MAS-100 NT Manual

User Manual Hardware

MAS-100 NT™ Microbiological Air Sampler

MAS-100 NT™ Microbiological Air Sampler

MAS-100 NT Microbial Air Sampler: The Leading Microbiological Air Monitoring Systems

MBV AG Microbiology and Bioanalytic Laubisrütistrasse Laubisrütistrasse 24 CH-8712 Stäfa

Tel. +41 44 928 30 80 Fax +41 44 928 30 89 Mail: [email protected] www.mbv.ch

MAS-100_NT_UM_0 MAS-100_NT_UM_01_e.doc

Table of content 1

Warning notices

4

1.1 1.2 1.3 1.4 1.5

Important Safeguards Operating the MAS-100 NT™ Environmental Conditions Warranty Malfunction of Instrument

4 4 4 4 4

2

Introduction

5

2.1 2.2 2.3 2.4 2.5 2.6

General Description Description of the MAS-100 NT™ Sampling Head Communication Programming the MAS-100 NT™ PC software MAS-100 NT™ Portable Air Sampler C&C

5 5 6 6 6 6

3

Basic Principle

7

4

Most Important Advantages of the MAS-100 NT

8

4.1

Comparison old MAS-100™ with new MAS-100 NT™

9

5

First Time Use of MAS-100 NT

10

5.1 5.2 5.3 5.4 5.5

Adjusting Sampling Plates on the MAS-100 NT™ Adjusting Petri dish Adjusting Contact plates First Time Connection to a PC New: SQS- Sequential Air Sampling

10 10 10 11 11

6

General Functions

12

6.1 6.2 6.3 6.4 6.5

Overview The Display First Time Use of MAS-100 NT™ = Activation of Calibration Reminder Switching ON and OFF the MAS-100 NT™ Intro Screens

12 12 12 13 13

7

Operation

14

7.1 7.2 7.3 7.4 7.5 7.6 7.7 7.8 7.9

Switching on the MAS-100 NT™ Starting the MAS-100 NT™ in STD or Standard Mode Manual or Template Mode (HACCP-Plan) Working with Templates Example of Protocol Created by the Software Process Settings Standard or SQS Sampling Mode Change the Sampling Volume Working with the SQS or Sequential Sampling Mode

14 14 14 15 15 16 16 16 16

8

Menu Settings

17

8.1 8.2 8.3 8.4 8.5 8.6 8.7 8.8

Shut Down Mode Selection Process Settings: Standard Volumes Delay Data User Selection Print Settings Sample Log

17 17 17 18 18 18 18 18

www.mbv.ch Version Version 1 released and approved: hzi/lk P:\Produkte\MAS-100 Family\10 MAS-100 NT\10.1 Neugeräte\Manuals\MAS-100_NT_UM_01_e.doc

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Table of content 1

Warning notices

4

1.1 1.2 1.3 1.4 1.5

Important Safeguards Operating the MAS-100 NT™ Environmental Conditions Warranty Malfunction of Instrument

4 4 4 4 4

2

Introduction

5

2.1 2.2 2.3 2.4 2.5 2.6

General Description Description of the MAS-100 NT™ Sampling Head Communication Programming the MAS-100 NT™ PC software MAS-100 NT™ Portable Air Sampler C&C

5 5 6 6 6 6

3

Basic Principle

7

4


8

4.1

Comparison old MAS-100™ with new MAS-100 NT™

9

5


10

5.1 5.2 5.3 5.4 5.5

Adjusting Sampling Plates on the MAS-100 NT™ Adjusting Petri dish Adjusting Contact plates First Time Connection to a PC New: SQS- Sequential Air Sampling

10 10 10 11 11

6

General Functions

12

6.1 6.2 6.3 6.4 6.5

Overview The Display First Time Use of MAS-100 NT™ = Activation of Calibration Reminder Switching ON and OFF the MAS-100 NT™ Intro Screens

12 12 12 13 13

7

Operation

14

7.1 7.2 7.3 7.4 7.5 7.6 7.7 7.8 7.9

Switching on the MAS-100 NT™ Starting the MAS-100 NT™ in STD or Standard Mode Manual or Template Mode (HACCP-Plan) Working with Templates Example of Protocol Created by the Software Process Settings Standard or SQS Sampling Mode Change the Sampling Volume Working with the SQS or Sequential Sampling Mode

14 14 14 15 15 16 16 16 16

8

Menu Settings

17

8.1 8.2 8.3 8.4 8.5 8.6 8.7 8.8

Shut Down Mode Selection Process Settings: Standard Volumes Delay Data User Selection Print Settings Sample Log

17 17 17 18 18 18 18 18


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8.9 8.10 8.11 8.12 8.13 8.14 8.15

