SHORT TERM CONFIDENTIAL DRYVIEW CHROMA Imaging System H210_0843AC Safety Manual
SHORT TERM CONFIDENTIAL Carestream Health, Inc. 150 Verona Street Rochester, New York 14608 United States © Carestream Health, Inc., 2012 Printed in China. CARESTREAM, CHROMA, and DRYVIEW are trademarks of Carestream Health, Inc. Pub No. 9G4259_en Rev.
SHORT TERM CONFIDENTIAL Table of Contents Safety, Warnings, and Cautions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -1 Safety Labels - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -4 Safety and Health Compliance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -7 Safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
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SHORT TERM CONFIDENTIAL Safety and Related Information Safety, Warnings, and Cautions Please read and understand all instructions before using the DRYVIEW CHROMA Imaging System. 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. Grasp plug and pull to disconnect.
Safety and Related Information SHORT TERM CONFIDENTIAL 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 door and oven main housing.
Safety and Related Information SHORT TERM CONFIDENTIAL CAUTION: This device should not be used in close contact with MRI devices, due to possible very high magnetic fields near an MRI unit. 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.
Safety and Related Information SHORT TERM CONFIDENTIAL 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 in English.
Safety and Related Information SHORT TERM CONFIDENTIAL Labels—Locations and Details See “Safety and Health Compliance” on page 7 for the specific details of the safety and health compliance. This label shows the serial number and model number of the device along with other important data items.
Safety and Related Information SHORT TERM CONFIDENTIAL Back view of the imaging system Additional labels for U.S., Canada, and Japan 3 1 2 4 Agency Statements 1 Product Label. This label states that the imager is a medical imaging printer. 2 Static Sensitive Equipment. This label identifies static-sensitive components. Connect a personal grounding strap to the appropriate ground before servicing this device. These panels may only be removed by a qualified service provider. Radio Frequency Energy.
Safety and Related Information SHORT TERM CONFIDENTIAL 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. UL 60950-1, 2nd Ed.
Safety and Related Information SHORT TERM CONFIDENTIAL 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.
Safety and Related Information SHORT TERM CONFIDENTIAL Guidance and Manufacturer’s Declaration for Electromagnetic Emissions 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. Emissions Test Compliance Electromagnetic Environment—Guidance RF emissions: Group 1 The imager uses RF energy only for its internal function.
Safety and Related Information SHORT TERM CONFIDENTIAL 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 Level Compliance Level Electromagnetic Environment—Guidance Electrostatic discharge (ESD): ± 6 kV contact ± 8 kV air ± 6 kV contact ± 8 kV air Floors should be wood, concrete, or ceramic tile.
Safety and Related Information SHORT TERM CONFIDENTIAL Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment - Guidance Voltage dips, short interruptions, and voltage variations on power supply lines: • EN61000-4-11 • 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 sec. <5 % Ut* (>95 % dip in Ut*) for 0.
Safety and Related Information SHORT TERM CONFIDENTIAL 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.
Safety and Related Information SHORT TERM CONFIDENTIAL 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.
Safety and Related Information SHORT TERM CONFIDENTIAL EU Directives 93/42/EEC Title: Council Directive Concerning Medical Devices. 1999/05/EC Title: Council Directive Concerning Radio and Telecommunications Terminal Equipment. 2006/95/EC Title: Council Directive on the Harmonization of the Laws of Member States Relating to Electrical Equipment Designed for Use within Certain Voltage Limits.
Safety and Related Information SHORT TERM CONFIDENTIAL Please Note The information contained herein is based on the experience and knowledge relating to the subject matter gained by the manufacturer prior to publication. No patent license is granted by this information. The manufacturer reserves the right to change this information without notice and makes no warranty, express or implied, with respect to this information.
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