Invuity PhotonBlade Instructions For Use Manual page 5

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.
3. Attach the provided holster to the surgical drape. Place the
cable of the device through the cutout in the side of the
holster.
4. Turn on the ESU. Follow the manufacturer's manual for
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)
20
35
50
20
35
50
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.
IFU 12296 Rev C
ConMed System 5000 ESU
(muscle)
Approximate Open
Mode Circuit Max. Voltage
(Volts)
Pure
Pure
Pure
Pinpoint
Standard
Standard
Invuity Customer Service: 866.711.7768
Power
(Watts)
400 20
450 35
500 50
700 20
1800 35
2500 50
Table 1
Valleylab FX-C ESU
(muscle, liver, kidney)
Approximate Open
Mode Circuit Max. Voltage
(Volts)
Low 380
Low 560
Low 560
Desiccate 900
Fulgurate 2500
Fulgurate 3000
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