Second Edition Sept 1994, Revised November 1994
First Edition: August 1993 (Revised October 1993)
MEDmetric Corporation, 7542 Trade Street, San Diego,
Ca 92121-2412
The KT1000/S™ is based on principles of instrumented knee articulation which are incorporated in Knee Ligament ARTHROMETER® models KT1000™ and KT2000™ . The accuracy of the KT1000/S™ is to within a fraction of a millimeter. No adjustments for accuracy are needed. Clinical measurements taken with the KT1000/S™ are accurate, repeatable and comparable to measurements taken under the same conditions with the KT1000™ and KT2000™. KT1000/S™ measurements have been shown to be within 1 mm of KT1000™ measurements taken on the same day, on the same subject, under anesthesia. Therefore, pre- and post-operative measurements taken with either the KT1000™ or KT2000™ may be readily and accurately compared to intraoperative measurements taken with the KT1000/S™.
The KT1000/S™ is designed to give the orthopedic surgeon immediate measurements of knee stability while in the O.R. The device may be used with or without the stabilizing straps, depending on the surgeon's technique.
The original design of and subsequent revisions to the KT1000/S™ have been based on the comments of orthopedic surgeons. Experience may well dictate additional enhancements, and we are interested in your comments regarding the KT1000/S™ and its use. Please address all correspondence to:
Dick Watkins
President
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
§ Thigh Support Platform/Carrying Case
§ Elastic proximal strap
§ Fabric distal strap
§ User's Guide
2. Sterilize only in a steam autoclave. Sterilize for approximately 30 minutes at 250°F, 15 lb/in².
Articulate the tibial and patellar rails to ensure dial moves freely. Grip the patellar paddle in your off hand. With the other hand, move the tibial bar up and down. The gears should glide smoothly and the dial should rotate freely. If movement seems sluggish, pull on the dial knob and twist dial; release. An instrument that does not operate smoothly should be scheduled for maintenance.
Emergency Flash Autoclave. Wrap the KT1000/S in a semi-membranous
towel and sterilize at:
| Pressure | Temperature | Time |
| 20 lb/in2 | 260 degrees F | 20 Minutes |
| 25 lb/in2 | 267 degrees F | 10 Minutes |
The flash autoclave process results in a rapid build-up of minerals
from the water on the metal surfaces of the KT1000/S™. The instrument should
be cleaned after surgery using the process below.
CAUTION: All components that will contact the patient must be cool to touch. A device that has not cooled has the potential to injure a patient.
CAUTION: All components that will contact the patient must be cool to touch. A device that has not cooled has the potential to injure a patient.
After removing the KT1000/S™ from the autoclave, allow enough time for the unit to cool. The metal components retain heat, and if the unit does not "stand" long enough, the patient may suffer burns from contact with the KT1000/S. Quick cooling may be achieved by quenching the device in sterile water.
a. Thigh Support Platform. Place thigh support platform (carrying
case) under the subject leg at a level proximal to the popliteal space.
Use a towel to protect patient from residual heat and abrasion. This platform
will keep the flexion angle of both knees symmetrical.
b. Foot Support Platform. A foot support platform (from the KT1000™ or KT2000™) may be used to establish initial tibial radial orientation. Place the foot support platform beneath a sterile drape under both feet of the patient at a level distal to the lateral malleoli. The patient's heels should rest on the foot pad immediately adjacent to the lateral upright ends. Please note: The KT1000™/KT2000™ foot support platform may not be sterilized.
"Over the Table-End" Method: Allow limb to extend over the
foot of the broken surgical table. Stabilize foot either with your body
or with the aid of an assistant to establish initial tibial radial orientation.
No foot or thigh support platform is used with this method.
Flex the Knee. Using a thigh support, towels or by manual
fixation, position knee to desired angle (between 20° and 35°).
Measure the angle of flexion using a goniometer; if necessary, adjust the
joint angle to ensure uniformity. The knee must be flexed sufficiently
for the patella to engage the femoral trochlea.
Position Patient's Foot. Have an assistant grasp the foot so that toes point to ceiling.
Tape Thighs. Excessive external rotation of the hip can be controlled by taping the thighs together.
