Orex Computed Radiography SCANGODEVICE RFID reader User Manual UG CS7600 Overview with new scan
Orex Computed Radiography Ltd. RFID reader UG CS7600 Overview with new scan
User mannual
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| Document ID | 1694495 |
| Application ID | sw8VCBWgDRJnfEio08/LSw== |
| Document Description | User mannual |
| Short Term Confidential | No |
| Permanent Confidential | No |
| Supercede | No |
| Document Type | User Manual |
| Display Format | Adobe Acrobat PDF - pdf |
| Filesize | 128.39kB (1604919 bits) |
| Date Submitted | 2012-05-10 00:00:00 |
| Date Available | 2012-05-14 00:00:00 |
| Creation Date | 1997-05-21 13:25:58 |
| Producing Software | Acrobat Distiller 8.1.0 (Windows) |
| Document Lastmod | 2012-05-06 11:21:43 |
| Document Title | UG_CS7600_Overview with new scan &.fm |
| Document Creator | FrameMaker 9.0 |
| Document Author: | Technical_Writer |
CS 7600 System Overview Introduction Note: The CS 7600 is intended for dental professionals. You are required to have training to use the CS 7600. CS 7600 is a scanner system for intraoral X-ray exposed imaging plates. The CS 7600 is intended for digital dental radiography using an imaging plate (storage phosphor plate) for radiographic diagnostic intraoral images. The CS 7600 system is used to scan and review intraoral dental X-ray images. When scanning the X-ray exposed imaging plate a digital image is previewed on the scanner’s LCD and saved to the scanner’s internal memory. After scanning, the scanner erases the imaging plate and ejects it. The imaging plate is ready for re-use. The exam acquisition’s scanned image is sent over the network to the workstation’s image Acquisition interface. 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. The scanner connects directly to the network, or is connected peer-to-peer to the workstation. The scanner can be optionally placed on a desk/counter top or mounted on a wall, using a special shelf (adapter). The system is composed of the following elements: • CS 7600 scanning device (page 4) • Smart imaging plates (page 6) • CS 7600 image Acquisition interface (page 11) • Scan & Go device (optional, page 9) Note: The scanner is supplied with a separate viewing and archiving software package: Kodak Dental Imaging Software, approved by Carestream Health. Note: The CS 7600 User Guide is also provided as a PDF file on the supplied CD-ROM. CS 7600_User Guide (8J4071)_Ed01 CS 7600 Components Overview Scanner Overview The CS 7600 scanner performs the functions necessary for scanning and acquiring images from the imaging plates. Figure 1 CS 7600 Front View 3.5" QVGA color LCD (320 X 240 pixels, landscape matrix) Function buttons for scanner use and menu navigation On/Off button + LED power indicator. On/Off button functions: • Turn scanner On: press for 1 second • Turn scanner Off (close application and files and then turn off): press for 2 seconds. Base Intraoral imaging plates tray Detachable insertion panel. The CS 7600 makes use of two insertion panel sizes according to the inserted imaging plates size (0–3 or 4). Front cover Back covers Chapter 2 CS 7600 System Overview Figure 2 CS 7600 Rear View Service door Base Cables compartment for power supply connection and interface ports (RJ-45 Ethernet port) Back cover Figure 3 Cables Compartment in Detail Power supply inlet RJ-45 Ethernet port (Ethernet activity LEDs: yellow indicates speed, green indicates link status) Service ONLY ports Compartment cover CS 7600_User Guide (8J4071)_Ed01 Smart Imaging Plates Overview The CS 7600 works with five imaging plate sizes: 0 to 4. The scanned image file size depends 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 Illustration Application Periapical exam (Pediatric dentistry) Bitewing exam (Pediatric dentistry) Periapical exam (Adult) Bitewing exam (Adult) Occlusal exam Chapter 2 CS 7600 System Overview The imaging plate has two sides: the active side for capturing the X-ray image and the inactive side. The active side of the imaging plate includes an orientation mark ‘c’ to facilitate accurate positioning within the patient’s mouth. The inactive side has a printed dot that corresponds to the location of the orientation mark on the active 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. Active side Inactive side Important: Use only Carestream imaging plates and hygienic sheaths! Hygienic Sheaths For each imaging plate size there is a corresponding one-time use, disposable, hygienic sheath for preventing cross contamination. The transparent side allows you to see the orientation mark for positioning the imaging plate correctly in the patient’s mouth while the opaque side