Spiegelberg HDM29.2 Manuel utilisateur

ICP Monitor

HDM29.2

Instructions for Use

Contents

Symbols used ............................................................................................... 3

General information ...................................................................................... 3

Warranty provisions ...................................................................................................3

Technical data ...........................................................................................................4

Original package contents .........................................................................................4

Tested accessories....................................................................................................4

User group and environment......................................................................................5

Indication and intended use .......................................................................... 5

Contraindication ............................................................................................ 6

Safety notes and warnings............................................................................ 6

Application and handling............................................................................... 9

Setting up the ICP monitor.........................................................................................9

Connecting the probe.................................................................................................9

Switch on the ICP monitor .........................................................................................9

Reading the ICP values ...........................................................................................10

Connecting to a patient monitor ...............................................................................10

Connecting to a computer........................................................................................10

Operation with battery mode....................................................................................11

Resumption of measurement after interruption ........................................................11

Ending the measurement.........................................................................................11

Cleaning ...................................................................................................... 11

Maintenance ............................................................................................... 11

Disposal ...................................................................................................... 12

Faults and errors ......................................................................................... 12

Symbols used

Refer to instructions for use

ON/OFF (press resp.)

Consult instructions for use Zero adjustment

Caution Power supply control lamp

Manufacturer Battery status indicator

Serial number

Equipotentiality

Catalogue number

Type BF applied part

Date of manufacture

NRTL approval mark for USA (US

testing company SGS)

Keep dry

Separate collection for WEEE (Waste

electrical and electronic equipment)

Keep away from sunlight

0297

Product complies with the

requirements of European Directive

93/42/EEC

Rx Only

Caution: Federal (USA) law restricts

this device to sale by or on the order of

a physician. Information note

General information

The instructions for use must be read carefully before use. The product may only be used according to

the described intended use. The manufacturer shall not assume liability or warranty for damage due to

inappropriate use or noncompliance with the instructions for use.

The product is to be transported and stored dry. The product is to be protected from sunlight. The

following conditions are to be maintained in order not to affect the product properties:

Transport conditions: -10 – 65°C, 10 – 90 % rel. hum.

Storage conditions: -10 – 35°C, 10 – 90 % rel. hum.

Ambient conditions in use: 10 – 35°C, 10 – 90 % rel. hum., 80 – 110 kPa

Warranty provisions

The warranty provisions laid down in Section 8 of the currently valid Terms and Conditions apply.

Technical data

The values given reflect nominal values and may, if applicable, deviate.

REF / Order number

HDM29.2

Software version

HDM 601D dated 04/10/2018

Measurement range

0 to +100 mmHg

Accuracy

+/- 2 mmHg

Operating voltage

115 to 230 V, ~ 50/60 Hz

Max. power consumption

40 VA

Weight

Approx. 1.5 kg

Monitor output

5 µV/mmHg/V

RS 232 C interface

9600 Bd, 8N1

Displays

Mean ICP [mmHg]

Systolic ICP [mmHg]

Diastolic ICP [mmHg]

Battery status indicator

Power supply indicator

Rechargeable battery

NiMH; 8.4 V; 1.6 Ah

Rechargeable battery life

24 months

Operating time battery

mode

Up to 6 hours

Charging time

2 – 8 hours

Classification

Class IIa (93/42/EEC)

Class I (IEC 60601-1)

Type BF applied part, permanent

operation

Not AP, not APG

IPX0

Maintenance of

rechargeable battery

Replace after 24 months

In accordance with

standards

IEC 60601-1

IEC 60601-1-2

Original package contents

ICP monitor HDM29.2

Mains cable

Monitor cable (optional)

Tested accessories

Spiegelberg probes and catheters

ICP probes

SND13.x.xx

IAP catheters

SND32.x.xx

Spare parts

Monitor cables

B.Braun/Lohmeier

KBL13.027.01

Criticare

KBL13.037.01

Datex-Cardiocap

KBL13.007.00/FV608

Datascope

KBL13.026.01

Digicare

KBL13.039.01

Dixtal

KBL13.042.01

Hellige 4th/5th generation

KBL13.003.00/FV609

Hewlett-Packard/Philips

KBL13.004.00/FV610

Marquette

KBL13.005.00/FV612

Mindray

KBL13.038.01

Nihon-Kohden 5-pin

KBL13.029.01

Propaque/Mennen

KBL13.009.00/FV617

Siemens/Dräger, 10-pin

KBL13.002.00/FV620

Siemens/Dräger, 16-pin

KBL13.024.01

Siemens/Dräger, 7-pin

KBL13.028.01

Space-Labs

KBL13.006.00/FV622

Nihon-Koden

KBL13.008.01/FV615

Computer cables RS 232, 9-pin

150 cm

KBL13.033.00/FV656

25 cm

KBL13.033.01

User group and environment

The ICP monitor should only be used by persons with a completed medical qualification as well as

having experience with neurological traumas (intensive care nurse).

