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Spiegelberg:
ICP-Monitor
HDM 26.1/FV500
HDM 26.1/FV503
Operating Instructions
Monitoring
Technology for
Brains
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Spiegelberg:
EG-Konformitätserklärung
EC Declaration of Conformity
Die Spiegelberg (GmbH & Co.) KG erklärt als Hersteller in alleiniger Verantwortung,
dass die im folgenden genannten Produkte die Anforderungen der Richtlinie
93/42/EG erfüllen. Das Qualitätsmanagementsystem entspricht den Forderungen
der Norm EN ISO 13485:2003 + AC:2009.
Spiegelberg (GmbH & Co.) confirms as the manufacturer, being solely responsible,
that the following products meet the requirements according to the Medical
Device Directive 93/42/EEC. The Quality Management System is in accordance with
the requirements of the standard EN ISO 13485:2003 + AC:2009.
Produkt: ICP-Monitor
Product:
REF: HDM 26.1/FV500
HDM 26.1/FV503
Gültig ab: SN: 985/10
Angewandte produktspezifische Normen: DIN EN 60601-1:1996
Applied product-specific standards:
Klassifizierung gem. 93/42/EG IIa
Classification acc. 93/42/EC
Zertifikate: 018737 MP29, 018737 MR2
Certificates:
Gültig bis: 2015-10-24
Valid until:
Benannte Stelle: DQS GmbH
Notified Body: August-Schanz-Strasse 21
60433 Frankfurt am Main
Germany
Benannte Stelle Nr.: 0297
Notified Body No.:
Dr. Andreas Spiegelberg
Geschäftsführer
Hamburg, 24.11.2010
Spiegelberg Persönlich haftende
(GmbH & Co.) KG Gesellschafterin:
Tempowerkring 4 Spiegelberg
21079 Hamburg Medizintechnik GmbH
Germany Hamburg
Geschäftsführer:
Dr. A. Spiegelberg
Registergericht Registergericht
Hamburg HRB 81393 Hamburg HRB 46157
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Contents
Safety instructions
Indication and Method
Monitor Operation
Cleaning
Connections
Faults
Technical Specifications
Approved Accessories
Symbols used
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Safety Instructions
The ICP-Monitor and the accompanying probes are designed for the
measurement of intracranial
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 monitor is used in
accordance with the operating
instructions, and
- the monitor is used with the
approved accessories.
Attention
The device is not intended for use in
areas where there is a danger of
explosion.
Attention
The device may be repaired only by
persons or companies that are
authorized to do so.
Attention
The device is not intended for use
during Electro-Surgery/Diathermy.
Attention
Grounding reliability can only be
achieved if the device is connected
to an equivalent power cord marked
„hospital grade“ or „hospital only“.
Attention
It must be ensured that the
classification of all connected
devices is suitible to the application
with regards to safety against
electric shock. The fact that leakage
currents are amplified if more than
one devices are connected to a
patient must be taken into account.
Attention
It is the sole responsibility of the user
to check that the electric installation
is in compliance with the local and
hospital-specific safety regulations
and that the system is in compliance
with the standard DIN EN 60601-1-1
„General standards, safety
regulations for electro-medical
devices“.
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Indication and Method
The ICP-Monitor and the probes are
intended for the monitoring of
intracranial pressure in the ventricle,
in the parenchyma, subdurally, or
epidurally.
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 ICP-Monitor.
For intraventricular or
intraparenchymal pressure
measurement the Air-Pouch is
placed in the ventricle or in the
parenchyma respectively. For
epidural or subdural pressure
measurements the Air-Pouch is
placed on the dura or under the
dura of the patient.
The intracranial 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 ICP
and the systolic and diastolic ICP are
shown. At the monitor output both
the mean pressure and the pulsatile
signal are available.
Once every hour the ICP-Monitor
opens the pressure transducer to
atmospheric pressure for zero
adjustment. The Air-Pouch is
then filled with the exact air
volume.
Monitor Operation
Make sure the correct mains
voltage is selected.
If selection of the voltage needs to
be changed, it can be selected after
opening of the cover of the selector
next to the power cord socket.
After changing the voltage, the
fuses need to be changed according
to the plate.
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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 air-tightness.
Monitoring is started by pushing the
button marked I/O. No manual zero
adjustment or calibration is
required.
Connect the power cord to the
monitor and to a power outlet. The
power control lamp indicates mains
operation.
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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 ICP
is shown in mmHg. Systolic and
diastolic ICP are also displayed.
Attention
Unplug the power cord
prior to cleaning.
Attention
No fluid should be
allowed to enter the
probe connector.
Attention
In case of unintentional
wettening of the device,
the power cord is to be
disconnected
immediately.
