HYCON ID Manual english 060607
Contents
1. H YCON 2006 12 11_16_56_45 Ext 7 Fam es hu Newark Fo File name HYCON_2006_12_11_16_56_43 txt Files of type Instrument fles Eucor txt Lancel Mark one or several files and click on lt Open gt The files are imported and you receive the following message Import instrument data C program files BiotestiRCS 2 PC11 00H con con 2006 12 11 16 56 435 tet Import successful You can check the imported data in view table Notes If the file is faulty and could therefore not be input the following error message is displayed CRE problem in instrument File HYCON_ 2007 02 11 16 56 55 txt File not imported In settings you can specify that the data is to be deleted after it has been 15 Biotest HYCON ID 1 0 imported 3 2 tl Recording results 3 2 1 Calling up sample To record the results you need to call up the sample from the database The fastest way to do this is via the identifier En Call up via database enter show results or via The following screen appears Identifier A Search For identifier in database Now you can enter or scan in the identifier After clicking on CIA Results window is called up Note If you use a scanner the hourglass cursor appears briefly while the identifier is established based on the scanned in data There is another way to call up the sample Using database display table or by clicking on Ela table appears w2. show results Clear all Release results hal Cleat Fm Je Click on lt OK gt to save the user data 2 1 3 User Log in log out When leaving his work station the user can log out with a mouse click without closing the program just click on the sad face The new user clicks on the smiley face Biotest User Manager 2 0 LA wi User name Z 5 SMITH Change password O O 5 Password E y Exit Enter your password click on lt OK gt and start working After entering the user name and the password you can change your password for example because it has expired Do not click on lt OK gt but on lt Change password gt The following window will be displayed and allows you to enter your new password Biotest User Manager Y 2 0 Care ds un F Username u E SMITH OF O oO 5 Password Password confirmation pe Click on lt OK gt to get to the Software Forgot your password See your administrator for help Biotest HYCON ID 1 0 2 2 Settings There are user specific default options which cannot be set during installation However they are necessary in order to work with the software Therefore they should be entered directly after installation Call up via Options Settings or directly via A You will find these buttons on each property tab lt p Exit settings without saving changes qa Save changes 2 2 1 Database The standard path is en
3. CPU me Comment O A 24 bons SMITH 05 042007 14524 CFU CPU me Comment a a A 45 bons SU TH 05 042007 15 CFU CPU me Comme wt T r q 72 bons Sig 134 re of espos Dk In print preview there is a choice between the following options E E mah gt Print the printer dialog box appears where the printer can be chosen and where printing can be started 58 Display of the page in print preview whole page width of page size 100 The current page size is displayed on the right different pages If the findings consist of several pages these arrows can be used to call up the 20 Biotest HYCON ID 1 0 Back to the result window no printout is performed 3 2 3 2 E Export Currently this option is not yet available The plan is that future versions will offer data export 21 Biotest HYCON ID 1 0 3 2 4 Database table The database table features a list of all samples of one database By double clicking on one entry the input mask for the results is display ed Note In the database table the sample data can only be displayed not changed However it is possible to sort the data by the various columns such as identifier or sample ID To do this simply click on the column heading by which you want to sort the data The column will be marked with a small triangle 3 2 5 Archive functions Create an archive In order to keep databases clearly structured it makes sense to archive
4. Lancel New new user is created see User Management Change This is where the administrator can change his password Delete The administrator cannot be deleted General settings for all users are made in the right column Password criterion This is where you define how many characters a password must have and whether it must include digits Password expires After a defined amount of time a new password must be entered upon logging in Password attempts If the defined number of attempts is exceeded the user can no longer log in and must see the administrator Are you the administrator And you forgot your password Please contact Biotest s Technical Support 2 1 2 User Management The user can change his password but has no further access to the User Management feature He can however carry out all tasks within the scope of his authorization examples import instrument data enter results print or release results User management is the administrator s task he is the only one who has access to this feature Biotest User Manager Y 2 0 Un gt User name RE LA 5 ADMIN User manager O CO 5 Password E DE Exit Clicking on lt User manager gt displays the user management dialog Biotest HYCON ID 1 0 Biotest User Manager 2 0 E TA User name Password criterion U i i cheractermn 8 Ls 5 1 character min O E CO af Password expires MEET si Password attempts
5. displayed Continue with lt Next gt Finally installation takes place Finish this first part of installation with lt Finish gt 1 2 2 Installation of the program Now the welcome window of the Hycon ID Tool is displayed Biotest HYCON ID 1 0 2 Biotest Hycon ID 1 0 InstallShield Wizard uN Welcome to the InstallShield Wizard for Biotest Hycon ID 1 0 The InstallShield Ri Wizard will install Biotest Hycon ID 1 0 on our computer To continue click Next WARNING This program is protected by copyright law and international treaties Cancel Please click on lt Next gt gt The license agreement is displayed Select accept Only then will you be able to click lt Next gt gt Information on the installed data is displayed this information can be found in the file readme txt in the installation folder of the Hycon ID Tool Click lt Next gt PC user und company is displayed Change if necessary and click lt Next gt gt Proposal of the DestName The standard subdirectory is C Program Files Biotest BHIDxxxx xxxx current version number By choosing Change you can alter the DestName This window can be used to perform changes or you confirm it with lt OK gt Overview of the settings prior to final installation Confirm with Install gt the installation will be carried out Finally this message will appear i Biotest Hycon ID 1 0 InstallShield Wizard 3 InstallSh
