Lotus handpiece Instructions for use
Contents
1. Lotus handpiece Instructions for use Lotus Ultrasonic Scalpel L Cutting edge thinking a Instructions for use handpiece Before using the product please read the following information thoroughly Important e This document provides instructions for using the Lotus Series 4 System It is not a set of instructions for surgical technique e This document should be read in conjunction with the Lotus Series 4 User Manual e Failure to follow the instructions may lead to serious surgical consequences e The device is provided cleaned and sterile and is intended for use in single procedure only Discard after use Do not attempt to resterilize Should the package be open or damaged it must be discarded e Store packaged devices in a cool dry area Caution Federal USA law restricts this device to sale and use by or on the order of a physician IFU Handpiece Issue 01 Lotus Ultrasonic Scalpel Cutting edge thinking Symbol meanings symbol Meaning O de Use A temperature Limit I ManutacturedBy IFU Handpiece Issue 01 Lotus Ultrasonic Scalpel L Cutting edge thinking a Intended use The Series 4 Lotus Coagulation and Cutting System is indicated for soft tissue surgical incisions when bleeding control and thermal injury are important Series 4 Lotus may be used as an adjunct to or substitute for electrosurgery laser surgery and traditional scalpels in general plastic urological gynaecological th2. continued 9 10 11 12 13 14 15 16 17 18 If the waveguide touches anything metal or plastic while activated the device may become damaged This device should only be used by surgeons who are 1 trained in the types of surgical procedures that are to be carried out and 2 trained in the specific use of ultrasonic surgical instruments Ensure that electrical insulation or grounding is not compromised After significant activation the distal end of the device may become hot Do not allow the blade to contact tissue immediately following activation Do not allow the device to contact tissue while not in use in case accidental activation should occur Care should be taken when operating in the vicinity of nerves The jaw liner may be damaged if the jaw is closed against an activated waveguide without tissue between them In case of equipment failure always ensure adequate back up equipment is available Do not use the device if the expiration date has passed or its sterility is compromised Never reuse any components of the disposable instrument IFU Handpiece Issue 01 Lotus Ultrasonic Scalpel L Cutting edge thinking a Transducer and handpiece Lotus torsion transducer Alignment fin Rubber rotation wheel Wraparound activation button Ergonomic Palm Fit grip Handpiece Spring loaded rubber trigger Ergonomic power select button Transducer ee IFU Handpiece Iss
3. Minimally invasive devices can vary in dimension from one manufacturer to another If combining devices from different manufacturers always ensure compatibility prior to commencing the procedure 2 Handle the device with care Do not attempt to modify the device Damage or changes can affect the ability to attain resonance and reduce the effectiveness of the device Do not use if damage is suspected 3 Blood and tissue may build up between the jaw and waveguide during surgery This can cause the tip of the device to become abnormally hot Remove any visible tissue build up from the device to prevent the increased risk of burn injury 4 Ensurethe jaw is closed when inserting the device into and removing from a trocar Do not bend the jaw backwards Take care when inserting the device into a quiver As with all energy sources Electrosurgery Laser or Ultrasound there are concerns over carcinogenic and infectious potential of the procedure by products e g tissue smoke plume and aerosols Effective protective equipment should be used for both open and laparoscopic procedures 7 Ifthe jaw becomes bent do not attempt to straighten it Dispose of the device and open a new one 8 Ifthe waveguide touches anything metal while activated sparks may be produced Therefore use caution when using in the presence of flammable gases or liquids IFU Handpiece Issue 01 Lotus Ultrasonic Scalpel Cutting edge thinking Warnings and precautions
4. oracic exposure to orthopaedic structures such as spine and joint space and other endoscopic and open procedures Contraindications The system is not indicated for cardiac surgery The handpiece is not indicated for coagulation and dissection of vessels larger than 5mm The device is not indicated for incising bone The device is not indicated for contraceptive tubal occlusion IFU Handpiece Issue 01 Lotus Ultrasonic Scalpel L Cutting edge thinking a Steps for use PON gt 2 p T 8 9 For handpiece ensure that the trigger is in the forward position Ensure that the Transducer Waveguide are disconnected from the Generator Slide the handpiece sleeve over the end of the waveguide Align the red dot or white stripe on the transducer case with the orientation stripe on the rotation wheel of the handpiece Slide the handpiece sleeve fully up against the transducer case and gently click into place Connect the transducer to the generator The white Power Select button on the front of the hand grip can be depressed to toggle the power level between high and low The coloured Activate button is used to activate the device The wheel on the front of the handpiece may be rotated to adjust the orientation of the jaw 10 For operating technique of the full system refer to the Lotus Series 4 User Manual IFU Handpiece Issue 01 Lotus Ultrasonic Scalpel L Cutting edge thinking n Warnings and precautions 1
5. ue 01 Lotus Ultrasonic Scalpel f Cutting edge thinking Distal tip schematic PTFE liner Coagulation energy Outer tube Active blade Drive cam IFU Handpiece Issue 01 Lotus SRA Developments Ltd Bremridge House Bremridge Ashburton Devon UK TQ13 7JX 44 1364 652426 www LotusUltrasonicScalpel com
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