Software User's Guide
Contents
1. 0 Anterior Posterior Lateral a Medial Anterior Posterior Reference Ring Frame Rotation deg Fo External Internal Update Views Apply First Strut To All Struts Fig 41 Postoperative screen for a Foot Case Medium 4 a v 15 Medium v 32 In the top portion of the Postoperative screen the position of the reference ring relative to the reference bone segment is entered Similarly to the Frame Parameters screen in the Preoperative Mounting Parameters reference ring translation in coronal medial lateral and sagittal anterior posterior planes is described in millimeters as translation of the center of the reference ring in relation to the longitudinal axis of the reference bone segment Three not present in the Preoperative Mounting Parameters screen section reference ring angulation parameters are added to the Postoperative screen These parameters reflect angular deviation of the reference ring orientation in the coronal AP view sagittal ML view and horizontal axial view planes from the orthogonal position relative to the reference bone segment On the AP view the reference ring angulation is described in degrees as an angle between the projection of the ring and the axis of bone segment with the medial side of the ring either up or down On the ML view the reference ring angulation is described in degrees as an angle between the projection of the ring and the axis of bone segment with th2. New Case Name Case 1_Copied on 13 03 2014 Create New Case Fig 55 Checkup screen 44 TL HEX SOFTWARE USER S GUIDE Software version 1 3 The standard software steps are now followed to complete the new planning from this starting point Fig 56 The surgeon should check and adjust Deformity Parameters if necessary Fig 57 The Frame Parameters section should be skipped and the surgeon should proceed to the Postoperative section where mounting parameters and strut parameters should be verified and adjusted if necessary This will result in a new prescription for the patient based on the starting point as chosen from the Checkup screen Log Out Patent Case Account About Postoperative End of Correction Schedule Case Data Deformity Parameters Frame Parameters Patient ID A TA Warming You are not allowed fo enter or provide any information that allows direcihy or indirectly the identification of your patient e g name birth date address email address phone number etc Please ise only an intemal confidential code to identidy Case Number your patient record when using this Software Case 4 Notes History Case Name This case is generated on the 13 03 2014 from case number 1 Case 1 Name Date 13 03 2014 Case four Side Left Right New Notes Case Four by Dr Arthurs Fig 56 Create New Case screen Note The surgeon should verify and if needed re enter the parameter
3. 12 03 2014 12 03 2014 Log Out ORTHOFIX Modify Patient Delete Patient 4 items in 1 pages 8 TL HEX SOFTWARE USER S GUIDE Software version 1 3 4 Patient and Case Management 4 1 Menu Structure Patient and Case menus include a list of patients or cases and allow the surgeon to add a new patient or case respectively All cases are related to a patient Fig 12 Therefore a new patient must be created prior to beginning a new case There are no restrictions on the number of cases that can be associated with each patient TL HEX TRUELON HEMAHOO SYSTEM Patient Case Account About List of Patients Search Add New Patient Add New Patient Add New Case No records to display 0 items in 1 pages Log Out TTL HEX THUSLOM MEXAPOO SYSTEM Patent Case Account About ORTHOFIX List of Cases Search Add New Case Add New Patient Add New Case Oitems in 1 pages 5 Wmslructiong li Patient A Fig 12 Patient and Case management menus and structure T IE Y CHETV A DE I CEDIG Fill AC Canftiunsarc AKFCIMAK gt 9 TL HEX SOFTWARE USER S GUIDE Software version 1 3 4 2 Add a New Patient Patient gt Add New Patient All patients are entered into the system through the Add New Patient menu The Add New Patient button can be used either in the List of Patients or List of Cases screen For each new patient Fig 13 surgeon should assign a Patient ID insert Patient Initials o
4. All cases for all patients in the List of Cases are sorted by the latest date created Fig 20 The List of Cases can be also sorted by clicking on any of the headers a part from Actions i e Patient ID Case Number Case Name Status Side Date Created Days Left A case can be in Active Received or Archived status Fig 19 CASE STATUS MEANING CONS ACTIVE _ Open and Modifiable RECEIVED Sent by Another User view ARCHIVED Read Only Oh iex Patient Case Account About TULL Oe PAC Grete Search Add New Patient Add New Case Modify View Send Case 1 12 03 2014 archive Delete Case2 12 03 2014 N te Case 3 j 12 03 2014 rs rs ee Sp Case 4 Active Le 12 03 2014 CL Modify View Send 12 03 2014 Archive Delete 12032014 Ma 6 items in 1 pages Fig 20 List of Cases screen 1 5 TL HEX SOFTWARE USER S GUIDE Software version 1 3 4 6 Send a Case User can send to another user a case in read only mode by clicking on the send link in the corresponding Actions field entering the username of the receiver in the pop up window and clicking on the button Fig 21 Warning You are not allowed lo enter or provide any information that allows directly of Indiectly the identification of Fig 21 Send Case Pop Up Window The receiver will receive a case with overwritten patient id i e RECEIVED CASES and initials i e Case from username
5. 30 0 30 0 31 0 32 0 32 0 33 0 34 0 35 0 36 0 36 0 37 0 38 0 39 0 40 0 40 0 41 0 40 40 40 39 38 38 38 38 37 37 36 36 36 36 35 35 34 34 34 34 34 33 33 32 32 32 32 32 32 32 31 31 31 30 30 30 30 30 30 30 30 30 FERESSSSLSSESSESRSSESSVCHSSHSSRSSRSERKKKLKKRKKLR SS ss long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long long ESLBLLELELELLEUERNDDRENNNE ES RRPRRRRRRRBRBRRRBRRBRRRRRRRBRRRB NBRPBRBESBRAEBBRESFSBLBRBBSBRBSANRY TFE mpa 888588885888 Fig 46 Report screen view before starting adjustments 37 TL HEX SOFTWARE USER S GUIDE Software version 1 3 The three buttons on the first part of the screen Print Prescription Print BOM and Print Report will generate on click a file in pdf format presenting the information from three different points of view The Prescription pdf file displays the adjustment schedule for the patient each row describes the strut adjustment to be made by the patient for each deformity correction step as specifie
6. Distal Second Ring Position mm Total Medium Acute Case Name Foot Frame Parameters Patient ID PATIENT A Postoperative Distal Support Ring Foot Plate 120mm Reference Ring ML Translation mm 02 Anterior Posterior Reference Ring Frame Rotation deg a v Medium UltraShort 4 28 1 18 39 Updated Frame Parameters screen for a foot case After clicking Up Side Left End of Correction Schedule ORTHOFIX Bone Type Foot Report Checkup Reference Ring Position Relative To Deformity Apex Osteotomy Fracture Level UltraShort 28 18 a v a y Medial Lateral Anterior Posterior Strut 5 mm 83 Medium 4 1 date Views check the bottom of the screen for struts that are out of range indicated by a red number An out of range strut can be addressed by modifying the mounting parameters of the Frame Parameters screen or the surgeon may proceed to Postoperative screen Preoperative Mounting Parameters portion of frame parameters can be skipped if the surgeon doesn t want to pre build a frame or doesn t have the possibility to do a pre plan of the surgery in this case he can proceed directly from choosing the support rings to Postoperative screen 30 5 4 Postoperative TL HEX SOFTWARE USER S GUIDE Software version 1 3 The Postoperative screen Fig 40 and Fig 41 provides the ability to enter two sets of parameters including frame mounting parameters
7. For each new case Fig 18 the surgeon should assign a Case Number and a Case Name reference associated with this case Select gender left right side bone type long bone or foot and the planning date followed by entering Notes associated with this case optional Proceed to the next step in the treatment planning process by clicking on the next arrow to the right hand side TL HEX Tramiel Hia PANTI Patient Case Account Case Data Deformity Parameters Frame Parameters Postoperative End of Correction Schedule Patient ID A Warming You are not allowed to enter or provide any information that allows directly PATIENT A or indirect the identiicaton of your patent 6 9 name birth date address email address phone number etc Please use only an mienmnal conidential code to identity Case Number your patient record when using this Software 4 Notes History Case Name blount s disease Planning Created Side Bone Type Left Right Long Bone New Notes Case One Notes Fig 18 Add New Case screen Warning Under the Orthofix Terms of Use End User License Agreement and Privacy Policy the surgeon shall never enter information that directly identifies a patient The patient number is intended to be used as an identifying link to the patient within the surgeon s patient management system 14 TL HEK SOFTWARE USER S GUIDE Software version 1 3 4 5 View Cases Case gt List of Cases
8. Itis recommended thatthe user change the password during the first login and periodically thereafter The Change Password screen Fig 62 appears by clicking on the Account pull down Simply enter the current password followed by entering and confirming the new password then click Change Password Passwords must be 6 or more characters and is case sensitive Log Out 4 a h F Cr HEX ae ORTHOFIX Patient Case Account About TRUELOK MENAH OO SYSTEM Change Password Old Password New Password Confirm New Password Cancel Change Password Fig 62 Change Password screen It is important to remember that the surgeon remains ultimately responsible for the confidentiality of the information entered into the software One of the ways to ensure confidentiality is to ensure password integrity by changing it at regular intervals and by keeping the password as secure as possible Warning Under the Orthofix Terms of Use End User License Agreement and Privacy Policy the surgeon should never enter information that directly identifies a patient The patient number is intended to be used as an Identifying link to the patient within the surgeon s patient management system 50 TL HEX SOFTWARE USER S GUIDE Software version 1 3 6 2 Prescription Preferences The Prescription Preferences screen appears after prescription preferences is chosen from the Account pull down Fig 63 User can optionally add defaul
