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Certifications:

ISO 9001:2008
EN ISO 13485:2003

USER MANUAL

Leading Through Innovation

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


 

Version : 1. 1

Issued : April 2013

Language Used : English

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.

Electroencephalograph (EEG) is used in the evaluation of brain disorders. Most commonly it


is used to show the type and location of the activity in the brain during a seizure. It is also used
to evaluate people who are having problems associated with brain function. These problems
might include confusion, coma, and tumor, long term difficulties with thinking / memory/
weakening associated with strokes.

1.2 INTENDED USE


An electroencephalogram (EEG) may be done to:
• Diagnose epilepsy and determine what types of seizures are occurring. EEG
is the most useful and important test in confirming a diagnosis of epilepsy.
• Identify the location of a suspected brain tumor, inflammation, infection (such
as encephalitis or meningitis), bleeding, head injury, or disease in the brain,
such as Parkinson's disease.
• Evaluate periods of unconsciousness or dementia.
• Help predict a person's chance of recovery after a change in consciousness.
• Confirm or rule out brain death in a person who is in a coma.
• Studies sleep disorders, such as narcolepsy.
• Monitor brain activity while a person is receiving general anesthesia during surgery.
1.3 FEATURES
• Up to 24 channels view.
• User Friendly interface and plug and play features.
• USB interface with sampling rate 1024 in hardware.
• Up to 4 Multiple Views of same patient.
• Simultaneous Analysis of Multiple Patients.
• 3D Brain Mapping with different colors schemas.
• Online/Offline Split Video (half, double size, default size screen).
• Resolution independent.
• Scrolling (Left to Right & Right to Left) and page wise analysis.

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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

1.4 MACHINE & ITS PARTS


• HEAD BOX FRONT VIEW – Below picture shows the Head Box which collect the
various electrical signals from patient’s brain through the electrodes.

Power On

Top View Bottom View

DC Channel

Side View

• TWO MODE’S SUPPLY SWITCH-


This switch is used to run machine in two different supply modes.
1. USB Mode:-If user wants to run head box as portable with laptop, then select
USB mode. No Need to attach the Adaptor Box.
2. Adapter Mode:-If user wants to run head box with computer then select
adapter mode & connect Adaptor Box thro’ external cable connecting between
adapter box & head Box power supply connector.

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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.

Front View Back View

• EVENT MARKER & RESPIRATION MODULE

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.

Event Marker Respiration Module

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USER MANUAL INTRODUCTION

1.5 BLOCK DIAGRAM


The below figure shows the basics of system block diagram of MAXIMUS 24 Channel.
The microvolt signals are received from the patient via the 24-electrodes placed on the
scalp of the patient and sent to pre-amplifier stages for strengthening of weak signals
and reducing noise due to offset potentials and common mode signals. The strength
signal is connected to multiplexer stage which leads to selection of various channels,
event marker & respiration module. The selected channel is converted into the digital
signal which is further processed & stored by the 32-bit controller. This stored data is
sent to Maximus. “Acquire” PC software through PC USB2.0 module. The USB2.0
module also power up the Maximus head box. Working of MAXIMUS 24 is mainly
divided into following parts –
1. Impedance Check – A virtual sine wave is given to all 24-channels and finds the
drop of amplitude in sine wave, which shows the impedance level between the
scalp and ground. The Impedance data is further send to PC software via 32-bit
micro-controller.
2. Acquire – Maximus-24. acquires the following data:
a) The 21-channel with common ref.
b) 2 bipolar channel
c) 1 DC channel.
3. Photic Flash – No need of any external supply to photic flash. PC software sends
the data like frequency of on/off signal to photic flash via – USB 2.0 module to
32 -bit micro-controller which drives the photic flash according to the input given by
PC software.

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USER MANUAL INTRODUCTION

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USER MANUAL ACQUISITION

2. ACQUISITION

PERFORMING THE MAXIMUS TEST

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

1. THE EEG ACQUISITION


For acquiring the EEG waveforms, you must connect the hardware with RMS Maximus-24
software and then initiate the acquisition. The RMS Maximus software acquires digitalized EEG
signals from the electrodes placed on the skull of the patient. The EEG waveform display on the
application main screen. To start the EEG acquisition.
a) Ensure the system is properly configured and electrodes are placed accurately. You
should also choose the correct montage or auto montage set to use. To use auto
Protocol, configure the auto protocol as desired and enable it.
b) If the system is not connected to the hardware, click the Start EEG in the acquisition
in Menu Bar. The software automatically recognizes the hardware is not connected
and gives the appropriate dialog box. During the system configuration, you must
specify the default setting for connecting to the hardware. You can choose to connect
to the hardware each time you start the RMS Maximus-24.EEG acquisition module.
c) To start acquiring the EEG and display the waveform on screen, click the start button
in the menu bar or Play button in the toolbar. The EEG waveforms acquired from the
hardware displays on the screen. If the video monitoring facility is used, the video also
displays.

