Brain Pressure Monitor HDM 13.3 Operating Instructions Ver 1.4E

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Contents

Pinout of DB 9 Socket 1: Uref Input 2: RxD 3: TxD 4: 5: Analog Output

6: Uref Output (2,5 V) 7: Digital Gnd 8: 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.

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 catheters are designed for the measurement of intracranial pressure. The manufacturer accepts responsibility for the safety, reliability and performance of the monitor only if:

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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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.

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Faults

Monitor operation

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.

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.

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.

Pressure measurements are started by switching on the monitor. 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 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.

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.

Connection of a Patient Monitor To connect a patient monitor the connecting cable is inserted into the socket of the ICP-Monitor and connected to the pressure transducer input of the patient monitor. Connect probe to the ICPMonitor. Switch on the BrainPressure Monitor. Wait for the digital display of the mean ICP. The pulsatile signal is displayed now on the monitor screen.

Connection of a Strip-Chart Recorder 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 Computer The RS 232 C interface permits communication with any computer.

Zero Adjustment of the Patient Monitor Disconnect the catheter from the ICP-Monitor. Leave the ICP-Monitor and the patient monitor switched on. Zero patient monitor using the zero button. Reconnect the probe. Switch off the ICP-Monitor. Switch it on again. Observe the display of the mean ICP on the ICP-Monitor and the pulsatile signal on the patient monitor. Connection of a CPP-Monitor Connect the ICP-Monitor to the RS 232 ICP socket of the CPP-Monitor.

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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, in the subdural space, or in the epidural space.

REF

HDM 13.3

Measurement range

-50 to +100 mmHg

Operating voltage

230 V~, 50/60 Hz or 115 V~, 50/60 Hz

Current requirement

0,1 A at 230 V~ 0,2 A at115 V~

Fuses

125 mA T at 230 V~ 250 mA T at 115 V~

For intracranial pressure measurements the air-pouch is placed in the head 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.

Voltage output

1V/50 mmHg at 1 kΩ

Pressure monitor output

5 µV/mmHg/V

RS 232 C interface

9600 Bd (other baud rates upon request)

Accuracy class

2

On the digital display the mean pressure is shown. At the monitor output both the mean pressure and the pulsatile signal are available.

Safety class

I / BF

Weight

3 kg

In accordance with standards

IEC 60601-1 IEC 60601-1-2

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.

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 required for accurate pressure transmission.

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Accessories 1.9.2003 AS/az

EG-Konformitätserklärung Declaration of Conformity Das Produkt Hirndruck-Meßgerät HDM 13.3 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 Brain-Pressure Monitor HDM 13.3 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

Dr. A. Spiegelberg

Description

Order number

CPP-Monitor

CPP 21.x

Spiegelberg-Probes and Catheters

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

Interconnect Cable for Spiegelberg CPP-Monitor 21.x

KBL 21.005.00

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 V oltage Input Voltage BNC-Plug Banana Plug 4 mm

KBL 13.030.00 KBL 13.031.00

Computer Cable RS 232 9-pin

KBL 13.033.00