dardes User Manual
Contents
1. CONTENTS List of Figures 11 1 2 1 3 1 4 1 5 1 6 1 8 1 9 2 1 2 2 Authorisation and Contact Pages r ou ee 0 nn An overview of all the actions that may be performed at the moment A list with all the current subjects 0 nn Randomisation Form and Result 2 aaa A visit this is also often referred to as a Form or an eCRF 2 2 oo on A complete Forni re se rt a eee ee a be ee Ree Gedo Re A An excerpt from the calendar in the demo trial 2 aa The calendar legend listing colour assignments and abbreviations The user profile of a user in the demonstration trial 2 2 2 2 Coon nn o oNNOAO O1 I SPW A typical form as seen by an auditor 2 2 2 Enno nn 9 A typical form as seen by a monitor ooa a 10 LIST OF FIGURES Preface This brief user s manual was designed to help users fa miliarise themselves with the basic functionality of the dardes system This particular version of the manual applies to most instances of the system however you are urged to try and find a manual specific to your par ticular trial as those are very likely to be less vague since the authors of these manuals knew of the particulars of the trial This manual is supposed to serve two distinct pur poses help users with the system if no specific docu mentation for their derivative of the system is available and to serve as a template for a user s manual for im plementors of the s2. See section 1 7 File Edit View History Bookmarks Tools Help Demo Trial gt Home gt Subjects gt Adverse Event Subject 0002 Clinic ID 9171071 A Adverse Event onset Describe adverse event includes duration sequence of events and treatment Was the event serious CYes CNo NA Did the event result in in patient hospitalisation A or prolongation of existing hospitalisation Pecans Noe INA Was event fatal CYes No NA E mu If Ves date of death Test laboratory data confirming event include procedures dates values results Has patient been removed from the study Cyes CNo FNA Was this AE expected or unexpected expected C unexpected NA Comments Related to Visit NA Figure 1 6 A complete Form There are a number of different areas of interest that are common to all forms From top to bottom these are The Title Bar This is the area right below the header that is present on all pages On the left you see the title of the current form Adverse Event and on the right there is a list of possible export possibilies e g PDF Clicking on the name of a format on the right will gen erate a version of the current form in that format Form Contents Next is a list of all the data related to the current form and the data that may be entered The first item is usually a Patient ID which cannot be modified CHAPTER 1 GENERAL USAGE Note that when
3. 1 8 that is linked from any page showing the calendar itself This legend explains the abbreviations and the colour codes used in the calendar cells Usually days that have any due forms i e those with a date field in the past that have not been locked yet are displayed in red and days on a weekend are shown with a slightly darker shade Thus red days in the calendar do not necessarily indicate an adverse event of any kind Ele Edit View History Bookmarks Tools Help Demo Trial gt Home Calenda Calendar Legend Abbreviations Colours AE Adverse Event Calendar days will be displayed with one of the following colours T Termination 23 77 Due Today or Overdue VI Visit 1 23 _ Stillto be done but not due yet Ve 23 Weekend Marker v3 Visit 3 V4 Visit 4 23 Regular Day of the Month V5 Visit 5 V6 Visit 6 v7 Visit 7 Padding for the Calendar El Figure 1 8 The calendar legend listing colour assign ments and abbreviations 1 7 User Profile The user profile allows users to change some of their personal details Which details may be modified is up to the particular trial administration to decide but in general you will be able to modify your password lan guage localisation settings and your phone number File Edit View History Bookmarks Tools Help Demo Trial s gt Home gt User Profile User Profile PDE Password Expiration Date 22 Nov 2033 11 53 41 CET Current Password N A New Pass
4. indicates forms that have not been locked yet even though they are due a thin plus is used for entries that have not been locked yet or which have not been created yet and which are not due in any way yet Interacting with the Calendar To see any of the forms for a specific day simply click on the cell in the calendar This will bring you to a list of things that happened on a particular day and it may allow you to add additional details e forms to that day Text Text entry fields either single or multi line Anything is allowed here special characters are auto matically escaped if necessary In multi line fields you may introduce line breaks with the enter key on your keyboard Multiple Choice Multiple choice fields either use drop down lists or a radio buttons There is always an N A Not Available option which is the default and indicates that no choice has been made i e that the field has not been processed or cannot be processed This is primarily used for trials with a large num ber of forms per patient or to add Adverse Events For CRFs which may be added an arbitrary number of times simply choosing the Create XXX link in the day view will not create the form itself instead you need to use the Save button as you needed to when creating a patient Calendar Legend Since trials usually employ differ ent abbreviations and distinct CRFs the calendar has a special calendar legend see figure
