Operation Manual
Contents
1. return to MEASUREMENTS REVIEW LANGUAGE The language is selected by using V and confirmed by Fig 7 Active key DATE AND TIME 18 In date and time settlement keys gt move the arrow pointer between year month day hour minute Gy keys change their value The date is settled in the order year month day When settled minutes seconds are reset The confirmation is done by Fig 9 Active keys AUTO PRINTOUT SETTINGS AUTO PRINTOUT decided if each measurement is printed ON printout after measurement OFF no printout after measurement The results with error or negative are not printed The printout state are changed with using V amp ZOOM FRAME The graph in zoom frame Fig 12 shows the sample temperature after crystallization induction in time of max temperature reaching 19 1 pixel is 0 001 C in vertical axis There is no mistake if the graph is outside the zoom frame It could happen if the sample crystallization is slow 11 4 MEASUREMENT STOP Pushing MODE in any moment of measurement or calibration will stop actual activity Fig 11 The sample could need time to defrosted the signalization is blinking cursor it depends on the measurement stage DO NOT TAKE OFF THE SAMPLE TUBE FROM MEASURING HEAD IN CASE NOT TO DAMAGE THE THERMISTOR PROBE MODE Fig 11 Active keys MoDE The keyboard is not active to the time of sample de2. Laboratory Equipment Manufacturer AN www mrclab com CE i Net CS OSMOMETER OSM 9 User s manual PLEASE READ THIS MANUAL CAREFULLY BEFORE OPERATION 3 Hagavish st Israel 58817 Tel 972 3 5595252 Fax 972 3 5594529 mrc mrclab com MRC VER 01 2 14 Q1 10 CONTENT INTRODUCTION MEASURING PRINCIPLE SPECIFICATION AND TECHNICAL DATA 3 1 Specification 3 2 Technical data 3 3 Packaging storage transport 3 4 Environmental protection TRAINING MEASURING PREPARATION SAMPLE COLLECTION AND PREPARATION 6 1 Warning infected sample treatment 6 2 Human bodyfluids treatment MEASURING HEAD 7 1 MEASURING HEAD OPERATION Switch on the OSMOMETER OSM 9 8 1 Calibration MEASUREMENTS 9 1 Measurements 9 2 Stop during measurements 9 3 Measurements finishing Operation note 10 1 Liquid dosage 10 2 OSMO KRIO sample tubes 10 3 Calibration and control solution 10 4 Control test measurements 10 4 1 Test of measurement precision 10 4 2 Test of measurement reproducibility 10 5 Information and practical hints 10 6 The stirring wire replacement O O CO CO CGO CON NNN ND DOO fF FH a ee ee ee a ea a RP O OO NNNNNN s a O 11 DESCRIPTION OF ADDITIONAL OSMOMETER FUNCTION 11 1 Power on the Osmometer OSM 9 11 2 Description of additional osmometer function 11 2 1 CALIBRATION 11 2 2 MEASUREMENTS 11 2 3 SETTINGS 11 2 3 1 MEASUREMENT HISTORY
3. 11 2 3 2 Header printout edition 11 2 3 3 LANGUAGE 11 2 3 4 DATE AND TIME 11 2 3 5 AUTO PRINTOUT 11 3 ZOOM FRAME 11 4 Measurement stop 11 5 Factory settlements restore 12 Measurement results printout 12 1 Serial transmission parameters 13 Osmometer service transport 13 1 Additional information 14 MEANING OF DISPLAYED ANNOUCEMENTS 14 14 14 15 16 17 18 18 19 19 20 20 20 20 21 21 21 21 21 22 1 INTRODUCTION The OSMOMETER OSM 9 is a compact micro processor controlled analyzer for easy and precise osmolality tests in samples of serum plasma urine or other body fluids The OSMOMETER OSM 9 makes the running of the osmolality test very easy a 100 ul of the sample are pipetted into a sample tube b The sample tube is attached to the measuring head c The measuring head is pushed down into the cooling chamber d Now the measuring cycle starts automatically e When the measuring is terminated the measuring head returns to its upper position again and the result is digitally displayed in mOsm kgH2O The 1 point calibration requires distilled water only and is one of the most practical features of this analyzer The calibration values are automatically calculated and stored in the microprocessor memory The microprocessor control and built in electronic components with high long term stability make the OSMOMETER OSM 9 an analyzer of easy application and reliable results 2 MEA
