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Owandy Radiology OWANDY-RX PORTABLE NOXPEN010A User Manual

Portable dental x-ray system
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EN • USER MANUAL
OWANDY-RX PORTABLE
NOXPEN010A • March 2023

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Summary of Contents for Owandy Radiology OWANDY-RX PORTABLE NOXPEN010A

  • Page 1 EN • USER MANUAL OWANDY-RX PORTABLE NOXPEN010A • March 2023...
  • Page 3 Owandy-RX Portable - User’s Manual NOXPEN010A Revision history Manual code NOXPEN010A Rev. Date Page/s Modification description 20.03.2023 Document approval Owandy Radiology SAS...
  • Page 4 Owandy-RX Portable - User’s Manual NOXPEN010A THIS PAGE IS INTENTIONALLY LEFT BLANK Owandy Radiology SAS...

  • Page 5: Table Of Contents

    7.1 >How to enter user option settings ..................46 7.1.1 Buzzer sound setting ....................46 7.1.2 Brightness setting ....................46 7.1.3 Device lock setting ....................47 TROUBLESHOOTING ..................48 8.1 Error and warning messages ....................48 8.2 Troubleshooting ........................49 MAINTENANCE PROCEDURE ................. 50 Owandy Radiology SAS...
  • Page 6 12.2.3 Appendix C characteristics of x-ray tube (ox/70-3) ..........59 12.2.4 Appendix D backscatter shield fastening method ..........61 OWANDY RADIOLOGY SAS has the right to modify products or their specifications to improve performances, quality or producibility Product and its accessories specifications may change without advice.
  • Page 7 Owandy-RX Portable - User’s Manual NOXPEN010A THIS PAGE IS INTENTIONALLY LEFT BLANK Owandy Radiology SAS...
  • Page 9 KEEP THIS OPERATOR’S MANUAL WITH THE EQUIPMENT AT ALL TIMES, AND REVIEW THE IMPORTANT INFORMATION WHENEVER REQUIRED. THE STATISTICS AND SPECIFICATIONS OF THIS UNIT AND MANUAL CAN BE MODIFIED WITH OR WITHOUT NOTIFICATION FOR THE IMPROVEMENT OF PERFORMANCE AND SAFETY. Owandy Radiology SAS...

  • Page 10: Introduction

    FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF PHYSICIAN OR WITH THE DESCRIPTIVE DESIGNATION OF ANY OTHER PRACTITIONER LICENSED BY THE LAW OF THE STATE IN WHICH HE PRACTICES TO USE OF ORDER THE USE OF THE DEVICE. Owandy Radiology SAS...

  • Page 11: Components

    THIS MANUAL CONTAINS IMPORTANT SAFETY INFORMATION. AN UNDERSTANDING OF THIS INFORMATION IS CRITICAL TO THE SAFE OPERATION OF YOUR EQUIPMENT. PLEASE ENSURE THAT YOU READ THE WARNING NOTICES BEFORE USING THE EQUIPMENT NOTE ASSEMBLY INFORMATION: NO ASSEMBLY IS REQUIRED Owandy Radiology SAS...

  • Page 12: Notice Of General Safety And Safe Operation

    OWANDY-RX PORTABLE should be used for the diagnosis, not for the therapy. Do not modify the equipment at your discretion and in case any modification is required unavoidably, ask the help of OWANDY RADIOLOGY or its authorized dealer for the service.
  • Page 13 ASSOCIATED HAZARDS, BUT ASSUMES NO RESPONSIBILITIES FOR AFTER-SALE POERATING AND SAFETY PRACTICES. OWANDY RADIOLOGY ACCEPTS NO RESPONSIBILITY FOR ANY GENERATOR NOT MAINTAINED OR SERVICED ACCORDING TO THE SERVICE MANUAL OR ANY X-RAY SYSTEM THAT HAS BEEN MODIFIED IN ANY WAY.

  • Page 14: Notice Of Safe Battery Use

    Make sure to charge the battery in the external environment from the patient. Make sure to use the battery only provided or approved by OWANDY RADIOLOGY. If non-standard or damaged batteries are used, there is a risk of fire and explosion.
  • Page 15 NOXPEN010A NOTE BATTERIES CAN BE REPLACED BY USERS. WHEN CHARGING THE BATTERY, THE EXPOSURE FUNCTION IS LOCKED. BE SURE TO TURN OFF THE EQUIPMENT WHEN NOT IN USE. THIS HELPS TO ENSURE THE LIFE OF THE BATTERY. Owandy Radiology SAS...

