Dental X-Ray Unit Operation manual

Manufacturer Declaration

We appreciate you kindly select our dental X-ray unit very much. Please read the operation
manual carefully before using the unit so that you could learn all the details about technical
specification, installation, operating methods maintenance and the transportation.

The preparation of this manual according with GB/T14436-93 <The general industrial
product guarantee files>, GB/T9969-2008 <industrial product specification conditions> and
other relevant standards, our company has the instruction of non-public publishing copyright,
any person or company shall not to copy or translated into another language the whole or any
section of this manual without the written consent of our company.

After-sales service responsibility

Our company only responsible for the performance and reliability of the instrument under the
following circumstances:

 Assembly, debug and repair personnel authorized by our company.

 Related electrical equipments according with national standards.
 Using the device according to the operation manual.

! Note：This device is not treatment device.

Warning：This device need to be use by trained

! professional or medical institutions.

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 Dental X-Ray Unit Operation manual

CONTENTS

I. Safety guidelines………………………………………………………3
II. Product main structure and performance…………………………8
III. Application…………………………………………………………… 8
IV. Product performance…………………………………………………8
V. Device identification…………………………………………………10
VI. The main structure …………………………………………………11
VII. Installation And Debugging…………………………………………12
VIII. Method of using………………………………………………………16
IX. Principle introduction…………………………………………… 19
X. Failure and maintenance……………………………………………19
XI. Attention matters…………………………………………………… 20
XII. Maintenance……………………………………………………………21
XIII. Effective occupied areas ………………………………………… 22
XIV. Packing list……………………………………………………………23
XV. Electrical schematic diagram………………………………………24

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 Dental X-Ray Unit Operation manual

I. Safety guidelines

1. Before working and testing, you must according with the safety instruction:
Please make sure the machine connect with the power correct,
check the equipment work carefully;
Please make sure equipment connect the ground correct;
Please make sure the power supply.
2. In addition, you also must according with the requirements of national special provisions
(for example: Occupational Safety and Accident Prevention Regulations).
Note: During using process, you should make the distance
! from the focus to skin as long as possible.

3. The equipment placement and storage place should be paid attention to the following:
Please do not use and save in inflammable and explosive places;
Please do not use and save in pressure, temperature, humidity,
over the allowed scope environment;
Please do not use and save in the water place;
Please avoid slope instability, vibration and impact (including handling);
Please note that the frequency of the AC power source and allow current
and voltage;
Keep well ventilated, avoid direct sunlight.
4. Equipment installation
You must according with the technical data to finish all installation tasks.
When finished the installation and before turn on the equipment, you must be sure
all the protective grounding line which the manufacturer provided linked normally.

In order to take clearly dental x-rays films and not disturb other
! electrical equipment using, please link the wiring from the electric
meter separately for dental X-ray machine, and the single wire
diameter > 1mm² ( like air conditioning wiring ).
5. Equipment maintenance
Because the equipment include the users operation and diagnosing patients, therefore
must be maintained, checked, diagnosed equipment maintenance every year,
mechanical transmission parts must be clean, lubrication and maintenance regularly,
ensure the equipment safety. And this equipment involved in high voltage electrical
control components, should check the safety of its insulation, grounding device reliability.

6. Products warning statement explain (oblique arm) :

Warning: Before finished the installation and removal the tube head,
you must push the balance arm to the toppest place, to avoid
the arm up and hurt person.
Explanation: Because the oblique arm elastic strongly, to prevent injury to people,
please accordance with the warning of the instructions in strictly, if make any
accidents caused by incorrect operation, we will not take any responsibility.

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7. The Symbol Instruction

NO. SYMBOL INSTRUCTION NO. SYMBOL INSTRUCTION

May cause an electric shock, damage of high Fragile with care

1 voltage components or debugging test points 7

2 Turn on the switch will produce radioactive rays. 8 Up

3 ! Caution 9 6 Stacking layer limit

4 Power off 10 Dryness

5 Power on 11 B Type

6 Protective earth

8. Electromagnetic compatibility

8.1 It may cause electromagnetic interference to other devices by air or by connecting cables.
EMC refers to the ability of the device to suppress the electromagnetic interference of
other devices without causing similar electromagnetic interference to other devices.
The product design according
with YY0505-2012 class 1, type A standard.
8.2 Guidelines and manufacturer statements
Comply with the following EMC electromagnetic compatibility radiation and
electromagnetic immunity declaration. see table 1, table 2.

