Indications For Use; Warnings And Precautions - Invuity PhotonBlade Instructions For Use Manual

Description
The Invuity PhotonBlade is a single-use, RF device with integrated LED-based illumination that is powered
by a replaceable battery. The PhotonBlade consists of a single blade with a rotatable and adjustable length
shaft. It is designed to be used with a 510(k) cleared electrosurgical unit (ESU). The PhotonBlade is operated
by use of an integrated hand switch or ESU footswitch similar to an electrosurgical pencil.

Indications for Use

The PhotonBlade is a monopolar RF device coupled with illumination that is indicated for cutting and
coagulation of soft tissue during general surgical procedures.
Contraindications
There are no known contraindications.

Warnings and Precautions

Cleaning and Sterilization:
• The PhotonBlade is provided sterile and intended for single use only. Do not re-sterilize.
• Completely inspect package prior to use. Do not use if the sterile packaging has been opened or
damaged.
• If tissue builds up on the blade of the device, use soft wet gauze or the provided slot in the holster to
clean the device electrode during the procedure. Do not use sharp or abrasive objects, such as a
scratch pad, on the PhotonBlade, as it may damage the device.
• After use, dispose of the PhotonBlade and the battery according to hospital procedures and in
accordance with local, state and federal laws and regulations.
Product Use:
• Based on the desired tissue effect the lowest energy settings should be used. It is not recommended to
use CUT or COAG settings over 50 watts or any power setting and mode that results in an output
voltage greater than 3000V. Consult the user manual of the electrosurgical unit (ESU) to determine
the voltage output characteristics for different power settings and modes. Refer to Table 1 in Step 5 of
the Set Up section for additional information.
• Turn off the Illumination when the device is not in use to prevent the battery life from declining.
• Instruments should be handled and operated by hospital personnel familiar with and trained with their
use. Handle all instruments with care.
• Inspect device package before use. Do not use if the device or packaging is opened or damaged.
• Before use, inspect the device and DO NOT USE the device if there are breaks, chips, cracks,
scratches, tears or missing insulation on the blade or telescoping shaft of the device.
IFU 12296 Rev C Invuity Customer Service: 866.711.7768 2