BRASSELER USA GEM Instructions For Use Manual

Digitial x-ray sensors

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DIGITIAL X-RAY SENSORS

INSTRUCTIONS FOR USE

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Summary of Contents for BRASSELER USA GEM

Page 1 DIGITIAL X-RAY SENSORS INSTRUCTIONS FOR USE...
Page 2: Table Of Contents
Mains Location Prevention of Cross-Contamination Sensor Inspection Disposal X-Ray Generator Settings Proper Care of the Brasseler GEM Digital Sensor System Image Quality Assurance Appendices Appendix A - EMC Information Appendix B - Specifications and Standards Appendix C - Product Symbols...
Page 3: Introduction
PC that the sensor is coupled to via USB connection. No modification of any kind is allowed to the Brasseler GEM Digital Sensor System. Any repair must be performed exclusively by Brasseler or a Brasseler authorized vendor.
Page 4: Device Overview
Proficiency with the Brasseler GEM Digital Sensor System It is critical that all operators of a Brasseler GEM Digital Sensor System read and understand this user guide and become familiar with the Brasseler GEM Digital Sensor System prior to using on patients.
Page 5: Conventions Used In The Manual
Current hardware system requirements are available on the Brasseler website. Technology and system requirements may change. Please consult your IT professional or Brasseler prior to the purchase of new hardware to make sure that it will be compatible with your Brasseler GEM Digital Sensor System.
Page 6: Installing The Brasseler Gem Digital Sensor System
Connect a GEM Sensor 1. Carefully plug the USB end of the GEM sensor cable into the computer’s USB port. Do not use force. Ensure that the plug is properly oriented with the USB port. Try rotating the USB plug if it does not easily insert into the USB port.
Page 7: Safety Considerations
Type BF applied parts and are safe for normal or accidental patient contact during use. Brasseler GEM Digital Sensor System do not have serviceable parts. Do not open the device to service it. All aspects of the sensor that are meant to be attended to by the operator are accessible without opening the internal components of the device.
Page 8: Proper Care Of The Brasseler Gem Digital Sensor System
There is a correlation between the distance of the cone to the sensor and the dose received by the GEM unit. The radiation that reaches the sensor decreases with the square of the distance. If you double the distance, the sensor receives only ¼ of the radiation.
Page 9: Appendix A - Emc Information
IMPORTANT: Portable/mobile radio frequency communications equipment can affect the function of the GEM unit as well as any other electronic medical equipment. This affect may result in image failure or image quality degradation. Brasseler GEM Sensor Systems are USB compliant devices and shall be used with USB compliant cables suitable for high speed/USB 2.0 cables.
Page 10 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The Brasseler GEM Digital Sensor System, used with a compliant computer, is intended for use in the electromagnetic environment specified below. The customer or the user of the Brasseler GEM Sensor System should assure that it is used in such an environment.
Page 11 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The Brasseler GEM Sensor system, used with a compliant computer, is intended for use in the electromagnetic environment specified below. The customer or the user of the Brasseler GEM Sensor system should assure that it is used in such an environment.
Page 12 FI-XRS systems used exceeds the applicable RF compliance level above, the Brasseler GEM Sensor Systems should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Brasseler GEM Sensor System.
Page 13 Recommended separation distances between portable and mobile RF communications equipment and the Brasseler GEM Sensor System The Brasseler GEM Digital Sensor System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the sensor can...
Page 14: Appendix B - Specifications And Standards
Pressure Temperature Usage 30% to 75% 700 hPa to 1060 5° to 30°C Brasseler Gem units are not suitable hPa in altitudes up to be operated in oxygen rich and/or to 3000 meters explosive environments Transportation and Storage 10% to 95% -40°...
Page 15: Appendix C - Product Symbols
APPENDIX C — PRODUCT SYMBOLS Symbol Title of the Reference Standard Fuction/ Description Manufacturer Symbol Number Containing per Standard Interpretation the Symbol Type BF 5333 IEC 60417 To identify a type BF To identify a type BF applied part applied part complying applied part complying with IEC 60601-1 with IEC 60601-1...
Page 16 Date of man- 2497 ISO 7000 To indicate the date on Date of manufacture ufacture which a product was manufactured Distributor 3724 ISO 7000 To identify the distribu- Distributor tor of a product. Catalogue 2493 ISO 7000 To identify the man- Catalogue number number ufacturer’s catalogue...
Page 17 Temperature 0632 ISO 7000 To indicate the max- Temperature limit imum and minimum limitation temperature limits at which the item shall be stored, transported or used This way up 0623 ISO 7000 To indicate correct This end up upright position of the transport package ISO 7000 Stocking Unit...
Page 18: Appendix D - Care Instructions
APPENDIX D - CARE INSTRUCTIONS This section contains the proper handling for the GEM intraoral dental sensors. Failure to follow these care instructions may result in voiding of the Warranty. Handling • Do not use force to pull the sensor out of the USB port it is plugged into. The joint between cable and housing can withstand more the 500 pulling cycles with a pulling force of 30 N.
Page 19: Examples Of Damage/Abuse
Examples of Damage / Abuse Below are examples of typical customer damage Acceptance Levels Acceptance Criteria Acceptance Definitions Target condition As shipped condition, close to Desirable condition perfect Acceptable condition Bite mark 1 – minor Condition is not necessarily perfect Bite mark 2 –...
Page 20 The Cypress Semiconductor Corporation holds the copyright of the USB interface used in these product(s). Language - English is the original language of this user manual. ©2022 Brasseler USA and RealCloud Imaging. All Rights Reserved. REV 0 B-5641B-09.22...