4. OSMO KRIO with sample inside is carefully moved from below onto the mandrel until the retaining spring engages The thermistor probe entering the sample tube and the stirring wire must not get damaged while positioning the sample tube and should not be touched when sample tubes are attached Pressure to the pressure point N and lower the measuring head into the cooling chamber The measuring head is then held in bottom position electromagnetically and measurement is started with displaying actual sample temperature Fig 12 1 Active key After measurement the measuring head will return to the upper position The calibration correction is done automatic and then it s counted and corrected value will be displayed 0 mOsm kgH2O Take off the sample tube carefully to avoid the thermistor probe and stirring wire damage Dry the thermistor probe and stirring wire by lintless tissue The blinking CURSOR BAR under ZOOM frame points sample defrosting Do not take off the sample tube from measuring head in case not to damage the thermistor probe NOTE When the power is switched off the memory will lose the calibration value So every time when the osmometer is switched on it requires a new calibration to compensate for the long term drift of the thermistor probe parameters 9 MEASUREMENTS 9 1 Measurements Just after calibration the Osmometer OSM 9 automatically goes to mode MEASUREMENTS READY FOR SAMPLE MEASUREMENTS RE
5. during the measuring cycle shows fig below ti temperature at which the crystallization in the super cooled solution is initiated tk lowering of the freezing temp of the solution according to the osmolality The general equation of tk to osmolality is influenced by several nonlinear functions of the electronic and mechanical components of the analyzer These values are calculated during the factory calibration and stored in the microprocessor memory in Osmometer OSM 9 3 SPECIFICATION AND TECHNICAL DATA A After having recieved your new OSMOMETER OSM 9 please check the content Any claims should be reported to your local dealer or to the manufacturer 3 1 Specification SPECIFICATION Osmometer OSM 9 Sample tubes OSMO KRIO Calibration solution 0 mOsm kgH2O Control solution 400 mOsm kgH2O 3 2 Technical data ibrati single point 0 mOsm kgH2O thermoelectric Peltier efect 100 ul 0 2000 mOsm kgH20 1 mOsm kgH20 reproducibility emperature in cooling chamber emperature crystalization initiation e Power supply 220V 10 15 50 60 Hz 50 VA Power switch and fuse are located on back side of the instrument Fuse WTAT500mA 250V e Port RS 232 to printer or PC e Ambient temperature 109C 350C e Storage temperature 100C 500C e Relative humidity 30 75 e Atm pressure 700 1060 hPa e Storage rel humidity 65 e Dimensions 300x200x170 290 mm e Weight 6 kg 3 3 PACKAGING STOR
6. A 1 O COOLING CHAMBER TEMP 11 9 CURRENT 1 25A Fig 13 Active key LE OA Efficiency stirring wire test by short pressing of key Electromagnet test operation put the empty sample tube ant the measuring head and insert it in cooling chamber see p 7 1 key will release the measuring head MODE key return to the MAIN MENU 13 1 Addition information A The manufacturer has rights to introduce changes and make a modernization of the osmometer during production cycle 14 MEANING OF DISPLAYED ANNOUCEMENTS The control programme controls the Osmometer OSM 9 work and every measurement procedure All defects are signalized by E proper number that are displayed in top of the screen CODE MEANING DEFECT REASON DEFECT REMOVING 21 a GO E not proper cooling E warming up the cooling remove warm source and chamber temperature chamber after 30 sec put MODE defect of cooling circuit Mm SERVICE E problems durig sample probka zbyt stezona crystalization over measurement limits gt 2000 mOsm kg H20 deformation of stirring E stirring wire change wire stirring wire assembly E SERVICE damage defect of the termistor E SERVICE probe the lack of crystal seeds repeat the measurement in the new sample tube E measurment head does sample tube bindingin defrost and dry the cooling not go out from the the cooling chamber chamber cooling chamber upper mechanism defect E SERVICE contaminat
7. ADY FOR SAMPLE Fig 3 2 Active key MODE Pipette 100 ul sample into a dry and clean sample tube OSMO KRIO Pay attention that no droplets remain on the inner side of the sample tube and that no air bubble is enclosed in the sample Sample tube OSMO KRIO with sample inside is carefully moved from below onto the mandrel until the retaining spring engages The thermistor probe entering the sample tube and the stirring wire must not get damaged while positioning the sample tube and should not be touched when sample tubes are attached Pressure to the pressure point N and lower the measuring head into the cooling chamber The measuring head is then held in bottom position electromagnetically and measurement is started with displaying actual sample temperature Just after measurement the measuring head will return to its upper position and the measurement result is displayed The result is now in MEASUREMENTS HISTORY memory The displayed temperature is a freezing temperature of sample The result is displayed continuously to the beginning of the next measurement The blinking CURSOR BAR under ZOOM frame points sample defrosting Do not take off the sample tube from measuring head in case not to damage the thermistor probe 10 TEMP 02 4 MODE Fig 12 Active key MODE In case of itself freezing before achieving 7 C temperature the osmometer makes the measurement result correction that take into account earlier c
