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NOTE

EMC requirements have to be considered, and the equipment must be

installed and put into service according to the specific EMC information

provided in the accompanying documents.

NOTE

Portable and mobile RF communications equipment can affect the X-ray

unit.

NOTE

External equipment intended for connection to signal input, signal output or

other connectors, shall comply with relevant IEC standard (e.g. IEC 60950

for IT equipment and the IEC 60601 series for medical electrical equipment).

In addition, all such combinations - systems - shall comply with the standard

IEC 60601-1, Safety requirements for medical electrical systems. Equipment

not complying to IEC 60601 shall be kept outside the patient area (more

than 2m (79 in.) from the X-ray unit). Any person who connects external

equipment to signal input, 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

local representative for help.

NOTE

Contact your service technician if you notice a decrease in image quality.

NOTE

If you take an exposure but the image does not appear in the Planmeca

Romexis program, you can import the image manually into Romexis. Refer

to the Planmeca Romexis User's Manual for details.

NOTE

Do not handle liquids near or on the X-ray unit.

NOTE

Never place or hang any objects on any part of the X-ray unit.

NOTE

Make sure that neither you nor your patient can get caught or hooked up on

any part of the X-ray unit. Keep loose items of clothing, hair and jewellery

tucked away safely.

NOTE

Do not touch the arm structures when the X-ray unit is moving.

5  Safety precautions

User's manual

Planmeca Viso G7 9

Содержание Viso G7

Страница 1: ...PlanmecaViso user s manual EN 30005931...

Страница 2: ......

Страница 3: ...button 18 8 6 Control panel 19 9 Before exposure 25 9 1 Preparing X ray system 25 9 1 1 Attaching patient supports 25 9 1 2 Preparing Planmeca Romexis 30 9 2 Preparing patient 30 10 2D panoramic expo...

Страница 4: ...equired 60 12 2 Test procedure 61 12 3 Evaluating test results 64 13 Help messages 66 14 Error messages 69 15 Cleaning and disinfection 70 15 1 Patient supports patient handles and touch screen 71 15...

Страница 5: ...Table of contents User s manual Planmeca Viso G7...

Страница 6: ...ements 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 produce up to date produc...

Страница 7: ...evice description The Planmeca Viso 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 produ...

Страница 8: ...ation 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 ava...

Страница 9: ...e e g smartphone hold the device steady over the QR code You will be directed to Planmeca s product registration page Go to Planmeca s product registration page at www planmeca com register 3 Select t...

Страница 10: ...ection for electrical and electronic equipment according to Directive 2002 96 EC WEEE Refer to instruction manual booklet Standard ISO 7010 Emergency stop Standard IEC 60417 Warning Electricity Standa...

Страница 11: ...nsibility 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 interrupte...

Страница 12: ...an be adjusted to suit offices with a low ceiling Contact your service technician for help CAUTION Make sure that there is no object under the X ray unit when you move the X ray unit down If something...

Страница 13: ...ove 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 justified for...

Страница 14: ...itioning 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 t...

Страница 15: ...connects external equipment to signal input 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...

Страница 16: ...NOTE Do not touch the glass windows of the sensor Fingerprints or other stains on the glass surface destroy image quality 5 Safety precautions 10 Planmeca Viso G7 User s manual...

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

Страница 18: ...ntroduction on page 11 Adjusting exposure values for current exposure on page 37 2D panoramic exposure and Adjusting exposure values for current exposure on page 50 3D exposure Testing information Ref...

Страница 19: ...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 lo...

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 14 Planmeca Viso G7 User s manual...

Страница 21: ...ent supports see section Patient supports on page 16 4 Patient handles 5 Touch screen see section Control panel on page 19 6 Moving column 7 Stationary column 8 Emergency stop button see section Emerg...

Страница 22: ...support 3 Temple pads for children 4 Fastening straps 5 Support bars 6 Bite piece for panoramic exposures 7 Chin rest for panoramic exposures 8 Chin cup 9 Chin support for panoramic exposures 10 Adap...

Страница 23: ...sure button when the X ray system is getting ready for an exposure The green light stops flashing and stays on continuously when the X ray system is ready for an exposure During exposure a yellow radi...

Страница 24: ...cy All movements of the X ray unit will be blocked and no radiation will be generated A help message will appear on the control panel Guide the patient away from the X ray unit Then release the emerge...

Страница 25: ...el 2 NOTE The options shown on the screen depend on the X ray unit configuration The views and values shown in this manual are only examples NOTE The X ray unit can be upgraded with new programs and f...

Страница 26: ...elect another option if available Main screen The main screen shows the name and the imaging programs of the X ray unit You can use the buttons at the bottom of the main screen to change the appearanc...

Страница 27: ...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 the home screen from another screen selec...

Страница 28: ...m moves to a new position The length of the blue section indicates the length of the movement the longer the section is the more the C arm will move The circle disappears when the C arm has reached th...

