User Manuals Communication Manual

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MAS-100 Iso NT/MH Microbiological Air SamplerUser ManualsCommunication ManualMAS-100 Leading Solution for Air Monitoring

ManufacturerMBV AGIndustriestraße 9CH-8712 StäfaSwitzerlandDistribution partnerMerck KGaAFrankfurter Straße 250D-64239 DarmstadtGermanyDocument historyRevisionDateHistory Harmonized the wording of all warning indications in order to be consistent throughout all MBV user manuals.Harmonized section structure to be consistent throughout all MBV user manuals.Added section 1.2.4 («Dual-Use» statement).Added EAC to section 1.4.Various typo corrections.0513.12.20160418.04.2016Update table of contents0318.04.2016Update due to Declaration of ConformityProfibus SPS Protocol Byte 18 is new in Byte 18 and 190231.07.2015Document structure enhancedSmall changes due to new Iso NT FW V2.8.5 and Iso MH V1.2.60104.02.2015First editionUp-to-date product information such as Service Information Letters (SIL) or the RSSnews feed is available via the MBV website www.mbv.ch.There, important product after-sales information about changes, issues, instructionsand news is provided to customers.Page 2 of 64

TrademarksThe following product names are used for identification purposes only and remain the exclusive property oftheir respective owners: The M is a registered trademark of Merck KGaA, Darmstadt, Germany Opticap is a registered trademark of Merck KGaA, Darmstadt, Germany Millipore is a registered trademark of Merck KGaA, Darmstadt, Germany Windows , Excel and Internet Explorer are registered trademarks of the Microsoft Corporation in theU.S. and other countries PDF is a registered trademark of Adobe Systems Inc. in the U.S. and other countries Safari is a registered trademark of Apple Inc. in the U.S. and other countries Firefox is a registered trademark of the Mozilla Corporation in the U.S. and other countries Google Chrome is a trademark of Google Inc. in the U.S. and other countriesRegistered trademarks of MBV AG MAS-100 in Switzerland MAS-100 Eco in Switzerland MAS-100 VF in Switzerland and other countries MAS-100 NT in Switzerland and other countries MAS-100 NT Ex in Switzerland and other countries MAS-100 Iso NT in Switzerland and other countries MAS-100 Iso MH in Switzerland and other countries MAS-100 CG Ex in Switzerland DA-100 in Switzerland and other countries DA-100 NT in Switzerland and other countriesCopyright 2016 MBV AG, all rights reservedThis document may not be reproduced, in whole or in part, in any form or by any means electronic ormechanical (including photocopying, recording, or any other process), without the written permission ofMBV AG, Switzerland.Information contained in this document may be subject to change without notice.Page 3 of 64

AbbreviationsThe microbiological air sampler MAS-100 Iso MH is designated hereafter as «Instrument».The Software MAS-100 Iso NT Air Sampler - C&C is designated hereafter as «PC Software».ApplicabilityThe information in this manual is valid for the following mponent designationRevision fromMain PCB MAS-100 Iso NT V6Main PCB MAS-100 Iso MH V6Firmware MAS-100 Iso NT V2.7Firmware MAS-100 Iso MH V1.0Software MAS-100 Iso NT Air Sampler - C&CSoftware MAS-100 Iso NT and MH Air Sampler - C&C V3.0 V3.1.14The PC Software works for these instruments: MAS-100 Iso MH MAS-100 Iso NT (Standard and RABS)The instrument will communicate its type and firmware version to the PC Software.The PC Software will interact with the instrument accordingly.Related user manualsThe following user manuals provide additional essential information:Document designationMAS-100 Iso NT Hardware ManualMAS-100 Iso MH Hardware ManualMAS-100 Iso NT Installation ManualMAS-100 Iso MH Hardware ManualDocument scopeDescribes hardware related topics.Describes the installation options.Contains technical information and the installationchecklist.MAS-100 Iso NT/MH Communication ManualDescribes the communication protocol used tocommunicate with the instrument via all availableinterfaces, e.g. Ethernet, Profibus and RS-232.DA-100 NT User ManualDescribes the adjustment and calibration procedures.MAS-100 Iso Pressure Test User ManualDescribes how to operate the pressure test kit.Page 4 of 64

