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SOLTIVE Laser Software Revisions
PN0015551_AF SOLTIVE Laser Instructions for Use
Your Soltive™ laser software and Instructions for Use have been updated.
Below is a summary of the changes. To obtain a hard copy of the updated IFU (PN0015551_AF) please
contact your local Olympus representative. All updated IFUs will be published on our website
(www.Olympus-Europa.com) once the translated IFUs are available.
What has changed:
1.
On page 50 of the IFU, the laser will deliver up to 40W and 4J per pulse through a 150 µm core fiber.
This was previously 25W and 3J per pulse. The following default settings have been increased up
from 25W and 3J when a 150um fiber is being used:
• Bladder Stone:
• Enucleation:
• Vaporization:
Table 1 Lithotripsy and BPH Preset Treatment Parameters
Lithotripsy
Bladder Stone
Left Pedal Name:
Bladder Stone
Energy: 4 J;
Frequency:
Pro: 8 Hz;
Premium: 14 Hz
150 µm fiber: 10 Hz
Pulse Width: 1
Right Pedal Name:
Hemostasis
Energy: 1 J
Frequency: 20 Hz
Pulse Width: 3
PN0024336_AA
+1 888 524 7266 or +1 763 416 3000 ● www.medical.olympusamerica.com
Wendenstraße 20, 20097 Hamburg, Germany ● Postfach 10 49 08, 20034 Hamburg, Germany
PN0024336_AA SOLTIVE Laser System Instructions for Use
4J x 8Hz (Pro)
4J x 10Hz (Premium)
1J x 34Hz (Pro)
1J x 40Hz (Premium)
2J x 16Hz (Pro)
2J x 20Hz (Premium)
Ureteral Stone
Left Pedal Name:
Soft Stone
Energy: 0.2 J
Frequency: 40 Hz;
Pulse Width: 1
Right Pedal Name:
Hard Stone
Energy: 0.6 J
Frequency: 14 Hz
Pulse Width: 1
Gyrus ACMI, Inc.
9600 Louisiana Ave. North ● Brooklyn Park, MN 55445 USA
OLYMPUS EUROPA SE & CO. KG
BPH
Enucleation
Left Pedal Name:
Left Pedal Name:
Enucleation
Vaporization
Energy: 1 J
Energy: 2 J
Frequency: Pro: 34 Hz;
Frequency:
Premium: 60 Hz
Pro: 16 Hz; Premium: 30 Hz
150 µm fiber: 40 Hz
150 µm fiber: 20 Hz
Pulse Width: 3
Pulse Width: 3
Right Pedal Name:
Right Pedal Name:
Hemostasis
Hemostasis
Energy: 1 J
Energy: 1 J
Frequency: 20 Hz
Frequency: 20 Hz
Pulse Width: 3
Pulse Width: 3
Addendum
June 16, 2021
Vaporization
Page 1 of 4

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Summary of Contents for Olympus SOLTIVE

  • Page 1 Your Soltive™ laser software and Instructions for Use have been updated. Below is a summary of the changes. To obtain a hard copy of the updated IFU (PN0015551_AF) please contact your local Olympus representative. All updated IFUs will be published on our website (www.Olympus-Europa.com) once the translated IFUs are available.
  • Page 2 Clinical Guide section of the IFU). Users of the Soltive laser may experience low retropulsion effects that may support longer durations of continuous lithotripsy without repositioning the fiber. A laser delivers heat to the surrounding fluid while it is emitting. In general, the heating effect is directly proportional to the average power of the laser settings.
  • Page 3 Addendum PN0024336_AA SOLTIVE Laser System Instructions for Use Revised positioning of wireless footpedals for pairing on page 33. Footswitch Unpaired 1 Footswitch Icon* 2 Continue Button To Start Pairing 8. Added to Step 6 on page 33: Then Click Continue within 4 seconds.
  • Page 4 Enzol enzymatic detergent, 70% Isopropyl alcohol, 5% bleach solution (page 54). 11. Added footswitch low battery indicator and popup window (page 56). Battery Warning 12. Updated Olympus Korea company address in the list of Distributors to: Olympus Korea Co., Ltd. Seocho-dong, Majestar City One...