CereLink ICP Monitor Instruction Manual Rev C June 2021

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Codman® CereLink® ICP Monitor

Instruction Manual IMPORTANT: Please read entire Instruction Manual before attempting to operate this unit.

Description • The Codman® CereLink® ICP Monitor (ICP Monitor) is a standalone portable device that continuously monitors intracranial pressure (ICP). When connected to a Codman CereLink ICP Sensor (ICP Sensor), the ICP Monitor provides a numeric display of the mean ICP, ICP waveform and mean ICP trend. For detailed waveform analysis, the ICP Monitor generates real time digital data and an output signal that can be interfaced directly to the pressure channel input on most patient bedside monitors.

Key Functions Key features provided by the ICP Monitor include: • ICP waveform display • Mean ICP numeric display • Historic mean ICP trend display with a box plot view • Historic mean ICP histogram • Continuous operation on AC power • Internal rechargeable battery for up to 2 hours of continuous operation • User programmable visual and audible mean ICP alarms that activate if the ICP value exceeds a user-specified limit • Real-time data streaming of mean ICP and/or ICP waveform through the USB connection • Data storage and export via USB: • 24 hours of ICP Waveform • 14 days of mean ICP • 50 screen shots • Data markers • Additional calculations based on mean ICP, including Pressure Time Dose (PTD), and time above predetermined thresholds • One-touch transducer zeroing function • Free-standing positioning or attachable to an IV pole • 7-inch color touch screen, that functions with or without the use of gloves 3

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SYSTEM OVERVIEW The small profile and light weight of the ICP Monitor make it ideal for monitoring ICP during patient transport. Included with the ICP Monitor is one AC Power Supply, a rechargeable battery and one CereLink ICP Extension Cable (Extension Cable) used to connect the ICP Sensor to the ICP Monitor. During the ICP Sensor zeroing process, the ICP Monitor automatically stores the zero-reference value in a memory element embedded in the ICP Sensor. This feature allows the user to reconnect the ICP Sensor to the same or different ICP Monitor without having to readjust the zero-reference value. CereLink Patient Monitor Interface Cables (Interface Cables) are available separately for connecting and synchronizing the ICP Monitor to a variety of compatible patient bedside monitors. Additional AC power supply (REF 82-6822), battery replacements (REF 82-6824) and Extension Cable (REF 82-6845) are also available separately. Contact your local Codman sales representative for full details. Please see Recommended Accessories and Reordering Information section for a list of compatible ICP Sensors, cables and additional accessories.

Intended User The ICP Monitor is designed for worldwide use in a clinical setting by qualified medical personnel, including the neurosurgeon, nurse, intensivist, trauma physician or other advanced-practice provider, who perform the operation of the ICP Monitor and placement of the ICP Sensors.

Indications for Use The ICP Monitor is intended for use as an interface between compatible strain-gauge type pressure transducers and standard physiological pressure monitoring systems. The ICP Monitor is also intended for use as an independent pressure monitor for displaying the mean, systolic and diastolic values of a physiologic pressure waveform in the absence of an external patient monitor.

Contraindications The ICP Monitor is contraindicated for use in a Magnetic Resonance (MR) environment. Refer to the ICP Sensor IFU for MR environment use.

MR Information The ICP Monitor is MR Unsafe. Do not bring the ICP Monitor or accessory cables into the MR environment.

WARNINGS • Read the entire instruction manual before attempting to operate the ICP Monitor. • Always zero the ICP Sensor prior to implantation. Never attempt to re-zero a sensor while implanted inside the patient. • Always verify physiological alarm limits are set appropriately for each patient prior to treatment. The physiological alarm can be disabled by manually turning it off or by selecting extreme limits. • Use of the ICP Monitor is restricted to one patient at a time. • Maintain strict sterile technique when connecting the ICP Sensor to the ICP Extension Cable. The ICP Extension Cable can be sterilized before use if desired, and has been tested to withstand 100 autoclave cycles. Cable performance beyond 100 autoclave cycles has not been evaluated. Refer to the ICP Sensor IFU and to the ICP Extension Cable IFU for more information. • Do not cover the ICP Monitor’s vents because it will increase internal temperature and cause overheating and possible device failure. • Keep device away from fluid sources. • Modification or disassembly of the ICP Monitor (including power supply, cables and sensors) is not permitted. Unauthorized modifications to the ICP Monitor can cause a malfunction resulting in serious patient injury, damage to internal circuitry or electric shock. • Explosion Hazard: Do not use in the presence of flammable materials (e.g., anesthetics, solvents, cleaning agents and endogenous gases). • Electrical Shock Hazard: • Use only Codman approved power supplies listed in Recommended Accessories and Reordering Information section. Use of another power supply may not provide electrical isolation from supply mains and protection against electrical hazards. • Do not remove side, front or rear panels. Contact Technical Support for service and repair. 4

