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Appendix

Thermo Scientific

PART 4: Operational qualification / user training

Topics to be covered

YES

Comments:

3. Presentation of the main views in the software

Comments:

4. Creating and inserting new applications, in the following order

Creating new reagents

Test and reagent view (F3)

Creating calibrator and control definition

Calibration and quality control view (F4)

Creating test definition

Test and reagent view (F3)

Defining calibrator values

Calibration and quality control view (F4)

Defining control values

Calibration and quality control view (F4) / Lot concentration tab

Parameters to file, PDF, hard copy if the printer has been installed

Uploading parameters from file or scanned 2D barcode

Comments:

5. Dilution possibilities of the software

Manual, automatic redilution for sample, automatic dilution from the application parameters, redilution manual
request

Comments:

6. Calibrations printed and/or saved to a folder to be created on the desktop

Comments:

7. Test parameters printed and/or saved to a folder to be created on the desktop

Comments:

8. Reports (F2 > Reports)

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Страница 2: ...or reference purposes only System configurations and specifications in this document supersede all previous information received by the purchaser Use of this analyzer in a manner not specified by the manufacturer could impair any protection provided by the analyzer No responsibility and no liability is assumed for any errors omissions damage or loss that might arise out of the use or inability to ...

Страница 3: ...y and bulky for one person alone to handle safely Figure 1 Safety labeling outside analyzer Safe operation Warning Follow the instructions to ensure the correct and safe operation All surfaces under the main cover are potential sources of toxicants and irritating biological agents Use protective gloves spectacles and clothes ...

Страница 4: ...ectacles and clothes when working with the waste water container The operator must be cautious when working with the cuvette waste bin Waste water container Warning The waste water container is a potential source of toxicants and irritating biological agents Treat the waste water container as other dangerous material in laboratory Use protective gloves spectacles and clothes when working with the ...

Страница 5: ...v Racks Caution Racks are potential sources of toxicants and irritating biological agents USB cable Information Use only for connection between the analyzer and workstation The maximum length of the USB cable is 2 meters ...

Страница 6: ...vi Thermo Scientific Figure 2 Safety labeling inside analyzer ...

Страница 7: ...Use protective gloves spectacles and clothes Figure 3 Tubing connector Tubing connector Warning The tubing connector of the waste water container is a potential source of toxicants and irritating biological agents Main cover Caution When closing the cover put your hands to the left and right side on its outer front surface see the blue areas in the sign and press the cover downwards until you hear...

Страница 8: ...ulating cover in its place Barcode reader Caution Laser detects the barcodes Keep the covers closed during analysis Laser radiation Do not stare into beam Class 2 laser product The laser follows the IEC 60825 1 2007 standard The maximum output of laser radiation is 1 mW The emitted wavelength is 650 nm ...

Страница 9: ...r measurement control and laboratory use Part 2 010 Particular requirements for laboratory equipment for the heating of material EN 61010 2 081 A1 IEC 61010 2 081 A1 CAN CSA C22 2 No 61010 2 081 Safety requirements for electrical equipment for measurement control and laboratory use Part 2 081 Particular requirements for automatic and semi automatic laboratory equipment for analysis and other purpo...

Страница 10: ...has been tested and found to comply with the limits for a Class B digital device pursuant to part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference in a residential installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interferenc...

Страница 11: ...mpanies should dispose of or recycle this product For further information on Thermo Fisher Scientific s compliance with these directives the recyclers in your country and information on Thermo Fisher Scientific products which may assist the detection of substances subject to the RoHS Directive contact us by e mail weee recycle thermofisher com ...

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Страница 13: ...ms 4 Inspecting analyzer 4 Returning analyzer damaged in transit 4 Chapter 3 Space and load requirements 5 Chapter 4 Setting up 9 Removing handles 9 Washing water containers and cuvette waste bin 10 Connecting peristaltic pump tube 10 Unsecuring probes and mixer 12 Checking probes 13 Placing rack labels 14 Checking filters 15 Installing ECM unit 17 Electrodes 18 Preparing reference electrode 20 Pr...

