Transcription
ENGLISHFOCUS User Manual51774-IMG rev. 13
CopyrightCode: 51774-IMG rev 13Date: 2 November 2015Copyright 11/2015 by Instrumentarium Dental, PaloDExGroup Oy.All rights reserved.FOCUS and CLINIVIEW are either a registeredtrademark or trademark of Instrumentarium Dental in theUnited States and/or other countries.All other trademarks are property of their respectiveowners.Documentation, trademark and the software arecopyrighted with all rights reserved. Under the copyrightlaws the documentation may not be copied, photocopied,reproduced, translated, or reduced to any electronicmedium or machine readable form in whole or part, withoutthe prior written permission of Instrumentarium Dental.The original language of this manual is English.Instrumentarium Dental reserves the right to makechanges in specification and features shown herein, ordiscontinue the product described at any time withoutnotice or obligation. Contact your Instrumentarium Dentalrepresentative for the most current information.Manufactured byInstrumentarium Dental, PaloDEx Group OyNahkelantie 160FI-04300 TuusulaFINLANDTel. 358 10 270 2000www.instrumentariumdental.comFor service, contact your local distributor.
Table of Contents1Introduction. 11.1 FOCUS . 11.2 Intended use . 11.3 User profile. 11.4 Symbols that may appear on the unit. 21.5 Type and version. 31.6 Labels on FOCUS . 41.7 Configurations . 51.8 Radiation protection guidelines . 71.9 Manufacturer's liability. 81.10 Disposal . 92Unit description . 112.1 Main parts . 112.2 Cones. 122.3 Symbols on remote control . 132.4 FOCUS with SmartBox option. 142.5 Unit mount model FOCUS . 153Preparations for the exposure. 173.1 Precautionary actions for safe use. 173.2 Switching the power on/off . 173.3 Selecting the cone. 183.4 Selecting the exposure parameters . 183.5 Positioning the patient. 203.6 AEC Automatic Exposure Control . 213.7 FOCUS with SmartBox . 213.8 Taking an exposure. 223.9 Monitoring of dose levels . 224Program mode . 234.1 Programmable anatomical time settings . 245Error messages. 256Maintenance . 276.1 Cleaning . 276.2 Disinfecting. 276.3 Periodic maintenance. 286.4 Radiation dose measurement . 296.5 Changing the fuses . 307Technical data. 317.1 Technical specifications . 317.2 EMC declaration. 358User's statement. 399Recommended exposure times. 4551774-IMG rev 13Instrumentarium Dentali
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1 Introduction1 Introduction1.1 FOCUS FOCUS is a microprocessor controlled intraoral x-ray unitwith a HF DC generator. FOCUS produces high qualitydental images with film or digital sensors.The well-balanced support arm is easy to move and verystable, keeping the unit motionless during the exposure.FOCUS' proprietary design has the VHF DC generator builtinto the horizontal part of the units support arm enablinggreater reliability and ease of installation and service.The VHF DC generator keeps the patient dose to theabsolute minimum. The user friendly remote controlfeatures pre-programmed anatomical time settings makingthe exposure selection quick and effortless. These settingscan be reprogrammed if needed.Other selections include 60 or 70 kV, exposure timesbetween 0.02 and 3.2 seconds, pediatric or adult modes,and film and digital modes. Exposures can be madedirectly from the remote control panel or with the optionalremote exposure button. With a choice of arm lengths andability to mechanically mount the unit in differentconfigurations, the FOCUS is a fully customizable x-raysystem.As the manufacturer we strongly recommend that you readthis manual before placing the unit into service.NOTE! FOCUS must be installed according to the FOCUSInstallation manual by a qualified technician. Only trainedpersonnel should be allowed to operate FOCUS.1.2 Intended useFOCUS is intended to be used for producing diagnostic xray radiographs of dentition, jaws and other oral structures.1.3 User profileThe unit is intended only for professionally qualified dentalor medicinal personnel.The typical user is a dental nurse with specific training forusing dental X-ray units.51774-IMG rev 13Instrumentarium Dental1
1 Introduction1.4 Symbols that may appear on the unitThe following symbols are used in FOCUSName and address of the manufacturerSerial numberX-ray source assembly: emittingRadiation warningFocal spotFiltrationConnector for remote controlProtective groundType B applied partDangerous voltageON or enabledOFF or enabledOperating instructionsRefer to operating instructions for moreinformation. The operating instructions canbe supplied electronically or in paper formatGeneral caution2Instrumentarium Dental51774-IMG rev 13