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SYSTEM OVERVIEW • The ICP Monitor contains a lithium ion battery: • Do not open the battery compartment or attempt to replace the battery while monitoring a patient or while the device is connected to the AC Power Supply. • Use in extreme conditions (e.g., extreme temperature, high humidity, deep discharge) may decrease battery performance. • Do not puncture the battery. • Do not dispose of in fire. • Do not short circuit battery contacts as battery may get hot, leak, ignite or explode. • Use only Codman approved batteries listed in Recommended Accessories and Reordering Information section. Use of another battery may present a risk of fire or explosion. • The device may become warm during normal operation and surface temperatures may reach up to 50oC. Avoid prolonged skin contact with the device (less than 5 minutes) to reduce heat-related concerns. The device complies with user-accessible surface temperature limits defined by the International Standards for Safety (IEC 60601-1).

Precautions • When using the CereLink ICP Monitor, always handle with care. • Routinely inspect all electrical plugs and connections; do not use if damaged. • Use only Codman approved accessories with the ICP Monitor, including Extension Cable, Interface Cables, ICP Sensors, Power Supply and Battery, listed in the Recommended Accessories and Reordering Information section. • To prevent injury to the patient, user or other persons, make sure that the battery cover is closed securely during use of the ICP Monitor. • When clamping the ICP Monitor to the IV pole, always verify that it is secure to prevent injury to the patient, user, or other persons, or damage to the ICP Monitor. • Ensure the CereLink Power Supply is grounded (See Figure 14 in Initial Setup): • Use only the CereLink Power Supply, which provides three or more electrical pins/contacts depending on the geographical region. • Connect the CereLink to only "hospital grade" or "hospital only" receptacles. • Do not attempt to bypass the grounding contact on the CereLink Power Supply by using an adapter. • NOTE: Failure to properly connect the CereLink ICP Monitor to a grounded power supply can affect the accuracy and performance of the pressure readings. • Ensure patient monitor is connected to a properly grounded power supply. • The connectors for both the Interface Cable and the Extension Cable must be properly aligned with the receptacles on the ICP Monitor before pushing these parts together. DO NOT twist the connectors. Twisting the connector in this manner will damage the pins and can lead to product malfunction. • The signal processing algorithms used to detect and display physiological pressure data may vary among patient bedside monitors of different make and model. Therefore, pressure data displayed by the ICP Monitor may not always be consistent with the data displayed on an externally connected patient bedside monitor. Refer to the patient bedside monitor manufacturer’s instruction manual for specific details regarding signal processing, calibration and accuracy. • The ICP Sensor must be zeroed at atmospheric pressure prior to implantation. • This device should be used in environments that meet the electromagnetic environment – guidance in Appendix A of this manual. • Exposure to electrostatic discharge (ESD) energy could damage the ICP Sensor connected to this device. Please refer to the ICP Sensor IFU for more information. • The ICP Sensor is susceptible to damage from defibrillation. The sensor may need to be replaced before ICP monitoring can resume. • Disconnect the ICP Monitor from the ICP Sensor before utilizing any electrosurgery equipment. The use of electrosurgical equipment (e.g., Monopolar, Bipolar, Diathermy) can cause damage to both the ICP Monitor and ICP Sensor if left connected. • Only use the USB port to download or stream data. The only devices that can be connected to the USB port are: • USB memory stick or USB flash drive. • USB to serial adapter (refer to Recommended Accessories section) connected to a computer that is properly grounded. (See Figure 23 in Appendix C) • Always disconnect the ICP Monitor from the power supply before wiping external surfaces. • Do not sterilize the ICP Monitor. 5

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ICP MONITOR LAYOUT: FRONT

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Figure 1: Front and Side of ICP Monitor

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Power Button • Press for 1 second to turn device on. • Blue light = Device powered on. • Press for 3 second to turn device off. • No light = Device powered off. External Power Source / Battery Charging Indicator • Green light = Device connected to external power supply. • No light = Device not connected to external power source.

