OrthoPilot – ACL Reconstruction V3.1

2. Product description WARNING

2.1 Intended use OrthoPilot® is a system for the computer-aided navigation of surgical instruments. OrthoPilot® Module ACL V3.1 is a module of the OrthoPilot® system and is used for the optimal positioning of drilling channels in ACL-reconstruction patients. The OrthoPilot® Module ACL V3.1 is supporting ACL reconstructions done in the single bundle as well as in double bundle technique. The system can be used in all cases of ACL reconstruction regardless of the choice of graft (hamstring or bone-tendon-bone). OrthoPilot® Module ACL V3.1 is also used to register and analyze the standard stability tests (anterior drawer test, rotation test, pivot shift test) for diagnostic purposes during ACL surgery. A pre- and post-op performed stability test allows the surgeon to evaluate the success of the performed ACL reconstruction. The Software for ACL-Reconstruction in used with the computer navigation system FS010, FS100 or FS101 and the instrument set for ACL navigation FS860M.

2.2 Indications and contraindications The system can be used in all cases of ACL reconstruction using the single or double-bundle technique, both for hamstring and bone-tendon-bone grafts. For information concerning contraindications, see package insert of ACL transplant fixation elements.

WARNING

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

Note For further details and information regarding OrthoPilot® Basic system FS100, see TA10004; for OrthoPilot® Basic system FS101, FS104, FS105, see TA012658 (GB); TA012815 (USA). Also refer to the instructions for use “OrthoPilot® operating system, operation, software” (TA012659 (GB); TA012816 (USA)/TA012821 (GB); TA012871 (USA)) prior to putting the product into operation.

3. Application The given software application is intended solely for ACL reconstruction procedures. The ACL transplant fixation elements selected for such procedures are not relevant.

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

4.1 Components necessary for use 4.1.1

OrthoPilot® Basic System

Designation

Art. no.

OrthoPilot® Basic System

FS010, FS100 or FS101

4.1.2

Software

Designation

Art. no.

OrthoPilot® software for ACL reconstruction V3.1

FS227

4.1.3

Passive transmitters (passive rigid bodies)

Designation

Art. no.

Passive transmitters, yellow (instruments)

FS633

Passive transmitters, blue (tibia)

FS634

Passive transmitters, red (femur)

FS635

4.1.4

Navigated instruments

Three different instrument sets are available for use with the ACL V3.1 application software: Instrument set: Passive RL adapter Designation

Art. no.

Straight pointer

FS871M

Hook pointer with RL adapter

FS856R

Tibial drill guide with RL adapter

FS854R

Transtibial pointer

FS869R

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Aesculap Orthopaedics

ACL Reconstruction V3.1

Instrument set: Passive Y adapter Designation

Art. no.

Straight pointer

FS871M

Hook pointer with Y adapter

FS855R

Tibial drill guide with Y adapter

FS853R

Transtibial pointer

FS869R

WARNING

Incorrect results from navigating with the wrong instrument selection! ¾ Ensure that the appropriate instruments with or without Y adapter or with RL adapter are used. ¾ Ensure that both instruments, hook pointer and tibial drill guide, are always used in each case with or without Y adapter or with RL adapter.

Optional Instrument set: Passive Designation

Art. no.

Straight pointer

FS871M

Hook pointer

FS865M

Tibial drill guide

FS863M

Transtibial pointer

FS869R

Note When starting the application software, the system will ask which instrument set is going to be used. The available instrument set must be entered in the field "Instrument set:".

Designation

Art. no.

Femoral drill guide

FS859R

Note If available, femoral drill guide FS859R can optionally be used intraoperatively with all instrument sets instead of transtibial pointer FS869R, and vice versa. 4.1.5

Designation

Art. no.

