user manual
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1. Height above seal level of the working place should below 3500 meters Power supply 110 240V 50 60 Hz three cores cable well grounded A well grounded power jack is required The maximum power consumption is 1KVA The instrument should be connected with exclusive cable if possible 11 URIT 800 Operating Manual The distance between jack and instrument should be less 5 meters Temperature rangeis 10 C 30 C with the variation lt 2 C H Relevant humility range is 35 RH 80 RH no coagulation 2 2 2 Procedure of Installation 1 Take out the instrument and place it on a level stable worktable For heat dispersion the rear of the instrument should keep away from wall or obstacles at least 20cm The bottom ofthe instrument should keep good air circulation 2 Take out the onboard online control cable connect one of the end to the RS 232 port on the computer and the other one to the RS 232 port onthe instrument Fix them with screws to avoid looseness and online failure 3 Connect the power cord to the power export port onthe rear of the instrument 4 Connect the joint end of the waste tube to the waste outlet and the other end to the waste flask 5 Before initial running check the liquid tubes to make sure that they are not bent and the waste solution can be discharged to the proper flask 6 Install the printer as the instructions provided by the printer supplier 7 Before operation warm up the instrum2. in the shortcut toolbar Refer to 4 1 1 for details 3 4 Setup of Itemtest Click the icon of Item Test in the shortcut toolbar to enterthe item test screen 3 4 1 Input of Patient Information 3 4 1 1 Edit of Single Item 1 Input the sample ID for Sample ID Date Name Sex and Age can be input when registering results 2 Select the items to be testedin Item List The selected items turn red The blue ones indicate individual items the green ones indicate profiles 3 Click ADD to complete the edit Return 1 to edit the next patient 3 4 1 2 Edit of Multiple Items 1 Input the starting sample ID for Sample ID Date Name Sex and Age can be input when registering results 2 Select the items to be tested in Item List The selected items turn red The blue ones indicate individual items the green ones indicate profiles 3 Input the number of multiple items and click COPY to complete the edit Each sample ID will add 1 in turn Return 1 to edit the next group of patients 3 4 2 Test Start When the patient information has been input clickthe CHECK button andthe test screen is displayed then click the TEST button When the progress bar of stable temperature turns into read time locate the sample cuvette under the probe and press the START button on the instrument The instrument will pipette the sample and perform test according to the item
3. OPY to add the selected items tothe Pending Item list For modifying the item of a certain sample select the sample ID and the item to be modified then click Evaluate For testing the same item for multiple samples select the item and input the sample number thenclick COPY For deleting a sample select the sample ID then click Delete Sample For deleting a pending item selectthe item then click Delete Item Upon completion of setup click TEST to enter the test screen Click RINSE to rinse the cell one time Then click START When the progress bar of stable temperature turns into stable time place the sample cuvette at the proper position Press the START button on the instrument the instrument beginning to pipette sample and perform test automatically 20 URIT 800 Operating Manual 4 2 Maintenance The maintenance menu includes following options COM Setup Instrument Checkup Adjust A D Rinse Tube ABS Checkup Adjust Temperature Adjust Pump and System Initialization 4 2 1 COM Setup Selecting COM Setup in Maintenance all the COM ports onthe computer will be checked by system After checkup a dialog is displayed for user to select a COM Select one and click TEST if the buzzer rings communication is successful If the buzzer has no response select another COM until communication is successful After confirmation click the S
4. It is must be emphasized that the fixed value serum should not be used ascalibration sample because of the huge difference between 29 URIT 800 Operating Manual 30 6 Reagent Sample and Waste 6 1 Reagent The reagent parameters are settable for the URIT 800 chemistry analyzer Only the certified reagents can be used to test Carefully read the instructions provided by reagent supplier before using it 6 2 Detergent The detergent that the instrument employs is open for choosing 6 3 Precautions When carrying out test and daily maintenance be sure to obey the operation regulations put on protective gloves clothes and goggles and avoid contacting the sample All the clinic samples should be handled according to the operation regulations as they may carry potential infectious disease Put on protective clothes gloves and eyeglasses No smoking and eating in working area Do not blow or suck the tubes Carefully dispose the wastes as they may carry potential contaminations and cause biologic and chemical hazard Obey the relevant regulations constituted by local Medical and Health Administration to dispose and drain the waste solution Store reagents according to the instructions offered by reagent supplier User has the obligation to establish measures for reagent keeping and use thus avoiding using expired reagents Storage should keep away from excessive hot or cold environment URIT 800 Operating Manual 7 Mainten
5. Manual Relative Humidity lt 80 Extremity 5C 40 C RH lt 85 Storage 207 55 C RH lt 95 Power Supply 110 240 V 50 60 Hz Power lt 100W Atmospheric Pressure 75kPa 106kPa Dimension 330 mm by 310mm by 175mm length by width by height Weight About5 5Kg O oO FP OON 1 2 Principle and Components 1 2 1 Principle Beer s law When a parallel monochrome light beam goes through an absorbent object gas liquid or solid some photons are absorbed and the lightintensity decreases from to lo The formula is K Absorbance coefficient L Thickness of object C Concentration of object I Intensity of shoot in light lo Intensity of shoot out light Measure lo and L and then calculate C according to the formula above The result willbe obtained through data conversion Figure1 va Cl esch Selective Filter and Amplifier Focus System Je Digit Area Figure 1 URIT 800 Operating Manual 1 2 2 Components The instrument consists of analyzer computer and printer figure 2 The URTI 800 system software monitors and controls the analyzer through the RS 232 port on the computer Computer and printer are optional accessories Computer requirement CPU over PentiumllI stable running mainboard with RS 232 port memory over 256M and windows XP operation system All the parts should consist with the relevant safety standards RS 232 Analyzer Computer Figure 2 The analyze