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Rubber Feet

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Mute Alarm Button: • Push to mute alarm for 3 minutes • No light = No alarm • Yellow light flashing = Alarming • Yellow light steady on = Alarming and Muted ICP Sensor Extension Cable Connection (yellow)

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Patient Bedside Monitor Interface Cable Connection (blue)

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Touch Screen

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High Speed USB Ports

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System Failure Indicator • Red light = System issue. Please refer to Troubleshooting section for details.

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Alarm Beacon • No light = No alarm • Yellow light flashing = Alarm or Alarm Muted • Yellow light steady on = System Failure

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ICP MONITOR LAYOUT: BACK

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Figure 2: Back of ICP Monitor

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System Information Label See Labeling Symbols Glossary section.

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Power Cable Retention Mechanism Refer to Figure 3.

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Battery Access See Battery Replacement section.

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Recessed Hand Hold

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Cooling Vents

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IV Pole Clamp

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Power Input

Figure 3: Power Cable Retention Mechanism Usage

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USER INTERFACE SCREENS ICP Waveform Screen (default screen)

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Figure 4: ICP Waveform Screen

A Mean ICP Status and Numeric Displays ICP Sensor connected, zeroed, and acquiring data in millimeters of mercury (mmHg). ICP value will flash if alarming. ICP Sensor connected, but not zeroed. ICP Sensor not connected.

B

Alarm Threshold Indicators and Alarm Status HIGH/LOW alarm thresholds and current mean ICP indicator (triangle). Mean ICP Indicator will flash if alarming.

Alarm ON. Alarm will sound if the mean ICP value exceeds the alarm threshold. Alarm OFF. Alarm will NOT sound if the mean ICP value exceeds the alarm threshold.

C

Dashed Lines in Graph Alarm threshold value.

D ICP Waveform E

ICP Waveform Scale Adjustment Press the button to cycle through the available ICP amplitude scales (0 to 30, 0 to 50, 0 to 100, 0 to 150, -50 to 50, -10 to 20).

F

Current Time and Date

G Time and Date the Sensor was Previously Zeroed H Sensor ID

Available when a sensor is connected or when there is data stored in the device. Provides a unique number to identify the data.

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USER INTERFACE SCREENS ICP Waveform Screen (default screen) Continued

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Figure 4: ICP Waveform Screen

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Patient Bedside Monitor Indicator Bedside Monitor NOT detected. Bedside Monitor Detected. Symbol flashes when monitor is not calibrated.

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External Power Status Indicator AC power NOT detected. AC power present and charging the battery.

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Battery Status (Level) Indicator Battery level full. Battery level low, 40% remaining. Battery level low, 20% remaining. A warning will be displayed when 15 minutes of battery life remains. Battery level critical. Charge immediately. If power is disconnected the device may shut down.

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Screen Toggle Button Access to trend, boxplot and histogram screens.

M Screen Shot Button Screen Images will be stored in memory and can be downloaded to a USB stick.

N Data Marker Button Mark special events on the trend screen. Refer to Using Data Markers section for more information.

O Home Button Refer to Home Screen section for more information.

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USER INTERFACE SCREENS Mean ICP Trend Screen The ICP Trend Screen displays the historic mean ICP values over a period of time. Additionally, the Pressure Time Dose (PTD) is also presented on this screen. PTD is a measure to quantify the burden and time spent above an ICP threshold. PTD represents the area under the curve above a user-defined threshold within the displayed time frame (refer to Analysis Threshold Setup Screen section for information on how to set the two available thresholds). For example, in the graphic below, the two thresholds selected are “22 mmHg” and “15 mmHg.”

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Figure 5: Mean ICP Trend Screen

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G Timescale unit of measure

Trend / Boxplot button

Amount of time between two grid line divisions. Toggle between trend and boxplot view.

