Dabi Atlante EAGLE User Manual
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USER’S MANUAL
THIS PAGE WAS INTENTIONALLY
LEFT BLANK
1
TABLE OF CONTENTS
1.
INTRODUCTION ................................................................................................................................ 5
2.
SYMBOLS ............................................................................................................................................ 6
3.
WARNINGS AND PRECAUTIONS .................................................................................................. 7
3.1.
WARNINGS AND/OR CAUTION DURING TRANSPORTATION AND STORAGE ................... 7
3.2.
TRANSPORTATION OR STORAGE ENVIRONMENTAL CONDITIONS ................................... 7
3.3.
INSTALLED EQUIPMENT CONDITIONS BETWEEN OPERATIONS ........................................ 7
3.4.
OPERATIONAL ENVIRONMENTAL CONDITIONS .................................................................... 8
3.5.
ADDITIONAL PROCEDURES PRIOR TO EQUIPMENT USE ...................................................... 8
3.6.
WARNINGS AND/OR CAUTION TO BE ADOPTED ..................................................................... 8
3.6.1.
WARNINGS AND/OR CAUTION DURING EQUIPMENT INSTALLATION ..................... 8
3.6.2.
WARNING AND/OR CAUTION DURING EQUIPMENT USE ............................................ 9
3.6.3.
WARNING AND/OR CAUTION AFTER EQUIPMENT USE/OPERATION ....................... 9
3.7.
CAUTION IN CASE OF ABNORMAL EQUIPMENT FUNCTION .............................................. 10
4.
EAGLE PANORAMIC X-RAY SYSTEM OVERVIEW ............................................................... 11
4.1.
DIGITAL SNAP-ON CONFIGURATION ...................................................................................... 11
4.2.
DIGITAL FIXED CONFIGURATION ............................................................................................ 12
4.3.
ANALOG CONFIGURATION ........................................................................................................ 13
4.1.
POWER SUPPLY UNIT OPTIONS ................................................................................................. 14
4.2.
FREE STANDING BASE (OPTIONAL) ......................................................................................... 14
4.3.
LIST OF ACCESSORIES ................................................................................................................ 15
5.
RECOMMENDED COMPUTER SYSTEM SPECIFICATIONS ................................................. 17
6.
COMPUTER SYSTEM CONFIGURATION .................................................................................. 17
6.1.
NETWORK ADAPTER CONFIGURATION .................................................................................. 17
6.2.
SOFTWARE INSTALLATION ....................................................................................................... 20
7.
IMAGING PROGRAMS ................................................................................................................... 24
7.1.
PANORAMIC PROFILES: .............................................................................................................. 24
7.2.
CEPHALOMETRIC PROFILES: .................................................................................................... 26
8.
CONTROL PANEL ........................................................................................................................... 27
8.1.
INTRODUCTION ............................................................................................................................ 27
8.2.
CONTROL PANEL KEYS .............................................................................................................. 28
8.3.
CONTROL PANEL INDICATING LIGHTS .................................................................................. 29
8.4.
REMOTE EXPOSURE SWITCH (OPTIONAL) ............................................................................. 29
8.5.
TURNING THE EQUIPMENT ON ................................................................................................. 30
8.6.
MAIN SCREEN ............................................................................................................................... 31
9.
PREPARING FOR THE EXPOSURE ............................................................................................. 35
9.1.
DIGITAL SNAP-ON SENSOR CONFIGURATION ...................................................................... 35
9.2.
DIGITAL FIXED SENSOR CONFIGURATION ............................................................................ 40
9.3.
BEFORE POSITIONING THE PATIENT ....................................................................................... 41
9.4.
GETTING THE SOFTWARE READY ............................................................................................ 41
10.
PANORAMIC EXPOSURES ............................................................................................................ 42
10.1.
GETTING THE SOFTWARE READY ........................................................................................ 43
10.2.
POSITIONING THE PATIENT ................................................................................................... 43
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10.3.
TAKING A PANORAMIC EXPOSURE ..................................................................................... 45
11.
CEPHALOMETRIC EXPOSURE ................................................................................................... 47
11.1.
GETTING THE SOFTWARE READY ........................................................................................ 47
11.2.
POSITIONING THE PATIENT ................................................................................................... 48
11.3.
TAKING A CEPHALOMETRIC EXPOSURE ............................................................................ 48
12.
PROCEDURES FOR REUSE ........................................................................................................... 50
12.1.
CLEANING .................................................................................................................................. 50
12.2.
DISINFECTION ........................................................................................................................... 50
13.
TROUBLESHOOTING GUIDE ....................................................................................................... 51
13.1.
UNIT OPERATION PROBLEM .................................................................................................. 51
13.2.
PATIENT POSITIONING PROBLEM
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....................................................................................... 52
14.
DISPOSAL OF THE UNIT ............................................................................................................... 58
14.1.
ENVIRONMENTAL CONTAMINATION ................................................................................. 58
15.
EQUIPMENT INSTALLATION, CORRECTIVE MAINTENANCE AND CALIBRATION. .. 59
15.1.
INSTALLATION OF THE EQUIPMENT ................................................................................... 59
15.2.
CORRECTIVE MAINTENANCE ............................................................................................... 59
15.3.
PREVENTIVE MAINTENANCE ................................................................................................ 59
15.4.
CALIBRATION ........................................................................................................................... 60
15.5.
NETWORK OF AUTHORIZED SERVICE TECHNICIANS ..................................................... 60
16.
TECHNICAL SPECIFICATIONS ................................................................................................... 60
16.1.
REGULATORY INFORMATION .............................................................................................. 60
16.2.
GENERAL INFORMATION ....................................................................................................... 61
16.3.
RADIOLOGICAL INFORMATION ........................................................................................... 61
16.4.
X-RAY GENERATOR ................................................................................................................. 62
16.5.
TESTED EQUIPMENT LAW NORM ......................................................................................... 62
16.6.
IRRADIATED FIELD SIZE DIGITAL PANORAMIC EXAM (PAN: ADULT AND CHILD –
TMJ – MAXILLARY SINUS) ..................................................................................................................... 67
16.7.
IRRADIATED FIELD SIZE – DIGITAL CEPH EXAM: ............................................................ 67
16.8.
TUBE SPECIFICATIONS ........................................................................................................... 68
16.9.
ELECTROMAGNETIC EMISSIONS ......................................................................................... 68
16.10.
16.11.
16.12.
ELECTROMAGNETIC IMMUNITY ...................................................................................... 69
CHARACTERISTIC COOLING OF THE X-RAY GENERATOR ......................................... 72
CHARACTERISTIC CURVES OF THE X-RAY TUBE. ........................................................ 73
17.
LABELS OF IDENTIFICATION ..................................................................................................... 74
17.1.
PACKAGE ................................................................................................................................... 74
17.2.
PRODUCT ................................................................................................................................... 75
18.
EQUIPMENT DIMENSIONS ........................................................................................................... 76
19.
WARRANTY ...................................................................................................................................... 77
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Attention
For greater safety:
Read and understand all instructions written in this manual before installation or use of the equipment.
This instruction manual should be read by all operators of the equipment.
This instruction manual was originally written in Portuguese.
Intended Use
Intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw and oral structures.
US FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY
OR ON THE ORDER OF A DENTIST OR PHYSICIAN.
CAUTION
Warning Statement
Only personnel authorized by Dabi Atlante are qualified to install and service this equipment. Any attempt to install or service this equipment by anyone not so authorized will void the warranty.
It is imperative that this equipment be installed, serviced, and used by personnel familiar with the precautions required to prevent excessive exposure to both primary and secondary radiation. This equipment features protective designs for limiting both the primary and secondary radiation produced by the X-ray beam. However, design features cannot prevent carelessness, negligence, or lack of knowledge.
Dabi Atlante requires anyone moving or transporting their machine to contact authorized service network Dabi Atlante.
