Related Manuals for Carestream DRX-Revolution
Summary of Contents for Carestream DRX-Revolution
- Page 1 DRX-Revolution Mobile X-ray System Safety and Regulatory Information 2012-02-28 9J0239 Version 4.0...
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Page 2: Table Of Contents
Table of Contents 1 Safety and Regulatory Information Manual Conventions............................1 Overview ................................1 Indications for Use............................2 Training ................................ 2 Safety and Related Information..........................3 Manufacturer’s Responsibility ........................3 Safety Symbols............................... 4 Radiation and X-ray System ........................... 6 Safety and General Compliance Information.................... 6 Maximum Permissible Dose (MPD)...................... - Page 3 System Requirements..........................17 US and Canada EMC Statements ........................18 Electromagnetic Emissions/Immunity ......................19 Wireless................................25 DRX-Revolution Wireless Systems ....................... 25 DRX-1 and DRX-1C System Detectors....................25 Grid Alignment Transmitter........................25 Wireless Compliance Information for EU Directive 1999/5/IEC..............26 Grid Alignment Intended Use ........................ 26 EC Declaration of Conformity..........................
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Page 4: 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, Inc. reserves the right to change this information without notice, and makes no warranty, express or implied, with respect to this information. -
Page 5: Indications For Use
System may cause serious injury to the patient, serious injury to the operator, or equipment damage. CAUTION Only allow trained X-ray personnel to operate the System. For training in the operation of this equipment, contact Carestream Health, Inc. 9J0239... -
Page 6: Safety And Related Information
Safety and Regulatory Information Safety and Related Information Manufacturer’s Although this equipment incorporates protection against X-radiation other Responsibility than the useful beam, practical design does not provide complete protection. Equipment design does not compel the operator or assistants to take the necessary precautions;... -
Page 7: Safety Symbols
Safety and Regulatory Information Safety Symbols The following symbols may be used for marking on this equipment: Emergency Stop button Follow the operating instructions Warning—dangerous voltage Dangerous voltage Warning— ionizing radiation Type B applied part Direct current Alternating current Collimator light Off (disconnect from the mains) On (power connected to the mains) Off (only for a part of the equipment) - Page 8 Safety and Regulatory Information On (only for a part of the equipment) Caution Non-ionizing radiation Tether cable Ethernet connection USB connection Protective earth (ground) Transport position >5º 9J0239...
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Page 9: Radiation And X-Ray System
Ensure exposure parameters are properly adjusted within safety limits. CAUTION Incorrect Collimator adjustment may cause unnecessary patient X-ray exposure. See the DRX-Revolution Mobile X-ray System Hardware Guide for instructions for adjusting the size of the exposure area. CAUTION Incorrect X-ray Tube and Collimator position could cause the X-ray field to be misaligned with the receptor, resulting in unacceptable images. -
Page 10: Maximum Permissible Dose (Mpd)
Safety and Regulatory Information CAUTION Materials between the Tube and the patient may adversely affect the resulting image. Maximum Permissible Various studies on the effects of X-radiation have provided a foundation for Dose (MPD) establishing the maximum permissible dose of X-radiation to which an occupational worker may be exposed. -
Page 11: Radiation Protection
Safety and Regulatory Information Radiation Protection Because exposure to high levels of X-radiation may pose a health risk, operators must ensure that they use all available methods to reduce their radiation dose to a level that is As Low As Reasonably Achievable (ALARA). This includes protection from the primary beam as well as scattered radiation. -
Page 12: Cdrh Compliance
IEC/EN 60601-1-3 The System is manufactured with radiation protection in accordance with Compliance IEC/EN 60601-1-3:1994. Electrical Rating DRX-Revolution Mobile X-ray System Voltage: 100/120/200/240/ VAC Current: 4.4/12.0/7.2/6.0 A Frequency: 50/60 Hz DRX-Revolution Grid Holder Voltage: 3.2 V (dc) Current: 1.5 A CARESTREAM DRX-1/DRX-1C System Detector Voltage: 12–1 8 V(dc) -
Page 13: Conforming Safety Standards
Safety and Regulatory Information Conforming Safety Standards UL 60601–1:2003 Medical Electrical Equipment, Part 1: General Requirements for Safety Canada CAN/CSA–C22.2 No. 601.1–M90—Medical Electrical Equipment—Part 1: General Requirements for Safety Europe EN 60601–1:1990 + A1+ A2—Medical Electrical Equipment—Part 1: General Requirements for Safety EN 60601–1–1:2001—Medical Electrical Equipment—Part 1–1: General requirements for safety —Collateral standard: Safety requirements for medical electrical systems... -
Page 14: Cautions
Safety and Regulatory Information Cautions Equipment Cautions The following are general safety precautions: • Do not remove the covers for any purpose. • Do not defeat or bypass built-in equipment safety features. • Observe all cautions, stated or implied, in the procedures. •... -
Page 15: General Use Cautions And Special Messages
Doing this may cause the equipment to malfunction. CAUTION The System includes no user serviceable parts. Contact Carestream Health, Inc. for service information. CAUTION This device must be maintained according to the directions in the System Hardware Guide. Failure to maintain this equipment as directed may result in injury, equipment malfunction, or unacceptable images. -
