MAS-100 NT® Microbiological Air SamplerMAS-100 NT® Microbiological Air Sampler (Firmware ≥ V1.4)MAS-100 NT® Microbiological Air Sampler: The Leading Microbial Air Monitoring SystemsIndex1Warning notices 4 1.1Operating the MAS-100 NT®4 1.2Environmental Conditions 4 1.3Warranty 4 1.4Malfunction of Instrument 4 2Introduction 5 2.1General Description 5 2.2Description of the MAS-100 NT®5 2.3Sampling Head 6 2.4Communication 6 2.5Programming the MAS-100 NT®6 2.6PC software MAS-100 NT® Portable Air Sampler C&C 6 3Firmware update MAS-100 NT®7 3.1Installation USB Driver on Windows Systems 10 4Basic Principle 11 5Most Important Advantages of the MAS-100 NT®12 5.1Comparison old MAS-100® with new MAS-100 NT®13 6First Time Use of MAS-100 NT®14 6.1Adjusting Sampling Plates on the MAS-100 NT®14 6.2Adjusting Petri dish 14 6.3Adjusting Contact plates 15 6.4Mounting to a Tripod 15 6.5New: SQS- Sequential Air Sampling 16 7General Functions 17 7.1Overview 17 7.2Control interface 17 7.3First Time Use of MAS-100 NT® = Activation of Calibration Reminder 18 7.4Message on display if calibration reminder is activated 18 7.5Switching ON and OFF the MAS-100 NT®19 7.6Charging the MAS-100 NT®19 7.7Intro Screens 19 8Operation 20 8.1Standard Mode MAS-100 NT® (STD) or Sequential Sampling Mode (SQS) 20 8.2Manual or Template Mode 20 8.3Working with Templates 21 8.4Example of Protocol Created by the Software 22 8.5Template Data 23 8.6Process Settings 23 8.7Standard or SQS Sampling Mode 24 8.8Change the Sampling Volume 24 8.9Working with the SQS or Sequential Sampling Mode 24 9Menu Settings 25 9.1Shut Down 25 9.2Mode Selection 25 9.3Template Data 26 9.4Process Settings: 26 9.5Standard Volumes 26 9.6Delay Data 26 9.7User Selection 27 9.8Print Settings 27 9.9Sample Log 27 9.10Alarm Log 28 9.11Config Device 28 9.12Time and Date 289.16System Info 29 10Printer Configuration 30 10.1General procedure of the printer configuration for MAS-100 NT Air Samplers 30 10.2Printer Epson TM-U220D 30 10.3Samsung Bixolon-275AG 30 10.4Other printer 30 10.5Manual input of the printer without SW 31 10.6MAS-100 NT online printing activation 31 11Cleaning and disinfection of MAS-100 NT® air sampler 32 11.1Air sampler housing 32 11.2Sampling head 32 11.3Inner parts of the air sampler 32 11.4Use of gases for disinfection 32 12Adjustment of Flow Sensor or Calibration of instrument 33 12.1Definition of Adjustment and Calibration 33 13Alarm ID and Description 33 13.1Alarm ID’s33 14Block Manual Interventions on the MAS-100 NT®34 15Interpreting the Results 34 15.1Feller Conversion Table for Sampling Head with 300 Holes 35 15.2Feller Conversion Table for Sampling Head with 400 Holes 36 16Technical Specifications 37 16.1Environmental Conditions 38 17Calibration Certificates 38 17.1Particle emission of MAS-100 NT®39 18Components Checklist 40 19Care and Maintenance 40 20Warranty 40 21CE-Conformity Certificate 41 22Revision History 421Warning notices1.1Operating the MAS-100 NT ®Read all instruction carefully before operating the instrument. The MAS-100 NT ®must be operated by specialized laboratory people only. They have to be aware and trained to work with laboratory instruments.1.2 Environmental ConditionsPlease read the instructions in chapter 16.11.3 WarrantyOnly special trained people certified by the manufacturer (MBV AG, Switzerland) are allowed to service the instrument. Instruments which have the seal destroyed will lose their warranty immediately.1.4 Malfunction of InstrumentIf the instrument doesn’t work according to this instruction manual please send it back to the manufacturer immediately.2 IntroductionMicro-organisms in the air are a potential risk for contaminating raw materials, semi-finished or end products and processes. Therefore the control of the contamination in the air is very important. The following industries are performing air monitoring as a standard procedure:∙pharmaceutical industry∙food industry∙hospitals∙cosmetics industry∙environment2.1 General DescriptionAccording to “The Rules Governing Medicinal Products1” and the International StandardISO 14698-1/22, the air must be analyzed for the presence of micro organisms.The new MAS-100 NT® is a new designed unit for microbiological air monitoring. The microbiological sampling is based on the well known and as standard method established impaction principle3. It works like all other MAS-Systems with standard 90mm Petri dishes or with the adapter for contact plates. The MAS-100 NT® is a further development of the