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Table of Contents
Related Manuals for DEXIS FOCUS
Summary of Contents for DEXIS FOCUS
- Page 1 ™ FOCUS Intraoral X-ray User manual 224451-PTU rev. 1 ENGLISH...
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Page 3: Table Of Contents
Contents 1 Disclaimer..........................5 2 Introduction........................... 6 ™ 2.1 FOCUS Intraoral X-ray......................6 2.2 Intended use..........................6 2.3 User profile..........................6 2.4 Signal words..........................6 2.5 Symbols that may appear on the device or its parts..............7 2.6 ... - Page 4 9 User's statement........................37 ™ FOCUS...
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Page 5: 1 Disclaimer
1 Disclaimer 1 Disclaimer ™ FOCUS Intraoral X-ray User manual, 224451-PTU r1. © Copyright 05-2022 by PaloDEx Group Oy. All rights reserved. ™ FOCUS is either a registered trademark or trademark of PaloDEx Group Oy. ™ DEXIS is a registered trademark or a common law trademark of Dental Imaging Technologies Corporation. -
Page 6: 2 Introduction
CAUTION! USA only: Federal law restricts this device to sale by or on the order of a dentist or other qualified professional. 2.3 User profile FOCUS is intended only for professionally qualified dental or medicinal personnel. The typical user is a dental nurse with specific training for using dental X-ray devices. 2.4 Signal words... -
Page 7: Symbols That May Appear On The Device Or Its Parts
Radiation warning Radiation generating unit X-ray source assembly: emitting Type B Applied part Dangerous voltage On or enabled Off or disabled Ethernet Connector for remote control Protective earth (ground) Focal spot Total X-ray filtration Do not reuse Recyclable ™ FOCUS... - Page 8 CE (0537) symbol UKCA (UK Conformity Assessed) marking NRTL Mark Conforms to AAMI ES60601-1:2006. Certified to CSA. Swiss authorised representative Importer Maximum number of boxes that can be stacked on the bottom box (Packaging) ™ FOCUS...
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Page 9: Type And Version
Portable and mobile RF communications equipment can interfere with operation of the medical electrical equipment. NOTICE! To maintain safe and correct operation of the device, only the approved accessories should be used. All the standard and optional items and approved accessories are suitable for use within the patient environment. ™ FOCUS... -
Page 10: Radiation Protection Guidelines
The protection against scatter radiation can be achieved by using the remote control or the remote exposure button not less than 2 m (7 ft) from the focal spot and ™ FOCUS... -
Page 11: Manufacturer's Liability
Follow all regulations on disposal of waste parts. The device has at least the following parts that should be regarded as non-environmentally friendly waste products: • X-ray source assembly • All electronic circuits and electronic boards • Plastic parts ™ FOCUS... -
Page 12: 3 Overview
Scissors arm Tube head Cone Remote control panel Optional: Remote exposure switch Use original FOCUS accessory remote exposure switch (recommended) or install a third party remote switch if it fulfills the following requirements: • Type: momentary push button • Contact rating 1A @ 120 VAC or 28 VDC (or better) •... -
Page 13: Cones
SSD 229 mm/9”, 35x45 mm Long cone, round Long cone, rectangular SSD 305 mm/12”, Ø60 mm SSD 305 mm/12”, 35x45 mm Short cone, full metal, rectangular Long cone, full metal, rectangular SSD 229 mm/9”, 35x45 mm SSD 305 mm/12”, 35x45 mm ™ FOCUS... -
Page 14: Control Panel
Ready for exposure light turns on when the device is set up and ready to take exposures. Press and hold down the exposure button to take an exposure. Exposure warning light Light turns on (yellow) when the device produces X-rays. ™ FOCUS... - Page 15 DAP (Dose Area Product, mGycm ) value. For more information on the DAP value, see chapter Monitoring X-ray dose levels on page Up and Down arrows Adjust the exposure time for an imaging program or scroll through device settings. ™ FOCUS...
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Page 16: 4 Using The Device
Exposure program settings on page 21. To detach the cone from the tubehead, rotate it counterclockwise and pull it off. ™ FOCUS... -
Page 17: Setting Up The Exposure Program
If you use conventional film imaging plates leave this inactive. The D LED indicates if the selection is active. Press one of the tooth buttons to select which part of the dentition is intended to be imaged. The LEDs in the control panel will indicate which selection is active. ™ FOCUS... - Page 18 Exposure mode (film or digital) • kV selection • Film speed * • Cone length * * Default settings for the device can be adjusted in the Program Mode. See chapter Exposure program settings on page 21 for more information. ™ FOCUS...