6. software citada di AAA A AE 4 2 IFSC SUC Sii a a iaa 4 2 1 USC fe a tele anotada ista 4 Zet PEAOSI CO A OSO 5 2 12 E E MARAT M ME RSS RER das 6 23 AISER LOG A OG OU menini eMail een tie ni 8 2 2 SENS ean ea n te ae et E a E ion ese ast tele di ie 9 A ER D O A O O O A EE EEE 9 2 2 2 MYSTIC el lei aii 10 223 Userdelned TISIOS nr O A A A A A 11 A A 12 2 2 4 1 Gl ah OOM CATE ONES a risa lia ita 12 2 2 4 2 EOcatlon clas SOS 13 2243 TEXPUSCA OF COMME Sisi la i 13 2 2 4 4 Text used for user defined fields 1 4 RL 14 ateo PEINE SCUMIGS dia Ai 14 3 WOFKINO With the SoftWare iia 15 3 1 MPoOrtinstUMentd ata rara AT es de alata an alan ealac Waal cea araas 15 3 2 FIC COPGINIG TOSUN S at in a tee 16 es Gala MUD Sample it 16 322 RESULT ONE microDiological analysis iia lin 17 3 2 2 1 A O A A TN 17 3 2 2 2 Data from the microbiological analysis o ococcoconococoocononoconcononoconcnnononononnonnnroncanononos 19 AE OUAIS e a Re ee ne a Le Do DU 19 3 2 3 1 PRIOR a ee ea ce a a ic 19 3 2 3 2 E ADOR A RU tn ate Sts ada ee ne at NON lu 21 32A PaB OC 0 NS Re E tn nl eae Tee ee ee eee Ree el D ee re eee 22 Ie D ACAV UNCION SSA SSA ASS 22 3 2 5 1 VIE WIR TIS SARC INV C reser tat cen aE A A A E aE 23 3 2 5 2 Back 10 mMmecurenta aladas iros trocito titan DIRE 24 326 NEW WOIKING ataDas Cusco 24 Sel OO ON a 25 A EEP OLA o suseiee repens sanunnsauacenatess Sunday a a S 25 4 AO E den 0 ci 26 4 1 EOG TG O Rad tre cdd side de A de d
7. unlimited Hew Change Delete OF Lancel General settings are made in the window to the right of the user list They are described in the chapter The Administrator Click on lt New gt to create a new user Biotest User Manager Y 2 0 ht wm User name W ur ok O oD 5 Password EN Cancel Password confirmation User language English ye Module authorization Ml Import instrument data C Show log entries C Sign off user Enter show results Select all _ Release results Clear all CIl Drink ea es User name The user must enter this name during login It should therefore be easy to memorize and not be too long Password When creating a new user the user name in lower case letters should be used as the password The user is then to change his password upon his first log in User language Please define for each user the language in which he works currently German or English Module authorization User rights may also be granted only for certain modules of the software In order to ensure the confidence principle the rights for typing and the rights for results release may be granted to different users Biotest HYCON ID 1 0 By clicking the right mouse button you can activate a context menu to select or deselect all modules at the same time Module authorization Import instrument data Show log entries Export data Sign off user Select all Enter
8. will guide you through the installation step by step 1 2 1 Installation of Database server First select the installation language Setup Sprache ausw hlen x Wahlen Sie die Sprache aus die wahrend der Installation benutet werden zoll Abbrechen Choose language used during installation Then installations starts with the Firebird welcome screen Biotest HYCON ID 1 0 9 Setup Firebird Database Server 2 0 Ioj xj Welcome to the Firebird Database Server 2 0 Setup Wizard This will install Firebird 2 0 0 on pour computer ltiz recommended that vou close all other applications before continuing Click Next to continue or Cancel to exit Setup cos Click lt Next gt gt The license agreement is displayed Select accept Only then will you be able to click lt Next gt gt Information on the installed data is displayed this information can be found in the file readme txt in the installation folder of the database server Click lt Next gt gt Proposal of the installation folder for the database server Please follow the proposal and simply click on lt Next gt An options menu is displayed As before you should not change the options but continue with lt Next gt There are two additional screens to confirm with lt Next gt without changing any options Finally an overview of the settings is displayed This time click lt Install gt Another information is
9. All the settings remain unchanged including the help tables 3 2 5 1 Viewing the archive To view an archived file it is necessary to enter the path to the archived file in the database property tab in settings 23 Biotest HYCON ID 1 0 0 xi lt q Y Mame of active database Es program files Biotest BHID 00 O h rchives bhid 0070406 9db Example SERVERT C Program Biotest Huconl D HID gdb M Activate Audit Trail Database Instrument file User defined fielde Help tables Printer settings You save the change by clicking on a Now you can work with the archived data as if it was a normal database In the status bar at the bottom of the window you can see which database is currently worked on bhid20070406 gdb 3 2 5 2 Back to the current database To do this you need to enter the path to the work database in the database property tab in settings The standardised path is Program files Biotest BHID1000 BHID gdb After clicking on W the change is saved and the work database reappears 3 2 6 New working database This option is used to create a new work database Warning This option should only be used after consultation with the Biotest product specialist Contrary to archiving the database is deleted immediately In addition all settings in the help tables property tab are deleted There specific information has been entered for you This needs be input again after a new datab
10. B port when the program asks for it In addition the data transmission software RCS 2 PC together with the analytical software Hycon 1D that are included on the CD Rom need to have been successfully installed see instructions further down Prior to the data transmission from the RCS High Flow sampler the PC must have been switched on and the Bluetooth interface must have been activated After switching on the air sampler you move from volume display to the service menu by pressing the Menu On key By pressing the Start Stop key once you get to the Bluetooth data transmission menu You confirm your choice by pressing the Menu On key Selection of Bluetooth data transmission Data transmission to the PC In order to establish a wireless data transmission to a personal computer you need to select the PC symbol To do this you need to use the START STOP key The PC field has a dark background By pressing the MENU ON key you start the data transmission On the screen display you will see the number of data records that are being transmitted to the personal computer If there is no data transmission or if the data transmission is faulty an error message appears This does not affect the data records which will be preserved This process can be terminated with the help of the MENU ON key and repeated at a later time Biotest HYCON ID 1 0 Selection of sampling data HYCON ID see also chapter 6 2 of the RCS High Flow operati
