Air Techniques Rxonly ProVecta 3D Prime Operating Instructions Manual Download Page 19 | Manualshive

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4.3

Model identification plate

1

2

1

Type plate of the unit

2

Type plate of the X-ray tube

4.4

Conformity assessment

This device has been subjected to conformity
acceptance testing in accordance with the cur-
rent relevant guidelines of the European Union.
This equipment conforms to all relevant require-
ments.

Product description

2210200496L41 1911V006

17

EN-
US

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Summary of Contents for Rxonly ProVecta 3D Prime

Page 1: ...EN US ProVecta 3D Prime Operating instructions 2210200496L41 2210200496L41 A7766 1911V006...

Page 2: ......

Page 3: ...itioning aids 19 5 5 Exposure button 20 5 6 Memory card slot 20 5 7 Sensor window 20 Usage 6 Operating the touch screen 21 6 1 Navigating 21 6 2 Using menus 21 6 3 Calling up messages on the touch scr...

Page 4: ...cians 48 Appendix 12 Program parameters 50 12 1 CBCT program parameters 50 12 2 Panoramic program parameters 50 13 Information on scattered radiation 52 13 1 CBCT scattered radiation 52 13 2 Pano sca...

Page 5: ...ing sym bols General warning symbol The warnings are structured as follows SIGNAL WORD Description of type and source of danger Here you will find the possible conse quences of ignoring the warning Fo...

Page 6: ...ask Wear protective clothing Disconnect all power from the unit Notice Emergency stop switch CAUTION X RAY ATTENTION X RAY ON WHEN EQUIPMENT IN OPERATION Warning X rays Warning risk of dangerous elect...

Page 7: ...information Comply with the guidelines laws rules and regulations applicable at the site of operation when you use this unit Prior to each use check the function and proper condition of the device Do...

Page 8: ...n a residential environment which normally requires Class B in accordance with CISPR 11 this device may not provide ade quate protection from radio communication services The operator may need to take...

Page 9: ...packaging away from children Reattach the transport locking devices Do not expose the unit to any strong vibrations or shocks Do not bump or pull the unit 2 13 Disposal Device The units and electronic...

Page 10: ...a 6 Small parts set e g screws nuts 7 Exposure switch with holder 8 Head supports with cushion 9 Hygienic protective covers for bite block 10 Bite block 11 Adapter for bite block 12 Chin holder for ma...

Page 11: ...from the manufacturer 3 2 Optional items The following optional items can be used with the device Bottom wall bracket set 16 inch short wall wall installation A7754 Fiber optic cable 5 m A7757 Fiber o...

Page 12: ...uthorized by Air Techniques Classification Medical device of class IIb FDA classification CFR Title 21 II General technical data Dimensions W x D mm in 572 5 x 1181 12 22 54 x 46 50 0 47 Height mm in...

Page 13: ...del Toshiba D 052SB Focal spot size as per IEC 60336 X ray tube mm in 0 5 0 02 Anode angle 5 Anode heat capacity kJ 35 Pulse break ratio 1 60 or more Duration of radiation exposure s 0 5 20 Maximum cu...

Page 14: ...V 70kV 60kV 50kV Maximum Rating Charts DC Center Grounded 1 2 3 4 5 6 5 10 20 25 15 0 2 9 3 0 3 1 3 2 3 3 3 4 3 5 Constant potential high voltage generator Nominal Focus Spot Value 0 5 TUBE CURRENT mA...

Page 15: ...m in 230 x 160 x 26 9 06 x 6 30 x 1 02 Active surface area mm in 135 8 x 36 4 5 35 x 1 43 Frame rate fps 53 5 107 2x2 binning 308 4x4 binning Greyscale bit 14 Acquisition mode FDD mm in FOD mm in ODD...

Page 16: ...electricity IEC 61000 4 2 2008 8 kV contact 2 kV 4 kV 8 kV 15 kV air Conforms Immunity to interference by high frequency electromag netic fields IEC 61000 4 3 2006 A1 2007 A2 2010 3 V m 80 MHz 2 7 GHz...