Alarm Log Config Device Time and Date Language Contrast Device Info System Info

19 19 19 19 20 20 20

9

Manual Adjustment of Flow Sensor

21

9.1 9.2

Definition of Adjustment and Calibration Adjustment of the Flow Sensor

21 21

10

Manual Calibration of MAS-100 NT with DA-100 NT

23

11

Automatic Adjustment and Calibration of MAS-100 NT with DA-100 NT

24

11.1

Automatic Adjustment and Calibration of MAS-100 NT™ with DA-100 NT

24

12

Create a Calibration Certificate with DA-100 NT

27

12.1

Example : Calibration Certificate

28

13

Manual Calibration of MAS-100 NTwith NTwith PC-Software

29

14

Create Test Protocol

30

15

Flow Adjustment Data

31

15.1 15.2

Printout Adjustment Data Calibration Reminder

31 32

16

Service Menu

33

16.1 16.2 16.3 16.4 16.5

Reset Memory Printer Configuration Sensors Pneumatic Test Statistic

33 33 33 34 34

17

Alarm ID and Description

35

17.1

Alarm ID’s

35

18

Block Manual Interventions on the MAS-100 NT

36

19

Interpreting the Results

36

19.1 19.2

Feller Conversion Table for Sampling Head with 300 Holes Feller Conversion Table for Sampling Head with 400 Holes

37 38

20

Technical Specifications

39

20.1

Environmental Conditions

40

21

Components Checklist

41

22

Care and Maintenance

41

23

Warranty

41


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1

Warning notices 1.1

Important Safeguards

1.2

Operating 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.

1.3


Please read the instructions in chapter 20.1

1.4

Warranty

Only special trained people certified by the manufacturer (MBV AG, Switzerland) are aloud to calibrate and service the instrument. Instruments which are opened by unauthorized people will loose immediately their warranty.

1.5

Malfunction of Instrument

If the instrument doesn’t work according to this instruction manual send it immediately back to the manufacturer.


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2

Introduction

Micro-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 environment

2.1

General Description 1

According to the “The Rules Governing Medicinal Products ” and the International Standard 2 Iso 14698-1/2 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 3 sampling is based on the well known and as standard method established impaction principle . It works like all other MAS-Systems with standard 90mm Petri dishes. The MAS-100 NT™ is a further 4 development of the standard MAS-100 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 GAMP4. The total system is fully validated. Improved communication like RS-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 ore may be programmed directly on the unit. Note:

The MAS-100 NT air sampler has been developed according to 5 GAMP 4 . The Soft- and Firmware are validated.

www.mbv.ch Version 1 released and approved: hzi/lk P:\Produkte\MAS-100 Family\10 MAS-100 NT\10.1 Neugeräte\Manuals\MAS-100_NT_UM_01_e.doc

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2.3

Sampling Head

The 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 0.6 or if you wish to continue to use 400 x 0.7mm lid. Please make sure that you select the appropriate lid in the Menu Device Info ( 8.14) Note:

The previous sampling head (400 x 0.7mm) is still available on demand

New 300 x 0.6mm Sampling head (perforated lid) Anodized in blue Impaction speed <20m/s

2.4

Old 400 x 0.7mm Sampling head (perforated lid) Anodized silver Impaction speed <11m/s

Communication

Up to date communication USB, RS-232, with other systems (PC, Printer; DA-100 NT).

2.5

Programming 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 software programming, please consult software manual.

2.6

PC software MAS-100 NT Portable Air Sampler C&C

The “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 access levels to set, read and program individual parameters in the MAS-100 NT™ (operating under Windows 95 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 stored 100 events of each type. The may be printed or exported into Excel. Note:

The MAS-100 NT is validated to ISO 14698-1 and -2, 2003/09


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3

Basic Principle

The 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 6 regulates the aspirated volume to a constant value of 100 Standard liters per minute. The MAS-100 NT™ automatically regulates this volume according to pressure and temperature an thus give all the time comparable results. For measurement in pharmaceutical industry the recommended sampling volume – according to international guidelines – should be 1000 liters.

air inlet

Petri dish

Anemometer

Blower

Air outlet


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4

• • • • • • • • • • • • • • • • • • • • •


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 7 new: validated hard and software for (HACCP , 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 (5.3) SQS-Cycle (see point 5.5) 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 according to international Guidelines: Isokinetic measurement, 0.45 m/sec, 100 liters/minute sampling volume adjustable from 1 – 2000 liters


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4.1

Comparison old MAS-100 with new MAS-100 NT MAS-100 ™

New: MAS-100 NT™

Benefit:

New design with better view and access for programming the menu screen. Illuminated graphic display.

400 x 0,7mm Sampling head

32 characters LCD display yes - no navigation

Menu in English

RS-232 communication HACCP-Software

No alarm logging No audible alarm Restricted sample logging

Manual calibration

Previous validation papers NiMH-recharchable batteries Non intelligent charging

300 x 0,6mm Sampling head Higher collection efficiency (400 x 0.7mm Sampling head through increased impaction on request) speed Graphic illuminated display better reading of display Menu guided navigation with Straight forward navigation to up and down arrow and direct menu points menu selection buttons Menu in English, German Multi lingual, user friendly and French pre programmed. Other languages on demand. USB communication Advanced communication Improved HACCP-Software Through windows login with Windows login and reporting traceability of user reporting (FDA 21CFR part 11) Alarm logging up to 100 Traceability of malfunction and error sampling Audible alarm Audible error reporting Up to 100 samples are Traceability of samples logged with date, time, user and volume Fully automatic calibration Unique for air samplers! Security, independent of cycle with automatic editing of calibration certificate with person, easy to use, saving DA-100 NT and PC calibration cost and time! New validation papers Validation according to according to ISO 14698-1/2 ISO-Standard Lithium-ion researchable No memory effect, improved batteries recharging time Intelligent charging Longer battery life Cost saving


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5


If the MAS-100 NT™ is used for the first time or after a calibration the “calibration reminder" has to be set. (see 6.3)

5.1

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.