8. AGE AND TRANSPORT The box package packing condition storage and transport it should be according to PN EN 60601 1 1999 p 10 1 p 6 8 3d p 3 p 6 1 v and ISO R 780 Unit box Osmometer s package should be according to second group division of medical instrument packages Label information manufacturer data and instrument type Production data and symbols regards proper transport position and storage Collective box 4 pcs osmometers in collective box should be placed without loose in collective box that is made from fivelayer cardboard in one layer storage Osmometers in unit box or collective box should be storage in clean and well ventilated room temperature from 10 C to 50 C and relative humidity not over 65 Maximum storage time is 1 year After that time the osmometr have to be validated by special test in authorized service Transport Ambient condition should be as below during the transport temperature 10 C 50 C humidity lt 85 Reclimatisation after transport should be done with power OFF the Osmometer in indication work conditions according to p 1 2 this standard through minimum 3 hours there should be no moisture at the Osmometer 3 4 Environmental protection Do not throw away this device as a garbage The Osmometer OSM 9 includes parts that could be utilized Useless devices should be send to service or to the utilization company electronic devices 4 TRAINING The producer or d
9. ETTING menu Fig 5 SETTING possibilities review printout deleting measurement history Fig 6 language change Fig 7 date and time setting Fig 8 ON OFF automatic printout after measurement Fig 9 Fig 5 Active keys MEASUREMENTS REVIEW Option in MEASUREMENTS REVIEW Fig 6 header printout edition print printout single result signed by the cursor print all printout all results from memory with header delete delete single result signed by the cursor delete all delete all measurement history Fig 6 Active keys Mi V O Move the cursor at the chosen result by Va max 99 results in memory W move cursor at the option Eisi accept of the option choice W return to the measurement result list The cursor returns to the measurement list just after deleting chosen result The results will automatically are in new order without deleted result Header printout edition Fig 14 Active keys E Possibilities in HEADER mode in MEASUREMENTS REVIEW the changing the second part of the header 38 signs choose V S edit option and confirm by the cursor will go under one of letter from edited text by Qa choosing from letter available in signs table 0123456789 space bar ABCDEFGHIJKLMNOPQRSTUWXYZ Move the cursor by using Oor gt and chose the next letter to edit The finished text is confirmed by Option print header single printout Option return
10. ON only after go into MEASUREMENTS or CALIBRATION or SERVICE INFORMATION 8 Switch on the OSMOMETER OSM 9 II Before power ON the Osmometer OSM 9 always dry the cooling chamber by lintless tissue Power ON the instrument using switch located on back side of the instrument Wait 5 min as measuring head will be ready The display will show the passing time as soon as the cooling chamber reaches work temperature OSMOMETER SLAMED GmbH GERMANY VER 80061107 Fig 1 Active key MODE CALIBRATION READY FOR CALIBRATION inform that Omometer OSM 9 is in calibration mode Fig 4 2 Active key Rinse the thermistor probe and stirring wire using distilled water Dried very carefully thermistor probe and stirring wire to avoid damage or deformation and fibers leaving Then go to calibration according to p 8 1 CALIBRATION NOTE Leaving fibers at the thermistor probe could cause sooner crystallization NOTE Deformed stirring wire could not initiate the crystallization Calibration The main function of the calibration is to do the correction of measurement block characteristics The change of these characteristics is on as natural process of thermistor probe getting older Pipette 100 ul calibration solution sample distilled water into a dry and clean sample tube OSMO KRIO Pay attention that no droplets remain on the inner side of the sample tube and that no air bubble is enclosed in the sample Sample tube