protects the active CS 7600_User Guide (8J4071)_Ed01 side of the inserted imaging plate from light damaging effects. The foam strip is a 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) Adhesive strip (for sealing the hygienic sheath) Foam stopper Sheath, transparent on one side and with a light protection barrier on the other side Chapter 2 CS 7600 System Overview Scan & Go Overview Scan & Go is an optional device that enables you to link the imaging plate to a specific exam acquisition (for example, patient) prior to acquisition. This information is retrieved by the scanner and the imaging plate is scanned automatically according to this information (resolution, target workstation, etc.). Scanned images are then routed automatically 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) USB 2.0 port On/Off button On/Off/Recording LED status indicator (blue) Turning On/Off, 3 short flashes Standby (intermittent flashing) Recording data to the imaging plate (successive short flashes) Battery LED status indicator (amber): Charging (static light) Low battery (successive short flashes) (light Off) battery charged Recording surface for imaging plate Mounting adapter CS 7600_User Guide (8J4071)_Ed01 Scan & Go Overview (for Scan & Go models released from June 2012) A new Scan & Go device is available from June 2012. The following improvements have been made to the new Scan & Go device: • Faster scanning - Approximately 1/4 sec instead of 1 sec • No battery - Therefore no need for charging. • No on off switch - Turns on automatically when the USB is connected. Figure 6 Scan & Go device (After June 2012) USB 2.0 port On/Off/Recording LED status indicator (blue) Power Up: One Flash & Beep (Internal FW) Beacon: Flashes blue every few seconds in idle mode (Not during Tagging) Tagging OK: One flash (long) & 1 bleep (long)R Tagging Fail: One Red flash (long) & 1 bleep (long)R Connected to USB: LED status indicator (green): Recording surface for imaging plate Mounting adapter 10 Chapter 2 CS 7600 System Overview Care stream Hea lth, Inc. 150 Verona Street Roche ster, NY 1 4 60 8, USA Reference: HT022_20120424_EN ATHT0296_20120424_EN 0086 Note: To use this Scan & Go, you need to install Acquisition 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 image acquisition version needs updating to V1.0.Rev 3 Note: This picture is for demonstration 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, close the Scanner Manager window. Note: In the rare case 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 delivered with the system. Intraoral Imaging Plate System CS 7600 Safety, Regulatory & Technical Specifications User Guide Notice The Regulatory Information & Technical Specifications User Guide for the CS 7600 includes information on the safety instructions, regulatory information and the technical specifications of the device. Please read and observe all warnings and instructions in this Guide and those marked on the unit. The information contained in this Guide may be subject to modification without notice, justification or notification to the persons concerned. Make sure you have the most current version. 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 document is originally written in English. Guide Name: Intraoral Imaging Plate System CS 7600 System Safety, Regulatory and Technical Specifications User Guide Part Number: 8J4070 Revision Number: 02 Print Date: 2012-06 The Brand names and logos reproduced in this Guide are copyright. 0086 Manufacturer Care stream Hea lth, Inc. 150 Verona Street Roche ster, NY 1 4 60 8, USA Authorized Representative in the European Community EC REP Carestream Health France 1, rue Galilée 93192 NOISY-LE-GRAND CEDEX FRANCE Contents Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Indications for Use . . . . . . Conventions in this Guide . . . Warning and Safety Instructions General Notice . . . . . . . . Laser Safety Instructions . . . Hygiene and Disinfection . . . Marking and Labeling Symbols .1 .1 .2 .4 .5 .5 .6 IEC Symbols 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 Rules . . . . . . . . . . . . . . . . . 18 Technical Specifications . . . . . . . . . . . . . . . . . . . . . . 19 Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . 19 Model . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 CS 7600 Technical Specifications . . . . . . . . . . . . . . 19 System Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Imaging Plate Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . RF Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CS 7600 Environmental Requirements . . . . . . . . . . . . . . . . . . . . . . Imaging Plates Environmental Requirements . . . . . . . . . . . . . . . . . 