EndoLift - Encision
Contents
1. Research Park 800 East Leigh Street Richmond VA 23219 Phone 1 877 226 9704 e mail info virtual ports com LB040 01 rev 12. Vira Ports Laparoscopy Systems EndoLitt Instructions for Use Table of Contents SYMBOLS WHEN THE SYSTEM ARRIVES ILLUSTRATIONS DEVICE DESCRIPTION INDICATIONS WARNINGS AND PRECAUTIONS STERILITAY CARE AND HANDLING SAFE OPERATION v Load the EndoLift on the Virtual Ports Applier v Insert the EndoLift into the internal operating cavity v Retract an organ with the EndoLift v Remove the Device TROUBLESHOOTING STORAGE AND SHELF LIFE CUSTOMER SERVICE INFORMATION CANE A E A A SE SEE G NOTICE It is important that you read the entire manual before you use the EndoLift It is unsafe to use this device before you have read and are thoroughly familiar with this document SYMBOLS Virtual Ports Ltd MANUFACTURER NAME 20 Alon HaTavor St Caesarea 38900 Israel MANUFACTURER ADDRESS Y MANUFACTURER LOGO Laparosco ATTENTION SEE INSTRUCTIONS FOR USE EXPIRATION DATE REFERENCE NUMBER AJ m 7 LOT NUMBER E DO NOT REUSE evs DATE OF MANUFACTURE STE RILE R ne Nor URE IF PACKACE IS OPENED OR DAMAGED Caution Federal law restricts this device to sale PRESCRIPTION USE STATEMENT by or on the order of a Applicable for U S A only physician WHEN THE SYSTEM ARRIVES As the box is unpacked check the content of the box against the item listed on the packaging slip If the content is incomplete notify Virtual Ports Check the content condition If the content is dam
3. aged notify Virtual Ports Do not use if the package suffered any damage ILLUSTRATION Figure 2 EndoLift Opened telescopic tube extended AA a X Figure 3 Virtual Ports Applier EndoLift Parts 1 Anchoring clip jaws Anchoring clip hook 3 Connecting wire covered with plastic tube 4 Telescopic Tube Closed Telescopic Tube Extended 6 Anchoring clips A Applier Parts 7 EndoLift Sleeve 8 Sleeve handle 9 Luer Lock Connector covered with cap 10 Rotation knob 11 Release button 12 Handle 13 Trigger 14 Detachable tube 15 Applier loop See Applier User Manual for more information DEVICE DESCRIPTION The Virtual Ports EndoLift is an internally anchored hands free organ retracting device for use in minimally invasive surgery The EndoLift is introduced into the internal operating cavity via a standard cannula diameter of 5 0 5 5 mm by means of the Virtual Ports Applier The first anchoring clip is attached onto the internal operating cavity wall on one side of the organ requiring retraction The Applier is then connected to the second anchoring clip and maneuvered to place the telescopic tube underneath the organ to be retracted Finally the second anchoring clip is attached onto the internal operating cavity wall on the other side of the organ thereby achieving the desired retraction The Applier is then removed and the port becomes available for use by other instrum
4. and the anchoring clips fits into the tube Problem When pulling the trigger to activate the clips nothing happens 1 e the jaws don t open Corrective action 1 Press the release button to disconnect the clip 2 Carefully re engage the hook with the Applier loop and pull back slightly to ensure the Applier loop is engaged at the curved J end on the hook 3 Pull the trigger to connect the clip and verify that the clip is activated Problem While approaching the desired anchoring site on the internal operating cavity wall or when removing the clip from the cavity wall the connecting wire gets tangled between the anchoring clip jaws Corrective action Open the jaws and maneuver the anchoring clip to correct the situation Use the rotation knob if necessary STORAGE AND SHELF LIFE The EndoLift is a sterile device and intended for single use only The EndoLift shelf life is 24 months The product should be stored in a clean and dry place Environmental storage and use conditions Temperature range 10 C to 60 C Relative humidity range 10 to 40 RH Atmospheric pressure 500 to 1060 hPa CUSTUMER SERVICE INFORMATION For technical support and service contact Virtual Ports at Israel Corporate Office Virtual Ports Ltd 20 Alon HaTavor St Caesarea 38900 Israel Phone 972 4 6277506 Fax 972 4 6275390 e mail info virtual ports com U S A Corporate Office Virtual Ports Inc Virginia Biotechnology
5. e of the anchoring clips 6 with the Applier loop Pull back gently on the trigger until the you hear a click indicating the clip is fixed to the Applier detachable tube 14 Push the sleeve 7 forward encasing the telescopic tube 4 Continue until the second clip of the EndoLift is also encased within the sleeve The EndoLift is now loaded and ready to be used o Insert the EndoLift into the internal operating cavity 6 Te Insert the loaded Applier into the internal operating cavity through a 5mm or larger cannula Pull back on the sleeve to expose the EndoLift Continue until the clip attached to the Applier is fully exposed e Retract an organ with the EndoLift 8 J 10 11 12 13 14 15 16 Choose a first anchoring site on the internal cavity wall Approach the site with the anchoring clip and and pull the trigger to open the jaws 1 and pinch the tissue at the desired location Release the Applier trigger and gently pull back the handle 1 in order to close the jaws on the anchoring site NOTE There is no need to apply excessive force onto the internal wall during the anchoring procedure Press the release button in order to separate the anchoring clip from the Applier Locate the second anchoring clip at the opposite end of the EndoLift and load it onto the Applier Maneuver the EndoLift telescopic tube under the organ to be retracted Attach the second anchoring clip onto the internal cavity wall to achieve the desi