The ICP monitor is intended exclusively for use in professional healthcare facility enviroment.

As the ICP-Monitor contains conductive components, it may not be used within or near an

electromagnetic field (e.g. MRT). Further information is provided in the accompanying brochure

Medical Electrical Devices according to IEC 60601-1-2.

Indication and intended use

The ICP monitor and the corresponding ICP probes are designed for the monitoring of intracranial

pressure (ICP) in the ventricle, in the parenchyma, subdurally, and epidurally. ICP monitoring is

indicated for craniocerebral trauma, diffuse and general hypoxia, subarachnoid haemorrhage,

pseudotumor cerebri, normal pressure hydrocephalus, postoperative swelling of the brain.

In addition, the ICP monitor can be used in combination with the Spiegelberg IAP catheter to monitor

intraabdominal pressure (IAP).

The air-pouch system consists of a plastic 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 Spiegelberg ICP monitor. For epidural or subdural pressure measurement, the air pouch is placed

on or below the dura of the patient for intracerebral measurement in the ventricle or in the parenchyma.

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 digital display then shows the mean as well as the systolic and diastolic intracranial pressure (ICP).

The ICP monitor output provides both the mean pressure as well as the pulsatile signal.

After 10 minutes and once hourly thereafter, the ICP monitor opens the pressure transducer to

atmospheric pressure for zero adjustment.

Contraindication

The ICP monitor may not be used for purposes other than those indicated. The contraindications to

ICP monitoring result from the contraindications of the ICP probes to be used, which include the

following points, among others: infections of the scalp, in patients receiving anticoagulant therapy,

bleeding tendency and when continuous monitoring by trained personnel cannot be guaranteed.

Safety notes and warnings

Handling of the ICP monitor is to be performed with care and caution.

The ICP monitor may only be used with approved accessories.

The ICP monitor may only be serviced and repaired by qualified personnel.

Before each use, check the ICP monitor for external damage that could affect the components

(e.g. heavily deformed housing).

A reliable contact with the protective earth is only guaranteed if the supplied power cable is used.

After heavy mechanical stress on the ICP monitor (e.g. due to dropping), the ICP monitor must

be sent to the manufacturer for inspection.

To avoid the risk of electric shock, the ICP monitor must only be connected to a power supply

system with a protective earth.

If fluid enters the ICP monitor unintentionally, the mains cable must be disconnected

immediately.

In order to prevent moisture due to condensation, the ICP monitor must be stored at room

temperature prior to use for some time.

The ICP monitor is not suitable for use in areas where there is a danger of explosions or in an

MR room or a magnetic field.

The ICP monitor is not intended for use in electrosurgery/diathermy.

After prolonged non-use of the ICP monitor, the entire battery capacity is no longer available.

The rechargeable battery should be replaced at least every two years.

It must be ensured that the classification of all devices connected to the ICP monitor is suitable

to the application with regard to protection from electric shock.

Avoid using the ICP monitor directly next to or with other stacked devices, as this could result in

an incorrect operation mode. If use in the prescribed manner is nonetheless necessary, the ICP

monitor and the other devices should be observed to ensure that they are working properly.

All configurations must comply with the IEC 60601-1-1 system standard. The person connecting

the devices is responsible for the configuration and must ensure that the system standard

IEC 60601-1-1 or corresponding national standards are complied with.

The use of accessories, transducers and leads other than those specified or provided by the

manufacturer of the ICP monitor may result in increased electromagnetic interference emissions

or reduced electromagnetic immunity of the device and result in faulty operation.

Portable HF communication devices (radio equipment) (including their accessories such as

antenna cables and external antennas) should not be used at a distance of less than 30 cm (or

12 inches) from the parts and cables of the ICP monitor designated by the manufacturer. Non-

observance can lead to a reduction in the performance characteristics of the ICP monitor.

Routinely check electrical plugs and cables. Do not use if they are damaged.

Do not immerse the cables in liquids and do not bring the electrical connection into contact with

liquids.

Do not sterilize the cable in an autoclave.

