User Manual with Installation Instructions
Contents
1. Cause If you capture images by pressing Quick intraoral image capturing button for both left and right side the other image is upside down Remedy Rotate button can be used to turn the image over Or use template which assists you in capturing images sequentially in a specified order and location in the patient s mouth Go to Template dialog by selecting Image Edit template What if image capturing buttons are not enabled Cause Patient is not selected Remedy Select patient Cause Snapshot device is not selected Remedy Select devices to be used from Tools Installed devices 203234 rev 3 Instrumentarium Dental 15 Printed copies of this document are considered uncontrolled 14369 1 Rev001 03 18 2014 5 Tips and hints 5 7 Using the Instrumentarium TWAIN software Refer the Instrumentarium TWAIN installation and user manual for all features and settings At the TWAIN options it is often preferable to select 1 Immediately proceed with acquiring a new image Snapshot This starts the image capture automatically and thus reducing the number of mouse click required 2 Under Snapshot Options Capture images in the continuous capture mode default to keep the sensor in the capture mode for successive images This allows several image capture in series without touching the keyboard 16 Instrumentarium Dental 203234 rev 3 Printed copies of this document are considered uncontrolled 1432. 2 1 Sensor main parts Snapshot Unit Sensor USB connector A S N D Indicator lights Orange Standby Green Ready for image capture Blinking Image transfer 2 2 Accessories for the sensor NOTE Ordering information for the Instrumentarium Dental accessories in chapter 6 7 Sensor holders Use sensor holders together with Snapshot for easier and more accurate patient positioning and for reducing the number of retakes Hygienic covers Protect the sensor with a hygienic cover when using it Use only proper covers provided by Instrumentarium Dental 4 Instrumentarium Dental 203234 rev 3 Printed copies of this document are considered uncontrolled 14369 1 Rev001 03 18 2014 203234 rev 3 2 Package contents Wall Mount set Fig 2 2 Wall mount set The Wall mount ensures a safe and convenient place to store the sensor when not in use Install the wall mount rack directly on the wall with screw provided or use the adapter for detachable installation A wall mount set is included in the sensor sales package Contact your local sales representative for ordering more sets Sensor Cable clip Use the Cable clip to compensate the weight of the cable when the sensor in use Attach the clip to e g lead apron A Cable clip is included in the sensor sales package Contact your local sales representative for ordering more Instrumentarium Dental 5 Printed copies of this document
3. discharge Compliance Level 2 4 6 kV for contact discharge 2 4 8 kV for air discharge Electromagnetic Environment Floors are wood concrete or ceramic tile or floors are covered with synthetic material and the relative humidity is at least 30 percent Electrical fast 2 kV for power 2 kV for power Mains power quality is that of a IEC 61000 4 11 30 dip in U for 25 cycles 30 dip U for 25 cycles transient burst supply lines supply lines typical commercial and or hospital IEC 61000 4 4 environment 1 kV for 1 kV for input output input output lines lines Surge 1 kV differential 1 kV differential Mains power quality is that of a IEC 61000 4 5 mode mode typical commercial and or hospital 2 kV common 2 kV common environment mode mode Voltage dips 5 96 lt 5 Mains power quality is that of a short gt 95 96 dip in U gt 95 96 dip in U typical commercial and or hospital interruptions for 0 5 cycle for 0 5 cycle environment If the user of and voltage 40 40 Instrumentarium Dental Snapshot variations on 60 dip in U 60 dip in requires continued operation during power supply for 5 cycles for 5 cycles power mains interruptions it is input lines 70 96 U 70 96 recommended that Instrumentarium Dental Snapshot be powered from an uninterruptible power supply or a 5 96 U lt 5 U battery gt 95 di
