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Appendices B & C
MinXray HF70DUL Type A ultra light
High Frequency Portable Dental X-ray unit
Installation and Operating Instructions
Version 2.0
This special purpose portable equipment is for dental radiography only.
It is not designed, nor does it meet, the standards for any other use.
MinXray, Inc.
3611 Commercial Avenue
Northbrook, Illinois 60062-1822
U.S.A.
Tel: 1-847-564-0323
Toll Free Tel: 1-800-221-2245 (U.S. and Canada)
Fax: 1-847-564-9040
Email: service@minxray.com
www.minxray.com
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Summary of Contents for MinXray HF70DUL
- Page 1 Appendices B & C MinXray HF70DUL Type A ultra light High Frequency Portable Dental X-ray unit Installation and Operating Instructions Version 2.0 This special purpose portable equipment is for dental radiography only. It is not designed, nor does it meet, the standards for any other use.
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Page 2: Table Of Contents
TABLE OF CONTENTS Introduction Certifications Recordkeeping Requirements Components Main Parts Warning statements, figures and symbols Installation Instructions Unpacking Assembly Instructions Pre-Operational Required Testing Installation Check list Operating Instructions BL70A Dental Cone Operation Safety Precautions Maintenance Technique Chart Specifications Schematic Diagram X-ray Tube Data Warranty... -
Page 3: Introduction
INTRODUCTION The MinXray model HF70D ultra light is a mono-block type high frequency portable dental x-ray unit. The HF70D can be used with conventional intraoral dental film or with solid-state digital radiographic intraoral sensors. It is supplied in a carrying case containing the x-ray tubehead/control, detachable dental cone (beam limiting device), detachable AC power cord, and detachable exposure cord with 2-stage exposure switch. -
Page 4: Certifications
This apparatus is sold with the understanding that the user assumes sole responsibility for radiation safety and that MinXray, Inc., its agents and representatives, do not accept any responsibility for: Injury or danger to patient or other personnel from x-ray exposure. -
Page 5: Recordkeeping Requirements
The dealer or distributor elects to hold and preserve such information, and to immediately furnish it to MinXray, Inc. when advised by MinXray or Director, Department of Health and Human Services, that such information is required for purposes of Section 359 of the Radiation Control for Health and Safety Act of 1968. - Page 6 TO: ALL MANUFACTURERS AND ASSEMBLERS OF DIAGNOSTIC X- RAY EQUIPMENT SUBJECT : Final Testing of Diagnostic X-ray Systems and Components Following Assembly. This letter is intended to establish HHS policy relative to final testing of a newly-assembled x-ray system or component before release to the user. Manufacturer Responsibility - The FDA believes that plant-based manufacturers must include in their assembly instructions a specific requirement that the assembler perform a test(s) for the applicable requirements of the FDA performance standard at the time of installation.
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Page 7: Components
COMPONENTS 1. X-ray Unit (Model HF70DUL Type A) 1 set 2. Power cord 1 pc. 3. Dental cone (Model BL70A) 1 pc. 4. Hand-held Exposure Switch and Cord 1 pc. 5. Instruction Manual 1 pc. 6. Carrying Case 1 pc. -
Page 8: Main Parts
MAIN PARTS OF MinXray HF70D ultra light Dental cone Angle indicator Backscatter Shield (Optional) Connector for exposure switch Connector for power cord Main power switch Exposure switch and cord Power cord... - Page 9 CONTROL PANEL 1. X-ray Indicator 6. kV Adjustment Button (-) 2. Ready Indicator 7. kV Adjustment Button (+) 3. Error Indicator 8. Exposure Time Adjustment Button (+) 4. kV Indicator 9. Exposure Time Adjustment Button (-) 5.
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Page 10: Warning Statements, Figures And Symbols
Warning statements, figures and symbols WARNING THIS X-RAY UNIT MAY BE DANGEROUS TO PATIENT & OPERATOR UNLESS SAFE EXPOSURE FACTORS & OPERATING INSTRUCTIONS ARE OBSERVED DANGER : HIGH VOLTAGE. NO USER SERVICEABLE COMPONENTS INSIDE. REFER SERVICE TO QUALIFIED SERVICE TECHNICIAN. FOR CONTINUED PROTECTION AGAINST HAZARDOUS CONDITION,... -
Page 11: Installation Instructions
INSTALLATION INSTRUCTIONS Unpacking The MinXray HF70D ultra light portable x-ray unit consists of an x-ray tubehead and control, mounting handle, dental cone, backscatter shield, exposure cord, power cord, and carrying case. If a stand is purchased with the HF70D, instructions for its assembly are included with the stand. -
Page 12: Pre-Operational Required Testing
3. Carefully screw the dental cone into the cone holder on the front of the HF70D. Avoid cross-threading the cone when attaching it to the HF70D. NEVER OPERATE THE HF70D UNLESS THE DENTAL CONE IS ATTACHED. 4. If the optional BSS Back Scatter Shield was purchased for use with your HF70D, slide it onto the open end of the dental cone after you attach the cone to the x-ray unit before use. - Page 13 4. Make exposure and read the measured value of exposure time on the NERO. 5. Measure value of exposure time at following settings with same procedure: 0.02, 0.04, 0.10, 0.20, 0.50, and 1.00 sec. 1-2 Instruments: NERO Model 6000M x-ray beam analyzer Manufactured by Victoreen, Inc.
