Operation Manual - en.cnnation.comen.cnnation.com/uploads/55ff66f6/Type C EEG(Nation7128W)...

NCC Medical Co., Ltd

Http://www.cnnation.com

Technical User’s Manual

Type C EEG System

Operation Manual

Nation7128W

http://www.cnnation.com/

Table of Contents Notice to Users ........................................................................................................................ 1

Rights and Responsibilities .............................................................................................. 5

Copyright Reservation ......................................................................................................... 5

Chapter 1 Hardware Configurations & Connections .......................................... 6

1.1 System Hardware Configuration .................................................................. 6

1.2 Hardware Operational Instructions ............................................................ 7

1.3 Hardware Technical Parameters ................................................................ 16

Chapter 2 Software Installation .................................................................................. 17

2.1 Software Installation Requirements ........................................................ 17

2.2 Software Installation Procedure ................................................................ 17

2.3 Serial No. Setup .................................................................................................... 19

2.4 EEG Montage & Leads Configuration ........................................................ 19

Chapter 3 Main Interface Operation ......................................................................... 22

3.1Toolbar ........................................................................................................................ 22

3.2 Data Directory Selection.................................................................................. 23

3.3 Case Library Drop-List ...................................................................................... 24

3.4 Case Library and Case Information Display......................................... 24

3.5 Management of Case Library ........................................................................ 25

3.6 User Information ................................................................................................. 26

3.7 Function Keys ......................................................................................................... 26

Chapter 4 Data Acquisition ............................................................................................. 31

4.1 Main Control Bar ................................................................................................... 31

4.2 Functional Menu Bar .......................................................................................... 32

Chapter 5 Playback and Analysis ................................................................................ 37

5.1 Playback .................................................................................................................... 37

5.2 Brain Electrical Activity Mapping Analysis ............................................ 43

5.3 Analysis ..................................................................................................................... 46

Chapter 6 Important Safety Information .............................................................. 49

6.1 Classification .......................................................................................................... 49

6.2 Device symbols ..................................................................................................... 49

Chapter 7 Maintenance & Servicing .......................................................................... 50

7.1 Cleaning and Disinfection ............................................................................... 50

7.2 Appearance Inspections .................................................................................. 51

7.3 Troubleshooting ................................................................................................... 52

7.4 Transportation and Storage Conditions ................................................. 53

Appendix A: Manufacturer Information .................................................................. 54

Appendix B: Power Supply & Battery Operation ............................................... 54

Appendix C: Electromagnetic Compatibility ......................................................... 54

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Notice to Users Users are advised to read this manual carefully before using this

equipment. The Users should follow the operation steps that is

consisted in this manual, otherwise it would lead to abnormal

operation results and cause damage to the equipment or even cause

injuries and physical dangers to the user. The company does not hold

any responsibility for any property damages, injuries or physical

dangers caused by the misuse of this equipment.

Precautions on using this device:

Equipment installation environment and location requirements:

Ensure the power switch is off when installing the device. The device should

only be switched on during examinations;

The location should have good ventilation to remove gases in the air which

will either affect the readings or cause danger to the users and patients;

There are temperature and humidity control device to ensure that the

appropriate test subjects skin temperature, the room temperature

maintained at 20°C ~ 24°C, humidity 20% to 80% is appropriate;

The location should have controlled lighting, preferably incandescent;

There should be a shading device in the location to help achieving better

results for flash-induced EEG examinations and sleep analysis;

The location should be soundproof to prevent external noise interference

during AEP examinations;

The device should be placed away from electrical instruments,

high-frequency radiant point, etc. to avoid interference during examination;

The location should have a special hand-washing station installed for the

convenience of use. After all, all operating personnel and the patient should

wash their hands first to release static electricity before the examination;

The device should be kept away from moisture or water, extreme air

pressure, excessive humidity and temperature, poor ventilation and acid

gas or alkaline dust during the examination;

Use of this device is not advisable in the presence of any flammable

anesthetics to prevent voltaic arc which may cause explosion;

This device is not suitable for use in places with chemical storage or gas

chambers such as a medical hyperbaric oxygen chamber, as it may

triggeran explosion or fire.

Type C EEG Operation Manual

2

Ground wire connection requirements of equipment:

This equipment complies with Class I in GB9706.1;

The ground wire must be used with the supplied 3-pin power plug.

Otherwise, it may cause electric shock to the patient and the operator;

An effective connection with the potential equalization terminal should be

secured for safe grounding;

When several medical devices are used together, all devices should be

grounded at the same place to prevent any potential differences between

the devices, which may cause electric shock to the patient and operating

personnel.

Precautionary Steps

1. Before Operation:

Check to ensure that the equipment is cleaned and are in good operating

conditions;

Place the equipment in appropriate position;

Make sure all the wire connections and lead connections are correct;

When the device is used with other instruments, extra measures should be

taken to avoid diagnostic errors or other problems, such as making sure

they share the same grounding;

Examinees should be notified that:

Taking food before the EEG examination may affect the result of the

examination;

They should wash their head and hair the night before the examination

They should stop taking medicine that may influence the central

nervous system 3 days before the examination;

They should remain calm, as the examination is painless and has no

side effects;

Children who refuse to cooperate in the examination may need to be

sedated with chloral hydrate or its equivalent.

2. During Operation:

Both the patient and the instruments should be given sustained, careful

attention;

To ensure patient‟s safety, switch off the power before removing the

electrodes and/or sensors, even just to switch the electrode positions;

Patient should avoid touching the devices directly for safety reasons.


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3. After Operation:

Return all the devices back to initial position before switching them off;

Gently remove the electrode line;

Clean the equipment and accessories for future use.

Other Notes:

Do not use this device for other uses than medical examinations;

If the device is connected with multiple instruments on the same patient

simultaneously, superimposed leakage current of each instrument will

cause security risk. Any such combination should be checked by relevant

security personnel before it is being put into use;

Removable multi-jack provided with the EEG system package is strictly for

use with instruments within the original system only;

When the system power is powered by the removable multi-jack socket with

isolation transformer, user should not connect non-medical electrical

equipment to the wall outlet directly;

The equipment parts that are in physical contact with human body after

equipment should be confirmed to be working in stable condition;

This amplifier of this instrument is powered by rechargeable battery, which

should be charged before operation;

The Acoustic & Visual stimulation for the stimulator is designed specifically

to meet the general safety requirements;

For instrument power supply, voltage and frequency of power supply used

for this instrument must correspond to the specifications in the manual;

The EEG amplifier, receiver, electrodes and stimulator are medical electrical

devices designed for use in a clinical environment;

Maximum allowable load for removable multi-jack socket is 2500VA;

Do not connect device electrodes to other conductive parts of the device or

to the ground;

The equipment and its attachments should be examined regularly;

This device does not have anti-defibrillation function, so it cannot be used

together with the defibrillator or any high-frequency surgical equipment;

When the device is used together with other equipment (such as a

pacemaker or electrical stimulation), safety of the combination should be

confirmed by clinical engineers, so it will not affect the equipment's

diagnostic results or cause harm to the patient.

Warning: Removable multi-jack socket should not be placed on the ground.


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Requirements for Accessories：

All accessories used together with the device should be approved by the

Company. Unapproved device and accessories will affect the effectiveness of the

instrument and safety to the users and patient.

Staff Requirements：

Operator must be trained, have some skills before they can operate the

equipment;

Operators must be familiar with electrical safety knowledge.

