YOSHIDA XP73 - Page 140

MainSpecication
138
Operation Manual
Item Specications
Recommended PC HP Z400 Workstation (Microsoft Windows
®
7 32bit)
RecommendedViewer
TrophyWindows(V6.12.12.0),MEDIADENT(V6),DBSWin(ver.5.2.0)
Apteryx Imageing (ver.3.12), SIDEXIS XG (ver.2.52)
* For equipment with Cephalometric
** For equipment with 3D function
*
1
This product is automatically stopped when the thermal circuit breaker attached to the X-ray tube head
senses the temperature of 60 ±5℃ (140 ±41°F)
*
2
The position of the phantom when CTDI100 is measured is where the rotating center of the arm and the
central axis of the phantom are matched, and the central point of the length of the probe in the phantom at
the direction of the axis and the height of focal point of the Z-ray bulb are matched.
*
3
Add 5kg in case of optional wide base.
*
4
Peak tube potential (Tube voltage) and Tube current are calculated from a reference-voltage signal
(feedback signal) measured at the control PCB by using a digital multimeter. The waveform of the signals
will become stable within 0.1 sec from the beginning of exposure, however response of multimeter needs
few seconds therefore the exposure time during the measurement is set to a time, which is enough to
measureasufcientlystablereference-voltagesignals.
*
5
This product employs a laser and was evaluated to CDRH 21 CFR Parts 1010 and 1040 using additional
allowance of Laser Notice 50 and determined to be a Class 2 Laser Product with Class 2 Laser radiation.
This product complies with the following EMC standards.
IEC 60601-1: 1988/A1: 1991/A2: 1995
IEC 60601-1-2: 2001/A1: 2004
IEC 60601-1-3: 1994
IEC 60601-1-4: 1996/A1: 1999
IEC 60601-1-6: 2004
IEC 60601-1-8: 2006
IEC 60601-2-7: 1998
IEC 60601-2-28: 1993
IEC 60601-2-32: 1994
IEC 60601-2-44: 2001/A1: 2002
IEC 60336: 2005
IEC 61223-3-4: 2000
IEC 61223-3-5: 2004
IEC 60825-1: 2007
IEC 62304: 2006
IEC 62366: 2007
UL 60601-1: 2003
CAN/CSA -C22.2 No. 601-1-M90
This product complies with DHHS 21 CFR Chapter I, Subchapter J at the date of manufacture.
X-era Smart is in conformity with the provisions of Council Directive 93/42/EEC as amended by the Directive
2007/47/EC concerning medical devices.
Performance Standards and European Union Directive 93/42/EEC (Medical Devices Directive).