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Specifications

| BRM2 Brain Monitor Reference Manual

Standards compliance information

The BRM2 Brain Monitor and its accessories have been designed to comply with the following
international and national standards.

International standards

National standards

IEC 60601-1

AS/NZS 3200.1.0

IEC 60601-1-1

EN 60601-1

IEC 60601-1-2

CAN/CSA C22.2 No. 601.1

IEC 60601-2-26

UL 60601-1

Classification for IEC 60601-1 and IEC 60601-2-26

The BRM2 Brain Monitor has the following classification:

•

Class 1 Equipment

•

Type BF Applied Part

•

Continuous Operation

•

Equipment not suitable for use in the presence of a flammable anesthetic mixture, with air or
Oxygen or Nitrous Oxide.

Содержание BRM3

Страница 1: ...ting single channel setup Cross cerebral right and left hemisphere and up to 3 channel monitoring simplifies patient hook up and provides additional data when needed Ease of Interpretation Collaborati...

Страница 2: ...ated EEG is the most commonly used digital trend for newborns and it s use has been integrated as a customary practice for assessment of EEG background in many intensive care nurseries 1 The Olympic B...

Страница 3: ...annel to an existing single channel setup Cross cerebral right and left hemisphere with up to 3 channel monitoring simplifies patient hook up and provides additional data when needed CFMsight Provides...

Страница 4: ...nitor roll stand starter kit power cord DAB OBM70003 Olympic Brainz Monitor Kit NZ AUS Includes Monitor roll stand starter kit power cord DAB OBM70004 Software options RecogniZe Seizure Detection Soft...

Страница 5: ...see inside Brainz BRM3 Brain Monitor Reference Manual...

Страница 6: ......

Страница 7: ...is manufactured by 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 Fax 1 650 802 6620 Emai...

Страница 8: ...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 2...

Страница 9: ...Brainz BRM3 Brain Monitor Reference Manual ii Part numbers for BRM3 Brain Monitor components 39 Authorized service centers 41 Warranty 42 Index 43...

Страница 10: ...porated Detailed operating instructions are provided in the BRM Onscreen Help System An overview of setup and operating instructions and detailed instructions for applying the Neonatal Sensor Set are...

Страница 11: ...t Any electrical signal detected by an EEG machine from an extra cerebral source for example electrode or cable movement AC supply noise ventilator noise Assessment In this document the term assessmen...

Страница 12: ...e 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...

Страница 13: ...or 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 procedur...

Страница 14: ...troduction 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...

Страница 15: ...d 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 contain...

Страница 16: ...tlet 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 ground...

Страница 17: ...ze any risk of the cables becoming wrapped around the patient s throat Use of accessory equipment Use of accessory equipment not approved by Natus Medical Incorporated or not complying with safety sta...

Страница 18: ...ted 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 A...

Страница 19: ...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 de...

Страница 20: ...ontaining 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 compon...

Страница 21: ...dable 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...

Страница 22: ...ble 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 Fast...

Страница 23: ...cket 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 moun...

Страница 24: ...wn 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...

Страница 25: ...pacers to the Touchscreen Monitor Stage 2 Connecting the components Using the figure below as a guide connect the DAU to the Touchscreen Monitor using the USB 2 0 cable Power supply cable to the Touch...

Страница 26: ...ad and follow the procedures described in Preparing the BRM3 Brain Monitor for use on page 18 Perform any electrical safety tests required by the guidelines for checking electrical equipment at your h...

Страница 27: ...ore turning on the device 3 Check that the cables are correctly connected see Figure 8 on page 16 4 Turn on the power switch and check that the green power indicator lights are illuminated on the powe...

Страница 28: ...l for test purposes This procedure constitutes a functional test of the EEG channels and sensor monitoring circuitry This check should be performed when the BRM3 Brain Monitor is first assembled if in...

Страница 29: ...10 Normal display when test plug inserted If the results described in the previous paragraph are not obtained 1 Follow any recommendations displayed on the Signal Status screen 2 If the problem persi...

Страница 30: ...System Setup to go to the System Setup screen 2 Touch the Screen Saver Enabled check box to select it Touch the check box again to de select it To change the activation delay of the screen saver touc...

Страница 31: ...and log in if you have not done so already The Main Menu screen is displayed 2 Touch System Setup to go to the System Setup screen 3 Touch Users to display the User Administration screen 4 Highlight...

Страница 32: ...our computer displays turn off the power switch 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 B...

Страница 33: ...s if the BRM3 Brain Monitor has been switched off and disconnected from the AC supply for more than two hours or if the battery is already depleted from a previous AC supply interruption To continue t...

