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1 Introduction

The manual applies to the following X-ray units:
•

Planmeca Viso G5

•

Planmeca Viso G7

NOTE

This manual is valid for Planmeca Viso software version 1.3.0 or later. This

software version is compatible with Planmeca Romexis software version

6.3.0 or later. To check the software version of your X-ray unit, select

Settings > About > 4100 Component Information > Viso ProTouch SW

Version.

Make sure that you are fully acquainted with the appropriate radiation

protection measures and these instructions before you use the X-ray unit.

Note that your X-ray unit may not feature all the options described in these

instructions. Refer to section "Licences (1700)" on page 89 for a list of

available licences.
These instructions include options that may not be available in all countries.

NOTE

The X-ray unit may be used by health care professionals only.

NOTE

Cone beam imaging should not be used for routine (or screening)

examinations. The imaging examinations must be justified for each patient to

demonstrate that the benefits outweigh the risks.

1.1 Device description

The X-ray unit uses cone beam computed tomography (CBCT) to produce

three-dimensional (3D) images of the maxillofacial and ENT anatomies.

Two-dimensional (2D) images are produced with the tomosynthesis method

(panoramic imaging) as well as conventional 2D radiography (cephalometric

imaging, 2D views). If the X-ray unit has an active ProFace licence, you can

take a 3D photo of the patient's face.
In CBCT a cylindrical volume of data is captured in one imaging procedure.

The data consists of several hundred sample images which are taken from

different directions to cover a certain pre-programmed target area. These

samples are used for 3D reconstruction (using a separate 3D reconstruction

PC) that can be viewed in three dimensions using a separate workstation

and the Planmeca Romexis software.

1.2 Intended use

The X-ray unit system is a system intended to produce two-dimensional (2D)

and three-dimensional (3D) digital x-ray images as well as three-dimensional

(3D) and four-dimensional (4D) optical images of the dento-maxillo-facial,

cervical spine and ENT (Ear, Nose and Throat) regions at the direction

of healthcare professionals as diagnostic support for pediatric and adult

patients.
The 3D face photo can be used for patient education or in order to follow the

results of medical treatments.

1 Introduction

User's manual

Planmeca Viso 1

Содержание Viso

Страница 1: ...Planmeca Viso user s manual EN 30005931 30005931...

Страница 2: ...o the appropriate requirements such as IEC 60364 equipment is used according to the operating instructions Planmeca pursues a policy of continual product development Although every effort is made to p...

Страница 3: ...unit 17 8 3 Patient supports 18 8 4 Exposure switch 19 8 5 Emergency stop button 19 8 6 Control panel 20 9 Before exposure 27 9 1 Preparing X ray system 27 9 1 1 Attaching patient supports 27 9 1 2 P...

Страница 4: ...12 2 Running QA test 77 12 3 Post test process 81 13 Settings 82 13 1 User settings 82 13 1 1 Language 1100 82 13 1 2 Operational Settings 1300 83 13 1 3 Network Settings 1400 85 13 1 4 Testing Routin...

Страница 5: ...puted tomography CBCT to produce three dimensional 3D images of the maxillofacial and ENT anatomies Two dimensional 2D images are produced with the tomosynthesis method panoramic imaging as well as co...

Страница 6: ...2 1 Usage environment This X ray unit is intended to be used in a professional healthcare environment such as dental offices clinics and similar environments 1 Introduction 2 Planmeca Viso User s manu...

Страница 7: ...ntation for the Planmeca Romexis program The Romexis package contains the following manuals User s Manual Technical Manual The original language of the manuals is English NOTE The User s Manuals are a...

Страница 8: ...g smartphone hold the device steady over the QR code shown on the screen You are directed to Planmeca s product registration page Go to Planmeca s product registration page at https www planmeca com...

Страница 9: ...ith EU 2017 745 Separate collection for electrical and electronic equipment according to Directive 2012 19 EU WEEE Consult electronic instructions for use Standard ISO 7000 1641 Refer to instruction m...