Страница 29: ...the settings of the X ray unit Selecting demo mode You can switch the demo mode on if you wish to practice or demonstrate the functions of the X ray unit without radiation and PC connection Settings U...

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 24 Planmeca Viso G7 User s manual...

Страница 31: ...supports for 2D panoramic exposures Attach these supports to the adapter You can use these supports for edentulous patients or for patients who are unable to bite 9 1 1 2 Attaching chin supports for...

Страница 32: ...r head support to the connector on the patient support base and then close the locking lever at the back To remove the rear head support first release the locking lever and then pull the head support...

Страница 33: ...it outwards NOTE Ensure that you insert the support bars the right way round The wider sides of the round end parts have to be on the inside as shown To remove the support bar first turn it inwards an...

Страница 34: ...use temple pads if you take exposures of children or patients with a small head Slide the temple pads onto the head support as shown Ensure that you slide the temple pads as far up as they will go NO...

Страница 35: ...ul 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 more than 50 mm 2 in Straps...

Страница 36: ...functions 9 2 Preparing patient Ask the patient to remove any spectacles hearing aids dentures hairpins and personal jewellery such as earrings necklaces and piercings as these can produce shadows or...

Страница 37: ...High contrast objects such as gold teeth or amalgam may cause artefacts in the image Place a protective lead apron over the patient s back if required 9 Before exposure User s manual Planmeca Viso G7...

Страница 38: ...ack if it is not already there You see this message 10 2 Patient positioning 1 Guide the patient to the X ray unit when you see this message The patient can sit or stand during the exposure NOTE We re...

Страница 39: ...3 Ask the patient to step forward grasp the patient handles stretch and straighten their back and neck and bite the bite piece The upper and lower incisors must be in the groove in the bite piece NOTE...

Страница 40: ...ion the patient s head so that the patient s midsagittal plane coincides with the midsagittal plane laser light The midsagittal plane laser light is shown in the middle of the patient s face 5 If you...

Страница 41: ...pport by turning the adjusting knob at the top 7 Select the forward button The sensor moves to the front You see this message The sensor contains digital cameras which stream live video of the patient...

Страница 42: ...t 9 Position the apices of the patient s upper central incisors within the image layer of the X ray unit A virtual layer light is shown with a green line on the screen Use your mouse cursor virtual co...

Страница 43: ...4 Adjusting exposure values for current exposure The exposure values have been preset at the factory for each patient size The preset exposure values are average values and they are only meant to gui...

Страница 44: ...alues you wish to use To improve the image contrast reduce the kV value To reduce the radiation dose reduce the mAs value 3 Select the green check mark button 10 5 Taking a 2D exposure NOTE Make sure...

Страница 45: ...e green lights stop flashing and stay on continuously when the X ray system is ready for an exposure You see this message 2 Ask the patient to swallow place their tongue flat against the roof of the m...

Страница 46: ...nd of the exposure NOTE Maintain audio and visual contact with the patient and X ray unit during exposure If the C arm stops moving during exposure or moves in an erratic way release the exposure butt...

Страница 47: ...7 The image is shown on the computer screen 10 2D panoramic exposure User s manual Planmeca Viso G7 41...

Страница 48: ...m Teeth 100 x H100 mm Jaw 140 x H100 mm Face 160 x H160 mm Skull 260 x H300 mm Two vertical image volumes 11 2 Selecting imaging program Select the 3D program you wish to use e g 3D Dental 3D Teeth Th...

Страница 49: ...in a sitting position 2 Use the height adjusting slider on the touch screen to move the X ray unit up or down until the chin cup is approximately level with the patient s lower jaw 3 Ask the patient...

Страница 50: ...light is shown in the middle of the patient s face 5 If you are using the rear head support You can slide the rear head support up or down for optimal support of the patient s head 11 3D exposure 44 P...

Страница 51: ...aps for additional head support if needed Refer to section Attaching top head support on page 27 for details 7 Select the forward button The sensor moves to the front You see this message 11 4 Selecti...

Страница 52: ...ead Use this button to select the side that you wish to expose The sensor moves to the selected side and an image of that side is shown on the screen You see this message Patient s left side selected...

Страница 53: ...usting exposure values for current exposure on page 50 11 6 Adjusting image volume position and size NOTE This function is not available for the Skull program You see two camera images of the patient...

Страница 54: ...ize hold your mouse cursor virtual control panel or finger touch screen on one of the small blue balls and move the ball to enlarge or reduce the volume size The ball turns red when you reach the limi...

Страница 55: ...w Dose ULD 1 Select this field to open a pop up window 2 Select the image resolution you wish to use The voxel size options are 600 450 300 150 and 75 micrometres 3 Select the ULD Ultra Low Dose butto...

Страница 56: ...alues are shown in the following tables Factory presets for voxel sizes 450 or 600 micrometres PATIENT SIZE kV VALUE mAs VALUE mAs VALUE WITH ULD Child XS 90 36 7 1 Small adult S 90 40 8 Medium sized...

