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10 Technical data

10 Technical data

10.1 Technical specifications

General information

Manufacturer:

PaloDEx Group Oy, Nahkelantie 160, FI–

04300 Tuusula, FINLAND

Quality system

In accordance with ISO13485 standard

Environmental management system

In accordance with ISO14001 standard

Conformity to standards:

IEC60601–1 (ed.3)+Am1
IEC60601–1–3: (ed.2)+Am1
IEC60601–1–6 (ed.3.1)
IEC60601–1–9 (ed.1)
IEC60601–2–28 (ed.2)
IEC60601–2–63 (ed.1)
IEC60601–1–2 (ed.4)

ANSI/AAMI ES60601–1: 2005+A1
CAN/CSA–C22.2 No. 60601–1:2014

standards
This product complies with DHHS 21 CFR

Chapter I, Subchapter J at the date of

manufacture.
The device is in conformity with the

provisions of Council Directive93/42/EEC

as amended by the Directive 2007/47/EC

concerning medical devices.
RoHS Directive 2011/65/EU

ORTHOPANTOMOGRAPH

™

OP 3D

Содержание ORTHOPANTOMOGRAPH OP 3D

Страница 1: ...ORTHOPANTOMOGRAPH OP 3D User and Installation manual ENGLISH 212972 rev 6 0 805 4913...

Страница 2: ......

Страница 3: ...ations 12 3 2 2 Panoramic lights 12 3 2 3 3D lights 13 3 3 Accessories 13 3 4 Other detachable parts 14 3 5 Emergency stop switch 15 4 User Interfaces 16 4 1 Graphical User Interface GUI 16 4 1 1 GUI...

Страница 4: ...omplete device calibration 73 9 8 1 Accessing the calibrations 73 9 8 2 Device Movement Calibration 74 9 8 3 Z Movement Limits 74 9 8 4 X Ray Generator Calibration 75 9 8 5 3D Pixel Calibration 75 9 8...

Страница 5: ...ntacting parts 104 10 4 Device dimensions 105 10 5 Symbols that may appear on the device or its parts 108 10 6 Electromagnetic Compatibility EMC tables 110 10 7 X ray tube assemblies 114 10 8 Minimum...

Страница 6: ...m or machine readable form in whole or part without the prior written permission of PaloDEx Group Oy The original language of this manual is English PaloDEx Group Oy reserves the right to make changes...

Страница 7: ...e dental area imaging both jaws 9 x 14 cm optional both jaws including TMJ FOV position and height fine tuning is possible according to scout images CAUTION USA only Federal law restricts this device...

Страница 8: ...poromandibular joint 2 6 Signal words The following signal words and labels are used in this document WARNING Indicates a hazardous situation which if not avoided could result in death or serious inju...

Страница 9: ...patient who is feeling insecure or has exceptional anatomy typically very tall or large patient use the Test mode first to demonstrate the device movements and to make sure that the rotating device d...

Страница 10: ...the patient environment at least 1 5m from the device The X ray device must be connected to a dedicated mains power outlet with protective earth The workstation and any other external devices must NOT...

Страница 11: ...atient handles 12 Mirror 13 Status indicator light 14 Chin rest 15 Head support 16 Head support locking lever 17 Lower shelf tray Additionally a workstation with MDD approved dental imaging software i...

Страница 12: ...ns A Tilt light Panoramic image layer B Midsagittal light C Horizontal light top of FOV FH light D Horizontal light bottom of FOV 3 2 2 Panoramic lights A Tilt light Image layer B Midsagittal light C...

Страница 13: ...Accessories Chin Rest Bite Block Lip Support 3D TMJ and edentulous patients Head Support with a detachable strap Disposable covers for patient positioning devices Disposable covers for Bite Block Dis...

Страница 14: ...chable parts CALIBRATION TOOLS 3D Geometry Calibration Phantom 3D QC Phantom 3D QC phantom holder QUALITY CONTROL TOOLS OPTIONAL 2D QC Test Phantom PAN QC phantom holder Copper filter 0 8 mm 1 8 mm 14...

