AtmoCONTROL FDA Edition Validatable in according to 21CFR Part 11 U. S. Food and Drug Administration Version 2.X.X SOFTWARE MANUAL 100% ATMOSAFE. MADE IN GERMANY. www.memmert.com | www.atmosafe.
Manufacturer and customer service Memmert GmbH + Co. KG Willi-Memmert-Straße 90–96 D-91186 Büchenbach Deutschland/Germany Phone: +49 (0)9122 925-0 Fax: +49 (0)9122 14585 E-mail: sales@memmert.com Internet: www.memmert.com Customer service: Service hotline: +49 (0)9171 9792 911 Service fax: +49 (0)9171 9792 979 E-mail: service@memmert.com © 2014 MEMMERT GmbH + Co.
AtmoCONTROL FDA Version About this manual Purpose and target group This user manual describes the installation and use of the MEMMERT programming software AtmoCONTROL. It is intended for use by trained personnel of the operator, who have the task of programming/operating MEMMERT appliances. If you intend to work with the software, please read this manual carefully before starting. Familiarise yourself with the software and simulate various tests before transferring programmes to the appliance.
AtmoCONTROL FDA Version Contents 1. End user licence agreement 6 2. Introduction 8 2.1 2.2 2.3 Description........................................................................................................................... 8 Supported MEMMERT appliances and parameters ............................................................ 8 Advanced functions of the AtmoCONTROL FDA version .................................................... 9 3. Installation 3.1 3.2 System requirements ............
AtmoCONTROL FDA Version 6. Protocol 6.1 6.2 6.3 Importing protocol from network .................................................................................... 30 Importing protocol from USB data medium..................................................................... 30 Exporting protocol............................................................................................................. 31 30 7. Printing 31 8. Options 31 8.1 8.2 8.2.1 8.2.2 8.3 8.4 Language ...................
AtmoCONTROL FDA Version 1. End user licence agreement NOTE - IMPORTANT - PLEASE READ THE FOLLOWING AGREEMENT TEXT CAREFULLY This end user licence agreement forms a legally binding agreement between you, whether a natural or a legal person, and MEMMERT GmbH & Co.KG. This licence agreement bindingly regulates the use of software licences of MEMMERT GmbH & Co.KG. The software licence may include also pertinent media and printed material as well as in online or electronic format (“software licence“).
AtmoCONTROL FDA Version The user must employ the SOFTWARE PRODUCT only for his own purpose unless expressly agreed otherwise. The user must notify MEMMERT GmbH & Co.KG without delay of any faults which occur, together with a brief description of the fault. §4 - RESTRICTED WARRANTY MEMMERT GmbH & Co.KG warrants for a period of 1 year that the data medium on which the SOFTWARE PRODUCT is supplied, is free from material faults and manufacturing faults.
AtmoCONTROL FDA Version 2) If one or several of the above terms should be or become invalid, this does not affect the effectiveness of the other terms. The invalid term is to be replaced by a valid term which as far as possible realizes the intended commercial purpose This also applies in case of a gap in the agreement. 3) This agreement is subject to the law of the German Republic. Legal domicile is the domicile of the licensor.
AtmoCONTROL FDA Version 2.3 Advanced functions of the AtmoCONTROL FDA version Within a closed system, this specially developed software meets the requirements of the Food and Drug Administration (FDA).
AtmoCONTROL FDA Version 3. Installation 3.1 System requirements Category Minimum system requirements Processor Pentium 1 GHz Main memory 1 GB Available free space on hard drive 4 GB Graphics VGA graphics and colour monitor Interfaces an available USB or Ethernet interface Operating system Windows 7, Windows 8 Software PDF Reader to display the help menu In addition, all signed in users must have write access to the directory C:\ProgramData\Memmert. 3.
