Olympic BrainZ Monitor Reference Manual Issue F Iteration 1 2011

All product names and brand names in this document are trademarks or registered trademarks of their respective holders. © Copyright 2011 Natus Medical Incorporated. All rights reserved. No part of this document may be photocopied or reproduced without the prior written consent of Natus Medical Incorporated. Product specifications may change without prior notice.

OBM00201 Natus Olympic Brainz Monitor Reference Manual Issue No:

F

Issue Date:

2011

Iteration:

1

Natus Medical Incorporated Excel-Tech Ltd. (XLTEK) 2568 Bristol Circle Oakville, Ontario L6H 5S1 Canada Telephone: Fax: Email: Website:

1-800-303-0306 (US/CAN) Worldwide: +1-650-802-0400 +1-650-802-6620 [email protected] www.natus.com

European Authorized Representative Natus Europe GmbH Robert-Koch-Str 1 82152 Planegg Germany

OBM Olympic Brainz Monitor Reference Manual | ii

Table of Contents Introduction... 1 About This Manual ... 1 Who Should Read This Manual ... 1 Intended Use ... 1 Safety Information... 2 Conventions ... 5 Terms and Abbreviations ... 5 Symbols ... 6 Olympic Brainz Monitor System Overview ... 7 Assembling the Olympic Brainz Monitor ... 10 Olympic Brainz Monitor Packaging ... 10 Assembling the Roll Stand ... 10 Attaching and Connecting the Components ... 13 Preparing the Olympic Brainz Monitor for First Use ... 17 Starting and stopping the Olympic Brainz Monitor ... 17 Setting up the Olympic Brainz Monitor ... 17 Changing the Language ... 18 Setting System Date and Time ... 18 Selecting the Graphs to Display ... 18 Configuring Archive and Export Locations ... 19 Checking for Normal Operation ... 19 Adjusting screen brightness and audio volume ... 19 Using Olympic Brainz Monitor Components ... 20 Moving the Olympic Brainz Monitor ... 20 Adjusting the Touch Screen Monitor Position ... 20 Using the Accessory Basket ... 21 Managing Cables ... 21 Restoring a Session after AC Power Interruption ... 22 Using the Online Help System ... 23 The Olympic Brainz Viewer ... 24 System Requirements ... 24 Installation ... 24 Maintenance ... 26 Checking for Normal Operation ... 26 Cleaning ... 26 Routine Maintenance ... 27 Calibrating the Olympic Brainz Monitor ... 28 Upgrading software ... 28 Servicing ... 29 Specifications ... 30 General Specifications ... 30 EEG Specifications ... 30

OBM Olympic Brainz Monitor Reference Manual | iii

DAB Specifications ... 31 Environmental Specifications ... 31 Standards compliance and normative references information ... 32 Safety Standard of Compliance and normative references ... 32 EMC Standard of Compliance and normative references ... 33 Declaration of compliance for IEC 60601-1-2 ... 35 Declaration of compliance for FCC ... 39 Replacement Parts ... 40 Authorized Service Centers ... 41 United States ... 41 Outside U.S ... 41 Appendix A: Assembling the Table Stand ... 42

OBM Olympic Brainz Monitor Reference Manual | iv

Introduction

Introduction In this section:        

About This Manual Who Should Read This Manual Intended Use Safety Information Conventions Terms and Abbreviations Symbols Olympic Brainz Monitor System Components

About This Manual This manual contains information that you need to assemble, configure, and safely operate the Natus Olympic Brainz Monitor (CFM). For instructions about operating the Olympic Brainz Monitor, applying a neonatal sensor set, and checking for signal quality, see the Quick Start topic in the Olympic Brainz Monitor online Help. It is important that you read the Quick Start section in the Olympic Brainz Monitor Help before you use the neonatal sensor set.

Who Should Read This Manual All users of the Olympic Brainz Monitor should read the Olympic Brainz Monitor Reference Manual, particularly Safety Information on page 2.

