PhotonBlade
®
Instructions for Use
MANUFACTURER
Invuity, I nc.
444 De Haro Street
San Francisco, CA 94107 USA
Tel: 866.711.7768
www.invuity.com
Consult Instructions for Use and Symbols Glossary on
this website: www.invuity.com/documentlibrary
IFU 12296 Rev C Invuity Customer Service: 866.711.7768
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
• 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 buildup 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
• Verify that all oxygen circuit connections are leak free before and during the use of electrosurgery.
Verify that endotracheal tubes are leak free, and the cuff is properly sealed to prevent oxygen leaks.
• Position the patient return electrode cable to avoid contact with the patient or other cables.
• Before installing or removing the patient return electrode, ensure that the handset is not connected to
the electrosurgical generator, or the generator is OFF or in Standby mode, if available.
• Confirm proper electrosurgical generator power settings before proceeding with surgery.
• Do not look directly at the LED light source while illumination is active. The light source is
extremely intense and may temporarily impair vision.
• Use of instruments for any purpose or in any manner other than described in this Instructions for Use
may c ause instrument damage or failure, which could result in patient or user injury.
• Position the cable to the side of the operating table to avoid contact with the patient or a potential
tripping hazard.
• When not in use, keep the device in the provided holster, with the holster securely attached to the
surgical drape, or a dry, non-conductive area away from the patient to prevent unintended contact
with patient or user.
• Avoid fluid contact with the device hand switch, as this may cause damage to the device.
• Do not use the PhotonBlade on small appendages, as monopolar electrosurgery may cause thrombosis
or unintended tissue injury.
• Follow all surgical fire precautions and hospital safety procedures. Do not use the device in the
presence of flammable gases such as nitrous oxide and oxygen. Do not activate the device until
vapors from alcohol-based skin prepping agents have dissipated.
• Do not activate the device near electrocardiograph electrodes, as the electrical current may cause
interference.
• Proper patient return electrode application is very important. Refer to the ESU and patient return
electrode Instructions For Use for guidance regarding the patient return electrode selection, placement
and application procedures. Do not rely entirely on the ESU impedance sensing feature as it can be
affected by a damaged (shorted) patient return electrode. It is recommended that the operator verify
appropriate placement and contact of the patient return electrode. Improper placement or application
of patient return electrode may cause patient injury.
• Activation of the device when not in contact with tissue, but close to a conductive object, may cause
capacitive coupling.
IFU 12296 Rev C Invuity Customer Service: 866.711.7768 4
3. Attach the provided holster to the surgical drape. Place the
4. Turn on the ESU. Follow the manufacturer’s manual for
ConMed System 5000 ESU
(muscle)
Valleylab FX-C ESU
(muscle, liver, kidney)
Approximate Open
(Volts)
Approximate Open
(Volts)
20
Pure
400
20
Low
380
35
Pure
450
35
Low
560
20
Pinpoint
700
20
Desiccate
900
35
Standard
1800
35
Fulgurate
2500
PhotonBlade: Directions for Use
Set-Up:
1. Place the patient return electrode on the patient. Connect the patient return electrode to the ESU.
2. Inspect the device package before use. Do not use if the device or packaging has been opened or
damaged. Remove the PhotonBlade from the package and inspect the tip of the device for damage.
Do not use if damaged.
cable of the device through the cutout in the side of the
holster.
setup instructions. Plug the PhotonBlade monopolar
connector into the monopolar port of the ESU.
5. 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.
Table 1 lists CUT and COAG power settings and modes used with the PhotonBlade device in
combination with the ConMed System 5000 and Valleylab FX-C ESUs to conduct in-vitro testing that
confirmed device performance in the specified tissue types.
Power
(Watts)
50 Pure 500 50 Low 560
50 Standard 2500 50 Fulgurate 3000
Mode
Circuit Max. Voltage
Table 1
Comparable output voltage characteristics to those shown in Table 1 can be obtained with other 510(k)
cleared electrosurgical units by using similar power settings and modes. Consult the user manual of the
electrosurgical unit to determine the voltage output characteristics for different power settings and modes.
