Memmert CELSIUS 10 FDA Manual do Utilizador

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Página 1 - USER MANUAL

Benutzerhandbuch "CELSIUS 2007 FDA-Edition"Stand: 02.12.10 1USER MANUALCELSIUS 10Control software for MEMMERT appliances – FDA EditionValid

Página 2 - Manufacturer and

10CELSIUS 10 FDA-Edition2.1.2 Advanced FDA Edition functionsWithin a closed system this specially developed software meets the FDA requirements. The F

Página 3 - About this manual

11CELSIUS 10 FDA-Edition2.2 System RequirementsCategory Minimum system reqirementsProcessorPentium 1 GHzMain memory1 GBAvailable free space on hard dr

Página 4 - Storage and forwarding

12CELSIUS 10 FDA-Edition2.3 Supported MEMMERT ovens and parametersOven type ParametersTempera-tureHumidity Vacuum CO2O2Fan speed Servo air flapIncubat

Página 5

13CELSIUS 10 FDA-Edition3. Preparation and installationAlways first install CELSIUS before you connect an oven to your computer. The installation of C

Página 6 - 11. Index 59

14CELSIUS 10 FDA-Edition6. You are shown the License conditions for the use of the software in German and English. You must accept the license conditi

Página 7 - End user

15CELSIUS 10 FDA-Edition9. In the next window, select the programme components/drivers that should be installed:►Select "CELSIUS 10.0" if yo

Página 8

16CELSIUS 10 FDA-Edition12. Click on "Finish" to complete the installation. CELSIUS 10.0 and the selected drivers are now installed on your

Página 9 - Introduction

17CELSIUS 10 FDA-Edition4.2 Start screen and licence fileCELSIUS FDA Version can be started only with a valid licence file containing a list of equip

Página 10 - 21 CFR Part 11

18CELSIUS 10 FDA-Edition4.2.1 LanguageProgramme interface and menus can be displayed in five languages (German, English, Span-ish, French and Italian)

Página 11 - System Requirements

19CELSIUS 10 FDA-Edition"File" menuMenu itemSubmenu itemsQuick call via DescriptionSee pageNew Profi le–Creates a new tempering profile. A po

Página 12

Manufacturer andcustomer serviceMemmert GmbH + Co. KGWilli-Memmert-Straße 90–96D-91186 BüchenbachDeutschlandPhone: +49 (0)9122 925-0Fax: +49 (0)91

Página 13 - Preparation and installation

20CELSIUS 10 FDA-EditionMenu itemSubmenu itemsQuick call via DescriptionSee pageFrom External MemoryCardLoads log files from the MEMoryCard in the ext

Página 14

21CELSIUS 10 FDA-EditionMenu itemSubmenu itemsQuick call via DescriptionSee pageExitEnds CELSIUS. If the function "Save Settings on Exit" is

Página 15

22CELSIUS 10 FDA-EditionMenu itemQuick call via DescriptionSee pageZoom OutZooms out of the time range displayed in the graphical view. The largest ti

Página 16 - Programme description

23CELSIUS 10 FDA-EditionMenu itemQuick access via DescriptionSee pageSave Settings on ExitWhen this function is enabled, the allocation of interfaces

Página 17 - Start screen and

24CELSIUS 10 FDA-Edition"Window" menuMenu itemDescriptionCascadeArranges windows in overlapping formTileArranges windows next to each otherA

Página 18 - Menu bar

25CELSIUS 10 FDA-EditionItemFunctionDescriptionSee page5Save tempering profile to fileSaves the current tempering profile to a file356Save tempering p

Página 19 - "File" menu

26CELSIUS 10 FDA-Edition5. Establish CELSIUS users and manage user rightsThe FDA version of CELSIUS has its own user management. CELSIUS users must h

Página 20

27CELSIUS 10 FDA-EditionEvery user can have individual rights assigned to him for the use of CELSIUS FDA Edition:User right DescriptionRun CELSIUS FDA

Página 21 - Menu "View"

28CELSIUS 10 FDA-Edition6. Connect ovens and external devicesAlways install the software and necessary drivers (e.g. USB) first before connecting an o

Página 22 - Settings"

29CELSIUS 10 FDA-Edition6.2 Connect ovens with an RS-232 interfaceTo connect an oven with an RS-232 interface, a twisted RS-232 connection cable in ac

Página 23 - Menu „Security“

3CELSIUS 10 FDA-EditionAbout this manualIntended use and target groupThis user manual describes the installation and use of the MEMMERT control softwa

Página 24 - Menu "?"

30CELSIUS 10 FDA-Edition6.3.1 Setting the IP address of the oven with XTADMIN1. Connect the oven whose IP address you want to change with a standard n

Página 25

31CELSIUS 10 FDA-Edition6.4 Connecting an external card readerIf you want to connect an external card reader (can be acquired separately as an accesso

Página 26 - Establish

32CELSIUS 10 FDA-Edition7.2 Logging on an oven1. In the "Settings" menu, select the menu item "Log-on Device" or click in the too

Página 27

33CELSIUS 10 FDA-EditionFor ovens logged on offline, the desired device configuration must be specified in another dialog. The configuration dialog ap

Página 28 - Connect ovens and external

34CELSIUS 10 FDA-EditionWhat setting options are available depends on what oven type is used for a tempering profile. The setting options for individu

Página 29

35CELSIUS 10 FDA-EditionDepending on the oven type, additional oven-specific functions are available at the bot-tom of the graphics window, such as f

Página 30 - XT-NANO xxx

36CELSIUS 10 FDA-EditionIf a coordinate is created in a prohibited area or you want to move it to such an area, the mouse cursor turns into a no-entry