6. Replace the pump aspirated B The pump has C Reset up parameter 4 deteriorated or for the pump cracked D Press 1 tocheck up C Improper parameter E lfthe problem recurs set forthe pump please contact URIT D Failed online URIT 800 Operating Manual No waterruns out when performing The analyzerhas no response to the directive from A Leakage with tubes B The pump has deteriorated or cracked A The COM cableis too long B The COM cableis not computer The working connected well indicator lamp is unlighted Failed A D adjustment Inaccurate test results or poor repeatability C Strong electromagnetic interference nearby A The lamp is broken B Air bubble orinsufficient water inthe cell C Dirty cell A Air bubble is the cell B The silica get pipe has deteriorated or cracked resulting in inaccurate pipetteed volume C Ageing with the light source lamp D Improper parameter set foritem test E Absence of earth wire with the power supply URIT 800 Operating Manual A Check up the leakage and reconnect the tubes B Replace the pump C lfthe problem recurs please contact URIT A Use the onboard cable B Fasten the cable C Remove the high power equipment D lfthe problem recurs please contact URIT A Please contact URIT B Drain off the liquid in the cell and repipette liquid to adjust If unfruitful reset up parameter for the pump C Rinse the cell with detergent or a
7. a EER ATRE AER e eE an ERR EREE 30 6 3 Precautions sec wicrcnck bec Shea chucecueiipecircwindsadiredeeh aiederceusderk bev iia eeGseeeus 30 T Ee e 34 Pls a 7 EE 34 7 2 Peristaltic DUMP gebiede Eegeregie Ee egener 39 Cat en EE 33 7 4 Precautions for Usage ccc gue eege 34 8 Troubleshooting inctannsanteeemtntenGameeecunnstecesetianecetioineetecamoesseauentunceenss 35 8 1 Troubleshooting Direction asic see AE EEN 35 8 2 Obtaining Technical Help EE 36 9 Transportation and Storage ose csc csicenvnianeusdeaisneresccenainassonaaenswehianauns 38 9 1 EES eer Ee Ee 38 9 2 Storage na eii ein ee eege 38 eer 39 let ek AE 40 Copyright and Declaration Copyright URIT MEDICAL ELECTRONIC CO LTD URIT Thank you very much for your purchase of the model URIT 800 chemistry analyzer All contents in this manual were strictly compiled according to the related laws and regulations in china as well as the specific condition of URIT 800 chemistry analyzer covering all the updated information before printing The URIT is fully responsible for the revision and explanation of the manual and reserves the right to renovate the relevant contents without separate notice Some of the demonstration pictures inthis manual are forreference and subject toreal objectif any differences All the information included is protected by copyright No any part of this document may be reproduced stored or transmitted in any form or by any means unless written authorizatio
8. instrument and computer execute Tube Rinse and wait for half an hour prior to routine test After work execute Rinse Tube several times Do not perform any other irrelevant operation with the computer lest virus intrude and cause damage tothe system URIT 800 Operating Manual 8 Troubleshooting VIN Caution Be careful to handle with malfunctions be sure to shut off the power supply before operation Ar Biological dangerous VWs Be sure to put on protective clothes gloves and even goggles when necessary before operation Troubleshooting is presented in this chapter If the malfunctions cannot be eliminated as per the instructions specified in this chapter or if you need more and detailed materials please contact URIT 8 1 Troubleshooting Directions Troubleshooting directions are designed to help user search and eliminate the malfunctions in the operation and also offer the ways to obtain timely and convenient technical help from URIT For correct and quick troubleshooting read through the operating manual carefully and be familiar with the operation and maintenance measures In general troubleshooting can be followed as three steps below Confirming malfunction Classing malfunction Eliminating malfunction The first step confirming malfunction You should find out what cause the malfunction and know what the instrument should be when inorder This stepis essential to eliminate malfunction The seco
9. parameters that have been set up previously If abnormality is detected in the test process and you need to cancel the current test clickthe RETURN button A dialog is displayed for confirmation Click OK to cancel the test 3 5 Registration of Result URIT 800 Operating Manual After a test has been completed click the RETURN button Then click the icon of Register Results in the shortcut toolbar Inputthe sample ID according to the test report of which all the test results are displayed Clicking Calculated Item all the items to be calculated are displayed When a piece of sample information has been registered click the SAVE button thenregister the next one until allthe sample information is input 3 6 Modification of Result If the test results show abnormality click the icon of Modify Results in the shortcut toolbar to enter the modification screen Select the item to be modified and enter the Modified Factor calculated bythe formula Factor QC target value x QC measured value Click MODIFY followed by clicking SAVE to complete the modification To avoid blind modification some objective factors e g the condition of patient s sample as well as the QC values tested several days ago should be taken into consideration 3 7 Recallof Sample Click the icon of Recall Samples results Referto 4 4 3 for details in the shortcut toolbar to review desired 3 8 He
10. to be pipetted 7 Unit Set up unit for test result 8 Temperature Selectable temperature NO instrument inside temperature 25 C 30 C 37 C 9 Others Set up parameters for reagent as requirement Blank L Blank Low Blank H Blank High Normal L Normal Low Normal H Normal High 10 Standard Standard number stand No The number of calibration The Maximumis 6 Standard factor The factor is input manually or calculated by system after calibration Standard 1 6 Input concentration of calibration item as required Clicking the specified key causes the following actions ADD Adds newitems to be tested DELETE Deletes existing items SAVE Saves new added or modified items PRINT Prints selected items RETURN Returns to welcome screen 4 1 2 Setup of Other Parameters Other Parameters is an extended function through which the items and test results from other instrument can be transmitted into the internal system and printed out with the same format Make your entries inthe inputfields Char If the normal low value is equal to the high value it means the results will be shown in char type for example positive negative etc Float Ifthe normal low value is lower than the high value it means the content will be inputin float type Clicking the specified key causes the following actions SAVE Saves the input information into database DELETE Deletes selected informati
