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GENORAY GIX-1 User Manual

Intraoral imaging system
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Intraoral Imaging System
GIX-1
For Veterinary Only
User Manual
UM-603 CE VET
2022.12.09 Document Ver. 1.4
Copyright 2012 by GENORAY Co., Ltd. All Rights Reserved

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Summary of Contents for GENORAY GIX-1

  • Page 1 Intraoral Imaging System GIX-1 For Veterinary Only User Manual UM-603 CE VET 2022.12.09 Document Ver. 1.4 Copyright 2012 by GENORAY Co., Ltd. All Rights Reserved...

  • Page 3: Preface

    Preface Preface This manual provides information on the introduction and operation of GIX-1 (hereinafter “Product”) and is written based on standard specifications. Some contents may differ depending on the purchased product and specifications, and some contents may be changed without prior notice to improve product performance.

  • Page 4: Copyright

    The copyright and intellectual property rights of all the contents and drawings of this manual are owned by Genoray. Any use, copying, circulation, or distribution without prior written permission from Genoray is strictly prohibited. Copyright 2012 by GENORAY Co., Ltd. All Rights Reserved...

  • Page 5: Table Of Contents

    2. Safety precautions ..................17 2.1) General safety precautions....................17 2.2) Radiation safety precautions ....................18 2.3) Precautions before using ..................... 19 2.4) Precautions when using ....................... 20 2.4.1) Instructions for Cleaning ....................23 2.5) Maintenance ........................25 GIX-1 User Manual 5 / 60...
  • Page 6 Appendix 2. Dose information ..............49 Appendix 3. Calibration ................. 51 A.3.1) Port-X II ..........................51 A.3.2) Port-X III ..........................51 A.3.3) Port-X IV (Port-X IVe, ZEN-PX4, ZEN-PX4e)................56 A.3.4) Other Portable Equipment ....................57 6 / 60 GIX-1 User Manual...

  • Page 7: Overview

    This manual is provided together with shipment of the product. This manual is applicable to the standard product specifications available at the time of shipping. For this reason, some contents herein may be different from features of the product delivered to your company. GIX-1 User Manual 7 / 60...

  • Page 8: 2) Notations In The Manual

    Used to arrange the steps of a task procedure in order. Used to describe the names or details of components in an image. Used to describe the order of actions in an image. 8 / 60 GIX-1 User Manual...

  • Page 9: 3) Warnings In The Manual

    This sign indicates instructions that must be checked by the user. Make sure that the user checks and follows the instructions marked with a “Notice” sign. This sign indicates instructions that must be noted by the user. GIX-1 User Manual 9 / 60...

  • Page 10: 4) Symbols Used In The Manual

    European Directive for Medical Devices 93/42/ EEC as amended by 2007/47/EC Manual as a class IIb device. Authorized Representative Manual in the European community Authorized Representative Label in the Swiss community Manual 10 / 60 GIX-1 User Manual...

  • Page 11: 5) Contents Of The Manual

     Chapter 5. Product Specification Provides the information regarding the standard of the product, its specifications, dimensions, environment of use, etc.  Appendix Provides the information regarding the operation of the product. GIX-1 User Manual 11 / 60...

  • Page 12: Overview Of The Product

    1.2.1) Introduction of the Product This product is an Intraoral Sensor to acquire an image for dentistry developed by Genoray Co., Ltd. This product acquires the images using portable X-ray devices used by dentistry.

  • Page 13: User Information

    1. Overview 1.2.4) User information User classification GENORAY classifies users as follows, depending on the scope of the product operation and use: Type Scope Refers to the users that operate the product to acquire images. Operator Professionals that acquire and review images ...
  • Page 14 1. Overview Training program GENORAY Co., Ltd. takes no responsibility for any damage or accidents caused due to inappropriate operation of the product. Every user should be trained on the usage instruction of the product before using it. The user should contact the manufacturer or the vendor for more information regarding usage training.

  • Page 15: 5) Medical Device Classification And Compliance

    This device is designed and developed in compliance with the following international standards and regulations: Standard IEC / EN 60601-1 IEC / EN 60601-2 IEC / EN IEC / EN 60601-3 IEC / EN 60601-2-45 GIX-1 User Manual 15 / 60...

  • Page 16: 6) Labeling

    1. Overview 1.2.6) Labeling 16 / 60 GIX-1 User Manual...

  • Page 17: Safety Precautions

    Ensure that any accessory or component of the product is not put around  the area of X-ray exposure. This product is not appropriate to be used in a location where there is  flammable anesthetics or oxygen. GIX-1 User Manual 17 / 60...

  • Page 18: Radiation Safety Precautions

    X-ray device can cause danger to both the user and the patient.  When using the product, all users should wear radiation prevention device. Perform exam accurately to prevent additional exams, so that the patient is  not excessively exposed to radiation. 18 / 60 GIX-1 User Manual...