11. SURING PRINCIPLE The osmolality of a solution is a function of the number of particles molecules and ions of the substances which are solved in 1 kg of the solvent The osmotic concentration or osmolality does not depend on the molecular weight of the solved substances The solved substances influence several physical parameters of the solution and can be measured For example If the osmolality increases the following parameters of the solution will change Osmotic Pressure increases Freezing Temparature decreases Boiling Temparature increases Vapour Pressure decreases A very significant method to measure the osmolality in biological liquids is the detection of the freezing point of the solution The relation of freezing point temperature and osmolality in diluted solutions is a linear function so that the basic cryometric rule says The lowering of the freezing point of the solution compared to the freezing point of the pure solvent is proportional to the osmolality of the solution The proportional coefficient called the cryometric constant K for water is 1 858deg x kgH20 Osm During the measuring process the sample is continuously cooled down from ambient to the super cool temperature of 7 C still being liquid Then the crystallisation is initiated and the temparature now raises to a maximum which equals to the freezing point corresponding to the osmolality of the sample The typical sample temperature course
12. frosting You can continue measurements from the moment of reaching by the sample temperature over zero or with using MODE return to MAIN MENU 11 5 Factory settlements restore To restore the factory settlements press before power ON the osmometer Then power ON the osmometer with still pressing key NOTE Remember to make an actual date and hour 12 MEASUREMENT RESULTS PRINTOUT To printout measurement results connect printer output RS232 to the Osmometer OSM 9 output RS232 from the rear side of the instrument Do the Osmometer OSM 9 and the printer connection without any power supply Do the connection in the order first Osmometer OSM 900 then the printer The printout is made after each measurement automatically NOTE Connected printer to the Osmometer OSM 9 has to be used to printing You do not use the printer disconnect it from the Osmometer OSM 9 The printer cooperates with the Osmometer OSM 9 RS 232 serial transmission graphical mode work cable 9 pin cannon input rear side of the osmometer 20 12 1 Serial transmission parameters speed 2400 bod format 8 bits even bit without even bit stop bit 1 Active signal TX DTR 13 Osmometer service transport A The instrument have to be disinfected before service transport Service contact give an information available in SERVICE INFORMATION p 4 MAIN MENU SERVICE INFO R NUMBER L 1B l DA 00K 2 A1 7 A2
13. ion of m clean the slide bar measuring head runner E not acceptable calibration wrong calibration sample use distilled water measurement result m the measurement head _ contamination of E clean the slide bar and does not do up and is measuring head runner mandrel with alcohol acc over the cooling chamber p 10 5 User s Manual MODE Fig 10 Active key MODE 22
14. istributor company arrange the training regards practical usage in place pointed by the user 5 MEASURING PREPARATION A Only qualified personnel can use the Osmometer OSM 9 You have to make sure during osmometer s work e Cable output have to be put into the output that is located at the rear side of the instrument Its earth continuity plug have to be plug into 230V 50 60Hz THE OSMOMETER OSM 9 MUST NOT BE IN USE IF THERE IS NO SURE IN CASE OF CONTINUITY EXTERNAL SAFETY CABLE IN THE INSTALATION OR IPS CIRCUIT e you must not take off the osmometr case it threats with current stroke e incase of osmometr is wet because of water or steam condensation f e just after removing from cold to warm room do not use the Osmometer OSM 9 e if there are any visible damage that could be the result of falling down do not use the Osmometer OSM 9 6 SAMPLE COLLECTION AND PREPARATION The sample collection and preparation is always according to inside procedures of your Diagnostic Laboratory and please apply below information Pipette 100 ul sample into a dry and clean sample tube Pay attention that no droplets remain on the inner side of the sample tube and that no air bubble is enclosed in the sample We recommend pipette fixed volume 100 ul precision error MAX 0 9 repeatability error lt 0 4 Sample tubes OSMO KRIO is single use only with special crystal seeds Maximum storage time of sample tubes OSMO KRIO is 1 year fr
