03 - Virgo EEG Rev 17
03 - Virgo EEG Rev 17
ELECTROENCEPHALOGRAPH
(Virgo – 24, Virgo – 32, Virgo - 40)
User’s Manual
AGHPL/ EEG/Virgo Series, Catalogue No. 3; Rev. 17, Eff. Date: 22.08.2020
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Allengers Global Healthcare Pvt. Ltd.
Table of Contents
A Word of Thanks -------------------------------------------------------------------------------------------------------------------- 2
Revision History ---------------------------------------------------------------------------------------------------------------------- 3
1. Introduction --------------------------------------------------------------------------------------------------------------------- 4
2. Intended Use-------------------------------------------------------------------------------------------------------------------- 5
3. Safety ----------------------------------------------------------------------------------------------------------------------------- 6
3.1. General Handling Precautions ---------------------------------------------------------------------------------------- 7
3.2. Symbol & Label ----------------------------------------------------------------------------------------------------------- 9
4. System Overview ------------------------------------------------------------------------------------------------------------ 10
4.1. Technical Specifications ---------------------------------------------------------------------------------------------- 11
5. Description of Device ------------------------------------------------------------------------------------------------------- 14
5.1. Main Machine Part & Accessories --------------------------------------------------------------------------------- 17
6. Unpacking & Installation -------------------------------------------------------------------------------------------------- 19
6.1. Virgo Software Installation ------------------------------------------------------------------------------------------ 20
6.2. Start up Procedure----------------------------------------------------------------------------------------------------- 21
6.3. Shut Down Procedure------------------------------------------------------------------------------------------------- 21
7. Executing EEG Test ---------------------------------------------------------------------------------------------------------- 22
8. Virgo EEG Software---------------------------------------------------------------------------------------------------------- 23
8.1. Configuration ----------------------------------------------------------------------------------------------------------- 24
8.2. Acquire ------------------------------------------------------------------------------------------------------------------- 34
8.2.1. Menu Bar: Acquire ---------------------------------------------------------------------------------------------- 36
8.2.2. Shortcut Menu: Acquire --------------------------------------------------------------------------------------- 40
8.3. Analyse ------------------------------------------------------------------------------------------------------------------- 41
8.3.1. Menu bar: Analyse ---------------------------------------------------------------------------------------------- 42
8.3.2. Shortcut Menu: Analyse --------------------------------------------------------------------------------------- 47
9. Product Life Cycle ------------------------------------------------------------------------------------------------------------ 52
10. Precaution & Maintenance -------------------------------------------------------------------------------------------- 53
11. Replacing Battery and Fuse -------------------------------------------------------------------------------------------- 55
12. Technical Reference ----------------------------------------------------------------------------------------------------- 56
13. Troubleshooting ---------------------------------------------------------------------------------------------------------- 59
13.1. Service Centers --------------------------------------------------------------------------------------------------------- 60
Warranty ----------------------------------------------------------------------------------------------------------------------------- 61
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A Word of Thanks
Thank you for purchasing the Allengers Virgo EEG. Allengers has used the latest microelectronic and
computer software technology to develop a compact, low maintenance and high quality EEG system. Our
goal is to enable healthcare professionals to provide quality and efficient patient care. With that in mind,
our product is designed with intuitive layouts and features that will enable more physicians to conduct
office-based tests, which will result in more timely diagnoses and enhanced patient outcomes.
We believe you will be pleased with the user-friendly operation of our product and with your results. As
your partner in healthcare, we look forward to working with you in the coming years as we develop even
more sophisticated diagnostic technology. Your thoughts, questions, and comments about our product are
welcome.
Copyright
Allengers owns all rights of this unpublished work and has the right to maintain this work as confidential.
This publication is to be used solely for the purposes of reference, operation, maintenance and repair of
Allengers products.
Allengers owns all rights to this work. Those having access to this work must not copy, use, or disclose the
information in this work without written authorization by Allengers.
Information in this document is subject to change without notice. Names and data used in the
examples are fictitious unless otherwise noted.
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Revision History
This Manual has a revision number located at the bottom of each page. It changes whenever the Manual is
updated
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1. Introduction
Allengers Virgo series of EEG test systems are designed using state of the art technology and more than 20
years of experience in design and manufacturing of medical equipments. Advanced digital signal processing
and brain mapping techniques are highlights of Allengers EEG.
Innovation of using computer technology to record the EEG has brought diagnostic neurology to the edge
of the 21st century. Digital EEG is providing the technologist and physician with greater flexibility in the
recording and interpretation of the EEG.
VIRGO EEG is intended for use under the direct supervision of a licensed Healthcare practitioner.
This manual provides a complete procedure for executing the EEG test using VIRGO-EEG.
Salient Features
Works on all Microsoft’s Windows platform like Windows XP, 7, 8, 10 (32 and 64 bit each)
Inbuilt EDF (European Date Format) converter.
Facility of online monitor cloning & control.
Facility of online update/print to PDF/email PDF through in software.
EEG software and drivers are digitally certified by Microsoft’s authorized certifying authority to
ensure reliability and security.
Facility to send EEG data in DICOM format to PACS Server.
Facility to export data to MATLAB/LAB View or compatible software.
Facility of online and offline video zooming (in case video option).
Facilities of calculator, notepad and calendar available on control bar in utility menu are available.
Facility for CSA/DSA/DDA (Compressed Spectral Array/ Density Spectral Array/ Dot Density Array).
It have flexible Photic stimulator based on high intensity LED’s.
Facility of Integrated impedance Check for electrode Connectivity
Unlimited No. of montages.
Internal / External Calibration signal available.
All the settings can be done at single stage configuration.
Able to view up to 64 channels.
Facility to reformat of gain, filter and sweep speed online/offline.
Facility to record and review EEG simultaneously and can write comments during review.
Facility to see one/ all display channels by double clicking on the respective channel.
