HP IAP 32.1, IAP-Monitor User Manual

Manufacturer
SpiegelbergSpiegelberg
Spiegelberg
SpiegelbergSpiegelberg (GmbH & Co.) KG(GmbH & Co.) KG
(GmbH & Co.) KG(GmbH & Co.) KG TT
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T
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TT
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21079 Hamburg21079 Hamburg
21079 Hamburg
21079 Hamburg21079 Hamburg GermanyGermany
Germany
GermanyGermany
Spiegelberg:
IAP-Monitor IAP 32.1
Phone:Phone:
Phone:
Phone:Phone: Fax:Fax:
Fax:
Fax:Fax: Email:Email:
Email:
Email:Email: http://wwwhttp://www
http://www
http://wwwhttp://www
0297
CE-marking according to directive 93/42/EEC
Technical alterations reserved.
+49-40-790-178-0+49-40-790-178-0
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Operating-Instructions
BEDIAP32.1.91 V 2.0 © by Spiegelberg (GmbH & Co.) KG, 2003
Innovative Measurement Technology for Medicine
9 2
Pinout of DB 9 Socket
1: Uref Input 2: RxD 3: TxD 4: 5: Analog Output
For use as a voltage output pins 1 and 6 are connected by a jumper.
For use as a monitor output the excitation voltage is fed into the reference input and the analog output is scaled down by a resistive divider.
Data Transmission across the RS 232 C Interface
The IAP-Monitor responds to single ASCII bytes:
To the monitor
´A´
´B´
´C´
6: Uref Output (2,5 V) 7: Digital Gnd 8: 9: Analog Gnd.
Response
Mean pressure in ASCII string format, terminated by ´Carriage Return´.
Mean pressure in binary format, 1/10 mm Hg resolution, two´s complement, two bytes, high byte first.
Instantaneous pressure in binary format, 1/10 mm Hg resolution, two´s complement, two bytes, high byte first. Response only after new value is read in (every 10 ms).
Contents
Safety instructions Indication and Method Monitor Operation Cleaning Connections Faults Technical Specifications Accessories
Safety Instructions
The IAP-Monitor and the accom­panying catheters are designed for the measurement of intraabdominal pressure. The manufacturer accepts responsibility for the safety, reliability and performance of the monitor only if:
- the installation, extensions, readjustments, modifications and repairs are performed by authorized personnel,
- the electric installation of the room is in accordance with the national regulations concerning rooms used for medical purposes,
- the monitor is used in accordance with the operating instructions, and
- the monitor is used with the approved accessories.
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2 3 4 5 6 7 8
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The device is not intended for use in areas where there is a danger of explosion.
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The device may be repaired only by persons or companies that are authorized to do so.
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The device is not intended for use during Electro­Surgery/Diathermy.
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Grounding reliability can only be achieved if the device is connected to an equivalent power cord marked „hospital grade“ or „hospital only“.
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Faults
The air-tightness of the air-pouch system is checked regularly. If a leak is detected, the red warning indicator shows alarm. When the leak is removed the red warning indicator disappears and the measurement is continued. If the leak has not been removed after one minute, in addition to the alarm display a chirp sound is emitted. To reset the alarm the monitor must be switched off and on again. The chirp sound stops after one minute, unless the monitor has been switched off before, and the digital display dissapears. The warning indicator continues to flash.
If a pressure limit is exceeded during probe filling the filling process is interrupted, the digital display shows ´E1´ and the chirp sound is emitted. This can happen if the air­pouch resists unfolding or if the tube is clamped. Switching off and on the monitor resets the system.
Monitor operation
After placement of probe the tube connector is inserted into the monitor socket and fastened by a slight clockwise turn. The soft material of the connector guarantees airtightness.
Pressure measurements are started by switching on the monitor. No manual zero adjustment or calibration is required.
If the digital display shows ´E2´ or ´E3´ during operation an internal fault has been detected. Contact the service in this case.
