Carestream DRYVIEW 6850 Safety Manual
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Carestream DRYVIEW 6850 Safety Manual

Carestream DRYVIEW 6850 Safety Manual

Laser imager
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Summary of Contents for Carestream DRYVIEW 6850

  • Page 2 DRYVIEW 6850 Laser Imager Safety Manual...
  • Page 3 150 Verona Street Rochester, New York 14608 © Carestream Health, Inc., 2010 CARESTREAM and DRYVIEW are trademarks of Carestream Health, Inc. Pub No. 2G8646 Rev. A...

  • Page 4: Table Of Contents

    Table of Contents Safety and Related Information Safety, Warnings, and Cautions .....................1 Safety Labels ..........................5 Safety and Health Compliance .....................11 Safety............................11 EMC ............................12 EU Directives ..........................17 CE Marking ..........................17 Please Note..........................18 Imager Specifications ........................18 Publication History ........................18...

  • Page 6: Safety, Warnings, And Cautions

    Always call an Authorized Service Provider of Carestream Health, Inc. products for any service or repair. • Do not operate equipment with a damaged power cord.
  • Page 7 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. Only an Authorized Service Provider of Carestream Health, Inc., products or customer’s qualified service personnel may perform installation and service maintenance.
  • Page 8 Contact your local or state solid waste authorities to determine if additional disposal requirements apply. In other regions, contact local or regional solid waste authorities for proper disposal guidance. Go to the Carestream Health web site, search for the Environmental Technical Summary document, and refer to the End-of-Life-Management section.
  • Page 9 Covers with this label may only be removed by an Authorized Service Provider of Carestream Health, Inc. products. USE OF CONTROLS OR ADJUSTMENTS, OR PERFORMANCE OF PROCEDURES OTHER THAN THOSE SPECIFIED HEREIN, MAY RESULT IN EYE DAMAGE.

  • Page 10: Safety Labels

    Safety and Related Information 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. Below is a key to understand the meanings of the shortened words on the safety labels: Symbol on label Definition...
  • Page 11 Safety and Related Information Symbol on label Definition Tension Drive Belt Lower Drive-Roller Belt Main Drive Belt Cooling Roller Drive Belt Processor Belt Path Short Drive Belt Cooling Section Drive Belt Long Drive Belt Drum Drive Belt 2G8646 2010-11-04...
  • Page 12 100/120/200/220/240V 12/12/7/7/7A 7F2301 6551576 50/60Hz 311346 3JZT Carestream Health, Inc. Rochester, NY 14608 TM: DryView 7F3118.E This label shows the serial number and model number of the Imager along with other important data items. Laser Radiation Warning Labels Class 3B invisible laser radiation. This label states that, “When open and interlocks defeated, avoid exposure to...
  • Page 13 Laser Diode High Voltage Warning Label This warning label indicates that high voltage is present under panels or enclosures where labels are attached. These panels may only be removed by an Authorized Service Provider of Carestream Health, Inc. products. 2G8646 2010-11-04...
  • Page 14 High voltage: Indicates that high voltage is present under panels where the label is attached. Only an Authorized Service Provider of Carestream Health, Inc. products should attempt access. Static Sensitive Equipment: Identifies static-sensitive components. Connect a personal grounding strap to appropriate ground before servicing this laser imager.
  • Page 15 Safety and Related Information Hot Surface Labels Drum end cap hot surface. This label indicates to use care near the processor drum end cap to avoid possible burns. Drum hinge hot surface. This label indicates to use care near the processor drum hinge to avoid possible burns. Drum hot surface.

  • Page 16: 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 21 CFR 900.12(e) Mammography Quality Standards Act; Quality Standards;...

  • Page 17: Emc

    Safety and Related Information 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.
  • Page 18 Guidance and Manufacturer’s Declaration for Electromagnetic Emissions The DRYVIEW 6850 Laser Imaging System is intended for use in the electromagnetic environment specified below. The customer or user of the 6850 Laser Imager should ensure that it is used in such an environment.
  • Page 19 Safety and Related Information Guidance and Manufacturer’s Declaration for Electromagnetic Immunity The 6850 Laser Imager 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. Immunity Test IEC 60601 Test Compliance Level...
  • Page 20 Safety and Related Information Guidance and Manufacturer’s Declaration for Electromagnetic Immunity The 6850 Laser Imager is intended for use in the electromagnetic environment specified below. The customer or user of the 6850 Laser Imager should ensure that it is used in such an environment. Immunity Test IEC 60601 Test Compliance Level...
  • Page 21 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.

  • Page 22: 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 Carestream Health France LES MERCURIALES 40, rue Jean Jaures...

  • Page 23: Please Note

    Carestream Health, Inc. reserves the right to change this information without notice and makes no warranty, express or implied, with respect to this information. 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 Carestream Health, Inc.
  • Page 25 150 Verona Street Rochester, New York, 14608 © Carestream Health, Inc., 2010 CARESTREAM and DRYVIEW are trademarks of Carestream Health, Inc. Pub No. 2G8646 Rev. A...

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