Wako Pure Chemical UTASWAKOI30 IMMUNO ANALYZER User Manual RedRay IM E

Wako Pure Chemical Industries,Ltd. IMMUNO ANALYZER RedRay IM E

User Manual

Instruction ManualInstruction ManualFirst EditionFULLY AUTOMATED IMMUNOANALYZERDecember 2009Wako Pure Chemical Industries, Ltd.
Introduction(i)µTASWako i30 Instruction ManualThank you for purchasing the μTASWako i30.The μTASWako i30 is an in vitro diagnostic medical device to analyze blood etc. using the specified reagents.Before using this equipment, please read this manual carefully to follow the safety information and the usage precautions described in the manual.Keep the manual near the μTASWako i30, so that you can refer to it whenever necessary.Copyright reserved.Copyright 2009 by Wako Pure Chemical Industries, Ltd.CAUTIONS1 No part or all of this manual may be reproduced in any form without prior permission.2 The information contained in this manual may be subject to change without prior notice.3 Wako Pure Chemical Industries, Ltd. shall not be liable for malfunction and damage result-ing from installation, relocation, remodeling, maintenance, and repair done by other than dealers specified by Wako Pure Chemical Industries, Ltd.4 Wako Pure Chemical Industries, Ltd. shall not be liable for malfunction and damage of Wako Pure Chemical Industries, Ltd. products due to the use of products of other manufac-turers not supplied by Wako Pure Chemical Industries, Ltd.5 Wako Pure Chemical Industries, Ltd. shall not be liable for malfunction and damage result-ing from remodeling, maintenance, and repair using repair parts other than those specified by Wako Pure Chemical Industries, Ltd.6 Wako Pure Chemical Industries, Ltd. shall not be liable for malfunction and damage result-ing from negligence of precautions and operating methods contained in this manual.7 Wako Pure Chemical Industries, Ltd. shall not be liable for malfunction and damage result-ing from use under environment conditions outside the range of conditions required for proper use of this product, such as power supply, installation environment, etc. contained in this manual.8 Wako Pure Chemical Industries, Ltd. shall not be liable for malfunction and damage result-ing from natural disasters such as fires, earthquakes, floods, lightning, etc.
INDEX(iii)µTASWako i30 Instruction Manual‣Safe Usage and Handling Precautions․Component Names and Functions‥Description of the Assay Principle…Operations‧Inventory and Maintenance󰜩Troubleshooting󰜪Parameter Setup󰜫Other FunctionsSpecifications/Consumables 󰜬
Contents(v)µTASWako i30 Instruction Manual1. Safe Usage and Handling Precautions ............................................................1-11.1 Definition of Specific Safety Precautions ...........................................................1-11.2 Precautions before Operating This Equipment..................................................1-11.3 Biohazards and Disposal ...................................................................................1-31.4 Laser Warning ...................................................................................................1-41.5 High Voltage ......................................................................................................1-41.6 Explosive Hazards .............................................................................................1-41.7 Electrical Hazards..............................................................................................1-51.8 Electromagnetic Compatibility (EMC) ................................................................1-61.9 Radio Specification ............................................................................................1-71.10 Waste Fluid........................................................................................................1-81.11 Installation Site Requirements ...........................................................................1-81.12 Action for Malfunction ........................................................................................1-101.13 Test Results for Diagnosis.................................................................................1-101.14 Quality Control ...................................................................................................1-111.15 Reagents ...........................................................................................................1-111.16 Handling Calibrators and Controls.....................................................................1-111.17 Handling Samples..............................................................................................1-121.18 Detergent...........................................................................................................1-121.19 Chip and Chip Cassette.....................................................................................1-121.20 Recording Paper................................................................................................1-131.21 Labels ................................................................................................................1-141.22 Periodic Maintenance ........................................................................................1-201.23 Product Warranty...............................................................................................1-202. Component Names and Functions ..................................................................2-12.1 Component Names............................................................................................2-12.1.1 External View.........................................................................................................2-12.1.2 Bottle Storage and Chip Station(The front door opened.)........................................................................................2-12.1.3 Sample Rack .........................................................................................................2-22.1.4 Rear Panel.............................................................................................................2-22.1.5 Chip, Reagent, Detergent......................................................................................2-32.2 Stand-by Switch.................................................................................................2-42.2.1 Stand-by Switch and Power Monitor Function.......................................................2-42.2.2 Emergency Stop and Action for Recovery.............................................................2-42.3 Pipetting and Measuring ....................................................................................2-52.4 Operation / Display Panel ..................................................................................2-62.4.1 MAIN Dialog ..........................................................................................................2-62.4.2 Numeric Keyboard.................................................................................................2-112.4.3 PID Keyboard ........................................................................................................2-122.5 SID Details.........................................................................................................2-132.6 PID Details.........................................................................................................2-133. Description of the Assay Principle ..................................................................3-1
ContentsµTASWako i30 Instruction Manual(vi)4. Operations .......................................................................................................4-14.1 Startup Inspection..............................................................................................4-14.1.1 Preparation before Turning the Stand-by Switch On.............................................4-24.1.2 Turning the Stand-by Switch ON ...........................................................................4-44.1.3 When the [Operator ID Function] Is Active ............................................................4-64.1.4 Turning off the Analyzer (Shut Down) ...................................................................4-74.1.5 Check List for Daily Checks before Use ................................................................4-94.1.6 Check List of Daily Checks after Use ....................................................................4-94.1.7 Preparation of Sample Rack..................................................................................4-104.1.8 Blood Collection Tube for µTASWako i30 .............................................................4-124.1.9 Placing Area for Barcode Label.............................................................................4-134.1.10 Amount of Sample .................................................................................................4-144.2 Calibration Operation.........................................................................................4-154.2.1 Calibration Operation Using Barcode Labeled Holder...........................................4-174.2.2 Calibration Operation with No Barcode Labeled ...................................................4-214.2.3 How to Check the Past Calibration Results...........................................................4-244.2.4 How to Calibrate by Selecting Reagent Bottle.......................................................4-254.2.5 Calibration Copy ....................................................................................................4-264.3 Quality Control Operation ..................................................................................4-274.3.1 QC Operation Performed Automatically with Barcode Reading ............................4-274.3.2 QC Operation by Selecting Reagent Bottle ...........................................................4-304.3.3 QC Operation for Old and New Reagent Bottles...................................................4-334.3.4 How to Browse Results of QC Operation (Quality Control Chart) .........................4-344.4 Standard Operation ...........................................................................................4-354.4.1 Order List Dialog and Sample Rack ......................................................................4-364.4.2 Manual Order Operation (Individual) .....................................................................4-374.4.3 Manual Order Operation (Batch) ...........................................................................4-384.4.4 Auto Request Operation (with Barcode)................................................................4-394.4.5 Worksheet Request Operation (with Barcode) ......................................................4-404.4.6 Worksheet Request Operation (without Barcode) .................................................4-414.5 Operation Methods ............................................................................................4-424.5.1 Details of Manual Order Operation (Individual) .....................................................4-424.5.2 Details of Manual Order Operation (Batch) ...........................................................4-464.5.3 Editing Batch Order ...............................................................................................4-474.5.4 Deleting Orders in Batch .......................................................................................4-484.5.5 Details of Auto Request Operation (with Barcode)................................................4-494.5.6 Details of Worksheet Request Operation (with Barcode) ......................................4-504.5.7 Details of Worksheet Request Operation (without Barcode) .................................4-524.6 Start Operation ..................................................................................................4-554.6.1 Sample Loading When Continuously Performing Operation .................................4-584.7 Completion of Operations ..................................................................................4-594.8 Emergency (STAT) Sample Operation ..............................................................4-614.8.1 STAT Operation Order ..........................................................................................4-614.9 Additional Sample Loading during Operation ....................................................4-634.10 Checking Operation Status................................................................................4-644.11 Checking Test Results.......................................................................................4-654.11.1 Flow of Checking Results ......................................................................................4-654.11.2 Result Dialog .........................................................................................................4-66
