OrthoPilot Software Module THA ACA 1.1

¾ Attention is drawn in particular to the following product information documents:

2. Product description

Instructions for Use

Art. no.

OrthoPilot® System FS100/FS010

TA010004

2.1 Intended use

OrthoPilot® System FS101 … FS105

TA012658

OrthoPilot® Operating System, Operation, Software (FS101/FS102)

TA012659

OrthoPilot® FS100/FS010-Operating System, Operation, Software

TA012821

OrthoPilot® THA ACA 1.1 Operating Technique

O43902

OrthoPilot® THA 3.3 Operating Technique

O27702

The intended use of this OrthoPilot® application is the navigated hip arthroplasty for patient lying in lateral position for both anterior and posterior approach. THA ACA is designed for aligning the anteversion and the inclination of an acetabular prosthetic cup within an acetabulum of a patient, based on the calculation of the Acetabulum Center Axis. The acetabular prosthetic cup is aligned relatively to Acetabulum Center Axis, calculated from selecting rim points located around the acetabulum of the patient. In addition, it provides leg length and offset information by palpating and relocating specific points on the leg.

BiCONTACT Brochure

O10702

Excia Brochure

O18802

2.2 Indications and contraindications

Metha Brochure

O28002

Trilliance Brochure

O37802

TRJ Brochure

O38102

PLASMACUP SC Brochure

O14702

PLASMACUP Delta

O10702

Plasmacup DC Brochure

O39802

Plasmafit Brochure

O45502

Cemented Cup Brochure

O10411

Threaded Ring SC Brochure

O15701

The system is used for primary hip joint replacement with implants approved by Aesculap for this application: PLASMACUP SC, DC, Delta, Screw Cup, PE Cup, Plasmafit Plus, Poly, Pro, BiCONTACT S, N, SD, D, H, Excia, Excia L, SLA, Metha modular and nonmodular, Trilliance, Trilliance H, TRJ. It is indicated for cup placement into acetabulum with different anatomical variations (protrusio, normal or dysplastic). The following cases constitute contraindications against hip navigation: • Altered hip geometry due to previous operations • Severe pelvic deformities • Severe deformity of the acetabular rim (it is not recognized as a circular anatomical shape on the pre-operative planning or intra-operatively. • If palpation of landmarks is not possible (e.g. due to adiposity) • Severe deformities of the femoral bone • Severe deformities of the knee Contraindications for individual prostheses are listed in the documentation enclosed with the respective products.

WARNING

Use of the product is also contraindicated if the bone properties or bone quality factors preclude the firm and safe anchoring of the transmitter fixation elements in the bone.

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Aesculap Orthopaedics

OrthoPilot® Software Module THA ACA 1.1

3. System components CAUTION

3.1 OrthoPilot® Basic System For information regarding OrthoPilot® basic system FS100 and FS010, 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.

3.2 Software Detailed information on working with the OrthoPilot® THA ACA 1.1 Software FS229 can be found in the Operating Manual for THA ACA 1.1 (O43902).

Bent or defective transmitters cause incorrect navigation results. ¾ Check the function of the passive transmitter according to instructions for use TA012659 "OrthoPilot® FS101 Operating System, Operation, Software" or TA012821 "OrthoPilot® FS100/FS010 Operating System, Operation, Software".

3.4 Accessories/Spare parts The components included in delivery are necessary for operating the system. The passive marker spheres must be ordered separately as required. Designation

Art. no.

Passive marker spheres (4x4 units, single-use)

FS617

Passive marker spheres (10x1 units, single-use)

FS614

3.3 Instruments

CAP passive marker spheres (3x4 units, single-use)

FS618SU

3.3.1

CAP passive marker spheres (4x4 units, single-use)

FS619SU

Designation

Art. no.

OrthoPilot® Software THA ACA 1.1

FS229

General instruments for hip navigation

Designation

Art. no.

Tray, hip navigation, universal

FS702

Tray, hip navigation, lateral position, anterior FS704 approach Tray, hip navigation, lateral position, posterior approach

FS705

Tray, passive transmitter

FS926

CAUTION

4

Bent instruments must not be used for navigation under any circumstances. Using bent instruments leads to erroneous results of angle and distance computations. ¾ Check the function of the instrument according to instructions for use TA012659 "OrthoPilot® FS101 Operating System, Operation, Software" or TA012821 "OrthoPilot® FS100/FS010 Operating System, Operation, Software".

Do not use accessories in combinations that are not mentioned in these instructions for use. CAUTION

4. Operating and handling the OrthoPilot® navigation system

4.1 General notes Note For detailed information on the OrthoPilot® basic system, see instructions for use TA012659 "OrthoPilot® FS101 Operating System, Operation, Software" or TA012821 "OrthoPilot® FS100/FS010 Operating System, Operation, Software".