Femoral or tibial K-wire transmitter fixation element, left

FS874R

Femoral or tibial K-wire transmitter fixation element, right

FS875R

K-wire ∅ 2.5mm with drill bit for tibial transmitter fixation, 100 mm long (2 pieces, sterile)

FS877R

K-wire ∅ 2.5mm with trocar tip for femoral transmitter fixation, 100 mm long (2 pieces, sterile)

LX055S

Standard Allen key

GB020R

4.1.6

Fig. 1

WARNING

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The configuration of the instrument sets described above may not be changed. Single instruments from the different instrument sets may not be combined to create a new instrument set! For example, an instrument with Y adapter may not be used with the ACL V3.1 application software at the same time as an instrument with RL adapter.

Transmitter fixation elements

Wire basket

Designation

Art. no.

Wire basket for OrthoPilot® ACL instruments

FS861R

Wire basket for OrthoPilot® transmitters

FS862R

4.1.7

Integrated instrument system

Designation

Art. no.

Complete set for navigated ACL reconstruction

FS860M

4.1.8

Accessories/Spare parts

Designation

Art. no.

10 x 1 piece Single-use passive marker

FS614

3 x 4 pieces Single-use passive marker

FS616

CAP single-use passive marker

FS618SU or FS619SU

Sterile container

JK414 P/T

¾ Do not use bent or damaged instruments. ¾ Make certain that there is a free line of sight between the camera and the transmitters that are active during each step of the surgical procedure. ¾ Prior to the surgical intervention, sterilize the instruments that will be used during the surgery. ¾ Also sterilize the instruments to be used (i.e. in case of failure of the computer-aided system) for manual application of the drilling channels for ACL reconstruction prior to the surgical intervention.

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 (GB); TA012816 (USA); TA012821 (GB); TA012871 (USA).

4.3 Operating principle of the OrthoPilot® software module OrthoPilot® software module ACL reconstruction FS227 allows for precise application of the drilling channels in ACL reconstruction procedures. Based on knee kinematics data, the computer performs isometry and impingement calculations, using intraoperatively registered movement parameters of the leg. The operating surgeon records the relevant anatomic structures by palpating them with a pointer. As an option, standard X-ray images can be integrated as an additional basis for navigation. The drill guides or the transtibial pointer for K-wire positioning can be positioned precisely with the aid of the computer. This allows for precise application of the drill holes for implanting the tendon grafts. The patient data are acquired intraoperatively, making preoperative CTscans unnecessary. The patient data are transferred to a computer via a camera, using two passive transmitters which are fixed on the patient. The instruments used in the surgery are also equipped with passive transmitters and can thus be seen in their position relative to the patient. In this way the operating surgeon obtains important data for navigating the instruments.

CAUTION

5. Working with the OrthoPilot® application software The following is an outline of the essential steps and critical points for successful data acquisition. The drilling channels are subsequently positioned with the help of the application software. This is to a large extent commensurate with the manual techniques for ACL reconstruction. The complete, intraoperative workflow for the navigated operation is described in detail in product information brochure no. O91302, Operating Technique OrthoPilot® ACL Reconstruction.

WARNING

User error! ¾ To ensure safe use of OrthoPilot® ACL application software, always follow Operating Manual O91302.

5.1 Special instruments for the OrthoPilot® application The special instruments are fitted with adapters for infrared transmitters. The navigation technology enables precise positioning of the instruments to the exact millimeter and angular degree. As OrthoPilot® is calibrated only for use with these special instruments, only Aesculap instruments intended for such a purpose 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 OrthoPilot® instruments and devices. ¾ Follow the instructions for use of the OrthoPilot® instruments.

The OrthoPilot® software module FS227 has been designed for exclusive use with the appropriate instrument system. All components mentioned in this document have been harmonized in such a way that they provide the user with an integrated system for positioning the drilling channels for ACL reconstruction.