Power
(Watts)
Mode
Circuit Max. Voltage
IFU 12296 Rev C Invuity Customer Service: 866.711.7768 5
Using the PhotonBlade:
1. Set the desired length and rotation of the device shaft:
a. To extend the shaft, unlock the handle nose cone by rotating it
90⁰ clockwise.
b. Pull the shaft distally to the desired length, and rotate the
shaft to the desired position.
c. Lock the nose cone by rotating it 90⁰counterclockwise.
Confirm that shaft is secured in the desired position before
proceeding.
2. To collapse the shaft of the device, loosen the nose cone, push on the
shaft to the desired length, then tighten the nose cone.
3. Adjust the length and rotation of the PhotonBlade shaft as needed
throughout the procedure.
4. To cut, press and hold the yellow button continuously on the
handswitch. The Cut button is the most distal on the hand-piece.
5. To coagulate, press and hold the blue button continuously on the
handswitch. The Coag button is the middle button on the hand-piece
6. To turn the illumination on, first ensure the device is not contacting
tissue, then press the white button on the handswitch once. The
illumination button is the most proximal on the hand-piece.
7. To turn the illumination off, first ensure the device is not contacting
tissue, then press and hold the white button on the hand switch for 2
seconds.
Notes:
a. Do not contact tissue when turning the illumination on or
off.
b. Turn off the illumination when the device is not in use to
preserve the battery.
8. Illumination has no effect on the CUT and COAG functions.
9. Keep the electrode clean throughout the procedure. Remove tissue
build-up with wet gauze pads or by sliding the blade through the
provided slot on the holster.
IFU 12296 Rev C Invuity Customer Service: 866.711.7768 6
10. Keep the waveguide clean throughout the procedure. Remove fluid or
Battery Replacement:
debris with a tapered swab.
1. The PhotonBlade will provide approximately 2 hours of illumination.
If the battery needs to be replaced:
a. Turn OFF the ESU and unplug the device from the ESU.
b. Then, press firmly inward and up on the battery compartment
door tab, located on the side of the monopolar connector.
c. Replace the battery with a new CR123A 3V battery. The
positive end of the battery should be oriented toward the
connector pins.
d. Dispose of the used battery according to hospital procedures
and in accordance with local, state and federal laws and
regulations.
e. Close the battery door and plug the connector back into the
ESU.
Note: The Cut and Coag functions of the device operate
independently of the illumination. If the illumination
decreases or stops, there is no effect on the Cut and Coag
functions.
After Surgery:
1. Turn off the ESU.
2. Disconnect the PhotonBlade connector and the patient return
electrode from the ESU.
3. Remove the battery from the battery compartment on the connector.
4. Discard the PhotonBlade and battery according to hospital
procedures and in accordance with local, state and federal laws and
regulations. Do not re-use the device.
IFU 12296 Rev C Invuity Customer Service: 866.711.7768 7
The Invuity PB1 PhotonBlade is intended for use in the electromagnetic environment specified below. The customer or user of the
Invuity PB1 Phot onBl a de should ensure that it is used in such an environment.
Emissions Test
Compliance
Electromagnetic Enviro nment – Guidance
RF Emissions
Group 1
The Invuity PB1 PhotonBlade must emit electromagnetic ener gy in order to
CISPR 11 Group 1 limits were followed as per clause 202.6.1.1.1
RF Emissions
CISPR 11
Complies
Harmonics
EN 61000-3-2
Flicker
EN 61000-3-3
Not Applicable1
Invuity PB1 Phot onBl a de should ensure that it is used in such an environment.
Immunity Test
IEC 60601
Test Level
Compliance Level
Electromagnetic Enviro nment
– Guidance
±8kV Air
Floors should be wood, concrete or ceramic
±1kV I/Os
Mains power quality should be that of a typical
Surge
±1kV Differential
±2kV Common
Mains power quality should be that of a typical
Voltage Dips/Dropout
>95% Dip for
5 Seconds
Not Applicable1
Mains power quality should be that of a typical
Power Frequency 50/60Hz
IEC 61000-4-8
3A/m
3A/m
Power frequency magnetic fields should be
environment.
ELECTROMAGNETIC COMPATIBILITY (IEC 60601-1-2 and IEC 60601-2-2)
The Invuity PB1 PhotonBlade complies with the appropriate IEC 60601-1-2 and 60601-2-2 specifications regarding
electromagnetic compatibility.