1 IntroductionCaution: Federal law restricts this device tosale by or on the order of a licensedhealthcare practitioner.Do not reuseRecyclableCE (0537) symbolMDD 93/42/EECETL MarkConforms to UL STD 60601-1Certified to CSA3155129This symbol indicates that the waste ofelectrical and electronic equipment must notbe disposed as unsorted municipal wasteand must be collected separately. Pleasecontact an authorized representative of themanufacturer for information concerning thedecommissioning of your equipment.1.5 Type and versionThe type and version of FOCUS is defined in the mainlabel of the unit located on the under side of the horizontalarm and in the tube / HV generator housing assembly labelon the tube head. The unit is class I, type B and with IP-20protection.The focal length is defined in the cone label in addition totype and version.The software version is momentarily displayed on remotecontrol display after switching the unit on.51774-IMG rev 13Instrumentarium Dental3
1 Introduction1.6 Labels on FOCUSLabels on the picture are for reference purposes only.Actual texts may not be accurate.4Instrumentarium Dental51774-IMG rev 13
1 Introduction1.7 ConfigurationsWARNING! USE LIMITATION: The unit or its parts mustnot be changed or modified in any way without approvaland instructions from the manufacturer.The use of accessories, transducers, and cables otherthan those specified may result in degradedELECTROMAGNETIC COMPATIBILITY of theEQUIPMENT and/or SYSTEM.WARNING! If you suspect any electro-magneticalinterference affecting or caused by the unit, call service.Portable and mobile RF communications equipment caninterfere with operation of the medical electrical equipment.FOCUS is delivered with one of the following configuration:FOCUS BASIC SYSTEMS:FOCUS x-ray machine with short reach 176 cm/ 69.2", 115 V,FOCUS x-ray machine with long reach 191 cm/ 75.1", 115 VFOCUS x-ray machine with extra long reach 216 cm/ 84.9",115 VFOCUS x-ray machine with short reach 176 cm/ 69.2", 230 VFOCUS x-ray machine with long reach 191 cm/ 75.1", 230 VFOCUS x-ray machine with extra long reach 216 cm/ 84.9",230 VEach FOCUS basic system is equipped with remotecontrol with 32.8 feet (10m) 8 wire cable with RJ-45 plugsand Installation manual.One chosen item from each module below is delivered withthe basic unit:TO BE CHOSEN FOR BASIC SYSTEM:ConesShort cone roundShort cone rectangular / Short cone rectangular for GermanyLong cone roundLong cone rectangularShort full metal rectangular coneLong full metal rectangular cone51774-IMG rev 13Instrumentarium Dental5
1 IntroductionWall mount platesWall mount plate for single studWall mount plate for 16” center studsManual languageEnglishItalianGermanFrenchFollowing accessories are approved items, and they canbe ordered separately.ACCESSORIESShort cone roundShort cone rectangularLong cone roundLong cone rectangularLong full metal rectangular coneShort full metal rectangular coneShort cone rectangular for GermanyShort horizontal arm 500 mm / 19.7 inLong horizontal arm 650 mm / 25.6 inExtra long horizontal arm 900 mm / 35.4 inAdditional remote control (one FOCUS unit can be installedwith two)Remote exposure button (one FOCUS unit can be installedwith two)Wall mount plate for single stud.Wall mount plate for 16" center studs.NOTE! To maintain safe and correct operation of FOCUS,only the approved accessories should be used. All thestandard and optional items and approved accessories aresuitable for use within the patient environment.6Instrumentarium Dental51774-IMG rev 13
