CFM Olympic BrainZ Monitor Technical Manual Rev 03 Aug 2019

All product names and brand names in this document are trademarks or registered trademarks of their respective holders. © Copyright 2019 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.

Natus Medical Incorporated

Excel-Tech Ltd. (XLTEK) 2568 Bristol Circle Oakville, Ontario L6H 5S1 Canada Telephone: 1-800-303-0306 (US/CAN) Worldwide: +1-650-802-0400 Technical Service +1 800 303 0306 Technical Service Fax +1 650 802 8680 E-mail: [email protected] Customer Service +1 800 303 0306 Customer Service Fax +1 650 802 6620 E-mail: [email protected] International Support - Please contact your local Distributor. Distributor locations can be found at www.natus.com

European Authorized Representative Natus Manufacturing Limited IDA Business Park Gort Co. Galway Ireland

OBM Olympic Brainz Monitor Technical Manual P/N 027051 Rev 03 (Revision Date: August 2019)

Table of contents Introduction ... 1 About this manual ... 1 Intended Use ... 1 Conventions used in this document ... 2 Introducing the Olympic Brainz Monitor ... 7 Assembling the Olympic Brainz Monitor ... 8 The packaged Olympic Brainz Monitor ... 8 Assembling the (Optional) Roll Stand ... 8 Attaching and connecting the components ... 12 Maintenance ... 16 Routine maintenance ... 16 After a change in local time ... 17 Calibration ... 17 Servicing ... 19 Equipment required for servicing ... 19 Troubleshooting ... 19 System Diagnostics log ... 19 Troubleshooting flowchart ... 20 Safeguarding data when servicing an Olympic Brainz Monitor ... 26 Checking for normal operation ... 26 Electrical safety testing ... 26 Upgrading software ... 26 Upgrading software – Manual Installation ... 27 Resetting user settings to Factory Default ... 27 Connecting the Olympic Brainz Monitor to a Network ... 28 Establishing network credentials for the Olympic Brainz Monitor ... 28 Use of Anti-Virus software ... 29 Installation of third-party software ... 30 Configuring a Network Printer... 31 Recalibrating the Touch screen Monitor using a keyboard ... 32 Specifications ... 33 General specifications ... 33 EEG specifications ... 33 Computed parameters ... 34 Displays ... 34 DAB specifications ... 34 Environmental specifications ... 34 Operation (all components) ... 34 Shipping and Storage (all components) ... 34 Technical overview ... 35 Introduction ... 35 Electrical design ... 35 Specifications ... 36 Calibration ... 36 Signal Processing ... 37 Olympic Brainz Monitor - User Interface ... 38 Main user interface... 38 Status bar ... 38 Marker region ... 39 aEEG display ... 39 Navigation controls... 39 Impedance and EEG display ... 39 Taskbar ... 40 Standards compliance and normative references information ... 41 Regulatory Standards of Compliance and Normative References ... 41 Declaration of compliance for IEC 60601-1-2 ... 42 Declaration of compliance for FCC ... 44 Olympic Brainz Monitor part numbers... 45 Spare parts ... 46 OBM Olympic Brainz Monitor Technical Manual P/N 027051 Rev 03 (Revision Date: August 2019)

Authorized service centers... 48 Appendix A - Assembling the Desktop Stand (Optional) ... 49

OBM Olympic Brainz Monitor Technical Manual P/N 027051 Rev 03 (Revision Date: August 2019)

Introduction

Introduction About this manual The Olympic Brainz Monitor Technical Manual The Olympic Brainz Monitor Technical Manual contains information required to assemble, maintain and service the Olympic Brainz Monitor, manufactured by Natus Medical.

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 HypoxicIschemic Encephalopathy 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.

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Introduction

Conventions used in this document Detailed operating instructions are provided in the Onscreen Help System and the Olympic Brainz Monitor Reference Manual.

Who should read this manual Healthcare institution service personnel should read this document. Explanation of Terminology This manual presents three types of precautionary information. The three types of statements carry equal weight; that is, they are of equal importance to the safe and effective use of the device. Each statement is categorized by using an introductory word in boldface as follows: Warning! Identifies conditions or practices that might present danger or possible injury to the pa tient and/or user. Important! An instruction provided to help ensure correct clinical results and provide quality assurance to the device’s procedures. Caution: An instruction that, if not followed, can result in a condition that could damage the device . Note: Information in this category is not considered precautionary, it is background information provided to clarify a particular step or procedure. Electromagnetic compatibility The OBM 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 OBM Olympic Brainz Monitor and the other device.



Re-route the device cabling.



Plug the devices into AC supply outlets on separate circuit branches.