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The unit cannot be repaired by the user.
5 6
Connections
Cleaning
After removal of the power cord the unit can be wiped off with a damp rag using a common disinfectant. No liquid whatsoever must be introduced into the catheter or into the connector of the monitor.
On the digital display the mean pressure is shown in mmHg.
During the first ten minutes after switching on the pulse amplitude (i.e. systolic pressure minus diastolic pressure) is additionally displayed marked by an ´A´.
During this time the mean pressure is displayed for three seconds, then the amplitude is displayed for one second.
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Unplug the power cord prior to cleaning.
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No fluid should be allowed to enter the probe connector.
Connection of a PatientConnection of a Patient
Connection of a Patient
Connection of a PatientConnection of a Patient MonitorMonitor
Monitor
MonitorMonitor
To connect a patient monitor the connecting cable is inserted into the socket of the IAP-Monitor and connected to the pressure transducer input of the patient monitor. Connect probe to the IAP­Monitor. Switch on the Brain­Pressure Monitor. Wait for the digital display of the mean ICP. The pulsatile signal is displayed now on the monitor screen.
Zero Adjustment of theZero Adjustment of the
Zero Adjustment of the
Zero Adjustment of theZero Adjustment of the Patient MonitorPatient Monitor
Patient Monitor
Patient MonitorPatient Monitor
Disconnect the catheter from the IAP-Monitor. Leave the IAP-Monitor and the patient monitor switched on. Zero patient monitor using the zero button. Reconnect the probe. Switch off the IAP-Monitor. Switch it on again. Observe the display of the mean ICP on the IAP-Monitor and the pulsatile signal on the patient monitor.
Connection of a Strip-ChartConnection of a Strip-Chart
Connection of a Strip-Chart
Connection of a Strip-ChartConnection of a Strip-Chart RecorderRecorder
Recorder
RecorderRecorder
To connect a strip-chart recorder with voltage input the appropriate cable is connected with the socket at the rear panel of the monitor and the input socket of the recorder.
Connection of a ComputerConnection of a Computer
Connection of a Computer
Connection of a ComputerConnection of a Computer
The RS 232 C interface permits communication with any computer.
Connection of a Connection of a
Connection of a CPP-Monitor
Connection of a Connection of a
Connect the IAP-Monitor to the RS 232 IAP socket of the CPP-Monitor.
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In case of unintentional wettening of the device, the power cord is to be disconnected immediately.
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Indication and Method
The IAP-Monitor and the catheters are intended for the monitoring of intraabdominal pressure in the stomach.
The air-pouch system consists of a hollow body connected to a pressure transducer by tubing. The pressure transducer, the electronic hardware, and the device for filling the air-pouch are integrated in the IAP-Monitor.
For intraabdominal pressure measurements the air- pouch is placed in the stomach of the patient. The intraabdominal pressure is transmitted across the thin pouch wall to the air volume in the pouch and transformed into an electric signal by the pressure transducer.
On the digital display the mean pressure is shown. At the monitor output both the mean pressure and the pulsatile signal are available.
Technical specifications
REFREF
REF
REFREF
Measurement rangeMeasurement range
Measurement range
Measurement rangeMeasurement range
Operating voltageOperating voltage
Operating voltage
Operating voltageOperating voltage
Current requirementCurrent requirement
Current requirement
Current requirementCurrent requirement
FusesFuses
Fuses
FusesFuses
VV
oltage outputoltage output
V
oltage output
VV
oltage outputoltage output
Pressure monitor outputPressure monitor output
Pressure monitor output
Pressure monitor outputPressure monitor output
RS 232 C interfaceRS 232 C interface
RS 232 C interface
RS 232 C interfaceRS 232 C interface
Accuracy classAccuracy class
Accuracy class
Accuracy classAccuracy class
Safety classSafety class
Safety class
Safety classSafety class
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IAP 32.1
-50 to +100 mmHg
230 V~, 50/60 Hz or 115 V~, 50/60 Hz
0,1 A at 230 V~ 0,2 A at115 V~
125 mA T at 230 V~ 250 mA T at 115 V~
1V/50 mmHg at 1 k
5 µV/mmHg/V
9600 Bd (other baud rates upon request)
2
I / BF
3 kg
Once every hour the IAP-Monitor opens the pressure transducer to atmospheric pressure for zero adjustment. The air-pouch is then filled with the exact air volume required for accurate pressure transmission.
In accordance with standardsIn accordance with standards
In accordance with standards
In accordance with standardsIn accordance with standards
IEC 60601-1 IEC 60601-1-2
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Accessories
1.9.2003 AS/az
EG-Konformitätserklärung Declaration of Conformity
Das Produkt
IAP-Monitor HDM IAP 32.1
entspricht den grundlegenden Anforderungen gemäß Anhang I der Richtlinie 93/42/EWG. Es ist als Klasse IIa klas­sifiziert.
Das Qualitätsmanagementsystem entspricht den Forderungen der Norm ISO 13485:2001 gemäß Zertifikat Nr. 18737 der DQS, benannte Stelle Nr. 0297.
The Product
IAP-Monitor IAP 32.1
is in accordance with the requirements of Annex I of the Manual Devices Directive 93/42/EEC. It is classified as class IIa.
The Quality Management System is in accordance with the requirements of the standard ISO 13485:2001 according to certificate no. 18737 of DQS, Notified Body No. 0297.
Spiegelberg (GmbH & Co.) KG
DescriptionDescription
Description
DescriptionDescription
CPP-MonitorCPP-Monitor
CPP-Monitor
CPP-MonitorCPP-Monitor
IAP-CatheterIAP-Catheter
IAP-Catheter
IAP-CatheterIAP-Catheter
Interconnect Cable forInterconnect Cable for
Interconnect Cable for
Interconnect Cable forInterconnect Cable for Spiegelberg CPP-Monitor 21.xSpiegelberg CPP-Monitor 21.x
Spiegelberg CPP-Monitor 21.x
Spiegelberg CPP-Monitor 21.xSpiegelberg CPP-Monitor 21.x
Monitor CablesMonitor Cables
Monitor Cables
Monitor CablesMonitor Cables
Bruker VM800/900 Corometrix Datex-Cardiocap Dräger VM 300 Hellige 4. Generation up Hellige 3. Generation Hewlett-Packard Horizon Kontron Marquette Marquette 7010 Nihon-Kohden Nihon-Kohden BMS 8300 Philips CM130 Propaque/Mennen Schiller CM-8 Siemens-Sirecust Space-Labs S&W, Danica
Order numberOrder number
Order number
Order numberOrder number
CPP 21.x
IAP 32.1.11
KBL 21.005.00
KBL 13.014.00 KBL 13.020.00 KBL 13.007.00 KBL 13.001.00 KBL 13.003.00 KBL 13.019.00 KBL 13.004.00 KBL 13.015.00 KBL 13.018.00 KBL 13.005.00 KBL 13.005.01 KBL 13.008.00 KBL 13.008.01 KBL 13.011.00 KBL 13.009.00 KBL 13.010.00 KBL 13.002.00 KBL 13.006.00 KBL 13.013.00
Dr. A. Spiegelberg
Recorder Cables for RecordersRecorder Cables for Recorders
Recorder Cables for Recorders
Recorder Cables for RecordersRecorder Cables for Recorders with Vwith V
with V
with Vwith V
oltage Inputoltage Input
oltage Input
oltage Inputoltage Input
BNC-Plug Banana Plug 4 mm
Computer Cable RS 232 9-pinComputer Cable RS 232 9-pin
Computer Cable RS 232 9-pin
Computer Cable RS 232 9-pinComputer Cable RS 232 9-pin
KBL 13.030.00 KBL 13.031.00
KBL 13.033.00
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