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HumaStar 600

| User manual

6

1.3 Intended Use of the Instrument

[IVD]

The instrument is intended for in vitro diagnostic application by professional

users. It has to be used for the expected purposes and in perfect technical con-
ditions, by qualified personnel, in working conditions and maintenance opera-
tions as described in this manual, according to the GENERAL SAFETY WARNINGS.

This manual contains instructions for professional qualified operators.
The external PC must not be used for purposes other than those designated in

this manual. The analyzer is designated for indoor use only. Recommendation
provided in the leaflet for all reagents and consumables have to be observed.

1.4 General Safety Warnings

Use only chemical reagents and accessories specified and supplied by HUMAN
and/or mentioned in this manual. Place the product so that it has proper ven-
tilation.

The instrument should be installed on a stationary flat working surface, free

from vibrations.
Do not operate in area with excessive dust.

Work at room temperature and humidity, according to the specifications listed

in this manual.
Do not operate this instrument with covers and panels removed.
Only use the power cord specified for this product, with the grounding conduc-
tor of the power cord connected to earth ground.
Use only the fuse type and rating specified by the manufacturer for this instru-
ment, use of fuses with improper ratings may pose electrical and fire hazards.

To avoid fire or shock hazard, observe all ratings and markings on the instru-

ment.
Do not power the instrument in potentially explosive environment or at risk of
fire.
Prior to cleaning and/or maintaining the instrument, switch off the instrument
and remove the power cord.
For cleaning use only materials specified in this manual, otherwise parts may
become damaged. It is recommended always to wear protective apparel and eye
protection while using this instrument. Respective warning symbols, if appear-
ing in this manual, should be carefully considered.

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Summary of Contents for HumaStar 600

Page 1: ...HumaStar 600 User Manual Cat No 16660 001...

Page 2: ......

Page 3: ...of ISE module excluded 10 2017 05 Update for Software 2 5 0 SYSTEM VERSION COPYRIGHT Copyright 2017 Human Gesellschaft f r Biochemica und Diagnostica mbH Wiesbaden Germa ny All rights reserved No part...

Page 4: ......

Page 5: ...PACKING 11 3 2 INSTALLATION 11 3 2 1 Installation Requirements 11 3 2 2 Electrical connections 12 3 2 3 Hydraulics 12 3 2 4 Handling of biological fluids 13 3 2 5 Computer setup 14 3 2 6 Parameters 15...

Page 6: ...tests 49 5 2 3 Removing a sample 50 5 2 4 Removing tests 51 5 2 5 Copy data 51 5 2 6 Loading samples 52 5 2 7 Removing a sample 53 5 2 8 Placing a sector on the tray 53 5 2 9 Removing a sector 54 5 2...

Page 7: ...ntitative 88 6 2 4 Limits 89 6 2 5 Reference classes 91 6 2 6 Advanced features 92 6 2 7 Consumption 94 6 2 8 Reagent substitution 95 6 2 9 Kits 96 6 3 SOLUTIONS 97 6 4 OPTIONS 98 6 5 CALCULATED METHO...

Page 8: ...Calibration 113 8 4 3 Clean System Bottles 114 8 4 4 Intensive Washer Cleaning 115 8 5 MAINTENANCE ON DEMAND 116 8 5 1 Cuvette Change 116 8 5 2 Lamp Replacement 117 8 5 3 Pump tube replacement 117 8 6...

Page 9: ...ument to the purchaser The HUMAN representative shall replace or repair any defective item at no charge except for transportation expenses to the point of repair This warranty excludes the HUMAN repre...

Page 10: ...alled on a stationary flat working surface free from vibrations Do not operate in area with excessive dust Work at room temperature and humidity according to the specifications listed in this manual D...

Page 11: ...ion Analytical instruments for in vitro diagnostic involve the handling of human samples and controls which should be considered at least potentially infectious Therefore every part and accessory of t...

Page 12: ...g label below 1 8 Additional Labels The labels used on Human products are among those specified by the interna tional Organisation for Standardization ISO They are placed at critical points on each in...

Page 13: ...the analyzing process and gives easy ac cess to advanced statistical functions and reports Versatile method setup com prises end point fixed point kinetics ISE coagulation calculated and externals Opt...

Page 14: ...HumaStar 600 User manual 10...

