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hatch X-RAY Operating Manual

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OPERATING MANUAL

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  • Page 1 OPERATING MANUAL...
  • Page 2 HATCH X-RAY Operating Manual Document Number UMN-004627-0-20 Document Revision Rev 01 Publication Language English Part Number 515-004627-0...
  • Page 3 HATCH X-RAY Operating Manual THIS PAGE IS LEFT BLANK INTENTIONALLY...

  • Page 4: Table Of Contents

    2.1. Safety Symbols ....................9 3 KNOW YOUR X-RAY UNIT .................. 11 3.1.  Key Component Identification ...............11 3.2. System Labels ....................12 3.3. Hatch X-Ray Reach Dimensions and Movements ........15 3.4.  Hatch X-Ray Wall mount Configurations ............16 3.5. Keypad Console ................... 20 4 OPERATING THE UNIT ..................23 4.1.
  • Page 5 HATCH X-RAY Operating Manual 6 MAINTENANCE ....................45 6.1. Cleaning and Disinfecting ................45 6.2. Caring for your Equipment ................45 6.3. Shipping and Long Term Storage ..............46 6.4. Preventive Maintenance ................47 6.5. Disposal of the Unit ..................47 6.6.
  • Page 6 Figure 1 : Identification of Wall Mount ................12 Figure 2 : Label Location ....................14 Figure 3 : Wall Mounted Hatch X-Ray Fully Extended Right Side and Top Views ..15 Figure 4 : Wall Mounted Hatch X-Ray Ground Clearance ..........15 Figure 5 : Wall Mounted Hatch X-Ray Vertically Extended .........16 Figure 6 : Hatch X-Ray Keypad Console with LCD Display ........21...
  • Page 7 Table 7 : Default exposure values – Custom modes (All) ..........35 Table 8 : Attention / Warning Messages ...............43 Table 9 : Tube seasoning....................46 Table 10 : Hatch X-Ray Optional Accessories ..............48 Table 11 : Error codes ....................49 Table 12 : Troubleshooting tips ..................50 Table A1 : Tube-Head specifications ................52...

  • Page 8: Introduction

    Hatch X-Ray gives you the highest level of service. 1.2. Indication for Use The Hatch X-Ray High Frequency Intraoral X-Ray is to be used as a source of X-Rays in Dental radiography. Only trained professionals should use this device.

  • Page 9: Included System Components

    Table 1: Hatch X-Ray System Components Wall Mounted Description Part No. Hatch X-Ray X-RAY, FS04,Wall Mount, 15” Extension arm F303-002381-0 Hatch X-Ray X-RAY, FS04,Wall Mount, 24” Extension arm F303-002382-0 Hatch X-Ray X-RAY, FS04,Wall Mount, 33” Extension arm...

  • Page 10: Safety And Precautions

    Make sure to read and understand the safety related instructions. • Make sure not to modify any component of the Hatch X-Ray system. Any modification may result in violation of compliance to the standards. Hatch X-Ray shall not be responsible for any...
  • Page 11 HATCH X-RAY Operating Manual Mains Line Connection. Mains Neutral Connection. X-Ray Emission/ON. Protective earth Mains Earth is required for continued protection against shock hazards. WEEE Symbol Follow proper procedures for disposing this equipment. Cannot be disposed as general waste.

  • Page 12: Know Your X-Ray Unit

    CHAPTER KNOW YOUR X-RAY UNIT 3.1. Key Component Identification As shown in “Figure 1”, Hatch X-Ray is comprised of the following components: 1. Base Unit The Base Unit provides mounting support for the Extension arm and scissor arm with attached tube-head. It provides system power connection and application via the Mains Power Line Cord and the Mains Power ON/OFF Switch.

  • Page 13: System Labels

    HATCH X-RAY Operating Manual Figure 1 : Identification of Wall Mount 3.2. System Labels This section lists the labels that are affixed on the unit. Please refer to “Figure 2” for the location where they are affixed. The mark number is given against each  label below. Label 1 : Base Unit Label Label 2 : Tube Housing Label for focal spot 0.4 Label 3 : Tube Housing Sl. No. Label...
  • Page 14 HATCH X-RAY Operating Manual Label 4 : System Label Label 5 : Hatch X-Ray Logo Label 6 : Angular Tape Label 7 : Extension Cone Label Label 8 : Scissor Arm Label Label 9 : Manufacturer Label Label 10 : Extension Arm Label Label 11 : Base Unit Sl.