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1. INTRODUCTION
The EAGLE Panoramic X-Ray Machine is a complete system for dental imaging capable of:
Analog Panoramic Profiles
Analog Cephalometric Profiles
Digital Panoramic Profiles
Digital Cephalometric Profiles
The digital machines use a CCD sensor with the traditional scintillator technologies and auto image processing that allow a speed up the diagnostic and improve the clinic workflow.
The equipment has three movement axes (two in orthogonal directions and one rotational) making it possible to execute elaborate imaging profiles.
It features a complex profile movement around the dental arch and radiographic emission compensation in the spinal region, when necessary reconstructing the dental arch into a plane image. Each individual profile prioritizes a set of characteristics improving diagnostic capabilities. For example, the standard panoramic prioritizes image layer width, constant vertical magnification and homogeneous exposure along the whole image.
Likewise, the low dosage profile prioritizes the reduction of dosage (time and anodic current).
The profiles can be applied to a variety of patients: adult or child; small, medium or large. The equipment has predefined exposure parameters depending on patient type.
However, the user can apply whatever is best for the situation.
The user interface is composed of a control panel located close to the patient chin rest and an exposure switch. A remote exposure switch installed outside the radiation room is optional. The exposure switch is a dead-man type switch.
Ease of patient positioning is complimented by the patient entry into the machine from the side .
There are three lasers available for positioning: Mid-Saggital plane,
Frankfurt Plane and Image Layer Plane (canine). These features make it possible for the user to precisely position the patient.
For patient comfort, a demonstration mode is also available making it possible to inform the patient of the procedure prior to exposure.
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2. SYMBOLS
Use the icons below to identify the symbols on your equipment.
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3. WARNINGS AND PRECAUTIONS
3.1. WARNINGS AND/OR CAUTION DURING TRANSPORTATION AND
STORAGE
The equipment must be transported and stored by observing the following:
Care should be taken to prevent falls and impact.
The arrows must be pointing upwards.
Do not stack
.
Protect against moisture, rainwater aspersion and wet ground.
Premature unpacking does not generate safety risks, but leads to the equipment warranty voidance.
This equipment must be unpacked and installed by an authorized technician.
3.2. TRANSPORTATION OR STORAGE ENVIRONMENTAL CONDITIONS
Environmental temperature range for transportation and storage
0ºC to +55ºC
(+32 F to 131 F)
3.3. INSTALLED EQUIPMENT CONDITIONS BETWEEN OPERATIONS
Storage ambient temperature range
Ambient temperature range recommended by manufacturer
+15 C a +30 C
(+59 F to 86 F)
Storage relative humidity range
+5 C to +45 C
(+41 F to 113 F)
30% to 75% (noncondensing)
Atmospheric pressure range 700 hPa to 1060 hPa
(525 mmHg to 795 mmHg)
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3.4. OPERATIONAL ENVIRONMENTAL CONDITIONS
Operation ambient temperature range
Ambient temperature range recommended
Operation relative humidity range
Atmospheric pressure range
+10 C to +35 C
(+50 F to 95 F)
+21 C a +26 C
(69.8 F to 78.8 F)
30% to 75%
(non condensing)
700 hPa to 1060 hPa
(525 mmHg to 795 mmHg)
3.5. ADDITIONAL PROCEDURES PRIOR TO EQUIPMENT USE
Even prior to its first use, the equipment must be cleaned and disinfected; the same additional procedures must be followed for reuse, as described in Chapter 11.
3.6. WARNINGS AND/OR CAUTION TO BE ADOPTED
3.6.1. WARNINGS AND/OR CAUTION DURING EQUIPMENT INSTALLATION
The equipment must be installed only by service technicians authorized by the manufacturer.
Place the equipment on a site where it will not be in contact with moisture or water.
Install the unit on a site where it will not be damaged by pressure, temperature, moisture, direct sunlight, dust or salts.
The equipment must not be submitted to inclination, excessive vibration or shock
(including during transportation and handling).
This equipment has not been designed for use in facilities where vapors, flammable anesthetic mixtures in contact with air, oxygen or nitrous oxide can be detected.
Check the equipment’s voltage when performing electric installation.
Failure to do so may damage the equipment.
The equipment must be properly grounded. Failure to do so may result in
“Safety Hazard”.
Depending on local regulation the X-Ray emission control may require installation outside the facility where the equipment is placed, and the operator may need visual contact with the patient through a window with radiological glass or similar, since the operator must not lose visual contact with the patient.
Mobile and portable RF communication equipment can affect the EAGLE
Panoramic X-Ray Machine.
This equipment must be solely used by health care professionals as it may cause radio interference or interrupt the operation of nearby equipment. Mitigatory measures, such as equipment re-orientation or replacement and the facility’s screening, may be necessary.
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3.6.2.WARNING AND/OR CAUTION DURING EQUIPMENT USE
The equipment must be operated only by qualified and trained professionals
(dentists, radiology technicians, hygienists or engineers).
Always observe the display messages, the equipment as a whole and the patient in order to detect any arising problems early.
In case occasional maintenance is required, use only services provided by
Authorized Service Technicians.
The equipment has been designed to withstand continual and intermittent operation; therefore, follow the cycles described in these operation instructions.
Since radiation exposure can cause damage to human cells, it is recommended that no one should remain in the radiographic examination
room, unless the patient requires restraint. In this case, such individual must be properly protected against X-Ray emission.
Although this equipment has been designed according to electromagnetic compatibility standards, it may, under very extreme conditions, interfere with other equipment. Do not use it with other devices that are sensitive to interference or with devices that create high electromagnetic disturbances.
ATTENTION
THE MANUFACTURER SHALL NOT BE LIABLE IN CASE:
THE X-RAY MACHINE IS USED FOR PURPOSES OTHER
THAN THOSE FOR WHICH IT HAS BEEN DESIGNED.
DAMAGE CAUSED TO THE EQUIPMENT, THE OPERATOR
AND/OR PATIENT AS A RESULT OF IMPROPER
INSTALLATION AND MAINTENANCE PROCEDURES IN
DISAGREEMENT WITH THE OPERATION INSTRUCTIONS
ACCOMPANYING THE EQUIPMENT.
IMPROPER EQUIPMENT OPERATION.
3.6.3. WARNING AND/OR CAUTION AFTER EQUIPMENT USE/OPERATION
Turn off the x-ray machine's master switch when it is not used for long periods of time.
Always keep the equipment clean for its next operation.
If the equipment is defective, do not try to fix it yourself, instead call for authorized technical assistance.
Do not replace any equipment parts. Do not disconnect the cable or other connections unnecessarily.
The EAGLE Panoramic X-Ray Machine must be off when other equipment such as an electric scalpel or other similar devices are being used.
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After using the equipment, clean and disinfect all parts that may have been in contact with the patient.
3.7. CAUTION IN CASE OF ABNORMAL EQUIPMENT FUNCTION
In case the equipment shows abnormal heating or noise or any other type of abnormality, check if the problem is related to any of the items listed in chapter 12. If the problem cannot be solved, turn off the equipment and call for Authorized Technical
Assistance. Use the website http://www.dabi.com.br or call Customer Service at telephone number: +55 (16) 3512-1212.
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4. EAGLE PANORAMIC X-RAY SYSTEM OVERVIEW
4.1. DIGITAL SNAP-ON CONFIGURATION
Moving
Mechanism
The following image shows the whole system with optional Ceph arm mounted.
Cephalostat Arm
Cephalostat (Optional)
Rotating Arm
X-Ray Tube
Head
Control Panel
Patient Handles
SNAP-ON Sensor
Head Support
SNAP-ON
Sensor Holder
Ear rods
Secondary
Collimator
Nose Support
Column
ATENTION
THE SECOND SENSOR IS OPTIONAL
Base (optional)
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4.2. DIGITAL FIXED CONFIGURATION
The following image shows the whole system. No optional ceph arm is available in this configuration.
Moving
Mechanism
Rotating Arm
X-Ray Tube
Head SNAP-ON Sensor
Head Support
Control Panel
Patient Handles Column
Base (optional)
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4.3. ANALOG CONFIGURATION
The following image shows the whole system with optional Ceph arm mounted.