4. Ed 2 in this Instrumentarium Dental Snapshot user manual Personal computer should only be connected to grounded outlet Inspect periodically the sensors Do not sterilize the sensor using autoclave or UV oven Make sure that the Ready LED illuminates before making an exposure Recommended exposure values are in the user manual Any service attempts by unauthorised persons are strictly prohibited Use a new disposable hygienic cover for every patient Operating temperature range is in the user manual To ensure patient safety please observe the following The PC shall be placed in the same room and outside patient environment at least 1 5 m from the patient and patient support The system leakage current must be checked to meet the limits of IEC 60601 1 1 This must be notified when connecting other equipments to PC The system leakage current can be achieved for example by using 60601 1 compliant PC medical PC or medical USB HUB or other appropriate isolation method Manufacturer s liability When installing the Instrumentarium Dental Snapshot system it is important to observe all warnings and precautions described in this manual As a manufacturer we can only assume liability for safe and reliable operation of the Instrumentarium Dental Snapshot system when Instrumentarium Dental 203234 rev 3 Printed copies of this document are considered uncontrolled 14369 1 Rev001 03 18 2014 203234 rev 3 6 6 6
5. LR 1 pc Positioning ring 1 pc 200333 Bitewing Refill S1 Refill Pack 10 pcs 200335 Posterior S1 Refill pack 10 pcs 200337 Periapical S1 Refill Pack 10 pcs 200338 Endo 1 Refill Pack 10 pcs 200334 Positioning ring Refill Pack 5 pcs 200339 Bitewing S2 Refill Pack 10 pcs 200340 Posterior S2 Refill pack 10 pcs Instrumentarium Dental Sensor holders optionally B Available separately B Two sizes M Consult your local dealer N for details 22 Instrumentarium Dental 203234 rev 3 Printed copies of this document are considered uncontrolled 14369 1 Rev001 03 18 2014 203234 rev 3 6 General information Other holders available from a third party suppliers 200330 Super Bite Senso Holders KerrHawe Super Bite Senso Anterior 2 pcs Super Bite Senso Posterior 2 pcs 200331 Kwik Bite Senso Holders KerrHawe Kwik Bite Senso 4 pcs 200332 Endo Bite Senso Holders KerrHawe Endo Bite Senso Anterior 2 pcs Endo Bite Senso Posterior 2 pcs KerrHawe Sensor holders optionally B Available separately Universal size Bitewing posterior pa Instrumentarium Dental Printed copies of this document are considered uncontrolled 14369 1 Rev001 03 18 2014 anterior endo Consult your local dealer for details 23 6 General information 6 8 Technical specifications Trademark Manufacturer s quality system Electrical and Mechanica
6. are considered uncontrolled 14369 1 Rev001 03 18 2014 2 Package contents 6 Instrumentarium Dental 203234 rev 3 Printed copies of this document are considered uncontrolled 14369 1 Rev001 03 18 2014 3 Installation 203234 rev 3 3 Installation 3 1 Cliniview Users 3 2 3 3 1 Install the CliniView software See instructions in the CliniView manual in the CliniView CD Connect the Snapshot sensor to the USB port of the computer The sensor is automatically detected by Windows All required files are installed from the sensor memory when connected for the first time Allow the sensor to complete the installation by initiating the image capture the software user interface The sensor is ready for use Take a test exposure TWAIN Users 1 Install the Instrumentarium TWAIN driver See instructions in Instrumentarium TWAIN installation manual in the Snapshot CD Connect the Snapshot sensor to the USB port of the computer The sensor is automatically detected by Windows All required files are installed from the sensor memory when connected for the first time Allow the sensor to complete the installation by initiating the image capture the software user interface The sensor is ready for use Take a test exposure Other software Users Follow instructions provided with the software Instrumentarium Dental 7 Printed copies of this document are considered uncontrolled 14369 1 Rev001 03 18
7. ray unit movement or have the unit serviced Cause Incorrect integration time Remedy Set the integration time in CliniView to be longer than the exposure time Images are burned out Cause Excessive exposure time Remedy Set shorter exposure time Remedy Change a long cone on the X ray unit TWAIN returns colorful image Cause The calling application does not support 16 bit image data Remedy Select preferred image depth By default select 8 bit image transfer at the TWAIN options 6 2 Maintenance and service Service There are no user serviceable parts Cleaning Use a cloth moistened in mild cleaning solution soap or mild disinfectant to clean the Snapshot unit Disinfecting the sensor Only the CMOS sensor can be immersed in disinfectant solution e g Virkon Cidex Follow the disinfectant instructions carefully Do not use aggressive chemicals CAUTION Do not immerse the Snapshot unit 18 Instrumentarium Dental 203234 rev 3 Printed copies of this document are considered uncontrolled 14369 1 Rev001 03 18 2014 6 3 6 General information Main label and symbols The main label can be found on the USB cable Snapshot TYPE Ser No IP44 pd Manufactured m Instrumentarium Dental Sensor s Nahkelantie 160 IP67 CNIZUS Fl 04300 TUUSULA Finland ETL CLASSIFIED 8 Fig 6 1 Main label N Attention consult accompanying documents Contains warnings and instructions ab
