User Manual
Table Of Contents
- 1 Safety and Regulatory Information
- Document Conventions
- Intended Use and Indications for Use
- Safety and Related Information
- DRX-1 System Product Information
- Disposal Information
- Operating Environment
- 2 Hardware and Operation
- Overview
- CARESTREAM DRX-1 System
- Cautions
- Installing the Hardware
- CARESTREAM DRX-1 System Battery
- Labeling the Detector
- DRX-1 Detector LED
- Positioning the Detector in the Bucky
- Range of Operation
- Wireless Operation
- Tether Operation
- Cleaning the Hardware
- With Each Occurrence of Patient Contact
- System Maintenance
1-4 7H8166
Safety and Regulatory Information
The DRX-1 System uses an existing exposure switch connector on the X-ray
equipment. No modification to the X-ray equipment is required. The intended
use of the X-ray equipment is not affected and the X-ray equipment remains
certified by the X-ray equipment manufacturer.
Model-specific documentation and cables are provided to allow service
personnel to connect and run functional testing on the DRX-1 System. The
DRX-1 System is compatible with the X-ray equipment listed on the Certificate
of Compatibility available from your local authorized service provider. Contact
your local authorized service provider for further information.
Product Safety
Standards
The following Product Safety Standards apply to CARESTREAM
DRX-1 System, which includes:
• CARESTREAM DRX-1 System Detector
• CARESTREAM DRX-1 System Tether Interface
USA UL 60601-1:2003 - Medical Electrical Equipment
Canada CAN/CSA-C22.2 No. 601.1-M90 (R2001) Medical Electrical Equipment
CAN/CSA-C22.2 No. 601.1S1-94 (R1999) - Supplement No. 1-94 to
CAN/CSA-C22.2 No. 601.1-M90
CAN/CSA-C22.2 No. 601.1B-90 (R2002) - Amendment 2 to CAN/CSA-C22.2
No. 601.1-M90
Europe EN 60601-1:1990 + Amendment 1:1993 + Amendment 2:1995 - Medical
Electrical Equipment
International IEC 60601-1:1988 + Amendment 1:1991 + Amendment 2:1995 - Medical
Electrical Equipment