Non-compliance with the following rules will result in complete exclusion of liability on the part of Aesculap: ¾ Check to make certain that all components are intact and functional. 5

Aesculap Orthopaedics

ACL Reconstruction V3.1

5.2 Options for OrthoPilot® application

WARNING

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

The following defaults are set with a view to installation of the OrthoPilot® ACL V3.1 - Application Software FS227 and can be adjusted individually to suit each user: Option

Installation default

Individually adjustable default

Entry of surgeon's name into the workflow step "Patient data"

None

Name of surgeon

Entry of department/clinic name into the workflow step "Patient data"

None

Name of department/ clinic

Entry of instrument set into workflow step "Surgical data"

Passive RL adapter

– Passive – Passive Y adapter – None

Choice of ACL reconstruction technique in workflow step "Surgical data"

None

– Single bundle – Double bundle

Selection of first drilling channel to be navigated in workflow step "Tunnel planning"

tibiaAM

– tibiaPL – femurAM – femurPL

Selection of second drilling channel to be navigated in workflow step "Tunnel planning"

femurAM

– tibiaAM – tibiaPL – femurPL

Selection of third drilling channel to be navigated in workflow step "Tunnel planning"

tibiaPL

Selection of fourth drilling channel to be navigated in workflow step "Tunnel planning"

femurPL

Entry of diameter for single bundle tibia drilling channel in workflow step "Tunnel planning"

None

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– tibiaAM – femurAM – femurPL – None – tibiaAM – tibiaPL – femurAM – None Diameter of drilling channel

Option

Installation default

Individually adjustable default

Entry of diameter for single bundle femur drilling channel in workflow step "Tunnel planning"

None

Diameter of drilling channel

Entry of diameter for double bundle tibia AM drilling channel in workflow step "Tunnel planning"

None

Diameter of drilling channel

Entry of diameter for double bundle tibia PL drilling channel in workflow step "Tunnel planning"

None

Diameter of drilling channel

Entry of diameter for double bundle femur AM drilling channel in workflow step "Tunnel planning"

None

Diameter of drilling channel

Entry of diameter for double bundle femur PL drilling channel in workflow step "Tunnel planning"

None

Diameter of drilling channel

Tibial X-ray planning in workflow step "Tibia X-ray: lateral view"

Yes

No (workflow step is removed)

Tibial X-ray planning in workflow step "Tibia X-ray: AP view"

Yes

No (workflow step is removed)

Anatomic landmark for Xray image matching in workflow step "Tibia X-ray: lateral view"

Yes (landmark is the spine of med. intercondylar tubercle)

No (landmark is tibial tuberosity)

Femoral X-ray planning in workflow step "Femur Xray: lateral view"

No

Yes

Comparison of the length Yes of Blumensaat's line between X-ray planning and landmark registration in workflow step "Femur Xray: lateral view"

No (workflow step is removed)

Option

Installation default

Individually adjustable default

Conduction of pre-op knee stability test in workflow step "Pre-op knee stability test"

Yes

No (workflow step is removed)

Conduction of post-op knee stability test in workflow step "Post-op knee stability test"

Yes

Conduction of pre-op pivot shift test in workflow step "Pivot shift test"

Yes

No (workflow step is removed)

Conduction of post-op pivot shift test in workflow step "Pivot shift test"

Yes

No (workflow step is removed)

Conduction of isometric calculation in workflow steps "Center tibia/femur tunnel"

Yes

No

Display of center between spine of med. intercondylar tubercle and anterior horn in workflow steps "Center tibia tunnel"

No (workflow step "Anterior horn lateral meniscus" is removed)

Yes

Display of distance to PCL in workflow steps "Center tibia tunnel"

Yes

No (workflow step "PCL anterior margin" is removed)

Display of distance to condylar cartilage-bone border in workflow steps "Center femur tunnel"

Yes

5.3 Safety and functionality

CAUTION No (workflow step is removed) CAUTION

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

Display of drill channel No position according to Watanabe in workflow steps "Center femur tunnel"

No (workflow step "Posterior cartilage border" is removed) Yes

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 nonnavigated 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. kinematics) can be re-registered by restarting the application software.

