Professional Documents
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ISO 9001:2008
EN ISO 13485:2003
USER MANUAL
Version : 1. 1
Disclaimer
All rights reserved. No parts of this manual may be reproduced in any form without the express
written permission of RMS.
Recorders & Medicare Systems (P) Ltd. (RMS) makes no representations or warranties with
respect to the contents hereof. In addition, information contained herein is subject to change
without notice. Every precaution has been taken in the preparation of this manual.
The manual should only be used with the supplied version of the software and hardware. Any
other uses result in loss or damage to the operating system or to the machine itself.
USER MANUAL INTRODUCTION
1. INTRODUCTION
1.1 SCOPE
An Electroencephalograph (EEG) measures & records the electrical activity of brain by using
sensors (electrodes) attached to head and this raw signal gets amplified and sent to (personal
computer) through USB for analysis .The PC records the brain’s electrical activity & display’s on
the screen.
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USER MANUAL INTRODUCTION
• Print Preview for analysis, Brain maps etc.
• Fully Synchronized video with data.
• Achieving data to CD/DVD hard disc.
• Drag and drop facility for event and comments.
• Amplifier configuration where channels can be swapped.
• Send archived data by email to any number of recipients and can be viewed data with
out installation of software.
• EEG Protocols with full montage setting and events.
• Amplitude Based DSA of whole record.
• All channels FFT for the applied montage and selected channels can be exported to
excel sheet.
• Coherence.
• Photic frequency up to 60 Hz.
• Light weight, small size and easy to use.
• 24 channels view with even single channel view
• New and interactive user interface.
• Compressed Spectral Array( CSA)
• Density Spectral Array (DSA).
• Online/Offline split Video (half, double size, default size screen).
• Full screen, Resolution independent, floating toolbars.
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USER MANUAL INTRODUCTION
Power On
DC Channel
Side View
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USER MANUAL INTRODUCTION
• PHOTIC FLASH
The Photic Flash is used to give stimulus on the patient’s eyes. When the flash is
given to the patient’s eyes, it effects the brain activity of the patient. This can be
observed by the EEG waveforms. To give Photic to the patient click on the Photic
Flash options in the software Photic Flash is connected to the Head box through
hardwire.
• ADAPTER BOX
Adapter box supplies +5 volts to the head box. Mode selection switch provided on
head box is used to select the Adapter Mode during acquisition.
The purpose of this external DC switch connected to the head box is to enable
recording of events without involving the RMS Maximus EEG software entirely. The
patient, the technician or a non-technical person present with patient can press this
button when the need arises. On doing so, a blank event is marked in the EEG
recording. The analyst can later refer to the video associating with the event to find
further details and add comments to the event text.
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USER MANUAL INTRODUCTION
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USER MANUAL INTRODUCTION
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USER MANUAL ACQUISITION
2. ACQUISITION
For successfully acquiring the EEG, you must have good knowledge and experience in the
electroencephalography domain. There are several recommended best practices that you
should follow for acquiring accurate EEG. You should calibrate the system and prepare the skin
of the patient, then place electrodes appropriately. Giving the patient adequate information
about the procedure makes the patient comfortable taking the test. Taking note of medication
and other factors that may affect EEG is also important for correct analysis. Once you start
acquiring the EEG, you must check the electrode Impedance. If Photic stimulation is required,
make sure it is properly configured as define in Photic in the Menu Bar. For video monitoring
and recording ensure the system is properly configured. You should also switch the EMG filter
on or off according to your needs. Following is the procedure:
1. The EEG Acquisition
2. Storing the EEG signal data.
3. Adding events and annotations.
4. Ending the EEG session
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USER MANUAL ACQUISITION
d) Make sure the electrode impedance is within limit. By checking the electrode
impedance you can ensure that the electrodes are properly attached to the scalp.
e) If the photic stimulation is required start the stimulation at the appropriate time.
f) To switch the EMG filter ON or OFF, click the EMG ON or EMG OFF in the menu bar.
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USER MANUAL ACQUISITION
Put Software CD in the Computer. The Auto run CD automatically opens the following
contents. Choose whether you want to install the RMS Maximus Software or to Explore RMS
Maximus Drivers Location or to Install Video Compression. To install the RMS Maximus
Software, click on “INSTALL RMS Maximus” option. Refer CD for further details.
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USER MANUAL ACQUISITION
NOTE –
1) When started in the acquisition mode, the RMS EEG application checks and identifies
the RMS EEG hardware connected with it. In case there is a problem, an appropriate
message displays.
