Olympic BrainZ Monitor Help Guide Rel 3.1.0.1500 July 2010

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Table of Contents Home Welcome Who should read this guide Intended use Safety information Conventions General usage guidelines Components of the Olympic Brainz Monitor

Quick Start Monitoring a patient Applying a neonatal sensor set Starting recording Checking signal quality Troubleshooting During a session you can... Pausing a session Ending a session Marking events Creating snapshots Archiving sessions Powering down the OBM

Interface Basics Startup screen Status bar Taskbar buttons Overlays Navigation controls Display modes On-screen keyboard

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Selecting the sensor sites Preparing the sites and applying the sensors

Viewer Viewer overview Installing the Viewer application Using the Viewer Selecting locations from the Viewer Reviewing bedside sessions remotely Scoring sessions from the Viewer

Monitor Monitoring Live monitoring mode aEEG monitoring EEG monitoring Impedance monitoring Electrode impedance view Impedance histogram Electrode impedance as it relates to signal quality

Recording Recording a session Entering patient information Entering electrode information Reviewing a session during recording Resuming a session Stopping session recording Restoring a session after AC power interruption

Review Reviewing a previously recorded session Navigating through a session Dragging to scroll and position timeline cursor Playing forward or backward EEG playback Nudging the timeline cursor Navigating through markers

Patient Creating a new session Opening a previously recorded session Working with the session list Viewing and editing patient information Ending a session

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Alerts Alerts overview DAB Communications Alert Viewing alerts Snoozing and dismissing alerts Alerts reference

Markers Markers Marker overview Adding a marker Viewing markers

Marker Navigation Navigating markers

Marker Editing Editing markers

Scoring Scoring basics Scoring tracks Marking a region Classifying a region Editing an existing region Navigating to adjacent regions Scoring background patterns Scoring seizures Customizing scoring track layout Defining report regions

Reports Reports Snapshots Configuring and previewing snapshot reports Viewing snapshots saved with a session

Printing To file Introduction file:///K|/CurrentProductDocs(Products)/OBM-Olympic Brainz Monitor/HELP/en/contents.html[7/14/2010 12:59:15 PM]

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Sending a report to file

Tools Sessions Session management Using the active sessions list Viewing session storage information Deleting sessions Archiving sessions Exporting a session Importing a session

Archive Archiving overview Working with archive locations Identifying archive status Working with the archive queue Monitoring archiving Recommended archiving procedures

Settings Introduction Defining marker presets Restoring default marker presets Customizing display preferences

System System maintenance utility Selecting language preference Setting system date and time Updating the software and firmware Configuring locations Preparing USB media for archiving, importing, and exporting Calibrating the screen Saving and restoring user settings Configuring a printer Configuring alerts The administrator's desktop The diagnostic event log Optional password protection Powering down the OBM

Diagnostics System health monitoring Diagnosing poor electrode sensor contact Archive workflow troubleshooting

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Storage media troubleshooting Network troubleshooting Tools for advanced troubleshooting Saving the diagnostic event log

About About Contact Release Notes Copyright 2010 Natus Pediatrics

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Welcome Thank you for choosing the Olympic Brainz Monitor (OBM). This online help guides you through the use of the OBM with topics ranging from the basics of monitoring to advanced workflows such as report generation and data management. Who should read this guide Intended use Safety information Conventions General usage guidelines Components of the Olympic Brainz Monitor Before using the Olympic Brainz Monitor, please familiarize yourself with the Safety information.

Who should read this document All users of the Olympic Brainz Monitor should read this document, particularly the Safety Information.

Intended use The Olympic Brainz Monitor (OBM) is a three channel electroencephalograph (EEG) acquisition system intended to be used in a hospital environment to record, collect, display and facilitate manual marking of aEEG recordings. The signals acquired from P3-P4, C3-P3 and C4-P4 channels are intended for use only with neonatal patients (defined as from birth to 28 days post delivery, and corresponding to a postconceptual age of 24 to 46 weeks) to display aEEG for monitoring the state of the brain. The signals acquired from P3-P4 channel is intended to assist in the prediction of and severity of Hypoxic-Ischemic Encephalopathy and long-term outcome in full term neonates (post-conceptual age of 37-46 weeks) who have suffered a hypoxic-ischemic event. The Olympic Brainz Monitor does not provide any diagnostic conclusion about the patient’s condition.