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Page 19: Patient Positioning
Ensure the correct patient positioning, imaging parameter selections and that the device is in Ready state with the indicator light turned green. Ask the patient to stay still during the whole imaging process. Protect yourself from radiation according to the local legislation. ™ FOCUS... -
Page 20: Monitoring X-Ray Dose Levels
DAP value. Press Digital mode and Down arrow buttons simultaneously. The mGycm LED is illuminated and the DAP value is shown on the display. NOTICE! The DAP value is shown for 5 seconds. ™ FOCUS... -
Page 21: 5 Device Settings
Short rectangular for sensor size 1 Short rectangular for sensor size 2 Exposure counter First (0 - 999) Second (1000 - 99000) AEC selection (NOT IN USE) AEC selection ON AEC selection OFF Set to Factory Defaults NOTICE! Beeps 2 times after confirmation ™ FOCUS... -
Page 22: Changing The Default Exposure Time Settings
The device beeps 2 times to acknowledge change to the settings. The set exposure time is now used as default for the tooth selection using the currently active sensor type. NOTICE! Different exposure times can be programmed for each sensor type. ™ FOCUS... -
Page 23: Default Exposure Time Settings
0,160 0,125 0,080 Maxillary cuspid 0,320 0,200 0,160 0,100 Maxillary molar 0,400 0,250 0,200 0,125 Occlusal 0,320 0,200 0,160 0,100 Mandibular incisor 0,200 0,125 0,100 0,063 Mandibular cuspid 0,250 0,160 0,125 0,080 Mandibular molar 0,250 0,160 0,125 0,080 ™ FOCUS... -
Page 24: 6 Error Messages
Door switch open Check that the door is closed (connected to Adjustment part) Door switch open Check that the door is closed (connected to Remote Control Panel) Exit Service mode System in Service mode ™ FOCUS... -
Page 25: 7 Maintenance
It is the owner's responsibility to supply or arrange for this service. Consult your authorized dealer for such service. In addition to periodic maintenance any deviation from normal performance should be immediately reported to your dealer. ™ FOCUS... -
Page 26: Radiation Dose Measurement
Remove the fuse from the base and replace it with a new one. Re-attach the fuse by pushing the base in and twisting it clockwise with a flat head screwdriver. Repeat this with each blown fuse. ™ FOCUS... -
Page 27: 8 Technical Data
IEC 60601-2-28 IEC60601-2-65 CAN/CSA –C22.2 No. 601-1-M90 CE models marked according to the Medical Device Directive 93/42/ EEC Device data ™ Product Name FOCUS Intraoral X-ray Type FOCUS Protection against electric shock Class I Degree of protection Type B Protection against the ingress of liquids... - Page 28 Dental care unit mount model device Horizontal arm length 330 mm (from axle to axle), 418 mm (total length) Generator module length 500 mm 32 mm Horizontal arm shaft diameter Main cable length 5230 mm (measured from generator module to the scissors arm) ™ FOCUS...
- Page 29 Apparent resistance of supply mains Power consumption 816 VA / 230 VAC 877 VA / 115 VAC US/Canada mains connector type 115 V / NEMA 6-15P or similar Power supply cords type H05VV5-F / AWG 14 (UL 2587) ™ FOCUS...
- Page 30 Length approximately 10 m (32.5 ft), RJ-45 plug at both ends remote exposure switch (8 wires) Transportation and storage -40°...+70°C (-40F...+158F), RH 10...100%, 500 – 1060 mbar Operating environment +10°...+40°C (+50F...+104F), RH max. 70%, 700 – 1060 mbar ™ FOCUS...
- Page 31 ‘kV correction factor’ is dependent on the selected kV • ‘Default dose’ is the dose measured for 70kV, 7mA and 1 s exposure. Any indicated DAP value is scaled from a dose that was measured for 70kV, 7mA, 1 second exposure. ™ FOCUS...
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Page 32: Emc Declaration
Complies Not to be used or installed near active HF SURGICAL EQUIPMENT and the Voltage fluctuations/ flicker RF shielded room of an ME SYSTEM for magnetic resonance imaging, where emissions the intensity of EM DISTURBANCES is high. IEC61000-3-3 ™ FOCUS... - Page 33 IEC 61000-4-8 commercial and/ or hospital environment. The device shall not be used closer than 15cm to sources of 50/60Hz magnetic field. NOTICE! U is the a.c. mains voltage prior to application of the test level. ™ FOCUS...
- Page 34 **Over the frequency range 150 kHz to 80 MHz, field strengths are less than 3 V/m. The Recommended Separation Distances are listed in the next table. NOTICE! These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. NOTICE! RF communications equipment can effect medical electrical equipment. ™ FOCUS...
- Page 35 External components WARNING! Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this device and result in improper operation. ™ FOCUS...
- Page 36 WARNING! The device should not be used adjacent to or stacked with other equipment; if adjacent or stacked use is necessary, the device should be observed to verify normal operation in the configuration in which it will be used. Interference may occur in the vicinity of equipment marked with the following symbol: ™ FOCUS...
- Page 37 SSD 229 mm/9”, 35 x 45 mm EQUIPMENT STATEMENT FOR TUBE HOUSING ASSEMBLY Maximum operating voltage is 70 kVp. Nominal focal spot is 0.7 mm. X-ray tube: D-0711SB or D-0711S. For additional information please refer to the tube specification sheets. ™ FOCUS...
- Page 38 With 230 VAC power supply systems the maximum line current during the exposure is 5 A, at stand by maximum 0.1 A. The system line fuses are 6.25 A slow blow type. TUBE RATINGS, TUBE HEAD COOLING CURVE ™ FOCUS...
- Page 39 10 s 2,50 s 100 s 0,25 s 10 s 3,20 s 128 s DIMENSIONAL OUTLINE OF THE TUBEHEAD NOTICE! Wiring diagrams, schematics, and other documents which are needed for repairing the device, will be supplied on request. ™ FOCUS...
- Page 40 The nominal tube current 7mA is obtained at the highest tube voltage 70kV. The max. electric output is obtained at 70 kV tube voltage and 7 mA tube current. The nominal power/exposure: 490 W The manufacturer reserves the right to make technical changes at any time. ™ FOCUS...
- Page 41 Contact your PaloDEx Group Oy representative for the most current information. Copyright © by PaloDEx Group Oy. All rights reserved. DEXIS™ is a registered trademark or a common law trademark of Dental Imaging Technologies Corporation. Headquarters PaloDEx Group Oy Nahkelantie 160 | FI-04300 Tuusula | FINLAND Tel.
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