KODAK 2200 Intraoral X-ray System User's Manual
Contents
1. RR RRE 6 5 Table 7 Exposure times in seconds for class D Speed films eeeeeeeeeseseee eene nennen nnn 6 7 Table 8 Exposure time corrections depending on selected setting 6 7 Tabl 9 Choice of film abore maa 6 8 Tabl 10 Choice of sensor type Lak kein 6 8 Table 11 Choice of storage phosphor plates 6 8 Table 12 Dose measured at extremity of 20 cm 8 in nnn 6 9 Table 13 Exposure surface versus type of collimator used uuueuuunnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnenn 6 10 1 Safety and Regulatory Information The information contained in this manual is based on the experience and knowledge relating to the subject matter gained by Carestream Health Inc prior to publication No patent license is granted by this information Carestream Health Inc reserves the right to change this information without notice and makes no warranty express or implied with respect to this information Carestream Health Inc shall not be liable for any loss or damage including consequential or special damages resulting from any use of this information even if loss or damage is caused by Ca2. 2 3 Labelillocati nse 2 4 Ceiling mounted ta etd etas ta 2 5 Mounted on Mobile Stand 2 6 Floor mounted Unit Optional nsn rennen 2 7 Control Timer r a r aE a aE a 2 8 3 Using UNG System atrio LT d d iideae 3 1 PoSItioninge mr AA ec e sure uen 3 1 Positioning the patient a a E e 3 1 Positioning the x ray generator 3 1 Positioning the dc dls 3 2 HI 3 3 Exposure Parametros 3 3 A 3 3 PROCOSSING 3 4 Setting MOd6GS xn eR rt 3 4 Additional F atures za EA Hrn AAA A A AS 3 5 it User 4 1 Entering the Mode 4 1 Changing the Parameters 4 1 Exitirigthe User Mode entree TE DDR TE DEED DE ect 4 1 Parameters cei te ote et ote ci Cet Lon lei t ib coe Cotto ei iL ct e Cotton 4 1 5 Care and e RE a RR 5 1 General Maintenance r a a a atr M 5 1
3. inc in France 1 Street Rochester NY 14 608 TROPHY LL MANUFACTURED June 2 KODAK 2200 SN XJYE123 5A 230 240V 50 60Hz CLASSIFIC COUPLING WITH RADIATION PERFORMANCES STANDARD 21 CFR Si Figure 4 Identification labels on standard mount Figure 5 Identification labels on Irix replacement mount SM731_K2200_01_en 06 2009 Ceiling mounted Unit Figure 6 KODAK 2200 Intraoral X ray System ceiling mounted unit 1 High frequency x ray generator Ceiling mounted unit containing the high frequency x ray generator s control electronics Separate timer control unit for the x ray generator Scissor arm On off switch with built in light Rectangular collimator d gt 06 2009 SM731_K2200_01_en 2 5 Mounted on Mobile Stand Optional Figure 7 KODAK 2200 Intraoral X ray System mounted on mobile stand High frequency x ray generator Mobile stand containing the high frequency x ray generator s control electronics Timer control unit for the x ray generator Scissor arm On off switch with built in light Rectangular collimator Handle Foot brake gt RO 2 6 SM731_K2200_01_en 06 2009 Floor mounted Unit Optional Figure 8 KODAK 2200 Intraoral X ray System floor mounted unit High frequency x ray generator Floor column containing the high freq
4. Fuse F1 is burned out or defective Replace the fuse Circuit breaker is off Turn on the circuit breaker Control unit doesn t light up Control unit is disconnected Connect the control unit Fuse F1 is burned out or defective Replace the fuse Control unit is defective Call a qualified service technician No x ray emission Generator is cooling Wait for the 01 message and the red LED on the control unit to disappear Radiology control key is defective Call a qualified service technician X ray emission works but exposure is too light or completely white Wrong exposure pre set program is being used Change the pre set program refer to the User Mode section Generator is positioned incorrectly Adjust the position of the generator Exposure time is too short Increase the exposure time Development time is too short Increase the development time refer to the development instructions Developer is too cold Heat the developer Developer is too old or diluted Pre set mode is incorrectly selected Replace with fresh developer Verify your exposure settings refer to the exposure procedure Receptor is facing the wrong way Reposition the receptor Unit was incorrectly installed Call a qualified service technician X ray emission works but exposure is too dark Wrong exposure pre set program is be