Operation of the OBM Olympic Brainz Monitor may be affected by mobile and portable RF communications equipment. Refer to Table 3 - Electromagnetic immunity on page 43 for further compliance information and advice relating to electromagnetic interference.

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Introduction

Terms and abbreviations The following table contains 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 electroencephalogram (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, a '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 a pair or combination of 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 of the Olympic Brainz Monitor. The DAB also contains the medical isolation circuitry used to protect both patient and 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 intended for production of graphic 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 giving a measurement of the quality of contact between the electrode and scalp, measured in kOhms.

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.

Sagittal Suture

A serrated line on the top of the skull that marks the junction of the two parietal bones.

Sensor Adaptor Set

A proprietary sensor array for use with sub-dermal needle electrodes, used to collect EEG signals from a neonate's brain.

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

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Introduction

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

Symbol or Icon

Standard Reference IEC 604175009

Graphical symbols for use on equipment

Stand-by

Standby (power on/off)

IEC 604175031

Graphical symbols for use on equipment

Direct current

Direct Current.

IEC 604175334

Graphical symbols for use on equipment

Defibrillation-proof type BF applied part

Defibrillation-proof type BF applied part equipment

ISO 7010M002

Graphical symbols - Safety colours and safety signs - Registered safety signs

Refer to instruction manual/booklet

Refer to operating instructions manual

ISO 70001641

Graphical symbols for use on equipment - Registered symbols

Operator's manual; operating instructions

Operating instructions

ISO 70000434A

Graphical symbols for use on equipment - Registered symbols

Caution

Caution

ISO 7010W001

Graphical symbols - Safety colours and safety signs - Registered safety signs

General warning sign

Warning

21 CFR 801

Title 21 – Food and Drugs – Chapter 1 – Food and Drug Administration, Department of Health and Human Services (Continued) – Subchapter H – Medical Devices – Part 801 – Labeling

Rx Only

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

EN 50419

Marking of electrical and electronic equipment in accordance with Article 11(2) of Directive 2022/96/EC (WEEE)

WEEE markings

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

IEC 604175021

Graphical symbols for use on equipment

Equipotentiality

Equipotentiality

ISO 70003650

Graphical symbols for use on equipment - Registered symbols

Universal Serial Bus (USB), port/plug

USB (connection to DAB, USB memory stick, USB printer).

ISO 70003082

Graphical symbols for use on equipment - Registered symbols

Manufacturer

Manufacturer

Authorized representative in the European Community

Authorized representative in the European Community

Date of manufacture

Date of manufacture

Standard Title

Symbol Title

Explanatory Text

ISO 70002497

Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements Graphical symbols for use on equipment - Registered symbols

ISO 70002607

Graphical symbols for use on equipment - Registered symbols

Use by date

Use-By-Date

ISO 70002492

Graphical symbols for use on equipment - Registered symbols

Batch code

Batch code

ISO 15223-1 Clause 5.1.2

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Symbol or Icon

Standard Reference ISO 70002493 ISO 70002498 ISO 15223-1 Annex B.2

Standard Title Graphical symbols for use on equipment - Registered symbols Graphical symbols for use on equipment - Registered symbols Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements

Symbol Title

Explanatory Text

Catalogue number

Catalogue number

Serial number

Serial number

Negation symbol

Product was not made with natural rubber latex

Do not re-use

Do not re-use

ISO 70001051

Graphical symbols for use on equipment - Registered symbols

ISO 70002606

Graphical symbols for use on equipment - Registered symbols

ISO 70000624

Graphical symbols for use on equipment - Registered symbols

Do not use if package is damaged Keep away from sunlight

ISO 70000626

Graphical symbols for use on equipment - Registered symbols

Keep away from rain

Keep dry

ISO 70000623

Graphical symbols for use on equipment - Registered symbols

Temperature limit

Temperature limit

ISO 70002620

Graphical symbols for use on equipment - Registered symbols

Humidity limitation

Relative humidity limit

ISO 70002621 ASTM F2503 Table 1 Symbol 3

Graphical symbols for use on equipment - Registered symbols Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment

Atmospheric pressure limitation

Atmospheric pressure limitation

MR Unsafe

Not safe to use in an MR environment

Do not use if package is damaged Keep away from sunlight

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Order of the screens Procedures may begin “On the Primary Display or Taskbar, touch xxx”, etc. In each case, it is assumed that the user has already set up the Olympic Brainz Monitor and switched on the equipment. Instructions for preparing the Olympic Brainz Monitor for use are provided at the beginning of this manual and are not repeated at the beginning of each procedure.