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H Waveform Trend Arrow: Right Press arrow to navigate trend data.

PTD Thresholds Dashed lines represent PTD thresholds. ICP Trend Scale Adjustment Press the button to cycle through the available ICP amplitude scales (0 to 30, 0 to 50, 0 to 100, 0 to 150, -50 to 50, -10 to 20). Waveform Trend Arrow: Left Press arrow to navigate trend data.

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Data Markers Icon marks the point in time special events occurred. Refer to Using Data Markers section for more information.

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Trend Time Label Time axis corresponding to the time the trend data was acquired.

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Timescale button Press the button to cycle through the available time scales (3 hr, 12 hr, 24 hr, 48 hr, 6 days).

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Trend Date Label Time axis corresponding to the date the trend data was acquired.

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ICP Trend Stats Section where the PTD calculations are displayed: 1. PTD = Pressure Time Dose (mmHg * hours) 2. (xx) = Pressure Threshold at which PTD is calculated (mmHg).

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USER INTERFACE SCREENS Mean ICP Boxplot Screen The ICP Boxplot Screen shows the same data from the mean ICP trend screen, but as a graphical representation of the statistical data. The box plot graphic uses descriptive statistics to display the distribution of the mean ICP data based on quartiles. The quartiles split the data into four equal groups based on five key values: minimum (0%), first quartile (25%), median (50%), third quartile (75%), and maximum (100%). The minimum and maximum represent the true extreme values in the data set. The median represents the middle number of the data set, the first quartile is the middle number between the minimum and the median and the third quartile is the middle number between the maximum and the median. Therefore, the box includes 50% of the data points around the median point. Additionally, the mean value within each time division is represented as green diamonds. The functionality of the Boxplot resembles that from the Mean ICP Trend screen.

Figure 6: Mean ICP Boxplot Screen

Maximum

3rd Quartile

Median 1st Quartile Minimum Figure 7: Boxplot

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USER INTERFACE SCREENS Mean ICP Histogram Screen The ICP Histogram screen shows the distribution of mean ICP values over a period of time. Additionally, the Time Above Threshold is calculated. Time above threshold is the total time the mean ICP has been above one of two user-defined thresholds within the selected timeframe (refer to Analysis Threshold Setup Screen section for information on how to set the thresholds). NOTE: The same thresholds used for the PTD calculations in the Mean ICP Trend Screen are used for the Time Above Threshold calculation.

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Figure 8: Mean ICP Histogram Screen

A ICP Time Above Threshold

C T Thresholds

1. T = Time above threshold (hours, minutes and %). 2. (xx) = Pressure Threshold at which T is calculated (mmHg).

Dashed Lines indicate T Thresholds.

D Histogram Distribution of mean ICP within the selected time window.

B Timescale Button Press the button to cycle through the available time scales (3 hr, 12 hr, 24 hr, 48 hr, 6 days).

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USER INTERFACE SCREENS Home Screen The Home Screen provides access to several frequently used monitor functions and is accessed by pressing the Home Button on the User Interface Screen.

Figure 9: Home Screen

Zero Sensor Pre-implantation Zeroing of the ICP Sensor. Only available if a sensor is detected.

Brightness / Volume Adjust the alarm volume and the screen brightness.

Alarm Setup Set mean ICP alarm limits.

Data Download Select and download stored data.

Patient Monitor Setup Synchronize ICP Monitor with external patient monitor. Only available if an external Patient Monitor is detected.

System Information Display Monitor’s serial number and software version.

Analysis Setup Set Pressure Time Dose (PTD) and Time Above Threshold limits.

Screen Toggle Exit the Home menu and return to the Waveform Screen.

Settings Button Access to additional monitor setting functions. Only available if a sensor is NOT connected.

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USER INTERFACE SCREENS Settings Screen The Settings Screen provides access to functions such as Time/Date and Language.

Figure 10: Settings Screen

Time / Date Set the current time and date.

Technician Access Information for Codman Service and Repair personnel.

Language Set the user interface display language.

Home Exit the Settings menu and return to Home menu.

