illumina 20040482 Operating Manual Download Page 3

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0 - Preface

Manufacturer

Infinium LiHa and Infinium RoMa Operating Manual - Document # 1000000110155 v00

0 - 1

0 Preface

For Your Safety

Before performing any work on or with the Infinium LiHa and Infinium RoMa,

first read the Operating Manual - Document # 1000000110155 v00 carefully,

in particular chapter 2 “Safety”.

0.1 Manufacturer

Address of

Manufacturer

0.2 Use of the Product

0.2.1 Intended Use

Intended Use

The Infinium LIHA/ROMA is an automated robotic solution for sample preparation.

Note:

This product is intended for research use only (RUO) and will not be for

clinical use.

0.2.2 Improper Use

Improper Use

The Infinium LiHa and Infinium RoMa must not be used with options or

components which are not approved by Illumina.

WARNING

The use of non approved options may impair the safety concept of the Infinium

LiHa and Infinium RoMa.
This means that the safety and compliance to national and international

standards, as required for UL/CSA certification, by EC directives, etc. cannot be

ensured any more.

Illumina Inc.

5200 Illumina Way
San Diego, CA 92122
United States

Summary of Contents for 20040482

Page 1: ...Infinium LiHa and Infinium RoMa Operating Manual Document 1000000110155 v00 Operating Manual Infinium LiHa and Infinium RoMa...

Page 3: ...automated robotic solution for sample preparation Note This product is intended for research use only RUO and will not be for clinical use 0 2 2 Improper Use Improper Use The Infinium LiHa and Infini...

Page 4: ...um LiHa and Infinium RoMa is tested and certified by the Canadian Standards Association CSA CSA Marking The CSA marking is affixed to the Infinium LiHa and Infinium RoMa Canada IC Compliance This Clas...

Page 5: ...the user s authority to operate the equipment Note This equipment has been tested and found to comply with the limits for a Class A digital device pursuant to Part 15 of the FCC rules These limits are...

Page 6: ...0 4 Infinium LiHa and Infinium RoMa Operating Manual Document 1000000110155 v00 0 Preface FCC Rules...

Page 7: ...0 2 0 5 FCC Rules 0 3 1 About This Manual 1 1 Reference Documents 1 2 1 2 Trademarks 1 2 1 3 Abbreviations 1 3 2 Safety 2 1 Safety Message Conventions 2 1 2 1 1 Signal Words 2 1 2 1 2 Safety Symbols 2...

Page 8: ...8 3 4 System Modules 3 9 3 4 1 Liquid Handling Arm LiHa 3 9 3 4 2 Robotic Manipulator Arm Standard RoMa 3 12 3 4 3 Positive Identification PosID 3 13 3 5 Chemical Resistance 3 17 3 5 1 Standard Mater...

Page 9: ...le 7 5 7 2 1 Maintenance Immediate Maintenance 7 5 7 2 2 Maintenance Table Daily Maintenance 7 6 7 2 3 Maintenance Table Weekly Maintenance 7 8 7 2 4 Maintenance Table Yearly Maintenance 7 8 7 3 Maint...

Page 10: ...eople s Republic of China 10 1 11 Spare Parts and Accessories 11 1 Software 11 1 11 2 Documentation 11 1 11 3 Infinium LiHa and Infinium RoMa Basic Accessories Kit 11 1 11 4 Carriers Racks Troughs 11...

Page 11: ...ded for everyone who wants to learn about the safe operation of the Infinium LiHa and Infinium RoMa and how to maintain its perfect working condition In particular laboratory personnel and operators a...

Page 12: ...nt 1000000110155 Infinium Assay Lab Setup and Procedures Guide Document 11322460 Any individual or separate operating manuals for optional equipment according to your order configuration can be applic...

Page 13: ...ld service engineer IAC Illumina Automation Control ILID Integrated liquid detector LH Liquid handling LICOS Liquid container supervisor LiHa Liquid handling arm MIO Monitored incubator option MP Micr...

Page 14: ...LiHa and Infinium RoMa Operating Manual Document 1000000110155 v00 1 About This Manual Abbreviations SPO Sensored pump option USB Universal serial bus UPS Uninterruptable power supply WHO World Health...