2) Once you start the RMS EEG application in acquisition mode, you should not connect
or disconnect any hardware components. When you connect or disconnect
components, errors may occur that can hamper the EEG Results.
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USER MANUAL ACQUISITION
Since the modules are designed to support specific aspects of the EEG, namely acquiring data
and analyzing it, the features and functionalities of the acquisition and analysis modules differ.
The user interface of the two modules of the RMS Maximus-24 EEG are however similar with
some exceptions, as discussed in the relevant chapters. These modules also share many
common features. This helps you to seamlessly work with both the modules. The following
figure depicts the RMS Maximus-24 EEG user interface. The size of the RMS Maximus-24 EEG
acquisition window can only be maximized and minimized and cannot be resized.
Title Bar
Menu Bar
In case machine is not connected then following message appears on the screen.
2.2.2 TITLE BAR – The status bar shows the Patient ID, age, gender, Photic and HV
Status, test time and the Channels.
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USER MANUAL ACQUISITION
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USER MANUAL ACQUISITION
16. MOVEMENT – Refer to the Events in the Menu Bar.
17. SEIZURE – Refer to the Events in the Menu Bar.
18. HV – Refer to the Events in the Menu Bar.
19. PHOTIC – Refer to the Photic in the Menu Bar.
20. PRINTER MARK – Refer to the Events in the Menu Bar.
21. SENSITIVTY + – This shortcut is used to increase the sensitivity of the EEG signal. For
details refer to the configuration -> settings part.
22. SENSITIVITY- – This shortcut is used to decrease the sensitivity of the EEG signal. For
details refer to the configuration -> setting part.
23. SWEEP- – This shortcut is used to decrease sweep rate of the EEG Signal. For details
refer to the configuration -> setting part.
24. SWEEP+ – This shortcut is used to increase the sweep rate of the EEG signal. For
details refer to the configuration -> settings part.
25. LPF – Low pass filter or ‘LF’. Click on this shortcut button, you can change the low pass
filter value. For details refer to the configuration -> settings part.
26. HPF – High pass filter or ‘HF’. Click on this shortcut button, you can change the high
pass filter value. For details refer to the configuration -> settings part.
27. NOTCH – Click on this shortcut button, you can change the notch filter value.
For details refer to the Notch in Menu Bar.
28. VIDEO ON/OFF – You can directly switch on or off the capturing of the video. For details
refer to the Video in the Menu Bar.
29. CAPTURE PHOTO – User can take still photos of the acquiring EEG signal for
future reference.
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USER MANUAL ANALYSIS
3. ANALYSIS
To open Analysis SW, double click on the ‘Analysis’ icon on desktop.
Title
Standard Menu Bar
Toolbar Active Screen
Status Bar
Analysis screen
The title bar shows the Patient ID, Age, Recording Time, Test Time, channels and No. of
pages.
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USER MANUAL REPORTING
4. REPORTING
4.1 EXPLANATION OF REPORTS
Any notes or Comments entered by the doctor can be seen in the report. Click on the Analysis
option. Select patient from option Patient Info and then click on the Print Report button. It will
give printout of the patient’s report. The report can be selected by clicking on the Report button
in the below shown figure.
Report Window
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USER MANUAL MAINTENANCE
5. MAINTENANCE
5.1 MAINTENANCE & CLEANING
GENERAL MAINTENANCE OF THE EQUIPMENT
It is important to maintain the RMS EEG equipment so it performs as desired and provides
accurate output. Following is the list of various tips for properly maintaining your RMS EEG
system.
• The installation engineer is responsible for explaining the finer points of operating and
maintaining the RMS EEG to you.
• Protect the EEG machine from any physical damage such as dents and caustic spills.
• Dust can cause major problems in your EEG machine to protect the equipment from
dust:
• Avoid congestion in the room where the machine is installed.
• Keep the machine in a dust free environment, preferably an air conditioned room.
• Ensure that only a trained technician operates your RMS EEG.
• The CPU of the computer contains sensitive hardware and software that are meant for
smooth running of the machine. Installation or regular use of any other application or
Software may affect their performance. Therefore, avoid using the computer for other
purposes, including internet access.
• Electrodes should be thoroughly cleaned using a soft brush.
DAILY CHECKLIST
• Clean the unit and the electrodes by removing conducting paste.
• Electrodes should be thoroughly cleaned in soap and water using a soft brush. Proper
cleaning must precede sterilization.
• After long–usage the surface of electrodes gets oxidized. In such a case electrodes should
be replaced to achieve high-quality EEG.
• Avoid keeping the cables and electrodes near any sharp edged material.
• Clear the dust from the Head Box.