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Connections
Connection of a Patient
Monitor
To connect a patient monitor the
connecting cable is inserted into the
socket of the ICP-Monitor marked
Monitor and connected to the
pressure transducer input of the
patient monitor.
Zero Adjustment of the
Patient Monitor
Push the button marked Zero. A
blinking „0.0“ ist displayed. Zero
patient monitor using the zero
button whilst the blinking „0.0“ is
displayed.
Connection of a CPP-Monitor
Connect the socket marked RS 232
of the ICP-Monitor to the RS 232
ICP socket of the CPP-Monitor.
Connection of a Device with
Voltage Input
To connect a device with voltage
input, the appropriate cable is
connected with the socket marked
„Monitor“ of the ICP-Monitor and
the input socket of the device.
Connection of a Computer
The computer is connected to the
socket marked RS 232.
Attention
The ICP-Monitor must only be used
with monitors and devices, that are
CE-marked and approved as an
electro-medical device.
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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
disappears. 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.
If the digital display shows
´E2´....´E9´ during operation an
internal fault has been detected.
Contact the service in this case.
Attention
The unit cannot be
repaired by the user.
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Technical Specifications
REF
Measurement range
Operating voltage
Current requirement
Fuses
Voltage output
Pressure monitor output
RS 232 C interface
Displays
Classifications
Weight
In accordance with standards
Product lifetime
Maintenance
Conditions for storage
Conditions for operation
Disposal of product
HDM 26.1/FV500
HDM 26.1/FV503
-50 to +100 mmHg
230 V~, 50/60 Hz
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 kW
5 µV/mmHg/V
9600 Bd
Mean ICP
Systolic ICP
Diastolic ICP
Power
Accuracy class 2
Safety class I / BF, permanent operation
IP 20 acc. IEC 529
Not AP, not APG
Not for use during Electro-Surgery/
Diathermy.
General Medical Equipment
3kg
IEC 60601-1
IEC 60601-1-2
IEC 60601-1-34
10 Years
None
-10°C - 70°C, 10% - 90% rel. hum.
0°C - 35°C, 10% - 90% rel. hum.
Contact us
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Pinout of RS 232 Socket
2: RxD
3: TxD
7: Gnd
Data Transmission across
the RS 232 C Interface
The ICP-Monitor responds to single
ASCII bytes:
To the monitor
´A´
´B´
´C´
Pinout of Monitor Socket
1: Uref Input
5: Analog Output
6: Uref Output (2,5 V)
9: Analog Gnd.
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.
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).
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Approved Accessories
Description
CPP-Monitor
Compliance-Monitor
Spiegelberg-Probes
Interconnect Cable for
CPP 21.x or CMP 27.x
Monitor Cables
B.Braun/Lohmeier
Criticare
Datex-Cardiocap
Datascope
Digicare
Dixtal
Hellige 5. Generation
Hewlett-Packard/Philips
Marquette
Mindray
Nihon-Kohden BMS 2301
Nihon-Kohden Lifescope
Ohmeda
Propaque/Mennen
Siemens/Dräger 10 pins
Siemens/Dräger 16 pins
Siemens/Dräger 7 pins
Space-Labs
REF
CPP 21.x
CMP 27.x
SND 13.x.xx
SND 32.x.xx
KBL 21.005.00
KBL 13.027.01
KBL 13.037.01
KBL 13.007.00/FV608
KBL 13.026.01
KBL 13.039.01
KBL 13.042.01
KBL 13.003.00/FV609
KBL 13.004.00/FV610
KBL 13.005.00/FV612
KBL 13.038.01
KBL 13.029.01
KBL 13.035.01
KBL 13.022.00/FV616
KBL 13.009.00/FV617
KBL 13.002.00/FV620
KBL 13.024.01
KBL 13.028.01
KBL 13.006.00/FV622
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Cables for Devices
with Voltage Input
BNC-Plug
Banana Plug 4 mm
Computer Cable RS 232 9-pin
150 cm
25 cm
Attention
The ICP-Monitor must only be used
with monitors and devices, that are
CE-marked and approved as an
electro-medical device.
KBL 13.030.00/FV654
KBL 13.031.00/FV653
KBL 13.033.00/FV656
KBL 13.033.01
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Attention
Alternating current
Fuse
Equipotential
Applied part type BF
Mains control lamp
Separate collection
On / Off
Symbols used
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Spiegelberg
(GmbH & Co.) KG
Tempowerkring 4
21079 Hamburg
Germany
Phone: +49-40-790-178-0
Fax: +49-40-790-178-10
Email: info@spiegelberg.de
http://www.spiegelberg.de
Version: 4 / 2011-12-02© by Spiegelberg (GmbH & Co.) KG, 2006
0297
Technical alterations reserved.
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