Intended Use The Olympic Brainz Monitor, a Cerebral Function Monitor (CFM), 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 post-conceptual 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 hypoxicischemic event.

The Olympic Brainz Monitor does not provide any diagnostic conclusion about the patient‟s condition.

OBM Olympic Brainz Monitor Reference Manual | 1

Introduction

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 enclosures of the touch screen monitor or DAB, especially when 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.



Take care to avoid spilling liquid into any opening in any part of the Olympic Brainz Monitor. Do not submerge any component in liquid. This may cause fire or electrical shock.

AC supply outlet 

Use only a three-wire, 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 4-1/2 lbs. (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 floor.

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.

OBM Olympic Brainz Monitor Reference Manual | 2

Introduction Transporting the Olympic Brainz Monitor 

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/electrosurgery or defibrillation equipment on a patient while the patient is 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 on the roll stand to avoid personal injury.

Patient strangulation hazard 

To minimize the risk of patient strangulation, position the DAB so as to minimize any risk of the cables becoming wrapped around the patient‟s throat.

Use of accessory equipment 

Use of accessory equipment that is not approved by Natus Medical Incorporated or that does not comply 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 systems standard IEC 60601-1-1. Anyone who connects additional equipment to such an accessory port configures a medical system, and is responsible for ensuring that the system complies with the requirements of the medical electrical systems standard IEC 60601-1-1. If in doubt, contact an Authorized Service Center or Natus Medical Incorporated. 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 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 and damaged.



The equipment has obvious signs of breakage.

Care when touching patient 

Do not touch any exposed metal parts at the rear panel of the touch screen monitor

OBM Olympic Brainz Monitor Reference Manual | 3

Introduction 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 this document for future use.

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 the 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 or 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 recording session. See Restoring a Session after AC Power Interruption on page 22.

Cleaning the Olympic Brainz Monitor 

Do not clean with concentrated bleach, corrosive chemicals, or abrasive cleaning compounds.

Servicing the Olympic Brainz Monitor 

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 Authorized Service Centers on page 41.

Disconnect when not in use 

If the equipment is not to be used for a long time, disconnect it from the AC supply outlet to avoid damage by transient over-voltage.

OBM Olympic Brainz Monitor Reference Manual | 4

Introduction 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 branches.

Operation of the Olympic Brainz Monitor may be affected by mobile and portable RF communications equipment. Refer to the Olympic Brainz Monitor Technical Manual (OBM00202) for further compliance information and advice relating to electromagnetic interference.

Conventions This manual uses the conventions described in the following table. Convention

Description A warning identifies actions or situations that could lead to personal injury or death. Read 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 describes the terms and abbreviations used on the Olympic Brainz Monitor and its packaging, or in this manual 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, rectifier, and semi-logarithmic amplifier.

Artifact

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

Session

In this document, the term session refers to an examination of a patient’s EEG activity using the Olympic Brainz Monitor.

Channel

A complete system for the amplification and conditioning of electrical signals from two or more electrodes.

Data acquisition box (DAB)

The DAB contains the interface between the low-level analog signals detected by the neonatal sensor set and the digital processing software

OBM Olympic Brainz Monitor Reference Manual | 5

Introduction 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 at 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.

ESD

Electro Static Discharge – Electro static discharge is defined as the transfer of electro static charges between bodies at different potential caused by direct contact or induced by electro static field.

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

Meaning When lit, indicates that touch screen monitor is receiving power. Direct current. Type BF equipment, defibrillator proof. Consult operating instructions. Attention: consult accompanying documents. PS/2 keyboard connector.

OBM Olympic Brainz Monitor Reference Manual | 6

Introduction US only: Caution: US federal law restricts this device to sale by or on the order of a physician.

Turn counterclockwise to loosen and unlock a fixture.

Turn clockwise to tighten and lock a fixture.

EU only: Do not dispose of the Olympic Brainz Monitor as unsorted municipal waste.

Equipotential terminal (connection to hospital grounding/earthing system).