5. Phosphor plate such as KODAK Imaging plates Properly placing the receptor is critical Check your dental radiography text for information about proper placement of the imaging receptor Improperly positioning the film or sensor results in errors on the radiograph such as distorted teeth and roots elongation magnification and or overlapping contacts The paralleling technique generally reduces the risk of such errors However if you improperly position the system angulation errors can occur angulation of the receptor to the tooth itself If the exit pattern of the beam is not aligned with the imaging receptor then part of the radiograph will not be exposed to radiation and the final radiograph will have some clear unexposed areas This defect is called cone cuts The imaging receptor is marked to indicate the tube side If the orientation is not correct the resulting radiograph is lighter and may show artifacts such as foil pattern or sensor cable 3 2 SM731_K2200_01_en 06 2009 Exposure Exposure Parameters Because each receptor film digital sensor or phosphor plate has its own sensitivity to x ray radiation the choice of receptor affects the exposure parameters For instance sensitivity class for conventional dental films is characterized with a letter D E or F where F is more sensitive than E and E more sensitive than Consequently the required dose for the correct exposure goes down with each in
6. Cea E A 5 2 Disinfecting 3 1 5 2 DD E i 5 2 Troubleshooting 5 3 6 a na ee 6 1 Compliance with International 6 1 X ray 6 4 X ray GON 3 22 ee 6 5 Tables of Exposure Times san 6 7 x ect e dde A A ala 6 9 List of Figures Figure 1 KODAK 2200 Intraoral X ray 2 1 Figure 2 Side view of KODAK 2200 Intraoral X ray 2 2 Figure 3 KODAK 2200 Intraoral X ray 2 3 Figure 4 Identification labels on standard 2 4 Figure 5 Identification labels on replacement nnns 2 4 Figure 6 KODAK 2200 Intraoral X ray System ceiling mounted 2 5 Figure 7 KODAK 2200 Intraoral X ray System mounted on mobile 2 6 Figure 8 KODAK 2200 Intr
7. based on quantitative values If you have any doubts consult your Sales Representative a CAUTION X rays can be dangerous if used incorrectly Take precautions even when following the instructions in this manual Use conventional commercially available equipment to protect yourself and your patients against scattered radiation risks e If you fail to comply with these instructions Carestream Health Inc will not be responsible for the safety reliability and characteristics of the equipment Warnings and Safety Instructions a CAUTION Do not operate the equipment in the presence of explosive liquids vapors or gases Do not plug in or turn on the system if hazardous substances are detected in the environment If these substances are detected after the system has been turned on do not attempt to turn off the unit or unplug it Evacuate and ventilate the area before turning off the system DANGER THIS IS AN ELECTRICAL UNIT DO NOT EXPOSE IT TO WATER SPRAY SUCH ACTION MAY CAUSE AN ELECTRICAL SHOCK OR A MALFUNCTION OF THE UNIT 1 2 SM731_K2200_01_en 06 2009 WARNING The user is responsible for the operation and maintenance of this unit This unit must only be operated by legally qualified persons The cover of the unit must not be opened by the user Inspection and maintenance operations should only be carried out by an approved technician WARNING This unit must be installed in an x ray room that complies wi
8. e EN 60601 1 4 IEC 60601 1 4 CSA 601 1 e UL60601 1 e EN ISO 14971 Electric power supply during exposure e 230 240 V 10 50 60 Hz 5 A apparent resistance 0 5 e 100 110 130 V AC 10 50 60 Hz 12 A apparent resistance 0 2 Q Electric power supply no exposure e 230 240 V AC 10 50 60 Hz 220 mA e 100 110 130 V AC 10 50 60 Hz 220 mA 06 2009 SM731_K2200_01_en 6 1 Rated high voltage and maximum corresponding current 70kV 7 mA Current voltage combinations for a maximum output power of 490W 70kV 7 mA Rated power for exposure time of 0 1 sec e 490W Rate of use e At 70 kV 7 mA and 0 1 sec and at the maximum tank temperature one exposure every 8 sec Minimum value of the current time product in the range of conformity 0 07 mAs at 7 Ma Selection of parameters 70kV 7 mA and 60 7 mA Area of conformity to IEC standard 60601 2 7 e Reproducibility of the emitted radiation conform e Linearity of the emitted radiation conform e Precision in radiography conform Measurement conditions e kV Indirect measurement using a kV peakmeter e mAs Direct measurement in the circuit using a mAs meter e Exposure time Indirect measurement on the kV signal at 75 of the peak value Type of protection against Class 1 equipment electric shock Degree of protection against Type B electric shock Protection against harmful Ordi t ingress of
9. a choice of extensions Figure 2 Side view of KODAK 2200 Intraoral X ray System Extension R Span A CG 645 47 0 cm 170 0 cm 18 5 in 66 15 16 in CG 646 64 8 cm 188 0 cm 25 5 in 74 in CG 648 82 5 cm 205 0 cm 32 5 in 80 11 16 in 5 Onloff switch Table 1 Type of Scissors Arms e Contains built in light 6 Rectangular collimator optional e Different sizes adapted to films and RVG sensors Additional options e Separate control timer e Separate exposure switch if the control panel is attached to the wall framework e Wall mounted unit for Irix replacement Ceiling mounted unit e Floor mounted unit e mounted on mobile stand SM731 K2200 01 en 06 2009 Wall Mounted Unit for Irix Replacement Figure 3 KODAK 2200 Intraoral X ray System Replacement of Irix System High frequency x ray generator Wall framework Control timer unit Separate exposure switch Scissor arm Rectangular collimator On off switch with built in light de Qu PA 06 2009 SM731 K2200 01 en 2 3 2 4 Label Locations 5375 e US MEDICAL EQUIPMENT WITH RESPECT TO ELECTRICAL FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL amp 0601 1 CAN ZSA C222 601 1 1EC50691 2 7 1 amp 0601 2 28 60601 1 3 iu Carestream Health Inc Made in France C 160 Verona Street TROPHY un Rochester NY 14 608 77435 Mar