  • Page 15: Figure 2 : Label Location

    HATCH X-RAY Operating Manual Label 15 : Radiation Caution Label Label 16 : UDI Label Label 17 : UL Mark Label Label 18 : Input Configuration Label Figure 2 : Label Location...

  • Page 16: Hatch X-Ray Reach Dimensions And Movements

    “Figure 3” to “Figure 5” show minimum and maximum clearances and dimensions for wall mounted. Figure 3 : Wall Mounted Hatch X-Ray Fully Extended Right Side and Top Views Extension Arm Lenght - A Max. Reach to Wall - B 15”(381mm)

  • Page 17: Hatch X-Ray Wall Mount Configurations

    HATCH X-RAY Operating Manual Figure 5 : Wall Mounted Hatch X-Ray Vertically Extended *15”/24”/33” Support Tube. 3.4. Hatch X-Ray Wall mount Configurations Can use Internal Keypad Console and Internal Exposure Switch (Optional) For Configurations 2 - 7 • RJ45-8P8C 35’ Cable: CAT-5 24AWG 4-Twisted Pair 1:1 Connection.
  • Page 18 HATCH X-RAY Operating Manual RJ45 (8P8C) with single door bell switch (optional) Can use both Keypad Consoles (internal and remote) with Internal Exposure Switch and single door bell switch. RJ45 (8P8C) with DOUBLE DOORBELL SWITCH (optional) Can use both Keypad Consoles (internal and remote) with Internal Exposure...
  • Page 19 HATCH X-RAY Operating Manual 3 WIRE WITH SINGLE DOORBELL SWITCH Can use Internal Keypad Console with Internal Exposure Switch and single door bell switch 3 WIRE WITH DOUBLE DOORBELL SWITCH (optional) Can use Internal Keypad Console with Internal Exposure Switch and double...
  • Page 20 HATCH X-RAY Operating Manual RJ11 (6P4C) WITH SINGLE DOORBELL SWITCH Can use Internal Keypad Console with Internal Exposure Switch and single door bell switch RJ11 (6P4C) WITH DOUBLE DOORBELL SWITCH (optional) Can use Internal Keypad Console with Internal Exposure Switch and double...

  • Page 21: Keypad Console

    Single Stud Mounting 3.5. Keypad Console All functional operating control of Hatch X-Ray is provided by the keypad Console located on the base of the unit. Consisting of an LCD display and keypad, it allows both automatic and manual selections of exposure parameters. The location of the panel controls and indicators are shown by “Figure 6”, while the function of...

  • Page 22: Figure 6 : Hatch X-Ray Keypad Console With Lcd Display

    3.5.3. Exposure Switch Controls exposure delivery - When pressed and held delivers exposure as set by desired procedure mode. Figure 6 : Hatch X-Ray Keypad Console with LCD Display Extinguished: Idle / Standby Green: Ready to Deliver X-Ray Exposure Status...
  • Page 23 HATCH X-RAY Operating Manual Selects the exposure preset appropriate MODE Key for the image receptor used. Accepts change in the selected param- SET Key eter. Uses the highlighted item in a list menu. SEL Key Selects the parameter to be modified. Toggles between Adult & Child Preset.

  • Page 24: Operating The Unit

    For young patients, it may be required that a guardian be available near the patient. In such cases, instruct the guardian Children to be on the same side of the X-Ray port; away from the X-Ray beam and behind the tube head. The guardian shall wear radiation protective clothing.

  • Page 25: Achieving The Best Image Quality

    9”(229mm) to 12.20”(310mm) ± 0.2”(5mm). 4.3. Achieving the Best Image Quality Hatch X-Ray is engineered to provide the best platform for dental radiographic imaging. However the best results are obtained when the equipment is used the right way. Practicing the following points will help the user make the best out of the equipment’s output.

  • Page 26: Figure 7 : Horizontal Angulation

    HATCH X-RAY Operating Manual Figure 7 : Horizontal Angulation (M – Molar; P – Pre-Molar; C – Canine) The Image Receptor and holder are not part of supplied accessories. NOTE Image Receptor Holder Using an image receptor holder and head positioning device is recommended since it gives precise control over the area to be imaged.