Warning: Computer, monitor and printer used with this equipment should meet

national safety standards, and the power supply to the medical equipment

should be insulated using an isolation transformer unit.

Clinical usage:

This device is designed for Electroencephalogram (EEG) monitoring and brain

evoked potential examination.

Indications of Use:

Diagnosis, sorting, prognosis & directions in drug use on epilepsy patients;

Diagnosis of cephalitis;

Diagnosis of Creutzfeldt-Jakob disease (CJD);

Diagnosis of subacute sclerosing panencephalitis (SSPE), also known as

Dawson disease or Dawson encephalitis;

Diagnosis to determine brain death status;

Distinguishing between coma and pseudo-coma;

Evaluation of sleep-disorder;

Monitoring of brain functionality during & after surgery;

Brain function evaluation to identify other diseases that affect the central

nervous system.

Contraindications:

Those with the following medical conditions should be advised against

undergoing the optional stimulation test module:

Patients with cardiac pacemakers or cardiac catheterization;

Patients with skin diseases;

Patients with bleeding tendencies;


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Patients who are susceptible to recurrent and/or systemic infections.

Applicability statement:

This manual is only applicable for Type-C EEG Systems stated below:

Nation 7128W

20/40 channels Digital EEG

Nation 7128WH

20/40 channels Ambulatory EEG

Rights and Responsibilities Information in text is subject to change, and the details of the changes will be

embodied in the updated version. NCC Medical does not assume responsibility

for any use or reliability for the software and device which is not provided by

NCC Medical or NCC's distributor.

Copyright Reservation NCC Medical Co., Ltd. reserves all rights to the copyright of this publication. This

manual is only for personal use of buyers, and any part of this manual cannot be

reproduced or transmitted, including photocopying and recording in any form or

by any means (electronic or mechanical) without the written permission of NCC

Medical Co., Ltd.


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Chapter 1 Hardware Configurations & Connections

1.1 System Hardware Configuration

Digital EEG is consisted of hardware and software as a whole. Hardware

configuration is as follows:

Type-C Wireless Bluetooth Digital Visual EEG Structure Block Diagram

2. System hardware consists of:

A. Computer module, consisting of host computer, monitor display,

keyboard, power line and mouse.

B. Printer (HP color ink jet printer recommended)

C. Type-C EEG signal amplifier (this EEG model has large DRAM)

D. Video System Module (for Video EEG)

E. Wireless Bluetooth EEG amplifier and Bluetooth Receiver

F. Workstation (Trolley or EEG working bag)


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G. Mini USB data cable (for dynamic data uploading)

H. Electrodes (Routine EEG checking equips regular electrodes,

long-time brain electricity monitor, dynamic EEG checking equips

brain electricity monitoring electrodes, epilepsy surgery special

equipment equips surgery use electrodes).

1.2 Hardware Operational Instructions

1.2.1 Type-C EEG Amplifier

A. Functions of Amplifier Buttons

1） Power switch: Press to switch on the amplifier; long press while amplifier

is on to switch it off.

2） Start/Left: In standby mode, press for 3 seconds and "are you sure start?"

message will appear on screen. Press again to confirm dynamic data

collection. During dynamic data collection, press button for 3 seconds and

"are you sure stop?" message will appear onscreen. Press again for 1

second to stop dynamic data collection. To cancel any operation, press

“Cancel” instead.

3） CANCEL/Right: Press the button for 3 seconds and "are you sure format?"

message will appear onscreen. Click “Start/Left” to confirm formatting, or

click “Cancel/Right” again to cancel formatting (All data in the amplifier will


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be deleted by formatting).

4） Set: Press for 5 seconds to change settings of dynamic EEG data collection,

including EEG channel numbers. When the channel number flashes, press

“Start/Left” key to switch channel numbers.

5） Event button: In dynamic recording mode, press this key will record the

time when you press the button in the DRAM; after dynamic recording mode

is ended, upload the data to the computer, the user may see the event

marked time within the uploaded data (E.g. Patient presses the key during

an epilepsy attack. After uploading the data, the staff can determine the

time of epilepsy attack on patient based on the event marked.).

6） Combination:

i. Power and Cancel/Right: Pressing “Power” and “Cancel/Right”

buttons together will lock the amplifier buttons. The buttons will not

work unless the two buttons are pressed again to unlock it.

ii. Start/Left and Cancel/Right: Pressing “Start/Left” and

“Cancel/Right” together to switch to waveform display mode. Press

“Start/Left” to switch the channel of the waveform displayed. Press

“Start/Left” and “Cancel/Right” together again to restore the main

interface.

iii. Cancel/Right and Setting: Press “Cancel/Right” and “Setting”

together to switch on or off the wireless Bluetooth connection. If the

Bluetooth has been connected, the connection will be disconnected; if

the Bluetooth has not been connected, the amplifier will search and set

up connection with the nearest Bluetooth receiver.

B. Amplifier Display

Items displayed on the amplifier display:


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1. Company name display, occasionally displays messages like “Are you sure

format?” etc.;

2. Product hardware revision number;

3. Product serial number display;

4. Date and time display. This can be synchronized with the date and time

displayed in the PC;

5. Hardware channel number display: After starting up, it will display the

current hardware channel numbers. In dynamic data collecting mode, user

may set up the number of data collecting channels;

6. Sampling rate display: Shows the current sampling rate: 00 = 128Hz, 01 =

256Hz, 02 = 512Hz;

7. Battery status display;

8. Bluetooth Connection Status: shows the current status of Bluetooth

connectivity, such as the ones shown below:

Connected via

USB Cable

Searching for

Bluetooth

No Bluetooth

Connection

Connected via

Bluetooth

Acquisition of

Status

9. Flash memory status: displays the total memory capacity of the DRAM;

10. Used flash memory: displays the quantity of dynamic data recorded;

11. During dynamic recording mode, the system time and recording time will be

displayed at the centre of the screen.

C. Electrodes Installation

The following are the types of electrodes used for this EEG amplifier:

There are two methods to install the electrode lines to the amplifier.

Method 1: Using line cards to install electrode lines, for compactness. The

installation schematic diagram is as follows:


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After putting the electrode lines on the electrodes slot, use screw 1 and 4 to

fix the 3 pieces of line cards. Screw 2 and 3 are assembled by the quality

department when the instrument leaves the factory, and does not need to be

touched on.

The following figure is the instrument graphic after installing the electrode:

Method 2: Install the electrodes to the amplifier electrode slots directly without

using the line cards.

For electrodes installation position sequence, please refer to the mark at the

back of the EEG amplifier, as shown in the following figure:


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D. Dynamic data uploading

When the EEG amplifier is in standby mode, connect it to the computer via

USB-HDMI interface. The EEG dynamic data can then be uploaded into the

computer using the EEG software.

1.2.2 Bluetooth Receiver

The Bluetooth Receiver is connected to the computer via USB, to act as the

receiving end of EEG signals transmitted from the amplifier via Bluetooth. The

receiver consists of 3 lights to indicate different status of the Bluetooth

connections with the computer.

Hardware driver is not installed, so the 3

lights are illuminating, prompting to install

the hardware driver.

Hardware driver is installed, but no amplifier

signal is detected within range.

Hardware connected to computer with

Bluetooth signal detected from EEG amplifier

nearby. Ready for EEG data acquisition.

Receiver is receiving data from Bluetooth

amplifier. The third light flashes quickly

throughout the process.


