CPP-Monitor CPP 21.1 Operating Instructions V2

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Safety instructions The CPP-Monitor and accessories are designed for the measurement and recording of the intracranial pressure, the arterial blood pressure, and the cerebral perfusion pressure. The manufacturer is only responsible for the safety, reliability, and performance of the unit, if: -

assembly, expansions, adjustments, modifications, and repairs are performed by personnel authorized by the manufacturer,

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the electrical installation of the operating room complies with the national regulations for rooms used for medical purposes,

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the unit is used in compliance with the operating instructions, and,

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the unit is used with approved accessories.

Danger Explosion Hazard. Do not use in the presence of flammable anaesthetics. Caution Shock Hazard. Do not remove cover. Service by qualified personnel only.

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Contents Introduction

3

Getting started Connections

4 5

Connecting Pressure Transducers Connecting the Spiegelberg: Brain-Pressure Monitor Connecting other Units

6 7 7

Outputs:

Connecting Patient Monitors Connecting other Output Units

8 9

Alarms:

Setting the Alarms Acknowledging the Alarms

10 11

Chart recorder:

Loading and and Unloading Paper 12 Starting and Stopping the Chart Recorder 13 Recording Mean Pressure or Current Pressure 13 What Information is seen on the Strip Chart? 14 Event Recording 15

Memory:

Storing and Replaying The Memory Card

16 17

Clock:

Setting the Date and Time

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Appendix:

Error Messages Cleaning Replacing the Fuses Operation Summary Technical Information Intervals and Scope of the Technical Safety Inspections Approved Accessories

19 19 19 20 21

Inputs:

24 25

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Introduction The Spiegelberg: CPP-Monitor measures intracranial pressure (ICP) and blood pressure (ABP), calculates the mean values, and represents them on a digital display. The cerebral perfusion pressure (CPP) is calculated and also represented on the digital display. Mean or current values of the pressures can be output on the built-in chart recorder. Alarms can be triggered via adjustable thresholds. Furthermore, event recording with automatic start and stop of the chart recorder is possible. The chart recorder works with thermal paper on rolls. The settings carried out by the operator are retained after switching off the unit and/or disconnection from the mains power. Pressure signals can be stored on a memory card. ICP measuring systems and pressure transducers other than the Spiegelberg: Brain-Pressure Monitor can also be used, if their technical safety compatibility has been proven by an authorized test center. The pressure data can be transmitted to patient monitors and chart recorders, or they can be processed by computers via an RS 232 C interface.

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Getting started After connecting the unit to the mains power and switching it on, a beep sound announces operation. The designations of the three pressures to be displayed are shown on the display: ABP: Arterial Blood Pressure ICP: Intracranial Pressure CPP: Cerebral Perfusion Pressure Initially, all measured values are only represented by dash marks. If signals have already been fed in or pressure transducers are connected, the corresponding pressure values are shown on the display. If signals are to be stored or replayed, the memory card is to be inserted into the slot at the left side of the unit such that the card label is facing up and the arrow is pointing into the unit. Before operation of the unit, the stock of paper should be checked and replenished, if necessary. See section "Loading and Unloading Paper" for instructions.

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Connections The unit has various input connections for ICP and ABP. ICP:

- Voltage input: for external units, input ICP socket connector at the rear of the unit.

For each pressure only one value is shown in the display, even if more than one unit are connected. The order of priority for the intracranial pressure is: Spiegelberg: BrainPressure Monitor, pressure transducer, external units. If, for example, a Spiegelberg: Brain-Pressure Monitor is not connected, the value from the pressure transducer connected to the red socket connector at the front of the unit will be accepted. If this is not connected either, the value of an external unit connected to the ICP socket connector at the rear of the unit will be accepted.

- Pressure transducer: red socket connector at the front of the unit.

For the ABP, the following order of priority applies: Pressure transducer, external unit.

- Voltage input: for external units, input ABP socket connector at the rear of the unit.

If, via pressure transducer, ABP and ICP are to be fed simultaneously into the red socket connector at the front of the unit, this can be done by means of a separately available junction connector.

- Spiegelberg: BrainPressure Monitor: RS 232HDM socket connector at the rear of the unit. - Pressure transducer: red socket connector at the front of the unit.

ABP:

Analog outputs are available for all three of the values shown on the display. In addition, there is an interface, to which a computer can be connected.