9. Posterior ML Plane Translation mm 0 Anterior Posterior End of Conecton Log Out ORTHOFIX Schedule Report Checkup Rotation deg 0 Extemal Internal Axial Translation mm 0 Short Long Li Optional Bone Length mm 0 Short Long 20 TL HEX SOFTWARE USER S GUIDE Software version 1 3 1 h 4 i Fes i Oy TL HEX ge m i Patient Case Account About CON Din ee ee es Tak Case Number 2 Case Name Foot Patient ID PATIENT A Side Left Case Data Frame Parameters Postoperative End of Conechon Schedule Report Checkup 0 External Internal ML Plane Angular Deformity deg Axial Translation mm 0 Apex Anterior Apex Posterior 0 Short Long T T ML Plane Translation mm Optional Bone Length mm 0 Anterior Posterior 0 Short Long T Update Views Fig 29 Default Deformity Parameters screen for a Foot Case Deformity description includes 3 angulations and 3 translations Fig 28 and 29 The three angulations are coronal plane angulation in AP view sagittal plane angulation in ML view and horizontal plane angulation rotation in Axial view Coronal plane angulation can be either varus or valgus depending whether the distal segment is bent towards or away from the midline respectively Sagittal plane angulation will be described as either apex anterior procurvatum or apex posterior
10. as the moving segment In the software diagrams the reference segment is indicated as a blue segment and the moving non reference segment as green The surgeon chooses a reference segment either proximal or distal Choosing proximal reference means that the frame and the deformity are oriented relative to the axis of the proximal segment The deformity parameters what the bone looks like should be described accordingly Therefore the translation and rotation of the distal segment is described in relation to the proximal segment If the distal segment is chosen as the reference segment the frame and the deformity are orientated relative to the axis of the distal segment and measurements would need to be taken in relation to this orientation For example medial translation of the distal bone segment would be described as lateral translation because the proximal segment would be translating laterally in relation to the distal reference segment Fig 3 In the description of foot cases the software diagram represents the deformity following the same rules as above but with a dedicated graphic Fig 4 Medial Translation Medial Translation Distal Reference Segment Fig 3 Fig 4 Fig 3 Description of moving bone segment translation depending on proximal or distal location of the reference segment Fig 4 For foot deformity the proximal segment is almost always used for referencing It is important to realize that changing from prox
11. menus The default assumption is that both proximal and distal external supports are perpendicular to the corresponding bone segment axis and located at 50 mm distance from the apex of the deformity or the osteotomy fracture level The screen provides the capability of adjusting the position of the reference ring in the coronal plane AP translation sagittal plane ML translation relative to the reference bone segment axis In addition the reference and moving ring positions can be adjusted in the axial direction relative to the apex of deformity or the osteotomy fracture level in the Reference Ring box xing BC Horizontal BC Moving Translation Ring Position B CD Moving Ring Position Full Ring 180mm p i Full Ring 180mm Reference Ring ML Translation mm Reference Ring Position Relative To nes Ring ML Translation mm Reference Ring Position Relative To o Anterior Posterior Deformity Apex Anterior Posterior Deformity Apex Osteotomy Fracture Level Ostesiomy Fractune Level Reference Ring Frame Rotation deg ce Ring Frame Rotation deg Medini Lme q1 v Li Medal Lateral o Antenor Posienor Fig 37 Description of Reference Ring Box relative to deformity apex a or osteotomy fracture level b In this section the reference ring position in the coronal and the sagittal planes is described in millimeters as the translation medial lateral and anterior posterior respectively of t
12. remove any filter click the Clear button Fig 17 A TTL HEX APOD SYSTEM Patient Case Account About ELO ra a Search Patient ID Case Number PATIENT A gt PATIENTB Modify Patient Delete Patient PATIENT C Modify Patient Delete Patient 3 items in 1 pages Fig 17 Search Section Expanded 13 The List of Patients can also be sorted in ascending or descending order by clicking on any of the column headings in the table Fig 16 a part from Actions Patient ID Initials Gender Last case created Active Cases Actions that can be performed on a patient are modify patient or delete patient if it has been created by the current user If it has been received from another user it can be viewed or deleted but not modified see 4 6 Send a Case for details on sending cases 4 4 New Case Case gt Add New Case Case menu includes two options List of Cases and Add New Case A new case can be added by selecting Add New Case from the Cases menu Alternatively surgeon can add a new case by clicking Add New Case in the List of Cases or in the List of Patients or create a new case after a new patient creation process When creating a new case the patient is selected from the drop down selector sorted by Patient ID to the right of Patient ID label If no patients have been entered the drop down selector will be empty Note A patient must be created before a case can be created
13. 1 mm increments relative to the orange line mark on the outer tube Fig 9 a The gradual adjustment is achieved by pulling and rotating the adjustment knob resulting in a noticeable detent tactile click every 0 5 mm of adjustment Gradual adjustment Is indicated by the same scale relative to the green line mark on the end of the threaded rod Fig 9 b The direction of adjustment is indicated by the direction clips The arrow of the direction clips is oriented according to the prescription see details in General Principles of TL HEX Frame Assembly TL 1405 OPT EO B ECE P OREO LPC ULE PP Pee Pea peepee NII 15 20825 30 35 40 45 50 55 60 RARARRARREE SFr ELLE LELLEL ES vleueuluueutuouuuts Fig 9 Indicators for acute a and gradual b adjustments on the TL HEX struts 6 TL HEX SOFTWARE USER S GUIDE Software version 1 3 3 User Access and Account Management 3 1 Obtaining Access Access to the TL HEX software Is controlled by an Username and Password The username and password can be obtained at www tlhex com by requesting a new account from the Home Page and following the onscreen instructions Upon a request being received by Orthofix it will be validated to confirm whether the applicant has undergone the necessary training to use the system safely and responsibly Once approved the surgeon s user account will be activated and Username and Password will be emailed to the applicant 3 2 Login Screen The TL HEX application is l
14. 15 17 long 38 h 28 med 34 20 long 11 28 long 15 18 long med 34 18 11 26 long 15 18 long ng 24 km i 4 15 g 11 26 long 15 18 long 37 24 med 34 12 long 11 24 long ha S S Eju iA oa 19 long 2 med 34 10 long 11 23 long 20 long a wd 34 8 long 22 long 20 long med 34 5 long 20 long long le IB ad 34 a long 20 long 2 long med 34 0 long 18 long long 5 ji long 11 17 long fh Le long 16 long long 11 14 tong oo long 11 14 long W long 11 long 11 33 long long 26 6s iong 11 33 long to fe D ololslsls s clsls s slelslo slelts elsls Fig 51 Report PDF file describing the acute and gradual adjustments to be made during the treatment page 1 41 TL HEX SOFTWARE USER S GUIDE Software version 1 3 Case Number 1 Print Date giovedi 13 marzo 2014 Case Name Case 1 Patient ID PATIENT A Side Left Bone Type Long Bone 28 03 2014 20 00 29 03 2014 08 00 29 03 2014 20 00 30 03 2014 08 00 30 03 2014 20 00 31 03 2014 08 00 31 01 04 2014 08 00 long O 31 01 04 2014 20 00 02 04 2014 08 00 34 02 04 2014 20 00 35 03 04 2014 08 00 37 04 04 2014 08 00 38 04 04 2014 20 00 39 05 04 2014 08 00 40 05 04 2014 20 00 41 06 04 2014 08 00 Fig 52 Report PDF file describing the acute and grad
15. 2 or two foot plates with the opening in opposite directions and six variable length struts The relative strut lengths determine the position of the rings in space Because the rings are attached to bone segments or to a bone segment and foot their position indirectly determines the position of the bone segment The Software is able to calculate strut length adjustments for surgeon s review and approval The software needs three sets of parameters to calculate correction These are 1 deformity parameters 2 frame parameters 3 mounting parameters The deformity parameters define to the software what the deformity or fracture displacement looks like The second set of parameters describes the size and shape of the frame that is to be used The third set of parameters designates where the frame s reference point is in relation to the fracture or deformity area With these sets of parameters the software will be able to calculate for surgeon review and approve appropriate strut adjustment for the patient to achieve the treatment goals Fig 1 Fig 2 Fig 1 TL HEX standard application with two rings and 6 variable length struts Fig 2 TL HEX application with one ring one foot plate and 6 variable length struts foot deformity correction 2 TL HEX SOFTWARE USER S GUIDE Software version 1 3 2 Nomenclature In the description of the fracture or deformity one of the bone segments Is defined as the reference segment and the other one