11. 2 kb g L 61 0 83 0 Report Date 2007 08 11 Operator 001 Checker Remark The results are only responsible for the current sample Economical URIT MEDICAL Sample 1D 001 Name Mike Outpatient No 001 Sample Type Serum Sex Male Inpatient No Test Date 2007 08 11 Age 30 Department intemal medicine Doctor Lee No Result Reference L H le Result Reference L H 1 00 3 00 mg l 1 00 3 00 mg dl 40 0 120 0 9 1 49 0 U L 61 0 83 0 g L Report Date 2007 08 11 Operator 001 Checker Remark The results are only responsible for the current sample Common URIT MEDICAL Sample ID 001 Name Mike No Item Byname Result Prompt Unit Reference L H Sex Male 1 ALP 0 48 L mg l 1 00 3 00 Age 30 2 AST 0 70 L mg di 1 00 3 00 Outpatient No 001 3 AKP 2 0 L 40 0 120 0 Inpatient No 4 GOT 0 5 L U L 9 1 49 0 Sample Type serum 5 TP 0 2 L g L 61 0 83 0 Department internal medicine Doctor Lee Test Date 2007 08 11 Report Date 2007 08 11 Operator 001 Checker Remark The results are only responsible for the current sample 40 URIT 800 Operating Manual Lu URIT MEDICAL WWW uritest com Tel 86 773 2832799 2883225 Fax 86 773 2804668
12. AVE button 4 2 2 Checkup of Instrument This function aims at the instrument maintenance and debugging Input the parameters according to prompts in the operation process and select TEST to validate The current temperature of the cell is displayed by system with the selectable temperature NO instrumentinside temperature 25 C 30 C 37 The A D value of current filter can be obtained by setting up the gain The peristaltic pump s move step and rate is settable to adjust the pipetted volume each time The factory parameter is 5001 L at a time If volume adjustment is necessary make sure the liquid fills the cell fully and overflows the cell exit about 10cm without air bubble between The number of filter and the diameter of cell are settable The status of START button can be checked When done click the SAVE button 4 2 3 Adjustment of Initial A D The A D value of each instrument has been adjusted in factory testing The gain A D and offset value vary with different filters Generally when the gain is 3 or 4 the initial A D value is about 34000 the offset valueis within 70 130 never 0 which are the optimum initial values for checking system Click Adjust A D to enter the screen of initial A D value Click SAMPLE to fill the cell with distilled water prior to adjustment Clicking ADJUST the gain and offset of different wavelengths are adjusted by system After adjustment the buzzer ring
13. Finally loosen the fixed clip on the cell and take out the cell from the cell hole For installation of the cell properly embed the cell in the hole and fix it with the fixed clip Then connect the tubes back to the corresponding inlet and outlet respectively 31 URIT 800 Operating Manual 4 Fixed clip Figure 4 Ah Caution For cleanliness of the cell do not touch the quartz window on the cell After each testing rinse the flow cell and fill it with water before turning off the instrument Rinse the cell with detergent once a week Aspirate detergent 2 milliliters and keep it in the cell for 5 minutes then aspirate distilled water 20 milliliters to wash off PON Biological Dangerous To avoid infections be sure to put on protective clothes gloves and even goggles when necessary 7 2 Peristaltic Pump The peristaltic pump is an essential part for liquid entering and draining The pump pipe is made of special silica gel When the error of pipetted volume is large or the pipetting fails replace the silica gel pipe with a new one in the same model figure 5 The steps for replacement are as follows 1 Drain offthe liquid in the flow path open the maintenance window on the left side of the instrument and take outthe tubes connected with the pump 2 Forcibly nip the two clamps on the pump base with your thumb and index finger and then take out the pump from the base 3 Forcibly nip the two clamps on the upper c
14. OPERATING MANUAL URIT 800 Chemistry Analyzer U URIT Medical Electronic Co LTD Contents Copyright and AGC an At EE 1 Pe Fete ax cca cn e E E E EE EERE EEEE EES 3 1 General Description EE 7 lcd Specifications E 7 1 2 Principle and Component incaicaniecnatdocortiaieendaniadsnaiaeencarcimaadswennes 8 To FUNCIONS EE 10 Pe EEE a E E E E E 11 2 1 Unpacking EE 11 2 2 Instrument Installation EE 11 2 3 Software Installation and Registration cccccceeeeeeeeeeeeenees 12 2 4 Software E E 13 2 5 Software Initialization eege Eegenheeten sh 13 BR FeO E 14 ie lk Solel ET EN 14 3 2 HEEN 44 3 3 Setup of Item Parameters xsi cusckiwnimdicataiwentionivenentiniucahiwnetdeieaneaten 15 3 4 Setup of Item test gesent tbe geste pg dete KEES ab deg eeh ageet 15 3 5 Registration e RE DE 15 3 6 Modification of Result EE 16 3 7 Recallof Sample E 16 3 8 Help RE ee Ee 16 3 9 Logo t EE 16 SLO lt a EE 16 e EE Ae e Seenen ee E EEEE EAE EEEE E EEEE E EREE E AE EEE 17 Ge Ee 17 GE le nt 21 4 3 Setup of System sn cnticubwccidccvsereabenctnenieheetinacemecuatedianonentalestaaannas 23 4 4 Processing of Result 24 dro Ael E 24 5 QC Analysis and Calibration E 26 ot Ee E 26 S2 CONG OC Proce eege 26 5 3 Analysis OF QC E TE 27 5 4 Treatments for Abnormality oyakiegtieferebegeh Seege Eed Ae et 28 5 5 Calibration and Mere e 29 6 Reagent Sample and Waste ccc ccceee eee eeeeeeeeeneeneneeneeeaes 30 01 Fee SOG EE 30 0 2 Detergent ssia nn anea Ea
15. Parameters a screen is displayed for setting The left field indicates the existing items which are displayed as the order set in Display and Print Order When adding anew item the parameters relating to Endpoint method are indicated as default values Setup of parameters In the screen of item parameters setup you can set up or modify parameters as required 1 Name and Byname Input the English item name and its byname in name and byname respectively 2 Assay Method The assay methods include endpoint rate two point dual wavelength etc clicking the Method icon an optional menu is displayed for selecting assay method 3 Wavelength The main wavelength range is 340nm 800nm For dual wavelength method you can select sub wavelength that also has the range of 340nm 800nm Clicking the Wavelength icon anoptional menuis displayed for selecting wavelength 4 Time Stable time the stable time of endpoint and dual wavelength method is from the sample being pipetted into cell to the test beginning The stable time of rate and two point is from the sample being pipetted into cell to the fist point being tested Read time used for rate and two point method The time is from the fist point being tested to the last point being tested 5 Blank URIT 800 Operating Manual Reagent and distilled water are selectable as blank mediums 6 Volume Set up volume of reaction solution
16. ample the formula of calculated item SIDF is TG6 UA EXP GLU For standardization of formula some arithmetic function are offered by system For error avoidance in calculation please replace the with the _ when inputting the item name if any Clicking the specified key causes the following actions URIT 800 Operating Manual ADD Adds new calculated items DELETE Deletes existing calculated items SAVE Saves input data RETURN Exits current setup 4 1 6 Setup of QC Target Value Refer to chapter 5 QC Analysis and Calibration for details 4 1 7 Input of QC Value When selecting the desired item the corresponding QC code is shown automatically Then you can input the QC code according to date and save the input content into system 4 1 8 Analysis of QC Chart Please referto chapter5 QC Analysis and Calibration for details 4 1 9 Item Test The first step of item testis to set up a job list Clicking Item Test the setup screen for item testis displayed First number the sample ID withthe rangeof 1 999 The ID 999 means QC In the item list the profiles are indicated with P at the head and shown in white characters onthe green background while the individual items are shown in white character on the blue background For editing items input sample ID for example 1 then select the desired items from Item List which will turn red Click ADD or