5.2

Adjusting Petri dish

Lift 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 play. 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 at most if you change Petri dish manufacturer. Note:

5.3

Do not over-tighten the blue jaws. If you do, the Petri dish may break and shed plastic debris in the aspiration unit and block the motor.

Adjusting Contact plates

New : 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 3 existing blue jaws by removing the Allen screw and replace with the 3 new blue jaws.

•

Place the positioning template and mark the centre (see picture) with a marker pen.

•

Remove the positioning template and put the Adapter ring as shown in the picture bellow.

•

Put now your contact plate in the adaptor and tighten 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 the stainless steel adapter holds firmly .


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5.4

First Time Connection to a PC

When connecting the MAS-100 NT™ the first time to a PC the USB driver has to be installed. The Driver is on the CD in the File “Driver FTDXX”.

5.5

New: SQS- Sequential Air Sampling8

A 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 of very great importance 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.

Volume

Time 240

1000

216 192

700

168 144

500

120 96

300

72 48

100 s e rt i L

24 g n il p m a s . 1

e s u a p

g n il p m a s . 2

e s u a p

g n il p m a s . 3

e s u a p

g n il p m a s . 4

e s u a p

g n il p m a s . 5

e s u a p

g n il p m a s . 6

e s u a p

g n il p m a s . 7


e s u a p

g n il p m a s . 8

e s u a p

g n il p m a s . 9

e s u a p

g in l p m a s . 0 1

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6

General Functions

6.1

Overview

The MAS-100 NT™ has built-in multilingual dialog 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 arrow flashes at the right side of the screen to navigate up and down the screen.

6.2

The Display The MAS-100 NT™ has a illuminated graphic display. Follow the text on the screen by pushing the button or the arrow keys. The top line shows date, time and the status of the batteries. 1

To start the instrument push the left down button (4) for about 1 second. The blue diode will light up.

2

4

6.3

3

First Time Use of MAS-100 NT = Activation of Calibration Reminder The MAS-100 NT™ has a built in calibration reminder. If the MAS-100 NT™ is used the first time a screen comes up with the question of setting the time you want to be reminded that the instrument should be recalibrated. The manufacturer recommends to recalibrate the instrument at least once a year. Choose a value from 1 up to 12 month. 0 means, that the reminder is inactivated.

Accept by pushing OK. With Back the first screen is displayed again. After activation fill in the calibration certificate with the date on which the instrument was first used and the date for recalibration.

Note:

You have to select a figure and push the “Accept” button in order to initialize the instrument. If you push not accept the MAS-100 will not work!


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6.4

Switching ON and OFF the MAS-100 NT

To switch on the MAS-100 NT™ push the left button (4) under the screen for about 1 second until the blue LED (run) illuminates. The program will start. To switch off push “Menu” select “Shut Down” and push “select” again and push 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.

6.5

Intro Screens

After switching the MAS-100 NT on there are two screens appearing. Both of them may be canceled (see 8.14) The first and second screen shows some information from the MAS-100 NT™.

Name: Each instrument may have a 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 for this instrument. Next Cal.: The time remaining until the next calibration is due. After about 5 second the screen moves to the start screen. By pushing the ok button it will move directly to the start screen. Note:

Both intro screen may be cancelled. (see 8.14)


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7 Note:

7.1

Operation Before operating the air sampler you will need to work through Section 6 “General functions”.

Switching on the MAS-100 NT

To switch on the MAS-100 NT™push the left button (4) under the screen for about 2 second until the blue LED (run) illuminates. The program will start.

7.2

Starting the MAS-100 NT in STD or Standard Mode

Standard mode sample the selected Volume within one sampling process. (see SQS Sequential Sampling chapter 7.9 for splitting the selected volume into fractions) Push “Start” to start sampling. Push menu to select menu If the Delay is deactivated (see 8.5) the Delay will not be displayed The screen will switch back to the first screen after 3 seconds If the User Selection is deactivated the User will not be displayed. (see deactivation of User in chapter 8.6)

7.3

Manual or Template Mode (HACCP-Plan) Choose Mode selection and push Select. Choose Manual or Template Mode Template: Up to 10 templates (HACCP-Plan) may be programmed in the PC-Software and downloaded to the MAS-100 NT™ with USB cable. (see Manual for PC-software)

Note:

If no templates are present on the MAS-100 NT™ the message: “There are no templates saved!” is displayed.


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7.4

Working with Templates With the software the user is able to create templates for the download to the MAS-100 NT™. Up to 10 templates or a total of 100 sampling places also called CCP, “critical control point” may be stored on the MAS-100 NT™.

The user can select a template for example “Template 1” and the Location and Device , all these names may be changed or renamed in the PC-software

Start 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. More about this read the Software Manual.

7.5

Example of Protocol Created by the Software


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7.6

Process Settings Push Menu and select Process Settings. Push Select to activate next screen.