16. 3 2014 08 00 22 27 03 2014 20 00 Fig 47 Prescription PDF file describing the struts adjustment to be made by the patient page 1 38 TL HEX SOFTWARE USER S GUIDE Software version 1 3 Print Date giovedi 13 marzo 2014 Case Number 1 Case Name Case 1 Patient ID PATIENT A Side Left Bone Type Long Bone Strut Adjustments in CLICKS Strut Reference Length RED ORANGE YELLOW GREEN BLUE PURPLE RED ORANGE YELLOW GREEN BLUE PURPLE Date Time _Struti Strut Struts Strut4 Struts Strut6 Struti Strut Struts Strut4 Struts Struts 28 03 2014 08 00 2 1 3 5 2 1 28 32 60 8 38 28 03 2014 20 00 29 03 2014 08 00 29 03 2014 20 00 7 30 03 2014 08 00 28 30 03 2014 20 00 29 31 03 2014 08 00 33 02 04 2014 08 00 34 02 04 2014 20 00 7 0404 2014 08 00 38 04 04 2014 20 00 9 05 04 2014 08 00 05 04 2014 20 00 06 04 2014 08 00 Fig 48 Prescription PDF file describing the struts adjustment to be made by the patient page 2 39 Adjustment for each strut is represented by number of clicks 1 2 rotation of the strut adjustment knob that is 1 2 mm and can be positive if strut lenght increases or negative when the strut lenght decreases In addition in the report file the gradual adjustment scale value in millimeters is displayed as a reference for each strut The direction clips are then applied to the rod end joints according to the pres
17. M 05 00 AM 09 00 AM 10 00 AM 17 00 AM 03 00 PM 04 00 PM 05 00 PM 09 00 PM 10 00 PM 11 00 PM Days Of Correction Instructions for Use Fig 45 Schedule screen Definitions Daily Correction Rate mm day translation distraction compression speed combination of all the linear speeds Angular Max Speed deg day angular rotation speed varus valgus correction Rotate Max Speed deg day axial rotation speed external internal rotation If continuing to the Report screen with struts that will potentially move out of range then once tthe next arrow to the right hand side is clicked the surgeon will be advised via a pop up window that struts are out of range 36 TL HEX SOFTWARE USER S GUIDE Software version 1 3 5 7 Report The Report screen displays the adjustment schedule for the patient resulting from the previously entered parameters plus acute and gradual adjustment values in millimeters for each strut fig 46 These values should be checked by the surgeon especially in extreme cases Log Out 11 JEN i ORTHOFIX TRLELOM PGRAROD GVSTEM Patent Case Account About Case Number 1 Case Name Case 1 Patient ID PATIENT A Side Left Bone Type Long Bone Case Data Deformity Parameters Frame Parameters Postoperative End of Correction Schedule Report Checkup Please review all information before completing and printing the prescription to ensure that it is accurate Prin
18. SOFTWARE USER S GUIDE TRUELOK HEXAPOD SYSTEM Software User s Guide Software Version 1 3 ORTHOFIX 1 INTRODUCTION 2 NOMENCLATURE 3 USER ACCESS AND ACCOUNT MANAGEMENT 3 1 OBTAINING ACCESS 3 2 LOGIN SCREEN 3 3 HOME PAGE 4 PATIENT AND CASE MANAGEMENT 4 1 MENU STRUCTURE 4 2 ADD A NEW PATIENT 4 3 LIST OF PATIENTS 4 4 ADD A NEW CASE 4 5 VIEW CASES 4 6 SEND A CASE 4 7 ARCHIVE A CASE 5 CASE PLANNING 5 1 CASE DATA 5 2 DEFORMITY PARAMETERS 5 3 FRAME PARAMETERS 5 4 POSTOPERATIVE 5 5 END OF CORRECTION 5 6 SCHEDULE 5 7 REPORT 5 8 CHECKUP 6 WEBSITE NAVIGATION 6 1 CHANGE PASSWORD 6 2 PRESCRIPTION PREFERENCES Orthofix wishes to thank the following surgeons for their contribution to the development of this User s Guide Franz Birkholtz M D Alexander Cherkashin M D Mikhail Samchukov M D William Terrell M D a SSE e gt SE EE wo CO Ow 11 12 13 14 15 17 17 17 23 29 33 34 35 42 45 48 49 TL HEX Software User s Guide Software version 1 3 The applicable End User License Agreement can be found at http tlhex com policies Eulapolicy html The applicable privacy policy can be found at http tlhex com policies privacypolicy html Security Precautions i to clear the browser history temporary Internet files cookies etc after logging out of the TL HEX Computer System Requirements Display Settings Screen resolution of 1024 x 768 Pixel or
19. The surgeon should review the acute gradual indication numbers in the Report screen either preoperatively to adjust the ring separation distance or postoperatively to schedule frame modifications on time The prescription row will be highlighted when strut readjustment shaded blue or exchange shaded red are required Fig 47 and Fig 48 The rows of lighter shading indicate the allowable range of days that are suitable for the re adjustment exchange the heavier shaded row indicates the last possible day for the strut change If the strut re adjustment exchange occurs on the last day marked by the solid color blue red box the existent prescription can be used If the strut readjustment exchange occurs prior to the last day a new prescription must be generated from that date The Checkup screen can be used to create a new case The Acute and Gradual values of the new strut if the exchange adjustment occurs prior to the last day of possible re adjustment exchange can be found using the conversion tables available online clicking on Instructions for Use link on the footer of the www tlhex com site If strut exchange is required shortly after the beginning of correction and was done before starting the correction the surgeon should return to the Postoperative screen and move through the End of Correction to re generate a prescription Note Please review all information before completing and printing the prescription to ensure that it
20. UIDE Software version 1 3 ORTHOFIX About Full Ring 120mm Foot Plate 120mm a Preoperative Mounting Parameters Reference Ring AP Translation mm Reference Ring ML Translation mm Reference Ring Position Relative To 0 Medial Lateral 0 Anterior Posterior Deformity Apex Osteotomy Fracture Level Reference Ring Position mm Reference Ring Frame Rotation deg 50 Proximal Distal Ki a v v Medial Lateral Anterior Posterior Second Ring Position mm 50 E Strut 5 mm 94 Medium Medium Medium Short Short 21 24 1 1 24 1 34 14 14 34 Fig 35 Frame Parameters screen for a Foot Case 26 TL HEX SOFTWARE USER S GUIDE Software version 1 3 In the example shown 180 mm full rings have been selected Fig 36 Should an open external support be chosen i e a 5 8 ring the relevant ring orientation open posteriorly open medially open anteriorly should be selected from the drop down menu The software will automatically change the orientation offset of the 5 8 ring in the Frame Rotation field with the relevant read only value This value can be overridden in the Postoperative Screen Note If choosing two 5 8 rings the openings can now be oriented in the same direction e g both open anteriorly posteriorly medially The proposed solution may not be applicable on a patient due to the position of the struts that can pass through the soft tissues The surgeon must check the
21. and in Received status Fig 22 Account About 8 items in 1 pages Fig 22 Received Case Listed in the List of Cases Screen 16 4 7 Archive a case To Archive a case user should click on Archive in the Actions field of a case A warning pop up reminds that the action cannot be reverted once a Case has been Archived it cannot be modified Fig 23 and Fig 24 TELOS EAFODD OSTEO Patent Search Add New Patient Add New Case Patient ID RECEIVED_CASES Case Number Case from TestUser PATIENT A PATIENT A Fig 23 Warning Pop Up i TIL HEX TELON PAPO GrETEnt Case Patient Search Add New Patient Add New Case Patient ID Case Number RECEIVED_CASES Case from TestUser PATIENT A Case 1 ATIENT Case 2 Case four Case 4 Case 5 Case 6 Page size 10 Account Case Name Case from TestUser Case Name Case from TestUser About Status Date Created Days Left Received 13 03 2014 24 s E IO NOTE You cannot modify this case after it is archived Are you sure you want to archive this case Cancel 12 03 2014 12 03 2014 Account About Status Date Created Days Left Received 13 03 2014 24 Active 12 03 2014 24 Active 12 03 2014 Active 12 03 2014 Archived 12 03 2014 12 03 2014 12 03 2014 12 03 2014 Fig 24 Performable Actions on an Archived Case An Archived Case cannot be modified Actions View Delete Modif
22. and strut lengths according to the postoperative position of the rings and struts Reference Ring AP Plane Angle deg 0 Medial Side Down Medial Side Up Reference Ring AP Translation mm 0 Medial Lateral Reference Ring Position mm 100 ki Proximal Distal Fig 40 Postoperative screen About Patient ID PATIENT A Reference Ring ML Plane Angle deg 0 Anterior Side Down Anterior Side Up Reference Ring ML Translation mm 25 Anterior Posterior Reference Ring Frame Rotation deg 0 External Internal Update Views Apply First Strut To All Struts Long 3 a 79 Log Out ORTHOFIX Reference Ring Position Relative To Deformity Apex Osteotomy Fracture Level 2 Medial Lateral Anterior Posterior 31 TL HEX SOFTWARE USER S GUIDE Software version 1 3 Tl HEX TALON HEKAPOO SYSTEM Patient Case Case Name Foot Deformity Parameters Reference Ring AP Plane Angle deg 0 Medial Side Down Medial Side Up Reference Ring AP Translation mm 0 Medial Lateral Reference Ring Position mm 90 Proximal Distal Account Frame Parameters ORTHOFIX About Patient ID PATIENT A Side Left EndoCarecon Schwa Chacun Reference Ring ML Plane Angle deg Reference Ring Position Relative To 0 Anterior Side Down Anterior Side Up Deformity Apex Osteotomy Fracture Level Reference Ring ML Translation mm