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Safety information Warnings Explosion hazard Do not use the Olympic Brainz Monitor in a flammable atmosphere (for example, where concentrations of flammable anesthetics may be present). Electrical shock hazard Do not open the enclosure of the touch screen monitor or DAB, especially while they are connected to the AC supply outlet. Do not attempt to connect or disconnect the Olympic Brainz Monitor's AC supply cable with wet hands. Make certain your hands are clean and dry before touching the AC supply cable. Disconnect the Olympic Brainz Monitor from any AC supply outlet before cleaning. Do not use liquid or spray detergents or cleaners. Take care to avoid spilling liquids into any opening in any part of the Olympic Brainz Monitor. Do not submerge any component in liquid. This may cause fire or electric shock. AC supply outlet Use only a three-way, grounded supply outlet for the Olympic Brainz Monitor. Never adapt the three-wire attachment plug of the Olympic Brainz Monitor to fit a two-wire supply outlet. If a three-wire, grounded supply outlet is not available, do not operate the Olympic Brainz Monitor. US only: Grounding reliability can be achieved only when the Olympic Brainz Monitor is connected to a supply outlet marked "Hospital Only" or "Hospital Grade". Supply voltage Make sure the supply voltage is correct before connecting the Olympic Brainz Monitor to the AC supply outlet. Power cable Position the AC power cable so that it will not be stepped on, or rolled over by wheeled equipment. Loading of Accessory Basket The accessory basket attached to the Olympic Brainz Monitor roll stand is designed to carry a load of no more than 4.5 lb (2 kg). Do not apply a load exceeding this amount. To ensure stability, the accessory basket must be mounted within 32" (80 cm) of the ground. Loading of Roll Stand The roll stand is designed to carry a load equal to the standard Olympic Brainz Monitor components and any Natus-recommended optional accessories. Do not apply a load exceeding the sum weight of these items. Transporting the Olympic Brainz Monitor

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Before moving the Olympic Brainz Monitor, lower the touch screen monitor to its lowest position on the roll stand and lock it firmly in position. Use with high frequency electrosurgical equipment Use of diathermy/electrosurgical or defibrillation equipment on a patient while they are connected to the Olympic Brainz Monitor may cause interference to the EEG signals and interruption of monitoring functionality. Use with MRI or CT scanners Do not use the Olympic Brainz Monitor in the vicinity of MRI or CT systems. Personal injury hazard Ensure that the touch screen monitor is securely mounted to the roll stand or desktop stand to avoid personal injury. Patient strangulation hazard To minimize the risk of patient strangulation, position the DAB so as to minimize the risk of the cables becoming wrapped around the patient's throat. Use of accessory equipment Use of accessory equipment not approved by Natus Medical, or not complying with safety standards equivalent to those met by the Olympic Brainz Monitor may lead to a reduced level of safety of the resulting system or failure of the Olympic Brainz Monitor to operate correctly. Connection to accessory equipment Accessory equipment connected to any accessory port of the touch screen monitor unit (including USB ports and Ethernet connections) must be certified to applicable IEC standards (IEC 60950 for data processing equipment and IEC 60601-1 for medical equipment). All configurations shall comply with the medical electrical standards IEC 60601-1-1. Anyone who connects additional equipment to such an accessory port part configures a medical system, and is responsible for ensuring that the system complies with the requirements of the medical electrical system standard IEC 60601-1-1. If in doubt, contact an Authorized Service Center or Natus Medical (see Contact). Note: Ethernet connections and associated network infrastructure must not exceed levels as defined in 60950-1. Network cables must be less than 30 meters in length. Indications for servicing If any of the following situations occurs, stop using the Olympic Brainz Monitor immediately and have it checked out by your healthcare institution's service personnel. The AC supply cable or attachment plug is damaged. The equipment has been exposed to moisture. The equipment does not work well, or does not work in the way described by this document. The equipment has been dropped or damaged.