19 20 21 21 22 Minimum Computer System Requirements . . . . . . . . . . 23 CS 7600_Safety, Regulatory & Technical Specifications (8J4070)_Ed02 iii iv 1 Safety Information Indications for Use The CS 7600 is intended for digital dental radiography using an imaging plate (storage phosphor screen) for radiographic 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 injury to yourself or others by following the safety instructions precisely. Important: Alerts you to a condition that might cause problems. Tip: Provides extra information and hints. Note: Emphasizes important information. CS 7600_Safety, Regulatory & Technical Specifications (8J4070)_Ed02 Warning and Safety Instructions WARNINGS Scanner • Read and understand this safety information before using the CS 7600. • To ensure safety, read all user guides carefully before using the system and observe all Warnings, Important and Notes located throughout the guides. • Keep this guide with the equipment. • You are responsible for the operation and maintenance of this device. You are required to have training to use the CS 7600. When necessary, have a trained authorized service technician carry out inspection and maintenance operations. • The CS 7600 is Class I, continuous operated stationary equipment without applied parts and has one signal input/output part. Product is provided with ordinary protection against the harmful ingress of water. • DO NOT use this device in the presence of a flammable anesthetics mixture with air or with oxygen or with nitrous oxide. • DO NOT remove or 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 electrical circuits within the system. Have the system checked by qualified service personnel. Do not attempt to replace any fuse. Fluids that seep into the active circuit components of the system may cause short circuits that can result in electrical fires. Therefore, do not place any liquid or food on any part of the system. Access to the rear inspection cover is allowed, as an exception, according to the instructions for Retrieval of the imaging plate in the Troubleshooting section of the user guide. • DO NOT operate the device if there is the threat of an earthquake. Following an earthquake, ensure that the device is operating satisfactorily before using it again. Failure to observe this precaution may expose patients to hazards. • DO NOT place objects within the field of operation of the device. • Connect this equipment ONLY to a mains power supply with protective ground to avoid any risk of electric shock. Chapter 1 Safety Information • The appliance coupler/inlet of the flexible power cord is used as a disconnecting device from the mains. • To dispose of the device or its components, contact a service technician. • No modification of this equipment is allowed. • DO NOT block air circulation around the unit. Always maintain at least 15 cm clearance around the unit to prevent overheating and damage to the system. • The scanner should be positioned so that there is always easy access to the mains power supply socket. Imaging Plates: • To prevent damage to the imaging plates and the possibility of image artifacts, avoid contact between the imaging plates and the following materials/solutions/solvents: Isopropyl alcohol, hydrogen peroxide and other peroxides, citrus-based cleaners, hand lotions and water-less hand sanitizers, as well as surfactants and 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, contact your local authorities. • Do not soak the imaging plate in any cleaning or disinfecting solutions. Do not autoclave; autoclaved imaging plates must be discarded. • Imaging plates should be stored in their original packing or storage box when they are not in use. Always store imaging plates in a dark and dry place. • Do not expose the imaging plates to light for long periods as this can have a degrading effect. • Do not store imaging plates in hot or moist conditions. • Do not fold, crease, or bend the imaging plates. • Avoid touching the imaging side of the imaging plates and be careful not to drag the imaging side of the imaging plate across any surface as this will damage the imaging plate. • Do not leave imaging plates where they can become damaged by liquid or chemical spills. • Read and follow the instructions in Material Safety Data Sheets (MSDS) for the CS Screen Cleaner. CS 7600_Safety, Regulatory & Technical Specifications (8J4070)_Ed02 • If a commercially prepared equivalent solution of diluted bleach is used, it should be used according to its manufacturer’s instructions. Computer: • DO NOT place the computer and the peripheral equipment connected to it in the immediate