8. set from the wall to clean it properly If the adapter is used the wall mount can be lifted upwards to detach If the wall mount is mounted with screws first loose the screws for 1 2 turn cew 5 4 Recommended exposure values Snapshot recommended exposure times for DC x ray units 60kV 7mA 7mA 9 cone 12 cone 9 cone 12 cone adult child adult child adult child adult child Maxillary incisor 0 20 0 10 0 40 0 20 0 10 0 05 0 20 0 10 Maxillary cuspid 0 20 0 10 0 40 0 20 0 10 0 05 0 20 0 10 Maxillary molar 0 32 0 16 0 63 0 32 0 16 0 08 0 32 0 16 Mandibular incisor 0 20 0 10 0 40 0 20 0 10 0 05 0 20 0 10 Mandibular cuspid 0 25 0 10 0 40 0 20 0 125 0 05 0 20 0 10 Mandibular molar 0 25 0 16 0 50 0 25 0 125 0 063 0 25 0 125 Bitewing 0 25 0 16 0 50 0 25 0 125 0 063 0 25 0 125 For AC units increase exposure time about 30 Snapshot recommended exposure times for DC x ray units 65kV 7 5mA 8mA 9 cone 12 cone 9 cone 12 cone adult child adult child adult child adult child Maxillary incisor 0 16 0 10 0 25 0 16 0 10 0 08 0 16 0 10 Maxillary cuspid 0 16 0 10 0 25 0 16 0 10 0 08 0 16 0 10 Maxillary molar 0 20 0 12 0 32 0 20 0 125 0 08 0 20 0 125 Mandibular incisor 0 125 0 10 0 20 0 16 0 10 0 06 0 16 0 10 Mandibular cuspid 0 125 0 10 0 20 0 16 0 10 0 06 0 16 0 10 Mandibular molar 0 20 0 16 0 32 0 20 0 125 0 08 0 20 0 125 Bitewing 0 20
9. size 2 36 48 x 25 84 mm Four rounded corners two corners with greater radius for better patient comfort in Sensor size 2 Sensor size 1 SC I 1 S1 Sensor size 2 SC I 1 S2 The sensor type is marked on the main label see chapter Main label for details 19 um x 19 um 1580 x 1050 pixels 19 um x 19 um 1916 x 1358 pixels Sensor size 1 40 cm Sensor size 2 40 cm USB 2 0 USB 2 0 High speed 500 mA maximum 3 meters 9 8 feet General applied part sensor BF type Ambient conditions Snapshot unit Transportation and storage temperature Operating temperature Relative humidity storage 40 60 40F 158F 10 40 50F 104F 10 93 Water tightness IP67 Sensor IP44 Snapshot unit Materials Sensor cover PA Sensor cable PUR Snapshot cover ABS Hygienic cover Ethylene Methyl Acrylate Copolymer 203234 rev 3 Instrumentarium Dental 25 Printed copies of this document are considered uncontrolled 14369 1 Rev001 03 18 2014 6 General information 26 6 9 Disposal At the end of useful working life of the device its spare and replacement parts and accessories make sure that you follow all local national and international regulations regarding the correct and safe disposal and or recycling of the device its spare and replacement parts and accessories The device and its spare and replacement parts and accessories may include parts that are made of or include materials that ar
10. 0 16 0 32 0 20 0 125 0 08 0 20 0 125 For AC units increase exposure time about 30 203234 rev 3 Instrumentarium Dental Printed copies of this document are considered uncontrolled 14369 1 Rev001 03 18 2014 5 Tips and hints 14 5 5 Optimizing the sensor performance The display and its brightness contrast settings as well as ambient lighting have a great impact on the diagnostic value of a digital image on screen Use Tools gt Monitor gt test Start Check to run a monitor test in the CliniView Software Image quality settings Best clarity requires correct exposure with adequate dose Make sure that you are using proper exposure settings for your X ray tube head The sensor can operate in two image quality modes The default mode of operation is standard quality It provides good performance for most clinical needs For occasional needs superior quality may be desirable Then select the high quality mode at the imaging software The high quality mode may require slightly higher dose and image processing time The file size is also larger On the other hand provides the best possible resolution and most accurate sensor calibration Image processing settings The raw image returned by the sensor is processed in the image viewing software This processing impacts the image brightness contrast and sharpness Best image processing parameters depend on the image data and diagnostic n
