BRM3 Reference Manual Issue 1 June 2007

BRM3 Brain Monitor Reference Manual

All product names and brand names in this document are trademarks or registered trademarks of their respective holders. © Copyright BrainZ Instruments Ltd, 2003-2007. All rights reserved. No part of this document may be photocopied or reproduced without the prior written consent of BrainZ Instruments Limited. Product specifications may change without prior notice. The BRM3 Brain Monitor is manufactured by: BrainZ Instruments Limited 25 Carbine Road, Mt Wellington, Auckland 1060 PO Box 51078, Pakuranga, Manukau 2140 New Zealand Telephone: Fax: Email: Website:

+64 9 978 8896 +64 9 978 8889 [email protected] www.brainz.com

EU Authorized Representative: BrainZ Instruments UK Limited Fountain Court, 2 Victoria Square, Victoria Street, St Albans Hertfordshire AL1 3TF United Kingdom BRM3 Brain Monitor Reference Manual Part No: Issue No: Issue Date: Iteration:

CZD00065; GE M1119311 1 June 2007 1.6

BRM3 Brain Monitor Reference Manual

Table of contents Introduction

1

About this manual ... 1 Conventions used in this document ... 2 Introducing the BRM3 Brain Monitor... 5 Safety information ... 7

Assembling the BRM3 Brain Monitor

11

The packaged BRM3 Brain Monitor... 11 Assembling the Roll Pole... 11 Attaching and connecting the components ... 15

Preparing the BRM3 Brain Monitor for use

18

Operating the BRM3 Brain Monitor ... 18 Setting up the BRM3 Brain Monitor... 18 Changing the language displayed... 18 Logging in ... 18 Setting the system date and time ... 19 Checking for normal operation... 19

Configuring the BRM3 Brain Monitor

21

Selecting which graphs are displayed ... 21 Setting up the screen saver ... 21 User administration... 21

Using the BRM3 Brain Monitor

23

Starting and stopping the BRM3 Brain Monitor ... 23 Main Menu screen ... 23 Performing an assessment... 24 Using the Roll Pole... 24 Using the Onscreen Help system... 26 Managing data files ... 27

Maintenance

31

Checking for normal operation... 31 Message codes ... 31 Cleaning... 31 Routine maintenance ... 32 Upgrading software ... 34 Servicing... 34

Specifications

35

General specifications ... 35 EEG specifications... 36 DAU specifications... 37 Environmental specifications ... 37 Standards compliance information... 37

BRM3 Brain Monitor Reference Manual | i

BRM3 Brain Monitor Reference Manual

Part numbers for BRM3 Brain Monitor components ... 39 Authorized service centers... 41 Warranty ... 42

Index

ii | BRM3 Brain Monitor Reference Manual

43

Introduction

Introduction This section explains how to read this document and defines the terminology and symbols used. It also provides a general overview of the BRM3 Brain Monitor.

About this manual The BRM3 Brain Monitor Reference Manual The BRM3 Brain Monitor Reference Manual contains information required to assemble, configure and safely operate the BRM3 Brain Monitor, manufactured by BrainZ Instruments Limited, of Auckland, New Zealand. Detailed operating instructions are provided in the BRM Onscreen Help System. An overview of setup and operating instructions, and detailed instructions for applying the BrainZ Neonatal Sensor Set are provided in the Quick Guide (provided with your BRM3 Brain Monitor). This manual does not contain instructions for applying the BrainZ Neonatal Sensor Set or the Sensor Adaptor Set. You must read the instructions supplied with these items before using them.

Who should read this manual All users of the BRM3 Brain Monitor should read the BRM3 Brain Monitor Reference Manual, particularly Safety information on page 7, which contains important safety information.

BRM3 Brain Monitor Reference Manual | 1

Introduction

Conventions used in 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 BRM3 Brain Monitor. A CAUTION identifies actions or situations that could damage the BRM3 Brain Monitor, or other equipment, or invalidate test results and measurements. Personal injury is unlikely. A NOTE contains advisory information about some aspect of the BRM3 Brain Monitor or its operation, or about a procedure or function.

Terms and abbreviations The following table contains the terms and abbreviations used on the BRM3 Brain 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 semilogarithmic amplifier.

Amplitude

A measurement of the level of brain activity detected as an electrical signal, measured in microvolts (μV) peak-to-peak.

