OrthoPilot Software Module THA 3.4

Instructions for Use

Art. no.

PLASMACUP Delta

O10702

Plasmacup DC Brochure

O39802

Cemented Cup Brochure

O10411

Threaded Ring SC Brochure

O15701

Plasmafit Brochure

O45502

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.

3. System components

The software application FS218 THA Pro 3.4 includes additionally the following implants:

3.1 OrthoPilot® Basic System Instructions for Use

Art. no.

Excia T

O56002

Bicontact E

O81002

For 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.

3.2 Software

2. Product description

Detailed information on working with the Orthopilot® THA 3.4 Software FS217, FS218 or FS219 can be found in the operating manual for THA 3.4 (O27702).

2.1 Intended use

Designation

Art. no.

The OrthoPilot® Software-Module THA is an application software for the computer aided navigation of surgical instruments, with the aim to achieve optimal positioning of hip endoprostheses in the patient’s joint. The patient data required for this procedure is registered intraoperatively. 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 between the instruments and the transmitter locations on the bone can be established by the computer.

OrthoPilot® Software THAplus

FS217

OrthoPilot® Software THAPro

FS218

OrthoPilot® Software Cup only

FS219

2.2 Indications and contraindications The system is used for primary hip joint replacement with implants approved by Aesculap for this application. The following cases constitute contraindications against hip navigation: • Altered hip geometry due to previous operations • Severe pelvic deformities • 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.

3.3 Instruments 3.3.1

General instruments for hip navigation

Designation

Art. no.

Tray, hip navigation, universal

FS702

Tray, hip navigation, supine position

FS703

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

FS705

Tray, passive transmitter

FS926

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Aesculap Orthopaedics

OrthoPilot® Software Module THA 3.4

3.3.2

3.4 Accessories/Spare parts

Specific instruments for using ultrasound

Designation

Art. no.

Ultrasound module

FS105

The components included in delivery are necessary for operating the system. The passive marker spheres must be ordered separately as required.

Ultrasound Rigid Body Adapter

FS910R/FS911R

Designation

Art. no.

Ultrasound gel

FS091

FS617

Ultrasound probe cover

FS092

Passive marker spheres (4x4 units, single-use) Passive marker spheres (10x1 units, single-use)

FS614

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

FS618SU

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

FS619SU

Note For detailed information on the operation of the specific instruments for using the ultrasound and on the operation of the passive infrared transmitters, see instructions for use TA012659 "OrthoPilot® FS101/FS102 Operating System, Operation, Software" or TA012821 "OrthoPilot® FS100/ FS010 Operating System, Operation, Software".

CAUTION

CAUTION

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/FS102 Operating System, Operation, Software" or TA012821 "OrthoPilot® FS100/FS010 Operating System, Operation, Software". Bent or defective transmitters cause incorrect navigation results. ¾ Check the function of the passive transmitter according to instructions for use TA012659 "OrthoPilot® FS101/FS102 Operating System, Operation, Software" or TA012821 "OrthoPilot® FS100/FS010 Operating System, Operation, Software". ¾ The risks associated with the use of the ultrasound probe, ultrasound adapter, ultrasound probe cover and ultrasound gel are specified in the instructions for use "OrthoPilot® Operating System, Operation, Software" (TA012659) and "OrthoPilot®System FS101 ... FS105" (TA012658).

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/FS102 Operating System, Operation, Software" or TA012821 "OrthoPilot® FS100/FS010 Operating System, Operation, Software".

4.2 Software module Hip Endoprosthetics FS217, FS218, FS219 (THA 3.4) 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 3.4 Software FS217, FS218 or FS219 can be found in the operating manual O27702.

4

4.3 OrthoPilot® special instruments for Aesculap hip endoprostheses The OrthoPilot® special instruments are fitted with adapters for infrared transmitters. Since OrthoPilot® is calibrated for use with these special instruments, 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. Use of an incorrect instrument causes incorrect navigation results.

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.

WARNING

5. Preparing a navigated operation Note For detailed information on the operation of the passive infrared transmitter, see instructions for use TA012659 "OrthoPilot® FS101/FS102 Operating System, Operation, Software" or TA012821 "OrthoPilot® FS100/ FS010 Operating System, Operation, Software".

