51774-img R13 User Manual Focus Eng - Frank's Hospital .

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

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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