Artifact

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

Assessment

In this document, the term ‘assessment’ refers to an examination of a patient’s EEG activity using the BRM3 Brain Monitor.

Channel

A complete system for the amplification and conditioning of electrical signals from a pair or combination of electrodes.

Data Acquisition Unit (DAU)

The DAU contains the interface between the low-level analog signals detected by the Neonatal Sensor Set or Sensor Adaptor Set and the digital processing software of the BRM3 Brain Monitor. The DAU also contains the medical isolation circuitry used to protect both patient and instrument in the unlikely event of an electrical fault. The DAU 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.

Electromyography (EMG)

Electrical activity associated with muscle movement.

Frequency

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

2 | BRM3 Brain Monitor Reference Manual

Introduction

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.

Intensity

A measurement of the electrical energy present in the frequency band of interest.

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.

Spectral Edge Index (SEI)

The SEI is calculated by processing the signals from the patient’s brain to obtain the frequency below which 90% of the EEG power spectrum lies, across a signal bandwidth of 2 to 20 Hz. Only EEG data not contaminated by noise, movement or other problems is used in the calculation of SEI. SEI is also known as Spectral Edge Frequency.

Tragus

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

Symbols The following table contains symbols and icons used on the BRM3 Brain Monitor and its packaging, or in this manual and other documentation.

Symbol or Icon

Meaning Touchscreen Monitor is receiving power when lit Direct Current Type BF Equipment 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

BRM3 Brain Monitor Reference Manual | 3

Introduction

Turn clockwise to tighten and lock the Roll Pole

EU only: Do not dispose of the BRM3 Brain Monitor as unsorted municipal waste. Equipotential Terminal (connection to hospital grounding/earthing system) USB (connection to DAU, USB memory stick, USB printer)

Order of the screens Procedures may begin “On the Main Menu screen, touch xxx” or “On the Login screen, touch xxx” etc. In each case, it is assumed that the user has already set up the BRM3 Brain Monitor, switched on the equipment and logged in. Instructions for preparing the BRM3 Brain Monitor for use are provided at the beginning of this manual and are not repeated at the beginning of each procedure.

4 | BRM3 Brain Monitor Reference Manual

Introduction

Introducing the BRM3 Brain Monitor The BRM3 Brain Monitor is a three-channel electroencephalograph (EEG) that detects and records small electrical signals from each hemisphere of the patient’s brain.

Figure 1: The BRM3 Brain Monitor System

BRM3 Brain Monitor Reference Manual | 5

Introduction

Components of the BRM3 Brain Monitor system Touchscreen Monitor The Touchscreen Monitor contains the microcomputer that processes the digital signal from the DAU, and the touch-screen visual display unit that displays results and allows the user to control the BRM3 Brain Monitor. It is powered from a separate power supply unit mounted on the Roll Pole. DAU The DAU conditions the EEG signals from the sensors and converts them to digital form for processing. It also contains the medical isolation circuitry used to protect both patient and equipment in the unlikely event of an electrical fault. Connecting cables The USB 2.0 Cable connects the DAU to the Touchscreen Monitor, providing a data circuit between the two modules. The USB 2.0 cable also provides the DAU with DC power. Roll Pole The Roll Pole provides an adjustable mounting platform for the components of the BRM3 Brain Monitor, and its accessories. It features an adjustable pole, lockable wheels and an Accessory Basket. Other items Other items supplied with the BRM3 Brain Monitor include: •

Data transfer accessories to allow files to be transferred to removable media.

•

Literature and software containing information about how to assemble and use the BRM3 Brain Monitor.

•

Disposable starter materials required when learning to apply a Neonatal Sensor Set or Sensor Adaptor Set.

Other items that may be used as optional accessories include: •

Printer mounting bracket.

•

BrainZ recommended printer, Hewlett Packard models HP450cbi , HP460cb and HP460wbt.

Intended use The BRM3 Brain Monitor and RecogniZe event detection algorithm are intended for use: •

to monitor the state of the brain by acquisition of electroencephalogram (EEG) signals, in clinical environments such as the intensive care unit, and for clinical research.

•

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 identify events in acquired EEG signals that may correspond to seizure activity in the patient. Event detections must be reviewed and interpreted by qualified clinical practitioners.