  • Page 16: Radiation Safety

    THIS EQUIPMENT SHOULD BE OPERATED IN THE AREA THAT IS MORE THAN 6 FEET AWAY FROM OTHER PERSONNEL, SUCH AS ASSISTANTS OR OTHER PATIENTS. IF THEY SHOULD STAY CLOSER THAN 6 FEET, IT IS RECOMMENDED THAT THEY WEAR A LEAD APRON, THYROID COLLAR, OR STAY BEHIND A LEAD SHIELD. Owandy Radiology SAS...

  • Page 17: Safety And Specifications

    Main Label of as unsorted municipal waste and must be collected separately. IEC60601-1 Degree of Protection from Electric Shock Main Label TYPE B Equipment Cradle Label, Serial number X-ray Generator Label Owandy Radiology SAS...
  • Page 18 No practical design can incorporate complete protection for operators or service personnel who do not take adequate safety precautions. Service and operating personnel only authorized and properly trained by OWANDY RADIOLOGY should be allowed to work with this X-ray system equipment. The appropriate personnel must be made aware of the inherent dangers associated with the servicing of high voltage equipment and the danger of excessive exposure to X-ray radiation during system operation.

  • Page 19: Composition Label

    This label is attached on the bottom of device. (Example) X-RAY GENERATOR LABEL This label is attached on the bottom of cone of device. (Example) CRADLE LABEL This label is attached on the bottom of cradle. (Example) Owandy Radiology SAS...

  • Page 20: Symbols On The Packing Of Portable Dental X-Ray System

    Owandy-RX Portable - User’s Manual NOXPEN010A 5.2.2 Symbols on the packing of portable dental x-ray system SYMBOL DESCRIPTION Temperature limitation Humidity iimitation Atmospheric pressure limitation Keep dry Fragile, handle with care This side up Recycle Owandy Radiology SAS...

  • Page 21: Applicable Standards And Regulation

    Use conditions: continuous working with intermittent load The products have not been evaluated for use in the presence of flammable anaesthetic mixture with air or nitrous oxide CLASSIFICATION – Regulation (EU) 2017/745 In according with Annex VIII Rule 10: CLASS IIb Owandy Radiology SAS...

  • Page 22: Technical Specification

    MAKE SURE TO USE THE BATTERY ONLY PROVIDED OR APPROVED BY OWANDY RADIOLOGY. USING AN UNAUTHORIZED BATTERY MAY RESULT IN SERIOUS INJURY AND EQUIPMENT DAMAGE. FOR DETAILS ON USING THE BATTERY, SEE ‘3. NOTICE OF SAFE BATTERY USE’ ON PAGE 12 Owandy Radiology SAS...

  • Page 23: Dosimetry Data

    WARNING MAKE SURE TO USE THE BATTERY CHARGER ONLY PROVIDED OR APPROVED BY OWANDY RADIOLOGY. USING AN UNAUTHORIZED BATTERY MAY RESULT IN SERIOUS INJURY AND EQUIPMENT DAMAGE. FOR DETAILS ON USING THE BATTERY, SEE ‘3. NOTICE OF SAFE BATTERY USE’ ON PAGE 12.
  • Page 24 Measuring Equipment (Dose Meter) Piranha R/F 557 (CB2-21030636) DOSE TABLE (70 kV, 3 mA, 0.5 sec, FOV: Ø 60 mm, SSD 200 mm) Exposure Time Dose (μGy) 0.02 53.09 0.05 141.55 289.46 0.15 437.20 584.61 0.25 732.48 879.63 1176.71 1471.88 Owandy Radiology SAS...
  • Page 25 200 mm (8 inches) respectively. When the leakage doses have been measured with each cover type (default, rectangular 2x3, and rectangular 3x4). The raw data about the results are shown in the table below. Owandy Radiology SAS...
  • Page 26 0.00175 90° 0.002007 0.002 0.002002 120° 0.001888 0.001881 0.001884 150° 0.001062 0.00106 0.001061 180° 0.001062 0.00106 0.001061 210° 0.001062 0.001061 0.001062 240° 0.000708 0.000701 0.000703 270° 0.000826 0.000823 0.000824 300° 0.000944 0.000939 0.000942 330° 0.007554 0.00755 0.007553 Owandy Radiology SAS...
  • Page 27 0.0007 90° 0.00071 0.000695 0.000699 120° 0.000355 0.000351 0.000354 150° 0.000592 0.00059 0.000591 180° 0.001065 0.001059 0.001062 210° 0.001893 0.001891 0.001892 240° 0.001183 0.00189 0.001892 270° 0.001301 0.0013 0.001301 300° 0.001538 0.001533 0.001534 330° 0.014314 0.014305 0.014309 Owandy Radiology SAS...
  • Page 28 200 mm (8 inches) respectively. TEST CONDITION Model Name OWANDY-RX PORTABLE X-Ray Generator Model Name EMB-DT703 (X-ray Tube: OX/70-3) Loading Factor 70 kV, 3 mA, 0.5sec Measuring Equipment (Radiation Dosimeter) RTI Scatter Probe (SP1-2111015) Phantom PMMA Phantom Owandy Radiology SAS...
  • Page 29 SHIELD 0° 163.4 146.5 30° 75.53 61.5 60° 99.61 65.51 90° 75.99 77.93 120° 103.9 93.56 150° 88.31 51.46 180° 19.74 26.81 210° 114.1 53.28 240° 95.5 107.0 270° 77.82 97.44 300° 86.15 93.11 330° 57.39 66.41 Owandy Radiology SAS...
  • Page 30 SHIELD 0° 161.7 207.0 30° 100.5 94.36 60° 89.23 95.62 90° 66.63 71.88 120° 94.47 101.2 150° 107.7 81.47 180° 27.16 27.73 210° 43.36 26.93 240° 70.4 70.51 270° 63.21 60.7 300° 68.23 68.12 330° 64.35 54.54 Owandy Radiology SAS...
  • Page 31 4.222 90° 15.40 8.101 4.222 120° 24.42 10.61 6.047 150° 26.36 10.95 6.618 180° 4.45 2.282 1.369 210° 28.07 13.12 8.101 240° 23.39 9.584 6.275 270° 16.89 8.215 5.02 300° 15.86 7.302 4.108 330° 11.98 10.61 4.564 Owandy Radiology SAS...
  • Page 32 4.450 90° 14.49 6.047 3.195 120° 22.59 9.356 5.933 150° 29.44 13.12 6.732 180° 5.249 2.624 1.597 210° 13.12 7.302 3.765 240° 20.31 9.014 5.59 270° 12.32 5.134 3.537 300° 16.66 7.531 4.678 330° 13.58 8.672 4.108 Owandy Radiology SAS...

  • Page 33: Mechanical Specification

    Main Body Weight [kg] 1.6 kg X-ray Round Type FOV: Ø 60 Beam Rectangular X-ray Beam Area FOV: 20 x 30, 40, 30 Type [mm] Limiting Device SSD (Source to Skin Distance) [mm] Cradle Dimension (unit: mm) Owandy Radiology SAS...

  • Page 34: System Features

    Micro-computer and a specialized circuit that FND LCD and precisely regulates the exposure technique factors (kV, mA, and exposure time) Pre-programmed exposure time makes the operation fast and easy Failure prevention of equipment by applying cooling time technology Best-in-class X-ray irradiation number Owandy Radiology SAS...

  • Page 35: General View Of Equipment

    Switch Port (and can be used as a service port) Strap Loop Connect the strap Display for the X-ray exposure settings and Control Panel operation conditions Includes the Mono Block (X-ray tube + high-voltage X-ray Generator generator) Owandy Radiology SAS...

  • Page 36: Control Panel

    L & R Adjustment and Move left or right for menu (or mode) selection Movement Exposure Button Rock Indicates the X-ray irradiation button is locked Indicator Indicates that user have entered the user option User Option Setting Indicator settings menu. Owandy Radiology SAS...

  • Page 37: Cradle

    ② The following displays and indicators light up: Sensor mode display Battery charging & level display X-ray exposure time display Patient type display Tooth type display ③ Make sure that at least one battery indicator light before operation. Owandy Radiology SAS...

  • Page 38: Operation Mode

    Press the Enter Button to get into the sensor mode and you can see the sensor mode area flickers. Use the Left & Right Key to select the desired sensor mode and press the Enter Key. SENSOR MODE ICON DR (Digital Radiography) CR (Computed Radiography) FM (Film) Owandy Radiology SAS...
  • Page 39 Press the Enter Button to get into the patient type and you can see the patient type area flickers. Use the Left & Right Key to select the desired patient type and press the Enter Key. SENSOR MODE ICON Adult (Big) Adult (Normal) Child Owandy Radiology SAS...
  • Page 40 Press the Enter Button to get into the tooth type and you can see the tooth type area flickers. Use the Left & Right Key to select the desired tooth type and press the Enter Key. SENSOR MODE ICON Incisor Canine Molar / Premolar Bitewing Owandy Radiology SAS...
  • Page 41 Use the Left & Right Key to adjust the desired the X-ray exposure time and press the Enter Key. The X-ray exposure time can be set in the range of 0.02 to 0.5 sec and adjustment by 0.01 sec step. Owandy Radiology SAS...

  • Page 42: Positioning The Patient

    ③ Place the cone of the portable dental x-ray system head in the area want to take an image. When holding the device, it is recommended to grip the handle by one hand and place the other on the underside of the Exposure Button and the cone as shown in the following figure. Owandy Radiology SAS...

  • Page 43: Positioning Instructions

    The following explains how to orient the angle to obtain the best-possible image from a particular tooth (in an isometrical radiography for instance). Owandy Radiology SAS...
  • Page 44 THE SOFT TISSUES SUCH AS GUMS IN THE PATIENT'S MOUTH. 6.2.4.3 Maxillary incisor The x-ray beam is directed downward at 45°. TEETH ANGLE OF INCLINATION Incisor Maxilla +45° 6.2.4.4 Mandibular incisor The x-ray beam is directed upward at 25°. TEETH ANGLE OF INCLINATION Incisor Mandible -25° Owandy Radiology SAS...
  • Page 45 NOXPEN010A 6.2.4.5 Maxillary canine The x-ray beam is directed downward at 45°. TEETH ANGLE OF INCLINATION Canine Maxilla +45° 6.2.4.6 Mandibular canine The x-ray beam is directed upward at 20°. TEETH ANGLE OF INCLINATION Canine Mandible -20° Owandy Radiology SAS...
  • Page 46 The x-ray beam is directed downward at 30°. TEETH ANGLE OF INCLINATION Molar and Premolar Maxilla +30° 6.2.4.8 mandibular molar and premolar The x-ray beam is directed upward at 5°. TEETH ANGLE OF INCLINATION Molar and Premolar Mandible -5° Owandy Radiology SAS...
  • Page 47 Failure to align the imaging sensor with the exit pattern of the X-ray beam can result in cone-cuts on the radiograph. The cone-cuts are clear areas that are shown on the radiograph when part of the radiograph is not exposed to radiation. Please refer to the following figure as an example of cone-cuts. Owandy Radiology SAS...
  • Page 48 When using the PID, the exit pattern of the X-ray device should be aligned perpendicular to the target receptor as shown in the following figure. NOTE ONCE THE PID IS PROPERLY ALIGNED, INSTRUCT THE PATIENT NOT TO MOVE Owandy Radiology SAS...

  • Page 49: X-Ray Exposure

    The X-ray exposure indicator lights up and audible buzzer sound is occurred.  Keep pressing until the X-ray exposure indicator light out and the audible buzzer sound  is stopped. ICON STATUS Green: Ready Yellow: X-ray On Owandy Radiology SAS...

  • Page 50: Using Battery

    ‘Lbt’ and lightning sign Not display Indicator blinking system Control Panel Normal Normal Brightness CAUTION A BLINKING BATTERY CHARGE INDICATOR MEANS IT NEEDS TO BE CHARGED. THE BATTERY MAY BE DISCHARGED IF LEFT (NOT USED) FOR A LONG TIME. Owandy Radiology SAS...
  • Page 51 NOTE X-RAY EXPOSURE IS NOT POSSIBLE DURING THE BATTERY CHRGING. Owandy Radiology SAS...
  • Page 52 ③ Install the new battery in the reverse order of removal. CAUTION DO NOT PULL EXCESSIVELY ON THE BATTERY CABLE. WORK WITH THE POWER SWITCH TURNED OFF. NOTE BATTERY CAN BE REPLACED BY USERS. IF YOU NEED TO REPLACE THE BATTERY, CONTACT THE SERVICE CENTER OR MANUFACTURER. Owandy Radiology SAS...

  • Page 53: Dimming, Sleep And Power Save Mode

    ① To save the battery, the power save mode is activated when the device is not used for more than 8 hours. ② To return to normal operation from the power save mode, turn off the power switch and turn it on. Owandy Radiology SAS...

  • Page 54: User Setting Options

    ② Select the brightness level (Lv.1 to Lv.3) using the left and right key and press the enter key. ③ Press the enter key and the right key to exit the user option setting mode. ※ Default: ‘Lv.1’ Owandy Radiology SAS...

  • Page 55: Device Lock Setting

    U.L1: X-ray exposure is possible at the lock status. Firstly press the X-ray exposure button at short time, secondly press the X-ray exposure button. You should hold the X-ray exposure button until the X-ray irradiation is complete. Owandy Radiology SAS...

  • Page 56: Troubleshooting

    When the enter key, left key or right key Check the enter key, left key or right key are pressed over 10 sec status Bad connect status with temperature Contact your Service Representative sensor cable Owandy Radiology SAS...

  • Page 57: Troubleshooting

    Decrease the exposure time is too light or completely white The I/O sensor is facing the Reposition the I/O sensor wrong way X-ray emission works, but exposure Exposure time is too short Increase the exposure time is too dark Owandy Radiology SAS...

  • Page 58: Maintenance Procedure

    (S/N) indicated on the device, can provide a rapid service. Maintenance OWANDY RADIOLOGY requires periodic constancy tests to ensure image quality and the safety of the patient and operator. Only OWANDY RADIOLOGY authorized technicians can perform inspection and service of this equipment.

  • Page 59: Maintenance Checklist

    TO CLEAN THE MAIN-BODY AND CRADLE, TURN OFF THE DEVICE AND PULL THE PLUG OUT THE BATTERY CHARGER FROM CRADLE. DO NOT EXPOSE THE DEVICE TO ANY LIQUIDS. DO NOT USE SPRAY CLEANER OR DISINFECTANT DIRECTLY INTO THE DEVICE AS THIS COULD CAUSE A FIRE. Owandy Radiology SAS...

  • Page 60: Disposal Of Waste

    ● PCB Board ● Cable Copper ● Transformer Copper ● Paper ● Packing ● Cardboard ● X-ray Tube ● Battery ● Other parts ● NOTE OBSERVE ALL REGULATIONS RELEVANT TO THE DISPOSAL OF WASTE IN YOUR COUNTRY. Owandy Radiology SAS...

  • Page 61: Quality Warranty

    OWANDY RADIOLOGY Co., Ltd. OWANDY RADIOLOGY Co., Ltd. shall not be liable any incidental or consequential damages arising out of or relating to the use of the product. OWANDY RADIOLOGY Co., Ltd. shall not be liable for any damages or losses occurring after the warranty period.

  • Page 62: Intended Operator And Service Personal Profile

    - Mild reading vision impairment or vision corrected to log MAR 0.2 Permissible - Average degree of aging-related short term memory Minimum impairments impairment - Impaired by 40 % resulting in 60 % of normal hearing at 500 Hz to 2 kHz Owandy Radiology SAS...

  • Page 63: Appendix A Technical Chart

    +/- 6kV contact +/- 6kV contact ceramic tiles. If the discharge (ESD) floor is in a synthetic material, the relative IEC 61000-4-2 +/- 8kV in the air +/- 8kV in the air humidity should be at least 30%. Owandy Radiology SAS...
  • Page 64 The magnetic field in the source the source frequency frequency should be equivalent (50/60Hz) to the those of IEC 61000-4-8 general commercial or hospital settings. Note: The UT is the main AC voltage before the test standards have been applied. Owandy Radiology SAS...
  • Page 65 Note 1: The high-frequency range is applied at 80MHz and 800MHz. Note 2: This guideline does not apply in all situations. Electromagnetic waves may be affected through absorption into and reflection from structures, objects and people. Owandy Radiology SAS...
  • Page 66 (W). Note 1: The high-frequency range is applied at 80MHz and 800MHz. Note 2: This guideline does not apply in all situations. Electromagnetic waves may be affected through absorption into and reflection from structures, objects and people. Owandy Radiology SAS...

  • Page 67: Appendix C Characteristics Of X-Ray Tube (Ox/70-3)

    Owandy-RX Portable - User’s Manual NOXPEN010A 12.2.3 Appendix C characteristics of x-ray tube (ox/70-3) Rating Charts Emission Characteristics Owandy Radiology SAS...
  • Page 68 Owandy-RX Portable - User’s Manual NOXPEN010A Thermal Curves Owandy Radiology SAS...

  • Page 69: Appendix D Backscatter Shield Fastening Method

    ② Remove the collimator and backscatter shield ring as the below picture. as the above ① picture. ③ Fastening backscatter shield and collimator as below picture. Lock the collimator by turning ※ Removing backscatter shield is the reverse of fastening method. Owandy Radiology SAS...
  • Page 70 Owandy-RX Portable User’s Manual – Panoramic image assessment NIMXEN010G Manufacturer: Owandy Radiology Co., Ltd Made by Korea 404, 504, 505Ho, Hanshin IT Tower II, 47, Digital-ro 9-gil, Geumcheon-Gu, Seoul 08511, Korea Obelis S.A Owandy Radiology SAS...
  • Page 71 User’s Manual NIMXEN010D Owandy Radiology SAS...

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