15. nt work we recommend before measurement to rinse the thermistor probe and stirring wire with distilled water and dry with lintless tissue In case runner contamination that could be observed Contamination of slide bar Signs slow or not full upwards movement of measurement head Action clean the slide bar with alcohol and clean contamination with lintless tissue Repeat it several times to the moment of achieving smooth in measurement head movement The slide bar cleaning ONLY with power off the Osmometer OSM 9 Osmometer cleaning A Power OFF the Osmometer OSM 9 before any clearing action Clean the osmometer case with smooth and wet cloth Do not use any organic solvents You can use soft detergent to remove of strong contamination and then clean it with wet cloth and dry 13 The stirring wire replacement The problem with sample freezing could be a result of stirring wire deformation Stirring wire changing unscrew the stirring wire screw with fingers and remove deformed stirring wire from the measurement head Mount a new stirring wire at the axis screw in such way that after it s mounting in the measurement head the bending end of stirring wire is in the direction of the thermistor probe DESCRIPTION OF ADDITIONAL OSMOMETER FUNCTION POWER ON THE OSMOMETER OSM 9 The information regards model manufacturer or instrument version will appear just after power ON the instrument Fig 1 The actual data and time will appear at the t
16. o not store the rest of control solution THE CONTROL SOLUTION IN OPEN AMPOULES WILL CHANGE IT S OSMOLALITY WITH TIME AND YOU MUST NOT USE IT AS OSMOLALITY STANDARD 10 4 1 Test of measurement precision Test of measurement precision you should according to below information Do 3 calibration test measurements according to p 5 MEASURING PREPARATION after power ON the Osmometer OSM 9 Use the calibration solution 0 mOsm kgH2O acceptable border error 1 mOsm kgH20O If this condition is not fulfill you must repeat measurement Next do the series of 10 control solution measurements control solution with known osmolality value that is settled in reference method You could count the osmometr precision error on the base of achieved results D Vs Vn Vn x 100 Vs mathematic average value from achieved series result Vy expected value nominal value of using osmolality standard The precision should be no worse than 0 5 12 10 4 2 Test of measurement reproducibility Test of measurement reproducibility should be done as below You could count the reproducibility error on the base of measurement results achieved in 10 measurement series according to p 9 P SD Vs X 100 SD square standard deviation from the series of achieved results SD JX V V Mn 1 V next value of achieved measurement result Vs mathematic average value from achieved series result n the number of mea
17. om the purchase date Sample tube OSMO KRIO could be storage in dry place without the sun operation temperature from 10 C to 40 C 6 1 Warning infected sample treatment NOTE Work only using single use gloves The thermistor probe is made from glass make sure that is always safe The thermistor probe could be damage by mechanical action cracking or breaking by hitting or the instrument falling down that could effect in user injuring Always after infected sample measurement rinse the measurement unit by special agent using in disinfection and then rinse all with big amount of distilled water 6 2 Human bodyfluids sample NOTE Work with human bodyfluids sample only using single use gloves 7 MEASURING HEAD 1 4 2 Osmometer OSM 9 measuring head 7 1 MEASURING HEAD OPERATION The sample tube OSMO KRIO is carefully moved from below onto the mandrel 1 until the retaining spring 4 engages The thermistor probe 2 entering the sample tube and the stirring wire 3 must not get damaged while positioning the sample tube and should not be touched when sample tubes are attached or removed The measuring head is lowered into the cooling chamber by applying pressure to the pressure point N The measuring head is mounted on the slide bar 5 as it is being lowered The measuring head is then held in bottom position electromagnetically The electromagnet is
18. op of the display The user could observe passing time at the display It is time that the Osmometer OSM 9 needs to be ready to work Fig 1 Active key DESCRIPTION OF ADDITIONAL OSMOMETER FUNCTION You can use MODE a during instrument preparation to measur ee as well as to normal work mode By pressing Bks you can go to MAIN MENU Fig 2 By wa keys you can choose points from menu Fig 2 Active key 14 CALIBRATION From MAIN MENU you can go to CALIBRATION mode The osmometr will display the preparation time if the cooling chamber is not ready Fig 4 Fig 4 Active keys Using Bis during cooling chamber preparation go to MAIN MENU As soon as the cooling chamber is ready to work the osmometer displays CALIBRATION READY FOR CALIBRATION Fig 4 2 Calibration activities are according to p 8 1 Fig 4 2 Active keys uaa go to the MAIN MENU MEASUREMENTS 15 From MAIN MENU you can go to MEASUREMENTS mode The osmometr will display the preparation time if the cooling chamber is not ready Fig 3 after that device go to CALIBRATION mode Fig 4 2 Fig 3 Active keys Using Bisi during cooling chamber preparation go to MAIN MENU As soon as the cooling chamber is ready to work the osmometer displays MEASUREMENTS READY FOR SAMPLE Fig 3 2 Measurement activities are according to p 9 1 Fig 3 2 Active keys ideal go to MAIN MENU SETTINGS 16 SETTING mode in MAIN MENU go to S