Split screen facility for viewing channels simultaneously comprising three different montages at the
same time.
Facility to search the patient from database by ID, patient name, DOB, referring doctor and test date.
Facility to write the data on CD/DVD.
Variable speeds to review an EEG data available.
Option to search events & comments available.
Facility to measure amplitude and frequency at any portion of EEG.
Display of time and events bar at the bottom of the screen.
Facility of Auto spike detection.
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2. Intended Use
The device is intended to acquire, store, and transfer biophysical parameters to EEG machines for the
purpose of assisting the diagnosis of neurological and sleep disorders, measurement and display of
cerebral and extra cerebral activity for EEG and Sleep Studies. These data may be used by the clinician in
Sleep Disorders, Epilepsies and other related disorders as a diagnostic tool. As with the predicate, the
information transferred to EEG will be stored, interpreted and printed with software programs. The device
is intended for use by medical personnel in any location within a medical facility, physician's office,
laboratory, clinic or nursing home or outside of a medical facility under supervision of a medical
professional.
The device will be available on all patient populations, including pediatrics.
Environmental Atmospheric
Temperature Humidity Remark
conditions Pressure
0% to 75% RH
Operating conditions +0C to +40C Protect the
(without condensation) 70 to 106
instruments from the
Storage and Transport 0% to 90% RH KPA
+0C to +40C vibration and shock
conditions (without condensation)
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3. Safety
This chapter provides overall safety requirements for the EEG system. Become familiar with the
information in this chapter before operating the device. Additional specific safety statements are included
when necessary later in the manual.
Safety Definition
The following types of safety statements are used in this manual.
Warning Warning Indicates that if you do not follow directions correctly injury can occur to the patient
or operator.
Caution Caution Indicates that if you do not follow directions correctly the equipment or software may
not operate properly or damage can occur to the equipment or software.
Contraindication
There are essentially no contraindications or risks associated with the proper use of EEG since it is a non-
invasive procedure. However, an EEG should not be performed if the patient required high concentration
oxygen, as the electrical currents from the EEG machine can ignite the oxygen resulting in an explosion.
Some patients may be asked to discontinue certain seizure medications days prior to the EEG recording,
which will increase the likelihood of seizure, which if occurs in an unmonitored setting can obviously cause
harm to the patient.
Mains Isolation
Mains isolation is done through disconnecting the Power Cord and USB cable from device inlet.
Proper use of this system depends on careful readings of all instructions and labels.
Turn OFF system power before connecting or disconnecting any system component(s) or
accessories. You may damage the device.
Do not disconnect or reconnect any system components or accessories with the system
Caution powered on. You may damage the components.
Do not autoclave any parts of VIRGO-EEG system.
Do not use acetone for cleaning the components of system.
Inspect the instrument and accessories regularly.
Do not make any modifications to the instrument.
In case of malfunction, call a technician and describe the problem precisely.
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Do & Don’ts
Wash hair of the patient before the test.
Don’t use hair cream, oils, or spray prior to test.
Electrode leads are connected in such a way that Impedance should be low as low for better recording.
EEG room should be isolated.
Ensure grounding of input supply (less than 5V between Earth and Neutral).
Don’t consume stimulants such as caffeine, Coffee, cold drinks, alcohol or tea prior to test.
Use disposable electrode for ground / reference signal to get better impedance.
Use only Allengers make Electrode leads and conducting paste for better recording.
Don’t use Computer for other applications.
Don’t use pen drive in computer it may cause damage operating software of EEG.
Use only Allengers make accessories for better result.
Before Operation
Check that the instrument is in perfect operating order.
Check that the instrument is grounded properly.
Check that all cords are connected properly.
Pay extra attention when the instrument is in combination with other instruments to avoid
misdiagnosis or other problems.
All circuitry used for direct patient connection must be doubly checked.
Check that battery level is acceptable and battery condition is in good when using battery-
operated models.
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During Operation
Both the instrument and the patient must receive continual, careful attention.
Turn off power OFF or remove electrodes and/or transducers when necessary to assure the
patient’s safety.
Avoid direct contact between the instrument housing and the patient.
The instrument must receive expert, professional attention for maintenance and repairs. When the
instrument is not functioning properly, it should be clearly marked to avoid operation while it is out of
order.
The instrument must not be altered or modified in any way.
When instrument is used with an electrosurgical instrument, pay careful attention to the application
and/or location of electrodes and/or transducers to avoid possible burn to the patient.
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Defibrillation-proof type
Serial Number Serial Connection Manufactured by
CF applied part
Authorized
Do not throw away
Representative in the Catalogue Number BF applied part
electrical equipment
European Community
Fragile
Maximum Weight Limit This side Up Stack Height
Handle with Care
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4. System Overview
Block Diagram
Sequence of Operation
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Photic Stimulation
Stimulation Mode 2 Modes 25 steps programmable & Single
Mode of operation Auto / Manual
Stimulation Rate 1-60 Hz
Stimulation Period 1 to 60 seconds
Light Source High intensity white LED’s
Light Intensity 60 to 80 candela light
Input Power supply DC 12.6 ± 0.2 V
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Environmental Limits
Temperature :0°C to 40°C
Operating conditions
Humidity : 0% to 75% RH (Non-Condensation)
Temperature :0°C to 40°C
Storage & Transport conditions
Humidity : 0% to 90% RH (Non-Condensation)
Atmospheric Pressure 70 to 106 Kpa
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5. Description of Device
Headbox: This is the main part of the EEG machine. The headbox is used to connect different type
electrodes e.g. ground electrode, active electrode, bipolar electrode, etc. depend on the purpose of the
study. The compact size headbox is easy to handle during operations and is illustrated below.