Page 16: Electrical And Flammable Cautions
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. NOTE: For instructions on cleaning the equipment, see the DRX-Revolution Mobile X-ray System Hardware Guide. 9J0239 1-13... -
Page 17: Caution Regarding Small-Object Image Handling
Safety and Regulatory Information Caution Regarding As with all digital imaging devices, there is the potential that some structures Small-Object Image could appear different in the digital image from an image created with an Handling analog device—such as a screen-film system—or with another digital device that has smaller individual detector elements. -
Page 18: Restrictions On Use
The hardware specified for use with the System has been selected, tested, and verified by Carestream Health, Inc. to meet the intended applications. All specified hardware meets applicable regulatory agency requirements for those countries where it is offered for sale with respect to its intended applications. -
Page 19: Disposal
Safety and Regulatory Information Disposal CAUTION This product contains lead in sealed lead-acid batteries and in the counterweight.. Disposal of components that contain these materials may be regulated due to environmental conditions. For disposal or recycling information, contact your local authorities. -
Page 20: Conforming Emc Standards
Safety and Regulatory Information Conforming EMC Standards For European Market Only Carestream Health France 1, rue Galilée 93192 NOISY-LE-GRAND CEDEX FRANCE System Requirements Equipment and systems meet the following requirements: IEC 60601–1-2:2007 Medical Electrical Equipment—Electromagnetic Compatibility Requirements and Tests, including CISPR 11:2009 + A1:2010 emissions to Class A limits. -
Page 21: Us And Canada Emc Statements
Safety and Regulatory Information US and Canada EMC Changes or modifications not expressly approved by Carestream Health, Inc. Statements could void the user’s authority to operate this equipment. NOTE: This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC Rules. -
Page 22: Electromagnetic Emissions/Immunity
Safety and Regulatory Information Electromagnetic Electromagnetic Compatibility Precautions Emissions/Immunity Medical electrical equipment requires special precautions regarding electromagnetic compatibility (EMC). Medical equipment must be installed and put into service according to the EMC information provided. Communications Equipment Portable and mobile radio frequency (RF) communications equipment can affect medical electrical equipment EMC performance. - Page 23 Safety and Regulatory Information Electromagnetic Emissions for Group 1, Class A Equipment The System is intended for use in the electromagnetic environment specified below. The customer or the user of the System should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment - Guidance RF Emissions...
- Page 24 Safety and Regulatory Information Electromagnetic Immunity for Equipment and Systems Fully Compliant with IEC 60601-1-2:2007 The System is intended for use in the electromagnetic environment specified below. The customer or the user of the System should assure that it is used in such an environment. Immunity Test IEC 60601 Compliance...
- Page 25 Safety and Regulatory Information Electromagnetic Immunity for Non-Life Supporting Equipment and Systems The System is intended for use in the electromagnetic environment specified below. The customer or the user of the System should assure that it is used in such an environment. Immunity Test IEC 60601 Compliance...
- Page 26 Safety and Regulatory Information Electromagnetic Immunity for Non-Life Supporting Equipment and Systems Field strengths from fixed transmitters, such as base station 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.
- Page 27 Safety and Regulatory Information Recommended Separation Distance Between Portable and Mobile RF Communications Equipment and the System The System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication equipment (transmitters) and the System as recommended below, according to the maximum output of the communications equipment.
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Page 28: Wireless
Mobile X-ray System Safety and Regulatory Information and release notes for the DRX-1 and DRX-1C System detectors. Intentional Radiator Wireless Compliance to Regulatory Requirements—See the DRX-Revolution Mobile X-ray System Safety and Regulatory Information and release notes for the DRX-1 and DRX-1C detectors. Grid Alignment... -
Page 29: Wireless Compliance Information For Eu Directive 1999/5/Iec
• Intel Centrino Ultimate N 6300 WLAN module, Model 633AN Refer to the appropriate manufacturer documentation for wireless regulatory declarations. The CARESTREAM DRX-Revolution Mobile X-ray System uses the same vendor, type, and model antennae originally certified with the Intel 6300 WLAN module and the DLink DAP 2553 Access Point. -
Page 30: Ec Declaration Of Conformity
Type Number: DRXRGA Declaration We, Carestream Health, declare under our own responsibility that this equipment is in compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC Wireless Standard: ETSI EN 301 489–V1.8.1 ETSI EN 300 330 Sections 7.3, 7.4, 7.5, 7.5.4 EMC Standard: EN 55022:2006 + A1:2007 (Emissions) EN 61000–4–2:2009 (Immunity Electrostatic Discharge) - Page 31 Safety and Regulatory Information The Grid Alignment Transmitter may be operated in all European Union countries listed below (and other countries following the EU Directive 1999/5/EC R&TTE) without restrictions. Austria Liechtenstein Belgium Lithuania Bulgaria Luxembourg Cyprus Malta Czech Republic Netherlands Denmark Norway Estonia...