Contents(vii)µTASWako i30 Instruction Manual4.11.3 How to Check Printed Test Results.......................................................................4-684.11.4 Recalculation Function ..........................................................................................4-704.11.5 Retransmission and Reprint ..................................................................................4-724.12 Re-run Operation ...............................................................................................4-734.12.1 Re-run Range ........................................................................................................4-744.12.2 How to Order Re-run Operation ............................................................................4-754.13 Power Outage and the Recovery.......................................................................4-795. Inventory and Maintenance .............................................................................5-15.1 About Inventory Key ..........................................................................................5-15.2 Consumables Dialog..........................................................................................5-25.2.1 Inventory Dialog.....................................................................................................5-35.3 How to Set Reagents and Consumables...........................................................5-45.3.1 Reagents ...............................................................................................................5-45.3.2 Chips .....................................................................................................................5-85.3.3 Detergent...............................................................................................................5-125.3.4 Purified Water and Waste Fluid.............................................................................5-145.4 Periodic Maintenance ........................................................................................5-185.5 Items of User Maintenance................................................................................5-195.5.1 Weekly Inspection .................................................................................................5-195.5.2 Monthly Inspection.................................................................................................5-205.5.3 Quarterly Inspection (once every 3 months)..........................................................5-245.5.4 Replacing Recording Paper...................................................................................5-255.5.5 Cleaning Outer Covers ..........................................................................................5-265.5.6 Liquid Leak Check around Bottles (Purified Water and Waste Fluid) and inside of the Maintenance Cover ...............................................................................................5-275.5.7 Liquid Leak Check When External Water Supply and Drainage Kit (optional parts) In-stalled ...................................................................................................................5-285.6 Maintenance Function .......................................................................................5-295.6.1 Error Log................................................................................................................5-305.6.2 Condition Monitor ..................................................................................................5-315.6.3 Washing Pipetting Probe .......................................................................................5-325.6.4 Washing Electrodes...............................................................................................5-335.7 Contrast Adjustment of Operation/Display Panel ..............................................5-345.8 Procedures before and after Long-term Disuse.................................................5-355.8.1 Storage ..................................................................................................................5-355.8.2 Re-Start .................................................................................................................5-356. Troubleshooting ...............................................................................................6-16.1 Error Indications.................................................................................................6-16.1.1 Error Indication Format..........................................................................................6-16.1.2 Error Level .............................................................................................................6-16.2 Error List ............................................................................................................6-2
ContentsµTASWako i30 Instruction Manual(viii)6.3 Corrective Action ...............................................................................................6-86.3.1 How to Recover from Chip Jamming.....................................................................6-86.3.2 How to Recover from Sample Rack Transfer Error ...............................................6-126.3.3 When Waste Fluid Filled Detected ........................................................................6-136.3.4 No Purified Water Supplied ...................................................................................6-146.3.5 When Reagent Surface Is Not Detected ...............................................................6-157. Parameter Setup..............................................................................................7-17.1 Parameter Setup List .........................................................................................7-17.2 Administrator Password and Parameter Setup Dialog ......................................7-27.3 Parameter Setup Methods.................................................................................7-37.3.1 Reference Interval Setup.......................................................................................7-37.3.2 Re-run Range Setup..............................................................................................7-57.3.3 Correlation Formula Setup ....................................................................................7-87.3.4 Date and Time Setup.............................................................................................7-117.3.5 Buzzer Setup .........................................................................................................7-127.3.6 Printer Setup..........................................................................................................7-137.3.7 Cal/QC Repeat Number ........................................................................................7-147.3.8 Inventory Warning Level Setup .............................................................................7-157.3.9 Operator ID Setup .................................................................................................7-167.3.10 Accumulative Test Counts.....................................................................................7-187.3.11 Data Communication & Barcode Setup.................................................................7-197.3.12 Data Export............................................................................................................7-267.3.13 Software Version ...................................................................................................7-287.3.14 Program Update ....................................................................................................7-297.3.15 Maximum Rack Number Setup..............................................................................7-317.3.16 Repeat Number for CV Setup................................................................................7-317.3.17 Pump Priming ........................................................................................................7-327.3.18 Options Setup........................................................................................................7-337.3.19 AFP Peak Setting ..................................................................................................7-348. Other Functions ...............................................................................................8-18.1 External Water Supply and Drainage Kit ...........................................................8-19. Specifications/Consumables............................................................................9-19.1 Specifications.....................................................................................................9-19.2 Standard Accessary List ....................................................................................9-29.3 Consumables.....................................................................................................9-29.4 Periodical Replacement Parts ...........................................................................9-39.5 Optional Parts ....................................................................................................9-3
1 Safe Usage and Handling Precautions1-1µTASWako i30 Instruction Manual11 Safe Usage and Handling PrecautionsThis section contains safety precautions which must be followed for the safe operation of the μTASWako i30. Before using this equipment, please read this chapter carefully and follow the precau-tions given, so that you can operate it correctly.1.1 Definition of Specific Safety PrecautionsSpecific safety precautions are noted by the terms WARNING, CAUTION, IMPORTANT, and additional information by NOTE. The respective meanings are as follows:WARNINGIndicates hazardous situations that may lead to serious injury, even death or the transmission of infectious agents if the precaution is not followed.CAUTIONIndicates hazardous situations that may lead to minor or moderate injury or physical damage ifthe caution is not followed.IMPORTANTIndicates improper handling that could have an adverse effect on the accuracy of the measure-ment values if the precaution is not followed.NOTE: Indicates procedures requiring special attention, instructions that must be followed, supplementary explanations, etc.1.2 Precautions before Operating This EquipmentCAUTIONBefore using this equipment, please read this Instruction Manual carefully so that you canoperate the equipment correctly.CAUTIONWhenever you operate this equipment, be sure to observe the precautions described in thismanual. Failure to do so may subject you to injuries, cause property damage, or produceincorrect test results.CAUTIONThis equipment is an in vitro diagnostic medical device using in vitro diagnostic agents.Do not use the equipment for other purposes.This equipment is classified as an in vitro diagnostic medical device under DIRECTIVE 98/79/EC.CAUTIONThis equipment is only to be operated by personnel appropriately trained for its intended use andcorrect operation. Patients do not come into direct contact with the equipment.