11. 2014 3 Installation 8 Instrumentarium Dental 203234 rev 3 Printed copies of this document are considered uncontrolled 14369 1 Rev001 03 18 2014 4 Using the Snapshot sensor 4 Using the Snapshot sensor 203234 rev 3 4 1 Positioning and exposure Snapshot sensor type size 1 S1 is designed for taking anterior periapical and pedodontic images The purpose of Snapshot sensor type size 2 S2 is to capture bitewing and horizontal periapical images 1 Protect the sensor with a hygienic cover and use an appropriate sensor holder See manufacturer s instructions for details 2 Start image capturing from the software see chapter 4 2 Capturing image with the CliniView software or 4 3 Capturing image with the TWAIN driver 3 Position the sensor NOTE prevent the patient biting the sensor cable lead the cable alongside the holder 4 Position the X ray tube head and make an exposure The Snapshot sensor has a wide operating range that allows a use of a fixed exposure value on the X ray head for typical imaging needs Use the image processing features of the imaging software to adjust the brightness and contrast of the image according to the actual exposure level on the sensor Try 0 200 s 60kV DC or 0 12 s 70kV DC The exact best value depends on the X ray tube head generator type mA SSD cone length and patient population children adult For optimized exposure and patient dose you can adjus
12. 4369 1 Rev001 03 18 2014 6 General information 32 Instrumentarium Dental 203234 rev 3 Printed copies of this document are considered uncontrolled 14369 1 Rev001 03 18 2014 Printed copies of this document are considered uncontrolled 14369 1 Rev001 03 18 2014 Instrumentarium Dental reserves the right to make changes in specification and features shown herein or discontinue the product described at any time without notice or obligation Contact your Instrumentarium Dental representative for the most current information Copyright 09 2008 by PaloDEx Group Oy All rights reserved Instrumentarium Dental Nahkelantie 160 P O Box 20 Fl 04300 Tuusula Finland Tel 358 45 7882 2000 Fax 358 9 851 4048 Americas Instrumentarium Dental Inc Milwaukee Wisconsin U S A Tel 800 558 6120 Fax 414 481 8665 Instrumentarium Dental Snapshot INSTRUMENTARIUM ibo duane 203234 rev3 Printedin Finland 09 2008 Printed copies of this document are considered uncontrolled 14369 1 Rev001 03 18 2014
13. 69 1 Rev001 03 18 2014 6 General information 6 General information 6 1 Troubleshooting PC does not recognize USB Remedy Remove USB hardware and reconnect Change USB port if needed Try using a powered USB HUB to connect the sensor if port change does not help Snapshot lights are not lit Remedy Remove USB hardware and reconnect Change USB port if needed Try using a powered USB HUB to connect the sensor if port change does not help Images are too grainy and light Cause Exposure factors KV mA s used are too low Remedy Increase exposure factors Cause Image adjustments have not been performed Remedy Adjust the image brightness contrast and gamma using CliniView software Images are too dark Cause Exposure factors used are too high Remedy Decrease exposure factors Cause Image adjustments have not been performed Remedy Adjust the image brightness contrast and gamma using CliniView software Lack of image contrast Cause Image adjustments have not been performed Remedy Adjust the image contrast using CliniView software Cause Exposure factors kV mA s used are not optimal Remedy Increase exposure factors 203234 rev 3 Instrumentarium Dental 17 Printed copies of this document are considered uncontrolled 14369 1 Rev001 03 18 2014 6 General information Images are blurred Cause The patient moved Remedy Prevent patient movement Cause The X ray source moved Remedy Prevent X
14. 69 1 Rev001 03 18 2014 Table of Contents T uou occ a E E 1 2 Package contents eoo eee eee etae ete lal iaa 3 2 1 Sensor Mall Darts 4 24 Accessories forthe SEMSON et re e 4 3 AMS TAM ATOM ics 7 S T USCIS pot eot ori de tet ated o rte ne a catu tues ts 7 3 2 TWAIN PER 7 Su Other software Users cre ee utra erbe a iba ian A EAE EE E dq da 7 4 Using the Snapshot SensOr cicscscccecscessscceseseccsadecseecceecdecasecseenaivesecssnsasssadecasseee 9 4 1 Positioning and CxPpOSure 2 2 ccc ccccceeccenecseseceesseseussescccnccocceceedeneseeeseneerseetaneente 9 4 2 Capturing image with the CliniView software sees 10 4 3 Capturing image with the TWAIN 10 Ey G R M a 11 5 T iHandlinj amndusifigi ioo et tte hth lates di deae ederet eee dett 11 5 2 Setting up the Operalory otto tet 12 5 12 5 4 Recommended exposure 13 5 5 Optimizing the sensor performance ccccccccccccseeeeeeeeeeeeeeeeeeeeeeeeeeeseeaneaeaesess 14 5 6 Using the CliniView software cesccesscscsceeseeeeeeeeeeeneeeneeeetteestestenseneseceeees 15 5 7 Using the Instrumentarium TWAIN 16 6 Generali