Страница 15: ...NOTICE An interrupted imaging process cannot be resumed A new image needs to be taken To release the emergency stop switch rotate it clockwise NOTICE Make sure that the emergency stop switch is not pr...

Страница 16: ...r to show messages if there are more than the ones shown 6 Imaging parameters Imaging parameters kV PAN only and mA can be manually adjusted according to the patient size and skull anatomy using the i...

Страница 17: ...the listed patient size icon to activate it Selecting a patient size according to the scanned patient adjusts the kV and mA to preset levels NOTICE Patient size presets can be adjusted from settings...

Страница 18: ...gments to select blue and deselect white them Panoramic imaging programs Indicates which imaging program is selected Press the imaging program icons to change the active imaging program Standard Panor...

Страница 19: ...ed in you can click and drag to scroll the image Brightness slider You can adjust the brightness of the shown preview image using the brightness slider Contrast slider You can adjust the contrast of t...

Страница 20: ...t 3 or 4 Both jaws and all teeth in them 3 and 4 TMJ 5 or 6 Both TMJ s 5 and 6 Whole dentition 3 4 5 and 6 NOTICE Both TMJs are selectable only if 9x14 FOV size is available You can select the whole d...

Страница 21: ...solution selection icon to open a list of available image resolutions Low Dose Technology resolution Standard resolution High resolution ENDO resolution Press on the listed resolution icon to activate...

Страница 22: ...the FOV position in Posterior P Anterior A direction and the right slider in Left L Right R direction You can also click and drag sideways on the image to adjust the FOV position It s recommended to a...

Страница 23: ...is selected 3D preview image is shown as a slice preview left and a rendered volume right on the GUI Press the preview projection icons to change the projection of the shown preview Coronal Sagittal...

Страница 24: ...ontrast slider You can adjust the contrast of the shown preview image using the contrast slider NOTICE Adjustment is not saved to the image OK button Press OK button to close the image preview 24 ORTH...

Страница 25: ...ough this menu See chapters Calibrations for the user and Complete device calibration for more detailed information on calibration programs and how to perform them 2 QUALITY CONTROL Shows a list of Qu...

Страница 26: ...reduce the effect of metals and other dense radiopaque objects on the 3D image It is recommended to keep MAR activated Force device language Change the language of the GUI if needed It is recommended...

Страница 27: ...authorized service personnel only The Service menu can be accessed only with a PIN code The Service menu contains Device settings Calibrations for installation and service of the device Optional imagi...

Страница 28: ...r YELLOW Illuminates when the device is radiating 6 Status indicator BLUE Illuminates when the device is in Error state The error details are shown on the GUI 7 Ready indicator GREEN Illuminates when...

Страница 29: ...for illustrative purposes only Pediatric Panoramic imaging program The Pediatric Panoramic imaging program provides a general view of the dental and facial anatomy based on panoramic imaging technique...

Страница 30: ...idths and height differences shown here are for illustrative purposes only TMJ lateral projection Lateral TMJ program provides a lateral view of the patient s left and right temporomandibular joints N...

Страница 31: ...d by the selected ROI FOV 5 x 5 Optimized for single site implants or localized diagnostics for example 3rd molar extractions impacted teeth periodontal cases root fractures single TMJ analysis endodo...

Страница 32: ...he image quality and radiation dose to the patient For example high resolution will produce more details than standard resolution but the radiation dose is also higher The unit offers a Low Dose Techn...

Страница 33: ...initialize Prepare the workstation Select imaging program Select patient size to set imaging parameters 95 kV 8 00 mA _ Place positioning accessories and position patient to the device Adjust FOV Take...

Страница 34: ...after 30 minutes of inactivity While in the power save mode the device cooling fan is not active but the positioning panel lights are lit The device wakes up from the power save mode when connection...

Страница 35: ...d seated patients It s recommended to have very tall patients seated for easier positioning 1 Press HOME button on the patient positioning panel The device moves to HOME Patient In position NOTICE Ens...