11. Biotest AG Biotest From Nature for Life Biotest Hycon ID Tool Release 1 0 Instruction Manual pg 2 HYCON ID Software pg 11 Landsteinerstrasse 5 e 63303 Dreieich GERMANY Telefon 0 61 03 8 01 0 e Fax 0 61 03 8 01 1 40 Copyright 2007 Biotest HYCON ID 1 0 INSTRUCTION MANUAL HYCON identification and documentation HYCON ID In combination with a RCS High Flow air sampler item no 940 216 and a personal computer this HYCON ID set facilitates with the help of barcode information the wireless collection storage and documentation of all important data covering airborne bacteria This way serious mistakes that may occur when documentation is produced manually e written down by hand can be avoided processing is very much accelerated and the use of paper documents is considerably reduced The HYCON ID set consists of the following components 1x Bluetooth adapter with installation software and instructions 1x Barcode scanner 1x Rechargeable batteries 1x Battery charger 1x CD Rom with installation programs data transmission program HYCON ID analytical program manual 1x Operation instructions In addition the following items are required 1x RCS High Flow air sampler item no 940 216 1x Personal computer with Windows 2000 system Pack 4 or Windows XP professional system Pack 2 operation with other Windows operating systems is possible but was not tested Minimum available ha
12. ase has been created Call up via database create new working database The following warning appears warung s x AN During this process a new database will be created Ci ProgrammelBiotest BHID0100014rchive BHID gdb Al current database tables will be lost We recommend to back up the database at the beginning Do you wank to continue 24 Biotest HYCON ID 1 0 Click on lt Yes gt The following message appears x new working database was generated A C Program files Biotest BHICH 000 BHID gdb By clicking on you can see for yourself Identifier Identifier Sample Dllo User def User def 2 gt S 3 2 7 a Online help Press the lt F1 gt key to get to the online help file This will automatically display the help text matching the currently open window lf you need help for another topic there are several methods to find it quickly e Use the index on the left side it s identical with the printed manual e Select Index or Keywords to enter the topic for which you need help This will display all the topics containing this keyword e Use the arrow keys to scroll back and forth This is quite useful when you are trying to familiarize yourself with a complex topic such as for example settings 3 2 8 Exit program e You can close the program by using the at the top right corner as in any Windows application e by selecting File Close e or directly by usin
13. attery housing is located Then you insert the scanner complete with battery backwards into the opening of the charging point Charging starts immediately and is finished after approximately three hours It is recommend to always keep the scanner in the charging point because it is easiest to scan with the device when it is fully charged The rechargeable battery can be charged around one thousand times afterwards it needs to be replaced with a new battery Defective and used rechargeable batteries need to be disposed of in accordance with local regulations Do not add to your household waste Do not throw into an open fire Disinfecting the scanner The scanner can be wiped with any common neutral disinfectant Treating it with gas or submerging it in a disinfectant solution is not recommended There is no warranty if due to incorrect use a disinfectant has entered and destroyed the scanner Scamning If the RCS High Flow sampler requests an input the barcode scanner is placed on the respective barcode at a distance of around 5 to 10 cm and the right hand key is pressed to read in the information red laser beam helps the device to focus As long as the key is pressed down the laser beam can be adjusted directly onto the label It is important to hold the device at a slight angle to the data matrix code in order to facilitate error free scanning this way there are fewer reflections of the labelling material The scanner reads all t
14. e 26 12 Biotest HYCON ID 1 0 1 Welcome 1 1 What is the Biotest Hycon ID Tool In combination with the RCS High Flow item no 040 216 the HYCON ID Tool is used for the wireless transmission collection archiving and printing of data covering the entire process of airborne bacteria collection lt is used wherever error free documentation of data on a microbiological collection process is prescribed or necessary in accordance with the microbiological monitoring of clean rooms This data includes information on the collection place the user the collection medium the collection device as well as the collection process itself sample volume date time of the collection specific information as well as the evaluation and interpretation of the microbiological analysis The scope of access and the user options of the HYCON ID depend on the access authorisations of the individual user which are assigned by an administrator 1 2 Installation Log into your system as administrator Place the CD into the CD drive of your PC lf the installation does not start automatically AutoPlay of CD start the programme BSl exe of the CD The following screen is displayed G Install HYCON ID Software En ste E qa Y a fg E m l Select the entry Install Hycon ID Software and confirm it by lt Start gt Installation runs in two steps First the database server is installed and then the software itself The InstallShield Wizard
