ICP-Monitor HDM 29.1.91V2 Operating Instructions V2.0

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Accessories Description

Order number

EG-Konformitätserklärung Declaration of Conformity

CPP-Monitor Compliance-Monitor

CPP 21.x CMP 27.x

Das Produkt

Spiegelberg-Probes

SND 13.x.xx SND 32.x.xx

24.11.2005 AS

ICP-Monitor HDM 29.1 entspricht den grundlegenden Anforderungen gemäß Anhang I der Richtlinie 93/42/EWG. Es ist als Klasse IIa klassifiziert.

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

KBL 21.005.00

Das Qualitätsmanagementsystem entspricht den Forderungen der Norm ISO 13485:2003 gemäß Zertifikat Nr. 18737 der DQS, benannte Stelle Nr. 0297.

Monitor 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

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

Recorder Cables for Recorders with Voltage Input BNC-Plug Banana Plug 4 mm

KBL 13.030.00 KBL 13.031.00

Computer Cable RS 232 9-pin

KBL 13.033.00

The Product ICP-Monitor HDM 29.1 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 13485:2003 according to certificate no. 18737 of DQS, Notified Body No. 0297. Spiegelberg (GmbH & Co.) KG

Dr. A. Spiegelberg

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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).

Contents Safety instructions Indication and Method Monitor Operation Cleaning Connections Faults Technical Specifications Accessories

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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 electric installation of the room is in accordance with the national regulations concerning rooms used for medical purposes,

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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.

Warning The device is not intended for use in areas where there is a danger of explosion. Warning The device may be repaired only by persons or companies that are authorized to do so. Warning The device is not intended for use during ElectroSurgery/Diathermy. Warning 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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Indication and Method

Technical Specifications

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.

REF Measurement range Operating voltage

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.

Fuses

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

Displays

For intraventricular or intraparenchymal pressure measurement the AirPouch 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.

Product lifetime

HDM 29.1 -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 kΩ 5 µV/mmHg/V 9600 Bd (other baud rates upon request) Mean ICP Systolic ICP Diastolic ICP Battery state Power NiMH; 7,2 V; 1,6 Ah 24 months 3h 2-8 h 2 I / BF 3.4 kg IEC 60601-1 IEC 60601-1-2 10 Years

Disposal of product

Contact us

Current requirement

Voltage output Pressure monitor output RS 232 C interface

Battery Battery Lifetime Running time on battery Charging time Accuracy class Safety class Weight In accordance with standards

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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.

Connect the power cord to the monitor and to a power outlet. The power control lamp indicates mains operation and charging of the battery. The battery is charged both in operation and switched off. The battery cannot be overcharged.

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.

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.

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

If the digital display shows ´E2´...´E9´ during operation an internal fault has been detected. Contact the service in this case. Warning The unit cannot be repaired by the user.

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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. Connect probe to the ICP-Monitor. Switch on the ICPMonitor. Wait for the digital display of the mean ICP. The pulsatile signal is displayed now on the monitor screen.

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

The battery state indicator shows the charging state of the battery.

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.

Warning Unplug the power cord prior to cleaning. Warning No fluid should be allowed to enter the probe connector. Warning In case of unintentional wettening of the device, the power cord is to be disconnected immediately.

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 Strip-Chart Recorder To connect a strip-chart recorder with voltage input the appropriate cable is connected with the socket marked Monitor of the ICP-Monitor and the input socket of the recorder. Connection of a Computer The computer is connected to the socket marked RS 232.