TKA stem & TKR application software e.motion, Columbus andEnduRo

Aesculap Orthopaedics

TKA stem & TKR application software e.motion®, Columbus® and EnduRo®

Contents 1. 2. 2.1 2.2 3. 4. 4.1

Safe handling ... 2 Product description ... 3 Intended use... 3 Indications and contraindications ... 3 Applications... 4 System components ... 4 Components necessary for use ... 4 For e.motion®... 4 For Columbus®... 4 For EnduRo® ... 4 4.2 Installing and starting the software... 4 4.3 Operating principle of the OrthoPilot® software module ... 5 5. Working with the OrthoPilot® application software... 5 5.1 Special instruments for the OrthoPilot® application... 5 5.2 Options... 6 5.3 Safety and functionality ... 6 5.4 Safe operation – plausibility checks... 6 5.5 Entering the patient data... 6 OrthoPilot® applications FS212, FS222 and FS225 ... 6 OrthoPilot® application FS230... 6 5.6 Data acquisition ... 7 5.7 Kinematic data acquisition ... 7 5.8 Locating the hip center without iliac transmitter... 7 5.9 Locating the hip center with iliac transmitter ... 8 5.10 Registration of anatomic landmarks... 8 5.11 Plausibility checks ... 9 5.12 Navigated bone preparation... 9 5.13 Quitting the software ... 9 6. Protocol ... 9 7. Information on the licenses used... 10 7.1 Info... 10 8. Technical Service... 11

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1. Safe handling The present instructions for use must be kept available and accessible for all O.R. staff and all other users! WARNING

WARNING

WARNING

WARNING

When the OrthoPilot® navigation system is used as an aid for implanting knee endoprostheses, all devices, the Basic System and the implants and instruments may only be used and applied as described in the respective instructions for use and product information documents. To ensure safe application of the OrthoPilot® software module, users must make themselves familiar with the contents of the instructions for use and all product information documents prior to using the system. The OrthoPilot® navigation system may only be used by qualified surgeons that are experienced in applying the manual operating technique and have received comprehensive training by Aesculap technicians or by surgeons experienced in using the navigation system! ¾ Prior to beginning surgery with the system, make certain all instruments required for the manual operating technique are available.

We specifically point to the following product information documents: Designation

Art. no.

Instructions for use of OrthoPilot® system FS100

TA010004

Instructions for use of OrthoPilot® system FS101….FS106

TA012658

Quick Guide for OrthoPilot® system FS104/FS106

TA012653

Instructions for use OrthoPilot® operating system, operation, software (FS101/FS102)

TA012659

Instructions for use OrthoPilot® FS100/FS010 operating system, operation, software

TA012821

Navigated surgical technique, product information for e.motion® and Columbus®

O33502

Navigated surgical technique, product information for EnduRo®

O40302

Navigated surgical technique, product information for TKA stem®

O44702

Manual operating technique, product information for e.motion®

O30602

Manual operating technique, product information for Columbus®

O37702

Manual operating technique, product information for EnduRo®

O38602

2. Product description

The Application is used in combination with the following Implant Systems: • e.motion® • Columbus® • EnduRo®

2.2 Indications and contraindications The system can be used in all cases where a revision arthroplasty of a knee is surgically indicated. Contra-indications for these prostheses are listed in the documentation enclosed with the respective implants. The presence of excessive damage to the joint can make the determination of the joint center from kinematic data unreliable. If this is the case, the software automatically selects joint centers that are calculated redundantly from points scanned with sufficient precision. As this procedure cannot be carried out on the hip, the system can be used in such cases only if the operation-side hip joint is sufficiently mobile.

WARNING

WARNING

A restricted range of movement of the hip joint, or a restricted range of movement coinciding with the indication for implanting an artificial hip, constitutes a contraindication against using the system! Use of the product is contraindicated in cases where bone characteristics or quality preclude the firm and secure anchoring of the transmitter fixation elements in the bone.

Note For further details and information regarding OrthoPilot® Basic system FS100, see TA010004; for OrthoPilot® Basic system FS101, see TA012658. Also refer to the instructions for use “OrthoPilot® operating system, operation, software” (TA012659/TA012821) prior to putting the product to use.

2.1 Intended use The application software working in connection with OrthoPilot® Basic System forms a computer-aided navigation system for surgical instruments, for optimal positioning of total knee endoprosthesis in the patient. The patient data required for this procedure are acquired intraoperatively, making preoperative CT-scans unnecessary. The system can be used in all cases in which a provision with a knee endoprosthesis is indicated. The link between patient and computer is established through infrared transmitters that are attached to the patient. These transmitters are then detected and located by an infrared camera linked to the computer. The instruments are equipped with infrared transmitters as well so that their spatial relationship with the points on the patient where transmitters are fixated can be computed.