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Connecting Pressure Transducers Pressure transducers for both ICP and ABP are connected to the red front socket connector by means of an adaptor cable. They can be calibrated and zeroed. For the ICP this is carried out in the same manner as for the ABP, which is described hereinafter:

Calibration:

Zeroing:

2. Press the ABP key; the setting display is shown.

1. Hold the pressure transducer freely in the air so that the atmospheric pressure can act upon it. 2. Press the ABP key. Instead of the normal pressure display, the setting display for the ABP is shown. The setting display shows the designation ABP to the left and the current measured value below that. To the right, the calibration factor and the alarm thresholds are displayed. For more details, see the section "Setting the alarms". 3. Press the Zero key for approximately four seconds until the display shows zero. If more than ten seconds pass between steps 2 and 3, the normal pressure display will return and step 3 can be carried out after pressing the ABP key once again. The normal pressure display will return likewise, if the ABP key is pressed again after appearance of the setting display.

1. Apply a known calibration pressure to the pressure transducer. This can be carried out with the pump and the manometer of a blood pressure meter. Wait for the display to come to a standstill.

3. Adapt the displayed pressure to the calibration pressure by pressing the Adjust-plus or -minus keys. These keys work progressively, i.e. the longer the keys are pressed, the faster the value changes in the display. During this process, the "cal%" display shows the deviation of this pressure transducer from the standard sensitivity of 5 µV/ mmHg/V, exact coincidence thus corresponding to 100 %. If this deviation is known for a certain pressure transducer, it can be set again at any time by means of the steps described, without a calibration pressure having to be applied to the unit. The zero point and calibration of the Spiegelberg: Brain-Pressure Monitor are automatically recognized by the CPP-Monitor. The voltage inputs for ABP and ICP at the rear of the unit can neither be zeroed nor calibrated.

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Connecting the Spiegelberg: BrainPressure Monitor The Spiegelberg: Brain-Pressure Monitor is connected to the rear of the CPP-Monitor via the socket connector marked RS 232-BPM. After switching on the Brain-Pressure Monitor, the CPP-Monitor displays the measured ICP value.

remain on the display of the CPPMonitor for two minutes, before it is replaced by dash marks. With newer versions, the dash marks appear immediately. If connected, the value of the unit coming next in the order of priority, is displayed instead of the dash marks.

If an older version of the Spiegelberg: Brain-Pressure Monitor is switched off, the last ICP value will

Connecting other units Measuring units of other manufacturers can be connected to the CPPMonitor via the analog voltage inputs at the rear of the unit. According to the order of priority, their values are shown on the display and the chart recorder only if no other units or sensors are connected. The CPP monitor may only be operated with units which have been proved safe for connection according to adequate tests carried out by an authorized test center.

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Connecting Patient Monitors ABP, ICP, and CPP can be displayed on patient monitors via the analog outputs. For this, the pressure sensor input of the patient monitor is connected to the ABP, ICP, or CPP analog output socket connector of the CPP-Monitor by means of an adaptor cable. To set the zero point of connected patient monitors, the signal outputs of the CPP-Monitor can be set to zero. Press the Zero key without selecting either of the pressures ABP, ICP, or CPP. The display "Outputs zero for monitor zero" is shown for ten seconds. During this time, the value 0 mmHg is output at all of the outputs of the CPP-Monitor, regardless of what pressure is being input to the unit. Furthermore, this function sets time markers on the chart recorder printout, which are shown as vertical lines beneath the zero line. If signals are stored in the memory card, the time markers are stored as well and will be shown along with the output. For more details regarding storing, see the section "Storing and Replaying".

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Connecting other Output Units Additional output units such as chart recorders or oscilloscopes, which can process analog voltage signals, can be connected to the CPP-Monitor via the three analog outputs. The required adaptor cables are available from the manufacturer. To set the zero point of connected output units, the signal outputs of the CPP-Monitor can be set to zero. Press the Zero key without selecting either of the pressures ABP, ICP, or CPP. The display "Outputs zero for monitor zero" is shown for ten seconds. During this time, the value 0 mmHg is output at all of the outputs of the CPP-Monitor, regardless of what pressure is being input to the unit. Furthermore, this function sets time markers on the chart recorder printout, which are shown as vertical lines beneath the zero line. If signals are stored in the memory card, the time markers are stored as well and will be shown along with the output. For more details regarding storing, see the section "storing and replaying". The connection of a computer is possible via the RS 232 I/O socket connector. The RS 232 interface may be used only in connection with the cables approved by the manufacturer of the CPP-Monitor for use with the respective computer.