Virgo 24: Top View Virgo 32: Top View
1 1
2 2
3 3
4 4
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An electroencephalogram (EEG) is a test that detects electrical activity brain using small, flat metal discs
(electrodes) attached to human scalp. Brain cells communicate via electrical impulses and are active all the
time, even when you're asleep. This activity shows up as wavy lines on an EEG recording.
EEG is one of the main diagnostic tests for epilepsy, diagnosing other brain disorders such as coma, tumors
and long-term difficulties with thinking or memory, or weakening of specific parts of the body (such as
weakness associated with a stroke).
An EEG is also used to determine brain death. It may be used to prove that someone on life-support
equipment has no chance of recovery.
When the optional features are added in EEG machine as per customer requirement, the optimal design of
device remain same, only the specification of connector plate is changed as shown below.
Connector Plate: Optional Features
With Battery Supply
1. Battery Charger
3 1
connector
2 2. Toggle switch for USB or
Battery Supply
With Ethernet connectivity 3. Ground Connector
4. DC electrode connector
6 5
4 5. Ethernet Connector
6. Main Power supply
connector
Battery Charger Box : This box is provided with Battery Powered Head box. This box gives a regulated DC
output to head box.
Front View Back View
Cord to Headbox
On/Off Switch Power ON indicator Mains Connector
Adaptor Box: This box is provided with Ethernet enabled head box. This box gives a regulated DC output to
head box & Photic flash.
ON/OFF Switch
Ground
connector Connectors
LED indications
Mains
Connector
Fuse
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Trolley: EEG trolley is helpdesk for installing Personal Computer (PC), Printer, etc.
Overall Dimension (LWH) (mm) 657 ±1 × 457 ±1 × 757 ± 1 mm
Overall Weight ≈ 27 Kg
Features Application
Durable , Perfect finish, Superb strength Hospitals
Four HDF laminated board shelves Nursing Home
with one slide shelf for keyboard Clinics
placement. Dispensaries
Powder coated study frame with 40 mm
diameter Pipe
4 no’s movable castors with brakes
Stand: EEG stand comes handy to install EEG head box & Photic flash. It is made of Durable stainless Steel
Material.
Overall Weight ≈ 6 Kg
Features
Durable , Perfect finish, Superb strength
Light weight, Adjustable height
Application
Hospitals
Nursing Home
Clinics
Dispensaries
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Photic Flash
The flashing light device consists of a Photic light where intensity,
frequency and duration of the emitted light are operator controlled.
The Flash light is positioned about a meter distance from the patient
head. The Photic stimulation is usually used as a part of routine EEG
test and can provoke seizure in certain percentage of patients.
Photic flash adapter
This is used to provide power supply to Photic flash.
Event Marker
Event marker is provided to mark the event externally. Event is marked on software
when Event marker is pressed.
Respiration/Airflow Sensor
This sensor is used for detection of respiratory situation of patient. The respiration
waveform is displayed on software screen.
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Earthing Cord
An optional 10 mtr. Earthing cord is provided to give additional path for electrical current
to return safely to the ground without danger to anyone in the event of a short circuit.
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Installation
The Device is installed by Allegers Service Engineer only. A proper infrastructure is required for installation
of Device as described below.
Physical Environment
The main requirement for the room where clinical Electroencephalogram (EEG) tests are performed is the
availability of sufficient space to cope with the complications. The room and the building where EEG test is
being performed, should allow for the easy access to patient, head box stand, Photic flash trolley and
monitoring equipment, the room should have sufficient ventilation. A controlled temperature and humidity
environment is preferred with Noise free.
The location of the ECG acquisition Device (Head Box) and the EEG electrodes is important to obtain
interference free display of EEG waveform. They should be away from vibrations, extreme temperature,
excessive humidity and large electrical appliances / X-ray equipments / RF transmitters.
Electrical Environment
The location of the Acquisition Device is more important to obtain interference free EEG.
The equipment should be connected to a separate single-phase 230V, 15A three pin wall outlet with
proper earthing. Proper earthing is mandatory to ensure the safety of the patient and noise free recording.
Voltage Stabilizer is recommended for the equipment.
The PC must have an online UPS with the isolation having a battery backup of at least 30 minutes.
Extension boxes should not be used.
Place the acquisition Device as far as possible from the electrical lines or source of static electricity. The
EEG signal can be disturbed if the acquisition device is situated in proximity to source of high voltage or
electrical lines. Avoid placing acquisition device close to any other diagnostic or therapeutic equipment like
X-ray machines, ultrasound machines, electrically operated beds etc, which could be a source of excessive
interference and EEG signal distortion.
Avoid the use of mobile phones in the vicinity
Warning
Safety requirement will not be satisfied if the above procedure is deviated.
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To manually configure the USB driver open Virgo EEG software. Click config option from Main window as
shown below.
On clicking CONFIG, configration window will appear. Click ‘Install digitally signed USB driver’ from this
window.
On selecting this option command prompt window will appear. After command prompt window below
mentioned window will load click install.
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Check Always trust software from “Allengers Medical System Limited” (optional).
There are many benefits of digitally signed USB Driver as described below.
With a Digital Code Signing certificate, you can sign a driver that will be trusted by any Windows OS
and the customers can avoid warnings telling them their drivers are from an un-trusted company.
This is beneficial for users in a number of ways. First, users can verify the driver they're
downloading and running on their computer came from a company, a source they trust.
If anyone tries modifying the driver files after releasing & signed digitally, then the signature on the
install Driver is no longer valid. User receives a warning that the driver is from an unknown source
and it shouldn't be trusted.
The signed drivers are valid for any version of Windows (Windows 8, Windows 7, or Windows Vista
32-bit or 64-bit).
Now the Acquisition Device and PC are ready for communicating between each
other.
Note: The login account must have administrative privileges for the system to function properly.
Double click the Virgo EEG desktop icon or go to start menu to open the application main screen.
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Note: The quality of electrodes and the method of applying the electrodes will strongly affect the
quality of ECG signal, please use standard electrodes and check impedance of all electrodes in the
starting of the test.