19. rystallization THIS CORRECTION IS ON AT MIN 4 C SAMPLE FREEZING Take off the sample tube carefully to avoid the thermistor probe and stirring wire damage Rinse the thermistor probe and stirring wire using distilled water Dried very carefully thermistor probe stirring wire to avoid damage or deformation and fibers leaving See point MEANING OF DISPLAYED ANNOUCEMENTS if at the display appear E The measurement result with an terror signalisation is not in memory Go to the next measurement without any additional action The sample tube with sample put on the thermistor probe and stirring wire assembly Put the sample tube into the cooling chamber by pushing the measurement head Please follow above instruction to execute next measurements 9 2 Stop during measurments You don t have to power off the Osmometer OSM 9 if the break in measurements in not over 90min Put a clean sample tube on cleaned and dried thermistor probe and stirring wire The second one put into the cooling chamber it makes the frosting process slower NOTE You have to power off the Osmometer OSM 9 if the cooling chamber is strong frosted the symptom is getting stuck of sample tube inside the cooling chamber Then you have to wait as the frost will melt and dry the cooling chamber with lintless tissue Just after that action go to p MEASURING PREPARATION 9 3 Measurements finishing After finishing all measurements power off the Osmometer OSM 9 wi
20. surements in series The reproducibility should be better then 0 5 10 5 Information and practical hints Keep the cooling chamber dry Especially dry the cooling chamber before you switch on the analyzer so that residual water cannot freeze and interrupt the measurement After having measured all samples and defrosted the cooling chamber it have to be always dried by lintless tissue After having measured all samples switch off the power Then rinse the thermistor probe and the stirring wire with distilled water and dry both of them carefully Empty sample tube attached on the rim of the thermistor probe during pause in measurements or after measurements make the thermistor probe and stirring wire safer Additional there is lower possibility of incidental damage The empty sample tube inserted into the cooling chamber protect the cooling chamber against contamination that makes measurement impossible to execute During the measuring cycles a thin layer of hoar frost covers normally the cooling chamber If this layer begins to turn into ice it could jam the sample tube In this case the osmometer has to be switched off for defrosting and after that it should be cleaned with lintless tissue Preparing the Osmometer OSM 9 to work is then according to point 5 MEASURING PREPARATION The empty sample tube inserted into the cooling chamber during measurements pause will make chamber frosting much more slower After long break in instrume
21. th power switch Clean the thermistor probe and the stirring wire with distilled water and dry carefully Empty sample tube put on the thermistor probe and stirring wire Dry a defrosted cooling chamber with lintless tissue and put into the empty sample tube 11 10 OPERATION NOTE 10 1 Liquid dosage We recommend pipette fixed volume 100 ul precision error MAX 0 9 repeatability error lt 0 4 10 2 OSMO KRIO sample tubes Sample tube OSMO KRIO is single use only with special crystal seeds Maximum storage time of sample tubes OSMO KRIO is 1 year from the purchase date Sample tube OSMO KRIO could be storage in dry place without the sun operation temperature from 10 C to 40 C 10 3 Calibration and control solution Calibration solution 0 mOsm kgH20 distilled water APPLICATION see point 8 1 Control solution 400 mOsm kgH2O osmolality standard is a compound of distilled water and NaCl that has fixed osmolality The amount of NaCl is 12 687g NaCl kgH2O and is used to Osmometer OSM 9 measurements control 10 4 Control test measurements Introduce with pipette the 100ul control solution 400mOsm kgH20O sample to the clean and dry sample tube During pipetting avoid making air bubble do not spill the sample at the sample tube wall Then go to the p MEASUREMENTS 9 1 The 400mOsm kgH20 control solution is available in single use ampoules After ampoules opening and making control measurements cycle d
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