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ONE ā User manual Page 3/44
Index
1 INTRODUCTION ............................................................................................................................................... 5
1.1 INTENDED USE ....................................................................................................................................................... 5
1.2 INTENDED PATIENT POPULATION ................................................................................................................................ 5
1.3 APPLICATION ENVIRONMENTS ................................................................................................................................... 6
1.4 APPLIED PARTS ....................................................................................................................................................... 6
1.5 FREQUENCY OF USE ................................................................................................................................................. 6
1.6 PRESCRIPTION USE STATEMENT ................................................................................................................................. 6
1.7 COMPLIANCE WITH STANDARDS ................................................................................................................................. 6
1.8 POWER SUPPLY ...................................................................................................................................................... 6
1.9 INSTALLATION PRECAUTIONS ..................................................................................................................................... 7
1.10 LIABILITY AND OPERATORS ........................................................................................................................................ 7
1.11 PACKAGING AND ENVIRONMENT ................................................................................................................................ 8
1.12 MARKING AND LABELLING SYMBOLS ........................................................................................................................... 8
1.13 ELECTROMAGNETIC INFORMATION ............................................................................................................................. 9
1.14 ELECTROMAGNETIC EMISSIONS ................................................................................................................................ 10
1.15 ELECTROMAGNETIC IMMUNITY ................................................................................................................................ 11
1.16 ENVIRONMENTAL RISKS AND DISPLACEMENT .............................................................................................................. 12
1.17 MANUFACTURER IDENTIFICATION ............................................................................................................................ 12
1.18 IDENTIFICATION LABEL ........................................................................................................................................... 13
2 CONTENTS ..................................................................................................................................................... 14
3 INSTALLATION ............................................................................................................................................... 14
3.1 PRECAUTIONS ...................................................................................................................................................... 14
3.2 EQUIPMENT INSTALLATION ..................................................................................................................................... 16
3.3 SOFTWARE INSTALLATION ....................................................................................................................................... 17
3.4 CONFIGURATION IN THE OWANDY IMAGING SOFTWARE ............................................................................................... 21
3.5 SHARING THE SENSOR AND BOX BETWEEN DIFFERENT WORKSTATIONS ............................................................................. 23
4 USE ................................................................................................................................................................ 24
4.1 PRECAUTIONS ...................................................................................................................................................... 24
4.2 SENSOR PRINCIPLES ............................................................................................................................................... 25
4.3 USE OF THE OWANDY XIO STANDALONE SOFTWARE ................................................................................................... 26
4.4 ACQUISITION OF AN IMAGE ..................................................................................................................................... 29
4.5 EXPOSURE TIMES .................................................................................................................................................. 31
5 HYGIENE AND MAINTENANCE ....................................................................................................................... 32
5.1 HYGIENE AND DISINFECTION ................................................................................................................................... 32
5.2 RECOMMENDED CLEANING AND DECONTAMINATION PROCEDURE .................................................................................. 33
5.3 MAINTENANCE..................................................................................................................................................... 34
6 TROUBLESHOOTING AND TESTS METHOD ..................................................................................................... 35
6.1 GENERAL ............................................................................................................................................................ 35
6.2 IMAGE QUALITY .................................................................................................................................................... 35
6.3 TESTS METHOD .................................................................................................................................................... 37
7 SPECIFICATIONS ............................................................................................................................................ 39
7.1 GENERAL SPECIFICATIONS ....................................................................................................................................... 39
8 ACCESSORIES ................................................................................................................................................. 42
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