17. ance To ensure reliable capability and prolong the instrument s life perform periodical maintenance for the instrument according to the operating manual For the problems cannot be solved or not be involved in this chapter please contact URIT or the local representatives d Caution Do not perform any maintenance other than specified in this chapter otherwise human injury and instrument damage may occur The unauthorized maintenance for instrument may cause system damage and human injury and invalidate the terms of maintenance service stated in contract After maintenance make sure the system is working in order Most maintenance is carried out with the instrument power off For your safety the main power supply sometimes is required to be cut off prior to maintenance Free of spills of water reagent etc on the instrument and electric units FON Biological dangerous ae Be sure to puton protective clothes gloves and even goggles when necessary before maintenance 7 1 Cell The precisely designed flowcell witha stainless steel quartz window can keep an accurate heat balance inside The temperature in the cell is controlled by Peltier element The inlet is narrow and close to light source while the outlet is a little wider figure 4 For replacement of the cell first drain off the liquid in the cell and flow path Then press the cell with one hand and take out the tubes of inlet and outlet with the other hand
18. bsolute alcohol several times D lfthe problem recurs contact URIT A reset the parameter for the pump B Replace silica get pipe for the pump C Readjust the initial A D D Reset item parameter according tothe reagent instructions E Ground the instrument with the onboard ground pole F Ifthe problemrecurs contact URIT 37 38 9 Transportation and Storage 9 1 Transportation The transportation must strictly follow the terms specified in order contact Mixed transportation with poison injurant and corrosive is forbidden 9 2 Storage The wrapped instrument can be stored in the breezy room with the temperature 20 C 55 C relative humidity below 85 Mixed storage with poison injurant and corrosive is forbidden URIT 800 Operating Manual Appendix A Replaceable Parts List T800MA 250V Power inputis 220V T1A 125V Power inputis 110V 2 1 switchingpowersupply Soe Powersupply fiter Fosse Onlinecontroicable Mainboard Amplifier boars mmm bm eil Gei Gei Ge URIT 800 Operating Manual 39 Appendix B Print Styles Traditional URIT MEDICAL Sample D 001 Name Mike Outpatient No 001 Sample Type serum Sex Male inpatient ne l Test Date 2007 08 11 Age 30 Department internal medicine Doctor Lee No Item Byname Result Prompt Unit Reference L H 1 ALP 0 48 L mg l 1 00 3 00 2 AST 0 70 L mg dl 1 00 3 00 3 AKP 2 0 L 40 0 120 0 4 GOT 0 5 L U L 9 1 49 0 5 TP 0
19. cian If the test results are not within the allowable range yet after completing the five steps above the instrument or reagent may be to blame Contact URIT orreagent supplier to get more technical help URIT 800 Operating Manual 5 5 Calibration and Procedure Calibration sample is used to calibrate the numerical value of the assay method The function is to eliminate or minimize the system error caused by instrument or reagent It is recommended that human serum matrix be employed to minimize the error caused from matrix effect 5 5 1 Whento Calibrate It is suggested to perform calibration every six months or under the below situations When installing and running the instrument initially When changing the reagentclass or the batch number unless otherwise specified When carrying out a protective maintenance or replace a essential component which may influence the capability of the instrument When the QC results reflect abnormality which cannot be rectified through general corrective measures 5 5 2 Procedure of Calibration Select the items to be calibrated in Item Parameter and input the numerical value offered by the supplier then click the SAVE button The system will perform calibration for this item prior to test process the calibration result and save it as standard reference for the item to be tested next time All the calibration and validation work are required to be recorded and compiled into document
20. d Add 4 East Alley Jiunua Road Guilin Guangxi541001 P R China Tel 86 773 2832799 2883225 Fax 86 773 2804668 Website www uritest com E mail export uritest com cn Version 2 2008 URIT 800 Operating Manual Preface This operating manual is applied to URIT 800 chemistry analyzer The purpose is to help user know the instrument s principle structure operation maintenance and troubleshooting etc Please strictly operate the instrument under the instructions described inthis manual Meanings of Symbols Caution Potential human injury or instrument damage Warning Dangerous electric shock Note Beware scald Biologically dangerous Grounded Power on Power off O O8kPePP Precautions For safety and efficiency please read the following safety tips carefully Any operation against the following precautions may incur system damage or human injury Caution If user dose not follow the instructions presented in this manual when operating the instrument the protective measures provided by the system may be failed URIT 800 Operating Manual Electric shock due to high voltage A Warning When the power supply is on do not open the cover other than the authorized maintenance man If liquid leaks into the instrument cut off power supply immediately Improper operation may cause electric shock and system damage Eye damage due tolight beam Ah Caution When the instrument is active d
21. e for control analysis 5 3 Analysis of QC Results 5 3 1 Input of QC Target and Standard Deviation Select QC Target Setup in TestSetup andinput the QC code as well as the target and SD that obtained before 5 3 2 Analysis of QC Chart Select QC Chart Analysis In the QC chart dialog the red line marks the target value while the blue lines mark 1SD 2SD 3SD 4SD Select the items from item List and make your entriesin QC Code and TestDate respectively The system will draw the QC curves in this period automatically If you select the Standard Qc by placing v mark the target value and SD are just those set in 5 3 1 Otherwise the system will recalculate the target value and SD of this period and draw the QC curves 5 3 3 Normal Distribution About 95 data are within X 2s 5 continuous data inthe same side are not allowed 5 continuous data step up or step down are notallowed 2 continuous points outside X 2S are not allowed 27 URIT 800 Operating Manual 28 Points outside X 2S are not allowed 5 3 4 Abnormality Drift System error is prompted Tendency change The capability of reagent or instrument has been changed Precision change Accidental error is large e g the instrument or reagent shows instability 5 4 Treatments for Abnormality 1 2 For abnormality carry out following procedures to deal with Fill in abnormality report and report