  • Page 27: Power Turn-On Procedure

    “Figure 14”. 4.5. Hatch X-Ray Operating Procedure Summary 1. Turn on Hatch X-Ray by performing the Power Turn-On Procedure provided in section “4.4”. 2.  Introduce  the  film,  plate  or  sensor  into  the  patient’s  mouth  according  to  the ...

  • Page 28: Exposure Settings And Tables

    By default the keypad console boots into Mode 2, Short cone, Adult, Endodontic, Maxillary Incisor Presets. The default or start-up exposure program is the exposure program set to operate Hatch X-Ray upon power turn-on of the unit. The default exposure program can be changed using the keypad Console by performing the Setting a Preset as the Start-up Mode procedure provided in section “5.4”.

  • Page 29: Exposure Delivery Procedure

    Button on the Doorbell switch to initiate the exposure. Here the unit prepares itself to deliver the exposure. This stage might take a few seconds. Verify that an audible beep occurs and the X-Ray status indication LED illuminates green. Stop or abort an exposure by simply pressing any key other than the Exposure Switch.

  • Page 30: Figure 12 : X-Ray - Results

    HATCH X-RAY Operating Manual Once the exposure is completed (or aborted while delivering), the X-Ray results screen displays the actual values of kV, mA and ms sensed. The Exposure Switch may be released once the X-Ray results screen displays. If the Exposure Switch is continued to be held, the next exposure will not be initiated.

  • Page 31: Table 2 : Default Exposure Values For Short / Long Cone Slow Film - Mode 1

    HATCH X-RAY Operating Manual Reference dose for different loading factors As per R20 chart Time Dose Dose (mS) Meter Meter Anatomy Reading Reading (mR) (mR) Cone Cone Short Long Short Long Bitewing 10.56 30.3 Maxilla 13.65 38.1 Incisors Mandible 10.56 30.3...

  • Page 32: Table 3 : Default Exposure Values For Short / Long Cone Fast Film - Mode 1

    HATCH X-RAY Operating Manual Reference dose for different loading factors As per R20 chart Time Dose Dose (mS) Meter Meter Anatomy Reading Reading (mR) (mR) Cone Cone Short Long Short Long Bitewing 8.49 27.34 Maxilla 10.56 30.3 Incisors Mandible 8.49 27.34...

  • Page 33: Table 4 : Default Exposure Values For Short / Long Cone - Mode 2

    HATCH X-RAY Operating Manual Reference dose for different loading factors As per R20 chart Time Dose Dose (mS) Meter Meter Anatomy Reading Reading (mR) (mR) Cone Cone Short Long Short Long Bitewing 11.93 11.93 Maxilla 10.56 11.93 Incisors Mandible 10.56 10.56...

  • Page 34: Table 5 : Default Exposure Values - Psp (Short Cone)

    HATCH X-RAY Operating Manual Time (mS) Anatomy Short Cone Bitewing Maxilla Incisors Mandible Maxilla Endodontic Canine Mandible Maxilla Molar Mandible Adult Maxilla Incisors Mandible Maxilla Canine Mandible Normal Exposure Maxilla Molar Mandible Maxilla Occlusal Mandible Bitewing Maxilla Incisors Mandible Maxilla...

  • Page 35: Table 6 : Default Exposure Values - Psp (Long Cone)

    HATCH X-RAY Operating Manual Time (mS) Anatomy Long Cone Bitewing Maxilla Incisors Mandible Maxilla Endodontic Canine Mandible Maxilla Molar Mandible Adult Maxilla Incisors Mandible Maxilla Canine Mandible Normal Exposure Maxilla Molar Mandible Maxilla Occlusal Mandible Bitewing Maxilla Incisors Mandible Maxilla...
  • Page 36 HATCH X-RAY Operating Manual Reference dose for different loading As per R20 factors Anatomy chart Time (mS) Dose Meter Reading (mR) Bitewing 19.3 Maxilla 15.97 Incisors Mandible 12.77 Maxilla 19.3 Endodontic Canine Mandible 15.42 Maxilla 33.93 Molar Mandible 19.3 Adult Maxilla 15.97...
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  • Page 38: Using The Control Console

    HATCH X-RAY Operating Manual CHAPTER USING THE CONTROL CONSOLE The keypad Console is the user interface allowing the operator to control the X-Ray system and get feedback from it. This section describes how to use the console to complete specific tasks. As a preface, the stages through which the  console passes before it becomes operable are described first. Power up On power up, the console displays the Start-up Screen as shown on the left.