10. water Continuous operation with Operation mode intermittent loading Not suitable for use in presence of flammable anesthetics or a Flammable anesthetics mixture of flammable anesthetics with air or oxygen or nitrous oxide 6 2 SM731_K2200_01_en 06 2009 Classification in Accordance with 60601 1 2 Group 1 class Ambient Operating Conditions e Temperatures 5 to 35 C e Relative humidity 30 to 85 e Atmospheric pressure 700 to 1060 hpa Storage Conditions e Temperatures 10 to 60 C e Relative humidity 10 to 95 e Atmospheric pressure 700 to 1060 hpa Transport Conditions e Temperatures 10 to 60 C e Relative humidity 10 to 95 e Atmospheric pressure 700 to 1060 hpa Dimensions and weight Control Unit 16x9x4cm 0 4 kg 6 3 x 3 5 x 1 6 in 0 9 Ib Wall framework 51 4 x 18 9 x 10 8 cm 4 1 kg standard 20 2 x 7 4 x 4 3 in 9 0 Ib Wall framework 42 0 x 30 9 x 9 8 cm 4 1 kg Irix replacement 16 5 x 12 2 x 3 9 in 9 0 Ib X ray emitting unit 43 8 x 22 6 x 12 cm 4 3 kg 17 2 x 8 9 x 4 7 in 9 5 Ib Scissor arm 87 3 13 3 6 3 9 kg 34 4 x 5 2 x 2 5 in 19 8 Ib Mobile stand optional 90 x 60 x 110 cm 40 kg 35 4 x 23 6 x 43 3 in 88 2 Ib Floor column optional 24 x 23 x 90 cm 20 kg 9 4 x 9 1 x 35 4 in 44 2 Ib Ceiling column 50 x 50 x 154 cm 12 8 kg 19 7 x 19 7 x 60 6 in 28 2 Ib Scissor arm e Equipp
11. 4 User Mode The User Mode allows you to select the settings to be used for the different pre set modes It also allows you to validate specific local requirements for some countries Entering the User Mode 1 Turn on the system The self test is activated Atthe end of the self test the software information is displayed for example F718 1 00 Quickly press the selection knob on the control timer to enter the menu You have access to the menu when USER is displayed The display intermittently shows the first parameter P 03 and the setting for example 0 To change from one parameter to another turn the selection knob step by step in any direction Changing the Parameters To change the parameters 1 Press and hold the selection knob at least 3 seconds until the display shows EDIT and you hear a sound The parameter value starts blinking Turn the selection knob to change the parameter value e To validate your choice press and hold the selection knob at least 3 seconds until COPY is displayed and a noise sounds e keep the initial value press the selection knob briefly until Abor is displayed The system returns to the parameters programs mode Exiting the User Mode To exit the User mode press the selection knob briefly Quit is displayed before the system returns to the operational mode Parameters N Parameters Choice P 03 Country of ins
12. KODAK 2200 Intraoral X ray System User s Manual A This document is originally written in English Manual Name KODAK 2200 Intraoral X ray System User Guide Document code SM731 Revision Number Rev 01 Printed Date 6 2009 The brand names and logos reproduced in this guide are copyright KODAK is a trademark of KODAK used under License RVG Trophy are registered trademarks of Carestream Health Inc All other names or products referred to in this document are used only for the purpose of identification and maybe the trademarks or the registered trademarks of their respective owners The RVG technology is the subject of and international patent registered by Carestream Health Inc 0086 Table of Contents 1 Safety and Regulatory Information eese nennen nnn 1 1 Conventions Used in This e aeaa e eaa 1 1 General Safety Guidelines s s RT 1 1 Warnings and Safety 1 2 Marking and Labelling 1 4 EEG3egulatlonsz sso iD M dl 1 5 WSF REQUIALIONS nv pectet ee be e tiis RR ee 1 5 2 System OV GI VIG Wool ee ee euere een here 2 1 COMPONENIS Er A AAA an erstere 2 1 Wall Mounted Unit for Irix
13. aoral X ray System floor mounted 2 7 Figure 9 KODAK 2200 Intraoral X ray System control timer unit 2 8 Figure 10 Patient positionirig root tort trr tr rer 3 1 Figure 11 Paralleling technique left and Bisecting technique 3 2 Figure 12 Heating and cooling curves for TROPHY 708 tube sees eene nennen nennen nnns 6 4 Figure 13 Heating and cooling curves for OCX 65 G tube 6 4 Figure 14 X ray generator 5 reco recorte oo e ooo ore DRM 6 5 Figure 15 Heating and cooling curves nn nennen nennen nnnnnnnnn nennen nennen nennen nenn nennen nn 6 6 List of Tables Table 1 Type of Scissors Arms ii ntis ken oko cese do ka as caca agas e anna an an Hannah nannte 2 2 Table 2 Parameters for User Mode cei ct oa sacs sce cu RP SR Ce 4 1 Table 3 Error Messages iii iia 5 2 Table 4 Troubleshooting a H 5 3 Table 5 Main characteristics Of the x ray generator 6 4 Table 6 Equipped x ray