  • Page 19: Precautions Before Using

    When you remove the sanitary cover on the product, be careful not to  damage it. For a defective sanitary cover, replace it with a new one and dispose of the  old one. Wrap the cover around the product as the following picture.  GIX-1 User Manual 19 / 60...

  • Page 20: Precautions When Using

    Water and other liquids must be kept at a distance to avoid penetration of the Product. Liquids may cause corrosion or the Product to short circuit. No protection is offered against liquid penetration. 20 / 60 GIX-1 User Manual...
  • Page 21  Do not let the cable get tangled. Make sure to organize the cable when not using the product.  Be careful not to damage the product while removing it from the positioning product. When the product is in the patient's mouth, let the patient keep looking at the operator. GIX-1 User Manual 21 / 60...
  • Page 22  Falling the product on the floor;  Leaving the product or its cable on the floor; The cable may get tangled with a chair and trip someone while walking;  Pinching the product or its cable. 22 / 60 GIX-1 User Manual...

  • Page 23: 1) Instructions For Cleaning

     Alcohols Isopropyl Alcohol, Methanol SEKUSID-NTM  ECOLAB PARAGERM Laboratories SEKUSEPT EasyTM  ECOLAB PARAGERM Laboratories Forbidden products SEKUSEPT AktivTM  ECOLAB PARAGERM Laboratories  FD333TM DURR DENTAL Laboratories FD322TM  DURR DENTAL Laboratories GIX-1 User Manual 23 / 60...
  • Page 24 If you fail to comply with this instruction, it may lead to the malfunction of the product.  The cover of the product is fragile enough to be damaged by impacts. Do not use improper cleaning tools. 24 / 60 GIX-1 User Manual...

  • Page 25: Maintenance

    Regular maintenance Regular maintenance should be performed according to need and frequency of use. Maintenance should consist of various checks performed by the user or a qualified service technician. GIX-1 User Manual 25 / 60...

  • Page 26: Instructions For Storage

    Keep the cable coiled around two hooks to keep organized. c. Keep the product with the holder on the wall at a new location.  When keeping the product in the box, keep it in the following picture. 26 / 60 GIX-1 User Manual...
  • Page 27  Storing the product in a bag with not enough space;  Leaving the product unattended on a shelf;  Storing several sets of the product with the same hook;  Coiling the cable of the product around only one hook; GIX-1 User Manual 27 / 60...

  • Page 28: 1) Cases Of Breakage Due To User's Negligence

    Cover damage due to user's negligence Trace of impact Trace of crush Deformation and holes Holes and damage Damage due to the use of prohibited Trace of the unapproved holder disinfection methods, such as alcohol, bleach, heat, UV, etc. 28 / 60 GIX-1 User Manual...
  • Page 29 Separation of the cable USB connector damage due to user's negligence Deformation of the connector Separation of the cable Deformation of the connector Deformation of the connector Trace of contact to water Deformation of the connector GIX-1 User Manual 29 / 60...
  • Page 30  It is possible to identify the cause of damage to the interior of the product, the cable, and the connector from the aspect of such damage.  The X-ray test can figure out if the cable and the connector are suitable to use. 30 / 60 GIX-1 User Manual...

  • Page 31: Image Acquisition

    Sanitary cover and cone index are not separately supported.  4. Check the acquired patient image using the software. Edit, transmit, save, and output image as needed. GIX-1 User Manual 31 / 60...
  • Page 32 3. Image Acquisition This page is intentionally left blank. 32 / 60 GIX-1 User Manual...

  • Page 33: Troubleshooting

    This chapter describes how to resolve problems that may occur during use of the product. If the product still does not work properly after taking the following troubleshooting measures, contact GENORAY and follow the instructions of the service manager. 4.1) Solutions for failed image acquisition...
  • Page 34  The ADC offset value of the sensor depends on computer power stability.  For the first time installation, measure the ADC offset without X-ray exposure and the Threshold value is set to a range that allows the sensor to operate properly. EX. Configuration.ini file 34 / 60 GIX-1 User Manual...

  • Page 35: How To Measure Adc Offset And Set Threshold When X-Ray Is Off

    OFF ADC offset is normal  Connect the The GIX-1 will be used with a connection to the hospital PC which supplies the power to it. to the USB port of the PC you want to install and run S11684S11685.exe.
  • Page 36 4. Troubleshooting 3. Change the Acquisition time[s] setting to 10 sec. The default value is 1 second. 4. Press the [Send] button. 36 / 60 GIX-1 User Manual...
  • Page 37 6. The threshold value is set as following guide. Integration Start Threshold is set by adding 5 to the ADC value maximum, Integration End Threshold is set by adding 2 to the ADC Offset value maximum. GIX-1 User Manual 37 / 60...
  • Page 38 4. Troubleshooting 7. If the ADC offset value is output normally, Threshold value can be set as below. The value below is when the ADC offset maximum is 435. 38 / 60 GIX-1 User Manual...
  • Page 39 4. Troubleshooting ADC Offset is abnormal  The ADC offset value of the GIX-1 sensor is affected by the power stability of the connecting computer.  The ADC Offset value can be output as a different value depending on the specific GIX-1 Sensor.
  • Page 40  If the ADC offset value is abnormal, we recommend using USB HUB or USB Repeater.  The figure below shows experimental results that can improve the output pattern of the ADC offset values. 40 / 60 GIX-1 User Manual...
  • Page 41 (active, powered, 5m) USB2.0 428 ~ 438 Power connection is DW-SUBE-5M essentially required. USB filter iSilencer 3.0® 425 ~ 439 Only sensor 417 ~ 447 Simple USB extension Cable mate 421 ~ 441 (1m) USB2.0 AM-AF GIX-1 User Manual 41 / 60...

