Maxray DX3000 User Manual
USER Manual
TABLE OF CONTENTS
1 DX-3000 ..................................................................... 5
1.1 INTRODUCTION ...................................................................................... 5
1.2 S
1.3 LABEL AND MARKING SYMBOLS ................................................................. 7
1.4 D
YMBOLS USED IN THIS MANUAL .............................................................. 6
EVICE LABELING .................................................................................... 8
2 WARNINGS AND INSTRUCTIONS ....................... 9
2.1 SYMBOLS AND DETAILS ............................................................................. 9
2.2
2.2.1 Warnings for product use .................................................................................. 9
2.2.2 Warnings for battery use ................................................................................. 10
2.2.3 Warning for product inspection ....................................................................... 10
2.3 WARNINGS FOR STORAGE ....................................................................... 10
WARNINGS FOR USE ................................................................................ 9
3 CAUTION AND INSTRUCTIONS ........................ 12
3.1 SYMBOLS AND DETAILS .......................................................................... 12
3.2 C
3.2.1 Caution for product storage ........................................................................... 12
3.2.2 Caution for product use .................................................................................. 12
3.3 CAUTION OF OTHER MATTERS ................................................................. 13
AUTION AND INSTRUCTIONS ................................................................. 12
4 ITEMS TO CHECK ................................................. 14
4.1 SYMBOL AND DETAIL ............................................................................ 14
4.2 I
TEMS TO CHECK .................................................................................. 14
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5 PRODUCT FEATURES ........................................... 15
5.1 OUTLINE ............................................................................................. 15
PRODUCT FEATURES .............................................................................. 15
5.2
5.2.1 Features ........................................................................................................... 15
5.3 PRODUCT SPECIFICATIONS ...................................................................... 16
5.3.1 Device main body ........................................................................................... 16
5.3.2 Battery Pack ..................................................................................................... 16
5.3.3 Battery pack charging adapter ........................................................................ 17
5.3.4 Battery charging cradle ................................................................................... 17
6 PRODUCT COMPOSITION .................................. 18
6.1 OUTLINE ............................................................................................. 18
PRODUCT COMPOSITION ........................................................................ 18
6.2
PRODUCT EXPLANATION ........................................................................ 20
6.3
6.3.1 Main body name ............................................................................................. 20
6.3.2 UI screen composition and functions ............................................................. 21
6.3.3
6.3.4
Buttons and functions ..................................................................................... 24
Battery pack and charging devices ................................................................. 26
7 HOW TO USE ........................................................ 29
7.1 POWER ON/OFF .................................................................................. 29
7.2 X-ray EXPOSURE POSITIONING .............................................................. 30
7.2.1 Patient’s positioning ........................................................................................ 30
7.2.2 Film or intraoral sensor positioning ................................................................ 31
7.2.3 DX-3000 positioning ......................................................................................... 32
7.3 X-ray EXPOSURE ................................................................................ 32
7.3.1 X-ray exposure sequence .............................................................................. 32
7.3.2
Setting X-ray Exposure time ......................................................................... 34
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7.4 ENVIRONMENT SETUP ............................................................................ 35
7.4.1 Environment setup screen ............................................................................... 35
7.4.2 Environment setup list .................................................................................... 36
7.5 FUNCTION SETUP .................................................................................. 38
7.5.1 Function setup screen ..................................................................................... 38
7.5.2 Function setup list ........................................................................................... 38
7.6 WIRED REMOTE CONTROLLER ................................................................. 41
7.6.1 Wired remote controller usage ....................................................................... 41
7.7 BATTERY ............................................................................................. 42
7.7.1 Mounting battery inside Main body ............................................................... 42
7.7.2 Battery level and charging .............................................................................. 43
8 MAINTENANCE AND STORAGE ....................... 47
8.1 MAINTENANCE AND STORAGE ................................................................ 47
8.2
8.2.1 Check for Product storage .............................................................................. 48
8.2.2 Charging adaptor and cradle storage ............................................................ 48
STORAGE ............................................................................................ 48
8.3 PRODUCT TRANSPORT, STORAGE CONDITIONS AND CONDITIONS OF USE ........48
8.3.1 Transportation and storage conditions .......................................................... 48
Optimal conditions of use ............................................................................... 49
8.3.2
8.4 ITEMS TO CHECK ................................................................................... 49
8.4.1 Frequent inspection items ............................................................................... 49
Periodic inspection items ................................................................................ 49
8.4.2
9 INSPECTION ITEMS BEFORE REPAIR ................50
9.1 CHECK ITEMS BEFORE REQUESTING INSPECTION .......................................... 50
TROUBLESHOOTING ............................................................................... 52
9.2
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10 PRODUCT SPECIFICATION AND QUALITY
ASSURANCE ................................................................ 53
10.1 PRODUCT SPECIFICATION ....................................................................... 53
10.2 Q
UALITY ASSURANCE ............................................................................ 54
11 DX-3000 TECHNICAL DOCUMENT ..................... 55
11.1 HIGH VOLTAGE GENERATOR .................................................................... 55
11.1.1 X-ray Tube : Toshiba D-081B ......................................................................... 55
11.2 ELECTROMAGNETIC COMPATIBILITY .......................................................... 57
11.3 R
ADIATION PROTECTION ........................................................................ 58
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MANUAL VERSION 3.0
Revision date: May/2014
USER Manual
1 DX-3000
1.1 Introduction
Thank you for purchasing the portable X-ray system from Iridium Dental. The
DX-3000 has been developed to not only take radiographs in an analog fashion using
conventional film, but also to be used in Dental Digital Radiography (DDR) using a digital
sensor. Please familiarize yourself with this manual and the X-ray unit prior to use.