5.5 Entering surgical data

CAUTION

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

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Aesculap Orthopaedics

ACL Reconstruction V3.1

5.6 Data acquisition Data are registered mainly in three different ways: • Registration of kinematic data • Registration of palpated anatomic landmarks • Registration of preoperative data via keyboard input

CAUTION

CAUTION

CAUTION

Imprecise registration of landmarks, leading to erroneous navigation results due to excessive distance between the transmitter on the tibia and the transmitter on the instrument! ¾ Position the K-wire fixation for the transmitter on the tibia at a distance of no less than 20 cm from the joint line.

CAUTION

Necrosis of the bone possible from excessive heat development if, due to hard corticalis, penetration of the K-wire is poor. ¾ Always use new and sharp single-use K-wires with drill bit on the tibia. ¾ If the tibial corticalis is very hard, pre-drill with a 1.5-2 mm drill, if necessary.

All data registration steps must be carried out with the best possible precision. Also, the 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 drilling channels.

5.9 Kinematic data acquisition The acquired kinematic data are used to determine isometry and impingement, as well as for the knee stability test (anterior drawer, int./ ext. rotation and pivot shift).

5.7 X-ray planning input As an option, preoperative X-ray planning of the tibial and femoral drilling channel positions can be integrated into the navigation process. 5.7.1

Quality of the X-ray images

CAUTION

CAUTION

Erroneous navigation results due to imprecise Xray images! ¾ Make certain that the scale of the X-ray image is correctly determined. ¾ Ensure that the lateral and AP views used in the X-rays are configured correctly. ¾ Make certain that any distortion of the X-ray images is kept to a minimum. Incorrect navigation results due to erroneous femoral X-ray planning! ¾ Disregard data from femoral X-ray planning if a warning is displayed on the screen.

5.8 Fastening the transmitter fixation elements Special fixation elements are used to help fasten the transmitters to the tibia or femur using K-wires. The stability of the fixation is crucial to the accuracy of the measurements and thus to the entire navigation process.

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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.

5.10 Registration of anatomic landmarks To enable the computation of the tibial exit point and the femoral insertion point of the drilling channels, some crucial landmarks for the application of the drill guides must be registered by the system. If, due to previous surgeries, some of the required landmarks no longer exist, some of the palpated data may be unreliable. In this case, the operating surgeon may only use those results of the redundant navigation calculations that are based on a reliable and accurate registration of the landmarks.

CAUTION

CAUTION

CAUTION

CAUTION

CAUTION

Erroneous navigation results from imprecise palpation of landmarks, particular during the early stages of handling OrthoPilot®! ¾ Always check the plausibility of the suggested dimensions and results against previous experience of the operating surgeon. ¾ If in doubt, compare the computed results with results obtained by mechanical means using standard ACL reconstruction instruments.

Erroneous navigation results due to selecting the wrong adapter pin when using instruments with Y adapter or RL adapter! ¾ Ensure that the correct adapter pin is used on the instrument during registration.

5.11 Optional measuring instrument

Erroneous navigation results due to use of the inappropriate tools with the selected type of instrument! ¾ Ensure that the correct type of instrument was selected, or that the correct instruments with or without Y adapter or RL adapter are used.

Note To obtain an exact measurement, both palpated points must have a fixed reference to the relevant transmitter of the reference space.

Erroneous navigation results if the Blumensaat line obtained through X-ray planning deviates by more than 3 mm from the Blumensaat line determined intra-articularly! ¾ Ensure that the points determined intraarticularly have been registered correctly (e.g. acquisition of "resident ridge" instead of the 12 o'clock over-the-top position on the posterior edge of the notch). ¾ If these points have been registered correctly, discard the navigation results from X-ray planning (source of error: scale of the X-ray image was probably incorrectly determined or the X-ray plane incorrectly adjusted). To obtain correct data, minimal force should be applied when using the instruments. Do not bend the instruments. Any use of bent instruments will result in incorrect computation of angles and distances. ¾ Check the pointer for proper functioning according to the specifications given in TA012659 (GB); TA012816 (USA); TA012821 (GB); TA012871 (USA) .