Page 15: ...r Manual 16660 001 3 2 Installation 3 2 1 INSTALLATION REQUIREMENTS Carefully read the safety instructions included in this manual Install the instrument on a hard floor with a resistance of at least...

Page 16: ...purified water should be used with less than 2 S cm and less than 100 CFU mL to avoid contamination of the system with ions and bacteria Described specification fall in CLSI Type 2 water catergory Le...

Page 17: ...s biological fluids Keep in mind the following considerations 1 Due to the presence of biological fluids some instrument areas are poten tially dangerous They are warned with the symbol see Figure 1 D...

Page 18: ...or higher Memory 4 Gb Ram Video board Graphics Enging GeForce 8400 or equivalent Monitor 17 VIS 15 7 Display resolution 1024x768 vertical refresh 70 Hz Colour quality 16 bits Hard drive 500 Gb SATA 3...

Page 19: ...yo directory has to be excluded from the scanning process Please refer to the documentation of the Anti Virus Software Don t use the predefined MS Windows folders 3 2 6 PARAMETERS There are few parame...

Page 20: ...options are provided batch and full random access 5 Coagulation Service only not in use 6 Online printing Enables printing selector of printout of pending acceptance samples and printout of manually a...

Page 21: ...ag is added to the result invalidate the result will be deleted The function to aspirate the same sample again can be enabled or disabled Refer also to section 4 1 1 Press Apply Changes in order to sa...

Page 22: ...type expiration date format and starting position In case of closed parameters values are predefined and no intervention is necessary 3 Sample configuration If Id position is not selected all barcode...

Page 23: ...formations for the communication with host computer 2 Options Select parameters according to specifications of your LIMS provider 3 2 6 2 Use Use parameters are split in several sections Cuvette absor...

Page 24: ...reading after cuvette change and the actual reading 2 Sample vials Two different sample diameters vials can be defined This fea ture is useful to define pediatric vials Volume calculations require ca...

Page 25: ...d Down allow moving methods to different positions in the final printout If not enabled sorting will take place alphabetically Press Apply Changes in order to save the changes 3 2 6 4 Sector definitio...

Page 26: ...can be on board at the same time On the right side of the screen all programed sectors are displayed Press New to add an other sector To define it as a STAT tick the box STAT sector and press Ok All...

Page 27: ...safte results is enabled test with following flag wrong direction initial ab sorbance limit high consumption correlation coefficient 0 8 and unsta ble ion can not be accepted 3 2 7 TOOLS 3 2 7 1 Trans...

Page 28: ...slation will modify only the screen the Translation control window has been opened All modifications done in Global will effect all entries in the software Modifications take effect only when program...

Page 29: ...window shows internal text and lower win dow the translation if present Sorting can be performed by internal or by translation There is also a built in search tool Entries can be deleted by press ing...

Page 30: ...captions will appear It is possible to add edit or delete text data text or lines for each band Following screen will be open when the Add or Edit but ton is pushed Text position size font can be mod...

Page 31: ...the Change button allows selecting the desired field to be shown The Texts are the true headers corresponding to the Data texts and can be fully modified by pressing Change button As an example the fo...

Page 32: ...3 3 2 TOP VIEW 2 5 1 4 3 6 1 On Off switch 2 Cooling switch 3 Waste tank 4 Washing pumps 5 Front Back dilutor 6 System Wash Container Figure 23 Front View 1 Back reaction tray 2 Front reaction tray 3...

Page 33: ...nition Five segments can be present simultaneously in the sample tray while up to 99 external out of tray sectors can be handled by the system STAT samples can be loaded in special high priority secto...

Page 34: ...0 alphanumeric characters For details on labeling position see figure Data expressed in mm Available codes for both sample barcodes or rea gent barcodes are Code 128 NCCLS recommend ed UPC EAN Code 39...

Page 35: ...results among others 3 4 1 LEVELS OF ACCESS System has different levels of access depending of the type of user Normal user Power user Supervisor Service Select in main menu Select Power User Supervis...

Page 36: ...ENU Import Methods QC Sets Calibration Sets Units Conversions and Translator information can be imported Service Backup creates a instrument image for service puposes Reconnect restarts the instrument...