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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.

2. STORING THE EEG


You can record the EEG for future reference and review. You should be able to identify the
waveforms or situations when you must start storing the EEG. Depending on unique
requirements, you can also stop the recording and later resume it. While recording the EEG,
you can also perform the tasks like photic stimulation, EMG Filter ON/OFF, placement of
electrode according to the selected montage. Since the EEG recording can be for many hours,
the EEG file size can be fairly large. You should take available disk space into consideration for
long EEG recording sessions. Deleting old and unwanted files is good method of freeing disk
space. The EEG signals are stored in files and are associated with patient records. You can
freeze the screen waveform during an EEG recording session. This does not affect the
recording. You can also take still photographs of the patient in addition to videos. This helps in
easy identification of the patient and appears when you access the patient record. To start
storing the EEG.
a) Ensure the EEG button on the toolbar is enabled. Alternatively, ensure EEG is selected
from the acquisition drop-down menu.
b) Click the ‘Record’ on the acquisition toolbar. Alternatively, select record in the Menu
Bar> acquisition drop down menu.
c) For audio video monitoring, images and sound from the default camera will be recorded
using predefined settings.
d) To pause or freeze the on screen EEG waveform displays for analysis and then resume
it. Click the Pause button on the acquisition toolbar. Alternatively, select freeze option
from drop down menu of acquisition. The data being acquired keeps storing on the hard
disk and is not affected by this. To resume the waveform display click ‘Play’ button.
e) To take a photograph of the patient, click “Capture the Photo” in the acquisition toolbar.
The system captures the current photo of the patient from the default video and stores it
in the folder allocated to the patient. This appears in the patient record.
f) To stop the EEG recording, click stop button in the acquisition toolbar. The Icon changes
to indicate that the EEG is being stopped. Alternatively, select stop option in the drop
down menu of acquisition. To resume storing the EEG, click this record option again.

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USER MANUAL ACQUISITION

3. ADDING EVENTS AND COMMENTS


Events are used to identify the significant actions that take place during an EEG session. These
events affect the EEG and must be noted for accurate analysis. For example, when the patient
talks, the action can be marked and identified using the event ‘Talk’. The event is marked in the
EEG and app location corresponding time the event was marked. You can also add comments
to the EEG for recording more detailed observations.
a) To add an existing user-defined or standard event during the EEG recording session,
click the appropriate button on the toolbar.
b) For standard or user defined event, select the event entry from the event drop down
menu in menu bar.
c) Use the hotkey designated to the event.
d) To add a comment, click the right mouse button on the work area where the
wave forms display and select ‘Enter Comment’ from the pop up menu. Type
your comment and close the dialog box.

4. ENDING AN EEG SESSION


Once you have acquired and recorded the EEG and satisfied with the results, you can stop the
EEG session. When to conclude an EEG session depends largely on how long the EEG
monitoring is needed by the concerned doctors. To end an EEG session.
a) If the EEG is being recorded, stop the recording by clicking the stop button in the
Acquisition toolbar.
b) You may disconnect the hardware from the PC.
You can now remove the electrodes from the skull of the patient. You may close the acquisition
module.

2.1 INSTALLATION PROCEDURE

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.

2.2 SOFTWARE FUNCTIONING


Maximus-24 channel PC software is divided into two parts.
a) Acquire
b) Analysis

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USER MANUAL ACQUISITION

2.2.1 THE RMS MAXIMUS-24 EEG USER INTERFACE


The RMS Maximus-24 EEG hardware and software components are used to perform an
EEG and supported functions. The RMS Maximums-24 EEG application displays and
records data gathered from the hardware components and allows you to manage and
analyze these records. Once you successfully installed the RMS Maximus-24 EEG, you
can start using it. It is recommended that you familiarize yourself with its user interface
before you start using the RMS Maximums-24 EEG. This helps you work with the system
easily and efficiently. To start the RMS Maximus-24 EEG from the shortcut icons.
1. Double click one of the following from the desktop.
ƒ Acquire – if you want to start the acquisition module to configure it and /or start
gathering scalp electric signals of the patient.
ƒ Analysis – if you want to start the analysis module to configure it and/or analyze
previously stored EEG recordings.
2. To start the RMS Maximus-24 EEG from the start menu
ƒ Click START on the taskbar and select the ALL PROGRAMS. From the list of
programs, select RMS Maximus-24 EEG. A sub menu displays with the options
to start the “Acquire” or the “Analysis” module of the RMS EEG package.