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Page 32: Compliance: Grid Alignment
Safety and Regulatory Information Compliance: Grid Alignment 9J0239 1-29... - Page 33 Safety and Regulatory Information 1-30 9J0239...
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Page 34: National Usage Restrictions
Safety and Regulatory Information National Usage NOTE: There are no restrictions on operation of the Grid Alignment Transmitter in the countries listed above. Restrictions Refer to the appropriate manufacturer documentation for European Union wireless regulatory declarations for the following products: •... -
Page 35: Collision Sensing Feature
Safety and Regulatory Information Collision Sensing Feature Drive System Motor Drive Two independent drive motors provide forward/reverse drive and directional control. Collision Sensing Frontal and Lateral Maximum Drive Speed Up to 5.6 kmvh (3.5 mph) Patient Vicinity CAUTION The barcode reader charger cannot be placed in the patient vicinity. -
Page 36: X-Ray Tube And Collimator
Instructions are provided to indicate the type of IMPORTANT: attachment plug that should be used for connection to the alternate voltage. Method of Cleaning See the DRX-Revolution Mobile X-ray System Hardware Guide for instructions on cleaning the equipment. 9J0239 1-33... -
Page 37: Extra Focal Dimensions
Safety and Regulatory Information Extra Focal Dimensions 21.0 mm (0.8 in.) 80.0 mm (3.1 in.) 184.0 mm (7.2 in.) 35.0 mm (1.4 in.) 79.0 mm (3.1 in.) 117.4 mm 430.0 mm 117.4 mm (4.6 in.) (16.9 in.) (4.6 in.) Key: Distance from the focal spot to the collimator mounting flange surface Distance from the near-focus shutter opening to the mounting flange surface The maximum opening size of near-focus shutters... - Page 38 Safety and Regulatory Information 21.0 mm (0.8 in.) 80.0 mm (3.1 in.) 172.0 mm (6.8 in.) 30.5 mm (1.2 in.) 74.0 mm (2.9 in.) 143.8 mm 430.0 mm 143.8 mm (0.6 in.) (16.9 in.) (0.6 in.) H239_8000GC Key: Distance from the focal spot to the collimator mounting flange surface Distance from the near-focus shutter opening to the mounting flange surface The maximum opening size the of near-focus shutters Maximum size of the far-focus shutters...
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Page 39: Labels
Safety and Regulatory Information Labels Systems Label Locations 1, 2, 3, 4 System Data Plate Generator label X-ray tube label Collimator label Emergency Stop label (2) AC voltage circuit breaker label (The DC voltage circuit breaker label is in the same location on the opposite side.) Transport position warning label Retractable power cord... - Page 40 Safety and Regulatory Information System Data Plate Sample Area No. Description Official product name Service code and serial number Manufactured date Model type as required / consistent with product safety test reports Voltage range, rated frequency in hertz and amps / consistent with product safety test reports: V = volts, Hz = hertz, A = amperes Symbols for product safety, EMC, and CE marking SFDA Registration number...
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Page 41: Detector /Grid Holder Weight Limit Label
Safety and Regulatory Information Detector /Grid Holder Weight Limit Label CAUTION Since the detector/grid is not a patient support device, it must be placed on a suitable surface, such as a table or a floor, before applying patient weight. The weight label indicates the acceptable limits of use that will not damage the detector. -
Page 42: Product Disclosure Table
Safety and Regulatory Information Product Disclosure Table Product Disclosure Table Table of hazardous substances’ name and concentration hazardous substances’ name Component name (Cr6+) (PBB) (PBDE) (Pb) (Hg) (Cd) (Detector) (X-ray Tube) (Circuit Board) (Collimator) (X-ray Generator) SJ/T 11363-2006 ×: SJ/T 11363-2006 o indicates hazardous substance concentration lower than MCV ×: indicates hazardous substance concentration higher than MCV Environmental Protection Use Period (EPUP) - Page 44 Carestream Health, Inc. 150 Verona Street Rochester, New York 14608 United States © Carestream Health, Inc. 2012 CARESTREAM is a trademark of Carestream Health, Inc. 9J0239 Printed in the United States...