F100 Size#1/F100 Size#2

Digital Intraoral X-ray Imaging System

Manual Information
Release Date: June 2022
Version ：V1.4
Copyright © Shenzhen Fussen Technology Co., Ltd. 2020
This Manual is applicable to digital intraoral X-ray imaging system F100
Size#1/F100 Size#2.

Declaration
This Manual is a reference for the operation, maintenance and
repair of the product. Users shall operate in strict accordance with
the contents of this Manual. Shenzhen Fussen Technology Co.,
Ltd (hereinafter referred to as “Fussen”) shall not be liable for any
failure or accident caused by not in accordance with the operating
instructions in this Manual.

Fussen owns the copyright in all the contents of this Manual and
may not be photocopied, copied or translated into any other
language without the express written permission of our company.

This Manual contains proprietary information protected by

copyright law, including but not limited to technical secrets, patent
information and other commercial secrets. Users shall have the
obligation to keep confidential and shall not disclose any of the
contents of this Manual to unrelated third parties.

User’s possession of this Product Manual does not imply

Fussen’s authorization and permission to the intellectual property
contained in the product.

The modification, renewal and final interpretation of this Manual

belong to Fussen.

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Manufacturer’s Responsibility
Fussen is considered to be responsible for the safety, reliability and
performance of the instrument only in the following cases: assembly
operations, expansion, re-adjustment, improvement and
maintenance are carried out by Fussen-approved personnel; the
electrical installation environment of the corresponding room
complies with national standards; and the instrument is used in
accordance with the operating instructions.

Fussen will provide circuit diagrams and other information for a

fee at your request to help you repair the Fussen parts that can
be repaired by appropriate and qualified technicians.

Application of the Manual

The manual mainly introduces functions of the Digital Intraoral X-
ray Imaging System and the way to operate it. Before the use of
this software, please read the manual of the devices that
connected to this software carefully.

This manual is designed for the clinics that using Digital Intraoral
X-ray Imaging System. It provides work-flow of a patient study.
Mostly, it’ll introduce the operation steps, system structure and
features. Attention, there’s no guideline and assistant for clinic
diagnosis.

Applicable Object
The manual is applicable to clinical professionals and other
authorized users.

Legend and Name

All legends provided in the manual are just for examples.
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All names shown in examples and legends are imaginary. It is

III
Coincidence if some body happens to have the same name
with that in the manual.

Description of the Terminology in this Manual

Warning: For an operation or situation that might result in personal
injury or death.

Caution: For an operation or situation that might cause damage to the

equipment, produce erroneous data, or result in process failure.

Note: Important information that you should be aware of.

IV
 Contents
1 Safety Guide.....................................................................1
1.1 Intended Use..................................................................1
1.2 System Components......................................................1
1.3 Operating Conditions......................................................2
1.4 Warnings and Notes.......................................................2
1.4.1Safety Warnings....................................................3
1.4.2Caution..................................................................5
1.4.3Notes.....................................................................5
1.5 Network Security Instructions............................................6
1.6 Mark and Label Symbols...................................................6
2 Overview..........................................................................8
2.1 Overview.........................................................................8
2.2 Installation and connection.............................................8
2.3 Computer and monitor....................................................9
2.4 Sensor............................................................................9
2.4.1Sensor Preparation..............................................10
2.4.2Image acquisition.................................................10
2.4.3 Sensor positioning............................................11
2.4.4Adjusting exposure time......................................14
3 Software Operation Guide..............................................16
3.1 Software Overview........................................................16
3.1.1System operation conventions.............................16
3.1.2System Function Overview..................................17
3.2 Basic examination operation.........................................19

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 3.2.1Start Up and Login to System..............................20
3.2.2Patient Registration.............................................22
3.2.3Image Acquisition................................................23
3.2.4Logout and Turnoff Computer..............................25
3.3 Examination Management............................................25
3.3.1Work list...............................................................26
3.3.2Registration..........................................................29
3.3.3Study list..............................................................30
3. 4 Image Acquisition......................................................36
3.4.1Acquisition preparation........................................36
3.4.2Acquisition procedure..........................................37
3.5 Image Browsing............................................................37
3.5.1Image Browsing...................................................38
3.5.2Image editing.......................................................44
3.6 Configuration Management..........................................46
3.5.1System management...........................................47
3.5.2Statistics..............................................................53
3.5.3User.....................................................................53
3.5.4Password.............................................................53
4 Disinfection and Maintenance...............................................54
4.1 Sensor disinfection and Sanitation...............................54
4.2 Cleanness of cables.....................................................56
4.3 Storage of the sensor...................................................56
4.4 Maintenance of the sensor...........................................56
4.5 Electrostatic discharge prevention................................57

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 4.6 Computer Data Protection............................................57
5 Care and Maintenance..........................................................58
5.1 Maintenance of the device............................................58
6 Accessories...........................................................................59
7 After-sales Service................................................................60
7.1 After-sales Service........................................................60
7.2 Contact Information......................................................60
Appendix 1 Specifications.....................................................61
Appendix 2 Troubleshooting..................................................63
Appendix 3 Registration Information......................................65

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IV
 1 Safety Guide

This chapter provides important safety information related to the

use of Digital Intraoral X-ray Imaging System.

1.1 Intended Use

This system is used together with a computer and a dental X-

ray machine for converting X-ray signals into digital signals.

The system is intended for dental radiographic examination and

diagnosis of diseases of the teeth, jaw, and oral structures. The
system is to be operated and used by dentists and other qualified
professionals.

The system is intended to be used in hospitals and clinics by

trained personnel under the direction of doctors.

Contraindication：Children and pregnant women should be used

with caution.

1.2 System Components

The system consists of sensor, USB cable, holder, image acquisition

workstation and its accessories (U Disk).

Image acquisition workstation is the software of Digital Intraoral X-

ray Imaging System (IOFC, Version 1.0.0).

The Computer system (including the monitor) are optional accessory, which
should conform to the standards of IEC60601-1 or IEC60950.

Sensor of the device is a type BF applied part.

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1.3 Operating

Conditions Environmental

Conditions

Ambient temperature：5℃～40℃

Relative humidity：30%RH~ 80%RH

Atmospheric pressure：700hPa～1060hPa
Power Conditions

Input power：DC 5V，500mA

PC operating platform CPU：

Intel CPU，≥2.0GHz

RAM：≥2G

Hard disk : ≥500G, (Expand the storage space according to the

specific situation.)

Monitor：1280X1024 resolution, Aspect ratio: 4:3

Operating system: Window7, Window8, Window10,

Window XP USB2.0 interface

1.4 Warnings and Notes

For the safe and effective use of this system, and to avoid the
possibility of system failure, we shall be familiar with the Windows
operating methods first, carefully read this User Manual, and
guarantee to be familiar with the IOFC software and the correct
method of operation. We need to pay special attention to the
following

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warnings and notes in the operation process.