14. ated heat 32 500 J Maximum continuous thermal dissipation 7W Amount of leaking radiation at maximum rate lt 0 25 mGy Maximum field of symmetrical radiation 6 cm 2 3 8 in diameter Position and tolerance of the focal point on the reference axis 0 mm 0 5 mm 0 020 in Table 6 Equipped x ray generator 406434 Figure 14 X ray generator a Reference axis b Target angle c Focal point 06 2009 SM731_K2200_01_en 6 5 16 20 30 4 50 60 N wo w 120 140 wo 189 Time In minutes Figure 15 Heating and cooling curves ofthe KODAK 2200 system tube head 6 6 SM731_K2200_01_en 06 2009 Tables of Exposure Times The following exposure timetables were established with a unit equipped with a standard cone with a focus to skin distance of 20 cm 8 inches 70kV 7mA Cone 20 cm 8 in 60kV 7 Cone 20 cm 8 in Maxillary Child Adult Large Maxillary Child Adult Large Incisor Bicuspid 0 119 0 180 0 227 Incisor Bicuspid 0 238 0 360 0 454 Premolar 0 152 0 230 0 290 Premolar 0 304 0 460 0 580 Molar 0 178 0 270 0 340 Molar 0 356 0 540 0 680 Mandibular Child Adult Large Mandibular Child Adult Large Incisor Bicuspid 0 099 0 150 0 189 Incisor Bicuspid 0 198 0 300 0 378 Premolar 0 106 0 160 0 202 Premolar 0 211 0 320 0 403 Molar 0 119 0 180 0 227 Molar 0 238 0 360 0 454 Bitewing Child Adult Large Bitewing Chil
15. ays the exposure time a CAUTION The operator must instruct the patient to refrain from moving during the entire exposure 06 2009 SM731_K2200_01_en 3 3 Processing Setting Modes 6 Acquire the image e Press the x ray exposure button on the control timer unit or on the remote exposure switch The x ray emission indicator lights up and an audible signal is emitted e Keep pressing until the x ray emission light goes out and the audible signal stops a CAUTION If you stop pressing the control key before the exposure ends a manipulator alarm is activated It indicates that the x ray emission was interrupted prematurely and that there is a risk of underexposure 7 Read the emitted dose Quickly press the selection knob The mGy indicator lights up and the dose in mGy is displayed Section 6 provides a table with emitted dosage based on exposure times see Table 12 When using conventional film process the film according to manufacturer s instructions Develop the film under safelight conditions in an automatic processor or manually If you use an automatic processor refer to the processor s manual Be sure to maintain the mechanically and keep the solutions replenished If you develop film manually follow precisely the manufacturer s recommendations for solution preparation development time and solution temperature Any deviation from the manufacturer s recommendations such as a solution that is too conc
16. bsidiary of Carestream Health Inc 4 rue F Pelloutier Croissy Beaubourg 77435 Marne la Vall e Cedex 2 France 33 1 64 80 85 00 6 12 SM731_K2200_01_en 06 2009
17. crease in sensitivity Like film different digital sensors have varying sensitivities so you need to adjust exposure for sensors as well This KODAK 2200 system allows you to use 2 different modes with pre set exposure times These modes are programmed when installing the equipment based on your local imaging systems as indicated in Tables 9 to 11 These tables are established under manufacturer s standard conditions and should be used as guidelines At any time you can modify these settings by following the procedure described in the Setting Modes below or in the User Mode section of this guide adjust your exposures as needed based the results you get from your system s exposure and processing actualize a change in your local imaging system Procedure 1 Turn on the system The on off button and Ready indicator light up 2 2 Select the exposure mode by pressing quickly the button position by position until the correct mode is displayed correct indicator lights up 60 70 3 Select the kV value by pressing quickly the button 7 e kV for high contrast radiographs for lower contrast radiographs that provide a wider latitude and more levels of grey for periodontal work t amp 4 Select the type of patient by pressing quickly the button child adult large 5 Select the tooth or the exposure time in case of manual mode by turning the selection knob The unit displ
18. d Adult Large Anterior 0 099 0 150 0 189 Anterior 0 198 0 300 0 378 Posterior 0 119 0 180 0 227 Posterior 0 238 0 360 0 454 Occlusal Child Adult Large Occlusal Child Adult Large 0 205 0 310 0 391 0 409 0 620 0 781 Table 7 Exposure times in seconds for class D Speed films Setting Correction Coefficient 01 92 96 0 08 02 90 0 10 5 03 88 0 125 5 04 84 0 16 05 80 0 20 06 75 0 25 07 68 96 0 31 08 60 96 0 40 S 09 50 96 0 50 S 10 37 0 63 5 11 21 96 0 79 S 12 0 1 00 S 13 26 96 1 26 14 59 1 59 15 100 2 00 16 152 2 52 Table 8 Exposure time corrections depending on selected setting 06 2009 SM731_K2200_01_en 6 7 Setting Kodak Insight S 08 Kodak E speed S 09 Kodak Ultra speed S 12 Kodak D speed S 12 Other films Speed class F S 08 or S 09 Other films Speed class E 09 or S 10 Other films Speed class D S 12 or S 13 Table 9 Choice of film type Brand Name Setting Kodak Kodak 5100 S 08 Kodak RVG 5000 08 Trophy RVG Access 08 Kodak Kodak 6100 size 1 amp 2 07 RVG 6000 07 Trophy RVG Ultimate S07 Trophy RVG Reference Hi Resol mode S07 Trophy RVGui Hi Resol mode S07 Trophy Kodak RVG 6100 size 0 05 Trophy RVG THD 05 Trophy RVG Reference Hi Sensi m
