Olympus SOLTIVE Bedienungsanleitung

Addendum

PN0024336_AA SOLTIVE Laser System Instructions for Use

PN0024336_AA Gyrus ACMI, Inc. Page 1 of 4

9600 Louisiana Ave. North ● Brooklyn Park, MN 55445 USA

+1 888 524 7266 or +1 763 416 3000 ● www.medical.olympusamerica.com

OLYMPUS EUROPA SE & CO. KG

Wendenstraße 20, 20097 Hamburg, Germany ● Postfach 10 49 08, 20034 Hamburg, Germany

SOLTIVE Laser Software Revisions June 16, 2021

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: 4J x 8Hz (Pro) 4J x 10Hz (Premium)

• Enucleation: 1J x 34Hz (Pro) 1J x 40Hz (Premium)

• Vaporization: 2J x 16Hz (Pro) 2J x 20Hz (Premium)

Table 1 Lithotripsy and BPH Preset Treatment Parameters

Lithotripsy BPH

Bladder Stone Ureteral Stone Enucleation Vaporization

Left Pedal Name:

Bladder Stone

Left Pedal Name:

Soft Stone

Left Pedal Name:

Enucleation

Left Pedal Name:

Vaporization

Energy: 4 J; Energy: 0.2 J Energy: 1 J Energy: 2 J

Frequency:

Pro: 8 Hz;

Premium: 14 Hz

150 µm fiber: 10 Hz

Frequency: 40 Hz; Frequency: Pro: 34 Hz;

Premium: 60 Hz

150 µm fiber: 40 Hz

Frequency:

Pro: 16 Hz; Premium: 30 Hz

150 µm fiber: 20 Hz

Pulse Width: 1 Pulse Width: 1 Pulse Width: 3 Pulse Width: 3

Right Pedal Name:

Hemostasis

Right Pedal Name:

Hard Stone

Right Pedal Name:

Hemostasis

Right Pedal Name:

Hemostasis

Energy: 1 J Energy: 0.6 J Energy: 1 J Energy: 1 J

Frequency: 20 Hz Frequency: 14 Hz Frequency: 20 Hz Frequency: 20 Hz

Pulse Width: 3 Pulse Width: 1 Pulse Width: 3 Pulse Width: 3

Addendum

PN0024336_AA SOLTIVE Laser System Instructions for Use

PN0024336_AA Gyrus ACMI, Inc. Page 2 of 4

9600 Louisiana Ave. North ● Brooklyn Park, MN 55445 USA

+1 888 524 7266 or +1 763 416 3000 ● www.medical.olympusamerica.com

OLYMPUS EUROPA SE & CO. KG

Wendenstraße 20, 20097 Hamburg, Germany ● Postfach 10 49 08, 20034 Hamburg, Germany

2. The treatment settings, such as Lithotripsy, buttons, have been reduced in height to accommodate 6

buttons per screen instead of only 4 (page 36 of the Graphical Interface Section).

Treatment Settings

3. There is a new Ureteral Stone Factory Preset under the Lithotripsy treatment mode.

4. Additional language options have been provided (page 25).

The language list now includes:

• English

• German

• Spanish

• Italian

• French

• Swedish

• Portuguese (on page 2)

Choosing a Language (Page 1 and 2)

5. Additional information about the effects of laser temperature have been provided (page 17 of the

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. If the average power of the laser exceeds

the cooling power that results from the irrigation temperature and flow rate, and the patient's ability to dissipate the heat,

then the fluid temperature will increase at the anatomical site until laser emission ceases. Inadequate cooling can also

result from using higher irrigant temperatures or from using larger diameter fibers with insufficient irrigation pressure to

compensate for the lower irrigation flow rate.

6. Added configuration feature, enabled by default, to automatically save system logs during

system bootup if a USB drive is connected to the port at the rear of the system (page 28).

Lithotripsy Soft Tissue BPH

Addendum

PN0024336_AA SOLTIVE Laser System Instructions for Use

PN0024336_AA Gyrus ACMI, Inc. Page 3 of 4

9600 Louisiana Ave. North ● Brooklyn Park, MN 55445 USA

+1 888 524 7266 or +1 763 416 3000 ● www.medical.olympusamerica.com

OLYMPUS EUROPA SE & CO. KG

Wendenstraße 20, 20097 Hamburg, Germany ● Postfach 10 49 08, 20034 Hamburg, Germany

7. Revised positioning of wireless footpedals for pairing on page 33.

To Start Pairing

8. Added to Step 6 on page 33: Then Click Continue within 4 seconds.

Footswitch Unpaired 1 Footswitch Icon*

2 Continue Button

Addendum

PN0024336_AA SOLTIVE Laser System Instructions for Use

PN0024336_AA Gyrus ACMI, Inc. Page 4 of 4

9600 Louisiana Ave. North ● Brooklyn Park, MN 55445 USA

+1 888 524 7266 or +1 763 416 3000 ● www.medical.olympusamerica.com

OLYMPUS EUROPA SE & CO. KG

Wendenstraße 20, 20097 Hamburg, Germany ● Postfach 10 49 08, 20034 Hamburg, Germany

9. Pairing will begin.

Pairing in Process

Successful pairing will be indicated in Figure Successful Pairing.

Successful Pairing

10. Added Cleaning Solutions statement: The outer surfaces are compatible with the following cleaning

solutions: 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

2F-3F, 12, Seocho-daero 38 gil, Seocho-gu

Seoul, 06655, Korea

T +82 1544-3200

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