Olympic Brainz Monitor Reference Manual Rev 06 Oct 2022

P/N: 027050 Rev 06 Natus Olympic Brainz Monitor CFM Olympic Brainz Monitor Reference Manual Revision Date: 10/15/2022 Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) 2568 Bristol Circle Oakville, Ontario, L6H 5S1 Canada Telephone: +1-905-829-5300 Worldwide: +1-650-802-0400 Website: natus.com Technical Service: +1-800-303-0306 Technical Service Fax: +1-650-802-8680 Technical Service Email: [email protected] Customer Service: +1-800-303-0306 Customer Service Fax: +1-650-802-6620 Customer Service Email: [email protected] International Support – Please contact your local Distributor Distributor locations can be found at natus.com EU Representative / Importer Natus Manufacturing Limited IDA Business Park Gort Co. Galway, Ireland Swiss Authorized Representative Arazy Group Switzerland GmbH Bruderholzallee 53 4059 Basel Switzerland [email protected] UK Responsible Entity Natus Nicolet UK Ltd Baynards Green Trading Estate Prospect House Oxfordshire Bicester OX27 7SG England, United Kingdom

OBM Olympic Brainz Monitor Reference Manual PN 027050 Rev 06 (Revision Date: Oct. 2022)

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Copyright © 2019–2022 by Natus Medical Incorporated. All rights reserved. All product names appearing on this document are trademarks or registered trademarks owned, licensed to, promoted, or distributed by Natus Medical Incorporated, its subsidiaries, or affiliates. Disclaimer Any serious incident that has occurred in relation to the device should be reported to Natus Medical Incorporated DBA Excel-Tech Ltd. (Xltek) and the competent authority of the Member State in which the user and/or patient is established.

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Table of Contents TABLE OF CONTENTS... 1 INTRODUCTION ... 3 About This Manual ... 3 Who Should Read This Manual... 3 Intended Use ... 3 Essential Performance ... 3 Intended User ... 4 Patient Target Group ... 4 Clinical Benefits ... 4 Contraindications / Residual Risks ... 4

SAFETY INFORMATION ... 4 Warnings and Precautions ... 4 Instructions to Access the eIFU ... 5 IFU in Printed Form ... 5 General Safety Information ... 6 Symbol Definitions ... 11 Terms and Abbreviations ... 16

OLYMPIC BRAINZ MONITOR SYSTEM OVERVIEW... 17 Touch Screen Monitor ... 17 DAB... 17 Connecting Cables... 17 Roll Stand... 18 Other Items ... 18 User Interface Screen ... 18

ASSEMBLY INSTRUCTIONS ... 19 Olympic Brainz Monitor Packaging ... 19 Assembling the Roll Stand... 19 Attaching and Connecting the Components ... 23

PREPARING THE OLYMPIC BRAINZ MONITOR FOR FIRST USE ... 26 Starting and stopping the Olympic Brainz Monitor ... 26 Setting up the Olympic Brainz Monitor ... 26 Changing the Language ... 27 Setting System Date and Time... 27 Activating and Configuring Detectors ... 27 Selecting the Graphs to Display ... 28 Configuring Archive and Export Locations... 29 Checking for Normal Operation ... 29 Adjusting screen brightness and audio volume ... 29

USING OLYMPIC BRAINZ MONITOR COMPONENTS... 30 OBM Olympic Brainz Monitor Reference Manual PN 027050 Rev 06

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Moving the Olympic Brainz Monitor ... 30 Adjusting the Touch Screen Monitor Position ... 30 Using the Accessory Basket ... 31 Managing Cables ... 31

RESTORING A SESSION AFTER AC POWER INTERRUPTION ... 32 USING THE ONLINE HELP SYSTEM ... 32 THE OLYMPIC BRAINZ VIEWER ... 33 System Requirements ... 33

MAINTENANCE ... 34 Checking for Normal Operation ... 34 Cleaning ... 34 Routine Maintenance ... 35 Weekly Maintenance ... 35 Quarterly Maintenance ... 35 Annual Maintenance ... 35 Calibrating the Olympic Brainz Monitor ... 36 Upgrading software ... 37 Servicing ... 37