Moving
Mechanism
Rotating Arm
Cephalostat Arm
Cephalostat (Optional)
X-Ray Tube
Head Film Holder
Head Support
Ear rods
Film
Holder
Nose Support
Control Panel
Patient Handles Column
Base (optional)
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4.1. POWER SUPPLY UNIT OPTIONS
The following image shows the Power Supply Unit options that can be used in all configurations.
Standard*
*Order on request
4.2. FREE STANDING BASE (OPTIONAL)
The following image shows the optional Free Standing Base.
Slim
The equipment will be fixed to the base and wall by an authorized technician during installation.
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4.3. LIST OF ACCESSORIES
2 Silicon chin rest cover
3 Chin rest for patient with teeth
4 TMJ and Sinus nose support
5 Chin rest for patient without teeth
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ATTENTION
ALL PARTS, ACCESSORIES AND OPTIONS DESCRIBED IN THIS
OWNER'S MANUAL ARE FOR EXCLUSIVE USE.
USE OF ANY PARTS, ACCESSORIES OR MATERIAL NOT
SPECIFIED OR PROVIDED IN THIS OWNER'S MANUAL IS USER'S
FULL RESPONSIBILITY.
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5. RECOMMENDED COMPUTER SYSTEM
SPECIFICATIONS
It is imperative that this computer system be dedicated for the EAGLE Panoramic
X-Ray Machine.
Table 1 – Recommended Computer Specifications
Operating System Windows 7 Professional – 64-bit
Windows 8 Professional
Windows 8.1 Professional
Windows 10 Professional
CPU
HDD
RAM
PCI
Intel ® Core ™ I5 3.0 GHz or higher
1 TB or higher
8 GB
PCI Express (PCIe) slot
NIC
Monitor
Gigabit Ethernet dedicated
21.5” - Resolution 1920x1080 or higher
ATTENTION
AN EXCLUSIVE NETWORK ADAPTER IS SHIPPED WITH
THE EQUIPMENT.
THE HARDWARE MUST BE INSTALLED BY AN
AUTHORIZED TECHNICIAN, OTHERWISE MAY RESULT
IN A VOID OF WARRANTY.
6. COMPUTER SYSTEM CONFIGURATION
6.1. NETWORK ADAPTER CONFIGURATION
To verify installation of the network card, follow the procedure:
1 – Verify the Windows system automatically installed the driver for the capture card.
Control Panel
All items
Control Panel
System
Device Manager
Network
Adapters
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2 - Make sure the network adapter is installed. If not, install the network card drive using the CD shipped with the equipment.
3 - After installation restart the computer.
To configure the network card, follow the procedure:
1 - Go to Control Panel
Network
Internet and Network Connections
2 - Click the right mouse button on the connection DESKTOP Intel Gigabit CT, and visit the properties.
3 - Go to Settings
Advanced tab and search for item “Receive Buffer”
4 - Initially, this setting is disabled. Change the value to 2048 and then click OK.
5 - Go to Settings
Advanced tab and search for item “Transmit Buffer”
6 - Initially, this setting is disabled. Change the value to
2048
and then click OK.
7 - Go to Settings
Advanced tab and search for item “Jumbo Frames”
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OK.
8 - Initially, this setting is disabled. Change the value to 9014 bytes and then click
9 - Go to Settings Power Management tab and uncheck all items.
10 – Select Internet Protocol TCP/IP Version
Proprieties
11 – Define the IP address 192.168.5.10 and Subnet Mask 255.255.255.0
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6.2. SOFTWARE INSTALLATION
Insert the accompanying media and execute the Setup.exe. The following screen should be displayed.
1 – Select the language
2 - Press NEXT:
3 – Read carefully the EULA and if you agree select “ I accept the agreement” and press NEXT
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4 – Click on the Checkbox if you want create a desktop icon and Press NEXT
5 - Press INSTALL to start the installation.
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6- The software will install all required software, please wait until if finish.
7 - Press FINISH to close the setup.
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8- After installation, access Windows Start Menu / All Programs / Dental Imaging
Software/ Dental Imaging Software. The main software window should display as follows:
ATTENTION
A DIGITAL VERSION OF THE SOFTWARE USER MANUAL WILL BE
AVAILABLE WITH TECHNICAL CHARACTERISTICS AND
GUIDELINES ON THE SOFTWARE OPERATION.
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7. IMAGING PROGRAMS
The EAGLE Panoramic X-Ray Machine contains a set of profiles.
7.1. PANORAMIC PROFILES:
There are eight panoramic profiles available: from P1 to P6, P17 and P23:
P1
P2
Program Description
Standard Panoramic:
This exposure has constant vertical magnification of the dental arch region, optimal layer width, and prioritizes homogeneous exposure during the entire imaging.
Temporomandibular Joint Exposure,
TMJ:
This double exposure fits the condyle in both closed and open mouth configuration into a single image.
P3
Sinus Exposure:
This exposure focuses on the maxillary sinus region.
P4
P5
Improved Orthogonally:
This exposure is the standard panoramic profile optimized for the beam to be more orthogonal in respect to the dental arch.
Low Dosage Panoramic Exposure:
This exposure is the standard panoramic profile with faster execution and lower dosage. The patient will receive less exposure, so as a result the overall image quality is decreased.
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P6
P17
P23
Child Panoramic Exposure:
This exposure has a 15% size reduction with respect to the standard panoramic profile.
Bitewing Exposure:
This exposure is a bitewing-like image profile from premolar and molar area including parts of maxilla, mandible and rami.
Improved Orthogonally Bitewing:
This exposure is the bitewing-like image profile optimized for the beam to be more orthogonal in respect to the dental arch.
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7.2. CEPHALOMETRIC PROFILES:
P8
Digital Cephalometric profile:
With this profile it is possible to execute the following digital images:
PA: Posterior-Anterior
AP: Anterior-Posterior
45º Degrees
Lateral
Carpal
P9
Low Dosage Digital Cephalometric profile:
With this profile it is possible to execute a lateral ceph with a smaller exposure area resulting in a lower dose to the patient.
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8. CONTROL PANEL
8.1. INTRODUCTION
The equipment has a control panel with six buttons and an LCD display as follows:
The LCD display is graphical and has important information of the current status of the machine to help the user operate the unit.
The keys have multiple functionality depending on the current state of the machine.
For instance, the PLUS key can increase the kV when in kV selection mode.
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8.2. CONTROL PANEL KEYS
The controls are shown and their functions on the main screen are shown below:
Plus Key:
Used to increase kV, select patient age (child and adult), size (small, medium and large) and radiography type (i.e. standard panoramic and low dosage).
Minus Key:
Used to decrease kV, select the patient age (child and adult), size (small, medium and large) and radiography type.
Select Key:
Used to change between adjustable functions: (patient size, biotype, kV, image layer position (canine) and radiography type).
Laser key:
Used to turn on/off positioning lasers: Mid-Saggital, Frankfurt and Image layer Position (Canine).
Key Up:
Used to increase the column height. The equipment has a soft-start system that ramps up the column for 5 seconds until it reaches its cruise speed. The system stops automatically when it reaches the upper height limit.
Key Down:
Used to decrease the column height. The equipment has a soft-start system that ramps up the column for 5 seconds until it reaches its cruise speed. The system stops automatically when it reaches the lower height limit.
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8.3. CONTROL PANEL INDICATING LIGHTS
Exposure-Signaling LED:
The LED at the center of the symbol will light up during x-ray exposure. An audible warning will also sound.
8.4. REMOTE EXPOSURE SWITCH (OPTIONAL)
A remote exposure switch installed outside of the radiation exposure room is available upon request or as required by state or country.
The remote exposure switch is a dead-man-like switch and illuminates during an exposure.
In order for the remote exposure switch to work properly the wall connector must have the proper cable (supplied) connected to the equipment. This is done during installation.
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8.5. TURNING THE EQUIPMENT ON
ATTENTION
THE UNIT IS CONFIGURED FOR A LINE VOLTAGE DURING
INSTALLATION BY THE TECHNICIAN ONLY. THIS IS A TECHNICAL
PROCEDURE AND CANNOT BE DONE BY THE USER.
