HDM26.1 FV500 and FV503 Operating Instructions Ver 4 Dec 2011

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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,

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the monitor is used in accordance with the operating instructions, and

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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 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.

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.

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.

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.

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.

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.

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Connect the power cord to the monitor and to a power outlet. The power control lamp indicates mains 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 air-tightness.

Monitoring is started by pushing the button marked I/O. No manual zero adjustment or calibration is required.

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On the digital display the mean ICP is shown in mmHg. Systolic and diastolic ICP are also displayed.

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.

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

Pinout of Monitor Socket

2: RxD 3: TxD 7: Gnd

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.

Data Transmission across the RS 232 C Interface The ICP-Monitor responds to single ASCII bytes: To the monitor

Response

´A´

Mean pressure in ASCII string format, terminated by ´Carriage Return´.

´B´

Mean pressure in binary format, 1/10 mm Hg resolution, two´s complement, two bytes, high byte first.

´C´

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

REF

CPP-Monitor Compliance-Monitor Spiegelberg-Probes

CPP 21.x CMP 27.x SND 13.x.xx SND 32.x.xx

Interconnect Cable for CPP 21.x or CMP 27.x

KBL 21.005.00

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

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

KBL 13.030.00/FV654 KBL 13.031.00/FV653

Computer Cable RS 232 9-pin 150 cm 25 cm

KBL 13.033.00/FV656 KBL 13.033.01

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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Symbols used

Attention

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Alternating current Fuse Equipotential Applied part type BF Mains control lamp

Separate collection

On / Off

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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: [email protected] http://www.spiegelberg.de

Technical alterations reserved.

© by Spiegelberg (GmbH & Co.) KG, 2006

Version: 4 / 2011-12-02

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