Lektrafuse Quick Reference Guide June 2017

QUICK REFERENCE GUIDE Lektrafuse® RF Generator 1

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1. “POWER ON” Indicator 2. Lektrafuse RF Generator Instrument Connector Port 3. Message Display 4. Fault Indicator 5. Regrasp Indicator 6. Foot Pedal Connector Port 7. RF Delivery Control Button or Mode Selection Button

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8. Ventilation 9. AC Power Cord Inlet 10. “ON/OFF” Power Switch 11. Fuse Holder 12. Equipotential Plug 13. Service Port

Display, Symbol or Icon RF ON /OF MODE PWR

SETTING UP THE LEKTRAFUSE SYSTEM 1. Connect the AC Power Cord to the RF Generator in the rear panel and into a hospital grade outlet (9). 2. Turn the power switch on the back panel to the “On” position (10). The “Power On” indicator will illuminate (1). 3. If desired, attach the foot pedal to the front panel (6). The arrow on the connector must be aligned with the arrow above the connector port for proper connection. 4. Remove the selected Caiman® sealing instrument from its sterile packaging and attach it to the instrument connector port (2) on the front of the RF Generator. The arrow on the connector must be aligned with the red dot above the connector port for proper connection. When properly connected a green light around the connector port will be illuminated. 5. A seal cycle can be initiated by pressing and releasing the foot pedal, the RF Delivery Control Button (7) on the RF Generator or the RF Button on the instrument. 6. The seal cycle will automatically terminate when sealing is complete. Pressing any of the three activation methods during a seal cycle will stop the cycle immediately.

Regrasp Messages

What it Means

User Action

REGRASP INDICATOR – OPEN Visually check seal – Manually cut. Clean jaws. Regrasp thicker tissue.

Jaws are covered with excess tissue, or the tissue bundle grasped is too thin.

Clean jaws with a wet sponge or regrasp a thicker tissue bundle.

REGRASP INDICATOR – SHORT Visually check seal – Manually cut. Check for metal or occlusion in jaw Remove excess fluids.

There may be metal (i.e. staples) or other foreign material between the jaws.

Open jaws, visually inspect and remove any foreign material or suction excess fluids in surgical field.

REGRASP INDICATOR – TIME Visually check seal – Reseal as needed. Seal cycle interrupted. Seal endpoint not reached.

The RF Generator reached its maximum seal time - without detecting a complete seal or user terminated RF delivery mid-seal.

Determine seal quality through visual inspection

If a regrasp occurs, do not divide tissue with the cutter. Open the jaws of the instrument and either visually examine the sealed vessel and manually divide it with surgical scissors OR reapply the jaws in the same area and deliver an additional RF cycle.

Definition RF DELIVERY BUTTON: Each press and release of the RF delivery button initiates or terminates RF delivery (Software-Version 1.8) MODE SELECTION BUTTON: Standard / Plus Mode (Software-Version 2.0 and higher) “POWER ON” INDICATOR: Lit indicator (green) indicates that the RF Generator is receiving power and is turned on. REGRASP INDICATOR: Lit indicator (amber) indicates that inadequate or incomplete sealing of the tissue within the Instrument jaws may have occurred. (see Regrasp Caution under section 7 in IFU). INSTRUMENT CONNECTOR PORT & INDICATOR: Identifies the connector port into which the connector attached to the end of the Instrument cable is placed.

Display, Symbol or Icon

For complete directions on setting up the Lektrafuse RF System please refer to the instructions for use found at www.caiman-aesculap.com

Definition FAULT INDICATOR: Lit indicator (red) indicates that a system fault has occurred. Instructions for User action will be presented in the Message Display. User should approach tissue sealing and division as if the Regrasp is also lit (see Regrasp Caution under section 7 in IFU). INSTRUMENT CONNECTOR PORT & INDICATOR: Lit ring (green) indicates correct connection of Instrument within instrument connector port on the front of the Lektrafuse RF Generator. FOOT PEDAL CONNECTOR PORT ICON: Identifies the connector port into which the connector attached to the end of the foot pedal cable is placed. Each press and release of the foot pedal initiates or terminates RF delivery.

AESCULAP ® – a B. Braun brand D-ST170178

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Aesculap AG | Am Aesculap-Platz | 78532 Tuttlingen | Germany Phone +49 7461 95-0 | Fax +49 7461 95-26 00 | www.aesculap.com