Fona XPan 3D - Technical Description; Equipment Classification and Standards

FONA XPan 3D Operating Instructions
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2. Technical Description
Equipment classification
IEC: Class I, type B equipment
with Class I LASER sources (IEC 60825-1).
CE: medical device listed in class IIb
This product complies with the following standards:
IEC 601-1
General requirements for safety
IEC 601-1-2
Electromagnetic compatibility
IEC 601-1-3
General requirements for radiation protection in diagnostic X-ray
equipment
EN 60601-1-4
Programmable Electrical Medical Systems
IEC 601-2-7
Particular requirements for the safety of high voltage generators of
diagnostic X-ray generators
IEC 601-2-28
Particular requirements for the safety of X-ray source assemblies and X-
ray tube assemblies for medical diagnosis
IEC 60825-1
Safety of laser products. Part 1: Equipment classification, requirements
and user’s guide
CE mark
This product meets the provisions of the European Council Directive
93/42/EEC relating to Medical Devices, and subsequent amendments
and integrations of which in the Directive 2007/47/EC of the European
Parliament and of the Council.
Nominal line voltage:
230 V ± 10%, 115 V ± 10%,
Nominal line frequency
50/60 Hz
Line fuse
8 A slow blow @ 230 V, 16 A slow blow @ 115 V
Mains Resistance
≤ 0.8 ohm at 230 V, ≤ 0.4 ohm at 115 V
Rating
1.25 kW
Curve form of high voltage
High frequency multi-pulse, ripple ≤ 4%
Tube Voltage
61 - 85 kV ± 5%, constant potential
Tube Current
4 - 10 mA ± 10%, direct current (DC)
Focus size
0.5 IEC 336
Inherent Filtration
> 3.0 mm Al @ 85 kV
Focus marking
Dot mark on generator’s cover
Beam size at image receptor
Pan mode: 13 x 0.5 cm +/- 10%
3D mode: 13 x 13 cm
Loading factor for leakage radiation
1.0 mA @ 85 kV
Leakage Radiation
≤ 1 mGy/h
Cool down pause
Variable pause depending on requested tube load
Maximum duty cycle
1/8
Column height
222 cm/87” (holes for wall plate at 210 cm/82.7” from floor)
Maximum height
229 cm/90.2”
Vertical displacement
92 cm/36.2”, da 90 a 182 cm (da 35 a 71.7”)
Vertical Movement
Motorized control with slow and quick motion
Weight
100kg/221lb
Self standing base
Optional on request. Order code 93 600 09000