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Chapter 2 Regulatory Information

Electromagnetic Compatibility Precautions

•

Medical electrical equipment requires special precautions regarding

electromagnetic compatibility (EMC).

•

CS 7600 must be installed and put into service according to the EMC

information provided in this document.

•

Communication Equipment: Portable and mobile Radio Frequency (RF)

communications equipment can affect the Electromagnetic Compatibility

of CS 7600s.

•

CS 7600 may be interfered with other equipment even if that other

equipment complies with CISPR emission requirements.

Classification in Accordance with EN/IEC 60601-1

Type of protection against

electric shock

Class 1 equipment

Degree of protection against

electric shock

Type B – No Applied Parts

Protection against harmful

ingress of water

Ordinary equipment, IPX0

Operation mode

Continuous operation

Conformity with EN/IEC 60601-1-2

Electromagnetic Compatibility Precautions

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Содержание CS 7600

Страница 1: ...ce Using the image Acquisition interface the image is processed and reviewed The image Acquisition interface sends the images to the Kodak Dental Imaging Software which archives the acquired images Th...

Страница 2: ...cape matrix 2 Function buttons for scanner use and menu navigation 3 On Off button LED power indicator On Off button functions Turn scanner On press for 1 second Turn scanner Off close application and...

Страница 3: ...1 Service door 2 Base 3 Cables compartment for power supply connection and interface ports RJ 45 Ethernet port 4 Back cover 1 4 3 2 1 3 2 4 1 Power supply inlet 2 RJ 45 Ethernet port Ethernet activit...

Страница 4: ...on the imaging plate size and the scanning resolution set by the user The smart function of the imaging plates is utilized when using the Scan Go device Table 1 Intraoral Imaging Plate Sizes Size Illu...

Страница 5: ...ctive side This dot is visible through the transparent hygienic sheath and is also helpful for positioning the imaging plate correctly in the patient s mouth Hygienic Sheaths For each imaging plate si...

Страница 6: ...stopper which prevents inserting the hygienic sheath by mistake into the scanner as long as the insertion direction is correct Figure 4 Hygienic Sheath front view 1 Adhesive strip for sealing the hygi...

Страница 7: ...omatically to the correct workstation associated to the correct exam acquisition and placed in the correct frame in the CS 7600 image Acquisition interface Figure 5 Scan Go device Before June 2012 1 U...

Страница 8: ...need for charging No on off switch Turns on automatically when the USB is connected Figure 6 Scan Go device After June 2012 1 USB 2 0 port 2 On Off Recording LED status indicator blue Power Up One Fl...

Страница 9: ...Carestream Health Inc 150 Verona Street Rochester NY 14 608 USA 0086 Reference HT022_20120424_EN ATHT0296_20120424_EN...

Страница 10: ...tion Interface V1 0 Rev 3 or higher Unlike previous versions this Scan Go does not use batteries Note If the Scan Go LED lights up green and the USB icon appears red there is a possibility that the im...

Страница 11: ...ation only and the Scanner version may vary Note If the scanner is already updated with Version 1 30 and you have clicked Update Scanner a message appears The scanner is already updated then click OK...

Страница 12: ...se that the Update Failed message appears restart the scanner press and verify that the scanner version is 1 30 Note For more information see the CS 7600 User Guide provided in the original CD deliver...

Страница 13: ...Intraoral Imaging Plate System CS 7600 Safety Regulatory Technical Specifications User Guide...

Страница 14: ...No part of this Guide may be reproduced without the express permission of Carestream Health Inc U S Federal law restricts this device to sale by or on the order of a dentist or physician This documen...

Страница 15: ...ols Used 7 Safety Labels 7 Label Locations 8 Declaration of Conformity 9 Regulatory Information 11 General Regulatory Information 11 Compliance with International Regulations 18 Compliance with FCC Ru...

Страница 16: ...iv...

Страница 17: ...diographic diagnostic intraoral images Conventions in this Guide The following special messages emphasize information or indicate potential risk to personnel or equipment WARNING Warns you to avoid in...

Страница 18: ...open system covers or plugs Internal circuits use high voltage capable of causing serious injury Fuses blown within 36 hours of being replaced by a qualified technician may indicate malfunctioning el...

Страница 19: ...nd lubricants The imaging plate contains Barium and should be considered hazardous or special waste in specific conditions at the end of its useful service life For disposal or recycling information c...

Страница 20: ...t is properly ventilated To obtain maximum image quality and visual comfort position the screen to avoid direct light reflections from internal or external lighting In order to guarantee medical grade...

Страница 21: ...etrieval of the imaging plate in the troubleshooting section of the user guide WARNING Laser radiation when cover is removed Avoid direct exposure to beam Class 3B laser inside Do not operate the syst...

Страница 22: ...local sales representative for additional information on the collection and recovery programs available for this product Warning General warning sign Using accessories other than those specified in t...

Страница 23: ...of the following symbols Safety Labels Label Description Caution consult accompanying documents Power On Off Caution Electrical shock hazard Label Description Location Caution Electrical shock hazard...

Страница 24: ...8 Chapter 1 Safety Information Label Locations The following figure illustrates the label locations of the CS 7600 components...

Страница 25: ...CS 7600_Safety Regulatory Technical Specifications 8J4070 _Ed02 9 Declaration of Conformity...

Страница 26: ...10 Chapter 1 Safety Information...

Страница 27: ...ment Part 1 6 General requirements for basic safety and essential performance Collateral Standard Usability EN ISO 14971 Medical devices Application of risk management to medical devices EN 980 Symbol...

Страница 28: ...munications equipment can affect the Electromagnetic Compatibility of CS 7600s CS 7600 may be interfered with other equipment even if that other equipment complies with CISPR emission requirements Cla...

Страница 29: ...power supply network that supplies buildings used for domestic purposes Harmonic emissions IEC 61000 3 2 Class A Voltage fluctuations flicker emissions IEC 61000 3 3 Complies Guidance and Manufacturer...

Страница 30: ...UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 s Mains power quality should be that of a typical commercial or hospital environment If the u...

Страница 31: ...nd mobile RF communications equipment should be used no closer to any part of the CS 7600 including cables than the recommended separation distance calculated from the equation applicable to the frequ...

Страница 32: ...not be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength i...

Страница 33: ...y of Transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output powe...

Страница 34: ...imits for a Class B digital device pursuant to Part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference in a residential installation This equip...

Страница 35: ...08 Model CS 7600 CS 7600 Technical Specifications System Specifications For external AC DC power supply medical grade complies with IEC 601 1 Components CS 7600 Dimensions without bracket 267 mm H 237...

Страница 36: ...Height mm 22 24 31 27 57 Width mm 35 40 41 54 76 Super high resolution SHR Height pixels 1356 1476 1500 1802 2800 Width pixels 2052 2298 2000 3009 3750 High resolution HR Height pixels 772 841 860 10...

Страница 37: ...torage and Transport Conditions RF Information Scan Go standard ISO15693 Frequency 13 56 MHz Ambient Operating Conditions Temperature 5 35 C Relative humidity 30 85 Non condensing Atmospheric pressure...

Страница 38: ...Conditions Storage and Transport Conditions Ambient Operating Conditions Temperature 5 35 C Relative humidity 30 85 Non condensing Atmospheric pressure 700 1060 hPa Ambient Storage Conditions in packa...

Страница 39: ...ng Open Glide 1 2 with 256 MB of video RAM The video RAM has major impact on system performance Monitor 1 monitor 17 or larger 1024 x 768 minimum screen resolution 32 bit color mode Your monitor is a...

Страница 40: ...24 Chapter 3 Technical Specifications...

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