19. e for this product 06 2009 SM731 K2200 01 en 1 3 Marking Labelling Symbols ATTENTION CONSULT ACCOMPANYING DOCUMENTS WARNING amp IONIZING RADIATION 4 4 amp IONIZING RADIATION a CHASSIS GROUND STUD PROTECTIVE EARTH POWER ON POWER OFF SM731_K2200_01_en 06 2009 EEC Regulations U S Regulations The Kodak intraoral x ray system is a Class 11 b medical device which bears the following mark of conformity 0086 a CAUTION U S federal law restricts this device to sale by or on the order of a dentist 06 2009 SM731_K2200_01_en 1 5 1 6 SM731_K2200_01_en 06 2009 2 System Overview Components Figure 1 KODAK 2200 Intraoral X ray System High frequency x ray generator e Transformer and associated electronics and an oil bathed x ray tube Beam limiting device e Radiation diameter 6 cm 2 3 8 in e Distance from x ray tube focal spot to skin 20 cm 7 7 8 in e Angle scale and handle to facilitate positioning Wall framework e Contains the high frequency generator s control electronics Control timer unit e Anatomical selection and display of parameters exposure time emitted dose e Self test of the microprocessor each time the unit is activated e Alarm during incorrect operation e 2 pre set modes or manual exposure settings 06 2009 SM731 K2200 01 en 2 1 4 Scissor arm Wall mounted with
20. ed with gas jack specially designed for this application proven to function correctly after more than 400 000 cycles 06 2009 SM731_K2200_01_en 6 3 TROPHY type 708 type OCX 65 G Rated high voltage 70 kV 70 kV Rated anodic power 490 W 490 DU neei 8 700 J 10 000 accumulated in the anode Rated value of focal spot 60336 1993 0 7 0 027 0 7 mm 0 027 in Target materials Tungsten Tungsten Target slope 19 19 Fila ellie 0 6 mm 0 023 in eq Al 0 6 mm 0 023 in eq Al materials Table 5 Main characteristics of the x ray generator 0 05 1 15 2 25 3 35 4 45 5m Figure 12 Heating and cooling curves for TROPHY TRX 708 tube Figure 13 Heating and cooling curves for OCX 65 G tube 6 4 SM731_K2200_01_en 06 2009 Equipped Generator Parameters Features IEC standard 60601 2 28 1993 Conform Type of protection against electric shocks Class 1 Degree of protection against electric shocks Type B Rated value of inherent filtration 1 5 mm 0 059 in Al Rated value of additional filtration Rated value of total filtration 1 0 mm 0 039 in Al 2 5 0 098 Al Beam limiting cone focal spot skin distance 20 cm 7 7 8 in during one hour of use Maximum accumul
21. entrated or diluted too hot or cold or if film is processed for the wrong amount of time will adversely affect the quality of the final radiograph 1 Select the mode to be set by pressing and holding the selection button for at least 3 seconds as many time as necessary to get the desired LED lighted 2 Press and hold simultaneously for at least 3 seconds the selection button and the knob until the display blinks The current setting is displayed 3 Modify the setting by rotating the knob until the new setting is displayed refer to the setting table as indicated in Tables 9 to 11 4 Validate your choice by pressing and holding the knob until the message copy is displayed or abort by pressing shortly the knob 3 4 SM731_K2200_01_en 06 2009 Additional Features KODAK 2200 Intraoral X ray System uses a high frequency technology that has several advantages e Shorter exposure times reducing the risk of blur due to movement of the patient or film during exposure e Reduction in x ray dose to patients because the KODAK 2200 System emits fewer soft rays absorbed by patients that do not contribute to the radiological picture Choice of high voltage between 60 kV and 70 kV e kV for high contrast radiographs giving a clear image of the endodontal instruments or clearly displaying tooth decay e for better reproduction of levels of grey soft tissue useful for periodontal work A thermal
22. ing used Change the pre set program refer to the User Mode section Exposure time is too long Decrease the exposure time Development time is too long Decrease the development time refer to the development instructions Developer is too hot Cool the developer Developer is too concentrated Adjust the concentration or replace the developer Pre set mode is incorrectly selected Verify your exposure settings refer to the exposure procedure Table 4 Troubleshooting 06 2009 SM731_K2200_01_en 5 3 6 Technical Specifications Compliance with International Standards Manufactured by Trophy A subsidiary of Carestream Health Inc 4 rue Pelloutier Croissy Beaubourg 77435 Marne la Vall e Cedex 2 France For Carestrem Health Inc 150 Veronal Street Rochester New York USA 14608 Models KODAK 2200 Compliance with International Regulations e Medical Device directives 93 42 European Economic Community EEC Class Il b e ElectroMagnetic Compatibility EMC directive 89 336 EEC e FDA Center for Devices amp Radiological Health CDRH 21 CFr title 21 sub chapter J USA e Radiation Emitting Devices Act C34 Canada e Medical Devices Regulations Canada Compliance with European and International Standards e EN 60601 1 IEC 60601 1 e EN 60601 1 3 IEC 60601 1 3 e EN 60601 2 7 IEC 60601 2 7 e EN 60601 2 28 IEC 60601 2 28