Position the ARTHROMETER®. Hold the KT1000/S™ on the anterior aspect of the tibia. When the patellar cup properly rests on the patella, the tibial bridge will rest on the tibial spine and the joint-line arrow will approximate the joint line of the knee. Orient the KT1000/S™ in the sagittal plane. Apply pressure on the patella pad to stabilize the patella. If the patella is unstable, flex the knee at a greater angle to bring the patella down into the femoral trochlea.
a. If desired, apply a strap to the distal "buttons" (the knobs protruding from the patellar rail) to stabilize the unit. This will ensure that the tibial rail follows the path of the tibia.
b. If desired, apply the proximal strap to the calf, threading it through the hangers on either side of the KT1000/S™ and securing the Velcro.
Replacement straps may be ordered from MEDmetric®. The KT1000/S™ may be operated without straps.
Adjust the ARTHROMETER®. Confirm that the joint line arrow is at the level of the joint line and that pressure on the patella stabilizes the patella in the femoral trochlea. To adjust the ARTHROMETER® for patella height, loosen the patella sensor adjustment knob (the silver-colored one) and position the tibia and patella rails nearly parallel with one another; tighten the knob.
Lift Dial. Rotate to approximate initial orientation along instrument length.
Stabilize the Patella. Place one hand on the thigh and the patella pad to stabilize the instrument. Push posteriorly on the patella pad until there is no further movement on the displacement dial. Maintain this pressure throughout the examination.
Note: Care must be taken to avoid tilting the instrument when pushing on the patellar paddle.
Adjust the Dial. While maintaining constant pressure on the patella reference pad, rotate the bezel to align the arrow with zero.
Note: Do not push down on the KT. Place thumb of "off" hand on proximal tibia, underneath the instrument.
Rotate the bezel until the arrow aligns with zero as you maintain pressure on the patella pad. Repeat until the dial returns to the same position three times. The testing reference position is the zero position from which all measurements are made.
Stabilize Patella
Apply Direct Force
Use one hand to stabilize patella; use the other to apply direct anterior manual force to the back of the patient's calf. Read and record displacement from the dial. Reestablish testing reference position by applying posteriorly directed force to the proximal tibia. Release. The dial indicator should return to 0 (±0.5 mm). Repeat the sequence three times and compare readings. Take an average of the measurements.
Warning: Use caution when applying force. If fixation is good, a solid feeling of end-point will be noticed with moderate force. Avoid applying a "manual maximum" force which may exceed the pull-out strength of graft-fixation.
Compare with Previous Measurements. Compare with measurement of noninvolved knee previously taken at the same flexion angle under anesthesia.
Post-operative Testing. Comparative post-operative tests may be made with the KT1000/S™, KT1000™ or KT2000™. Clinical measurements taken with the KT1000/S™ are accurate, repeatable and comparable to measurements taken under the same conditions with the KT1000™ and KT2000™. KT1000/S™ measurements have been shown to be within 1 mm of KT1000™ measurements taken on the same day, on the same subject, under anesthesia. Therefore, pre- and post-operative measurements taken with either the KT1000™ or KT2000™ may be readily and accurately compared to intraoperative measurements taken with the KT1000/S™.
2. Instrument Rotation during Test. Stabilize against rotation with hand on patellar pad. Adjust restraining strap.
3. Instrument Lifts as Force Applied. Apply straps. Re-orient patellar force to avoid lift of tibial bridge from the distal tibial spine.
4. Blocked Tibial Excursion. Clear popliteal area and proximal calf from obstruction. Use thigh support if necessary to provide clearance and control flexion.
5. Tibial Rotation. Use foot support platform (from KT1000™ or KT2000™) to orient limb.
6. Excessive External Rotation of the Hip. Tape thighs together.
Patellar Stability. Hold the patella pad with your index finger and thumb. With your long finger, feel the patella margin as you push down on the pad, If the patella is mobile, a measurement artifact is likely. Increase the flexion angle to obtain a deeper trochlear seating and patellar stability.
Instrument Rotation. As you apply anterior-posterior forces to the lower limb, hold the patellar pad firmly across its entire width to control instrument rotation. To illustrate the importance of maintaining rotational stability, try this test: With the KT1000/S™ in the test position on the knee, and while holding the instrument by the patella pad, rotate the KT1000/S™ slightly about the tibial axes. Observe the dial indicator as the instrument "reads" the bony topography.
Instrument Teetering. This is caused by placing patellar pressure too far forward on the pad. To illustrate this source of error, try applying too much force forward on the patellar pad during trial testing so that the back of the instrument lifts off the distal tibia. Observe the dial during this maneuver.
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 failed 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
e-mail: info@medmetric.com
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. All invoices are due and payable thirty (30) days from date of shipment unless otherwise indicated.
Prices. Orders will be invoiced 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.