A-3. Summary Of Specifications; Table 15. Specifications - Dentsply Sirona Schick 33 User Manual

A-3. Summary of Specifications

I
TEM
EMC/Safety
Quality
Classification
Mode of Operation
Additional Notes
Supply Voltage
Supply Current
Power
Consumption
Weight
Dimensions
Cable Length
Technology
Pixel Size
Line Pairs
Active Sensor
Area
External
Dimensions
Cable Length
Schick USB Module and Sensors
The system has passed North American Safety Certification and
complies with international EMC, safety, and quality standards below.

Table 15. Specifications

Medical Electrical Equipment – Part 1: General
IEC60601-1:2005
Requirements for basic safety and essential performance
+CORR.1(2006)
+CORR.2(2007)
Medical Electrical Equipment – Part 1-2: General
IEC60601-1- requirements for basic safety and essential performance -
2:2007 Collateral standard: Electromagnetic compatibility
Requirements and tests
UL Standard for Safety Medical Electrical Equipment – Part
UL60601-1 1: General Requirements for Safety – Edition 1, Issued
2003/04/25
Designing, testing and labeling reusable medical devices for
AAMI TIR12:2004 reprocessing in health care facilities: A guide for device
manufacturers
Medical Electrical Equipment – Part 1: General
CAN/CSA C22.2
Requirements for Basic Safety and Essential Performance
No. 60601.1:08
Council Directive of 14/6/ 1993 concerning medical devices
amended by directives 98/79/EC (27/10/98);
93/42/EEC
2000/70/EC(16/10/2000); 2001/104/EC(7/12/2001);
2007/47/EC(5/9/2007)
Class II, Type BF equipment
Not Category AP Equipment
Not Category APG Equipment
Equipment is intended for continuous use
Equipment is not suitable for use in the presence of a Flammable Anesthetic
Mixture with Air or with Oxygen or Nitrous Oxide.
+5V DC (derived for PC USB port)
250 mA (derived for PC USB port)
0.9W
2.4 oz. (68g)
4.26 x 2.45 x 0.95 in. (10.8 x 6.2 x 2.4 cm)
5 m (maximum)
CMOS-APS (Active Pixel Sensor)
15 µm, image acquisition in 15 µm
28 lp (33.3 lp - Nyquist Limiting Frequency)
Size 0 18 x 24 mm
Size 1 20 x 30 mm
Size 2 25.6 x 36 mm
Size 0 23.6 x 31.9 x 7.5 mm
Size 1 25.4 x 38.3 x 7.5 mm
Size2 31.2 x 43.0 x 7.5 mm
2.70 m (maximum)
100003870 Rev. 4
V
ALUE
71