Page 15: ...ociated with the use of the Infinium LiHa and Infinium RoMa 2 1 Safety Message Conventions 2 1 1 Signal Words WARNING indicates the possibility of personal injury or even loss of life if the instructi...

Page 16: ...finium RoMa Operating Manual Document 1000000110155 v00 2 Safety Safety Message Conventions Hot surface hazard Wear protective gloves Read this Disturbance of functions by electromagnetic RF waves Do...

Page 17: ...ed in any way without prior consultation and written approval of Illumina Authorized modifications to the system may only be performed by an FSE certified for the repair and upgrading of the Infinium...

Page 18: ...oratory apparel rubber gloves safety goggles etc as appropriate Unsafe operating condition and wrong measuring results in the process if the system is leaking If liquid is dripping from the tips or ot...

Page 19: ...acceptable prior to use of the instrument Wrong sample results due to disturbances such as electromagnetic fields or supply voltage fluctuations caused by external devices Do not place devices emittin...

Page 20: ...re to good laboratory practices and have read and understood the instructions in the Operating Manual 2 4 1 Operator The operator lab technician works for the operating company Required Skills No spec...

Page 21: ...o door locks The safety concept of the Infinium LiHa and Infinium RoMa assumes that the front safety panel is always closed when the instrument is running WARNING If the options which require modifica...

Page 22: ...LiHa and Infinium RoMa must not be removed or disabled during operation In the event such elements were removed e g for maintenance work operation may only be resumed when all protective and safety d...

Page 23: ...are attached to the Infinium LiHa and Infinium RoMa instrument It also shows their locations The following table explains the significance of the notices b Fig 2 2 Safety notices attached to the produ...

Page 24: ...May 8 2019 PosID Safety Notices on the PosID The figure shows the safety notices that are attached to the PosID Class 2 Laser Product pursuant to IEC 60825 1 2007 Complies with 21 CFR 1040 10 except...

Page 25: ...ains an embedded visible low power laser barcode scanner Warns against direct viewing into laser beam or its reflections a According to IEC EN 60825 1 On barcode scanner see Fig 2 4 2 10 C Label for p...

Page 26: ...CLASS 2 LASER PRODUCTa that contains an embedded visible low power laser barcode scanner Warns against direct viewing into laser beam or its reflections a According to IEC EN 60825 1 2007 WARNING The...

Page 27: ...lity for the appropriate decontamination of the entire equipment WARNING Biological or chemical hazard and or radioactive radiation Contamination hazard due to parts of the instrument which are not co...

Page 28: ...2 14 Infinium LiHa and Infinium RoMa Operating Manual Document 1000000110155 v00 2 Safety Decontamination Declaration...

Page 29: ...iHa and Infinium RoMa The Infinium LiHa and Infinium RoMa is a precision instrument designed for automating specific steps in the Illumina Infinium Array Workflow The Infinium LiHa and Infinium RoMa i...

Page 30: ...type plate A you find the following information Identification data Model REF Ordering information material number revision level Production date SN Serial number Technical data U f Supply voltage Vol...

Page 31: ...2 Technical Data 3 2 1 Dimensions and Weights Instrument Overall Dimensions The figure shows the dimensions of the instrument Fig 3 2 Instrument overall dimensions 870 mm 34 2 in 875 mm 34 4 in 780 mm...

Page 32: ...Instrument equipped with Instrument height Liquid handling arm LiHa 980 mm 38 6 in Robotic manipulator arm RoMa 920 mm 36 2 in Tab 3 2 Instrument modules weights Infinium LiHa and Infinium RoMa 150 P...

Page 33: ...3 Status Lamp The status lamp is located above the diluters in the center of the instrument front surface It displays the instrument operational states with red and green light that is either continu...

Page 34: ...the barcode scanner near the instrument Operating Conditions Pipetting Conditions Storage Conditions Transport Conditions Operating temperature 15 C to 32 C 59 F to 90 F Operating humidity 30 to 80 re...

Page 35: ...signed and tested to CISPR 11 Class A In a domestic environment the system may cause radio interference in which case measures may need to be taken by the operator or the operating company to mitigate...

Page 36: ...mend degassing the system liquid For further information on this issue please contact your responsible application specialist In order to ensure that during operation no air bubbles form in the pipett...