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
CISPR 11
Not Applicable1
1
The Invuity PB1 PhotonBlade does not contain AC power ports. The Invuity PB1 Photo nBlade is battery powered.
perform its intended function. Nearby electronic equipment may be affected
when RF is energized. As per IEC 60601-2-2, test was performed in a mode
with EUT switched on and in an idle state with the HF output not energized.
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The Invuity PB1 PhotonBlade is intended for use in the electromagnetic environment specified below. The customer or user of the
ESD
IEC 61000-4-2
EFT
IEC 61000-4-4
±6kV Contact
±2kV Mains
±6kV Contact
±8kV Air
±1kV I/Os1
tile. If floors are synthetic, the R/H should be
at least 30%
home, commercial or hospital environment.
IEC 61000-4-5
IEC 61000-4-11
Magnetic Field
1
The Invuity PB1 PhotonBlade does not contain AC power ports. The Invuity PB1 PhotonBlade is battery powered.
IFU 12296 Rev C Invuity Customer Service: 866.711.7768 8
0.5 Cycle
60% Dip for
5 Cycles
30% Dip for
25 Cycles
>95% Dip for
Not Applicable1
home, commercial or hospital environment.
home, commercial or hospital environment. If the
user of the Invuity PB1 PhotonBlade requires
continued operat ion during powe r mains
interruptions, it is recommended that the Invuity
PB1 PhotonBlade be powered from an
uninterruptible power supply or battery.
that of a typical home, co mmer cial or hospital
The Invuity PB1 PhotonBlade is intended for use in the electromagnetic environment specified below. The customer or the user of the
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment –
Conducted RF
3 V
3 V
Portable and mobile RF communications equipment should be
used no closer to any part of the Invuity PB1 PhotonBlade,
including cables, than the recommended separation d istance
calculated from the equation applicable to the frequency of the
transmitter.
d = 1.2√P
Radiated RF
3 V/m
3 V/m
d = 1.2√P 80 MHz to 800 MHz
Where P is the maximum output power rating of the transmitter
in watts (W) according to the
is
the recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an
electromagnetic site sur vey
compliance level in each frequency range.
Interference may occur in the vicinity of equipment marked
with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
from structures, objects and people.
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur
Recommended separation distances between portable and mobile RF communications equipment and the
Invuity PB1 PhotonBlade
Separatio n dis ta nce acc ording to frequency of transmitter (m)
150 kHz to 80 MHz
d = 1.2√P
80 MHz to 800 MHz
d = 1.2√P
800 MHz to 2.5 GHz
d = 2.3√P
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1 1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
Invuity PB1 Phot onBl a de should assure that it is used in such an environment.
IEC 61000-4-6
IEC 61000-4-3
150 kHz to 80 MHz
rms
80 MHz to 2.5 GHz
rms
guidance
Recommended separation distance
d = 2.3√P 800 MHz to 2.5 GHz
transmitter manufacturer and d
a
, should be less than the
b
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection
radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accu r acy. To assess the electromagneti c
environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which the Invuity PB1 PhotonBlade is used exceeds the applicabl e RF compliance level above, the Invuity PB1
PhotonBlade should be observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the In vuity PB1 PhotonBlade.
b.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
can help prevent electromagnetic interference by
d mobile RF communications equipment (transmitters) and the Invuity PB1
IFU 12296 Rev C Invuity Customer Service: 866.711.7768 9
is the maximum output power rating of the
anufacturer.
tructures,
Warranty
INVUITY warrants, for the earlier of (i) the expiration date, if applicable, or (ii) one (1) year from the date of
purchase, that this medical device is free from defects in both material and workmanship when used normally
for its intended purposes. Suitability of the medical device for any surgical procedure shall be determined by
the user alone (in light of relevant instructions for use) and not by INVUITY, and such user shall be
responsible for understanding how to use the device for its intended purpose. In the event that purchaser
believes that any INVUITY medical device is defective, purchaser will promptly notify INVUITY. Any
INVUITY brand named instrument delivered from INVUITY proving to be defective will, as purchaser’s
sole and exclusive remedy, be replaced at no charge or the amount paid refunded, at INVUITY’s discretion,
so long as the defect is discovered and reported to INVUITY within the earlier of thirty (30) days of
discovery or one (1) year of purchase, and INVUITY determines that the product is defective and is covered
by the warranty. Notwithstanding, INVUITY shall not be responsible for normal wear and tear, including
minor cosmetic damage compromise or defect caused by re-sterilization. INVUITY does not repair, sharpen,
recoat or otherwise refurbish any used product. The foregoing limited warranty and limited obligation of
replacement is void and of no effect in the event that there is any modification made to the medical device or
the medical device is used for any purpose other than its intended purpose.