7.7

Standard or SQS Sampling Mode

Process Settings STD Mode: Volume: 1000l

Back

7.8

Select STD or SQS with arrow keys. Push Change and select STD for Standard sampling or SQS for Sequential sampling (see 5.5)

Change

Change the Sampling Volume


Back

7.9

Select Volume with up and down arrows. Push Change and select the desired volume with the up and down arrows. Push Save and twice Back to go to the Start screen.

Change

Working with the SQS or Sequential Sampling Mode 9

The SQS Sequential Sampling splits the selected volume into fractions over a selected time. The Standard mode samples the selected volume within one sampling process. (see chapter 5.5) Process Settings Mode: SQS Volume: 1000l Fractions: 10 Duration: 04:00h Back 01.01.2007

Change 09:32

SQS(10) Mode: Volume: 1000l Duration: 04:00h Start

Note:

Select Menu and Process settings and then Change and select SQS (sequential sampling Mode) with the up or down arrows. Save to store new value. Push Change and select next parameter and change it to your requirements. Volume : 0 - 2000 l (selects the Standard Volumes, see 8.4) Fractions: 2 - 50 Duration: 23:59 h The 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 pushing Abort.

Menu

The minimum Volume for 1 Fraction is 20 liters


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8

Menu Settings

Push Menu on the start screen to access the 3 Main Menu screens.

All Menu position are explained below.

8.1

Shut Down Choose the Shut Down menu. Push Select. Shut down device? is displayed. Confirm with OK. The device will shut down. OK

8.2

Mode Selection Choose between Manual sampling or Template (HACCP-Plan) sampling. A Template may be created in the MAS-100 NT C&C software.

8.3

Process Settings:


Back

Change

Process Settings Mode: SQS Volume: 1000l Fractions: 10 Duration: 04:00h Back

Choose Standard (see chapter 7.2 ) or SQS Mode (see chapter 7.9) Move with the arrows , push Change to choose your values.

Change


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8.4

Standard Volumes

Standard Volume Volume 1: 50l Volume 2: 100l Volume 3: 250l Volume 4: 500l Volume 5: 1000l Back

8.5

Change

Choose the Volume with the arrow keys and push Change. Set the desired Volume with the arrow keys and push Save. Example: If you would only have one volume 1000l for selection, put the other volumes to 0.

Delay Data

Delay Data Delay: Time:

Back

8.6

5 Volumes are pre set. All of them may be changed from 0 to 2000 l. If you choose 0 this volume will not be displayed any more.

Off 1 min

If Delay is On (active) you may select a time between 1 and 120 min for a delayed start. If you don’t want to use this option leave it in the OFF position,

Change

User Selection It is possible to choose among 10 Users. With the PC-Software it is possible to rename the User. If it is in No position the user selection will not appear after the start. If it is in YES position after pressing the start button one has to choose a User before it is possible to start a sampling.

8.7

Print Settings Chose Print settings and Select. If no printer is connected it will be displayed on screen. Push OK to quit.

8.8

Sample Log

Log Selection Nr of entries: Log ID:

30 30

Select Log ID to show Back

Up to 100 samples are logged in the system. Each may be reviewed individually. After 100 logs the first one will be overwritten! You always get the last 100 logs If a printer is connected it is possible to make a printout of the sample log. Select the Nr of entries and then push Show. Scroll through the windows. Push Print for a hard copy.

Show


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Sample Log ID:31 2/3 Start D. : 02.03.07 11:06 Start T. : End D. : 02.03.07 End T. : 11:06 Back

8.9

Next

Alarm Log

Log Selection Nr of entries: Log ID:

30 30

Select Log ID to show Back

8.10

Show

Back

In this menu the following parameters are selected and defined:

Select

Time and Date

Time/Date Time: 15:39 Date: 02.03.2007 Format: EUR Summer: On Back

8.12

(see chapter 17)

Config Device

Config Device Time/Date Language Contrast Device Info

8.11

Up to 100 alarms are logged in the system. Each may be reviewed individually. After 100 logs the first one will be overwritten! You always get the last alarm 100 logs.

Change

Select Time and adjust with the arrows Select Date and adjust with arrows Choose between EUR/JAP/USA date format Select between summer and wintertime by choosing ON/OFF

Language 3 languages are programmed. Choose between German, English and French (Spanish in preparation)

Language

Language:

Back

English

Change


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8.13

Contrast Contrast of the display may be regulated from 0 to 10

Contrast

Contrast:

Back

8.14

0

Change

Device Info Name: Name of device (can’t be changed) Location: may be renamed with the MAS-100 NT™ software. ™ Dep.: may be renamed with the MAS-100 NT software. S. Head: Choose between 400 x 0,7 or 300 x 0,6 mm Sampling head Skip Intro:1 First Intro skipped 2 first and seconded Intro skipped, 0 both Intros will appear

8.15

System Info Relevant information’s for the instrument. Push Back to quit.


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9

Manual Adjustment of Flow Sensor

9.1

Definition of Adjustment and Calibration

Adjustment: Adjustment means to adjust a to a minimum deviation compared to a standard. Calibration: Is a comparison to a given value at defined conditions.

