LUMENIS Stellar Optima - Device Description; Intended Use; Intended User; Preoperative Instructions

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Device Description:

The Device is supplied in a suitcase. It consists of an IPL connector (Optima Lightguide adaptor), fiber, and

plastic handle and trigger button via BLE battery operated, and disposable tip. The fiber transmits the IPL energy

from the IPL source system to the treatment area through the fiber tip. The communication between the device

and the IPL system is done via BLE module, operated using trigger button.

The Treatment hand-piece accessory includes Lightguide Identification mechanism, enabling the IPL system to

recognize if the accessory is connected.

Intended Use:

The Stellar Optima Treatment Hand-piece, with the Intense Pulsed Light (IPL) hand-piece (with a spectrum of

400-1200 nm) is intended for aesthetic and dermatological skin procedure applications, and indicated for:

Benign cutaneous vascular lesions, including facial, truncal and leg telangiectasia, and erythema of rosacea.

Intended User:

Patient treatment is the responsibility of licensed practitioners

PreOperative Instructions:

The following technique is required to ensure safe use of the Stellar Optima Treatment Hand-Piece:

 Do not bend the fiber more than 30mm radius.

 Extract the treatment hand-piece from its original suitcase and place it on a dedicated cradle.

 Clean the Lightguide adaptor optical surface and the fiber edge using 70% alcohol wipes before each use.

 Make sure to attach disposable tip to fiber end to protect the fiber and treated area before operating the

Treatment hand-piece.

 Avoid dropping, stepping over, stretching and pulling the fiber cable to prevent damage.

Operating Instructions:

 Pull the Battery Contact Insulator to enable battery operation if attached.

 The green LED should be indicating the hand-piece is ON.

 Connect the Lightguide adaptor to the IPL source.

 Use the trigger button to prompt IPL energy delivery through the fiber to the treatment area.

 The BLE is used to deliver the trigger request, to transfer data such as hand-piece SN, number of pulses

etc.

PostOperative Instructions

 Dispose of the single use tip

 Place the Treatment Hand-Piece back to its dedicated cradle or store it back into its original suitcase after

covering the Lightguide adaptor with its original cap cover.