Planar C3i/EX manual EU Declaration of Conformity for Medical Application

Page 58

EU Declaration of Conformity for Medical Application

A Declaration of Conformity has been filed for this product. For additional copies of the Declaration of Conformity document, contact Planar Systems.

Dome CX/Dome EX digital flat-panel displays meet the essential health and safety requirements, is in conformity with, and the CE marking has been applied according to the relevant EU Directives listed below, using the relevant section of the following EU standards and other normative documents;

EU EMC Directive 89/336/EEC

EU Electromagnetic Compatibility Directive

EN 60601-1-2 (2001)

Medical Electrical

Equipment

Section 1.2. Collateral standard electromagnetic compatibility requirements

EN 55011 (Class B)

Limits and methods of measurements for radio

 

interference characteristics of industrial, scientific,

 

and medical equipment

IEC 1000-3-2

Harmonic emissions

IEC 1000-3-3

Voltage fluctuations/flicker emissions

IEC 1000-4-2

Electrostatic discharge requirements for industrial

 

process measurement and control equipment

IEC 1000-4-3

Radiated electromagnetic field requirements for

 

industrial process measurement and control

 

equipment

IEC 1000-4-4

Electrically fast transients for industrial process

 

measurement and control equipment

IEC 1000-4-5

Surge requirements

IEC 1000-4-11

Voltage variations/dips/interrupts

IEC 1000-4-6

Conducted immunity

IEC 1000-4-8

Magnetic field immunity

 

Conformance to the Medical Device Directive

 

93/42/EEC

EN 60601-1 Medical

Part 1: General requirements for safety

Electrical

 

Equipment

 

Image 58 Contents
User’s Guide 020-0377-01A Contents Product Information Symbol explanations Intended useSafety precautions Safety tipsUnpacking and handling tips Preventing fire and injuryCleaning the display Shipping/storing the display Disposal informationDVI cable About the Display System RequirementsDisplay Components Display Positions Tilt range Height rangeDesk Stand Features Stand cable coverInstalling the Display Moving from Dome C3i to Dome EX Display SystemTo enable Eprom Set the DIP Switch on the Dome DX2 BoardTo disable VGA To set landscape mode as default display modeInstall the Display Controller To install the display controllerConnect the Video and Power Cables To connect the cablesInstallation preparation Install Dome DX2 Driver and Dome CXtra SoftwareRequired Sun software packages To install the driver and Dome CXtra Installing the Display Configure Display Settings Overriding the default display mode To edit the OWconfig fileDome Display To modify the OWconfig file Using visual classes To check the default visual To emulate a PseudoColor visual classSunallplanes Shape MIT-SHM Look Default visual id For visual Dome Display Configuring the Common Desktop Environment Configure the Window EnvironmentRunning OpenWindow from the console To use one or more Dome devices To use a Dome device with a Sun consoleDpms Screen Saver Screen saver tipsTo set the Dpms Screen Saver To use the setenv command Console ModificationDome CXtra Software Appendix Troubleshooting Problem Possible Cause SolutionDome C3i Specification Category Characteristic Item SpecificationReliability Power SupplyEnvironment Dome E2 Specification Power Supply Dome E3 Specification EMI shielding No emission of low-level radiation Temperature Dome E3c Specification Display Mtbf 30,000 hours Backlight Dome E5 Specification Display Mtbf 50,000 hours Backlight Video Modes 2560 xConnector Ports Details of DIN connectorsLED Status Lights Power-up sequence information from LED Index 21-22 Regulatory Compliance Canada, European Union, United StatesPage Fax + 358 9 420 EU Declaration of Conformity for Medical Application FCC Compliance Statement Japan AustralianChina KoreaStandard Warranty Return Procedure Standard WarrantySummary Summary Limitations and Exclusions of Dome Displays Limitation of Implied WarrantiesExclusion of Damages Effect of Local LawMedicalsales@planar.com Medicalsupport@planar.com