Note:

9.2

The values in L/min are always standard Liters. Liter at 1013.25 mbar and 20°C

Adjustment of the Flow Sensor

The instrument must be off. To get into the calibration Menu press and hold the 1 and 4 keys (see Display 6.2) simultaneously for about 3 seconds until the Fabtest menu is displayed. 10

To adjust the MAS-100 NT™ Flow sensor you need a DA-100 Note:

11

or a DA-100 NT

Digital Anemometer.

The manufacturer suggests to calibrate the instrument using the DA-100 NT together with the MAS-100 NT™ software. Choose Adjustment Mode Choose Manual Adjustment and push Select.

Change the Cal. Flow with up or down arrows. Push Start Notice: To have always values above 100 L/min choose a value of 102.5 L/min. The accuracy of the MAS-100 NT™ is +/- 2.5%.

Push Start Change the Blower PWM value until you get a mean flow value which is +/- 0.5 l close to the indicated mean flow value. Push Next

Note:

If you use a DA-100 please don’t forget to calculate standard Liters. See DA-100 Manual


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Flow Sensor Enter mean flow during calibration Cal.Flow: XX.X

Abort

Perform 3 measurements and take the mean value. Enter this value in the Adj. Flow: field with the up and down arrows.

Push Next to continue

Next

Sensor successfully adjusted will appear on the display if everything was correctly adjusted. Enter with the + or – key the validity of the adjustmentn (0 – 12 month) Push Exit to get out of this Menu

Note:

If wrong values are introduced a probability calculation is verifying the values and does give a error if the entered values is wrong!


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10

Manual Calibration of MAS-100 NT with DA-100 NT

The instrument must be off. To get into the calibration Menu press and hold the 1 and 4 keys (see Display 6.2) simultaneously for about 3 seconds until the Fabtest menu is displayed. 12

To calibrate the MAS-100 NT™ Flow sensor you need a DA-100 Anemometer. Note:

13

or a DA-100 NT

Digital

The manufacturer suggests to calibrate the instrument using the DA-100 NT together with the MAS-100 NT™ software. Choose Adjustment Mode Choose Calibration and push Select.

Connect the DA-100 NT to Device (MAS-100 NT) Push Start, Starting up blower, please wait… is displayed. The DA-100 NT automatically starts to measure the volume and displays the values and the Deviation of the Calibration. Note the values.

Note:

If you use an old DA-100 perform the Manual Adjustment and don’t forget to calculate the Volume into Standard liters. Run the MAS-100 in the manual Standard mode for 1000 litres. Read the values from the DA-100 and put them in the certificate. A certificate is on each product CD delivered with the system.


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11


11.1


Note:

Take care that no miss measurement occurs due to turbulences of the air. If possible protect the anemometer from any air currents which could directly affect it. If checking the MAS-100 NT™ yields that the values deviate by more than ± 2.5 % of the calibration flow, the instrument has to be recalibrated. The MAS-100 NT™ is equipped with an anemometer regulating a constant mass flow.

Automatic Procedure (SOP): 1.

Visually check the lower edge of the perforated sampling head to make sure that there are no notches or unevenness. This could lead to a leak between the lid and the sealing ring. If the sampling head is damaged replace it with a new one.

2.

Stand the DA-100 NT on the perforated lid of the MAS-100 NT™ and connect the cable between the two instruments. Connect the MAS-100 NT™ with the USB-cable also to the PC.

3.

Start the Software on the PC and start the MAS-100 NT™

4.

Start the Software on the PC and put the MAS-100 NT™ on. Choose Calibrator in the Access level menu. Type in “mascal” in the Password box and quit with OK


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5.

Calibration Menu

6.

Select Sampling head Choose the sampling head you are working with. (see 2.3)

7.

Set the validity of the Calibration Chose between 1 – 12 month. If you select 0 the calibration reminder is deactivated. If you push the Set calibration Validity button, the reminder will be activated through the software.


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8.

Flow Adjustment

9. Select Calibration Flow (to avoid mass flow lower then 100 Liter/min choose 102.5 Liters) 10. Select Calibration Span: Select 10.0 l/min in order to select a calibration span from 97.5 to 107.5 l/min. (If you have selected the calibration flow to 100.0 l/min the curve would be 95.0 to 105.0 l/min) 11. Select “Automatic + Calib. with certificate”, push Start and confirm the Calibration window with yes. 12. Push Next: The DA-100 NT will automatically be switched on and the calibration process works automatically through its steps.

13. If the calibration has passed an automatic calibration certificate is printed and stored in the path according the settings in this window.

14. It is possible to block the measurement with the MAS-100 NT™ if the calibration date is expired. Activate the box to enable measurement after expiration of calibration date.

15. If a calibration is not accepted by the system displays Calibration Error: invalid sensor gain. Make sure everything is correctly connected, the DA-100 NT is positioned on the MAS-100 NT™ sampling head and retry the Automatic calibration cycle.

If again the calibration Error occurs control if the system allows to aspirate the total Calibration flow. (Calibration Flow + ½ of Calibration span) If the System doesn’t reach its total flow it has to be calibrated manually. (see chapter 9)


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12

Create a Calibration Certificate with DA-100 NT

Start the “Flow Calibration Test. If the Deviation from the Air Flow is within the ± 2.5 % (green field with the mean value of 3 measurements) see picture below a new calibration certificate may be printed. Note:

If you have an old DA-100 fill in the values in the calibration certificate delivered with the product CD.