5. takes you longer to complete the form than the time granted by the timeout then once you click Save you ll be logged out instead and so the data is lost If the form really is too long to complete in the al lotted time 20 minutes by default one workaround is to complete the form incrementally making sure to hit Save before the timeout is complete and to then resume filling in the form Alternatively if you already completed the form and you notice you ve hit the timeout already without the system telling you so then you may try to open one of the links at the top of any page in a new window or tab and then re authenticating in that other window or tab This would re establish the current session so you could then safely hit the Save button on the original form
6. trial protocol or possibly also including current status information or important things that need to be done You will most likely have received a hard copy version of all that is listed here Depending on the trial and your access rights you may see additional elements on this page that were not described Please refer to the manual for your particular trial for more information on these 1 4 MANAGING SUBJECTS 1 4 Managing Subjects Whenever you choose the Manage Subjects item you will be presented with a list of all the currently registered subjects for this particular trial to which you currently have access to File Edit View History Bookmarks Tools Help ofie r Contac zA Demo Trial Developer Investigator investigator gt Home gt Subjects Developer Centre Subjects Y In Exelusion Criteria 9171071 Group B Regular Treatment male s50 Documents New Subject 9 Visit 2 Date 02 Apr 2009 Figure 1 3 A list with all the current subjects This list is formatted as a table that contains all the basic information To get access to all the documents CRFs etc related to a subject use the Documents link in that particular subject s table row There may also be a number of direct links to specific CRFs These are formatted with a symbol to the left that indicates the current status If this symbol is a red question mark then that is usually an indication that th
7. adcrumbs will take you to that particular location Links The top right of the header contains a list of in formative links as well as the log out button Clicking 1 3 The Home Page Upon successfully logging in you will be taken to the Home page shown in figure 1 2 Here you will gen erally encounter two columns on the left there is a list of things that may be done at the moment on the right there is usually a brief protocol primer File Edit View History Bookmarks Tools Help Demo Trial Contact User Profile Developer Investigator investigator Developer Centre Home Home Subjects Trial Information Manage Subjects Use this to create list or modify subjects and their details Protocol Reminders New Subject S Demo Trial Create a new subject User User Profile Change preferences or choose a new password E Figure 1 2 An overview of all the actions that may be performed at the moment Subjects The links in this paragraph allow manipulat ing the trial subjects to which you currently have access i e all that are being treated in your centre Manage Subjects takes you to a list of subjects The forms to fill out are accessible using this list as are CHAPTER 1 GENERAL USAGE any of the information links will display that informa tion using the logout button will cancel the currently active session so that the session ID may not be used for any further requests You should alw
8. ays use the log out function User Details The area on the right of the header con tains information related to the currently authenticated user i e the user s name role and associated centre Note When logged into the system in test mode there will be a big red marker indicating that you are currently logged into a test mode instead of the real trial This is to prevent anyone from inadvertedly ran domising patients in this mode instead of the real trial mode Automatic Log out Whenever any user of the system is inactive for longer than the amount of time configured for a specific trial usually 20 minutes the user is au tomatically logged out to prevent others from gaining access to the system by examining the browser history or similar methods subjects that have not been randomised yet in case the registration process of a new subject was not completed See section 1 4 for more details New Subject will take you to a form that allows registering new subjects as long as those meet the re quirements for the trial Randomisation is accessible as part of the registration process User This section encompasses settings related to your own profile User Profile is a link that takes you to the settings screen for your own profile There you may change the interface language among other things See section 1 7 for more details Trial Information This is a free form paragraph usu ally containing a primer on the