Страница 14: ... Thermo Scientific Appendix 1 Removing transport casing 29 Appendix 2 Sample rack types 31 Appendix 3 Consumables and accessories 35 Appendix 4 Installation operational and performance qualification 39 Glossary 49 ...

Страница 15: ...ssed to the personnel responsible for installing the analyzer The operator must be trained in and should have a knowledge of handling the analyzer Note It is recommended to follow good laboratory practices GLP Product documentation The product documentation consists of the following manuals Operation Manual contains instructions on how to operate the analyzer during normal operation once it has be...

Страница 16: ...s and updated the Consumables and accessories list and the IQOQ procedure A July 2012 N12273 4 1 Updated information about configuration of ECM electrodes and contents of Start up kit B October 2012 N12273 4 1 PC configuration information and filter tables updated A June 2013 N12273 5 0 Updated system configuration information A October 2013 N12273 5 1 Checked the content against 5 1 software Upda...

Страница 17: ...n of software or damage to equipment or property Document conventions Important abbreviations and terms in this manual are spelled out in Glossary The last command of the user interface menu path is presented in bold for example Select F2 Samples New Menu names in the user interface are shown in bold for example Select the correct test from the Test name drop down menu in the Results view Paramete...

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Страница 19: ...ing error or master used too much time Thermo Fisher Scientific is not responsible for possible errors due to 3 rd party software installed by customer Note It is not recommended to connect the workstation to the Internet due to the risk of viruses unless specifically requested by Thermo Fisher Scientific in order to join a remote support session To use remote connection refer to the instructions ...

Страница 20: ...C Relative humidity 40 80 non condensing Altitude 2000 m from the sea level Heat output 680 without ECM 750 with ECM BTU h Electromagnetic environment basic electromagnetic environment residential office laboratory light industry industrial electromagnetic environment Water requirements Follow the local water regulations set for the laboratory The following specification is a minimum requirement f...

Страница 21: ...page 29 for unpacking instructions 3 Remove packing material inside the analyzer Note Handle analyzer carefully Recycling packing material To recycle the packing material follow the local recycling instructions Table 6 Packing materials Packing item Material Packing case Cardboard Pallet Wood Plywood fumigated according to the standard ISPM 15 Screws Metal Fe Protection tube Polythene PE LD CFC HC...

Страница 22: ...serial number with the shipping list to verify that the received product is correct Checking delivery items Check that all items are included in the delivery in accordance with the shipping list Inspecting analyzer The analyzer requires careful handling before installing Examine the analyzer to see if any damage occurred during transportation Returning analyzer damaged in transit If the analyzer h...

Страница 23: ...behind the system for proper air circulation and for maintenance and electrical connections In addition allow at least 70 cm 27 6 in of vertical clearance between the top of the analyzer and any shelves above it Place the workstation on the right side of the analyzer Each power plug must have own wall outlet It is not recommended to use extension cables Note It is recommended to have UPS for power...

Страница 24: ...width H 62 24 4 Analyzer height main cover closed H2 130 51 2 Analyzer height main cover opened D 70 27 6 Analyzer depth main cover closed D2 80 31 5 Analyzer depth main cover opened D3 11 4 3 Analyzer depth max exceeding of table edge main cover closed L 20 7 9 Clear space for air circulation on the left side L2 40 15 8 Clear space for maintenance on the left side R 20 7 9 Clear space for air cir...

Страница 25: ...3 Space and load requirements Space and load requirements Thermo Scientific 7 Figure 5 Placing analyzer and workstation on table ...

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Страница 27: ...ette waste bin Connecting peristaltic pump tube Unsecuring probes and mixer Checking probes Placing rack labels Checking filters Installing ECM unit Setting up workstation and connecting cables Removing handles To remove handles turn handles counterclockwise Figure 6 Removing handles ...

Страница 28: ... use rinse deionized water container with deionized water and waste container and cuvette waste bin with tap water Figure 7 Cleaning containers and cuvette waste bin Connecting peristaltic pump tube To connect peristaltic pump tube 1 Open the right cover plate 2 Remove the tube holder clamp 3 Place the yellow tube over the peristaltic pump ...

Страница 29: ...4 Setting up Setting up Thermo Scientific 11 4 Attach the tube fittings to their place 5 Put the tube holder clamp in its place ...