15. e identifier data matrix codes have the following format Identifier for the sampling location Subsequently up to 82 characters can be scanned in LOC Identifier for the user Subsequently up to 82 characters can be scanned in Identifier for own information Subsequently up to 82 characters can be scanned in Identifier for own information Subsequently up to 82 characters can be scanned in DF2 As soon as all the data has been scanned in the disk symbol on the display has a dark background Now the sampling process can be started Biotest HYCON ID 1 0 Data transmission on a personal computer and scanning data into the HYCON ID software First you establish a Bluetooth connection with the personal computer as described above Start the personal computer and in the Bluetooth Manager after installation the icon appears at the bottom right hand corner of the task bar open the Bluetooth settings dialog box right hand mouse click on the Bluetooth Manager icon Bluetooth Einstellungen Bluetooth InFormationsaustausch Drahtlose Dateiibertragung Remotekametra Neue Verbindung hinzuf gen Optionen Bluetooth aktivieren Hilfe Info Beenden Bluetooth Manager lv 17 14 Icon of the Bluetooth manager Bluetooth Einstellungen 15 x Bluetooth Ansicht Hilfe ES Bluetooth RCS y FLOW ID Yerbinden verbinduna trennen L schen Details Desktopyer
16. eable at any time which operator performed a specific action This is why the Biotest Hycon ID Tool features the user management function which has proven valuable in the Biotest HLA Typing Software The software distinguishes between the Administrator who administers the users and the Users who are authorized to create the reports The administrator assigns the user names and determines which requirements a password must fulfill He defines the rights for each user An example The confidence principle can be ensured by defining the rights for the evaluation and release However the administrator himself is not authorized to perform typing assays or release reports The user can change his password but has no further access to the User Management feature He can however carry out all laboratory tasks within the scope of his authorization examples administer type or release lots or print reports When leaving his work station the user can log out with a mouse click without closing the program Biotest HYCON ID 1 0 While using the user management the following prompts may be displayed Do you really want to delete the user This appears if a user is accidentally about to be deleted from the list Password does not meet the criteria The password entered does not match the password criteria established by the system administrator Password not confirmed The repeated password is incorrect User name already present Attemp
17. ed background are input and cannot be changed The white fields can be used to enter details or to select information from the list The orange coloured fields in the upper left hand section feature information on the used test strip a brief description of the used test strip the item number under which the strip can be ordered from Biotest the batch number and the expiry date of the strip The middle section contains up to four freely definable comments Identifications such as room or personnel ID are entered in settings in the user defined fields property tab This is where you determine whether the information is input by the device or entered manually Fields that input by the device and which therefore cannot be changed are coloured pink If repeatedly the same data is entered manually this can also be specified and saved In settings in the Help tables property tab under the respective user defined field Text of user def field 1 Test Building K Room 227 Building E Room 226 Building L Room 143 Loc D Loc F The blue rows of fields on the right hand side show the instrument data instrument number protection cap number rotor number as well as the expiry date of the calibration The green fields below contain the data on the performed measurement At a later date the CFU m is calculated based on the volume and the result of the microbiological analysis Note The meaning of error codes is ex
18. emperature out of range No evaluation possible please repeat sample Out of specification possibly secondary contamination please repeat sample Save result By clicking on the green check mark you save the entries for this count Now the logged in user and the date time is displayed under the comments Edit result 19 Biotest HYCON ID 1 0 As long as the findings are not yet released saved entries can still be changed Note Do not forget to save entries after changing them 3 2 3 Output of findings 3 2 3 1 Printout At any time there is the option to print findings The printout will contain all information that is displayed in the Results window The printout will also feature the Released or Not released status The header and the footer of the printout are configured in the Printer settings property tab in settings After clicking on the print button the print preview appears Hycon result report agar Stipi TE Samma kE Ithe r 226001 000014 AE 10 341115 Lot 2280507 Epilation dat 05 01 2007 sertsamplli Svp sampling Conti Dat Company vz Mlcroblolog eal Estig Eboratony amp Biotest Marcher Blest hetime dto 100744 Cap 10 HU Robrio H277 Calbraton 02122m hiengisamplhg Ho A OT le mel a Cotithg3 Dae Ra ult rolag gad Sample 10 00004 Location Loc Name M m FH Comme at 1 Room 225 Comme rt WU 123456 11 12 2006 162310 e 1000 11 12 2006 16 00 Error cade O CFU
19. en dpfung erstellen Umbenennen Anderes Symbol Establishing a connection with the RCS device Biotest HYCON ID 1 0 Establish a connection with the RCS device by clicking on the Verbinden field in the Bluetooth Einstellungen dialog window ATTENTION a connection can only be established if the data transmission to the PC see above has been activated and the RCS device is sending A small symbol showing two hands green and yellow indicates a successful connection E Bluetooth Einstellungen yg loj x Bluetooth Ansicht Hilfe Bluetooth RES HIGH FLOW ID Verbindung Interlinked hands symbolise the connection between the RCS device and the computer Now you can start the RCS2PC transmission software and read in the data from the device into the PC Make sure that the connection is maintained If necessary repeat the connection process Follow the instructions below regarding the scanning of data records and or the calling up of samples their processing and printing 10 Biotest HYCON ID 1 0 Biotest Hycon ID Tool release 1 0 Manual HYCON ID Software Biotest HYCON ID 1 0 Table of contents 1 A proin 1 1 1 Whats the Biotest Hycon ID Ora 1 1 2 darete in ela PRA ER A E EEA EAE ASA EE A EN AAEE Ce E A ENA EEE E A E E EE 1 heck Nstalaton orDatabase SOVET sra irse 1 k22 IMIStAN AION OV ING progran ii mater dns teste ee tn nid ne 2 1 3 System Te quitementS unid A AA AN 4 1 4 Features of the
