User Manual
Table Of Contents
- 4343W X-ray Detector
- Table of Contents
- List of Tables
- List of Figures
- 1.0 Scope
- 2.0 Contraindication
- 3.0 Intended Use
- 4.0 Audience
- 5.0 Abbreviations
- 6.0 Definition of Symbols
- 7.0 Standards and Regulations
- 8.0 Description of the 4343W
- 8.1 Shipment Contents
- 8.2 Optional Parts
- 8.3 X-ray Detector Surfaces and Features
- 8.4 X-ray Detector Dimensions
- 8.5 X-ray Detector Specifications
- 8.6 Environmental Considerations
- 8.7 X-ray Detector Battery
- 8.8 Optional Varex Provided Inductive Battery Charger
- 8.9 Designing a Custom Inductive Battery Charger
- 8.10 Using a Third-Party Inductive Battery Charger
- 8.11 Power-on and Power-off Sequence
- 8.12 Reboot Sequence
- 8.13 LED Status Indicator Behavior
- 8.14 Position Sensing
- 8.15 Detector Sharing
- 9.0 The Detector Configuration File
- 10.0 System Software
- 11.0 Maintenance
- 12.0 Troubleshooting
- 13.0 Disposing of the X-ray Detector and Battery
- 14.0 Safety - Electromagnetic Interference
- 15.0 Regulatory
- Index
4343W X-ray Detector
4 www.vareximaging.com
REFERENCE MANUAL
7.0 Standards and Regulations
The 4343W X-ray Detector is designed to be compliant with the requirements detailed in Table 3
below. All regulatory certificates are valid only if the original accessories are used. All regulatory
certificates are rendered invalid if any modifications to the Product are made, or any portion
thereof, without obtaining the prior written authorization of Varex Imaging.
.
Table 3 Standards and Regulations
Detector Standard Description
UL 60601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety 1st ed.
IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for Safety 2nd ed.
EN/IEC 60601-1 2006+A1:2013/ 2005+A1:2012 (ED. 3.1)
ANSI/AAMI ES60601-1
(2005)
Medical Electrical Equipment – Part 1: General Requirements for Basic Safety
and Essential Performance.
CSA-C22.2 No 60601-1
(2008)
Medical Electrical Equipment, Part 1 General Requirements for Basic Safety
and Essential Performance.
CAN/CSA-C22.2 No
601.1-M90, 2005
Medical Electrical Equipment, Part 1 General Requirements for Safety.
EN/IEC 60601-1-2 Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety
and Essential Performance Collateral Standard: Electromagnetic
Compatibility 4th ed.
93/42/EEC European Union Medical Device Directive
2014/30/EC European Union Electromagnetic Compatibility Directive
2014/53/EU European Union Radio Equipment Directive
FCC Part 15 Subpart E Telecommunication - Intentional Radiators and Unlicensed Devices
EN 301 893 Wideband Transmission Systems: 5GHz
EN 301 489-1 Radio Equipment - Electromagnetic Compatibility
EN 301 489-17 Broadband Data Transmission Systems
4343W has the capability to be internally powered.
MDD Class IIa
A Declaration of Conformity has been filed for this product and available upon request by contacting
Varex Imaging.