The Gemini EVO 810+980 soft tissue laser has been developed with Cybersecurity integrated throughout the total-product-lifecycle. Activities such as threat modeling, requirements documentation,

penetration testing, and post market management planning have been executed for the device.

The Gemini EVO 810+980 soft tissue laser has been developed with Cybersecurity capabilities such as secure boot and code signing, using industry standard algorithms.

The Gemini EVO 810+980 soft tissue laser supports the ability to provide Cybersecurity Routine Updates and Patches remotely. The device provides notification on the Guided Touch Interface, mobile app and

and web interface (Dashboard) when a new update is available. The user then has the ability to install the update directly into the device with any of these options. (Figure: 20.1)

A manufacturers statement on medical device security (MDS2) is available upon request for the Gemini EVO 810+980 soft tissue laser.

ELECTROMAGNETIC ENVIRONMENT GUIDANCE

ELECTROMAGNETIC COMPATIBILITY

Notice: The Gemini EVO 810+980 soft tissue laser complies with all requirements for electromagnetic compatibility according to IEC 60601-1-2: 2014.

CAUTION: 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.

Portable and mobile Radio Frequency (RF) communications equipment can affect medical electrical equipment.

WARNING: The use of 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 EMMISSIONS or decreased IMMUNITY of the Gemini EVO 810+980 soft tissue laser.

Accessories:

Medical grade power supply - Maximum length 6ft (1.8 meters)

Activation Pedal:

Wireless Bluetooth at 2.4GHz

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 -94.8dBm

and uses GFSK modulation. The pedal is pre-configured by the manufacturer to only sync with the Gemini EVO 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.

DEFINITIONS

Emission (electromagnetic): When electromagnetic energy is emitted by a source.

Interference Immunity: The ability of a device or system to work without errors even if there is electromagnetic interference.

Immunity Level: The maximum level of a certain electromagnetic interference that affects a particular device or system, where the device or system remains operative with a certain level of performance.

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