USB (e.g., connection to DAB, USB flash drive, etc.). Pins of connectors identified with the ESD warning symbol shall not be touched.

Olympic Brainz Monitor System Overview The Olympic Brainz Monitor, a Cerebral Function Monitor (CFM), is a three-channel electroencephalograph (EEG) that detects and records small electrical signals from both hemispheres of the patient‟s brain.

OBM Olympic Brainz Monitor Reference Manual | 7

Introduction Figure 1: Olympic Brainz Monitor system

Tilt mechanism Touch screen monitor

Roll pole

DAB

Accessory basket

AC power cable

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.

OBM Olympic Brainz Monitor Reference Manual | 8

Introduction

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 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: 

Printer (recommended: HP network printer).

User Interface Screen The main user interface screen appears when you turn on the Olympic Brainz Monitor. This screen displays the graphs, including aEEG, EEG, and Impedance. For more information about these graphs, see online Help. By touching the buttons displayed at the bottom of the screen, you can access the major functions of the Olympic Brainz Monitor. The functions you can control from the main user interface screen are: 

Patient - Examine previously recorded sessions, create a new session, and update patient information for the current session.



Markers - Add markers, navigate through a session to specific markers, and use manual scoring tools to mark regions of the session for background patterns and suspected seizure activity.



Reports - Create snapshots of a session, print snapshots, and export session data in comma-separated value (CSV) format so that it can be imported into various data analysis tools.



Tools - Manage session data, import sessions from and export sessions to external media such as USB flash drives and network locations, manage session archiving, configure various display settings, exit to the maintenance utility, and shut down the Olympic Brainz Monitor.



Help - View the Help system for conceptual and procedural information.



Start and stop session recording.

OBM Olympic Brainz Monitor Reference Manual | 9

Assembling the Olympic Brainz Monitor

Assembling the Olympic Brainz Monitor In this section:   

Olympic Brainz Monitor Packaging Assembling the Roll Stand Attaching and Connecting the Components Read this section as you unpack the Olympic Brainz Monitor from its shipping packaging and before you begin to assemble the device.

Olympic Brainz Monitor Packaging The Olympic Brainz Monitor is supplied in the following separate packages: 

A large, narrow box that contains the roll stand components (extendable pole, base with casters, power code cleat, accessory basket assembly, and tilt mounting bracket).



A wide box that contains the touch screen monitor.



A small box that contains the DAB with integrated USB 2.0 cable.



A package that contains the AC power cable.



A small box that contains Olympic Brainz Monitor documentation, the Olympic Brainz Viewer CD, a box of sensors, and a sensor application kit.

Assembling the Roll Stand Stage 1: Unpacking the components 1. Unpack the components of the roll stand onto a large flat work surface. Keep the contents of each carton separate. 2. Check the cartons carefully for fastenings and accessories (normally packed in small plastic bags). Stage 2: Attaching the accessory basket To ensure stability, the accessory basket must be mounted within 32” (80 cm) of the floor.

1. Clip one of the plastic mounting brackets onto the long side of the accessory basket with the extra horizontal reinforcing. See Figure 2 on page 11. 2. Slide the mounting bracket up the vertical ribs of the accessory basket. 3. Clip the other mounting bracket directly underneath the first one and slide into position. 4. Locate the extendable pole. 5. Slide the accessory basket onto the bottom of the extendable pole, positioning it on the lower part of the pole, within 32” (80 cm) of the floor. 6. Tighten the two Phillips screws to fasten the accessory basket to the extendable pole.

