FONA XPan 3D Plus
39
13. 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 60601-1:2005
Medical electrical equipment - Part 1: General requirements for basic
safety and essential performance
IEC 60601-1-2:2007
Medical electrical equipment - Part 1-2: General requirements for basic
safety and essential performance - Collateral standard: Electromagnetic
compatibility - Requirements and tests
IEC 60601-1-3:2008
Medical electrical equipment - Part 1-3: General requirements for basic
safety and essential performance - Collateral Standard: Radiation
protection in diagnostic X-ray equipment
IEC 60601-2-63:2012
IEC 60601-1-6:2010
IEC 62366:2007
Medical electrical equipment - Part 2-63: Particular requirements for the
basic safety and essential performance of dental extra-oral X-ray
equipment
Medical electrical equipment - Part 1-6: General requirements for basic
safety and essential performance - Collateral standard: Usability
Medical devices - Application of usability engineering to medical devices
IEC 60825-1:2007
Safety of laser products. Part 1: Equipment classification, requirements
a
nd user’s guide
US FDA 21CFR1020.30
Performance Standards for Ionizing Radiation Emitting Products:
Diagnostic X-ray Systems and their major Components
US FDA 21CFR1020.31
Performance Standards for Ionizing Radiation Emitting Products:
Radiographic Equipment
US FDA 21CFR1040.10
Performance
Standard
for
Light
Emitting
Products:
Laser products
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.
Manufacturer
FONA S.r.l
, via G.Galilei, 11, 20090, Assago (MI)
Nominal line voltage
230 V ± 10%, 115 V ± 10%,
Nominal line frequency
50/60 Hz
Line fuse
T8 A 250V for 230 V version; T16 A 250V for 115 V version
Mains Resistance
≤
0.8 ohm at 230 V,
≤
0.4 ohm at 115 V
Rating
1350 (W or VA)
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 60336
Total Filtration
> 2.5 mm Al/70 kV IEC 60522
Focus marking
Dot mark on generator’s cover
Beam size at image receptor
(theoretical)
Pan mode: 130 x 3.6 mm
2
3D mode: 130 x 130 mm
2
Cephalometric mode: 290x230 mm
2
Loading
factor
for
leakage
radiation
1.25 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
