Related Manuals for Eighteeth HyperLight-G
Summary of Contents for Eighteeth HyperLight-G
- Page 1 Model: HyperLight-G Hand-held Dental X-ray System USER MANUAL Changzhou Sifary Medical Technology Co.,Ltd.
- Page 2 2022-03-04 拟制: 拟制日期: 2022-03-04 审核: 审核日期: 2022-04-01 批准: 批准日期: 修改经历 DCR No. 版本号 新增/修改条款号 修改内容 修改日期 CR-2022-70-01 新增 Version: S01 IFU-7035101 Issued: 2021.11.5 Size:197mmX140mm...
-
Page 3: Table Of Contents
Content 1. Overview ............................1.1 Content ................................1.2 Packing list and coding ............................2. Symbol instruction ......................... 3. Foreword ............................3.1 Scope of application ............................3.2 Contraindications ..............................4. Safety Precautions ......................... 4.1Radiation Safety ..............................4.2 Leakage Dose ............................... 5. Installation ............................ 5.1 Plug in the charging cable ........................... -
Page 4: Overview
1 Overview 1. Overview 1.1 Content 1. HyperLight-G Main Body 2. Base Holder (optional) 3. Power Adapter 4. Backscatter Shield (optional) 5. Remote control switch（optional） Page 4 / 42... - Page 5 1 Overview 1.2 Packing list HyperLight-G Main Base Holder (optional) Body (1 pcs) Power Adapter (1 pcs) Remote control switch Backscatter Shield (optional) (optional) 5 / 42 Page...
-
Page 6: Symbol Instruction
2 Symbol Instruction 2. Symbol Instruction 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 WEEE directive Keep dry... - Page 7 2 Symbol Instruction Remote control switch Medical device Dangerous Voltage: Electrical Shock Hazard Page 7 / 42...
-
Page 8: Foreword
3. Foreword 3.1 Scope of application The HyperLight-G Hand-held Dental X-ray System is indicated for use only by a trained and qualified dentist or dental technician for both adult and pediatric subjects as an extraoral diagnostic dental X-ray source to produce X-ray images using intraoral image receptors. - Page 9 11. When battery leakage occurs, handle the leakage according to local laws and regulations to avoid environmental pollution. 12. The HyperLight-G should not be used in environments where flammable cleaning agents are present. 13. Do not spray alcohol on the connection interface.
- Page 10 17. Battery replacement by untrained personnel may cause damage to the machine. Disclaimer: HyperLight-G is sold with the understanding that the user assumes sole responsibility for radiation safety (as well as any state, provincial, or local regulatory compliance) and that Sifary, its agents or representatives, do not...
-
Page 11: Safety Precautions
4. Safety Precautions 4.1 Radiation Safety The HyperLight-G 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 12 Standard Title Edition IEC 60601-2-65 Complies with X-ray 2017 equipment for dental intra-oral radiography IEC 60601-2-65:2017 HyperLight-G A list of protective devices accessories Name Remark Lead sheath Built into the main body Beam Limiting Device Built into the main body...
-
Page 13: Leakage Dose
4.3 Scatter The significant zone of occupancy for operators has been further verified by internal testing. A HyperLight-G 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 14 4 Safety Precautions scatter (zone of occupancy) Permissive Range 65kV 2mA 0.5s < 0.2 mGy/h 14 / 42 Page...
-
Page 15: Installation
5 Installation 5. Installation 5.1 Plug in the charging cable First open the silicone cover, then plug one end of the charger into the machine and the other end into the socket. The charging icon will be displayed on the screen at this time. 5.2 Install backscatter radiation shielding Put the backscatter radiation shielding on the machine. -
Page 16: Operation
6 Operation 6 Operation 6.1 Operation panel instructions Symbol Type Choose adult mode or child mode Choose tooth type Increase exposure time Reduce exposure time Press two buttons at the same time to lock or unlock the machine. Press these two buttons at the same time to change the receiver type. -
Page 17: Poweron/Off
6 Operation 6.2 Power On/Off 6.2.1 Power On 1. First, long press the power button until the screen enters the boot interface. 2. Make sure that the battery level is not lower than the figure below. Battery level 1 6.2.2 Power Off Long press the power button to shut down. -
Page 18: Screen Instructions
6 Operation 6.3 Screen instructions Item Description Digital Sensor or Use the sensor or phosphor Phosphor Plate plate to receive X-rays Film Use the Film to receive X-rays During the exposure process, the finger released the Abnormal exposure exposure button, causing the time exposure to be forcibly terminated. - Page 19 6 Operation Use the power adapter to The battery is low charge the machine. The machine is locked and Machine lock cannot be exposed. Remaining Battery Indicates remaining battery Indicator level. Battery Charging Indicates the battery charger is Indicator connected to the device. Tube Voltage/Current Indicates the tube voltage and Indicator...