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Setting the Alarms For ABP, ICP, and CPP, the upper and lower alarm thresholds can be set. The alarm is either triggered when, within five seconds, the value of the respective pressure exceeds the threshold at least twice or continuously. Depending on whether the current pressure or the mean pressure is set for the respective pressure, the alarm threshold reacts correspondingly to either the current pressure or the mean pressure. Attention: the mean pressure is always shown on the display so that the alarm can be triggered even though the display has not reached the threshold. The alarm thresholds are individually activated and set for each pressure. For the ICP and the CPP this is carried out in the same manner as for the ABP, which is described hereinafter: Select the ABP by pressing the ABP key. Instead of the normal pressure display, the setting display for the ABP is now shown. The setting display shows the designation ABP to the left and the measured value beneath that. The calibration factor and the alarm thresholds are displayed to the right. The alarm is activated by pressing the Alarm On/Off key. A in front of the designation ABP indicates that the alarm has been switched on.

After a period of more than ten seconds since activation of the ABP key, the normal pressure display returns, and activation of the alarm is only possible after pressing the ABP key again. The normal pressure display returns likewise if the ABP key is pressed again while the setting display is shown. The setting of the alarm thresholds can be adjusted as follows: Select the ABP by pressing the ABP key, which then causes the setting display to be shown. The thresholds are marked by arrows on the right side: Arrow pointing up = upper threshold, arrow pointing down = lower threshold. The displayed thresholds can now be altered by the respective Alarm max plus and -minus keys. The keys act progressively, i.e. the longer they are pressed, the faster the value will change in the display. After approximately ten seconds without a key being pressed or after pressing the ABP key a second time, the normal display will be shown again.

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Acknowledging the Alarms Triggering an alarm usually results in an acoustic and an optical signal. The acoustic signal is suppressed when event recording is active. For more detailed information, see section "Event Recording". After an alarm is triggered, the acoustic signal can be silenced, i.e. the alarm can be acknowledged, by pressing any key. The message "Alarm acknowledged" is shown on the display. If the cause of the alarm has already been eliminated at this time, the normal display is shown. The optical signal is an arrow, which is situated in front of the designation of the respective pressure. If the arrow points up, an upper threshold has been exceeded. If the arrow points down, a lower threshold has been exceeded. If both have happened successively, the arrow will point in both directions. When the arrow flashes, the cause of the alarm still exists. The arrow continues to flash even after the alarm has been acknowledged. The flashing does stop only when the pressure is back within the limits. In this case, the arrow disappears when the alarm is acknowledged. Otherwise, the arrow remains without flashing, while the acoustic signal continues to sound off. Thus it is possible to determine, whether the cause of the alarm has already been eliminated, when acknowledging the alarm.

It is also possible for the arrow to point in both directions, but only to flash in one direction. This indicates that the alarm threshold is still being exceeded in the flashing direction, and that the other limit had been exceeded before. The following applies generally: in front of the pressure designation: Alarm thresholds are active, no current alarm. Acoustic signal: Sounds off with alarm, can be shut off any time. Flashing arrow: Upper or lower alarm threshold is presently exceeded corresponding to the direction of the arrow. Non-flashing arrow: The cause of the alarm has been eliminated, but the alarm itself has not been acknowledged yet.

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Loading and Unloading Paper Loading paper:

Unloading paper:

1. Unscrew the side paper cover.

1. Unscrew the side paper cover. Tear off the paper at the tearing edge.

2. Push the paper roll onto the roller with some unrolled paper sideways into the slot. 3. Screw the paper cover on again. About 20 cm of paper should protrude out of the unit. 4. Place the paper lever into the lower position. 5. Pressing the Start/Stop key starts the chart recorder roller. The paper, which is slightly folded upwards by 2 - 3 inches, is guided between the silver and black round plates. It is then pulled into the chart recorder. It may be necessary to assist by slightly pushing the paper forward. The paper end that comes out again is to be pulled slightly outwards.

2. Press the Start/Stop key for approximately four seconds. A fast feed and a subsequent return transport create a paper loop. 3. Shift the paper lever to the lower position. The chart recorder roller rotates in reverse for approximately 20 seconds. During this time, pull slightly on the paper loop, thus removing the paper from the chart recorder. 4. Remove the paper roll sideways out of the unit. 5. Screw the paper cover on again.