Notes:

 This system is not suitable for home use.

 The pictures and windows in this manual are for reference only.

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1.4.1 Safety Warnings

Warnings

1. Failure to operate the instrument and the system in accordance

with the safety instructions may endanger patient safety. The
manufacturer shall not assume compensation liability for any
damage caused by improper use.

2. The system should be installed by a qualified service engineer.

Do not turn on the power until all cables have been properly
installed and confirmed.

3. Before using this system, users should receive professional

training and read this Manual carefully.

4. This system is not used for treatment.

5. This system is not applied to the households.

6. The diagnosis and examination functions of this system should

be combined with the clinical study of the patient. The diagnosis
results are for reference only by the doctor.

7. EXPLOSION HAZARD - This device cannot be used in a

mixture of flammable anesthesia and air or oxygen or nitrous
oxide.

8. This system has no water proof devices. Do not use this

system in a place where water may enter the device.

9. Do not spill any liquid on this system or allow it to flow into

this system, otherwise there will be a risk of electric shock.

10. Do not spray detergent on the instrument. Prevent the cleanser

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from entering the instrument and thus damage the electronic
components, and avoid organic solvents to form combustible
gases or to damage the internal components.

11. Once the instrument fails, immediately turn off the device and
contact Fussen or an authorized representative.

12. Connect this device and the device used in the patient
environment must meet the requirements of IEC 60601-1.

13. When more than one medical device is connected to the

patient, consider the sum of the leakage current of all devices.
Please be careful to use.

14. Risk of electric shock - Do not use wet hands to plug the
power supply. Make sure that the hand that touches the power
cord is clean and dry.

15. Do not touch patients and accessible parts of non-medical

electrical equipment at the same time.

16. Any non-medical equipment (such as an external printer) is

not allowed to be used within 1.5m / 6ft of the patient.

17. Do not move the main components during operation.

18. Only accessories provided and recommended by the

manufacturer can be connected to the system.

19. Pay attention to and guard against electrostatic discharge

(ESD) and electromagnetic interference (EMI) with other
instruments.

20. Use of instruments such as electrosurgical devices, MRI

equipment, etc. under a very strong EMI source might have a
negative impact.

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1.4.2 Caution

Caution

1. Before use, users must check whether the cables and sensor
have damages that might affect patient safety or instrument
performance. The recommended inspection period is once a
week or less. If any significant damage is found, it is
recommended to replace the damaged components before use.

2. If the system’s power cord is missing, damaged, or not

available, select an alternative power cable which meets the
original specifications and your local codes.

3. For environmental protection, the device and fittings shall be

disposed of in accordance with local regulatory requirements or
returned to the manufacturer for recycling or appropriate disposal.

4. Select a power cable with proper rating to minimize risk.

5. There are no user-serviceable parts in this system. All repairs

must be done by Fussen’s service personnel.

1.4.3 Notes

Notes

In order to avoid damaging the system, do not use it in the following

environments:

1. locations with direct sunlight;

2. environment with drastic temperature changes;

3. dusty environment;

4. locations near the heat sources;

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5. more humid environment.

1.5 Network Security Instructions

Digital Intraoral X-ray Imaging System software can run in a

variety of Windows systems. Its security software is Tencent
computer butler. After the device is connected to the computer
USB interface, the system can use USB communication protocol
to control the device for oral data acquisition. Data can be
exported through usb flash disk, mobile hard disk and other
external storage devices.

Remote control is not allowed in this system.

1.6 Mark and Label Symbols

Graphical
Description
symbols
Serial number

Date of manufacture

Authorized representative in the European

Community/ European Union

Manufacturer

Electrical:
WEEE (Waste of Electrical and Electronic
Equipment) Marking. Separate treatment
from general waste at end of life.

CE Mark

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 This way up.

Stacking limit by number

Fragile, handle with care.

Keep dry

Temperature limit

Humidity limitation

Atmospheric pressure limitation

Unique device identifier

CLASS II equipment

TYPE BF APPLIED PART

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P/N Part number

Refer to instruction manual/ booklet.

Recyclable

Protection level of digital intraoral X-ray

imaging system against water and
particulate matter

Direct current

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 2 Overview

2.1 Overview

USB acquisition card

Sensor

Figure 2-1 Overview

2.2 Installation and connection

1. Install IOFC software on the computer:

1) Copy the calibrate template 'defect_ 1000x1500.dft' and
'gain_ 1000x1500.gn' which you can get from USB Disk
coming together with sensor. Shows as below.
Open USB disk of Fussen, and open Detector folder:

Copy 'defect_ 1000x1500.dft' and 'gain_ _1000x1500.gn’:

2) Open 'Fussen' folder (In IOFC software installation

directory), then open 'IOFC' folder, open 'work_ dir' folder,
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 open 'Pluto0001X' folder, open 'Correct' folder, open
'Default', and finally paste 'defect_ 1000x1500.dft' and 'gain_
1000x1 500.gn' here.
3) Can start IOFC software for use now.

2. Connect the USB acquisition card to the computer, and put

the cable in order to avoid unnecessary contact which may
damage the sensor.

3. Install the sensor holder on the wall in a shield room. Put the
sensor in the holder when not in use.

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 Figure 2-2 Holder

2.3 Computer and monitor

Put the computer and monitor on the operation zone or nearby

so that they are within the dentist's sight when he is on the chair.

For the visualization of X-ray image, try to choose high

performance monitor. Avoid placing the monitor on a location with
direct or reflective light, or it may interrupt the reading of clinical
information.

Caution

 Poorly adjusted or poor-quality monitors may display images

wrongly, leading to misdiagnosis.

2.4 Sensor

The sensor is an X-ray sensitive device. It contains cables on

the back, but it won't affect the filming of the front side.

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The sensor needs to be used with a dental X-ray machine in
medical unit to obtain X-ray image of teeth, jaws and other
intraoral structures.

The sensor connects to the computer via USB2.0 interface.

Before it connects to the computer, the IOFC software needs not
to be started. The sensor can be pulled out when the computer is
powered on. But do not pull it out during image acquisition to
avoid damaging.

Warning

 Generally, the sensor is compatible with generators which

meet the intraoral X-ray standard. High voltage generators
which with normal or high frequency can be used, but it must
operate at 55 - 100KV.

 X-rays pours into the sensor from the head of the high
voltage generator which needs a device for support and to
makes itself steady to avoid motion blur caused by X-ray
source vibration.

 The sensor won't be compatible with high voltage

generators in lower specifications.

2.4.1 Sensor Preparation

To ensure safety and sanitation, the sensor must be used in

compatible with barrier envelopes. Every patient must be
provided with a new barrier envelope which is specially designed
for the sensor.