1 Safe Usage and Handling PrecautionsµTASWako i30 Instruction Manual1-21CAUTIONWako Pure Chemical Industries, Ltd. shall not be liable for malfunction and damage resultingfrom connection with other devices or use of software not supplied by Wako Pure ChemicalIndustries, Ltd.CAUTIONThe accessories (for example, AC power cable, etc.) are specified only for this equipment. Donot use the specified accessories for other equipment.CAUTIONDo not place cups or containers with liquids on the equipment. If liquids spill over the equipment,fire or electrical shock may occur.CAUTIONDo not place heavy objects on the equipment, and do not apply force on the equipment. Thismay results damage and/or malfunction on the equipment.CAUTIONDo not have an impact shock on the equipment. Otherwise, malfunction and/or damage on theequipment may occur.CAUTIONDo not strike or scratch the operation/display panel using a sharp-pointed instrument(mechanical pencil or ballpoint pen, etc.). This may results damage and/or malfunction on theequipment.CAUTIONThe settings described in Chapter 7 include important settings, which affect test results such ascorrelation formula. The settings must be operated only by the administrators who have theresponsibility for the use of the equipment. Inputting a password allows the administrators tooperate the administrator tools.CAUTIONDo not remodel the µTASWako i30.CAUTIONThe durability period for this equipment is 6 years after installation at your site.(This period is valid as long as the precautions for use are followed and regular periodicmaintenance is performed correctly.)As the concerns for safety or performance will increase when this period of 6 years expires,please consult your customer support for advice.
1 Safe Usage and Handling Precautions1-3µTASWako i30 Instruction Manual1CAUTIONWhenever you operate or touch the parts labeled, be sure to observe the precautionsdescribed in Sec. 1.21 (P1-14) “Labels”.CAUTIONKeep ethanol away from fire as it is highly flammable, when using it for disinfection or cleaning.1.3 Biohazards and DisposalWARNINGAs used (contaminated) consumables (e.g., used chips, sample tubes, blood collection tubes, reagents, calibrators, Controls, or detergent’s cups) and contaminated swabs or cloths used for cleaning the equipment are infectious waste, process the waste correctly in compliance with any applicable regulations in your country, such as by incineration, melting, sterilization or disinfec-tion. Even if you entrust a dealer with the disposal, ensure to process the waste correctly in com-pliance with any applicable regulations.WARNINGWhen discarding the equipment that may be contaminated with blood samples, be sure to pro-cess it correctly in compliance with any applicable regulations in your country because it is infec-tious waste.WARNINGWhen handling blood samples and performing maintenance (cleaning the analyzer), always fol-low biohazard procedures (e.g., wearing gloves, lab coat, and safety goggles), referring to the sample handling rules of your facility. If any part of the body comes in contact with samples, immediately rinse the contaminated body part thoroughly under running water and then disinfect the body part using ethanol for disinfection. Seek medical assistance if necessary.WARNINGDo not touch used chips and sample tubes with bare hands as these are contaminated with blood sample. If any part of the body comes in contact with contaminated consumables, immedi-ately rinse the contaminated body part thoroughly under running water and then disinfect the body part using ethanol for disinfection. Seek medical assistance if necessary.WARNINGWhen samples come in contact with the equipment’s components, immediately clean and disin-fect the components using soft cloth moistened with ethanol for disinfection.CAUTIONThe LCD display lamps in this product contain mercury, which must be recycled or disposed of inaccordance with local, state, or federal laws.
1 Safe Usage and Handling PrecautionsµTASWako i30 Instruction Manual1-411.4 Laser Warning<Embedded laser>The μTASWako i30 has a built-in laser [class 3B, 638nm, maximum 45 mW (CW)].<Safety standard>This equipment complies with FDA performance standards for laser products except for deviations pur-suant to Laser Notice No.50, dated (June 24, 2007).This equipment is a Class 1 laser product (designed according to IEC60825-1:2001).<Laser safety>As above, this equipment conforms to the FDA performance standards (Laser Notice No.50), so the laser radiation is designed to be safety. As long as the users operate the equipment correctly, so that the safety is fully guaranteed. <Covers of the equipment>The covers of the equipment are secured using screws.If the screws are loosened or the covers are removed, the laser beam may be leaked.Be sure not to loosen the screws and not to remove the covers, except for by technicians specially trained.WARNINGDo not remove the covers secured by screws.As the equipment has a built-in laser source, the laser radiation may expose to users to harm their eyes. If the equipment is possible to be abnormal, please contact your customer support for assistance.CAUTIONUse of controls or adjustments or performance of procedures other than those specified hereinmay result in hazardous radiation exposure.1.5 High VoltageThis equipment uses high voltage.As long as the users operate the equipment correctly (including user maintenance), there are no risks to touch the high voltage at all.WARNINGDo not remove the covers secured by screws.Otherwise, electrical shock may occur as the equipment includes high voltage inside.1.6 Explosive HazardsWARNINGAs this equipment is not explosion-proof, be sure not to use flammable and explosive gas around the equipment.