• Maintain the record of the number of hours of operation of the unit on each day. This will
help in determining the type of maintenance routines to be carried out by RMS engineers
during routine maintenance.
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USER MANUAL MAINTENANCE
WEEKLY CHECKLIST
• Check all connectors outside the unit are functional or not.
CORRECTIVE MAINTENANCE
The corrective maintenance consists of repairing a device that has been put out of service due
to improper use or mishandling. In case of detecting a break-down in the system which impedes
its normal use, disconnect the device from power supply and contact the nearest RMS customer
support location. Specify as much details as possible the type of problem detected.
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USER MANUAL APPENDIX
A APPENDIX
A1. SCREEN SYMBOLS –
5 Calibration 29 Stop
9 Seizure 33 Zoom
16 Frequency 40 Notch(F9)
Spectrum
17 Program Amp 41 Play Video
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USER MANUAL APPENDIX
21 Sen(-F5) 45 Load Previous
Patient
22 Sweep(-F6) 46 Load Next Patient
USB
DC1 - Channel 1
Photic
Equipotential
• LABELS ON PACKING
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USER MANUAL APPENDIX
General Specifications
Type of protection Class II A
Degree of protection Type BF
Computer IBM
Communication Interface USB
Computer Configuration
CPU IBM compatible(Core 2 duo latest 2.4GHz)
Operating System Windows XP
RAM 1 GB (Min.)
Display Format 24 Channel
EEG Unit
A/D Resolution 16 Bit
Input channel 24 Channel 21 EEG Channel
Bipolar -2 channel
1 DC channel
Filters Low Pass Filter
Auto:0.1,0.3,0.5,1.0,3.0,5.0 Hz
Manual:0 to 7 Hz, single pole
High Pass Filter
Auto:15,35,& 70 Hz single pole
Manual:10 to 99 Hz
Notch:50/60Hz with 4 Hz. Stop band(Min.30 db)
Muscle Rej.: ON/OFF,30Hz,Double Pole
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USER MANUAL APPENDIX
Environmental Conditions
Storage Conditions:
Temperature 0 - 40°C
Operating Conditions:
Temperature 0 - 35°C
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USER MANUAL APPENDIX
A.5 ACCESSORIES
Accessories Quantity
Photic Flash 1
USB Cable 1
Micro pore Tape 1
Earthing Cord 1
Electrode Type-I EG-EGS 50
Electrode Type-II GND -EGS 1
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USER MANUAL APPENDIX
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USER MANUAL APPENDIX
Contact Details :
Product Description :
Model : Serial Number:
Date of Installation : __________________Date of Warranty Expiry:
Dear Customer,
Thank you for purchasing our Product.
RMS warrants that the above mentioned product will be free from defects in material and
workmanship for a period of 12 months from the date of Supply/Installation.
However, the consumables & accessories viz. rechargeable batteries, patient cables,
temperature probes, NIBP Cuff, SPO2 probes etc. are covered by 6 months warranty only from
date of installation.
To obtain warranty service, customer must register the complaint with Local office of RMS or its
Authorized Dealer in the Area. Customer is required to send the following equipments to RMS’s
Service Centre duly packed for Service or Repairs:
1. ECG Machines,
2. Patient Monitors,
3. Bio Chemistry analyzer.
4. Audiometer.
5. Pulse Oximeter.
6. Spirometer.
7. And any other equipment which is portable.
For other equipments, viz. EEG, EMG, Stress Test System, X-Ray machines, Polyrite etc., RMS
will depute its engineer within a reasonable time to repair the machine. Although most of the
repair work will be carried out at customer’s premises, certain parts requiring specialized goods
and equipments will have to be sent to our Works at Panchkula, Haryana for repairs. In such
cases, the responsibility of packing and shipping (including shipping charges, duties, taxes and
other charges) of the defective product/part to our Works lies with the customer.
The warranty is governed by the Terms & conditions (given overleaf).
(Authorized Signatory)
Name: _____________________________ Date_________________________________
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USER MANUAL APPENDIX
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USER MANUAL APPENDIX
Contact Details :
Product Description :
Model : Serial Number:
Date of Installation : __________________Date of Warranty Expiry:
Dear Customer,
Thank you for purchasing our Product.
RMS warrants that the above mentioned product will be free from defects in material and
workmanship for a period of 12 months from the date of Supply/Installation.
However, the consumables & accessories viz. rechargeable batteries, patient cables,
temperature probes, NIBP Cuff, SPO2 probes etc. are covered by 6 months warranty only from
date of installation.
