3 kOhm
Recommended External Patient Monitor Specifications
The DirectLink ICP Module is compatible with patient monitors that
meet the following specifications:
Transducer excitation voltage range 2.5 to 6.5 VDC
Zero range At least +⁄-50 mmHg
Frequency Response At least 10 Hz
Isolation Type BF or Type CF
Transducer Sensitivity
5 uV/Vex/mmHg
Nominal transducer output
impedance
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 Catalog Number
DirectLink ICP Extension Cable 82-6840
Patient Monitor Interface Cable, Dräger/Siemens
(10 pin)
82-6880
Patient Monitor Interface Cable, Philips (12 pin) 82-6881
Patient Monitor Interface Cable, GE (11 pin) 82-6882
CODMAN MICROSENSOR Basic Kit, sterile 626631, 626631US, 82-6631*
CODMAN MICROSENSOR Plastic Skull Bolt
Kit, sterile
626632, 626632US, 82-6632*
CODMAN MICROSENSOR Ventricular Catheter
Kit with Tuohy-Borst Adapter, sterile
626633, 626633US, 82-6633*
CODMAN MICROSENSOR Metal Skull Bolt
Kit, sterile
626638, 626638US, 82-6638*
CODMAN MICROSENSOR Ventricular Catheter,
sterile
626653, 626653US, 82-6653*
*Product availability may differ by country; please contact your local
Codman Neuro Representative for information.
Troubleshooting
Device
behavior
When the
Behavior
Occurs
Possible cause Recommended Solutions
The self-test
does not
start
Immediately
after connecting
interface cable
to the module
and to the
patient monitor
Damaged interface
cable.
a) Replace the Patient Monitor
Interface Cable. Make sure self-
test completes successfully.
b) If the self-test does not start,
replace the module.
Red status
LED is
illuminated
During self-test Button press during
startup OR faulty 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.
After the
self-test
Patient monitor may
not be compatible with
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.