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NCC Medical Co., Ltd Http://www.cnnation.com Technical User’s Manual ---USB EEG System--- Operation Manual Nation7128W-D24(U)

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NCC Medical Co., Ltd

Http://www.cnnation.com

Technical User’s Manual

---USB EEG System---

Operation Manual

Nation7128W-D24(U)

Table of Contents

Notice to Users ............................................................................................................................. 1

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

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

Chapter 1 Hardware Connection .............................................................................................. 6

1.1 Amplifier Introduction .......................................................................................................... 7

1.2 The connection of Amplifier ............................................................................................... 8

Chapter 2 Software Installation and Setup ............................................................................ 9

2.1 Software Installation Requirements .................................................................................. 9

2.2 Software Installation Procedure ........................................................................................ 9

2.3 Driver installation ................................................................................................................ 10

2.4 Serial No. Setup ................................................................................................................... 11

2.5 Leads Configuration ........................................................................................................... 14

2.6 Display and Sampling ........................................................................................................ 15

Chapter 3 Main Interface .......................................................................................................... 17

3.1 Toolbar.................................................................................................................................... 17

3.2 Data Directory Selection .................................................................................................... 19

3.3 Case Library Drop-List ....................................................................................................... 19

3.4 Case Library and Case Information Display ................................................................. 19

3.5 Management of Case Library ........................................................................................... 20

3.6 User Information .................................................................................................................. 21

3.7 Function Keys ...................................................................................................................... 21

Chapter 4 Data Acquisition ...................................................................................................... 25

4.1 Main Control Bar .................................................................................................................. 25

4.2 Functional Menu Bar .......................................................................................................... 26

Chapter 5 Playback and Analysis .......................................................................................... 31

5.1 Playback ................................................................................................................................. 31

5.2 Brain Electrical Activity Mapping Analysis ................................................................... 38

5.3 EEG Tendency Analysis ..................................................................................................... 40

2

Chapter 6 Maintenance and Servicing .................................................................................. 43

6.1 Cleaning and Disinfection ................................................................................................. 43

6.2 Appearance Inspections .................................................................................................... 44

6.3 Troubleshooting ................................................................................................................... 45

6.4 Transportation and Storage Conditions ........................................................................ 46

Chapter 7 Important Safety Information ............................................................................... 47

7.1 Classification ........................................................................................................................ 47

7.2 Device Symbols ................................................................................................................... 47

Appendix A Manufacturer Information ........................................................................ 48

Appendix B Power Supply & Battery Operation ........................................................ 48

Appendix C Electromagnetic Compatibility ............................................................... 48

1

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:

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 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;

If possible, the EEG room should be located close to nerve medicine and pediatrics

for the convenience of access for patients;

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

switched on during examinations;

The device should be placed away from electrical instruments, high-frequency radiant

point, CT, MRI, etc. to avoid interference during 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 trigger an explosion or fire.

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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.

3. After Operation:

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

Gently remove the electrode line gently;

Clean the equipment and accessories for future use.

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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 system master controller unit, EEG amplifier and electrodes, Acoustic &

Visual 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;

The new silver electrodes and silver support electrodes should be dipped in normal

saline for 2 hours when used for the first time for better effectiveness; after the usage,

please dip the electrodes in normal saline.

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 Routine 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;

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

Applicability statement:

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

Nation 7128W:

24 channels Routine EEG

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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 Connection

System Hardware Configuration

Integrated connection diagram for Type-D EEG System

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1.1 Amplifier Introduction

Area 1 is the working state of hardware

Power light: light green means the system is working normally

Area 2 is the EEG channels

Cable connection: connect the cables to the hole.

Area 3 is the impendence testing function

a) Connect the cables to the correct holes

b) Open the amplifier power, and the power light will turn green.

c) Press the Ω button and the 5K indicator will turn green, it means the

impendence testing is open and the threshold is 5K (Note: impendence

testing can’t work with collection at the same time.)

d) Link position of lead wire and amplifier will appear yellow caution light if lead

wire's impedance is more than 5K and represent fail to test impedance. Link

position of this lead wire and amplifier will appear green light if lead wire's

impedance is less than 5K and represent success to test impedance.

e) Click "SET" button to adjust impedance testing threshold, adjustable levels:

5K\10K\15K\20K.Click "ON/OFF" button after testing to close impedance

testing function. Amplifier connection

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1.2 The connection of Amplifier

Area 1: EEG interface to connect all in one electrode cable instead of the 24 channel

EEG cables to collect data

Area 2: USB port, connect the USB-DB9 cable, the other side of the cable connects

to the PC for power supply and data transmission.

