Stryker LF2019 Instructions For Use Manual Download Page 8

Remanufactured LigaSure Exact Dissector, Without Nano-coating 

Page 8 of 9 

 

Standards and IEC Classifications

 

 

The Remanufactured LigaSure Exact Dissector, Without Nano-coating meets all pertinent clauses of IEC 60601-1 Edition 

3+A1;C1, IEC 60601-1-2, and IEC 60601-2-2 Edition 6.0. 

 

If the Remanufactured LigaSure Exact Dissector, Without Nano-coating experience loss or degradation of the essential 

performance described in these instructions as a result of EMC disturbances, there would be no effect to intended use. 

 

The medical device is suitable to be used in the Professional Healthcare Facility Environment. 

 

Environmental Parameters

 

 

Operation and Storage

 

Ambient Temperature Range 

10 to 40 °C (50 to 104 °F) 

Relative Humidity 

15% to 90% non-condensing 

Transport 

Ambient Temperature Range 

-20 to 60 °C (-4 to 140 °F) 

Relative Humidity 

15% to 90% non-condensing 

 

Warranty 

 

Remanufactured Products 

 

Stryker warrants all remanufactured  products, subject to the exceptions provided herein, to be free from defects in 

remanufacturing and to substantially conform to the product specifications contained in the documentation provided by Stryker 

with the products for one use in accordance with the instructions for use of such product. 

 

Products for which Stryker is the Original Manufacturer 

 

Stryker warrants all products for which it is the original manufacturer, subject to the exceptions provided herein, to be free from 

defects in design, materials and workmanship and to substantially conform to the product specifications contained in the 

documentation provided by Stryker with the products for a period of one year from the date of purchase. 

 

General Warranty Terms Applicable to All Products 

 

TO THE FULLEST EXTENT PERMITTED BY LAW, THE EXPRESS WARRANTY SET FORTH HEREIN IS THE ONLY 

WARRANTY APPLICABLE TO THE PRODUCTS AND IS EXPRESSLY IN LIEU OF ANY OTHER WARRANTY BY 

STRYKER, EXPRESSED OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OR 

MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.  IN NO EVENT WILL STRYKER’S LIABILITY 

ARISING IN CONNECTION WITH THE SALE OF THE PRODUCT (WHETHER UNDER THE THEORIES OF BREACH 

OF CONTRACT, TORT, MISREPRESENTATION, FRAUD, WARRANTY, NEGLIGENCE, STRICT LIABILITY OR ANY 

OTHER THEORY OF LAW) EXCEED THE PURCHASE PRICE, CURRENT MARKET VALUE OR RESIDUAL VALUE OF 

THE PRODUCTS, WHICHEVER IS LESS.  STRYKER SHALL NOT BE LIABLE FOR INDIRECT, SPECIAL, 

INCIDENTAL, PUNITIVE OR CONSEQUENTIAL DAMAGES RESULTING FROM ANY BREACH OF WARRANTY OR 

UNDER ANY OTHER LEGAL THEORY. 

 

This warranty shall apply only to the original end-user purchaser of products directly from Stryker or a Stryker authorized 

distributor. This warranty may not be transferred or assigned without the express written consent of Stryker.  

 

This warranty does not apply to:  (1)  products that have been misused, neglected, modified, altered, adjusted, tampered with, 

improperly installed or refurbished;  (2)  products that have been repaired by any person other than Stryker personnel without  

the prior written consent of Stryker;  (3)  products that have been subjected to unusual stress or have not been maintained in 

accordance with the instructions in the user manual or as demonstrated by a Stryker representative;  (4)   

 

 

products on which any original serial numbers or other identification marks have been removed or destroyed; or (5) products 

that have been repaired with any unauthorized or non-Stryker components. 

 

Summary of Contents for LF2019

Page 1: ...entified ISO 15223 1 2016 2492 Batch code Indicates the manufacturer s batch code so that the batch or lot can be identified ISO 15223 1 2016 1641 Consult instructions for use Indicates the need for the user to consult the instructions for use ISO 15223 1 2016 1051 Do not re use Indicates a medical device that is intended for one use or for use on a single patient during a single procedure ISO 152...

Page 2: ... and division of vessels lymphatics and tissue bundles 2 3 mm away from unintended thermally sensitive structures such as nerves and parathyroid glands The LigaSure system has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures Do not use the LigaSure system for these procedures Contraindications for Use The LigaSure system has not been shown to...

Page 3: ...ach side arrow shows direction for cutting Cable cord Connector purple and white Precaution The nano coating featured on the original device is not present on this product Adjunctive use of nerve monitoring device is recommended during nerve sparing procedures such as thyroidectomies radical neck dissection and parotidectomies Secondary hemorrhaging after tonsillectomy is a potentially serious adv...

Page 4: ...nerator Refer to the generator user s guide for additional set up information During Surgery The LigaSure Sealer Divider can be used during surgery both to manipulate and dissect tissue and to seal and cut vessels and tissue bundles Instructs for use of the instrument during a procedure are provided in this section Warning Avoid placing fingers between the jaws or ring handles Injury to the use ma...

Page 5: ...the system only when the instrument is in direct contact with the target tissue to lessen the possibility of unintended burns Do not activate the instrument while instrument jaws are in contact with or in close proximity to other instruments including metal cannulas as localized burns to the patient or physician may occur Eliminate tension on the tissue when sealing and cutting to ensure proper fu...

Page 6: ...ssel or tissue After inspecting the seal the surgeon should create a second seal adjacent to the first seal before cutting as described below A tone with multiple pulses indicates that the seal cycle was not completed Refer to the Troubleshooting section for possible causes and corrective actions Do not cut tissue until you have verified that there is an adequate seal 6 To seal adjacent tissue ove...

Page 7: ... The user is grasping thin tissue or not enough tissue open the jaws and confirm that a sufficient amount of tissue is inside the jaws If necessary increase the thickness of the tissue that is grasped and reactivate the seal cycle Too much tissue between the jaws The user is grasping too much tissue open the jaws reduce the amount of tissue tat is grasped and reactivate the seal cycle Activating o...

Page 8: ...of one year from the date of purchase General Warranty Terms Applicable to All Products TO THE FULLEST EXTENT PERMITTED BY LAW THE EXPRESS WARRANTY SET FORTH HEREIN IS THE ONLY WARRANTY APPLICABLE TO THE PRODUCTS AND IS EXPRESSLY IN LIEU OF ANY OTHER WARRANTY BY STRYKER EXPRESSED OR IMPLIED INCLUDING BUT NOT LIMITED TO ANY IMPLIED WARRANTY OR MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE IN ...

Page 9: ...he initial warranty period has expired by the time the product is repaired or replaced for thirty 30 days after delivery of the repaired or replaced product When a product or component is replaced the item provided in replacement will be the customer s property and the replaced item will be Stryker s property If a refund is provided by Stryker the product for which the refund is provided must be r...

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