Table of contents1General information91.1Safety information91.1.1Severity levels91.1.2Specific safety information for the instrument91.2Operation111.2.1Personnel qualification111.2.2Intended product use111.2.3Operating conditions111.2.4«Dual-Use» statement111.3Warranty111.3.1General111.3.2Quality statement111.3.3Contact121.3.4Exclusion clauses121.4Product labeling132Instrument description143Profibus interface description144Ethernet interface description145RS-232 interface description155.1Communication parameters155.2RS-232 to RS-485156USB interface description157Common Interface Protocol167.1Introduction167.2Interface Operations Overview167.2.1Command anatomy167.2.2Passing parameters167.2.3Operations177.2.4Errors handling177.3Execute command (%CM#Id)187.3.1Start/Stop measurement187.3.2Alarm acknowledge187.3.3Load default values187.3.4Reset memory197.3.5Calibration197.3.6Service mode197.3.7Set valve states207.3.8Set digital output207.3.9Sampling head207.4Check password/write password (%CP/WP#Id)207.5Read/write settings (%RS/WS#Id)20Page 5 of 64

7.5.1Process settings207.5.2Delay data217.5.3User selection217.5.4Time/Date217.5.5Head ID227.5.6Location227.5.7Protected mode227.5.8Online print227.5.9Calibration validity time237.5.10Lock calibration237.5.11Predefined standard volumes237.5.12Time and date format247.5.13Summertime247.5.14HMI position (MAS-100 Iso NT only)247.5.15Printer selection247.5.16Pump power for decontamination257.5.17Digital flow guard signal for decontamination257.5.18Threshold for analog flow guard signal for decontamination257.5.19Lock decontamination257.5.20RS-232 interface settings267.5.21Profibus interface settings267.5.22Ethernet interface settings277.5.23Sampling head277.5.24Head count287.5.25Head selection287.5.26CNS Delay287.5.27Head ID of head287.5.28Location of head297.5.29Pneumatic connection lengths between manifold and head297.5.30Pipe diameter297.5.31Pneumatic connection lengths between device and manifold307.5.32Maximum allowable flow deviation from target air flow307.6Read measurement values (%RM#Id)317.7Read system information (%RI#Id)327.7.1Instrument name327.7.2Hardware version327.7.3Software version327.7.4Date of last adjustment327.7.5Calibration validity337.7.6Serial number337.7.7Number of probe log entries337.7.8Number of alarm log entries337.7.9Statistic data347.7.10Running fraction35Page 6 of 64

7.7.11Adjustment/Calibration error357.7.12Actual (current) flow adjustment data367.7.13Ambient pressure adjustment data377.7.14Instrument model377.7.15Previous (last) flow adjustment data387.7.16Date of previous (last) adjustment387.7.17Flow calibration test data for test protocol397.7.18Flow calibration test data for calibration certificate397.7.19Saved flow calibration data407.7.20Calibration activation date407.7.21Flow calibration values407.7.22Saved flow calibration values417.7.23Date of last adjustment of head417.7.24Date of previous adjustment of head417.7.25Flow adjustment data of head427.7.26Flow adjustment data of previous adjustment of head437.7.27Calibration validity of head437.7.28Calibration activation date of head447.7.29Saved flow calibration data of head447.7.30Saved flow calibration flow values of head447.7.31Maximum allowable flow deviation from target air flow for test protocol457.7.32Saved maximum allowable flow deviation from target air flow of head457.7.33Software beta version457.7.34Target adjustment flow457.7.35Adjustment flow correction467.7.36Adjustment flow correction of head467.7.37Software compatibility467.8Read states (%ST#Id)467.8.1Measurement states467.8.2Alarm state477.8.3Warning state487.8.4Technical faults497.8.5Valve states497.8.6Adjustment/Calibration state507.8.7Digital inputs517.8.8Digital outputs517.8.9All states527.8.10Fieldbus state537.8.11State flush flow available537.8.12Currently active head537.8.13Position sensor547.8.14Read probe log entry (%RP#Id)547.9Read alarm log entry (%RA#Id Index Values)568Profibus communication57Page 7 of 64

8.1Profibus communication protocol selection578.2Standard Profibus protocol578.3SPS Profibus protocol588.3.1Input data598.3.2Output data608.3.3Used formats618.3.3.1On / Off618.3.3.2Numeric618.3.3.3Measurement nical sion628.3.3.10Printer selection628.3.3.11User ID62Page 8 of 64

