User Manual

7H8166 1
Table of Contents
1 Safety and Regulatory Information
Document Conventions ....................................................................................................................................1-1
Intended Use and Indications for Use...............................................................................................................1-1
Safety and Related Information.........................................................................................................................1-2
Medical Equipment Classification...............................................................................................................1-2
Compatibility with Other Manufacturer’s Equipment ..................................................................................1-3
Product Safety Standards............................................................................................................................1-4
EMC Standards for Detector and System.....................................................................................................1-7
Safety .........................................................................................................................................................1-7
Additional Guidance and Manufacturer’s Declaration - Electromagnetic Emissions/Immunity....................1-7
Electromagnetic Compatibility Precautions...........................................................................................1-7
Communications Equipment ................................................................................................................1-8
Replacement of Cables, Accessories, or Transducers ...........................................................................1-8
Other Equipment..................................................................................................................................1-9
Shielded Locations ...............................................................................................................................1-9
DRX-1 System Product Information................................................................................................................1-14
DRX-1 System Detector ............................................................................................................................1-14
DRX-1 System Battery Charger..................................................................................................................1-15
DRX-1 System Battery...............................................................................................................................1-16
DRX-1 System Console .............................................................................................................................1-16
DRX-1 System Wireless Access Point ........................................................................................................1-17
DRX-1 System Tether Interface.................................................................................................................1-17
Patient Vicinity .........................................................................................................................................1-18
Mode of Operation...................................................................................................................................1-18
Labels ......................................................................................................................................................1-19
Disposal Information .....................................................................................................................................1-24
Operating Environment ..................................................................................................................................1-24
For European Market Only.......................................................................................................................1-24
General Contact Information ....................................................................................................................1-25
2 Hardware and Operation
Overview ..........................................................................................................................................................2-1
CARESTREAM DRX-1 System ............................................................................................................................2-2