Manufacturer
SpiegelbergSpiegelberg
Spiegelberg
SpiegelbergSpiegelberg
(GmbH & Co.) KG(GmbH & Co.) KG
(GmbH & Co.) KG
(GmbH & Co.) KG(GmbH & Co.) KG
TT
empowerkring 4empowerkring 4
T
empowerkring 4
TT
empowerkring 4empowerkring 4
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
+49-40-790-178-0
+49-40-790-178-0+49-40-790-178-0
+49-40-790-178-10+49-40-790-178-10
+49-40-790-178-10
+49-40-790-178-10+49-40-790-178-10
info@spiegelberg.deinfo@spiegelberg.de
info@spiegelberg.de
info@spiegelberg.deinfo@spiegelberg.de
.spiegelberg.de.spiegelberg.de
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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.
10
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“.
7 4
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.
3 8
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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eighteight
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 kΩ
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
1 10
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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