23. le when you make an exposure manual mode 70 0 1 sec The message E 01 which means Operator Error is displayed when you make an exposure manual mode 70kV 1 0 sec and release the control button before the exposure time has elapsed Timer self test Turn on the system to activate the self test e test starts with a simultaneous test of the display and alarm lights e The unit proceeds to the systems test At the end of this test indicated by a short beep the firmware version and the total number of exposures divided by 10 made by the machine since installation is displayed e Ifthe test is not successful an Error code is displayed on the display 06 2009 SM731 K2200 01 en 5 1 Cleaning Disinfecting Clean the outside of the system with a damp paper towel or soft cloth using an alcohol based non corrosive cleaner If necessary wipe off surfaces with disinfectant a CAUTION Do not allow liquids to drip into the system Do not spray cleaner or disinfectant directly onto the machine Protect the system from contamination using barriers available from dental distributors Follow the manufacturer s safety recommendations when using the cleaner or disinfectant Error Messages Error Message 101 and a red LED lights up on the control unit Cause Cooling cycle this message can appear during a period of intensive use How to cancel Do not turn
24. lm or the sensor and processing the film Positioning Positioning the patient Seat the patient with the sagittal plane vertical e For radiography of the upper maxillary the Frankfort plane nose ear plane must be horizontal For radiography of the lower maxillary the occlusal plane must be horizontal Figure 10 Patient positioning Positioning the x ray generator The scissor arm allows you to accurately position the generator for any type of exposure The beam limiting device maintains a distance of at least 20 cm 8 in between the focal spot and the skin which allows you to use either the paralleling technique or the bisecting technique Paralleling technique The positioning tool used in the paralleling technique allows you to align the beam and the receptor An adapted collimator reduces the dosage by limiting surface exposure Bisecting technique When using the bisecting technique do not use a rectangular collimator This limits the risk of misaligning the x ray beam and the image receptor 06 2009 SM731_K2200_01_en 3 1 Figure 11 Paralleling technique left and Bisecting technique right Positioning the imaging receptor Using the KODAK 2200 Intraoral X ray System you may create an x ray image on one of three different types of imaging receptors Conventional silver halide films such as KODAK INSIGHT or KODAK ULTRA SPEED dental films Digital sensors such as KODAK RVG sensor
25. ne la Vall e 0086 L MANUFACTURED October 2009 Installation Date NOCEL KODAK 2200 Kos EI xwe 4 6A 230 240V 50 6092 CLASSIFICATION COMPLERS WITE N E RADIATION PERFORMANCES STANDARD 11 CFR SUBCHAPTER J WARNING This x ray unit may be dangerous to patient and operator unless safe exposure factors and operating instructions are observed Carestream Healt Inc Made in France ual 180 Verona Stree REP TROPHY Rochester NY 14 608 77435 la Vall e MANUFACTURED October 2000 Installation Data MODEL KODAK 2200 Tube EN 12 230 240V prone dd FIR imm SN 868541 Tot FIN 2 0 7 mm TON Complies with H E W Radiation Performance Standard 21 CFR SUBCHAPTER J Health Made in France 5 et Rochester NY 14 608 MANUFACTURED June 2009 MODEL KODAK 2200 XJYE123 Add Filt 1mmAL SN 868541 mm Tot Filt 2 17 E 0 7 Hv 70 kv HV Complies with W Radiation Performance Standard 21 CFR SUBCHAPTER J WARNING This x ray unit may be dangerous to patient and operator unless safe exposure factors and operating instructions are observed 55 4 YAS us MEDICAL EQUIPMENT WITH RESPECT TO ELECTRICAL SHOCK FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL amp 0601 1 CAN ZSA C222 601 1 1EC50691 2 7 1 amp 0601 2 28 60601 1 3 9038 e m
26. ode 02 Trophy RVGui Hi Sensi mode 02 Other brands Adjust your sensor type Table 10 Choice of sensor type Brand Name Setting Kodak CR 7400 12 Other brands Adjust the phosphor plate type Table 11 Choice of storage phosphor plates 6 8 SM731_K2200_01_en 06 2009 Emitted Doses To obtain the dose in multiply values in the tables by the exposed surface The exposed surface depends on the collimator that is used and is indicated in Table 13 7mA 60kV 7mA D cep Table 12 Dose measured at extremity of 20 cm 8 in Note Dose accuracy 30 mGy 06 2009 SM731_K2200_01_en 6 9 Collimator Format Used with Used type mm digital with film su ace sensor 19 24 Size 0 4 6 23 35 Size 1 Size 0 22x 35 8 3 Size 1 24 x 40 1 9 ize 2 12 1 Sie Size 2 31 41 Standard 60 mm Size 3 27 x 54 28 3 diameter Size4 57x76 j Table 13 Exposure surface versus type of collimator used 6 10 SM731 K2200 01 en 06 2009 06 2009 SM731_K2200_01_en Licensed Product Carestream Health Inc 2009 The Kodak trade mark and trade dress are used under license from Eastman Kodak Company SM731 1 06 09 Trophy A su