- Page 14 If the peak tube potential needs adjustment: (1) remove the 4 screws on the side of the top cover of the HF70D, and lift the top off of the body of the unit; (2) adjust the potentiometer "VR3" on the printed circuit board M9142 located on top of the lower portion of the unit (see Fig.
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Page 15: Installation Check List
INSTALLATION CHECK LIST HF70DUL Type A INSTALLATION CHECK LIST Fill out this checklist SERIAL NO. when installation is DATE complete. MANUFACTURED EQUIPMENT LOCATION TEST ACCEPTANCE RESULTS CHECK DESCRIPTION LIMITS Line Voltage 110~130 V ……….V NO GO Line Voltage ≤ 4.8% ………..%... -
Page 16: Bl70A Dental Cone
CHECK: Confirm that there are no cracks or chips on the dental cone. If there are any cracks or chips on the dental cone, replace it with a new, intact cone. NEVER OPERATE THE X- RAY UNIT WITH A DAMAGED DENTAL CONE. MinXray, Inc. 3611 Commercial Avenue Northbrook, Illinois 60062-1822 U.S.A. -
Page 17: Operation
HF70DUL Type A OPERATION INSTRUCTIONS Operation 1. Connect the AC power cord to a grounded electrical outlet. Check the label on the HF70D for the correct AC input voltage and amperage required. 2. Turn on the main power switch on the HF70D. The kV and sec LED displays will light and remain on. -
Page 18: Safety Precautions
Please keep this equipment away from likely sources of RF radiation. If the operator is hand holding the HF70DUL Type A during exposure, the operator must wear lead gloves, a lead apron, and a monitoring dosimeter. Only use model BL70A dental cone (beam limiting device) for hand held use. -
Page 19: Maintenance
If ERROR INDICATOR is lit even after the EXPOSURE SWITCH is released, it means an unusual situation has occurred. Turn off the MAIN POWER SWITCH, wait 3 minutes, then start procedures over again. If the ERROR INDICATOR remains on, contact your dealer or MinXray for service. - Page 20 Every 2 years Radiation leakage should be measured by qualified service personnel. If leakage radiation at 1 meter is > 10 mR/h, contact MinXray Technical Service department for assistance. Follow these steps to take these measurements: Set ion chamber of the x-ray dosemeter at a distance of 1 meter from the HF70D at...
- Page 21 Calculate the leakage radiation mR/hour = ( raw output reading ) mR × 3600 × ( duty cycle )1 / 60 If this HF70DUL Type A is to be hand held in use, then the following additional measurements of radiation leakage should be taken every 2 years.
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Page 22: Technique Chart
MinXray HF70D ultra light High Frequency Portable Dental X-ray Unit Output setting: 65 kVDC @ 10mA Patient size: Adult Source-Image Distance: 8’’ Exposure times (sec.) Exposure time (sec.) Angle (degrees) Direct radiography D speed film Maxillary Molars 0.08 0.24 Bicuspids 0.08... -
Page 23: Specifications
MinXray HF70DUL Type A ultra light SPECIFICATIONS Rating Line Voltage AC, single-phase, 120V, 50/60Hz Line voltage regulation 4.8% Input current Stand by: 0.165A Momentary: 14.5A Maximum output power 70kVDC, 10mA Protection against electrical shock Type B, Class I Mode of operation... - Page 24 WITH GROUND PIN Stand Fits MinXray X100S tripod Environmental conditions for transport and storage Ambient temperature range -40℃ 70℃ Relative humidity range(including condensation) 100% Atmospheric pressure range 500hPa 1060hPa The MinXray HF70D is compatible with all radiographic imaging modalities, including digital.
- Page 29 HF70DUL Type A TUBE HOUSING COOLING CURVE TIME (MINUTES)
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Page 30: Warranty
The warranty on the beam limiting device is provided solely by its manufacturer. The liability of MinXray, Inc. is limited to repair or replacement of any parts that MinXray determines to be defective. Parts proving defective will be repaired or replaced free of charge, F.O.B.
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