1 Introduction1.8 Radiation protection guidelinesThe device emits X-ray radiation for medical purposes. Theunit may cause an injury if used improperly. Theinstructions contained in this manual must be read andfollowed when operating the FOCUS. All government andlocal regulations pertaining to radiation safety must beobserved.NOTE! for USA:Many provisions of these regulations are based onrecommendations of the National Council on RadiationProtection and Measurements. Recommendations fordental x-ray protection are published in NCRP Report #35available from NCRP Publications, 7910 WoodmontAvenue, Suite 1016, Bethesda, MD 20814.Personal radiation monitoring and protective devices areavailable and recommended for staff members. It is alsorecommended to provide the patient with a protectiveapron. Consult the physician before taking images ofpregnant patients.WARNING! FOCUS must not be used in rooms whereexplosive hazards exist.Use FOCUS with radiation protection in accordance withIEC 60601-1-3 (and/or local requirements).PROTECTION BY DISTANCEIn all examinations the user of the x-ray equipment shouldwear protective clothing. The operator does not need to beclose to the patient during normal use. The protectionagainst scatter radiation can be achieved by using theremote control or the remote exposure button not less than7 feet (2 meters) from the focal spot and the x-ray beam.The cable length of the optional remote exposure button isapproximately 32 feet (10 meters). The operator shouldmaintain visible contact with the patient and techniquefactors. This allows immediate termination of radiation bythe release of the exposure button in the event of amalfunction or disturbance.51774-IMG rev 13Instrumentarium Dental7
1 IntroductionWARNING:This x-ray unit may bedangerous to patient andoperator unless safeexposure factors andoperating instructionsare observed.Caution information on remote control1.9 Manufacturer's liabilityAs a manufacturer we can only assume liability of safe andreliable operation of this unit when FOCUS installation was performed according to theFOCUS Installation Manual supplied with the unit.FOCUS is used according to the FOCUS User'sManualMaintenance and repairs are performed by a qualifiedFOCUS dealerOriginal or authorized spare parts are usedIf service on the unit is performed, a work order describingthe type and extent of repair must be provided by theservice technician. This must contain information ofchanges of nominal data or work range performed. Thework order must furthermore indicate the date of repair, thename of the company concerned and a valid signature.User should keep this work order for future references.8Instrumentarium Dental51774-IMG rev 13
1 Introduction1.10 DisposalWhen the unit does no longer meet the manufacturer'sintended operational specifications, despite propermaintenance and repair, then the unit is no longerserviceable and should be replaced. Follow all regulationson disposal of waste parts. FOCUS has at least thefollowing parts that should be regarded as nonenvironmentally friendly waste products:- X-ray source assembly- All electronic circuits51774-IMG rev 13Instrumentarium Dental9
1 Introduction10Instrumentarium Dental51774-IMG rev 13
2 Unit description2 Unit description2.1 Main parts51774-IMG rev 131.Mounting plate2.Horizontal Arm3.Adjustment part4.Tube head5.Cone6.Scale for Cone Angle7.Remote Control with cable (RJ/45 plugs)Instrumentarium Dental11
2 Unit description2.2 ConesShort cone roundShort cone rectangularLong cone roundLong cone rectangularShort full metal rectangularconeLong full metal rectangularcone12Instrumentarium Dental51774-IMG rev 13
2 Unit description2.3 Symbols on remote controlMaxillary molarMaxillary premolar/canineMaxillary incisorsBitewingMandibular molarMandibular incisor/bicuspidMandibular cuspidOcclusalExposure buttonX-ray source assembly: emittingReady for exposurePatient Size SelectionDigital mode selectionVoltage selection, 60 or 70 kVRadiation warningExposure time & DAP displayExposure time controlAUTO (AEC: Automatic ExposureControl) Selection51774-IMG rev 13Instrumentarium Dental13
2 Unit description2.4 FOCUS with SmartBox option1.SmartBox2.Sensor selection button, both sides3.Sensor selection indicator (LED) lights4.Sensor connector module5.Sigma-sensor6.Sensor holderSensor selection14Instrumentarium Dental51774-IMG rev 13
2 Unit description2.5 Unit mount model FOCUS412351774-IMG rev 131.Horizontal arm2.Generator module3.Shaft of the horizontal arm4.Main switchInstrumentarium Dental15
2 Unit description16Instrumentarium Dental51774-IMG rev 13