Page 37: ...t information Samples define and order chemistry ISE coagulation and calculated tests Tests review pending reactions and analysis results Reagent tray graphically insert or remove reagents in tray Sam...

Page 38: ...end and restart dilutions Allows to momentarily stopping dilutions for sample and STAT load 3 Running options can be selected by operator according requirements which depend on the moment and opportun...

Page 39: ...volumes to accom plish the processing of the on tray samples as well as reagent availability With right click in mouse options about operations are shown In addition Information on missing or expired...

Page 40: ...u Data from samples are added to this identification screen Id type collec tion date Also tests and number of replicates are incorporated This load can be performed method by method or with the aid qu...

Page 41: ...lable Click apply to place vials in the tray Sample Tray Menu A sample tray consists of five sectors 19 samples each User can prepare and load additional sectors while instrument is operating Primary...

Page 42: ...Menu Reagent blanks can be programmed in this menu If they are within the automatic set up limits they can be viewed and validat ed Historical results can be viewed and asessed in order to help reage...

Page 43: ...System Description 39 Method Definition Menu New methods for the open channels can be set up by the supervisor For the closed channels the limits and reference classes can be set Figure 42...

Page 44: ...HumaStar 600 User manual 40...

Page 45: ...window will show pending anal ysis present and required reagents and any other flagged condition If one or more samples are not listed verify that samples are already positioned in sam ple tray and ha...

Page 46: ...ot detectors one in each probe They operate based on a differential pressure principle Clot detector is installed in Maintenance Service Parameters Instrumentals Others Detectors automatically calibra...

Page 47: ...four letters of its method name When two or more method names start with the same four letters an asterisk is shown for both One dot under the name indicates second reagent R2 2 points a third reagent...

Page 48: ...utions diluents and C Clean Yellow Reagent not in use Light Gray Free position Dark Gray Reagent not in use or removed 5 1 2 LOADING BARCODED REAGENTS DILUENT AND CLEANING SOLUTIONS Barcoded reagents...

Page 49: ...k when done or Cancel to abort Press Apply Changes and the reagent tray turn the selected position to the bottle insert remove area Message will be Put CREA 1 in position 2 Open the cover insert the r...

Page 50: ...item then press and hold Shift key while selecting the last item Alternatively for extended selection use the mouse by click and drag Alternatively to remove a reagent or solution from a particular p...

Page 51: ...t is to the front tray if not otherweise specified at the applica tion protocol of the method For tray assignment follow There is a unique feature consisting an automatic reassignment of methods to th...

Page 52: ...ss the Patient Menu button 1 Patient Information are shown at the Patient report All fields are automat ically confirmed and only the Patient Id is mandatory Patient Id cannot be modified only option...

Page 53: ...tor 2 Programmed tests for the sample Id shown above 3 Quick load to add tests 4 Predefined profiles to add multiple tests To define a profile see section 5 9 1 5 Samples can be placed immediatley on...

Page 54: ...rofiles in Quick load panel or Profiles panel When replicates of the same sample are required use the Add Test button or press method ID several times in the Quick load window Without requiring its in...

Page 55: ...ist on the right window and then press Delete Test Select tests to remove from the list Press Ok when done or Cancel to abort 5 2 5 COPY DATA New samples can be generated by copying data from another...

Page 56: ...panel Point the mouse over the desired position and all sample test information will be dis played on the right panel Data are also available for printout in Reports Input Tray 5 2 6 1 Loading barcode...

Page 57: ...7 REMOVING A SAMPLE To remove samples from a sector first click on a sector ID from the list of sectors and then press Remove Sample Select the sample IDs or sector posi tions to remove Press Ok when...

Page 58: ...le sector in sertion removal area Remove the sector When done press Ok button to confirm the operation 5 2 10 LOADING A STAT A STAT sample placed on a STAT sector or STAT position has priority over al...

Page 59: ...th trays Data include condition initial and actual air blank Online printing When laser or inkjet printers are used samples are print ed once batch is ready This option allows printing even if batch i...

Page 60: ...ated test can be insert Calculated Calculated results can be checked and confirmed Done Results can be reviewed sorted by last name sample Id or patient Id Using the Print button results and patient r...

Page 61: ...fferent ways and operator has full control on the display of the results This is a post run operation and is not related to the online printing controlled by Maintenance Parameter Software Press the P...

