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Eighteeth HyperLight User Manual

Portable dental x-ray unit
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Rx only
Model: HyperLight
Portable Dental X-ray Unit
USER MANUAL
Changzhou Sifary Medical Technology Co.,Ltd.

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  • Page 1 Rx only Model: HyperLight Portable Dental X-ray Unit USER MANUAL Changzhou Sifary Medical Technology Co.,Ltd.
  • Page 2 Version: 01 IFU-7035013 Issued: 2023.12.11 Size:197mmX140mm...

  • Page 3: Table Of Contents

    Content 1. Overview ................... 6 1.1 Content ....................6 1.2 Packing list .................... 7 1.3 Device Lable ..................7 2. Symbols ..................8 3. Foreword ................. 10 3.1 Indication for use ................10 3.2 Contraindications ................10 3.3Intended User Profile ................11 4.
  • Page 4 6.5 Use of exposure function............. 23 Positioning Instructions ..............24 6.6.1 Paralleling technique ............... 24 Bisected angle technique ........... 24 6.6.2 6.6.3 Recommended angle and default exposure time for each tooth type ..................... 26 Ensuring Image Quality ..............28 Dose Area Product (DAP) ............... 28 Essential performance ..............
  • Page 5 13 Operator Training Test Answers ........... 49 14 Service Life ................50 Page 5 / 51...

  • Page 6: Overview

    1 Overview 1. Overview 1.1 Content 1. HyperLight Main Body with backscatter shield 2. Base Holder 3. Power Adapter 4. Power Cord 5. Remote control switch（optional） Page 6 / 51...

  • Page 7: Packing List

    1 Overview 1.2 Packing list HyperLight Main Body Base Holder Power Adapter (1 pc) (1 pc) with backscatter shield (1 pc) Power Cord (1 pc) Remote control switch (optional) 1.3 Device Lable Page 7 / 51...

  • Page 8: Symbols

    2 Symbols 2. Symbols If the instructions are not followed properly, operation WARNING may lead to hazards for the product or the user/patient. Additional information, explanation of operation and NOTE performance. Serial number Type B applied part Alternating current Direct current Dispose of in accordance with the country’s specified procedures Keep dry...
  • Page 9 2 Symbols Medical device Dangerous Voltage: Electrical Shock Hazard Federal law restricts the sale of this device by or on the Rx only order of a dentist Page 9 / 51...

  • Page 10: Foreword

    •The HyperLight is contraindicated in cases where patient/user carry medical implants such as pace makers or cochlear implants etc. • Pregnant women. The medical practitioner must weigh the benefits conferred by use of the device against the potential hazard to the pregnant woman and fetus resulting from radiation exposure.

  • Page 11: Intended User Profile

    3 Foreword diagnostic purposes. 3.3Intended User Profile Considerations Requirement Description Education A licensed dentist or dental hygiene, radiologist and graduates of relevant bachelor’s degree (national qualifications) Knowledge The operator must have understood: 1.treatment and diagnosis of dental disease; 2.terms and guidance of diagnostic medical radiation devices;...
  • Page 12 11. When battery leakage occurs, handle the leakage according to local laws and regulations to avoid environmental pollution. 12. The HyperLight should not be used in environments where flammable materials are present. 13. Do not spray alcohol on the connection interface.
  • Page 13 3 Foreword regulatory compliance) and that Sifary, its agents or representatives, do not accept responsibility for: 1) any injury or danger to personnel from X-ray exposure, 2) image over/under exposure due to poor operating techniques or procedures, 3) equipment not properly serviced or maintained in accordance with instructions contained in this publication.

  • Page 14: Safety Precautions

    4. Safety Precautions 4.1 Radiation Safety The HyperLight was designed to be used in clinical settings (e.g., a dental office) and controlled settings where transportation or use of other X- ray devices might be prohibitive due to the device’s size and/or mobility.
  • Page 15 Standard Title Edition IEC 60601-2-65 Complies with X-ray 2017 equipment for dental intra-oral radiography IEC 60601-2-65:2017 HyperLight A list of protective devices accessories Name Remark Lead sheath Built into the main body Beam Limiting Device Built into the main body...

  • Page 16: Leakage Dose

    4.3 Scatter The significant zone of occupancy for operators has been further verified by internal testing. A HyperLight device was remotely fired into a water phantom（25 X 25 X 10cm）repeatedly, with an ion chamber recording radiation readings in the room, first to establish the vertical significant zone of occupancy and then to establish the horizontal significant zone of occupancy.

  • Page 17: Installation

    5 Installation 5. Installation 5.1 Plug in the charging cable First open the silicone cover, then plug one end of the power adapter into the machine, plug the other end into the power cord, and finally plug the other end of the power cord into the power socket.The charging icon will be displayed on the screen at this time.