Top View
Right View Left View
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Icon Description
Allow user to enter the patient information and proceed with the new EEG Test.
Allow user to review the already tested EEG. By selecting a patient from the list,
the record can be accessed. The review provides various options to view the
recorded test.
Allow user to configure the VIRGO system. This option provides facility for
configuring display, doctor and hospital information. Edit Event, Photic flash
setting, interface options, bipolar and DC channel Setting.
Exits the VIRGO-EEG program and returns to the windows desktop.
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8.1. Configuration
Select ‘CONFIG’ form main screen, following window will appear.
General: Allows you to configure the VIRGO-EEG system. By default this windows display on screen by clicking
on configuration. This option provides facility for configuring display as a default screen like low pass filter, high
pass filter, sweep rate, sensitivity, Deflation, scroll mode, Default montage, Post HV period, Event Marker, Notch
filter, Muscle filter, line frequency, view time, calibration rate, calibration level display format on screen
Printing: Allows configuring the printing format on Virgo-EEG system. This option provides facility for
configuring printing for printouts like grid printing on paper, doctor name & address, logo, page format, printing
Event: Allows configuring events on Virgo-EEG system. This option provides facility for edit Events by clicking on
Edit event.
Photic: This option provides facility for configuring operation for photic flash in required frequency.
Interface: Allows configuring Hardware Interface control. Option provides two interface option to operate
Virgo-EEG, one is USB interface and other is Ethernet.
Bipolar & DC: This option provides facility for Edit bipolar as EEG channels and DC channel.
DICOM: This option provides the facility to send marked pages for printing to DICOM server as a non dicomized
image
Display Name: This option provides display names in montage bar for selected active or reference channels.
Data Transfer: This option provides facility to send the digital data to the selected Comm. port (Serial port).
SPO2/HR: This option provides the facility to interface Spo2/HR module with EEG software.
HL7: HL7 International specifies a number of flexible standards, guidelines, and methodologies by which various
healthcare systems can communicate with each other. This ability to exchange information should help to
minimize the tendency for medical care to be geographically isolated and highly variable.
In Virgo EEG Application we use this HL7 to transfer/send the report to the hospital information systems which
accepts the HL7 format data so that our software is compatible with their HL7.
Click on this button to save all changes on screen.
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General: Configuration
Option Description
This option provides facility of master display every time when application opens. The
parameters are Sensitivity, Low filter, high filter, and deflection is set in drop down windows.
Low filter range is up to 0 to 7 Hz,
Master
High filter range is from 10 to 99
Sensitivity range is from 1 to 1000
Deflected range is from 2 to 1000
There are two options in scroll mode.
Scroll Mode a) Page wise: In page wise scrolling, the pages of EEG trace move one by one.
b) Scrolling: In scrolling the waveforms move continuously without defining the page.
Default By this option we can select the default color of the screen i.e. the background color of the EEG
Screen Color trace.
By this option we can select the default calibration mode i.e. with filter without filter.
Calibration Screen2video waveform only: By using this option only the waveform area will be recorded as
mode video while making screen to video.
Show line on Event marking: A vertical line appears before any event.
User Defined Use this option to make a user defined high filter, low filter and sensitivity value for execution of
Filters EEG test.
Notch Filter: Allows the user to ON/OFF Notch filter (By default it is ON in EEG application window).
Muscle Filter: Allows the user to ON/OFF Muscle filter (By default it is ON in EEG application window).
BLC filter: This allows the user to On/OFF baseline correction filter.
Default Montage: User can select Default montage every time when execute the new patient record or open
the EEG application windows.
Post HV Period: This option allows selecting the options from the drop down for marking event for selecting
time period after giving hyperventilation’s by patient.
Event Marker: It consists of two options: ON/OFF. Select On to activate external marker switch.
Line Frequency: It shows two options 50Hz and 60Hz. One of them can be selected at a time as per electricity
standards of location (clinic, hospital and test lab) where the test is performed.
View Time: It consists of two options RECORDING and ACTUAL. In Recording the total time of recording is
shown whereas in Actual/Real, actual time taken for recording is shown.
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Calibration Rate: By selecting this calibration rate range can be set. Calibration level range is from 1 to 10 Hz.
Calibration Level: By selecting this calibration level range can be set. Calibration level range is from 2 to
1000µV.
Analyse as recorded: Select this option to view patient record through VIRGO-EEG.
Navigational Icon on wave: User can navigate the EEG data by moving the mouse cursor on screen itself.
Display Montage Name in Analysis: It shows the montage name in bigger font on the analysis waveform
This option shows the further options to be selected or deselected. If the major grid is required on
EEG trace then mark in box drawn in front of the option major grid. Similarly in case of minor
View
grids, calibration mark, montage image, montage bar, clock, events and comments mark tick in
front of option in the box if required.
User
Select this option to enable auto protocol. On selecting this option, the EEG test runs as per
defined
defined protocol. This option allows user to execute various event automatically.
Protocol
Edit This option is highlighted after selecting ‘User Defined protocol. This option allows user to execute
Protocol various event automatically. Click Edit protocol to edit the parameters as described below.
1 2 3 4
Click to save all the changes and close edit protocol windows.
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Printing: Configuration
Option Description
Fill the details of location such as Name, Address where the test is performed.
Test Lab
Select color of text to print on EEG reports print outs.
Select these options for EEG printouts
Major Grid: To print major grid. Select color of major by clicking button.
Minor Grid: To print minor grid. Select color on minor grid by clicking button.
Print to Scale: By selecting this option user can make EEG record pages fit to scale.
Montage Pictorial: To print image of electrode combination.
Photo in Report: To print patient image in the report.
Options
Print doctor name in report: To print doctor name on print outs.
Photo On EEG: To print patient image on all report formats with current EEG signal.