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Chapter 2 Software Installation and

Setup

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 XP/Vista/7/Win8

CPU: Speed is 2G or above, 32 bits CPU

Hard Disk: 500GB and above

Memory: 2G and above

Graphic Card: AMD integrate graphic card or any type independent graphic card, cannot

use Intel integrate graphic card

Printer: HP or Epson color inkjet printer

2.2 Software Installation Procedure

1.1 Put the CD into the CD-ROM.

1.2 Open it by mouse right-click, there are 3 files in it. They are “ EEGSetup” 、

“stdgain.cfg” and “ Update”. Run installation file (double click “EEGSetup”) in the CD,

software will install automatically on your computer (Please select target path C :).

1.3 Click “next” always, then click “ok” and “finish” finishing the EEG software installation.

(Please do not close the window as shown in fig. 1 before fig.2 appear during installation. )

Fig. 1

Fig. 2

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2.3 Driver installation

2.3.1 Right-click "My computer"→ Single click "Manage"→ single click" Device

manager"→ click "Universal serial Bus controllers", then you will find driver " Unknown

device " in the list.

2.3.2 Right click “Unknown device”, select “Update Driver Software”--- “Browse my

computer for driver software”

2.3.3 Click Browse-select driver-“ C:\USBdrive\UsbDriver x86x64\***” “According to

your operation system select relevant driver program(32bit system select X86, 64 bit

system select X64)”, then, click OK- “Next”, the driver will start install

2.4 After installed driver software, in Device manager, you will find “Nation

EZ-USB(X86X64)” in the list.

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2.4 Serial No. Setup

Method 1:

Open CD and find the file “Stdgain.cfg”, copy this file to “C:\ EngNCERP\ CFG” folder.

Method 2:

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. Double click icon "EEG.exe" on desktop to open the main interface of EEG

software ( If the icon not show on desktop, please open the folder “C:\ EngNCERP\

BIN” and find “Mfile.exe”, right click it and select “send to desktop(create

shortcut)”, and change the shortcut name to “EEG”), shown in Fig. 2-1 below:

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Fig. 2-1 Main Interface

3. Click on “Setup” button on the upper right screen to enter the system setup

interface (See Fig. 2-2). Click “Engineer Setting-Lead Edit" next to enter the

montage or leads editing interface (See Fig. 2-3).

Fig. 2-2 System Setup Fig. 2-3 Montage Interface

4. Click on "Configure" button on the top right corner, and a login prompt will pop-up.

Input the password "Nation" and click "OK" to enter the EEG channel

configuration interface (See Fig. 2-4).

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Fig. 2-4 EEG Channel Configuration Interface

5. At the channel configuration interface, click on "Serial No." to open a small

interface of serial number library (See Fig. 2-5).

Fig. 2-5 Serial Number Library

6. In the Serial Number Library, the white space on the left displays the serial

numbers recognized by the software system. Click on “Add Serial No.” then input

the EEG amplifier serial number, and the serial number will be added into the

library (For Type-D EEG, the serial number can be found on the hardware at

delivery). The serial number is usually the 6 former digits of the amplifier serial

number.

7. If the serial number inputted is incorrect, the amplifier will not be recognized by the

software system. To correct it, click on the incorrect serial number and click on

"Delete Serial No." to remove the incorrect entry.

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8. After registering the correct hardware serial number, click "Exit" to close the

library and then click “Save” button on the channel configuration interface to close

it and return to the montage interface.

2.5 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.

Hardware Configuration

Drop-down List

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.

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.

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Fig. 2-6 EEG Channel Configuration

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 “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.

2.6 Display and Sampling

1. “Display and Sampling” is accessible from the System Setup. It is used to edit

the display for the EEG recording and playback interfaces, as well as the sampling

rate. Fig. 2-8 shows the interface for the Display and Sampling configuration

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menu.

Fig. 2-8 Display and Sampling

2. Unit Mensuration: 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.

3. Colors of the EEG waveform display can be modified at user’s choice.

4. 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.

Now the EEG software is ready for use in examinations.

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Chapter 3 Main Interface

To begin, double-click icon "EEG.exe" 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:

3.1 Toolbar

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 for a

specific EEG case data;

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Fig. 3-1B Search Interface

: To playback the selected EEG cases in the playback interface. If the data is

recorded with video, the video will also be played;

: This icon will let you add additional 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 add or change case information or patient information for a

selected case;

Fig. 3-1C Case Info Interface

: Prints a report for the selected case. Different templates will generate different

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reports;

: Opens the help information catalog;

: Opens the version information window;

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

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".