Page 62: ...the reaction measurements In Use Actual calibrations can be reviewed deleted or printed Historic Former calibrations can be reviewed or reactivated for the ac tual use The calibration is shown in the...

Page 63: ...sor and Power user can define a new calibrator set 5 4 1 1 Defining a calibrator set Open the Calibration Menu and select on the left side the Calibrator Set Submenu To edit the definition of an alrea...

Page 64: ...tor set select the test and press Delete Test Once no further modifications are required for the calibrator set press Ok to finish or Cancel to abort Once tests are loaded in the grid concentration va...

Page 65: ...u tion 1 1 and the blank If included they are within the defined number i e Di lution of 6 it is 1 1 1 2 1 4 1 8 1 16 and blank The concentration of mother solution is defined in the Vial sector A min...

Page 66: ...you want the calibration to take into account Press Ok when done or Cancel to abort To request at a later time another method from the calibrator set select the cali bration from the list on the righ...

Page 67: ...e box in front of a replicate which should be excluded from the calibration curve calculation Column to the right of each function will show the least squares adjusting val ue Select function with min...

Page 68: ...ters Logit5 Abs R K 1 exp a b ln Conc c Conc where K a b c are automatic adjusting parameters Calibration fit parameter is shown in all cases If curve is forced to pass through zero functions logit 4...

Page 69: ...stop mode or during start operation 5 5 Reagent Blank Reagent Blank can be measured in the automatic procedure or directly from the Reagent Blank Menu When the automatic measurement starts blanks are...

Page 70: ...cceptance is programmed and or the reac tion is flagged the reagent blank has to be manually accepted When replicates are taken they can be accepted or reject indi vidually The final result is the ave...

Page 71: ...the use of Control Sets A control set is a vial of a given brand and lot containing all the desired analytes with their respective admissible ranges Control sets from different brands and levels can b...

Page 72: ...of QC samples of a special period can be dis played or printed Done Controls mesured in a specific time frame can be dis played Tests can be deleted only out of the statistics a rerun can be requested...

Page 73: ...ROUTINE TASKS 69 5 6 1 CREATING A CONTROL SET Open the Quality Control Menu and select on the left side the Control Set Submenu To define a new control set press New Figure 68 Figure 69...

Page 74: ...est Define the number of default Replicas for each test within each control set This number will be used every time the control set is used or scheduled Repeat this operation for each required test on...

Page 75: ...l set press New Select the desired control set in the list on the left side Tick at least one box in front of a test name to select them and enter the number of replicates Repli cates can be set indiv...

Page 76: ...and place in the instrument as indicated in 5 2 6 If the barcode reading procedure is performed and a control set is recognized it will be associated with any pending action already defined in the sc...

Page 77: ...each column Selectors can be used separately or together Selectors act as logical AND which allows refining the selection The result are dislayed including the low and high limits and they are marked...

Page 78: ...splay a Levy Jennings graph with relvant statis tical data and the Westgard rules violations as shown below To print the displayed data press the Print button Before the print will be displayed an opp...

Page 79: ...e main screen press Details again The red color indicates that the results are out of the assigned range or out of WR Westgardrules green they are inside the assigned range Additionaly su pervisor can...

Page 80: ...the Control Vial Id given in the Control Set 2 Link the samples Press the Link Samples tab Select the Twin Id Press the Refresh Lists button to display all controls which correspond to high and low l...

Page 81: ...For identification purposes entries will be shown in alternate colors yellow and white Every entry can be unlinked by selecting one of both components and pressing the Unlink button Select the desire...

Page 82: ...rols respectively The intersection of both median lines is called the Manhattan Median The dia gonal through the Manhattan Medial is the ideal location high correlation position for the pairs Points n...

Page 83: ...ey are immediately in the Pending QC status shown in red in the left side of the screen They can be removed by dragging and dropping on the trash symbol They remain as pending until they are in the li...

Page 84: ...tests 5 9 1 DEFINING A SAMPLE PROFILE To define a new sample profile press New Enter a Profile Id and use the Quick load to add test by double click the test name Tests can also be added or deleted us...

Page 85: ...volumes of reagent and sample the times when the ab sorbance measurements shall be taken by the photometer and the calculations to obtain the final result ISE methods define the ion selective electrod...