22. emperature Adjustment This function is just for factory testing only open to URIT technicians or technicians authorized by URIT 4 2 7 Pump Adjustment This function is just for factory testing only open to URIT technicians or technicians authorized by URIT 4 2 8 System Initialization After installation and registration the software must perform initializing and read internal data prior tonormal running For initialization select Temperature parameter initialization and Pump parameter initialization to initialize That done that is the software has read out the default parameters reenter the software as requirement to complete the initialization Note For initialinstallation bothtwo items should be selected for initialization 4 3 Setup of System The menu of system setup includes following items Operator Password Doctor Department Operator and Chart Color 4 3 1 Setup of Operator Password Click Operator Password in System Setup to set up or modify the password When initially inputting the user name you can set up the corresponding password through this function If the password has existed it will be shown inthe old password After modification the new password will be saved as the operator password forthe sequentlogin 4 3 2 Setup of Doctor The doctors can be denoted with codes or names depending on the requirement of lab URIT 800 Operating Manual 23 4 3 3 Setu
23. ent for 20 30 minutes until the heat and light source are stable 2 3 Software Installation and Registration 2 3 1 Software Installation Run the SETUP EXE on the onboard CD and execute the operation step by step according to the prompts provided by the system When the installation has been completed the shortcut icon of URIT 800 is set up automatically on the desktop by the installer program then you canrun the URIT 800 through double click 2 3 2 Software Registration Run the URIT 800 software and select Registration in Help menu The logon screen is displayed Make yourentry for User Name which will be showed on the test report as the title Click the Device ID to getthe device ID and feed it back to URIT to get the registration ID in return and then input it in the Registration ID That done click the Registration button Alternatively our engineer can finish the registration for you Note The methods of the software installation and registration are subject to URIT 800 Operating Manual change without prior notice Please refer to the installation instructions accompanied withthe onboard CD 2 4 Software Online Turn on the power switch on the instrument Click twice the URIT 800 icon on the desktop to run the registered software The initial logon account is Operator user Password user Input the password and click OK If the input password is correct the OK butto
24. face Allows multi user management The test results can be summed up and analyzed according to different users requirement 12 Visually dynamic display Displays the whole test process and detects the 10 abnormality such as air bubble disturbance URIT 800 Operating Manual 2 Installation AN Caution U ser shall not attempt installation of this instrument after its delivery URIT s service representative will install the instrument for its safe and exact operation Before installation User shall make preparations for satisfying the installation requirements in accordance with this manual 2 1 Unpacking Please check the carton according to following procedures 1 Carefully unpack the package and take out the URIT 800 chemistry analyzer and accessories 2 Inspect the instrument and accessories for quantity and visible signs of damage according tothe standard list 3 If anyloss ordamage exists contact the distributor or manufacturer immediately 2 2 Instrument Installation 2 2 1 Requirement of Installation Just forroom installation and use Table board or ground must be level Gradient lt 1 200 Good ventilation Free from direct sunshine Free from hot source and wind source Free from corrosive and flammable gas No shake with the table board or ground Free from noise source and electricity source interference Do not be close to the brush motor and the electric equipment which are often turned onor off
25. he cell can be pipetted through the setting of pipette in Abs checkup Perform rinse 10 15 times with absolute alcohol Shut off the power supply and then wipe the appearance of the instrument with clean gauze or gauze moistened with water or disinfector when necessary Caution Be sure to operate the instrument with care avoiding being lacerated by the instrument shell PON Biological dangerous KI To avoid infection be sure to put on protective clothes gloves and even goggles when necessary Do not discard the used gauze at will after wiping the instrument Dispose itas perthe relevant regulations 7 3 3 Monthly Maintenance The operationis as weekly maintenance Inspect the cell for air bubble and foreign bodies 7 4 Precautions for Usage 1 7 8 9 Free from dust and moist Air conditioner is recommended The optimum ambient temperature is 15 25 C Free from electric leakage and static electricity Make sure the instrument is well grounded For the absence of earth wire on the power socket the ground pole outside the instrument should be grounded to ensure safety and stability It is suggested that the power socket be for instrument exclusive use Be sure to use certified reagents Reagents taken out from icebox should not be used immediately until they reach the room temperature To avoid confusion differentsamples should be registered with different codes After turning on the
26. it to your lab manager Simply and quickly review the operation process to find out the possible cause If no evident error is found follow the steps below to find out the cause Retest the same control sample This step is mainly for checking whether operator caused the error Additionally this step can also check out whether the random error existed If so the retested results should be within the allowable rang control limit Ifnot proceed to the next step Obtain anew bottle of control sample to retest the abnormal items If the retested results are within the allowable range it means the previous bottle of control sample has expired or deteriorated as being laid aside for a long time If not proceed tothe nextstep Obtain a new set of control sample to retest the abnormal items If the retested results are within the allowable range it means the previous set of control sample has problem Then Inspect the expiration date and storage ambient to find out the cause If not proceed tothe next step Maintain the instrument and retest the abnormal items Inspect the instrument for replacement of filter and cleanness of cell If the retested results are not within the allowable range proceed to the next step Recalibrate the instrument and retest the abnormal items Perform calibration with the new calibration solution If the retested results are not within the allowable range yet proceed to the next step Obtain help from techni
