Reference and User's Guide for the LH1000

LH1000 Arthroscpoic Leg Holder

First Edition 1993, Revised July 1996
MEDmetric® Corporation, 7542 Trade Street, San Diego, CA 92121-2412
Copyright 1993


Contents

Thank You
Introduction
Warnings
Satisfaction Assurance
LH1000 Description
Operating Room Use
Cleaning Techniques
Limited Warranty
Terms and Conditions of Sale


Thank You

Thank you for acquiring the MEDmetric® LH1000™.

The LH1000™, first introduced in 1980 and known as the "SurgAssist™", is the product of research and development beginning prior to 1979. MEDmetric® founder Lawrence L. Malcom, Ph.D., developed the prototypical model which is the basis for this third generation of arthroscopic leg holder. Design improvements are continually incorporated which enhance the usefulness of the LH1000™. As significant improvements or new features are developed, you will be notified and given the opportunity to upgrade your device.

This User's Guide has been prepared by the professional staff of MEDmetric® to aid you in application of the LH1000™ to your diagnostic and arthroscopic surgery cases. Illustrates suggested methods of set-up and draping while using the LH1000™. We are certain that you will find the practice of arthroscopy much more efficient and enjoyable when using this product.

We are very interested in your comments regarding the LH1000™ and its use. Your observations may guide us in producing a design enhancement which will improve performance of the instrument. Please address all correspondence to:
 
 

MEDmetric® Corporation
7542 Trade Street
San Diego, California 92121-2412
Phone: (858) 536-9122 or (800) 995-6066;
fax: (858) 536-9303; E-Mail: info@medmetric.com







Dick Watkins
President


Introduction

LH1000™ is a convenient and easy-to-use limb stabilization system which is designed specifically for application during diagnostic and surgical arthroscopy. LH1000™ offers the surgeon the following benefits: For diagnostic arthroscopy, LH1000™ allows one-hand control of varus or valgus opening without the need for an assistant. During surgical arthroscopy with LH1000™, an assistant can easily control the flexion angle and medial or lateral opening entirely from the patient's foot. The design permits lengthy application of varus or valgus stress without assistant fatigue and unsteadiness



 

Warnings

While the LH1000™ has been designed with the utmost consideration for safety, no product is entirely safe in every situation. The following warnings and contraindications always should be observed.

WARNING: Potential tourniquet effect. The device should remain in the tightened position only as long as one would utilize a tourniquet.

WARNING: To assure complete arrest of blood flow, a tourniquet always should be applied proximal to this device. Using this device without a proximal tourniquet could result in venous stasis alone without associated arterial stasis.

WARNING: Clinical judgment must be used to be sure that this device is never applied to patients who are at risk of nerve or vascular compression, or who are at risk of vascular accidents.

WARNING: The augmented proximal joint stability provided by this device permits the manual application of higher levels of varus or valgus stress. Excess stress application will cause ligamentous stretching or tearing. Remember, the collateral ligament must resist over ten (10) times the tension force that you are applying to the foot for varus or valgus stretch.

WARNING: Since the foot of the operating table is to be lowered during arthroscopy, be sure that this device is clamped to the stationary central section of the able and not to the table foot section.

WARNING: For large or obese patients, avoid pinching skin as the strap is tightened.
 
 
 



 

Satisfaction Assurance

MEDmetric® Corporation assures customer satisfaction. If for any reason during the first ten (10) days following delivery of your LH1000™ you are dissatisfied with it, you may return your instrument in "as new" condition for full credit of the price paid or pledged.

We ask only that you provide us with the cause of your dissatisfaction in writing and that you inform us of your intention prior to return of the instrument.

Shipping charges are the responsibility of the purchaser. In the event of returned equipment, your account will be credited with the purchase price and applicable sales taxes only. You will be billed for the shipping charges.

We feel that ten (10) days of use is adequate to determine your acceptance of the instrument. Therefore, no extensions of the ten (10) day satisfaction guarantee will be made, except by express written authorization.
 


Dick Watkins
President
 



 

LH1000 Description



 
 

  • Buckle
  • Nylon Strap
  • Stainless Steel Bar
  • Nylon Strap Guard
  • Coated Foam Cushion (replaceable)
  • Powder Coated Aluminum Base

  •  

     
     
     

    Note: The newest LH1000™ units have a quick-release pin in the base. This secures the base at one of three positions and allows for medial/lateral adjustment of the leg holder.
     
     
     
     


    Operating Room Use

    1. Position the Patient on the operating room table so that the knee joint lies beyond the edge of the table break. Do this before attaching the LH1000™ to the table.

    2. Mount the LH1000™ on the lateral rail of the O.R. table after the patient is in position..

    3. Apply Standard Pneumatic Tourniquet to the limb in most proximal position possible so maximum room remains for the LH1000™ and allowing greatest distal exposure of the sterile field..

    4. Lift Patient's Leg and place in the LH1000™ on the table under it.

    5. Secure the LH1000™ to the most distal portion of the side rail on the central section of the O.R. table by using a standard clamp. These standard O.R. table clamps are added or removed from the table by hooking them through the notched section of the table side rail.

    6. Check the patient's location relative to the O.R. table, and shift the patient's position so that the distal edge of the tourniquet just touches the proximal edge of the LH1000™. This provides maximal exposure distal to the LH1000™ for your sterile field.