Note: If the Deviation from the Air Flow is bigger than ± 2.5 % (red field with the mean value of 3 measurements) see picture below, a new calibration has to be performed.

Print calibration certificate: Press the “Create Calibration Certificate” button. Enter the Certificate Nr: ……………and press ok.

An automatic PDF-file is created. Print out the certificate and sign it. (See example next page)


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12.1

Example : Calibration Certificate


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13

Manual Calibration of MAS-100 NTwith PC-Software

Note: Take care that no miss measurement occurs due to turbulences of the air. If possible protect the anemometer from any currents which could directly affect it. If checking the MAS-100 NT™ shows that the standard litres deviate by more than ± 2.5 %, the of the calibration flow instrument has to be calibrated. Manual Procedure (SOP): 1.

Visually check the lower edge of the perforated sampling head to make sure that there are no notches or unevenness. This could lead to a leak between the lid and the sealing ring. If the sampling head is damaged replace it with a new one.

2.

Stand the DA-100 NT on the perforated lid of the MAS-100 NT™. Switch the DA-100 NT on with the blue knob.

3.

Connect the PC with USB cable and start the MAS-100 NT™ software.

4.

Select Access level, then Calibrator (default password: mascal) and Manual Calibration. Select Calibration Flow (to avoid mass flow lower then 100 Liter/min choose 102.5 Liters)

5.

Select Adjustment Span: Select 10.0 l/min in order to select a calibration span from 97.5 to 107.5 l/min. (If you have selected the calibration flow to 100.0 l/min the span would be 95.0 to 105.0 l/min)

6.

Select Manual Adjustment, push Start and confirm the Calibration window with yes.

7.

Adjust the Speed in % in order to reach the set calibration flow. Take 3 values, calculate the mean value and push next. Adjust the mean value in the Mean flow [l/min] window.

8.

Push Next

9.

If the calibration was successful the following window is displayed. Push the OK Button to accept the calibration and transfer the values to the MAS-100 Iso NT.

10. Make now 3 measurements with the DA-100 NT and fill in the results in your own certificate.


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14

Create Test Protocol

In the “Flow calibration Test” (Calibration Menu) it is possible to make a test protocol for the MAS-100 NT™. Connect the DA-100 NT and the PC to the MAS-100 NT™ and push the button Create Test Protocol. With this option it is possible to make a control measurement of the MAS-100 NT™ at any time without changing the calibration data and values. The title of the document will be “Test Protocol” instead of “Calibration Certificate” (see chapter 12)


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15

Flow Adjustment Data

In the following window , it is possible to get some technical information on the last and the actual adjustment of the flow sensor. Choose Actual or Last Adjustment and make a printout with the “Print Adjustment Data” button:

15.1

Printout Adjustment Data


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15.2

Calibration Reminder

The MAS-100 NT™ issues a calibration reminder. The calibration reminder can be set to a figure of between 0 and 12 months. If 0 months is selected, no calibration reminder is issued. If, for example, you select 6 months, a 6 month period is calculated from the date you exit this menu. Once the defined period is up, the following message is displayed: Calibration expired Note:

The reminder has to be set by the user, at the time of first use of the MAS-100 NT™. (see 6.3)


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16

Service Menu

The Service menu is a menu only for service people for checking some key values on site. It should not be used by untrained people. To get into the Service Menu of the MAS-100 NT™ push and hold the arrow keys 1 and 2 simultaneously for about 2 seconds while the unit is on. (see Display 6.2)

16.1

Reset Memory Select Sample or Alarm log to clear the logged data. Select All to clear both the Sample and Alarm data. Push select and OK.

16.2

Printer Configuration Select Printer Config. Select Onl. Printer: to ON/OFF. If it is ON and a printer is connected after each run a printout is printed. Printer: Select a pre configured printer. Samsung Bixolon SRP-275 or Epson TM-U220 Printer settings shows values. Push Back to main Menu

16.3

Sensors Push Select on Sensors. The two screens are displayed for information on different sensors and values. For information only!


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16.4

Pneumatic Test In this position the blower may be switched on and off manually.

16.5

Statistic In the statistics menu it is possible to see total working hours of Device (Instrument) and blower.


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17

Alarm ID and Description

In the list you will find all the alarms which could appear if the MAS-100 NT™ doesn’t work properly. The alarms will be announced with an acoustic sound from the MAS-100 NT™ and displayed on the screen. It will be logged in the alarm log file of the MAS-100 NT™ and also be displayed in the alarm log file of pc-software. (see chapter 8.9 ) Quit the alarm by pressing the quit button on the instrument. If a remote switch is connected the LED became red during alarm. Press the remote button once to quit the alarm. The LED turns to green.

17.1

Alarm ID’s Alarm ID 91 92 93 94 95 97 98 99 100 101 102 103 104 105

Description Blower did not reach minimal rotation, blower does not start Minimal flow for starting measurement not reached Flow to high Target flow not reached Flow to low Device temperature too high Last measurement/sterilisation was interrupted by power down Sampling duration to low Calibration not valid Calibration required Target Volume to low High Flow Sensor Power Supply out of tolerance Measurement stopped Battery discharged


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18

Block Manual Interventions on the MAS-100 NT

The MAS-100 NT™ may be locked from the PC-Software. (see Menu Process and device settings in the PC software). Only start and stop functions are active. All other functions are deactivated. To change any of the parameters the advanced user has to deactivate the “Protected Mode” in the software.