Страница 34: ...e required height 3 Tighten the height adjustment knob to lock the roll pole in the new position To adjust the angle of the Touchscreen Monitor 1 Hold the Touchscreen Monitor firmly on the bottom 2 Lo...

Страница 35: ...ogging in to the BRM3 Brain Monitor entering patient details attaching and removing the Neonatal Sensor Set checking signal quality Configuring the BRM3 Brain Monitor changing the main display screen...

Страница 36: ...g will collapse the components topics underneath the title To view a topic from the Contents Tree 1 Locate the topic title in the Contents Tree expanding headings as necessary until the desired topic...

Страница 37: ..._RAW One minute median values of all measured parameters aEEG waveforms XC and BiL EEG waveforms 1 25 Hz EEG waveforms 1 123 Hz Archived snapshots are named according to the same conventions as previ...

Страница 38: ...place with field enter an identifier or code word for your own reference 7 To archive the assessment at the default level clinical touch OK To archive the assessment at summary or raw levels touch Sum...

Страница 39: ...le Manager screen 2 Touch Close Deleting files To delete files from either internal storage or removable media 1 Select the file you want to delete in either the Internal Storage or Removable Media fi...

Страница 40: ...he following cleaning instructions and warnings BRM3 Brain Monitor including Touchscreen Monitor DAU and connecting cables Normal cleaning Clean by wiping with a soft cloth dampened with detergent and...

Страница 41: ...archived See Patient Data File Manager screen on page 28 Note that the selected file s archive status is shown beneath the Internal Storage file list 2 Delete those files that have been previously ar...

Страница 42: ...n DAU Calibration The DAU is factory calibrated and does not require periodic re calibration Touchscreen Monitor Calibration The Touchscreen Monitor may be recalibrated if it is not responding correct...

Страница 43: ...o complete calibration button The calibration procedure will restart after 10 seconds Upgrading software The BRM3 Brain Monitor software can be easily upgraded in the field when required Upgrades may...

Страница 44: ...voltage 24 VDC 3 33 A maximum 80 W Battery back up pack Back up time Approximately 30 minutes run time during a power failure depending on battery condition and charge level Discharge recharge cycles...

Страница 45: ...80 84 88 92 and 96 Hz aEEGFilter 0 2 Hz 60 dB decade 2 12 Hz 12 dB decade 12 16 Hz 1 dB 10 Hz level 16 30 Hz 120 dB decade Spectral Edge 90 for 2 20 Hz bandwidth Computed parameters Cross cerebral and...

Страница 46: ...The following environmental conditions must be maintained to avoid damage to the BRM3 Brain Monitor Operation all components Temperature 0 to 40 C 32 to 104 F Relative humidity 25 to 90 at 40 C non co...

Страница 47: ...ion for IEC 60601 1 and IEC 60601 2 26 The BRM3 Brain Monitor has the following classification Class 1 Equipment Type BF Applied Part Continuous Operation Equipment not suitable for use in the presenc...

Страница 48: ...mplete Roll Pole assembly base and casters extendable pole Accessory Basket power supply mounting bracket tilt mounting bracket CZA00022 Neonatal Sensor Set Box of 20 sensor sets 3 electrodes per set...

Страница 49: ...nitor Reference Manual 40 AnalyZe CD Software to review downloaded data on a PC CZX0001 3 Battery back up pack Lithium ion battery CZA00025 Printer mounting bracket For mounting a recommended printer...

Страница 50: ...ctly United States Natus Medical Customer Service Email Customer_Service natus com Telephone 1 800 303 0306 Worldwide 1 650 802 0400 Fax 1 650 802 6620 Natus Medical Technical Service Telephone 1 800...

Страница 51: ...s displaying 21 H Help system 26 I Icons displayed on the BRM3 Brain Monitor 3 Intended use 6 L Language changing 18 Logging in 18 M Main Menu screen 23 Main screen graph selection 21 Maintenance 31 M...

Страница 52: ...www natus com...

Страница 53: ...n Monitor Reference Manual see inside Reference Manual for a detailed guide to the BRM2 Interpretation Guide to facilitate interpreting BRM2 traces Technical Manual for technical assistance and troubl...

Страница 54: ...tice The BRM2 Brain Monitor is manufactured by BrainZ Instruments Limited 25 Carbine Road Mt Wellington Auckland 1060 PO Box 51078 Pakuranga Manukau 2140 New Zealand Telephone 64 9 978 8896 Fax 64 9 9...

Страница 55: ...he BRM2 Brain Monitor 20 Starting and stopping the BRM2 Brain Monitor 21 Performing an assessment 21 Using the Onscreen Help system 23 Managing data files 26 Restoration after AC supply interruption 2...