27. lp For any problems and questions in operation click Help to get convenient and detailed help 3 9 Logout When you have completed your test click the icon of Logout in the shortcut menu Thelogin screenis displayed again for other users to entersystem to manage their own test information conveniently 3 10 Ending Please carry out following operation when your work ends 1 Put reagents into icebox 2 Dispose the useless serum cuvette according to relevant regulations 3 Rinse theinstrument atleast 10 times 4 Click Exit in shortcut menu and turn off the instrument 5 Turn off the host computer display and power supply 6 Wipe the worktable with clean soft cloth 16 URIT 800 Operating Manual 4 Settings The software of URIT 800 chemistry analyzer mainly includes five menus Test Setup Maintenance System Setup Results Processing and Help Next are the detailed instructions 4 1 Setup of Test 4 1 1 Setup of Item Parameters The first step of item testis to set up item parameters Proper item parameters can effectively ensure the accuracy of test results Whatever assay method you take the essentials include item name assay method wavelength unit and decimal blank low blank high temperature sample volume reagent volume stable time measure time standard low standard high When inputting the item name please replace the with the _ ifany Selecting the Item
28. ment is intended for use in conjunction with certain reagents to measure a variety of samples such as serum urine cerebrospinal fluid and plasma Its features are speediness convenience high sensitivity accuracy standardization and micro volume etc This software with friendly interface is convenient for operation User can operate the instrument through clicking the mouse and export the test results statistical results and working curves through the external printer 1 1 Specifications 1 1 1 Technical Specifications 1 Light Source Long life halogenlamp 6V 10W 2 Wavelength Range 300 800nm 3 Assay Method Endpoint rate two point dual wavelength multi standard absorbance turbidimetry reagent blank coefficient single point calibration and multi point calibration etc Photometric Range 0 3 0 Abs Linearity Error lt 0 5 within0 5 1 8Abs Resolution 0 001Abs 0 0001Abs for Internal calculation Drift Rate lt 0 002Abs 20min Sample Volume 200u L 3000 u L variable 500 u Lis recommended 9 Cell Temperature NO instrumentinside temperature 25 C 30 C 37 C 0 1 C 10 Carry over lt 1 11 Reproducibility CV lt 1 0 12 Item Upto 200 items 13 Memory Upto 100 000 test results 14 Output Standard data port 15 Quality Control with quality control and statistic procedure showing QC curves Gelee et ee a 1 1 2 Powerand Ambient 1 Ambient Temperature 10 C 30 C URIT 800 Operating
29. n by URIT All instructions must be followed strictly in operation In no event should URIT be responsible for failures errors and other liabilities resulting from user s noncompliance with the procedures and precautions outlined herein Limitation of Liability URIT warrants to the original purchaser that this instrument will be free from defects in materials and workmanship for a period of one year from the later of the date of original purchase or installation URIT assumes no liability in the following situations even during the period of warranty 1 Failure due to abuse the instrumentor neglect the maintenance 2 Use reagents and accessories other than manufactured or recommended by URIT 3 Failure due to operate not under the instructions described in the manual 4 Replace accessories not specified by URIT or after maintenance or repair by a service agent not approved or authorized by URIT Caution URIT makes no warranties either express or implied as to product quality performance and value as a commodity or applicability for any particular purpose URIT 800 Operating Manual Technical service and troubleshooting are provided by URIT If the instrument has malfunction please contact the agency authorized by URIT If the problem cannot be solved through telephone directions professional technician and sale representative will be sent to offer you timely service Manufacturer URIT Medical Electronic Co Lt
30. n disappears otherwise the OK button does not disappear and checkup of operator and password is necessary Selecting COM Setup in Maintenance all the COM ports onthe computer will be checked by the system automatically After checkup a dialog is displayed Select proper COM and click the TEST button Ifthe buzzer rings communication is successful If the buzzer has no response please select other COM until the communication is successful After confirmation click the SAVE button 2 5 Software Initialization After installation and registration the software should perform initializing and read the internal instrument data before its normal running Selecting System Initialization in Maintenance the initialization screen is displayed Select Temperature parameter initialization and Pump parameter initialization by placing v mark and click the INIT button For initial installation both should be selected Then Reenter the software to achieve initialization for the software URIT 800 Operating Manual 3 Operation Caution For convenient operation please refer tothe online help when operating the instrument AA Biologically dangerous Toavoid infection please put on protective gloves clothes and even goggles when necessary To avoid unnecessary damage to the instrument resulting from improper operation please read the operating manual with care pri
31. nd step classing malfunction The instrument malfunction can be classed into three categories Malfunction relating to hardware Malfunction relating to software Malfunction relating to sample analysis 35 URIT 800 Operating Manual 36 The malfunction relating to hardware and software only can be solved by URIT or the qualified engineer authorized by URIT The malfunction relating to sample analysis can be eliminated by operator himself under the instructions from URIT The third step eliminating malfunction The maintenance engineer takes proper methods and procedures to get rid of malfunction If the operator can eliminate it with the help of engineer the delay is shortened much more 8 2 Obtaining Technical Help The common malfunction and troubleshooting are listed below If the problem cannot be solved with the methods described inthe list or if you need more technical help contact URIT vd Symptom Possible Gauss A The COM cableis A Fasten the cable Failed online loose B Selecta proper COM B Improper COM C lfthe problem recurs please contact URIT Turning on the A Replace the fuse power supply the Defective fuse T 0 8Adelay fuse fan andlamp don t B Ifthe problem recurs please contact URIT work Turning on the 3 Power supply the Broken lamp Please contact URIT fan works while the lamp doesn t Pressing the START A The pump is not A Reinstall the pump button no liquid is installed well B