Страница 10: ...Warning hot surface Standard ISO 7010 General warning Standard ISO 7010 4 Symbols 6 Planmeca Viso User s manual...

Страница 11: ...ponsibility of the user to ensure that all local safety requirements are met CAUTION The patient positioning lights are laser lights Do not stare into the laser beam CAUTION If an exposure is interrup...

Страница 12: ...t when you move the X ray unit down If something is in danger of becoming trapped release the height adjusting slider immediately to stop the movement Clear any obstruction before moving the X ray uni...

Страница 13: ...ays first move the X ray unit down before you position the patient in the X ray unit NOTE Cone beam imaging should not be used for routine or screening examinations The imaging examinations must be ju...

Страница 14: ...ditioning in the X ray room It is recommended to keep the room temperature between 20 C and 25 C at all times NOTE If exposures are taken in rapid succession the X ray tube may overheat and a cooling...

Страница 15: ...nput signal output or other connectors has formed a system and is therefore responsible for the system to comply with the requirements of IEC 60601 1 If in doubt contact your service technician or loc...

Страница 16: ...NOTE Portable mobile devices and other high frequency electromagnetic energy emitting devices used close to the X ray system may affect the system s performance Diagnostic information of the X ray im...

Страница 17: ...n safety and or radiation safety for cone beam computed tomography devices Pediatric X ray Imaging http www fda gov Radiation EmittingProducts RadiationEmittingProductsandProcedures ucm298899 htm Medi...

Страница 18: ...values for current exposure on page 43 2D panoramic exposure and Adjusting exposure values for current exposure on page 60 3D exposure The X ray unit provides the following specific testing informati...

Страница 19: ...he X ray system off when it is not in active use 7 1 Switching X ray unit on The on off switch is located on the underside of the column top 7 2 Switching 3D reconstruction PC on The on off switch is...

Страница 20: ...8 Main parts 8 1 General view of X ray system 1 X ray unit 2 3D reconstruction PC 3 Planmeca Romexis program 4 Ethernet switch 8 Main parts 16 Planmeca Viso User s manual...

Страница 21: ...tient supports see section Patient supports on page 18 4 Patient handles 5 Touch screen see section Control panel on page 20 6 Moving column 7 Stationary column 8 Emergency stop button see section Eme...

Страница 22: ...emple pads for children optional 4 Fastening straps optional 5 Support bars 6 Bite piece for panoramic exposures 7 Chin rest for panoramic exposures 8 Chin cup 9 Chin support for panoramic exposures 1...

Страница 23: ...xposure a yellow radiation warning light illuminates on the exposure switch It indicates that the X ray unit is generating radiation 1 Exposure switch 2 Exposure button 8 5 Emergency stop button Press...

Страница 24: ...ples NOTE The X ray unit can be upgraded with new programs and features Contact your dealer for further information NOTE Never allow patients to touch the screen when they are positioned in the X ray...

Страница 25: ...display varies depending on which Viso model is in use The control panel pictures used in this manual are example images only and may not correspond to for example the Planmeca Viso G5 display Home bu...

Страница 26: ...ram group button Accept button To accept a selection select the green check mark button Cancel button To cancel a selection and close a pop up window select the red cross button Home button To go to t...

Страница 27: ...uch screen to move the X ray unit up or down Move the slider up to move the X ray unit up Move the slider down to move the X ray unit down The X ray unit moves slowly at first then faster About circle...

Страница 28: ...on Checking DAP value DAP Dose Area Product The DAP value shown on the screen before you take an exposure is an estimate The actual DAP value is shown after the exposure Patient name When a patient is...

Страница 29: ...you wish to practice or demonstrate the functions of the X ray unit without radiation and PC connection For more information see section Operational Settings 1300 on page 83 You see these symbols in...

