Acteon X-MIND prime Bedienungsanleitung

USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C

X-MIND prime

User Manual

 
User Manual –Contents 
 
USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C 
I 
 
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

 
User Manual –Contents 
 
USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C 
II 
 
7.1
 
Quality check tools 39
 
7.2
 
Functioning of the indicator lights 40
 
7.3
 
Laser alignment check 40
 
7.4
 
Image quality check 41
 
7.4.1
 
Geometry check 41
 
7.4.2
 
Signal to noise check 43
 
7.5
 
Dosimetry test (paragraph for authorised personnel) 45
 
7.6
 
LOG book 47
 
7.6.1
 
Image quality check 47
 
7.6.2
 
Verification of radiological parameters 48
 
8.
 
GENERAL INSTRUCTIONS FOR USE 49
 
8.1
 
Switching the device ON and OFF 49
 
8.1.1
 
Emergency button 49
 
8.2
 
Positioning the chin support 50
 
8.3
 
Keyboard - Description and functions 51
 
8.4
 
Graphical User Interface - Description and functions 53
 
8.4.1
 
Main GUI area functions 55
 
8.5
 
Digital sensor 56
 
8.6
 
Making an exam 57
 
8.7
 
Anatomic / Manual exposure 58
 
8.7.1
 
Anatomic exposure 59
 
8.7.2
 
Manual exposure 59
 
8.8
 
Panoramic and Bitewing exams 60
 
8.8.1
 
Laser references 60
 
8.8.2
 
Preparation of the device 61
 
8.8.3
 
Preparation of the patient 68
 
8.8.4
 
Taking an exposure 71
 
8.8.5
 
Image processing windows 74
 
8.9
 
Sinus exam 77
 
8.9.1
 
Preparation of the patient 79
 
8.9.2
 
Taking an exposure 81
 
8.10
 
TMJ exam 83
 
8.10.1
 
Preparation of the device 85
 
8.10.2
 
TMJ closed mouth: preparation of the patient 88
 
8.10.3
 
Carrying out the first exposure 90
 
8.10.4
 
TMJ open mouth: preparation of the patient 92
 
8.10.5
 
Carrying out the second exposure 94
 
8.11
 
Table of pre-set anatomic parameters 95
 
9.
 
ERROR MESSAGES 96

User Manual –Contents

USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C

III

10.

MAINTENANCE 99

11.

PANORAMIC IMAGE ASSESSMENT 101

11.1

Proper positioning of the patient 102

11.2

Patient positioning errors 104

11.2.1

Turned head 104

11.2.2

Tilted head 105

11.2.3

Downward angulation of the head 106

11.2.4

Backward angulation of the head 107

11.2.5

Tongue effect 108

11.2.6

Spine effect 109

Note

No part of this publication can be reproduced, transmitted, transcribed or

translated without the approval of ACTEON.

This manual in English is the original Manual version.

User Manual –Contents

USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C

THIS PAGE IS INTENTIONALLY LEFT BLANK

User Manual - Introduction

USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C

1. INTRODUCTION

Note

This manual is updated for the product it is sold with, to guarantee an adequate

reference for using the product properly and safely.

The manual may not reflect changes made to the product that do not affect

operating procedures or safety.

X-MIND prime, manufactured by de Götzen, is an X-ray device for the radiographic

analysis of the maxillo-facial complex.

X-MIND prime performs Panoramic, Half-panoramic, Low dose Panoramic, Frontal

dentition, Ortho Rad Panoramic, Bitewing Bilateral, Bitewing Left and Bitewing Right,

Sinus and TMJ of the maxillo-facial complex.

The aim of this Manual is to instruct the user on the safe and effective use of the device.

The device must be used complying with the procedures described in this Manual and

never be used for purposes other than those indicated herein.

Please read this Manual thoroughly before starting to use the unit; it is advisable to keep

the manual close to the device, for reference while operating.

X-MIND prime is an electrical medical device and can only be used under the supervision

of a physician or of highly qualified personnel, with necessary knowledge of X-ray

protection. The user is liable for legal compliance in relation to the installation and

operation of the device.

1.1 Icons appearing in the manual

This icon indicates a “NOTE”: please read the items marked by this icon

thoroughly.

This icon indicates a “WARNING”: the items marked by this icon refer to safety

aspects of the patient and/or operator.

User Manual –Specification of the intended use

USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C

2. SPECIFICATION OF THE INTENDED USE

2.1 Application and medical purpose

X-MIND prime is an extra-oral dental panoramic X-ray unit to radiograph teeth, jaw and

oral structures.

The device is operated and used by dentists, radiologists and other legally qualified

health care professionals. It can be used with both paediatric and adult patients.

Caution

Federal law restricts this device to sale by or on the order of a dentist, a radiologist or

another legally qualified health care professional.

2.1.1 Intended patient population

X-MIND prime system can be used with the following type of patient:

•

Age: paediatric (from about 7 years) to geriatric

•

Patient status:



self-sufficient patient (the patient can autonomously place himself as requested

by the physician)



non self-sufficient patient (the patient is assisted by medical personnel).



In any case the patient must be conscious, not anaesthetized and not

incapacitated

•

Nationality: multiple.

2.1.2 Operator Profile

This system may only be operated by persons who have suitable experience in radiation

protection or knowledge of radiation protection and who have been instructed in the

operation of the X-ray equipment.

2.1.3 Application environments

X-MIND prime may be used in professional buildings (e.g. hospitals, private clinics) or in

residential buildings. For the purpose of EMC environment classification both

installations are classified as "Professional healthcare facility environment".

Note

In the radiographic room, direct audio and visual communication between

operator and patient shall be always possible. Otherwise, provide proper

support (i.e. lead glass or similar, interphone, etc.).

User Manual –Specification of the intended use

USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C

2.2 Applied parts

During normal use, X-MIND prime is in contact with the patient via the handle, the chin

rest and bite and the temple clamp, classified as Type B applied parts.

User Manual –Specification of the intended use

USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C

2.3 Typical doses delivered to the patient during extra-

oral exams

The air kerma at the entrance of the X-ray image receptor for the standard PANORAMIC

exam is:

2.2

2.5

2.8

3.2

3.6

4.5

5.6

6.3

7.1

Air Kerma [mGy]

2.54

2.79

3.17

3.55

4.06

4.56

5.07

5.70

6.34

7.10

7.99

9.00

2.65

2.91

3.31

3.71

4.24

4.77

5.30

5.96

6.62

7.41

8.34

9.40

2.87

3.16

3.59

4.02

4.60

5.17

5.75

6.46

7.18

8.05

9.05

10.20

3.10

3.41

3.87

4.34

4.96

5.58

6.20

6.97

7.75

8.68

9.76

11.00

3.24

3.56

4.05

4.54

5.18

5.83

6.48

7.29

8.10

9.07

10.20

11.50

3.52

3.89

4.40

4.93

5.63

6.34

7.04

7.92

8.80

9.86

11.10

12.50

The air kerma for the other exams available on the equipment can be calculated using

the ratios in the table below:

Exam

Ratio

Child panoramic

0.92

Child half-panoramic

0.52

Child low dose

0.77

Half-panoramic

0.55

Low Dose

0.85

Ortho Rad panoramic

0.90

Frontal dentition

0.33

Bitewing L or R

0.24

Bitewing L and R

0.47

TMJ

0.71

Sinus

0.65

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