4.4 Options and configurations The OrthoPilot® software can be adapted to the individual user's requirements in various ways. Four workflows (OrthoPilot® THAplus / OrthoPilot® THAPro Cup First / Orthopilot® THAPro Stem First / OrthoPilot® Cup only) can be installed by persons authorized by Aesculap, see operating manual O27702. The following options are available: • Patient position: supine position or lateral position • Surgical approach (lateral position): posterior or anterior 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. • Setting the initial value for the trial cup size: Any size between 40 and 68 resp. 70 for Plasmafit • Selection of the cup angle definition (radiographic/operative/ anatomical) • Recording of the initial cup center with trial cup/reamer • Reamer size graduation: 1 mm • Deactivation of the "Trial cup navigation" step • Display of cup depth during cup navigation • Deactivation of the "Box chisel navigation" step (THAPro) • Deactivation of the "Rasp navigation” step • Display and graphic representation of measured/computed values • Deactivation of the step for checking the bone references • Activation of the "Final Result" step (THAPro)

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.

5.3 Positioning of the equipment trolley and camera The optimum position for the equipment trolley and camera is described in operating manual O27702.

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Aesculap Orthopaedics

OrthoPilot® Software Module THA 3.4

5.4 Covering the patient ¾ Cover the patient in such a way that the palpation of the anterior pelvic plane (anterior superior iliac spine and symphysis) will not be obstructed. ¾ If used, take into account the screw used to attach the reference transmitter to the pelvis when covering the patient. ¾ Make certain that the cover is not too thick and that it is of even thickness in the region of the iliac spine. ¾ If ultrasound is used, ensure that the cover allows a sterile scan of the spine and symphysis with the ultrasound probe. Avoid air pockets or creases in the cover film as these can adversely affect the image quality and navigation accuracy.

5.5 Attaching the transmitter 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 O27702.

WARNING

CAUTION

6

If the operating surgeon can no longer be sure that a transmitter is securely attached to the bone or to the instrument (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 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.

5.6 Description of the schematic workflow

THAplus

Patient Data Implant Selection Reamer Selection Handle Selection

optional available, if multiple instruments are installed

Ipsilateral Pelvic Point Contralateral Pelvic Point Symphysis

Guided Contralateral Pelvic Point Guided Symphysis

Ultrasound

Guided Ipsilateral Pelvic Point

Initial Femur Acquisition Acquire pelvis check reference Acquire with reamer

Palpate Reamer Depth Reference Point Selected Reamer

Original Hip Acquisition

Original Hip Acquisition

Selected Reamer

Check pelvis reference

Reamer Navigation Trial Cup Navigation Final Cup Navigation

Plasmacup Select ion

Record Cup Center

End of „cup

Selected Handle Rasp Navigation Trial Reduction Stem Navigation Reduction

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Aesculap Orthopaedics

OrthoPilot® Software Module THA 3.4

Patient Data Implant Selection

THA Pro

Reamer Selection

optional

Handle Selection

available, if multiple instruments are installed

Ipsilateral Pelvic Point Contralateral Pelvic Point Symphysis

Guided Contralateral Pelvic Point Guided Symphysis

Ultrasound

Guided Ipsilateral Pelvic Point

Initial Neutral Position Knee reference palpation Anterior Ankle Point Acquire femur check reference

Check pelvis reference

Acquire pelvis check reference Palpate Reamer Depth Reference Point Acquire with reamer

Selected Reamer Original Hip Acquisition

Check femur reference

Original Hip Acquisition Selected Reamer Reamer Navigation Trial Cup Navigation

Record Trial Cup Center

Final Cup Navigation

Selected Handle

Record Cup Center

Box Osteotome Navigation

Selected Handle

Rasp Navigation

Box Osteotome Navigation

Final Cup Navigation

Rasp Navigation

Record Cup Center

Stem Navigation Final Result

8

CUP FIRST

STEM FIRST

Cup Implant Selection

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 O27702 and must be observed and followed.

CAUTION

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

CAUTION

CAUTION

CAUTION

Special care must be taken that the instruments, especially the pointer, are not moved at all during data registration until the data has been saved. The data is saved as soon as the foot switch is released. At the same time the software automatically moves to the next step of the operation. 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. 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. To ensure safe use of OrthoPilot® THA 3.4 application software, always follow operating manual O27702.