To obtain warranty service, customer must register the complaint with Local office of RMS or its
Authorized Dealer in the Area. Customer is required to send the following equipments to RMS’s
Service Centre duly packed for Service or Repairs:
1. ECG Machines,
2. Patient Monitors,
3. Bio Chemistry analyzer.
4. Audiometer.
5. Pulse Oximeter.
6. Spirometer.
7. And any other equipment which is portable.
For other equipments, viz. EEG, EMG, Stress Test System, X-Ray machines, Polyrite etc., RMS
will depute its engineer within a reasonable time to repair the machine. Although most of the
repair work will be carried out at customer’s premises, certain parts requiring specialized goods
and equipments will have to be sent to our Works at Panchkula, Haryana for repairs. In such
cases, the responsibility of packing and shipping (including shipping charges, duties, taxes and
other charges) of the defective product/part to our Works lies with the customer.
The warranty is governed by the Terms & conditions (given overleaf).
(Authorized Signatory)
Name: _____________________________ Date_________________________________
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USER MANUAL APPENDIX
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USER MANUAL APPENDIX
ATTENTION
RMS makes no warranty of any kind, expressed or implied, including, but not limited to, the
implied warranties of merchantability and fitness for a particular purpose. RMS assumes no
responsibility for errors that may appear in this document. RMS makes no commitment to
update or to keep current the information contained in this document.
CUSTOMER RESPONSIBILITY
This product and its components & accessories will perform reliably only when operated and
maintained in accordance with the instructions contained in this manual, accompanying labels,
and/or leaflets. A defective product should not be used. Parts which may be broken or missing
or are plainly worn out, distorted or damaged should be immediately replaced with genuine
replacement parts manufactured by or made available by RMS or from sources recommended
by RMS. The responsibility of RMS for a malfunctioning product is limited by the warranty set
forth in this manual. Should repair or replacement of this product become necessary after the
warranty period, the customer should seek advice from RMS prior to such repairs or
replacement. If this product needs repair, it should not be used until all repairs have been
carried out and the unit is functioning properly and is ready for its intended use. The owner of
this product bears sole responsibility for any malfunction resulting from improper use or
maintenance, or repair by any unauthorized person or agency , as well as for any malfunction
caused by parts which are damaged or modified by anyone other than RMS.
WARNINGS
This machine uses a USB cord for power. Inspect the USB Cable often for fraying or other
damage. Do not operate the machine with a damaged power cord or plug. Improper
grounding is a safety hazard.
• Connect the machine only to RMS supplied or recommended accessories
• Do not allow the conductive parts of the electrodes and connectors to contact other
surfaces or ground.
• Periodically check the system ground integrity (the voltage between neutral and earth
leads of power supply should be less than 5V) and the system leakage current.
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USER MANUAL APPENDIX
• A power interruption during a recording could cause loss of data in the current
recording. If there are frequent/ unannounced power interruptions, RMSPL recommends
using a reputed Un-interruptible Power Supply (UPS) to help prevent interruptions.
• Electrical shock hazard. Do not remove covers. Refer servicing to qualified personnel.
• In all cases, the original data must be reviewed if a clinical decision is involved.
• Do not turn on any power until all cables have been properly connected and verified.
• To guard against any potential injury, disconnect all recording electrodes from the
machine Before turning the system power off and on.
• Electrical Shock Hazard. DO NOT remove covers. Refer servicing to RMS qualified
personnel.
CAUTIONS
• Use this machine in controlled humidity rooms with an anticipated humidity range of 20%
to 70%.
• Turn OFF the machine before cleaning. Prevent detergent solution or cold sterilization
agents from seeping into the Instrument. Exercise extra caution around controls,
connectors and panel edges. DO NOT use abrasives.
• If the machine is not functioning properly, do not operate it until all necessary repairs have
been made and unit it is tested for proper functioning in accordance with the RMS
published specifications. It is recommended that all repairs be performed by qualified
service representative only.
• Do not over-tighten the connector securing screws.
• Do not attempt to open the equipment
• Follow all safety standards and guidelines set by your place of employment
IMPORTANT
• Do not attempt any procedures requiring specialized test equipment or access to
machine interiors.
• Adversely affect the functioning of the machine.
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Recorders & Medicare Systems (P) Ltd.
H.O. & Works: 196, Industrial Area, Phase 1, Panchkula‐134113 (Haryana), INDIA.
Ph.: +91‐172‐2564196, 2565196, Fax: +91‐172‐2566196
Regd. Office: 181/5, Industrial Area, Phase 1, Chandigarh‐160002, INDIA.
Website: www.rmsindia.com, e‐mail: helpdesk@rmsindia.com