Caution

For the details about sanitation, please refer to Charpter4 "

Disinfection and Maintenance ".
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2.4.2 Image acquisition

To obtain a fine image via X-ray, the traditional radiology rules

should be obeyed. Put the sensor with a barrier envelop on into
the mouth to take X-ray photography. And it should be used in
compatible with dental X-ray machine to obtain images of root
canal, periodontal, decayed teeth, dental crown or wisdom teeth.

2.4.3 Sensor positioning

Put the sensor in the mouth in the same way no matter what kind
of positioning system is used.

Figure2-3 Sensor positioning

2.4.3.1Positioning the sensor for lower jaw image acquisition

To obtain lower jaw image via positioning sensor, please refer to

the following steps.

1. Have the patient retract his tongue to the back of his mouth,
insert the sensor and keep it stay horizontal.

2. Slowly rotate the sensor downward and place it in a vertical position.

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3. Slide the sensor so that its center faces the teeth that needs to
be X-rayed, and ask the patient to press his tongue against the
sensor's back. In order to frame the tooth root, do not hesitate to
press the oral mucosa. The patient then relaxes the tongue which
naturally attaches

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to the sensor.

For premola rand incisor, it is preferable to move the sensor

toward the middle of the mouth by pressing the tongue when the
oral muscle is relaxed. The sensor's rigidity with the positioning
system will be helpful for image acquisition.

2.4.3.2Positioning the sensor for upper jaw image acquisition

To obtain upper jaw image via positioning sensor, please refer to

the following steps.

1. Have the patient retract his tongue to the back of his mouth,
insert the sensor and keep it stay horizontal.

2. Rotate the sensor upward so that it is in a vertical direction or

parallels with the target teeth's long axis.

3. Slide the sensor so that its center faces the teeth which need to
be X-rayed. Place the sensor in oral central by utilizing the
palatine arch's arc.

2.4.3.3Positioning systems

The positioning principle of the sensor in oral cavity is the same

as that of the traditional radiography. For the sensor's rigidity,
patients may need a short adaptive phase. But this rigidity can
prevent distortion of the X-ray images.

Users could use different kinds of positioning systems for the

sensor. How to place the sensor is based on patient shape,
operator habits, and other needed information, not just on the
positioning system itself. The operator can change positioning
systems according to the external parameters, such as turning from
parallel projection technique to angular bisector projection
technique, or turning from using fingers to
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using Rinn positioning system.

Table2-2 Positioning examples

Examples Description

Molarsonupper jaw

The upper jaw's arc

is helpful to place
the sensor which
faces the root for
filming. It is better to
use stirrup
positioning system
for parallel projection
technique.
Incisors on upper
jaw

For angular bisector

projection technique,
the patient presses
the sensor against
the teeth with a
finger. For parallel
projection technique,
rotate the sensor so
that it moves away
from the teeth's
cutting edge and is
parallel to the long
axis of the tooth.
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 Incisorsonlowerjaw

Slide the sensor

backward so that it is
parallel to the long
axis of the tooth, and
slightly retract the
tongue. The sensor's
blunt edge can press
the bottom of the
mouth to fully face
the root.

2.4.4 Adjusting exposure time

For normal radio diagnosis, exposure time depends on the

following items.

The generator

The patient's condition

The teeth need to be exposed

It provides the exposure time guidelines of a common DC

generator(60kV,2mA) in Table2-3, and these are approximations. For
special generators, the exposure time needs to be adjusted
specially.

There are two basic rules for adjusting exposure time.

If the image is too dark, decline the exposure value.

If the image is too bright, increase the exposure value.

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 Table2-3 Exposure time of the sensor

High resolution
Acquisition mode
S(adult) S(child)

Incisor& canine 0.15-0.2 0.1-0.15

Premolar 0.2-0.35 0.15-0.25

Upper jaw molar 0.5-0.6 0.3-0.4

Lower jaw molar 0.4-0.5 0.15-0.3

Note
 The exposure time in table2-3 are the recommended time.
Operators can set it based on their own habit and
experience.

 The technique and exposure time are based on usual

conditions, representing the average adults and children.
The distance between the sensor and the generator's focus
is approximately 23cm. The exposure time varies,
depending on the patient and X-ray angle. The dose is
relatively increased in proportion to the square of the
distance.

 The time in the program is proportional to the square of the

distance. If the distance between the sensor and the
generator's focus increases, the dose needs to increase too.

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 3 Software Operation Guide

3.1 Software Overview

3.1.1 System operation conventions

The interactions between the system and the operator are

basically completed with mouse and keyboard. The main operation
conventions are shown in below tables.

Table3-1 Operation conventions on mouse

Operations by
Description
mouse

Single click on left mouse button to

Left single click select a button or icon. Click, release
or quickly click/release mouse button.

Right single click Single click on right mouse button

Single click on and hold left mouse

Drag button and then drag the cursor to the
target position.

Single click on and hold right mouse

Right single click
button and then drag the cursor to the
and drag
target position.

Double-click Two quick clicks on left mouse button

Conventions of related button operations on keyboard is given

below.

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Table3-2 Operation conventions on keyboard

Examples Description

The button is activated (in normal

Button is available
color) and click it to perform some
actions.
The button is deactivated (in gray
Button is
unavailable color), or click it to activate it.

Choose one or more options under a

check box.

Check button Choose one option under a radio

button. Choose a tab on a tab page.

Select part of or all texts in a text box.

Horizontal scroll bar Drag it horizontally with mouse.

Vertical scroll bar Drag it vertically with mouse.

Enter Press ENTER key on keyboard

Options with * are mandatory, and

Text box some options are selected
automatically and cannot be changed.

3.1.2 System Function Overview

The software IOFC consists of several modules, each of which

fulfills specific functions to perform examination process and
provide valid diagnostic image data.

Patient management: patient work list, patient registration, patient

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study list. It is mainly for patient information management.

Image acquisition: filming, marking tooth position, etc. It is mainly for

photographic examination.

Image Viewer: processing, display, layout, tools. It is mainly for

image viewing and processing.

Configuration: system management, inspection management, user

management, password changes. It is mainly for system configuration.

Main software features are as below.

Case management

Case management functions include patient information, check

information and image management.

DICOM3.0 standard Work list inquiry service make it available to

search and download clinical data from HIS/PACS.

Image acquisition

Digital photography.

Set sensor parameters.

Restart sensor-driven.

Real-time automatic window width/ level adjustment.

Real-time edge enhancement.

Select and rotate images based on different gesture.

Display patient information, examination information, device

information and image information.

Real-time indication of number of images which can be stored.

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Image processing

Window width /level adjustment

Positive and negative film conversion, image scaling, horizontal shift,

mirroring, rotation, zoom-in display.