Страница 30: ...2 Thermo Scientific 6 Place the ECM probe wash peristaltic pump tube in a similar way 7 Close the right cover plate Unsecuring probes and mixer To unsecure the probes and the mixer 1 Remove the foam plastic 2 Open the screws on the support arms ...

Страница 31: ...tting up Checking probes Thermo Scientific 13 3 Remove the support arms Checking probes Check that the probes are straight and in their places The service engineer adjusts the probe to the correct positions ...

Страница 32: ...he following figures 3 Stick the barcode label as shown in the following figures Make sure that the barcode is not aligned on the tube position s lip and there is no gap between the lip and the barcode Figure 9 Aligning a barcode on the rack 1 Lip of the tube position 2 Barcode Note Make sure you place the correct rack labels on the racks The rack IDs are divided as follows Sample rack 9 standard ...

Страница 33: ...el and infolabel on 18 position sample rack for tubes ID numbers 451 499 Figure 12 Barcode label rack ID label and infolabel on 18 position sample rack for cups ID numbers 401 449 Checking filters Make sure the filters are placed on the filter wheel in the right order If the order of the filters has to be corrected refer to the Service Manual for instructions on changing filters ...

Страница 34: ...lters is given in the Service Manual chapter Changing filters or at F5 Configuration Filter 4 Screw the plastic cover back in its place Table 9 Filter sets Wavelengths in nm Water Wine Juice Enzymes food Beer 340 X X X X X 380 405 X X 420 X X X X 430 X 480 X X 492 X 510 X X X X 520 X X X X 540 X X X X X 550 575 X X X X X 600 X X X X X 620 X X X 660 X X X X X 700 X X X X 750 X 880 X Note A 275 nm f...

Страница 35: ... the ECM unit Analyzer ordered with the ECM unit includes Electrode White Assembly A Electrode White Assembly B for the conductivity measurement Note For measurement you need to additionally order an ECM Start up kit 986200 which contains an electrode EC Assembly needed in conductivity measurement Figure 13 Analyzer with ECM unit ...

Страница 36: ...igure 15 Main parts of the electrode 1 Electrode pin 2 Electrode cap 3 Colored dot 4 Positioning dowel pins 5 Electrode chamber 6 Small O ring 7 Sample channel Place the electrodes always from rod to probe according to the order in the following table To prevent connecting wires and electrodes wrong connect wire and electrode having the same color mark ...

Страница 37: ...onnecting wire 1 White Assembly A not connected 2 Reference electrode Brown Brown 3 pH electrode White White 4 EC Assembly Transparent Black 5 Spacer slice Transparent 6 White Assembly B Transparent Transparent Figure 16 Connecting wires and electrodes Note Calibrate the tests and run quality controls after working with the ECM unit ...

Страница 38: ...hamber of the electrode 8 Install the internal electrode pin loosely do not tighten 9 Remove the cap from the reference filling solution bag 10 Tightly screw the reference electrode tube fitting into the filling solution bag tube fitting 11 Squeeze the bag to partly fill the electrode chamber if needed The filling solution should be above the connection from the filling bag to the inner chamber Se...

Страница 39: ...rding to the order in Order of ECM electrodes from rod to probe on page 19 7 Push the clamp and metal rod into place Note The alignment rod should snap into place when a groove is in the right position It can be helpful to insert the rod as far as you can and then pull the rod back slowly until it clicks into place 8 Tighten the thumb screw 9 Lift the clamp handle to clamp the electrodes into plac...

Страница 40: ...t the tube of the rinse liquid bag to the tube coming from the ECM dispensing pump 2 Hang the bag in its place 3 Select F5 Actions Add ECM rinse liquid to fill the tube with liquid Testing ECM electrodes To test the electrodes 1 Run start up procedure as described in Operation Manual 2 Run and accept a calibration 3 Review the calibrations of each electrode For more information about calibration r...

Страница 41: ...use extension cables Note It is recommended to have UPS for power loss protection in analyzer and workstation Connect UPS only to the workstation monitor and analyzer Do not connect UPS to the printer Figure 19 PC port connections 1 Power cable 2 Monitor 3 In reserve 4 Touchscreen 5 CAN USB connection between analyzer and workstation 6 Printer optional 7 Proprietary connector reserved for LIS conn...