HDM29.2 - Front panel

HDM29.2 - Rear panel

Application and handling

In the following, the application parts are referred to as "probes". This term includes both the ICP probes

and the IAP catheter. The individual steps apply equally to both product groups.

Setting up the ICP monitor

The ICP monitor must be placed on a level surface in order to be used for its intended purpose. The

display panel must be freely accessible to the user.

The distance to the patient must be selected so that the connected probe is not tensioned or pulled

out.

1. Connect the ICP monitor to a power source using the supplied mains cable.

2. Check whether the ICP monitor is correctly connected to the mains (mains control lamp (7) lights

up).

3. If necessary, connect the equipotential bonding connector (10) with an equipotential bonding box.

NOTE! If the ICP monitor is used in battery mode, make sure that the rechargeable battery

is fully charged before use.

Connecting the probe

WARNING! Before connecting the probe, neither the connector on the probe nor the

probe connection (1) must be disinfected, as fluid could otherwise enter the probe

connection (1). This could lead to damage of the ICP monitor.

NOTE! The ICP monitor must be switched off before connecting the probe.

1. Insert the probe into the patient according to the manufacturer's instructions.

2. Connect the probe connector to the probe connection (1) of the ICP monitor.

3. Turn the connector clockwise until the probe is firmly connected to the ICP monitor.

NOTE! The probe must be firmly connected to the ICP monitor to prevent leakage and the

resulting deviations in measurement values.

Switch on the ICP monitor

NOTE! A segment test is performed after switching on the ICP monitor. All segments of

the display (3, 4, 5, 8) including the red arrow at the probe connection (1) light up. Only

then, is appropriate use possible.

1. Press the On/Off button (6) to switch on the ICP monitor.

2. Check whether all segments in the display (3-8) light up during the segment test.

3. Wait until the filling process of the probe is completed and the median ICP is shown in the display

(3). This can take up to 30 s.

WARNING! Do not press the On/Off button (6) and the "Zero" button (2) simultaneously.

This leads to problems during initialisation, which causes incorrect initial values to be

displayed.

NOTE! No manual zeroing or calibration is required after switching on the ICP monitor.

NOTE! If there is a fault at the probe connection (1) or the pneumatic unit, a red arrow on

the probe connection (1) lights up.

WARNING! When operating on mains power, check that the mains control lamp (7) is on.

Otherwise, the ICP monitor runs in battery mode and discharges.

Reading the ICP values

The median ICP in mmHg (3) is shown in large digits on the display of the ICP monitor. The systolic

(5) and diastolic (4) ICP can be read in mmHg to the right.

NOTE! The display values of the systolic (5) and diastolic ICP (4) must be used to confirm

the median ICP (3).

NOTE! If the amplitude between the systolic (5) and diastolic ICP (4) is very low or non-

existent, this indicates an error. In this case, check the probe for kinks, constriction,

pinching or a faulty connection to the ICP monitor and check whether the ICP monitor is

switched on.

NOTE! An unstable signal path indicates a leakage in the pneumatic system. In this case,

shut down the ICP monitor and contact the manufacturer.

Connecting to a patient monitor

NOTE! Only cables authorized by Spiegelberg may be used for connecting the ICP

monitor.

1. Connect the monitor cable to the rear connector "Monitor" (11) and the ABP input of the patient

monitor.

2. Switch on the patient monitor and the ICP monitor (if not already done).

3. Press the "Zero" button (2) on the ICP monitor. The message "0.0" flashes on the display (3).

4. Zeroing of the patient monitor within 10 s according to the manufacturer's specifications.

5. Compare the median ICP on the ICP monitor (3) with the display on the patient monitor.

NOTE! The ICP monitor must always be switched on when in use with a patient monitor.

If the patient monitor is connected to an ICP monitor which is switched off, the patient

monitor may display a pressure signal without amplitude. This does not reflect the actual

measured value.

NOTE! During initialisation of the ICP monitor (zeroing the probe), a display of up to 100

mmHg may appear on the patient monitor. This does not reflect the actual measured

value.

NOTE! The screw connections of the monitor cables must be tightened firmly to prevent

disconnection when moving the ICP monitor.

Connecting to a computer

NOTE! Only cables authorized by Spiegelberg may be used for connecting the ICP

monitor.

Connect the computer cable to the "RS 232" (12) connector on the back of the ICP monitor and the RS

232 connector of the computer.

NOTE! The screw connections of the computer cables must be tightened firmly to prevent

disconnection when moving the ICP monitor.

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