Channel SNS/LF/HF: To print channel sensitivity, low filter and high filter on print out.
Print EEG in B/W: To print patient report in black and white.
Save Report in sample report list: To Save current patient report in sample report database.
Save Print out as PDF: To save print out in PDF format.
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Event: Configuration
This screen shows the List of predefined Events. User can also edit/add or delete an event by selecting an
event and clicking ‘Edit Event’.
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Photic: Configuration
3
1
4
5
6
1. Click on drop down windows to select Photic set for 2. Double click to open Edit Frequency windows to edit
edit. required frequency and click ‘OK’ to save.
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Interface: Configuration
Hardware Interface
Select USB when the head box is connected to PC through USB interface.
Select Ethernet and fill IP address & Port No when the head box is connected through Ethernet connection.
Note: Whenever a wrong option is selected for interface, a message “New Hardware not connected”
displays on main screen. Check all connection and return to the application.
Email Settings: Configure the Email by these settings.
This window display Bipolar/EEG, DC/EEG & EEG Channels. User can edit name of these channels. Changes
are displayed on screen and print outs.
Note: These Channels varies/ activated/ Deactivated as per model of Virgo EEG.
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DICOM: Configuration
Digital Imaging and Communications in Medicine (DICOM) store, exchange, and transmit medical images.
Dicom Settings
Calling AE title: The common name to be kept here as PACS server so that the incoming connection
can be identified by PACS server.
DICOM server IP Address: The IP address where the PACS server is running.
DICOM server Port No.: : The Port no. where the PACS server is running.
Select Enable Option to Send Marked Pages for Printing to DICOM/PACS Server to highlight the “send
DICOM” button in printing tag.
This option is used to change the display name of active & reference channel in montage bar as well as in
printouts
Click Add to add new Row, Delete to delete selected Row & Delete All to delete all Rows.
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Select Send Data to Comm Port (LabView/Matlab etc) to enable data sending option.
Communication Setting
Select the desired Comm Port on which the data is to be transferred.
Select the value of Baud Rate to send the data.
Select Send 0x32,0x33 as Sync Bytes option to send the hex 32 & hex 33 or dec 50 and dec 51 before the
start of every packet based on number of channels displayed in montage.
Data Type
Select Stored option so that recorded data can be sent later on or as needed.
Select Live to send live recording simultaneously to the selected port.
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SPO2/HR: Configuration
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8.2. Acquire
Click ‘Acquire’ on Main Screen of application window the EEG test screen appears.
A typical test screen window is shown below.
Title Bar
Menu
Bar Shortcut
Menu
EEG
Montage Graph
Bar
Test
Time
Title Bar: Title bar display the patient information, no. of pages, channel, etc.
Menu Bar: This horizontal bar contains drop down menu for various option related to EEG test.
Shortcut Menu: This bar contains various commands, through these command user can control the EEG
test with single click.
Montage Bar: This vertical bar displays the current EEG Leads.
Use this sliding scroll to change the opacity of Montage bar.
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Patient Information Window: This window can be selected form ‘Menu bar’ (PATIENT) & ‘Shortcut Menu’
(NEW).
Fill all the Patient Information in this window. Fill information related to doctor, hospital, etc in other
information. This information is reflected in printouts of EEG Report.
Click this button to create auto case ID as ‘YYYYMMDDHHMMSS’
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PATINET: Select this option to add ‘New Patient’ or to view/ change current
‘Patient Info’. Select exit to return to the main testing screen
Event Bar: To view Event bar on the EEG trace. It is adjustable and can be placed anywhere on the EEG trace.
Montage Image: To view the the montage view of the electrode placement.
Annotations: Press to open Screen for typing the doctor comments on patient report.
PHOTIC: Select to change the photic flash setting.
Auto: Select to automatically gives flash to the patient as per settings already done
in the window.
Manual: Select to give the flashes manually.
Auto Set: This option has 6 further options of Set 1, Set 2, Set 3, Set 4, Set 5 and Set 6. Each set contains a list
of frequencies. When it is in Auto mode then the set will change one by one automatically.
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Select ‘Split Screen’ to divide screen in two parts for half EEG & half Video.
Select ‘Full Screen Video’ to view full screen video.
MONTAGE: Select this to change Montages, Edit Laplacian, Edit Average or Edit Montages.
Select the montages from this list
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Edit Montage – This option provides facility for Edit montage, make a new montage and change montage.
1 2 3
1: Configure the channel combination such as Edit channel, sensitivity, Low filter, high filter and color on the
combination channel. Right click the button to insert channel, delete row and montage displays.
2: This shows the current sequence for all the montages.
3: Allow you to configure the montage. This option provides the facility for Edit channel; auto advance option
will add the channel number automatically.
User can change the sweep speed according to requirement but by default value will be the previous one
selected in test screen.
Selecting ‘Auto advance’ option adds the selected channel number automatically.
Use this to move the current Use this to move the current Use this to save the current
montage “Upward”. montage “Downward”. montage sequence.
Allow to save the display montage By this option we can make new By this option we can save edited
as a new montage. montage as per requirement. montage with changes.
Click to close this window. If there is any change a message displays on screen “you have made certain changes.
Do you want to save all changes made”, User can close without saving the data.
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SENSITIVITY: It is the SWEEP: Speed at which LOW FILTER: This filter HIGH FILTER: This filter
minimum magnitude of EEG information is allows only the specific allows only specified high
input signal required to displayed across the low frequency signals to frequency signals to pass
produce a specified screen. pass and filter out higher and filter out lower
output signal. frequencies. frequencies.
UTILITIES: Select this option for adding comment, notepad, calculator, calendar, etc.
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To toggle between EEG data and internal calibration data on VIRGO EEG Screen. The EEG signal
display on screen when this button is active
This button shows impedance of all electrodes placed on patient. The impedance limit is to set
the acceptable limit. When the impedance of electrode exceeds the selected impedance limit,
than that particular electrode impedance is shown in respective color. Click close button to close
the window and click save button to save the impedance.
