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Anoxomat

Mark II CTS

User’s guide

Appendix D

Regulatory notices

Regulatory

approval type

Description

U.S. Safety

This product has been designed to meet the intent of UL 61010-1 3rd edition, “Electrical Equipment for

Measurement, Control and Laboratory Use; Part 1: General Requirements.”

Canadian Safety

This product has been designed to meet the intent of CAN/CSA C22.2 No. 61010-1 3rd edition,

“Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use - Part 1:

General Requirements.”

CE Declaration of

Conformity: EMC

This product meets the intent of Directive 2014/30/EU for Electromagnetic Compatibility. Compliance was

demonstrated using the following standards, as listed in the Official Journal of the European Communities:

Consult the Declaration of Conformance certificate shipped with the product for the latest update.

IEC/EN 61326-1: 2nd Edition, IEC/EN 61326-2-6: 2nd Edition,

“Electrical Equipment for Measurement, Control,

and Laboratory Use.” This equipment has been designed and tested to CISPR 11 as a Class A digital device. In a

domestic environment it may cause radio interference, in which case you may need to take measures to

mitigate the interference.

Do not use this device in close proximity to sources of strong electromagnetic radiation (e.g. unshielded

intentional RF sources), as these can interfere with the proper operation.

CE Declaration

of Conformity:

Low Voltage

This product meets the intent of Directive 2014/35/EU, the Low Voltage Directive. Compliance was

demonstrated using the following standards as listed in the Official Journal of the European Communities:

Consult the Declaration of Conformance certificate shipped with the product for the latest update.

IEC 61010-1, 3rd Edition,

“Safety Requirements for Electrical Equipment for Measurement, Control and

Laboratory Use Part 1: General Requirements.”

IEC 61010-2-101: 2nd Edition

“Safety Requirements for Electrical Equipment for Measurement, Control and

Laboratory Use - Part 2-101: Particular Requirements for In Vitro Diagnostic (IVD) Medical Equipment”.

FCC: Part 15, Subpart

B, Class A

This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:

This equipment is to be operated in a commercial environment only.

If not installed and used in accordance with the instruction manual, may cause harmful interference

to radio communications.

Canadian ICES-003

This Class A digital apparatus complies with Canadian ICES-003.

Cet appareil numérique de la classe A est conforme à la norme NMB-003 du Canada.

Japan VCCI

This Class A digital apparatus complies with VCCI technical requirement V-3.

EC Declaration of

Conformity: WEEE

This product meets the intent of Directive 2012/19/EU for Waste Electrical and Electronic Equipment (WEEE).

Consult the Declaration of Conformance certificate shipped with the product (if required) for the latest update.

EC Declaration of

Conformity: RoHS

This product meets the intent of Directive 2011/65/EU for “Restriction of the Use of Certain Hazardous

Substances in Electrical and Electronic Equipment.”

U.S. FDA Listing

The Anoxomat®, along with the accessories by Advanced Instruments, are listed with a U.S. Department of

Health and Human Services, Food and Drug Administration, as:

Anoxomat® Class 1

Accessories Class 1

Health Canada

The Anoxomat®, along with the accessories by Advanced Instruments are licensed with Health Canada,

Therapeutic Products Directorate, Medical Devices Bureau, as:

Anoxomat® Class 1

Accessories Class 1

Содержание Anoxomat Mark II CTS

Страница 1: ...Anoxomat Mark II CTS user s guide ...

Страница 2: ...Fig 1 8 Gas connection setup 10 Fig 1 9 Edit gas mixture 11 Fig 1 10 Setup language 11 Fig 1 11 Set date time 11 Fig 1 12 Unlock registration code 13 Fig 1 13 Registration 13 Fig 1 14 Jar setup 13 Fig 1 15 Add user 14 Fig 1 16 Registered user 14 Fig 1 17 Connect printer 15 Fig 1 18 Choose printer 15 Fig 1 19 Enter fixed ip address 15 Fig 1 20 Set IP address of network card 16 Table 1 1 Anoxomat Ma...

