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Installation

6

Requirements

6.1

Installation/setup room

❯

The unit may only be used in a room that has
been set up specifically for this purpose (e. g.
an x-ray room). Do not use outdoors.

❯

Do not expose the unit to direct sunlight or
heat.

❯

The setup room may not contain any major
interference fields (e. g. strong magnetic fields).
They could cause malfunction in the unit.

6.2

Monitor

The monitor must meet the requirements for digi-
tal X-ray with a high light intensity and wide con-
trast range.
Strong ambient light, sunlight impinging directly
onto the monitor and reflections can make it
more difficult or even impossible to perform a
diagnosis based on the X-ray images.

Installation

2121100020L29 2101V007

15

EN-
US

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Содержание G9510A

Страница 1: ...EN US SensorX Installation and Operating Instructions 2121100020L29 2121100020L29 G9501 2101V007 ...

Страница 2: ......

Страница 3: ... 14 5 Function 14 Installation 6 Requirements 15 6 1 Installation setup room 15 6 2 Monitor 15 6 3 System requirements 16 7 Installation 17 7 1 Fitting the sensor holder 17 7 2 Electrical connection 17 7 3 Installation with VisionX 18 7 4 Installation with DBSWIN 18 8 Commissioning and first start up 19 8 1 Configuring the unit in VisionX 19 8 2 Configuring the unit in DBSWIN 20 8 3 Commissioning ...

Страница 4: ...Appendix 14 Recommended exposure times 32 15 Handover record 33 Contents 2 2121100020L29 2101V007 EN US ...

Страница 5: ...versions Item number G9510A 2121100021 G9520A 2121100022 1 1 Warnings and symbols Warnings The warning notes in this document highlight possible injury to persons or damage to machi nery They are marked with the following warning sym bols General warning symbol The warnings are structured as follows SIGNAL WORD Description of type and source of danger Here you will find the possible conse quences ...

Страница 6: ...tructions Wear hand protection Use a mask Wear eye protection Wear protective clothing Do not reuse Protection class II Type BF applied part XX YY Lower and upper temperature limits XX YY Lower and upper atmospheric pressure limits no condensation XX YY Lower and upper humidity limits 1 2 Copyright information All electronic drawings processes names soft ware and appliances mentioned here are pro ...

Страница 7: ...e for monitoring patients over a long term period 2 2 General safety information The sale or prescription of this device by a medical practitioner is subject to the restrictions of the applicable Federal Acts The device may be used only under permanent supervision by a dentist or licensed medical practitioner Caution Federal law restricts this device to sale by or on the order of a Doctor Comply w...

Страница 8: ...be monitored in order to ensure that they are working cor rectly NOTICE Reduced performance features due to insufficient distance between unit and mobile HF communication devices Keep at least 30 cm distance between the unit including parts and cables of the unit and mobile HF communica tion devices wireless units including their accessories such as antenna cables and external antennas 2 5 Essenti...

Страница 9: ...ispose of such items in accordance with current federal national state and local govern ment rules and regulations 2 10 Protection from cybersecurity threats The unit is to be connected to a computer that can be connected to the Internet Therefore the system needs to be protected from threats from the Internet Use antivirus software and update it regularly Look for evidence of possible virus infec...

Страница 10: ...g Instructions SensorX Size 2 G9520A SensorX Size 2 Sensor Calibration data carrier Sensor holder Adhesive pad Velcro strip Cable holder USB extension cord 1 m Hygienic protective covers qty 100 Imaging software VisionX Imaging software DBSWIN Installation and Operating Instructions 3 2 Accessories The following items are required for operation of the device depending on the application The hygien...

Страница 11: ...nit and must be reordered sep arately Hygienic protective covers Size 1 qty 100 G9550 Hygienic protective covers Size 1 qty 500 G9551 Hygienic protective covers Size 2 qty 100 G9554 Hygienic protective covers Size 2 qty 500 G9555 Product description 2121100020L29 2101V007 9 EN US ...

Страница 12: ... x 1 54 x 0 25 Cable length sensor m in 2 5 98 43 Max USB cable extension m in 1 39 37 Computer connection USB 2 0 Compatible with USB 3 0 Sensor characteristics Active sensor size W x H mm in 20 x 30 0 79 x 1 18 Min pixel size µm 19 Max no of pixels 1050 x 1580 Theoretical resolution LP mm 26 3 Sensor type CMOS Scintillator Structured CsJ scintillator on fibre optics Product description 10 212110...