Follow all product-use instructions while using the product.
PRODUCT USAGE
This product is a medical device, and it should only be used as a digital X-
ray radiography device for X-ray radiography in the proper facility.
WARNING
This X-ray unit may be dangerous to the patient and operator unless
safeexposure factors and operating protocol are observed.
TYPE B Applied Part
A "Type B Applied Part" provides the lowest degree of patient
protection and is not suitable for direct cardiac application.
CAUTION
For proper usage and safety purposes, please ensure that only legally
qualified personnel (Doctor, Medical Treatment Radiological Technologist,
Medical Treatment X-ray Technologist) may use this product after it
has been fully familiarized by the contents of this user manual.
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1.2 Symbols used in this Manual
SYMBOL NAME DETAIL
Radiation
warning
Warning
Caution
Check
The “Radiation Warning” sign explains details
about possible radiation hazards and the potential
for injury or death with improper use.
The "Warning" sign explains details about improper
use which may cause physical damage to the product.
The "Caution" sign explains details about
improper use which may cause bodily harm to
the user.
The "Check" sign explains instructions that users
must follow for product installation, operation, and
maintenance.
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1.3 Lables and markings: Symbols
SYMBOL NAME DESCRIPTION / FUNCTION
Electrical protection
Radiation warning
Warning
Consult
accompanying
documents
Manufacturer
information
Manufacture date
Serial number
Insulated patient application (Type B).
This symbol indicates radiation hazards.
This symbol indicates general hazards.
This symbol advises the reader to consult the
accompanying documents.
This symbol is followed by the name and
address of the device manufacturer.
This symbol is followed by the device
manufacture date in the form YYYY-MM.
This symbol is followed by the device serial
number.
Representatives
information
Separate collection
for electrical and
electronic equipment
This symbol shows manufacturer’s
EU representative information.
Indicates the need for separate collection of
electrical and electronic equipment in
compliance with the Waste Electrical and
Electronic Equipment (WEEE) Directive. This
symbol indicates that electrical and electronic
equipment wastes must not be disposed as
unsorted municipal waste and must be collected
separately. Please contact the manufacturer or
an authorized disposal company to
decommission your equipment according to
local regulations
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1.4 Device labeling
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2 Warnings and instructions
2.1 Symbols and details
The "Warning" sign explains details about improper use which may cause
physical damage to the product.
2.2 Warnings for use
2.2.1 Warnings for product use
Ensure that the radiation exposure limit required for image diagnosis is not exceeded.
If radiation exposure safety regulations and operation-related guidelines are not
followed during use of this product, both patient and operator may be at risk.
Only legally qualified personnel are permitted to operate this device.
Use this device only for its designated purpose.
If any abnormalities are found with the patient while using the device, stop using the
device immediately and ensure patient safety.
Do not make any modifications to the device.
If you suspect any product malfunctions (such as oil leakage) while using the product,
turn off the power immediately and contact the closest customer support center.
Make sure a fire extinguisher is on-site in case of a fire emergency.
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2.2.2 Warnings for battery use
Use only the provided designated battery!
Do not expose the battery to strong electrical currents, and keep it away from sharp
objects.
If the battery is kept under high temperature, it may explode.
Do not let the battery become wet or be kept in damp conditions.
Store batteries in a locked cabinet.
Do not allow the battery terminals to come into contact with any metallic substance or
surface.
2.2.3 Caution for product inspection
Do not touch the product, charger, or power plug with wet hands. Doing so may
cause an electric shock.
During the cleaning process of the product, do not use wet-wipe cloths or
spraying products. Only clean the product once the battery has been removed.
2.3 Warnings for storage
Moisture, salinity, dust, etc. can affect the performance of the device. Do not store
the device in places with such conditions.
Do not store the product in direct sunlight or places with frequent temperature changes
for long periods of time. Under these conditions, the voltage generator's
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cooling and insulating oil could shrink, swell, freeze, or overheat, causing critical
damage to device functions.
Do not store product with explosive gas or chemicals.
Do not leave the battery pack connected to the charger during storage. When the
battery is used or charged for too long, it may shorten battery lifespan or increase the
danger of explosion.
The device must be stored in the protection case. If kept elsewhere, it may
cause critical damage to device functions.