-
Page 20: Use Of Exposure Function
6 Operation 6.4 Use of exposure function 1. After selecting the exposure time, short press the exposure button to Warning 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 21: Positioning Instructions
6 Operation 4. When the screen display is finish, it means that the exposure has been completed. Positioning Instructions 6.5.1 Paralleling technique The sensor is placed in a holder which is used to align the sensor parallel to the long axis of the teeth. Page 21 / 42... -
Page 22: Bisected Angle Technique
6 Operation 6.5.2 Bisected angle technique The patient holds the sensor in place with his/her finger. The X-ray beam is directed perpendicularly towards an imaginary line, which bisects the angle between the sensor plane and the long axis of the tooth. Position the tube head to the patient according to the accepted standard positioning procedures. - Page 23 (i.e., higher cancer risk per unit dose of ionizing radiation), so unnecessary radiation exposure is particularly important for pediatric patients. When using HyperLight-G, consider the patient's age, body size, physical habits, and clinical indications when validating the exposure time Settings.
- Page 24 • 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-G has a small 0.7mm 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 25 A duty cycle of 1:30 is required after each X-ray discharge to prevent over-heating damage to the X-ray tube. 6.8 Calibration Checks The HyperLight-G is factory calibrated and tested prior to release . The following is a detail of the testing equipment, used at the factory, to 25 / 42...
- Page 26 6 Operation check conformance of the HyperLight-G. Using other test instruments may yield differing results. Finally, IBA sensors will be used for performance testing. Compare the results with the factory release parameters (indicated in the chart below). For results outside these parameters, discontinue use and contact your dealer/distributor or Sifary.
-
Page 27: Cleaning
7.1 Foreword The parts for clinical application contamination are the outer surfaces of the HyperLight-G main body, 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 28 HyperLight-G plastic prematurely. Never apply sprays or liquids directly on the surfaces of the device. The HyperLight-G main body, base holder, backscatter shield, and the power adapter are not designed to be subjected to any kind of sterilization procedure.
-
Page 29: Maintenance
It is strongly recommended that only authorized Service Representatives, trained specifically on the HyperLight-G device, maintain and service the device. Annual Maintenance: Observe the following steps for annual maintenance of the HyperLight-G. -
Page 30: 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 31: Technical Data
10 Technical Data 10 Technical Data 10.1 Main Body Technical Data Changzhou Sifary Medical Technology Manufacturer Co., Ltd. Model HyperLight-G Software version HLG 1 Total Weight 3.5kg±20% Charger power supply ~100-240V 50/60Hz Power supply Lithium ion battery: 14.8V, 2000mAh ±... - Page 32 10 Technical Data Use: in enclosed spaces Ambient temperature: 10°C ~ 40°C Ambient conditions Relative humidity: 30%-75% Atmospheric pressure: 700hPa ~ 1060hPa Ambient temperature: -20 °C ~ +55 °C Relative humidity: 20% - 80 %, Transport and storage non-condensing at > 40 °C conditions Atmospheric pressure: 70 kPa - 106 32 / 42...
-
Page 33: X-Ray Tube Specifications And Characteristics
10 Technical Data 10.2 X-ray Tube Specifications and Characteristics Filament voltage 3.2-3.9V Maximum filament current 2.8A Nominal tube voltage 70kV X-ray source assembly 7000J maximum heat content Maximum anode cooling rate 130W Nominal anode input power 1000W Target material Tungsten Minimum target angle 16°... - Page 34 10 Technical Data Page 34 / 42...
- Page 35 10 Technical Data Page 35 / 42...
-
Page 36: Emc Tables
11 EMC Tables 11 EMC Tables Guidance and manufacturer’s declaration – electromagnetic emissions HyperLight-G is intended for use in the electromagnetic environment specified below. HyperLight-G The customer or the user of the should assure that it is used in such an environment. - Page 37 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The HyperLight-G is intended for use in the electromagnetic environment specified below. The customer or user of the HyperLight-G should ensure that it is used in such an environment. Immunity IEC 60601 test...
- Page 38 (m). Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The HyperLight-G is intended for use in the electromagnetic environment specified below. The customer or user of the HyperLight-G should ensure that it is used in such an environment. 38 / 42...
- Page 39 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the HyperLight-G device The HyperLight-G is intended for use in the electromagnetic environment in which radiated disturbances are controlled. The customer or user of the HyperLight-G can help prevent...
- Page 40 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz. WARNING Use of accessories and cables other than those specified or provided by the manufacturer HyperLight-G could result in increased electromagnetic emissions or decreased HyperLight-G electromagnetic immunity of and result in improper operation.
-
Page 41: Statement
12 Statement 12 Statement Service Life The service life of HyperLight-G 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 42 12 Statement Changzhou Sifary Medical Technology Co., Ltd Add: No.99, Qingyang Road, Xuejia County, Xinbei District, Changzhou City, 213000 Jiangsu, P. R. China Email: info@sifary.com Web: www.eighteeth.com Page 42 / 42...