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1.2.3 Electrodes Configurations

The following are the recommended configurations of electrodes used with

Type-C EEG system:

8 Channels：

16 channels：


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Electrocardiograph wear schematic diagram:

Dynamic Holter schematic diagram:


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1.2.4 Optional Hardware Modules

a. Video System Module

The main components for Video System Module:

Camera

Lens PAN/TILT

Video transform interface IS485-232

Power supply for camera (24V)

5 Pins color arranging cable

Cross screwdriver (small)

Inner hexagonal spanner(5MM)

Lens control line (two bayonet)

Network cable

Video module (Internal video card & video software)

Video System Module Connection


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b. Photic Stimulator

Photic Stimulator with

Tripod Photic Stimulator Lamp

The main components for Photic Stimulator:

Photic stimulation Lamp

Tripod for photic stimulator lamp

Rock arm

Signal control cable for photic stimulator lamp

Controller of photic stimulator

USB cable(AA interface)

Photic Stimulator Connection


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1.3 Hardware Technical Parameters

Hardware Running Environment Requirements

Environment temperature:+10°C～+30°C

Relative humidity: should not be large that 80%

Power: microcomputer, video camera, printer working voltage: AC220V (+5%～

-10%); 50Hz±1Hz;

Amplifier Inner Power Voltage: DC6V (+5%～-10%);

Atmospheric Pressure: 860hPa～1060hPa

EEG Amplifier Parameters

Calibration Voltage: 100μV, error within±5%

Sensitivity: 10μV/cm，error within±5％

Time Constant: 0.1s、0.2s、0.3s, error≤±20%

Noise Level: ≤2μVP-P

CMRR: ≥90dB

Amplitude-Frequency Characteristics: 1Hz～60Hz error +5% ～ -30%

Endurable Polarization Voltage: Add±300mV DC polarization voltage, the

change of sensitivity is within ±5%

Input Impedance: ≥10MΩ


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Chapter 2 Software Installation

2.1 Software Installation Requirements

The following are the specifications to install and use the EEG system. For any equivalent substitutes, it is advisable to check with the supplier

beforehand. Operation System: Windows 7 Ultimate (32-bit version) PCU: Pentium 2.0G Hz and above

Hard Disk: 500GB and above Memory: 2GB and above

Graphic Card: AMD integrate graphic or any type independent graphic card,

cannot use Intel integrate graphic card. Printer: HP or Epson color inkjet

printer

2.2 Software Installation Procedure

Steps for EEG Software Installation:

1. To begin, insert the installation CD that is available in the EEG System

package into the computer. If the CD cannot be found, please request for

technical support from the supplier.

2. Double-click “Setup.exe” program in the installation CD, and a pop-up

installation interface will appear.

3. Install the EEG program at default settings in C: drive and click “Next”

whenever prompted by the software. The setup will then be completed

within minutes.

4. 2 folders will be created in C: drive after installation is complete, namely

“ENGEEG” and “USB Driver”.

5. After installation of the software, a shortcut with the EEG icon will appear at

the desktop. Double-click the “EEG” icon and a dialog of system information

might pop up. Click “OK” to proceed.

6. The main interface of the EEG software will open, and from there click

“Setup”"Display and Sampling", check the "Sampling Frequency" at

“Normal”, and then click “OK”. Exit the platform, and the system

information will not appear again.

Steps for Bluetooth Receiver USB Driver Installation:

1. Connect the Bluetooth receiving box to the computer via USB cable (AA

interface). The computer will recognize the new hardware automatically,

prompting for the next step of hardware installation.

2. Choose to "Install hardware from a list or specific location" and click "Next".


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3. Choose the option "Include this location in the search", then set the target

directory as "C:\USB drive\ eegdy", or look for the driver file “eegpt.sys”.

Click "Yes" and then click "Next".

4. The system would install the driver program automatically. If any dialog

regarding "Hardware setup" pops up again, click "Continue anyway".

5. Once installation is completed, click “OK” to finish driver installation of

Bluetooth Receiver.

Steps for EEG Amplifier USB Driver Installation:

1. Sometimes the user needs to transfer EEG data stored within the amplifier

into the computer, which cannot be done via Bluetooth. This is the purpose

of installing the USB interface for EEG amplifier, so that these data can be

uploaded into the computer via Mini USB.

2. The installation steps for EEG amplifier is mostly the same as the installation

steps of the Bluetooth receiver, except the connection of EEG amplifier to

the computer is by Mini USB, and the driver directory is "C:\USBdrive\eegc".

The rest of the procedure is the same.

Steps for Photic Stimulator Installation (Optional):

4.1. Connect the photic stimulator to the computer by connecting a USB cable

(AA interface) with its controller. The computer will recognize the new hardware

automatically. A dialog frame "Find new hardware wizard" will pop up and

select "Yes, this time only", and then click "Next".

4.2. Select "Install from a list or specific location" and click "Next".

4.3. Select "Include this location in the search" and click "Next". Browse

pull-down menu and set the path as "target path: C\USB drive\ bluth". Then

click "Next".

4.4. The system will start to install driver automatically. The dialog frame of

"Hardware installation" would pop up, and click "Continue anyway".

4.5. click “ok “to finish installation.


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2.3 Serial No. Setup

1. Registering the EEG amplifier serial number into the software is important to

make sure that EEG amplifier is the only one recognized by the software, so

the software will not confuse its input with other EEG amplifiers or machines

in the vicinity.

2. Usually the serial number will be installed automatically after installing the

software. If not, please put the CD software into the computer, then copy the

file “stdgain.cfg” to “C:\ENGEEG\CFG” and replace the old one, the serial

number will be shown automatically.

2.4 EEG Montage & Leads Configuration

1. EEG leads can be configured from the Leads Edit/Montage Interface (See

Fig. 2-3) accessible from the system setup. The configurations may differ

slightly based on the EEG type selected and the inclusion of

multi-parameters.

2. At the Leads Edit/Montage Interface, click on the drop-down list box of

“Hardware Configuration” on the top left to select the EEG configuration

to be used. The columns below will display the existing EEG channel

configurations.

3. To create a new set of configuration, click “Add” on the top right list; to work

on a previously set channel configuration, click on “Edit” instead.

4. The EEG channel configuration is shown in Fig. 2-6, displaying a diagram

with selectable EEG channels on the left and the current EEG channel

configuration on the right. If the EEG type selected includes

“multi-parameter”, an expanded data list will be shown in the middle.


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Fig. 2-6 EEG Channel Configuration

5. Input a name for channel configuration plan in the hardware configuration

textbox on the top.

6. There are 2 columns in the list on the right, the first column showing the

recording electrodes and the second column is for reference electrodes.

Click on the electrode name in the diagram on the left, and the lead will be

registered in the highlighted box with the corresponding channel number at

the list right side of the interface. Repeat this step to the number of EEG

leads required.

7. If there is a need to redo the configuration, click on the box and then select

the correct channel; if the channel is not used, click “Delete Data Source”

to clear the box; if there is a need to redo the plan from the beginning, click

“Clear” to clear ALL boxes.

8. Click "Save" button after setup is completed to exit the channel

configuration and saving the new channel configuration; if the previous

channel configuration is to be used instead, click “Exit” to close the

interface and abort the new settings.

9. The new set of EEG configuration will see added to the list of channel

configurations, whereby the currently selected configuration will be

highlighted. To remove an existing configuration, select it and then click


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“Delete”.