Select original display, full screen display and histogram display of

target area; window width/level adjustment.

Image annotation, including orientation and text.

Image output

DICOM3.0 standard archiving service will archive images to the

server and support automatic transfer in background.

Image backup function allows images to backup on CD/DVD, and

the backup compact disk allows automatic slide show of images
on embedded browser.

Image export function allows to export patient examination to the

specified location, supports DCM, DCMDIR, JPG and BMP,and
supports standard formats and compression formats.

3.2 Basic examination operation

This part mainly describes how to implement the examination of a

patient with the computer. Before basic examination operation,
make sure the sensor is connected to the computer, which has
already installed the IOFC.

The computer is the main part of the digital oral X-ray imaging
system to interact with users.

The computer can:

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 Log in to the system.

Register locally to add a new patient, and edit existing

information.

Load the sensor driver and wait for the sensor to be

ready. Exposure to obtain X-ray images.

Browse images, delete, save or export.

Close an examination after finishing shooting all images for

it. Select a destination to export images.

Get the work list from HIS.

Modify information for the patient whose images have been

acquired.

3.2.1 Start Up and Login to System

Start up and login to system with the following procedures.

1. Power on and login to the computer.

2. Start and login to IOFC.

Start IOFC (which can be set to start automatically in system), and

a login dialog box will pop up during start-up, as shown below.

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Enter correct user name and password on the login window, and
click OK to log in, or click Cancel to exit. (If you don't know the
login password, consult your system administrator.) The factory
default user name and password is "admin".

Note:

 When being entered, the password will not be displayed as

characters.

 The password is case sensitive. For password modification,

refer to related system management settings.

After successful login, the home screen of IOFC will be displayed

as shown below.

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3.2.2 Patient Registration

After successful login, the home screen will display. Before image
acquisition, related patient and examination information must be
confirmed. In registration window, the information in examination
list comes from local registration.

3.2.2.1Registration

There are three accesses to registration screen: clicking

on registration screen, clicking at lower left corner of

Work list screen, or clicking at lower left corner of Study list

screen.

The patient registration window is as below.

Patient information can be input to the columns on patient

registration screen, including examination ID, patient ID, name,
gender, age, examination type, physician's name, etc.

Click to start image acquisition. Refer to "3.2.3 Image

Acquisition" for more details.

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3.2.2.2Quick Search

Registered patients who did not complete the examination will list

on Work list screen, allowing operations such as

update study information, delete study, start study.

Search for a patient: Search for a registered patient by index.

The user can enter a patient ID or name in search area of Work

list screen or Study list screen, and then click to

search for the examination data within a certain time.

Accurate and fuzzy search are available.

For accurate search, the user can enter full patient ID or name in

the text box, and then press Enter or click . The system will
list the target patient which meets the search conditions.

3.2.3 Image Acquisition

There are three accesses to image acquisition screen: clicking

on Work list screen, clicking on Registration screen or

clicking on Study list screen.

Select the patient on Work list screen, and click to enter

image acquisition screen.

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Select tooth template (Permanent or Deciduous), and select the
position of teeth to be photographed.

Click START to start acquisition. There will be 30s to wait for X-

rays and the countdown will show on the screen.

When the status bar displays "Ready to acquire image, please

expose", press the high voltage generator's remote to produce X-
rays. The sensor will generate an image and pass it to the
computer once it received X-rays.

Click to store the image and complete the examination.

Caution

Wait until the sensor is stable to start filming.

Warning

It is must to take proper precautions and strictly follow the

operating procedures during filming, otherwise the X-ray system may
cause harm to the patient and the operator.

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3.2.4 Logout and Turn off

Computer Logout

Tip: When some examination is currently pending, it is better not

to log out to avoid losing data. Before log out, the user should
ensure all examinations are closed.

Click in the home screen of IOFC to display user login

window, and then click OK to exit IOFC or log in with another
user's identity. To login to the system with a new user, the IOFC
has to be restarted.

Caution

The computer should be shut down every day to ensure a

complete system reset process, or the system performance may
go down.

Shut down computer

Please shut down the computer in the following sequence.

1. Select Close in Start menu to display close window.

2. Select the option of closing computer

3. The computer stores data and shut down.

Please follow the steps above to turn off the computer, for
incorrect operation may led to data loss.

3.3 Examination Management

This section mainly manages the patient's examination, mainly

including the information management of the patient information
registration, the work list, the study list, etc.

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3.3.1 Work list

Click on home screen to enter the Work list. The

registered but not yet checked lists are listed in this column.
These patients to be checked include the patients registered in
the worklist as well as the locally and rapidly registered patients
who have not yet been checked.

List information

The list included the information of the patients to be checked:

patient ID, name, gender, age, date of birth, check type,
description, etc. The check information can be configured for
display, and can be configured according to the hospital
requirements. Click , a dialog box will pop up for
configuring.

30
In the configuration dialog box, the optional field bar contains the
patient information fields that can be added for display, while the
selected field bar contains the currently added patient information
fields. It is likely to configure the patient information via the ">, <,
>>,
<<". Furthermore, the alignment in the list includes "Align left,
Align center, Align right", which can be sorted by clicking the Up
and Down buttons according to the sequence displayed in the
selected field bar. After configuration, click OK for success
verification, or click Cancel to give up the configuration.

Refresh work list

Click to refresh Work list based on the conditions as

specified. Users can use Worklist service to acquire any
registered patient work list.

Note:

Worklist can be refreshed automatically based on settings. Refer

to instructions on system management for more details.

Patient display and searching on Work list

Examination management provides search function based on certain

31
conditions. Users can specify search condition in search column
and then click to refresh the list of search results displayed.

Search conditions include registration date/time, patient ID, and

name. Available search condition of registration date includes
"Today, 2 days, 3 days, 1week" and "customized". After specifying
search conditions, click to perform search, and any
patient who meets the conditions will display in Work list.

Delete items on Work list

Select a patient on Work list and click to pop up a

deletion confirmation box. Click OK to delete the selected patient
record or click Cancel to cancel deletion.

Note:

Once a record is deleted, it cannot be recovered!

Start examination

Select a patient from Work list, and double click on it or single click
to enter image acquisition screen for filming.

Modify examination information

32
Click at the lower left corner of Work list screen to enter
information modification screen.

When the modification is done, click OK to save it or click Cancel

to exit.

3.3.2 Registration

Click on the home screen or click at the lower

left corner of Work list screen or Study list screen to enter local
patient registration window.

33
Enter patient information in corresponding columns of Register
screen, including accession, patient ID, name, gender, height,
weight, date of birth, examination description, doctor, diagnosis
description, etc. When entering the date of birth, the system will
automatically calculate the age and display it.