23. chedule Report Chackup Rotation deg Proumal Distal ge Extemal Internal AP Plane Angular Deformity deg Axial Translation mm 25 Valgus Varus 0 Shot Long AP Plane Translation mm Optional Bone Length mm 02 Medial Lateral 0 20 Short Long Fig 31 Updated Deformity Parameters screen 23 TL HEX SOFTWARE USER S GUIDE Software version 1 3 Log Out Tan bp w p ORTHOFIX TLHEK Patent Case ACCOUNT About a g Case Data Deformity Parameters Frame Parameters Postoperative End of Correction Schedule Report Checkup 2 Proximal Distal Extemal Internal AP Plane Angular Deformity deg ML Plane Angular Deformity deg Axial Translation mm 0 gt Valgus Varus 30 Apex Anterior Apex Posterior o Shot Long AP Plane Translation mm ML Plane Translation mm Optional Bone Length mm ija Medial Lateral o Antenor Posterior 0 Short Long 7 Update Views Fig 32 Updated Deformity Parameters screen for a Foot Case Note It is an important safety mechanism to check whether the diagrams on the software correspond to the deformity that is seen on the patient s x rays and or clinically Click Update Views after any changes or updates to deformity parameters Once satisfied with the deformity parameters that have been entered click on the next arrow to the right hand side to the Frame Parameter
24. cription If strut elongation is required positive numbers in the prescription the arrow on the clip should point in the same direction as the reference arrow on the adjustment knob Fig 49 a If strut shortening Is required negative numbers in the prescription the clip should be applied with the arrow pointing in the opposite direction of the arrow on the adjustment knob Fig 49 b Fig 49 Orientation of direction clips for strut elongation In most of the cases the orientation of direction clips remains the same throughout the treatment In some cases with a rotational deformity correction the direction of strut adjustments in the prescription may change from positive to negative or from negative to positive In this situation the surgeon should instruct the patient about the day the change of direction occurs and either schedule a clinic visit for the orientation change of the direction clip or instruct the patient on how to make this orientation change to the direction clip In addition the direction of strut adjustment may change from positive to negative in cases of extreme elongation of the long strut acute adjustment indicates 80 mm and gradual adjustment indicates O mm left on the strut scale even though additional strut elongation is still required This situation may occur when external supports are placed too far from each other and maximal elongation of the longest available strut is not enough to achieve the desired amount
25. d in the schedule Fig 47 and Fig 48 This document must then be printed and the hard copy must be Issued to the patient and can also be saved for the record The print out should be checked for correctness and readability and the patient should be instructed to contact the surgeon in case the prescription becomes lost or damaged Note All information must be reviewed by the surgeon before completing and printing the prescription to ensure that It is accurate Dr Test Print Date giovedi 13 marzo 2014 Test Hospital Hospital Street i C Number 1 London UK UK 00000 FRE SR UE 00000000 ASE AIME LASE Patient ID PATIENT A Side Left Bone Type Long Bone Strut Adjustments in CLICKS Strut Reference Length ORANGE YELLOW GREEN BLUE PURPLE RED ORANGE YELLOW GREEN BLUE PURPLE 7 a gi 4 i i s wa 4 saka i No Date Time Strutt Strut Strut Struts Struts Strut6 Strut Strut Strut3 Strut4 Struts Strut 0 17 03 2014 00 00 0 0 0 40 35 34 35 17 03 2014 08 00 La a 42 B A O0 3 17 03 2014 20 00 kn AP ah 18 03 2014 08 00 18 03 2014 20 00 wi a 19 03 2014 08 00 19 03 2014 20 00 T 20 03 2014 08 00 20 03 2014 20 00 21 03 2014 08 00 21 03 2014 20 00 11 22 03 2014 08 00 12 22 03 2014 20 00 13 23 03 2014 08 00 14 23 03 2014 20 00 15 24 03 2014 08 00 16 24 03 2014 20 00 17 25 03 2014 08 00 118 25 03 2014 20 00 19 26 03 2014 08 00 20 26 03 2014 20 00 21 27 0
26. e anterior side of the ring either up or down On the axial view the reference ring angulation rotation is described in degrees as external or internal rotation relative to the longitudinal axis of the reference bone segment If proximal referencing was chosen the ring orientation tab will determine the rotational frame offset If distal referencing was chosen the ring orientation tab will determine the rotational frame offset Fig 42 In the axial plane translation of the reference ring proximal distal along the longitudinal axis of the reference bone segment is described in millimeters as a distance from the center of the reference ring to specific point of interest deformity apex or osteotomy fracture level ML view Axial view Reference Ring ML translation Reference Ring Reference Ring AP angle ML angle Frame Rotation Reference Sires Reference Ring Rina position AP translation JP Ring position Lateral waitin osterin Anterior Fig 42 Reference ring angulation translation and rotation parameters in AP view a ML view b and Axial view c At the bottom of the screen Fig 40 and Fig 41 the strut mounting parameters are entered for all six struts Parameters for each strut are described in three fields The first field indicates the strut size e g ultra short short medium long The second field is the acute length for the strut in millimeters which is read off the scale relative to the acute lengt
27. e Data Deformity Parameters Frame Parameters All the corrections in this section are over under corrections relative to biomechanically aligned segment AP Over Under Correction deg ML Over Under Correction deg 0 7 H Valgus D Varus 0 z D Apex Anterior Apex Posterior AP Over Under Translation mm ML Over Under Translation mm 0 Medial Lateral o Anterior Posterior T Update Views Fig 44 End of Correction screen Click on Update Views to check the final struts length ORTHOFIX Schedule Report Checkup Over Under Rotation deg 0 External Internal Over Under Bone Length mm 20 Shortening Lengthening T Note The Report should be referenced for final strut position acute and gradual and strut size 35 5 6 Schedule The Schedule screen Fig 45 allows the surgeon to enter specific parameters related to bone segment movement during the deformity correction Those parameters include maximum rate of bone segment translation Daily Correction Rate in mm day maximum rate of bone segment angular correction Angular Max Speed in degrees day maximum rate of bone segment rotation Rotate Max Speed in degree day or desired days of correction Days of Correction Treatment start date may be adjusted using Latency Period days and Correction time may be selected in the appropriate box The correction rates and the days of correction are correlated and therefore the su
28. eckup has been launched from the Report Screen If necessary use the Calendar to select the date the new case should begin Click Create New Case and a new case will be generated using the parameters of the bone segment position and the strut length values from the date selected as starting point The Create New Case screen is used in the following situations e Changes in parameters of strut adjustment e Unplanned strut readjustment or exchange e Residual correction is required e Next treatment phase for the staged correction Before clicking on Create New Case the new case number and new case name can be entered into the corresponding fields Clicking on Create New Case will open Case Data screen for the newly generated case All the deformity and frame parameters will be transferred from the previous case at the date of check up oe D e i d y L TTL HEX ORTHOFIX Patient Case Account About TELOK HAMAS OO SYSTEM Case Number 1 Case Name Case 1 Patient ID PATIENTA Side Left Bone Type Long Bone ones marana rantaman R te Per kelan Displaying Report line number 0 based on treatment range of 17 03 2014 06 04 2014 AP Angle deg 25 Valgus ML Angle deg 25 ApexAnterior Rotation deg 0 AP Translation mm 0 ML Translation mm 0 Axial Translation mm 0 Total Strut 5 imm 214 Size Long Long Acute 0 15 Gradua 14 33 To Create New Case New Case Number CopyOf_1
29. ed distracted away from the reference bone segment the second option long is used in description of the axial translation Fig 30 In addition the Optional Bone Length is included in description of the axial translation Again the software provides two options to indicate whether the bone is short or long and supports the entry of the relevant amount of bone length discrepancy in millimeters Note The bone length is a clinical parameter indicating limb length discrepancy relative to contralateral limb and will not change bone segment orientation in the software diagrams Axial Translation mm 20 Short Long Optional Bone Length mm 0 Short Long v Fig 30 Description of translation along the longitudinal axis and bone length a contralateral normal limb b short limb as result of bone shortening without axial translation c short limb due to axial translation of bone segments Note that the combined length of bone segments B and C is shorter than the length of contralateral bone segment A The combined length of segments D and E however is equal to the length of contralateral bone segment A 22 TL HEX SOFTWARE USER S GUIDE Software version 1 3 Click Update Views at any time to refresh the display according to the parameters entered Fig 31 and Fig 32 Log Out 4 IL HEX i Patient Case our j a ORTHOFIX Frame Parameters Postoperative End of Corechon S
30. en done for the day by logging off the surgeon should close the Internet Browser then reopen browser clear the browser history open TL HEX application and login e The session will automatically time out after 30 minutes The surgeon should close the Internet Browser then reopen browser clear the browser history open TL HEX application and login e The about menu item contains general information about the product and its website The site footer links provide legal information about Cookies Eula Privacy and contact support information Contact us to reach our Customer Care and Instruction for use for accessing all needed support material and literature Log Out TL HEX WADI CRAPO SETAR Patient Case Account About Case Number Case 4 Case Name Case four Patient ID PATIENT A Side Left Case Data Deformity Parameters Frame Parameters Postoperative End of Correction Reference Segment Fig 60 Three dotted loading animation 48 TL HEX SOFTWARE USER S GUIDE Software version 1 3 100 Proximal Distal D Mediai Lateral Second Ring Position mm Anterior Posterior A 80 v Fig 61 Popup window for calculation of strut lengths EE A Z m pm 1 7 LI mm pa EEIE m I I ga a T LIC VY CANETAINADE cED C Ai BE Cnatteuansrarnrn IAFCIARAR 1 gt 9 i L H E A IUFIVWVARE USER S O U IDE SOTtware version gt 6 1 Change Password