Страница 56: ......

Страница 57: ...e BRM2 Brain Monitor An overview of setup and operating instructions and detailed instructions for applying the BrainZ Neonatal Sensor Set are provided in the training CD Introducing the BRM2 Brain Mo...

Страница 58: ...or or its operation or about a procedure or function Other symbols The following table contains other symbols and icons used on the BRM2 Brain Monitor and its packaging or in this manual and other doc...

Страница 59: ...rode Conductor applied over or inserted into a region of the scalp or brain to detect electrical activity of the brain Electroencephalograph EEG Medical electrical equipment intended for production of...

Страница 60: ...Manual Introducing the BRM2 Brain Monitor The BRM2 Brain Monitor is a three channel electroencephalograph EEG that detects and records small electrical signals from each hemisphere of the patient s b...

Страница 61: ...al Cable connects the Isolation Unit to the Monitor and provides DC power to both the Isolation Unit and the Data Acquisition Unit UTP Serial Cable connects the Data Acquisition Unit to the Isolation...

Страница 62: ...erating rooms and in research facilities When used in conjunction with other clinical data the BRM2 Brain Monitor is intended for use solely with neonatal patients in monitoring the state of the brain...

Страница 63: ...ounded supply outlet for the BRM2 Brain Monitor Never adapt the three wire attachment plug of the BRM2 Brain Monitor to fit a two wire supply outlet If a three wire grounded supply outlet is not avail...

Страница 64: ...ter a qualified biomedical engineer or technician must ensure that the resulting system complies with IEC 60601 1 1 and that there is no hazard caused by the summation of leakage currents Use of acces...

Страница 65: ...urs accidentally reconnect the cables or resume the current assessment See Restoration after AC supply interruption on page 29 Cleaning the BRM2 Brain Monitor Do not clean with concentrated bleach cor...

Страница 66: ...components with the supplied cables as shown in Figure 1 on page 4 Isolation Unit and Data Acquisition Unit power supply The Isolation Unit and Data Acquisition Unit are supplied with DC power from t...

Страница 67: ...or Main Menu screen The Main Menu screen allows you to access the major functions of the BRM2 Brain Monitor by touching buttons displayed on the touch screen The functions controlled from the Main Men...

Страница 68: ...leaves the factory System Setup screen The System Setup screen provides access to user settings and system functions Touch System Setup on the Main Menu to display the screen Main screen graph selecti...

Страница 69: ...zed personnel To activate the screen saver touch the Screen Saver Enabled check box to select it Touch the check box again to de select it To change the activation delay of the screen saver touch the...

Страница 70: ...to display the System Setup screen 2 Touch Set Date and Time to display the Set Date and Time screen 3 To change the year touch one of the two arrows on either side of the year at the top of the calen...

Страница 71: ...ged although the password can The account cannot be deleted For security reasons the administrator must change the password of the ADMIN account before the BRM2 Brain Monitor is used in any applicatio...

Страница 72: ...pe the user s job title and touch Enter 6 Type the name of the hospital or other location in which the BRM2 Brain Monitor is in use and touch Enter 7 Type an initial password for the user and touch En...

Страница 73: ...Onscreen Keypad type the new password and touch Enter touch the Confirm Password field retype the new password and touch Enter 6 Touch Update to save your changes The account s current password will o...

Страница 74: ...e BRM2 Brain Monitor in front of you by holding the roll pole rather than the Monitor unit Hold the roll pole firmly while traversing small steps such as the lip of an elevator cage When you have posi...

Страница 75: ...and electrodes The accessory basket attached to the BRM2 Brain Monitor s roll pole is designed to carry a load of no more than 11 lb 5 kg Do not apply a load exceeding this amount to the basket Manag...

Страница 76: ...the BRM2 Brain Monitor where you are able to see and reach both the touchscreen display and the patient Connect the power cord of the BRM2 Brain Monitor to a suitable AC supply outlet 2 Turn the AC S...

Страница 77: ...reconnect the cables or resume the current assessment See Restoration after AC supply interruption on page 29 Performing an assessment In this Reference Manual the term assessment is used to mean an e...

Страница 78: ...rehensive instructions for operating the BRM2 Brain Monitor are provided in the BRM2 Onscreen Help System see page 23 Instructions for applying the BrainZ Neonatal Sensor Set are also contained in the...

Страница 79: ...onal information about logging in to the BRM2 Brain Monitor entering patient details attaching and removing the BrainZ Neonatal Sensor Set checking signal quality changing the main display screen susp...