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USER INTERFACE SCREENS ICP Alarm Setup This screen is accessed by selecting HOME -> ALARM SETUP. Use this screen to select the HIGH and LOW alarm for the mean ICP value. The HIGH and LOW alarm can be turned ON/OFF with the switch on the left (green indicates alarm is ON). Alarm values must be within -50 to 150mmHg and the HIGH alarm value must always be greater than the LOW value.

Figure 11: ICP Alarm Setup Screen

Analysis Threshold Setup Screen This screen is accessed by selecting HOME -> ANALYSIS SETUP. Use this screen to select the HIGH and LOW levels used for the Pressure Time Dose (PTD) and Time Above Threshold calculations (refer to Figure 5 and 8). The HIGH and LOW levels can be turned ON/OFF with the switch on the left (green indicates that the alarm is ON). The threshold values must be within -50 to 150mmHg and the High value must always be greater than the Low value.

Figure 12: Analysis Threshold Setup Screen

Data Download Screen This screen is accessed by selecting HOME -> DATA DOWNLOAD. Use this screen to select which data to download to an external USB memory drive. Note that more than one item can be selected for download. Refer to Data Download section for additional information.

Figure 13: Data Download Screen

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INITIAL SETUP 1

Unpack the ICP Monitor WARNING: Use only Codman approved accessories with the ICP Monitor (see the Recommended Accessories and Reordering Information section). Remove the contents from the shipping box and verify the following items are included: • CereLink ICP Monitor (REF 82-6820) • Power Cord with Region-Specific Adapter Plug (REF 82-6822) • Rechargeable Lithium Ion Battery already installed (REF 82-6824) • Extension Cable (REF 82-6845) • User Manual After unpacking the contents, inspect the items for any signs of damage. If any damages are discovered, notify the carrier and the supplier. Retain all shipping contents and boxes for examination.

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Prepare the Power Cord Adapter Plug Remove the Power Cord from the package and attach the region-specific adapter plug or cord to the power supply.

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Plug the ICP Monitor into AC Power Connect the power supply to the ICP Monitor by inserting the connector end into the Power Input (see Figure 2). Insert the grounded electrical plug (with three or more electrical pins/contacts depending on the geographical region) of the Power Cord into a grounded wall outlet and ensure the Power Indicator light is green. Use the Power Cable retention mechanism (see Figure 3) to prevent the Power Cord from detaching from the ICP Monitor. Use only provided CereLink ICP Power Supply. • Use only the CereLink power connection, which provides three or more electrical pins/contacts depending on the geographical region. • Connect only to “hospital grade” or “hospital only” receptacles.

Do not attempt to bypass the grounding contact on the CereLink Power Supply by using an adapter. Earth ground symbol. Connection plug must have three or more electrical pins/contacts. Figure 14: CereLink Power Supply Configuration

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INITIAL SETUP 4 5

Charge the Battery to Full Capacity Keep the ICP Monitor plugged in for at least 5 hours to charge the battery to full capacity. Turn on the ICP Monitor Press the Power Button on the front of the ICP Monitor for at least 1 second (see Figure 1). The Power Button will illuminate to indicate that the device is on. After approximately 20 seconds, while performing internal self-checks, the ICP Monitor will display the “Codman CereLink” logo. Confirm that the battery is fully charged.

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Specify the Language From the Home Screen, select Settings (see Figure 9), then select Set Language (see Figure 10). Choose the desired language.

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Set the Time and Date From the Home Screen, select Settings (see Figure 9), then select Set Time/Date (see Figure 10). Adjust the time and date as needed.

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Set the Alarm Volume and Screen Brightness From the Home Screen, select Volume/Brightness (see Figure 9), then adjust desired alarm volume and desired screen display brightness.

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Turn off the ICP Monitor Press the Power Button on the front of the ICP Monitor for at least 3 seconds (see Figure 1). The ICP Monitor will display the “Codman CereLink” logo to indicate that the shutdown process has started.

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SETUP FOR CLINICAL USE 1

Position the ICP Monitor The ICP Monitor is intended to be securely positioned on a hard flat surface, or securely clamped to an IV or equipment pole next to the patient. a1 Set on Hard, Flat Surface Position monitor at eye level so screen can be viewed comfortably. OR a2 Mount to IV Pole Secure monitor clamp to the IV pole at eye level so the screen can be viewed comfortably. The pole clamp fits poles between 19mm and 38mm in diameter. NOTE: Make sure to position the device is such a way that the power supply plug on the back of the device and cable connections on the side of the device are accessible.