Страница 36: ...dentulous patients TMJ imaging Bite Block Chin Rest Lip Support Chin Rest Lip Support Chin Rest 3D Imaging Lower jaw or both jaws Upper jaw Lip Support Chin Rest Lip Support Chin Rest NOTICE The Chin...

Страница 37: ...if using the Bite Block to bite the notches CAUTION Evaluate the condition of the patient s dentition before using the Bite Block If the patient s teeth are more fragile than a normal healthy patient...

Страница 38: ...y on the incisors and the root tips of lower and upper incisors are parallel to the tilt light The ORTHOfocus feature automatically determines the optimum panoramic image layer enabling forgiving pati...

Страница 39: ...or similar between the patient s front teeth to separate the jaws 12 Check that the patient s head is straight and not rotated and the patient s midline coincides with the midsagittal light 13 Turn t...

Страница 40: ...g a Panoramic Bitewing or TMJ image 1 Ensure the correct patient positioning imaging program selection imaging parameters and ask the patient to stay still during the imaging process 2 Ask the patient...

Страница 41: ...nal is played 5 Hold the exposure button down until all movements have stopped NOTICE The device also plays a program end tone when the imaging process is complete 6 The Scout image appears on the GUI...

Страница 42: ...ifacts etc 16 Acknowledge the preview by pressing the OK button 17 Continue to take the next image if multiple images need to be taken 18 Press End Study to end the study or return to imaging program...

Страница 43: ...rfaces can be wiped clean with a soft cloth dampened with a mild detergent for example soapy water DO NOT use abrasive cleaning agents or polishes Surfaces that the patient touches All surfaces and pa...

Страница 44: ...f the reminders contact your service for assistance NOTICE QC programs produce X rays Protect yourself from radiation 7 2 1 PAN QC NOTICE The PAN QC is an optional yet recommendable procedure and is m...

Страница 45: ...er d Low contrast holes must be visible four holes if using 0 8 mm filter and two holes if using 1 8 mm filter NOTICE You should also compare the new QC image to the reference image taken during the i...

Страница 46: ...the GUI 9 The QC image appears on the workstation showing the result of the check 10 Workstation Visually evaluate the image using the dental imaging software for visual defects such as artifacts NOT...

Страница 47: ...7 Maintenance 11 If the image fails or any visual defects are apparent redo the QC program If it fails again recalibrate the device or contact service ORTHOPANTOMOGRAPH OP 3D 47...

Страница 48: ...the change the frequency of the re calibration reminders contact service for assistance The device must be re calibrated completely at least once a year by a service technician according to chapter Co...

Страница 49: ...on program by pressing the calibration name and follow the instructions on the GUI NOTICE Performed calibrations are indicated with green colour and the completion date of the calibration All calibrat...

Страница 50: ...tton to take the calibration image 4 When the exposure warning stops and the program end tone is played the program is complete 5 The calibration image appears on the GUI 6 Acknowledge the calibration...

Страница 51: ...erform the calibrations in this order 3D Geometry Calibration 5x5 FOV 3D Geometry Calibration 6x9 FOV 3D Geometry Calibration 9x11 FOV 3D Geometry Calibration 9x14 FOV 3D Geometry Calibration Phantom...

Страница 52: ...o oil is leaking from the tube head Check that all covers and mechanical parts are correctly secured and have not come loose Check that any vents in the covers are not blocked with dust and that no du...

Страница 53: ...power the device off or the image will be erased Device cannot be driven upwards or downwards 1 Up down slider is on safe mode 2 Mechanical safety device on the driving motor has activated 3 Positioni...

Страница 54: ...talled and the position from where the user takes images must be correctly shielded from the radiation that is generated when the device is operated Follow the local radiation and safety requirements...

Страница 55: ...irements When you install the device ensure that There is enough space at the front and sides of the device to allow patients to enter and exit the device easily Patients in wheelchairs will require m...

Страница 56: ...unting bolts for floor and wall fastening are not included in the delivery The fixing hardware used to fix the device to the wall must be of correct type for the wall The type and length of hardware t...