Page 17: ...kHz repetition frequency Conforms Immunity to interference line line IEC 61000 4 5 2005 0 5 kV 1 kV Conforms Immunity to interference by surges line earth IEC 61000 4 5 2005 0 5 kV 1 kV 2 kV Conforms...

Page 18: ...n 1406 mm 55 35 in 1963 mm 77 28 in 601 mm 23 66 in 2090 mm 82 28 in 345 12 mm 13 58 0 47 in 1181 4 12mm 46 51 0 47 in 1545 12 mm 60 83 0 47 in 1212 mm 47 72 in 572 5 mm 22 54 in Product description 1...

Page 19: ...X ray tube 4 4 Conformity assessment This device has been subjected to conformity acceptance testing in accordance with the cur rent relevant guidelines of the European Union This equipment conforms t...

Page 20: ...via a reconstruction computer a grey value coor dinate image is generated in the three spatial dimensions This three dimensional coordinate model corresponds to a volume graphic that is made up of in...

Page 21: ...7 Mid sagittal positioning beam 8 Grips The applied parts in accordance with IEC 60601 1 are Grips Head supports with cushion Positioning aids e g bite block and mounting for bite block chin support...

Page 22: ...e 1 2 1 Indicator lamp LED 2 Exposure button 5 6 Memory card slot The unit has a slot for a memory card The slot is needed for service purposes only 5 7 Sensor window The active sensor surface is indi...

Page 23: ...To open the menu tap Fig 2 Example expanded menu Select a command 6 3 Calling up messages on the touch screen The Messages view shows a history of all previ ous messages Messages are subdivided into...

Page 24: ...e C shaped angle connector piece is positioned Persons can be injured during this Nobody may be present in the area of the rotating unit arm while the unit is being switched on Use the main power swit...

Page 25: ...rs are correct con tinue to work directly on the unit Parameter overview Depending on the chosen image acquisi tion program different parameters are available e g the image volume is not available for...

Page 26: ...Narrow jaw arch Wide jaw arch Child s jaw arch Usage 24 2210200496L41 1911V006 EN US...

Page 27: ...volume of 5x5 cm Resolution 120 m CBCT 5x5 Mandible Molar right The X ray image depicts the right molar region of the mandible with a volume of 5x5 cm Resolution 120 m CBCT 5x5 Mandible Premolar righ...

Page 28: ...ly shows the right dental area Left The image only shows the left dental area Orthogonal The image shows the complete dental area and is generated perpendicular to the maxillary arch This prevents ove...

Page 29: ...ngs Temporomandibular imaging Maxillary joint lateral The image shows the lateral maxillary joints for an open and closed mouth in 4 fold depiction in one image Maxillary joint PA The image shows the...

Page 30: ...Sinus images Sinus PA The X ray image shows the posterior anterior sinuses Usage 28 2210200496L41 1911V006 EN US...

Page 31: ...article is damaged after use and cannot be reused Dispose of single use articles after use Inserting the head supports If no head supports are inserted or if they are dirty insert new head supports b...

Page 32: ...ock is used without a hygienic protective cover refer to the instructions under Inserting the positioning aid for panoramic images with hygienic protec tive cover optional and the reprocessing instruc...

Page 33: ...hygienic protective cover If the bite block is used without a hygienic protective cover refer to the instructions under Inserting the positioning aid for panoramic images with hygienic protec tive cov...

Page 34: ...ng instruc tions Optionally place a hygienic protective cover over the bite block Inserting the positioning aid for the maxillary joint image Correct image acquisition is only possible with the chin s...

Page 35: ...med that he she can press the emergency stop switch in the event of anxiety during image acquisition The patient has been informed that he she has to place his her tongue against the roof of the mouth...

Page 36: ...upper lip against the chin support Sinus image acquisition Position the patient so that his her bottom lip presses lightly against the chin support Adjusting the position with the positioning beams T...

Page 37: ...nt over extends the cervical vertebral column to the rear by approx 10 to 15 Fig 3 Frankfurt plane laser height at the lower edge of the eyes Correct any inclination of the head via the height of the...