1 Safe Usage and Handling Precautions1-5µTASWako i30 Instruction Manual11.7 Electrical HazardsWARNINGThe power supply voltage applied to the equipment is AC100 - 240V.To avoid electrical shock, follow the precautions as bellow:- Avoid installation sites where water may splash, etc., on the equipment.- Make sure that the equipment is properly grounded to a protective earth lead for indoor wiring.- Make sure that all cables have been properly connected.WARNINGPlug the power cable of the equipment into an outlet with a grounding receptacle. If the equip-ment is not grounded to a protective earth, this may cause electrical shock.WARNINGWhen plugging the power cable in or removing it from an outlet, be sure to hold onto the plug body, not just the cable. Otherwise, the power cable will have physical damage, so that electrical shock or danger of fire may result.WARNINGDo not remove covers secured by screws from the equipment. Otherwise, contacting exposed hazardous voltage may cause electrical shock, or touching moving parts may cause injury.
1 Safe Usage and Handling PrecautionsµTASWako i30 Instruction Manual1-611.8 Electromagnetic Compatibility (EMC)CAUTIONThis equipment conforms to the following EMC requirements:- EN61326-1:2006 (Class A)- FCC Part 15 Subpart B:2009, Class A- ICES-003 Issue No.4, Class AIf this equipment does cause harmful interference to other devices, which can be determined by turn-ing the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:Consult your customer support for help.CAUTIONDo not use other devices (such as mobile phone) which generate and can radiate radiofrequency energy near the equipment. Otherwise, physical damage or malfunction on theequipment may occur.<Statements for EN61326-2-6>NOTE: It is the manufacturer's responsibility to provide equipment electromagnetic compatibil-ity information to the customer or user.On the other hand, it is the user's responsibility to ensure that a compatible electromag-netic environment for the equipment can be maintained in order that the device will per-form as intended.This equipment complies with the emission and immunity requirements described in EN61326-2-6.This is a class A product. In a domestic environment, this product may cause radio inter-ference in which case the user may be required to take adequate measures.This equipment has been tested and found to comply with the limits for a Class A digitaldevice, pursuant to Part 15 of the FCC Rules. These limits are designed to provide rea-sonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a res-idential area may cause harmful interference in which case the user will be required to correct the interference at his own expense.This Class A digital apparatus complies with Canadian ICES-003.Cet appareil numerique de la class A est conforme a la norme NMB-003 du Canada.- Reorient or relocate the receiving device.- Increase the separation between the equipment.- Connect the equipment into an outlet on a circuit different from that to which the otherdevice(s) are connected.
1 Safe Usage and Handling Precautions1-7µTASWako i30 Instruction Manual1This equipment has been designed and tested to CISPR 11 Class A. In a domestic environment it may cause radio interference, in which case, you may need to take measures to mitigate the interference.The electromagnetic environment should be evaluated prior to operation of the device.Do not use this device in close proximity to sources of strong electromagnetic radiation (e.g.unshielded intentional RF sources, mobile phone), as these may interfere with the proper operation.1.9 Radio SpecificationCAUTIONThis equipment conforms to the following Radio requirements:-EN301 489-17 V1.3.2-EN301 489-1 V1.8.1-EN300 330-2 V1.3.1-FCC Part 15 Subpart C 15.225-RSS210 Issue 7If this equipment does cause harmful interference to radio or television reception, which can be deter-mined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:-- Reorient or relocate the receiving antenna.-- Increase the separation between the equipment and receiver.-- Connect the equipment into an outlet on a circuit differentfrom that to which the receiver is connected.-- Consult the dealer or an experienced radio/TV technician for help.You are cautioned that changes or modifications not expressly approved by the party responsible for compliance could void your authority to operate the equipment.This device complies with FCC RF radiation exposure limits set forth for an uncontrolled environment. The antenna used for this transmitter must be installed to provide a separation distance of at least 20 cm from all persons and must not be co-located or operating in conjunction with any other antenna or transmitter.Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference , including interference that may cause undesiredoperation of the device.This equipment 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 rea-sonable protection against harmful interference in a residential installation. This equip-ment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio com-munications. However, there is no guarantee that interference will not occur in a particular installation.This Class B digital apparatus complies with Canadian ICES-003.Cet appareil numèrique de la classe B est conforme à la norme NMB-003 du Canada.