Страница 30: ...Closing virtual control panel Click on this cross if you need to close the virtual control panel on the computer screen 8 Main parts 26 Planmeca Viso User s manual...

Страница 31: ...port base Steps 1 Press the trigger down and hold 2 Attach the adapter by sliding it into place in an upright position 3 Release the trigger 9 1 1 2 Removing adapter About this task Follow these instr...

Страница 32: ...supports below for edentulous patients or for patients who are unable to bite 9 1 1 4 Attaching chin supports for 3D exposures Steps 1 Attach the support shown below to the adapter PNE_Chin3 eps 9 1 1...

Страница 33: ...s 1 Release the locking lever 2 Pull out the head support 9 1 1 7 Attaching support bars About this task Follow these steps to attach the support bars to the patient support base Steps 1 Remove the pl...

Страница 34: ...nnecting pins when inserting it into the patient support base to keep it steady Results The support bar is locked into place when you hear a clicking sound 9 1 1 8 Removing support bars Steps 1 Pull t...

Страница 35: ...to adjust the head support to suit the size of the patient s head 3 You can use temple pads when you take exposures of children or patients with a small head Slide the temple pads onto the head suppo...

Страница 36: ...ad as shown NOTE Be careful when you handle the straps Do not let the straps hit the patient in the eye or face NOTE Do not overstretch the straps The straps lose their elasticity if you pull them mor...

Страница 37: ...spectacles hearing aids dentures hairpins and personal jewellery such as earrings necklaces and piercings as these can produce shadows or reflections in the image The patient should also remove any lo...

Страница 38: ...maging and provides a wide exposure that shows the entire exposure area on a single plane Bitewing The Bitewing program produces bitewing images from premolar and molar areas including parts of maxill...

Страница 39: ...rojections of the maxillofacial region as shown in the example below 1 Planmeca Viso G5 projection example results 2 Planmeca Viso G7 projection example results 10 2 Selecting imaging program Steps 1...

Страница 40: ...ight corner of the imaging program option 10 3 Patient positioning Steps 1 Guide the patient to the X ray unit when you see this message NOTE The message does not display if the fast forward option is...

Страница 41: ...en their back and neck and bite the bite piece The upper and lower incisors must be in the groove in the bite piece NOTE If you are using the chin support position the patient so that the chin touches...

Страница 42: ...ith the midsagittal plane laser light The midsagittal plane laser light is shown in the middle of the patient s face 5 If you use the rear head support you can slide it up or down for optimal support...

Страница 43: ...camera images of the patient s head on the control panel a front view and a side view The preset position of the panoramic image layer is shown with a blue area in both views Carefully position the pa...

Страница 44: ...between the patient s second incisor and the canine The selected position is shown in the bottom right corner e g 1 mm Position the apices of the patient s upper central incisors within the image lay...

Страница 45: ...Use the segmentation buttons to select the active exposure areas 10 2D exposure User s manual Planmeca Viso 41...

Страница 46: ...re still correctly positioned Reposition them if necessary 10 4 Selecting patient size Steps 1 Use this button to select the patient size XS Child S Small adult M Medium sized adult L Large adult XL E...

Страница 47: ...posure values are shown in the following table Factory presets for panoramic exposures Patient size kV value mAs value Child XS 64 110 Small adult S 66 125 Medium sized adult M 68 140 Large adult L 70...

Страница 48: ...patient in the Planmeca Romexis program About this task Follow these steps to take a 2D Panoramic exposure Steps 1 Select the forward button Green lights flash on the control panel and exposure button...

Страница 49: ...yellow radiation warning lights illuminate on the exposure switch and on the control panel Additionally you hear a radiation warning tone and see a radiation warning symbol on the control panel You ca...

Страница 50: ...rom the X ray unit 7 The image is shown on the computer screen Results The image is shown on the computer screen 10 6 2 2D View exposure Before you begin Make sure that you have selected the correct p...