SPECIFICATIONS ... 38 General Specifications ... 38 Display... 38 Accessory Basket ... 38 Power Supply (External) ... 38 EEG Specifications ... 38 Computed Parameters ... 38 Display Modes ... 38 DAB Specifications ... 39 Environmental Specifications ... 39

STANDARDS COMPLIANCE AND NORMATIVE REFERENCES INFORMATION ... 40 Regulatory Standards of Compliance and Normative References ... 40

DECLARATION OF COMPLIANCE FOR IEC 60601-1-2 EDITION 4.0 ... 41 Electromagnetic Emissions ... 41 Electromagnetic Immunity ... 42

DECLARATION OF COMPLIANCE FOR FCC ... 43 REPLACEMENT PARTS ... 44 AUTHORIZED SERVICE CENTERS ... 45 United States ... 45 Outside U.S. ... 45

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Introduction About This Manual This manual contains information that you need to assemble, configure, and safely operate the Natus Olympic Brainz Monitor (OBM). 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. Important: 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 4.

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 assessment of HypoxicIschemic Encephalopathy severity and long-term outcome, in full term neonates (post-conceptual age of 37-46 weeks) who have suffered a hypoxic-ischemic event.



The RecogniZe seizure detection algorithm is intended to mark sections of EEG/aEEG that may correspond to electrographic seizures in only the centro-parietal regions of full term neonates (defined as from birth to 28 days post-delivery and corresponding to a postconceptual age of 37 to 46 weeks). EEG recordings should be obtained from centro-parietal electrodes (located at P3, P4, C3 and C4 according to 10/20 system). The output of the Recognize algorithm is intended to assist in post hoc assessment of EEG/aEEG traces by qualified clinical practitioners, who will exercise professional judgment in using the information.



The Background Pattern classification algorithm is intended for neonatal patients, defined as from birth to 28 days post-delivery, and corresponding to a post-conceptual age of 37 to 46 weeks, in clinical environments such as the intensive care unit, operating room, and for clinical research.



To analyze and identify background patterns in aEEG, including continuous and discontinuous activity, burst suppression, low voltage, and inactive patterns. The aEEG must be obtained from a pair of parietal electrodes located at positions corresponding with P3 and P4 of the International 10/20 System. The output of the background pattern classification algorithm must be reviewed and interpreted by qualified clinical practitioners.

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

Essential Performance This device is defined as continuous-use EEG equipment. Locating the equipment near a source of electromagnetic interference may result in degradation of recorded EEG data. If EEG data appears noisy, move the device farther from the source of the interference.

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Intended User The Olympic Brainz Monitor is intended to be used by a variety of clinicians on neonates to acquire and utilize EEG signals, when used in conjunction with other clinical data, in intensive care areas, Operating Room, Emergency Room, and clinical research lab.

Patient Target Group Full term neonatal patients (defined as from birth to 28 days post-delivery, and corresponding to a postconceptual age of 37 to 46 weeks).

Clinical Benefits To monitor the state of the brain. For determination of, and long-term monitoring of the neurological status of patients that may have suffered a hypoxic-ischemic event For monitoring of neurological status to assist in the clinical management and treatment of the patient by observing how the treatment affects the neurological status as shown by the OBM. To assist in the prediction of neurological outcome. To monitor and record frequency and intensity of ‘events’ to assist in management of anti-convulsive therapy. To assist in the prediction of and severity of Hypoxic-Ischemic Encephalopathy and long-term outcome in infants who have suffered a hypoxic-ischemic event.

Contraindications / Residual Risks There are no known contraindications or side effects.

Safety Information Warnings and Precautions This section provides information on safety warnings and precautions. It is important to read and understand this safety information before using the system. WARNING: Indicates a hazardous situation that, if not avoided, could result in death or serious injury. CAUTION: Indicates a hazardous situation that, if not avoided, could result in minor injury, material damage, or delay in use. Important: An instruction provided to help ensure correct clinical results and provide quality assurance to the device’s procedures. Note: Information in this category is not considered precautionary, it is background information provided to clarify a particular step or procedure.

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Instructions to Access the eIFU A copy of the Instructions for Use in PDF format is in the associated product area: CFM Olympic Brainz Monitor: www.natus.com/natus-support Search for Olympic Brainz Monitor Reference Manual and choose the version for your local language. The files can be printed, saved, or searched using Adobe Reader. A copy of Adobe Reader can be downloaded directly from Adobe Systems (www.adobe.com).