3 Preparations for the exposure3 Preparations for the exposure3.1 Precautionary actions for safe useCheck that the site of the unit allows FOCUS to be set in allpositions without making contact with any objects.WARNING! Proper grounding cannot be ensured unlessFOCUS is connected to properly wired hospital gradeoutlet.WARNING! If the patient is using a pacemaker, consult themanufacturer of the pacemaker before taking an exposureto confirm that the x-ray unit will not interfere with theoperation of the pacemaker.WARNING! Make sure that you don’t touch the patient andany exposed electrical connectors simultaneously.3.2 Switching the power on/offThe power switch is located on the bottom of the accessblock. Turn the switch to the ON (I) position to switch theunit on. The green light indicator will illuminate. The systemwill reset and run a self-test.NOTE! The unit mount model has the power switch locatedon the end of the generator module.The remote display will light up and read the previouslyused exposure time. Also, light indicators will illuminaterepresenting the previously used values for the digital,Auto and kV selection.The green READY light will illuminate when an exposurecan be made.To shut the unit down, turn the switch to the OFF position(O). For permanently installed units, this is the primarymethod of isolating the unit from mains supply.WARNING! Shut down the unit in case of errors orunexpected operation.51774-IMG rev 13Instrumentarium Dental17
3 Preparations for the exposure3.3 Selecting the coneCone selection includes round or rectangular short or longcones.If a cone with different length from that set in the factory isneeded, go to programming mode and select the desiredcone length as described in the “Program Mode” section ofthis manual. Remove the cone by rotating it and pulling itout. Then push and rotate the new cone in. RINN, or othertypes of film/sensor holders can be used with these cones.Note! Make sure that the values set in the programmingmode correspond to the cone length and shape.3.4 Selecting the exposure parameters181.Press the kV button to toggle between the two choices,60 kV or 70 kV. The LED will indicate the selection.2.Press the patient size button to toggle between the twochoices, Adult and Pediatric. The adjacent light willindicate the selection.3.Press the D button to select between Film and Digitalmode. The light is ON in Digital mode.Instrumentarium Dental51774-IMG rev 13
3 Preparations for the exposureCAUTION! Assure that the right image capture devicemode (Film/Digital) is on.Use of the AEC is recommended when FocusLink isconnected. Then select only the kV. See Chapter 3.6.51774-IMG rev 134.Press one of the buttons representing the eightanatomical time settings (tooth buttons). The adjacentlight indicator will illuminate corresponding to theselection. All other tooth button light indicators will beoff.5.The exposure time may be adjusted manually with theUP and DOWN buttons. The exposure time is basedon the tooth type, patient size, exposure mode (film ordigital), value of kV, film speed and cone length. Theexposure time is shown on the display to two decimalplaces. Whenever one of the determining parametersis changed, the value for the exposure time isrecalculated and the display is updated.6.Close the door if a door switch is installed.Instrumentarium Dental19
3 Preparations for the exposure3.5 Positioning the patient1.Set the patient's head into correct position according toselected imaging modality.2.Place the film packet /sensor into the patient's mouth.Bring the tube head close to the patient's skin and aimthe beam towards the film/sensor observing thecorrect angle of the beam. The horizontal angle of thecone is indicated on the scale located around thevertical joint of the tube head.Note! Always use disposable hygienic covers on thesensors or sterilize them before placing them onpatient’s mouth to prevent cross contamination.20Maxillary occlusalMaxillary anteriorMaxillary molarMandibular occlusalMandibular anteriorMandibular molarMandibular canineBitewingInstrumentarium Dental51774-IMG rev 13
3 Preparations for the exposure3.Use the focal length as long as possible to keep theabsorbed dose as low as reasonably achievable.4.Instruct the patient to avoid any movement during theexposures.WARNING! Take care not to hit the patient with the unitduring the positioning of the patient.Note! If the resulting image isn’t adequate, ensure that thepatient positioning, the film/sensor positioning and theexposure values are correct for the wanted exposure.3.6 AEC Automatic Exposure ControlAEC function is for controlling the exposure timeautomatically. This feature is possible only withSigma intraoral digital sensor system fromInstrumentarium Dental. AEC function is achievedby data exchange over