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Confirm Date and Time It is important to confirm that the time and date are set correctly so that all acquired data is tagged with the correct information. The ICP Monitor will display the current system date and time on any of the main screens (see Figure 4). If incorrect, adjust time and date by selecting Home Screen, then Settings (see Figure 9), then Set Time/Date (see Figure 10).

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Connecting a New ICP Sensor Connect

a Connect the ICP Extension Cable to the yellow connector on the ICP Monitor. The ICP Extension Cable may be autoclaved according to the associated instructions for use. Follow your institution’s procedures and maintain sterile technique. NOTE: Cable Connectors are push/pull. DO NOT twist. • Extension Cable connector tab and arrows should face forward, in same direction as the monitor screen. • Push yellow connector into yellow port until you hear a click. • To remove cable, grab gray textured part of connector and pull away from monitor.

Remove

Figure 15: Connecting ICP Sensor

b While maintaining sterile technique, connect the ICP Sensor to the ICP Extension Cable. The connection is a tight fit with no audible or tactile click.

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Once the sensor is connected, the monitor will play a sound and will display the zero symbol.

Zero Sensor ICP Sensors must be “zeroed” before implantation. The zeroing process is performed to calibrate the Sensor to atmospheric pressure prior to measuring ICP. Follow the zeroing steps included in the Instructions for Use packaged with the ICP Sensor and Extension Cable. CAUTION: Do NOT submerge the tip of the ICP Sensor vertically in a deep pool or cup of sterile water or sterile saline. Doing so will impose a hydrostatic pressure on the ICP Sensor diaphragm that is higher than atmospheric pressure, resulting in an inaccurate zero reference.

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SETUP FOR CLINICAL USE a Prepare to zero the device by laying the tip of the ICP Sensor flat in a shallow pool of sterile water or sterile saline.

b Access the sensor zeroing menu by selecting the Home button from any of the main screens and then the Zero Sensor option.

c

While keeping the tip of the ICP Sensor flat and still in the sterile water or sterile saline, press the zero button on the ICP Monitor screen.

Figure 16: Zeroing Process Start NOTE: The device is equipped with an algorithm that will detect when the sensor is ready to be zeroed (see Figure 16). • Zero button will NOT be available if sensor is moving. • Zero button will NOT be available if sensor is already implanted.

Figure 17: Zeroing Process Not Available

d When sensor zeroing has been successful, the date and time will be displayed on the screen (see Figure 18).

Figure 18: Zeroing Process Successful

e To confirm the Mean ICP value is zero, return to the ICP Waveform Screen (see Figure 4). If necessary, repeat the zeroing steps.

f While maintaining sterile technique, disconnect the ICP Sensor from the ICP Extension Cable before implantation and after zeroing. Follow the implantation steps listed in the Instructions for Use packaged with the ICP Sensor.

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Reconnecting an ICP Sensor after Implantation After the ICP Sensor has been zeroed and surgically implanted, reconnect sensor to the ICP Extension Cable on the side of the ICP Monitor. NOTE: The sensor can be reconnected to any CereLink ICP Monitor. It is not required to use the same monitor used for the zeroing process. Historic trend data will not be transferred if the sensor is connected to a new CereLink device.

Existing Sensor Data Data from two different sensors cannot be stored on the same monitor. Prior sensor data MUST be deleted before using a new sensor. When a new ICP Sensor is detected, the device will: 1. Confirm deletion of data. OR 2. Recommend disconnecting sensor to prevent data loss. NOTE: If the sensor is disconnected, monitoring will NOT resume until the previous sensor is reconnected, or the stored data is downloaded through the USB (see Data Download section). 19