IFU in Printed Form You can obtain instructions for use in printed form upon request. The instructions for use will be provided at no additional cost; and within seven (7) calendar days of receiving the request. Contact Natus Medical Incorporated – Worldwide: +1-650-802-0400 or Website: natus.com

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General Safety Information Before using the Olympic Brainz Monitor, read all sections of this manual carefully. Observe all precautions to ensure the safety of the patient and those near the instrument. In addition, please refer to your hospital policy and procedure for EEG administration. Warning Statements WARNING: Explosion hazard

 Do not use the Olympic Brainz Monitor in a flammable atmosphere (for example, where concentrations of flammable anesthetics may be present). WARNING: 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. WARNING: AC Supply Outlet  Class 1 Device “WARNING: To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.” If a three-wire, grounded supply outlet is not available, do not operate the Olympic Brainz Monitor. Note: 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.”  User is not to position ME equipment in such a way as to make it difficult to operate the disconnection device. WARNING: Supply Voltage  Make sure the supply voltage is correct before connecting the Olympic Brainz Monitor to the AC supply outlet. WARNING: Power Cable  Position the AC power cable so that it will not be stepped on or rolled over by wheeled equipment. WARNING: Mounting on Roll Stand

 The Olympic Brainz Monitor utilizes a certified medical panel PC designed to accommodate the standard VESA 75/100 mm mounting configuration. When assembled as noted in the Technical Reference Manual and attached to the optional roll stand (PN OBM00003) it is tested to meet the standards stated in this manual. It is the customer’s responsibility to correctly assemble and attach the Olympic Brainz Monitor (PN OBM00401) to the roll stand or any other mounting solution that meets the same standards.

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WARNING: 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. WARNING: 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. WARNING: 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. WARNING: Use with High Frequency Electrosurgical Equipment  Do no connect the Olympic Brainz Monitor to the patient while using diathermy/electrosurgery or defibrillation equipment on the patient WARNING: Use with MRI or CT Scanners

 Do not use the Olympic Brainz Monitor in the vicinity of MRI or CT systems. WARNING: Personal Injury Hazard

 Ensure that the touch screen monitor is securely mounted on the roll stand to avoid personal injury. WARNING: 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. WARNING: 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. WARNING: 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 3 meters in length.

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WARNING: 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. WARNING: Care when Touching Patient

 Do not touch any exposed metal parts at the rear panel of the touch screen monitor unit (including connectors) while simultaneously touching a patient. WARNING: Electrical Stimulator Hazard

 Do not use the Olympic Brainz Monitor simultaneously with electrical stimulators. WARNING: Electromagnetic Immunity  Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.  Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.  Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the OBM Olympic Brainz Monitor , including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. Note: The Olympic Brainz Monitor is intended for use in an electromagnetic environment in which radiated Electromagnetic disturbances are controlled; proper precaution should be taken to prevent adverse events to Patient and Operator. Olympic Brainz Monitor can help prevent electromagnetic interference by maintaining a minimum distance of 30 cm (12 inches).

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Caution Statements CAUTION: 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. CAUTION: Do Not Autoclave

 Do not autoclave any component of the Olympic Brainz Monitor, as serious and irreversible damage may result. CAUTION: Ventilation

 Do not obstruct the passage of air behind or around the touch screen monitor or block the ventilation inlet holes at its rear. CAUTION: Indoor Use Only  The Olympic Brainz Monitor is intended for indoor use only. CAUTION: 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. CAUTION: Electrostatic Discharge

 Pins of connectors identified with the ESD warning symbol shall not be touched. CAUTION: 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 32. CAUTION: Cleaning the Olympic Brainz Monitor

 Do not clean with concentrated bleach, corrosive chemicals, or abrasive cleaning compounds. CAUTION: 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 45. CAUTION: 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.

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CAUTION: Electromagnetic Compatibility The Olympic Brainz Monitor complies with the electromagnetic compatibility requirements of IEC 606011-2 along with particular standard requirements of IEC 60601-2-26. 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 (027051) for further compliance information and advice relating to electromagnetic interference.