  • Page 39: Selecting A Pre-Set

    (except History mode) there are 30 pre-sets available. To select one from this 30, use the patient type key and the tooth anatomy keys. E.g. to take X-Ray image of maxillary canine of a child • Repeatedly press the ADULT/CHILD key to select child (bottom LED).

  • Page 40: Modifying Exposure Parameters

    HATCH X-RAY Operating Manual 5.3. Modifying Exposure Parameters The exposure parameters programmed in the console should be suitable for most of the applications. However, they may be modified to fine tune the exposure. The following section explains this procedure. Return to Home Screen (if required) Highlight the parameter Press SEL key to highlight the parameter that needs to be modified.

  • Page 41: Setting The Default Start-Up Mode

    HATCH X-RAY Operating Manual 5.4. Setting the Default Start-up Mode By default the console selects mode 2, adult, and maxillary incisor during start-up. If you wish to select another combination as the default start-up mode, proceed as follows. Return to Home screen.

  • Page 42: Configuring Accessories

    HATCH X-RAY Operating Manual 5.6. Configuring Accessories Depending on the type of film and cone used with the system, the console varies  the exposure duration to ensure proper exposure. Follow the procedure below to change the cone type and film speed used. Return to Home Screen. Press MODE key to enter Mode Selection Screen. Scroll using the UP / DOWN keys to highlight ‘Config  Accessories’ from the list and press SET key.
  • Page 43 HATCH X-RAY Operating Manual Attention/Warning Screen Condition Messages ATTENTION Config Accessories SET key pressed on “Save and return” option No modification made to  without modifying any settings. accessories. ATTENTION Config Accessories Any one of the following keys pressed. Press UP/DOWN to 1) Mode scroll or SET to accept.

  • Page 44: Table 8 : Attention / Warning Messages

    HATCH X-RAY Operating Manual Attention/Warning Screen Condition Messages ATTENTION Parameter Modification  UP / DOWN keys - mS pressed from 200mS mS limited to 200. / 40mS respectively. Use mA < 7 for full 210mS-3500mS options range. Press again to not available when mA is continue.
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  • Page 46: Maintenance

    Use a non-acetone based disinfectant liquid. Cleaning Methods: In order to ensure proper hygiene, especially when protective barriers are not used between each patient, clean and disinfect Hatch X-Ray by thoroughly performing the following procedures: Make sure that the unit is completely dry before plugging in or turning power back on.

  • Page 47: Shipping And Long Term Storage

    HATCH X-RAY Operating Manual • Avoid free swinging of the arms or tube head. Meaning, always guide the movements with your hand. • Do not hang external loads or weights on the tube head or extension arm. The arm and base units are designed for its own weight and may not hold an additional weight.

  • Page 48: Preventive Maintenance

    Hatch X-Ray’ Dealer Service representative. Call your authorized Hatch X-Ray’ dealer for service. Since the interior of the CAUTION unit contains high voltage components, failure to heed this warning may result in equipment damage, personal injury and/or death.

  • Page 49: Optional Accessories

    HATCH X-RAY Operating Manual 6.6. Optional Accessories “Table 10” lists the description and ordering number for accessory components currently available for use with Hatch X-Ray to meet your professional needs. Contact your Hatch X-Ray Dealer for additional information. Description Part No.

  • Page 50: Troubleshooting

    CHAPTER TROUBLESHOOTING Hatch X-Ray has been designed with safety features to protect the patient and operator in case of failure of an electrical component. The system automatically checks for errors and will report a malfunction by means of an error code on the Keypad Console display.

  • Page 51: Table 12 : Troubleshooting Tips

    HATCH X-RAY Operating Manual Listed below provides troubleshooting tips to help the user recover from an equipment fault condition. It lists observed problems as well as recommends the corrective actions.. Observed Problem Recommended Action Switch off mains power. Wait for 2 minutes. Switch on  Error state with mains power.

  • Page 52: Annex A Technical Specifications

    HATCH X-RAY Operating Manual ANNEX TECHNICAL SPECIFICATIONS Tube-Head Specifications High Frequency, Microprocessor Controlled, Generator Type Constant Potential (DC) Control of High Voltage Closed Loop High Voltage Range 60kV – 70kV Settable (Step size 1kV) Accuracy of High Voltage < ± 5% High Voltage Ripple >...