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SETUP FOR CLINICAL USE Alarms The ICP Monitor activates three types of audio/visual alarms to indicate problems or situations that require immediate attention: 1. Physiological Alarms CAUTION: The Physiological alarm can be disabled by manually turning it off or by selecting extreme limits. Alerts the user that the patient’s mean ICP value has exceeded the specified alarm threshold set by the user. Physiological alarms can be muted temporarily for 3 minutes by pressing the mute button on the front of the device (see Figure 1). These alarms will be stored along with the historic trend data and can be retrieved via USB (refer to Data Download section). NOTE: Alarm functionality can be tested any time a sensor is connected by setting the alarm limit below the ICP value. 2. System Alerts Alerts the user of situations that require user action, including: a. New ICP Sensor connected. User must acknowledge if old data can be erased. Otherwise, sensor must be disconnected. b. ICP Sensor disconnected from the Extension Cable. c. ICP Sensor failure. d. Screen shot limit reached. Oldest image will be overwritten. e. Mean ICP trend data limit reached. Oldest data will be overwritten. f. Battery charge at 10%. 3. System Failure Alarm Alerts the user that there is a system malfunction and in general, the device becomes unusable. Contact Technical Support for further instructions (see Troubleshooting section). Alarm Priority Alarm Type

Audio Indicator

Visual Indicator

System Failure Alarms Medium Patient ICP will not continue Will override all to be monitored. other alarms. Troubleshoot system as it may be unusable.

Burst of 5 pulses with a maximum volume of 60dBA (during active ICP monitoring).

Fault indicator will illuminate and yellow screen will be displayed identifying the error code. Alarm beacon will illuminate yellow (during active ICP monitoring).

Physiological Alarms

Burst of 5 pulses with a maximum volume of 60dBA.

Prompt attention to patient is necessary to prevent a potential harm to occur.

Alarm Beacon will flash yellow ICP value will flash. Active alarm: Mute button will flash yellow as sound is played. Audio Paused: Mute button will illuminate yellow (not flashing).

ICP monitoring may stop for Burst of 3 pulses technical reasons (e.g. sensor with a maximum disconnected, low battery). volume of 60dBA.

Popup message will appear on the screen indicating the alert type and waiting for user action.

System Alerts

Alarm Priority

Medium Will override System Alerts.

Low

Action

Patient ICP has exceeded the alarm limit.

Prompt attention to device is necessary to prevent a potential harm to occur.

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SETUP FOR CLINICAL USE Taking a “Screen Shot” To save an image displayed on the ICP Monitor screen, press the Screen Shot button. Up to 50 images (10 for each main screen) can be stored at the same time. After 10 images, of the same screen type, the oldest image in memory will be overwritten. Images can be downloaded to a USB memory drive via the Data Download option on the Home menu.

Using Data Markers Use the Data Marker button on right side of the screen (see Figure 4) to identify and save in memory special events in real time. For example, use the Data Marker before and after patient transport, administration of medication, change in dosage, or any other interventions or procedures. Every time the Data Marker button is selected, a unique number (1-99) will be displayed on the screen to identify the event marker. Log this number on the patient history file along with the event information. The Mean ICP Trend Screen (see Figure 5) will display all event markers on a pop-up screen at the time the data was tagged. The pop-up screen will read “Data Marker #X, Set in trend screen”. After 99 stored events, the data marker counter will reset to one. The Data Marker ID is linked to the mean ICP trend data and can be downloaded via USB (refer to Data Download section).

Data Download The device can store the following data: • The last 24 hours of the ICP waveform (100 samples per second) • Last 14 days of mean ICP values (1 sample every 10 seconds) • Last 14 days of physiological alarm conditions • Last 14 days of event markers • 50 screen shots Data will be overwritten once the memory capacity has been reached, starting from the oldest data point. A warning will be displayed prior to overwriting data except for ICP waveform. The ICP waveform will be replaced every 24 hours. Make sure to download waveform information as frequently as necessary. Stored data will not be lost if the sensor is disconnected or the monitor is powered down. To Download Data: 1 Insert a digital memory device into the USB port on the right side of the monitor. USB device should meet the following specifications: • USB 2.0 • 8 to 32 GB capacity • FAT32 format

2 Select the data to download from the options available in the Data Download menu found in the Home Screen (see Figure 9).

The data will be downloaded to the memory device and a confirmation screen will appear when the data transfer is complete. Data is saved as a text file. Refer to Appendix B: Data Download File Format for details on how to interpret the saved data.

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