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

a) 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:

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

storage media;

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

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

b) 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.

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c) Case restore

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

be covered later.

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 information

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 4.

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 Acquisition]: Click this to open the EEG data acquisition interface;

[VEEG Acquisition]: Click this to open the EEG data acquisition interface

with video recording.

[CNV Acq]: Useless for this type EEG.

[ERP Acq]: Useless for this type EEG.

[P50 Acq]: Useless for this type EEG

[VideoERP Acq]: Useless for this type EEG.

Fig. 3-7A Add Case

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

the menu includes Case Information, Display and Sampling, Engineer Setting, Event

Setting.

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Fig. 3-7B System Setup

a. Case Library Settings/Case information 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).

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).

b. Display and Sampling: See Chapter 2, Section 2.6.

c. Engineer Setting: This menu includes: Lads edit, Report Template, Help(See Fig

3-7B-3)

Leads Edit/Montage: See Chapter 2, Section 2.5 on “Leads Configuration”.

Report Template Revision: This section allows access to the report template in

word format, enabling user customization of the reports to be printed.

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

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

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 and color (Fig. 3-7B-4).

e. Help: Opens the help file.

f. Exit: Closes the System Setup menu.

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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 listed 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.

1.5 Calibrate: No use for users. It is used for calibrating the gain by the manufacturer.

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Please do not use it without the operator of the manufacturer.

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.

4.2 Functional Menu Bar

2.1 Montage

Click to choose different set of Lead Settings/Montages (e.g. MON1,

MON2).

2.2 Overview

Click shows the leads configuration layout, with the channel numbers

shown in red with the respective leads.

Fig. 4-2 Overview

2.3 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.

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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

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

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waveforms acquisition at reduced smoothness.

2.5.3 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.

2.6 Speed

Click to choose a different waveform display speed. The display rate

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

2.7 EEG Sensitivity

The control adjusts the vertical scales of the EEG waveforms in

μV/cm units (See Fig. 4-7).

2.8 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.

2.9 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.

2.10 PSG Parameter

Not available for this type.

2.11 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, 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.

2.12 Stimulation Setup

For EEG configurations with stimulators, is used to generate the

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

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Fig. 4-8 Event Settings

Fig. 4-9 Stimulation Setup

Fig. 4-8A Deep Breathing

Options

a. 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). This is also used for PSG

data acquisition.

b. Flash stimulation: This requires the flash 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.

2.13 Video Switch

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 Calibration

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

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operated under the guidance of technical personnel.

2.15 Case information

Check or edit the current patient related information.

2.16 Switch of Brain Tendency

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

in Chapter Five for details.

2.17 Lens PAN controller

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

system, as shown in Fig. 4-10. This only works with Lens PAN Controller installed

with the video system.

Fig. 4-10 Lens PAN controller

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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 Parameter", “Video Switch” 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 a 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.

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Fig. 5-2 Spike-wave Settings

1.3.2 Breath Calibration:

Unlike the one in PSG acquisition, this Breath Calibration is done manually, so it

will not analyze the breath if the user did not use this function in the acquisition

phase. User will select data between 30s - 5 minutes and click this button for

finishing Breath Calibration manually to generate a calibration value for breath

analysis.

1.3.3 Analysis:

This includes parameter analysis and reports for brain wave tendency and sleep

analysis. More details will be covered in Section Three.

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.

1.3.5 Self-defined event

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

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

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

c. Click on the waveform to place the event marker.

d. The waveform will be labeled with the self-defined event.

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

1.4 Functional button Area 2:

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

“Undo” and “Map”.

1.4.1 Measurement:

a. Click "Measurement" button for displaying selection of measure frame, as shown

in Fig. 5-4.

b. Click on the waveform to be measured, and a window of measurement will be

displayed, as shown in Fig. 5-5.

Fig. 5-4 Measurement Fig. 5-5 Ruler

c. Click on the waveform, and a cross label will pop-up with the time, frequency and

amplitude of the particular point will be measured.

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d. 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.

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

waveform in a longer time frame.

f. Exit: Return to the playback interface.

1.4.2 Multi-Parameter Measurement

a. Click on the "Multi-Parameter Measurement" 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

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

Fig. 5-7 Multi-parameter measurement

c. 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.

