1/6/2024 0 Comments Bluex dentalEven if compliant to specifications of electromagnetic compatibility, it is recommended not to use the equipment in presence of external electromagnetic fields, such as those generated by cellular phones, which might interfere with the electronic circuits of the system. IntraOs 70 Operators Manual 6 Make sure to carefully manoeuvre the suspension arms to position the tube-head in order prevent harm to the fingers in areas where they may be pinched. It is therefore recommended that the equipment be operated by trained personnel only, in accordance with existing law. 1.7 Warning X-ray equipment produce ionising radiation that may be harmful if not properly controlled. 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. 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. 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 maintain the equipment in compliance by following the manufacturers recommended maintenance schedule. 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 Operators Manual. To provide this Operators Manual to the User. 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. 31 Radiographic equipment IntraOs 70 Operators Manual 5 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. 30 Diagnostic x-ray systems and their major components. 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. 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. 1.3 Equipment Classification FDA: IntraOs 70 is a Class II equipment (21 CFR 872-1800). The features of the system make it easy to use, and grant long life with minimum maintenance. The system can be configured for wall, unit or mobile solutions and different types of timers and tube-heads. 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 unit is manufactured under a Quality Control System which grants full compliance to specifications. 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. 19 Appendix D Alarm Conditions.20 Appendix E Identification Labels.21 Appendix F Cooling Curves.22 Table of Contents IntraOs 70 Operators Manual 4 1. 7 2.3 Mechanical System.7 2.4 Weights.8 2.5 AutoSet Timer. Technical Data.6 2.1 Tube-Head G.6 2.2 Beam Limiting Device. 4 1.3 Equipment Classification.4 1.4 Applicable Standards.4 1.5 Obligation of the Installer.5 1.6 Obligation of the User. Thank you for notifying us any error found in this document. Via Mario Idiomi 1/8-33 20090 Assago ITALY tel.+39.0245712171 fax +39.0245703385 e-mail IntraOs 70 X-ray Equipment Operators Manual English Edition USA Version 3.0 June 2006 Printed 12:14 PM Code 0 Blue X Imaging is committed to Total Quality. IntraOs 70 X-ray Equipment Operators Manual Blue X Imaging Srl Via Idiomi 1/8-33 20090 Assago ITALY e-mail IntraOs 70 Operators Manual 2 Blue X Imaging S.r.l.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |