Owandy Radiology Ow-RX User Manual
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Owandy Radiology Ow-RX User Manual

Intra-oral x-ray unit
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Ow-RX: User Manual
0051
Version July, 2019 (Rev. 7)

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Summary of Contents for Owandy Radiology Ow-RX

  • Page 1 Ow-RX: User Manual 0051 Version July, 2019 (Rev. 7)
  • Page 3 Release of FW version 1.4 for wireless X-ray button. (Ref. RDM 8416) 14.02.18 14, 17, 22, 33, Modified duty cycle value. 34, 55 Wireless switch conformity update (RED Directive). (Ref. RDM 8668) 07/2019 Removed reference to FCC ID Ow-RX (Rev. 6)
  • Page 4 USER MANUAL Revision history THIS PAGE IS INTENTIONALLY LEFT BLANK Ow-RX (Rev. 6)

  • Page 5: Table Of Contents

    Mobile stand configuration ..............23 5.3.4 Configuration with remote X-ray button ..........24 5.3.5 Configuration with wireless X-ray button ........... 25 TECHNICAL DATA 6.1 Method for measuring the technical factors .......... 29 6.2 Tube characteristic curves ..............30 Ow-RX (Rev. 6)
  • Page 6 10.2 Typical defects caused by incorrect positioning ........64 11. MAINTENANCE No part of this publication may be reproduced, transmitted, transcribed or translated without the prior written consent of the manufacturer. This manual in English is the original version. Ow-RX (Rev. 6)

  • Page 7: Introduction

    The manual may not reflect changes to the product that do not affect operating modes or safety. The Ow-RX intra-oral X-ray unit takes high quality intra-oral X-rays thanks to reduced exposure times and the small dimensions of the focus spot.

  • Page 8: Specification Of The Intended Use

    Federal law restricts this device to sale by or on the order of a dentist, a radiologist or another legally qualified health care professional. 2.1.1 Intended patient population Ow-RX system can be used with the following typology of patient: • Age: pediatric to geriatric •...

  • Page 9: Applied Parts

    USER MANUAL Specification of the intended use Applied parts During normal use, Ow-RX comes in contact with the patient through the collimator front plastic ring, classified as Type B applied part. Ow-RX (Rev. 6)

  • Page 10: Typical Doses Delivered To The Patient During Intraoral Examinations

    Specification of the intended use Typical doses delivered to the patient during intraoral examinations The dose ranges delivered by Ow-RX to the patient during intraoral examinations are given in the table below. The actual value depends on the type of receptor selected (film, digital sensor, phosphor plate) and on the focus-to-skin distance (20 cm without optional collimator cone, 30 cm using optional collimator cone).
  • Page 11 Beam limiting device type Area Ø 5,8 cm standard beam limiting device 26,41 cm 4,5x3,5 cm rectangular beam limiting 15,75 cm device 2,5x3,5 cm rectangular beam limiting 8,75 cm device 2,0x3,0 cm rectangular beam limiting 6,0 cm device Ow-RX (Rev. 6)

  • Page 12: Safety Information

    X-ray generating units. The manufacturer cannot be held responsible for: • use of Ow-RX equipment different from the purpose for which it was originally designed, • damage to the unit, the operator or the patient, caused both by...

  • Page 13: Warnings

    Before performing any maintenance operation, disconnect the unit from the power supply using the provided circuit breaker. Ow-RX is an electro-medical device and therefore it can be used only under the supervision of suitably qualified medical personnel, with the necessary knowledge on X-ray protection.

  • Page 14: Electromagnetic Emissions

    Safety information 3.1.1 Electromagnetic emissions In accordance with the IEC 60601-1-2 standard, Ow-RX is suitable for use in the electromagnetic environment specified below. The customer or user of the system must ensure that it is used in the said environment.

  • Page 15: Electromagnetic Immunity

    Safety information 3.1.2 Electromagnetic immunity In accordance with the IEC 60601-1-2 standard, Ow-RX is suitable for use in the electromagnetic environment described below. The customer or user of the system must ensure that it is used in the said environment.
  • Page 16 EMC environment of use IEC 60601-1-2 level The RF portable and mobile communications units should not be used closer to any part of the Ow-RX, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

  • Page 17: Recommended Separation Distances To Portable And Mobile Radio Equipment

    3.1.3 Recommended separation distances to portable and mobile radio equipment Ow-RX is designed to operate in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the system can help prevent electromagnetic interference by ensuring a minimum distance between mobile and...

  • Page 18: Protection Against Radiation

    Use the specific leaded aprons to reduce the undesired effect of secondary radiations for the patient. NOTE:  In reference to the image receptor used, the operator must consider the presence of residual radiation. Ow-RX (Rev. 6)

  • Page 19: Environmental Risks And Displacement

    Illegal disposal of the product by the holder implies the application of administrative sanctions provided by law Ow-RX (Rev. 6)

  • Page 20: Symbols Used

    USER MANUAL Safety information Symbols used In this manual and on the Ow-RX itself, apart from the symbols indicated on the keypad, also the following icons are used (see Chapter 7): Symbol Description Device with type B applied parts In some of its parts, the device contains materials and liquids that, at...

  • Page 21: Cleaning And Disinfection

    During cleaning operations, make sure that the detergent and/or liquids do not enter inside the unit or remain on the painted surfaces. Parts in contact with the patient's skin To ensure the hygiene of these parts, they should be periodically disinfected with a 2% glutaraldehyde solution. Ow-RX (Rev. 6)

  • Page 22: Description

    USER MANUAL Description DESCRIPTION Identification plates Ow-RX (Rev. 6)
  • Page 23 USER MANUAL Description Ow-RX plate Ow-RX plate for configuration with Wireless X-ray button MET certification plate Tube-head plate DP arm Extension arm WARNING plate plate plate Collimator 30 cm (optional) Wireless X-ray button (optional) plate plate Ow-RX (Rev. 6)

  • Page 24: Functions, Models And Versions

    (sensitivity), the phosphor sensor, the digital sensor or a customised user mode "Custom mode". The Ow-RX X-ray unit has an LCD display with dimensions of 84mm x 45mm (240x128 pixel) which makes it easier for the operator to perform all operations, guaranteeing the immediate and complete display of the exposure parameters.

  • Page 25: High Frequency (Hf) Generator

    RX generator tube to conduct the electric current in one direction only. This generates a "train" of RX impulses. The Ow-RX unit instead uses constant-voltage technology that generates continuous and stable emission of X-rays. This reduces the emission of soft rays, guaranteeing the constancy of the emission parameters, kVp and mA.

  • Page 26: Tube-Head

    One contact signals the status of the unit as operative and ready to be used, the second emits the X-rays. The connection methods and the requirements necessary for the signalling devices are described in the "Service Manual". Ow-RX (Rev. 6)

  • Page 27: Configurations

    USER MANUAL Description Configurations 5.3.1 Standard configuration Figure 1 Tube-head Scissors arm Extension arm Timer X-ray button Ow-RX (Rev. 6)

  • Page 28: Remote Timer Configuration

    Wall support Remote timer X-ray button NOTE:  Verify that, in the radiological room, direct audio and visual communication between operator and patient is always possible. Otherwise, provide proper support (i.e. lead glass or similar, interphone, etc.). Ow-RX (Rev. 6)

  • Page 29: Mobile Stand Configuration

    USER MANUAL Description 5.3.3 Mobile stand configuration Figure 3 Tube-head Scissors arm Stand Timer X-ray button WARNING: The mobile version must be positioned so that the plug disconnection is not difficult. Ow-RX (Rev. 6)

  • Page 30: Configuration With Remote X-Ray Button

    Figure 4 Remote X-ray button (optional) NOTE:  Verify that, in the radiological room, direct audio and visual communication between operator and patient is always possible. Otherwise, provide proper support (i.e. lead glass or similar, interphone, etc.). Ow-RX (Rev. 6)

  • Page 31: Configuration With Wireless X-Ray Button

    Figure 5 Wireless X-ray button (optional) NOTE:  Verify that, in the radiological room, direct audio and visual communication between operator and patient is always possible. Otherwise, provide proper support (i.e. lead glass or similar, interphone, etc.). Ow-RX (Rev. 6)

  • Page 32: Technical Data

    USER MANUAL Technical data TECHNICAL DATA Technical characteristics Equipment Ow-RX Manufacturer OWANDY RADIOLOGY 77183 Croissy-Beaubourg - France Class Class I with type B applied parts (according to EN 60601-1 classification) Protection degree IPX0 standard device Line voltage 99-264 V∼ Rated voltage 110-240 V∼...
  • Page 33 USER MANUAL Technical data Tube-head characteristics Manufacturer Owandy Radiology Rated voltage 60-65-70 kV (selectable) Tubehead power 420 W Total filtration ≥ 2.5 mm Al eq. @ 70 kV HVL (Half value Layers) > 2 mm Al eq. Transformer insulation Oil bath...
  • Page 34 Extension arm 30 cm 1.9 kg Scissors arm with tube-head support 10 kg Timer + wall support 5.05 kg Net weight of the mobile stand 31 kg Timer + mobile stand support 4.7 kg Tube-head 5 kg Ow-RX (Rev. 6)

  • Page 35: Method For Measuring The Technical Factors

    NOTE:  It is recommended to perform annually the technical factors measure according to the local rules, checking that the technical factors accuracy is within the limits given in the technical characteristics. Ow-RX (Rev. 6)

  • Page 36: Tube Characteristic Curves

    USER MANUAL Technical data Tube characteristic curves D-045 Emission & Filament characteristics Load Ow-RX (Rev. 6)
  • Page 37 USER MANUAL Technical data Anode cooling curve Tube-head cooling curve Curva raffreddamento monoblocco Time [min] Ow-RX (Rev. 6)

  • Page 38: Reference Standards

    Safety and Essential Performance. ANSI/AAMI ES60601-1:2005 Medical electrical equipment, Part 1: General requirements for basic safety and essential performance 0051 Guarantees Ow-RX compliance with Directive 93/42 and as amended (subsequent amendments and additions) CFR 21 Code Federal Regulation. Sub Chapter J...

  • Page 39: Reference Standards Related To Wireless Switch (Applicable Only To Configurations With Wireless X-Ray Button)

    Reference standards related to wireless switch (applicable only to configurations with wireless X-ray button) The wireless switch for Ow-RX complies with the following standards: ETSI EN 300 220-2 v.3.1.1 ETSI EN 301 489-3 v.1.6.1 and Final Draft ETSI EN 301 489-3 v.2.1.1...

  • Page 40: Declaration Of Conformity In According To The Red Directive 2014/53/Eu

    Declaration of conformity in according to the RED Directive 2014/53/EU OWANDY Radiology Declare under our sole responsibility that the product: Product name: Wireless switch for Ow-RX Trade name: OWANDY Radiology Type: 7659303200 to which this declaration relates is in conformity with essential requirements and other relevant requirements of the RED Directive 2014/53/EU.

  • Page 41: Dimensions

    USER MANUAL Technical data Dimensions FRONT VIEW Figure 8: Dimensions of the wall version Figure 9: Dimensions of the mobile stand version Ow-RX (Rev. 6)

  • Page 42: General Instructions For Use

    GENERAL INSTRUCTIONS FOR USE Control panel - Description and functions The Ow-RX control panel is divided into function areas, plus a display to view the operative messages and error signals. The following figure shows a general view of the control panel, while details on each functional area are provided in the following pages.
  • Page 43 The following figure shows the LCD display; details of every function area are shown on the following pages. "Tooth anatomic structure" indication "kV values" indication "Patient size" Type of receptor indication indication "Exposure time" "Dose" indication indication Figure 11: LCD display Ow-RX (Rev. 6)

  • Page 44: Tooth Anatomic Selection" Key

    (Lower) (Upper) (Rear) (Front) 7.1.2 “Increase/Decrease” key The "Increase" or "Decrease" keys are used to scroll the different selections in the menus or to manually change the exposure times. Ow-RX (Rev. 6)

  • Page 45: Select Size" Key

    Also in this case the exposure times will change. An acoustic signal is emitted each time a key is pressed and the selected size will be displayed. Ow-RX (Rev. 6)

  • Page 46: Function" Key (Selection Of Receptor, Cone Presence And Kv Value)

    If the cone is not present, the relative icon will not appear on the display. 6. The value of kV applied to the tube will start to flash. 7. Use the "Increase" and "Decrease" keys to select the required value (60 kV / 65 kV / 70 kV). Ow-RX (Rev. 6)
  • Page 47 As the setting menu is cyclic, it will return to point 1 (receptor type selection). 9. To exit the setting menu, hold down the "Function" key for approx. 2 s. The system will return to the ready for X-ray state. Ow-RX (Rev. 6)

  • Page 48: System Use

    "woken up" by pressing any key (except for the X-ray button). Similarly, switching off occurs when the system is switched off by pressing the power switch located on the right side of the timer cover. The LEDs and the display will turn off. Ow-RX (Rev. 6)

  • Page 49: Programmed/Manual Exposure

    With the programmed (anatomic) selection, it is possible to select the type of receptor used (different types of film, phosphor and digital sensors), the size of the patient and the kV value. Ow-RX (Rev. 6)

  • Page 50: Performing A Programmed Exposure

     These values are related to film type F. The Ow-RX system can be programmed to use film with different sensitivity levels; the programmed times vary depending on the film's multiplicative factor. It is possible to request this setting from the technician during installation.
  • Page 51 It is appropriate that the user adapts the pre-set exposure times according to local regulatory requirements (if any) and the type of receptor used as described in paragraph 8.3. A service technician is required to reset the default times. Ow-RX (Rev. 6)

  • Page 52: Performing A Manual Exposure

    USER MANUAL System use 8.2.2 Performing a manual exposure Ow-RX makes it possible to work not only using the programmed mode described above, but also using the manual function. To access the manual function, press one of the two keys “Increase”...

  • Page 53: Storing Customised Times

    USER MANUAL System use Storing customised times Ow-RX makes it possible to customise the programmed exposure times in order to adapt them to the user’s actual conditions of use. Proceed as follows to store the customised times: 1. Use the “Increase”...

  • Page 54: Preparing The Tube-Head

    If you want to use the 30 cm extension cone, apply it to the end of the tube-head’s 20 cm cone. WARNING: If the 30 cm extension cone is applied, the pre-set exposure times will be automatically doubled in order to obtain the same radiographic result. Ow-RX (Rev. 6)
  • Page 55 USER MANUAL System use MANDIBLE -15° -15° INCISIVI CANINI incisors canines incisives canines -10° -5° PREMOLARI MOLARI premolars molars prémolaires molaires Figure 12 Ow-RX (Rev. 6)
  • Page 56 USER MANUAL System use MAXILLA +40° +40° INCISIVI CANINI incisors canines incisives canines +30° +20° PREMOLARI MOLARI premolars molars prémolaires molaires Figure 13 Ow-RX (Rev. 6)
  • Page 57 0 ° rc = R A G G IO C E N T R A L E m a i n b e a m ra y o n c e n tra l Figure 15 Ow-RX (Rev. 6)

  • Page 58: Exposure Techniques

    X-ray beam can be correctly measured using the graduated scale located on the tube-head. Figure 16 Legend Figure 16: A – Longitudinal axis of the tooth B – Bisector C – Film surface D – Occlusal surface RC – X-ray beam Ow-RX (Rev. 6)
  • Page 59 (see Figure 17), to prevent an overlapping of structures (see Figure 18). Figure 18 Figure 17 (Incorrect position) (Correct position) Legend Figure 17 and Figure 18 RC – X-ray beam Ow-RX (Rev. 6)

  • Page 60: Parallel Technique

    This technique makes it easier to obtain more accurate and repeatable X-rays than with the bisector technique (see Figure 19 and Figure 20). HORIZONTAL SECTION film Figure 19 VERTICAL SECTION Figure 20 Ow-RX (Rev. 6)

  • Page 61: Exposure With The Supplied X-Ray Button

    6. If the X-ray button was already pressed at the end of the cooling pause, the exposure will be inhibited and the error “E11” will be displayed. NOTE:  All the system statuses are shown on the display during the exposure: preheating, X-ray emission and the cooling pause. Ow-RX (Rev. 6)

  • Page 62: Exposure With The Wireless X-Ray Button (Optional)

    Low battery Very high 2 sequences Replace battery (see of 5 flashes paragraph 8.7.1) Very low battery Very high 4 sequences Replace battery (see of 5 flashes paragraph 8.7.1) Wireless button faulty LED off Contact the technical support Ow-RX (Rev. 6)

  • Page 63: Indication Of The Battery Charge Status And Replacement

    Matching procedure between the remote control and timer The wireless X-ray button will only work with the timer with which it was combined. If for some reason the two devices must be combined again, proceed as described in the Service Manual. Ow-RX (Rev. 6)

  • Page 64: Display Of The Number Of Exposures Made

    With the ready for X-ray status, the user is able to view the number of exposures made by pressing the “Increase” and “Tooth automatic selection” keys at the same time. The number will be shown on the display for approx. 3s. Ow-RX (Rev. 6)

  • Page 65: Error Messages On The Display

    USER MANUAL Error messages on the display ERROR MESSAGES ON THE DISPLAY Ow-RX is fully controlled by a microprocessor which controls the programming of the emission parameters and signals the various conditions of the machine, the possible abnormalities and errors via displayed messages.

  • Page 66: Fatal Errors During X-Ray Emission

    None Protection intervention None Spurious CPU reset None WARNING: If an error message appears and the buzzer sounds, always turn off the system. In any case, the intervention of the back up timer always stops X-ray emission. Ow-RX (Rev. 6)

  • Page 67: Non Fatal Errors

    If E11 is displayed, release the X-ray button; if this has not been pressed, this indicates a fault, therefore call the support service. Ow-RX (Rev. 6)

  • Page 68: Control And Correction Of Any Errors In The Dental X-Rays

    If the film is exposed from the wrong side, the layer of lead will absorb a large quantity of radiation during exposure. The result will be a lighter X-ray and the film will show herringbone shaped marks. Ow-RX (Rev. 6)
  • Page 69 • If the film is left in a hot water bath for too long (for example, overnight), the emulsion may soften and detach partially from the base of the film. After development, the film will appear scratched. Ow-RX (Rev. 6)

  • Page 70: Typical Defects Caused By Incorrect Positioning

    The X-ray beam is not perpendicular to the bisector of the angle formed by the longitudinal axis of the tooth and by the film. X-rays with the top of the tooth elongated • Probably caused by the excessive folding of the film in the patient's mouth. Ow-RX (Rev. 6)

  • Page 71: Maintenance

    Frequency Type of check Annually Correct adjustment of the rotation friction mechanism of the extension arm and of the scissors arm Annually Correct balancing of scissors arm, making proper adjustment when necessary Ow-RX (Rev. 6)
  • Page 72 Cause ..........Maintenance: Date ..... Technician ....Cause ..........Maintenance: Date ..... Technician ....Cause ..........Maintenance: Date ..... Technician ....Cause ..........Maintenance: Date ..... Technician ....Cause ..........Maintenance: Date ..... Technician ....Cause ..........Ow-RX (Rev. 6)
  • Page 73 USER MANUAL Maintenance Ow-RX (Rev. 6)
  • Page 74 Cod. 6959902203_Rev.6 0051...

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