Страница 42: ...e Operation Manual To set up and connect cables 1 Connect the USB cable between the analyzer and workstation 2 Connect the serial R232 adapter to the proprietary connector 3 Connect the monitor to the PC If ELO touchscreen suffers from poor aspect ratio and image quality do the following a Open the Main Menu from the monitor adjustment keys below the screen b Navigate to Image Setting c Choose Asp...

Страница 43: ...1 Keyboard 2 Handheld barcode scanner optional USB Flash drive The front panel also provides a USB port for a USB Flash drive or an optional handheld barcode scanner 5 Connect the mouse to the keyboard 1 Mouse 6 Connect the analyzer s power cable ...

Страница 44: ...4 Setting up Setting up 26 Thermo Scientific 7 Connect the workstation s power cable ...

Страница 45: ...uble clicking the icon on the desktop 5 Log on the program 6 Follow the IQ OQ procedure to configure analyzer and workstation Note Reference Manual in English and the folders for all language versions of Operation Manual and Installation Manual are placed on the computer s desktop Note For more information about normal operations refer to Operation Manual Configuring analyzer settings ...

Страница 46: ...yzer Tick interval sec Shows the length of the tick in seconds Tick is a basic measurement unit for the analyzer Additional module Define the additional module used in the analyzer If no additional module is used select None The default value is set by the manufacturer Max water blank SD A Define the maximum allowed limit for water blank standard deviation SD Max allowable absorbance A Define the ...

Страница 47: ...A Thermo Scientific 29 Removing transport casing ...

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Страница 49: ...ume Diameter x height Note 0 5 ml cup 2 ml cup 4 ml cup 13 x 25 mm 13 x 25 mm 17 x 38 mm Recommended cup height Recommended cup height Supported tubes Volume Diameter x height Note 5 ml tube 7 ml tube 10 ml tube 13 x 75 mm 13 x 100 mm 16 x 100 mm Positions 5 9 only Sample rack 9 blue Positions 9 Rack ID 80 99 Color Blue Supported cups Volume Diameter x height Note 0 5 ml cup 2 ml cup 4 ml cup 13 x...

Страница 50: ...es 451 499 Color Black Supported cups Volume Diameter x height Note 0 5 ml cup 2 ml cup 13 x 25 mm 13 x 25 mm Supported tubes Volume Diameter x height Note Note The service engineer must do the rack adjustment before this rack can be used 7 ml tube 13 x 100 mm Only non barcoded tubes In the Sample rack 9 standard and Sample rack 9 blue sample tubes can be secured in place by using a tube support p...

Страница 51: ...ing cups Note When inserting the cup make sure the cup shoulder stays above the top edge of the rack Figure 23 Inserting sample tubes Note The test tubes must be non transparent in color If transparent tubes are used a sticker is needed on the side ...

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Страница 53: ... bottles 16 pcs 984030 Washing solution 4 5 4 x 20 ml 980929 Washing solution 4 5 6 x 100 ml 980659 Cleansing solution 100 ml 981712 Tubing maintenance solution 6 x 20 ml 984330 ECM pH 2 standard 2 x 60 ml 984331 ECM pH 4 standard 2 x 60 ml 984332 ECM pH 7 standard 2 x 60 ml 984333 ECM pH 10 standard 2 x 60 ml 984334 ECM pH 12 standard 2 x 60 ml 984335 ECM conductivity 0 1 standard 1 pc 984336 ECM...

Страница 54: ... Support Plate 6 pcs Table 13 Start up kit 986100 Ordering code Item 986100 Start up kit 1 pc Consists of 981712 Tubing maintenance solution 6 x 20 ml 986540 DECACELL cuvettes 5400 tests 989221 2 ml sample cups 1000 pcs 981456 20 ml reagent bottles 16 pcs Table 14 Complete start up kit 986101 Ordering code Item 986101 Complete start up kit 1 pc Consists of 981712 Tubing maintenance solution 6 x 20...