27. off the system The error message will disappear when the system returns to a satisfactory temperature a CAUTION If you turn off power to the system the microprocessor does not calculate the cooling time and for safety reasons considers that the system has not gone into the cooling cycle 102 Request for a x ray tube seasoning Refer to Installation Manual E 01 plus audible alarm Release of the radiography control button before the end of the exposure The display shows the remaining exposure time Based on this time decide whether to develop the film or make another exposure Press the selector knob to stop the alarm E02 The radiography control was activated while the unit was being powered on E 03 E 04 Problems with the exposure time control E 10 to E 18 kV voltage error E 20 to E 24 Filament voltage error Turn off the system and restart If the problem persists call a qualified service E30 Problem with voltage to main power supply technician and discontinue using the or to chemical capacitor equipment E 40 to E 46 System error problems with the microprocessor on the power board E 50 to E 54 Problems with the I2C bus the connection between the control panel and the power board Table 3 Error Messages 92 06 2009 SM731 K2200 01 en Troubleshooting Problem Nothing lights up Cause Unit is disconnected Solution Connect the unit
28. restream Health Inc negligence or other fault Conventions Used in This Manual a CAUTION Caution points out procedures that you must follow precisely to avoid damage to the system or any of its components yourself or others Note loss of data or corruption of files in software applications Notes provide additional information such as expanded explanations hints or reminders Important Important highlights critical policy information that affects how you use this manual and this product General Safety Guidelines This product is designed and manufactured to ensure maximum safety of operation Operate and maintain it in strict compliance with the safety precautions and operating instructions contained in this manual This product meets all the safety requirements applicable to medical equipment However anyone attempting to operate the system must be fully aware of potential safety hazards There are no user serviceable parts in this system The product must be installed maintained and serviced by qualified service personnel according to procedures and preventive maintenance schedules in the product service manual If your product does not operate as expected contact your Service Representative Do not modify this product in whole or in part without prior written approval from Carestream Health Inc The assembly extensions adjustments modifications and repairs must be performed by an authorized Service Repre
29. safety system prevents generator from overheating in case of intensive use This system can prohibit any exposure as long as the generator did not cool The error message 01 appears on the display unit a red LED lights up on the control unit and an audible signal is emitted until the cooling period is over a CAUTION Do not turn off the system If you turn off power the microprocessor does not calculate the cooling time and for safety reasons considers that the system has not gone into the cooling cycle While exposure is taken the exposure time counts off on the control unit display If the exposure is interrupted such as by releasing the key the audible and visible manipulator alarm is activated and the remaining exposure time is displayed This information makes it easier to decide whether to develop the film or to start another exposure if the remaining time is short you may develop the film To stop the manipulator alarm press the selection knob A self test automatically activates when you turn on the unit The self test checks the display the alarm lights and all the systems If the self test detects a problem an error code is displayed When the test is completed a short beep sounds and the display shows the firmware version and the total number of exposures divided by 10 taken by this unit since it was installed 06 2009 SM731_K2200_01_en 3 5 3 6 SM731_K2200_01_en 06 2009