standard MAS-1004 system.The major advantages are the compact design, the improved security features and the enhanced connection possibilities. The new sampler is very easy to handle. Hard- and software have been developed according to GAMP 45. The total system is fully validated. Improved communication likeRS-232, USB, are available. All functions and parameters as well as the calibration procedure may be done with the new MAS-100 NT® calibration and communication-software. They may also be programmed directly on the unit. A big display on the unit allows the selection of all relevant factors. An alarm- and sample-log records the last 100 events and may be exported or printed at any time. As in other MAS-Systems the mass flow is measured and guarantees a flow of 100 liters/min.The MAS-100 NT® is validated according to the EN ISO 14698 standard.2.2 Description of the MAS-100 NT®The MAS-100 NT® is an improved version of the MAS-100. Improved electronic communication features, validated software, easy and automatic calibration and added safety feature makes this air sampler unique. The impaction speed was also improved and the system is now delivered with a sampling head of 300 x 0.6mm holes. All parameters are controlled and changed from the software or may be programmed directly on the unit.Note: The MAS-100 NT® air sampler has been developed according toGAMP 4. The Soft- and Firmware are validated.1 The Rules Governing Medicinal Products In The European Community Vol. IV: Guide to Good Manufacturing practice for medicinal products, 1992072 ISO EN 14698-1 and 2 Clean rooms and associated controlled environments- Biocontamination control Part 1 and Part 2 (Ref. Number: ISO 14698 -1:2003(E))3 New Sampler for the Collection, Sizing, and Enumeration of Viable Airborne Particles, A. Andersen, U.S. Army Chemical Corps Proving Groung, Dugway, Utha., 19584 MAS-100, Qualification of air sampler systems: The MAS-100, Meier R. und Zingre H., (Swiss Pharma 1-2/00)2.3 Sampling HeadThe new (300 holes x 0.6mm) sampling head is specially designed for standard Petri dishes and improved impaction speed. The sampling heads are exchangeable.You can use either the 300 x 0.6mm or if you wish to continue using the 400 x 0.7mm lid. Please make sure that you select the appropriate lid in the Menu Device Info (9.15)New 300 x 0.6mm Sampling head (perforated lid) Anodized in blue Impaction speed <20m/sOld 400 x 0.7mm Sampling head (perforated lid) Anodized silver Impaction speed <11m/s2.4 CommunicationUp-to-date communication: USB, RS-232 with other systems (PC, Printer; DA-100 NT).2.5Programming the MAS-100 NT ®All functions may be programmed over the display or over the MAS-100 NT ®Software delivered with each system. This Manual will describe mainly the programming over the display. For more information on software programming, please consult software manual.2.6PC software MAS-100 NT ® Portable Air Sampler C&CThe “MAS-100 NT ®Portable Air Sampler C&C ” is a new validated communication and calibration software. It is delivered with the system. The software permits to select between 5 different accesslevels to set, read and program individual parameters in the MAS-100 NT ®(operating under Windows 2000 or higher)A special calibration menu with the possibility of fully automatic calibration (adjustment of flow sensor,calibration of MAS-100 NT ®and printing calibration certificate) is available.A new alarm- and sample-log file is implemented and stores 100 events of each type. The logs may be printed or exported into Excel.Note: The previous sampling head (400 x 0.7mm) is still available on demand Note: See MBV website (www.mbv.ch ) for latest software versions. Note: See MBV website (www.mbv.ch ) for latest software versions. Note: The MAS-100 NT ®is validated to ISO 14698-1 and -2, 2003/093 Firmware update MAS-100 NT®Download tool needed: Tool software on MBV website www.mbv.chBefore updating the Firmware on the MAS-100 NT® the latest PC Software needs to bedownloaded and installed. The windows drivers for communication with the MAS-100 NT® are included in the PC Software. The drivers are installed automatically after the PC software isinstalled and the MAS-100 NT® is connected to the PC via USB for the first time. After installation of the drivers, the PC Software needs to be closed.If you encounter problems with installation of the drivers, please read chapter 3.1.1. Go to MBV website – Software MAS-100 NT2. Download latest Firmware Download Tool