10. When the EEG amplifier is registered into the software and the EEG channel

configuration is completed, click “Exit” to close the Leads Edit/Montage

Interface.

WARNING: Do not change the data source without guidance, or the

software may not work properly.


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Chapter 3 Main Interface

Operation

To begin, double-click icon "EEG" at the desktop to open the main

interface of the EEG program (See Fig. 3-1).

Fig. 3-1 EEG Software Main Interface

This interface has seven main parts:

3.1Toolbar

The toolbar at the top left side of the interface has 12 buttons as follows:

Fig. 3-1A Toolbar

Functions of each button:

: Copy selected case data from one case library to other case library;

: Move selected case data from case library to clipboard;

: Use this button to insert copied/cut case data to selected case library;

: Delete selected case data from the case library;

: Click this icon will prompt an interface like in Fig. 3-1B to help looking


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for a specific EEG case data;

: To review the selected EEG case in the playback interface. If the data

is recorded with video, the video will also be played;

: Click this to collect additional EEG data to a selected case. If video was

included in the previous recording, it is advisable to include video for the

additional recording too;

: Select this to modify case information or patient information for a

selected case;

: Prints a report for the selected case based on template selected;

: Opens the help information catalog;

: Opens the version information window;

: Click this icon to close the software when all examinations are done.

Fig. 3-1B Search Interface Fig. 3-1C Case Info Editing Interface

3.2 Data Directory Selection

The Data directory selection is on the top left side of interface, right below the

toolbar. This displays the data storage location in the computer. To change a

data storage location, either input data directory location in display box for

modification or search, or click the button behind the display box to bring up

"Browse folders" dialog box, choose a directory location and then click "Ok".


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Fig. 3-2 Data Directory Selection

3.3 Case Library Drop-List

The case library drop-list is below the data directory at the top left side of the

main interface, used to select a case library. Click once brings out a drop-down

menu, with a selection of directories showing cases of different types. Selecting

a case type will list all the case data related to the case type, which the location

of case data is determined by the case type selected when it is first created.

Fig. 3-3 Case Selection

3.4 Case Library and Case Information Display

The case library shows all case data recorded under a selected case type. Select

a case in the list and the detailed case information will be displayed on the right.

A case need to be selected for most commands in the toolbar (Fig. 3-1A) to

work.


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Fig. 3-4 Case Library is on the left, Case Information is on the right

3.5 Management of Case Library

1) Case library introduction

This system has been equipped with several case libraries, such as

untreated, epilepsy, child, brain trauma, normal, brain tumour, headache,

cerebrovascular disease, etc. Case data can be stored into one of the above

case libraries either by indicating the case before recording, or moving the

case data using the copy, cut and paste commands in the toolbar.

2) Case backup, delete and restore

Case backup

As the quantity of big EEG data increases, the need to backup case data arises. Case backup can be done in the following steps:

1）Use backup disks to rewrite EEG data into CD-ROM, floppy disks and

other storage media;

2）Select the cases that will be backup from the case library;

3）Right-click on the selected cases and select the backup location.

Case delete

Cases which are outdated or done incorrectly can be manually deleted from the

case library. Select the cases to be deleted in the library, right-click and then

select the [Delete] button in the toolbar.

Note: Case deleted cannot be restored without backup. So make sure to backup

the important information before deleting.

Case restore

Backup case data can be restored into the computer using the Holter function.

Details will be covered later.


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Fig. 3-5 EEG Case Data Backup

3.6 User Information

The tag area is right above the function keys. Double-click the tag area to bring

up a dialog box to modify user name. Click "ok" after modification to confirm.

Fig. 3-6 Modification of user

3.7 Function Keys

There are 3 major function keys on the upper right of the main interface, namely

[Add Case], [Setup], and [Holter].

1. [Add Case] creates a new case record and proceeds to the data acquisition

phase. Details of data acquisition will be covered in Chapter 5.

a) Make sure EEG amplifier is on and connected to the computer.

b) Click [Add Case] to open a window as shown in Fig. 3-7A.

c) Select the type of EEG channel configuration, and then input a case

identifier and any case details necessary.


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d) Finally, select the type of EEG data acquisition to be carried out. This will

lead the user to the data acquisition phase, which will be covered in

Chapter 4.

[EEG Sampling]: Click this to open the EEG data acquisition

interface;

Video EEG Sampling: Click this to open the EEG data acquisition

interface with video recording.

Fig. 3-7A Add Case

2. [Setup] opens the system setup menu as shown in Fig. 3-7B. The options

available in the menu includes case library settings, display and sampling,

case info, event info, leads edit/montage, and report template revision.


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Fig. 3-7B System Setup

a) Case Library Settings/Case Database Setup: This section defines

the type of case libraries for system management. Simply add new

libraries by typing the name in the lower white box and then click “Add”,

and remove a library by selecting it in the list and then click “Delete”

(See Fig. 3-7B-1).

b) Display and Sampling: This is used to edit the display and the

sampling rate for the EEG recording and playback interfaces. Fig. 3-8

shows the interface for the Display and Sampling configuration menu.

Measurement: This modifies the scales for the EEG waveform

displayed. The blue line indicates 3cm, which is the default length

and height for both scales. It is recommended not to change these

scales to prevent the EEG waveforms measured from intersecting

each other on the report.

Colors of the EEG waveform display can be modified at user‟s

choice.

EEG Sampling Frequency can be set at “Normal” (128Hz), “Twice”

(256Hz), or “Third” (512Hz). It is recommended to stick with

“Twice” (256Hz) as the output does not differ greatly beyond that.

c) Case Info: This section works similarly to the Case Library Settings,

except it modifies the selection of case information details for ease of

filling the case records, such as “Patient Status”, “Physician‟s Name”,

“Clinical Diagnosis”, “EEG Diagnosis”, “EEG Map Diagnosis”,

“Examination Type”, and “Medication” (See Fig 3-7B-2).

d) Event Info: This section works similarly to the Case Library Settings

and Case Info above, except it modifies the labels you can put for the

event markers during the data acquisition phase and the playback and

analysis phase, in terms of name (Fig. 3-7B-3) and color (Fig. 3-7B-4).

e) Leads Edit/Montage: Please go to Chapter 2, Section 4 on “Leads

Configuration”.

f) Report Template Revision: This section allows access to the report

template in word format, enabling user customization of the reports to

be printed.


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Fig. 3-7B-1 Case Database setup Fig. 3-7B-2 Case info settings

Fig. 3-7B-3 Event Setup Fig. 3-7B-4 Event Color Selection

Fig. 3-8 Display and Sampling

g) Help: Opens the help file.

h) Exit: Closes the System Setup menu.

3. [Holter] is useful for dynamic data management. It is important for

uploading dynamic EEG data into the computer.

a) To use this function, click [Holter] to open the Holter Data Management

window;

b) Click “Transform file” and locate the ambulatory EEG data to be

imported into the software.


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Fig. 3-9 Holter Data Management

c) The raw data located will be transformed into EEG data and added into

the case library. A transform message will appear at the start of data

conversion, and when the conversion is done, the message shown

below will appear:

Fig. 3-11 Transform File Progress

d) Case data will upload to the raw data directory automatically after the

data conversion is completed, which can be found and replayed in the

“untreated” case library.

e) [Time Setting] in the Holter menu enables synchronizing of the time

shown on the amplifier and the computer upon activation. Note that the

amplifier needs to be connected to the computer via MINI-USB interface

and has been recognized by the computer system.

f) [Formatting] is used to format the Flash memory holding the

ambulatory data. Note that the Flash memory must be installed into the

amplifier, and the amplifier has connected to computer via MINI-USB

cable.

g) [Exit] closes the Holter menu and returns user to the main interface.


