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 4
3.
SAFETY INFORMATION 6
3.1
Warnings 7
3.1.1
Precautions while using laser centring devices 8
3.2
Protection against radiation 9
3.2.1
Pediatric Use: Summary 10
3.3
Information about Electromagnetic Compatibility 11
3.3.1
Electromagnetic emissions 12
3.3.2
Electromagnetic immunity 13
3.4
Cybersecurity measures 14
3.5
Environmental risks and disposal 15
3.6
Symbols used 16
4.
CLEANING AND DISINFECTION 18
5.
DESCRIPTION 19
5.1
Identification labels and laser labels 19
5.1.1
Identification labels and laser labels 20
5.2
Functions, models and versions 21
6.
TECHNICAL CHARACTERISTICS 22
6.1
Dimensions 28
6.2
Tube loading curves, anode heating and cooling curves 31
6.3
PC requirements 34
6.3.1
PC minimum characteristics 34
6.4
Software 35
6.5
X-MIND prime – PC communication 35
6.6
Reference standard 36
7.
QUALITY ASSURANCE PROGRAM 38
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