AtmoCONTROL FDA Version When starting AtmoCONTROL FDA, you have to login as AtmoCONTROL user with your user name and password. Users are created and managed by the AtmoCONTROL administrator (see page 33). If unencrypted data of a previously installed version of AtmoCONTROL other than the FDA edition are detected when you start AtmoCONTROL FDA for the first time, you are asked whether these data should be encrypted. This is required for compliance with the FDA requirements.
AtmoCONTROL FDA Version 4.2.1 Menu bar Device 1 2 3 4 5 1 2 3 4 5 6 7 8 9 Program Connect online via Ethernet Connect offline from USB device Connect offline from database Disconnect device Disconnect all devices 6 7 8 9 10 11 Protocol New Load Save Save As...
AtmoCONTROL FDA Version 4.2.3 Status bar The status bar gives an overview of the appliances logged on to AtmoCONTROL. Appliances can be added and removed again. If the appliance is connected to the computer via Ethernet and it has already been logged on once, it is automatically recognised and the current operating state (temperature, alarms) is displayed (Fig. 1). 1 2 UF 260plus Laboratory 180.0°C i 3 4 Fig.
AtmoCONTROL FDA Version 4.3.2 Via Ethernet with AtmoCONTROL 1. Click on “Help”“Upload license file to device”. 2. In the window now opening, select the licence file (*.lic) and click “OK”. 3. Enter the IP address of the appliance you want to transfer the licence to. A description of how to set the IP address is provided in the user manual of the corresponding appliance. 4. Click on “Upload” to start transferring the licence.
AtmoCONTROL FDA Version 4.4.3 Connecting a device using database file 1. Click on DeviceConnect offline from database. 2. A window opens, in which you can open the device database file of the (*.atdb or *.atdbx) type. 4.4.4 Log file If a device is added – no matter whether this is done using a USB stick or via Ethernet – the log file Log.
AtmoCONTROL FDA Version 5. Programme 5.1 Editor window 5.1.1 Overview In the Editor window, programmes can be created: sequences of various parameters (e.g. temperature, pressure and humidity), which the appliance then implements from a definable point in time. To be able to create a programme in AtmoCONTROL, the appliance which is to perform the programme must be listed in the status bar and selected (clicked on). The appliance can, but does not have to, be connected to the computer via the network.
AtmoCONTROL FDA Version To create a programme, drag the individual parameter icons onto the editor thread one after another in the desired order, while holding down the left mouse button (Fig. 3 and Fig. 4). To assist the correct positioning, a red insertion mark is displayed at the insertion position. With the zoom icons in the toolbar list (see section 4.2.2 on page 12) or with the mouse wheel, you can zoom in or out of the display or have the entire programme displayed. Ramp 05 21.
AtmoCONTROL FDA Version 5.1.3 Setting parameters If a parameter icon is selected (clicked) on an editor thread, it is displayed with an orange frame. The adjustable values – in the example on the right, the ramp name, the duration of the ramp and the setpoint temperature – have a grey background. To adjust values, click successively on the corresponding fields – in the example on the right, the setpoint temperature.
AtmoCONTROL FDA Version Broad parameter representation Depiction in Meanicon bar ing Depiction on editor thread Function and adjustment options Function Maintains a set temperature for a specific time.
AtmoCONTROL FDA Version Depiction in Meanicon bar ing Depiction on editor thread Function and adjustment options Function 2 h:30 m Increase Change humidity + 5.0 %rh - 5.0 %rh ? on 40.7 %rh hold p Hold pressure Tolerance band 70.
AtmoCONTROL FDA Version Narrow parameter representation With the narrow parameter representation, no time progression can be set, in contrast to broad parameter representation. The setting made immediately becomes active at the respective position – and remains active until it is changed by the insertion of a new parameter icon of the same type. Depiction Meaning in icon bar Depiction on editor thread CO 2 50% ? 2 CO 15 0 Adjustment options/ comments 0 to 20 percent For a setpoint ≠ 0.
AtmoCONTROL FDA Version Depiction Meaning in icon bar Depiction on editor thread Adjustment options: open/close Close/open door at the position in the programme at which the icon was inserted.