FocusLink digital communicationline between Sigma and FOCUS. Communication makesalso possible that exposure times, kV and mA aretransferred automatically from FOCUS to user applicationsoftware in both manual and automatic exposure modes.FocusLink is a separate item of Sigma accessory list, seeSigma manual.AEC is controlled from FOCUS control panel. Operation ofSigma or user application software is not changed. AECfunctions only after Sigma has been connected to FOCUSand FOCUS is operational. When AEC is selected fromFOCUS, Sigma changes it's internal operation to supportthe AEC function.AEC can be turned on and off with the AUTO button, whichalways turns on the digital mode unless the digital mode ison already. Deselection of digital mode always deselectsAEC mode too. When AUTO is selected, the display ofremote controls is inactive. After an exposure the exposuretime is displayed, however.3.7 FOCUS with SmartBoxFor operating and installation instructions, see Sigma user& installation manual.51774-IMG rev 13Instrumentarium Dental21
3 Preparations for the exposure3.8 Taking an exposure1.READY light will illuminate on the remote control whenthe unit is ready for exposure.2.Use either the hand-held/wall external exposure switchor the exposure button on the remote control.3.Press and hold the exposure button through the entireexposure cycle until the audible signal terminates.Note! In the AUTO (AEC) mode the time of pressing is alittle longer than in the manual mode.During the exposure, the yellow warning light will illuminateand the beeper will be activated. These two actions willstop when the exposure is completed or if the exposurebutton is released prematurely. The exposure time displaywill go blank during the exposure and will reflect theelapsed time of the actual exposure afterwards.Note! When using the system in an extremely highelectromagnetic environment interferences may changeimage quality. If interference appears, contact yourFOCUS dealer.3.9 Monitoring of dose levelsThe calculated dose is displayed as the product of doseand beam area as measured by a dose area product(DAP) mGycm2 and can be observed from the remotecontrol panel.To see the DAP value (mGycm2) after an exposure, pressthe “digital mode” and “down” button simultaneously.The DAP value is shown approx. 5 seconds while themGycm2 LED light is illuminated.Note! The DAP value is depended on the selected cone.Before reading the DAP value, be sure that the right conetype is selected from program mode (see chapter 4).22Instrumentarium Dental51774-IMG rev 13
4 Program mode4 Program modeEnter or exit the program by pressing and holding the kVbutton for two seconds or more. The beeper will soundthree times. No exposures may be taken while in theprogram mode. The READY light will be off.The menu selections are scrolled with the UP and DOWNbuttons. Enter or exit the selection by pressing the kVbutton. Data is edited with the UP button.The program mode will exit automatically after it remainsidle for 30 seconds. When control returns to the operatingmode, the display will show the updated exposure time.Menu SelectionsDisplay ContentsFilm SpeedPr1SFSESdPr2123456Pr32 digits displayed3 digits displayedPr4AEC--Pr5Pr61-8Pr7fast film (Speed F)fast film (Ekta speed, E)slow film (Ultra speed, D)Cone selectionshort roundshort rectangularlong roundlong rectangularshort rectangular for sensor size 1short rectangular for sensor size 2Exposure CounterFirst (0 - 999)Second (1000 - 99000)Automatic AEC selection*Automatic AEC selection ONAutomatic AEC selection OFFSet Factory Defaults, two beepsSpeaker adjustmentspeaker volume (1 min. 8 max.)DAP Cumulative Dose Area Productto reset cumulative counter, press DSensor type selection**genericSigmaPhosphor PlatePreheat boost adjustment ***51774-IMG rev 13Instrumentarium DentalPr8GENSIGPHOPr923
4 Program modeMenu SelectionsDisplay ContentsFilm SpeedPr1OnDIS(On, if generator revision 1.x)(Disabled, if generator revision 2.x)* If FocusLink is connected, the “D” is always switched on,when the image capturing is started in CLINIVIEW software. If AEC is selected in Pr4, the AEC is switched onalso.** Different exposure times can be programmed for eachsensor type (similar way as described in 4.1Programmable anatomical time settings)*** This program applies only if the FOCUS firmware is3.12 or greater. The parameter has been set properly inthe factory. If the firmware need to be upgraded in field, setthis parameter correctly according to the generatorrevision.4.1 Programmable anatomical time settingsThe anatomical time settings (tooth buttons) have beenpreprogrammed by the factory but can be changed ifnecessary by the user.First increase or decrease the exposure time with UP andDOWN buttons. Then press and hold the correspondingtooth button for two seconds or more. The beeper will beeptwo times. The new time setting is now saved into thememory.24Instrumentarium Dental51774-IMG rev 13