31. h orange mark The third field is the gradual length for the strut in millimeters which is read off the same scale relative to the gradual length green mark Note that the strut types lengths in conjunction with the previously entered deformity parameters will define the position of the second moving ring relative to the moving bone segment Clicking on the Apply First Strut To All Struts button the strut size selected for the first strut will be applied automatically to all the other struts If preoperative planning was performed previously all data including frame mounting parameters and strut lengths is transferred automatically to the corresponding fields of the Postoperative screen The Surgeon should confirm the data or adjust it if necessary Strut type ultra short short medium and long as well as both acute and gradual adjustment lengths recorded at the end of the surgery should be confirmed or adjusted in the corresponding fields These adjustments will describe not only the final shape and orientation of the frame but also where it is located in relation to the bone segments Clicking on the Update Views at this point will render software generated diagrammatic models that reflect the bone deformity and frame position on the x rays In case of a discrepancy the surgeon should go back and check all the variables before proceeding to the next step If changes are made in the Postoperative screen followed by changes to defor
32. he center of the reference ring in relation to the longitudinal axis of the reference bone segment While Reference Ring Position along the longitudinal axis of the reference bone segment proximal distal is described in millimeters as a distance from the center of the reference ring to the specific point of interest Similarly the position of the second ring is described in millimeters as a distance from the same point of interest Either the apex of the deformity or the level of the osteotomy fracture can be chosen as point of interest Fig 37 If the point of interest is Osteotomy Fracture Level the two fields below are editable and surgeon can enter in millimeters the horizontal fragments translation of the osteotomy fracture anterior posterior and medial lateral If Deformity Apex is selected the two fields are grayed out If the AP or ML translation was entered into the deformity parameters section the osteotomy fracture level is automatically chosen as point of interest The surgeon has the ability to adjust previously entered horizontal segment translation depending on the distance between the point of interest and deformity apex 28 TL HEX SOFTWARE USER S GUIDE Software version 1 3 Note Although the surgeon can skip the Pre Operative Mounting Parameters section it is suggested that the surgeon completes the Preoperative that section This simplifies the overall data entry and then the application suggests the opti
33. higher Supported Browsers Microsoft Internet Explorer Version 8 or 9 Microsoft and Internet Explorer are either registered trademarks or trademarks of Microsoft Corporation in the United States and or other countries Internet Connection High speed Internet connectivity is recommended Language Setting Select the Language setting in the Internet Explorer browser for the country of origin This will provide the correct date setting My Username gt My Password gt My Email Address 2 The following provides a sequential overview of the process for a case management with TL HEX software LOG IN PREOPERATIVE If the frame IS not pre assembled go directly to the Postoperative phase POSTOPERATIVE Obtain an account at www tihex com following the onscreen instructions Log in the TL HEX software https app tlhex com Create a New Patient Create a New Case related to a patient Specify the Deformity Parameters Indicate the Frame Parameters Complete the Mounting Parameters section to pre assemble the frame Confirm or adjust postoperative values and struts configuration Visualize the end of correction parameters providing added over under correction if required Determine the schedule for the correction planning Visualize and print the report Visualize and print the prescription for the patient Use the checkup function to create a new case star
34. imal to distal referencing will change direction of translation in both AP and ML views and the direction of rotation in the Axial view but will not change length or angulation parameters because these are mathematically independent of the point of reference To minimize measurement errors on the x rays the shortest segment should be used as a reference segment For example if a correction was performed around a proximal tibial osteotomy or fracture the proximal segment should be used for referencing If surgeon is dealing with a distal femoral fracture or deformity the distal segment should be used as the reference segment if the surgeon works with foot deformity for example Equinus foot the proximal segment Is almost always used for referencing 3 TL HEX SOFTWARE USER S GUIDE Software version 1 3 There are three diagrams in the software The first diagram is the AP view diagram corresponding to the standard AP x ray of the limb The second diagram is the ML view diagram representing the standard ML x ray of the limb There are orientation keys on these two diagrams that indicate the medial lateral and anterior posterior aspects respectively The third diagram is the Axial view diagram representing the view we would have when looking either up or down the limb from the reference segment On this diagram the orientation keys are anterior posterior medial and lateral Fig 5 WAS edial Medial CINE Fig 5 Standard AP vie
35. is accurate LIF WV CRF RTIAILlA Dr Licr pasIc Pinter fc Cu _5 s H E X SOF VV A DE IISER S GI DE Softwa re version 1 2 IL FICN IOVFPI WARE UDER D UVIVE DO0ILVVarTe VErT gt oIOTrI lu D J The Prescription Preferences previously entered and associated to a patient will be printed in the upper left corner of this file see section 6 2 Prescription Preferences for details Prescription file has been optimized for black and white printing In order to distinguish between blue and red shaded rows a black contour has been added to the red cells This document must then be printed and the hard copy must be issued to the patient and can also be saved for the record The print out should be checked for correctness and readability and the patient should be instructed to contact the surgeon in case the prescription becomes lost or damaged The Print BOM button produces a Bill Of Material file listing the materials that only cover the TL HEX components needed for the treatment This includes rings foot plates and struts Fig 50 Case Number 1 BOM Prin Date giovedi 13 marzo 2014 Case Name Case 1 Patient ID PATIENT A Side Left The listed materials only cover the TL HEX components needed for the treatment This includes rings foot plates and struts Fig 50 Bill of Material PDF The Print Report button generates a pdf file of the report screen and it is intended for the doctor to print a
36. l Internal Update Views Apply First Strut To All Struts IH Long 0 35 Fig 43 Updated Postoperative screen with errors related to incorrect strut lengths 34 TL HEX SOFTWARE USER S GUIDE Software version 1 3 5 5 End of Correction The End of Correction screen Fig 44 displays the position of the bone segments and the frame at the end of the treatment deformity correction The software assumes that at the end of deformity correction the bone segments should be in perfect alignment with no limb length discrepancy amount of lengthening will be equal to the amount of limb length discrepancy value entered at the Deformity Parameters screen For foot application the software assumes that the end of correction should be achieved when the two segments are perpendicular The screen however provides the surgeon the opportunity to override the default position as desired Additional adjustments include coronal plane AP view and sagittal plane ML view angulation and translation and horizontal plane axial view internal external rotation The values entered represent the desired bone segment position at the end of deformity correction This is useful if an overcorrection or undercorrection is desired at the end of deformity correction e g Blount s deformity correction where a 10 degree overcorrection is desired CTL HEX Patient Case Account About DO OD BrT Case Number 1 Case Name Case 1 Patient ID PATIENT A Cas
37. lso after the surgery It has one tab working or non working depending on the case The struts are numbered by the surgeon according to the following rules The RING ORIENTATION is the tab from which struts 1 and 2 orginate is important to determine the way the frame is rotated around the limb when referencing proximally is always on the proximal ring regardless of which segment is chosen as the reference segment The RING ORIENTATION is the tab on the distal ring situated opposite to the proximal one is important to determine the way the frame is rotated around the limb when referencing distally S always on the distal ring 284 regardless of which segment is chosen as the reference segment e 5 8 Rings open medially For a 5 8th ring open medially on the proximal reference limb segment with no rotational defect the ring orientation Is the nearest angulated end tab that is anti clockwise from the anterior point of the limb The anti clockwise rotation is for both right and left limbs The ring orientation tab rotation is always anti clockwise which means for the left limb there is an external rotation value and for the right limb there is an internal rotation value e The rotational values are automatically calculated The software will create a prescription for surgeon review and approval indicating direction and daily amount of adjustment for each strut TL HEX struts Fig 7 consis