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

Main Acquisition Screen

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.

2.2.3 MENU BAR –

2.2.4 ACQUISITION TOOL BAR –

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USER MANUAL ACQUISITION

New Patient Pause


Record
Patient Information Stop
Calibration Play
EEG Impedance Check

Eyes Open Printer Mark


Eyes Close Photic
Hv
Drowsy Seizure
Awake Movement
Asleep Jerk

Sensitivity + Capture Photo


Video On/Off
Sensitivity - Notch
Sweep -
HPF
Sweep + LPF

Maximus-24 EEG Acquire Toolbar

1. NEW PATIENT – Refer to the file in menu bar.


2. PATIENT INFORMATION – Refer to the file in Menu Bar.
3. CALIBRATION – Refer to the Acquisition in Menu Bar.
4. EEG – Refer to the Acquisition in Menu Bar.
5. IMPEDANCE CHECK – Refer to the Acquisition in Menu Bar.
6. PLAY – Refer to the Acquisition in Menu Bar.
7. STOP – Refer to the Acquisition in Menu Bar.
8. RECORD – Refer to the Acquisition in Menu Bar.
9. PAUSE – Refer to the Acquisition in Menu Bar.
10. EYES OPEN – Refer to the Events in Menu Bar.
11. EYES CLOSE – Refer to the Events in Menu Bar.
12. DROWSY – Refer to the Events in the Menu Bar.
13. AWAKE – Refer to the Events in the Menu Bar.
14. ASLEEP – Refer to the Events in the Menu Bar.
15. JERK – Refer to the Events in the Menu Bar.

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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

Waveform display section Montage Bar

Analysis screen

3.1 Title BAR

The title bar shows the Patient ID, Age, Recording Time, Test Time, channels and No. of
pages.

3.2 MENU BAR

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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.

Patient Info- Window


Clicking on the Report option opens the following window. Select the desired template from the
list given on the right side of the window. And then Click on the Save Sample option. Then
printout can be taken by clicking on the Print Report button.

Report Window

Note: Refer CD for Complete Acquisition, Analysis& Reporting details.

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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 –

S.No ICON SYMBOL S.No. ICON SYMBOL

1 Load Patient 25 EEG

2 Patient 26 Search event


information
3 Enter Patient 27 Play
information
4 Impedance 28 Record

5 Calibration 29 Stop

6 Open 30 Next Page (F2)

7 Print 31 Auto Fwd

8 Impedance 32 Next Event

9 Seizure 33 Zoom

10 Insert tab or page m 34 Analyse

11 Mark attention 35 Measurements


seeking area on
screen for print
12 Prev.event 36 Split screen

13 Auto Bwd 37 Single amplitude


map
14 Prev.page (F3) 38 Trimaps

15 Frequency Maps 39 HF(+/_F8)

16 Frequency 40 Notch(F9)
Spectrum
17 Program Amp 41 Play Video

18 Program 42 Start Page Range


Frequency for
Archiving
19 Frequency 43 Scroll Mode
Tabula ON/OFF
r
Analysi
s
20 Sen(+F5) 44 Freeze waves

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21 Sen(-F5) 45 Load Previous
Patient
22 Sweep(-F6) 46 Load Next Patient

23 Sweep(+F6) 47 Switch Mode(ASIS


or
Normal)
24 LF(+/_F7)

A.2 ABBREVIATIONS USED-

ID Identification number HF High Filter mm/sec Millimeter per


second
EEG Electroencephalograph LF Low Filter ACQ Acquisition

EMG Electromyography Sec Seconds Sens Sensitivity

µv/m Microvolt/millimeter CH Channel Freq. Frequency


m
Hz Hertz M Master Setting

A.3 MACHINE SYMBOLS SERIAL NUMBER LABEL (FOR MACHINE)

USB

DC1 - Channel 1

Photic

Equipotential

• LABELS ON PACKING

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A.4 TECHNICAL SPECIFICATIONS

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

Sampling Rate 1024 Hz./Channel

Storage Rate 256 Hz/Channel


Input Impedance >10 M Ohm
Frequency Response 0.1 to 100 Hz
CMMR > 100 dB
Time Constant 1.6 sec to 0.032 sec
Sensitivity 1 to 1000 µV/mm(User Selectable)

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Voltage Resolution < 0.3 µV

Noise Level < 0.3 µV RMS


Recording & Printing
Recorder Windows Compatible inkjet/LaserJet.
Power Supply
USB Power Requirement 5V USB ,500 mA
Adaptor Power Supply (optional) ~ 220 - 240V, 50Hz ± 10%
Mechanical
Head Box: 69X216X146mm
Dimensions (mm) Photic Flash :54mmX285mmX72mm

Weight 500 Gram Approx.