BEFORE TURNING ON THE UNIT MAKE SURE THE UNIT IS
CONNECTED TO THE CORRECT VOLTAGE.
ATTENTION
To turn on or off the unit use the on/off switch on the base of the equipment.
When the main switch is turned on, the machine will perform a self-check. If everything is within specifications, the display will show the x-ray counter.
During the self-check, the following screen will be shown on the display:
The machine can be configured to display an exposure counter that is displayed after the machine initialization and after each exposure.
Note: The exposure counter can be hidden by an authorized technician.
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8.6. MAIN SCREEN
The main screen is shown below. To switch between functions use the SELECT key. Notice that only one item on the screen is selected each time. In the case shown below, the size is selected.
INFO →
LINE
ADULT / →
CHILD
SMALL/
MEDIUM →
LARGE
KV →
← PROFILE
IMAGE
← LAYER
POSITION
↑ mA
↑
TIME
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FUNCTION
INFO LINE
ADULT /
CHILD
SMALL /
MEDIUM /
LARGE
DESCRIPTION DISPLAY INFORMATION
AND EXPLANATION
Displays current status of the machine.
Equipment is not ready to expose xrays. If exposure switch is pressed the equipment will operate in demonstration mode (no x-ray exposure).
Equipment is ready to expose x-rays.
Equipment is cooling down. Wait until counter reaches zero.
Allows the user to select between adult and child. This function along with the small/medium/large function can be used to display predefined kV selections in order to assist the operator.
This value is selected using
PLUS/MINUS KEYS.
Please be aware that the values of kV indicated are for reference only.
No selection
Child selected
Adult selected
This function is used along with ADULT / CHILD function to pre-select the kV.
This value is selected using
PLUS/MINUS KEYS
Please be aware that the values of kV indicated are for reference only.
Size not selected
Small patient selected
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Medium patient selected kV mA
TIME
IMAGE
LAYER
POSITION
Large patient selected
This function is used to fine tune the kV after selecting the patient age and size or to directly select the kV.
The range of kV is from 60kV to 85kV in increments of
2.5kV.
This value is selected using
PLUS/MINUS KEYS
If the kV is left unchanged the equipment will be in demonstration mode. In this mode no x-ray is exposed.
The anodic current is not user adjustable. The value indicated is optimum for image generation in each profile.
No kV selected: Demonstration mode.
Example of kV selection: 75 kV.
Indication that current profile uses
8mA of anodic current.
In all profiles the value is not user adjustable.
Value indicating that current profile has 14 seconds of x-ray exposure.
This function allows the user to adjust the image layer towards the back or front of the dental arch in panoramic profiles.
The adjustment is made using the following keys:
PLUS : moves layer towards back of dental arch.
MINUS: moves layer
The image layer positioning change commands are accepted when the image layer icon is selected on the screen.
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PROFILE
SELECTION towards front of dental arch.
The image and text indicate the selected profile.
Example with standard panoramic selected.
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9. PREPARING FOR THE EXPOSURE
This section describes operations required for exposing images.
The type of radiography depends on machine type and the media (sensor snap or sensor fixed) position.
This section describes the steps required before positioning the patient on the machine.
9.1. DIGITAL SNAP-ON SENSOR CONFIGURATION
INSERTING/REMOVING THE SNAP-ON SENSOR FOR PANORAMIC OR
CEPHALOMETRIC POSITION
A safety wrist strap is provided with the snap-on sensor and should be used to avoid dropping and consequent loss of warranty. The safety wrist strap is made of a flexible, anti- allergic material. The safety wrist strap is shown in the picture below.
35
To use it, follow the procedure below.
Pass the first strap loop inside the sensor handle.
Pass the second strap loop inside the first one.
Pull the strap until the sensor is tightly secured.
36
Insert your hand into the strap loop.
Adjust the safety strap to your wrist.
ATTENTION
THE SENSOR IS FRAGILE. WHILE REMOVING, HANDLING OR
INSERTING THE SENSOR HOLD IT TIGHTLY AND WITH
APPROPRIATE CARE. WARRANTY WILL BE VOIDED IF THE
SENSOR IS DROPPED.
37
In order to remove the SNAP-ON Sensor from the Holder (cephalostat or C-arm) proceed as indicated in the instructions below.
1. Hold the sensor tightly with your left hand and push the locking button with your right hand.
2. Rotate the knob 180 degrees until you release the sensor.
3. Remove the sensor carefully.
38
In order to insert the sensor follow the steps below.
1. Insert the sensor carefully. 2. Rotate the knob 180 degrees until you lock the sensor
3. Hold the sensor tightly with your left hand and push the locking button with your right hand
39
9.2. DIGITAL FIXED SENSOR CONFIGURATION
CHANGING FOR PANORAMIC OR CEPHALOMETRIC MODE
In order to change from Panoramic to Cephalometric mode, pull the locking button close to the panoramic sensor in C-arm. The equipment will automatically change the configuration to Cephalometric mode. close to the panoramic sensor in C-arm. The equipment will automatically change the configuration to Panoramic mode.
In order to change from Cephalometric to Panoramic mode, push the locking button
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9.3. BEFORE POSITIONING THE PATIENT
Ask the patient to remove any glasses, hearing aids, dentures, and personal jewelry such as earrings, necklaces, and hairpins.
If required, place a protective lead apron over the patient’s body. Always follow local regulation.
9.4. GETTING THE SOFTWARE READY
Open the Imaging software and press New Exposure. Make sure the green light is on before exposure.
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10. PANORAMIC EXPOSURES
This section uses operation concepts described on previous sections. Please refer to those sections when needed.
This procedure will produce a full size panoramic exposure. If the child program is selected, the width and height of the exposed area will be slightly reduced.
For this procedure it is necessary to use a chin rest. There are three different type of chin rest, as you can see in the picture below.
Chin rest for patient with teeth
Chin rest for patient without teeth Chin rest for Sinus and
TMJ
The first one is used for a patient with teeth and it has three parts (bite guide, chin rest and a silicon chinrest cover). The second is used for a patient without teeth and it has two parts (chin rest support and a plastic chin rest). The third is used for both kinds of patients (with or without teeth) for only the Sinus and TMJ profiles.
Insert the appropriated chin rest into the adapter. Insert the adapter into the holes on the patient support table. Please see the picture below for reference to usage of the bite guide.
Silicon chinrest cover
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Head positioner
Bite guide
Chin rest
Before positioning the patient, completely open the head support.
Select the required panoramic profile (from P1 to P23).
Select the correct exposure parameters in accordance with the patient characteristics. The table below gives the suggested parameters. Please use these values as a reference only. If necessary, change the values according to your needs.
Patient Size and
Age kV
Child Adult
ATTENTION
IF THE REQUIRED DIAGNOSTIC VALUE CAN BE REACHED
WITH LOWER VALUES THAN THE ABOVE TABLE
INDICATES, YOU SHOULD USE THOSE LOWER VALUES.
ALWAYS TRY TO MINIMIZE THE RADIATION DOSAGE TO
THE PATIENT.
10.1. GETTING THE SOFTWARE READY
Enter Imaging Software and be sure that the green light is on indicating that the sensor is ready. Refer to previous sections for assistance if required.
10.2. POSITIONING THE PATIENT
Guide the patient to the unit in front of the chin rest. If necessary, adjust the height of the unit using the Up and Down keys of the control panel.
For a patient with teeth, ask them to step forward, grasp the patient handles, stretch up and bite the bite guide. The incisal edges of the maxillary and mandibular teeth must be in the groove of the bite guide.
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For a patient without teeth use the specific chin rest that doesn´t have a bite guide.
Ask patient to lean his/her chin against it.
Press the laser key to operate the patient positioning laser lights in order to assist with proper patient positioning. The laser diodes will automatically switch off after a period of time, or if the exposure button has been pressed. If the laser diodes turn off before you complete the patient positioning, press the laser key again.