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Symbol Definitions Symbol

Standard Reference ISO 7000 / IEC 60417 Symbol 5009

IEC 60601-1, Table D.1 #4

IEC 60417-5334 IEC 60601-1 Table D.2 #10

ISO 15223-1 Symbol 5.4.3

ISO 15223-1 Symbol 5.4.4

IEC 60601-1 Table D.1 #10

IEC 60601-1 Table D.2 #2

21 CFR Part 801.109(b)(1)

Standard Title

Symbol Title

Explanatory Text

Graphical symbols for use on equipment

Stand-by

Medical electrical equipment - Part 1: General requirements for basic safety and Essential performance Graphical symbols for use on equipment Medical electrical equipment - Part 1: General requirements for basic safety and essential performance Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied Medical electrical equipment - Part 1: General requirements for basic safety and essential performance Medical electrical equipment - Part 1: General requirements for basic safety and Essential performance LabelingPrescription devices

Direct current

Identifies the switch or switch position by means of which part of the equipment is switched on in order to bring it into the stand-by condition. Indicates on the rating plate that the equipment is suitable for direct current only; to identify relevant terminals.

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Defibrillationproof type BF applied part Follow instructions for use

Defibrillation-proof type BF applied part equipment Refer to instruction manual/ Booklet. NOTE on ME EQUIPMENT "Follow instructions for use”

Consult instructions for use

Indicates the need for the user to consult the instructions for use.

Caution

Indicates the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical device itself.

General warning sign

Indicates a hazard of potential personal injury to patient or operator.

Prescription only

Indicates that the product is authorized for sale by or on the order of a licensed healthcare practitioner.

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Symbol

Standard Reference 2012/19/EU

IEC 60601-1, Table D.1 #8

ISO 7000-3650

ISO 15223-1 Symbol 5.1.1

ISO 15223-1 Symbol 5.1.2

ISO 15223-1 Symbol 5.1.3

ISO 15223-1 Symbol 5.1.4

ISO 15223-1 Symbol 5.1.5

ISO 15223-1 Symbol 5.1.6

Standard Title

Symbol Title

Explanatory Text

Waste Electrical and Electronic Equipment (WEEE)

Disposal at end of operating life instructions

Medical electrical equipment - Part 1: General requirements for basic safety and Essential performance

Equipotentiality

Indicates that electrical and electronic equipment waste should not be discarded together with unseparated waste but must be collected separately. Identifies the terminals which, when connected, bring the various parts of an equipment or of a system to the same potential, not necessarily being the earth (ground) potential, e.g. for local bonding.

Graphical symbols for use on equipment Registered symbols Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied

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Universal Serial Bus (USB), port/plug

USB (e.g., connection to the DAB, USB flash drive, etc.)

Manufacturer

Indicates the medical device manufacturer.

Authorized representative in the European Community

Indicates the Authorized representative in the European Community.

Date of manufacture

Indicates the date when the medical device was manufactured.

Use-by date

Indicates the date after which the medical device is not to be used.

Batch code

Indicates the manufacturer's batch code so that the batch or lot can be identified.

Catalogue number

Indicates the manufacturer’s catalogue number so that the medical device can be identified.

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Symbol

Standard Reference ISO 15223-1 Symbol 5.1.7

ISO 15223-1 Symbol 5.4.5 (Reference Annex B for the general prohibition symbol) ISO 15223-1 Symbol 5.4.2

ISO 15223-1 Symbol 5.2.8

ISO 15223-1 Symbol 5.3.2

ISO 15223-1, Symbol 5.3.4

ISO 15223-1 Symbol 5.3.7

ISO 15223-1 Symbol 5.3.8

ISO 15223-1 Symbol 5.3.9

Standard Title

Symbol Title

Explanatory Text

Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied

Serial number

Indicates the manufacturer's serial number so that a specific medical device can be identified.

Not made with natural rubber latex

Indicates that the medical device is not made with natural rubber latex.

Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied

Do not re-use

Indicates that the medical device is intended for one use, or for use on a single patient during a single procedure.

Do not use if package is damaged

Indicates a medical device that should not be used if the package has been damaged or opened.

Keep away from sunlight

Indicates a medical device that needs protection from light sources.

Keep dry

Indicates a medical device that needs to be protected from moisture.

Temperature limit

Indicates the (storage) temperature limits to which the medical device can be safely exposed.