9. bpm l Additional medication provided CYes CNo NA lj If Yes please provide the reason I Comments lj Adverse Event Cves CNo CNA lj Subject willing to continue CYes CNo CNA ij Monitor Status Not Verified y Figure 2 2 A typical form as seen by a monitor 2 4 Troubleshooting Forms with red question marks If you see a lot of these even though you are certain that you have com pleted the form in question bring it up and make sure you ve also locked the form No data available instead of the list of subjects This is a warning message that only occurs before you register the first subject for your particular centre or any centre in the case of a monitor account If you re certain there are subjects registered with the trial for example because you asked a someone else participat ing in the trial then most likely that other person is registered with a different centre and you do not have sufficient access rights to see his or her subjects Log In Issues There are a number of reasons for this The most obvious is that you can t remember your cur rent account details If that is the case ask someone designated to talk with the technicians or use the In formation link to find an appropriate technical contact Another reason for this is that the trial is currently locked This would occur whenever software on the server is being updated and typically you would be presented with a short no
10. cular form field For integers only digits and an optional sign are allowed For decimals only digits an optional sign and either a dot or a comma are allowed Group markers as in 1 000 00 or 1 000 00 are not allowed for either type of numeral since they may easily be confused with the decimal separator especially since both the dot and comma are allowed as separators 1 6 The Calendar In trials employing the calendar trying to get to a subject s list of documents will automatiacally open the calendar view Eile Edit View History Bookmarks Tools Help Basics Calendar F Visit 1 April y 2009 z Show Month Y Date 02 Apr 2009 j 3 FSH AA Y In Exclusion Criteria April 2009 Randomisation Result 1 a 3 4 Group B Regular Treatment vi gt pr Treatment Br Visit 2 5 amp 2 8 2 10 iii Date 02 Apr 2009 v3 va Mists LJ Date 05 Apr 2009 12 13 14 15 16 17 18 Visita y5 Date 09 Apr 2009 yts 19 20 2i 22 23 4 25 16 Apr 2009 v6 23 Apr 2009 26 27 28 29 30 yi yz Date 30 Apr 2009 p El Figure 1 7 An excerpt from the calendar in the demo trial In this view the area to the right of the page is gen erally reserved for the calendar and the left contains a summary of all the forms for the chosen subject as shown in figure 1 7 The forms in the summary have an icon code preceding them a v indicates forms that have been completed and properly locked a red ques tion mark
11. dardes User Manual Datinf GmbH May 11 2009 2008 2009 Datinf GmbH This document is part of a series of documents intended to describe the dardes system As such it contains privileged information and may not be reproduced in any form without prior written consent lf you have received a copy of this document without being entitled to please erase the file or otherwise destroy the information immediately and notify the copyright holder Thank you for your cooperation Contents AAA Sn a oe Ar a A ER a a a SE ar de cee ds AN ae a T ot A Contents nase A o ie O de ad List of FIgUrese a re a co A da Ue es mee he Dee o of Preface os a o A o a LD a A Bet a System Requirements muni 2 aw a A ee OR AO ge a able ee ww wa Bd 1 General Usage 1 1 Logging invanid out s gt sere aaa e ee ok ge EO an L2 Gereral Navigation 24 42 Adaya bad Ree ee RA 1 3 The HomePage te DA tl ted tea Oy a e dd i Be AS Ni EN ea 1 4 Managing Subjects i get la cde oe Ge Seek Ae a die Hed ee at RE 1 5 Forms Visits ERES A Re At ee SR ue ae oases 1 6 he Calendar 2 5 2 m SA oe Bek le WEY hee ee a PEPE Be Meee lef User Profiles m rs el Yee le otk E a OE ee A 2 Special Details 21 Auditors a e 44 Aa 2 nA es ee Bed he eet eo ke eet De oe Db we bn AS 2 2 Administrators zn 22 00 5 U bie we Pe Be pe SSE TEP oe EL se ee 2 3 Monitors a Se A a RT De AA Fes tee te eyed a ae He ek A 2 4 Troubleshooting 2 4 223 Kr a e oh be elie A a A A Index
12. e CRF is due meaning that it has a date field in the past and it hasn t been locked yet This feature was added to make sure that pre dated CRFs that need to be filled out are easily accessible Introducing new Subjects On your home screen choose the New Subjects item from the list of actions or alternatively use the New Subjects link as described in section 1 3 After clicking this link you will be pre sented with an empty form which needs to be filled out in order to create a new patient The patient will not have been created until you successfully used the save button that is until there were no reported issues with the values you entered File Edit View History Bookmarks Tools Help In Exclusion Criteria 3 IS ln Subject 0003 Clinic ID 197129619816 Inclusion Criteria Eyes No C Yes No C Yes No NA E NA NA patient information sheet provided patient s questions answered written consent received Exclusion Criteria Yes Yes CYes No NA Yes No NA No No NA E NA Known HIV infection Active uncontrolled infection positive pregnancy test unwilling to use effective contraception during the study E a Form describing the different in and exclusion criteria Subject creation will usually involve a Clinic Patient ID Any ID or mnemonic will do here this is just to add some sort of context to the pati