Table 1 Electromagnetic emission

Guide and manufacturers declaration—Electromagnetic emission

Dental X-ray machine is expected using in the following provisions of the electromagnetic environment, buyers or
users shall ensure that using it in the electromagnetic environment.

Emission test Conformity Electromagnetic environment, guide

Dental X-ray machine in order to finish its expected function

RF emission
Class 1 must launch electromagnetic energy. Nearby electronic
GB 4824
equipment may be affected.

RF emission Dental X-ray machine is suitable for the household or not

Type A
GB 4824 residential low-voltage supply network of public and not all the
facilities used in the direct connection.
Harmonic emission
Inapplicability
GB 17625.1

Voltage fluctuation/launch
Inapplicability
GB 17625.2

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Table 2 Electromagnetic immunity

Guide and manufacturers declaration—Electromagnetic immunity

Dental X-ray machine is expected using in the following provisions of the electromagnetic environment, buyers
or users shall ensure that using in the electromagnetic environment.

Immunity test IEC 60601 Electrical level According Electromagnetic immunity—Guide

with level
Electrostatic ±6kV Contact discharge ±6kV The ground should be wood, concrete or
discharge ±8kV Air discharge ±8kV ceramic tile, if the ground covered with
GB/T 17626.2 synthetic material, the relative humidity
should be at least 30%.
Electrical transient ±2kV For the power cord ±2kV Network power supply should have a
bursts ±1kV For the input/output ±1kV typical commercial or the quality of
GB/T 17626.4 line medical environment.

Surge ±1kV Wire to wire ±1kV Network power supply should have a
GB/T 17626.5 ±2kV Wire to ground ±2kV typical commercial or the quality of
medical environment.

The power input line < 5%UT for 0.5 cycles <5%UT Network power supply should have a
voltage sag and (up the UT, > 95% sag) typical commercial or the quality of
short supply 40%UT for 5 cycles (up medical environment. If dental X-ray
interruption and the UT, 60% sag) 40%UT machine user needs to run continuously
voltage change 70% UT, for 25 cycles during power outage, then recommend the
GB/T 17626.11 (up the UT, 30% sag) 70%UT dental X-ray machine adopts
< 5%UT for 5 seconds uninterruptible power supply or batteries.
(up the UT, > 95% sag) <5%UT

Power frequency 3A/m 3A/m Power frequency magnetic field should

magnetic field have in a typical commercial or hospital
（50/60Hz） environment level of power frequency
GB/T 17626.8 magnetic field characteristics of the typical
place.
Note：UT Refers to the communication network voltage before applying test voltage.

Installation must notice:

Install the equipment as far away from other electrical equipment as possible.
Adjust the position between this equipment and other equipment/ installation
Angle could reduce electromagnetic interference.
Changing other equipment wiring position can be reduce the
electromagnetic interference.
Changing other equipment power path can be reduce the electromagnetic interference.
Specified electromagnetic compatibility environment see table 3 and table 4.

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Table 3 Electromagnetic immunity

Guide and manufacturers declaration—Electromagnetic immunity

Dental X-ray machine is expected using in the following provisions of the electromagnetic environment, buyers
or users shall ensure that using in the electromagnetic environment.
Immunity IEC 60601 Electrical level According Electromagnetic immunity—Guide
test with level
Using portable and mobile radio frequency
communication equipment close to any part of the
dental X-ray machine should not more than
recommended separation distance, including the
3V（effective value） 3V cables. The distance by the transmitter frequency
The radio
150 kHz ～ 80 MHz （ effective and the corresponding formula
frequency value） The recommended separation distance
150 kHz ～ d=1.2 p (see table 4)
transmission
80 MHz d=1.2 p 80MHz～800MHz
GB/T
17626.6 d=2.3 p 800MHz～2.5GHz

