Technical Manual
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Technical Manual
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.
OBM00202 Natus Olympic Brainz Monitor Technical Manual Issue No: Issue Date: Iteration:
F 2011 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
Table of contents Introduction ... 1 About this manual ... 1 Intended Use ... 1 Conventions used in this document ... 1 Introducing the Olympic Brainz Monitor ... 6 Assembling the Olympic Brainz Monitor ... 7 The packaged Olympic Brainz Monitor ... 7 Assembling the Roll Stand ... 7 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 ... 27 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 ... 29 Configuring a Network Printer... 30 Recalibrating the Touch screen Monitor using a keyboard ... 31 Replacing the Hard Drive... 31 Specifications ... 34 General specifications ... 34 EEG specifications ... 34 Computed parameters ... 35 Displays ... 35 DAB specifications ... 35 Environmental specifications ... 35 Operation (all components) ... 35 Shipping and Storage (all components) ... 35 Technical overview ... 36 Introduction ... 36 Electrical design ... 36 Specifications ... 37 Calibration ... 37 Signal Processing ... 38 Olympic Brainz Monitor - User Interface ... 39 Main user interface... 39 Status bar ... 39 Marker region ... 40 aEEG display ... 40 Navigation controls... 40 Impedance and EEG display ... 40 Taskbar ... 41 Standards compliance and normative references information ... 42 Safety Standard of Compliance and normative references ... 42 EMC Standard of Compliance and normative references ... 43 Declaration of compliance for IEC 60601-1-2 ... 44 Declaration of compliance for FCC ... 47
Olympic Brainz Monitor part numbers... 48 Spare parts ... 49 Authorized service centers... 51 Appendix A - Assembling the Desktop Stand (Optional) ... 52
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 Olympic Brainz Monitor does not provide any diagnostic conclusion about the patient‟s condition.
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.
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 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.
OBM Olympic Brainz Monitor Technical Manual | 1
Introduction
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
Table 3 - Electromagnetic immunity
on p. 45 further compliance information and advice relating to electromagnetic interference.
OBM Olympic Brainz Monitor Technical Manual | 2
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.
Sagital 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
Meaning Touch screen Monitor is receiving power when lit. Direct Current. Type BF Equipment, defibrillator-proof. 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.
Turn anti-clockwise to loosen and unlock the Roll Pole height adjustment.
Turn clockwise to tighten and lock the Roll Pole height adjustment.
EU only: Do not dispose of the Olympic Brainz Monitor as unsorted municipal waste.
Equipotential Terminal (connection to hospital grounding/earthing system). USB (connection to DAB, USB memory stick, USB printer). Pins of connectors identified with the ESD warning symbol shall not be touched.
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Introduction
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 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 OBM00010 Starter Kit).
Package containing the AC power cable (may be packaged into the OBM00010 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 OBM00010 Starter 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 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 posi tion.
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 8.
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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Assembling the BRM3 Brain Monitor
Stage 4: Attaching the AC power cable cleat 1.
Attach the two parts of the power cable cleat 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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Assembling the BRM3 Brain Monitor
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
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Assembling the BRM3 Brain Monitor
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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Assembling the BRM3 Brain Monitor
Attaching and connecting the components Stage 1: Attaching the Touch screen Monitor
Before attaching the Touch screen Monitor, ensure that the height adjustment knob (if equipped) and the tilt adjustment lever are firmly tightened.
Electro-static discharge (ESD) – Pins of connectors identified with the ESD warning symbol should not be touched without taking the necessary precautions. The connectors marked with ESD warning symbols must be handled by individuals trained on handling ESD sensitive material.
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.
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Assembling the BRM3 Brain Monitor
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 14.
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Assembling the BRM3 Brain Monitor
6.
Fully tighten the four screws into the tilt mounting bracket.
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
Power supply cable to the Touch screen Monitor.
An Equipotential Terminal is provided to optionally connect to a hospital ground/earth system.
Equipotential terminal
Figure 10 - 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 (OBM00201 – Olympic Brainz Monitor Reference Manual).
The Olympic Brainz Monitor touch screen computer is supplied with several clamp-on ferrite blocks. In order to make the CFM more resistant to noisy line conditions, these may be optionally applied to the power cable within approximately 30 cm of the touch screen monitor.
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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