Remedi Portable Dental X-Ray Device

REMEX-T (K) 100 Portable X-Ray Equipment

The REMEX-T (K) 100 Portable X-ray Equipment is designed for use by trained dentists and dental technicians as an extra-oral x-ray source to produce diagnostic x-ray images using intra-oral imaging. It is intended for use on adults, children, and pregnant women.

Responsibilities and Compliance:

• The owner/operator is responsible for verifying ongoing compliance with exposure limits, leakage radiation, beam alignment, and calibration of kVp and mA.
• Annual verification may be required by a qualified service technician, as mandated by federal law.
• Compliance with local, state, and federal regulations is the responsibility of the owner/operator.

Cleaning Instructions:

• Ensure the adapter is unplugged before cleaning.
• Ensure the power is off on the REMEX-T (K) 100 during cleaning.
• Use only an alcohol-based disinfectant with a tissue or cloth moistened with liquid or spray.
• The REMEX-T (K) 100 and its adapter must not be subjected to any sterilization procedure.

Specifications:

• Classification: Class IIb (Annex IX, Rule 10, Council Directive 93/42/EEC as amended by Directive 2007/47/EC)
• Model: REMEX-T100, REMEX-K100 (model name varies by X-ray tube)
• Electric Shock Protection Type:
  • Class II equipment (Exposure mode)
  • Built-in power supply equipment (Charge mode)
  • Type B Applied part

Power Specifications:

• AC/DC Adapter:
  • Input: 100-240 Vac, 50/60 Hz, 1.5 A
  • Output: 12.6 Vdc, 1.5 A
• Rechargeable Battery:
  • 11.1 Vdc, 1500 mAh
• Power Input: 160 VA (in charging mode)

X-Ray Tube Specifications:

• Tube Voltage: 70 kV (Fixed)
• Tube Current: 2 mA (Constant)
• Exposure Time Range: 0.01 s ~ 1.3 s
• Focal Spot Size: 0.4 mm (conforming to IEC 60336: 1993)
• Natural Filtration: Min. 1.0 mmAl / 0.8 mmAl

Filament Characteristics:

• 1.0 ~ 4.0 V, 2.2 ~ 3.0 A (max filament current)
• 2.0 ~ 3.5 V, 2.2 ~ 3.0 A (max filament current)

Anode Specifications:

• Angle: 12.5°/12.0°
• Thermal Properties: 4.3 kJ / 7.0 kJ
• Maximum Anode Heat Dissipation Rate: 430 W / 560 W

Protection and Operation:

• Water and Particulate Ingress Protection: IPX0
• Mode of Operation: Continuous
  • Recharge time of the high voltage tank is 10 sec.
• Expected Service Life: 5 years

Basic Performance:

• Accuracy of Loading Factors:
  • Tube voltage accuracy: less than 10%
  • Tube current accuracy: less than 20%
  • Irradiation time accuracy: less than 5% + 50 ms
  • Tube current time accuracy: ± (10% +0.2 mAs)
• Repeatability of Radiation Output:
  • Coefficient of variation of measured air kerma values: less than 0.05