vicinity of the patient in the unit. Leave at least 1.83 m distance between the patient and the unit. The computer and the peripheral equipment must conform to the IEC60950 standard. • See your computer installation guide for details of the data processing system and screen. Leave a sufficient amount of clear space around the CPU to ensure that it 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 leakage current, the computer connected to the system should be a medical-grade computer or connected to the mains through medical-grade power supply. This is not relevant if the system is connected to a laptop by USB through an isolator or network cable. General Notice WARNINGS If the product does not operate properly or fails to respond to the controls as described in the product accompanying documentation: • Follow the safety precautions as specified in this guide. • Stop using the unit and prevent any changes to it. • Immediately contact the service office, report the problem, and await further instructions. Chapter 1 Safety Information Laser Safety Instructions WARNINGS The CS 7600 is a CLASS 1 Laser product. • During normal operation, always keep the unit enclosed in its protective cover to prevent the outside area from being exposed to laser radiation. • During normal operation, do not remove the cover. Only authorized service personnel may remove the cover. • Do not operate the system while the service door is open • Access to the rear inspection cover is allowed, as an exception, according to the instructions for Retrieval 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 system while the service door is open. Hygiene and Disinfection WARNINGS • • Do not use chemical autoclave for disinfecting the detachable insertion slot panel. To prevent cross-contamination, use a new hygienic sheath for each new patient. WARNING 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. CS 7600_Safety, Regulatory & Technical Specifications (8J4070)_Ed02 Marking and Labeling Symbols Label Description In the European Union, this symbol indicates: DO NOT discard this product in a trash receptacle; use an appropriate recovery and recycling facility. Contact your 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 this document with the exception of those sold by Carestream Health may result in a lower level of security for the entire system. General mandatory action sign. Refer to instruction manual / booklet. Manufactured Date. Manufacturer’s address. Chapter 1 Safety Information IEC Symbols Used The system may have labels with one or more of the following symbols Label Description Caution—consult accompanying documents Power On/Off Caution—Electrical shock hazard Safety Labels Label Description Location Caution—Electrical shock hazard PM board Laser-emitting product Optical head Class 3B laser product Optical head and on the scanner inside scanner back cover CS 7600_Safety, Regulatory & Technical Specifications (8J4070)_Ed02 Label Locations The following figure illustrates the label locations of the CS 7600 components. Chapter 1 Safety Information Declaration of Conformity CS 7600_Safety, Regulatory & Technical Specifications (8J4070)_Ed02 10 Chapter 1 Safety Information 2 Regulatory Information WARNING: Any changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate this equipment. General Regulatory Information Compliance with European and International Standards EN 60601-1 / IEC 60601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety EN 60601-1-2 / IEC 60601-1-2 Medical Electrical Equipment, Part 1-2: Electromagnetic Compatibility EN 60601-1-6 / IEC 60601-1-6 Medical Electrical Equipment, 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 Symbols for use in the labeling of medical devices EN 1041 Information supplied by the manufacturer of medical devices EN 62304/IEC 62304 Medical device software - Software life cycle processes EN 300 330-2 Electromagnetic Compatibility and Radio Spectrum Matters CS 7600_Safety, Regulatory & Technical Specifications (8J4070)_Ed02 11 Classification in Accordance with EN/IEC 60601-1 Type of protection against electric shock Class 1 equipment Degree of protection against Type B – No Applied Parts electric shock Protection against harmful ingress of water Ordinary equipment, IPX0 Operation mode Continuous operation Electromagnetic Compatibility Precautions Conformity with EN/IEC 60601-1-2 Electromagnetic Compatibility Precautions 12 • 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. Chapter 2 Regulatory Information Guidance and Manufacturer’s Declaration - Electromagnetic Emissions (IEC 60601-1-2) The CS 7600 is intended for use in the electromagnetic environment