Environmental Conditions

Storage Conditions:

Temperature 0 - 40°C

Non-Condensing humidity 0 – 80%

Operating Conditions:

Temperature 0 - 35°C

Non – Condensing humidity 0 – 80%

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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

Electrode Type-III JUMPER-I -EGS 1

Electrode Type-IV Jumper-Ii-EGS 1

Respiration Transducer (OPTIONAL) 1


Software CD 1
Maximus Quick Installation Guide 1
Event Marker 1
Recording Paste 2
Carry Bag 1
Cleaning Brush 1

A.6 SAFETY INSTRUCTIONS


1) Our unit is designed for use by medical clinicians. Although this manual may
Illustrate monitoring techniques, this system should only be used by a trained
technician who knows how to take and interpret a patient’s vital signs.
2) Never use damaged cables or leads. These must be replaced before any
connection to humans is made.
3) Always use a suitable electrode gel and proper skin preparation to ensure a
low –impedance contact. Using electrodes without electrode gel can result in burns
to the skin or discomfort for the subject.
4) Always ensure that there is good electrode contact at all times. Electrodes that
are left on a subject for some time need to be checked for dry contacts.
5) Subjects with implantation or external cardiac pacemakers, a cardiac condition,
or a history of epileptic episodes should be treated under proper supervision.
6) Avoid using multiple portable sockets - outlets. Individual connection of each
piece of equipment to fixed mains socket – outlets is the preferred means of
connection. If multiple portable socket outlets are used, they are subject to

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USER MANUAL APPENDIX

the following constraints:


a) They shall not be placed on the floor.
b) Additional multiple portable socket outlets or extension cords shall not
be connected to the system.
c) They shall only be used for supplying power to the equipment which is
intended to form part of the system.
7) This equipment must not be connected to any other equipment as combined leakage
currents could exceed safe limits.
8) Use of accessories, transducers, and cables other than those specified may
result in degraded electromagnetic compatibility performance of this device.
9) Do not operate this product with MRI (Magnetic Resonance Imaging) equipment.
10) If the machine has been dropped or damaged it should be checked by qualified
service personnel to insure proper operation prior to use.
11) There are no user serviceable parts inside the product.
12) The machine should not be used on the patients who are linked to heart/lung
machines.
13) Place the unit and the accessories in locations where they cannot harm the patient
/any personnel if they fall off a shelf or mount.
14) Never place fluids on top of this monitor. In case of fluid spilling on the monitor,
disconnect power cord, wipe clean immediately and have the monitor serviced to
ensure that no hazard exists.
15) The machine should not be stacked directly on top of other equipment, and vice
versa.
16) Make frequent electrical and visual checks on cables and electrode wires.
17) Ensure the AC rating (230V, 50Hz) for the device is correct for the AC voltage at the
installation site before using the machine.

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USER MANUAL APPENDIX

A.7 WARRANTY CARD


CERTIFICATE OF WARRANTY

Customer Name & Address:

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).

For Recorders & Medicare Systems Pvt. Ltd. Dealer:

(Authorized Signatory)
Name: _____________________________ Date_________________________________

Employee Code: ______________________

(One Copy is to be retained by customer & One copy to be send to CS (HO)