Page 38: ...fly don t press and hold The head supports automatically touch against the head of the patient at a defined pressure 7 5 Start a test run The test run ensures that the unit can perform the image acqui...

Page 39: ...the unit is ready to take an image Trigger the image by pressing and holding the button on the exposure switch until the acous tic signal stops and the control lamp goes out The scan times depend on...

Page 40: ...urned to its starting position by touching Start position Otherwise the C shaped arm is positioned via the imaging soft ware during adjustment of the parameters 7 7 Emergency stop switch The emergency...

Page 41: ...s switched on and the parameters are confirmed on the touch screen the C shaped angle connector piece is positioned Persons can be injured during this Nobody may be present in the area of the rotating...

Page 42: ...g it with disinfectant Only clean the touch screen with a soft cloth and a commercially available cleaning agent The surface of the unit must be cleaned and dis infected if it is contaminated or soile...

Page 43: ...fection wipe Alternatively use a quick acting surface disin fectant on a soft lint free cloth Comply with the operating instructions of the disinfectant Reprocessing the cushions see 9 Reprocess ing U...

Page 44: ...upports Plus non critical The operator is responsible for correct classifica tion of the medical products defining the reproc essing steps and performing the reprocessing 9 2 Reprocessing procedure in...

Page 45: ...e free and display material com patibility with the product Only use disinfectants that are aldehyde free and display material compatibility with the product Do not use any rinse aid danger of toxic r...

Page 46: ...issed by the rinsing process Secure the components with a suitable fixture of the washer disinfector 9 7 Check for function After the end of the cleaning and disinfection cycle check the components fo...

Page 47: ...se of the medical device after reprocessing 9 10 Storing parts for sterilization Comply with the stated storage conditions Store the parts protected against contami nation Dust protected e g in a lock...

Page 48: ...ction inter val Inspection work Every 3 years Functional test of the display Are all symbols displayed Functional test of the exposure button Do the various status LEDs light up Check that the mechani...

Page 49: ...ntenance work Every 3 years Visually and acoustically check the linear movement on the rotating unit Check the operation of the lift motor Does the unit lift and lower with minimal noise Usage 2210200...

Page 50: ...ltage Check the mains cable and electrical connection replace if necessary Contact technician Check the mains fuse in the building On off switch is defective Contact technician Unit not responding The...

Page 51: ...ured Make the user account con trol settings according to the information in the installation instructions USB dongle not detected Check whether the USB don gle included in scope of deliv ery is plugg...

Page 52: ...normal image volume 5x5 11 s 4 0 mA 6 3 mA 8 0 mA 10 0 mA 11 0 mA mGy mGyc m2 mGy mGyc m2 mGy mGyc m2 mGy mGyc m2 mGy mGyc m2 79 kV 3 02 118 85 4 63 182 22 5 88 231 56 7 36 289 75 8 08 318 22 94 kV 4...

Page 53: ...12 5 mA 14 0 mA mGy mGycm2 mGy mGycm2 74 kV 17 27 108 81 19 38 122 11 80 kV 19 76 124 46 22 17 139 68 Appendix 2210200496L41 1911V006 51 EN US...

Page 54: ...458 8 287 6 89 3 180 12 9 4 6 1 3 225 410 5 288 7 98 2 270 663 2 301 4 112 4 315 429 7 194 2 92 3 13 2 Pano scattered radiation Test equipment Dosimeter Radcal 9015 Test conditions Program parameters...

Page 55: ...4 5 mR h 110 0 mR h 14 9 mR h 120 0 mR h 15 3 mR h 130 0 mR h 15 8 mR h 135 0 mR h 16 5 mR h 140 0 mR h 14 8 mR h 150 0 mR h 15 mR h 160 0 mR h 0 mR h 170 0 mR h 0 mR h 180 0 mR h 0 mR h 190 0 mR h 0...

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Page 60: ...her the need is digital imaging utility room equipment or merchandise Air Techniques can provide the solution via our network of authorized professional deal ers Air Techniques family of quality produ...

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