5 Error messages5 Error messagesThe error messages are grouped into two categories. Usererrors (H) and system fault errors (E). User errors musteither be acknowledged or it will be removed once the erroris corrected. When system faults occur, a servicetechnician should be contacted.Display Contents51774-IMG rev 13Error or FailureActionE1KV failureContact theserviceE2MA failureContact theserviceE3PREH failureContact theserviceE4Tube head too hotor too coldWait for valid tubehead temperatureE5Line voltage lowContact theserviceE6Sigma link error orsensor not readyContact theserviceE7EEPROM failureContact theserviceH1(necessarywaiting time)Duty cycleWait for tube tocoolH2(flashesalternately withelapsed exposuretime)Premature buttonreleaseAcknowledge withUP or DOWNbuttonH3Door switch open(connected toAdjustment part)Check that door isclosedH4Door switch open(connected toRemote) ControlPanelCheck that door isclosedH5System in ServicemodeGo to the usermodeInstrumentarium Dental25
5 Error messagesDisplay Contents26Error or FailureActionH6Current Sigmaclocking mode andresolutionselection do notsupport AEC.Change resolutionmode to minimumdose inCLINIVIEWsoftware. Thiserror messagemay appear onlywith CLINIVIEW3.0 or earlierH7Exposure out ofrange, exposurecancelled (in AECmode)Too muchattenuationbetween thesensor and thetube. Check thatthe tubehead andthe sensor arecorrectly aligned.Instrumentarium Dental51774-IMG rev 13
6 Maintenance6 Maintenance6.1 CleaningThe cone should be cleaned after every patient usage.Items and surfaces that are not given special instructionsfor cleaning, disinfecting and sterilizing, can be cleanedwith a soft cloth moistened with disinfectant after eachusage.WARNING! Always disconnect FOCUS from the powersupply or switch off the power prior to cleaning ordisinfecting the unit. Do not allow any liquid to enter theunit interior.CAUTION! Do not allow water or other cleaning liquids toenter the unit interior since these may cause damage.CAUTION! See Smart Box sensor module cleaninginstructions on the Sigma User and Installation Manual.Use a cloth moistened in cool-to-lukewarm, soapy water toclean the unit, and prevent coagulation and thus facilitatethe removal of protein substances. Then wipe with a clothmoistened in clear water. Mild detergent solution can beused. Never use solvents of any kind. If you are uncertainof the nature of cleaning agent, do not use it.For example, the following cleaning agents are allowed(and not allowed) to clean the unit panels:Allowed:Soap, Butylalcohol, Ethanol (ethyl alcohol) 96%, Methanol(methyl alcohol).Not allowed:Benzene, all chlorine solutions, Phenol, Acetone, Aceticether6.2 DisinfectingUse Ethanol 96% for disinfecting of equipment. Wipemanually with clean cloth moisturized in disinfectantsolution. Never use corrosive or solvent disinfectants. Allitems and surfaces should be dried before next usage.Note! Wear gloves and other protective gear duringdisinfecting process.51774-IMG rev 13Instrumentarium Dental27
6 MaintenanceWARNING! Do not use any disinfecting sprays since thevapor could ignite causing injury.Disinfecting techniques for both the unit and the room mustcomply with all laws and regulations that have jurisdictionwithin which the unit is located.6.3 Periodic maintenanceThis unit is designed to provide reliable performance andmany years of customer satisfaction. In order to assuresafe performance, the unit must be checked by a qualifiedservice technician. The time of service depends on theusage of the u
51774-IMG rev 13 Instrumentarium Dental 1 1 Introduction 1.1 FOCUS FOCUS is a microprocessor controlled intraoral x-ray unit with a HF DC generator. FOCUS produces high quality dental images with film or digital sensors. The well-balanced support arm is easy to move and very stable, keeping the unit motionless during the exposure.