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Aesculap Orthopaedics

TKA stem & TKR application software e.motion®, Columbus® and EnduRo®

3. Applications

For e.motion®

The software application described in this document is intended exclusively for use with the following implant systems: • e.motion® • Columbus® • EnduRo®

CAUTION

Further information regarding the use of the respective system components can be found in the appropriate instructions for use and product information documents.

4. System components

Designation

Art. no.

OrthoPilot® system

FS010/FS100/FS101

Passive transmitters

FS633, FS634 and FS635

Active transmitters

FS601

OrthoPilot® single-use passive markers

FS616 or FS617

OrthoPilot® CAP single-use markers

FS618SU or FS619SU

For use with active transmitters: TIU module or SCU module

FS100 FS101

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Art. no.

Navigation set

NP610 or NP611

Alignment block

NE440R

Foot plates

NE441 NE442

Revision navigation set

NE194

Revision tibia cutting block

NE196R and NE197R

4-in-1 Revision cutting block, sizes F2-F8

NE722RNE728R

For Columbus®

4.1 Components necessary for use

For use of ultrasonic devices for intraoperative imaging: Ultrasound module

Designation

FS101 only

Designation

Art. no.

Revision set

NQ600

Revision navigation set passive

NQ594

Revision navigation set active

NQ596

For EnduRo® Designation

Art. no.

Revision set

NP300

Revision navigation set passive

NP650

4.2 Installing and starting the software Note For further details regarding the installation and start-up of the software, as well as other system technical information, see instructions for use “OrthoPilot® operating system, operation, software” TA012659/TA012821.

4.3 Operating principle of the OrthoPilot® software module The OrthoPilot® software modules FS212, FS222, FS225 and FS230 for orthopedic applications in knee arthroplasty, in combination with the above system components, allow precise guidance for drill holes and bone cuts as well as the implantation of endoprostheses. The given, patientspecific anatomic-geometrical elements, such as leg axes and pelvis position, which provide the basis for the alignment of the bone-preparation cuts and of the endoprostheses, are determined by the computer by means of kinematic and palpation data registered intraoperatively. The operating surgeon records the relevant anatomic structures by palpating them with a pointer. This allows a precise computation of the bone preparation steps, the implant bed and the implant position and, consequently, precise, computer-controlled positioning of the navigated instruments.

CAUTION

The OrthoPilot® software modules FS212, FS222, FS225 and FS230 are designed for exclusive use with the appropriate instruments or endoprosthesis system, respectively. All components mentioned in this document have been harmonized in such a way that they provide for the user a complete system for bone preparation and/or prosthesis implantation.

5. Working with the OrthoPilot® application software The following is an outline of the essential steps and critical points for successful data acquisition. The subsequent, necessary bone preparation steps are also performed with the help of the application software. These steps are largely identical to the steps required for a manual TKR operation. The complete, intraoperative workflow for the navigated operation is described in detail in product information brochure no. O33502, O40302 and O44702, “Operating technique OrthoPilot® TKR - Total Knee Revision”.

WARNING

User error! ¾ To ensure the safe use of the OrthoPilot® TKR application software, comply with operating manual O33502, O40302 or O44702.

5.1 Special instruments for the OrthoPilot® application The special instruments are fitted with adapters for infrared transmitters. Navigation technology allows instrument positioning with millimeter and angle-degree precision. Therefore, the OrthoPilot® navigation system is equipped with extremely precise adjusting mechanisms for the resection depth, the frontal and sagittal angles, and the rotation. As OrthoPilot® is calibrated only for use with these special instruments, only Aesculap instruments may be used with the system. The special instruments are subject to the relevant guidelines and regulations for cleaning and sterilization of autoclavable instruments. Further information in this regard can be found in the appropriate instructions for use of the implants, instruments and devices.

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Aesculap Orthopaedics

TKA stem & TKR application software e.motion®, Columbus® and EnduRo®

5.2 Options

WARNING

5.4 Safe operation – plausibility checks User error! ¾ Any settings may be changed only by Aesculap software specialists.