Toggle between start and stop EEG data Acquisition of VIRGO-EEG on Screen. When acquisition
starts the button is active and when acquisition stops button is deactivated.
Click this option to save data in hard disk drive. In this all patient data is saved in current file.
User can freeze the data on screen but storage of data in patient record will continue as it is
stored before.
Press to open a drop down list of events marked during data acquiring in patient record, selected
event marked in current data display on for screen windows, these are default list for VIRGO-EEG
event’s like eyes open, eye close, eye blinked, drowsy, awake, asleep, jerks, movement, seizure
on, seizure off, print archives, talking and Artifacts.
By HV event button the selected event will get marked on the EEG trace and running time of HV
display on the right side of the screen corner.
Toggle between start and stop Photic Flash during data acquisition of Virgo EEG on screen. When
click on this button photic flash starts as per the photic protocol selected in photic menu or in
configurations. When flash is ‘ON’ the button is active and when flash is ‘OFF’ button is
deactivated.
It allows the user to save patient video data acquisition in hard disk drive. All patient video data
is saved in current patient file.
It allows the user to save patient image in current patient information database in hard disk
drive. Patient image is saved in current patient file.
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8.3. Analyse
Press ‘Analyse’ from Main Screen to anyalyse the recorded EEG.
The position of Title Bar, Menu Bar, Shortcut Menu & Montage Bar is same as in Acquire window. All the
information related to this is described below.
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Some option are different in Analyse menu bar from Acquire menu bar as described below.
BMPARAM: This option is highlighted when Brain Mapping Window is activated. Two sub option options
are presents in this.
Reference: This option is used for brain mapping. FreqMapSen: User
User can select the reference for the test from the can select the
options given such as Linked Ear, CAR (Common Frequency sensitivity
Average Reference), A1, A2 or NIL. from the given
options. This option
is used for Brain
Mapping Frequency
Spectra.
OPTIONS
Zoom: Moving the cursor in the EEG screen will zoom in that
area in zoom window. Check Mark (√) will appear against zoom,
when it is ‘ON’. To close zoom window, again click “options-
zoom” or icon.
Amplitude Duration: The highlighted portion indicates the area to be measured and the box below
represent the measured time and amplitude. Check mark (√) will appear against amplitude dura on
under options menu when measurements are ‘ON’. To go out of this measurement mode, click “options-
amplitude duration” again.
Split: There are three options in the split button.
2 Screen: This window displays the record of the patient by splitting it. User can view the record of
the same patient at two times with same or different montages.
3 Screen: This window displays the record of the patient by splitting it. User can view the record of
the same patient at three times with same or different montages.
Video: The window displays the record of the same patient by splitting it. User can view the record
of the same patient and half screen video (If recorded).
When any option of the ‘Split’ is selected check mark (√) is appeared against split. To come back to
normal Analyse mode click optionssplit screen Selected option (i.e. 2 screen, 3 screen, Video screen).
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CSA/ DSA: Click to open compressed spectral array (CSA)/Density spectral array (DSA) viewer.
Below mentioned table appears, select the type you want to view.
Menu Bar
Information
Bar
Up down
Button
Bar
Display Area
Note: Up/down buttons on the right most side are for changing the maximum amplitude/ power being
displayed. These buttons are enabled only when Auto scale is OFF. You can choose scale to be
amplitude (µV) or power (µV^2) from scale sub menu.
Edit: Click on Edit Menu. Click copy to copy the client area (area where graphs appear) to the clipboard.
One can paste this image in “Microsoft Word” to get the printout of his own choice or for saving it in file.
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Type: Click on this option, the following options are displayed to view the spectra.
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Table: The table shows Absolute Power, Relative Power, Peak power frequency (Frequency at which
power is maximum) and median Power frequency (Frequency below which lies 50% of total power and
remaining 50% is above it) for each electrode in each frequency band for selected duration of EEG data.
Use scroll bar to scroll the table.
Total Table: It shows the frequency range for selected channel as per EPOCH duration.
Power scale: Click on this menu these options are displayed µV, µV^2.
µV: Use it for selecting µV as the units of the graph.
µV^2: Use it for selecting µV^2 (Power) as the scale for the type of spectrum being viewed.
Properties: If there is a check mark √ against Auto Scale, then scale is Auto in which so ware
automatically calculates the scale to be used to avoid cluttering of spectra. This value is displayed in the
non editable text box Auto Max field. Otherwise, user can type the value in Fixed Max field to define his
own scale, which is used when check mark (√) is not there against Auto scale i.e. Scale is not in Auto
mode.
Average Draw: Click on this menu these option are display bar type, Continuous display on screen.
Bar type: Selection of bar type will display the Average spectrum in bar type i.e. each frequency with its
amplitude/Power is represented by a bar.
Continuous: Select continuous for displaying the average spectrum as continuous graph, rather than
bar at each frequency.
CSA Draw: Click on this menu these options are display black white and color.
Black_White: Selection of Black_white will display the CSA in black color.
Color: Selection of color will display the CSA in four predefined band colors as shown on display
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1. Subject Information: It shows the total recorded pages, total time, and total disk space used by the
current patients recording. Data path where data of current patient is stored and archive path where
archived data will be stored.
2. Options: It shows these parameters:
Drive: It shows CD / DVD ROM drive
Full Subject Data: It will archive full subject’s data.
Pages: It will archive specified no. of pages
By events: Archive the EEG data by selecting the desired Event(s) from the event combo box and
duration of that event by clicking the Up/Down button under before(s) and after(s) i.e. the time before
and after the selected event.
3. Archive for:
Normal Archive: It will simply archive the complete record to the archive path.
Auto run CD/DVD: It will simply archive the complete data on CD/DVD which can be played on any
computer without reinstalling the complete software.