1 Safe Usage and Handling PrecautionsµTASWako i30 Instruction Manual1-811.10 Waste FluidWARNINGWhen discarding waste fluid, be sure to process it correctly in compliance with any applicable regulations in your country, such as laws for preventing water pollution and for sewerage system. Otherwise, this may cause environmental pollution or go against the laws.WARNINGThe waste fluid may contain infectious substances. When handling the waste fluid, always follow biohazard procedures (e.g., wearing gloves, lab coat, and safety goggles), referring to the sam-ple handling rules of your facility. Do not touch the waste fluid directly with bare hands.If any part of the body comes in contact with waste fluid, immediately rinse the contaminated body part thoroughly under running water and then disinfect the body part using ethanol for dis-infection. Seek medical assistance if necessary.WARNINGWhen waste fluid is spilled over the equipment, always follow biohazard procedures (e.g., wear-ing gloves, lab coat, and safety goggles) to wipe out the spilled fluid and disinfect the part using ethanol for disinfection.CAUTIONFor the information about the concentrations of toxic or harmful substances which the reagentscontain, refer to the instructions for use accompanied with the reagents.1.11 Installation Site RequirementsWARNINGPlug the power cable of the equipment into an outlet with a grounding receptacle.If the equipment is not grounded to a protective earth, this may cause electrical shock.CAUTIONAvoid the following installation sites:- Places where spills or water leakage may occur.- Places where the equipment is exposed to direct sunlight.- Places near sources of heat such as heaters.- Places where the temperature may drastically change.- Places where the equipment is subject to vibration or its support table is unstable.- Slope places.- Dusty area.- Windy places such as the wind from air conditioner directly blows.- Places where electromagnetic radiation exists.(1) Install the equipment in the following environmental conditions:Location: Indoor use (No direct sunlight exposed)Illumination: Below 6,000 cd/m2 (lux)
1 Safe Usage and Handling Precautions1-9µTASWako i30 Instruction Manual1(2) Use the equipment under the following electrical requirements:(3) Plug the equipment into an independent AC outlet separate from other devices.(4) For the installation site, empty space is necessary as follows: at least 10 cm on the right-handside; at least 15 cm on the left-hand side; at least 0.5 cm on the back; at least 50 cm on the front;at least 15 cm on the upper side of the equipment.IMPORTANTKeep the required empty space around the equipment for the installation work. Otherwise, exhaust heat will not work properly to cause adverse effects on test results.Altitude: Up to 2,000mTransient overvoltage cate-gory:IIPollution degree: 2Ingress protection rating: IPX0 (No Protection)Operating temperature: 15 to 30°C (59 to 86°F)[Temperature shift during operation must bewithin 2 degrees.]Operating humidity: 30 to 80% RH (no vapor condensation)Input voltage: 100 - 240V ~Voltage fluctuation range: ±10%Frequency: 50 - 60 HzPhase: SingleRated current: 4 - 1.7 AType of protection againstelectrical shock:CLASS 1 EQUIPMENTOOOOWallBackLeft RightFrontOver 150mmOver 500mmOver100mmOver 10mm
1 Safe Usage and Handling PrecautionsµTASWako i30 Instruction Manual1-101(5) The load on a rubber foot of the equipment is approx. 8 kg. Make sure that the strength of the floorat the installation site is acceptable.CAUTIONDo not move the equipment to another installation site.This may results injury or damage on the equipment.Even if moving within the same facility, please contact your customer support.1.12 Action for MalfunctionCAUTIONWhen the equipment generates unusual noise, smell, or smoke, immediately unplug the powercable, and contact your customer support.CAUTIONDo not place any objects near the wall socket so that the power cable’s plug of the equipmentcan be easily pulled out from the wall.CAUTIONFor emergency, empty space on the back is necessary to unplug the power cable connectorfrom the appliance inlet of the analyzer.1.13 Test Results for DiagnosisIMPORTANTMake a diagnosis in a comprehensive manner, considering other relative test results or clinical situation.IMPORTANTIn case that malfunction (errors) of the equipment are displayed (printed) before/during test pro-cessing, or warning indications are printed out along with test results, the test results may NOT be accurate. Refer to Chapter 6: “Troubleshooting” and rerun the tests.IMPORTANTTo maintain the accuracy of your test results, daily quality control is necessary. Perform quality control using Controls.IMPORTANTThe equipment has a function to compensate test results using predetermined coefficients. How-ever, when reviewing the performance and the results, use measurement values before the com-pensation.
1 Safe Usage and Handling Precautions1-11µTASWako i30 Instruction Manual11.14 Quality ControlIMPORTANTWhen using the equipment, run Controls to monitor the equipment maintains its performance properly.Incorrect test results will cause wrong diagnosis and may lead the patient to danger.1.15 ReagentsWARNINGAs used (remaining) reagent bottles and the adapters for opening are infectious waste, process the waste correctly in compliance with any applicable regulations in your country, such as by incineration, melting, sterilization or disinfection. Even if you entrust a dealer with the disposal, ensure to process the waste correctly in compliance with any applicable regulations.IMPORTANTPlease read the instructions for use of the reagents carefully to follow the instructions and use them correctly.IMPORTANTDo not use reagents other than specified on “μTASWako i30 Reagent Consumable Supply List”.IMPORTANTIn case that the power has not been supplied for a period of time, load reagents into the storage after the temperature reaches below 10°C (50°F). When the reagents are stored beyond the required storage temperature described in the reagent package or the instructions for use, the reagents may deteriorate.1.16 Handling Calibrators and ControlsWARNINGAs used (remaining) calibrators and Controls in cup are infectious waste, process the waste cor-rectly in compliance with any applicable regulations in your country, such as by incineration, melting, sterilization or disinfection. Even if you entrust a dealer with the disposal, ensure to pro-cess the waste correctly in compliance with any applicable regulations.IMPORTANTTo obtain test results, it is necessary to perform calibration; more specifically, measuring calibra-tor for each reagent bottle.Be sure to perform calibration each time a reagent bottle is set.IMPORTANTTo maintain the system accuracy and observe the calibration condition, we recommend measur-ing Controls for quality control.
1 Safe Usage and Handling PrecautionsµTASWako i30 Instruction Manual1-1211.17 Handling SamplesWARNINGWhen handling samples, always follow biohazard procedures (e.g., wearing gloves, lab coat, and safety goggles), referring to the sample handling rules of your facility. If any part of the body comes in contact with samples, immediately rinse the contaminated body part thoroughly under running water and then disinfect the body part using ethanol for disinfection. Seek medical assis-tance if necessary.IMPORTANTMake sure that there are no foreign matter in the sample. If there are fibrin deposit in the sample, remove them before the measurement. The foreign matter or fibrin may clog in the pipetting probe to cause malfunction of the equipment.IMPORTANTThick samples sometimes clog in the pipetting probe and decrease the pipetting volume to cause adverse effects on test results.IMPORTANTWhen sample is left in a sample cup for a long time, the sample may concentrate.Particularly, in case that the amount of the sample is small, pay attention to the concentration. The evaporation of the sample may increase the error of the measurement accuracy.1.18 DetergentWARNINGAs used (remaining) detergent bottles are infectious waste, process the waste correctly in com-pliance with any applicable regulations in your country, such as by incineration, melting, steriliza-tion or disinfection. Even if you entrust a dealer with the disposal, ensure to process the waste correctly in compliance with any applicable regulations.IMPORTANTThe equipment performs pipetting samples and reagents using a pipetting probe. To wash the probe thoroughly, the equipment uses the detergent for μTASWako. If the detergent is not used properly, the pipetting probe may not be washed thoroughly.Be sure to use the specified detergent and follow the number of times for use. Do not refill deter-gent into the bottle.1.19 Chip and Chip CassetteWARNINGDo not touch used chips with bare hands. This may cause infection. If any part of the body comes in contact with contaminated consumables, immediately rinse the contaminated body part thoroughly under running water and then disinfect the body part using ethanol for disinfection. Seek medical assistance if necessary.
