Blue X IntraOs 70 User manual

IntraOs 70
X-ray Equipment
Operator’s Manual
Blue X Imaging Srl Via Idiomi
1/8
-
33
20090 Assago ITALY e
-
mail [email protected]

IntraOs 70 – Operator’s Manual
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Blue X Imaging S.r.l.
Via Mario Idiomi 1/8-33
20090 Assago ITALY
tel.[phone]
fax [phone]
e-mail [email protected]
www.bluex.it
IntraOs 70 X-ray Equipment
Operator’s Manual – English Edition USA
Version 3.2 December2006
Printed 04/12/2006 11:20 AM
Code 69 500 01110
Blue X Imaging is committed to Total Quality.
Thank you for notifying us any error found in this document.

IntraOs 70 – Operator’s Manual
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1. Introduction ...................................................................................4
1.1 Congratulations......................................................................4
1.2 Purpose ..................................................................................4
1.3 Equipment Classification.......................................................4
1.4 Applicable Standards.............................................................4
1.5 Obligation of the Installer......................................................5
1.6 Obligation of the User ...........................................................5
1.7 Warning .................................................................................5
2. Technical Data...............................................................................6
2.1 Tube-Head G .........................................................................6
2.2 Beam Limiting Device ..........................................................7
2.3 Mechanical System................................................................7
2.4 Weights..................................................................................8
2.5 AutoSet Timer .......................................................................9
3. Operating instructions .................................................................10
3.1 Demonstration .....................................................................10
3.2 Beam Limiting Device ........................................................10
3.3 AutoSet Timer .....................................................................10
3.4 Operation .............................................................................14
3.5 Safety...................................................................................15
3.6 Cleaning...............................................................................15
3.7 Disinfecting .........................................................................16
3.8 Functional Check.................................................................16
4. Disposing of obsolete equipment ................................................16
Appendix A System Components .......................................................17
Appendix B Icons................................................................................18
Appendix C Exposure Table ...............................................................19
Appendix D Alarm Conditions............................................................20
Appendix E Identification Labels........................................................21
Appendix F Cooling Curves................................................................22
Table of Contents

IntraOs 70 – Operator’s Manual
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1. INTRODUCTION
1.1 Congratulations
Congratulations! You have purchased a state of the art equipment
which will assist in your profession day after day performing
consistently for many years.
The unit is manufactured under a Quality Control System which grants
full compliance to specifications.
1.2 Purpose
The IntraOs 70 X-ray Equipment is design to fulfil the needs for intra-
oral radiography in the general dental practice.
The system can be configured for wall, unit or
mobile solutions and different types of timers
and tube-heads.
The features of the system make it easy to use,
and grant long life with minimum maintenance.
1.3 Equipment Classification
•FDA: IntraOs 70 is a Class II equipment (21 CFR 872-1800).
•IEC: IntraOs 70 is a Class I, type B equipment
1.4 Applicable Standards
The IntraOs 70 system configurations, all equipped with the AutoSet
timer, comply with the following standards.
IEC 601-1 General requirements for safety
IEC 601-1-2 Electromagnetic compatibility
IEC 601-1-3 General requirements for radiation protection in
diagnostic X-ray equipment
IEC 601-2-7 Particular requirements for the safety of high voltage
generators of diagnostic X-ray generators
IEC 601-2-28 Particular requirements for the safety of X-ray source
assemblies and X-ray tube assemblies for medical
diagnosis
21 CFR 1020.30 Diagnostic x-ray systems and their major components
21 CFR 1020.31 Radiographic equipment

IntraOs 70 – Operator’s Manual
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1.5 Obligation of the Installer
Obligation of the Installer is:
•To make sure that the line voltage specified be the
Manufacturer of the equipment is available and within the
specified range.
•For safety reasons verify that a proper switch is
available to disconnect from line voltage supply when needed
during installation
•To install and test the equipment with due diligence according to
the installation instructions from the Manufacturer.
•To provide this Operator’s Manual to the User.
1.6 Obligation of the User
It is the responsibility of the User:
•To use the system following the instructions and recommendations
contained in this Operator’s Manual.
•To maintain the equipment in compliance by following the
manufacturer’s recommended maintenance schedule. Failure of the
user to properly maintain the equipment may relieve the
Manufacturer, or his Agent, from responsibility for any injury,
damage, or non-compliance which may result.
•To report promptly to the Health Authority in charge and to the
Manufacturer or to its Agent any accident involving this medical
device or any alteration in features and/or performances which
could cause death, injuries or health hazard to Patient and/or
Operator.
Important information to be gathered and to be included in the
report to the Manufacturer are the type and serial numbers of the
involved items which can be retrieved from the technical labels.
1.7 Warning
X-ray equipment produce ionising radiation that may be
harmful if not properly controlled.
It is therefore recommended that the equipment be operated
by trained personnel only, in accordance with existing law.