The OrthoPilot® software can be adapted to the individual user's requirements in various ways depending on the application: • Use of active IR transmitters only • Use of passive IR transmitters only • Activating/Deactivating acoustic feedback messages • If the range of motion or the mobility of the hip is restricted, the alternative method for registering the hip center must be applied (using a reference basis on the iliac crest) • Optional kinematic data registration for the ankle (precise palpation is particularly importance in cases of joint stiffness) • Second reference point for the resection depth on the tibia head • Palpation of the epicondyles as reference for the rotation of the femoral component • Display of individual steps (as a memory aid for the surgeon): "Remove Osteophytes", "Check Tibia Size" • Inspection of the mechanical, lateral, distal femur angle (mLDFA) using data from X-ray imaging

5.3 Safety and functionality

CAUTION

CAUTION

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The precision of the values displayed during the operation primarily depends on the quality of the landmarks registered kinematically or through palpation. Optimal data acquisition requires adequate knowledge of the anatomic conditions. The bone structures displayed on the screen are not based on diagnostic imaging procedures carried out on the patient undergoing the surgical procedure. Consequently, the display does not represent the bone structure of the individual patient; it only serves as a visual aid for intuitive user guidance.

As with every technical device, OrthoPilot® is subject to possible malfunctions due to technical faults or user errors. However, since interventions performed with the OrthoPilot® navigation system can be aborted at any time, to be continued with standard instruments, such malfunctions do not present an additional risk to the patient, provided they are discovered at an early enough stage. Therefore it is important, particularly at the early stages of using OrthoPilot®, to continuously check the plausibility of the steps suggested by the system. Should there arise any doubts as to whether the system is functioning correctly, the test procedure must be repeated (if possible), or the intervention must be continued by non-navigated surgery using the conventional operating technique.

CAUTION

In case of technical problems during the surgical intervention, e.g. if the program suddenly shuts down, the anatomic geometry (e.g. the axis relations) can be re-registered by restarting the application software. If the axis situation is re-registered after the restart, its plausibility with regard to the radiological picture (e.g. image of the entire leg under load in a standing position) must be checked again.

5.5 Entering the patient data OrthoPilot® applications FS212, FS222 and FS225

CAUTION

When entering the patient data, care must be taken that the appropriate camera position and side are selected for the actual operating side. Failure to do so will result in incorrect computations by the application software.

OrthoPilot® application FS230

CAUTION

In this module, the camera can be positioned both contralaterally and ipsilaterally to the side of operation when the patient data are entered. Here, it must be ensured that during the data acquisition there is no mix-up between the medial and lateral side of the leg to be operated on.

5.6 Data acquisition

5.8 Locating the hip center without iliac transmitter

Data are registered through three different, basic methods: • Kinematic data registration • Registration of palpated anatomic landmarks • Registration of preoperative data via keyboard input

This method of kinematic data registration is most sensitive in terms of data precision, because only one reference transmitter on the femur is used. In this way, additional trauma to the patient, caused by a second reference transmitter on the iliac crest, is avoided. Normally, the message “Data inadequate” is displayed if the quality of the registered data is not good enough. Otherwise, the program automatically moves to the next program step as soon as sufficient data have been measured and recorded.

CAUTION

CAUTION

All kinematic measurements and palpations must be carried out with the best possible precision. Also, other data used as input for the OrthoPilot® system must be determined with maximum precision. Generally, each step of the program sequence should be confirmed as soon as the respective measurement result is displayed on screen and found matching the user’s intention. The values displayed at the time of confirmation are saved to the log file and used for further calculations. Erroneous data confirmation or incorrect data input can result in miscalculations and, consequently, incorrect positioning of burr holes, incisions and implants.

CAUTION

Since this registration of the hip center is unique, in that it relies exclusively on the position and alignment of a navigation reference base in relation to the infrared camera (thereby avoiding a reference base at the iliac crest), it is extremely important that the camera position relative to the operating table remains fixed throughout such registration. (In all other steps, the relative position of two reference bases is used for data registration. Hence these results are impervious to camera movements.)

5.7 Kinematic data acquisition Kinematic data are registered for determining the joint centers (hip, knee and ankle).

CAUTION

If transmitters are moved too rapidly, the camera may be unable to track the transmitters, causing the traffic light symbol to signal red. This can happen in all steps in which the transmitters are moved through a relatively large area.

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Aesculap Orthopaedics

TKA stem & TKR application software e.motion®, Columbus® and EnduRo®

5.9 Locating the hip center with iliac transmitter Fixating a transmitter on the iliac crest is indicated in cases where the user prefers safe and precise determination of the hip center by means of two reference transmitters. This method should be applied if the necessary immobilization of the pelvis and, consequently, the precise determination of the location of the hip head center cannot be ensured otherwise. The pelvis tends to move inadvertently in the following cases: • Restricted range of movement of the hip • Adiposity of the patient • Inconvenient position of a tourniquet • Patients with peridural or spinal anesthesia without adequate immobilization

CAUTION

CAUTION

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Discrepancy between the OrthoPilot® data and radiographic data are likely to affect the postoperative outcome. If the surgeon will not tolerate the discrepancies between the femoral axis angles taken from X-ray images and the angles given by OrthoPilot® and if a repeat measurement of the hip without a pelvic pin does not produce a satisfactory result, the kinematic hip measurement must be carried out with the pelvic pin. The pelvic pin eliminates all interference in the computation of the hip center, e.g. relative movement between the pelvis and the camera. The kinematic hip center may be registered through free movement (without the defined circle on the screen) only after a reference basis has been fixed on the iliac crest with a bone screw. As this method of data registration requires relatively wide movements of the hip, it involves the risk of coincident pelvis movements, which, if only one transmitter is used, would remain undetected and could affect the computation of the hip center.