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Chapter 4 Data Acquisition Data acquisition phase is the software interface where EEG data is measured

and recorded. To access to Data Acquisition, click [Add Case] at the main

interface and select a recording mode. The interface is shown in Fig. 4-1.

Fig. 4-1 Data Acquisition Interface

The interface consists of 2 toolbars: Main Control Bar at the bottom and

Functional Menu Bar on the left.

4.1 Main Control Bar

The commands to initiate and end the data acquisition are in this control bar. It

also shows the local time and the recording time.

The command keys are list below:

1.1 Help: opens the help file.

1.2 Version: displays the version information.

1.3 Local System Time: Displays the current system time.

1.4 Recording Time: Displays the current case recording time, i.e. duration of

the EEG recording done thus far.


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1.5 Calibrate: Click to activate automatic calibration.

1.6 Monitor: Displays the current EEG waveform measurements without

recording it. Useful for checking the lead connections. The background

color turns white in monitoring mode.

1.7 Record: Records the EEG data and displays the waveform measurements.

The background color follows the display settings (black for default).

1.8 Stop: Stops EEG data acquisition process.

1.9 Exit: Ends the EEG data acquisition interface.

1.10 Color: Displays the events marked on the measured waveforms.

When using this function at waveform tracing, marking an event on the

waveform will change the waveform color into the event color;

Only when using "Pre-Defined Events" in the "Event" function that the

waveform color can be changed;

Amongst the events, short-time events like eyes Open and eyes Close

will only change the waveform color for 2 seconds, whereas long-time

events will change the waveform color until the event is over.

4.2 Functional Menu Bar

o Montage

Click to choose different set of Lead Settings/Montages (e.g.

MON1, MON2).

o Overview

Click shows the leads configuration layout, with the channel

numbers shown in red with the respective leads.


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Fig. 4-2 Overview

o Page Setup

sets the number of channels to be displayed on each page. A

list shown below in Fig. 4-3 appears when the key is clicked.

Fig. 4-3 Page Setup Fig. 4-4 Page Index

2.4 Page Index

enables “jumping to other pages” to observe the EEG

waveforms. Number of pages is set in the Page Setup option mentioned

above. When clicked, a drop-down list appears like the one in Fig. 4-4.

2.5 Display Control

lets the user decide which of the current channels to display

on-screen, and which channels to hide. A checklist like in Fig. 4-5

appears by clicking the button:

Fig. 4-5 Display

Control

Fig. 4-5A Waveform

Color Settings

Fig. 4-6 Display

Speed

Fig. 4-7 EEG

Sensitivity


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2.5.1 For example, uncheck the box for , and the O2-Ref channel will

be removed from the waveform display.

2.5.2 Check “No Scale” to remove the time scale display at the bottom of the

waveform interface; also, check “By Point” to improve the displaying

sample rate of the waveforms acquisition at reduced smoothness.

2.6 Choose “Wavecolor” to change the color of waveform (See Fig. 4-5A).

User can change the wave color of a channel by clicking on the channel

name and selecting a color. User can also change the color of all channels

by clicking “SameColor”. Click “OK” afterwards to save the color changes

and return to the acquisition interface, or click “Cancel” to discard all

color changes before exiting.

2.7 Speed

Click to choose a different waveform display speed. The display

rate is measured in the unit of cm/s (See Fig. 4-6). We usually choose

3.0cm/s.

2.8 EEG Sensitivity

The control adjusts the vertical scales of the EEG waveforms in

μV/cm units (See Fig. 4-7). We usually choose 100uv/cm or 80uv/cm.

2.9 Low Pass & High Pass

Filter controls to block out external noise interference. Low pass filter

range: None, 5Hz, 10Hz, 15Hz, 20Hz, 30Hz, 40Hz, 45Hz, 60Hz; High

pass filter range: None, 0.01s, 0.02s, 0.03s, 0.1s, 0.2s, 0.3s, 1s, 2s, 3s.

2.10 Notch

This option is to set the EEG notch for blocking out power line

interference. For some countries, the EEG notch is 50Hz and for the

others, 60Hz.

2.11 PSG Parameter

This function is not available for Type-C EEG System.

2.12 Event

This is the settings for events during the EEG data acquisition. The setup

is shown in Fig. 4-8.

The selection of events can be configured in the System Setup, under

“Events Info”.

To mark an event, simply choose an event (with respective color code)

and the mouse-click on the waveform at the timings event occur.

“Breath Sound” option enables the software to generate sound to guide

the patient in deep breathing over an arbitrary period, to make events

observations easier.

“Auto Add” option will help mark a selected event during the waveform

recording.

Note: User can stop long time event (Breathing and Flash) and event

color by right click on the waveform area.


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2.13 Stimulation Setup

For EEG configurations with stimulators, is used to generate

the stimulation for data acquisition. Fig. 4-9 shows the setup interface.

2.12.1 Deep Breath: Set the breath frequency and duration for “Breath Sound”

option in the Event settings. Inhale percent refers to the time interval

between the sounds of inspiration (breathing in) and expiration

(breathing out).

2.12.2 Flash stimulation: This requires the photic stimulator connected to the

system to work. The flash stimulation can be programmed to run up to 10

cycles with 5 phases at varying frequency, duration and time intervals.

Up to 10 stimulation programs can be stored for future examinations.

The following are the steps to use the flash stimulation feature:

Click on to choose the stimulation plan to use or edit;

Save plan: Click this button to save the currently set plan;

Cycle Index: Click to choose how many cycles will the stimulation last.

Phase: Displays detailed information of each stimulation phase.

Stimulate Freq: User can set the stimulation frequency of each phase

from 1Hz to 30Hz.

Stimulate Time: User can set the stimulation time of each phase from 5s

to 60s.

Time interval: User can set the time interval between each phase.

OK: Click this to save the changes and close the window.

Default: Reset the parameters to system default values.

Cancel: Click this to close window without saving the changes.

Fig. 4-8 Event Settings

Fig. 4-9 Stimulation Setup

Fig. 4-8A Deep Breathing

Options


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2.13 Video

If a video is installed to the system, this can be used to toggle the video

display on screen. Note: It is recommended to set the video compressor

setting to DivX MPEG4 Fast-Motion for optimum video performance.

2.14 Adjusting

This function is a test function used on the EEG amplifier. It should only

be operated under the guidance of technical personnel.

2.15 Case info

Check or edit the current patient related information.

2.16 Brain Ten.

This toggles the interface for brain trend analysis. Refer to Playback and

Analysis in Chapter 5 for details.

2.17 Lens PAN controller (PTZ Control)

This opens the control interface for Lens PAN Controller of the video

camera system, as shown in Fig. 4-10.

Fig. 4-10 Lens PAN controller


37

Chapter 5 Playback and Analysis

5.1 Playback

From the main interface, select the case to be analyzed from the case list and

then click "Play" on the toolbar to enter the playback and analysis interface.

Fig. 5-1 Playback Interface

1.1 Information bar:

The information bar at the top screen displays the patient name and various

parameters (sensitivity, display speed, filter status) of the waveforms

displayed on screen.