Страница 3: ...cs report 27 Table 3 2 Primary and one secondary gas supply 22 Table 3 2 Primary and two secondary gas supplies 22 Chapter 4 Maintenance 28 4 1 Maintaining the Anoxomat 28 4 2 Maintaining jars 28 Fig 4 1 Cracked jar 29 Fig 4 2 Cracked jar 29 Chapter 5 Troubleshooting and service 30 5 1 Service and maintenance cautions 30 5 2 Obtaining service 30 5 3 To return an instrument for repair or replacemen...

Страница 4: ...structions in the literature accompanying this product The lightning flash with arrowhead symbol within an equilateral triangle is intended to alert the user to the presence of uninsulated dangerous voltage within the product s enclosure that may be of sufficient magnitude to constitute risk of electric shock to persons The static symbol within an equilateral triangle is intended to alert the user...

Страница 5: ...rm temperature variations or locations that exceed the specified operating environment temperatures Never use this product in a wet area To avoid injury or fire hazard do not operate this product in an explosive atmosphere Do not install or use the product on an unstable non level work surface Do not operate this product with the covers removed or unsecured FCC requirements WARNING Changes or modi...

Страница 6: ...ed atmosphere in an anaerobic jar The condition is created by evacuating a jar and filling it again with a oxygen free gas mixture according to the Method of McIntosh and Fildes The Advanced Instruments Anoxomat Mark II CTS system controls this process by means of an embedded computer and performs various quality assurance tests to ensure that conditions for optimum bacterial growth are precisely ...

Страница 7: ...ts before operating your instrument 1 2 Obtain additional items To install the Anoxomat you will need to obtain the following items Adjustable wrench to tighten the dual stage regulator Adjustable joint pliers to tighten the gas tube clamps Gas cylinder containing appropriate anaerobic mixture Dual stage regulator 1 8 bar Refer to Section 1 4 1 1 Unpack the instrument In order to set up your instr...

Страница 8: ...and insurance to apply Have the transportation company inspect items fill out a Report of Concealed Damage and file your claim Then notify Advanced Instruments immediately for repair or replacement 5 Fill out the warranty card enclosed Mark the appropriate boxes if you wish to receive additional information Mail or fax to 781 320 8181 1 4 Install the primary standard gas supply For creating standa...

Страница 9: ...inter paper 3 Connect the printer power supply assembly See instructions for Activating the Printer later in this chapter 1 6 Connecting to a computer or network optional If your Anoxomat includes a data interface to a computer or network Use a cross link Ethernet cable to connect the Anoxomat directly to the network card of the computer Use a standard patch cable to connect to a network See instr...

Страница 10: ...r and a keyboard will appear 1 9 Setting up the instrument This section is restricted for use by the Supervisor who is required to enter the Set up Code from the red label Fig 1 4 before defining or changing settings 1 Press Setup The setup code screen displays with keyboard Fig 1 6 2 Enter the Setup Code from the red label Fig 1 4 and press Ok The main Set up screen displays Fig 1 7 Setup gas con...

Страница 11: ...r Anoxomat press Language on the setup screen and select your preference from the Language screen Fig 1 10 Setup date and time If your Anoxomat is equipped with a printer and or is using a data interface the date and time of a process will appear on the printout or in the database Fig 1 11 To set the date and time press Date time on the Setup screen Using numbers enter the date as two digit day tw...

Страница 12: ...ly increases the risk of ignition and fire Never use such hazardous gas mixtures with the Anoxomat For other jar composition results see Additional Gas Connection section Hydrogen gas at 14 is considered flammable therefore it is recommended that any gas mixture should not be purchased above such limit High concentrations of oxygen are a potential fire hazard for operators It is not recommended to...

Страница 13: ... input data e g Jar ID contents of jars job reference etc before each recipe is started 1 On the Registration screen press Jar Setup The Jar Setup screen Fig 1 14 displays a list of options and corresponding check boxes 2 Using the soft touch pen or your fingernail select the fields you want to include by tapping each box to place a checkmark If you checked a box by mistake tap again to remove the...

Страница 14: ...e user code will not appear anywhere but will need to be entered each time a recipe is started 4 Press Submit to add the name and code to the list of registered users Fig 1 16 5 Repeat steps 2 4 for each registered user 6 To delete a registered user select the entry from the Registered Users list and press Remove 7 Press Close to save your settings and exit to the Registration screen When you have...