19

Interpreting the Results

14

First, the total microbial count is corrected based on Feller’s statistical correction table (see Section 19 “Appendix”), then it is converted to contaminant particles per cubic meter. The correction table is based on the principle that as the number of organisms per sampling rises, the chance that several organisms will enter the same hole in the perforated lid also increases. (A table of statistical corrections according to Feller for the MAS-100 in a plastified cover is provided separately with each sampler). Important: With the new MAS-100 NT™ a sampling lid of 300 x 0.6mm is delivered as standard. If you wish to have a sampling lid 400 x 0.7 please specify when ordering the system!


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19.1

Feller Conversion Table for Sampling Head with 300 Holes

Positive hol e conversion table MAS-100

Impaction Lid 300 x 0.6

MBV AG, 8712 Stäfa

Pr

r = Number of colony forming units counted on 90 mm Petri dish

= Probable statistical total

r

Pr

r

Pr

r

Pr

r

Pr

r

Pr

r

Pr

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 19 20 21 22 23 24 25 26 27 28 29 30 32 33 34 35 36 37 38 39 41 42 43 44 45 46 47 49 50 51 52 53 55

51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100

56 57 58 59 61 62 63 64 66 67 68 69 71 72 73 74 76 77 78 80 81 82 83 85 86 87 89 90 92 93 94 96 97 98 100 101 103 104 105 107 108 110 111 113 114 115 117 118 120 121

101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150

123 124 126 127 129 131 132 134 135 137 138 140 142 143 145 146 148 150 151 153 155 156 158 160 161 163 165 167 168 170 172 174 175 177 179 181 183 184 186 188 190 192 194 196 198 200 202 203 205 207

151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192 193 194 195 196 197 198 199 200

209 211 213 216 218 220 222 224 226 228 230 232 235 237 239 241 243 246 248 250 253 255 257 260 262 264 267 269 272 274 277 279 282 284 287 289 292 295 297 300 303 306 308 311 314 317 320 323 326 329

201 202 203 204 205 206 207 208 209 210 211 212 213 214 215 216 217 218 219 220 221 222 223 224 225 226 227 228 229 230 231 232 233 234 235 236 237 238 239 240 241 242 243 244 245 246 247 248 249 250

332 335 338 341 344 347 350 353 357 360 363 367 370 374 377 381 384 388 391 395 399 403 407 410 414 418 422 427 431 435 439 444 448 452 457 462 466 471 476 481 486 491 496 501 507 512 518 523 529 535

251 252 253 254 255 256 257 258 259 260 261 262 263 264 265 266 267 268 269 270 271 272 273 274 275 276 277 278 279 280 281 282 283 284 285 286 287 288 289 290 291 292 293 294 295 296 297 298 299 300

541 547 553 560 566 573 580 587 594 601 609 616 624 632 641 649 658 667 677 686 696 707 717 728 740 752 765 778 791 805 820 836 853 871 889 909 931 954 979 1006 1036 1069 1107 1150 1200 1260 1335 1435 1585 1885

The values in the table are calculated from the basic formula (Feller, 1950 )

Pr = N [1/N + 1/N-1 + 1/N-2 + 1/N-r+1]


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19.2

Feller Conversion Table for Sampling Head with 400 Holes

Positive hol e conversion table MAS-100

Impaction lid 400 x 0,7mm

MBV AG, 8712 Stäfa

Pr

r = Number of colony forming units counted on 90 mm Petri dish

= Probable statistical total

r

Pr

r

Pr

r

Pr

r

Pr

r

Pr

r

Pr

r

Pr

r

Pr

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 22 23 24 25 26 27 28 29 30 31 32 33 34 35 37 38 39 40 41 42 43 44 45 47 48 49 50 51 52 53

51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100

54 56 57 58 59 60 61 63 64 65 66 67 68 70 71 72 73 74 76 77 78 79 80 82 83 84 85 87 88 89 90 92 93 94 95 97 98 99 101 102 103 104 106 107 108 110 111 112 114 115

101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150

116 118 119 120 122 123 124 126 127 128 130 131 133 134 135 137 138 140 141 142 144 145 147 148 150 151 153 154 156 157 158 160 161 163 164 166 167 169 171 172 174 175 177 178 180 181 183 185 186 188

151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192 193 194 195 196 197 198 199 200

189 191 193 194 196 197 199 201 202 204 206 207 209 211 212 214 216 218 219 221 223 224 226 228 230 232 233 235 237 239 241 242 244 246 248 250 252 254 255 257 259 261 263 265 267 269 271 273 275 277

201 202 203 204 205 206 207 208 209 210 211 212 213 214 215 216 217 218 219 220 221 222 223 224 225 226 227 228 229 230 231 232 233 234 235 236 237 238 239 240 241 242 243 244 245 246 247 248 249 250

279 281 283 285 287 289 291 293 295 297 299 301 304 306 308 310 312 314 317 319 321 323 325 328 330 332 335 337 339 342 344 346 349 351 353 356 358 361 363 366 368 371 373 376 378 381 384 386 389 391