Tips: Items with * are required. Ensure the patient name and ID
are input correctly. Every patient has a unique ID. Incorrect input
will cause duplicate records and make it difficult for information
search. For convenience and uniqueness, system will automatically
generate patient ID. The patient ID can be changed manually by
users, but it is recommended not to change.

For any wrong information, users can correct or revise it, or click

to delete it. When the wrong information are removed, enter

correct information and click to start image acquisition.
Refer to "3.2.3 Image acquisition" for more details.

3.3.3 Study list

Management and operations on Study list are similar to what's on

Work list. Click on the home screen to access Study
list where all patients who has been registered and examined are
listed.

34
Study list contains two parts. The left side is the patient list. The
right side is the examination list.

List information

The list includes patient information, including patient ID, name,

gender, age, height, weight, date of birth, accession, body part,
description, number of images, archive, printing tag, etc. These
information can be configured based on hospital's requirements.
Click to pop up a dialog box for configuration.

The patient list configuration window is shown below.

35
The examination list configuration window is shown below.

In the configuration dialog box, the optional field bar contains the
patient information fields that can be added for display, while the
selected field bar contains the currently added patient information
fields. It is likely to configure the patient information via the ">, <,
>>,
<<". Furthermore, the alignment in the list includes "Align left,
Align center, Align right", which can be sorted by clicking the Up
and Down buttons according to the sequence displayed in the
selected field bar. After configuration, click OK for success
verification, or click Cancel to give up the configuration.

Patient display and searching on Study list

Examination management provides search function based on certain

conditions. Users can specify search condition in search column
and then click to refresh the list of search results displayed.

Search conditions include registration date/time, patient ID, and

name. Available search condition of registration date includes
"Today, 2 days, 3 days, 1week" and "customized". After specifying
36
search conditions,

37
click to perform search, and any patient who meets the
conditions will display in Work list.

Note: If patient ID, accession and name are empty, the

condition will be unrestricted.

Delete items on Study list

Select a patient from Studylist and then click to pop up a

deletion confirmation box.

If it is select from patient list, the dialog box is as below.

If it is selected from the examination list, the dialog box is shown

as below.

Click OK to delete the record, or click Cancel to give up the deletion.

Browse image

Select an examination from examination list, and then double click it or

38
Single click to enter image viewer screen.

Supplement examinations

Select a patient in Study list and click to enter image

acquisition screen for supplementing examinations without
registration.

Modify images

To modify an acquired image for its window width and window

level, tooth position and tag, etc., click to enter image
viewer for modification.

Archive images

To archive acquired images, click to pop up a dialog box,

and then choose a configured server and click Send.

Burn/Export

Click , a burning dialog box pops up as shown below.

39
Related burning options are provided at the upper part of the
window. Data in standard format or compressed format are
available.

Select Create ISO to create an ISO data file at specified location

for burning.

If burning function is available in PC, select Burn Disc and then

insert a blank compact disk to CD driver for burning.

Related data exporting options are provided at the lower part of

the window. Available formats included: DICOM,DICOMDIR, BMP
and JPG.

First click ... to specify a location for export, and then select an
export format, at last click Export.

In case of DCMDR format, the file will be stored in a folder named after
Volume Label under the target folder.

In case of DCMIMG/BMP/JPG format, the file will be stored in a folder

named after Patient ID/Name under the target folder.

Tips: If patient list is chosen currenly, all patient images selected

will be burnt or exported. If examination list is choose currenly,
40
only images

41
related to the examination selected will be burnt or expoted.

3. 4 Image Acquisition.

This part mainly introduces the operations and cautions of

image operation.

Select a patient on Work list or register a patient on Register

screen, click to start image acquisition.

For patients who have done examination before and need

reexamination, click on Study list to start image

acquisition without reenter the patient's information.

Image acquisition screen shows as below.

3.4.1 Acquisition preparation

Cover the sensor with a barrier envelop, and then insert it in the
patient's mouth, place it in the corresponding place and use a
positioning system.

Power on the X-ray machine and set well exposure

parameters. Note: please refer to Section 2.4 for details.

42
3.4.2 Acquisition procedure

1. Select a tooth template (permanent or deciduous), and

select a tooth position.

2. Click Start and wait for the explosion notification on status bar.

3. Exposure: press high-pressure remote button and release

after the first alarm, which means x-ray generation, while a
second time rang is on behalf of the end of the x-ray. If not
ring twice, check the pressure and the remote control.

4. After exposure ends, image display area (right side) will

display the image you have just taken.

5. To continue shooting, repeat step 1-2.

6. Click to complete the examination.

Caution

Wait until the sensor is stable to start filming.

Warning

It is must to take proper precautions and strictly follow the

operating procedures during filming, otherwise the X-ray system may
cause harm to the patient and the operator.

3.5 Image Browsing

This part mainly introduces methods and operations of image

browsing.

Double click records on study list or single click on Study

list screen to enter image browsing screen.

43
Image browsing screen has two functions: image browsing and
image editing.

3.5.1 Image Browsing

To enter image browsing screen, click on Study list screen

or double click an examined item. Image browsing screen displays
a patient's all acquired images in a course of treatment. The
images display on the corresponding position on tooth template.
When in image browsing screens, the image's window width and
window length, tooth position and tags can be modified.

Below is an image browsing screen.

It displays from the upper figure that the upper jaw's incisors were
all get examined. Select one examined tooth position and click
on the image to show all the images of the tooth. The images
will display reverse chronological order for clear contrast.

44
Tooth position template

Click to display or hide tooth position template.

Modify tooth position

Select an image and click to display tooth position

template. Select the tooth position you want to mark in the
template and click OK, the image's tooth position is modified
successfully.

Layout switch

45
Click to pop up layout window, move the mouse to select
the desired layout, and press the left mouse button to achieve the
layout switching.

In non 1x1 layout, double click on the image to maximize it, and
double click it to restore it.

Import image

Select a tooth position on the template, click Start, click to

import an existing image in DICOM format.

Page turning

If the images cannot be showed in a page layout, click

and to turn the page.

Save images as BMP/JPG

Click to save the image, which supports BMP, JPG and DCM.

46
Save the current image

Click to save the current image.

Save study

Click to complete image save and record refresh, and

return to study list.

Toolbar

Toolbar buttons can operate and manage the image.

Delete the current image.

ROI transfer window, press the left mouse button to

convert into ROI window width/level adjustment functions.

The default window width and window level.

Histogram W/L, click it to pop up histogram w/l window.

47
 Fit size

Text labels, click it and the left mouse button convert to

text label，click in the image area to display the text input box.

90 degrees clockwise

90 degrees

anticlockwise Flip
vertical

Flip horizontal

Restoration

Angle measurement

Distance measurement

Delete the current tools, including labels, angle,

distance, cutting boxes, etc.