Page 37: ...provided in other sections The LiHa arm is used for pipetting actions in different volume ranges depending on the tip types used and the features of the liquid system LiHa Operating Ranges Subject Ref...

Page 38: ...m to 38 mm 1 mm Tab 3 8 LiHa positioning accuracy at 9 mm spacing with all 8 tips simultaneously Axis Accuracy X 0 4 mm 0 016 in Y 0 4 mm 0 016 in Z 0 4 mm 0 016 in a a Worn parts may result in deteri...

Page 39: ...mm 150 l conductive liquid in sample tubes with a diameter of 16 mm 5 ml conductive liquid in reagent trough Wetted Materials The standard liquid system components that come into contact with either s...

Page 40: ...reagent blocks deep well plates etc from one to another position on the worktable or for storage onto the shelf ATTENTION Improper transport of labware microplates etc Use only labware that is rigid...

Page 41: ...rmless Work range for carriers clear worktable i e no elements such as incubators that restrict the PosID access range present The PosID can read the carrier ID in any grid positiona Work range for co...

Page 42: ...op character Allows for a modulo 43 check digit Use only with check digit modulo 43 Code 39 Full ASCIIb Same as code 39 standard but can encode the complete 128 ASCII character set including asterisk...

Page 43: ...X3 182 and DIN EN 1635 Illumina recommends using grade A for best reading performance A quality system in the production of barcode labels must be employed to ensure the conformity to the quality gra...

Page 44: ...iers 3 4 3 1 Permissible Barcode Types Note Depending on the application software not all barcode types readable by the PosID may be supported Refer to your Application Software Manual to find out the...

Page 45: ...Acetone o o x o o o o o Acetonitrile C2H3N o x o nd nd nd o Formic acid 100 o x x x o o x o o Ammonium hydroxide 25 o x o o o o nd o o Chloroform o x o x o x x Dimethyl formamide o o o o o DMSO o x o...

Page 46: ...x x Petroleum ether 30 50 o x x o nd nd nd x Hydrochloric acid 32 o x o o o o o o Trichloroacetic acid 40 o o o o o o x a Kel F Tab 3 15 Chemical resistance table cont Material FEP PVC Silicone POM P...

Page 47: ...g main electronic boards and power supply Robotic Arms It can be equipped with liquid handling arm LiHa The LiHa includes a liquid system with diluters The LiHa is used for liquid handling pipetting d...

Page 48: ...chanical Structure The figure shows the main parts of the Infinium LiHa and Infinium RoMa Fig 4 1 Infinium LiHa and Infinium RoMa instrument overview A C D H B E F G A Housing B Diluters with syringes...

Page 49: ...and racks are needed for Replacement loading unloading of carriers or racks during operation The identification of tubes microplates troughs etc on carriers by the PosID 4 2 3 Liquid System Structure...

Page 50: ...rm LiHa Cross References List of cross references to information provided in other sections Overview The liquid handling arm is part of the liquid system and is used for pipetting tasks Subject Refere...

Page 51: ...four or eight sampling tips are arranged on one liquid handling arm The tips can be moved independently in Z direction In Y direction equidistant tip spreading of 9 38 mm 0 31 1 5 in is possible Tip...

Page 52: ...ions on the worktable or for storage in the microplate shelf The RoMa standard coordinate system consists of five axes the X axis the Y axis and the Z axis defining linear movements and the R Axis def...

Page 53: ...e to the existing RoMa arm cable The latter powers the scanner and transmits all data back and forth between IAC and the scanner After performing the scanner alignment using various IAC tools as outli...

Page 54: ...panel one or two gas springs facilitate the opening of the panel Standard Front Safety Panel Functions of Safety Panel The standard front safety panel has the following function Restrict access to mov...

Page 55: ...are The application software is programmed in such a way that if the safety panel is open the process cannot be started the door locks can only be unlocked when the process is stopped or in pause mode...

Page 56: ...ll carriers and containers must be labeled with barcodes How Does it Work The PosID body runs past the carriers to scan the carrier ID barcode through the front aperture With its gripper the PosID pul...

Page 57: ...e carrier identification are scanned The figure shows how vertical barcodes e g on tubes or reagent troughs are scanned Fig 4 9 Barcode scanner position for scanning carrier ID Fig 4 10 Barcode scanne...