Страница 57: ...e switch and door switch PIN 1 2 3 4 5 6 7 8 SIGNAL EXPSW READY GND 5V WARNING DOORSW USE Exposure switch connection LOW signal when device is ready LOW signal when exposure is ON Door switch connecti...

Страница 58: ...Use spirit level to ensure that the wall and floor of the chosen installation location are straight enough to allow the device to be installed vertically straight 7 Detach the preinstalled installatio...

Страница 59: ...N If the device cannot be bolted to the floor an additional wall bracket or exhibition stand is required See chapter Additional wall bracket installation and Exhibition stand installation for more ins...

Страница 60: ...n covers Ensure that the outer column cover plate is properly in place and doesn t scratch the inner column cover 17 Attach the floor screw covers on the screw heads 18 Pull the carriage to the edge o...

Страница 61: ...ore information NOTICE If mains connection type needs to be changed see chapter Mains power configuration for more information 22 Move the carriage against the column NOTICE If the device is installed...

Страница 62: ...ng gets caught between the carriage and the column NOTICE A latch locks the carriage in place when it is lifted on to the column 26 Lift the carriage locking bolts 3 pcs up and tighten them to 25 Nm t...

Страница 63: ...to prevent it from falling down NOTICE Be careful not to scratch the unit with the metal supports attached to the plywood cover 29 Detach the plywood top cover and the metal supports on top of the car...

Страница 64: ...top shelf 2 screws 34 Detach the rotating unit support from the carriage 4 screws push the rotating unit outwards a bit and lift the support off from the rotating unit NOTICE The rotating unit can no...

Страница 65: ...cables will move when the unit is driven upwards Ensure that the cables connected to the device are long enough so that the unit can be driven to upmost position without causing any strain to the cab...

Страница 66: ...side covers together and ensure that they sit properly 5 Secure the side covers in place with the remaining four 4 screws NOTICE When securing the left cover ensure that the horizontal lasers sit in...

Страница 67: ...liding the mirror down to lock it in place 8 Route the mains cord exposure button cable Ethernet cable and other optional cables through the cable clamp on the rear of the device 9 Attach the back pan...

Страница 68: ...aps in the column and turning the upper side in place 11 Attach the filler strips over the gaps under the carriage back plate 12 Attach the patient handles with four screws Tighten the screws to 10 Nm...

Страница 69: ...e the head support into the rods 15 Attach the exposure button holder to the column or other metallic surface using its built in magnets or screw it to a non magnetic surface 16 Remove all remaining p...

Страница 70: ...the same network same subnet By default the device is configured to retrieve its IP address automatically from the DHCP server in the network For the network configuration with static IP address you m...

Страница 71: ...information on how to configure the imaging software for device connection required for the static IP address configuration NOTICE When configuring a static IP address it must be set for both the devi...

Страница 72: ...by inspecting the proper grounding of user touchable metallic parts 9 Check that the IEC 60601 1 leakage current levels are not exceeded 10 Check the functionality of the power switch 11 Check that t...

Страница 73: ...d in the PIN code protected Service menu NOTICE The calibrations programs in the Service menu are intended for service technicians only and not to be performed by the end user of the unit NOTICE The d...

Страница 74: ...the maximum height of the device required especially for low room installations No calibration tools are required when performing this calibration NOTICE The maximum height of the device must be at le...

Страница 75: ...g stops and the program end tone is played the program is complete 9 8 5 3D Pixel Calibration This program calibrates the sensor for 3D imaging No calibration tools are required when performing this c...

Страница 76: ...ensure that the positioning lights are correctly aligned If the lights do not hit the grooves they need to be re aligned See chapter Patient positioning light adjustment 4 Protect yourself from radia...

Страница 77: ...image appears on the GUI NOTICE If the collimator calibration fails and the GUI informs you to adjust the height or tilt of the collimator adjust the collimator according to chapter Collimator adjustm...

Страница 78: ...libration data for reconstructing 3D images NOTICE This calibration produces X rays Protect yourself from radiation Perform the calibrations in this order 3D Geometry Calibration 5x5 FOV 3D Geometry C...

