OrthoPilot – TKA application software e.motion, Columbus and VegaSystem

Aesculap Orthopaedics

TKA application software e.motion®, Columbus® and Vega System®

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

Safe handling ... 2 Product description ... 3 Intended use... 3 Indications and contraindications ... 3 Application... 4 System components ... 4 Components necessary for use ... 4 For e.motion®... 4 For e.motion® MIOS ... 4 For Columbus®... 5 For Vega System® ... 5 4.2 Installing and starting the software... 5 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... 6 5.2 Options... 6 5.3 Safety and functionality ... 6 5.4 Safe operation - plausibility checks ... 6 5.5 Entering the patient data... 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 ... 7 5.10 Registration of anatomic landmarks... 8 5.11 Plausibility checks ... 8 5.12 Navigated bone preparation... 8 5.13 Quitting the software ... 8 6. Protocol ... 9 7. Technical Service... 9

1.

Safe handling

The present instructions for use must be kept available and accessible for all OR 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 be used only by qualified surgeons who are experienced in manual operating techniques and have received comprehensive training by Aesculap technicians or surgeons experienced in using the navigation system! ¾ Prior to beginning surgery with the system, ensure that all the appropriate manual instruments are available.

Attention is drawn in particular to the following product information documents:

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Designation

Art. no.

Instructions for use for OrthoPilot® System FS100

TA010004

Instructions for use for OrthoPilot® System FS101….FS106

TA012658

Quick Guide for OrthoPilot® System FS104/FS106

TA012653

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

TA012659

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

TA012821

Navigated Operating Technique, Product Information for e.motion®, e.motion® IQ, Columbus® and Vega System®

O39702

Designation

Art. no.

Manual surgical technique, product information for e.motion®

O25902

MIOS surgical technique, product information for e.motion®

O28602

Manual Operating Technique IQ, Product Information for e.motion®

O43602

Manual surgical technique, product information for Columbus®

O24002

MIOS surgical technique, product information for Columbus®

O28502

Manual Operating Technique, Product Information for Vega System®

O43302

2.

2.2 Indications and contraindications The system can be used in all cases where revision arthroplasty of a knee is surgically indicated. Contraindications for these prostheses are listed in the documentation enclosed with the respective implants. The presence of excessive damage to the joint can render 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

Product description 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! Bone properties or bone quality factors precluding the firm and safe anchoring of the transmitter fixation elements in the bone also present a contraindication.

2.1 Intended use The FS207, FS208 and FS226 application software is a software module for the computer-aided navigation of surgical instruments, with the aim to achieve optimal positioning of knee endoprostheses in the patient’s joint. The patient data required for this procedure are registered intraoperatively, making preoperative CT-scans unnecessary. Two (optionally three) active or passive infrared transmitters applied on the patient provide the link between the patient and the computer. The transmitters are located by an infrared camera connected to the computer. The instruments are also fitted with infrared transmitters, so that the spatial correlation to the patient can be ascertained by the camera and the transmitters on 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 into operation.

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Aesculap Orthopaedics

TKA application software e.motion®, Columbus® and Vega System®

3.

Application

For e.motion®

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

CAUTION

4.

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

System components

4.1 Components necessary for use Designation

Art. no.

OrthoPilot® system

FS100/FS101

Passive transmitters

FS633, FS634 and FS635

Active transmitters

FS601

OrthoPilot® single-use passive markers

FS616 or FS617

For use with active transmitters: TIU module or SCU module

FS100 FS101

Standard Designation

Art. no.

Navigation set

NP610 or NP611

Alignment block

NE440R

Foot plates

NE441RM, NE442RM

MIOS Designation

Art. no.

Navigation set

NP610 or NP611

MIOS instruments

NE490

IQ

For use of ultrasonic devices for intraopera- FS101 only tive imaging: Ultrasound module

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Designation

Art. no.

Navigation set IQ

NS720

For e.motion® MIOS Designation

Art. no.

Navigation set

NP610 or NP611

Orientation block with

NQ955R or NQ945R

Y foot plate

NQ945R

4.3 Operating principle of the OrthoPilot® software module

For Columbus® Standard Designation

Art. no.

Navigation set

NP610 or NP611

Orientation block with

NE324T

Foot plates

NE441RM, NE442RM

MIOS Designation

Art. no.

Navigation set

NP610 or NP611

MIOS instruments

The OrthoPilot® software modules FS207, FS208 and FS226 for orthopedic applications in knee arthroplasty allow precise guidance for the application of drill holes and bone cuts and for the implantation of endoprostheses. The given, patient-specific 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 precise computation of the bone preparation steps, the implant bed and the implant position and, consequently, precise, computer-controlled positioning of the navigated instruments.