13. ed on the fly from the data in the database at the time of the request Subject In Exclusion In a subject s Documents auditors find additional controls to in or exclude a sub ject from the trial In general all subjects start out as included but they may be excluded from the final re sults for example due to non compliance with the trial protocol or premature terminal episodes Limitations Auditors may not create new patients modify forms in any way other than by adding audit information or unlock forms for others to modify Mon itors on the other hand may do this Due to the flexibility of the system administra tors may also grant other user groups parts of their own special privileges such as creating users or cen tres etc It is also conceivable that there are special semi administrator roles in larger trials dedicated to user management for example Since administrators will usually be given the longer contractors manual there is no need to describe all aspects of their special access rights here 10 2 3 Monitors Monitors serve a very similar purpose to the audi tors except that they are allowed to actively modify form data File Edit View History Bookmarks Tools Help Demo Trial gt Home Subjects p Visit 2 Subject 0001 Clinic ID 901790813618096 Date 62 Ga Roos I Systolic Blood Pressure mmHg I Diastolic Blood Pressure mmHg T Pulse
14. ent for reference by au ditors monitors or other staff members You should not use anything sensitive like the the patient s name or his or her social security number which would give away the identity of the patient to anyone that would not other wise have access to the patient s clinical records Randomisation Depending on the trial there may be an option to randomise subjects trial groups In these trials this process completely replaces the process of cre ating a new patient To randomise a patient you would go about as follows 1 Click on New Subject on your home page or the subject list 2 Fill in the form as appropriate a If there is a randomise button simply click it instead of save and the patient will be randomised b Otherwise click save and you will be taken to the form that allows randomisation which you should then fill out and whose randomi sation button you should use upon comple tion 3 If randomisation is not possible you will receive an error message describing why randomisation was not possible Once the subject is randomised you will be taken to a summary page describing the subject s trial group and some other metadata This is available from the subject s documents Note All forms related to the randomisation process will automatically have been locked after the randomi sation has completed successfully This is to prevent tampering with the randomisat
15. entering the data for your form you should not use the enter button on your keyboard to confirm individual bits of information Hitting this button will submit the form as a whole to the server and you may be redirected to some other form or page Buttons At the bottom of the page is usually a row of buttons unless there is nothing that can be modified for the current form In this example there is only a Save button One of the buttons will have a bold font this is the action that will be performed if you hit the enter key on your keyboard instead of clicking Locking It is very important that CRFs which you have completely filled out are locked This mechanism tells auditors and monitors that you think the data in this particular form is complete and correct and it also tells the system that a form has been fully processed In trials using the calendar feature this controls the forms with the red question marks shown on the subject list To lock a form simply either use the Lock but ton or check the Lock checkbox and click on Save whichever is shown on the form This will prevent you from entering additional data unless a trial monitor un locks the form for you for example if there is something missing Exporting e g to PDF Usually you will be al lowed to export the forms to a different format e g for printing or archival This is fairly easy to do simply open up the form you wish ex
16. ion criteria Ele Edit View History Bookmarks Tools Help Demo Trial gt Home Subjects p Io Subject randomised DE Please print this page and add the printout to the subject s file Proceed to Documents Randomisation Result Subject 0003 Clinic ID 197129619816 Summary Centre Developer Centre Current User Developer Investigator investigator 02 Apr 2003 18 24 46 Randomisation Date Treatment Group A Experimental Treatment Randomisation Criteria Sex male el b This page is displayed after randomisation completes success fully Take note of the treatment group Figure 1 4 Randomisation Form and Result 1 5 Forms Visits eCRFs The term Form is used throughout the programme to describe an Electronic Case Report Form eCRF This is also often called a Visit as this is what most forms are all about Eile Edit View History Bookmarks Tools Help Demo Trial gt Home Subjects Visit 1 PDF Date J Provide clinic specific Patient ID Date of Birth ih aol Sex Male Female NA Systolic Blood Pressure mmHg Diastolic Blood Pressure mmHg Pulse bpm Additional medication provided Yes No CNA If Yes please provide the reason ll Figure 1 5 A visit this is also often referred to as a Form or an eCRF These forms however are also used in other places such as Adverse Events or even the user profile