LIMITATION OF LIABILITY. INVUITY DOES NOT ACCEPT LIABILITY TO CUSTOMER OR ANY
THIRD PARTY BEYOND THE REMEDIES EXPRESSLY SET FORTH HEREIN, INCLUDING ANY
LIABILITY FOR PRODUCTS NOT BEING AVAILABLE FOR USE. IN NO EVENT SHALL INVUITY
BE LIABLE FOR LOST PROFITS, LOSS OF BUSINESS, LOSS OF USE, COSTS OF PROCUREMENT
OF SUBSTITUTE GOODS, OR ANY OTHER CONSEQUENTIAL, EXEMPLARY, INCIDENTAL,
SPECIAL, INDIRECT OR PUNITIVE DAMAGES, HOWEVER CAUSED AND UNDER ANY THEORY
OF LIABILITY, WHETHER BASED IN CONTRACT, TORT (INCLUDING NEGLIGENCE) OR
OTHERWISE EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, OR FOR ANY CLAIM
BY ANY THIRD PARTY, EXCEPT AS EXPRESSLY PROVIDED HEREIN.
CUSTOMER ACKNOWLEDGES UNDERSTANDING THAT NO OTHER REPRESENTATION OR
WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, WITH RESPECT TO THE PRODUCT AS TO
ITS MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR ANY OTHER MATTER,
EVEN WHEN APPLIED OR UTILIZED IN ACCORDANCE WITH ITS INSTRUCTIONS, ARE MADE
OR GIVEN BY INVUITY. AND INVUITY EXPRESSLY DISCLAIMS ALL SUCH
REPRESENTATIONS AND WARRANTIES.
Invuity, the Invuity logo, and PhotonBlade are registered trademarks of Invuity, Inc.
The products referenced in this document may be covered by one or more patents.
See: www.invuity.com/patents. All rights reserved.
IFU 12296 Rev C Invuity Customer Service: 866.711.7768 10
Document Number
IFU 12296 Rev C
Page 11 of 12
INSTRUCTIONS FOR USE
PhotonBlade
Rev
CO #
Description
Approved Date
Effective
Date
Originator
A
16-0732
Added "D uring use, do not allow the illumination
12/09/16
12/12/16
J. Hegener
B
17-0339
Added to Product Use Section: • Before use,
tissue.
05/30/17
06/07/17
A. Leos
C
17-0605
Removed symbols and text and add e-IFU/
electrode.
09/26/17
09/26/17
J. Wentz
REVISION HISTORY
output surface of the PhotonBlade to be
obstructed. The high intens ity illuminati on has
the potential to cause thermal damage or injury if
the output surface is obstructed by tissue, gloves,
or other material." to the warnings and
precautions section.
Added bullets 2-9 under the safety section of
warnings and precautions, regarding fire and
combustion risk with electrosur gical devices.
Modified instructions for light operation to add 2
second hold for illumination off. Updated pictures
for new button layout.
Re-formatted (tabular) layout and made minor
grammatical and error corrections. Add printing
instructions page.
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.
• 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, inc luding
burns.
• While activating energy, be aware o f critic a l
anatomy that is in contact with the blade,
waveguide a nd 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. Added to during use: or rest on
Symbols Glossary website. Replaced ™ with ®
on PhotonBlade and updated the trademark
disclaimer. Updated with ne w i mage s. Updated
printing instructions. Added safety information
about implantable leads and patient return
Document Number
IFU 12296 Rev C
Page 12 of 12
INSTRUCTIONS FOR USE
PhotonBlade
PRINTING INSTRUCTIONS
Print in-house or at an approved supplier.
Do not print Revision History or Printing Instructions pages (page 11 & 12).
Print double si de d, boo kle t sty le in black ink on whi te paper.
Fold in booklet (folde d siz e is 8.5 in x 5.5 in (REF)) and staple f old.
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