Use the laser to position the Mid-Saggital plane, the Frankfurt plane and adjust the
Image layer position.
If required adjust the Frankfurt laser position using the indicated adjusting key on the tubehead.
Laser adjusting key
If required, adjust the image layer position using the plus and minus key while in layer positioning mode on the main screen.
CAUTION
THE LASERS USED ON THE EQUIPMENT ARE CLASS I LASERS
INDICATING THAT THE POWER OUTPUT IS MINIMAL. HOWEVER,
AS GOOD PRACTICE, AVOID INTENTIONALLY EXPOSING USER
AND PATIENT EYES TO THE LASER BEAM.
For Sinus and TMJ profiles you need to use a specific chin rest. This chin rest has a nose support and the patient needs to lean his/her nose against it.
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10.3. TAKING A PANORAMIC EXPOSURE
When "Ready to Expose" is shown on the display the system is ready to take an exposure.
Ask the patient to close their lips on the bite guide, swallow, place their tongue flat against the roof of their mouth, breathe normally, and stand as still as possible.
Move to a protected area without losing direct eye contact to the patient.
Press and hold down the exposure button. The machine will first move to the start position and then it will proceed with the exposure. During exposure, a visual LED and audible beeping will indicate the presence of x-ray emission.
The exposure switch is a dead-man like switch. If released, the x-ray exposure will stop immediately. Otherwise, after the rotation has completed and audible beeping stops you may release the exposure switch.
Upon completion of the exposure, the arm will rotate to the patient exit position. At this point, you may guide the patient out of the machine.
ATTENTION
MAINTAIN AUDIAL AND VISUAL CONTACT WITH THE PATIENT
AND UNIT DURING THE WHOLE EXPOSURE PROCESS. IF THE
EXPOSURE OR MOVEMENT STOPS DURING THE PROCESS DUE
TO AN INTERNAL ERROR, RELEASE THE SWITCH AND ASSIST
THE PATIENT OUT OF THE MACHINE.
In order to reset the rotating arm for the next patient, press the SELECT button on the control panel.
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FOR TMJ
PROFILE (P2)
ONLY
TMJ PROFILE, P2, IS A DOUBLE EXPOSURE. AFTER THE FIRST
EXPOSURE, POSITION THE PATIENT WITH OPEN MOUTH AND
PROCEED WITH THE SECOND EXPOSURE.
The machine will enter a cool down process to setup for the next exposure. The display will indicate the status of the machine. Cool down time will vary based on the type of exposure taken last.
For digital machines you may save the image as required using the File/Save menu in the software.
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11. CEPHALOMETRIC EXPOSURE
This section will occasionally use procedures described in previous sections. Please refer to those sections when needed.
This procedure will produce a cephalometric exposure as selected:
PA
Waters PA
AP
Lateral
Basal-Hirtz axial
45 degrees
Carpal
ATTENTION
BEFORE START, OPEN THE HEAD POSITIONER AND
REMOVE THE CHIN REST AND BITE GUIDE FROM THE
PATIENT SUPPORT.
Select the correct exposure parameters in accordance with the patient characteristics. The table below gives the suggested parameters. Please use these values for reference only. If necessary, adjust the values according to your needs.
Patient Size and
Age kV – DIGITAL VERSION
Child Adult
ATTENTION
IF THE REQUIRED DIAGNOSTIC VALUE CAN BE REACHED
WITH LOWER VALUES THAN THE ABOVE TABLE
INDICATES, YOU SHOULD USE THOSE LOWER VALUES.
ALWAYS TRY TO MINIMIZE THE RADIATION DOSE TO THE
PATIENT.
11.1. GETTING THE SOFTWARE READY
Enter Imaging Software and be sure that the green light is on indicating that the sensor is ready. Refer to previous sections for assistance if required.
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11.2. POSITIONING THE PATIENT
Guide the patient to the unit in front of the ceph arm rest. Adjust the height of the unit using the UP and DOWN keys on the control panel or ceph head as necessary.
Ask the patient to step forward and hold still while you prepare the ceph head.
Rotate the ceph head into the desired position (PA,AP, WATERS PA, CARPAL,
BASAL-HIRTZ AXIAL, LATERAL OR 45 DEGREE).
Open the ear holders using the appropriate knob. Position the patient and rotate the knob so that the patient will be securely positioned using the ear holders.
Press the light key to turn the patient positioning laser lights on in order to properly align the patient's head. The laser diodes will automatically switch off after a period of time, or if the exposure button has been pressed. If the laser diodes turn off during patient positioning, press the light key again.
Use the laser to position the Frankfurt plane.
THE LASERS USED ON THE EQUIPMENT ARE CLASS I LASERS
INDICATING THAT THE POWER OUTPUT IS MINIMAL. HOWEVER,
AS GOOD PRACTICE, AVOID INTENTIONALLY EXPOSING USER
AND PATIENT EYES TO THE LASER BEAM.
CAUTION
11.3. TAKING A CEPHALOMETRIC EXPOSURE
When "Ready to Expose" is shown on the display the system is ready to take an exposure.
Move to a protected area without losing direct eye contact with the patient.
ATTENTION
KEEP CONSTANT EYE CONTACT WITH THE PATIENT AND
ASSURE HE/SHE HAS BOTH HANDS DOWN DURING THE
PROCESS. IN DIGITAL CEPH THIS IS ESPECIALLY IMPORTANT
SINCE THE MECHANISM IS AUTOMATIC. IF THE PATIENT
BEHAVES UNEXPECTEDLY STOP THE EXPOSURE AT ONCE.
Press and hold down the exposure button. The rotating arm will first move to the start position and then begin exposure. During this period, an audible beeping and visual LED will indicate the presence of x-rays.
The exposure switch is a dead-man like switch. If released, the x-ray exposure will stop immediately. Otherwise, after the rotation has completed and audible beeping stops you may release the exposure switch.
Upon completion of the exposure, the arm will rotate to the patient exit position. At this point, you may guide the patient out of the machine.
48
The machine will enter a cool down process to setup for the next exposure. The display will indicate the status of the machine. Cool down time will vary based on the type of exposure taken last.
For digital machines you may save the image as required using the File/Save menu in the software.
49
12. PROCEDURES FOR REUSE
12.1. CLEANING
Using a clean moist cloth product, clean the equipment’s surface such as the head positioner, patient handles, nose support, silicon chin rest cover, chin rest, ear rods, temple stabilizers on a regular basis.
It is recommended to use a moist cloth product with the following chemical properties: corrosion inhibitor, humectant effect, flotator; high tension-active power, anti-static effect, biodegradable, non-toxic, non-flammable.
The use of other chemical products is not recommended as it may damage the equipment.
CAUTION
DO NOT USE ORGANIC SOLVENTS, SUCH AS THINNER, TO
CLEAN THE EQUIPMENT. IN CASE THE DEVELOPING SOLUTION
IS SPILLED ON THE PANEL, CLEAN IT IMMEDIATELY, SINCE
SUCH SOLUTIONS MAY DISCOLOR IT.
12.2. DISINFECTION
To ensure the prevention of cross-contamination, the operator must dispose of the bite guide after each usage.
CAUTION
ALWAYS TURN OFF THE MAIN SWITCH BEFORE PERFORMING
DAILY MAINTENANCE PROCEDURES.
CAUTION
AVOID SPILLING WATER OR OTHER SOLUTIONS INSIDE THE
EQUIPMENT, AS IT COULD CAUSE SHORT CIRCUITS.
CAUTION
FOR CLEANING, DO NOT USE MICRO ABRASIVE MATERIALS,
STEEL WOOL, ORGANIC SOLVENTS OR SOLVENT-CONTAINING
DETERGENTS, SUCH AS ETHER, STAIN REMOVER, GASOLINE,
ETC.
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13. TROUBLESHOOTING GUIDE
13.1. UNIT OPERATION PROBLEM
Remote exposure button not actuating
Symptom
Equipment does not turn on
Digital image doesn't appear on the screen
Possible Cause
Mains voltage not available
Action required
Wait for mains voltage to be available.