  • Page 18: Operation

    6 Operation 6 Operation Position operator inside significant zone of occupancy behind the Hyperlight, and wear radiation safety apron. Collimator cone and backscatter shield are protective devices provided by manufacturer. 6.1 Operation panel instructions Symbol Type Choose adult mode or child mode...

  • Page 19: Power On/Off

    6 Operation 6.2 Power On/Off 6.2.1 Power On 1. First press the power button and then release, then the screen will enter the boot interface. 2. Make sure that the battery level is not lower than the figure below. Battery level 1 6.2.2Screen Lock The screen is automatically locked at startup to prevent unauthorized use.

  • Page 20: Screen Instructions

    6 Operation 6.3 Screen instructions Item Description Bitewing Lower Molar Upper Molar Selects the tooth type. Canine Incisor The machine is locked and Machine lock cannot be exposed. Use the sensor to receive X- Digital Sensor rays Page 20 / 51...
  • Page 21 6 Operation Phosphor Use the Phosphor Plate to Plate receive X-rays Film Use the Film to receive X-rays Indicates remaining battery Remaining level. Battery When the indicator light starts Indicator to red glow, it means the battery needs to be charged. Battery Indicates the battery charger is Charging...

  • Page 22: Settings Interface

    6 Operation 6.4 Settings interface After starting up, you can press the buttons at the same time to enter the setting interface, press the to turn the page, and press the and the to adjust the displayed parameters. Press the button to save your changes and exit settings.

  • Page 23: Use Of Exposure Function

    6 Operation 6.5 Use of exposure function 1. After selecting the exposure time, short press the exposure button to enter the ready state.  During the exposure, keep pressing the exposure button until the exposure is over. During the exposure, if you release the exposure button, the exposure will stop immediately...

  • Page 24: Positioning Instructions

    6 Operation 3. When the screen display is finished, it means that the exposure has been completed. Positioning Instructions 6.6.1 Paralleling technique The sensor is placed in a holder which is used to align the sensor parallel to the long axis of the teeth. 6.6.2 Bisected angle technique The patient holds the sensor in place with his/her finger.
  • Page 25 6 Operation Position the tube head to the patient according to the accepted standard positioning procedures. Page 25 / 51...

  • Page 26: Recommended Angle And Default Exposure Time For Each

    (i.e., higher cancer risk per unit dose of ionizing radiation), so unnecessary radiation exposure is particularly important for pediatric patients. When using HyperLight, consider the patient's age, body size, physical habits, and clinical indications when validating the exposure time Settings.
  • Page 27 6 Operation Upper +30˚ Molar Maxilla: +45˚ Canine Mandible: -20˚ Maxilla: +45˚ Incisor 0.08 Mandible: -25˚ +5˚~ +8˚ Bitewing Lower -5˚ 0.25 Molar Upper Adult +30˚ Molar Maxilla: +45˚ Canine 0.32 Mandible: -20˚ Maxilla: +45˚ Incisor Mandible: -25˚ Phosph or Plate +5˚~ +8˚...

  • Page 28: Ensuring Image Quality

    • DC voltage X-ray generation is efficient in delivering energy at the level optimized for diagnostics, with shorter exposure times required. • The smaller the focal spot, the better the resolution. The HyperLight has a small 0.4 focal spot. As with the suspended tubehead of a conventional wall-mounted X-ray system, some motion of the tubehead during actual exposures is possible.

  • Page 29: Essential Performance

    The HyperLight is factory calibrated and tested prior to release. The following is a detail of the testing equipment, used at the factory, to check conformance of the HyperLight. Using other test instruments may yield differing results. Finally, We will perform performance tests on each machine.MagicMax will be used for performance testing.
  • Page 30 6 Operation Test Acceptance Timer Settings and Corresponding Acceptable Descriptio Limits Ranges 0.05s 0.1s 0.5s Tube 65kV±10% 58.5- 58.5- 58.5- 58.5- 58.5- voltage 71.5 kV 71.5 kV 71.5 kV 71.5 kV 71.5 Timer 0.03- 0.08- 0.475- 0.95- 1.9- 0.02-2s Accuracy 0.07s 0.12s 0.525s...

  • Page 31: Cleaning And Disinfection

    7.1 Foreword The parts for clinical application contamination are the outer surfaces of the HyperLight main body with backscatter shield and base holder. For hygiene and sanitary safety purpose, these components must be cleaned and disinfected between different patients to prevent any contamination. This concerns the first use as well as the subsequent uses.
  • Page 32 The HyperLight main body with backscatter shield, base holder, the power adapter and power cord are not designed to be subjected to any kind of sterilization procedure.  Use any anti-contamination bag that can cover the HyperLight for each patient use to prevent cross-contamination. Page 32 / 51...

  • Page 33: Maintenance

    It is strongly recommended that only authorized Service Representatives, trained specifically on the HyperLight device, maintain and service the device. Annual Maintenance: Observe the following steps for annual maintenance of the HyperLight.