V12xx.zip3. When asked, download or open the zip-file (in Win XP, follow the instructions of theAssistant, in Win 7, Explorer-window will open with the “Download_MBV_V12xx.exe”)4. Download latest Firmware Update V 1.x and safe the zip-file to your favourite folder5. Extract the Firmware Update V 1.x in your favourite folder. This will be a file named: “MBVMAS-100 NT, V1.x (15).Tim”6. Execute the “Download_MBV_V12xx.exe”-file (the PC- Software needs to be closed)7. Accept the Security Warning and execute8. Firmware Download Wizard is opened9. In the Firmware Download Wizard choose “Select File”10. Select the file “MBV MAS-100 NT, V1.x (15).Tim” from your favourite folder11. Press next; Switch on the MAS-100 NT® while holding the ON-Button until successfulmessage appears12. Press button Start download, the loaded firmware will be downloaded to the MAS-100 NT®.Do not interrupt the Download Process!13. Download should be successful. If not, shut down device and restart procedure.14. Disconnect the MAS-100 NT® from the USB port of your PC and restart yourMAS-100 NT® device, use the scroll down button and go to System Info15. Press select, and have a look to the line SW Version – Firmware update was successful ifthe downloaded Firmware-Version 1.x is written into System infoNote: A detailed view of the Firmware Update follows on the next pages.1. Start the Firmware Download Utility (Wizard)2. Press Select File / Select the file “MBV MAS-100 NT, V1.x (15).Tim” from your hard disk3. Press Next4. Switch on the MAS-100 NT®5. Press button Start download, the loaded Firmware will be downloaded to the MAS-100 NT®6. Do not interrupt the download process!7. Download successful. The device is automatically shut down. Exit Wizard.8. Disconnect the MAS-100 NT® from the USB port of your PC and restart the MAS-100 NT®, use the scroll down button and go to System Info9. Press select, and have a look to the line SW Version – Firmware update was successful if the downloaded Firmware-Version 1.x is written into System infoNote: See MBV website (www.mbv.ch) for latest Software and Firmware Versions.3.1 Installation USB Driver on Windows SystemsThe needed drivers are installed automatically after the PC software is installed and the MAS-100 is connected to the PC via USB for the first time. If not, go to System, Hardware Manager; under theUSB-Controller section, choose the “FTDI FT8U2XX Device” to update the driver manually. Choose the automatic search function. If you need to install manually, read the following instructions.1. On the first screen of the wizard, select checkbox: “No, not this time” to avoid searching for asuitable driver and press next2. On the second scree n of the wizard select checkbox “Install from a list or specified location(Advanced)” and press next3. On the third screen of the wizard set the checkbox “include this locat ion in the search:” andselect the subdirectory “Driver FTDXX” of the location where you installed the MAS-100 NTPortable Air Sampler software (in most cases in C:\Program Files\MBV\MAS-100 NTPortable\Driver FTDXX) and press next4. Windows will start to install the driver and shows a warning message (Windows Logo TestWarning)MBV tested the driver thoroughly and did not find any risk of impairing or destabilizing the Windows operating system and therefore recommends pressing the button 'Continue Anyway' to continue installation of the driver.5. Now the device driver FDTI FT8U2XX is being installed6. When the installation of the driver has finished successfully, Windows shows the followingmessage: “Completing the Found New Hardware Wizard”.Press “Finish”- Button7. The USB driver is now installed and the MAS-100 Portable Air Sampler software ready to use4 Basic PrincipleThe MAS-100 NT® is a high-performance instrument that is based on the principle of the Andersen air sampler (see 2.1), which aspirates air through a perforated plate. The resultant airflow is directed onto a standard agar poured plate. After the collection cycle, the Petri dish is incubated and the colony forming units (CFU) are counted. The MAS-100 NT® operates with a high-performance suction device, and the aspirated volume is continuously monitored. The system measures the inflow of air and regulates the aspirated volume to a constant value of 100 Standard6 liters per minute.The MAS-100 NT® automatically regulates this volume according to pressure and temperature so that it gives comparable results all the time. For measurement in pharmaceutical