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Introduction

Introducing the Olympic Brainz Monitor The Olympic Brainz Monitor is a three-channel electroencephalograph (EEG) that detects and records small electrical signals from each hemisphere (P3, C3 for the left; P4, C4 for the right) of the patient’s brain.

Figure 1 - The Olympic Brainz Monitor System

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Assembling the Olympic Brainz Monitor This section contains information about unpacking the Olympic Brainz Monitor, assembling the Roll Stand supplied with the Olympic Brainz Monitor, attaching the Touch screen Monitor unit 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.

The packaged Olympic Brainz Monitor The Olympic Brainz Monitor is supplied in several packages: 

Large, narrow box containing the (Optional) Roll Stand components (extendable pole, base with casters, power cable cleat, Accessory Basket assembly and tilt mounting bracket).



Wide box containing the Touch screen Monitor.



Small box containing the DAB with integrated USB 2.0 cable (may be packaged into the OBM00410 Starter Kit).



Package containing the AC power cable (may be packaged into the OBM00410 Starter Kit)



Small box containing Olympic Brainz Monitor documentation, the Olympic Brainz Monitor System Software (on USB) and Viewer CD, a box of sensors and a sensor application kit (this is the OBM00410 Starter Kit).

Assembling the (Optional) 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 below 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 OBM00 401 to the roll stand or any other mounting solution that meets the same standards. 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 ground. 1.

Clip one of the plastic mounting brackets onto the long side of the Accessory Basket without the extra horizontal reinforcing. See Figure 2.

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 ground.

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Assembling the BRM3 Brain Monitor

6.

Tighten the two Philips screws to fasten the Accessory Basket to the extendable pole.

Figure 2 - Assembling the Accessory Basket 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 9.

4.

Using the 3/16” hex key, fasten the pedal assembly to the pole with the two ¼-20 x ¾” socket head cap screws.

5.

Turn the roll pole upright and check that the roll stand is steady. If it is unsteady, re-tighten the socket head cap screws.

Figure 3 - Assembling the base

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Stage 4: Attaching the AC power cable cleat 1.

Attach the two parts of the power adapter/cable mounting bracket to the extendable pole and tighten the two Phillips screws. See Figure 4.

Figure 4 - Attaching the AC power cable cleat

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Stage 5: Attaching the handle 1.

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.

2.

Affix the adhesive plastic screw cover to the top of the tilt mounting bracket.

3.

Tighten the tilt adjustment lever.

Figure 6 - Attaching the tilt mounting bracket

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Attaching and connecting the components Stage 1: Attaching the Touch screen Monitor

Warning! Before attaching the Touch screen Monitor, ensure that the height adjustment knob (if equipped) 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 12.

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 13.

5.

Slide the tilt mounting bracket on the roll stand such that the slots slide under the screw heads. Note the roll stand is not shown to simplify the Figure. Thread the two screws through the two holes on the bracket into the monitor. See Figure 8 on page 13.

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Figure 8 - Attaching VESA mounting adaptor to the touch screen monitor 6.

Fully tighten all the screws.

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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

 Power adapter to the Touch screen Monitor. Important! An equipotentiality terminal is provided to optionally connect to a hospital ground/earth system

Figure 9 - Connecting the components

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Assembly of the Olympic Brainz Monitor is now complete. Before first use: 

Read and follow the procedures described in Preparing the Olympic Brainz Monitor for use (027050 – Olympic Brainz Monitor Reference Manual).



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).

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Maintenance

Maintenance Routine maintenance

Weekly 1.

Archive recently-recorded data files onto the USB memory stick or network location as described in the Online Help System.

2.

In the case of USB storage media, use a laptop or a desktop PC in conjunction with the USB media, to transfer the archived data files onto other media or a file server for long-term storage.

Quarterly 1.

Use the Tools/Files/Active overlay to review all sessions in the Olympic Brainz Monitor’s internal storage that have been previously archived.

2.

Move archived sessions to the Tools/Files/Trash. Permanently delete those sessions in the Trash that have been present since the previous Quarter. Delete those files that are no longer required.

Annually The following checks should be carried out every twelve months, or according to the protocol for checking electrical equipment at your healthcare institution. 1.

2.

Visually check to ensure: 

The AC power cable or attachment plug is not damaged.



Connecting cables and connectors are not damaged or worn.



Screws used to fasten the Touch screen Monitor or other accessories to the Roll Stand have not become loose.



The hex nut screw and the screws fastening the stabilizing weight underneath the base have not become loose.



The equipment has not been dropped, and shows no other obvious signs of damage.

Record a short test session and ensure that the Olympic Brainz Monitor correctly initiates recording and does not report a DAB calibration error.

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