Страница 15: ...he user at the end of each cycle 1 13 Activating the data interface optional If you purchased the optional Data Interface feature you will need to setup and activate the software before you can transfer data to a network or PC 1 On the Setup screen press Interface 2 Enter the Data Interface Code from the red label Fig 1 4 and press Ok The Network Settings screen displays Fig 1 19 Connecting to a n...

Страница 16: ...omat directly to the network card of the PC Contact your system administrator for a range of IP addresses to be used and enter a fixed IP address Fig 1 19 Set the IP address of the network card in your PC within the same range Fig 1 20 Reboot the Anoxomat to activate the connection See Chapter 3 Data Interface Fig 1 20 Set IP address of network card ...

Страница 17: ...ubes micro well plates or other samples in the jar using the Petri dish holder 2 Add catalysts to jar for anaerobic bacterial cultivation It is also recommended to use optical oxygen indicator strip or appropriate QC plate in the jar 3 Place the lid on the jar and slide the jar clamp over the lid Tighten finger tight only the jar clamp screw If the ergonomic jars are used close the clamps on each ...

Страница 18: ...appears in the Connected column it means that the jar is under vacuum Possibly it was partly processed and did not pass a QA test When a appears for one of the parts of the Quality Assurance this means that the jar has passed that particular test A means that the jar failed on that specific step of the Quality Assurance In this case the Anoxomat does not process the jar any further The jar may be ...

Страница 19: ...n and is ready for the next job The last performed recipe stays active This can be checked in the Active recipe section Fig 2 3 on the main screen 2 5 Quality Assurance program For the standard microaerophilic and anaerobic recipe a standard quality assurance level has been set as default The Anoxomat automatically enables this quality assurance level To disable the quality assurance setting press...

Страница 20: ... once the test is complete and the recipe reselected 2 7 Changing the default Quality Assurance level for a recipe To change the default setting for the standard quality assurance level 1 Press the Program recipes button on the bottom of the Main screen to display the Program Recipes screen Fig 2 5 2 Select the recipe for which you want to change the default quality assurance level The Edit Recipe...

Страница 21: ...use of the Anoxomat and determine which user processed which samples with the Anoxomat See Chapter 1 Registration Setup to activate this option Starting a recipe using the Registration Input screen 1 Press the Start Continue button If you have registered one or more users the Details Fig 3 1 screen will be displayed 2 Enter the user code and press Start Continue The Jar Content Fig 3 2 screen will...

Страница 22: ...uture reference see Activating pre programmed or user defined recipes 3 4 Additional jar connections If you need to be able to process more than one jar at a time you can order one or more additional jar connections including software update The Anoxomat allows a maximum of 4 jar connections jars and gases 3 5 Additional gas connections If your type of culture or research requires more than one ga...

Страница 23: ...s option with the Anoxomat the code can be found on the red protection label Fig 1 4 or may be supplied by your local dealer if purchased later Enter the code and press the Ok button The New Recipe screen Fig 3 5 displays 4 Define end percentage O2 In the gas composer partition of the screen define the end concentration O2 either by moving the scroll bar to the right or by using the scroll button ...

Страница 24: ...ted to 400 500 or 600 mbar Depending upon the required O2 level the Anoxomat may perform more cycles than usual to reach the gas mixture in the jar 7 Specify the recipe name Click in the space and the screen keyboard will appear Enter the description for this recipe The name and other relevant information of the recipe will appear in the Active Program section on the Main screen 8 Save the recipe ...

Страница 25: ...ted the thermal or dot matrix printer you can request a printout of each recipe run on the Anoxomat A detailed printout Fig 3 7 of each jar can be attached to the lids using small clips available from Advanced Instruments thereby eliminating any mix up of jars If the optional Registration Input screen was configured and activated in your Anoxomat the additional information will be included on the ...

Страница 26: ...work Settings screen see Chapter 1 Activating the data interface 3 Your Anoxomat web page Fig 3 10 appears displaying your serial number Click on Recipes The CSV file will be generated and displayed Fig 3 11 Transferring data to a Microsoft Excel database The Excel database provided by Advanced Instruments includes search additional input and statistical evaluation functions Copy the Excel file pr...