Страница 57: ...e the minus or plus signs to set the exposure values you wish to use To improve the image contrast reduce the kV value To reduce the radiation dose reduce the mAs value 3 Select the green check mark b...

Страница 58: ...movement during exposure and then compensates for the effects of the movement during image reconstruction We recommend that you use this setting when taking exposures of children patient size XS or r...

Страница 59: ...e Planmeca Romexis program 1 Select this field to open a pop up window 2 Select the Scout button 3 Select the green check mark button 4 Select the forward button NOTE The Scout button is already selec...

Страница 60: ...old down the exposure button for the duration of the exposure During exposure yellow radiation warning lights illuminate on the exposure switch and on the control panel Additionally you hear a radiati...

Страница 61: ...nd 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 selected...

Страница 62: ...king a 3D exposure NOTE Make sure that you have selected the correct patient in the Planmeca Romexis program NOTE After scout views the X ray system is automatically ready for a 3D exposure Go directl...

Страница 63: ...sage NOTE Move to a protected area The green lights stop flashing and stay on continuously when the X ray system is ready for an exposure You see this message 2 Ask the patient to stay as still as pos...

Страница 64: ...control panel You see two preview images the progress bar below the first image 1 shows the capture progress and the slider below the second image 2 allows you to view the captured frames from differe...

Страница 65: ...he image is shown on the computer screen The image processing time depends on the selected settings For example if you selected the ULD Ultra Low Dose button you have to wait longer before the image a...

Страница 66: ...d on your computer for this purpose NOTE The views shown here are from software version 5 0 1 The views may be slightly different in later software versions To check the software version of your Planm...

Страница 67: ...the Device Tool QA program on your computer 2 Select the Viso button 3 On the next screen select the option Viso Production and QA VISO button at the bottom of the screen 12 3D quality control User s...

Страница 68: ...6 Press and hold down the exposure button to take an exposure 7 You see this message when done NOTE You may have to wait for a few minutes before the message appears You see a blue spinning circle on...

Страница 69: ...exposure as instructed in steps 5 and 6 10 Select the Next button at the bottom of the screen 11 Take a third exposure as instructed in steps 5 and 6 12 Select the Create report button at the bottom o...

Страница 70: ...g Refer to the help section of your browser for details 14 Select this cross to close the Device Tool QA program 12 3 Evaluating test results Evaluate the test results according to the following table...

Страница 71: ...ted Tomography are very thin Their thickness is set by the size of the detector elements which remain constant during product life Therefore it is not necessary to measure the thickness SNR Signal to...

Страница 72: ...moving the C arm Press and hold down the exposure button for the entire duration of the exposure H102 The exposure button is stuck or the cable is short circuited Release the exposure button Contact...

Страница 73: ...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 H1...

Страница 74: ...production test H181 The imaging process was cancelled in Planmeca Romexis H182 Timeout in image data transmission Exposure was interrupted Contact your service technician for help H186 No IP address...

Страница 75: ...n 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 not...

Страница 76: ...nd wipe the surface with the cloth Contact your service technician for help if sprays liquids or foams enter the system Planmeca approved cleaning agents Manufacturer Brand name Alpro Medical CleanWip...

Страница 77: ...screen Wipe these parts after each patient using a Planmeca approved surface disinfectant Use a Planmeca approved cleaning agent for cleaning stains and dirt if needed Patient supports 15 Cleaning and...

Страница 78: ...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 15 Cleaning and disinfection 72 Planmeca Viso G7 User s manual...

Страница 79: ...ipe the other surfaces regularly using a Planmeca approved surface disinfectant Use a Planmeca approved cleaning agent for cleaning stains and dirt if needed 15 Cleaning and disinfection User s manual...

Страница 80: ...rantee 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 u...

Страница 81: ...requirements of Directive 2006 66 EEC The risks involved and the necessary precautions must be taken into account when handling waste products NOTE FOR 3D RECONSTRUCTION PC Delete all patient data fro...

Страница 82: ...10 0 5 SC Focal spot size according to IEC 60336 2005 0 5 x 0 5 mm Filtration 3D Total 2 5 mm Al 0 2 mm 0 5 mm Cu Pan SmartPan ProCeph Total 2 5 mm Al Tube housing front cover quality equivalent filtr...

Страница 83: ...eph 1 13 Duty cycle for height adjustment 25 s ON 400 s OFF Line voltage 100 220 V 50 60 Hz 230 240 V 50 Hz Line current 8 17 A Input power Stand by 150 VA Exposure 1800 W Line harmonics Cos better th...

Страница 84: ...060 hPa Max altitude 2000 m 1 25 miles Image properties ProCeph Flat panel pixel size 139 m Flat panel active surface 302 x 249 mm 11 89 x 9 80 in 3D Flat panel pixel size 139 m Flat panel active surf...

Страница 85: ......

Страница 86: ...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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