Power supply cable is unplugged from back of equipment
Power supply cable is unplugged from wall socket
Unit circuit breaker turned off
Main ON/OFF switch turned off
Blown fuse
Cable disconnected
Plug it into the equipment
Plug it into the wall socket
Turn on unit circuit breaker
Turn on main ON/OFF switch.
Replace the fuse
Connect the cable
Image acquisition software Reinstall the software
Acquisition button wasn´t selected
Select the acquisition button
Remote exposure cable disconnected
Connect remote exposure cable again
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13.2. PATIENT POSITIONING PROBLEM 1
The standard panoramic image is showed below.
A error in the patient positioning may generate several failures in the image.
Symptom Possible Cause Action required
The teeth appear more
Head tilted patient.
Patient position to tune in amplified on one side and narrower on the other.
Check the position of the relation to the median sagittal plane of the patient with the laser line sagittal plane
Head tilted to the right
Head tilted to the left
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Symptom Possible Cause
The teeth appear more
The patient's head rotated.
Patient position for posterior amplified on one side and teeth in relation to the focal narrower on the other. plane
Action required
Check the position of the sagittal plane of the patient with the laser line
Head turned to the right
Symptom
Incisors and canines narrow and unsharp.
Head turned to the left
Possible Cause Action required
Position of the arch is equipment by positioning anterior of the focal plane.
Adjust the focal plane of the the Canine red laser on the tooth Canine tooth.
53
Symptom
Incisors and canines wide and unsharp.
Possible Cause Action required
Adjust the focal plane of the
Position of the arch is equipment by positioning posterior of the focal plane. the Canine red laser on the tooth Canine tooth.
Symptom Possible Cause Action required
A row of teeth is bent upwards. The lower incisors are deformed. TMJ joints are very high and are often cut
Patient's head is tilted
Reposition the patient relying on the Frankfurt forward plane laser off from the image.
54
Symptom
A row of flat teeth. Unable to see the roots of the upper teeth.
Possible Cause
Patient's head is tilted back
Action required
Reposition the patient relying on the Frankfurt plane laser
Symptom Possible Cause
Central area of the image is very clear and deformed.
Patient neck is not stretched
Shadow of the column. software
Action required
Ask the patient to take a step forward and stretch your neck.
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Symptom Possible Cause Action required
Incisors and canines teeth blurred.
Anterior teeth behind the focal plane
Adjust the focal plane by positioning the Canine red
Anterior teeth ahead of the laser on Canine tooth. focal plane
Anterior teeth behind the focal plane
Anterior teeth ahead of the focal plane
Possible Cause Symptom Action required
Upper arch outside the chin is not leaning against image area chin rest
Ask the patient to rest his chin on the support.
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You can not see the bottom edge of the jaw in the cortical cross-sectional images.
Symptom
The patient's shoulders touch the X-ray head or digital sensor / cassette holder.
The nape of the patient touch the X-ray head
You can not see the cortical bone cross-sectional images.
Rows of teeth overexposed.
Artefact in the image
Patient is too large for the unit
Possible Cause
Patient is too large for the unit
The inclination of the patient's head is not correct
Action required
Reverse the patient's hands on the patient handles: Left on the right side and viceversa
Check the positioning of the patient head and reposition the patient
Ask for the patient to more forward bite and adjust the equipment using the canine laser to reposition the equipment
The inclination of the patient's head is not correct
Patient without teeth (molarpremolar) in the molar plate
The patient wasn´t placed correctly. The patient's position is oblique to the image layer.
Reposition the patient
Use cotton rolls and take a new exposure.
Reposition the patient
Tongue was not against the roof of palate
Patient did not remove the metal artifacts
Ask patient to swallow and place tongue against the roof of palate
Ask the patient to remove eyeglasses, hearing aids, dentures, and personal jewelry, such as earrings, necklaces and hooks.
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14. DISPOSAL OF THE UNIT
14.1. ENVIRONMENTAL CONTAMINATION
In order to prevent environmental contamination or improper disposal of the
EAGLE Panoramic X-Ray Machine, the equipment must be disposed of (according to local, state, or federal regulations) at an appropriate site.
The equipment contains materials and solutions listed below which, upon completion of its useful life, must be disposed of at the appropriate sites.
In particular, the equipment contains the following materials and/or components:
Tubehead: non-conductive oil, lead, copper, iron, aluminum, glass, tungsten.
Control panel and shooter: iron, copper, aluminum, glass resin, non-biodegradable plastic material.
Column, rotating arm and extensions: iron, lead, aluminum, copper, glass resin and non-degradable plastic material.
The manufacturer and/or its distributors are not responsible for improper disposal by the buyer.
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15. EQUIPMENT INSTALLATION, CORRECTIVE
MAINTENANCE AND CALIBRATION.
15.1. INSTALLATION OF THE EQUIPMENT
This equipment must be installed by authorized service technicians from Dabi Atlante because only he/she has the tools, information, and training needed to perform this task.
15.2. CORRECTIVE MAINTENANCE
All instructions to use the equipment as intended are provided in this user manual. If problems are detected and cannot be corrected with the instructions in the troubleshooting section, contact the Dabi Atlante Service Department.
Note: Do not open the equipment or try fix to it yourself or with the help of someone without training/authorization. This could worsen the problem or produce a failure that could endanger the safety of the equipment.
Warranty will be voided if original parts are removed/replaced by non-authorized
Service technicians.
15.3. PREVENTIVE MAINTENANCE
Dabi Atlante strongly recommends a preventive maintenance be performed on your equipment at least every two years. All service requests must be submitted through Dabi
Atlante’s Service Department by calling our number at +55 (16) 3512-1212.
Dabi Atlante has an extensive authorized service network to install and service our products. The authorized service network have been specifically trained by our organization in the service and installation of Dabi Atlante products. We strongly recommend that you use one of our authorized service network to service Dabi Atlante products. To the extent you use third parties other than our authorized service network to service Dabi Atlante products, we cannot accept responsibility or liability for any work performed by those third parties and any resulting damages or liability attributable thereto. In no event shall Dabi
Atlante be liable to you or any other third party for any direct, indirect, punitive, incidental, consequential or special damages or lost profits arising from, relating to or connected with, the installation of or repair of a Dabi Atlante product by someone other than an our authorized service network.
Always refer to your state and local regulations to determine how often to perform a preventive maintenance on your equipment as the regulations may supersede manufacturers’ recommendation.
Owners of Dabi Atlante X-Ray machines must call Dabi Atlante Service
Department for all reasons listed below but not limited to:
- Preventive maintenance at least every two years
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- Physical relocation of machine
- Changing the power source to a different power source from original installation
- Questions/Help related to compliance with your state, and local regulations regarding radiological equipment
- Corrective Maintenance
- Physical damage that may affect radiation safety
- Interrupted movement, unusual noises, leaks, etc.
To schedule a preventive maintenance on your equipment contact the Service
Department by dialing our number at +55 (16) 3512-1212.
15.4. CALIBRATION
The equipment calibration must be performed by an authorized service technician during installation and during corrective or preventative maintenance.
15.5. NETWORK OF AUTHORIZED SERVICE TECHNICIANS
The installation and all services performed on DABI ATLANTE equipment/products should be done by technicians authorized by DABI ATLANTE, otherwise, warranty will be voided.
To request electrical schematics, or component specifications not found in this manual, call the authorized service network DABI ATLANTE.
