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DENTAL X-RAY OPERATOR'S INSTRUCTIONS (for USA) Wall Mount Type....WK WARNING This X-ray equipment may be dangerous to patient and operator unless safe exposure factors, operating instructions and maintenance schedules are observed. CAUTION Federal law restricts this device to sale by or on the order of a dentist.
5-1. According to Section 513 of Federal Food, Drug and Cosmetic Act and 21 CFR Part 806, the BELMONT PHOT-X IIs Model 505 is classified as CLASS II Medical Device. 5-2. According to IEC 60601-1, the BELMONT PHOT-X IIs Model 505 is classified as follows. a. Protection against electric shock : Class I Equipment b.
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6. SYMBOL In this book, on the labels or on the control panel of the PHOT- X IIs Model 505, following symbols are used. Confirm the meaning of each symbol. Date of Instructions (Power) (Power) Manufacture Protection Exposure X-ray Ready Grounding Switch Emission...
[ 2 ] LAYOUT OF CONTROLS ① ⑪ Main Power Switch Image Receptor Selection Switch ② ⑫ Ready Indication is intentionally omitted ③ ⑬ Exposure Time Adjustment Switch (Down) kV Selection Switch ④ ⑭ Exposure Time Adjustment Switch (Up) mA Selection Switch ⑤...
[ 2 ] FUNCTION OF CONTROLS ① Main Power Switch Pushing the upper side of this switch to the ON position energizes the x-ray unit. ② Ready Indication This indication becomes green when the exposure time is set and the line voltage is within operable range (108 ~ 132Vac).
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⑪ Image Receptor Selection Switch To get optimal images the exposure timer adjustment according to the sensitivity of image receptor is important. The PHOT-X IIs has 16 density settings Image Receptor Selection windows for each three kinds of image receptors, i.e. film, digital sensor and phosphor plate.
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⑲ Radiation Dose Indication Estimated air kerma (radiation dose) at distal end of cone can be displayed below the exposure time display window. This value is calculated by kV, mA, exposure time and cone type selected at the moment. The value displayed below the ready indication is sum of estimated air kerma of each exposure after the power switch has been turned on.
[ 4 ] OPERATING PROCEDURES 1. Turn ON the Main Power Switch ①. NOTE : Do not turn on the main power switch while touching the LCD screen, as the touch sensor initializes the sensitivity when the power is turned on. 2.
[ 5 ] SETTING MODE By touching the setting mode switch at bottom left corner, the normal operation mode can be changed to the setting mode or service mode. There are 13 setting modes and each purposes of those settings are as follows. 1.
10. Color of background The default color of the back panel at the normal operation mode is blue. This color can be changed to green or pink. And also there are two patterns for pink. 11. Screen saver setting If the unit is left without being operated and the main power switch is kept on, display will go into screen saver mode.
[ 7 ] DIGITAL IMAGING SYSTEM No x-ray image receptor is integrated into the PHOT-X IIs Model 505 x-ray system. If an image receptor is used with the PHOT-X IIs Model 505, the type and performance of the receptor should be as follows. 1.
[ 9 ] ERROR CODES If an abnormal condition exists in the unit, or a malfunction occurs, an error code, code condition, and the possible solution will be displayed on the LCD screen. Please refer to the table below. Error Condition Step to be Taken Possible Solution...
Maintenance personnel : Qualified dealer service personnel who has the experience with Belmont’s x-ray or has been trained by Belmont. But item 7 - 10 of the maintenance check list on Page 14 should be verified routinely by treatment room personnel.
MAINTENANCE CHECK LIST Parameter Acceptance limit Frequency Procedures when failed OK/NG 1. Line voltage Confirm the line voltage is within Yearly Connect to the power supply 120V±10%. within 120V±10%. Check Also confirm the voltage drop disconnection of wire or during exposure is within 5%. connection failure.
[ 11 ] TECHNICAL DATA (Stationary Anode) or KL11-0.4-70 (See the label on head) (IEC 60366) Nominal focal (D-046), 12 deg (KL11-0.4-70) collimator SSD of cone + 40mm °C °C collimator -15-...
( ) =mm is the Pass Thru Plate Width, if Optional 097PTP is ordered and Housing Side Panels are Removed. 5-5/8" (142) 31-1/2" Max. 46-7/8" (1190) 2-1/4" 3-3/16" (800) Stroke 43-5/16" (1100) (80) (58) Maximum Reach 84-1/8” with 40.0” arm (2122) (1000) 75-5/8”...
[ 14 ] ELECTROMAGNETIC COMPATIBILITY (EMC) This product conforms to EMC standard IEC 60601-1-2:2014+AMD1:2020. 1. Caution to EMC and Compliance with information in attached document Medical electrical equipment requires special attention to EMC and it must be installed and used according to the EMC information provided in this instruction manual.
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IEC 60601 Electromagnetic Immunity test Compliance level environment - test level Proximity magnetic fields should be 134.2 kHz 65 A/m 134.2 kHz 65 A/m Proximity at levels characteristic of a typical Pulse Modulation 2.1 kHz Pulse Modulation 2.1 kHz magnetic field location in a professional healthcare 13.56 MHz 7.5 A/m 13.56 MHz 7.5 A/m...
4. Essential performance Unless the exposure switch is pressed, x-ray is not exposed. If the Essential performance is lost or deteriorated, the device may operate inadvertently and may harm the patient, the operator, and the surrounding people. [ 15 ] DISPOSAL 1.
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NOTE s on of a ara elmont Book No. 1A0 elmont r e omerset ew erse 0 www belmonte u p com Fax.:(732)526-6322 / (800) 280-7504 Printed in Japan 2024-08...
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