17. oe Phone 44 555 555555123 Fax 44 555 555555123 Email jo doe example com Internet www example com jo doe Fax 44 555 555555123 Email info example com Internet www example com Technical Contact Datinf GmbH Tubingen Phone 49 7071 2536960 Fax 49 7071 2536962 Email info datinf de Internet www datinf de El a This is the authorisation page Note the System Version that b The types of contacts listed here may be slightly different is displayed in the lower right corner of the screen depending on whether you re logged in or not Figure 1 1 Authorisation and Contact Pages 4 1 2 General Navigation All pages other than the authorisation page consist of a page header to the far top of the screen and the content area which occupies the remaining lower por tion of the screen The other sections of this chapter generally explain the content area whereas this section describes the header itself Trial Name The title on the top left indicates which trial you re currently participating in Breadcrumbs Below the trial name is a list of so called breadcrumbs This form of navigation represents a trail of links you d normally follow to get to the loca tion you are at the moment For example when viewing a form of a particular subject you ll see trail elements such as home subjects subject NN and the name of the form you re currently editing Clicking on any of these bre
18. opardising any of the real patient data User Name This is the name you have been given as part of your user credentials This identifies your ac Ele Edit View History Bookmarks Tools Help IIA AA a Demo Trial User Name AAA Information count complete with language settings and the contact details for inquiries Each change you make to any data will have this name tacked on for auditors and monitors to see Password The other part of your user credentials In put to this box will usually be hidden with asterisks or similar to help against eavesdropping Login Button Click this or hit the enter or return key on your keyboard to submit your credentials If the authorisation process is successful you will be redi rected to the Home page otherwise you will be taken back here Information Link Following this link will lead you to a list of contacts responsible for this trial as in figure 1 1b Among others this includes a technical contact whom to contact in case you lose your user details System Version In case of bug reports or other is sues it is generally very helpful to provide this version to the developers Eile Edit View History Bookmarks Tools Help Demo Trial Contact Sponsor Demo Sponsor Phone 44 555 555555123 Principal Investigator Jane Doe Phone 44 555 555555123 Fax 44 555 555555123 Email jadoe example com Internet www example com ja doe Trial Office Monitoring John D
19. ot Verified z Update Audit Information Figure 2 1 A typical form as seen by an auditor Audit Trail Auditors as well as monitors are allowed to see the audit trails of forms This includes any mod ification to any of the values including a timestamp 2 2 Administrators Administrators are not usually allowed to see most of the details that non administators are allowed to see but instead they are tasked with managing users centres and access right distribution However any administra tor could easily either grant her or himself the right to view all the details that for example a monitor is able to see or create a new user with the appropriate role In theory they could even change their own account s user role accordingly and the person modifying the field and any comments added to a field by auditors or monitors Comments To add a comment to an arbitrary value simply fill in its Comment field and use the Save or Update Audit Information button Form Audit Status Auditors are allowed to set a sta tus flag for each form All of the forms start out with an audit status of not verified which auditors may mod ify appropriately Auditors are also allowed to read the anloguous status information set by monitors on a form Statistics On all pages an auditor will find a tab in the upper right hand corner of the screen to switch to preliminary live statistics These statistics are gener at
20. ote You are not allowed to modify your e mail address because the system actively uses this on cer tain occasions If you really need to change your e mail address then you need to contact an administrator or someone responsible for talking with the technicians Language In most trials you will be allowed to modify your own language settings This setting will not only influence the language that is used in the user interface but also certain spelling details the date format used throughout the interface and which day the calendar starts on thus the difference between British English and American English Certain trials may make even more details dependant on the language setting Chapter 2 Special Details 2 1 Auditors Auditors are supposed to verify that the data entered is correct and sound They may not actively modify any data but they are allowed to see preliminary statistics and they are allowed to decide which subjects are to be included and which aren t in the final results Fle Edit View History Bookmarks Tools Help Demo Trial gt Home Subjects gt Visit 2 Subject 0001 Clinic ID 901790813618096 Date 02 Apr 2009 Systolic Blood Pressure mmHg Diastolic Blood Pressure mmHg Pulse bpm I Additional medication provided NA I If Yes please provide the reason I Comments I Adverse Event NA I Subject willing to continue NA l Monitor Status Not Verified Auditor Status N