5.10 Registration of anatomic landmarks

CAUTION

To obtain correct data, only apply mild force when using the pointer. Do not bend the pointer. Any use of bent instruments will result in incorrect computation of angles, distances and implant size. ¾ Check the pointer for proper functioning according to the specifications given in TA012659/TA012821.

CAUTION

Especially at the early stages of operating with OrthoPilot®, inaccurate palpation of the points can result in incorrect measurements/data (e.g. femur size). Therefore, always perform plausibility checks of suggested dimensions. If in doubt, compare the electronic data with mechanical measurements obtained with the knee® instruments.

CAUTION

The calculation of the knee and ankle centers uses both palpation and kinematic data depending on the software module. In this way the joint centers are located with optimum precision. However, if large discrepancies between the two data sets are found, the software uses the joint center determined by palpation. Therefore, the palpations must be carried out with particular care.

5.11 Plausibility checks

CAUTION

CAUTION

Data registration must be accompanied by plausibility checks of the recorded anatomy. The displayed angle between the femoral joint line (tangential to the distal femoral condyles) and the mechanical femur axis must be compared with the preoperative planning data. Any discrepancies found in this comparison may make it necessary to delete data already registered and repeat the steps “Locating the hip center” and “Medial and lateral dorsal condyles”. Once the data registration is complete, the overall leg axis angles must be checked for plausibility. If any discrepancies are found in this check, the surgeon may have to delete data already registered and repeat the steps “Locating the hip center”, “Medial and lateral dorsal condyle”, “Anterior corticalis point”, “Medial and lateral malleolus” and “Anterior central point”. Should such discrepancies persist, the iliac reference point or the manual technique may have to be used instead.

5.12 Navigated bone preparation Note Further steps and the complete, intraoperative workflow for the navigated operation are described in detail in product information brochure no. O33502, O40302 and O44702, “Operating technique OrthoPilot® TKR Total Knee Revision”.

5.13 Quitting the software Note For further details and information on the OrthoPilot® operating system, operation, software, see TA012659/TA012821.

6. Protocol Note See instructions for use “OrthoPilot® operating system, operation, software” TA012659/TA012821.

CAUTION

CAUTION

Should the medial and lateral sides have been mixed-up when palpating the landmarks, or the registered data prove to be completely incorrect anatomically, a warning message indicating that the palpation data are incompatible is displayed on the screen before the "mechanical leg axis" is displayed. This means that all data already registered must be deleted and registered again. This is done by moving back through the program sequence by pressing the left foot switch. As the foot switch is kept pressed for a while, the respective data are deleted and can be registered again.

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Aesculap Orthopaedics

TKA stem & TKR application software e.motion®, Columbus® and EnduRo®

7. Information on the licenses used The following software licenses are used in the OrthoPilot® software module TKA stem FS230: • LGPL The product FS230 uses Qt framework version 4.6.2 under the LGPL license version 2.1. Qt is protected by copyright C 2009 Nokia Corporation and/or its subsidiaries. Contact: Nokia Corporation ([email protected]) • Apache The product FS230 includes software developed by the Apache Software Foundation (http://www.apache.org/). This is authorized by Apache license version 2.0. Parts of this software are based on copyright-protected software, copyright C 1999, IBM Corporation., http://www.ibm.com • Touch-It Virtual Keyboard The product FS230 uses Touch-It Virtual Keyboard® developed by Chessware SA and is protected by copyright C (http://www.chessware.ch/virtualkeyboard/). We have agreed to the licensing conditions for the above software products. For further information, please contact your national B. Braun/Aesculap agency.

7.1 Info Further information can be obtained by pressing the information button (i-button) in the top right part of the screen when the application is running, see Fig. 1

Fig. 1

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8. Technical Service For service, maintenance or repairs, please contact your national B. Braun/ Aesculap representatives. Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses. Service addresses Aesculap Technischer Service Am Aesculap-Platz 78532 Tuttlingen / Germany Phone: +49 7461 95-1148 Fax: +49 7461 16-2887 E-Mail: [email protected] Other service addresses can be obtained from the address indicated above.

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