industry the recommended sampling volume – according to international guidelines – should be 1000 liters.6 Standard Liter = volume at 1013.25 mbar and 20°C Air inlet Petri dish Anemometer BlowerAir outlet5 Most Important Advantages of the MAS-100 NT®∙new: illuminated easy navigation display∙new: multi lingual, implemented languages, English, French and German (other languages on demand) (Spanish in preparation)∙new: automatic calibration cycle and automatic printing of calibration certificate∙new: validated hard and software (up to 100 tests programmable)∙new: validation documents according to ISO 14698∙new: data logging for sample and alarms∙new: USB communication for error-free results and automatic record-keeping∙new: long live Lithium-ions rechargeable batteries∙new: improved design∙calibration reminder∙Adapter-Kit for RODAC-Plates (6.3)∙SQS-Cycle (see point 6.5) may be selected. If this cycle is activated, the desired volume may be split up to 50 sequences over a period of total 24 hours∙anemometer for mass flow control∙indication of low airflow∙real time clock and calendar∙compact and easy to use∙easy and automatic adjustment and calibration∙adjustable for different Petri dish sizes∙battery operation∙Full recharge time approx. 3.5 hours∙Total running time approx. 5.5 hours∙Total aspiration approx. 33000 litres∙according to international Guidelines: Isokinetic measurement, 0.45 m/sec, 100 litres/minute∙sampling volume adjustable from 1 – 2000 litres5.1 Comparison old MAS-100® with new MAS-100 NT®400 x 0,7mm Sampling head 300 x 0,6mm Sampling head(400 x 0.7mm Sampling head onrequest)32 characters LCD display Graphic illuminated displayyes - no navigation Menu guided navigation with upand down arrow and directmenu selection buttonsMenu in English Menu in English, French,German, Spanish, Polish,Czech, Italian and Portuguese RS-232 communication USB communicationSoftware Improved Software withWindows login and reporting6 First Time Use of MAS-100 NT®If the MAS-100 NT®is used for the first time or after a calibration the “calibration reminder" has to be set. (see 7.3)6.1 Adjusting Sampling Plates on the MAS-100 NT®Before using the MAS-100 NT® for the fist time you will need to adjust the Petri dish support.6.2 Adjusting Petri dishLift off the perforated lid and place a Petri dish on the dish support. Use a 3 mm Allen key to adjust the three blue jaws until the Petri dish is securely supported and there is no clearance (see picture). Check that the Petri dish is properly supported by turning the sampling head to the horizontal position. The Petri dish support is now adjusted. The procedure need only be repeated if you change Petri dish manufacturer.Note: Do not over-tighten the blue jaws. If you do, the Petri dish may break andshed plastic debris in the aspiration unit and block the motor.6.3 Adjusting Contact platesNew: The MAS-100 NT ®may be used with commercially available contact plates. The use of a special Adapter No. 1.09214.0001 and Sampling head N0. 1.09213.0001 is necessary.∙ Take the Allen key and exchange the 3existing blue jaws by removing the Allenscrews and replace with the 3 new blue jaws.∙ Place the positioning template and mark thecentre (see picture) with a marker pen.∙ Remove the positioning template and put theAdapter ring as shown in the picture bellow.∙ Put the contact plate in the adaptor andtighten the 3 Allen screws. The marked point should be in the centre of the contact plate as shown in the picture.Note:∙ Tighten the blue jaws and make sure that thestainless steel adapter holds firmly.6.4Mounting to a TripodThe MAS-100 NT ®may be used with a Tripod. The Tripod and the special “quick -change adapter” are available from your supplier.6.5New: SQS- Sequential Air Sampling 7A newly developed control system allows a measurement with the MAS-100 NT ®over a prolonged time with a single agar plate. Hereby, without any microbial loss, up to 50 air samples can be accumulated on the same Petri dish over a period of several hours.The main advantage of this method is that the risk of secondary contamination by the operators during the exchange of plates is reduced to a minimum. This is very important for ambient air monitoring in sterile zones. In addition, by collecting sequential samples over a prolonged period of time the randomization is improved and thus a more reliable result obtained. Moreover, instead of several 90mm standard Petri dishes, only one dish has to be evaluated, thus reducing the