Página 31 - Logging on ovens

37CELSIUS 10 FDA-Edition ►loop:The tempering profile is repeated endlessly from the beginning, until the user ends the tempering profile. This command

Página 32 - Logging on an oven

38CELSIUS 10 FDA-Edition►Move the mouse cursor over the vertical axis in the temperature, humidity, pressure, CO2 or O2 windows. The mouse cursor turn

Página 33 - Working with CELSIUS

39CELSIUS 10 FDA-EditionWorking with Working with vacuum ovens VO in the graphical viewin the graphical viewWith vacuum ovens VO, the temperature and

Página 34 - Controller active

4CELSIUS 10 FDA-EditionOther documents that you must read:Please also read the user manual for the respective oven to be operated with the software an

Página 35

40CELSIUS 10 FDA-Edition8 9Timehh:mmPeriodhh:mmFlapTypeFanEdit Profile21 3 4 5 6 7Tabular View (example)1 Ramp segment No. ...2 Beginning of ramp seg

Página 36 - Ramp close statements

41CELSIUS 10 FDA-Edition8.1.6 Executing a tempering profileBefore a tempering profile is started, disable the screen saver and the energy-saving mode

Página 37

42CELSIUS 10 FDA-Edition8.1.7 Saving and loading tempering profilesIn order to prevent any alteration of files, CELSIUS FDA encrypts all profile and p

Página 38

43CELSIUS 10 FDA-Edition8.1.8 Printing a tempering profileIn order to print a tempering profile, click on or select "File or select "File→

Página 39

44CELSIUS 10 FDA-Edition8.2.2 Recording the actual progressionWhen a tempering profile is run, the actual values of the oven are displayed in the gra

Página 40 - Inserting and deleting lines

45CELSIUS 10 FDA-EditionLogging with Logging with vacuum ovens VOThe logged measured values for temperature and vacuum for vacuum ovens VO are entered

Página 41 - 1 2 3 4 5 6 7 89 10

46CELSIUS 10 FDA-Edition8.2.3 Saving and loading protocol data (*.pro) If the option "Create Log File" is enabled when a tempering profile i

Página 42

47CELSIUS 10 FDA-EditionAfter data have been read in, aselection dialog appears. Here you can select the period of time for which you would like to di

Página 43 - Protocol

48CELSIUS 10 FDA-Edition8.2.6 Export log data in tabular form (Report)With the report function, it is possible to print log data in tabular form or

Página 44 - Temperature

49CELSIUS 10 FDA-EditionA dialog window appears in which you can specify what is to be included in the report:2134567Report options and presentation a

Página 45 - Logging with

5CELSIUS 10 FDA-EditionContent1. End user licence agreement 72. Introduction 92.1 Description ...

Página 46

50CELSIUS 10 FDA-Edition8.3 Ending work with CELSIUS You can end work with CELSIUS ►via "File"→"Exit"►by closing the programme wi

Página 47 - Start Test #4

51CELSIUS 10 FDA-EditionTypical arrangement of an entry in the audit trail file: Typical arrangement of an entry in the audit trail file: Type Time st

Página 48

52CELSIUS 10 FDA-EditionExamples of successful authorization tests:Examples of successful authorization tests:Examples of denied authorization test an

Página 49

53CELSIUS 10 FDA-EditionElectronic signatures can not be deleted or overwritten as long as the file has not been altered. If a signed profile is alter

Página 50 - Ending work with CELSIUS

54CELSIUS 10 FDA-Edition10.3 Backup FolderIf you want verification of all changes to the temperature profiles and protocol files, it is possible to cr

Página 51

55CELSIUS 10 FDA-Edition10.3.1 Automatic backup of versions in the backup folderAs evidence for all alterations of temperature profiles and protocol d

Página 52 - Electronic signature

56CELSIUS 10 FDA-Edition10.6 Working with MEMoryCardMEMMERT ovens with P fittings are equipped MEMMERT ovens with P fittings are equipped MEMMERTwith

Página 53 - Settings and

57CELSIUS 10 FDA-Edition10.8 Programme languageThe programme and the menus can be displayed in five different languages. How you can change the langua

Página 54 - Backup Folder

58CELSIUS 10 FDA-Edition10.10 Deinstalling CELSIUS You must have administrator rights to be able to deinstall CELSIUS.If you want to remove CELSIUS fr

Página 55 - 13:24:00 Uhr

59CELSIUS 10 FDA-Edition11. Index21 CFR Part 11 10*.bin file 19, 47, 54*.cel file 54*.pro file 16, 19, 20, 25, 43, 46, 54AAdditional functions 35

Página 56

6CELSIUS 10 FDA-Edition8.2 Protocol ...

Página 57 - Connection details

60CELSIUS 10 FDA-EditionProgramme shortcuts 14Protocol 23, 25, 43, 46, 47Protocol file 16, 19, 20, 25, 41, 46, 47, 56Protocol files 47, 54RRamp cl

Página 61

Memmert GmbH + Co KG | PO Box 1720 | D-91107 Schwabach, Germany | Tel. +49 (0) 9122-925-0 | Fax +49 (0) 9122-145-85 | Email: [email protected] | www

Página 62

7CELSIUS 10 FDA-Edition1. End user licence agreementNOTE - IMPORTANT - PLEASE READ THE FOLLOWING AGREEMENT TEXT CAREFULLYThis end user licence agreeme

Página 63

8CELSIUS 10 FDA-EditionMEMMERT GmbH & Co.KG accepts no responsibility for errors, faults or damage which result from incorrect operation, use of u

Página 64 - 18.09.2013

9CELSIUS 10 FDA-Edition§8 - CHOICE OF LAWAll legal relations between the parties, including delict law, are subject to the law of the Ger-man Republic

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