1.2 Waveform Display Area: Displays the waveforms measured and recorded.

1.3 Functional Button Area 1:

“Mode”, “Overview”, “Pg Setup”, “Pg Index”, “Speed”, “Sensitivity”, “L-Pass”,

“High Pass”, “EEG Notch”, "Sleep Para.", “Video” and “Case Information”

works just like the ones in the acquisition phase.

1.3.1 Spike Wave Analysis:

This function uses autonomic analysis method to detect all the spike

waves that are measured during the data acquisition phase. All the

spike waves will be compiled into a list.

Note: As autonomic analysis is mechanical method, much external

interference will also be recognized as spike waves, so the analysis

report is for reference only, and the doctor need to give medical

judgment based on his understanding of the measured results.


38

Fig. 5-2 Spike-wave Settings

1.3.2 Breath Calibration:

This function is not available for Type-C EEG System.

1.3.3 Analysis:

This includes parameter analysis for brain wave tendency analysis.

More details will be covered in Section 3.

1.3.4 Predefined Event:

User can use this function to mark events in the measured waveforms,

at the corresponding timings with one of the pre-defined event markers.

User can also remove event markers from the list of events marked

throughout the waveform display.

Fig. 5-3A Predefined Event Fig. 5-3B Self-defined event

1.3.5 Self-defined event

User can mark an event in the waveforms with a self-defined event.

1.3.5.1 Click the "Add" button to define a new event.

1.3.5.2 Input the event name and select the color of event, and then click “OK”.

1.3.5.3 Click on the waveform to place the event marker.

1.3.5.4 The waveform will be labeled by self-defined event.

1.4 Functional button Area 2:


39

The functional buttons at the bottom row consist of “Play”, “Measure”,

“Ruler”, “Print”, “Undo” and “Map”.

1.4.1 Measure:

1.4.1.1 Click "Measure" button for displaying selection of measure frame, as

shown in Fig. 5-4.

1.4.1.2 Click on the waveform to be measured, and a window of measurement

will be displayed, as shown in Fig. 5-5.

Fig. 5-4 Measure Fig. 5-5 Ruler

1.4.1.3 Click on the waveform, and a cross label will pop-up with the time,

frequency and amplitude of the particular point will be measured.

1.4.1.4 User can filter waveforms independently by inputting the value into the

frame and the values less than that amplitude value will be filtered out

during measurement.

1.4.1.5 User can zoom in to view the waveform more closely, or zoom out to see

the waveform in a longer time frame.

1.4.1.6 Exit: Return to the playback interface.

1.4.2 Multi-Parameter Measurement

1.4.2.1 Click on the "Multi-Parameter" to open a dialog box as shown below in

Fig. 5-6 and select the corresponding parameter for measurement.

Fig. 5-6 Selection of Multi-Parameter Measurement

1.4.2.2 The interface for Multi-Parameter Measurement is shown in Fig. 5-7.


40

Fig. 5-7 Multi-parameter measurement

1.4.2.3 2 horizontal lines and 2 vertical lines will appear in the waveform display,

which the user can drag the lines to change the measured values of the

waveforms. The measured values are taken by the distance between

the lines, and the values will be displayed at the top row.

1.4.2.4 Exit to the measurement function by clicking the "Exit" button to delete

the measurement lines and values in this interface.

1.4.3 Ruler

Click "Ruler" button opens the selection interface of ruler.

Frequency ruler, amplitude ruler and other rulers can be chosen to

measure the parameters of the measured waveforms.

As this is an old measurement method for user‟s preference, users are

recommended to use the auto-measure functions instead.

Fig. 5-8 Ruler


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1.4.4 Print 1

Click on “Print 1” and a window as shown in Fig. 5-9 will pop-up:

Fig. 5-9 Window of Print 1

1.4.4.1 Input the analysis report into the dialog box and click "Save".

1.4.4.2 Print: 5 seconds of measured waveforms in the current waveforms area

will be printed with analysis report.

1.4.4.3 Print 2: 8 seconds of measured waveforms in the current waveforms

area will be printed, but without analysis report.

1.4.4.4 User can select the print template to do the printing, or even a

customized template.

1.4.4.5 To add a new printing template:

Click "Add" and then locate the template file.

Input the template name and content of template.

Click “Apply” to save the template.

1.4.4.6 Delete template:

Select a template from the drop-down list.

Click "Delete" to delete the template, and choose “Yes” when prompted.

1.4.4.7 Exit: Cancels printing and return to the Playback Interface.

1.4.5 Print 2

1.4.5.1 For this print option, the selection of templates works just like “Print”.

1.4.5.2 After selecting a template, click "Print 2" and the screen will return to

the waveform display interface to choose the waveform timings.

1.4.5.3 Left-click waveforms arbitrarily to determine the parts of the waveform

to be printed.

1.4.5.4 The selected portions of the waveforms will be labeled in red, as shown

in Fig. 5-10 below:


42

Fig. 5-10 Print 2 Interface: Selected waveform portions are in red

1.4.5.5 Click "Print 2" again, and the waveform selected will be printed in cross

model along with the waveform parameters. No reports will be

generated from this printing method.

1.4.6 Undo

Delete the selection of mapping and print waveform.

1.4.7 Mapping

This is used to do the brain mapping and analysis. Details will be

covered in the next section.

1.4.8 Edit

User can save the cropped waveforms into subsections. If video is

recorded, the video data can also be saved. A new case file named

“XXXnew” will be generated in the case library.

1.4.9 Exit

Click this to close the playback and analysis interface of EEG

waveforms.

1.5 Waveform Display Area and Playing Data Control Area

1.5.1 Shortcut Buttons

: Display the waveform in the first page.

: Display the waveform in the previous page.


43

: Display the waveform in the next page.

: Display the waveform in the last page.

: Display the waveform in last second.

: Display the waveform in next second.

1.5.2 Playing Data Control Area

Fig. 5-11 Playing Data Control Area

This bar is bottom of playback interface, useful for navigating the

waveform to appointed time.

1.5.2.1 Browsing Waveform: Click on the timing position on the Playing Data

Control Area, and the waveform from that timing will be displayed.

Events marked will have a colored mark signifying its timing and

duration, and click at the point left before the colored mark will display

the waveform right when the event occurred.

1.5.2.2 Playing the waveform

After selecting the speed of playing from this pull down menu, click

“Play” and the waveform will be automatically played; Playing “one

speed” according to the value of “paper speed” which has been set. If

your setup is 3cm/s in the “paper speed”, the waveform will move 3cm

in one second by playing “one speed”. If your selecting is “10x speed”

from this menu, the waveform will move 30cm in one second.

5.2 Brain Electrical Activity Mapping Analysis

2.1.1 From the Playback Interface, click on the “Mapping” button to begin.

2.1.2 Select the waveform portions to be mapped, just like “Print 2”.

2.1.3 Click on “Mapping” button again when all the mapping is done, and the

software will process the mapped waveforms and initiate the Brain

Electrical Activity Mapping Analysis (See Fig. 5-12).


44

Fig. 5-12 Brain Electrical Activity Mapping Interface

2.2 The Brain Electrical Activity Mapping Interface shows the brain mapping on

the left and the mapped EEG waveforms on the right.

The brain mapping displays the distribution of different EEG waves in

different frequency ranges, showing brain activity in specific areas for the

chosen time;

Whereas the waveforms on the right are cropped out of the original

waveforms and put together. This is useful feature to isolate the portions of

uncorrupted EEG waveforms from those experiencing external interference.