Display or hint patient information, including label,

angle, distance, etc.

48
 Gray pseudo-color

ROI magnifier

Point gray
valu
e

Image display adjustment, click it to pop up image

adjustment screen.

Advanced processing, reprocess images if you are

not satisfied with current treatment (original image should exit).

49
 Anti-color

Zoom in

Zoom

out Real
size

Click it to adjust window width and window

level. Clip tool, click it to clip the image.

Invalid

Zoom in or out

Move
3.5.2 Image editing

Most operations in image editing are the same as what in image

browsing. But during image editing, it could update examined
images on patient information and replace with another patient's
information.

Click in Study list screen to enter image editing screen.

50
Update examination information

Click to pop up information update dialogue box.

If it needs to replace the study,switch to the Replace screen and

select a record in study list to replace.

On image editing screen, select an examined image and click

to show all the images of the teeth.

51
3.6 Configuration Management

This section mainly describes the system configuration management

and related control functions.

System management main menu provides several system control and

management functions, including:

System management

Statistics

Study

Use

Password

Most operations are described in detail below.

Note: Different user permissions have different system

management operations. Administrator-level users can perform
system management functions of all the permissions while
granted user depending on their privileges level.

Click on the status bar to enter management options.

52
3.5.1 System management

Click to enter system management window, including

the machine configuration, working list, storage configuration,
remote configuration, IO information, IO tools and service
settings.

Local settings

1> System parameters

It includes Modality, Work mode and Store Directory.

Store Directory: Specify the patient examination image path on the

local computer storage space.

Machine parameters

Hospital Name: The current system hospital name, which will be

stored in the DICOM attributes of the image.

53
Hosp abbr: as a local registration number prefix, such as hospital
prefix HS, and it automatically generated number is DXxxxxxxx
registration form, such as in below figure.

Device name: corresponding DICOM standard of this device's ATTitle,

used to identify the device.

IPAddress: The IP address of the

device. Delay time: network connection

time.

Record time: it check the records to identify locally saved time and
after this time it will automatically clean up.

Minimum space: When the system detects the storage space is

less than this threshold, it then began to organize hard disk
space, delete the earlier inspection information.

Log level

The level of details of the recording process, detail level followed

by normal mode, common mode, a detailed model and full model.

Other

Language: Support switch between Chinese and English.

Type: The default check type (IO).

CharacterSet: Character set in the system has been

used. Virtual Keyboard: Enable/ disable the virtual

keyboard. Work list

54
When RIS through Work list service requires registration and
Work list server in this configuration parameters, refer to the
relevant knowledge about Work list Dicom standard.

Device Name: Work list Server DICOM AETitle.

IP Address: Worklist server IP.

Port number: Worklist Server service port number.

Modality: whether the type of filter inspection.

Device Name: whether AETitle consistency identified.

Auto Refresh: whether Worklist refresh automatically, eliminating

the need to manually refresh each time.

Character Set: WorkList server character set.

Storage Configuration

55
When archiving, PACS server in this configuration parameters are
stored on DICOM knowledge which can refer to DICOM standard.

Device Name: PACS server's DICOM AETitle.

IP Address: PACS server IP.

Port number: PACS server service port number.

Syntax: DICOM transfer syntax is stored.

Send Mode: After collecting images, click Save Dicom whether automatic
archiving, eliminating the need to manually archive each.

The system can be configured 2 Dicom storage servers

simultaneously. IO information

IO information is for the four corners of the image display overlay

information.

Choose one corner, such as the upper left corner, and then select
the comment which was never configured and needs to be
displayed, click Add to add it to the angular position, or select a
comment from the angle configuration information and click
remove to remove it. Information also can be moved up and

56
down at each corner. The

57
information displayed can be configured by

the: Hospital name

Patient name

Patient ID

Patientage

Body Part Examined

Study date

Study time

Series date

Series time

Patient sex

Patient size

Patient weight

Patient birthday

Exam number

Series number

Image number

Manufacturer

Modality

Accession Number

Study Instance

UID
58
Series Instance UID

SOP Instance UID

Acquisition date

Acquisition time

Diagnoses Description

Study Description

Series Description

Referrings Physicians Name

Performing Physicians Name

Read Study Physicians Name

IO Tools

Tools in toolbar can be configured in this screen: the buttons

selected will show on left in image view screen.

Click button Up or Down to adjust index of the chosen button.

59
3.5.2 Statistics

Click to enter Statistics window. Set related dates and click

to display the sensor's total exposure times in these dates. Click >
OK to delete history records. Once the record is deleted, it cannot be
recovered.

3.5.3 User

Click User to enter user management window and set the information.

A user with administrator permissions may manage other users

including users to add, modify, license rights and other control.

3.5.4 Password

Click Password to enter password window to modify password.

60
 4 Disinfection and Maintenance

4.1 Sensor disinfection and Sanitation

Please refer to "2.4.1 Sensor Preparation" to ensure safety and

sanitary.

Note

1. The provided sensor is not disinfected.

2. Disinfect the sensor and keep it clean in accordance with the

following guidelines:

It is recommended to use barrier envelopes dedicated for sensor

with CE mark according to 93/42/EEC. Biological compatibility of the
barrier envelope shall be in compliance with ISO 10993, and each
patient must be provided with a new barrier envelope.

For environmental protection, any used barrier envelope must be

recycled or disposed properly.

When selecting a disinfecting product, check the product list in

the manufacturer's manual.

Once been used, the barrier envelop must be discarded, and the
sensor must be thoroughly disinfected.

If the barrier envelope has been damaged during the oral

examination, or when the sensor is polluted when the barrier
envelope is removed, the sensor must be thoroughly disinfected
as described below:

- Prepare disinfectant according to the manufacturer’s product

instructions, and there shall be no bleach and ethyl alcohol in the
61
solution;

- Do not use abrasives to clean the sensors or cables;

- Only use the cold disinfection products authorized by the

local dental regulatory authorities.

When using sterilized products, please refer to the safety

precautions recommended by the manufacturer.

If the cables are not mechanically damaged, they can be soaked

in a disinfectant solution. If mechanical damage is found, contact
Fussen's technical support department for consulting.

Use a disinfecting towel to clean the sensor and several

centimeters of the cable before use. Wipe the sensor's surface
with a sterile solution and keep it away from the ground at all
times.

Recommended disinfectants：

WIP'ANIOS Premium(ANIOS Laboratories) To clean the

sensor and cable, use disinfecting wipes approved for

use in accordance with the established procedure or

medical alcohol .

SEKUSID-N (Ecolab Paragerm

Laboratories)

SEKUSEPT Easy (Ecolab ParagermLaboratories)

FD333 (DURR Dental Laboratories)

FD332 (DURR Dental Laboratories)

Caution
62
1. Do not put the sensor into a high-pressure sterilizer, otherwise it
will damage the instrument.