32. o not directly look at the light beam emitting from the lamp source which may cause injury to your eyes Skin damage due to chemicals PON Biologically dangerous If chemical adheres to the human body infection may occur Do not directly touch the sample mixed solution and waste solution Be sure to put on protective gloves clothes or even goggles when necessary If chemical sticks to the human body handle it according to the working standard procedure and consulta physician Some reagents are strong acid or basic Please use them carefully and avoid direct contact If the reagent sticks to hands or clothes immediately wash it off with water and soap If the reagent goes into the eyes wash it off with alot of water and consult an oculist Disposal of waster solution A Biologically dangerous KE The discharge and disposal of reagent control solution calibration URIT 800 Operating Manual solution detergent and waste solution are regulated by certain standard provisions Please observe the local discharge standards and consult the reagent supplier or distributor Intended use VIN Caution The instrument is mainly employed to quantificationally analyze the serum plasma urine and cerebrospinal fluid etc If the instrument is to be used beyond the intended use consult URIT first When doing clinical diagnosis based on the test result clinical symptom and other testresults should also be considered Ambient Ah Cauti
33. olved from freeze dried control sample Make sure the added volume is accurate and consistent each time redissolving the freeze dried control sample Fierce shake is avoided by all means when redissolving the freeze dried control sample Store the control sample according to requirement do not use the expired products Test the control sample at the same condition as that of the patient sample 26 URIT 800 Operating Manual 5 2 3 Setup of QC Target and Control Limit The QC target and control limit value can be obtained from the control sample manufacturer or from following methods Setup of temporary target value Test a new set of control sample Obtain the results of at lest 20 control tests and calculate their mean value and standard deviation SD as the temporary target value and temporary SD respectively Setup of regular target value Obtain the accumulative mean values of the original 20 data and all the tested data collected for 3 5 months as the regular value and SD respectively Setup of control limit The new set of control sample is required to fix the control limit thatis usually denoted with some SD i e denoted with the multiple of SD The control limit of differentitems quantitative test depends on their QC regulations 5 2 4 QC Procedure In Item Test if you input 999 for Sample ID the code of the current control sample is required and the relevant QC results will be saved to databas
34. on The instrument should be installed in the ambient specified in the manual otherwise inaccurate results or even system damage may occur If relocation is necessary please contact URIT or local representatives Usage A Caution 1 Operate the instrumentas the operating manual Improper operation may incur error results or even system damage and human injury 2 For the first use of the instrument please perform calibration and quality controlto confirm the instrument s working order 3 Perform quality control before using the instrument Otherwise the results may be inaccurate 4 The instrument s RS 232 port is required to be connected with the computer s RS 232 port rather than any other cables Please use the special cable provided by URIT or representatives 5 As a special monitor for the software the computer installed with any software and hardware other than specified by URIT may cause bad influence on the instrument Do not run any other software URIT 800 Operating Manual when the instrument is active otherwise computer virus infection may incur 6 Do no touch the display mouse and keyboard when your hands are wet orstuck with chemicals URIT 800 Operating Manual 1 General Description The URIT 800 chemistry analyzer instrument for short is a computer controlled instrument based on the principle of photoelectric colorimetry integrated with electronics optics and mechanics The instru
35. on 18 URIT 800 Operating Manual RETURN Exits current setup 4 1 3 Setup of Profile Profile means an independent test name which is shared by some collected items All the items for option in database are showed inthe middle filed the input profile names are showed in the left field and the items that belong to a certain profile are showed inthe right field Input the profile name and click Add Profile Then add desired items to the profile through the functionof ADD and DELETE Clicking the specified key causes the following actions ADD Adds items to profile DELETE Deletes items from profile Add Profile Adds profiles Delete Profile Deletes profiles RETURN Exits current setup 4 1 4 Setup of Display and Print Order For the order of display and print sequence the targets to be tested including biochemical items external items and calculated items Clicking the specified key causes the following actions ADD Adds selected items inthe leftitem listto the right order list INSERT Inserts selected items in the left item list at the desired position in the right order list SAVE Saves sequenceditems into system RETURN Exits current setup 4 1 5 Setup of Calculated Items Some items are calculated and the corresponding results are named calculated results which are of great help for doctors diagnosis The calculating aggregation composed of arithmetic function is called calculated item For ex
36. or to operation The system offers the convenient shortcuts toolbar that are indicated with icons under the menu bar The routine work can be performed by clicking the icons in turn from left to right 3 1 Start up 1 Open the display and host computer 2 Open the analyzer 3 Run URIT 800 chemisty analyzer software and login the main screen 3 2 Preparations 1 Inspect the waste flask to see whether it is full If so dispose the waste solution according torelevant regulations 2 Click the icon of Rinse Tube in the shortcut toolbar The instrument is rinsed one time with distilled water then goes to standby status 3 Click Instrument Checkup in Maintenance and set proper temperature for the cell NO instrument inside temperature 25 C 30 C 37 C Default temperature forthe cellis 37 C 4 Half an hour later for standby the light source lamp is expected to be stable and the temperature reaches the expected level 5 Rinse the instrument five times with distilled water 6 Click the icon of Adjust A D in the shortcut toolbar to adjust the instrument automatically If problem appears refer to the seventh item in Troubleshooting 7 Confirm whether the instrument needs to be calibrated Refer to chapter 5 QC Analysis and Calibration for details 14 URIT 800 Operating Manual 3 3 Setup of Item Parameters For setup of item parameters click the icon of Item Parameters
