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Summary of Contents for Carestream DRYVIEW Chroma
- Page 1 CARESTREAM DRYVIEW CHROMA Imaging System H210_0843AC Preliminary Safety Manual...
- Page 2 150 Verona Street Rochester, New York 14608 © Carestream Health, Inc., 2011 CARESTREAM and DRYVIEW are trademarks of Carestream Health, Inc. Pub No. 9G4259_en Rev. 30...
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Page 3: Table Of Contents
Table of Contents Safety, Warnings, and Cautions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -1 Safety Labels - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -4 English Text on Labels - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -4 Labels - Locations and Details - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -4... -
Page 5: Safety, Warnings, And Cautions
Safety and Related Information Safety, Warnings, and Cautions Please read and understand all instructions before using this product. RISK OF ELECTRIC SHOCK This equipment is operated with hazardous voltage which can shock, burn, or cause death. • Remove wall plug before servicing equipment. Never pull on cord to remove from outlet. - Page 6 Safety and Related Information CAUTION Double pole/neutral fusing. CAUTION Do not use a cell phone within 2 m of this device. This proximity includes any imager behind a wall adjacent to your location. CAUTION Do not use a microwave oven within 4 m of this device. Electromagnetic radiation from a microwave oven is only an issue if after the oven door is closed and latched, the seal does not maintain an electromagnetic tight fit between the oven...
- Page 7 The magnetic field in the area where this equipment is installed must be less than 50 G. CAUTION Do not substitute or modify any part of this equipment without prior written approval of Carestream Health, Inc. CAUTION Federal law prohibits dispensing without a prescription. CAUTION...
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Page 8: Safety Labels
Safety and Related Information Safety Labels Safety labels are attached to the imager in compliance with international standards. English Text on Labels Some names on the labels are shortened and left in English. Below is a key to understand the meanings of the shortened words on the safety labels: Symbol on label Definition... - Page 9 Safety and Related Information Additional labels for U.S., Canada, and Japan NOTE: These labels appear on the side panel of the DICOM interface. Agency Statements Static Sensitive Equipment. This label identifies static-sensitive components. Connect a personal grounding strap to appropriate ground before servicing this device. These panels may only be removed by a qualified service provider.
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Page 10: Safety And Health Compliance
Safety and Related Information Safety and Health Compliance This equipment has been tested for, and complies with, the following Safety and Emissions Standards. Certificates of Compliance and Declarations of Conformity have been issued as shown below. Safety United States FDA 21CFR 807 Premarket Notification 510(K): Regulatory Requirements For Medical Devices. - Page 11 Safety and Related Information Canada CAN/CSA-C108.6-M91, Class A: Limits and Methods of Measurement of Electromagnetic Disturbance Characteristics of Industrial, Scientific and Medical (ISM) Radio-Frequency Equipment. Intentional Radiation IC for CHROMA Imager: 7027A-4900 This Class A digital apparatus complies with Canadian ICES-003. CET APPAREIL NUM ENRIQUE DE CLASSE A EST CONFORME A LA NORME NMB-003 DU CANADA.
- Page 12 Safety and Related Information Guidance and Manufacturer’s Declaration for Electromagnetic Immunity The imager is intended for use in the electromagnetic environment specified below. The customer or user should ensure that it is used in such an environment. Immunity Test IEC 60601 Test Compliance Level Electromagnetic Environment - Level...
- Page 13 Safety and Related Information Guidance and Manufacturer’s Declaration for Electromagnetic Immunity The imager is intended for use in the electromagnetic environment specified below. The customer or user should ensure that it is used in such an environment. Immunity Test IEC 60601 Test Compliance Electromagnetic Environment - Guidance Level...
- Page 14 Safety and Related Information Guidance and Manufacturer’s Declaration for Electromagnetic Immunity Note 1 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. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
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Page 15: Eu Directives
CE Marking Documents concerning the conformance of this product to Council Directive 93/42/EEC of 14 June 1993 concerning Medical Devices can be obtained from the Carestream Health, Inc. European Representative at: Carestream Health France 1, rue Galilée... -
Page 16: Please Note
Carestream Health, Inc. shall not be liable for any loss or damage, including consequential or special damages, resulting from the use of this information, even if loss or damage is caused by the negligence of Carestream Health, Inc. or other fault. Imager Specifications See the User’s Guide, 9G4260.
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