1 Safe Usage and Handling Precautions1-13µTASWako i30 Instruction Manual1WARNINGAs used chips are infectious waste, process the waste correctly in compliance with any applica-ble regulations in your country, such as by incineration, melting, sterilization or disinfection. Even if you entrust a dealer with the disposal, ensure to process the waste correctly in compliance with any applicable regulations.WARNINGDo not use a defective or cracked sample cup. The defective sample cup or scattering sample may cause contamination, infection, and injury.IMPORTANTWhen loading a chip cassette, be sure to remove the chip tie beforehand and then set it cor-rectly. If the chip cassette is not loaded correctly, the trouble, such as the equipment does not work or is broken, will occur.IMPORTANTDo not use a chip that has been dropped out once from the chip cassette accidentally. Other-wise, the accurate test result may not be obtained.IMPORTANTDo not handle a chip and a chip cassette by wet hands.The chip is contaminated, so that the accurate test result may not be obtained.IMPORTANTUsed chips and sample cups cannot be reused. If used ones are reused, the accurate test results may not be obtained.IMPORTANTDo not use chips other than specified for the equipment. Otherwise, the accurate test results may not be obtained.IMPORTANTUse chips after warming up to the room temperature. Otherwise, the accurate test results may not be obtained.1.20 Recording Paper(1) Use the specified recording paper for the μTASWako i30.(2) Do not use paper other than the type specified. Otherwise, the printer head may be damaged.
1 Safe Usage and Handling PrecautionsµTASWako i30 Instruction Manual1-1411.21 LabelsWARNINGDo NOT peel off the labels on the equipment.If the labels are unclear to read, or have been peeled off, it is necessary to replace them with new ones. Please contact your customer support for assistance.• Name-plate/HHS label/FCC label/US mercury labelName-plate US mercury label HHS labelFCC label㧦This symbol shows the alternating current. This Class B digital apparatus complies with Canadian ICES-003.Cet appareil numèrique de la classe B est conforme à la normeNMB-003 du Canada.This device complies with Part 15 of the FCC Rules.Operation is subject to the following two conditions:(1) this device may not cause harmful interference, and(2) this device must accept any interference received,including interference that may cause undesired operation.FCC ID X2IUTASWAKOI30IC ID 8779A-UTASWAKOI30
1 Safe Usage and Handling Precautions1-15µTASWako i30 Instruction Manual1• Stand-by switch Stand-by switch
1 Safe Usage and Handling PrecautionsµTASWako i30 Instruction Manual1-161• Biohazard label<Biohazard label>The label means biohazard (infections) warning.Be sure to follow biohazard procedures (e.g., wearing gloves, lab coat, andsafety goggles). When discarding infectious waste, be sure to process itcorrectly in compliance with any applicable regulations in your country.SamplerCap pocketfor waste bottleChip disposal boxChip exit Sample rack stationWaste bottleElectrophoresisunit Waste bottle capChip disposal cover
1 Safe Usage and Handling Precautions1-17µTASWako i30 Instruction Manual1• Laser caution labels㧨Laser caution label㧪 Leaked laser beam may cause blindness. Do not remove covers secured by screws. 㩷
1 Safe Usage and Handling PrecautionsµTASWako i30 Instruction Manual1-181• High temperature caution labelCAUTIONWhen you lay a hand on the part during use or just after use, you may get burned. When performing the maintenance or the inspec-tion, be sure to check that the part has com-pletely cooled down.• Caution labelCAUTIONBe sure to use the specified power cable packed as an accessary.CAUTIONSupply purified water into the purified water bottle.NOTE: The purified water must be either dis-tilled water or ion-exchanged water (the electric conductance must be under 1µS/cm.)High temperature caution label The high temperature part is the fin of the radiator above the label.Caution labelCaution label
1 Safe Usage and Handling Precautions1-19µTASWako i30 Instruction Manual1• Name-plate of external water supply and drainage kit (option)Name-plate
1 Safe Usage and Handling PrecautionsµTASWako i30 Instruction Manual1-2011.22 Periodic MaintenanceIn order to maintain the safety and the performance of the equipment, the periodic maintenance and inspection are necessary.The maintenance and inspection by the customer are described in the body of this manual in detail.We recommend our maintenance support contract for the maintenance by the technicians trained for the equipment.1.23 Product WarrantyWako Pure Chemical Industries, Ltd. warrants this equipment for one year from the date of the initial installation.If this equipment does not function during the warranty period only in the case of manufacturer’s defect, your customer support will repair or replace the parts without charge.However, we shall not liable for malfunction and damage of the following cases:(1) The equipment has been operated incorrectly.(2) The equipment has been repaired or remodeled by dealers other than specified by Wako PureChemical Industries, Ltd.(3) The parts or reagents not specified by Wako Pure Chemical Industries, Ltd. have been used forthe equipment.(4) The malfunction or damage has been caused by reasons other than this equipment.(5) The equipment has been used in the severe condition, such as high temperature, high humidity,corrosive gas, or vibration.(6) The malfunction or damage is caused by fires, earthquakes, and other natural disasters.(7) After the first installation on the site, the customers have moved or transported the equipment onlyby themselves.(8) The malfunction or damage of the consumables or the equivalent parts.
