Invuity PhotonBlade Instructions For Use Manual page 3

• DO NOT activate energy unless the active
edge of the blade is in direct contact with
tissue. Failure to ensure the active edge of
the blade is in direct contact with target
tissue while activating energy could result
in patient injury, including burns.
• While activating energy, be aware of critical anatomy that is in contact with the blade, waveguide and
telescoping shaft. The waveguide and telescoping shaft should not be touching or retracting tissue
while activating energy.
• Stop using the device if energy discharge is observed from any other areas besides the active edge of
the blade.
• Do not touch the blade or telescoping shaft assembly while the Cut or Coag function is activated, as
this may result in injury.
• Do not contact metal objects or instruments with the PhotonBlade while the Cut or Coag function is
activated, including sutures, staples or clips, as this may cause patient or user injury, tissue damage,
or damage to the device.
• During use, do not allow the illumination output surface of the PhotonBlade to be obstructed or rest
on tissue. The high intensity illumination has the potential to cause thermal damage or injury if the
output surface is obstructed by tissue, gloves, or other material.
• Operate the device using the lowest power settings and the shortest tissue-contact time required for
the desired effect, as electrosurgery may cause unintended damage to surrounding tissue.
• When in use, keep the device in motion to prevent tissue build up on the electrode. However, the
blade may be held stationary to spot coagulate. The blade should be carefully cleaned as tissue build-
up occurs.
• Only contact the patient with the blade of the device. Do not insert the device into tissue beyond the
blade, as unintended injury or damage to the device may occur.
• Only use CR123A 3V batteries for the illumination function.
Safety:
• Do not use in patients that have electronic implants such as cardiac pacemakers without first
consulting a qualified professional (e.g. cardiologist). Possible hazards exist because interference
with the action of the electronic implant may occur, the implant or implantable leads may be
damaged.
• Do not place active accessories near or in contact with flammable materials, flammable gases, or high
levels of oxygen. Electrosurgical accessories that are activated or hot from use can cause a fire.
• Do not use electrosurgery in the presence of flammable anesthetics.
• Both oxygen and nitrous oxide support combustion. Avoid enriched atmospheres, which may result in
fires and burns to patients or surgical personnel.
• The following substances contribute to increased fire and explosion hazards in the operating room:
o Flammable substances (such as alcohol-based skin prepping agents and tinctures)
o Naturally occurring flammable gases which may accumulate in body cavities such as the
bowel
o The sparking and heating associated with electrosurgery can provide an ignition source.
Observe fire precautions at all times. When using electrosurgery in the same room with any of
these substances or gases, prevent their accumulation or pooling under surgical drapes, or
within the area where electrosurgery is performed.
IFU 12296 Rev C Invuity Customer Service: 866.711.7768 3