Regulatory Compliance; Electromagnetic Environment Guidance - Gemini 810 DIODE LASER Manual Del Usuario

SERVICE AND TROUBLESHOOTING
ERROR MESSAGES
An error message will flash where the Power Indicator is normally displayed.
OUTPUT POWER VARIANCE
If you notice an Error code "OP" flashing on the display, it means the laser output power is beyond the 20%
Please restart the laser unit by pressing the ON/OFF button. If problem persists, contact the manufacturer for assistance.
OVERHEATING
The Gemini 810 + 980 diode laser is designed to perform surgical procedures at a specific temperature. High power and long procedures may cause the laser unit to heat
up to the temperature threshold.
Please wait a few minutes for the temperature to descrease before resuming normal operations.
ACTIVATION PEDAL DISCONNECTED
The Gemini 810 + 980 diode laser is equipped with a long range Bluetooth chip.
Please check the two AA batteries in the activation pedal and replace if needed. Press the activation pedal once to reactivate the connection with the laser unit. The
Bluetooth icon on the activation pedal will turn blue, and the Bluetooth symbol will appear on the display, when the laser is in Active mode and the activation pedal is
successfully connected.
DISPLAY FAILURE
If the glass electroluminescent display fails to turn on, there will be an audio warning that says, "Display communication error."
"SOUND"
Please plug the AC/DC power supply into the laser unit and restart the system by pressing the ON/OFF button. If the problem persists, contact the manufacturer for
assistance.

REGULATORY COMPLIANCE

FCC/INDUSTRY CANADA TWO PART STATEMENT
This device complies with FCC Part 15 and Industry Canada license exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device
must accept any interference, including interference that may cause undesired operation of the device.
Le present appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de licence. L'exploitation est autorisée aux deux conditions suivantes: (1) I'appareil ne doit pas
produire de brouillage, et (2) I'utilisateur de I'appareil doit accepter tout brouillage radioélectrique subi, meme si le brouillage est susceptible d'en compromettre le fonctionnement.
PER INDUSTRY CANADA RSS RULES:
This device complies with Health Canada's Safety Code. The installer of this device should ensure that RF radiation is not emitted in excess of Health Canada's requirement.
Information can be obtained at http://www.hc-sc.gc.ca/ewh-semt/pubs/radiation/radio_guide-lignes_direct/index-eng.php
Cet appareil est conforme avec Santé Canada Code de sécurité 6. Le programme d'installation de cet appareil doit s'assurer que les rayonnements RF n'est pas émis au-delà de l'exigence de Santé Canada.
Les informations peuvent être obtenues: http://www.hc-sc.gc.ca/ewh-semt/pubs/radiation/radio_guide-lignes_direct/index-eng.php

ELECTROMAGNETIC ENVIRONMENT GUIDANCE

ELECTROMAGNETIC COMPATIBILITY
Notice: The Gemini 810 + 980 diode laser complies with all requirements for electromagnetic compatibility according to IEC 60601-1-2: 2014.
Medical electrical equipment needs special precautions regarding electromagnetic compatibility (EMC) and needs to be installed and put into service according to the EMC information
provided in the following tables.
CAUTION
Portable and mobile Radio Frequency (RF) communications equipment can affect medical electrical equipment.
Accessories other than those specified, except those supplied or sold by Ultradent Products, Inc., as replacement parts for internal or external components, may result in increased
WARNING
EMMISSIONS or decreased IMMUNITY of the Gemini 810 + 980 diode laser.
Accessories: Medical grade power supply - Maximum length 6ft (1.8 meters) Ultradent P/N: 8981
Activation Pedal: Wireless Bluetooth at 2.4GHz Ultradent P/N: 8982
Description: The activation pedal uses Bluetooth BLE 4.0 technology, which operates at a frequency of 2402 to 2480 MHz with TX power of +0dBm and RX sensitivity of -93dBm and uses GFSK modulation.
The pedal is pre-configured by the manufacturer to only sync with the Gemini laser unit that has a matching unique identifier. This prevents interference with other RF wireless technologies that may
be present.
As a safety measure, any termination of the Bluetooth link between the activation pedal and the laser unit during use will result in the immediate termination of any laser emission. Reference the
Service and Troubleshooting section of this manual should you encounter any connectivity issues between the laser unit and the activation pedal.
This device has passed wireless coexistence testing with common devices found in dental practices at a minimum separation distance of 30 cm.
12
±
variance per regulation.