2 Component Names and Functions2-1µTASWako i30 Instruction Manual22 Component Names and Functions2.1 Component Names2.1.1 External View2.1.2 Bottle Storage and Chip Station(The front door opened.)CAUTIONThe USB connector of this analyzer is used only for USB memory. Do not use the USBconnector for other purposes.PrinterStand-by Switch(power monitor)Maintenance coverChip disposal coverChip disposal boxChip exitOperation/display panelRack coverRack entryFront doorChip station Waste bottle cap Reagent container USB connector (only for USB memory) Contrast adjustment lever Waste bottle Purified water bottle Air filter
2 Component Names and FunctionsµTASWako i30 Instruction Manual2-222.1.3 Sample Rack2.1.4 Rear PanelCAUTIONWhen the analyzer generates unusual noise, smell, or smoke, or other emergency situations thatneed emergency stop occur, immediately unplug the power cable, and contact your customersupport.CAUTIONDo not connect the communication connectors or the LAN connector to a host computer or PCwhich has not been approved by IEC/UL60950-1.Sample rack STAT lever Power inletVent (Air vent)Vent (Air vent)Vent (Air vent)Vent (Air vent)Communication connector 1 & 2LAN
2 Component Names and Functions2-3µTASWako i30 Instruction Manual22.1.5 Chip, Reagent, DetergentChip cassetteChip tieChipInformation tag Reagent trayReagent bottleInformation tagAdapter (reagent bottle opener)ԘԝDetergent bottleDetergent bottle
2 Component Names and FunctionsµTASWako i30 Instruction Manual2-422.2 Stand-by Switch2.2.1 Stand-by Switch and Power Monitor FunctionNOTE: The Stand-by switch is used only for starting up the analyzer.To stop the analyzer, use the [Shut Down] key on the operation/display panel.During operation process, the [Shut Down] key is not active.The Stand-by switch has a lamp that indicates the power supplied condition.The indicator of the Stand-by switch means as follows:<Indicator lamp of the Stand-by switch and power supplied condition>2.2.2 Emergency Stop and Action for RecoveryCAUTIONWhen the analyzer generates unusual noise, smell, or smoke, or other emergency situations thatneed emergency stop occur, immediately unplug the power cable, and contact your customersupport.IMPORTANTWhen carrying out emergency stop, press the Stand-by switch to initialize the analyzer after recovering the emergency stop condition. If the initialization is not carried out, the reagent con-tainer condition is not guaranteed, therefore, the reagents may not be stored properly.IMPORTANTWhen the power is not supplied for a certain period of time, the reagent's performance may degrade. After recovering from the emergency stop condition, run controls and make sure that the performances of the reagents and the analyzer are reliable before use.When the power is supplied after the emergency stop, the reagent container is powered and the ana-lyzer will be being powered OFF, but in the Stand-by condition.By pressing the Stand-by switch, the orders just before the emergency stop will be cancelled, although the already obtained test results have been memorized. The test results during operation process will be errors.In case of two-way communication, simply select the [START] key to restart.In case of using worksheet, receive the worksheet again.Indicator lamp of the Stand-by switch Power supplied unit / conditionSlowly ON/OFF The reagent container is only powered.ON The analyzer (all) is powered.Quickly ON/OFF (within 1 sec.) Temperature control error for the reagent container
2 Component Names and Functions2-5µTASWako i30 Instruction Manual22.3 Pipetting and MeasuringThis manual describes a process during the “Operating” process as the “Pipetting” process or the “Measuring” process distinctly. The “Pipetting” and the “Measuring” mean as follows:Operating Pipetting Measuring The front door cannot be opened.Sample pipetting is in processing.The rack cover cannot be opened.Approx. (a number of tests) x 3 min.The last pipetting into the last chip is completed,and the measurement is in processing.The rack cover can be opened.(Approx. 6 min.)
2 Component Names and FunctionsµTASWako i30 Instruction Manual2-622.4 Operation / Display Panel2.4.1 MAIN DialogNOTE: Grayed key is not active now.+P5CORNG0GGFUOKP4CEM%QXGT7PNQEMGFAnalyzer status key Remaining sample display (indicator and number displayed) Results key STAT / Re-run key Inventory key Shut Down key Orders key STOP / START /Auto Start / Auto Start Cancel keys Operator ID switching key MENU key FEED key The analyzer condition is indicated by the message and the color.ITGGP㧦 Sample loading available[GNNQY㧦 Processing (Operating, etc.)QTCPIG㧦 Action is necessary.By pressing the analyzer status key, the display turns to the condition display dialog.For routine operation, the colored indicator means the remaining ordered samples. The denominator indicates the ordered samples and the numerator indicates the completed samples NOTE: Remaining samples for calibration and control tests will not be displayed (counted). The FEED key is used to advance recording paper in the printer. Paper advances one line each time the key is selected. The key is used to stop (shut down) the analyzer.NOTE: The Stand-by switch is used only for powering the analyzer on. It is imposible to stop the analyzer by the Stand-by switch.The key is used to switch to the MENU dialog. The key is used to browse test results. The key is used to start or stop operations. The key name depends on the analyzer condition. The key is used to switch operator ID. When the setting is “The operator ID is not in use”, the key will not be displayed. The key is used to order operations. The key name depends on the communication settings. The key is used to check the inventory of reagents and consumables. The condition is indicated by the color. ޓޓFullޓLow (reached to the alarm point)ޓޓEmpty exists. During operation process, the [STAT] key will be displayed. The key is used to operate STAT samples. When re-run lists exist after operation, the Re-run key will be displayed. Refer to Sec. 4.10 (P4-64)Refer to Sec. 4.8 (P4-61), 4.12 (P4-73)Refer to Sec. 2.4.1.2 (P2-8)Refer to Sec. 2.4.1.3 (P2-9)Refer to Sec. 4.1.3 (P4-6)Refer to Sec. 4.1.4 (P4-7)Refer to Sec. 2.4.1.1 (P2-7)Refer to Sec. 5.1 (P5-1)Refer to Sec. 4.11.1 (P4-65)
2 Component Names and Functions2-7µTASWako i30 Instruction Manual22.4.1.1 Remaining sample display (indicator and number displayed)For routine operation, the colored indicator means the remaining ordered samples.The denominator indicates the ordered sam-ples and the numerator indicates the com-pleted samples.The remaining part (colored) of the indicator indicates the current operation status, such as expanding and shortening repeatedly on the left figure.NOTE: Remaining samples for calibration and control tests will not be displayed (counted).NOTE: When operating STAT samples after interruption, the STAT orders will be counted in the denominator.NOTE: When the communication setting is "Bidirectional + Batch (+ Barcode or- Barcode)”, the denominator is the order of the worksheet.NOTE: When the communication setting is “Bidirectional + Individual”, the num-ber will not be displayed.Completed samplesOrdered samples (+STAT sample orders)
2 Component Names and FunctionsµTASWako i30 Instruction Manual2-822.4.1.2 [Orders], [Host Order], [ONLINE], [OFF LINE] keysThe key name depends on the communication settings.Refer to Section 7.3.11 (P7-19) for the communication settings.Communica-tion settingKeys DescriptionsBidirectional + IndividualON LINE / OFF LINE When the communication is established, the [ON LINE] key will be displayed.When selecting the [ON LINE] key, the commu-nication with the host computer is disconnected and the [OFF LINE] key will be displayed.When selecting the [START] key during the [ON LINE] status, the [OFF LINE] key will be auto-matically displayed if the response from the host computer is not received.NOTE: During operation process, the key cannot be switched.Bidirectional + Batch + BarcodeHost Order / OFF LINE The key is used to receive worksheet in batch from the host computer.If the response from the host computer is not received, the [OFF LINE] key will be automati-cally displayed.Bidirectional + Batch - BarcodeHost Order / OFF LINE The key is used to receive worksheet in batch from the host computer after designating a num-ber of samples.If the response from the host computer is not received, the [OFF LINE] key will be automati-cally displayed.One-way: Results onlyOrders The key is used to switch to the order dialog.None Orders Orders can be browsed.
