Aesculap Orthopaedics OrthoPilot

Transcription

1 Aesculap Orthopaedics OrthoPilot Instructions for use/technical description ACL Reconstruction V3.0 Gebrauchsanweisung/Technische Beschreibung ACL-Rekonstruktion V3.0 Mode d emploi/description technique Reconstruction ACL V3.0 Instrucciones de manejo/descripción técnica Reconstrucción de ACL V3.0 Istruzioni per l uso/descrizione tecnica Ricostruzione ACL V3.0 Instruções de utilização/descrição técnica Reconstrução ACL V3.0 Bruksanvisning/Teknisk Beskrivning Rekonstruktion ACL V3.0 Návod k použití/technický popis Rekonstrukcích ACL V3.0

2 Aesculap Orthopaedics ACL Reconstruction V3.0 Contents 1. Safe handling Product description Intended use Indications and contraindications Application System components Components necessary for use OrthoPilot Basic System Software Passive transmitters (passive rigid bodies) Navigated instruments Transmitter fixation elements Wire basket Integrated instrument system Accessories/Spare parts Installing and starting the software Operating principle of the OrthoPilot software module Working with the OrthoPilot application software Special instruments for the OrthoPilot application Options for OrthoPilot application Safety and functionality Safe operation plausibility checks Entering surgical data Data acquisition X-ray planning input Quality of the X-ray images Fastening the transmitter fixation elements Kinematic data acquisition Registration of anatomic landmarks Optional measuring instrument Plausibility check Navigation of the drilling channels Quitting the software Protocol Technical Service Distributor Safe handling Federal law restricts this device to sale by or on order of a physician! The present instructions for use must be kept available and accessible for all OR staff and all other users! When the OrthoPilot navigation system is used as an aid for ACL reconstruction, 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. Attention is drawn in particular to the following product information documents: 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! Prior to beginning surgery with the system, ensure that all the appropriate manual instruments are available. Instructions for use of OrthoPilot system FS100 Instructions for use of OrthoPilot system FS101, FS104, FS105 Quick Guide for OrthoPilot System FS104/ FS106 Instructions for use OrthoPilot operating system, operation, software (FS101, FS102) Instructions for use of OrthoPilot FS100/ FS010 operating system, operation, software Operating Technique OrthoPilot ACL Reconstruction TA TA (GB) TA (USA) TA TA (GB) TA (USA) TA (GB) TA (USA) O

3 2. Product description 4. System components 2.1 Intended use The FS227 application software is a software module for the computeraided navigation of surgical instruments, with the aim of positioning the drilling channels for ACL reconstruction. The patient data required for this procedure are registered intraoperatively, making preoperative CT-scans unnecessary. Two 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. 4.1 Components necessary for use OrthoPilot Basic System OrthoPilot Basic System Software FS100 or FS 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. For further details and information regarding OrthoPilot Basic system FS100, see TA10004; for OrthoPilot Basic system FS101, FS104, FS105, see TA (GB); TA (USA). Also refer to the instructions for use OrthoPilot operating system, operation, software (TA (GB); TA (USA)/TA (GB); TA (USA)) prior to putting the product into operation. 3. Application Bone properties or bone quality factors precluding the firm and safe anchoring of the transmitter fixation elements in the bone also present a contraindication. OrthoPilot software for ACL reconstruction V Passive transmitters (passive rigid bodies) Passive transmitters, yellow (instruments) Passive transmitters, blue (tibia) Passive transmitters, red (femur) Navigated instruments Three different instrument sets are available for use with the ACL V3.0 application software: Instrument set: Passive RL adapter Straight pointer Hook pointer with RL adapter Tibial drill guide with RL adapter Transtibial pointer FS227 FS633 FS634 FS635 FS871M FS856R FS854R FS869R 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. Instrument set: Passive Y adapter Straight pointer Hook pointer with Y adapter Tibial drill guide with Y adapter Transtibial pointer FS871M FS855R FS853R FS869R 3