Страница 27: ...er additional information to an existing recipe In the Edit recipe area at the bottom of the Overview sheet Fig 3 14 you can input free text Click Save to add or update your remarks to the recipe View Anoxomat statistics Select the day result sheet Fig 3 16 to view statistical information about the work done with the Anoxomat The table displays the quantity of jars per day and per result Fig 3 14 ...

Страница 28: ... jars Spray a little Teflon spray in the snap shut coupling to keep the coupling lubricated Clean and apply acid free Vaseline on the rubber O ring of the lid only with the standard jars Clean and leave dry no Vaseline the seal in the ergonomic jar lids To be certain that the jars are maintained correctly and regularly a small box with necessities to maintain all jars working with the Anoxomat sta...

Страница 29: ...ns of excessive wear Also closely inspect the jar if it fails the Jar Test or Seal Leak Test during processing And finally inspect the jar if the Pump Time Exceeded or Fill Time Exceeded message is displayed Deep horizontal cracks especially near the top are indications that the jar has been dropped or the clamps have been tightened excessively Fine vertical cracks are signs that the jar has been ...

Страница 30: ... the human body or other conductor may damage system boards or static sensitive devices Never perform internal maintenance without following recommended static protection procedures The product is equipped with operator accessible fuses If a fuse blows it may be due to a power surge or failure of a component Replace the fuse only once If the fuse blows a second time it is probably caused by failur...

Страница 31: ...or similar tool to pry open the fuse compartment door Slide out each fuse holder Visually check for a blown fuse If there is any doubt test the fuses with a continuity checker or ohmmeter or simply replace them with new fuses Check error messages The software of your instrument is designed to display specific error messages many self explanatory that will help you discover the source of your probl...

Страница 32: ...l the outer ring of the snap shut coupling downward Gas connection has not passed the corresponding test Gas input test failure No pressure from gas cylinder Check if gas cylinder is open Pressure supplied by the reducing valve is lower or higher than 1 75 bar 15 bar 25 5 2 psi Check output pressure on the reducing valve The reducing valve does not indicate real pressure Check actual pressure in t...

Страница 33: ...heck In case the jar tube is bent cracked or torn contact your local Anoxomat distributor or Advanced Instruments Jar has not passed the corresponding test There isn t enough activity to achieve and maintain an anaerobic atmosphere in the jar Catalyst activity test failure No catalyst in the jar Insert catalyst in the appropriate location and restart the recipe Catalyst not generated Exchange the ...

Страница 34: ...and turn on system again Select screen option Retry starting the Anoxomat and check box Restore factory defaults and click OK Error Setting file is corrupted default settings are loaded As the error appears press OK The system will restart with factory default settings All laboratory specific data i e recipes registrations software activation codes will need to be re entered Touch screen does not ...

Страница 35: ...bate a quality control plate before processing any patient sample to avoid any loss of patient sample Printer does not function Power connection is loose Tighten connection Serial cable is loose Re seat connection No communication with external computer Cable is unplugged Plug in cable Ethernet cable is damaged Replace cable Ethernet connector is damaged Service the instrument to replace connector...

Страница 36: ... 1J 2G 220V Anoxomat controller 1 Jar and 2 gas connections 1J 3G 220V Anoxomat controller 1 Jar and 3 gas connections 2J 1G 220V Anoxomat controller 2 jar and 1 gas connection 2J 2G 220V Anoxomat controller 2 jar and 2 gas connections 2J 3G 220V Anoxomat controller 2 Jar and 3 gas connections 3J 1G 220V Anoxomat controller 3 Jar and 1 gas connection 3J 2G 220V Anoxomat controller 3 Jar and 2 gas ...

Страница 37: ...16mm tubes Anoxomat accessories and supplies AN2GC Additional gas connection AN2JC Additional jar connection AN2BCS Barcode scanner AN2ISC1 Registration input screen AN2DI Data interface AN2PPR Pre programmed recipes AN2TT Track and trace package AN2UPF User programming function AN2TP1 Recipe printer thermal paper or medical grade paper AN2TP3 Dot matrix printer for plain paper MT2000 Jar maintena...