5 AtmoCONTROL FDA Version Depiction Meaning in icon bar Depiction on editor thread JUMP TARGET STAND BY 15 LOOP Loop 4X Adjustment options/ comments The programme jumps back from the insertion position to a position that can be freely selected and repeats the sequence between n times (adjustable). When inserting a loop function, an icon for the jump target is automatically inserted at the programme start. Holding the mouse key down, move it to the beginning of the range that is to be repeated.
AtmoCONTROL FDA Version 5.2 Simulating the programme sequence (preview) While creating the programme, you can display the prospective progression of all parameters as a diagram at any time. To do this, click on "Simulation" (Fig. 7). Depending on the complexity of the programme, it may take a few seconds for the simulation to be calculated and displayed. Fig.
AtmoCONTROL FDA Version 5.3.3 Transferring programme via Ethernet To be able to transfer a programme via Ethernet, the appliance and computer must be connected via Ethernet, the correct IP address set (see page 13) and the appliance switched on. Click ProgramUpload to device. The programme is uploaded to the appliance and can be started there. 5.3.4 Transferring a programme via USB storage medium 1. Click ProgramExport to USB drive. The programme is saved on the USB storage medium connected. 2.
AtmoCONTROL FDA Version 5.4 Programme examples For reasons of space, it is not possible to present programme examples with all the available parameters for all MEMMERT appliances here. Instead, a number of simple example programmes will be presented to familiarise you with how a programme is structured. Caution: It is important that you run through a number of programme examples to get to know AtmoCONTROL before you actually transfer and run programmes on the appliance. 5.4.
AtmoCONTROL FDA Version 5.4.2 Programme example with door locking 3 4 Tolerance band 1,7 K/min 1 2 1 6 6 3 95 °C 45 °C 7 8 5 5 2 20 °C 12:00 h ≥ 0:30 h Fig. 9 The door is locked at the beginning of the programme (1). Then, the appliance heats up to 95.0 °C C (2) and maintains this temperature for 12 hours (3). Subsequently, the temperature is lowered (5) for 30 minutes (4) to 45.0 °C C and then, the door is opened (6).
AtmoCONTROL FDA Version 5.4.3 Programme example sterilisation 4 6 Tolerance band 1 0% 2 3 1 100 % 100 % 0 % 6 180 °C 5 0% 2 4 7 3 20 °C 3:00 h Fig. 10 At the beginning, the fan is switched on to 100 % (1) and the air flap is closed (0 %) (2). Then, the appliance heats up to 180.0 °C C (3) and maintains this temperature for 3 hours (4).
AtmoCONTROL FDA Version 5.4.4 Programme example loop 1 4 Unload 7 2 3 3 5 6 8 9 6 0% 80% 0% 80% 0% 80% 0% 80% 0% 80% 0% 80% 0% 80% 0% 80% 0% 80% 0% 80% 0% 80% 0% 250 °C 2 5 1h 1h 1 4 20 °C 1h 1h 1h 1h 1h 1h 1h 1h 1h 1h 1h 1h 1h 1h 1h 1h 1h 1h 1h 1h 8 Fig. 11 First, the appliance heats up to 250.0 °C (2) for one hour (1). Then, the fan begins to run at 80 % power (3) and the temperature is lowered for one hour (4) to 20.0 °C (5). Subsequently, the fan is switched off (6).
AtmoCONTROL FDA Version 6. Protocol 6.1 Importing protocol from network To be able to import a protocol via network, the appliance and computer must be connected to the network, the correct IP address set (see page 13) and the appliance switched on and logged in to AtmoCONTROL. Click on the "Protocol" button (Fig. 12); the protocol data of the appliance are transferred and displayed and can be further processed – e.g. exported to a spreadsheet file format (see Section 6.3). Fig.