Email: It will archive the data which can be emailed to any recipient.
This option opens the form where we have to type the recipient’s email address.
This option starts archiving the data as per the user selection.
This option burns the archived data to the CD / DVD according to the user selection.
FFT: By this option user can select the channel which can be transformed into FFT(Fast Fourier Transform).
Frequency analysis: It shows the frequency component i.e. Delta, theta, alpha and beta of selected
channels of the duration specified by the user.
Manually calculate Frequency Range: The highlighted portion indicates the area to be measured and the
box below represent the measured frequency of the selected channels.
Dot Density Array (Amplitude based DSA): This option shows Amplitude which is based on Density Spectral
Area.
Export: Select this option to export the raw data to the excel sheets.
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SCREEN TO VIDEO
This option is used for recording all the activitiese of screen. The below
mentioned options are displayed in Screen to video
Start: Start the recording of screen.
Pause: Pause the recording of screen.
Resume: Resume the recording.
Stop: To stop the recording of screen, the recorded file is saved in drived.
Show Files: This option will show all the recorded files.
User can search the patient data by ID, Name, Age, etc.
Click ‘OK’ to load the selected patient for review to analyse.
Click ‘Delete’ to delete the data of selected patient. A confirmation window will appear,
click ‘Yes’ to delete or ‘No’ to close this window.
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This button shows the report window. A list of all the patients report are displayed on screen.
Report Examples
Patient Analyse Report
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Click to start EEG page fast rewind, and stop EEG data Click to move single EEG page rewind.
by click on screen
Click to open Next page. Click to start move EEG page fast forward, and stop
EEG data by click on screen
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Click this button; a window appears which have options of Brain map,
Frequency Distribution, Successive amplitude brain map.
Frequency Table
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Click to open a list of event marked and attached It shows the current displayed on page marked for
event with current display EEG data. print, all mark page display on screen Yes or No.
Click to open patient video display on screen yes or Click to see the report. User can select scroll or page
no. by page option.
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The materials used in this product are MS, ABS, SS, PVC, rubber, copper, tin, lead, nylon, aluminium, brass,
Poly carbonate sheet, wood, discreet electrical component & Li-ion battery which can be disposed as per
provided instruction. The packaging material such as carton boxes can be recycled or disposed in the public
waste disposal site.
MS, ABS, SS, PVC, rubber, copper, tin, lead, nylon, aluminium, brass, Poly carbonate sheet, electrical
component should not be treated as household waste and should be recycled.
Since Li-ion batteries contain less toxic metals than other types of batteries which may contain lead or
cadmium they are generally categorized as non-hazardous waste. Mining is the best way to dispose this
material.
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Precautions
Whenever a new EEG is installed for the use on patient, it should first be thoroughly checked for
safety by a qualified person in the laboratory in which it is to be used.
EEG machine must be properly grounded. This is usually accomplished by plugging the power cable
plug into properly wired grounded outlet.
There should be periodic checkups by bio-medical engineer to see that there is no excessive
electrical leakage from EEG machines.
When the equipment exhibits any of the following symptoms, it should be taken out of service
immediately, repaired and checked by a competent technician:
Equipment that is wet or has been subjected to spillage of liquids.
Equipment that becomes unusually hot or gives off unusual odors or sounds.
Damaged or cracked insulation in power cable.
Use only hospital grade grounded electrical outlets.
Use standard accessories provided by Allengers only for safety and reliability.
Turn off the Power after using the system.
Keep the system clean to ensure continuous trouble-free operation.
Make sure the patient does not touch the system or any other electronic devices.
Electrodes and wires should be securely positioned and protected from known source of artifact.
Cleaning
Turn off the power and disconnect the power cords from the wall outlet before cleaning the devices
and accessories.
Wipe the external surfaces with the soft cloth damped with water or mild soap.
Do not allow liquids to enter the system.
If liquids have entered the system, notify the Authorized Technical Assistance Center to have the
system inspected.
Standard disposable electrodes should be used. Dispose the used electrodes immediately after
removing them from the patient to prevent that they are reused.
The EEG electrodes should be cleaned after every test. Use cotton cloth to wipe the dirt and gel.
Wipe the display screen (TFT) regularly to ensure readouts are clearly visible.
Caution
Do not use any strong solvents or abrasive cleaning materials.
Maintenance
Checks before Each use
Before each use, visually inspect the device, the leads and the electrodes for signs of mechanical
damage.
Verify that all cords and connectors are securely seated to ensure proper connectivity.
If you detect damages or impaired functions that may result in a hazard to patient or the operator, the
device must be repaired before it can be used again.
After using the unit, clean the electrodes by removing the electrodes by removing the recording paste.
Do not use abrasive chemical detergents.
Clean the unit by dry/damp cloth.
Do not pull the electrodes.
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Periodic Checks
To ensure correct and long lasting operation of the equipment, it is necessary to periodically carry out the
following checks by an Authorized Technical Assistance Center. Recommended periods given below may
vary depending on the frequency.
Assessing the condition of equipments : every one month
Checking all the electrodes, cable and connectors : every month
General check on functional efficiency of the device : every 2 month
Safety checks (leakage current) : every 2 month or after any repair
Note
Single Use: Single-use accessories are not designed to be re-used. Re-use may cause a risk of
contamination and affect the measurement accuracy.
Sterilization: For details about cleaning, disinfecting and sterilizing the reusable accessories, see the
instructions for use in the accessory package or the "Supplies and Accessories" catalog. Do not reuse
single-use disposable accessories.
On request manufacturer will provide Circuit Diagrams, Component Part Lists, Descriptions, Calibration
Instructions, or other information that will assist Service Personnel to repair those parts of ME
Equipment that are designated by the manufacturer as repairable by Service Personnel.
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The Battery is replaced by Allengers Service Engineer only. To avoid fire risk, always replace the battery
with the same type.