63
2. Do not immerse the sensor and the USB interface in the liquid.

Note

Part of the USB cable can be immersed into disinfectant for

sterilization, but do not immerse the sensor in the liquid.

4.2 Cleanness of cables

Carefully clean cables with a disinfecting towel.

To clean the cable, hold the sensor with one hand and wipe it with
the other. Wipe from the end of the sensor for 9 feet, and do not
pull the insulation of the cable. Slide with disinfecting towels
without applying force. The pressure from the fingers to the cable
must be minimal.

4.3 Storage of the sensor

It is strongly recommended that the sensor be stored in the

packing box or hung on the holder after use every day to avoid
falling down or coming into contact with decontamination products
when cleaning the office.

4.4 Maintenance of the

sensor Warning

1. Refer to below guidelines to prevent sensor from damage.

2. To maintain the sensor's life, please follow the below steps.

Do not place the sensor in a sterilizer or autoclave.

Do not pull cable, even during replacing a barrier

envelop. Do not crush or pedal cable.

Do not drop the sensor.

64
 Do not ask the patient to bite on the sensor or cable.

Do not disconnect the sensor within 90 seconds during

asynchronous mode or acquisition.

Do not apply force, bend or pull cable at one end of the

sensor. Do not immense the sensor in water.

4.5 Electrostatic discharge prevention

To prevent electrostatic discharge, please follow the following steps.

When the sensor is not connected, store the sensor in the packing
case.

Do not touch the display screen and sensor at the same time, or
the sensor will be seriously damaged.

Do not touch the contact point of the USB connector on the sensor.

4.6 Computer Data Protection

The database must be backed up to any reusable high-capacity

storage medium, such as magnetic tape, ZIP disk, DAT digital
audiotape.

Store any copy of data at safe location in accordance with

computer supplier's recommendation.

65
 5 Care and Maintenance

Users should be familiar with all the operating methods of this

system. Please read this Manual carefully. Do not use this system
until you understand the entire operation process.

Digital Intraoral X-ray Imaging System only requires simple

maintenance during operation. However, only correct operations
can ensure that this system is able to operate in a steady state for
a long time. Therefore, you must comply fully with the precautions
and maintenance items provided by the manufacturer.

Warnings

Turn off the power supply before cleaning.

Caution

Avoid to spray liquid on the device during cleaning.

5.1 Maintenance of the device

1) Keep the main unit and monitor clean. The box of the sensor
can be cleaned with a soft wet cloth and only use a small amount
of water to prevent liquids from seeping into the device. If
necessary, use a mild cleaning agent, but carefully remove all the
residue.

2) The main unit and monitor shall be placed at a dry location with
good ventilation and not exposed to thick dust or humidity. Air
duct cooling system shall be kept well-ventilated.

66
 6 Accessories

Warning

Only use the accessories provided by the manufacturer, otherwise

there will be no guarantee of performance.

Table 6-1 Standard Accessory List

Accessory Quantity

F100(Size#1)/F100(Size#2) 1 pcs

Holder 1 pcs

Barrier Envelope 10 pcs

USB Drive 1 pcs

Table 6-2 Optional Accessory List

Accessory Quantity

Computer 1 pcs

Digital Intraoral X-ray Imaging System and its accessories can be

purchased from the manufacturer or local dealers.

67
 7 After-sales Service

7.1 After-sales Service

Fussen guarantees that all products meet the label specifications

on the products, and that there are no defects in materials and
technologies during the warranty period. The warranty period
refers to 2 years after the products arrive at the dealer.

Warranty will not be provided in case of the following circumstances:

a) damages due to transportation;
b) damages caused by improper use and maintenance;
c) any damage caused by modification or repair conducted by
the personnel un- authorized by Fussen;

d) accidental damages;
e) replace or remove the product serial number label or
the manufacturer’s label.

f) Scratches on the sensor surface.

7.2 Contact Information

If you have any questions about maintenance, technical

specifications or instrument failure, please contact your dealer or
Fussen’s After-sales Service Department.

E-mail: info@fussengroup.com

Production and after-sales service address: 2F, Building #B,

Haomai Furniture Industry Zone, Pingshan District, Shenzhen,
China, 518118

68
 Appendix 1 Specifications

Product Classification

Standard type of protection against

electric shock Class II anti-electric shock device

Standard degree of protection

against electric shock Type BF application part

Degree of protection against the

liquid IP68

Operating mode Continuous operation

Product Specifications

size#1: 25.03 x 38.53 x 4.5 mm (±0.1)

Sensor dimensions
size#2: 31.62x45x4.5mm(±0.1)

size#1: 20mmx30mm
Effective imaging area
size#2: 26mmx35mm

size#1:1000 x 1500
Maximum pixel matrix
size#2:1300×1800

Pixel size size#1/size#2: 20 um

Environmental Requirements

Temperature range

Operation +5°C ~ +40°C

Shipping & storage -20℃ ~ + 55℃

69
 Humidity range

Operation 30%~80%

Shipping & storage ≤93% (non-condensing)

Atmospheric pressure range

Operation 700hPa ~ 1060hPa

Shipping & storage 700hPa ~ 1060hPa

Performance Parameters

Size#1/Size#2:
Limited:25 lp/mm （Theoretical data）
Spatial resolution Typical:>18lp/mm（Real data）

Artifact None

70
 Appendix 2 Troubleshooting

When you encounter problems with image, please refer to the

below troubleshooting table. If the problem persists, or it is not
included in the following content, please contact Fussen after-
sales service department for technical support.

Below are some troubleshooting and solutions for

users. Table A-1 Troubleshooting and

solutions

Description Corrective Action

Check high voltage generator

Check the connection between the sensor's

After triggering the USB 2.0 and the computer.
X-ray, no image is
Check if the power supply in the center is
displayed.
normal.

Contact the dealer.

The exposure time is too short, increase the

exposure time.

The selected acquisition mode does not

The image is dull correspond to X-ray dose.
and textured. Check the high voltage generator to see if its
voltage is too low (less than 60kV).

The high voltage generator is too far away

from the patient to match the chosen dose.

71
 Check the contrast and brightness settings
on the display to make sure there are no
problems with the screen display.

The exposure time is too long, shorten the

exposure time.

The selected acquisition mode does not

The image is too
correspond to X-ray dose.
dark.
Check the contrast and brightness settings
on the display to make sure there are no
problems with the screen display.

The patient moves during exposure.

The image is fuzzy. The head of the generator is

unstable. Use an image filter.

The working surface of the sensor is not

oriented in the X-ray direction.

The X-ray dose is not enough.

The image is white. The sensor is not connected or improperly

connected.