AtmoCONTROL FDA Version 6.3 Exporting protocol With Protocolexport, you can export a freely definable protocol logging period into a file of the types *.csv or *.xlsx (Excel), which can be processed in spreadsheet programmes (Fig. 13). 7. Printing With the "Print" function, you can print out programmes in the editor window, as well as simulations and protocols – depending on what is currently displayed. 8. Options 8.
AtmoCONTROL FDA Version 8.2.2 Use 1. Insert the USER-ID USB stick with the USER-ID file into the computer with AtmoCONTROL. 2. In the Options menu bar, click on USER-ID. 3. A window appears with the functions of the logged on appliance that can be blocked (depending on the appliance type). 4. Click on the lock icon next to the functions that should be blocked or released, and confirm this with OK. 5. Eject and remove the USER-ID USB stick, insert it in the appliance and activate.
AtmoCONTROL FDA Version 8.4 Backup folder You can set up a backup folder in which AtmoCONTROL saves backup copies of programmes and user data. To do so, click on “Options””Edit Backup Folder”. You can either use the default folder or select a different one. 9. FDA functions (menu item “Security”) 9.1 Adding and deleting users and manage user rights The FDA version of AtmoCONTROL comprises an own user management, which is independent of Windows.
AtmoCONTROL FDA Version Here, you can: ► add new users ► change existing user passwords ► assign and remove user rights ► remove users The user management can only be accessed by users the administrator has assigned the right to do so. 9.2 Changing the user password and user Via the menu item “Security”→”Change password”, the user currently logged in can change his/her password. Via the menu item “Security”→”Change user”, a different user than the one currently logged in can log on.
AtmoCONTROL FDA Version 9.4 Traceability by means of a protected audit trail file All actions performed in AtmoCONTROL FDA are saved in an encrypted file and can be displayed in HTML format in your internet browser (audit trail). The time span to be displayed can be defined using two calendars. The audit trail function can be accessed via the menu item “Security”→”Audit trail”. All important functions and activities are saved in the audit trail.
AtmoCONTROL FDA Version 10. Event codes of the log file Log.txt (see page 15) Error codes for Generation 2012 appliances Status: October 09, 2012 In case of a hardware error of the oven, the controller displays the following error codes in a status / error window, as well as logs them in the “Log.txt” file in the “Config” directory on the SD card. The position of the error number further specifies the position of the error.
AtmoCONTROL FDA Version 306: Comm Err 401: Humidity Sensor 402: Humidity Min Al 403: Humidity Max Al 404: Water tank empty 405: Temp Sensor Defunct 406: Sensor Alarm 407: Temp Min Alarm 408: Temp Max Alarm 409: Temp Auto Alarm 410: Lights Off 501: Sensor CO2 Error 502: CO2 Empty 503: CO2 Auto Switch 504: CO2 Min Alarm 505: CO2 Max Alarm 506: Sensor O2 Error 507: N2 Empty 508: O2 Min Alarm 509: O2 Max Alarm 601: Vacuum Sensor Error 602: No Shelf 603: Vacuum Min Alarm 604: Vacuum Max Alarm 700: Power Min Bor
AtmoCONTROL FDA Version Index 21 CFR Part 11 9 A Air flap position 21 B Backupverzeichnis 33 Benutzer wechseln 12 C Calendar 22 CFR Part 11 9 Change humidity 20 Change temperature 19 Clock timer 22, 26 Closing door 22 CO2 21 Creating a programme 16 Customer service 2 D Database file 15 Defrost 22 Device licence 13 Disconnecting a device 15 Door locking 27 E Editor threads 16 Editor window 16 email 32 Enlarge view 12 Ethernet interface 8 Exporting protocol 31 F Fan speed 21 FDA-Funktionen 33 Fold down
AtmoCONTROL D30396 | Date 09/2014 englisch Memmert GmbH + Co. KG Willi-Memmert-Straße 90-96 | D-91186 Büchenbach Tel. +49 9122 925-0 | Fax +49 9122 14585 E-Mail: sales@memmert.com facebook.com/memmert.family Die Experten-Plattform: www.atmosafe.
