General description

The medical device is a Class I medical device.

Intended Use

This product is an augmented reality (AR) headset equipped with a 3D viewer and two cameras to provide stereoscopic, real-time viewing of the area magnified by the lenses. The 3D viewing glasses of the headset capture real-time images of the viewing area and, in addition to displaying them on the 3D glasses, they can store them on the console or transmit them in real time via a standard communication channel to other computers or devices, facilitating procedures for the doctors performing them. The device enables dentists not only to understand and perform procedures in the best possible way but especially to do so without needing to tilt or move their head, eliminating or greatly reducing musculoskeletal problems in the back and neck.

Medical Device Classification

Orisview facilitates the use of other medical devices, meaning it is a medical device that supports achieving the purpose of medical devices.

User

The product must be used only by professional medical personnel fully familiar with the manual. Patient population: not specified

Contraindications

Use the device according to the manual’s instructions. Do not connect the product’s USB-C ports to uncertified equipment or power supplies. This device does not come into contact with the patient and is not a chemical, biological, or blood-related device. It has no side effects.

Orisview Headset

Group	Name	Description
1	3D Camera Group	Group containing the two cameras for 3D vision and two LED spotlights (white and yellow) to adequately illuminate the focused working area
2	Shade	The magnetically attached shade can be of two types: passive or active. It increases display clarity by reducing perceived ambient light levels
3	Head Cap	The head cap is the part of the headset that fits snugly on the head and houses the pads for fine adjustment of the fit on the operator’s head. Inside the cap, two Velcro pads (top and side) are inserted and chosen based on the operator’s head circumference. Pads should be replaced depending on usage frequency
4	Head Pads	Velcro pads installed under the head cap (top and side). Available in 4 sizes (S, M, L, XL) to better fit the user’s head. Should be replaced based on usage frequency
5	Head Cap Tightening Knob	Device to lock the headset on the operator’s head. Turn clockwise to tighten, counterclockwise to loosen
6	Cable for Connecting to Control Console	Cable to connect the headset to the control console. Equipped with a special connector with retention system to prevent accidental disconnections
7	Augmented Reality 3D Viewing Group	3D AR viewing system where the cameras’ images are projected in real time. The AR glasses provide stereoscopic vision of the focused area. The 3D viewing group can slide forward to allow wearing the headset with prescription glasses
8	Up/Down Adjustment Knob	The headset has two side knobs allowing vertical adjustment of the viewing group for a fine fit
9	Audio	The headset includes an audio system with microphone and speakers

NOTE

The headset adjustment systems are available in the belt-mounted Console. The visor overlays the most important information related to its operation: magnification level, battery status, active LED spotlight, video and audio recording status.

Control Console with Wireless Transmitter

Components

Group	Name	Description
1	Headset Connection Port	Connector for the cable connection to the Orisview headset. The connector has retention to avoid unwanted disconnections. Take care when unplugging to avoid damage. Do not connect uncertified cables.
2	ON/OFF and Reset Button	Button to power the device on and off. Pressing it when off powers on the system. Pressing it when on prepares shutdown but requires confirmation on the touchscreen or joystick to complete. This double step avoids accidental shutdowns. Holding the button for more than 8 seconds forces a console reboot.
3	Power LED	Green LED indicating device status. Solid green during normal operation, blinking during initialization, pulsing during battery charging.
4	Charging Port	Connector for power supply cable. Low-voltage DC connector for battery charging. Use only the supplied power adapter.
5	MODE3 Button: Visor/ Shade Brightness	Changes the function of knob⑧. Pressing this button sets knob⑧ to adjust internal headset speaker volume.
6	MODE2 Button: Speaker Volume	Changes the function of knob⑧. Pressing this button sets knob⑧ to adjust internal headset speaker volume.
7	MODE1 Button: Magnification Level	Default mode for knob⑧. There are 5 magnification levels displayed as overlay numbers 1 to 5 in the 3D visor.
8	Multifunction Knob	Pressing this knob cycles the white and yellow LED spotlights ON/OFF. Rotating it clockwise or counterclockwise adjusts brightness.
9	LED Spotlight Knob and Button	Controls the two LED spotlights on the front with the stereo cameras. Pressing toggles the white and yellow LEDs ON/OFF sequentially. Rotating adjusts brightness.
10	Video ON/OFF Wireless Transmission Button	Activates video transmission via WiFi. Press and hold until blue LED⑪ lights up. Hold again to stop transmission and turn LED off.
11	On-Air LED	Blue LED indicates wireless 3D video transmission is active.
12	A/V Recording Button on SD	Starts local recording of 3D video and ambient audio on the console’s internal SD memory. Red LED⑬ lights when recording is active.
13	Local Rec LED	Red LED indicating local SD recording is active.
14	Mute Button	Activates mute to block audio recording or transmission. Can be used in local recording or wireless streaming mode. Red LED⑮ lights when active.
15	Mute LED	Red LED indicating mute is active.
16	Joystick	Joystick for interacting with the console’s user interface menus displayed on the LCD screen⑰.
17	Display	Touchscreen for displaying and managing the console user interface menus. Allows programming system features and checking status. Interaction via touchscreen and/or joystick⑯.
18	Belt Loops	Loops for attaching a shoulder strap or belt