1General informationThis section provides information of general interest regarding the instrument.1.1Safety information1.1.1Severity levelsWarning!Symbols in red boxes indicate hazardous situations which could result in danger to lifeand/or serious injury and/or irreparable damage to the instrument.Attention!Symbols in yellow boxes indicate critical situations which could result in light injuriesand/or damage to the equipment and/or unreliable air sampling results.NoteSymbols in green boxes indicate information which may be of major interest for the user.1.1.2Specific safety information for the instrumentHazard of dangerous voltage inside the power supply.Do not open the power supply.Always keep the areas of electric parts dry (e.g. USB plugs).Hazard of explosion and/or fire.The instrument contains a Lithium-Ion battery which might catch fire if damaged.Hazard of explosion and/or fire.The instrument is not explosion protected; never use it in explosion hazard areas.Hazard of serious injury and/or death.The used decontamination gas may be toxic, corrosive, flammable or explosive.Ensure the safety according to the safety data sheet of the used decontamination gas.Hazard of injury and/or damage to the instrument.Make sure that the equipment does not drop on the floor.Always ensure secure hold and stability.Hazard of damage to the instrument.Read the instructions in this user manual carefully before any usage of the instrument andpay attention to all warnings.Keep this manual in a designated place, accessible for all users for future reference.Ensure that all personnel have read and understood the content of this manual.Page 9 of 64

Hazard of damage to the instrument.Do not spill liquids into the electric/electronic connections or through the sampling heads.Hazard of damage to the instrument.Do not perform any intervention inside the instrument.Only trained, qualified and authorized technicians are allowed to perform repair andmaintenance activities.Hazard of damage to the equipment.The system power cord must be easily accessible at all times.Pull the plug rather than the cord to disconnect the system from any electrical outlet.Keep the power cord off the passage; make sure it is not pinched at the plug, electricaloutlets, and the point from which it is connected to the system.Hazard of damage to the instrument.The piping downstream of the decontamination outlet must be unblocked and free ofobstructions.Otherwise an excessive backpressure could build up and release decontamination fluid intothe instrument.Hazard of damage to the instrument and/or wrong air sampling results.The instrument is a precision device for industrial and laboratory use.The instrument shall only be operated by trained, qualified and authorized personnel asstated in section 1.2.1.Hazard of damage to the equipment and/or wrong air sampling results.Any application other than the intended use is not covered by warranty.For additional information, please consult section 1.2.2 and section 1.3.Hazard of wrong air sampling results.Using the instrument with the «Easy-Clean» base requires additional considerations duringadjustment and calibration:Always perform calibrations and adjustments with the MAS-100 Family Calibration Diskwith 85mm diameter or a Petri dish inside the sampling head.Hazard of wrong air sampling results.An adequate handling of the Petri dish and of the instrument are essential.Always follow good cleanroom practices to make sure that the Petri dish and sampling headdo not get contaminated.Hazard of wrong air sampling results.The manufacturer declines any responsibility for misuse of the PC Software and forentering wrong results.It is the sole responsibility of the user to fill-in the correct values.This system was not developed to meet the technical requirements from 21 CFR part 11 andinternational regulations regarding GxP regulated records.If data generated by this system in a GxP regulated environment is needed, ensure tomaintain paper recording in accordance with GxP procedures.Page 10 of 64

Hazard of cross contamination.The FDA considers the separation of penicillin production from other drug products forhuman use as a GMP requirement (21 CFR211.46(d)), therefore we recommend that you takeany precaution for installing and handling your MAS system accordingly.1.2Operation1.2.1Personnel qualificationThe instrument is a precision device for industrial and laboratory use. Its use should be restricted to trained,qualified and authorized personnel only.1.2.2Intended product useThe instrument is intended solely for the collection of air samples at ambient pressure onto a microbiologicalculture medium in order to monitor the microbiological air quality in contamination-controlled areas, such ascleanrooms, isolators, operating theatres, flow hoods, etc.1.2.3Operating conditionsThe instrument must be calibrated and operated in similar environmental conditions. Please consult theoperating conditions in section «Technical specifications» of the respective instruments Hardware Manual.1.2.4«Dual-Use» statementThe MAS-100 Iso NT/MH is an instrument designed solely for civilian purposes and is excluded in the scope ofthe European «Dual-Use» regulation EC 428/2009.1.3Warranty1.3.1GeneralThis section informs about the warranty of the instrument and the procedures to fol

The Software MAS-100 Iso NT Air Sampler - C&C is designated hereafter as «PC Software». Applicability The information in this manual is valid for the following configurations: Component Component designation Revision from Hardware Main PCB MAS-100 Iso NT Main PCB MAS-100 Iso MH V6 V6 Firmware Firmware MAS-100 Iso NT Firmware MAS-100 Iso MH V2.7 V1.0 Software Software MAS