expenditure on equipment and labor.Illustration of a sequence7SQS-Sequential air sampling; Validation of the microbial count in the air using the MAS-100; Swiss Pharma 26 (2004) No.11, 9-11Time1. s a m p l i n gp a u s e2. s a m p l i n gp a u s e3. s a m p l i n gp a u s e4. s a m p l i n gp a u s e5. s a m p l i n gp a u s e6. s a m p l i n gp a u s e7. s a m p l i n gp a u s e8. s a m p l i n gp a u s e9. s a m p l i n gp a u s e10. s a m p l i n g24. m i n48. m i n72. m i n96. m i n120. m i n144. m i n168. m i n192. m i n216. m i n240. m i n7 General Functions7.1 OverviewThe MAS-100 NT® has built-in multilingual dialogue software. To navigate through the graphic display just follow the proposals indicated on the screen. There are four buttons, two underneath the screen for accepting the proposed action and the arrows at the right side of the screen to navigate up and down the screen.7.2 Control interfaceThe MAS-100 NT® has an illuminated graphic display. Follow the text on the screen by pressing the button [3], [4] or the arrow keys [1], [2] to choose a mode or select values.The top line shows date, time and the status of the battery.To start the instrument, press the left down button (4) for about 2 seconds. The blue diode will light up.142 37.3 First Time Use of MAS-100 NT® = Activation of Calibration ReminderThe MAS-100 NT® has a built-in calibration reminder. If theMAS-100 NT® is used the first time a screen comes up with the questionof setting the time you want to be reminded that the instrument should berecalibrated. The manufacturer recommends recalibrating the instrumentat least once a year. Choose a value from 1 to 12 months. 0 means, thatthe reminder is disabled.Accept by pressing OK. With Back the first screen is displayed again.After activation, fill in the calibration certificate with the date on which theinstrument was first used and the date for recalibration.Please configure instrument to your specification (e.g. language, date format, etc.)see config device 9.117.4 Message on display if calibration reminder is activatedIf the calibration reminder is activated the MAS-100 NT® will display aWarning before each run: Recalibration needed!The MAS-100 NT® can still be operated. Recalibration should beperformed as soon as possible.If the calibration reminder is activated and in the PC software“Block measurement if calibration validity expired” box is activated it isnot possible to start a sampling. An Alarm: “Recalibration needed!” is displayed on the MAS-100 NT®. To be able to continue it is compulsory to calibrate the instrument. Software setting in the Adjustment / Calibration MenuNote: The manufacturer suggests setting the calibration reminder for 12months from first switch on.Note: You have to select a figure and press the “A ccept” button in order toinitialize the instrument. If you press “not accept” the MAS-100 NT® willnot work!Note: Adjustment and Calibration should performed only by either authorizedpersonnel or authorized service center using DA-100 or DA-100 NT.MAS-100 NT7.5Switching ON and OFF the MAS-100 NT ®To switch on the MAS-100 NT ®press the left button (4) under the screen for about 2 seconds until the blue LED (run) lights up. The program will start.To switch off press “Menu” select “Shut Down” and press “select” again and press the “ok” button for the question “Shut down device?” If no further manipulations are made on the Instrument and no run is started, the instrument will switch off automatically after 5 minutes.Connect the charger to the power and to the MAS-100 NT ®,the instrument will switch on automatically and can’t be shut down.7.6Charging the MAS-100 NT ®The MAS-100 NT ®has to be charged before first time use. The battery sign is fully black when fully loaded. With decreasing battery capacity the battery becomes transparent.If the transparency reaches ¾ of the battery it should be recharged.Connect the charger to the power and to the MAS-100 NT ®. Make sure that the red point of the charging plug matches the black point of the handle. See picture.The MAS-100 NT ®wi ll switch on automatically and can’t be shut down. Shut down function is disabled. A connector symbol is blinking duringcharging. When fully charged, the connector symbol is permanently on.∙ Full recharge time approx. 3.5 hours ∙ Total running time approx. 5.5 hours ∙ Total aspiration approx. 