  • Page 34: Troubleshooting

    9 Troubleshooting 9 Troubleshooting When trouble is found, check the following points before contacting your distributor. If none of these are applicable or the trouble is not remedied even after action has been taken, the product may have failed. Contact your distributor.

  • Page 35: Technical Data

    10 Technical Data 10 Technical Data 10.1 Main Body Technical Data Changzhou Sifary Medical Technology Manufacturer Co., Ltd. Model HyperLight Software version HL 1 Package Dimensions 489mm×367.5mm×219mm (±10%) Total Weight 4kg±20% Charger power supply ~100-240V 50/60Hz Power supply Lithium ion battery: 14.8V, 2500mAh ±10% Input AC Current 1.2A max...
  • Page 36 10 Technical Data Apparent resistance of supply ≤2Ω main Intermittent operation Mode of operation ON/60s OFF Use: in enclosed spaces Ambient temperature: 10° C ~ 40° C Ambient conditions Relative humidity: 30%-75% Atmospheric pressure: 70 kPa - 106 kPa Ambient temperature: -20 ° C ~ +55 ° C Transport and storage Relative humidity: 20% - 80 % conditions...

  • Page 37: X-Ray Tube Assembly Specifications And Characteristics

    10 Technical Data 10.2 X-ray Tube Assembly Specifications and Characteristics Filament voltage 2.8-3.4V Maximum filament current Nominal tube voltage 70kV X-ray source assembly 4500J maximum heat content Maximum anode cooling rate 110W Nominal anode input power 600W Target material Tungsten Minimum target angle 12°...
  • Page 38 10 Technical Data ： Page 38 / 51...
  • Page 39 10 Technical Data Page 39 / 51...

  • Page 40: Emc Tables

    11 EMC Tables 11 EMC Tables Guidance and manufacturer’s declaration – electromagnetic emissions HyperLight is intended for use in the electromagnetic environment specified below. HyperLight The customer or the user of the should assure that it is used in such an environment.
  • Page 41 225° , 270° and commercial or hospital Voltage dips, short 315° 315° environment. If the user of interruptions and HyperLight requires voltage variations 0 % UT; 1 cycle 0 % UT; 1 cycle continued operation during on power supply and 70 % UT;...
  • Page 42 11 EMC Tables Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The HyperLight is intended for use in the electromagnetic environment specified below. The customer or user of the HyperLight should ensure that it is used in such an environment. Immunity IEC 60601...
  • Page 43 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The HyperLight is intended for use in the electromagnetic environment specified below. The customer or user of the HyperLight should ensure that it is used in such an environment. Electromagnetic Environment – Immunity...
  • Page 44 Nowadays, many RF wireless equipments have being used in various healthcare locations where medical equipment and/or systems are used. When they are used in close proximity to medical equipment and/or systems, the medical equipment and/or systems’ basic safety HyperLight and essential performance may be affected. The has been tested with the immunity test level in the below table and meet the related requirements of IEC 60601-1- 2:2014.
  • Page 45 5800 217Hz 5785 WARNING Use of accessories and cables other than those specified or provided by the manufacturer HyperLight could result in increased electromagnetic emissions or decreased HyperLight electromagnetic immunity of and result in improper operation. Cable information: Cable Name...

  • Page 46: Operator Training Test

    12 Operator Training Test 12 Operator Training Test 1) A parent must wear a lead apron if they stay in the room when x-rays are taken of their child. a. Yes b. No 2) How is the unit locked and secured when not in use? a.
  • Page 47 Manual 10) Required exposure times typically differ from film to sensor. a. True b. False 11) HyperLight should be inspected at least once per year by a qualified technician. a. True b. False 12) What is the source to skin distance (SSD) in accordance with FDA regulations? a.
  • Page 48 16) If your state department has restrictions for HyperLight, list the restrictions. _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ 17) Any charger that fits the DC port on my HyperLight is compatible. a. True b. False 18) Leaving the HyperLight on the charger will (Improve/Degrade) function of my device.
  • Page 49 13 Operator Training Test Answers 13 Operator Training Test Answers 1. A 2. C 3. A 4. A 5. B 6. A 7. C 8. B 9. B 10. A 11. A 12. A 13. B 14. A or B – depends on each state’s regulation 15.

  • Page 50: Service Life

    14 Service Life 14 Service Life Service Life The service life of HyperLight series products is 5 years. Maintenance MANUFACTURE will provide circuit diagrams, component part lists, descriptions, calibration instructions to assist to SERVICE PERSONNEL in parts repair. Disposal The package should be recycled. Metal parts of the device are disposed as scrap metal.
  • Page 51 Changzhou Sifary Medical Technology Co., Ltd Add: No.99 Qingyang Road, Xuejia County, Xinbei District, 213000 Changzhou, Jiangsu China Tel: +86-0519-85962691 Fax: +86-0519-85962691 Email:Info@sifary.com Web: www.eighteeth.com NOTICE Any serious incident should be reported to manufacturer and competent authority. Page 51 / 51...

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