Page 58: ...e it monitors the presence of the tubes in the rack This is necessary because the barcode scanner cannot distinguish between a tube with missing or incorrectly positioned barcode and a missing tube Fi...

Page 59: ...lues to transmit it as a valid result Barcode Types Barcodes on Containers There is a variety of different barcode types Not all types are suitable for container identification for data security reaso...

Page 60: ...ubes valves and connectors The distribution of the system liquid is effected by the movement of the diluter pistons in one or several strokes The figure shows the schematic diagram of the standard liq...

Page 61: ...ems are available for 2 tip 4 tip and 8 tip instruments with optional features in different materials and with suitable accessories Aspirating Tubing Pipetting Tubing With all tubing systems the pipet...

Page 62: ...4 16 Infinium LiHa and Infinium RoMa Operating Manual Document 1000000110155 v00 4 Description of Function Liquid System...

Page 63: ...other sections can be found here https support illumina com content dam illumina support documents documentation chemistry_documentation infinium_assays infinium infinium assay lab setup and procedur...

Page 64: ...5 2 Infinium LiHa and Infinium RoMa Operating Manual Document 1000000110155 v00 5 Putting into Operation Startup...

Page 65: ...finium LiHa and Infinium RoMa instrument Power ON OFF Switch The power ON OFF switch is located at the instrument s lower right corner A status light in the switch indicates if the instrument is switc...

Page 66: ...ke sure that the instrument is running Before pressing the pause button in order to resume a process make sure that the instrument is pausing and that the safety panel is closed WARNING Injuries cause...

Page 67: ...NG Automatically moving parts Injuries crushing piercing possible if the safety panels are not in place or if the standard front safety panel is installed The standard front safety panel is partially...

Page 68: ...fore and during instrument use check the worktable for the safety of its layout Liquid System Liquids ATTENTION Leakage of the liquid system By the continuous up and down movements of the syringes dur...

Page 69: ...anged on one Liquid Handling arm Each tip must be exactly in line with the center of the tube to maximize the distance between wall and tip ATTENTION Possible malfunction due to tip clogging Using liq...

Page 70: ...racks and plates on the instrument s worktable The operator should verify these positions accordingly before executing any program In the event of power failure or an otherwise aborted run all partial...

Page 71: ...prohibited The operator might need to open or remove the work area safety panels for instrument setup cleaning and maintenance purposes For detailed procedures refer to cross references above 6 3 3 S...

Page 72: ...oftware The instrument is now ready to receive commands from one of the available application software packages 4 Perform the necessary checks before starting a run Refer to cross references above 6 3...

Page 73: ...ip waste bag if necessary 3 Check the system liquid container and refill if necessary If possible place the system liquid container on worktable level to avoid pressure difference in the supply tubing...

Page 74: ...ance procedures have been performed Make sure that there are no air bubbles in the tubing and that there are no liquid droplets on tips Refer to cross references above RoMa Gripper If the instrument i...

Page 75: ...lace a carrier during an application ATTENTION Make sure that the stop pins limit the carrier movement correctly otherwise crashes or incorrect pipetting may occur Positioning Pins If a positioning pi...

Page 76: ...wrong carrier When loading carriers always slide them all the way to the stop at the lock pin When carriers need to be removed always remove them completely from the worktable Never remove or place a...

Page 77: ...ication e g in a carrier that does not allow the containers to be identified by the PosID pay attention to the following Strictly follow the loading instructions provided by the software Double check...

Page 78: ...ssociated with the corresponding tube size Therefore the carriers are not handled correctly if the inserts are exchanged Do not change the strip rack inserts Do not exchange the carrier barcode flags...

Page 79: ...with a sufficient amount of supernatant Note For further information on sample preparation please refer also to the recommendations given by your manufacturer and by the WHO 6 3 4 4 Connecting Liquid...

Page 80: ...e waste tubing must not be longer than necessary The waste tubing must not be kinked or squeezed reduction of clear cross section The waste tubing must not rise after wash station back pressure The wa...

Page 81: ...Cross References List of cross references to information provided in other sections Before switching the instrument off some maintenance tasks might need to be performed e g tip cleaning Refer to cro...

Page 82: ...t or even defective If a harsh crash occurred contact your local service organization to have the instrument checked RoMa Crash After a crash with the RoMa check the gripper and the RoMa alignment 6 4...

