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CARESTREAM DRX-1 System
Safety and Regulatory Information
with
Hardware
User's Guide
H224_0028HC
Version 3.0
PN 7H8166
6 April 2009

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Summary of Contents for Carestream HEALTH DRX-1 System

  • Page 1 CARESTREAM DRX-1 System Safety and Regulatory Information with Hardware User’s Guide H224_0028HC Version 3.0 PN 7H8166 6 April 2009...
  • Page 3: Table Of Contents

    DRX-1 System Product Information........................1-14 DRX-1 System Detector ..........................1-14 DRX-1 System Battery Charger........................1-15 DRX-1 System Battery..........................1-16 DRX-1 System Console ..........................1-16 DRX-1 System Wireless Access Point ......................1-17 DRX-1 System Tether Interface.........................1-17 Patient Vicinity ............................1-18 Mode of Operation...........................1-18 Labels ..............................1-19 Disposal Information .............................1-24 Operating Environment ..........................1-24...
  • Page 4 Table of Contents Cautions ................................2-3 Installing the Hardware............................2-3 Attaching Accessories..........................2-4 Turning the System On and Off........................2-4 CARESTREAM DRX-1 System Battery.........................2-5 Installing the Battery ..........................2-5 Removing the Battery ..........................2-6 Labeling the Detector ............................2-7 DRX-1 Detector LED............................2-7 Positioning the Detector in the Bucky.......................2-9 Positioning the Detector on a Tabletop.....................2-10...
  • Page 5: Safety And Regulatory Information

    Safety and Regulatory Information The information contained herein is based on the experience and knowledge relating to the subject matter gained by Carestream Health, Inc. prior to publication. No patent license is granted by this information. Carestream Health reserves the right to change this information without notice, and makes no warranty, express or implied, with respect to this information.
  • Page 6: Safety And Related Information

    Not suitable for use in the presence of flam- mable anesthetics or a mixture of flamma- ble anesthetics with air or oxygen or nitrous oxide. CARESTREAM DRX-1 System Tether Interface Medical Electrical Equipment Classification Type of protection against electrical shock: Class I Equipment. Degree of protection against electrical Type B.
  • Page 7: Compatibility With Other Manufacturer's Equipment

    (DRX-1 System Equipment Interface Box). The isolation device is designed to prevent any failures, loss of power or power surge in the DRX-1 System from affecting the X-ray equipment. Prep Start DRX-1 System...
  • Page 8: Product Safety Standards

    Safety and Regulatory Information The DRX-1 System uses an existing exposure switch connector on the X-ray equipment. No modification to the X-ray equipment is required. The intended use of the X-ray equipment is not affected and the X-ray equipment remains certified by the X-ray equipment manufacturer.
  • Page 9 Safety and Regulatory Information The following Product Safety Standards apply to the CARESTREAM DRX-1 System. The DRX-1 System includes the following: CARESTREAM DRX-1 System Detector (one or more) CARESTREAM DRX-1 System Battery (any quantity) CARESTREAM DRX-1 System Battery Charger CARESTREAM DRX-1 System Tether Interface...
  • Page 10 Electrical Equipment The following Product Safety Standards are applicable to: • CARESTREAM DRX-1 System Battery Charger • CARESTREAM DRX-1 System Console • CARESTREAM DRX-1 System Wireless Access Point UL 60950-1, Information Technology Equipment - Safety - Part 1: General Requirements Canada CAN/CSA C22.2 No.
  • Page 11: Emc Standards For Detector And System

    NOTE: For CARESTREAM DRX-1 System Battery Charger or Battery EMC information and instruction for use, see the CARESTREAM DRX-1 System Battery Charger User’s Guide.
  • Page 12: Communications Equipment

    System will be available prior to production release of the product. Shielded Locations The typical location of the CARESTREAM DRX-1 System will be in a shielded room only because the system functions with sources of X-Ray energy. The CARESTREAM DRX-1 System is fully compliant with the requirements of IEC 60601-1-2:2004 without being located in a shielded room.
  • Page 13 Guidance and Manufacturer’s Declaration - Electromagnetic Emissions The CARESTREAM DRX-1 System is intended for use in the electromagnetic environment specified below. The customer or the user of the CARESTREAM DRX-1 System should assure that it is used in such an environment.
  • Page 14 Electromagnetic Immunity for Equipment and Systems Fully Compliant with IEC 60601-1-2:2004 The CARESTREAM DRX-1 System is intended for use in the electromagnetic environment specified below. The customer or the user of the CARESTREAM DRX-1 System should assure that it is used in such an environment. Immunity Test IEC 60601...
  • Page 15 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The CARESTREAM DRX-1 System is intended for use in the electromagnetic environment specified below. The customer or the user of the CARESTREAM DRX-1 System should assure that it is used in such an environment.
  • Page 16: Drx-1 System Detector

    RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the CARESTREAM DRX-1 System is used exceeds the applicable RF compliance level above, the CARESTREAM DRX-1 System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the CARESTREAM DRX-1 System.
  • Page 17 Distributed evenly over the detector area: 125 kg (275 lb) Electrical Ratings 12-18V dc, 3A NOTE: For Computer, CARESTREAM DRX-1 System Battery Charger, and CARESTREAM DRX-1 System Battery regulatory information and instruction for use, see the manufacturer’s User Guide. 7H8166...
  • Page 18: Drx-1 System Battery Charger

    Safety and Regulatory Information DRX-1 System Battery Charger NOTE: For complete information on the CARESTREAM DRX-1 System Battery Charger, see the CARESTREAM DRX-1 Battery Charger User’s Guide. CARESTREAM DRX-1 System Battery Charger Carestream Carestream DRX1 System H223_0004BA Size 38 x 14 x 18 cm Weight 2.26 kg (5 lb)
  • Page 19: Drx-1 System Console

    Safety and Regulatory Information DRX-1 System Battery NOTE: For complete information on the care and handling of the DRX-1 System Battery, see the CARESTREAM DRX-1 System Battery User’s Guide. 21 x 15 x 0.5 cm Size Weight 0.4 kg (12.4 oz) Electrical Ratings 14.8V dc, 2.1Ah (nominal) capacity...
  • Page 20 Electrical Ratings 100-240V ac, 0.75A 50/60 Hz NOTE: For Computer, CARESTREAM DRX-1 System Battery Charger, and CARESTREAM DRX-1 System Battery regulatory information and instruction for use, see the CARESTREAM DRX-1 System Battery Charger User’s Guide and the CARESTREAM DRX-1 System Battery User’s Guide.
  • Page 21: Patient Vicinity

    Wireless Access Point are not medical electrical equipment and should not be placed in the patient vicinity. CAUTION Keep all electronic devices (wireless or hardwired) three feet from the detector when in use. Mode of Operation DRX-1 Detector Continuous DRX-1 System Tether Interface Continuous 7H8166 1-17...
  • Page 22: Labels

    This label indicates a requirement of one-second maximum exposure time for the DRX-1 System Detector. This label should be adhered close to the Console or on the DRX-1 System Monitor so that it is readily seen. The label means: CAUTION: MAXIMUM EXPOSURE TIME IS ONE SECOND.
  • Page 23 Safety and Regulatory Information DRX-1 Battery Dataplate Label 7H8166 1-19...
  • Page 24 Safety and Regulatory Information DRX-1 System Detector Dataplate Label System Console Label 1-20 7H8166...
  • Page 25 Safety and Regulatory Information System Tether Interface System Label 7H8166 1-21...
  • Page 26 Safety and Regulatory Information Detector Labeling Battery H224_0053AA H224_0054GA < 23 Kg < 125 Kg < 50 Lb < 275 Lb Tube Side H224_0052GA ID Label Weight Label 1-22 7H8166...
  • Page 27: Disposal Information

    NOTE: For disposal information for the CARESTREAM DRX-1 System Battery Charger or CARESTREAM DRX-1 System Battery see the CARESTREAM DRX-1 System Battery Charger User’s Guide or the CARESTREAM DRX-1 System Battery User’s Guide.
  • Page 28: General Contact Information

    General Contact Carestream Health, Inc. Information 150 Verona Street Rochester, New York 14608...
  • Page 29: Hardware And Operation

    Hardware and Operation Overview The CARESTREAM DRX-1 System lets you connect a digital DR Detector to an analog system and capture images digitally. Use the existing analog console to set up the exam and determine the technique. Then, expose the subject with the DRX -1 System and view and manipulate the image on the computer using Image Viewing Acquisition Software.
  • Page 30: Carestream Drx-1 System

    DIRECTVIEW Software. Mouse—Lets you access the Image Viewer Screen and DIRECTVIEW Software. DRX-1 System Battery Charger—Charges 3 DRX-1 batteries at one time. DRX-1 System Battery —Provides power to the detector. Bar-code Scanner—Reads the detector bar-code, enters patient data. DRX-1 System Wireless Access Point—Provides communication for the Wireless System.
  • Page 31: Cautions

    Perform periodic maintenance to ensure continued safe use of the equipment. CAUTION The system must be repaired only by authorized service personnel. Installing the Hardware All equipment installations and adjustments must be performed by personnel authorized by Carestream Health only. 7H8166...
  • Page 32: Attaching Accessories

    Carestream Carestream DRX1 System To turn the DRX-1 System On: Press the ON switch on the UPS. Press the ON switch on the computer and monitor. When the software initializes, select the DRX-1 icon on the monitor. To turn the DRX-1 System Off: Select the Quick Menu in the lower left corner of the monitor.
  • Page 33: Carestream Drx-1 System Battery

    CARESTREAM DRX-1 System Battery. The DRX 1 System provides a battery charger with three charging slots for batteries for the DRX-1 System detector. You can purchase additional batteries separately. The battery is keyed for proper orientation in the detector. • A battery is required for wireless or tethered use.
  • Page 34: Removing The Battery