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The equipment has obvious signs of breakage. Care when touching patients Do not touch any exposed metal parts at the rear panel of the touch screen monitor unit (including connectors), while simultaneously touching a patient. Electrical stimulator hazard Do not use the Olympic Brainz Monitor simultaneously with electrical stimulators. Cautions Read all documentation Read this document, and any other operating instructions or other documentation packed with the Olympic Brainz Monitor, carefully before operating the instrument in a clinical setting. Keep all documents for future reference. Do not autoclave Do not autoclave any component of the Olympic Brainz Monitor, as serious and irreversible damage may result. Ventilation Do not obstruct the passage of air behind or around the touch screen monitor or block ventilation inlet holes at its rear. Indoor use only The Olympic Brainz Monitor is intended for indoor use only. Conductive parts Do not allow the conductive parts of the electrodes and associated connectors, including the Reference (or neutral) electrode, to contact other conductive parts, including ground, while the Olympic Brainz Monitor is being used for a monitoring session. Electro-static discharge (ESD) Pins of connectors identified with the ESD warning symbol shall not be touched. Disconnection of cables and AC supply Do not disconnect any of the cables connecting the Olympic Brainz Monitor's components, operate the power switch, or disconnect the AC supply, while the Olympic Brainz Monitor is in use. If any of these conditions occurs accidentally, reconnect the cables (if necessary) and resume the current monitoring session. See Restoring a session after AC power interruption. Cleaning the Olympic Brainz Monitor Do not clean with concentrated bleach, corrosive chemicals or abrasive cleaning compounds. Servicing the Olympic Brainz Monitor

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Do not open the enclosures of the touch screen monitor or DAB for any reason. If any component is faulty, contact your healthcare institution's service personnel or an Authorized Service Center. See Contact. Disconnect when not in use If the equipment is not to be used for a prolonged period, disconnect it from the AC supply outlet to avoid damage from transient over-voltage. Electromagnetic compatibility The Olympic Brainz Monitor complies with the electromagnetic compatibility requirements of IEC 60601-1-2. Operation of the device may affect, or be affected by, nearby equipment due to the effects of electromagnetic interference. If this happens: Increase the separation between the Olympic Brainz Monitor and the other device. Reroute the device cabling. Plug the devices into AC supply outlets on separate circuit breakers. Refer to the Olympic Brainz Monitor Technical Manual for further compliance information and advice relating to electromagnetic interference.

Conventions Warnings, cautions and notes A WARNING identifies actions or situations that could lead to personal injury or death. Take note of all warnings before you operate the Olympic Brainz Monitor. A CAUTION identifies actions or situations that could damage the Olympic Brainz Monitor or other equipment, or could invalidate test results and measurements. Personal injury is unlikely. A NOTE contains advisory information about some aspect of the Olympic Brainz Monitor or its operation, or about a procedure or function. Terms and abbreviations The following table contains the terms and abbreviations used on the Olympic Brainz Monitor and its packaging, or in this online help and other documentation.

Term or Abbreviation

Meaning

Amplitude-integrated electroencephalograph (aEEG)

A time-compression technique for presenting long EEG recordings, using an asymmetrical filter, peak detector, and semi-logarithmic scale.

Artifact

Any electrical signal detected by an EEG machine from an extra-cerebral source (for example, electrode or cable movement, AC supply noise, or ventilator noise).

Session

In this document, the term session refers to an examination of a patient's EEG activity using the

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Olympic Brainz Monitor.

Channel

A complete system for the amplification and conditioning of electrical signals from two or more electrodes, or in the more generic sense, a stream of data derived from such channels.

Data Acquisition Box (DAB)

The DAB contains the interface between the lowlevel analog signals detected by the neonatal sensor set and the digital processing software of the Olympic Brainz Monitor. The DAB also contains the medical isolation circuitry used to protect both the patient and the instrument in the unlikely event of an electrical fault. The DAB is normally positioned close to the patient, often hung a the side of an incubator or cot.

Electrode

Conductor applied over, or inserted into, a region of the scalp to detect electrical activity of the brain.

Electroencephalograph (EEG)

Medical electrical equipment used to produce graphical recordings and/or a visual display of electrical activity of the brain.

Frequency

The number of complete cycles of repetitive waves in one second, measured in Hertz (Hz).

Impedance

The opposition to the flow of an electric current through a conductor, which gives a measurement of the quality of contact between the electrode and scalp. Impedance is measured in kOhms (kΩ).

Neonatal sensor set

A proprietary, non-invasive, self adhesive sensor array used to collect EEG signals from a neonate's brain.

Reference electrode

An electrode used as a reference point for the suppression of interfering signals detected by other electrodes or their cables.

Sagital suture

A serrated line at the top of the skull that is the junction of the two parietal bones.

Tragus

The prominence in front of the external opening of the ear.

Symbols The following table contains symbols and icons used on the Olympic Brainz Monitor and its packaging, or in this manual or other documentation.