Fone number:
E-mail:
Address:
+55 (16) 3512-1212 [email protected]
Av. Presidente Castelo Branco nº 2525 – Lagoinha – Ribeirão Preto –
SP - Brazil CEP 14095-903
16. TECHNICAL SPECIFICATIONS
16.1. REGULATORY INFORMATION
Manufactured by: Dabi Atlante Industria Médico Odontológica S/A
Phone Number: +55 (16) 3512-1212
Address: Av. Presidente Castelo Branco nº 2525 – Lagoinha – Ribeirão Preto/SP – Brazil
CEP 14095-903
Reference type X-Ray Panoramic
60
Model
Equipment classification according to FDA
Classification class (risk class)
Protection against harmful water penetration
Application safety level in the presence of a flammable anesthetic mixture with air, oxygen or nitrous oxide
CLASS II
EAGLE
Equipment classification according to standard NBR IEC 60601-1
Protection against electric shock “Type-B” applied parts“
CLASS I (NBR IEC 60601-1)
Ordinary equipment - IPX0
(Sealed equipment without protection against water penetration)
Unsuitable equipment
Operation mode Operation Intermittent
16.2. GENERAL INFORMATION
Mains power voltage
Number of phases
Current type
Mains power frequency
Delay fuses
Power consumption
Stand by consumption
Net weight without a cephalostat
Net weight with a cephalostat
Net weight of X-Ray generator
Column height adjustment
Minimum room sizes for installation
110/127/220 or 240 V
1 or 2
AC (alternating current)
50 or 60 Hz
10A -110/127V 5A -220/240A
1.25 kVA
0.070 kVA
253.5 lb
335.1 lb
34.2 lb
2.30 ft
5.90 x 8.20 ft
Warning: pieces of the equipment may cause shock
16.3. RADIOLOGICAL INFORMATION
General Information
Exposure time accuracy
Maximum operation factor
Tube voltage (kVp)
Accuracy at the kVp value
±10 %
1 : 25s
Adjustable from 60 to 85 kVp, 2.5 steps.
± 10 %
Accuracy at the anodic current value ± 20 %
Maximum energy accumulated in 1 hour 1120 mAs
Cassette type
Information Specific for Panoramic Profiles
Complete panoramic exposure time/current
Flat
Standard – 14s – 8mA
Improved orthogonally – 14s – 8mA
Low dose –11s – 6mA
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Maxillary sinus
Open mouth + closed mouth TMJ exposure time (TMJ 1 + TMJ 2 )
Child – 10.5s – 8mA
8s – 8mA
10s – 8mA
Bitewing
Mean magnification
Analog cephalometric exposure time/current
7.6s – 8mA
1 : 1.22
Source to Image Distance SID 1.69 ft
Information Specific for Cephalometric Profiles
0,1 to 3s – 8mA
Complete digital cephalometric exposure time/current
10 or 16,5 – 8mA
Low Dosage digital cephalometric exposure time/current
Film dimension for analog cephalometric exposure
6,6 or 11s – 8mA
8” x 10”
Mean magnification
Source to Image Distance SID
1:1.1
5.41 ft
For this equipment proper patient positioning is required to produce a good quality image.
The operator must stay away at least 9 feet from the equipment during exposure to minimize the amount of ionizing radiation risk.
16.4. X-RAY GENERATOR
Generator type
Operating frequency
Maximum operation voltage
Heating and cooling curve
Output power
Output power during 0,1s
Total filtration
Radiation escape
Equipment
High-frequency constant potential generator
100 kHz
85 kVp
See Graphic on item 15.13 of this manual
680 W (85kV x 8mA)
680 W (85kV x 8mA)
0.01 ft Al eq. @ 85 kVp (This value takes all mitigating circumstances that exist from the emission source to the output of equipment)
< 1.00mGy/h at 85kV / 8mA
CLASS I - Type-B applied part
When submitted in charge the equipment emits ionizing radiation.
Operation mode Intermittent
The X-Ray Generator is mounted by the manufacturer.
X-Ray machine with radiologic protection according to NBR IEC 60601-1-3:2001.
X-Ray generator EAGLE NBR IEC 60601-2-7:1998
X-Radiation-emitting set EAGLE NBR IEC 60601-2-28:2001
Radiological equipment associated EAGLE NBRIEC60601-2-32:2001
16.5. TESTED EQUIPMENT LAW NORM
EN 60601-1 (1990);
62
Amendment 1 EN 60601-1 (1992);
Amendment 2 EN 60601-1 (1995);
Amendment13 EN 60601-1 (1995);
UL 60601-
60601-1-4-2004
EN 60601-1-3 (2001);
EN 60601-2-7 (2001);
EN 60601-2-28 (2001);
EN 60601-2-32 (2001);
IEC 60601-1;
Emenda 1 IEC 601-1;
IEC 60601-1-2;
CISPR 11, edição 3.1 (1999);
IEC 61000-4-2 (1999);
IEC 61000-4-3 (1998);
IEC 61000-4-4 (1995);
IEC 61000-4-5 (1995);
IEC 61000-4-6 (1996);
IEC 61000-4-11 (1996);
IEC series 60601-1 Medical Electrical Equipment - Part 1: General requirements for safety;
EN 980:2003 (Ed. 2) - Graphical symbols for use in the labeling of medical devices;
ISO 14971 - Medical devices - application of risk management medical devices;
ISO 9687: 1993 - Dental equipment - graphical symbols;
ISO 7494 - Norma dental units;
ISO 13485-2 - Quality systems - medical devices;
ISO 780 - Packaging - pictorial marking for handling goods;
ISO 11144 - Norma dental equipment - connections for supply and waste lines.
Reference axis between the target angle and the focal point of the X-ray tube:
90º With axis of anode and cathode, respective
Target angle with reference axis:
5º Reference axis angle between the target and the focal point of the x-ray generator mounted : measurements of x-ray generator mounted:
318mm x 440mm x 212mm weight of X-ray generator mounted:
34.6 lb.
Tolerances of the focal point in relation in relation to the axes of reference:
X=
0.5mm (lateral)
Y=
0.5mm (depth)
Z=
0.5mm (height)
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64
65
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16.6. IRRADIATED FIELD SIZE - DIGITAL PANORAMIC EXAM (PAN: ADULT
AND CHILD – TMJ – MAXILLARY SINUS)
16.7. IRRADIATED FIELD SIZE – DIGITAL CEPH EXAM:
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Manufacturer TOSHIBA
Model D-054
Focus size 0.5 – IEC 60336
Equivalent filtration
Anode angle
0.003 ft Al equiv.
5 º
Anode material
Maximum voltage
Tungsten
105 kVp
Thermal capacity
Max thermal capacity and cooling time curve
Maximum current
30 kJ
See graphic thermal curve on item 15.13.
24mA rectified by half or whole wave and
20mA constant potential
Maximum filament current 4.0A / 8.0V
Frequency DC
Maximum exposure time 20s
Max anodic power 680kW
EMISSIONS
Manufacturer’s guidelines and declaration - electromagnetic emissions
The EAGLE Panoramic X-Ray Machine has been designed for use in electromagnetic environments, according to the specifications below. The client or X-Ray Machine operator must ensure that the equipment is used in such type of environment.
Emission assays Compliance Electromagnetic Environment
Guidelines
RF emissions ABNT NBR
IEC CISPR 11
Group 1 The EAGLE Panoramic X-Ray uses
RF energy only for its internal functions. However, RF emissions are very low and are not likely to cause any interference with electronic equipment nearby.
RF emissions ABNT NBR
IEC CISPR 11
Harmonic emissions IEC
61000-3-2
Emissions due to voltage/scintillation fluctuation IEC 61000-3-3
RF emissions CISPR 15
Class A
Class A
In compliance
In compliance
The EAGLE Panoramic X-Ray
Machine is suitable for use in all types of facilities, including residential facilities and those directly connected to the public system of low -voltage electric power supply for residential buildings.
The EAGLE Panoramic X-Ray
Machine is not suitable for interconnection with another piece of equipment.
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16.10. ELECTROMAGNETIC IMMUNITY
Manufacturer’s guidelines and declaration - electromagnetic immunity
The EAGLE Panoramic X-Ray Machine has been designed for use in electromagnetic environments, according to the specifications below. The client or X-Ray Machine operator must ensure that the equipment is used in such type of environment.
Immunity Assays ABNT NBR IEC 60601 Compliance Level
Electrostatic discharge (ESD)
IEC 61000-4-2
Assay Level
± 6 kV by contact
± 8 kV by the air
± 6 kV by contact
± 8 kV by the air
Electromagnetic environment -Guidelines
Floors must be finished with wood, concrete or ceramics. In case the floor is covered with synthetic material, relative humidity must be at least
30%.