Страница 51: ...rol panel and exposure button when the X ray system is getting ready for an exposure You see this message NOTE Move to a protected area The green lights stop flashing and stay on continuously when the...

Страница 52: ...tch and on the control panel Additionally you hear a radiation warning tone and see a radiation warning symbol on the control panel You can follow the imaging process on the virtual control panel NOTE...

Страница 53: ...ake the exposure with the same settings Select this button if you want to go to the home screen 7 Release the patient from the head support 8 Guide the patient away from the X ray unit Results The ima...

Страница 54: ...11 3D exposure 11 1 3D dental programs 3D dental programs include 3D programs 3D ENT programs Special programs 3D programs 3D ENT programs 11 3D exposure 50 Planmeca Viso User s manual...

Страница 55: ...size Volume range Note Tooth 50 50 mm 30 30 mm 60 60 mm 5 mm steps 75 m voxel possible only with volumes smaller than 70 x 70 mm TMJ 50 50 mm 30 30 mm 60 60 mm 5 mm steps Teeth 100 100 mm 70 30 mm 120...

Страница 56: ...ize Volume range Note Tooth 50 50 mm 30 30 mm 60 60 mm 5 mm steps 75 m voxel possible only with volumes smaller than 70 x 70 mm TMJ 50 50 mm 30 30 mm 60 60 mm 5 mm steps Teeth 90 90 mm 70 30 mm 90 90...

Страница 57: ...TE When taking a 3D image for jaw tracking with the Planmeca 4D Jaw Motion system select the Face program See Planmeca Viso 4D Jaw Motion user s manual for more information Results The sensor moves to...

Страница 58: ...ient can sit or stand during the exposure NOTE We recommend that you image patients with poor health in a sitting position 2 Use the height adjusting slider on the touch screen to move the X ray unit...

Страница 59: ...ou use the rear head support you can slide the rear head support up or down for optimal support of the patient s head 6 If you use the top head support You can adjust the head support by turning the a...

Страница 60: ...patient s left or right side About this task Follow these instructions to select the patient s left or right side NOTE This function is not available for the Skull program The sensor contains digital...

Страница 61: ...to the selected side and an image of that side is shown on the screen You see this message Patient s left side selected Patient s right side selected 11 5 Selecting patient size Steps 1 Use the butto...

Страница 62: ...images of the patient s head on the control panel a front view and a side view The preset position and size of the image volume are shown with a blue area in both views You can use either or both view...

Страница 63: ...her adjusted in that direction The selected volume size diameter and height is shown in the bottom right corner of the screen Viso_UM_M096 eps NOTE With Tooth program you can alternatively use the but...

Страница 64: ...OTE The available options depend on the selected program NOTE The exposure values will automatically change according to the selected patient size image resolution and ULD setting The preset exposure...

Страница 65: ...2 120 20 Factory presets for Sinus Nose and Airways programs Child XS Small adult S Medium sized adult M Large adult L Extra large adult XL Voxel size kV mAs kV mAs kV mAs kV mAs kV mAs 600 90 14 90 1...

Страница 66: ...nt correction button 4 if you wish to minimise the effects of movements on the image The Planmeca CALM function is an algorithm that detects patient movement during exposure and then compensates for t...

Страница 67: ...utomatically saved in the Planmeca Romexis program under 2D images CBCT tab Make sure that you have selected the correct patient in the Planmeca Romexis program NOTE The scout view function can yield...

Страница 68: ...s flash on the control panel and exposure button when the X ray system is getting ready for an exposure You see this message NOTE Move to a protected area The green lights stop flashing and stay on co...

Страница 69: ...Additionally you hear a radiation warning tone and see a radiation warning symbol on the control panel 7 If needed you can now fine adjust the volume position and size To fine adjust the volume positi...

Страница 70: ...and move the ball to enlarge or reduce the volume size The ball turns red when you reach the limit value i e when the volume diameter or height cannot be further adjusted in that direction The select...