4.2 Software module Hip Endoprosthetics FS229 (THA ACA 1.1) The OrthoPilot® software module Hip Endoprosthetics allows precise implantation of Aesculap hip implants. The operating surgeon records relevant anatomic structures intraoperatively by palpating them with a pointer. This allows navigated bone preparation and computation of the absolute and relative implant position. Note Detailed information on working with the OrthoPilot® THA ACA 1.1 Software FS229 can be found in the Operating Manual for THA ACA 1.1 (O43902).

4.3 OrthoPilot® special instruments for Aesculap hip endoprosthesis The OrthoPilot® special instruments are fitted with adapters for infrared transmitters. Since OrthoPilot® is calibrated for use with these special instruments only, the system may only be used for implanting Aesculap hip endoprostheses. 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. The instrument to be used for each respective step is indicated at each navigation step.

4.4 Options and configurations The OrthoPilot® software can be adapted to the individual user's requirements in various ways. Two workflows can be installed by persons authorized by Aesculap, see operating manual O43902. The following options are available: • Surgical approach (lateral position): posterior or anterolateral After installation the selection can be made intraoperatively. The following options can be set by persons authorized by Aesculap. These options cannot be changed during the operation. • Selection of the cup angle definition (radiographic/operative/ anatomical) • Reamer size graduation: 1 mm • Deactivation of the "Trial cup navigation" step • Display and graphic representation of measured/computed values • Deactivation of the step for checking the bone references • Deactivation of the "Rasp navigation" step • Deactivation of the "Trial reduction” step • Deactivation of the "Stem navigation" step • Deactivation of the "Stem reposition" step Settings may be changed only by Aesculap software specialists. WARNING

4.5 Installing, starting and exiting the software Note For further details regarding the installation, start-up and exiting of the software, as well as other general technical system information, see instructions for use “OrthoPilot® Operating System, Operation, Software” TA012659/TA012821.

Use of an incorrect instrument causes incorrect navigation results. WARNING Note For detailed information on the operation of the passive infrared transmitter, see instructions for use TA012659 "OrthoPilot® FS101 Operating System, Operation, Software" or TA012821 "OrthoPilot® FS100/ FS010 Operating System, Operation, Software".

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Aesculap Orthopaedics

OrthoPilot® Software Module THA ACA 1.1

5. Preparing a navigated operation

5.6 Description of the schematic workflow For a detailed description of the schematic workflow, see operating manual THA ACA 1.1 O43902

5.1 Preoperative planning using radiographic images Aesculap considers it necessary to carry out adequate preoperative planning prior to any navigated surgery. This planning is carried out using appropriate X-ray images and Aesculap X-ray templates, taking into account the planned implant size and the resulting values for the leg length and offset.

5.2 Preparation of the OrthoPilot® navigation system Note For information regarding the OrthoPilot® basic system FS010/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.

6. Safety notes on the navigation steps The critical aspects of a successful data registration are given below. The full, intraoperatively navigated workflow is described in detail in the product information operating manual THA ACA 1.1 O43902 and must be observed and followed.

6.1 General safety notes on the workflow All data registration steps must be carried out with the best possible precision. CAUTION

5.3 Positioning of the equipment trolley and camera The optimum position for the equipment trolley and camera is described in operating manual O43902.

CAUTION

5.4 Covering the patient ¾ If used, take into account the screw used to attach the reference transmitter to the pelvis when covering the patient.

Special care must be taken that the instruments, especially the pointer, are not moved at all during data registration until the data have been saved. The data are saved as soon as the foot switch is released. At the same time the software automatically moves to the next step of the operation.

To enable the registration of the spatial position of the pelvis, a reference transmitter must be attached to the pelvis. The position of this transmitter must not change throughout the operation. For a detailed description of the use and attachment of the transmitter, see operating manual for THA 3.3 O27702.

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 and used for further calculations. Erroneous data confirmation or incorrect data input can result in miscalculations and consequently incorrect navigation results.

If the operating surgeon can no longer be sure that a transmitter is securely attached to the bone or to instruments (e.g. if a bone screw has come loose), all measurement data must be considered invalid. In such cases, either the entire procedure must be restarted from the beginning or the surgery must be continued without navigation.

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.

5.5 Attaching the transmitter

WARNING

CAUTION

6

The anatomy of the patient must be taken into account when attaching the instruments to the bone. Incorrect positioning of the fixation screw can cause injury to important anatomical structures with serious consequences.

