Owandy Radiology i-max touch 3D, User Manual

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User Manual - Contents
NIMXEN020I
Owandy Radiology SAS
Contents
1. INTRODUCTION ....................................................................................... 1
1.1 ICONS APPEARING IN THE MANUAL .............................................................................. 1
2. SPECIFICATION OF THE INTENDED USE.............................................. 2
2.1 APPLICATION AND MEDICAL PURPOSE ........................................................................ 2
2.1.1 INTENDED PATIENT POPULATION .................................................................... 2
2.1.2 OPERATOR PROFILE ........................................................................................... 2
2.1.3 APPLICATION ENVIRONMENTS ......................................................................... 2
2.2 APPLIED PARTS ................................................................................................................ 3
2.3 TYPICAL DOSES DELIVERED TO THE PATIENT DURING EXTRA-ORAL EXAMS ...... 3
2.3.1 PANORAMIC MODE .............................................................................................. 4
2.3.2 3D MODE ............................................................................................................... 6
3. SAFETY INFORMATION .......................................................................... 7
3.1 WARNINGS......................................................................................................................... 8
3.1.1 PRECAUTIONS WHILE USING LASER CENTRING DEVICES ........................... 9
3.2 PROTECTION AGAINST RADIATION ............................................................................. 10
3.2.1 PEDIATRIC USE: SUMMARY ............................................................................. 11
3.2.1.1 INTRODUCTION ..................................................................................... 11
3.2.1.2 REFERENCES FOR PEDIATRIC DOSE OPTIMIZATION ..................... 11
3.2.1.3 DEVICE SPECIFIC FEATURES AND INSTRUCTIONS ........................ 11
3.3 INFORMATION ABOUT ELECTROMAGNETIC COMPATIBILITY .................................. 12
3.3.1 ELECTROMAGNETIC EMISSIONS .................................................................... 13
3.3.2 ELECTROMAGNETIC IMMUNITY ...................................................................... 14
3.4 CYBERSECURITY MEASURES ...................................................................................... 15
3.5 ENVIRONMENTAL RISKS AND DISPOSAL .................................................................... 16
3.6 SYMBOLS USED .............................................................................................................. 17
4. CLEANING AND DISINFECTION ........................................................... 19
5. DESCRIPTION ........................................................................................ 20
5.1 IDENTIFICATION LABELS AND LASER LABELS ........................................................... 20
5.1.1 POSITION OF IDENTIFICATION LABELS .......................................................... 20
5.1.2 WARNING AND CAUTION LABELS ................................................................... 21
5.2 FUNCTIONS, MODELS AND VERSIONS ........................................................................ 22
6. TECHNICAL CHARACTERISTICS ......................................................... 23
6.1 DIMENSIONS ................................................................................................................... 29
6.2 TUBE LOADING CURVES, ANODE HEATING AND COOLING CURVES ..................... 32
6.3 PC REQUIREMENTS ....................................................................................................... 34
6.3.1 PC MINIMUM CHARACTERISTICS .................................................................... 34
6.3.2 PC SUGGESTED CHARACTERISTICS .............................................................. 35