In the formula：
The radio 3V/m 3V/m
80 MHz ～ 2.5 GHz 80 MHz ～ P——According to the manufacturer provide
frequency the transmitter maximum rated power
2.5 GHz
output, unit is watts(W);
radiation d——The recommended separation distance,
GB/T the unit is meter(M).
17626.3 Fixed type strength of the transmitter based on
electromagnetic surveya to determine,
each frequency rangeb should be less
than the level.
May appear interference near the following
mark symbol of the equipment

Note I： In the frequency of 80 MHZ and 800 MHZ, using the formula of high frequency.
Note II： These guides may not be suitable for all situation, electromagnetic propagation by buildings, objects,
and the effect of absorption and reflection of the body.
a. Stationary transmitter, such as: wireless (cellular/cordless) phones and ground mobile radio station, amateur
radio, AM and FM radio and television broadcasting, etc., the field intensity in theory can predict. For the
evaluation of fixed RF transmitter electromagnetic environment, electromagnetic site survey should be taken into
account. If measured dental X-ray machine field strength is higher than the place of the above applicable radio
frequency (RF) in line with the level, the dental X-ray machine should be observed to verify their works. If the
observed abnormal performance, the supplementary measures may be required, such as to readjust direction or
location of dental X-ray machine.
b. Through 150 KHZ ~ 80 MHZ frequency range, the field strength should be lower than 3 V/m.

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Table 4 The recommended separation distance between portable

and mobile radio communication equipment or system

The recommended separation distance between portable and mobile radio communication equipment and the
dental x-ray machine
Dental X-ray machine is using expected in the radiofrequency radiation harassment controlled
electromagnetic environment. Communications equipment based on maximum rated power output, the purchaser
or the user can through the following recommended by maintaining a portable and mobile radio communication
equipment (transmitter) and the minimum distance between dental X-ray machine to prevent electromagnetic
interference.
The maximum Corresponding to different frequency transmitter isolation distance
rated power output M
of the transmitter 150 kHz ～ 80 MHz 80MHz～800MHz 800MHz～2.5GHz
w d=1.2 p d=1.2 p d=2.3 p
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
To the table not listed transmitter maximum rated power output and recommended isolation distance is d,
unit meters (M), determine by the available transmitter frequency corresponding column, here P is provided by
the manufacturers transmitter maximum rated output power, unit watts (W).
Note I： In the frequency of 80 MHZ and 800 MHZ, using the formula of high frequency.
Note II ： These guides may not be suitable for all situation, electromagnetic propagation by buildings,
objects, and the effect of absorption and reflection of the body.
Notice:
The product cable as the following table:

NO. Name Length(m) Shielding or no

1 Power cable 3 no

2 Connected cable 2.8 no

The product installation and using shall ensure the above electromagnetic compatibility
environment to make sure equipment operation normally.
Do not use this equipment near the strong radiation source , otherwise may interfere
with the equipment normal work.
Please purchase and use the equipment accessories and cables sold by the manufacturer,
otherwise it may increase the equipment or system launch or the reduce the immunity result.
Should not be close to or stacked with other devices, if it must be close or stacked,
it should be observed to be able to work normally in the configuration.
In the case of electromagnetic interference, it should be capable of achieving its basic
performance. Its basic performance includes:
--The normal work of each part and various preset parameters do not change randomly.
--The operation mode of the equipment is not changed randomly, no error alarm reported.

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II Product main structure and performance

[Link] working principle
High voltage generator provide high voltage on both ends of the X-ray tube filament and a metal
target, X ray tube cathode filament produced a large number of electrons in a vacuum tube
high-speed movement, hit the metal target, to produce x-rays.
In hospital when using dental X-ray take image, X-ray generator emit x-rays through the body teeth, muscle groups
such as density, will be through the body's tissues with image information of X rays by dental medical film image
receiver, show the density of different tooth tissue images, used for clinical diagnosis.
2. Product main structure
Dental X-ray machine consist by x ray tube head, console, frame, it is the fixed X-ray machine.
[Link] performance：
Tube voltage：60/70kVp
Tube current：8mA
Exposure time：0.01s～9.99s. Step number according to the priority of R '10 series.
4．Device Type
According to the protection of the risk of electric shock, this equipment belong to class
I type B applied part.