37. over of the pump with your thumb and index finger and then take out the lower cover 4 Take down the wore pump pipe from the upper cover then take down the two closing rings from the wore pipe and clip them in the new pipe 32 URIT 800 Operating Manual 5 Push the new pipe into the interspace between the rotating wheel and the inner wall of the upper cover Hold down the two closing rings to clip the outlet of the upper cover with the opening upward 6 Join the upper cover with the lower cover Forcibly press until the covers join with each other totally 7 Aim the center of the pump at the motor shaft and press the pump until it is set on the base 8 Connect the tubes back to the pump _ Zo Upper Cover Clamps 4 Base Clamps e Upper Cover A A d C Lower Cover j 3 Figure 5 7 3 Cleanliness 7 3 1 Daily Maintenance Perform rinse 10 15 times after turning on the instrument and 10 20 times before turning offthe instrument Wash the waste flask dk Biological dangerous 4 SL To avoid infection be sure to put on protective clothes gloves and even goggles when necessary 7 3 2 Weekly Maintenance Using detergent contains active enzyme soak the cell for certain time Note do not soak a long time if the detergent is strong caustic Then rinse the cell with 33 URIT 800 Operating Manual distilled water several times The detergent that soaks t
38. p of Department The departments can be denoted with codes or names depending on the requirement of lab 4 3 4 Setup of Operator The operators can be denoted with codes or names depending on the requirement of lab 4 3 5 Setup of Chart Color You can set up your favorite colors for charts Default chart colors provided by system can also be customized as required The changed colors are valid only after saved 4 4 Processing of Results The menu of result processing includes following items Modify Results Register Results and Recall Results 4 4 1 Modify Results Refer to 3 6 for details 4 4 2 Register Results Refer to 3 5 fordetails 4 4 3 Recall Results Click Recall Results to review the tested sample information Select one search method date item doctor outpatientno operator or all and click SEARCH The desired records will be shown in the patient information list Print Prints the records selected fromthe Patient Information List 4 5 Help The help menu includes three submenus Help Registration and About Software 24 URIT 800 Operating Manual 4 5 1 Help If you have any problems in operation click help to obtain details 4 5 2 Registration Input user s name and registration ID to complete registration for the software 4 5 3 About Software You can find the copyright number and registration information abo
39. r is composed of sampling system light path system liquid circuit system and hardware circuitry Figure 3 shows the appearance of the analyzer Power Input Fan Power Switch Waste Outlet RS232 Ground Pole Window EN aa Of Indicator Light f san l gt l Figure 3 URIT 800 Operating Manual 1 3 Functions 1 Integrated assay methods Endpoint rate two point dual wavelength 2 3 absorbance etc Proper parameter setup Reagent blank and distilled water blank are applied to test to ensure the accuracy of test results Credible calculating method Coefficient single point calibration and multi point calibration etc Large capacity storage Up to 200 items and 100 000 test results Test results QC data item standard and item setup are saved in the system database for analysis and statistic Quality control Perfect QC function for QC data statistic storage and QC chart drawing Various print formats Three print formats are selectable traditional economical and common Strong search function Search indexes include test date patient s name doctor number of outpatient operator display all etc Open reagent Reagent is optional user can set up items to be tested as required Data share External date can be transmitted into the system 10 Modifying results Patients information and test results can be modified in flexibility and convenience 11 User friendly inter
40. s and the adjusted results are saved automatically as reference values for the sequent tests 21 URIT 800 Operating Manual It is recommended to adjust the initial A D value under following conditions When installing instrument or replacing computer When operating the instrument after along distance shipping When replacing a halogen lamp When replacing a cell When filter has deteriorated Whenever testresults show abnormal fluctuation 4 2 4 Rinse Tube Carrying out tube rinse can clean the tubes and cell and keep the cell humid Click tube rinse to enterthe screen of tuberinse Input the rinse times and clickthe RINSE button to start rinsing automatically It isrecommended torinse tubes under following conditions At the start of the day s run At the end ofthe day srun After testing high concentration solution Along time for disuse The initial A D value is abnormal Ah Caution For the air bubble or foreign body that is difficult to wash off in the cell try to rinse it with absolute alcohol or detergent recommended by URIT 4 2 5 Checkup of ABS In the Abs checkup dialog you can check any filters inthe left wavelength list and quickly analyze the liquid of different absorbance Clicking the specified key causes following actions SAMPLE Pipettes solution to be tested in the cell ZERO Zerosthe ABS ofcurrent solution RETURN Exits current screen 22 URIT 800 Operating Manual 4 2 6 T
41. ut this software here URIT 800 Operating Manual 29 5 QC Analysis and Calibration 5 1 General The meanings of reliability about test results have two aspects one is high precision i e the good repeatability of test results which mainly aims at eliminating or minimizing the influence caused by random error and depends on the perfect room QC system to guarantee The other one is accuracy i e the test results are correct and close to the true values which mainly aims at eliminating or minimizing the influence caused by system error and depends on the proper assay method and correct calibration to guarantee Therefore itis necessary to strictly select certified control sample and calibration solution and use them according to their instructions 5 2 QC and QC Procedure The control sample is just used together with the sample to be tested To minimize the test error it is required to keep the control sample stable in storage 5 2 1 Class of Control Sample Mixed serum freeze dried and liquid control sample classified by the different physical properties of control samples Fixed value and non fixed value control sample classified by the presence absence of measurement value You can select one kind of control sample above as the room control sample as required 5 2 2 Usage and Storage Strictly use control sample according to the instructions provided by the supplier Make sure the high quality of the solution rediss
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