6. The chart recorder roller only rotates for approximately ten seconds. The rotation can be stopped by shifting the paper lever. 7. When the lever is in the bottom position, the position of the paper can be subsequently corrected in the chart recorder. 8. For recording, place the lever in the top position.

The passage of the paper through the printer seen in a cross-section from the side.

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Starting and Stopping the Chart Recorder The chart recorder can be started and stopped by means of the Start/ Stop key. When starting, the first scale is printed. The trailer after stopping prints the time and date completely on the paper. The LED next to the Start/Stop key indicates that the chart recorder is active, which, in case of slow printing speeds, cannot be easily noticed otherwise.

The printing speed can be changed by pressing the plus and minus keys directly next to the LEDs . The minus key decreases the speed whereas the plus key increases it. If the speed is changed while printing is in progress, an advance is carried out, and a new scale is printed with the changed speed.

The current printing speed is displayed by the LEDs to the left above the chart recorder.

Recording Mean Pressure or Current Pressure The LEDs on the left next to the Mean key indicate wether the respective pressure appears on the chart recorder as a mean value. If the LED of the respective pressure is off, the pressure is being recorded as a current value. Attention: the mean value is always shown on the display. The respective setting can be changed as follows: After pressing the ABP, ICP, or CPP key, the setting display appears as usual. If the Mean key is now pressed, the recording is changed

over from the current to the mean pressure or vice-versa, which can be seen by the LEDs. After a period of more than ten seconds since activation of the respective ABP, ICP, or ABP key, the normal pressure display returns as usual.

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What Information is seen on the Strip Chart ? The course of the pressures versus time is shown on the strip chart. The measuring ranges are as follows: ABP: 200 mmHg ICP: 60 mmHg CPP: 200 mmHg. If alarm thresholds are active, they are represented on the chart as thick dotted lines. Alarm thresholds are not stored in the memory card, see section "storing and replaying". Consequently, the alarm thresholds are not printed out during replay. triggered alarms are indicated by a black line below the respective trace. This is not done with stored diagrams. If a value overflows or underflows its measuring range, a line above or below the respective diagram appears during this period . The time and date are indicated in the bottom line at the beginning of each printout and every ten centimeters. In the recording mode, the printed time corresponds to the real time. In the replay mode, the recording time is printed out.

In the event recording mode, the trigger point of the alarm is indicated by a vertical mark in the bottom line in addition to the time. Moreover, this vertical line can also be created by pressing the Zero key once to mark events. It is stored along with the signals in the memory card and printed out along with the replayed signals. A new measuring scale is printed every ten centimeters. Single channel operation: In case only ABP or only ICP is measured, the entire width of the paper is used for the one channel.

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Event Recording Event Recording is a special mode of operation of the chart recorder. Using this mode, the chart recorder only starts when an alarm is triggered. Doing so, a certain time before exceeding the alarm limit, a header, and a certain time after the normal range is reached again, a trailer, are also recorded.

alarm threshold, a vertical mark appears on the bottom margin of the paper. This marks the point in time that the alarm was triggered. The lengths of the headers and trailers are dependent on the printing speed: 5 cm/hr. : 30 min. = 25 mm 15 cm/hr. : 10 min. = 25 mm

The event recording mode is switched on and off again by means of the Event Record key. The active state is indicated by the LED. Only if alarm thresholds are active, which can be recognized by a in the display, the event recording mode can be activated. In the event recording mode of operation, the exceeding of an alarm threshold does not cause an acoustic alarm. This is indicated by a diamond instead of the in front of the designation of the measured value in the display. Each time the event recording mode of operation is switched on anew, the acoustic alarm signal can be switched on as well. In order to do this, press the Event Record key for at least four seconds while switching on event recording. In addition to the horizontal lines, which mark the exceeding of the

30 cm/hr. : 5 min. = 25 mm 1 mm/sec. : 50 sec. = 50 mm 25 mm/sec. : 6 sec. = 150 mm.