This instrument can be used, with the help of the straight pointer, to measure any distances between two palpable points in two different reference spaces (tibia and femur).

CAUTION

Undefined measurement if one of the palpated points does not have a fixed reference to the transmitter of the reference space (e.g. point on femur in the tibial reference space is independent of flexion angle)! ¾ Ensure that both palpated points have a fixed reference to the transmitter of the reference space.

5.12 Plausibility check As is the case for all technical devices, the OrthoPilot® navigation system is subject to malfunctions caused by the way it is used or, in exceptional cases, by technical problems. Surgery with the OrthoPilot® navigation system can be interrupted at any time and completed with the standard instrument set for ACL reconstruction. ¾ To ensure correct functioning of the OrthoPilot® navigation system, continuously check the steps suggested by the system (especially if the user has only recently started to use OrthoPilot®). ¾ If there is any doubt, repeat the procedure or change to manual ACL reconstruction. This also applies in cases of software malfunction, e.g. if the program terminates unintentionally, or does not respond to input. Navigation of the drilling channels must be accompanied by plausibility checks of the recorded anatomy. CAUTION

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Aesculap Orthopaedics

ACL Reconstruction V3.1

5.13 Navigation of the drilling channels Navigation of the drilling channels is the last surgical step in the program prior to the postoperative stability test. The OrthoPilot® system assists the operating surgeon in positioning the tibial and femoral drilling channels in two separate program steps, taking into account various criteria (e.g. isometry, impingement, anatomic landmarks and X-ray planning) that are relevant for correctly positioning the drilling channels in ACL reconstruction.

CAUTION

Erroneous navigation results due to selecting the wrong adapter pin when using instruments with Y adapter or RL adapter! ¾ Ensure that the correct adapter pin is used on the instrument during registration.

6. Protocol Note See instructions for use “OrthoPilot® operating system, operation, software” (TA012659 (GB); TA012816 (USA); TA012821 (GB); TA012871 (USA)) . The most relevant screenshots from the operation, produced automatically, as well as manually created screenshots, are integrated as jpg files into the html file and also saved separately in the folder.

CAUTION

CAUTION

CAUTION

CAUTION

Erroneous navigation results due to use of the inappropriate tools with the selected type of instrument! ¾ Ensure that the correct type of instrument was selected, or that the correct instruments with or without Y adapter or RL adapter are used. Incorrect navigation results due to erroneous femoral X-ray planning! ¾ Disregard data from femoral X-ray planning if a warning is displayed on the screen. Incorrect result recorded in the documentation file if the insertion point of the femoral drilling channel is recorded too late! ¾ Always record the femoral insertion point before punching in the transtibial pointer.

Note Further steps, as well as the complete, intraoperative workflow for the navigated operation are described in detail in product information brochure no. O91302, Operating Technique OrthoPilot® ACL Reconstruction.

5.14 Quitting the software Note For further details on how to quit the software, as well as other system technical information, see instructions for use “OrthoPilot® operating system, operation, software” (TA012659 (GB); TA012816 (USA); TA012821 (GB); TA012871 (USA)) .

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The documentation of the navigation data does not necessarily reflect the actual medical outcome of the operation. ¾ Make certain the navigation results are registered at the correct time and with the navigated instrument positioned correctly.

7. Technical Service ¾ For service and repairs, please contact your national B. Braun/Aesculap agency. Any modifications carried out on medical technical equipment may result in loss of warranty rights and 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] Or in the US: Aesculap Implant Systems, LLC. Attn. Aesculap Technical Services 615 Lambert Pointe Drive Hazelwood, MO 63042 Aesculap Repair Hotline Phone: +1 800 214-3392 Fax: +1 314 895-4420 Other service addresses can be obtained from the address indicated above.

8. Distributor Distributor in the US/Contact in Canada for product information and complaints Aesculap Implant Systems, LLC. 3773 Corporate Parkway Center Valley, PA 18034 USA

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