Safety Manual Publication No.
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Contents Safety and Related Information Safety, Warnings, and Cautions....................................................................................................... 1 Safety Labels ............................................................................................................................... 4 System Labels .............................................................................................................................. 5 Safety and Health Compliance ...................
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.
Safety, Warnings, and Cautions DANGER This equipment is not contained in a sealed cabinet. Do not use this equipment in locations where it can come in contact with liquids, including body fluids. Caution The operator must not touch or have contact simultaneously with the patient and the laser imaging system. Caution Do not use a cell phone within 2.0 m (6.6 ft) of a laser imager. This proximity includes any imager behind a wall adjacent to your location. Caution Do not use a microwave oven within 4.
Safety, Warnings, and Cautions Caution 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. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment.
Safety, Warnings, and Cautions Safety Labels Safety labels are attached to the laser imager in compliance with international standards. English Text on Labels Some names on the labels are shortened and left in English.
Safety, Warnings, and Cautions System Labels Laser Radiation Warning 1 Class 3B invisible laser radiation. This label states: “When open and interlocks defeated, avoid exposure to the beam.
Safety, Warnings, and Cautions Back Panel and Agency Statements Figure 1: Laser Imager Back Panel 6 Item Label Description 1 FCC compliance Describes compliance, if applicable for the country of installation. 2 Product States that the imager is a Laser Imaging Printer.
Safety, Warnings, and Cautions Item Label Description 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. • Static Sensitive Equipment. Identifies static-sensitive components. Connect a personal grounding strap to the appropriate ground before servicing this laser imager. These panels may only be removed by an authorized service provider.
Safety and Health Compliance 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.
Safety and Health Compliance provide reasonable protection against harmful interference in a commercial or light industrial installation. • • FCC Rules and Regulations, Title 47, Part 15, Subpart C, Radio Frequency Devices: Intentional Radiators. “FCC ID: U726950” RF Exposure Guidance: This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment.
Safety and Health Compliance 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.
Safety and Health Compliance Electromagnetic Environment— Guidance Immunity Test IEC 60601 Test Level Compliance Level Surge: ±1 kV differential mode ±2 kV common mode ±1 kV differential mode ±2 kV common mode Mains power quality should be that of a typical commercial or hospital environment. <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 Health Compliance 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 laser imager should ensure that it is used in such an environment. Portable and mobile RF communications equipment should be used no closer to any part of the system, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Safety and Health Compliance Additional Guidance and Manufacturer’s Declaration–Electromagnetic Emissions/Immunity Electromagnetic Compatibility Precautions 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 in this document.
Safety and Health Compliance External Cables Listing 14 Description Length Shielded? Cable, Category 5E, Shielded RJ45 to RJ45, Patch Cord, 4 Pair 2.1 m (7.0 ft) Yes Cord Assembly, Power, China 2.5 m (8.2 ft) No Cord Assembly, Power, Continental Europe Schuko 2.5 m (8.2 ft) No Cord Assembly, Power, India/South Africa 2.5 m (8.2 ft) No Cord Assembly, Power, North American 3.0 m (10.0 ft) No Cord Assembly. Power, UK, Fused 2.5 m (8.
Safety and Health Compliance 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.
Safety and Health Compliance 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. Contact your local authorized representative for additional information.
Publication History Revision Date A 2014-04-30 First release B 2014-06-09 Draft, with additional FCC and RF guidance. Added cables listing.
Carestream Health 150 Verona Street Rochester, NY 14608 USA © Carestream Health, Inc., 2014 Made in the USA. Pub. No. AB3145_en Rev.