21. ported and then click one of the links on the upper right e g the PDF link in the example above Clicking that one would generate a file in the PDF format and automatically open it You could then either save it or print it directly Do note that importing of this data is not sup ported so even though you will have a hardcopy you cannot feed it back to the system Issues Trying to Save a form with invalid data will result in a so called issue These prevent the form from being saved and a summary of the problematic data is shown Some issues may be overridden Common Data Types A variety of data types may occur in any given form The exact types that are avail able depend on the particular trial but there are a num ber of types you will almost certainly encounter Dates This includes combinations of a year month and day possibly excluding the day compo nent Date entry fields are localised meaning the field arrangement depends on the language setting you chose in your profile For example users that chose to use American English will be presented with the fields in MM DD YYYY order whereas users of the British English language setting will see the fields in DD MM YYYY order The server keeps track of the 1 6 THE CALENDAR actual date entered and properly arranges the data for each user regardless of the format used to enter the data Numerals Either integers or decimals depending on the parti
22. tice describing when the pro gramme will be back on line on possibly also why it was taken offline in the first place Lastly your account may have been deactivated CHAPTER 2 SPECIAL DETAILS Forms Just like auditors monitors may see the audit trail and comment on current field values Unlike moni tors however they may change any form data and they are allowed to unlock previously locked forms effectively allowing them to modify each and every regular CRF in the system Form Monitor Status Monitors have their own status information field for each and every form analoguous to the audit status that auditors have Limitations Monitors may not view current live statis tics and they may not in or exclude subjects from a trial Additionally they may not view the audit status set by an auditor even though auditors may view the monitor status set by a monitor This may happen for various reasons and the techni cal staff members that may deactivate accounts will not usually know the reason why an account was disabled as this tends to be a decision made by the trial manage ment If you re certain that your account was disabled in error you should thus contact your trial management contact not members of the technical staff Automatic Log Out The automatic log out feature is a very simple yet effective security feature However this feature does also incur a slight risk of data loss if you ve been filling out a form and it
23. word N A New Password Verification N A r el Figure 1 9 The user profile of a user in the demonstra tion trial Password Expiration Date This field indicates the day and exact time your password will become invalid You will be notified of an imminent password expiration after 4 5th of the time between last modification and maximum password liftime of a password for trial have passed i e for a typical trial where passwords are valid for 90 days you will be notified whenever you haven t modified your password for 72 days After the password has expired the only action you may take upon logging in are profile modifications un til you change your password again Trying to use any other page in the system will simply redirect you to this CHAPTER 1 GENERAL USAGE form Current Password New Password and Verification To actually change your password you need to con firm your current password enter a new password that meets the requirements displayed to the right of the New Password field and verify the new password by entering it a second time If the password has been changed successfully you will be taken back to the log in page to log in with the new details Phone You are allowed to modify the phone number listed here This may be used by administrators mon itors or auditors to contact you in case there are any unresolved issues with some of the data you entered You should keep this current N
24. ystem For this reason and because dardes is most flexible the manual is a bit more vague than one would expect System Requirements The requirements to use the dardes system are very modest All that is needed is a properly configured web browser that allows access to the Internet The operating system should be irrelevant Supported web browsers are Firefox 2 x Opera 9 and Internet Explorer 7 The browser must have SSL TLS encryption support enabled Newer or different browsers may work as well LIST OF FIGURES Chapter 1 General Usage 1 1 Logging in and out Before using the system all users are required to log in or authenticate This is to prevent unauthorised access to the system Additionally all modifications to any forms or other system data are kept in an electronic log Among other things the user name used to log in to the system is stored along with a record of the modifications Figure 1 1a shows the default log in screen This screen may look slightly different depending on the trial usually bearing the logos of sponsors and relevant par ties There are six important elements on this page Mode The Mode is where you decide which data set to use Ordinarily you will simply choose the Trial mode which is the real data set for the trial Usually there is also a Test Trial mode which is a sandbox of sorts with a separate data set This latter mode is used to famil larise yourself with the system without je
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