20. field under the disk symbol must indicate ON If it is turned to OFF it needs to be switched to ON by pressing the and keys Getting to the menu by pressing the Menu On key Selection of code type The code can consist of two parts a so called identifier part and the actual information part The identifier helps the RCS High Flow air sampler to identify the type of information For example the identifier LOC indicates that the subsequent information refers to the sampling location Without an identifier the information is simply saved without allocation i e on call which may due to possible mix ups lead to incorrect entries Therefore the HYCON ID system is designed to be used with identifiers However if somebody wants to use his own codes whose identifiers are different from the HYCON ID or which have no identifier at all it is also possible to input another code There are three types of code entry ON all codes are recognised and correctly allocated due to identifiers There is no need to stick to a particular order when scanning in information ON Barcodes with identifiers OFF Barcodes without identifiers PRE Barcodes with pre scanned identifiers OFF no codes have identifiers Therefore it is necessary to adhere to the scanning order PRE the scanning process consists of two parts first the identifier needs to be scanned in from the enclosed table or the attached code cards This needs
21. first user defined field and it should be made impossible to change it again This is why here the display option is chosen Note A field where data is only displayed but cannot be changed has a pink background Edit These fields can be used to enter additional information that was not recorded during the sampling such as the name of the sampler or a keyword regarding the location of the sampling Note It is possible to specify and save comments for an entry field in order to ensure that these do not need to be entered repeatedly by hand each time Any comments that are saved in the Help tables can be called up by clicking on the arrow E It is also always possible to enter random comments No check Four fields are available Nevertheless if certain fields are not required both check marks mark relating to the unnecessary fields are removed In the above example the user defined field 4 is therefore not displayed 11 Biotest HYCON ID 1 0 2 2 4 Help tables As to the help tables there is a database navigation bar below the tables Hi A D HO This is used to administer table entries The first table entry is displayed The previous entry is displayed The next entry is displayed The last entry is displayed The table is newly sorted TTT i Add another line Delete entry 2 2 4 1 Clean room categories ens OO Cl lt e Y Test of user def field 2 Test of user def field 3 Tes
22. g the El button 29 Biotest HYCON ID 1 0 4 Annex 4 1 Log file If in the Database property tab under settings the Activate audit trail option is activated a log file compliant with 21 CFR Part 11 is being kept e Activate Audit Trail This is where all events are recorded By calling up File display logged entriesor by clicking on E you can view this log file pee Log entries LOG TIME LoG_USER LOG_ACTION 06 04 2007 14 23 12 06 04 2007 14 34 32 06 04 2007 14 54 45 06 04 2007 14 34 53 06 04 2007 14 55 05 06 04 2007 14 55 10 06 04 2007 14 56 24 06 04 007 14 30 35 06 04 2007 14 54 14 06 04 2007 15 07 22 06 04 2007 15 01 41 06 04 2007 15 10 20 06 04 2007 15 25 03 06 04 2007 15 46 52 06 04 007 16 47 30 06 04 2007 16 48 06 CAC problem in instrument file HYCON 2007 02 11 76 56 55 txt File no Sample IO 00047 was stored Sample ID OO002 was stored Sample ID 00004 was stored Sample ID 00048 was stored Sample IO 00050 was stored Result stored Sample ID 00004 Date 13 72 2006 Germs 0 30 24 h Result stored Sample ID 00004 Date 14 12 2006 Germs 3 30 48h Sample ID 00004 was released Settings stored Result stored Sample ID 00047 Date 13 12 2006 Germs 2 30 24h Settings stored Settings stored Settings stored Database C ProgrammeBiotest4BHID1 100 bhid gdb opened Settings stored 26 O Biotest AG 2007
23. here all samples are listed Biotest Hycon ID 1 0 0 0 Ideritifer maa 2 I a notons FRE EE CUE ns 2007 rons ETA oz 2260507 M Smith PNOCO2 Biotest 941115 05 01 2007 110034 226050700004 00004 2260507 JLoc IM Smith PNO20 Room 225 UE 123456 Biotest 941115 05 01 2007 10034 226050700048 00048 2260507 LocF IM Smh PNOZ0 Biotest 841115 05 01 2007 10034 226050700050 00050 2260507 M Sm h PNOZO Biotest 1941115 05 01 2007 10034 Copyright c 2007 Biotest AG By double clicking on an entry you call up the Results window 16 Biotest HYCON ID 1 0 3 2 2 Result of the microbiological analysis The Results window is subdivided into several sections ey Bb xX z enla 226050700004 ed Sample IC 00004 a Manufacture Biotest Location loss re TS Hame M Smith FPNO2I Pap o aa SS Comment Room225 y Rotor no H2233 Calibration 02122007 Article no Lot Expiration date 11 12 2006 16 29 00 Volume L Inteerval sampling No 11 12 2006 16 30 00 Error code mE of interval a Start sampling Stop sampling Counting 1 Date CFU CFU mr Comment SMITH 06 04 2007 14 38 24 Counting Date CFU CFU nr Comment fiai22006 3 30 48 hows SMITH 06 04 2007 14 38 33 Counting Date CFU CFU nr Comment N5122006 7 30 72 hourd x Y 3 2 2 1 Buttons Cancel The Results window is closed Any
24. ield Wizard Completed The InstallShield Wizard has successfully installed Biotest Hycon ID 1 0 Click Finish to exit the wizard Confirm by clicking lt Finish gt After the installation of the software has been completed the desktop and the program start menu will feature the corresponding Biotest HYCON ID entry Biotest HYCON ID 1 0 1 3 System requirements Computer e Operating system Windows 2000 Service Pack 4 or Windows XP Professional Service Pack 2 Maybe the software would run with other operating systems but this is not validated e Minimal free disk storage 100 MB e Minimal main storage 256 MB e Screen resolution 1024 x 768 Note The option Big fonts must not be selected Note If your personal computer systems does not meet the system requirements mistakes long waiting times and potential programme crashes can be the consequence 1 4 Features of the software The Biotest Hycon ID Tool features the following functions mport Hycon ID data from data files e g generated by RCS2PC nter and show results JJ elease results D rint results elete results xport data in preparation ata table view of all results orking with different databases rchive function alidated 21 CFR Part 11 compliant software ser definable settings for results comments printouts 2 First Steps CICI lt 6 E 9 2 1 UserManager According to 21 DFR Part 11 it must be clearly trac