Symbol or Icon

Meaning When lit, indicates that touch screen monitor is receiving power Type of BF equipment

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Consult operating instructions Attention: consult accompanying documents PS/2 keyboard connector US only: Caution: US federal law restricts this device to sale by or on the order of a physician EU only: Do not dispose of the Olympic Brainz Monitor as unsorted municipal waste Equipotential terminal (connection to hospital ground/earthing system) USB (connection to DAB, USB flash drive, USB disk drive)

General usage guidelines A note about online help navigation

The

arrows to the right take you back to the top of the current page.

To move to the previously viewed page, use the navigation buttons located on the help sidebar. , press the To search for a specific item, activate the on-screen keyboard by pressing Search field located near the top of the page, and then type your search criteria and press Search.

Components of the Olympic Brainz Monitor Touch screen monitor The touch screen monitor processes the digital signal from the data acquisition box (DAB) and displays the results on a touch screen unit that allows you to control the Olympic Brainz Monitor. The touch screen monitor is equipped with a medical-grade power supply. DAB The DAB converts the EEG signals from the sensors to digital form for processing. The DAB also contains circuitry that protects both patient and equipment in the unlikely event of an electrical fault. Connecting cables The DAB is equipped with a permanently affixed USB 2.0 cable that provides a data circuit between the DAB and the touch screen monitor. The USB 2.0 cable also provides the DAB with

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DC power. Roll Stand The roll stand provides an adjustable mounting platform for Olympic Brainz Monitor components and accessories. The roll stand features an adjustable pole, lockable wheels, and an accessory basket. Other items Other items supplied with the Olympic Brainz Monitor include the following: Data transfer accessories for transferring files to removable media. Literature and software that describe how to assemble and use the Olympic Brainz Monitor. Disposable starter materials to help you learn how to apply a neonatal sensor set. Other items that can be used as optional accessories include the following: OBM Network Laser Printer OBM Desktop Stand Kit OBM Neonatal Sensor Set OBM Sensor Application Kit OBM Wrap Hats (pack of 10 with dots) OBM Skin Markers (pack of 10) OBM USB Memory Stick OBM Low Impedance Needle Electrodes Any accessory that is connected to the touch screen monitor and draws power from a separate AC source introduces a potential risk to patient safety by creating a current path bypassing the medical grade power supply. Both the touch screen monitor and accessory must be connected to a medical grade isolation transformer to mitigate risk to the patient.

Copyright 2010 Natus Pediatrics

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Quick Start

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Quick start guide Monitoring a patient Applying a neonatal sensor set Starting recording Checking signal quality Troubleshooting During a session you can... Pausing a session Ending a session Marking events Creating snapshots Archiving sessions Powering down the OBM

Monitoring a patient Full operating instructions are available in the Olympic Brainz Monitor (OBM) online Help. 1. Set up the OBM close to the patient and check that the connections are correct. 2. Hang the data acquisition box (DAB) from a convenient hook or handle on the incubator or cot. 3. Switch on the power switch and wait for the system to power up to the main display. 4. Touch the record button, enter patient details (optional), and then press Next. Select either the 3-electrode or 5-electrode configuration (according to the number of sensors you are using), and press Start Recording. The OBM starts live monitoring mode. 5. Apply the neonatal sensor set. Use the Electrode impedance view to check impedance levels of the individual sensors. When using a 5-electrode configuration, check the impedance levels of the first two sensors before applying the remaining sensors. 6. Enter a marker to indicate when preparations are complete (optional). 7. During live monitoring you can:

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    - mark an event     - archive sessions to a USB device or network shared folder     - create snapshot reports and (optionally) send them to a USB device or network printer     - review previously recorded session data (while continuing to record new data in the background)     - manually score regions of aEEG for background patterns and seizure activity     - monitor electrode sensor contact quality A note about the user interface Use the buttons on the taskbar at the bottom of the main window to access primary operations (see Interface Basics). Most operations (except Home and Record) use overlays to display information and options. The overlays have buttons down the left side that access additional options and functions. Many overlay pages also have tabs across the top for more views and options. For example, to access the Tools/Archive/Content overlay, do the following: 1. Press the Tools button in the taskbar. The Tools overlay opens. Press the Tools button once to open the overlay to half the height of the window. Press the Tools button again to open the overlay to the full height of the window. By default, all overlays except the Reports overlay open to half height. 2. In the Tools overlay, press the Archive button in the left sidebar. The Tools/Archive overlay opens. 3. Press the Content button at the top of the Tools/Archive overlay. The Tools/Archive/Content overlay opens. To close an overlay completely:

Press the Home button

at the left end of the taskbar.