2.3 This interface has the following functional keys:

2.3.1 [Page up] [Page down] shifts the timeline of the EEG waveforms at the

right side of the interface.

2.3.2 [Zoom In] [Zoom Out] changes the proportion of the waveforms

displayed on the right side of interface.

2.3.3 [Filter] function is useful in controlling lead interference. This can be

done with the following steps:

2.3.3.1 Click [Filter] to enter the filter setup. The color of all the EEG leads will

be shown in red. For leads that do not require filtering, click on them to

change them to white, as the white leads will not be filtered.

2.3.3.2 Change the high pass frequency value and/or low pass frequency value,

and then press [OK]. The resulting waveforms should have observable

changes, which will in turn changes the brain mapping results and

hence the analysis results.


45

Fig. 5-13 Mapping Filter Interface

2.3.4 [Frequency] is used to set the frequency range of the system. Click the

button to enter the Freq setup interface, complete with corresponding threshold

values of waveforms from δ wave to β wave. To modify the frequency range of

each wave segment, simply change the corresponding threshold values and

then click “OK”. So to change the frequency range from 8.0Hz — 11.0Hz to

9.0Hz — 11.5Hz, simply change the values of the wave shown in the white boxes,

and then click “OK”.

Fig. 5-14 Frequency Threshold Settings

2.3.5 [Frequency Spectrum] performs a variety of analyses to EEG waveform.

Click the button and it will enter the spectrum interface, which has “Graph”,

“Percentage Map”, “Histogram”, and “Digital Map” analysis interfaces, using

different forms to display the energy distribution for each channel, the

respective percentage values, etc. User can even choose to print these

spectrum interfaces for future reference.


46

Fig. 5-15 Frequency Spectrum: Clock-wise from top-left are [Graph],

[Percentage Map], [Digital Map], and [Histogram] at bottom-left

2.3.6 [Left View], [Right View], [Top View] are command keys to switch the

viewing angle of the brain electrical activity mapping display, which is useful in

locating the active area in the brain during analysis.

2.3.7 [Ruler]: Click it to switch between relative scale and absolute scale. The

different choice of scale will lead to different results when printing the

corresponding report.

2.3.8 [Print], [Print2]: Just like in the playback interface, these will print the

mapping report with or without the analysis report.

5.3 Analysis

In the playback interface, click the „Analyse‟ to bring up a pull-down menu

as shown in Fig. 5-16.

http://dict.cnki.net/dict_result.aspx?searchword=%e7%bb%9d%e5%af%b9%e6%a0%87%e5%b0%ba&tjType=sentence&style=&t=absolute+scale


47

Fig. 5-16 Analysis Menus

For Type-C EEG System, only EEG Tendency Analysis is available.

3.1 EEG Tendency Analysis

In the playback mode, click the “Analyze”, then select the “EEG Tendency

Analysis”. An electrode selection window will appear so the user can choose

the electrodes to be analyzed.

3.1.1 Click on the trend diagram, and it will show the current energy level,

peak energy frequency, and (relative and absolute) energy values.

Fig. 5-17A

Montage

Setting

Fig. 5-17B Trend Diagram

Fig. 5-17C

Energy

Values

3.1.2 The buttons at the lower right side are

adding/reducing one channel trend, toggle 2D/3D trend display (See Fig.

5-17D), time interval setting (between 1s to 120s), Frequency Gain

Parameter Setup, EEG Trends Setup, and minimize EEG trend display.

Fig. 5-17D 3D EEG Trend Display

3.1.3 Every trend channel is decided by the type of energy trends and EEG

channel selected. Each channel can display a different trend, and the

user can decide which channel is it displaying for.

3.1.4 The user can also apply different filters and scaling to every trend

channel. Click on the “Filter” at the right side of the trend channel, and


48

the frequency point and energy filter dialog box will pop-up, as shown in

Fig. 5-18.

Fig. 5-18 Selection of EEG

values for display in EEG

Trend Analysis

Fig. 5-19 Frequency Point

Energy Filter

3.1.5 In the Frequency Point Energy Filter settings, the user can select the

analysis frequency point to filter, then use button “>>”, click “Ok” or

“Apply”. The selected frequency points will not be used in the analytical

operation.

3.1.6 Click “Frequency Gain Parameter Setup” to bring up a dialog box to set

the gain for each frequency point. As shown in Fig. 5-20.

Fig. 5-20 Frequency Gain

Parameter Setup

Fig. 5-21 EEG Trend Analysis

Parameter Setup

3.1.7 Click “EEG Trend Setup”, and the system will pop-up the frequency gain

parameter dialog box, which the frequency range and scope of each

wave to be used in the analysis can be shown (See Fig. 5-21).


49

Chapter 6 Important Safety

Information

6.1 Classification

According to GB9706.1,

NATION series EEG is classified to:

Electric shock protection types: 1. Inner power (dynamic or wireless

Bluetooth EEG recorder)

2. I-model（regular or portable EEG）

Electric shock protection level: 1. B-model（dynamic or wireless Bluetooth

EEG recorder)

2. BF-model（regular or portable EEG）

Hazard fluid in protection level: Normal device

Safety level under using in anesthesia

fuel and air mixture or Oxygen or

nitrous oxide mixed gas:

Not applicable

Operating method: Continuous operation

The disinfection and sterilization

methods recommended by the

manufacturer:

Applicable

6.2 Device symbols

1. : BF-model application section

2. : B-model application section

3. ～ : AC

4. : Note (please refer to the files attached with device)


50

Chapter 7 Maintenance &

Servicing This chapter is about the correct way to maintain the equipment in good

condition for the maximum duration, and solutions to problems that keep the

equipment from working properly.

Device maintenance inspection does not include the internal structure of the

apparatus, which can be carried out only by technicians or operators.

In view of the security of the apparatus and the requirements of access, internal

maintenance and testing equipment must be done by the authorized service

personnel. When the equipment is not working normally, it should be clearly

marked to avoid working under abnormal conditions.

Maintenance of equipment includes visual inspection, periodic cleaning and

system self-check routine. The following describes a simple run-through of the

basic maintenance procedures.

7.1 Cleaning and Disinfection

Warning! Disconnect the power supply of the equipment before cleaning or

disinfecting it to prevent electrocution.

1. Outer surface (master controller unit, EEG amplifier, ERP stimulators, video

recording system, printer and host computer, etc.):

Outer surface of equipment should be cleaned regularly with non-depilate

soft cloth soaked wet in mild, diluted soapy water.

To avoid damaging the equipment, user is advised to:

Always clean equipment according to the manufacturer's recommended

dilution and cleaning method.

Always wipe the equipment with a clean and dry cloth after cleaning.

Never use cleaning material with wax to clean the equipment.

Never splash or spray water or any cleaning solution onto the

equipment, or allow the liquid to influx to the back of the switch or the

connectors or any air vents of the equipment.

Never use the following agents for cleaning of EEG equipment: Acetone,

ketone, alcoholic cleansers and any abrasive cleaning agents or

solutions.

Failure to conform to the cleaning recommendations above may cause

dissolving or distortion to the outer coating of the equipment, corrosion

to the characters on the labels, or even lead to equipment failure.

2. The Display Screen

！


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Please keep in mind that the screen should be cleaned with clean soft fabric

cloth that is wet by glass cleaning detergent. Do not spray the detergent

onto the screen directly, and do not use alcohol or any medical disinfectant

to do the cleaning.