  • Page 42: In Case Of Image Acquisition Failure During X-Ray Exposure After Raising The Adc Offset Setting From The Default Value

    < When X-ray on ADC offset.  Reason for the the status :  If the X-ray signal, which is irradiated to the GIX-1 sensor through the subject, is too low, the sensor doesn't receive the X-ray signal and cannot capture the moment when the X-ray occurs.

  • Page 43: Specifications

    Sensor plate thickness 5.6 mm GIX-1 Area array size 26 mm x 34 mm PortView Resolution >20-line pair/mm actual Size 2 Dynamic Range 16-bit (0 to 5000) Interface USB 2.0 Cable Length 2.0 m GIX-1 User Manual 43 / 60...
  • Page 44 Sensor plate thickness 5.4 mm Area array size 25.99 mm x 36.00 mm EV71JU213 26.3 lp/mm theoretical, Size 2 Resolution >20-line pair/mm actual Dynamic Range 12-bit (0 to 4095) Interface USB 2.0 Cable Length 3.0 m 44 / 60 GIX-1 User Manual...
  • Page 45 5. Specifications Specification-MTF/DQ  Size 1  Size 2 GIX-1 User Manual 45 / 60...

  • Page 46: Intraoral Sensor Usage Environment

     Relative Humidity: 70 % or less  Atmospheric pressure: 700~1060 hPa (70~106 kPa) To avoid damaging the product's cables and connectors, do not store or use the product near strong heat and fire. 46 / 60 GIX-1 User Manual...

  • Page 47: Appendix 1. Waste Treatment Method

    ● Connectors ● Packaging material Paper ● Plastic ● Disposal When disposing, please observe the disposal regulations and guidelines of each country and region. For more information, please contact the manufacturer or sales company. GIX-1 User Manual 47 / 60...
  • Page 48 Appendix 1. Waste treatment method This page is intentionally left blank. 48 / 60 GIX-1 User Manual...

  • Page 49: Appendix 2. Dose Information

    The condition of the X-ray exposure is the recommended condition of exposure to use the product. The actual condition of exposure can vary depending on the specification of the product or the environment of use. GIX-1 User Manual 49 / 60...
  • Page 50 Appendix 2. Dose information This page is intentionally left blank. 50 / 60 GIX-1 User Manual...

  • Page 51: Appendix 3. Calibration

    1. Install the intraoral sensor and the calibration jig in front of the beam limiting device of the equipment. 2. Configure the X-ray exposure condition for calibration. The exposure condition is as follows: 80 m sec (70 kV, 2 mA is the default).  GIX-1 User Manual 51 / 60...
  • Page 52 Appendix 3. Calibration 3. Run the program window and check Configuration > Sensor Calibration. Configure 4. Click the [Apply] button and close the configuration. 5. Rerun the configuration window and click the Calibration tab. Calibration 52 / 60 GIX-1 User Manual...
  • Page 53 6. When you fill in the Serial Number of the equipment, the [Model Name] and the [Sensor Name] will be populated automatically. Calibration 7. Input the image acquisition count at [Number of images for FFC]. Calibration 10 times of acquisition are recommended for the calibration. GIX-1 User Manual 53 / 60...
  • Page 54 Appendix 3. Calibration 8. When you click the [Set a count] button, the system begins capturing images and the calibration starts automatically. Calibration 9. Click the [Open Calibration Folder] button. Calibration 54 / 60 GIX-1 User Manual...
  • Page 55 Appendix 3. Calibration 10. Check that the FFC files are created and finish the calibration. GIX-1 User Manual 55 / 60...

  • Page 56: A.3.3) Port-X Iv (Port-X Ive, Zen-Px4, Zen-Px4E)

    2. Click the [Menu] > [Configuration] > [Create FFC]. Note that the X-ray is exposed automatically as you create an FFC file. 3. When you click the [Create FFC] button, the FFC feature is performed automatically. 56 / 60 GIX-1 User Manual...

  • Page 57: A.3.4) Other Portable Equipment

    Appendix 3. Calibration A.3.4) Other Portable Equipment Refer to the manual of the corresponding equipment. GIX-1 User Manual 57 / 60...
  • Page 58 Appendix 3. Calibration This page is intentionally left blank. 58 / 60 GIX-1 User Manual...

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