6. ents The EndoLift s position may be changed several times during the surgical procedure as needed When the EndoLift is no longer required it is removed from the internal operating cavity by means of the Applier and disposed of INDICATIONS The EndoLift is indicated for internal organ retraction during minimally invasive surgery WARNINGS AND PRECAUTIONS It is important for the EndoLift operator to be familiar with this manual its precautions procedures and safety issues The following labels are used in this manual to identify important concerns death AN A Warning indicates a situation in which the user or the patient may be in danger of injury or Warnings Any special care to be exercised by a practitioner or patient for the safe and effective use of the Precautions device NOTE Emphasize important instructions A WARNINGS Lack of familiarity with the device prior to use could result in damage to the device and serious injury The EndoLift is provided STERILE and is intended for SINGLE PATIENT USE ONLY DO NOT RESTERILIZE Re use of the EndoLift may lead to serious infections The Virtual Ports Applier is a reusable instrument It MUST be processed before each use according to the instructions in the User Manual supplied with the device The accompanying instructions only describe the proper use of the EndoLift and are not recommending any surgical procedure The EndoLift should only be used by persons with adequate tra
7. ining and experience in minimally invasive and general surgery Do not attach the anchoring clips to tissues other than the internal operating cavity wall Do not make contact between the EndoLift and an electrosurgery electrode Accidental application of electrosurgery on the EndoLift could cause tissue damage and further complications A PRECAUTIONS Do not attempt to operate the EndoLift with any instrument other than the Virtual Ports Applier Doing so could damage the EndoLift and cause tissue injury Make sure to use the EndoLift Sleeve REF AP164A with the Applier Use of a different sleeve could cause device malfunction Handle the device with care to avoid both patient and personnel accidental injury when opening the anchoring clip s jaws STERILITY CARE AND HANDLING Each EndoLift is packaged individually in sterile sealed pack The EndoLift is disposable and should not be reused Sterility of the EndoLift is ensured until the expiration date printed on the pack unless the sterile sealed pack has been damaged or previously opened The EndoLift should be stored in a dry location SAFE OPERATION e Load the EndoLift on the Virtual Ports Applier L pas 3 4 5 Make sure the EndoLift Sleeve REF AP164A 7 is assembled on the Applier The Applier loop 15 should be visible at the distal end If it is not release the trigger 13 and press the release button 11 in order to bring it forward Engage the hook 2 of on
8. red retraction Visually inspect the retraction before continuing with the surgical procedure If the retraction is satisfactory remove the Applier from the internal operating cavity Remove the EndoLift 17 18 19 20 2A 22 23 24 25 Insert the Applier through the cannula into the internal operating cavity Engage the hook of one of the anchoring clips with the Applier loop Pull the trigger to open the jaws and move the clip away from the internal cavity wall NOTE 1 Once the clip is removed from the internal cavity wall release the trigger to close the jaws and avoid accidental tissue injury Press the release button 9 to release the anchoring clip from the Applier Engage the second anchoring clip with the Applier and remove it as well Push the sleeve 12 forward until the EndoLift is completely covered Remove the Applier with the EndoLift from the body Pull back on the sleeve 12 to expose the EndoLift Press the release button 9 in order to disconnect the EndoLift from the Applier TROUBLESHOOTING 1 2 3 Problem When the clip does not fit into the Applier detachable tube and gets stuck on its end Corrective action 1 Press the release button and disconnect the clip 2 Carefully re engage the hook and pull back slightly to align the anchoring clip with the Applier tube without pulling the trigger yet 3 Once the clip is aligned pull the trigger until you hear a click
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