4 Aesculap Orthopaedics ACL Reconstruction V3.0 Instrument set: Passive Optional Straight pointer Hook pointer Tibial drill guide Transtibial pointer FS871M FS865M FS863M FS869R 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:". Femoral drill guide If available, femoral drill guide FS859R can optionally be used intraoperatively with all instrument sets instead of transtibial pointer FS869R, and vice versa Transmitter fixation elements Femoral or tibial K-wire transmitter fixation element, left Femoral or tibial K-wire transmitter fixation element, right K-wire 2.5mm with drill bit for tibial transmitter fixation, 100 mm long (2 pieces, sterile) K-wire 2.5mm with trocar tip for femoral transmitter fixation, 100 mm long (2 pieces, sterile) Standard Allen key FS859R FS874R FS875R FS877R LX055S GB020R Wire basket Fig. 1 Wire basket for OrthoPilot ACL instruments Wire basket for OrthoPilot transmitters FS861R FS862R 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 V3.0 application software at the same time as an instrument with RL adapter Integrated instrument system Complete set for navigated ACL reconstruction FS860M Incorrect results from navigating with the wrong instrument selection! Ensure that the appropriate instruments with or without Y adapter or with RL adapter are used. 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 Accessories/Spare parts 10 x 1 piece Single-use passive marker FS614 3 x 4 pieces Single-use passive marker FS616 Sterile container JK414 P/T 4

5 4.2 Installing and starting the software 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 TA (GB); TA (USA); TA (GB); TA (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. 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. User error! To ensure safe use of OrthoPilot ACL application software, always follow Operating Manual O 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. 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: Check to make certain that all components are intact and functional. Do not use bent or damaged instruments. 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. Prior to the surgical intervention, sterilize the instruments that will be used during the surgery. 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. 5

6 Aesculap Orthopaedics ACL Reconstruction V Options for OrthoPilot application User error! Settings may be changed only by Aesculap software specialists. Option Entry of diameter for single bundle femur drilling channel in workflow step "Tunnel Installation default Individually adjustable default Diameter of drilling channel The following defaults are set with a view to installation of the OrthoPilot ACL V3.0 - Application Software FS227 and can be adjusted individually to suit each user: Option Entry of surgeon's name into the workflow step "Patient data" Entry of department/clinic name into the workflow step "Patient data" Entry of instrument set into workflow step "Surgical data" Choice of ACL reconstruction technique in workflow step "Surgical data" Installation default Passive RL adapter Individually adjustable default Name of surgeon Name of department/ clinic Passive Passive Y adapter Single bundle Double bundle Entry of diameter for double bundle tibia AM drilling channel in Entry of diameter for double bundle tibia PL drilling channel in Entry of diameter for double bundle femur AM drilling channel in Entry of diameter for double bundle femur PL drilling channel in Diameter of drilling channel Diameter of drilling channel Diameter of drilling channel Diameter of drilling channel Selection of first drilling channel to be navigated in Selection of second drilling channel to be navigated in Selection of third drilling channel to be navigated in Selection of fourth drilling channel to be navigated in Entry of diameter for single bundle tibia drilling channel in workflow step "Tunnel tibiaam femuram tibiapl femurpl tibiapl femuram femurpl tibiaam tibiapl femurpl tibiaam femuram femurpl tibiaam tibiapl femuram Diameter of drilling channel Tibial X-ray planning in workflow step "Tibia X-ray: lateral view" Tibial X-ray planning in workflow step "Tibia X-ray: AP view" Anatomic landmark for X- ray image matching in workflow step "Tibia X-ray: lateral view" Femoral X-ray planning in workflow step "Femur X- ray: lateral view" Comparison of the length of Blumensaat's line between X-ray planning and landmark registration in workflow step "Femur X- ray: lateral view" (landmark is the spine of med. intercondylar tubercle) No No (landmark is tibial tuberosity) 6

7 Option Conduction of pre-op knee stability test in workflow step "Pre-op knee stability test" Installation default Individually adjustable default 5.3 Safety and functionality 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. Conduction of post-op knee stability test in workflow step "Post-op knee stability test" Conduction of pre-op pivot shift test in workflow step "Pivot shift test" 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. Conduction of post-op pivot shift test in workflow step "Pivot shift test" Conduction of isometric calculation in workflow steps "Center tibia/femur tunnel" Display of center between spine of med. intercondylar tubercle and anterior horn in workflow steps "Center tibia tunnel" Display of distance to PCL in workflow steps "Center tibia tunnel" Display of distance to condylar cartilage-bone border in workflow steps "Center femur tunnel" No (workflow step "Anterior horn lateral meniscus" is No No (workflow step "PCL anterior margin" is No (workflow step "Posterior cartilage border" is 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 nonnavigated surgery using the conventional operating technique. 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. Display of drill channel position according to Watanabe in workflow steps "Center femur tunnel" No 5.5 Entering surgical data 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. 7