specified below. The customer or the user of the CS 7600 should assure that it is used in such an environment. Emissions Test Compliance RF emissions CISPR 11 Group 1 RF emissions CISPR 11 Class A Harmonic emissions IEC 61000-3-2 Class A Voltage fluctuations/ flicker emissions Complies IEC 61000-3-3 Electromagnetic Environment - Guidance The CS 7600 uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The CS 7600 is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The CS 7600 is intended for use in the electromagnetic environment specified below. The customer or the user of the CS 7600 should assure that it is used in such an environment. Immunity Test IEC 60601 Test Level Compliance Electrostatic ±6 kV ±6 kV contact contact discharge (ESD) ±8 kV air ±8 kV air IEC 61000-4-2 ±2 kV for power supply Electrical fast transient/burst lines IEC 61000-4-4 ±1 kV for input/output lines Electromagnetic Environment Guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. ±2 kV for power supply Mains power quality should be that lines of a typical commercial or hospital ±1 kV for environment. input/output lines CS 7600_Safety, Regulatory & Technical Specifications (8J4070)_Ed02 13 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity (Continued) ±1 kV line(s) to line(s) Surge IEC 61000-4-5 ±2 kV line(s) to earth Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 < 5 % UT ( > 95 % dip in 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 Power frequency (50/60 Hz) 3 A/m magnetic field IEC 61000-4-8 14 ±1 kV line(s) to line(s) Not applicable < 5 % UT ( > 95 % dip in 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 3 A/m Chapter 2 Regulatory Information Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of the CS 7600 requires continued operation during power mains interruptions, it is recommended that the CS 7600 be powered from an uninterruptible power supply or a battery. Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Guidance and Manufacturer’s Declaration - Electromagnetic Immunity (IEC 60601-1-2) The CS 7600 is intended for use in the electromagnetic environment specified below. The customer or the user of the CS 7600 should assure that it is used in such an environment. Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Portable and 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 frequency of the transmitter. Recommended separation distance Conducted RF IEC 61000-4-6 3 Vrms 150 kHz to 80 MHz 3.5 d = ( ------- ) P V1 [V1]= 3 V 3 V/m Radiated RF [E1]= 3 V/m 80 MHz IEC to 2.5 61000-4-3 GHz 3.5 d = ( ------- ) P E1 80 MHz to 800 MHz d = ( ------ ) P 800 MHz to 2.5 GHz E1 where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol: CS 7600_Safety, Regulatory & Technical Specifications (8J4070)_Ed02 15 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity (IEC 60601-1-2) (Continued) NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot 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 in the location in which the CS 7600 is used exceeds the applicable RF compliance level above, the CS 7600 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the CS 7600. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. 16 Chapter 2 Regulatory Information Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the CS 7600 (IEC 60601-1-2) The CS 7600 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the CS 7600 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the CS 7600 as recommended below, according to the maximum output power of the communications equipment. Separation Distance (m) According to Frequency of Transmitter Rated Maximum Output Power of Transmitter (W) 150 kHz to 80 MHz 3.5 d = ( ------- ) P V1 80 MHz to 800 MHz 3.5 d = ( ------- ) P E1 800 MHz to 2.5 GHz d = ( ------ ) P E1 0.01 0.12 0.12 0.23 0.1 0.38 0.38 0.73 1.2 1.2 2.3 10 3.8 3.8 7.3 100 12 12 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance (d) in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Note: The communication without disruption has been determined to be essential performance with regard to electromagnetic compatibility. CS 7600_Safety, Regulatory & Technical Specifications (8J4070)_Ed02 17 Compliance with International Regulations The product conforms to the following safety standards: IEC 60601-1:2005 Medical Electrical Equipment - Part 1: General requirements for safety and essential performance, EN/IEC 60825-1:94 + a1(97) + a2(01) + Cor1(02), EN 60601-1:06/IEC 60601-1:05, UL 60601-1:03, rev. 06, IEC 60825-1:93+A1:97+A2:2001 (for LED module), IEC 60825-1:2007 (for laser module CAN\CSA-C22.2 No. 601.1-M90, JIS T 0601-1:1999. This device complies with 21CFR 1040.10. • Medical Device Directives 93/42/ European Economic Community (EEC), Class IIa follow the rule 16 as amended by 2007/47/EEC. • The CS 7600 is an active device specifically intended for scanning of X-ray diagnostic images. • ElectroMagnetic Compatibility (EMC) directive 89/336/EEC, Group 1, Class A • Radio and Telecommunications Terminal Equipment directives 1999/5/EEC • FCC rules part 15/EN 300 330-2 V1.3.1/47CFRp15sb.C/RSS/210:07 Issue 7 Compliance with FCC Rules This equipment has been tested and found compliant with the limits 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 equipment generates, uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that the interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: • Increase the separation between the equipment and receiver. • Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. • Consult the dealer or an experienced radio/TV technician for help. This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: • This device may not cause harmful interference. • This device must accept any interference received, including interference that may cause undesired operation. 18 Chapter 2 Regulatory Information 3 Technical Specifications Manufacturer Carestream Health, Inc. 150 Verona Street Rochester, New York - USA 14608 Model CS 7600 CS 7600 Technical Specifications System Specifications Components CS 7600 Dimensions (without bracket) 267 mm (H), 237 mm (W), 260 mm (D) Weight Approximately 6 kg Power supply* SL Power Model #: MW174KB2403F01 100 – 240 V (ac), 50/60 Hz, 1.5 A Laser wavelength 635 – 660 nm (Class 3B) Laser power Up to 12 mW * For external AC/DC power supply medical grade, complies with IEC 601-1 CS 7600_Safety, Regulatory & Technical Specifications (8J4070)_Ed02 19 Imaging Plate Specifications Imaging Plate Dimensions Imaging 0 Plate Size Height (mm) 22 24 31 27 57 Width (mm) 35 40 41 54 76 Height Super high (pixels) resolution (SHR) Width (pixels) 1356 1476 1500 1802 2800 2052 2298 2000 3009 3750 Height High (pixels) resolution (HR) Width (pixels) 772 841 860 1026 1580 1169 1308 1150 1713 2122 Height (pixels) 435 474 480 578 900 Width (pixels) 659 738 640 966 1200 High speed (HS) Imaging Plate Scanning Resolution Resolution Level Practical Resolution (LP/mm*) Super high resolution (SHR) 17 High resolution (HR) 14 High speed (HS) *LP/mm: Line pairs per millimeter (measured on grid resolution target, in scan direction) 20 Chapter 3 Technical Specifications RF Information. RF Information Scan & Go standard ISO15693 Frequency 13.56 MHz CS 7600 Environmental Requirements Ambient Operating Conditions Ambient Operating Conditions Temperature 5 – 35 °C Relative humidity 30 – 85 % Non-condensing Atmospheric pressure 700 – 1060 hPa Storage and Transport Conditions Ambient Storage Conditions (in packaging) Temperature -10 – 60 °C Relative humidity 10 – 95 % Non-condensing Atmospheric pressure 700 – 1060 hPa CS 7600_Safety, Regulatory & Technical Specifications (8J4070)_Ed02 21 Imaging Plates Environmental Requirements Ambient Operating Conditions Ambient Operating Conditions Temperature 5 – 35 °C Relative humidity 30 – 85 % Non-condensing Atmospheric pressure 700 – 1060 hPa Storage and Transport Conditions Ambient Storage Conditions (in packaging) Temperature -10 – 60 °C Relative humidity 10 – 95 % Non-condensing Atmospheric pressure 700 – 1060 hPa 22 Chapter 3 Technical Specifications Minimum Computer System Requirements Item Viewing and Acquisition Comments CPU 2 GHz Intel® Dual Core™ or AMD Athlon or higher For best performance it is recommended to use an Intel® Dual Core™ processor. RAM 1 GB ( 2 GB recommended ) RAM has a major impact on system performance. • Hard disk drive Graphic board Monitor Operating system • 4 GB for software installation 80 GB minimum ( 250 GB recommended ) free space to use the software Nvidia/ATI based board The video RAM has major supporting Open Glide 1.2 with impact on system 256 MB of video RAM performance. • • • 1 monitor 17" or larger 1024 x 768 minimum screen resolution, 32-bit color mode • Windows 7 Ultimate/Professional with SP1, 32/64-bit Windows XP Professional with SP3 Windows Vista Ultimate with SP2, 32-bit • • Your monitor is a vital component in displaying quality images. Low-quality monitors will impede proper diagnoses and treatment. Ethernet interface 100/1Gb LAN card USB 2.0 3 ports 4 ports recommended CD/DVD drive DVD-ROM drive Required to install the product software Audio speakers 1 speaker To enable hearing audible alarms initiated by the system and the Scan & Go option. CS 7600_Safety, Regulatory & Technical Specifications (8J4070)_Ed02 23 24 Chapter 3 Technical Specifications
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