25. is field is important if you use a bar code scanner Apart from the identifier other data is input via the bar code scanner This would lead to incorrect information appearing in the identifier field Therefore if the identifier of a sample is input with a bar code scanner the programme must be informed of this This is done via an additional character that is sent by the bar code scanner at the beginning By default this character is a comma ASCII character 44 If your scanner needs to be programmed in a different way the respective ASCII Code can be entered here 10 Biotest HYCON ID 1 0 2 2 3 User defined fields This is where the fields are defined which are located in the middle upper section of the results window Mame Display E dit User defined field 1 Location 0o User defined field 2 Name User defined field 3 Comment 1 User defined field 4 Comment2 a m m ja ala 1 Database Instrument fle User defined fields Help tables Printer settings This setting produces the following picture when a sample is called up Location Loc 4 h us A Grel PNO202 y Comment 1 Room 223 hd Four user defined fields are available which are configured as follows Name The name appears to the left of the field as description Display If for example during sampling the location is recorded as well this information is input together with the instrument data This means that the location appears in the
26. itions are required repeatedly If these comments are specified and saved here they can be inserted during the evaluation via a list of options This will ensure that the same processes are described in a standardised way Test of user def field 2 Test of user def field 3 Test of user def field 4 Class specifications Location classes Comment text Text of user def field 1 Comment text 03 days 25 centigrade 03 days 30 centigrade OF days 25 centigrade OF days 30 centigrade 10 days 25 centigrade 0110 days 30 centigrade Out of specification range Possibly secondary contamination please repeat sample Database Instrument file User defined fields Help tables Printer settings Note At any time you have the option of adding to the comments or of entering 13 Biotest HYCON ID 1 0 your own comments 2 2 4 4 Text used for user defined fields 1 4 The types of text specified here depend on the default settings in the User defined fields section lt is here where for example it was determined that the sampling location is displayed in field 1 The check mark in display means that this information is read out from the device Therefore there is no need to specify texts for field 1 Field 2 is to be used to enter the person who has extracted the sample Therefore as the text user defined field 2 a list of users is specified who at a later point can be selected from the option me
27. ng manual You use the HYCON ID sub menu to determine which data is going to be recorded via barcodes and transmitted to the RCS High Flow system prior to the sampling process After choosing the respective symbol on the service menu you enter the HYCON ID menu by pressing the Menu On key Selection of HYCON ID HYCON ID Menu Information covering the following topics can be chosen AGAR all information on the used agar strip complete with product number batch and expiry date In addition the barcode features an individual sample number This information is obligatory and cannot be deactivated USER information on the user LOC information on the sampling location DF1 Free information 1 DF2 Free information 2 Selecting information option Selecting information Activating information With the help of the and keys you can move to the desired fields and select your options using the START STOP key Using the and keys you can change the suffix in front of the fields from to indicates that this information needs to be scanned in prior to the scanning process By pressing the Menu On key you return to the service menu Biotest HYCON ID 1 0 Scanner Recharging the batteries Prior to use the rechargeable battery needs to be charged using the charging device provided For this purpose the rechargeable battery must be placed into the underside of the scanner where an empty b
28. nu q Y Clase specications Location classes Comment text Text of user def field 1 Text of user def field 2 Test of user def held 3 Test of user def field 4 Elaine Miller Hermione Granger Fon Weasley H 4 co Database Instrument file User defined fields Help tables In the same way standardised entries can be specified for fields 3 and 4 2 2 5 Printer settings Here you determine what the header and footer of a print out are going to look like Four header and four footer lines are available for this purpose In addition the logo of the institute can be inserted This will appear in the top right corner of the print out Header Company TE Microbiological testing laboratory Footer Signature of responsible Logo image file C Mtemplatestimages company logo jpg Database Instrument iile User defined fielde Help tables Printer settings 14 Biotest HYCON ID 1 0 3 Working with the software 3 1 Import instrument data First of all the instrument data is input This requires a click on Y or on file import instrument data The well known Windows open dialog appears and the folder that has been entered as the instrument data file folder in settings is opened Look ir E Hycon as E ci Ez IS H CON 2006 12 11 16 56 40 txt HYCON 2006 12 11 16 56 41 txt HYCON 2006 12 11 16 56 42 bxt 2 HYCON 2006 12 11 16 56 44 txt HYCON 2007 02 11 16 56 55 txt
29. ound 80 percent of the memory has been taken up the fill level of the memory is displayed as a percentage figure on the screen for three seconds after the device has been switched on As soon as the memory has been filled to 100 the saving of any further new record causes the respective oldest record to be deleted Therefore it is recommended to lose no time downloading the saved records on a computer with analytical software After a successful transmission the memory can be wiped Setting up the wireless transmission of data via Bluetooth see also chapter 6 1 of the operating instructions for RCS High Flow The RCS High Flow air sampler can either be connected to a barcode scanner from which it receives data or it can connect with a personal computer in order to transmit this data Establishing a connection with a scanner After turning on the air sampler you can change from the volume display to the service menu picture on the left by pressing the Menu On key By pressing the Start Stop key you move to the icon with the radio signal which will then have a dark background Biotest HYCON ID 1 0 After choosing the appropriate symbol in the service menu you press the Menu On key to get to the Bluetooth data transmission menu Selection of Bluetooth data transmission Data transmission to the scanner To carry out wireless data transmission from the HYCON ID set cat no 940 360 with the help of the scanner the