Humidity limitation

Indicates the range of (storage) humidity to which the medical device can be safely exposed.

Atmospheric pressure limitation

Indicates the acceptable upper and lower limits of atmospheric pressure for transport and storage.

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Symbol

Standard Reference

Standard Title

Symbol Title

Explanatory Text

ASTM F2503

Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment

MR Unsafe

Not safe to use in an MR environment

Medical Device Ordinance SR 812.213

Indicates the Authorized Representative in Switzerland

Indicates the Authorized Representative in Switzerland

UKCA Medical Device Regulation (SI 2002 No 618, as amended) (UK MDR 2002)

UKCA Mark

Signifies United Kingdom technical conformity

Swiss Medical Device Ordinance (MedDO) UKCA Medical Device Regulation (SI 2002 No 618, as amended) (UK MDR 2002) MDR 2017/745

MDD 93/42/EEC

EU Medical Device Regulation

CE marking

Signifies European technical conformity.

Notified body number may appear under symbol.

EU Medical Device Directive

ISO 15223-1 Symbol 5.1.9

Distributor

An indication of the Distributor

Indicates the entity distributing the medical device into the locale

ISO 15223-1 Symbol 5.1.8

Importer

An indication of the Importer

Indicates the entity importing the medical device into the locale

ISO 15223-1 Symbol 5.1.11

Country of Origin

Country of Origin (Made in…)

ISO 15223-1 Symbol 5.7.7

Medical Device

An indication of Medical Device

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Identify the country of manufacture of products. The CC shall be replaced by the two letter country code or three letter country code device in ISO 3166-1. Indication that device is a Medical Device

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Disposal Instructions: Natus is committed to meeting the requirements of the European Union WEEE (Waste Electrical and Electronic Equipment) Regulations 2014. These regulations state that electrical and electronic waste must be separately collected for the proper treatment and recovery to ensure that WEEE is reused or recycled safely. In line with that commitment Natus may pass along the obligation for take back and recycling to the end user, unless other arrangements have been made. Please contact us for details on the collection and recovery systems available to you in your region at natus.com. Electrical and electronic equipment (EEE) contains materials, components and substances that may be hazardous and present a risk to human health and the environment when WEEE is not handled correctly. Therefore, end users also have a role to play in ensuring that WEEE is reused and recycled safely. Users of electrical and electronic equipment must not discard WEEE together with other wastes. Users must use the municipal collection schemes or the producer/importers take-back obligation or licensed waste carriers to reduce adverse environmental impacts in connection with disposal of waste electrical and electronic equipment and to increase opportunities for reuse, recycling, and recovery of waste electrical and electronic equipment. Equipment marked with the below crossed-out wheeled bin is electrical and electronic equipment. The crossed-out wheeled bin symbol indicates that waste electrical and electronic equipment should not be discarded together with unseparated waste but must be collected separately.

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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 Amplitude-integrated electroencephalograph (aEEG) Artifact Session Channel

Data acquisition box (DAB)

Electrode Electroencephalograph (EEG) Frequency

Impedance

Neonatal sensor set Reference electrode Sagittal suture Tragus ESD

Meaning A time-compression technique for presenting long EEG recordings, using an asymmetrical filter, peak detector, rectifier, and semilogarithmic amplifier. Any electrical signal from an extra- cerebral source (for example, electrode or cable movement, AC supply noise, ventilator noise). In this document, the term session refers to an examination of a patient’s EEG activity using the Olympic Brainz Monitor. A complete system for the amplification and conditioning of electrical signals from two or more electrodes. The DAB contains the interface between the low-level 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 at the side of an incubator or cot. Conductor applied over, or inserted into, a region of the scalp to detect electrical activity of the brain. Medical electrical equipment used to produce graphical recordings and/or a visual display of electrical activity of the brain. The number of complete cycles of repetitive waves in one second, measured in Hertz (Hz). 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). A proprietary, non-invasive, self-adhesive sensor array used to collect EEG signals from a neonate’s brain. An electrode used as a reference point for the suppression of interfering signals detected by other electrodes or their cables. A serrated line at the top of the skull that is the junction of the two parietal bones. The prominence in front of the external opening of the ear. 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.

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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.

Figure 1: Olympic Brainz Monitor System

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 DC power.

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