Страница 71: ...ibed above Make new fine adjustments until the image volume is in the correct place 11 11 Taking 3D exposure Before you begin Make sure that you have selected the correct patient in the Planmeca Romex...

Страница 72: ...e button when the X ray system is getting ready for an exposure You see this message NOTE Move to a protected area The green lights stop flashing and stay on continuously when the X ray system is read...

Страница 73: ...trol panel If you take a skull exposure with two image volumes the lower volume 1 2 is imaged first and the upper volume 2 2 last The C arm is automatically moved up between the volumes You can follow...

Страница 74: ...elected the second phase of the exposure i e the image of the selected exposure area is taken NOTE In this phase no radiation is used The C arm moves around the patient s head and the image is generat...

Страница 75: ...ime depends on the selected settings For example if you selected the ULD Ultra Low Dose button you have to wait longer before the image appears If you took a skull exposure with two image volumes you...

Страница 76: ...e screen until the Frankfort line and the patient s eye are correctly positioned as shown in the image below NOTE You can move the Frankfort line and eye markers using a finger touch screen or the mou...

Страница 77: ...NOTE Do not release the exposure button before the end of the exposure s NOTE Maintain audio and visual contact with the patient and X ray unit during exposure If the C arm stops moving during exposur...

Страница 78: ...to retake the exposure with the same settings Select this button if you want to go to the home screen 7 Remove the fastening straps if used Release the patient from the head support 8 Guide the patie...

Страница 79: ...Results The image is shown on the computer screen 11 3D exposure User s manual Planmeca Viso 75...

Страница 80: ...compatibility CAUTION Only qualified service technicians may perform QA testing using the full Planmeca Device Tool installation If performing the QA test using the Device Tool QA program read this s...

Страница 81: ...the 3D QA phantom to the patient support base 2 Switch on the X ray unit 3 Start the Device Tool QA in the clinic computer 4 From the Device Tool launcher select the VISO left option 12 3D quality con...

Страница 82: ...ton to continue Planmeca QA tests consists of the following test QA 3D C Arm Center QA 3D Middle Arm Center QA 3D Middle Arm Offset 8 Select the QA 3D C Arm Center from the calibration task list if no...

Страница 83: ...and click the Start button 11 Press the exposure button to take the exposure CAUTION Protect yourself from radiation The following image view appears 12 Select the QA 3D Middle Arm Offset from the ca...

Страница 84: ...report page you can select which of the QA tests you want to include in the report 15 Once your selections are ready click Create Report The report opens in a new browser window For more information o...

Страница 85: ...ith Pass example below QA test passes After successful QA test remove the 3D QA phantom from the patient support table QA test fails If the QA test fails the unit is not correctly adjusted and calibra...

Страница 86: ...only examples Select the settings symbol on the main screen to enter the settings menu Settings that can be entered by the user User About Settings that can be entered by service personnel only passwo...

Страница 87: ...e you wish to use 3 Select the green check mark button 13 1 2 Operational Settings 1300 13 1 2 1 Mode 1310 Steps 1 Select User 1300 Operational Settings 1310 Mode 2 Select the mode you wish to use 131...

Страница 88: ...diation and PC connection 1312 Normal Mode 3 Select the green check mark button 13 1 2 2 Scout Settings 1320 Steps 1 Select User 1300 Operational Settings 1320 Scout Settings 2 Select the default scou...

Страница 89: ...1600 on page 88 13 1 3 Network Settings 1400 About this task Follow these steps to view network settings Steps 1 Select User 1400 Network Settings 2 Select the network settings you wish to view 3 Sel...

Страница 90: ...cted area 5 Press and hold down the exposure button for the duration of the exposure The C arm does not move when you take a test exposure 6 Select the green check mark button 13 1 4 2 3D test exposur...

Страница 91: ...n a tube head seasoning process This is necessary if the X ray unit has not been used for a week or more and or if you receive error message E332 Severe arcing across X ray tube 2 Select the START but...