The BRM3 Brain Monitor does not provide any diagnostic conclusion about the patient’s condition.

6 | BRM3 Brain Monitor Reference Manual

Introduction

Safety information Warnings Explosion hazard Do not use the BRM3 Brain 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 Touchscreen Monitor, DAU or power supply unit, especially while they are connected to the AC supply outlet. Do not attempt to connect or disconnect the BRM3 Brain Monitor’s AC supply cable with wet hands. Make certain your hands are clean and dry before touching the AC supply cable. Disconnect the BRM3 Brain 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 BRM3 Brain 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 BRM3 Brain Monitor. Never adapt the three-wire attachment plug of the BRM3 Brain Monitor to fit a two-wire supply outlet. If a three-wire, grounded supply outlet is not available, do not operate the BRM3 Brain Monitor. US only: Grounding reliability can only be achieved when the BRM3 Brain 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 BRM3 Brain Monitor to the AC supply outlet. Power supply unit Use only the power supply unit supplied with the BRM3 Brain Monitor or a genuine replacement part (XPiQ model PCM80PS24). 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 BRM3 Brain Monitor Roll Pole is designed to carry a load of no more than 4½ lb (2 kg). Do not apply a load exceeding this amount. To ensure stability, the Accessory Basket must be mounted within 32” (80 cm) of the ground.

BRM3 Brain Monitor Reference Manual | 7

Introduction

Loading of Roll Pole The Roll Pole is designed to carry a load equal to the standard BRM3 Brain Monitor components and any BrainZ-recommended optional accessories (e.g. a printer mounting bracket and printer). Do not apply a load exceeding the sum weight of these items. Install the printer mounting bracket above the Accessory Basket. To ensure stability, the printer mounting bracket must be mounted at least 8” (21 cm) below the height adjustment knob. Transporting the BRM3 Brain Monitor Before moving the BRM3 Brain Monitor, lower the Touchscreen Monitor to its lowest position on the Roll Pole and lock in firmly in position. If a printer is fitted, close the paper holder. Use with high frequency electrosurgical equipment Do not use diathermy/electrosurgery or defibrillation equipment on a patient while they are connected to the BRM3 Brain Monitor. This may cause interference to the EEG signals and could damage the device. Disconnect the Neonatal Sensor Set from the DAU while any such procedure is being carried out. Personal injury hazard Ensure that the Touchscreen Monitor is securely mounted on the Roll Pole, to avoid personal injury. Patient strangulation hazard To minimize the risk of patient strangulation, position the DAU so as to minimize any risk of the cables becoming wrapped around the patient’s throat. Use of accessory equipment Use of accessory equipment not approved by BrainZ Instruments Limited, or not complying with safety standards equivalent to those met by the BRM3 Brain Monitor, may lead to a reduced level of safety of the resulting system or failure of the BRM3 Brain Monitor to operate correctly. Connection to accessory equipment Accessory equipment connected to any accessory port of the Touchscreen Monitor unit (including USB ports) 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 part 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 BrainZ Instruments Limited. See Authorized service centers on page 41. Indications for servicing If any of the following situations occurs, stop using the BRM3 Brain 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.

8 | BRM3 Brain Monitor Reference Manual

Introduction

Care when touching patient Do not touch any exposed metal parts at the rear panel of the Touchscreen Monitor unit (including connectors), while simultaneously touching a patient. Electrical stimulator hazard Do not use the BRM3 Brain Monitor simultaneously with electrical stimulators.

Cautions Read all documentation Read this document, and any other operating instructions or other documentation packed with the BRM3 Brain 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 BRM3 Brain Monitor, as serious and irreversible damage may result. Ventilation Do not obstruct the passage of air behind or around the Touchscreen Monitor or block the ventilation inlet holes at its rear. 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 BRM3 Brain Monitor is being used for an assessment. Disconnection of cables or AC supply Do not disconnect any of the cables connecting the BRM3 Brain Monitor’s components, operate the power switch, or disconnect the AC supply, while the BRM3 Brain Monitor is in use. If any of these conditions occurs accidentally, reconnect the cables (if necessary) and resume the current assessment. See Restoration after AC supply interruption on page 24. Cleaning the BRM3 Brain Monitor Do not clean with concentrated bleach, corrosive chemicals or abrasive cleaning compounds. Servicing the BRM3 Brain Monitor Do not open the enclosures of the Touchscreen Monitor, DAU, or power supply unit, 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.