WARNING

NE340

For Vega System® Designation

Art. no.

Navigation set IQ

NS720 or NP636 with NP611

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.

5.

The OrthoPilot® software modules FS207, FS208 and FS226 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 the user with an integrated system for bone preparation and/or prosthesis implantation.

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. O39702, “Operating technique OrthoPilot® TKA - Total Knee Arthroplasty”.

WARNING

User error! ¾ To ensure safe use of the OrthoPilot® TKA application software, always follow Operating Manual O39702.

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Aesculap Orthopaedics

TKA application software e.motion®, Columbus® and Vega System®

5.1 Special instruments for the OrthoPilot® application These 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 resection depth, frontal and sagittal angles, and 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.

5.3 Safety and functionality

CAUTION

CAUTION

5.2 Options

WARNING

User error! ¾ Settings should be changed only by Aesculap software specialists.

The OrthoPilot® software can be adapted to individual users’ requirements in various ways: • Use of active IR transmitters only • Use of passive IR transmitters only • Activation/Deactivation of 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 (requiring a reference basis on the iliac crest) • Optional kinematic data registration for the ankle (precise palpation is particularly important if the joints are stiff) • Second reference point for the resection depth on the tibia head • Palpation of the epicondyles as a reference for the rotation of the femoral component • Display of individual steps, as a reminder: "Remove Osteophytes", "Check Tibia Size" • Inspection of the mechanical, lateral, distal femur angle (mLDFA) using data from X-ray imaging

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.

5.4 Safe operation - plausibility checks 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 and continued manually with standard instruments, such malfunctions do not pose an additional risk to the patient, provided they are discovered in good time. Therefore it is important, particularly during the early stages of using OrthoPilot®, to continuously check the plausibility of the steps suggested by the system. Should any doubts arise 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 there are any technical problems during the surgical intervention, e.g. if the program suddenly shuts down, the anatomic geometry (e.g. the axis ratios) can be re-registered by restarting the application software. If the axis ratios are reregistered after restarting, 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

CAUTION

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

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

CAUTION

CAUTION

All data registration steps must be carried out with the best possible precision. Also, other data to be entered into 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 is found to match the user’s intentions. 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 bore holes, incisions and implants.

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

CAUTION

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.

5.9 Locating the hip center with iliac transmitter Fixating a transmitter on the iliac crest is indicated when 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 during localization of the hip center and, consequently, the precise determination of the location of the femoral 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 under peridural or spinal anesthesia who are inadequately immobilized

CAUTION

5.8 Locating the hip center without iliac transmitter This method of kinematic data registration in the hip center is most sensitive in terms of data precision, because only one reference transmitter is used on the femur. 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.

Since this registration of the hip center is the only one to exclusively use the position and alignment of a navigation reference basis in relation to the infrared camera (thereby avoiding a reference basis at the iliac crest), it is extremely important that the camera position relative to the operating table is not moved during the entire registration procedure. (In all other steps, the relative position of two reference bases is used for data registration. Hence these results are impervious to camera movements.)

CAUTION

Any discrepancy between the OrthoPilot® data and radiographic data is likely to affect the postoperative outcome. If the surgeon is unwilling to accept the discrepancies between the femoral axis angles taken from X-ray images and the angles given by OrthoPilot®, and 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 pelvic movements, which, if only one transmitter is used, would remain undetected and could affect the computation of the hip center.

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Aesculap Orthopaedics

TKA application software e.motion®, Columbus® and Vega System®

5.10 Registration of anatomic landmarks

CAUTION

CAUTION

CAUTION

To obtain correct data, minimal force should be applied 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. Especially at the early stages of operating with OrthoPilot®, inaccurate palpation of the points can result in incorrect measurements/displays (e.g. femur size). Therefore, always check for plausibility of the suggested dimensions. If in doubt, compare the electronic data with mechanical measurements obtained with the knee® instruments. The calculation of the knee and ankle centers uses both palpation and kinematic data. 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

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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. The angle is then displayed for comparison against the preoperative planning data. Any discrepancies found in this comparison may necessitate deletion of the data already registered and repetition of the steps “Locating the hip center” and “Medial and lateral dorsal condyles”.

CAUTION

Once 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 the 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.

CAUTION

CAUTION

Should the medial and lateral sides become confused 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 after registration of the anterior central point. This means that all data already registered must be deleted and registered again. This is done by moving back through the program using the left foot switch. Keeping the foot switch depressed for a longer period enables the respective data to be deleted and then re-registered.

5.12 Navigated bone preparation Note Further steps, as well as the complete, intraoperative workflow for the navigated operation, are described in detail in product information brochure O39702, “Operating technique OrthoPilot® TKA - Total Knee Arthroplasty”.

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.

7.

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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