33000 liters7.7 Intro ScreensAfter switching on the MAS-100 NT ®there are two screens appearing. Both of them may be canceled (see 9.15)The first and second screen shows some information about theMAS-100 NT ®.Name: Each instrument may have an individual name. This may be programmed with the PC-Software. Dep.: Second possibility to specify the instrument for example “Department”.S/N: Serial number S. Head: The sampling head which has to be used with this instrument.Next Cal.: The time remaining until the next calibration is due. After about 5 seconds the screen changes to the start screen. Bypressing the ok button it will change without delay to the start screen.Note: Both intro screens may be cancelled. (see: Skip intro 9.15)8 Operation8.1 Standard Mode MAS-100 NT® (STD) or Sequential Sampling Mode (SQS) Standard mode sample the selected Volume within one sampling process. (see SQS Sequential Sampling chapter 8.9 for splitting the selected volume into fractions)Press “Start” to start sampling.Press menu to select menuIf the Delay is deactivated (see 9.6) the Delay will not be displayedThe screen will switch back to the first screen after 3 secondsIf the User Selection is deactivated the User will not be displayed. (seedeactivation of User in chapter 9.7)8.2 Manual or Template ModeChoose Mode selection and press Select.Choose Manual or Template ModeTemplate: Up to 10 templates may be programmed in the PC-Softwareand downloaded to the MAS-100 NT® with USB cable.(see Manual for PC-software)Note: Before operating the air sampler you will need to read through Section 7“General functions”.Note: If no templates are present on the MAS-100 NT®the message: “Thereare no templates saved!” is displayed.8.3Working with TemplatesWith the software the user is able to create templates for the download tothe MAS-100 NT ®. Up to 10 templates or a total of 100 sampling places also called CCP, “critical control point” may be stored on theMAS-100 NT ®.The user can select a template for example “Template 1” and theLocation and Device, all these names may be changed or renamed in the PC-softwareStart the sampling on the MAS-100 NT ®. After the test the values are uploaded to the PC and the values are used to create an automatic protocol. For further Informations please read the Software Manual.Note: Templates can only be generated using the PC software8.4 Example of Protocol Created by the SoftwareNote: The report logo can be changed via the PC software.8.5 Template DataTemplate Data permits to clear the data collected in a Template and reuse the same template again. It may also be used to erase a complete Template.Select “Template Data” and choose the Template with the up and down arrows. Press “Select” and decide whether you want to delete the data inthe “Template” or only the Da ta collected in the selected Template.To be sure that no important data is erased by accident theMAS-100 NT ®asks again if you really want to delete the data or delete the Template. Accept with ok or press “Back” to go back twice to themain Menu8.6Process SettingsPress Menu and select Process Settings. Press Select to activate next screen.Note: To delete the templates or the data in the template the “Protected Mode”in the PC-Software must be inactive.8.7 Standard or SQS Sampling ModeSelect STD or SQS with arrow keys.Press Change and select STD for Standard sampling or SQS for Sequential sampling (see 6.5)8.8Change the Sampling VolumeSelect Volume with up and down arrows. Press Change and select thedesired volume with the up and down arrows.Press Save and twice Back to go to the Start screen.Insert space between 1000 and l8.9 Working with the SQS or Sequential Sampling ModeThe SQS 8Sequential Sampling splits the selected volume into fractions over a selected time. The Standard mode samples the selected volume within one sampling process. (see chapter 6.5)Select Menu and Process settings, then Change and select SQS(sequential sampling Mode) with the up or down arrows. Save to store new value. Press Change and select next parameter and change it to your requirements. Volume: 0 - 2000 l (selects the Standard Volumes, see 9.5) Fractions: 2 - 50Duration: 23:59 hThe Start screen shows now that the SQS Mode is selected with 10 fractions of a total of 1000l (100 l / fraction) and the sample is taken over the time of 4 hours beginning from start time.The sampling process may be stopped at any time by pressing Abort.8SQS-Sequential air sampling; Validation of the microbial count in the air using the MAS-100; Swiss Pharma 26 (2004) No.11, 9-11Note: The minimum Volume for 1 Fraction is 20 liters。