Page 83: ...e and reliability of the instrument regularly carry out the maintenance and cleaning tasks In case of any problems and for inquiries contact the local service organization Additional Documents In the...

Page 84: ...ce active cleaning agent Decon Laboratories Limited UK www decon co uk Please contact the manufacturer Decon 90a Surface active cleaning agent Decon Laboratories Limited UK www decon co uk Please cont...

Page 85: ...ion Instrument part Cleaning agent Liquid system includ ing waste system Water alcohol weak detergent base Suitable for flushing are Bleach Decon Contrad Terralin protect Worktable Water alcohol weak...

Page 86: ...nance and Repairs Tools and Consumables Note After use of weak detergents base or bleach thoroughly clean with water and wipe dry to totally remove the cleaning agent and obtain normal operating condi...

Page 87: ...mple and Explanations Example for a maintenance table followed by explanations Instrument Component Specifies the instrument or one of its individual components on which a maintenance task must be per...

Page 88: ...3 Fixed Tips of LiHa 7 15 Check for damage See section 7 3 3 Fixed Tips of LiHa 7 15 System liquid container Make sure that it is full Waste container Make sure that it is empty Plate Washer Flush wi...

Page 89: ...7 19 Worktable Clean See section 7 3 5 Worktable 7 17 Safety panel Clean See section 7 3 6 Safety Panels 7 17 Wash station Clean using a detergent or anti septic solution See section 7 3 4 Wash Stati...

Page 90: ...10 Arm Guide 7 21 PosID Clean laser output window and No Tube sensor See section 7 3 9 Positive Identi fication PosID 7 19 Clean PosID working area of the worktable abrasion Lint free cloth and alcoh...

Page 91: ...rod Clean Call Illumina customer support to perform the task Liquid system diluters Replace syringe Call Illumina customer support to perform the task Liquid system diluters Replace 3 way valve Call I...

Page 92: ...re hanging on the fixed tips before the instrument is switched on or when it is in stand by mode if the syringes are leaking e g liquid accumulates around the diluters before the instrument is switche...

Page 93: ...for 1 minute If no droplets are formed the liquid system is tight 6 If the system is still leaky remove the top cover of the instrument by loosening the two outer screws 7 Tighten the tubing connecti...

Page 94: ...ecommended before each application run Flush Procedure To flush the liquid system 1 Make sure that the system liquid container is full 2 Switch on the instrument and start the IAC software 3 Flush the...

Page 95: ...acid and base in sequence Disinfectant Note If a system liquid other than de ionized water is used clarify the suitability of the cleaning agents with the manufacturer To fill the liquid system and a...

Page 96: ...ight get loose if these elements were not tightened properly This may result in leakage of the liquid system To avoid this problem proceed as follows Tightening Syringe and Plunger Lock Screws 1 Manua...

Page 97: ...and contact with aerosols when accessing the worktable by wearing adequate protective clothing Checking Fixed Tips for Damage Visually inspect the before switching on the instrument Make sure that the...

Page 98: ...ning Clean the wash station as follows 1 Wipe the surface of the wash station with a suitable cleaning agent e g water alcohol disinfectant to remove any spilled reagent Note Do not use bleach to clea...

Page 99: ...7 3 6 Safety Panels Cleaning the Safety Panels Perform the following procedure to clean the safety panels Wipe the inner and outer surface of the safety panels with a suitable cleaning agent e g water...

Page 100: ...oMa worktable The wash station can be cleaned on the worktable 2 Before cleaning remove the barcode labels from the carriers if possible 3 Wipe the surface of the racks carriers and the gripper with a...

Page 101: ...er proceed as follows WARNING Laser light CLASS 2 LASER PRODUCT Do not stare into beam nor into its reflections on the worktable Caution Use of controls or adjustments or performance of procedures oth...

Page 102: ...to the PosID Fig 7 4 PosID barcode scanner 2 Switch the instrument off 3 Remove the carriers in front of the PosID to gain access to the PosID 4 Visually check the laser output window B for cleanlines...

Page 103: ...Robotic manipulator arm Cleaning the Arm Guide In order to avoid uneven movements of the arm use a cotton tab or a lint free tissue on a screwdriver to clean the arm guide roller and a lint free tissu...