38. mal strut type and length Preoperative Mounting Parameters section allows preassembly of the frame before surgery to mimic the patient s deformity Clicking the Update Views button after entering the mounting parameters will reveal the preassembled frame construct and render a optimal set of strut lengths that will result in the required frame Fig 38 and Fig 39 090 H L amp ORTHOFIX f TA EX Patient Case Account TRUELOK HEXAPOO SYSTEM About Case Number 1 Patient ID PATIENT A Bone Type Long Bone Deformity Parameters i i Checkup Proximal Support Ring Distal Support Ring Full Ring 180mm Full Ring 180mm a Preoperative Mounting Parameters Reference Ring AP Translation mm Reference Ring ML Translation mm Reference Ring Position Relative To 0 Medial Lateral 25 Anterior Posterior Deformity Apex Osteotomy Fracture Level Reference Ring Position mm Reference Ring Frame Rotation deg 100 Proximal Distal S Medial Lateral Y v a Second Ring Position mm Anterior Posterior 80 Strut Simm 179 Long 20 Fig 38 Updated Frame Parameters screen 29 TL HEX SOFTWARE USER S GUIDE Software version 1 3 Case Number 2 Case Data Deformity Parameters Proximal Support Ring Full Ring 120mm a Preoperative Mounting Parameters Reference Ring AP Translation mm 0 Medial Lateral Reference Ring Position mm 90 Proximal
39. mity parameters frame parameters section should be skipped over assuming that the frame is already placed on the patient and the surgeon is just modifying deformity parameters or frame position relative to reference bone segment HCP will then need to update views on the Post Op screen to reflect the deformity modification 33 TL HEX SOFTWARE USER S GUIDE Software version 1 3 In the software the strut length entries are validated against the type size of struts selected If the entered value exceeded the range for any given strut an error is indicated and the strut size length should be corrected prior to proceeding to the next step Fig 43 Log O 4 TL E La OR HOFIX X Patient Account About Case TANGAN EXAPOO SYSTEM ase Number 1 Case Name Case 1 Patient ID PATIENT A Le Bone Type Long Bone inner correct the following St e nge 0 35 ul bam ar 2 PRE KG M E 7 cassos Doomy Paans Fane Pana Reference Ring AP Plane Angle deg Reference Ring ML Plane Angle deg Reference Ring Position Relative To 0 Medial Side Down Medial Side Up 0 Anterior Side Down Anterior Side Up Deformity Apex Osteotomy Fracture Level Reference Ring AP Translation mm Reference Ring ML Translation mm 0 Medial Lateral 25 Anterior Posterior Medial Lateral Reference Ring Position mm Reference Ring Frame Rotation deg Anterior Posterior 100 Proximal Distal 0 Extema
40. nd maintain a hard copy as a permanent record for the patient s file Similar to prescription pdf file the report row will be highlighted when strut readjustments shaded blue or exchanges shaded red are required The rows of lighter shading indicate the allowable range of days that are suitable for the readjustment exchange the heavier shaded row indicates the last possible day for the readjustment exchange Fig 51 and Fig 52 Case Number 1 Print Date giovedi 13 marzo 2014 Case Same Case 1 Patient ID PATIENT A Side Left Bone Type Long Bone No Date Time RE AGIT ee OK 17 03 2014 00 00 long t 17 03 2014 08 00 long 17 03 2014 20 00 long 18 03 2014 08 00 long 18 03 2014 20 00 f long 19 03 2014 08 00 long 19 03 2014 20 00 long 20 03 2014 08 00 long 20 03 2014 20 00 long 21 03 2014 08 00 long 21 03 2014 20 00 f long 22 03 2014 08 00 long 22 03 2014 20 00 long 23 03 2014 08 00 long 23 03 2014 20 00 long 24 03 2014 08 00 long 24 03 2014 20 00 long 25 03 2014 08 00 long 18 25 03 201420 00 long 26 03 2014 08 00 long 26 03 2014 20 00 long 27 03 2014 08 00 long 27 03 2014 20 00 long 28 03 2014 08 00 long gt 14 long 5 med 34 5 long 11 35 long 15 14 long g med 34 amp 11 34 long 15 LS long 0 40 long o 32 med 34 30 tong 11 33 long 15 16 long a med 34 11 32 long 15 16 long 7 11 30 long 15 16 long med 34 2 long 11 29 long
41. ng the surgery see 5 4 Postoperative Visualize the expected results at the end of correction If necessary specify the eventual over under correction parameters to be considered in the treatment see 5 5 End of Correction Define the schedule by specifying the latency period the maximum rates and speeds of correction or the desired days of correction see 5 6 Schedule Once all data is approved by the surgeon the schedule will be calculated and the prescription is generated The prescription can be saved and a hard copy will be given to the patient For each correction step the number of turns the patient must make are indicated for each strut for both acute and gradual adjustments A hard copy of the bill of materials and the report may be generated The report is a more detailed view for the surgeon indicating the length settings for the gradual and acute setting on the strut see 5 7 Report Surgeon can use the checkup function to generate a new case starting from a specific date of the treatment This new case will report all the parameters updated to the selected date The Surgeon can then proceed to setup a new deformity correction treatment see 5 8 Check up 1 Introduction The TL HEX is a circular external fixator based on Ilizarov principles This frame consists of a hexapod made up of two rings circular external supports Fig 1 one ring and one foot plate U shaped plate for foot deformity correction Fig
42. ocated at http app tlhex com This location provides the Login screen Fig 10 Enter a valid Username and Password in the appropriate text fields and click to gain access to the software Click Forgot your Username or Password link to retrieve username or to reset the password ORTHOFIX IL HEX TRUELOK HEXAPOD SYSTEM Username The future of the hexapod system built on solid circular Password fixation experience Sign ln Forgot your Username or Password version 1 3 Fig 10 TL HEX software Login screen To reset the password user is asked to provide the username in the relevant field and click Reset Password A new password is generated and sent by email To retrieve or restore the username user needs to contact directly the TL HEX Customer Care tlhexcustomercare orthofix com Note the release 1 2 will be maintained to serve the countries where the new release 1 3 has not been approved yet 3 3 Home Page After a successful login the user accesses directly the list of patients Fig 11 TTL HEX TELOK rAXAPOO EVETEM Search Add New Patient SS Patient ID PATIENT RECEIVED_CASES PATIENT B PATIENT C a gt Fig 11 TL HEX software Home Page PA RC PB PC Page size 10 X TL HEX SOFTWARE USER S GUIDE Software version 1 3 Account About TTT e F Gen Male NIA wel a Last Ce gt Cri 4 ti ic 5 17 03 2014 13 03 2014
43. patent le a name birth date address email address phone number etc Please use only an intemal confidential code to identity your patent record when using this Software PatientiD PATIENT A Patient Initials PA Gender Male Female Prescription Preferences Prescription Notes for PATIENT A Optional Select Prescription Address for PATIENT A Or Dr Test Clinic Test Hospital Heaith road 1 Hospital Street Texas US 008 London UK UK 00000 512123123 00000000 Preview Cancel Save Patient Create Case Fig 14 Add New Patient Screen with Expanded Prescription Preferences Section TL HE TRUELOK HEXAPOO SYSTEM Patient Case Account About Case Data Deformity Parameters Frame Parameters Postoperative End of Correction Schedule Report Checkup OL ue nt dei Gs ard pet oo D tente or indirectly the identificabon of your patient e g name birth date address ema address phone number etc Please use only an intemal confidential code to identify Case Number your patient record when using this Software Patient ID Left Right New Notes Fig 15 New Case associated to the Brand New Patient Warning Under the Orthofix Terms of Use End User License Agreement and Privacy Policy the surgeon shall never enter information that directly identifies a patient The patient number is intended to be used as an identifying link to the patient within the surgeon s patient management s
44. r other reference associated with this patient and select patient Gender Optionally user can associate to a patient specific Prescription Notes and a Prescription Address expanding the Prescription Preferences menu Fig 14 see 6 2 Prescription Preferences for details about setting addresses Clicking on Save Patient will complete the creation process and open the List of patients screen which will include all previously entered patients as well as the newly created one On the other hand clicking on Save amp Create Case will save the new patient and will open a new ready to use case already associated to the newly created patient Fig 15 TTL HEX TELE HELURCE SET Patient Case Account About Add New Patient Patient ID PATIENT A 4 Warning You are nol allowed to enter or provide any information that allows directly or indinectly the identification of your pabent e g name birih date address email address phone number etc Please use oniy an intemal confidential code to identify your paleni record when using this Software Patient Initials PA Gender Male Female Prescription Preferences Save Patient Fig 13 Add New Patient screen 10 TL HEX SOFTWARE USER S GUIDE Software version 1 3 Log Out IL HEX Patient Case Aoeount TR ae rra TEA Modify Patient Ah ibaa cts are so sent 0 sur cx prose an Garda at owe cacy orindiecty the identficaton of your