Page 86: ...ogous to sample reaction If extra precision is required measurement is computed as the average of the first and extra precision readings as M A1 Ae1 2 B Limitations Reagent times for R2 R3 if any shal...

Page 87: ...t and second absorbance readings A1 and A2 are taken at specified times NT1 and NT2 after last reagent addition Real reading times in seconds since last reagent addition are observed RT1 and RT2 Measu...

Page 88: ...excluding all 10 points one by one System will select the condition of best correlation excluding the worst point if necessary Measurement Consumption evaluation is calculated per 1 minute as C Ac2 Ac...

Page 89: ...ood Sample material used for the method not available for Calculated and External methods Units Predifined in the scroll down menu More can be added in the Options menu Decimals 0 to 6 Decimal positio...

Page 90: ...to 500 l Set in increments of 1 l 2nd Reagent Check or No Check 5 to 500 l Check the box to use a second reagent Set in increments of 1 l 3nd Reagent Check or No Check 5 to 500 l Check the box to use...

Page 91: ...eagent is present When Extra Preci sion is used recommended two consecutive readings are averaged Fixed Point Readings Incubation is the time interval between addition of last reagent and the first re...

Page 92: ...ill be checked and result will be flagged if direction is wrong and the result has to be manually accepted Calibration type Curve Linear Check No Check Check if one or more calibrators should be used...

Page 93: ...ck Check if a reagent blank should be used in the calculation of the result Sample replacement with Diluent Reagent Select which solution should be used Diluent Drop down menu All diluents defined in...

Page 94: ...Insert a low absorbance limit Concentration duplication limit Result verification check normal repetion can be triggered according to each laboratory need Low limit 999999 to 999999 Insert a low abso...

Page 95: ...rmal limits or reference values for the various types of samples men women children etc Reference classes can be added to the method definition using particular low and high limits Reference classes a...

Page 96: ...ive instead of a numerical value Insert the function or and the value for the decision between posi tive and negative 6 2 6 ADVANCED FEATURES Advanced features include procedures to avoid contaminatio...

Page 97: ...lineartiy in methods with very low absorbances Interfering methods Add or delete methods which interfer the existing method Sample Acceptance Manual Automatic Manual to send all results to the Pendin...

Page 98: ...ime before first sec 0 to Define the time when the check should take place rec ommendation incubation 60 sec set to 15 incubation 60 sec set to 30 Behaviour Conservative Check No Check Check and durin...

Page 99: ...a different method or a predifined diluent drop down menu If Use Method is chosen select the method this method belongs to R2 and R3 2nd Reagent Check No Ceck Check to apply a reagent or diluent for...

Page 100: ...rcoded reagents different kit sizes can be used The information of the first kit are automatically insert from the Main and Ad vanced tab If a second Kit size should be used insert the BCR code the on...

Page 101: ...and before going to Standby Tip Rinse 16663 25 901 Rinse the probe after Tip Clean ISE solutions described in the ISE User Guide User defined Generic and specific dilutents required in some methods S...

Page 102: ...pe and press Ok to con firm or Cancel to abort Once the solution is set up only BCR code is possible to change To delete a solution select the solution in the table and press Delete 6 4 Options To add...

Page 103: ...measurement units are displayed to add a new measurement unit press Add and type in the unit and press Ok to confirm or Cancel to abort to delete select the line and press Delete 6 5 Calculated method...

Page 104: ...s and insert the low and high limit Press Ok to confirm or Cancel to abort 6 6 External Methods To add modify delete or print an external method press the Method Definition Menu button and select the...

Page 105: ...ds In brief the method ID and measuring units can be modified Method correla tion concentration duplication limits and reagent blank and calibration auto matic acceptance limits can be set Reference c...

Page 106: ...on period etc of individual reactions In Options basic method parameters are defined wavelengths number of reagents volumes total measuring time In Calibration page analysis type is defined and fit fo...

Page 107: ...ISE Module Cat no 16663 03 103 7 ISE MODULE CAT NO 16663 03 See HumaStar 600 ISE MODULE User Manual 16663 1...

Page 108: ...HumaStar 600 User manual 104...