BRM3 Brain Monitor Reference Manual | 9

Introduction

Electromagnetic compatibility The BRM3 Brain 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 BRM3 Brain Monitor and the other device.

•

Re-route the device cabling.

•

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

Refer to the BRM3 Brain Monitor Technical Manual for further compliance information and advice relating to electromagnetic interference.

10 | BRM3 Brain Monitor Reference Manual

Assembling the BRM3 Brain Monitor

Assembling the BRM3 Brain Monitor This section contains information about unpacking the BRM3 Brain Monitor, assembling the Roll Pole supplied with the BRM3 Brain Monitor, attaching the Touchscreen Monitor unit and connecting the components. Read this section as you unpack the BRM3 Brain Monitor from its shipping packaging, and before you begin to assemble the device.

The packaged BRM3 Brain Monitor The BRM3 Brain Monitor is supplied in three cartons: •

a large, narrow box containing the Roll Pole components (extendable pole, base with casters, power supply mounting bracket, Accessory Basket assembly and tilt mounting bracket).

•

a wide box containing the Touchscreen Monitor, power supply unit, DAU, USB 2.0 cable, USB memory stick and test sensor lead.

•

a small box containing the AC power cable, BRM3 Brain Monitor documentation, the AnalyZe CD, a box of sensors and a sensor application kit.

Assembling the Roll Pole Stage 1: Unpacking the components 1.

Unpack the components of the Roll Pole 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.

BRM3 Brain Monitor Reference Manual | 11

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.

Lie the extendable pole on its side on a clear, flat work surface.

2.

Locate the hex nut screw.

3.

Place the base over the stepped end of the extendable pole and insert the hex nut screw through the center hole in the base (a flat washer and spring washer should already be fitted). See Figure 3.

4.

Tighten the hex nut screw with a ½” (13 mm) socket wrench.

5.

Turn the base upright and check that the Roll Pole is steady. If it is unsteady, re-tighten the hex nut screw.

Figure 3: Assembling the base

12 | BRM3 Brain Monitor Reference Manual

Assembling the BRM3 Brain Monitor

Stage 4: Attaching the power supply unit 1.

Attach the two parts of the power supply mounting bracket to the extendable pole and tighten the two Philips screws. See Figure 4.

2.

Locate the AC power cable.

3.

Fasten the AC power cable to the power supply mounting bracket using the Philips screw and washer provided.

4.

Fasten the power supply unit to the mounting bracket using the two velcro securing straps.

5.

Tidy away the AC power cable by winding it around the cable tidy.

Figure 4: Attaching the power supply unit

BRM3 Brain Monitor Reference Manual | 13

Assembling the BRM3 Brain Monitor

Stage 5: Attaching the tilt mounting bracket 1.

Place the tilt mounting bracket on top of the extendable pole and position it on the side opposite the height adjustment knob. Tighten the three Philips screws.

2.

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

3.

Tighten the tilt adjustment lever.

4.

Tighten the height adjustment knob.

Tilt adjustment lever

Figure 5: Attaching the tilt mounting bracket

14 | BRM3 Brain Monitor Reference Manual

Assembling the BRM3 Brain Monitor

Attaching and connecting the components Stage 1: Attaching the Touchscreen Monitor Before attaching the Touchscreen Monitor, ensure that the height adjustment knob and the tilt adjustment lever are firmly tightened. The Touchscreen Monitor and DAU are packaged in the same carton. 1.

Unpack the Touchscreen Monitor and remove the plastic wrapping. Place the Touchscreen Monitor face down on a clean, smooth work surface.

2.

Locate the four plastic spacers packaged with the tilt mounting bracket. These will sit between the tilt mounting bracket and the Touchscreen Monitor.

3.

Attach two of the four spacers to the top two holes on the back of the Touchscreen Monitor, turning the screws three complete turns only. The spacers must only be loosely attached at this stage. See Figure 6.

Figure 6: Attaching the top two spacers to the Touchscreen Monitor

4.

Lift the Touchscreen Monitor onto the top two holes of the tilt mounting bracket.

5.

Insert the two spacers over the two bottom holes on the back of the Touchscreen Monitor and tighten the screws fully.

BRM3 Brain Monitor Reference Manual | 15