Страница 79: ...optional NOTICE The PAN QC is an optional yet recommendable procedure and is mandatory to be performed where local regulations require it NOTICE The device s country selection needs to be configured...

Страница 80: ...c High contrast resolution the distinguishable line pair resolution should be 3 1 LP mm or better when using 0 8mm Copper filter 2 5 LP mm or better when using 1 8mm Copper filter d Low contrast holes...

Страница 81: ...e QC programs See chapter Device configuration 1 GUI Go to Settings menu 2 GUI Select Quality Control menu 3 GUI Select 3D QC program from the list 4 Attach the 3D QC phantom holder and the 3D QC phan...

Страница 82: ...d on the visible image quality NOTICE You should also compare the new QC image to the reference image taken during the installation or the latest service Doing this helps you ensure that the image qua...

Страница 83: ...e local regulations require it 1 GUI Go to Settings menu 2 GUI Select Quality Control menu 3 GUI Select Panoramic Beam Size Verification program from the list NOTICE The Panoramic Beam Size Verificati...

Страница 84: ...switch cable to the connector J2 inside the remote exposure switch 2 Attach the remote exposure switch to the wall with two screws NOTICE Guide the remote exposure switch cable through the small cut...

Страница 85: ...lug connection NOTICE If device has been delivered from the factory with plug connection it has already been configured accordingly To access the switch you must detach the Back panel plate by removin...

Страница 86: ...he fuse from the socket and replace it with a new one Install the fuse by pushing the fuse cap in and rotating it clockwise with a screwdriver The 10A and 15A fuses are physically of different sizes a...

Страница 87: ...rough the additional wall bracket holder 5 Lift the wall bracket holder up to the position where the rail has openings on both sides to fit the holder in 6 Slide the holder in the rail to the required...

Страница 88: ...Attach the device column on the exhibition stand See the installation instructions supplied with the exhibition stand for more details 3 Complete the installation according to the normal installation...

Страница 89: ...n which direction One full turn of the screw 360 equals about 0 7 mm 4 To rotate the collimator LEFT RIGHT loosen the two upper locking screws 1 the lower locking screw 2 and turn the adjustment screw...

Страница 90: ...ent is required only in special cases 1 Pull the left and right sensor collar cover halves downwards 2 Pull the inner collar cover half downwards to unlock the teeth holding the covers together 3 Pull...

Страница 91: ...lights are aligned improperly adjustment is needed to ensure correct patient positioning Correct alignment of the lights can be ensured by checking that the lights hit and are parallel to the grooves...

Страница 92: ...5 Re attach the covers NOTICE When reattaching the left side cover ensure that the horizontal lasers sit in the middle of the groove so that the cover does not block the positioning light beam 6 Attac...

Страница 93: ...e 3D Geometry Calibration Phantom to the device and verify the correct alignment of the lights with Device Geometry calibration program selected 6 Repeat the process if light is still not aligned corr...

Страница 94: ...e 3D image It is recommended to keep MAR activated Force device language Change the language of the GUI if needed It is recommended not to force the language of the GUI but change the language profile...

Страница 95: ...to country specific regulations for example change the maximum selectable mA for imaging NOTICE For PAN QC to be used with 1 8mm Cu filter select Germany Door Switch If an optional Door Switch has be...

Страница 96: ...b for 3D verification test The PAN Testing program allows adjustment of the exposure values kV and mA for the tests The 3D Testing program allows selection of different radiaton modes High ENDO Resolu...

Страница 97: ...column interconnection cables install the packaging supports back to their original place and install the plywood supports in reverse order to what is described in chapter Installing the device 10 Loo...

Страница 98: ...dards IEC60601 1 ed 3 Am1 IEC60601 1 3 ed 2 Am1 IEC60601 1 6 ed 3 1 IEC60601 1 9 ed 1 IEC60601 2 28 ed 2 IEC60601 2 63 ed 1 IEC60601 1 2 ed 4 ANSI AAMI ES60601 1 2005 A1 CAN CSA C22 2 No 60601 1 2014...