15. General information B PC installation was performed according to manuals supplied with the PC CliniView PC software is installed and used according to the Installation amp User Manual for CliniView Software B The Instrumentarium Dental Snapshot system is installed and used according to the Installation amp User Manual for the Instrumentarium Dental Snapshot system Maintenance and repairs are performed by a qualified the Instrumentarium Dental Snapshot Dealer and W Original or authorized replacement parts are used If service on the equipment is performed a work order describing the type and extent of repair must be provided by the service technician This must contain information of changes of nominal data or work range performed The work order must furthermore indicate the date of repair the name of the company concerned and a valid signature The user should keep this Service Report for future reference If you have any problems or difficulties when capturing images please refer to troubleshooting in the user manual Please find the electromagnetic compatibility tables according to IEC 60601 1 2 Ed 2 in this Instrumentarium Dental Snapshot user manual Use only USB cable delivered with the device to ensure proper operation according to specification Image Acquisition System Requirements Electrical safety IEC 60950 for office use or IEC ISO 60601 1 medical PC Processor Pentium 600MHz or better
16. Instrumentarium Dental Snapshot Intraoral Sensor Installation amp User Manual 203234 rev3 INSTRUMENTARIUM Printed copies of this document are considered uncontrolled 14369 1 Rev001 03 18 2014 Printed copies of this document are considered uncontrolled 14369 1 Rev001 03 18 2014 Copyright Manufactured by Code 203234 rev3 Date 10 September 2008 Document code D503023 rev 3 Copyright 09 2008 by PaloDEx Group Oy All rights reserved Documentation trademark and the software are copyrighted with all rights reserved Under the copyright laws the documentation may not be copied photocopied reproduced translated or reduced to any electronic medium or machine readable form in whole or part without the prior written permission of Instrumentarium Dental The original language of this manual is English Instrumentarium Dental reserves the right to make changes in specification and features shown herein or discontinue the product described at any time without notice or obligation Contact your Instrumentarium Dental representative for the most current information CE 0537 Instrumentarium Dental Nahkelantie 160 P O Box 20 FI 04300 Tuusula FINLAND Tel 358 45 7882 2000 Fax 358 9 851 4048 For service contact your local distributor Printed copies of this document are considered uncontrolled 14369 1 Rev001 03 18 2014 Printed copies of this document are considered uncontrolled 143
17. Windows 2000 XP Vista 32 bit Hard disk 10 GB CD ROM Yes Keyboard Yes Mouse Yes USB port Yes USB 2 0 Accessories Audiocard and speakers optional Operating system Windows 2000 not recommended not supported by TWAIN 5 0 XP SP2 Vista 32 bit See Microsoft Windows System Requirements Main memory RAM Windows 2000 XP and Vista 32 bit 256 MB or more Instrumentarium Dental 21 Printed copies of this document are considered uncontrolled 14369 1 Rev001 03 18 2014 6 General information 6 7 Accessories Accessories Part no Description 203441 Intraoral sensor hygienic cover size 1 generic fits the Snapshot size 1 sensor 203442 Intraoral sensor hygienic cover size 2 generic fits the Snapshot size 2 sensor 203435 Sensor cable clip 10 pcs 203357 Wall mount set 5169578 Hygienic covers 200162 Instrumentarium Sensor holder starter kit Size 1 Bitewing holder 1 pc Posterior holder UR LL 1 pc Posterior holder UL LR 1 pc Periapical holder UR LL 1pc Periapical holder UL LR 1 pc Endo holder UR LL 1 pc Endo holder UL LR 1 pc Positioning ring 1 pc 200163 Instrumentarium Sensor Holder Starter Kit Size 2 Bitewing holder 1 pc Posterior holder UR LL 1 pc Posterior holder UL LR 1 pc Periapical holder UR LL 1pc Periapical holder UL LR 1 pc Endo holder UR LL 1 pc Endo holder UL
18. able and mobile RF communications equipment can affect the system Instrumentarium Dental 27 Printed copies of this document are considered uncontrolled 14369 1 Rev001 03 18 2014 6 General information described below The Snapshot is suitable for use in the specified electromagnetic environment The purchaser or user of the Snapshot should assure that it is used in an electromagnetic environment as fluctuations flicker emissions IEC 61000 3 3 Emissions Test Compliance Electromagnetic Environment Radio Frequency Group 2 The Instrumentarium Dental Snapshot must emit Emissions electromagnetic energy in order to perform it s intended CISPR11 function Nerby electronic equipment may be affected Radio Frequency Class B The Snapshot is suitable for use in all establishments Emissions including domestic establishments and those directly CISPR11 connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic IEC 61000 3 2 The Snapshot is suitable for use in all establishments emissions Class A including domestic establishments and those directly connected to the public low voltage power supply IEC 61000 3 2 network that supplies buildings used for domestic purposes Voltage Complies The Snapshot is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network th