30. sentative Your radiology system must be installed in premises that comply with applicable standards Personnel operating and maintaining this system should receive training and be familiar with all aspects of operation and maintenance KODAK 2200 Intraoral x ray system is intended to be used at the direction of dentists oral surgeons and orthodontists for x ray imaging of the dento maxillo facial area 06 2009 SM731_K2200_01_en 1 1 e To ensure safety read all user manuals carefully before using the system and observe all Caution Important and Note callouts located throughout the manual Keep this manual with the equipment Reading this manual does not qualify you to operate test or calibrate this system Unauthorized personnel are not allowed access to the system If the product does operate properly or fails to respond to the controls as described in this manual e Follow the safety precautions as specified in this manual e Stop using the equipment and do not make or authorize any changes to it e Immediately contact your Service Representative report the problem and await further instructions systems manufactured by Carestream Health Inc comply with safety standards throughout the world for optimum protection against radiation risks aware of the product specifications and of system accuracy and stability limitations Consider these limitations before making any decision
31. tallation 0 for all countries except those having specific local requirements Refer to Installation Manual P 4 1 Film mode setting S 01 to S 16 4 2 Digital mode setting S 01 to S 16 P 05 Tube seasoning procedure Changes OFF to ON Refer to Installation Manual P 06 Show mode ON to disable X ray emission OFF default to enable X ray emission Table 2 Parameters for User Mode 06 2009 SM731 K2200 01 en 4 1 4 2 SM731_K2200_01_en 06 2009 5 Care and Maintenance General Maintenance Important If the result of any of these checks is not satisfactory discontinue using the equipment and contact an authorized technician To make sure that the system functions correctly you must have it serviced annually by an authorized technician In addition every three months inspect the equipment and make sure of the following Generator The certification label is legible There are no oil leaks Mechanical support The framework is securely attached to the wall All the labels are legible The scissor arm is stable in all positions Control unit and electrical installation e The symbols are legible The control unit cable and the power supply cable in good condition The ground is correctly installed The radiology control key returns to its initial position after use Functioning The audible signal is audible and the x ray emission light is visib
32. th current installation standards From this location visual or audio communication must be maintained with the patient together with access to the control interface during exposure WARNING Do not operate the unit if there is the threat of an earthquake Following an earthquake ensure that the unit is operating properly before using it again Failure to observe this precaution may expose patients to hazards WARNING X ray equipment can be hazardous to patients and the operator if the exposure safety factors and operating instructions are not observed WARNING Do not place objects within the field of operation of the unit WARNING We recommend that the patient and the operator wear protective lead lined aprons unless other Radiation Protection Protocols apply locally Ensure that any parts of the unit that may come into contact with the patient and the operator have been disinfected after each patient has been exposed to x rays If the unit develops a fault turn it off and display a sign that states Out of Service WARNING The operator must ask the patient to refrain from moving during the entire period of exposure In the European Union this symbol indicates that when the last user wishes to discard this product it must be sent to appropriate facilities for recovery and recycling Contact your local sales representative for additional ERE information on the collection and recovery programs availabl
33. uency x ray generator s control electronics Timer control unit for the x ray generator Scissor arm On off switch with built in light Rectangular collimator Extension Arm N NOa 06 2009 SM731_K2200_01_en 2 7 Control Timer Unit Figure 9 KODAK 2200 Intraoral X ray System control timer unit Display Exposure time emitted dose selection X ray exposure button X ray emission control light Cooling indicator Child Adult Large selector kV selector Receptor selector 2 pre set modes 1 manual mode Teeth selector 10 Bitewing selector 11 Occlusal selector 12 Selection knob e Pre set mode Rotate the knob to select tooth e Manual mode Rotate the knob to select the exposure time e Press the knob quickly to display the latest measure dose emitted 13 Warning lonizing radiation Oe E e 2 8 SM731 K2200 01 en 06 2009 3 Using the System Every dental specialist would like to produce high quality intraoral radiographs that reveal maximum detail with the minimum dose to the patient show teeth and anatomic structures accurately with a minimum of distortion or magnification and have optimal density and contrast to maximize their use for the detection of dental diseases To obtain high quality intraoral radiography with maximum details take extra care in three steps of the radiography process positioning the patient the x ray generator and the imaging system exposing the fi
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