30. plained in the user manual of the sampler 18 Biotest HYCON ID 1 0 of airborne bacteria 3 2 2 2 Data from the microbiological analysis For each sample up two three results of the microbiological analysis can be recorded Date CFU CFU m This is where the date of the reading is entered If nothing is entered here the current date appears However it is also possible to enter a random date The number of the CFUs on the test strip Note If there are more than 200 CFUs the test strip can no longer be analysed It is recommended to repeat the measurement with a lower sample volume This value is calculated by the program If the room is assigned to a clean room category it checks whether the requirements have been adhered to If the maximum number of bacteria has been exceeded the following message appears Warnung Xl Value out of specification Location Loc E Class Max CFU m 1 Calculated CFU mi 3 PLEASE CONTACT A SUPERVISOR CFU oF Comment ls 10 Value out of specification SMITH 06 04 2007 15 01 41 30 24 hours E Comment This is where for example the incubation conditions or notes on the findings can be entered If repeatedly the same data is entered manually it can be specified in settings in the Help tables property tab under comment text Afterwards it can be selected here Comment 30 72 hours de 1 day de 3 days 32 56 dave Incubation t
31. rd disk storage 100 MB Minimum working memory 256 MB Screen resolution 1024 x 768 Biotest agar strips with barcode labels The use of the following is recommended but not urgently required Additional barcode labels for collection site users or two further items of information It is possible to order an additional barcode label printer with labels and software to generate a data matrix code item no 940365 to produce these barcode labels Barcode scanner with cable item no 940 368 for the connection to the USB interface of a personal computer With the help of this input device and based on the barcode on the agar strip any associated data can be swiftly called up in the analytical program This is important for facilities such as microbiology laboratories who are in charge of the incubation and analysis of the agar strips Biotest HYCON ID 1 0 Setting up the RCS High Flow system Setting up the wireless transmission of collected data on the RCS High Flow air sampler The RCS High Flow air sampler acts as an interface between the barcode scanner and the personal computer on which the analytical software is installed lt collects information from barcodes which is transmitted from the barcode scanner to the air sampler via a Bluetooth interface lt adds its own information to the actual collection process volume date time etc saving it on an internal memory Up to one thousand data records can be collected this way lf ar
32. results that have not been saved are rejected Save results Newly entered results are saved before the Results window is closed Print results Print preview appears See also chapter on Output of findings X D lt Delete results warning message appears Best tigung p xj 2 Do you really want to clear the current record JS Wo Cancel If you confirm this by pressing lt Yes gt the whole sample is deleted not just the results of the 17 Biotest HYCON ID 1 0 microbiological analysis Release When the microbiological analysis is finished the result is released After clicking on the release button the following message appears Best tigung 3 xX After release it is impossible to change or add the results of this record 2 Should the results be released now c No Cancel The results will only be released after you have clicked on lt Yes gt This is indicated in the top right hand corner Result released The released results can neither be changed nor deleted Identifier and sample ID The identifier as well as the sample ID are displayed at the top As soon as the recording of the results for one sample is finished you can enter or scan in the next sample in the Identifier field This way several results can be entered one after the other Note Any results that have not been saved will be lost at this moment Instrument data The fields with a colour
33. t of user def field 4 Class specifications Location classes Comment text Text of user def field 1 Class Max CFU ne 100000 1 f 10 100 Ho D H Database Instrument file User defined fielde Help tables Printer settings The maximum number of CFU m for clean room categories A to D in accordance with EU directives has already been specified and saved If you use your own classification it can be entered here This setting will only have an effect in combination with the site categories table 12 Biotest HYCON ID 1 0 2 2 4 2 Location classes This is where information about the rooms used for the sampling and the specifications that these rooms need to comply with is entered EE oa lt e Y Test of user def field 2 Test of user def field 3 Test of user def field 4 Class specifications Location classes Comment text Test of user def field 1 Location less Clean room 1 A Room E Room B C Room E C Room D E Staff room D Database Instrument file User defined fields Help tables Printer settings Note When the limit for a specific room category has been exceeded this will be clearly indicated a A Wale Qu of pedint i Lion Loc Das Mas CPL Ime 1 Calculabod CRU line 3 PLEASE COMTACT 4 SUPERIEUR 2 2 4 3 Text used for comments During the microbiological analysis of the samples the same comments such as a statement on incubation cond