  • Page 53: Figure A-1 : X-Ray Tube Insert Rating Chart-Ox/70-4

    Tube Insert Model OX/70-4 Focal Spot (IEC336) Anode angle 16° Anode material Tungsten Insert Inherent filtration  0.5 mm Al equivalent @ 70 kV Anode thermal capacity 7 kJ Table A2 : X-Ray tube insert specifications Figure A-1 : X-Ray Tube Insert Rating Chart-OX/70-4...

  • Page 54: Figure A-2 : X-Ray Tube Insert Thermal Data-Ox/70-4

    HATCH X-RAY Operating Manual Figure A-2 : X-Ray Tube Insert Thermal data-OX/70-4 Figure A-3 : Heating and cooling curve - Product’s tube inserts-OX/70-4...

  • Page 55: Table A3 : Mechanical Dimensions And Weight

    HATCH X-RAY Operating Manual Mechanical Dimensions and Weight Wall Mount 15” Extension arm - 97 lbs Approx. Total Weight of System (including packing carton) 24” Extension arm - 102 lbs Approx. 33” Extension arm - 107 lbs Approx. Weight of Tube Head 9.4 lbs Approx.

  • Page 56: Table A4 : Mains Power Requirements

    HATCH X-RAY Operating Manual Inrush Current Peak 30 A for 2ms at mains turn on Input Power Factor > 0.9 during any exposure Electrical Classification Class I, Type B Line, Neutral and Earth (Earth is Electrical Connection mandatory), 1-Phase Table A4 : Mains power requirements Environmental Conditions Temperature : +10°C to +40°C...
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  • Page 58: Annex B Declaration Of Conformity

    Medical Device Name: High Frequency Dental X-Ray System Medical Device Model: Hatch X-Ray Device variants: 303-00238X-0 - Hatch X-Ray X-ray with focal spot size 0.4 in wall mount configuration with Extension arm, where X= 1,2,3 B2: Following standards under which conformity is declared ANSI/AAMI ES 60601-1: A1:2012 C1: 2009/(R) 2012 and A2:2010/(R) 2012 IEC 60601 - 1: ED 3.1 (2012)
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  • Page 60: Annex C Guidance And Manufacturer's Declaration

    According to: IEC 60601-1-2: 2014 (4 edition) (Group 1, class A, for use in Hospitals) (Not LIFE-SUPPORTING) Hatch X-Ray is tested as per applicable IEC standards, to be used under electromagnetic environment specified below. The customer or the user of Hatch  X-Ray should assure that it is used in such an environment.
  • Page 61 HATCH X-RAY Operating Manual Guidance and manufacturer’s declaration – Electromagnetic immunity – For all EQUIPMENT and SYSTEMS Electromagnetic EN 60601 test Compliance Immunity test environment - level level guidance Floors should be wood, concrete ±8 kV contact- ±8 kV contact-...

  • Page 62: Table C2 : Guidance And Manufacturer's Declaration - Electromagnetic Immunity - For

    HATCH X-RAY Operating Manual Mains power quality should be that of a typical 0% UT for 0,5 0% UT for 0,5 commercial cycle cycle or hospital At 0°, 45°, 90°, At 0°, 45°, 90°, environment. If Voltage dips, short 135°, 180°, 135°, 180°,...
  • Page 63 - guidance Portable and mobile RF communications equipment should be used no closer to any part of the Hatch X-Ray, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

  • Page 64: Table C3 : Guidance And Manufacturer's Declaration - Electromagnetic Immunity - For All Equipment And Systems That Are Not Life-Supporting

    RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which Hatch X-Ray  is used  exceeds the applicable RF compliance level above, the Hatch X-Ray should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Hatch X-Ray b.
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  • Page 66: Annex D Contact Details

    HATCH X-RAY Operating Manual ANNEX CONTACT DETAILS Hatch GROUP INC 4181 Sladeview Crescent, Unit #36 Hatch X-Ray Mississauga, Ontario, Canada L5L 5R2 Office Number: (905) 997-7171...
  • Page 67 HATCH GROUP INC 4181 Sladeview Crescent Unit # 36, Mississauga, Ontario, Canada L5L 5R2 OPERATING MANUAL; PART NO.: 515-004627-0 REV. 01...

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