251 252 253 254 255 256 257 258 259 260 261 262 263 264 265 266 267 268 269 270 271 272 273 274 275 276 277 278 279 280 281 282 283 284 285 286 287 288 289 290 291 292 293 294 295 296 297 298 299 300

394 397 400 402 405 408 411 413 416 419 422 425 428 431 433 436 439 442 445 449 452 455 458 461 464 467 471 474 477 480 484 487 491 494 497 501 504 508 511 515 519 522 526 530 534 537 541 545 549 553

301 302 303 304 305 306 307 308 309 310 311 312 313 314 315 316 317 318 319 320 321 322 323 324 325 326 327 328 329 330 331 332 333 334 335 336 337 338 339 340 341 342 343 344 345 346 347 348 349 350

557 561 565 569 573 578 582 586 591 595 599 604 608 613 618 622 627 632 637 642 647 652 657 662 667 673 678 684 689 695 701 706 712 718 724 730 737 743 749 756 763 769 776 783 791 798 805 813 820 828

351 352 353 354 355 356 357 358 359 360 361 362 363 364 365 366 367 368 369 370 371 372 373 374 375 376 377 378 379 380 381 382 383 384 385 386 387 388 389 390 391 392 393 394 395 396 397 398 399 400

836 844 853 861 870 879 888 897 907 917 927 937 947 958 969 981 992 1005 1017 1030 1043 1057 1071 1086 1102 1118 1134 1152 1170 1189 1209 1230 1252 1276 1301 1327 1356 1387 1420 1456 1496 1541 1591 1648 1715 1795 1895 2028 2228 2628

The values in the table are calculated from the basic formula (Feller, 1950 )

Pr = N [1/N + 1/N-1 + 1/N-2 + 1/N-r+1]


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20

Technical Specifications

General:

Specification:

Flow rate:100 Liters / Min Standard sampling volumes: Freely definable sampling volumes:

100 liters / min. ± 2.5%, 50, 100, 250, 500, 1000 liter 1 to 2000 liters ,volumes individually selectable between 0 and 2000 liters. 0 volumes are not displayed

Sampling head : Diameter: Weight: Material: Autoclavable:

Ø 10.9 cm 1.5 kg Aluminium anodized 20 minutes at 121°C

MAS-100 Iso NT™ Height: Length: Weight: Carrying case

25.0 cm 28.3 cm 2.3 kg Plastic

Additional information: Tripod screw Battery pack Motor Battery charger input: Charger output Display: Lifetime RTC Battery: Processor: Gas regulation: Guidelines: CE approval :

For use with normal camera tripod Li-Ion 6V 110-240 Volt, 1.5A 50-60Hz 12 V DC /2.5 A Alphanumeric graphic display Approx. 10 years Micro-Processor Mass flow meter 73/23/EEC, 89/336/EEC, DIN EN 61326-1:1997, DIN EN 61010-1:2001, GAMP 4.0:2001 Emission: EN 61326-1:2006, EN 55011:1998+A1:99 Immunity EN 61326-1:2006, EN 61000-4-2:1995 EN 61000-4-3:1995:2002, EN 61000-4-4:1995 EN 61000-4-5:1995, EN 61000-4-6:1996 EN 61000-4-8:1993, EN 61000-4-11:2004


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20.1


Altitude: Temperature: Maximum relative humidity:

Mains supply-voltage:

Transient over-voltage:

Up to 2000 m or above if specified by manufacturer 0 to 40°C 80 percent for temperatures up to 31°C, decreasing linearly to 50 percent relative humidity at 40°C; Fluctuations must not exceed ± 10 percent of the nominal voltage; other supply voltage: fluctuations as stated by the manufacturer Acc. to INSTALLATION CATEGORIES (OVERVOLTAGE CATEGORIES) I,II, and III and normal category is II;POLLUTION DEGREE 1 or 2 in accordance with IEC 664


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21

Components Checklist

™ 1 x 06.6200.01 MAS-100 NT 1 x 06.9048.01 Carrying case 1 x 06.8001.01 Battery charger and plugs 1 x 06.7901.01 USB cable 1.5m 1 x 06.6052.01 CD with PC-Software and User-manual, USB Driver and Excel certificate for old DA-100 1 x 06.6053.01 3mm Allen key

Optional accessories: 1 x 06.6014.01

22

Cable: RS-232 to Lemo –socket for MAS-100 NT

Care and Maintenance

The MAS-100 NT™ should be periodically calibrated (see chapter 9 - 11). The perforated lid and dust cover are autoclavable (15 min/121 °C). Make sure that the holes in the perforated lid are not clogged. Dirt may be removed from the exterior of the MAS-100 NT™ by wiping with a cloth moistened with a mixture of 60-80% alcohol/water or with one of the commonly used disinfectants. The outside of the instrument may also be cleaned with alcohol/water solution. Avoid spilling liquid into the electrical/electronically connections.

23

Warranty

The MAS-100 NT™ has a 2 years warranty against failure due to malfunction of electrical and electronic components (see invoice date). The MAS-100 NT™ is a precision instrument for industrial and laboratory use and should only be operated by qualified personnel.


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MAS-100 NT Manual

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