Adverse Effects; System Specifications - Ultradent Products Gemini 810 DIODE LASER Mode D'emploi

GENERAL SAFETY CONSIDERATIONS

ADVERSE EFFECTS

If used properly, there are no known adverse effects of using the Gemini 810 + 980 diode laser. Please thoroughly read and understand all warning, precautions, and contra-indications in this manual
prior to use.
EYE AND SKIN PROTECTION
While the Gemini 810 + 980 diode laser is in use, doctors, system operators, auxiliary staff, patients, and anyone in the operatory must wear the appropriate safety eyewear that has been designed for use
with the wavelengths of 800 nm and higher that are associated with lasers. Eye protection must conform to Specification DIN EN207 Annex II of the Directive 89/686/EEC with optical density of OD+5 for
the wavelength range of 800 nm–1000 nm such as NoIR Laser Company filter model CYN.
Nominal Ocular Hazard Distance (NOHD) is the distance from the source of laser emission to the point where it no longer exceeds its Maximum Permissible Exposure (MPE – highest level of laser radiation
to which a person may be exposed without hazardous effects or adverse biological changes in the eyes or skin). The Nominal Hazard Zone (NHZ) is the space within which the level of direct, reflected,
or scattered radiation during normal operation exceeds the appropriate MPEs. The outer limit of the NHZ is equal to the NOHD. The NOHD for persons wearing recommended safety glasses is shown in
Table 1 below.
EMERGENCY SHUTDOWN OPTIONS:
Perform any of these actions to terminate laser emissions in the event of a real or perceived emergency: (Figures: 2.10, 2.3, 2.7, 1.2 (Option: 12))
Press the emergensy "STOP" Button. (Figure: 1.2, Option: 14)
Press the "ON/OFF" button. (Figure: 1.2, Option: 15)
Remote interlock open circuit deactivates the Laser. (Figure: 1.4, Option: 5)
Touch the ACTIVE/STANDBY keypad selection. (Figure: 1.2, Option: 12)
Release your foot from the Activation Pedal. (Figure: 2.7)

SYSTEM SPECIFICATIONS

Gemini 810 + 980 Diode Laser
Dimensions of Laser Unit:
Dimensions of Foot Pedal:
Weight:
Laser classification:
Delivery system:
Wavelength:
Maximum power:
Aiming beam wavelength:
Aiming beam power:
Beam divergence:
Power range:
Pulse frequency:
Pulse width:
Duty cycle:
Voice confirmation:
Power requirements:
Current:
Battery:
Wireless frequency:
Maximum Operating Altitude:
THE GEMINI 810 + 980 DIODE LASER COMPLIES WITH THE FOLLOWING
• IEC 60825-1
• EN/ES 60601-1
10
Table 1: NOHD (INCHES/CM)
RADIATION
SOURCE
FIBER OPTIC TIP
(DIRECT)
6.7" (L) x 6.6" (W) x 10.1" (H) - 17.2 cm (L) x 17.0 cm (W) 25.7 cm (H)
6.1" (L) x 5.0" (W) x 4.1" (H) - 15.5 cm(L) x 12.7 cm (W) 10.4 m (H)
2.2 lbs - 1.0 Kg
Class IV laser device
Optical Fiber
810 nm or 980 nm ± 10 nm
Dual Wavelength ± 10 nm
810 nm @ 2.0 Watts ± 20%
980 nm @ 2.0 Watts ± 20%
Dual Wavelength @ 2.0 Watts ± 20%
650 ± 10 nm
5mW max
383 mrad
0.1 Watt to 2.0 Watts Average
50 Hz
Variable
Variable
YES
100-240 VAC @ 50 to 60 Hz - 13V
4.0 Amps
11.1V Rechargeable Lithium Ion
Bluetooth at 2.4 GHz
5,000 meters or 16,404 feet
• IEC 60601-1-2
• IEC 60601-2-22
MPE mW Without Eye
Divergence
cm 2 Angle Protection
104 in
1.66 22° (+/- 1°)
265 cm
(50% @ 810nm / 50% @ 980nm)
• 21 CFR 1040.10 and 1040.11
• FCC parts 15 and 18 (47 CFR)
With Recom-
mended Eye
Protection
1.04 in
2.65 cm