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Storing and Replaying The CPP-Monitor can store up to 24 hours of signals on a memory card. When the memory card is full, the oldest data is overwritten. Storing is started by pressing the Store key. The LED next to the key indicates the storing mode of operation. ICP, ABP, and CPP are now stored onto the memory card. Pushing the Store key again terminates storing, the LED goes off. It is possible to erase all data on the memory card when the Store is pressed for at least four seconds. The following safety inquiry can be acknowledged by pressing the zero key. Pressing any other key prevents the data from being erased. If the Replay key is pressed, the starting time and date of the oldest set of stored signals is shown in the top line of the display. The recording stop time, i.e. the end of the last recording, is shown in the bottom line. The replay LED indicates the replay mode of operation. The Start/Stop LED flashes. Pressing the Start/Stop key starts the output. The Replay LED lights up and the stored signals are output on the chart recorder. By pressing the Start/Stop key, the output can be interrupted. The Start/ Stop LED flashes again, and the output can be continued by pressing the

Start/Stop key. Output operation that is in progress can be terminated by pressing the replay key. When the output starting time and output stopping time are displayed after pressing the Replay key for the first time, the starting time can be set forward or backward in hour steps with the Adjust-plus and -minus keys. If the beginning of a new recording is within such an hour step, the starting time jumps to the start of this recording. By pressing the Zero key, the starting time is reset to the beginning of the oldest recording. The time scale of the output can be set with the plus and minus keys for speed. The speeds 25 mm/s and 1 mm/s are not available for replay. If they are set, the printout will be carried out with 30 cm/hr. The time scale can be altered during replay by changing the speed. This forces a new scale to be printed with the new valid time scale. Alarm thresholds and alarms are not stored in the memory card.

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The Memory Card Installing and removing the memory card Insert the memory card into the slot at the side of the unit such that the card label is facing up and the arrow is pointing into the unit. To remove it, press the button next to the memory card. The card moves slightly out of the unit and can then be completely removed. New memory card

tion. Use only lithium batteries of the type BR 2325 or equivalent types. If stored data are not to be lost while changing the battery, change the battery while the memory card is inserted in the switched on CPP- Monitor. The battery condition indicator When the service life of the battery is coming to an end, the CPP-Monitor indicates this in two steps:

Before the CPP-Monitor allows storage onto a new memory card for the first time, the following message is shown on the display: "No ID on memory card. Press Zero to write ID". After pressing the Zero key, the memory card is given an identification, that the CPP-Monitor will be able to recognize.

1. "Memory card change battery" The battery should be changed to be on the safe side.

Changing the battery

Wrong batteries or batteries that are not installed correctly can explode and damage the unit. Dispose of old batteries as special waste.

The battery compartment is located on the side of the memory card adjacent to the plug. Open it by unfastening the screw using a small Philips screwdriver. Pull the compartment out. Remove the used battery and insert a new one, with the "+" side facing upwards according to the marking. Close the compartment. Tighten the screw again, and the memory card is now ready for opera

2. "Memory card battery empty" The data will be lost when the CPP-Monitor is switched off. Attention

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Setting the Date and Time By pressing the Clock key, the date and the time are shown on the display. If the key is pressed for approximately four seconds, one of the values flashes. It can now be changed by means of the Adjust-plus and -minus keys. Pressing the Clock key again causes the next value to flash. With further pressing of the Clock key, all of the values can be set one after the other and the normal pressure display reappears on the display. The normal pressure display reappears likewise if no key has been pressed for ten seconds. The clock of the unit has an internal battery. This means that the clock continues to run even when the unit is switched off. The clock is programmed for leap years and normal years. However, the clock does not automatically change over between summer time (daylight savings time) and winter time.

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Error Messages The unit indicates every error condition by means of three beeps. This usually means that the operation initiated by pressing a certain key cannot be carried out, because e.g. there is no paper, there is no memory card, or the respective ABP, ICP, or CPP key had not been pressed beforehand. With some error conditions, a selfexplanatory message appears. It disappears again after ten seconds, or it can be made dissappear before that by pressing any key. This keystroke does not cause any other action. This means that, when there is an error message on the display and e.g. the chart recorder should be started, the chart recorder key must be pressed twice, since at the first press of the key the error message dissappears,

and the second press starts the chart recorder. The following beeps are not error messages: One, long beep. Self-test after switching on the unit. One, short beep confirms an action that has just been carried out, e.g. the press of a key.

Cleaning The unit can be wiped off with a damp rag using a common disinfectant.

Replacing the Fuses The main fuses are located in a compartment in the power connection socket at the rear of the unit. To exchange the fuses, press the snaplock together and then remove the compartment. Replace the fuses and

reinsert the compartment. Make sure to use fuses with the correct rating.