Page 109: ...uency Task Daily Inspection and Cleaning of Probes Check and Replace System Solutions Empty Waste Bottle Hydraulic Testing System Flush Weekly Intensive Cuvette Cleaning Cuvette Water Blank Service Ba...

Page 110: ...put Comments Day start at 0 to 24 o clock Set the time of routine start Day Ends at 0 to 24 o clock Set the time of routine stops Service Backup at 0 to 24 o clock Set the time when the Backup should...

Page 111: ...ications 8 1 2 STATUS A list of maintenance tasks is presented in this window with the dates and times that were last executed as well as the times that are next scheduled for The ac tivities are main...

Page 112: ...ently remove protein deposits or solids from tip with a cotton swab soaked in 70 Alkohol Dry with lint free tissue 5 Press Ok when done The scheduler will be updated automatically 6 After Cleaning the...

Page 113: ...in the reagent tray replace if necessary 8 2 3 EMPTY WASTE BOTTLE The waste bottle is placed on a scale and if the bottle is full the system will show an alarm Open the front door empty the waste bot...

Page 114: ...agent tray Approximately 25 min are needed to clean all cuvettes 1 Open the Maintenance scheduler status screen and press Perform behind the Intensive Cuvette Cleaning function 2 Check the box for Fro...

Page 115: ...min and if accept ance criteria are fulfilled cuvettes are considered clean 1 Open the Maintenance scheduler status screen and press Perform behind the Cuvette Water Blank function 2 The cuvette wate...

Page 116: ...he optimum reading position in the middle of each cuvette Please perform this maintenance directly after intensive cuvette clean and cu vette water blank to ensure the cuvettes in Pos 1 are clean The...

Page 117: ...ill take approximately 3 minutes The screen will show the pump steps settings and new pump steps required for system delivery in all four wash steps 1 Perform a System Flush refer to 8 2 4 2 Open the...

Page 118: ...To clean the bottles follow the below instructions 1 Open the Maintenance scheduler status screen and press Perform behind the Clean System Bottles function 2 Take out and empty the system wash bottl...

Page 119: ...the Operation menu select 1 Check the box for Front and Back in the Intensive washer cleaning section 2 Select the C Clean for the Solution to use 3 Check if C Clean Ref 16663 20 is placed on the reag...

Page 120: ...the usage value of 25 000 is reached Maintenance Operations Wear All cuvettes should be changed at the same time To change cuvettes open the Reaction Tray Menu 1 Press Change and a following pop up wi...

Page 121: ...as a useful life given by a pre fixed number of work cycles When that number is surpassed instrument will show a message for tubing replacement At the earliest opportunity the replacement must be done...

Page 122: ...limit is reached the system issues a warning The maintenance should be done as soon as possible but there is no need to interrupt routine work When a replacement is done the reset button should be pre...

Page 123: ...xceeded Preset limit is surpassed Replace at the earliest op portunity Front Back pump turns exceeded Preset limit is surpassed Replace at the earliest op portunity There is no enough cleaning solutio...

Page 124: ...s on and off analyzer 2 Check that reagent was not frozen Check color changes sediments turbid ity no foam 3 Check for mixed reagents from different lots or re use of reagent bottles All methods 1 Ver...

Page 125: ...6 For some kinetics verify if sample volume is too low 7 For some kinetics verify centrifugation increase time and speed Kinetics with normal values too high 1 Perform energy noise and photometric st...

Page 126: ...Repetition or dilution two point kinetics This is not actually an error it is because volume absorbance change relation ship is not linear and so it is necessary to dilute standard and compare Reacti...

Page 127: ...d or lack of linearity Au tomated reflex testing Full quality control Levy Jennings and Twin plots Westgard rules Import export data methods and historic files Automatic backup procedure Test selectio...

Page 128: ...Optics Double beam Photometric Range 0 1 to 3 6 A Measuring wavelength 340 to 800 nm selectable among 12 wavelengths Photometry Single or Dou ble wavelength simultaneous reading ISE Unit Na K and Cl m...

Page 129: ...125...

Page 130: ...HumaStar 600 User manual 126...

Page 131: ......

Page 132: ...HUMAN Gesellschaft f r Biochemica und Diagnostica mbH Max Planck Ring 21 65205 Wiesbaden Germany Tel 49 6122 9988 0 Fax 49 6122 9988 100 eMail human human de www human de...

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