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

CAUTION

CAUTION

For the safe handling of the ultrasound, follow instructions for use "OrthoPilot® Operating System, Operation, Software" (TA012659) and "OrthoPilot® System FS101….FS105" (TA012658) prior to use.

6.2 Selection of implants Selecting incorrect parameters (e.g. Implant type or size) causes incorrect navigation results. CAUTION

6.3 Registration of anatomical landmarks

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.

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Aesculap Orthopaedics

OrthoPilot® Software Module THA 3.4

CAUTION

CAUTION

The precision of the values displayed during the operation primarily depends on the quality of the landmarks registered with ultrasound or through palpation. Optimal data acquisition requires adequate knowledge of the anatomic conditions. The landmarks to be registered though palpation are described in operating manual O27702. If the image quality is poor, the ultrasound navigation should be discontinued and the landmarks should be registered with the pointer. If the image quality is poor in overweight patients, in whom registration though palpation is not possible, the operation should be continued manually. The ultrasound machine is calibrated for fatty tissue between 35°- 38° and may therefore only be used for recording the patient's pelvic inlet plane.

6.5.2

Trial cup / Final 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

6.6 Stem implant navigation 6.6.1

Initial femur referencing

CAUTION

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

CAUTION

6.6.2

Reamer navigation

CAUTION

CAUTION

10

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.

Selecting a different patella or trochanter point than described in the operating manual can cause incorrect calculations of the leg length and offset values.

Rasp navigation

CAUTION

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

Aesculap offers optimized rasp handles for most approaches. The available rasp handles are specified in operating manual O27702 or in the instructions for use for the corresponding system.

6.5 Cup navigation 6.5.1

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).

CAUTION

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

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.

CAUTION

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.

CAUTION

CAUTION

6.6.3

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.

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

CAUTION

6.6.4

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

FS217

OrthoPilot® THAplus Software

IIa

FS218

OrthoPilot® THAPro Software

IIa

FS219

OrthoPilot® Cup only Software

IIa

Final Result (only available for THAPro)

If the step "Final Result" is enabled, a wrong recorded (far from the hip center) femoral check point can lead to inaccurate values.

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

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5.6 Popis schématického postupu

THAplus

Pacientova data Vyber implantát Vyber reamer Vyber zavDGČþ Spina Iliaca anterior superior reference

optional available, if multiple instruments are installed

Spina Iliaca contralaterální reference Symphyse

Guided Contralateral Pelvic Point Guided Symphysis

Ultrasound

Guided Ipsilateral Pelvic Point

Initial Femur Acquisition Pelvis reference recheck Acquire with reamer

Palpate Reamer Depth Reference Point Selected Reamer

OYČĜ pelvis reference

Original Hip Acquisition Selected Reamer

Original Hip Acquisition Navigace reameru Navigace zkušební jamky Navigace jamky Nahraj centrum jamky Selected Handle

Plasmacup Selection

End of „cup only“ workflow

Navigace rašplí Trial Reduction 1DYLJDFHGĜtNX Reduction

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Aesculap Orthopaedics

OrthoPilot® Software Module THA 3.4

Pacientova data Vyber implantát

THA Pro

optional

Vyber reamer

available, if multiple instruments are installed

Vyber zavDGČþ Spina Iliaca anterior superior reference Spina Iliaca contralaterální reference Symphyse Ultrasonic

Guided Ipsilateral Pelvic Point Guided Contralateral Pelvic Point Guided Symphysis Neutrální pozice Knee reference palpation Kontnik Anterior reference Femur reference recheck

OYČĜ pelvis reference

Pelvis reference recheck Palpate Reamer Depth Reference Point Acquire with reamer

Selected Reamer Original Hip Acquisition

Original Hip Acquisition

OYČĜ femur reference

Selected Reamer Navigace reameru Navigace zkušební jamky

Nahraj zkušební implantát

Finální navigace jamky

Selected Handle

Nahraj centrum jamky

Osteotom navigace

Selected Handle

Navigace rašplí

Osteotom navigace

Navigace jamky

Navigace rašplí

Nahraj centrum jamky

Navigace GĜíku Finální kontrola

58

CUP FIRST

STEM FIRST

Cup Implant Selection