Страница 38: ...imately 7 Liter 0 25 cubic feet per jar Jars per cylinder Microaerophilic Anaerobic 10 Liter 150 bar 700 200 10 Liter 200 bar 200 250 50 Liter 150 bar 3600 1000 50 Liter 200 bar 4900 1400 Operating conditions Temperature 10 C to 32 C 50 F to 91 F Humidity 20 80 relative humidity non condensing Dimensions inches centimeters Width 12 8 32 0 Depth 20 8 52 0 Height 11 2 28 0 Weight Pounds Kilograms Ne...

Страница 39: ...oid the user s authority to operate this product previously issued factory approvals and the user s rights under the warranty The distributor or dealer may have applied additional local national or international approvals to this product Consult the distributor or dealer for more information and documentation Connections to this product must be made with shielded cables Use of non shielded cables ...

Страница 40: ...rmance certificate shipped with the product for the latest update IEC 61010 1 3rd Edition Safety Requirements for Electrical Equipment for Measurement Control and Laboratory Use Part 1 General Requirements IEC 61010 2 101 2nd Edition Safety Requirements for Electrical Equipment for Measurement Control and Laboratory Use Part 2 101 Particular Requirements for In Vitro Diagnostic IVD Medical Equipme...

Страница 41: ...ms of this warranty in no case include any obligation or responsibility for transportation charges or arrangements All results calibrations effectiveness medical diagnoses and interpretations are the responsibility of the user THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES REPRESENTATIONS AND CONDITIONS OF ANY KIND EXPRESSED OR IMPLIED IN FACT OR BY LAW IN NO EVENT SHALL ADVANCED INSTRUMENTS BE ...

Страница 42: ... personnel if advised immediately by the user of the occurrence of any accident The user warrants that 1 The instrument will be used reasonably 2 The instrument will be regularly maintained according to this manual including a log of all service tests and repairs performed on the equipment and records will be kept of all requests for repair made to Advanced Instruments where such repairs were beyo...

Страница 43: ...by Advanced Instruments assuming English reading personnel or supervision If neither the supervisor nor the operator reads English the user agrees to obtain accurate translations of the instrument labels instructions user s guides and or manuals provided Under direct on the job supervision of the supervisor or other professional in charge In which there are no known defects or uncorrected repairs ...

Страница 44: ...ion Appendix F The DB 9 RS 232 port on your instrument conforms to the DTE EIA 232 standard and can reliably communicate over shielded cable up to 10 meters in length This port is reserved for communication to the printer software updates and factory testing purposes ...

Страница 45: ...al arrow Printer Enter RS232 Bar code Attention Caution hot surface Dangerous voltage Lifting hazard Calibrator Content Control Negative control Positive control Flammable Fragile Irritant Keep dry Date manufactured Sterile The below list of symbols is for reference only Not all symbols shown may be used on this instrument or in the accompanying documentation ...

Страница 46: ...nstructions Lot number Use by Expiration date Authorized representative Part number Sufficient for x tests Open here Low fluid level Keep hands clear Manufacturer Latex free Diluent See instructions for temperature guidelines Potential puncture hazard Electronic equipment dispose of properly ...

Страница 47: ...cision has been made to replace or dispose of this product Contact the supplier who sold you the product Whether this was Advanced Instruments itself or one of its authorized dealers this supplier should be knowledgeable about the national and local regulations governing disposal and recycling of products in your area In some cases this supplier may be legally obligated to accept the product from ...

Страница 48: ...rk II ________________________________________________________________________________ Serial number _________________________________________________________________________________________ Software revision ______________________________________________________________________________________ ...

Страница 49: ...49 Anoxomat Mark II CTS User s guide Service log Date Problem symptom Action ...

Страница 50: ...egarding the proper operation of your instrument please contact our Hot Line Technical Service department by calling one of the following numbers 800 225 4034 toll free within the USA and Canada 8 00am 4 30pm EST after normal business hours dial 781 320 9000 1 781 320 9000 elsewhere 1 781 320 0811 fax Hot Line Technical Service Advanced Instruments and worldwide distributor network provides 24 7 c...

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