Fast electric transients /pulse train (“Burst”)
IEC 61000-4-4
Impulses
IEC 61000-4-5
± 2 kV on the mains supply line
± 1 kV on the input/output line
± 2 kV on the mains supply line
± 1 kV on the input/output line
The quality of power supply must be that of hospital facilities or of typical business facilities.
Voltage drops, short interruptions and voltage variations on the mains supply input lines
IEC 61000-4-11
±1 kV - differential mode
± 2 kV - regular mode
< 5% Ut
(>95% of voltage drop in Ut) per 0.5 cycle
40% Ut
(60% of voltage drop in
Ut) per 5 cycles
70% Ut
(30% of voltage drop in
Ut) per 25 cycles
<5% Ut
(>95% of voltage drop in Ut) per 5 seconds
±1 kV - differential mode
± 2 kV regular mode
< 5% Ut
(>95% of voltage drop in Ut) per 0.5 cycle
40% Ut
60% of voltage drop in Ut) per 5 cycles
70% Ut
(30% of voltage drop in Ut) per 25 cycles
<5% Ut
(>95% of voltage drop in Ut) per 5 seconds
The quality of power supply must be that of hospital facilities or of typical business facilities.
The quality of power supply must be that of hospital facilities or of typical business facilities.
In case the user of the
EAGLE Panoramic X-Ray
Machine required continuing operation during power supply interruption, the equipment should be supplied by an uninterrupted source or battery.
Magnetic field in the mains supply frequency (50/60
Hz) IEC 61000-4-8
3A/m 3A/m Magnetic fields in the mains supply frequency should be in similar levels to those of a typical hospital or business facility.
Note: Ut is the mains supply AC voltage prior to the application of the assay level.
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Manufacturer’s guidelines and declaration - electromagnetic immunity
The EAGLE Panoramic X-Ray Machine has been designed for use in electromagnetic environments according to the specifications below. The client or X-Ray Machine operator must ensure that the equipment is used in such type of environment.
Immunity Assays IEC 60601 Assay
Level
Compliance
Level
Electromagnetic environment -
Guidelines
Portable and movable RF communication equipment must not be used near any of the parts of the EAGLE
Panoramic X-Ray Machine, including
Conducted RF
IEC 610004-6
Radiated RF
IEC 610004-3
3 Vrms
150 kHz up to
80MHz
3 V/m
80 MHz up to 2.5
GHz
3 Vrms
3 V/m cables, with a shorter separation distance than recommended, calculated from the equation applicable to the transmitter’s frequency. Recommended
Separation Distance. d = 1.2 √ P d = 1.2 d = 2.3
√ P - 80 MHz up to 800 MHz
√ P - 800 MHz up to 2.5 GHz, where P is the transmitter’s maximum nominal output power in watts (W), according to the transmitter‘s manufacturer, and d is the recommended separation distance in meters (m).
It is recommended that the field intensity established by the RF transmitter, as determined by an electromagnetic inspection on the site, a should be less than the compliance level in each frequency range. b Interference may occur around the equipment marked by the following symbol:
NOTE 1: In 80 MHz and 800MHz, the higher frequency range is applied.
NOTA 2: These guidelines may not be applicable in all situations. Electromagnetic propagation is affected by absorption and reflection by structures, objects and people. a Field intensities established by fixed transmitters, such as stations for base radio, telephone
(cellular/wireless), mobile ground radios, amateur radio, AM and FM radio transmission and TV broadcast cannot be theoretically predicted accurately. In order to evaluate the electromagnetic environment due to fixed RF transmitters, an electromagnetic inspection of the site is recommended. If the measurement of the field intensity on the site where the EAGLE
Panoramic X-Ray Machine is used exceeds the applicable RF compliance level described above, the equipment’s operation should be checked in order to ensure it is within normal
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standards. In case abnormal performance is observed, additional procedures, such as reorientation and replacement of the EAGLE Panoramic X-Ray Machine may be required. b It is recommended that field intensity should be lower than 3 V/m above the frequency range of 150 kHz to 80 MHz.
Recommended separation distances between portable and mobile RF communication equipment and the EAGLE Panoramic X-Ray Machine
The EAGLE Panoramic X-Ray Machine has been designed for use in electromagnetic environments where RF radiated perturbations are controlled. The client or user of the EAGLE
Panoramic X-Ray Machine can help prevent electromagnetic interference by keeping a minimum distance between portable and movable RF communication equipment (transmitters) and the EAGLE S Panoramic X-Ray Machine, as recommended below, according to the maximum output power of the communication equipment.
Maximum nominal Separation distance according to the transmitter’s frequency (m) output power of the transmitter (W)
150 kHz up to 80 MHz d = 1.2 √ P
80 MHz up to 800
MHz d = 1.2 √ P
800 MHz up to 2.5 GHz d = 2.3 √ P
100 12 12 23
For transmitters with maximum nominal output powers that are not listed above, the recommended separation distance d in meters (m) can be determined by using the equation applicable for the transmitter’s frequency, where P is the transmitter’s maximum nominal output power in watts (W) according to the transmitter’s manufacturer.
NOTE 1: In 80 MHz and 800MHz, the separation distance for the higher frequency range is applied.
NOTA 2: These guidelines may not be applicable in all situations. Electromagnetic propagation is affected by absorption and reflection by structures, objects and people.
THE EQUIPMENT SHOULD NOT BE USED ADJACENT TO OR
STACKED ON OTHER EQUIPMENT, RECOMMENDATIONS
OF THIS MANUAL MUST BE FOLLOWED.
WARNING
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WARNING
TO ENSURE SAFE OPERATION, THE OPERATOR MUST
TURN AWAY FROM EQUIPMENT FOR SAFETY TO AVOID
COLLISION WITH MOVING PARTS. THE PATIENT SHOULD
BE INFORMED OF ALL MOVEMENTS THAT THE
EQUIPMENT WILL PERFORM. THE PATIENT SHOULD ALSO
BE TOLD NOT TO MOVE DURING THE EXPOSURE. IT IS THE
RESPONSIBILITY OF THE OPERATOR TO WATCH THE
PATIENT AND INTERRUPT THE EXPOSURE IN SUCH
EVENTS. IMPORTANT: THE STRENGTH OF THE
MOVEMENT IS NOT ENOUGH TO HARM THE OPERATOR
OR PATIENT.
DO NOT USE ACCESSORIES, TRANSDUCERS, PARTS OF
INTERNAL COMPONENTS AND CABLES OTHER THAN
WARNING
THOSE SPECIFIED AND PROVIDED BY THE
MANUFACTURER. DOING SO CAN RESULT IN INCREASED
EMISSIONS OR DECREASED IMMUNITY OF THE ESE.
16.11. CHARACTERISTIC COOLING OF THE X-RAY GENERATOR
72
16.12. CHARACTERISTIC CURVES OF THE X-RAY TUBE.
Exposition Time
73
17. LABELS OF IDENTIFICATION
17.1. PACKAGE
74
17.2. PRODUCT
75
18. EQUIPMENT DIMENSIONS
76
19. WARRANTY
The Warranty Certificate should be completed by the Authorized Technical Dabi
Atlante and one copy must be left with owner to prove the equipment warranty. The remaining copies will be send to the Distributor and to the factory.
The warranty is limited to repair or replacement of parts with manufacturing defects, not including the repair of defects originating in:
- Failure to observe the operating and maintenance instructions;
- Falls or knocks;
- Improper storage;
- Action of nature agents;
- Installation and service performed by persons not authorized by Dabi Atlante;
- Damage to the painted parts and plastic painted or not, caused by misuse;
The warranty period is 1 (one) years from the date of installation, provided that the equipment has not been stored for more than 1 (one) years from the date of issue of the invoice customer billing, first owner, until the date of installation.
Date: September, 2016 Document Version: 04
Responsible Author: Daniel R. de Camargo
Approved by: Marco Candolo
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