Страница 80: ...he top right of each screen accesses the Help page appropriate to the current screen The Help screen The Help screen is divided into two main panes Contents Index pane You can switch between the Conte...

Страница 81: ...ing the topic titles displayed in the Contents Tree Touching the to the left of the heading will expand the heading into its component topics Touching the to the left of the heading will collapse the...

Страница 82: ...0820 brm Start Date is the date on which the recording was started in the format yyyymmdd Where two or more assessments on the same patient are performed on the same calendar day suffixes _1 _2 _3 etc...

Страница 83: ...the left side of the Monitor or connect a USB drive to either of the USB ports at the rear of the Monitor 2 Wait 5 seconds then touch Refresh to update the file lists in the Patient Data File Manager...

Страница 84: ...first Result The progress of the copy operation is shown by the Progress bar 8 Touch Close to close the Patient Data File Manager screen Do not remove the Compact Flash card from the Monitor or disco...

Страница 85: ...nd record data into the same data files when AC power is restored The resulting data file will have a blank period corresponding to the AC power interruption To continue the same assessment after an A...

Страница 86: ...ge 21 2 If the Login screen appears enter a valid user name and password into the appropriate fields Touch Log In to log in to the BRM2 Brain Monitor 3 When the Main Menu screen appears touch Assess P...

Страница 87: ...roblem persists please contact your healthcare institution s service personnel or contact an Authorized Service Center See Servicing on page 34 Touch Cancel on the Signal Status screen to end the chec...

Страница 88: ...y naturally Disconnect the BRM2 Brain Monitor from the AC supply outlet before cleaning Use only a damp cloth for cleaning do not use liquid or spray detergents Never pour liquid into any opening in a...

Страница 89: ...d be carried out every twelve months or according to the protocol for checking electrical equipment at your healthcare institution 1 Visually check to ensure The AC power cord or attachment plug is no...

Страница 90: ...the software upgrade then retain the CF card or CD ROM in case it is needed again Servicing Information on troubleshooting servicing procedures and spare part details are included in the BRM2 Technic...

Страница 91: ...x 4 375 x 286 x 104 mm Isolation Unit 3 x 1 x 6 80 x 30 x 150 mm Data Acquisition Unit 3 x 1 x 7 98 x 37 x 187 mm Weight Monitor 11 lb 8 oz 5 2 kg Isolation Unit 7 oz 215 g Data Acquisition Unit 12 o...

Страница 92: ...90 and 95 Hz aEEG Filter 0 2 Hz 2 12 Hz 12 16 Hz 16 30 Hz 60 dB decade 12 dB decade 1 dB 10 Hz level 120 dB decade Spectral Edge 90 for 2 20 Hz bandwidth Computed parameters Cross cerebral and Bilate...

Страница 93: ...ut impedance 33 M in parallel with 4 7 nF Allowed DC offset 0 75 VDC at input Noise 1 Vp p Common mode rejection 135 dB Bandwidth 0 5 122 Hz Environmental specifications The following environmental co...

Страница 94: ...standards National standards IEC 60601 1 AS NZS 3200 1 0 IEC 60601 1 1 EN 60601 1 IEC 60601 1 2 CAN CSA C22 2 No 601 1 IEC 60601 2 26 UL 60601 1 Classification for IEC 60601 1 and IEC 60601 2 26 The...

Страница 95: ...trodes with Positioning Guides and Sensor Adaptor Instructions CZA00012 M1099297 Sensor Application Kit Sample of required items for sensor application NuPrep gel wrap hat skin marker CZX00010 6600 09...

Страница 96: ...tor Interpretation Guide Dutch CZD00053 M1100227 BRM2 Brain Monitor Interpretation Guide Spanish CZD00052 M1100229 BRM2 Brain Monitor Technical Manual Technical information and troubleshooting CZD0001...

Страница 97: ...ve Jupiter FL 33458 USA Tel Fax Tel Fax 1 561 575 5000 1 561 575 5070 86 27 8571 2536 86 27 8571 2655 United Kingdom GE Healthcare Customer Service Technical Support Center 71 Great North Road Hatfiel...

Страница 98: ...thereof Warranty for product supplied by GE Healthcare This Product is sold by GE Healthcare under the warranties set forth in the following paragraphs Such warranties are extended only with respect...

Страница 99: ...9 restoring 28 H Help system 23 I Icons displayed on the BRM2 Brain Monitor 2 Indications for use 6 Isolation Unit 5 power supply 10 L Language changing 10 M Main Menu screen 11 Main screen graph sele...

Страница 100: ...BRM2 Brain Monitor Reference Manual 44 BRM2 Brain Monitor Reference Manual...

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