SHORT TERM CONFIDENTIAL Preliminary Safety Manual Publication No.
SHORT TERM CONFIDENTIAL All rights reserved. No part of this manual may be reproduced or copied in any form by any mean graphic, electronic, or mechanical, including photocopying, typing, or information retrieval systems without written permission.
SHORT TERM CONFIDENTIAL Contents 1 Safety and Related Information Safety, Warnings, and Cautions .................................................................................................... 2 Safety Labels ............................................................................................................................ 5 System Labels ...........................................................................................................................
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SHORT TERM CONFIDENTIAL Safety and Related Information 1 Safety and Related Information 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.
SHORT TERM CONFIDENTIAL Safety and Related Information Safety, Warnings, and Cautions Please read and understand all instructions before using this product. DANGER 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. Do not attempt to service or repair the imager yourself to avoid exposure to dangerous voltage, laser beam, or other danger.
SHORT TERM CONFIDENTIAL Safety and Related Information Caution Do not use in the presence of flammable anesthetics, oxygen, or nitrous oxide. This equipment does not have a gas-sealed electronics enclosure and could ignite any flammable or explosive gases present in its environment. Caution This equipment uses a DICOM network port, and is intended to connect to other medical devices. It is not intended to be connected directly outside the building.
SHORT TERM CONFIDENTIAL Safety and Related Information Caution In the U.S., exhausted filters are considered to be non-hazardous waste according to the US Environmental Protection Agency Resource Conservation Recovery Act (RCRA). Municipality owned and licensed solid waste management facilities are an appropriate disposal option. Contact your local or state solid waste authorities to determine if additional disposal requirements apply.
SHORT TERM CONFIDENTIAL 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.
SHORT TERM CONFIDENTIAL Safety and Related Information Laser Radiation Warning 1 Class 3B invisible laser radiation. This label states: “When open and interlocks defeated, avoid exposure to the beam.
SHORT TERM CONFIDENTIAL Safety and Related Information Back Panel and Agency Statements Figure 1: Laser Imager Back Panel 1 3 2 4 3 5 6 Item Label Description 1 FCC compliance Provides FCC ID and Industry Canada, describes compliance. 2 Product States that the imager is a Laser Imaging Printer. 3 Agency labels and Class 1 Laser Safety • High voltage. Indicates that high voltage is present under panels where the label is attached. Only an Authorized Service Provider should attempt access.
SHORT TERM CONFIDENTIAL Safety and Related Information Item Label Description 4 Japanese import license Allows importation into Japan. 6 Power cord inlet Covers the power cord inlet when shipped from manufacturing. Shows the voltage at which the imager must be operated. The label is removed or moved during installation. Hot Surface Figure 2: Hot Surface Labels This label indicates that you must use care where the label is installed to avoid possible burns.
SHORT TERM CONFIDENTIAL 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 Standards United States • 21 CFR 1040.
SHORT TERM CONFIDENTIAL Safety and Related Information EMC Standards United States • FCC Rules and Regulations, Title 47, Part 15, Subpart B, Class A: Radio Frequency Devices: Unintentional Radiators. • This equipment has been tested and been found to comply with the limits for a Class A digital device pursuant to part 15 of the FCC rules. Those limits are designed to provide reasonable protection against harmful interference in a residential installation.
SHORT TERM CONFIDENTIAL Safety and Related Information Guidance and Manufacturer’s Declaration for Electromagnetic Emissions The system is intended for use in the electromagnetic environment specified below. The customer or user of the system should ensure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment— Guidance RF emissions: Group 1 The system uses RF energy only for its internal function.
SHORT TERM CONFIDENTIAL Safety and Related Information Immunity Test IEC 60601 Test Level Compliance Level Surge: ±1 kV differential ±1 kV differential • EN61000-4-5 • IEC 61000-4-5 Voltage dips, short interruptions, and voltage variations on power supply lines: • EN61000-4-11 • IEC 61000-4-11 Power frequency (50/60 Hz) magnetic field: • EN61000-4-8 • IEC 61000-4-8 1.
SHORT TERM CONFIDENTIAL Safety and Related Information Guidance and Manufacturer’s Declaration for Electromagnetic Immunity The system is intended for use in the electromagnetic environment specified below. The customer or user of the system should ensure that it is used in such an environment.
SHORT TERM CONFIDENTIAL Safety and Related 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.
SHORT TERM CONFIDENTIAL Safety and Related Information EU Directives • 93/42/EEC Title: Council Directive Concerning Medical Devices • 1999/5/CE Title: Council Directive Concerning Radio Equipment and Telecommunications Terminal Equipment Figure 3: Recycling Label In the European Union, this symbol indicates that when the last user wishes to discard this product, it must be sent to the appropriate facilities for recovery and recycling.
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SHORT TERM CONFIDENTIAL Publication History Publication History Revision Date Reason for Change A 2012-07-27 Preliminary - for Gate 2 (preliminary) review AA2205_en | 2012-07-27 17
SHORT TERM CONFIDENTIAL Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 United States © Carestream Health, Inc., 2012 Printed in China. CARESTREAM and DRYVIEW are trademarks of Carestream Health, Inc. Pub No.