CAUTION

CAUTION

To ensure safe use of OrthoPilot® THA ACA 1.1 application software, always follow operating manual O43902. CAUTION

CAUTION

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.

6.3 Registration of anatomical landmarks 6.3.1

Digitization of anatomical landmarks

CAUTION

CAUTION

The color-coding of the transmitter is displayed during each navigation step. Use of an incorrect transmitter causes incorrect navigation results. CAUTION

6.2 Selection of implants

6.3.2

CAUTION

6.3.3

The precision of the values displayed during the operation primarily depends on the quality of the landmarks registered through palpation. Optimal data acquisition requires adequate knowledge of the anatomic conditions. The landmarks to be registered though palpation are described in operating manual THA ACA 1.1 O43902.

Acetabular plane acquisition

Selecting incorrect parameters causes incorrect navigation results. CAUTION

To obtain correct data, minimal force should be applied when using the pointer. ¾ Do not bend the pointer. Using bent instruments results in erroneous computation of angles and distances. ¾ Check the pointer for proper functioning according to the specifications given in TA012659/TA012821.

Acetabular plane is obtained by a series of palpations, which have to be performed in the right order. Mis-ordering of palpations can cause incorrect calculations of the cup orientation. The order of palpations is described in operating manual THA ACA 1.1 O43902.

Femur functional plane acquisition

CAUTION

Femur functional plane is obtained by the palpation of patella and ankle points, with the leg in neutral position and tibia in flexion. Selecting a different femur or tibia position than described in the operating manual can cause incorrect calculation of the cup position.

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Aesculap Orthopaedics

OrthoPilot® Software Module THA ACA 1.1

6.4 Checking the pelvis transmitter

6.6.2

Rasp navigation

Use the menu for checking the pelvis reference to ensure that the rigid body has not been displaced. CAUTION

CAUTION

6.5 Cup navigation CAUTION 6.5.1

Reamer navigation

CAUTION

CAUTION

6.5.2

Selection of the incorrect reamer, incorrect configuration of the instrument (bent reamer) or incorrect reamer size cause incorrect intervals of distance and incorrect positioning. This step requires particular care. The distance intervals indicated serve only as rough reference values, based on the previously registered points of the acetabulum (fovea centralis points). They are not an indication of the actual thickness of the medial wall. The operating surgeon must in all cases observe the anatomical conditions. If this rule is not followed, the bone and vital vessels in the underlying structures may be damaged.

CAUTION

CAUTION

Incorrect alignment/combination of the rigid body or adapter on the rasp handle can cause incorrect calculations of the leg length and offset values. The correct combination and alignment of the adapter and rigid body on the rasp handle are indicated in the corresponding software step.

Trial cup/cup implant navigation To avoid damage, the transmitter and its adapter must be removed from the insertion instrument when the trial cup is removed.

CAUTION

CAUTION

CAUTION

8

To achieve sufficient accuracy, it is important that the palpation of the points to be palpated in this step is carried out in exactly the same way as in the subsequent steps, during the rasp/stem navigation and trial reduction/stem repositioning (identical knee bend, identical patella and trochanter point). Selecting a different patella or trochanter point than described in the operating manual can cause incorrect calculations of the leg length and offset values.

The quality of the bone anchoring is of highest priority when implanting the Metha prosthesis. The OrthoPilot® navigation system does not have any data that would allow an assessment of the stability of the anchoring. Consequently, the operating surgeon must never be tempted by the displayed data to aim for optimal kinematics of the joint reconstruction at the expense of the stability of the stem anchoring. Selecting an incorrect rasp size causes incorrect navigation results.

6.6 Stem implant navigation Initial femur acquisition

Aesculap offers optimized rasp handles for most approaches. The available rasp handles are specified in operating manual THA 3.3 O27702 or in the instructions for use for the corresponding system. The use of an incorrect adapter or rasp handle can cause incorrect calculations of the leg length and offset values. The rasp handle used can be selected in the corresponding software step. The adapter to use and its alignment are indicated in the same step.

CAUTION

6.6.1

Incorrect connection of the rigid body with the adapter or of the adapter with the rasp handle can cause incorrect calculations of the leg length and offset values.

CAUTION

CAUTION

For all cemented stems (excluding Trilliance), the stem size to use for a specific rasp size is specified in the operating manual and is shown on the rasp navigation screen. Use of a different stem size to the one indicated can cause incorrect results.

6.6.3

Trial reduction/repositioning Incorrect reduction of the joint causes incorrect navigation results.

CAUTION

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

7. Technical Service ¾ 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. Aesculap Technical 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.

8. Technical data Classification acc. to Directive 93/42/EEC Art. no.

Designation

Class

FS229

OrthoPilot® THA ACA Software

IIa

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