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USER MANUAL APPENDIX

Terms and Conditions


1. The warranty is valid only in case the equipment is operated as per instructions given in
the User Manual and normal Power Line Voltage & Frequency.
2. RMS shall not be obliged to furnish warranty service in case of:
- Where the machine has been installed, serviced, repaired, opened or tampered by any
unauthorized person.
- Damage caused by the use of Non- RMS supplies, Parts, Consumables & accessories.
- Damage resulting from modification and integration with other products.
- Damage due to electric power fluctuations.
- Damage caused by mice, lizards, rodents, cockroaches etc.
-Any defect, failure or damage caused by improper use, operation by un-qualified
Technicians, inadequate maintenance and care.
3. The warranty is limited to repair/replacement of material parts and dose not cover
consumables like paste, jelly and electrodes etc which are consumed during normal
operation of machine.
4. This warranty shall not extend to glassware items & parts which are subject to normal wear
& tear.
5. The warranty also does not cover breakages of any item due to misuse.
6. Parts repaired or replaced under the warranty are warranted for the remaining period of
Original warranty period only.
7. This warranty will apply to the original purchase only.
8. This warranty will be the sole and only remedy, either express or implied, for RMSPL
products.
9. Customers can avail services under Annual Maintenance Contract after the warranty period.
10. All vacuumatic items, in case of X-Ray machines & C-Arms (X-ray Tubes & Image
Intensifying Tubes) are subject to pro-rata warranty and these items going defective during
the warranty period shall be replaced as per following replacement policy. (This is in line
with the warranty being extended to us by suppliers of these items)
a) Price of the X-Ray Tube or I.I. Tube = Rs. X
b) Un-expired portion of the warranty = Y Months
c) Pro-Rata Credit to be allowed to Customer = XxY/12
d) Replacement cost to be borne by Customer = a)-c) = Rs. ___________
11. This warranty shall be subject to following limitations & exclusions:-
a) Damage, defects and or malfunctions resulting from Dust, interference of foreign objects,
natural disaster, Lightning, fire, water and or liquid substances, exposure to sunlight,
improper ventilation, drop from height, inoperative/leaking batteries, civil unrest or
accidents.
b) Software Media which does not conform to the specifications referred to in the operating
instructions.
c) Loss of any Data or memory and or setting during operation and or in the course of any
repair/service.
d) Units on which the Serial No. has been defaced modified or removed.
e) If the product is used in Industrial or Rental purposes.
12. This Warranty shall be applicable in Republic of India only.
13. The warranty is subject to the jurisdiction of Panchkula courts.

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USER MANUAL APPENDIX

A.8 WARRANTY CARD


CERTIFICATE OF WARRANTY

Customer Name & Address:

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).

For Recorders & Medicare Systems Pvt. Ltd. Dealer:

(Authorized Signatory)
Name: _____________________________ Date_________________________________

Employee Code: ______________________

(One Copy is to be retained by customer & One copy to be send to CS (H

27
USER MANUAL APPENDIX

Terms and Conditions


1. The warranty is valid only in case the equipment is operated as per instructions given
in the User Manual and normal Power Line Voltage & Frequency.
2. RMS shall not be obliged to furnish warranty service in case of:
- Where the machine has been installed, serviced, repaired, opened or tampered by
any unauthorized person.
- Damage caused by the use of Non- RMS supplies, Parts, Consumables &
accessories.
- Damage resulting from modification and integration with other products.
- Damage due to electric power fluctuations.
- Damage caused by mice, lizards, rodents, cockroaches etc.
- Any defect, failure or damage caused by improper use, operation by un-qualified
Technicians, inadequate maintenance and care.
3. The warranty is limited to repair/replacement of material parts and dose not cover
consumables like paste, jelly and electrodes etc which are consumed during normal
operation of machine.
4. This warranty shall not extend to glassware items & parts which are subject to normal
wear & tear.
5. The warranty also does not cover breakages of any item due to misuse.
6. Parts repaired or replaced under the warranty are warranted for the remaining period
of Original warranty period only.
7. This warranty will apply to the original purchase only.
8. This warranty will be the sole and only remedy, either express or implied, for RMSPL
products.
9. Customers can avail services under Annual Maintenance Contract after the warranty
period.
10. All vacuumatic items, in case of X-Ray machines & C-Arms (X-ray Tubes & Image
Intensifying Tubes) are subject to pro-rata warranty and these items going defective
during the warranty period shall be replaced as per following replacement policy. (This is in
line with the warranty being extended to us by suppliers of these items)
a) Price of the X-Ray Tube or I.I. Tube = Rs. X
b) Un-expired portion of the warranty = Y Months
c) Pro-Rata Credit to be allowed to Customer = XxY/12
d) Replacement cost to be borne by Customer = a)-c) = Rs. ___________
11. This warranty shall be subject to following limitations & exclusions:-
a) Damage, defects and or malfunctions resulting from Dust, interference of foreign objects,
natural disaster, Lightning, fire, water and or liquid substances, exposure to sunlight,
improper ventilation, drop from height, inoperative/leaking batteries, civil unrest or
accidents.
b) Software Media which does not conform to the specifications referred to in the operating
instructions.
c) Loss of any Data or memory and or setting during operation and or in the course of any
repair/service.
d) Units on which the Serial No. has been defaced modified or removed.
e) If the product is used in Industrial or Rental purposes.
12. This Warranty shall be applicable in Republic of India only.
13. The warranty is subject to the jurisdiction of Panchkula courts.

28
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.

WARNING, CAUTION & NOTE SYMBOLS


Please read and follow all WARNINGS, CAUTIONS and NOTES provided in this manual. To
avoid the possibility of injury, damage to the product or loss of data, observe these safety
precautions while operating the system.

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.

29
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.

30
                            
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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 

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