45. real feasibility of the frame before applying on the patient These points can be anyway overcome by adding a 3 8 ring This component allows in fact to transform a 5 8 into a full rings so using this technique it s possible to apply two 5 8 rings with the opening on the same side very useful in trauma cases 4f 2 ORTHOFIK Hex Patient Case Account About Case Number 1 Case Name Case 1 Patient ID PATIENT A Side Left Bone Type Long Bone Case Data Deformity Parameters End of Correction Report Checkup Distal Support Ring Select Distal Ring Full Ring 100mm ML Translation mm Reference Ring Position Relative To Anterior Posterior Deformity Apex 120mm Osteotomy Fracture Level 140mm F R deg Medial Lateral 160mm a z Anterior Posterior 180mm 200mm 220mm 240mm 280mm Strut 6 imme 111 Medium Fig 36 Frame Parameters screen Note for extreme cases rings too oblique or overlapping each others the preoperative planning can suggest solutions that must be verified If preoperative option is used verify the feasibility of the frame opening also in the postoperative screen In case the frame is not realizable then the surgeon must change some parameters in preoperative screen such as the distance between the rings 27 TL HEX SOFTWARE USER S GUIDE Software version 1 3 The optional Preoperative Mounting Parameters section appears underneath the external support selection drop down
46. recurvatum Horizontal plane angulation can be described as internal or external rotation With internal rotation for example the distal segment is rotated along its longitudinal axis towards the midline Because the rotation is difficult to measure radiologically this parameter will be most commonly established clinically All angulations are described in degrees Their direction is independent regardless of whether proximal or distal referencing is chosen Similarly the three possible segment translations are described in the AP view coronal plane ML view sagittal plane and Axial view In the coronal plane the translation can be medial or lateral Medial translation for example means that the moving segment is translated medially relative to the reference segment In the sagittal plane the translation can be anterior or posterior Note that these two translations are described in millimeters in relation to the reference segment and direction of translations will change depending on whether proximal or distal referencing is used see 2 Nomenclature for details 21 TL HEX SOFTWARE USER S GUIDE Software version 1 3 The third type of translation occurs along the longitudinal axis of the limb In the software the axial translation is described in millimeters as short or long The first option short is used when the moving bone segment is translated compressed towards the reference bone segment When the moving bone segments is translat
47. rgeon can determine the prescription calculation either choosing a speed parameter or choosing the Days of Correction Once the Calculate by parameter Is determined by the surgeon the other parameters are automatically calculated by the software The software is able to come up with a solution using also decimals Surgeon has to carefully review the calculation to ensure it is accurate It is necessary to enter a values in the Calculate By box and Correction Time s box prior to clicking Calculate A warning message will appear if no value was chosen in either of these boxes The Correction Times table provides the flexibility to have the prescription calculated for one or more adjustments during each treatment day up to 4 different correction time per day can be selected E Log Out x Patent About TRES RARE GTA Case Account Case Number 1 Case Name Case 1 Patient ID PATIENT A Side Left Bone Type Long Bone Case Data Deformity Parameters Frame Parameters Postoperative End of Correction Schedule Surgery Date Latency Period days 5 Calculate By Daily Correction Rate mm day Treatment Start Date lunedi 17 marzo 2014 Correction Time s Calculate 12 00 AM 06 00 AM 12 00 PM 06 00 PM Calculation Results 01 00AM 07 00AM 01 00 PM 07 00 PM Daily Correction Rate inm day Angular Max Speed deg day Rotate Max Speed deg day 02 00AM 08 00 AM 02 00 PM 08 00 PM 03 00 AM 04 00 A
48. s bone length or over under correction 45 TL HEX SOFTWARE USER S GUIDE Software version 1 3 Log Out TL HEX i i lamn gt 3 ORTHOFIX TELOR HEKAPOD STE Patent Casse Account A bout Na Frame Parameters Postoperative End of Correction Schedule Report Checkup Rotation deg 0 External intemal AP Plane Angular Deformity deg ML Plane Angular Deformity deg Axial Translation mm 12 valgus Varus 12 Apex Anterior Apex Posterior 10 Short Long AP Plane Translation mm ML Plane Translation mm Optional Bone Length mm 0 Media Lateral 0 Anterior Posterior 0 Short Long Fig 57 Verify deformity parameters 46 TL HEX SOFTWARE USER S GUIDE Software version 1 3 6 Website Navigation e In general it is good practice to click the Update Views after making any changes to the on screen parameters This will provide visual confirmation that the changes are as intended User can click on each image to enlarge it In a pop up window Fig 58 Fig 58 Enlarge image in a pop up window by clicking on it Regardless of whether the Update Views is clicked after changing one or more parameters the new parameters will be saved once either the next arrow to the right hand or one of the function tabs are clicked When a new case is initiated the flow Is from left to right To go back to a pre
49. s screen or click on the Frame Parameter tab if it is active darker font 24 TL HEX SOFTWARE USER S GUIDE Software version 1 3 5 3 Frame Parameters Frame Parameters screen Fig 33 consists of two drop down menus for each of the proximal and distal external supports ring type and ring size and an optional section Preoperative Mounting Parameters that can be expanded collapsed as desired Fig 34 TL HEX re L ES ng P ORTHOFIX Patent 5e Account Report Checkup Full Ring 5 8 plus 3 8 sif Open Anteriorly Ring 3 5 8 Open Medially Ring 518 Open Pesteriorty Ring L pont Piste Fig 33 Frame Parameters screen and Preoperative Mounting Parameters section collapsed IL HEX Patient s cc About ORTROFIX Case 1 THUEL OK HEXAPOO SYSTEM ase Account Case Number 1 Case Name Case 1 Patient ID PATIENT A Bone Type Long Bone a ro Pannes eaaa eee Select Proximal Ring Select Distal Ring a Preoperative Mounting Parameters Reference Ring AP Translation mm Reference Ring ML Translation mm Reference Ring Position Relative To 0 Medial Lateral 0 Anterior Posterior Deformity Apex Osteotomy Fracture Level Reference Ring Position mm Reference Ring Frame Rotation deg 50 Proximal Distal Medial Lateral Second Ring Position mm Anterior Posterior 50 v Fig 34 Preoperative Mounting Parameters section Expanded 25 TL HEX SOFTWARE USER S G
50. sion will be migrated in read only mode in version 1 3 If surgeon wants to modify one of these cases he should create a brand new case with the new software release entering all the relevant parameters from the prior version case deformity frame and post operative 18 5 Case Planning 5 1 Case Data Case data includes Patient ID Case Number Case Name reference associated with this case anatomical site left or right bone type long bone or foot new notes and date of planning see 4 4 Add a New Case for details 5 2 Deformity Parameters Once the case information is entered click on the next arrow to the right hand side to move to the Deformity Parameters screen to enter parameters associated with the deformity Fig 26 and 27 Fig 27 AP view a and ML view b radiographs of an Equinuus foot 19 TL HEX SOFTWARE USER S GUIDE Software version 1 3 The first step is to choose the reference segment Fig 28 The surgeon Is free to choose either the proximal or distal segment as the reference segment depending on the clinical scenario see 2 Nomenclature for details TRS Case Data Deformity Parameters Reference Segment Proamal Distal 0 Valgus Varus AP Plane Translation mm 02 Medial Lateral Fig 28 Default Deformity Parameters screen Oe my OD EE Patient Case Account About Frame Parameters Postoperative ML Plane Angular Deformity deg 07 Apex Anterior Apex
51. t Prescription Print BOM Print Report Strut Length A Acute G Gradual t 17 03 2014 00 00 17 03 2014 08 00 17 03 2014 20 00 18 03 2014 03 00 18 03 2014 20 00 19 03 2014 08 00 19 03 2014 20 00 20 03 2014 08 00 20 03 2014 20 00 21 03 2014 08 00 21 03 2014 20 00 22 03 2014 08 00 22 03 2014 20 00 23 03 2014 03 00 23 03 2014 20 00 24 03 2014 03 00 24 03 2014 20 00 25 03 2014 08 00 25 03 2014 20 00 26 03 2014 08 00 26 03 2014 20 00 27 03 2014 08 00 27 03 2014 20 00 28 03 2014 08 00 28 03 2014 20 00 29 03 2014 08 00 29 03 2014 20 00 30 03 2014 08 00 30 03 2014 20 00 31 03 2014 08 00 31 03 2014 20 00 01 04 2014 08 00 01 04 2014 20 00 02 04 2014 08 00 02 04 2014 20 00 03 04 2014 08 00 03 04 2014 20 00 04 04 2014 08 00 04 04 2014 20 00 05 04 2014 08 00 05 04 2014 20 00 06 04 2014 08 00 si iQ eu 8 _ N Tg CO g long long long long long long long long long long long long long long long long long long long long long long long long long long long long 000000000000 0 000000000000 000 ONN FW DD D 8 8 38333333333333333333333333 14315433 Li 33333443443 TE reer errr reread 0 0 0 0 0 0 0 0 0 0 0 0 0 o 0 0 0 9 o 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 17 0 18 0 16 0 18 0 19 0 20 0 20 0 21 0 22 0 22 0 22 0 24 0 24 0 24 0 26 0 26 0 26 0 28 0 28 0 29 0
52. t of two telescoping aluminum tubes an outer tube A and an inner tube B which can be locked together at various lengths using the side locking bolt C and clamp washer D The inner tube is attached to a spring loaded black knurled adjustment knob E The adjustment knob mates with the threaded rod F in a manner such that the rod translates relative to the inner tube when the knob is rotated This will provide gradual changes of overall strut length in 0 5 mm increments Each strut has two special joints G H one at the base of the outer tube tube end joint and the other at the end of the threaded rod rod end joint Each joint has a mounting stud I J which can be inserted into the mounting holes on the ring tabs and held in place by the locking screw The new UltraShort strut has a different design in order to be applied in special cases very severe angular deformity extreme Equinus foot etc Anyway the most important features two telescoping tubes the adjustment knob and the locking bolt have been preserved Fig 8 F LUS A Fig 7 TL HEX strut structure Fig 8 TL HEX ultra short strut structure The TL HEX struts allow performing acute and gradual adjustment The acute adjustment of the strut length is achieved by untightening the side locking bolt sliding the inner tube relative to the outer tube to the desired length and re tightening the locking bolt Acute adjustment is indicated by the inner tube scale in