34. t to enter a new user whose name already exists Password expired Please enter a new password This appears if the password has expired according to the criteria established by the system administrator More than 3 failed attempts Please inform the system administrator The system administrator has allowed a maximum of 3 failed attempts to enter a password This limit has been exceeded User language not selected Each user needs to enter his dialog language 2 1 1 The Administrator The administrator assigns the user names and determines which requirements a password must fulfill He defines the rights for each user An example The confidence principle can be ensured by defining the rights for the evaluation and release However the administrator himself is not authorized to perform typing assays or release reports After logging in the administrator has access to the user management Biotest User Manager 2 0 dd wi User name a E 5 ADMIN User manager O co 5 Password E OK Ed The password for the first log in is ADMIN admin The administrator should change the password therea ter The user management dialog is displayed Biotest HYCON ID 1 0 Biotest User Manager 2 0 User name Password criterion ABAE oo anise cee eet fi character min Fee Milure fou Life Password expires MEET w amp Biotest Password attempts unlimited Hew Change Delete OF
35. tered during installation Here it can be changed if necessary for example in order to have access to a specific Archive By default the site log audit trail is deactivated All transactions are recorded in the site log This way one can check at any time which user carried out which actions If you need to comply with 21 CFR Part 11 the audit trail needs to be activated To do this click on the check mark e Y Mame of active database C Program files Biotest EHID1000 bhid gdb Example SERVERT C Program Biotest HyconlO BHID gdb M Activate log Database Instrument tile User defined fields Help tables Printer settings Biotest HYCON ID 1 0 2 2 2 Instrument data file This is where you enter the location of the files that are read from the Hycon ID device The Hycon folder has been entered as the default value in the installation directory of the RCS2PC software This is where the data of the sampler of airborne bacteria is filed using the hycon txt format Y Instrument folder ARES 2 POCHO Hacont Syntax serveridriveipathlarc_ db Filer M Delete instrument file after import Dec character code of barcode prefix 44 Database Instrument file User defined fields Help tables Printer settings After the import Delete instrument file after import is activated as default value This ensures that instrument data files are not input twice Character code for bar code reader Th
36. the released data from time to time Archived data can be reviewed at any time Note It is always the complete database that is archived Therefore one should ensure that all samples have been completed and released To archive data proceed as follows Select Database Archive working database warning message appears warnung ee xl AN During this process all data of the working database Programme Biotest BHID1 100 BHIC gdb Will be transferred to the archiving database and will be deleted afterwards The help tables are not affected Do ou want Eo continue 22 Biotest HYCON ID 1 0 If you click on lt Yes gt the following window appears Mame of new archive database LO E fy ell De sktoj p E My Computer al My Netw ork F File name BHIC 20070406 adb Save as type Databases gdb Cancel Here you can choose where the archived data is to be saved In this example an additional folder called Archives was created under C Program files Biotest BHID1000 A file name in the form of BHIDyyyymmdd gdb is proposed This can be changed although it is important to keep the ending gdb Click on lt Save gt in order to create the archive After successful archiving the following message appears G Database was archived to C iprogram tiles Biotest SHIDI O00 archives BHID20070406 gdb If you click on now you will see the empty database Note
37. to be followed by scanning in the code with the relevant information This way even codes without identifiers can be correctly allocated However the correctness of any information that is subsequently scanned in cannot be ensured Biotest HYCON ID 1 0 On the RCS High Flow system one can choose these settings using the and keys By pressing the Menu On key you return to the service menu and save the chosen setting If this setting is activated the disk symbol is always on display lt indicates that the sampling process starts with the search for a scanner to obtain specifically selected sampling information Only when this information has been fully transmitted to the air sampler identifiable by a black disk symbol the actual sampling process can begin START STOP Establishing a connection with a personal computer First of all the Bluetooth adapter included with the HYCON ID set needs to be installed on the PC together with the software provided To do this please follow the respective instructions in the operation manual In particular after the system has been rebooted it is important to ensure that a Bluetooth symbol appears at the bottom left hand corner of the desktop If this is not the case the program needs to be restarted via START Programs Bluetooth Ensure that a port larger than COM 4 has been chosen the first COM Ports are for actual serial interfaces The Bluetooth adapter must only be inserted into an US
38. ypes of barcodes and data matrix codes f 7 CD ES gt a 2 Biotest HYCON ID 1 0 Starting the sampling process with barcode scanning The disk symbol in the display always indicates that the sampling process does not start until all the information that has been stipulated in the HYCON ID menu has been transmitted to the RCS High Flow system with the help of the scanner see above If codes with identifiers have been chosen ON Mode the display shows all selected items of information Recognition of the code is followed by an acoustic signal after which the displayed information is ticked off as having been confirmed The order in which the information 5 entered is random If codes without identifiers have been chosen OFF Mode the display screen only shows the information that is to be scanned in In this context it is essential that the correct code is scanned in In this setting the device cannot identify whether the information is correct As soon as the information has been transmitted the next information request appears on the display lf prior to reading in a code without identifier an identifier is to be scanned in PRE Mode the process consists of two parts first you read in the relevant identifier and then you scan in the appropriate information taking care to indicate that the subsequent information belongs to the identifier because the device itself does not recognise this connection Th
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