8 Aesculap Orthopaedics ACL Reconstruction V 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 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. 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! Position the K-wire fixation for the transmitter on the tibia at a distance of no less than 20 cm from the joint line. Necrosis of the bone possible from excessive heat development if, due to hard corticalis, penetration of the K-wire is poor. Always use new and sharp single-use K-wires with drill bit on the tibia. If the tibial corticalis is very hard, pre-drill with a mm drill, if necessary. 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 Quality of the X-ray images 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. Erroneous navigation results due to imprecise X- ray images! Make certain that the scale of the X-ray image is correctly determined. Ensure that the lateral and AP views used in the X-rays are configured correctly. 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! 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. 8

9 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. Erroneous navigation results due to selecting the wrong adapter pin when using instruments with Y adapter or RL adapter! Ensure that the correct adapter pin is used on the instrument during registration. Erroneous navigation results due to use of the inappropriate tools with the selected type of instrument! Ensure that the correct type of instrument was selected, or that the correct instruments with or without Y adapter or RL adapter are used. 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! 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). 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. Check the pointer for proper functioning according to the specifications given in TA (GB); TA (USA); TA (GB); TA (USA). Erroneous navigation results from imprecise palpation of landmarks, particular during the early stages of handling OrthoPilot! Always check the plausibility of the suggested dimensions and results against previous experience of the operating surgeon. If in doubt, compare the computed results with results obtained by mechanical means using standard ACL reconstruction instruments Optional measuring instrument 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). To obtain an exact measurement, both palpated points must have a fixed reference to the relevant transmitter of the reference space. 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)! Ensure that both palpated points have a fixed reference to the transmitter of the reference space 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. 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 ). 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. 9

10 Aesculap Orthopaedics ACL Reconstruction V 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. Erroneous navigation results due to selecting the wrong adapter pin when using instruments with Y adapter or RL adapter! Ensure that the correct adapter pin is used on the instrument during registration. Erroneous navigation results due to use of the inappropriate tools with the selected type of instrument! Ensure that the correct type of instrument was selected, or that the correct instruments with or without Y adapter or RL adapter are used. 6. Protocol See instructions for use OrthoPilot operating system, operation, software (TA (GB); TA (USA); TA (GB); TA (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. The documentation of the navigation data does not necessarily reflect the actual medical outcome of the operation. Make certain the navigation results are registered at the correct time and with the navigated instrument positioned correctly. Incorrect navigation results due to erroneous femoral X-ray planning! 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! Always record the femoral insertion point before punching in the transtibial pointer. 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 Quitting the software 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 (TA (GB); TA (USA); TA (GB); TA (USA)). 10

11 7. Technical Service 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 Tuttlingen / Germany Phone: Fax: ats@aesculap.de Or in the US: Aesculap Implant Systems, LLC. Attn. Aesculap Technical Services 615 Lambert Pointe Drive Hazelwood, MO Aesculap Repair Hotline Phone: Fax: 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 Corporate Parkway Center Valley, PA USA 11

12 CE marking according to directive 93/42/EEC CE-Kennzeichnung gemäß Richtlinie 93/42/EWG Marquage CE conforme à la directive 93/42/CEE Identificación CE en conformidad con la directriz 93/42/CEE Marchio CE conforme alla direttiva 93/42/CEE Simbolo CE, em conformeidade com a Directiva 93/42/CEE CE-märkning i enlighet med direktiv 93/42/EEG CE-oznaèení podle smìrnice 93/42/EHS Technical alterations reserved Technische Änderungen vorbehalten Sous réserve de modifications techniques Sujeto a modificaciones técnicas Con riserva di modifiche tecniche Salvo alterações técnicas Med reservation för eventuella tekniska ändringar Technické zmìny vyhrazeny TA-Nr /11 V1 Änd.-Nr. Aesculap AG Am Aesculap-Platz Tuttlingen Germany Phone Fax