Emc Tables; Regulatory Certifications; Technical Data - B.A. International Ultimate 1400 Mode D'emploi

12
BA International hereby confirms that the Ultimate 1400 unit complies with the Directive 93/42 EC and the Standards
IEC 60601-1 and IEC 60601.

8.2. EMC Tables

See Annex One

8.3. Regulatory Certifications

93/42/EEC
2002/95/EC
IEC 60601-1
IEC 60601-1-2
ISO 10650-2
EN 62471
IEC 62471

9. Technical Data

This device is provided with 2 batteries. The Ultimate 1400 and battery should not be disposed of in normal domestic
waste. For environmental reasons, please dispose of the device and battery according to local environmental guide-
lines or regulations.
Classification of product Class I, according to rule 12, Council Directive 93/42/EEC
Applied part Type BF
Protection from liquids IP XO
Handpiece
Light source
Wavelength
Average light intensity
Operation
Light guide
Battery
Battery performance
Dimensions
Weight
Charger Station
Input
Capacity
Radiometer
Dimensions
Weight
Ultimate 1400.indd 12
Council Directive 93/42/EEC of Date concerning medical devices amended by Directive
2007/47/EC, annex 1
Restriction of the use of hazardous substances in electrical and electronic equipment
2005 Medical Electrical Equipment (General requirements for basic safety and essential
performance)
2005 – Medical electrical equipment – Part 1-2: General requirements for safety and
essential performance – Collateral standard: Electromagnetic compatibility – Require-
ments and tests
2007 Dentistry – Powered polymerization activators – Part 2: Light-emitting diode (LED)
lamps
2008 Photobiological Safety of Lamps and Lamp Systems
2006 Photobiological Safety of Lamps and Lamp Systems
High power Light Emitting Diode
400-480 nm with peak at 450-455 nm and 415-420 nm
1400 mW/cm
2
Intermittent use, 20 cycles @ 10 sec/3 minute pause
Diameter 8 mm optical fiber (autoclavable @ 134 °C, max. 20 minutes)
Lithium-polymer, rechargeable, 3.7 V, 270 mAh
> 80 cycles @ 10 seconds
Triangular shape; approx. diameter 15.5 mm x length 160 mm with battery inserted
70 gr. (approx.)
6 VDC, < 1 A
Simultaneous automatic charging of 2 batteries with overcharging protection
Built-in, optical indication for light intensity
Length 145 mm x width 60 mm x height 30 mm without battery mounts
170 gr. (approx.)
30.01.15 16:14