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Compliance
This device is in compliance with medical device directive 93/42 EEC classified as class IIa (according to
annex IX rule 10), List of standards for the evaluation of product compliance
Reference Description
MDD 93/42/EEC Medical Device Directive
EN 60601-1:2006/A1:2013 General requirements for basic safety and essential performance
EN 60601-1-2:2015 Electromagnetic compatibility requirements and testing
ISO 15223-1:2012 Medical Devices- Symbols to be used with Medical device labels, labeling
and information to be supplied – Part 1: General Requirements
EN ISO 14971:2012 Medical devices – Application of risk management to medical devices
EN 60601-2-26:2003 Particular requirements for the safety of Electro-encephalographs.
EN 60601-1-8:2007 Medical electrical equipment - Part 1-8: General requirements for basic
safety and essential performance - Collateral Standard: General
requirements, tests and guidance for alarm systems in medical electrical
equipment and medical electrical systems
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Table 2: Guidance and manufacturer’s declaration – electromagnetic immunity – for all EQUIPMENT and
SYSTEMS (see clause 5.2.2.1 f)
Guidance and manufacturer’s declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The customer or the
user should assure that it is used in such an environment.
Electromagnetic environment –
Immunity Test EN 60601 test level Compliance level
guidance
Electrostatic discharge ±8 kV contact ±8 kV contact Floors should be wood, concrete
(ESD) ±2 kV, ±4 kV, ±8 ±2 kV, ±4 kV, ±8 kV, or ceramic tile. If floors are
IEC 61000-4-2 kV, ±15 kV air ±15 kV air covered with synthetic material
the relative humidity should be at
least 30%.
Electrical fast ± 2 kV for power ± 2 kV for power Mains power quality should be
transient/burst supply lines supply lines that of a typical hospital
environment.
IEC 61000-4-4 ± 1 kV for ± 1 kV for
input/output lines input/output lines
Surge ± 1 kV line(s) to ± 1 kV line(s) to Mains power quality should be
line(s) line(s) that of a typical hospital
IEC 61000-4-5 ± 2 kV line(s) to ± 2 kV line(s) to environment.
earth earth
Voltage dips, short 0 % UT 0 % UT Mains power quality should be
interruptions and for 0.5 cycle for 0.5 cycle that of a typical hospital
voltage variations on at 0, 45, 90, 135, at 0, 45, 90, 135, environment.
power supply input lines 180, 225, 270 and 180, 225, 270 and
IEC 61000-4-11 315 degrees 315 degrees
0 % UT 0 % UT
for 1 cycle for 1 cycle
70 % UT 70 % UT
for 25 cycle for 25 cycle
single phase: single phase:
at 0 degrees at 0 degrees
0% UT 0% UT
for 250 cycle for 250 cycle
Power frequency 30 A/m 30 A/m Power frequency magnetic fields
(50/60Hz) magnetic should be at levels characteristic
fields of a typical location in a typical
IEC 61000-4-8 commercial or clinical or hospital
environment.
Note – UT is the AC mains voltage prior to application of the test level.
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Table 3: Guidance and manufacturer’s – electromagnetic immunity – for all EQUIPMENT and SYSTEMS that
are not LIFE-SUPPORTING (see 5.2.2.2)
Guidance and manufacturer’s declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The customer or the
user should assure that it is used in such an environment
Immunity test EN 60601 test Compliance level Electromagnetic environment-guidance
level
Portable and mobile RF communications
equipment should be used no closer to any
part of the Device, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency
of the transmitter.
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
A. Field strength from transmitters such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters,
an electromagnetic site survey should be considered. If the measured field strength in the location in
which the device is used exceeds the applicable RF compliance level above the device should be
observed to verify normal operation. If abnormal performance is observed, additional measures may
be necessary, such as reorienting or relocating the device.
B. Over the frequency range 150 kHz to 80 MHz, field strength should be less than 3V/m.
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13. Troubleshooting
Fault Possible Cause/ Corrective Action
Check all the lead wires are connected to the electrodes properly.
Check for proper contact between all elctrodes and the patient.
Verify that the electrodes wires and cables are not damaged or worn
Excessive Noise/ disturbance in out.
EEG recording Check that the electrodes are fresh, moist, and sticky, not dry or hard.
Check electrode expiry date on package.
Check Ground electrode is properly attached to the patient.
Ground and Neutral should be less than 3V.
Check whether the Acquisition Device is properly connected to PC or
not.
Power on LED on acquisition
Check the USB cable for any damage.
device is not lit.
If still the problem persists, contact the authorized Technical
Assistance Center.
When connected to PC warning Check USB Cable. Insert properly in PC & adapter box.
message is shown in Acquire Adapter should be switched ON.
Mode. ‘Hardware Not Found’ Check the drivers of USB.
Straight line or Flat EEG line Check the connectivity of all the electrodes.
Machine is not getting in Check the fuse and if needed replace it.
ON/OFF state Check Power Cable.
Check the contact between the electrodes and skin.
Problem is seen with the Drift
Electrode Surface should not be dirty.
of the waveform
Ensure that patient does not move when the test is being conducted.
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Although every effort is made by our Local Service Centre to attend & satisfy the service requirements of
our esteemed customers, following officials can be contacted at our Head Office for immediate solution to
our customer’s sales/service needs:
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Warranty
Allengers provide warranty to its products against all defects in materials and workmanship. Products or
accessories are fully tested & examined to operate within given specifications. Allengers will repair or
replace any products which prove to be defective during the warranty period, provided these products are
used as prescribed operating instructions. If the products need to be returned to the manufacturer for
repair or examination, please follow proper packing instructions or call our sales/service representative.
Warranty does not include accessories/ consumables, batteries and fuses.
Refer ‘Warranty Card’ included with this manual to read all the Terms & Conditions.
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