2 Component Names and Functions2-9µTASWako i30 Instruction Manual22.4.1.3 [START], [STOP], [Auto Start], [Auto Start Cancel] keys[START] keyThe START key is used to start operation.[STOP] keyThe key is used to stop the current operation during operation process.[Auto Start] key[Auto Start Cancel] keyDuring warming up process, the left will be dis-played.The key is used to reserve automatic start that the operation automatically will start just after the analyzer has been warmed up.When the automatic start is being reserved, [Auto Start] will be displayed on the analyzer status key.When the automatic start is being reserved, the [Auto Start Cancel] key is displayed and the reservation can be canceled by the key.Stop/PipettingStop/Measuring Warming upAuto Start#WVQOCVKE5VCTV(TQPV%QXGT.QEMGF9CTOKPI7R(TQPV%QXGT7PNQEMGF
2 Component Names and FunctionsµTASWako i30 Instruction Manual2-1022.4.1.4 [MENU] keyThe key is used to switch to the MENU dialog.The MENU dialog has the following menu:•CAL/QC Order•CAL Results• QC Results• Calibration Copy• MaintenanceWhen the message "Rack Cover Unlocked" is displayed on the status indicator key, the [Release Rack Cover locks].key will be effec-tive on the main menu.This key is used when loading the next sample at the end of the operation process or when loading STAT sample./'074GNGCUGNQEMUThis key is used for when the unlock error of the front dooror the rack cover occurs.4GNGCUG4CEM%QXGTNQEMUThis key is used to unlock the rack cover during operaion process.4GNGCUG4CEM%QXGTNQEMU4GNGCUG4CEM%QXGTNQEMU+P5CORNG(TQPV%QXGT.QEMGF+P5CORNG4CEM%QXGT7PNQEMGFMAIN dialog MENU dialog
2 Component Names and Functions2-11µTASWako i30 Instruction Manual22.4.2 Numeric KeyboardOn numeric data input dialog, the common numerical keyboard will be displayed.By selecting a numeric data input field, the numeric keyboard will be displayed.The left figure is an example for inputting SID.SID details: Refer to Section 2.5 (P2-13)PID details: Refer to Section 2.6 (P2-13)Inputting data on the keyboard followed by the [ENTER] key enters the data into the field.Key Descriptions[0] - [9] Inputs Numeric character[-] Inputs Minus sign[.] Inputs Decimal point[C] Clears Current field at all.[<] [>] Moves the cursor.[BS] Back spaceClears a figure each.[ENTER] The input data is accepted, and the previous dialog will appear.Each manual order dialog6GUV4CEM 5+&2+&&KNZ2QU%*+2 #(2.  &%2 5+&Data nameInput data field
2 Component Names and FunctionsµTASWako i30 Instruction Manual2-1222.4.3 PID KeyboardIn PID input field on the order dialog, the common PID keyboard will be displayed.By selecting the PID key, the PID keyboard will appear.Using the [123] key and the [ABC] key, the input mode can be switched between numerical and alphabetical.A maximum of 13 alphanumerical characters can be input for a PID.Inputting alphanumerical characters on the PID keyboard followed by the [ENTER] key enters the PID data.Available alphanumerical characters Numerical input Alphabetical input12 ABC abc3 DEF def4 GHI ghi5JKL jkl6MNO mno7 PQRS pqrs8 TUV tuv9 WXYZ wxyz0 - # / ? ! . , : ; ( )%..PID key on the order dialog 2+&2+&2+&Switchs between numerical and alphabetical PID numerical keyboard PID alphabetical keyboard
2 Component Names and Functions2-13µTASWako i30 Instruction Manual22.5 SID DetailsThe SID is an ID number for a sample which given in sequence of tests everyday.The SID is 13 numerical characters, consisting of year (4 characters), month (2 characters), day (2 characters), test type (1 character), and sequential number (4 characters). However, in the SID input dialog, the five characters are only displayed, eliminating data of year, month, and day. And, the characters to be input are 4.NOTE: For calibration, the SID will not be given.NOTE: Once inputting a SID, the next SID will be incremented by one for the previous SID.NOTE: When the date changes, the SID’s count will be reset, starting from “00001”. At the timing of the reset, “SID reset to 1 due to Date change” will appear.The message is displayed when the analyzer has been using at 0 o’clock. Also, when the SID has been reset after turning the Stand-by switch on, the message will be displayed.However, during operation process, the SID will not be reset.NOTE: If the date does not change after the shutdown, the SID will not be reset to “00001”.2.6 PID DetailsThe PID is a number that distinguishes an individual patient.When using a sample with a barcode, the read barcode data will be automatically input.201210310000100001 SID details Fully displayed (13 characters) Shortened (5 characters) DateޓޓOct. 31, 2012Serial number Test type 0 : Routine test E : STAT test C : Control test 5+&TGUGVVQFWGVQ&CVGEJCPIG

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