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d. 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.

Fig. 5-8 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.

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

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

b. Print: 5 seconds of measured waveforms in the current waveforms area will be

printed with analysis report.

c. Print 2: 8 seconds of measured waveforms in the current waveforms area will be

printed, but without analysis report.

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d. User can select the print template to do the printing, or even a customized

template.

To add a new printing template:

a) Click "Add" and then locate the template file.

b) Input the template name and content of template.

c) Click “Apply” to save the template.

e. Delete template:

a) Select a template from the drop-down list.

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

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

1.4.5 Print 2

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

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

waveform display interface to choose the waveform timings.

c. Left-click waveforms arbitrarily to determine the parts of the waveform to be

printed.

d. The selected portions of the waveforms will be labeled in red, as shown in Fig.

5-10 below:

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

e. 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

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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.

: 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 at the bottom of the playback interface, useful for navigating the

waveform to appointed time.

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 right

before the colored mark will display the waveform right when the event occurred.

1.5.3 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

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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 “Map” button to begin.

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

2.1.3 Click on “Map” 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).

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.

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

the following steps:

a. 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.

b. 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.

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

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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.

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 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.

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3. 1 Click on the trend diagram, and it will show the current energy level, peak energy

frequency, and (relative and absolute) energy values.

Fig. 5-22A

Montage Setting Fig. 5-22B Trend Diagram

Fig. 5-22C

Energy

Values

3. 2 The buttons at the lower right side are adding/reducing one

channel trend, toggle 2D/3D trend display, time interval setting (See Fig. 5-22D),

Frequency Gain Parameter Setup, EEG Trends Setup, and minimize EEG trend

analysis display.

Fig.

5-22D

Time

Interval

Setting

Fig. 5-22E 3D EEG Trend Display

3. 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

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which channel is it displaying for.

3. 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 the frequency point and

energy filter dialog box will pop-up, as shown in Fig. 5-24.

Fig. 5-23 Selection of EEG

values for display in EEG

Trend Analysis

Fig. 5-24 Frequency Point

Energy Filter

3. 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. 6 Click “Frequency Gain Parameter Setup” to bring up a dialog box to set the gain

for each frequency point. As shown in Fig. 5-25.

Fig. 5-25 Frequency Gain Parameter

Setup

Fig. 5-26 EEG Trend Analysis Parameter

Setup

3. 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. 5-26).

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Chapter 6 Maintenance and 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.

6.1 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

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

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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

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.

6.2 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.

2. Service and maintenance procedures

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

production process made during the product manufacturing.

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

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.

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Circuit diagrams of the equipment, the accessory parts list and other technical

information are only provided for authorized service personnel in servicing the

equipment.

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.

6.3 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 2 function keys on the EEG amplifier box, 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 are lost due to computer system error. The user can recover

the driver programs from the installation CD disk provided 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 hardware failure of the amplifier causes the installation to fail. The user may

confirm by following the operations mentioned in 1) to determine whether the issue is

caused by the amplifier. If this problem happens, please return to our company for

repair.

3) Another possible cause is that the operating system is not compatible with the

instrument. It is found that 64-bit Windows operating system (OS) does not recognize

the driver programs of the EEG instrument. The OS type can be checked by

right-clicking “computer” at the Start Menu and choose “Properties”. If this is the case,

please use a different computer for installation or contact the supplier for technical

support.

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

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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.

6.4 Transportation and Storage Conditions

A. Environmental temperature range: —40°C ~ 40°C;

B. Relative humidity: ≤90%

C. Atmospheric pressure range: 960hPa ~ 1060hPa.

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Chapter 7 Important Safety Information

7.1 Classification

According to GB9706.1-2007, the EEG System is classified as:

Type of shock protection

The amplifier is operated with internal

power supply. The controller is class I

device.

Audio and video stimulator is operated

with special power supply.

Level of shock protection BF-type

Inlet liquid protection grade IPX0

Whether the device have protection for defibrillator electric

discharge effect No

Safety grade under the condition of the mixture of flammable

anesthetic gas with air, oxygen or nitrous oxide Device is not AP nor APG type

Operation of work system Continuous operation

System power supply voltage AC 220V, 50HZ

Disinfection and sterilization methods recommended by

manufacturer Applicable

7.2 Device Symbols

1. : BF type equipment

2. ~ : (AC)

3. !

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

4. : Fuse

5. ︱ : Power On

6. ○ : Power Off

7. : Equipotential plasma

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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 exceeding YY0505 specified

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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