19. at supplies buildings used for domestic purposes Table 6 2 Electromagnetic emissions IEC 60601 1 2 Ed 2 28 Instrumentarium Dental Printed copies of this document are considered uncontrolled 14369 1 Rev001 03 18 2014 203234 rev 3 6 General information Recommended Separation Distances for Portable and Mobile RF Communications Equipment IEC 60601 1 2 Frequency of Transmitter Equation Rated Maximum 150KHz to 80 MHz Separation Distance 80 MHz to 800 MHz d Ei Separation Distance 800 MHz to 2 5 GHz E Separation Distance Output Power of meters meters meters Transmitter watts 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 34 10 3 69 3 69 7 38 100 11 67 11 67 23 34 Table 6 3 Recommended Separation Distances for Portable and Mobile RF Communications Equipment IEC 60601 1 2 Ed 2 203234 rev 3 Instrumentarium Dental Printed copies of this document are considered uncontrolled 14369 1 Rev001 03 18 2014 29 6 General information Instrumentarium Dental Snapshot is suitable for use in the specified electromagnetic environment The purchaser or user of Instrumentarium Dental Snapshot should assure that it is used in an electromagnetic environment as described below Immunity Test Electrostatic discharge ESD IEC 61000 4 2 IEC 60601 1 2 Test Level 2 4 6 kV for contact discharge 2 4 8 kV for air
20. e non environmentally friendly hazardous These parts must be disposed of in accordance with all local national and international regulations regarding the disposal of non environmentally friendly or hazardous materials The following hazardous materials and substances can be found in the device its spare and replacement parts and assemblies lead Pb sensor The locations of all the spare and replacement parts and assemblies listed above can be found in the service and or installation manual supplied with the device Instrumentarium Dental 203234 rev 3 Printed copies of this document are considered uncontrolled 14369 1 Rev001 03 18 2014 203234 rev 3 6 General information 6 10 Electromagnetic Compatibility EMC tables These Electromagnetic Compatibility tables according to IEC 60601 1 2 Ed 2 in chapter 7 5 consists of WARNING When used Instrumentarium Dental Snapshot adjacent to other equipment such configuration should be carefully observed to ensure that electromagnetic interference EMI does not degrade performance The use of Instrumentarium Dental Snapshot attached to Instrumentarium Dental Focus x ray as presented in this user manual has been verified by the manufacturer WARNING USE LIMITATION External components The use of accessories transducers and cables other than those specified may result in degraded ELECTROMAGNETIC COMPATIBILITY of the EQUIPMENT and or SYSTEM WARNING Port
21. eeds The purpose of the processing is to enhance contrast in the diagnostically interesting areas and filter noise The default values for image processing have been determined to satisfy most clinical needs The user may save new default values if there is a consistent need to adjust every image In the software user interface there is a possibility to return the factory defaults NOTE When using the Instrumentarium TWAIN there is typically multiple image processing applied The default image processing at the application should be minimal to avoid over processing The average image quality should be superior already at the TWAIN preview window The daily brightness contrast adjustment to accommodate patient to patient variation is most conveniently done at the calling application Instrumentarium Dental 203234 rev 3 Printed copies of this document are considered uncontrolled 14369 1 Rev001 03 18 2014 5 Tips and hints Sensor timing parameters The sensor timing should not normally be changed The sensor time out must be longer than the time normally required for positioning when the sensor is in the ready for image capture Exceeding the time out time will cause the sensor to go from the ready state to the standby state The sensor integration time must be longer than the longest exposure time used 5 6 Using the CliniView software Refer the CliniView User manual for all CliniView features What if image is upside down
22. he transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey are less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Co Field strengths from fixed transmitters such as base stations for cellular telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be estimated accurately To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be performed If the measured field strength exceeds the RF compliance level above observe Instrumentarium Dental Snapshot to verify normal operation in each use location If abnormal performance is observed additional measures may be necessary such as re orienting or relocating Instrumentarium Dental Snapshot Over the frequency range 150 kHz to 80 MHz field strengths are less than V m The Recommended Separation Distances are listed on page 21 Note These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Table 6 5 RF immunity of non life support equipment or system IEC 60601 1 2 203234 rev 3 Instrumentarium Dental 31 Printed copies of this document are considered uncontrolled 1