    Hardware and Operation Installing the Battery H224_0016AC Push the battery firmly down until the latch catches. NOTE: See the CARESTREAM DRX-1 System Battery Charger User Guide for information on the battery and charger use, specifications, and disposal. Removing the Battery Place a tool such as a ball-point pen in the release slot and push down on the latch.
  • Page 35: Labeling The Detector

    Hardware and Operation Labeling the Detector The labels that come with the detector help you: Uniquely identify the detector. Orient the detector correctly in use. Go to Key Operator Functions > Equipment Management to view the selections of DRX-1 labels to choose from. Labels are grouped by colors and number series so that you can keep the same scheme in each room.
  • Page 36 Hardware and Operation Label H224_0019AC LED Pattern Meaning Action 1 Green Flash Detector is in Standby, no study is active; No action required. Detector is not being Console may not be connected. Low used. Power. 2 Green Flashes System is on, and Ready. No action required.
  • Page 37: Positioning The Detector In The Bucky

    Hardware and Operation Positioning the Detector in the Bucky For optimum performance, it is important to position the detector properly in the Wall Stand Bucky or the Table Bucky when performing an exam. To provide a visual guide for positioning, Service places a set of two positioning labels on each Bucky at installation to indicate how to orient the detector for portrait and landscape exams.
  • Page 38: Positioning The Detector On A Tabletop

    Hardware and Operation Example of Labels Applied to Table Bucky Positioning Labels Positioning the If you are not using a Bucky, for best image quality, place the detector on the table top away from any part of the table that generates noise. To do this, Detector on a move the Table Bucky to one side of the drawer and place the detector on the Tabletop...
  • Page 39: Using Two Or More Detectors

    Hardware and Operation Using Two or More Using two or more detectors in a room makes detector identification even Detectors more important. Make sure that the label on the detector matches the icon on the Console before exposing the patient. You must use the bar-code scanner while on the screen to read the bar-code on the detector when moving the detector to a new room.
  • Page 40: Using Detectors In Two Or More Rooms

    Hardware and Operation Using Detectors in The identification labels make it easy to prevent mixing of detectors from one Two or More Rooms room to another. Keep a different color scheme for each room and then subsequent detectors can be assigned labels within that color. You can register the same detector on two consoles.
  • Page 41: Tether Operation

    • Improves workflow. • Does not interfere with grid or ion chamber operation. To remove the DRX-1 System Detector from the tether and use it wirelessly, disconnect the tether. Make sure the DRX-1 System Detector comes into patient contact in wireless mode only.
  • Page 42: Tether Interface Box

    Hardware and Operation Tether Connection On Detector NOTE: The detector will function properly with a non-charged battery installed when the tether is properly connected and operating. It is not necessary to remove the battery to recharge it if the battery has not reached end of life and can be re-charged.
  • Page 43: With Each Occurrence Of Patient Contact

    Hardware and Operation CAUTION Isopropyl alcohol is a flammable solvent. Read and follow instructions in the Material Safety Data Sheet (MSDS). CAUTION Do not immerse the equipment in liquid. To clean the detector: Disconnect the detector from its power source. Remove the tether.
  • Page 44: System Maintenance

    The CARESTREAM DRX-1 System must be maintained in good operating order at all times to provide safe conditions for operating personnel and patients. The DRX-1 System must also be maintained to prevent possible loss of patient or image data. With each occurrence of patient contact: •...
  • Page 45: Grid Recommendation

    Hardware and Operation • No cables have abrasions or damage, particularly in locations where cables are draped and subject to stress. Grid Recommendation Artifacts are not visible when the following grids are used. • 103 line pair/inch low frequency stationary grid Protective Enclosures When there is a risk of fluids contacting the detector, place the detector in a protective bag.
  • Page 47 Index Numerics using two or more, 2-11 using two or more rooms, 2-12 1 blue flash, 2-8 weight limit, 1-19 1 green flash, 2-8 wireless operation, 2-12 2 blue flashes, 2-8 detector calibrations, 2-16 2 green flashes, 2-8 detector LED, 2-7 3 blue flashes, 2-8 disposal information, 1-24 3 green flashes, 2-8...
  • Page 48 Index patient contact, 2-15 perform periodic maintenance, 2-3 protective enclosures, 2-17 radiographer, 2-1 repairing the detector, 2-16 spraying cleaning solution, 2-14 System, 2-2 system console label, 1-21 system overview, 2-1 tether, 2-1 removed during the exam, 2-14 removing, 2-13 replacement, 2-14 tether interface label, 1-22 traditional film, 2-1 turning the system off, 2-4...
  • Page 50 Carestream Health, Inc. 150 Verona St. Rochester, NY 14608 CARESTREAM is a trademark of Carestream Health, Inc. © Carestream Health, Inc. 2008. 7H8166...

Table of Contents