Страница 99: ...lip support and head support Use environment In environments where no flammable anesthetics nor flammable cleaning agents are present Mode of operation Continuous operation intermittent loading Safet...

Страница 100: ...Power consumption 2 3 kVA 220 240 VAC 1 65 kVA 100 120 VAC Maximum impedance of mains 0 2 Recommended circuit breaker max 30 mA Mains cord EU 16 A 250 VAC 50 60 Hz H05VV F3G1 5 US 15 A 125 VAC 50 60 H...

Страница 101: ...d Accuracy of radiation output 95 Panoramic 3D image detector Technology Sensor type CMOS Image receptor area 147 x 112 mm 5 78 x 4 4 User interface Program and technical factors selection exposure co...

Страница 102: ...specifications NOTICE The values given in this chapter apply to 220 240 VAC devices The technical factors and their ranges are limited and may differ from the given values when using a device configu...

Страница 103: ...P range LDT 280 m 2 0 4 0 mA 1 49 1 40 s 33 63 mGycm 2 Standard 200 m 4 0 12 5 mA 3 06 2 87 s 137 402 mGycm 2 High 125 m 2 0 4 0 mA 9 99 s 224 448 mGycm 2 5 x 5 ENDO 80 m 2 0 4 0 mA 20 0 s 448 895 mGy...

Страница 104: ...nfiguration Air KERMA production can be calculated by dividing the provided DAP value with the active sensor area 10 3 Patient contacting parts Part type Type of contact Contact duration Head Support...

Страница 105: ...6 5 96 2 in 188 mm 7 4 in 759 5 mm 29 9 in 60 15 mm 2 4 0 6 in 320 20 mm 12 6 0 8 in A 0 05m2 400 20 mm 15 7 0 8 in 20 mm 0 8 in 219 mm 8 6 in 450 mm 17 7 in 16 mm 0 6 in 900 1655 nominal 940 mm 35 4...

Страница 106: ...1 7 in 1100 mm 43 3 in 340 mm 13 4 in Absolute minimum dimensions Recommended minimum dimensions INSTALLATION IN MAX 15 ANGLE LEFT RIGHT 1377 mm 54 in max 15 max 15 99 mm 4 in 765 mm 30 in 1375 mm 54...

Страница 107: ...plywood supports to be removed before lifting the carriage on the column as they might hit the wall Absolute minimum dimensions Recommended minimum dimensions WALL BRACKET DIMENSIONS 450 mm 18 in 30...

Страница 108: ...r model number Caution Radiation warning Laser warning Radiation emitting device Type B Applied part Dangerous voltage On or enabled Off or disabled External warning light Exposure switch Remote expos...

Страница 109: ...e waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately Please contact an authorized representative of the manufacturer for inf...

Страница 110: ...ent Not to be used or installed near active HF SURGICAL EQUIPMENT and the RF shielded room of an ME SYSTEM for magnetic resonance imaging where the intensity of EM DISTURBANCES is high Table 1 Electro...

Страница 111: ...common mode 0 5 1 kV differential mode 0 5 1 2 kV common mode Mains power quality is that of a typical commercial and or hospital environment Voltage dips short interruptions and voltage variations on...

Страница 112: ...transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey are less than the complian...

Страница 113: ...applies NOTICE These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people USE LIMITATION External compone...

Страница 114: ...should be used no closer than 30 cm 12 to any part of the device including cables specified by the manufacturer Otherwise degradation of the performance of this equipment could result See Table 4 Sep...

Страница 115: ...10 Technical data ORTHOPANTOMOGRAPH OP 3D 115...

Страница 116: ...ith 4GB memory NVIDIA Quadro M2000 with 4GB memory NOTICE Always refer to the KaVo Driver documentation for details on the supported GPU and driver versions GPU requirements may change at any time whe...

Страница 117: ...representative for the most current information Copyright by PaloDEx Group Oy All rights reserved 216453 2 Headquarters PaloDEx Group Oy Nahkelantie 160 P O Box 20 FI 04301 Tuusula FINLAND Tel 358 10...

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