Page 104: ...5 to 3 70 ethanol 30 H2O Commercially Available Agents For commercially available agents that can be used for decontamination or disinfection refer to cross references above Hints Concerning Decontam...

Page 105: ...E is made 8 1 Troubleshooting Table Trouble shooting by the Operator The following table lists problems and errors and gives instructions on how to eliminate them Tab 8 1 Troubleshooting table Problem...

Page 106: ...not accord ing to specifications Check if barcode type is permissible See 3 4 3 2 3 13 Barcode label position not according to specifications Check barcode label position on container See 3 4 3 2 3 13...

Page 107: ...r on wash station Overflow of wash station Waste tube is below liquid surface in the waste con tainer Use a wash container with fixed wash tubing inlet Algae block the wash sta tion Clean the wash sta...

Page 108: ...8 4 Infinium LiHa and Infinium RoMa Operating Manual Document 1000000110155 v00 8 Troubleshooting Troubleshooting Table...

Page 109: ...associated with the waste material from the process run on the Infinium LiHa and Infinium RoMa Treat these substances and disposables such as wash liquid etc in accordance with good laboratory practi...

Page 110: ...lamp is off before switching the instrument on again 4 Unplug the power cord from the power supply at the rear of the instrument 5 Disconnect the instrument from the PC Fig 9 1 Power Switch Fig 9 2 P...

Page 111: ...interface cable from the USB port on the Te CU board behind the left access door Or Disconnect the RS 232 interface cable from the Te CU board 7 Clean and if necessary decontaminate the entire instru...

Page 112: ...tion of a qualified Illumina service person only Due to the heavy weight trained relocation staff is needed to lift the instrument 9 2 1 Unpacking The unpacking of the instrument may be done by a qual...

Page 113: ...to information provided in other sections Protect the instrument against dust and debris with a cover For long term storage pack the instrument in its original packing Store all manuals and the Maint...

Page 114: ...9 6 Infinium LiHa and Infinium RoMa Operating Manua l Document 1000000110155 v00 9 Shutdown Transport and Storage Storage...

Page 115: ...Electronic Industry Standard SJ T11364 2014 Marking for the Restriction of the Use of Hazardous Substances in Electronic and Electrical Products requires the marking for the restriction of the use of...

Page 116: ...r the restriction of the use of hazardous substances Marking Explanation This marking indicates that this electronic product contains certain hazardous substances and can be safely used during the env...

Page 117: ...No Plain Text Designation p n Label Designation 1 Illumina Automation Control IAC 6 3 1 Tab 11 2 Documentation No Plain Text Designation p n Label Designation 1 Infinium LiHa and Infinium RoMa Oper at...

Page 118: ...s Troughs 11 4 1 Carriers for Microplates Tab 11 4 Carriers for microplates Plain Text Designation Label Designation Widtha Reference Carrier for microplates RoMa 3 pos landscape orientation CARRIER M...

Page 119: ...1 3 11 4 2 Carriers for Tubes Tab 11 5 Tube carriers Plain Text Designation p n Label Designation Widtha Reference Carrier for tubes 16 mm 6 x 16 pos Set of 6 carriers RACK STRIP 16 POS TUBE 16MM 6 PC...

Page 120: ...Wash waste stations Plain Text Designation p n Label Designation Widtha Reference Wash waste station standard PP 8 wash positions shallow at rear 1 waste position at center 8 wash positions deep at f...

Page 121: ...Accessories Tips and Accessories Infinium LiHa and Infinium RoMa Operating Manual Document 1000000110155 v00 11 5 11 5 Tips and Accessories Contact your local service representative for information on...

Page 122: ...11 6 Infinium LiHa and Infinium RoMa Operating Manual Document 1000000110155 v00 11 Spare Parts and Accessories Tips and Accessories...

Page 123: ...Contacts Technical Assistance For technical assistance contact the Illumina technical support Website www illumina com E Mail techsupport illumina com Illumina customer support toll free telephone num...

Page 124: ...22493 31 207132960 New Zealand 0800 451 650 Norway 47 800 16836 47 21939693 Singapore 1 800 579 2745 South Korea 82 80 234 5300 Spain 34 911899417 34 800300143 Sweden 46 850619671 46 200883979 Switzer...

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