III Application

1. The scope of application: dental X-ray machine get the human oral cavity image by x ray
photography used for medical imaging diagnosis.
2. The scope of using: Need trained oral dentists or technician to use. For adults and children's
Diagnosis.

IV Product performance
1．Conditions of operation:
1.1 Atmospheric pressure: 70Kpa~106Kpa
1.2 Environmental temperature:+10℃～+40℃
1.3 Relative humidity:30%～75%
2．Condition of transportation and store:
2.1 Environmental temperature: -40℃～+70℃
2.2 Relative humidity:10%～100%
2.3 Atmospheric pressure:50KPa～106KPa
3．Power supply： Voltage: Single phase AC 220V±22V;50/60Hz±1Hz
Power capacity:＞1.1kVA Power resistance:＜2Ω

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 Dental X-Ray Unit Operation manual

4. Specifications：
4.1 Tube voltage：60/70kVp
4.2 Tube current：8mA
4.3 Power: 0.339kW
4.4 Earth Leakage Current
Normal state：≤0.5 mA Single failure state≤1 mA
4.5 The way of running: Break load; continuous operation
4.6 Loading time: 0.01～9.99s,follows R’10 series
4.7 X-ray glass:
Modle：XD2-1.4/85 stationary anode tube
manufacturer：Hangzhou Wandong Electrical Co., Ltd.
Focus Fuse nominal Anode
value Current voltage V Working anode input thermal
Normal Target
A frequenc power capacity
voltage KV angle
y kW （KJ）
HZ

85 1.5 12° 2.5 2.8±0.7 50～60 1.4 9

4.8 X-ray source components

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 Dental X-Ray Unit Operation manual

4.8.1 Maximum continuous heat dissipation: 170 W

4.8.2 Maximum heat capacity: 12700 HU
4.8.3 Angle of X-ray tube anode target face shaft of the benchmark: 12 °
4.8.4 The tolerance of focus position to the shaft of the benchmark ≤1 mm.
4.8.5 X-ray source components total filtration: ≥2.5 mmAl
Non-removable material 0.5mmAl, Detachable material 2mmAl
4.8.6 X-ray source components weight: 7.5 kg
4.8.7 High voltage transformer
High voltage transformer: 1:226
Nominal power: 339 W
4.8.8 The largest wild: 3.14 x 262 (mm2)
4.8.9 Leak radiation: < 0.25 mGy/h (conditions for 60 kV, 8 mA)
4.8.10 Around vertical axis rotation: 360 °
4.8.11 Around horizontal axis corner: 270 °
4.8.12 X-ray source components adjustable range: 700 mm
4.9 The distance from focus to skin: 210mm
4.10 Activity arm horizontal turning angle : ≥±40°
4.11 Activities arm up-down range: ≥400 mm
4.12 Current: 5 A
4.13 Insurance tube type: RF1-20-10A 250 V, 10A

4.14 Weight: 30 Kg
4.15 Service life：6 years

V Device Identification

[Link] Label： 2. X ray tube component label:

DENTAL X-RAY UNIT

DENTAL HN-08 X-RAY TUBE PART
Model:JYF-10B
X-RAY TUBE: XD2-1.4/85
Classification :IEC Class I B type CLASSIFY:CLASS I,TYPE B
Input:220± 22V 50/60Hz P≤0.9kVA single-phase FOCUS SIZE:1.5mm
power resistance<2Ω TOTAL FILTRATION: ≥2.0mmAL
Output:60/70Kvp 8mA 4Sec Input power:500VA RUN:INTERVAL LOAD CONTINUOUS RUN
The way of operation:
INPUT:SINGLE-PHASE:220± 22V 50/60Hz
break load,continuous operation
OUTPUT(MAX):60/70kV 8mA
SN: Date: 2460
SN: Date:

VI The main structure

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