The high voltage generator shall be checked

by qualified professionals to ensure that it
emits X-rays.

72
 Appendix 3 Manufacturer Information

Manufacturer: Fussen Technology Co., Ltd.

Manufacturer address: 3F, Building #B, Minlida Industrial Building,

Zone 4, Honghualing Industrial Zone, 1189 Liuxian Avenue,
Pingshan Community, Taoyuan Street, Nanshan District, 518055
Shenzhen, Guangdong, PEOPLE'S REPUBLIC OF CHINA

Product Name: Digital Intraoral X-ray Imaging System

Product Models: F100(Size#1)/F100(Size#2)

Production Date: See the label for details

Product Life Cycle: 5 years

73
 Appendix 4 EMC declaration

Instructions for use

The Digital Intraoral X-ray Imaging System,model F100(Size#1)/

F100(Size#2) is suitable for home healthcare environments and
so on.

Warning ： Don’t near active HF surgical equipment and the RF

shielded room of an ME system for magnetic resonance imaging,
where the intensity of EM disturbances is high.

Warning ： Use of this equipment adjacent to or stacked with

other equipment should be avoided because it could result in
improper operation. If such use is necessary, this equipment and
the other equipment should be observed to verify that they are
operating normally.

Warning: Use of accessories, transducers and cables other than

those specified or provided by the manufacturer of this equipment
could result in increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in improper
operation.”

Warning ： Portable RF communications equipment (including

peripherals such as antenna cables and external antennas)
should be used no closer than 30 cm (12 inches) to any part of
the Digital Intraoral X-ray Imaging System,
Model:F100(Size#1)/F100(Size#2),
including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.

74
If any：a list of all cables and maximum lengths of cables (if applicable),
transducers and other ACCESSORIES that are replaceable by the
RESPONSIBLE ORGANIZATION and that are likely to affect
compliance
of the ME EQUIPMENT or ME SYSTEM with the requirements of Clause
7(EMISSIONS) and Clause 8 (IMMUNITY). ACCESSORIES may be
specified either generically (e.g. shielded cable, load impedance)
or specifically (e.g. by MANUFACTURER and EQUIPMENT OR
TYPE REFERENCE).

If any：the performance of the ME EQUIPMENT or ME SYSTEM that

was determined to be ESSENTIAL PERFORMANCE and a
description of what the OPERATOR can expect if the ESSENTIAL
PERFORMANCE is lost or degraded due to EM DISTURBANCES (the
defined term “ESSENTIAL PERFORMANCE” need not be used).

Technical description

1. All necessary instructions for maintaining BASIC SAFETY and

ESSENTIAL PERFORMANCE with regard to electromagnetic
disturbances for the excepted service life.
2. Guidance and manufacturer’s declaration -electromagnetic
emissions and Immunity
Table 1

Guidance and manufacturer’s declaration -

electromagnetic emissions

Emissions test Compliance

RF emissions Group 1

CISPR 11

75
RF emissions Class B

CISPR 11

Harmonic emissions Not application

IEC 61000-3-2

Voltage fluctuations/ Not application

flicker emissions

IEC 61000-3-3

Table 2

Guidance and manufacturer’s declaration -

electromagnetic Immunity

Immunity Test IEC 60601-1-2 Compliance

level
Test level

Electrostatic discharge ±8 kV contact ±8 kV contact

(ESD)
±2 kV, ±4 kV, ±8 kV, ±15 ±2 kV, ±4 kV,
kV
IEC 61000-4-2 ±8 kV, ±15 kV
air
air

Electrical fast Power supply lines：±2 Not

kV

76
transient/burst input/output lines：±1 kV application

IEC 61000-4-4

Surge line(s) to line(s)：±1 kV. Not

application
IEC 61000-4-5 line(s) to earth：±2 kV.

100 kHz repetition

frequency

Voltage dips, short 0% 0.5 cycle Not

application
interruptions and
At 0º, 45 º, 90 º, 135 º,
voltage variations on 180
power supply input º, 225 º, 270 º and 315 º
lines
0% 1 cycle
IEC 61000-4-11
And

70% 25/30 cycles

Single phase: at 0

0% 300 cycle
Power frequency 30 A/m 30 A/m
magnetic field
50Hz/60Hz 50Hz/60Hz
IEC 61000-4-8

Conduced RF 150KHz to 80MHz： Not

application

77
IEC61000-4-6 3Vrms

6Vrms (in ISM and

amateur radiobands)

80% Am at 1kHz

Radiated RF 10 V/m 10 V/m

IEC61000-4-3 80 MHz – 2,7 GHz 80 MHz – 2,7

GHz
80 % AMat 1 kHz
80 % AM at 1
kHz

NOTE UT is the a.c. mains voltage prior to application of the test

level.

78
Table 3

Guidance and manufacturer’s declaration - electromagnetic Immunity

Radiated RF Test Band Service Modulation Modu Distan IMMU

lation ce NITY
IEC61000-4-3 Frequ (MHz)
(W)
ency (m) TEST
(Test
LEVEL
specifications (MHz)
for (V/m)
ENCLOSURE
PORT 385 380 TETRA 400 Pulse 1,8 0.3 27
IMMUNITY to –390
modulation
RF wireless
18 Hz
communicati
ons
equipment) 450 380 GMRS 460, FM 2 0.3 28
–390
FRS 460 ± 5 kHz
deviation

1 kHzsine

710 704 – LTE Band 13, Pulse 0,2 0.3 9

787
17 modulation
745
217 Hz
780

810 800 – GSM 800/900, Pulse 2 0.3 28

960
TETRA 800, modulation
870
iDEN 820, 18 Hz
930
CDMA 850,

LTE Band 5

1720 1 700 GSM 1800; Pulse 2 0.3 28

–
CDMA 1900; modulation
1845

79
1970 1 990 GSM 1900; 217 Hz

DECT;

LTE Band 1, 3,

4, 25; UMTS

2450 2 400 Bluetooth, Pulse 2 0.3 28

–
WLAN, modulation
2 570
802.11 b/g/n, 217 Hz

RFID 2450,

LTE Band 7

5240 5 100 WLAN 802.11 Pulse 0,2 0.3 9

–
5500 a/n modulation
5 800
217 Hz
5785

80
Shanghai International Holding Corp.
GmbH (Europe)
Eiffestrasse 80, 20537 Hamburg Germany

Fussen Technology Co., Ltd.

3F, Building #B, Minlida Industrial

Building, Zone 4, Honghualing Industrial
Zone, 1189 Liuxian Avenue, Pingshan
Community, Taoyuan Street, Nanshan
District, 518055 Shenzhen, Guangdong,
PEOPLE’S REPUBLIC OF CHINA
E-mail: info@fussengroup.com

Web: www.fussengroup.com