Страница 55: ...eference electrode 1 pc 984997 pH electrode 1 pc 984399 EC Assembly 1 pc SP09701 Spacer slice 9 mm 1 pc 980659 Cleansing solution 100 ml 984340 ECM prime 4 x 20 ml 984998 ECM rinse liquid 4 x 400 ml Table 16 Upgrade kits Ordering code Item SP10973 Touchscreen 1 pc SP10992 2D scanner 1 pc SP06730 ECM upgrade kit Electrodes and standard solutions must be ordered separately 1 pc Note Upgrade kits inc...

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Страница 57: ... the steps that must be done when installing analyzer at the customer site Installation Qualification is to be done with a qualified person Operational Qualification OQ Parts 3 4 and 5 of this form describe the steps to ensure that the analyzer is operating correctly and operated by skilled users Operation Qualification is to be done with a trained and certified person Performance Method Qualifica...

Страница 58: ...pproved by Customer s name Place Date Signature Comments Vendor rep s name Place Date Signature Comments PART 2 Installation qualification Items included N A YES NO Check the items delivered with the analyzer to ensure that they are present 1 Binder contains the following items Hard disk image in the DVD or USB memory key Manufacturing certificate Empty USB flash drive for data saving Warning labe...

Страница 59: ...able 2D scanner hand held Comments 6 Proper voltage 110 230V available Comments 7 All cables connected to the PC If needed for 2D scanner printer LIS and the analyzer Comments 8 Peristaltic pump tubings installed For more information refer to Connecting peristaltic pump tube on page 10 Comments 9 Printer and UPS installed Do not connect the printer to the UPS Comments 10 Workstation warranty trans...

Страница 60: ...Comments If something is missing the item will be sent by the vendor who will confirm the delivery date PART 3 Operational qualification N A YES NO 1 Analyzer visual check All parts are undamaged Comments 2 If applicable install the electrodes For more information about electrodes refer to Installing ECM unit on page 17 Comments 3 System powered up Analyzer and workstation gets power Comments 4 Re...

Страница 61: ... the laboratory employs check digits CLSI AUTO02 A2 for ensuring the integrity of the sample identification process Barcode setup discussed with applications and all implications limitations explained Comments 10 Temperature settings For more information about configuration instructions refer to Service Manual Comments As default Set as C 11 Connection to LIS For more information about LIS connect...

Страница 62: ...ose one of the following options Use the QR code go to http survey clicktools com app survey go jsp iv 1o99tfv0uoqbs scan and e mail to system support fi thermofisher com Approved by Customer s name Place Date Signature Comments Vendor rep s name Place Date Signature Comments If something is not working correctly copy this document and contact to your local vendor If there is a problem with the an...

Страница 63: ...ibrator values Calibration and quality control view F4 Defining control values Calibration and quality control view F4 Lot concentration tab Parameters to file PDF hard copy if the printer has been installed Uploading parameters from file or scanned 2D barcode Comments 5 Dilution possibilities of the software Manual automatic redilution for sample automatic dilution from the application parameters...

Страница 64: ...waste container for cuvettes Error messages in general Error reporting tool Comments 10 Preventive maintenance procedures Daily Weekly Monthly Comments 11 Safety procedures for example User safety Microbiological contamination from the dispensing probe Laboratory safety Disposal of all wastes according to laboratory procedure Analyzer material safety Comments 12 Additional general instructions to ...

Страница 65: ...overed YES NO Exit the software Comments Approved by Customer s name Place Date Signature Comments Vendor rep s name Place Date Signature Comments PART 5 Operational qualification Name of the people trained Signature User training course during the installation period Laboratory manager Users ...

Страница 66: ...isher com Analyzer serial number Software version Date of installation Check digit in use OUT OF BOX FAILURE REPORT if needed Description Actions CUSTOMER DETAILS Name of laboratory Country This protocol is available as an Online version Use QR code or visit our support desk at http survey clicktools com app survey go jsp iv 1o99tfv0uoqbs Yes No Installation Qualification Kit 981704 Pass Fail Dist...

Страница 67: ...agent Water CLSI Clinical and Laboratory Standards Institute E ECM Electrochemical Measurement G GLP Good Laboratory Practices I ID Identification L LIS Laboratory Information System Q QC Quality Control S SD Standard Deviation U UPS Uninterruptable Power Supply ...

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