Страница 92: ...Exposure Values 1600 Steps 1 Go to 1600 Exposure Values to check the default kV and mA settings for 3D or Panoramic imaging The values can be adjusted as follows 5 kV increments for 3D 2 kV increments...

Страница 93: ...e a program licence Steps 1 Select User 1700 Licences 2 Select the licences you wish to activate 3 Enter the licence code that you have received for this licence on this X ray unit 4 Select the green...

Страница 94: ...ponent Information Show Component Information to view the set up or current software versions of the X ray unit To view software build information Select About 4100 Component Information Show Detailed...

Страница 95: ...ect About 4200 Archive 4210 Error History to view a list of the error messages that have been generated by the X ray unit The errors are shown in chronological order with the latest error message on t...

Страница 96: ...0 Archive 4220 Exposure Statistics to view statistical data about the X ray unit 13 2 3 Product Registration 4300 For more information on product registration see section Product registration on page...

Страница 97: ...Contact your service technician if you need to replace the exposure switch H105 Emergency stop button The emergency stop button has been activated All movements of the X ray unit are blocked and no r...

Страница 98: ...e C arm cannot be moved higher Clear any obstruction before continuing H150 Height movement was stopped because the patient support base cannot be moved lower Clear any obstruction before continuing H...

Страница 99: ...nsmission Exposure was interrupted Contact your service technician for help H186 No IP address defined for 3D sensor H187 Problem during image data transmission Exposure was interrupted Contact your s...

Страница 100: ...an error message e g E201 appears on the control panel An error message indicates that the X ray unit has a problem that needs to be solved before further exposures can be taken The X ray unit will n...

Страница 101: ...acturers NOTE Follow the instructions provided by the manufacturer of the cleaning agent disinfectant and autoclave NOTE FOR SPRAYS LIQUIDS AND FOAMS Do not apply sprays liquids or foams directly on t...

Страница 102: ...Patient supports 16 Cleaning and disinfection 98 Planmeca Viso User s manual...

Страница 103: ...Patient handles and touch screen NOTE These parts can be autoclaved at 134 C 273 F They can be autoclaved at least up to 100 times 16 Cleaning and disinfection User s manual Planmeca Viso 99...

Страница 104: ...Wipe the other surfaces regularly using a Planmeca approved surface disinfectant Use a Planmeca approved cleaning agent for cleaning stains and dirt if needed 16 Cleaning and disinfection 100 Planmeca...

Страница 105: ...arantee patient and user safety and ensure consistent image quality The annual maintenance service includes inspection of the following X ray unit adjustments and quality control checks Data security...

Страница 106: ...ponents containing hazardous materials must be disposed of in accordance with waste legislation and instructions issued by the local environmental authorities The following parts contain hazardous was...

Страница 107: ...mm Al 0 2 mm 0 5 mm Cu Pan SmartPan ProCeph Total 2 5 mm Al Tube housing front cover quality equivalent filtration not included in the specified total filtration 0 3 mm Al 70 kV HVL 2 6 mm Al Anode v...

Страница 108: ...nt 8 17 A Input power Stand by 150 VA Exposure 1800 W Line harmonics Cos better than 0 9 Max permissible apparent impedance of supply mains 0 5 ohm 100 VAC Max continuous heat dissipation 250 W Intern...

Страница 109: ...mm 11 89 x 9 80 in 3D Flat panel pixel size Planmeca Viso G5 127 m Planmeca Viso G7 139 m Flat panel active surface Planmeca Viso G5 157 5 x 157 5 mm 6 20 x 6 20 in Planmeca Viso G7 299 7 x 246 3 mm 1...

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Страница 112: ...Planmeca Oy Asentajankatu 6 00880 Helsinki Finland tel 358 20 7795 500 fax 358 20 7795 555 sales planmeca com www planmeca com...

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