Do not place the device on a high shelf where it may become a falling hazard.
Do not store the device in the trunk of a car or a cargo van where it may be move
freely and become damaged. If it must be transported by vehicle, be sure that it is
secured tightly.
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3 Caution and instructions
3.1 Symbols and details
The "Caution" sign explains details about improper use which may cause
bodily harm to the user.
3.2 Caution and instructions
3.2.1 Caution for product storage
Moisture, salinity, dust, etc. can affect the performance of device. Do not store the
device in places where such conditions may be present.
Do not store the product in direct sunlight or places with frequent temperature changes
for long periods of time.
Do not store the product with explosive gas or chemicals.
Do not leave the battery pack connected with the charger during storage.
3.2.2 Caution for product use
Please maintain regular temperature and moisture levels for normal operation.
During use or transportation of the device, please be careful to avoid severe shocks or
vibration.
Wear a protective lead apron or equivalent radiation protection gear during use.
Keep the product clean for proper usage.
Use care when disconnecting the battery pack cradle from the charger.
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3.3 Caution for other matters
In the event that the device breaks down, mark it as such and send it to
a designated professional at the A/S center.
Do not let patients touch the device. Do not leave it unsupervised.
If the device is dropped, turn it off and remove the battery. Return the unit to the
manufacturer for inspection.
For discarding the product:
This symbol indicates the need for separate collection of electrical
and electronic equipment in compliance with the Waste Electrical and
Electronic Equipment (WEEE) Directive. This symbol indicates that
electrical and electronic equipment wastes must not be disposed as
unsorted municipal waste and must be collected separately. Please
contact the manufacturer or an authorized disposal company to
decommission your equipment according to local regulations.
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4 Items to check
4.1 Symbol and Detail
The "Check" sign explains instructions that users must follow for product
installation, operation, and maintenance.
4.2 Items to Check
Check the condition of the device and battery pack before using. Confirm
the that the device is operating properly.
Check the part that makes direct contact with patients for any abnormalities.
Use the device only in the designated sequence.
Use the device in a stable environment with good ventilation.
Check the remaining battery power display. If the remaining battery power is not
sufficient, recharge the battery prior to use.
Use the battery-pack charger exclusively for this product when charging.
not let metallic products or other foreign substances touch the battery pack
Do
terminals. Keep it clean by using a dry cloth.
Ensure that the device and all of its parts are regularly inspected.
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5 Product Features
5.1 Outline
In Chapter 5, the features and specifications of this device are explained for safe usage.
5.2 Product Features
5.2.1 Features
> Medical Device Name: Portable X-ray System
> Model Name: DX-3000
> Display: 2.5” LCD (Resolution: 128 x 64)
- Adult and child mode
- Film and digital mode
- Remaining battery life
- Exposure time setup by
> Function for user
- Film and digital mode selection
- Maximum or Minimum exposure time setup
- Exposure time unit setup
part of the teeth
- Single wired remote controller operation and exposure selection button
- Automatic shutoff time-setup
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- Continuation of LCD backlight time setup
> Removable and rechargeable battery supply.
5.3 Product specifications
5.3.1 Device main body
> Device Name: Portable X-ray System
> Tube voltage: 65 kV (Fixed)
> Tube current: 2.5 mA (Fixed)
> X-ray tube focal spot size: 0.8 mm
> Power consumption: 285 VA
> Cooling method: OIL Cooling Method
> Total filtration: Over 1.5 mmAl (inherent: 0.8 mmAl, fixed type added filter: 0.7 mmAl)
> Target Angle: 20˚
> Time setting function: 0.02 – 2.5 sec. (Including film / digital mode)
> Exposure time unit setting function: 0.01 – 0.1 sec.
> Distance to target: Distance between target and Focal Spot > 20 cm (8 [inch])
> Main body size: 166(L) x 240(W) x 82(H) mm (except length of cone)
> Main body weight (exclusion battery): 2.2 kg
5.3.2 Battery Pack
Model name: PF435060HP-4S
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Cell material: Lithium Polymer
Charging conditions
- Charging current: 1.0 [A]
- Charging voltage: DC 16.8 [V]
- Temperature range: 0 – 40 [℃]
Usage conditions
- Maximum output current: 26 [A]
- Output voltage: DC 15 [V]
- Temperature range: -20 – 60 [℃]
5.3.3 Battery pack charging adapter
Model name: BPL910S16N01
Input voltage: AC 100 – 240[V], 50/60 [Hz], 0.5 [A]
Output voltage: DC 16.8[V]
Output current: 1.0 [A]
5.3.4 Battery charging cradle
Model name: D910
Charging voltage: DC 16.8 [V]
Charging current: 1.0 [A]
Discharging voltage (at the time of battery connection): varies depending on
discharging condition.
Discharging current (at the time of battery connection): varies depending on
discharging condition
Size: 77.5(L) x 72.3(W) x 49.3(H) [mm]
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