Applying a neonatal sensor set 1. Lay out the sensor application materials, including the sensor set and positioning aid (in the sensor pouch). Place the wrap hat under the head, aligning the head with the body.

2. Keep the positioning aid vertical and parallel to the face. Align it so that the letter at the ear tragus is the same as the letter at the sagittal suture. The forward edge of the positioning aid should touch the tragus.

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3. Mark the two sensor sites, one on each side of the positioning aid, at the ends of the arrow.

4. Part the hair vertically at the first mark by using a damp gauze pad, so that a small bald spot is created at the site

5. Pat the site and the surrounding hair dry, keeping the hair parted. DO NOT RUB. Note: Keeping a finger next to the bald spot helps. (Hint: The pen mark washes off.)

6. Using a little NuPrep™, clean the exposed scalp, working up and down the length of the parting. Hold the skin taut as you clean.

7. Remove the NuPrep™ with a damp gauze pad, working outwards from the center to keep the hair parted.

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8. Pat the site and the surrounding hair dry, as before, maintaining the bald spot.

9. Apply the first sensor directly over the clean bald spot with the sensor wire upwards.

10. Repeat the previous steps for the second sensor site. In a similar way, prepare the site for the Reference sensor on the shoulder, neck, or behind the ear. (Choose a site with no hair so that it is unlikely to be dislodged.)

11. Connect the neonatal sensor set to the DAB (data acquisition box) and check the contact quality of the sensors by starting a new monitoring session. Check the impedance level of each sensor by using the Electrode Impedance View. (An impedance reading under 5 KΩ indicates good contact quality.) Note: When applying a 3-lead configuration, you can perform the impedance level check only after you have applied all leads. In this case, skip to step 13. 12. When the contact quality of both electrodes is OK, use the wrap hat to secure the sensors, and then turn the head.

13. Prepare the sites and apply the sensors to the second side, as before. When the contact quality for all the sensors is OK, fold the wrap hat around the head and secure with tape. Note: Keep an eye on the Electrode Impedance View while securing the wrap hat, making sure contact quality is maintained.

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14. Carefully gather the lead wires emerging from the wrap hat and guide them out of the way (securing the amplifier to the bed sheet using the supplied clip).

Starting recording To begin live monitoring of the patient:

1. Press the record button. 2. Optionally, enter patient information, and press Next. 3. Select the electrode configuration. If you select a 3-electrode configuration, do not attach the other two electrodes to the DAB. Otherwise excessive electrical interference might result. The electrode configuration you select must agree with the number of electrode sensors you applied to the patient. 4. Press Start Recording. For more information about session recording, see Recording.

Checking signal quality During live monitoring, ensure the Electrode Impedance View is selected. To start Electrode Impedance View: Press the impedance selector button. The Electrode Impedance View displays the individual impedance values of each electrode measured in kΩ as follows: Values below 5 kΩ are considered good. Values above 10 kΩ are poor. Values above 20 kΩ are extremely poor (generating a Signal Quality Alert). Read more about the Electrode Impedance View.

Troubleshooting For information about troubleshooting poor impedance and signal quality, see Diagnosing poor electrode sensor contact.

During a session you can...

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General Change display modes between biparietal and bilateral views Select supplemental data displays (Impedance, EEG) Review previously recorded data for the current session Use the live impedance view to monitor sensor contact quality Determine the status and alert mode of the session Pause or resume session recording

Patient Edit patient details Review stored snapshots Send stored snapshots to a USB memory stick End the session Open previously recorded session for Review

Markers Mark an event Edit existing markers View a list of all markers in the session Navigate through the session using the marker list Manually score background patterns

Reports Create snapshots Send snapshots to a printer Send the session to a CSV ASCII file

Tools Manage session archiving Import and export sessions Manage system storage space Configure clinical configuration settings (for example, customize one-touch markers) Launch the OBM maintenance utility (system configuration tools)

Maintenance utility Select language preference Set system date/time Configure storage locations Prepare archive media Update the OBM software Calibrate the screen Save and restore system settings to/from a USB storage device Connect the bedside unit to a network View the diagnostic event log Configure group access to maintenance utility features

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