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
Tel. +41 44 928 30 80 Fax +41 44 928 30 89 Mail:
[email protected]
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
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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
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
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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
Environmental Conditions
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:
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The MAS-100 NT air sampler has been developed according to 5 GAMP 4 . The Soft- and Firmware are validated.
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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) The previous sampling head (400 x 0.7mm) is still available on demand
Note:
New 300 x 0.6mm Sampling head (perforated lid) Anodized in blue Impaction speed