3. Cleaning of EEG Accessories

a. The Lead Wires for Connecting Electrodes

Note:

Patient lead wires can be cleaned using warm, damp cloth with mild soap

suds, or by using isopropyl alcohol.

Do not use acetone or ketone solutions to do the cleaning; do not use

high-pressure steam sterilization or any autoclave cleaning agent.

Do not soak the patient lead wires.

b. Earphones

Note:

Before and after using earphones, the part of the earphones in physical contact

with the ear should be cleaned with 75% medicinal alcohol.

Earphones can be cleaned using warm, damp cloth and mild soapy water, or

by using isopropyl alcohol.

Do not use acetone or ketone solutions to do the cleaning; do not use

high-pressure steam sterilization or any autoclave cleaning agent.

Do not soak the earphones.

c. Electrodes

Remove the conductive paste film from the surface of the electrode plate

after use.

Clean the electrode plates with absorbent cotton cloth with alcohol, and

then make it dry.

Warning: Do not use any abrasive or grinding materials to clean the

electrodes, for any scrape on the electrode plate may lead to inaccurate

readings in future use.

7.2 Appearance Inspections

Note:

Inspect the external parts of equipment periodically. Only authorized service

personnel can replace the damaged parts.

1. Each time after use, clean the patient lead wires and equipment before

performing appearance inspection to detect damage of components in time.


52

2. Service and maintenance procedures

a. The product only requires minimal maintenance due to the high level of

production process made during the product manufacturing.

b. The replacement fuse must be same as the regulated type. (T2A250v)

c. It is recommended that users maintain and calibrate the device

periodically, at least once a year or whenever any problem is suspected.

The device should be returned to the supplier if any complex detection

and calibration is necessary.

d. Circuit diagrams of the equipment, the accessory parts list and other

technical information are only provided for authorized service personnel

in servicing the equipment.

e. When the power indicator of the amplifier turns orange and begins

flashing, the battery is running out, so it is time to recharge the

amplifier with the charger. Under normal operation, the power light is

always green.

Note: Do not use the equipment to test when charging.

Warning:

The warranty is valid as long as the accessories used are provided by the

supplier or purchased from third party sources approved by the supplier.

If isolation transformer is used, the total power consumption of the display,

printer and host computer should not be larger than the output power of the

isolation transformer.

7.3 Troubleshooting

The functional changes listed below are all the possible problems that may

happen after using the instrument for some time.

1. The keys are not working

There are 6 function keys on the EEG amplifier, where some of the keys may

be invalid or with poor contact. For this problem, please contact the supplier

for repair according to the terms of service.

2. The computer system cannot identify the EEG instrument.

There are a few reasons that cause this problem to occur:

1) The driver programs may be lost due to computer system error. The user

can recover the driver programs from the installation CD disk provided


53

with the EEG system package if you are sure that the computer is not

infected by viruses or malware and the system is not damaged;

2) The amplifier hardware failure may have caused the installation to fail. The

user may confirm whether the issue is caused by the amplifier by following

the operations mentioned in 1). If the hardware is not recognized by the

computer despite having the driver programs installed, then hardware

failure can be confirmed. Please return the amplifier to the supplier for

servicing.

3. When the user is running an EEG examination, the waveform of one or

several channels are straight line or there is significant interference in the

signal output.

The possible causes to this problem are:

1) The quality of the electrode wires deteriorated due to wear and tear over a

long time of use, so normal waveform data cannot be collected. The

electrode wires are consumable materials with life cycle of one year in

general. If this is the problem, user is recommended to purchase for new

electrode lines from the supplier.

2) Amplifier failure causes the waveform output to be straight line or have

significant interference. The user may exchange the electrode wires of the

channels with output issues with the normal ones to confirm whether it is

caused by the electrode wires or the faulty in the amplifier. If amplifier

failure is confirmed to be the cause, then please return the amplifier to the

supplier for servicing.

4. The rechargeable battery may not work properly after it is used for a long

time, or due to the equipment not being used for a long time. In either case,

the battery will last shorter than expected duration. This can also happen

when the battery is damaged due to external factors.

The battery should be replaced with a new battery from the supplier or any

sources recommended by the supplier. The old battery should be disposed of

according to the local safety regulations.

7.4 Transportation and Storage Conditions

a) Environment temperature range: -40°C～55°C;

b) Relative humidity range: ≤95%;

c) Atmospheric pressure range: 960hPa～1060hPa.


54

Appendix A: Manufacturer Information

Company Name: NCC Medical Co., Ltd

Business Registration Number: 310114000270268

Medical Instrument Manufacturing License Number: The number is 20030710

from Shanghai Food Drug Administration.

Organization Code: 63080226－X

Company Address: No.68, Nansha Road, Minhang District, 200245 Shanghai,

P.R.China

Contact information:

Technical Engineer

Speed Su Jeter Xu

Email: [email protected] Email: [email protected]

Mobil: +86-18821108071 Mobil: +86-18821107327

Appendix B: Power Supply & Battery

Operation

Please check whether the voltage of the power corresponds to the value written

on the power label.

To ensure safe and reliable battery operation over long term, the following

operation procedures need to be practiced:

◇ The actual lifetime of batteries may differ from stated lifetime, depending on

the battery manufacturers, room temperature, frequency of use and

frequency of recharging.

◇ In the events of being opened or burned, or incorrect installation, the battery

may explode or leak and end up causing injuries to the user.

◇ The battery should be replaced immediately when the following happens:

Abnormal battery performance such as low battery durability after

being fully recharged.

The lifetime of the battery is stated to be 2 years; even then the battery

can still be recharged for future use.

Appendix C: Electromagnetic

Compatibility

This equipment has not been implemented with YY0505-2005 EMC testing

according to state regulations. However, electromagnetic environment

mailto:[email protected]


55

exceeding YY0505 specified parameters will seriously interfere with the

equipment and result in the device not achieving its intended performance

levels. Therefore, electromagnetic effects in the test environment should be

avoided, identified and resolved before using the equipment.

Here below are some common sources of electromagnetic interference

and relevant solutions:

1. Strong electromagnetic interference from radio or cell phone:

This equipment and / or system can be installed in other locations. Emission

sources such as mobile phones should stay away from the equipment and /

or system, or be switched off during examinations.

2. Using AC power for the equipment and / or system, and radio interference

from other devices:

Confirm the source of interference and if possible, remove the interference

source. Otherwise, please adopt a different power supply.

3. Direct or indirect static electricity influence:

Before use, confirm that all operators and patients contacting the

equipment do not have direct or indirect static electricity by washing their

hands clean.

4. Interference from radio receivers, such as radio or television:

The device and / or system should be kept away as far as possible from the

radio receivers.

5. Lightning interference:

When lightning occurs near the equipment and / or system, it will cause

very high voltage surge to the device and / or system.

In this case, unplug the AC power line from device and / or system, and use

battery power or an uninterruptible power supply to operate the device and

/ or systems.

6. Usage with other devices:

When the device and / or system is positioned near or stacked with other

devices, the output of the devices and / or systems may interfere with each

other. Please confirm with the supplier in advance that the devices and / or

systems can be used together safely.

7. Use of non-specified accessories, transducer and / or cable:

If this device and / or system use non-specified accessories, transducer and

/ or cables, electromagnetic radiation will increase and reduce

electromagnetic immunity. Electromagnetic requirements of this equipment

and / or system are consistent with the specified configuration. The

equipment and / or systems should be used by the specified configuration.

NCC Medical Co., Ltd

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