23. l safety Patient connection Sensor technology IMAGE QUALITY Resolution Grayscale Holders SOFTWARE MAIN FEATURES Operating system Operating software Full Mouth Series File sizes X ray shield in the sensor Snapshot ISO 9001 ISO 13485 Medical Equipment with respect to electrical shock fire and mechanical hazards only in accordance with UL2601 1 1997 CAN CSA C22 2 No 601 1 M90 0537 According to IEC 60601 1 1998 Am1 1991 Am2 1995 CE models marked according to the Medical Device Directive 93 42 EEC Device classification II b Applied part BF type CMOS 26 3 Ip mm theoretical 4096 gray levels A full set of color coded KerrHawe and Sigma M sensor holders with easy instructions for comfortable and accurate positioning Windows XP SP2 or Vista 32 bit CliniView Instrumentarium TWAIN FMS user defined 0 8 MB uncompressed file Sensor size 1 1 3 MB uncompressed file Sensor size 2 Lead Pb 24 Instrumentarium Dental 203234 rev 3 Printed copies of this document are considered uncontrolled 14369 1 Rev001 03 18 2014 Dimensions Outer dimensions Active image area Sensor shape Sensor type PIXEL SIZE Sensor size 1 Sensor size 2 Sensor cable length Sensor unit PC connection USB USB cable length 6 General information 86 x 25 x 14 mm 26 x 37 mm 31 x 44 mm Snapshot unit Sensor size 1 Sensor size 2 Sensor size 1 30 02 x 19 95 mm Sensor
24. nformatlo Do cuu decia cascades MEL EM UT 17 Troubleshooting aun ed Set a t teal alten States 17 6 2 Maintenance and service 18 6 3 Main label and symbols doe od ideal ne ele ol 19 6 4 Warnings and precautions aceti teet ete aot uo eene eet Pear eene titre due 20 6 5 Manufacturer s liability eter RAG Res Ibo eee cuo C 20 6 6 Image Acquisition System Requirements 21 SAT AEN aUe cet edu e C Ie EORR ERA COUR DIR 22 6 8 Technical SpeciiCallOriS eoo gen pce d 24 6 9 MIS DOS all ce eo rre ie Ded aeos du eta bes eee t te cun ren pua 26 6 10 Electromagnetic Compatibility EMC 27 203234 rev 3 mrumenaiumDenal i Printed copies of this document are considered uncontrolled 14369 1 Rev001 03 18 2014 ii Instrumentarium Dental 203234 rev 3 Printed copies of this document are considered uncontrolled 14369 1 Rev001 03 18 2014 1 Introduction 1 Introduction 203234 rev 3 The Snapshot digital intraoral sensor is designed to produce high quality digital X ray images of teeth and adjacent structures instantly To view enhance store send and print images use the CliniView imaging software or another imaging application through the Instrumentarium TWAIN driver For taking intraoral images you need the comple
25. out the safety of the unit If these warnings are not observed serious risks and injury may be caused to the patient and operator C If the unit has CE marking it is CE marked according to 0537 the Medical Device Directive 93 42 EEC USB connection Type BF equipment IP44 The degree of protection provided by the Snapshot unit Protected against solid objects over 1mm tools wires amp small wires Protected against water sprayed from all directions limited ingress permitted IP67 The degree of protection provided by the sensor Totally protected against dust Protected against the effects of immersion between 15 cm and 1m AWTERTE I WTS GK Revised May 30 2003 Us ETL CLASSIFIED 203234 rev 3 This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment Table 6 1 Symbols Instrumentarium Dental 19 Printed copies of this document are considered uncontrolled 14369 1 Rev001 03 18 2014 6 General information 20 6 4 6 5 Warnings and precautions Do not immerse the Snapshot unit If a IEC 60950 compliant non medical PC is used it must not be brought in to the patient environment Find the electromagnetic compatibility tables according to IEC 60601 1 2
26. p in U gt 95 dip in U Power 3 A m 3 A m Power frequency magnetic fields frequency are at levels characteristic of a 50 60 Hz typical location in a typical magnetic field commercial and or hospital IEC 61000 4 8 environment NOTE is the a c mains voltage prior to application of the test level Table 6 4 Electromagnetic immunity IEC 60601 1 2 Ed2 30 Instrumentarium Dental Printed copies of this document are considered uncontrolled 14369 1 Rev001 03 18 2014 203234 rev 6 General information Instrumentarium Dental Snapshot is suitable for use in the specified electromagnetic environment The purchaser or user of Instrumentarium Dental Snapshot should assure that it is used in an electromagnetic environment as described below Immunity IEC Compliance Electromagnetic Test 60601 1 2 Level Environment Test Level Portable and mobile RF communications equipment are used no closer to any part of Instrumentarium Dental Snapshot including cables than the recommended separation distance calculated from the equation appropriate for the frequency of the transmitter Conducted 3V 3V Recommended Separation Distance RF IEC 150 kHz to 3 5 61000 4 6 80 MHz WP 1 Radiated 3 V m RFIEC 3 V m 3 5 61000 4 3 80 MHz to a WP 2 5 GHz 80 MHz to 800 MHz 7 d WP Ei 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts W according to t