53. t prescription notes and or enter addresses different from the first entered during registration phase At the beginning of the patient creation process the HCP can link to a new patient any of the addresses previously created using this menu The link between address and patient can always be modified using the modify action in the List of patients menu and selecting a new preference Log Out TLELON Patient Case Account About Prescription Preferences Default Address Default Prescription Notes Optional Dr Test Clinic Health road 1 Texas US 008 US 512123123 Add Additional Address Additional Addresses Test Hospital Hospital Street London UK 00000 UK 00000000 Fig 63 Prescription Preferences screen For technical support or information on Software Use please contact the Customer Care tlhexcustomercare orthofix com For further support contact info and resources refer to www tlhex com Manufactured by ORTHOFIX Srl Via Delle Nazioni 9 37012 Bussolengo Verona Italy Your Distributor is Telephone 39 045 6719000 Fax 39 045 6719380 CE _ D www orthofix com ORTHOFIX TL 1406 PL E0 A 06 14
54. ting from the date selected parameters Access to the TL HEX software is controlled by Username and Password These can be obtained at www tlhex com by requesting a new account and following the onscreen instructions see 3 1 Obtaining Access Enter a valid Username and Password in the appropriate text fields and click Sign In to gain access to the software see 3 2 Login Screen In the Add New Patient screen create a new patient if the patient doesn t exist Each case must be linked to an existing patient see 4 2 Add a New Patient To start a new treatment create a new case Select patient from the ones available in the drop down list providing the information required Case Name Case Number Side Bone Type see 4 4 Add a New Case Describe the deformity starting from the reference segment identification Then provide the relevant parameters relative to the angular deformity rotation translation and bone length discrepancy see 5 2 Deformity Parameters Indicate the ring type and size that will be used for the frame see 5 3 Frame Parameters If desired complete this section with details of the planned frame position relative to either the deformity apex or the osteotomy fracture level Strut types and lengths are being suggested see 5 3 Frame Parameters Provide the actual frame parameters and position as mounted and adjust modify the struts configuration to adapt them to the configuration obtained duri
55. ual adjustments to be made during the treatment page 2 42 TL HEX SOFTWARE USER S GUIDE Software version 1 3 The Actions column allows for each row two different actions that can be made Details and Checkup By clicking on the Details link for any day in the report table the system will generate a pop up window with a view of the bone segments and frame orientation of that particular day as well as the corresponding struts length with Acute Gradual values Fig 53 and Fig 54 By clicking on the Checkup link in the Report table the Checkup screen will be launched for the selected day and time Ss ee ee a ee oe ee ee et ees 1 Te eee es TE ee Us AP Angle deg 25 Valgus ML Angle deg 25 ApexAnterior Rotation deg 0 AP Translation mm 0 ML Translation mm 0 Axial Translation mm 0 Strut E mm 21 AP Angle deg 0 ML Angle deg 0 Rotation deg 0 AP Translation mm 0 ML Translation mm 0 Axial Translation mm 20 Long Siu amp iene Fig 54 Details at the end of the treatment 43 TL HEX SOFTWARE USER S GUIDE Software version 1 3 5 8 Checkup The Checkup screen Fig 55 provides the position of the bone segments and the frame with corresponding strut adjustment values at any particular day of treatment deformity correction When the Checkup screen is opened it defaults to the Treatment Start Date or the treatment date from which the Ch
56. vious tab during a case creation process click the arrow to the left hand of the screen or one of the function tabs Note These actions will not actually save the new parameters A warning pop up window will advise the user Fig 59 For example the user begins with the Case Data tab followed by Deformity Parameters tab etc Tabs that are not appropriate to the next step of the case planning process are grayed out Once the case Is completed the user can navigate freely between tabs AP Plane Angular Deformity deg Axial Translation mm 9 Valgus Vars e Apex Anterior Apex Posteria 02 Short Long o Medial Lateral Shot Long iy ji The current page is not valid and cannot be saved Select OK to continue or Cancel to remain on the page Cancel Fig 59 Warning pop up window when the arrow to the left hand of the screen is clicked during a case creation process 47 r Ian ftinara warcinn 1 2 SoTtware version 1 3 e The TL HEX software is designed for minimal response wait time However in the event of Internet transmission delays a three dots loading animation is displayed while the user s PC is waiting for a response from the TL HEX server Fig 60 e In certain situations such as a ring size change recalculation of the strut lengths is required In these situations the popup window appears on the screen Fig 61 e Incase of temporary loss of Internet connection and or wh
57. w a ML view b and Axial view c software diagrams The proximal reference segment is indicated in blue and the distal moving segment in green There is valgus procurvatum deformity of the limb as evidenced by the direction of angulation on the AP view The frame is comprised of two rings interconnected by 6 struts In all three diagrams the ring orientation is marked with red dots Fig 6 Standard AP view a ML view b and Axial view c software diagrams The proximal reference segment is indicated in blue and the distal moving segment in green There is procurvatum deformity of the foot as evidenced by the direction of angulation on the AP view The frame is comprised of one ring and one foot plate In all three diagrams the ring orientation is marked with red dots The struts are attached to full rings 5 8 rings or foot plates in pairs using special angulated tabs around the circumference of the external support Each full ring or foot plates has 3 working tabs which will have struts attached to them and three non working tabs Each 5 8 ring has 3 working and 2 non working tabs The footplate will have 3 working tabs For proper identification the struts are numbered using color number clips The clips are numbered from 1 to 6 and color coded as red 1 orange 2 yellow 3 green 4 blue 5 and purple 6 The new 3 8 component allows for transforming a 5 8 into a full ring In case of need this component can be added a
58. y View Send Archive Delete Modify View Send Archive Delete Modify View Send Archive Delete ee a w Send Delete Modify View Send Archive Delete Modify View Seng Archive Delete Modify View Send Archive Delete 6 itams in 1 pages Actions View Delete Modify View Send Archive Delete Modify View Send Archive Delete Archive Delete 8 items in 1 pages As per the List of Patients user can expand the search bar in order to search the content based on a specific criteria Enter the search criteria in the relevant field and press Search button User can search by Patient ID Status Case Number Side using the This Date After This Date or Before This Date logic To remove any Case Name Bone Type and Data Created filter click the button Fig 25 17 TL HEX SOFTWARE USER S GUIDE Software version 1 3 Patient Account About This Date Add New Patient Add New Case 12 03 2014 AT 12 03 2014 Archive Delete Modify View Send 12 03 2014 A ni D iere 12 03 2014 se Modify View Send f 4 a a 12 08 2014 39 ote ets Giles mi 1 pages Fig 25 Search Section Expanded The List of Cases can also be sorted in ascending or descending order by clicking on any of the headers except Actions Patient ID Case Number Case Name Status Side Data Created Days left Fig 20 Upgrade from version 1 2 to 1 3 Case Version Management Cases created with a prior software ver
59. ystem 11 TL HEX SOFTWARE USER S GUIDE Software version 1 3 4 3 List of Patients Patient gt List of Patients User can also view all of the patients by clicking List of Patients This option appears as the cursor hovers over the Patients field of the Navigation menu From this list Fig 16 a the surgeon can select a patient which will expand the list of cases associated to this patient Fig 16 b TL HEX THEO PE RAPOO SVETEM Patient Account About Search Add New Patient Add New Case PATIENT PATIENT B PATIENT C Fig 16 a List of Patients screen TL HEX FLAC MEADS ETETEN Patient Account r Search Add New Patient 4 PATIENTA blount s disease PATIENTE PATIENT Fig 16 b List of Patients screen with relative list of cases expanded 12032014 Modify Patient Delete Patient Modify Patient Delete Patient Modify Patient Delete Patient 3 items in 1 pages Leg Out ORTHOFIX Archive Delete Modify Patient Delete Patient Modify Patient Dele Patient 3 items in 1 pages 12 TL HEX SOFTWARE USER S GUIDE Software version 1 3 Expand the Search Bar to search the content based on a specified criteria Enter the search criteria in the relevant field and press Search button User can search by Patient ID Status Case Number Side Case Name Bone type and Data Created using the This Date After This Date or Before This Date logic To
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