OBM Olympic Brainz Monitor Reference Manual | 10

Assembling the Olympic Brainz Monitor Figure 2: Assembling the accessory basket

Within 23” (80 cm) of ground level

Mounting brackets

Stage 3: Attaching the base to the extendable pole 1. Insert the bottom end of the pole in the base, ensuring that the locator pin is seated in the slot provided. 2. Lay the roll stand on its side on an empty, flat work surface. 3. Align the two mounting holes in the foot pedal assembly with the two threaded mounting holes in the bottom of the pole, ensuring that the foot pedal is positioned between two legs of the base. See Figure 3 on page 11. 4. Using the 3/16” hex key, fasten the pedal assembly to the pole with the two 1/4-20 x 3/4” socket head cap screws. 5. Turn the roll pole upright and check that the roll stand is steady. If it is unsteady, retighten the socket head cap screws. Figure 3: Assembling the base

Foot pedal assembly

Stage 4: Attaching the AC power cable cleat 

Attach the two parts of the power cable cleat mounting bracket to the extendable pole and tighten the two Phillips screws. See Figure 4 on page 12.

OBM Olympic Brainz Monitor Reference Manual | 11

Assembling the Olympic Brainz Monitor Figure 4: Attaching the AC power cable cleat

Cable cleat

Stage 5: Attaching the handle 

Attach the two parts of the handle assembly to the extendable pole and tighten the two Phillips screws. See Figure 5. Figure 5: Attaching the AC handle

Stage 6: Attaching the tilt mounting bracket 1. Place the tilt mounting bracket on top of the extendable pole and position it on the side facing the basket. Tighten the three Phillips screws. See Figure 6 on page 13. 2. Affix the adhesive plastic screw cover to the top of the tilt mounting bracket. 3. Tighten the tilt adjustment lever.

OBM Olympic Brainz Monitor Reference Manual | 12

Assembling the Olympic Brainz Monitor Figure 6: Attaching the tilt mounting bracket

Tilt mounting bracket

Attaching and Connecting the Components Stage 1: Attaching the touch screen monitor Before attaching the touch screen monitor, ensure that the height adjustment knob and the tilt adjustment lever are firmly tightened.

The touch screen monitor is packaged in a separate carton. 1. Unpack the touch screen monitor and remove the plastic wrapping. Place the touch screen monitor face down on a clean, smooth work surface. 2. Locate the four M4 x 16mm screws packaged with the tilt mounting bracket. 3. Attach the VESA mounting adaptor to the back of the touch screen monitor using the four M4 x 16mm screws. See Figure 7 on page 14.

OBM Olympic Brainz Monitor Reference Manual | 13

Assembling the Olympic Brainz Monitor Figure 7: Attaching VESA mounting adaptor to the touch screen monitor

4. Thread two M4 x 8mm screws into the two top threaded holes of the VESA mounting plate, leaving 4mm of thread exposed. See Figure 8 on page 14. Figure 8: Attaching VESA mounting adaptor to the touch screen monitor

5. Lift the monitor onto the tilt mounting bracket, by guiding the two M4 screws into the slots of the mounting bracket. Thread the last two M4 x 8mm screws into the bottom two threaded holes in the VESA mounting adaptor. See Figure 9 on page 15. 6. Fully tighten all the screws.

OBM Olympic Brainz Monitor Reference Manual | 14

Assembling the Olympic Brainz Monitor Figure 9: Attaching the touch screen monitor to the roll pole

Stage 2: Connecting the components Using the figure below as a guide, connect the: 

DAB to the touch screen monitor using the DAB‟s integrated USB 2.0 cable (by using one of the four USB 2.0 ports on the back of the touch screen monitor or one of the two USB ports located under the side panel).



Power supply cable to the touch screen monitor.

An Equipotential Terminal is provided to optionally connect to a hospital ground/earth system. Figure 10: Connecting the components

Equipotential terminal

Assembly of the Olympic Brainz Monitor is now complete.

OBM Olympic Brainz Monitor Reference Manual | 15

Assembling the Olympic Brainz Monitor Before first use: 

Read and follow the procedures described in Preparing the Olympic Brainz Monitor for Use on page 17.



Perform any electrical safety tests required by the guidelines for checking electrical equipment at your healthcare institution, in accordance with the appropriate national standards (for example DIN VDE 0751 and AS/NZS 3551).

OBM Olympic Brainz Monitor Reference Manual | 16