27. pies of this document are considered uncontrolled 14369 1 Rev001 03 18 2014 5 Tips and hints 5 Tips and hints 5 1 Handling and using Use the Sensor Cable Clip to avoid loose Snapshot unit to force down the sensor from patient s mouth 1 Press the clip button to attach the cable to the clip 2 Attach the clip to e g lead apron Use Safely remove hardware function in the icon tray when disconnecting the Snapshot B Do not disconnect the Snapshot before the image is displayed on the screen To prevent the patient biting the sensor cable lead the cable alongside the holder 203234 rev 3 Instrumentarium Dental 11 Printed copies of this document are considered uncontrolled 14369 1 Rev001 03 18 2014 5 Tips and hints 5 2 Setting up the operatory The sensor cable is 3 m long If it is not enough use a powered active USB hub as an extension Two sensors of a different size can be simultaneously connected to the PC Make sure you do not overload your USB port Do not connect other device to the HUB If you have start up problems with the sensor try another USB port at your computer 5 3 Cleaning Sensor Only the CMOS sensor can be immersed in disinfectant solution Do not immerse the Snapshot unit 12 Instrumentarium Dental 203234 rev Printed copies of this document are considered uncontrolled 14369 1 Rev001 03 18 2014 Wall mount set 5 Tips and hints Remove the whole wall mount
28. t the exposure settings with the help of the guidance given in chapter 5 4 Recommended exposure values Instrumentarium Dental 9 Printed copies of this document are considered uncontrolled 14369 1 Rev001 03 18 2014 4 Using the Snapshot sensor 4 2 Capturing image with the CliniView software Single image 1 Start the CliniView software and select the patient 2 Start image capturing in Cliniview by pressing the Start intraoral image capturing button 3 Position the sensor Select the exposure values and press the exposure button 4 When finished stop image capturing and save the image Using a template To take several images of the same patient you can use a template Click the template button before starting image capturing B Choose a template and set as default some of the ready templates Alternatively add or edit your own template Adjusting an image B Images can be adjusted with a variety of image adjustment tools See CliniView manual for details W For quick adjustment you can use modality specific adjustment buttons 4 3 Capturing image with the TWAIN driver 1 Launch the Instrumentarium TWAIN application from your image capture application In TWAIN user interface select Capture Snapshot Message Ready for exposure is shown on the display 4 Position the sensor Select the exposure values and press the exposure button 10 Instrumentarium Dental 203234 rev 3 Printed co
29. te system which consists of Snapshot intraoral sensor Intraoral X ray unit Workstation with USB connectivity CliniView or another imaging application Sensor holder and hygienic cover See 6 6 Image Acquisition System Requirements Before using the sensor read the Warnings and Precautions in this manual Read the following manuals to familiarize yourself with the operation of the unit before installing and using it Snapshot User Quick Guide Snapshot Installation amp User Manual CliniView Installation Manual CliniView User Manual Instrumentarium TWAIN Installation amp User Manual CAUTION USA only Federal law restricts this device to sale by or on the order of a dentist or other qualified professional Instrumentarium Dental 1 Printed copies of this document are considered uncontrolled 14369 1 Rev001 03 18 2014 1 Introduction 2 Instrumentarium Dental 203234 rev 3 Printed copies of this document are considered uncontrolled 14369 1 Rev001 03 18 2014 2 Package contents 2 Package contents 203234 rev 3 User Quick Guide Fig 2 1 Snapshot intraoral sensor N Imaging application CD CliniView includes software and manuals Snapshot CD TWAIN driver Snapshot manuals User Quick Guide Sensor Cable Clip d UE Ls Wall mount set Instrumentarium Dental 3 Printed copies of this document are considered uncontrolled 14369 1 Rev001 03 18 2014 2 Package contents
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