Страница 13: ...x 1896 Theoretical resolution LP mm 26 3 Sensor type CMOS Scintillator Structured CsJ scintillator on fibre optics 4 3 Electromagnetic compatibility EMC The information on electromagnetic compatibility EMC applies to both SensorX Sensor Size 1 and Size 2 Electromagnetic compatibility EMC Interference emission measurements Electromagnetic interference radiation CISPR 11 2009 A1 2010 Group 1 Class B...

Страница 14: ...ith respect to near fields of wireless HF communication devices Radio service Frequency band MHz Test Level V m TETRA 400 380 390 27 GMRS 460 FRS 460 430 470 28 LTE band 13 17 704 787 9 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE band 5 800 960 28 GSM 1800 CDMA 1900 GSM 1900 DECT LTE bands 1 3 4 25 UMTS 1700 1990 28 Bluetooth WLAN 802 11 b g n RFID 2450 LTE band 7 2400 2570 28 WLAN 802 11 a n 5100...

Страница 15: ...umidity 80 Air pressure hPa 750 1160 Height above sea level m ft 2000 6562 Ambient conditions during storage and transport Temperature C F 20 to 60 4 to 140 Humidity 10 to 95 Air pressure hPa 750 1160 Height above sea level m ft 16000 52493 Product description 2121100020L29 2101V007 13 EN US ...

Страница 16: ...o be fitted with a hygienic protec tive cover and to be placed in the mouth of the patient It is activated via an imaging software e g DBSWIN During the X ray procedure the X rays are received by the scintillator luminescent material installed in the sensor and are converted into beams of light These light beams are recorded by the sensor as image information digitalized and transmitted to the com...

Страница 17: ...ot contain any major interference fields e g strong magnetic fields They could cause malfunction in the unit 6 2 Monitor The monitor must meet the requirements for digi tal X ray with a high light intensity and wide con trast range Strong ambient light sunlight impinging directly onto the monitor and reflections can make it more difficult or even impossible to perform a diagnosis based on the X ra...

Страница 18: ...ust be assured The following additional system requirements must also be met Drive DVD ROM Interface USB 2 0 USB 3 0 Total maximum cable length USB 5 m Software VisionX from version 2 4 10 order number E7300 DBSWIN from version 5 17 order number E7200A VistaEasy Image Bridge For the system requirements of the computer systems visit the download area at www airtech niques com document no E7201 Inst...

Страница 19: ... adhesive pad Fastening the sensor holder using the Velcro strip Thread the Velcro strip into the sensor holder Fasten the sensor holder with the Velcro strip 7 2 Electrical connection Combining devices safely Take care when connecting units together or to parts of other systems as there is always an ele ment of risk e g due to leakage currents Only connect units when there can be no question of d...

Страница 20: ... it is important that the USB connection on the PC and if necessary the socket outlet for the power supply are easily accessible and that the appli ance can be unplugged if necessary 7 3 Installation with VisionX Install the additional component If the additional component of the unit was not installed along with the installation of the imaging software it can be installed later on Place the data ...

Страница 21: ...re approximately 20 C to body temperature approxi mately 37 C during application Before starting every time check the entire system for damage Perform and document safety checks in accordance with national regulations VDE 0751 1 IEC 60601 1 Carry out and document an acceptance test in accordance with national regulations The unit supports the following imaging pro grams VisionX manufactured for Ai...

Страница 22: ... not included in the list it needs to be created using Create X ray emitter Under Image acquisition device select the device with which the X ray images will be imported The selection list contains only the image acquisition devices fitting with the X ray emitter If the image acquisition device is not included in the list the device still needs to be con nected to the software Click on or go to th...

Страница 23: ... Select Start All Programs Air Techniques VistaEasy VistaConfig or In DBSWIN double click the Config Mod ules tab followed by ScanX Net Activate the connected unit in the Registered column Click the Edit button Change the device name Designation as required Click Apply to save the configuration Installation 2121100020L29 2101V007 21 EN US ...

Страница 24: ...s requirement devi ates from national requirements please follow and apply the corresponding national require ments The image quality test is carried out with VisionX Inspect see VisionX handbook order number E7303 2110200001 The following aids are required VisionX Inspect imaging software Test phantom for 2D X rays see 3 3 Optional items Positioning the test phantom On the right hand side of the ...