    Note: Since the LH1000™ is not attached to the limb or obstructing it in any way at this point, you are free to raise or abduct the limb if desired during prep. After prep, it is recommended to apply the stockinet and Esmarck bandage for maximal venous drainage. Additionally, be sure to utilize the advantage of gravitational postural drainage by lifting the leg to a vertical position before inflating the tourniquet. Due to the open design of the LH1000™, vertical manipulation of the leg is not obstructed.

    7. Put an impervious drape on the table while the leg remains lifted, and secure the drape with towel clips.

    8. Support the patient's leg. Lower the foot of the O.R. table to 90° and complete the sterile draping in the usual manner. Note that the compact, low-profile design of the LH1000™ permits maximal knee exposure even on small legs. This low-profile design also permits supra-patellar arthroscopic approaches and posterior medial or lateral approaches.

    If Arthrotomy becomes Necessary

    When the surgeon elects to perform arthrotomy in the midst of a surgical arthroscopy procedure, the LH1000™ may be removed easily:

    1. Have non-sterile assistant reach under drape and unbuckle strap, pulling it entirely free of the buckle.

    2. The leg is now free to be raised, flexed and rotated in the usual manner for arthrotomy.

    3. For maximum sterility, re-prepping is recommended before the onset of arthrotomy.
     

    Surgeon Technique with Assistant

    During arthroscopy, the surgeon and assistant may work from a seated position. The assistant manually controls the flexion angle and medial or lateral opening entirely from the foot. The assistant can sit to the right or the left of the patient and to the side or behind the surgeon.
     

    Surgeon Technique Working Alone

    For diagnostic arthroscopy, the LH1000™ allows the surgeon complete one-hand control over the degree of joint opening, usually without the necessity of an assistant. If an assistant is not used, may surgeons control the degree of joint opening during surgical arthroscopy by using the pressure of their lateral thigh on the patient's foot, or by putting the patient's foot between their knees when they are sitting.


    Cleaning Techniques

    Since the LH1000™ sits outside the sterile field, no sterilization in necessary. When it is necessary to clean the cushion, use soap and water. Betadine will stain the cushion cover. A towel should be used to shield the surface from betadine stains.

    The cushion and strap guard will not withstand the high temperatures of autoclave; it is recommended that the cushion remain at temperatures below 130ºF/53ºC.

    Replacement cushions are available directly from MEDmetric® Corporation.



     

    Limited Warranty

    This warranty is limited to the original purchaser.

    MEDmetric® products are warranted by MEDmetric® Corporation to the original purchaser to be free from defects in materials and workmanship for a period of one (1) year from the date of purchase. MEDmetric® agrees within this warranty period to replace or repair, at MEDmetric's® option and without cost to the purchaser, any part or parts, returned to MEDmetric®, with transportation charges prepaid, which upon MEDmetric's® examination discloses to have been defective as a result of defects in materials and/or workmanship. In no event shall MEDmetric® be held liable for transportation expenses or any expense other than the cost of service, repair or replacement of defective parts in accordance with provisions of this warranty. Warranty services may be arranged by contacting:
     
     

    MEDmetric® Corporation
    7542 Trade Street
    San Diego, California 92121-2412
    Telephone: (858) 536-9122 or (800) 995-6066; fax: (858) 536-9303






    Misuse, abuse, neglect or unauthorized repairs or alterations shall void this warranty.

    No implied warranties of any nature whatsoever expressly including warranties of merchantability and fitness for a particular use, shall exceed the duration of this express warranty. It being recognized that the one (1) year period from the date of purchase is a reasonable warranty period for inspection of the products to allow determination as to whether there are defects in material and workmanship, and that the warranty period is a reasonable period for such an implied warranty to exist.

    MEDmetric® shall not be liable for incidental or consequential damages of any nature, and MEDmetric's® sole liability shall be for the repair or replacement of defective parts pursuant to this warranty.

    MEDmetric® will not be liable for commitments or agreements made by any of its employees, agents or dealers not in compliance with this warranty. This warranty is expressly in lieu of any other warranty, express or implied. This warranty gives specific legal rights to the purchaser of MEDmetric's® products covered hereby. Purchasers may also have legal rights which vary from state to state.



     

    Terms and Conditions of Sale


    When MEDmetric® Corporation accepts an order, it shall become a binding contract subject to our terms and conditions of sale and will not be subject to countermand without the written consent of MEDmetric® Corporation .

    Terms. All invoices are due and payable thirty (30) days from date of shipment unless otherwise indicated.

    Prices. Orders will be priced at the prices in effect at the date of the order. Prices are subject to change without notice.

    Deliveries. Promises of shipments are estimated as closely as possible. Our Traffic Department cooperates fully in obtaining the best service from the transportation companies, and we always use our best efforts to ship within the time promised. However, we cannot always guarantee delivery dates. Unless otherwise agreed, all merchandise is F.O.B. our factory. Special shipping requests are subject to additional charges.

    Returns. Merchandise may not be returned without our prior consent.

    Warranty. All products manufactured by MEDmetric® Corporation are warranted exclusively in accordance with our limited warranty.

    Product Changes. We reserve the right to redesign, alter or modify our products without incurring any liability whatsoever to any prior buyer of our products.

    Product Specifications. All products supplied by us are designed to perform in accordance with specifications that are available from us and should be consulted prior to use. If you are in doubt, please consult our Engineering Department.

    Attorney's Fees and Costs. If any acknowledgments at law or inequity is necessary to enforce or interpret the Terms of Purchase and Sale contract which becomes mutually binding upon our acceptance of your order, subject to the terms and conditions of sale herein, the prevailing party shall be entitled to reasonable attorney's fees, costs and necessary disbursements in addition to any other relieve to which he may be entitled.