Страница 25: ...ntrast 3 High contrast Draw a measuring line from the center point of the test image to the edge boundary between dark light contrast The measured result must be less than 30 mm The diameter of the useful radiation field field size at the end of the tube must not exceed 60 mm In VisionX Inspect the useful radiation field can be measured with the measuring function in the tool box Refer also to the...

Страница 26: ...Standard 26 3 LP mm Low resolution 13 15 LP mm The transmission time is just a few seconds depending on sensor size and settings 9 1 Taking an X ray image Check before every use ü The sensor and cable are not damaged ü The sensor and cable have been cleaned and disinfected Wear hand protection Start the computer Start the imaging software Select the desired image mode Make SensorX ready for image ...

Страница 27: ... to the imaging software No further X ray image can be taken during data transmission 10 Cleaning and disinfection When cleaning and disinfecting the unit and its accessories comply with national directives standards and specifications for medical prod ucts as well as the specific specifications for dental practices or clinics NOTICE The use of unsuitable agents and methods can damage the unit and...

Страница 28: ... Dental Health Care Settings from the Centers for Disease Control and Prevention Accessories of the medical device are also sub ject to reprocessing Classification recommendation based on proper use of the product Semi critical A Semi critical medical product A medical product which comes into contact with mucous membrane or pathologically changed skin The operator is responsible for correct class...

Страница 29: ...he reprocessing method The reprocessing procedure was validated as fol lows Pre cleaning Lint free disposable wipe Manual cleaning Monarch disinfection wipes Air Techniques Manual disinfection Monarch disinfection wipes Air Techniques 11 3 General information Comply with all national directives standards and specifications for the cleaning disinfection and sterilization of medical devices as well ...

Страница 30: ...he unit to steam sterili zation The outer surfaces of the applied part can be cleaned and disinfected manually using cleaning and disinfection wipes Cleaning Thoroughly wipe down the outer surfaces for 1 minute with a cleaning wipe Then allow for 1 minute exposure to the agent Check to make sure that no soiling is visible any longer Disinfecting Thoroughly wipe down the outer surfaces for 1 minute...

Страница 31: ...12 Maintenance The unit is maintenance free Usage 2121100020L29 2101V007 29 EN US ...

Страница 32: ...nstalled correctly Re install the device driver see installation and configura tion manual Error code E 0077 Software installation corrupt Inform your Service Techni cian Error code E 1001 The unit is not connected Connect the unit to the USB port Incorrect sensor size selected in software Select the correct sensor size Unit is defective Inform your Service Techni cian Error code E 1002 Multiple s...

Страница 33: ...26 Incorrect image mode Select a different image mode Inform your Service Techni cian Error code E 2006 No image mode selected Select the desired image mode Error code E 10014 Sensor calibration data not installed Install the sensor calibration data see installation and con figuration manual Error code E 10016 Sensor calibration data incorrect Inform your Service Techni cian Troubleshooting 212110...

Страница 34: ...Tube length 30 cm 60 kV μGy 70 kV μGy 60 kV μGy 70 kV μGy Upper jaw Incisor 0 080 s 605 0 080 s 858 0 160 s 553 0 100 s 478 Premolar 0 120 s 928 0 100 s 1069 0 160 s 553 0 100 s 478 Molar 0 160 s 1243 0 120 s 1276 0 200 s 693 0 125 s 583 Bitewing 0 160 s 1243 0 120 s 1276 0 200 s 693 0 125 s 583 Mandible Incisor 0 080 s 605 0 080 s 858 0 160 s 553 0 100 s 478 Premolar 0 120 s 928 0 100 s 1069 0 16...

Страница 35: ...rder number REF Serial number SN o Visual inspection of the packaging for any damage o Unpacking the medical device and checking for damage o Confirmation of the completeness of the delivery o Instruction in the proper handling and operation of the medical device based on the operating instructions Notes Name of person receiving instruction Signature Name and address of the qualified adviser for t...

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Страница 40: ... Höpfigheimer Str 17 74321 Bietigheim Bissingen Germany www duerrdental com Manufactured for Distributed by Air Techniques Inc 1295 Walt Whitman Road Melville New York 11747 3062 USA Phone 800 247 8324 Fax 888 247 8481 www airtechniques com ...

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