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User manual - Uricha Ver 2.3-CT

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1. A qualified user has to make sure that the environmental condition is suitable the installationiscorrect the use and maintenance are proper according to the general safety rules as well as to the particular precautions described in the manual However the user is not entitled to repair the instrument s A qualified technician is entitled to maintain and fix the instrument according to the instructionsgiven usingthe original spare parts e Maintain room temperature and humidity as specified in the manual gt The instrument has to be used as described in this manual If it is not use the protection provided by the instrument may be impaired 4 fe Alterations to the instrument are strictly prohibited The user is liable and solely responsible for any improper modification to the instrument and for the consequences derived asa result gt If the instrument need extraordinary maintenance contact ROBONIK service or an authorized service center Specialized technicians who will be able to repair the instrument using original spare parts will carry out the maintenance This IVD equipment complies with the emission and immunity requirements as per 1EC61326 series Warning This equipment has been designed and tested to CISPER11 Class A In a domestic environment it may cause radio interference in which case you may need to take measuresto mitigate the interference t An advisory t
2. URICHA 3 3 Technical Specifications URICHA Test AS Measurement Principle Reflectance photometry Optical Measurement RGB Sensor Test Strip Strips 10 Input 100 240V 50 60 Hz 0 5A min Adaptor Specification Output 12V DC 1 5A min 3 Pin Adapter with Earthing Power Wattage 18 Watts minimum Operating Position On horizontal flat rigid amp vibration free surface Operating Conditions Temperature From 8 C to 352 C Relative Humidity up to 85 Storage Conditions Temperature From 10 C to 50 C Relative Humidity up to 85 Size mm L XB X H 235 x 170 x 130 Weight 1 40 Kg Version No 02 Effective Date JAN 2013 Page 8 of 39 URICHA 8 5 1 Result To view the result of the test run select RESULT option MENU RESULT RESULT ESC LIST RESULT SEARCH BY PID TOTAL RECORD 250 8 5 1 1 List Result List Result will display the following screen which consists of Sr no PID if any date along with ESC SEL NEXT and PREV options ABC 27 4 11 RESULT PQR 27 4 11 SEARCH BY PID TOTAL RECORD 82 PST 27 4 11 XYZ 27 4 11 RESULT 27 4 11 27 4 11 10 15 30 SEQ NO 1 27 4 11 PID RST BLD Ery ul UBG mg d 27 4 11 BIL mg dl eee PRO mg dl 27 4 11 NIT KET mg dl 27 4 11 GLU NORM 5 27 4 11 LEU NEG Version No 02 Effective Date JAN 2013 Page 33 of 39 URICHA 8 4 2 Data Transfer through Serial cable DATA TRANSFER DATA TRANSFER SEND
3. Start Print option it will print the amplitudes of Green Red amp Blue until user selects the Stop Print option When user selects the Start Print option it displays the msg string Print Start LAMP AMPLITUDE GREEN 1701 5 START PRINT RED 1574 6 STOP PRINT BLUE 2274 4 ESC PRINT START The printout of the Lamp Amplitude LAMP AMPLITUDE 1707 1580 2280 1707 1579 2281 1707 1580 2281 Version No 02 Effective Date JAN 2013 Page 25 of 39 URICHA Similarly BATCH EMPTY is displayed when the batch is empty without any sample details BATCH EMPTY 4 Batch means bunch of samples And Maximum Samples per batch is 25 User can enter maximum 25 samples in each batch If you try to add more samples then it will display the message string BATCH FULL BATCH FULL 8 2 DIAGNOSTICS Select DIAGNOSTICS from the Main menu it will display following screen DIAGNOSTICS LAMP AMPLITUDE PRINTER TEST MOTOR TEST CLEAR MEMORY Submenus of screen DIAGNOSTICS are gt Lamp Amplitude gt Printer Test gt Motor Test gt Clear Memory Version No 02 Effective Date JAN 2013 Page 24 of 39 8 START UP SCREEN 8 1 TEST URICHA If selected Test from the Main Screen it will display following screen which consists of SEQ NO BATCH INFO Load Strip amp ESC options URINE ANALYZER 5 5 11 MEDICARE 10 18 25 DATA DIAGNOSTICS UTILITIES DATA
4. DATA VIA SERIAL WAIT DATA SENDING TOTAL RECORDS 250 TOTAL RECORDS 250 DATA TRANSFER MAIN SCREEN DATA SENDING OVER TOTAL RECORDS 250 8 5 Data Select DATA option present on the main menu screen It will display the screen consisting of Result and ESC options URINE ANALYZER 5 5 11 DATA MEDICARE 10 15 25 TEST DATA ESC DIAGNOSTICS UTILITIES DATA TRANSFER Version No 02 Effective Date JAN 2013 Page 32 of 39 URICHA 4 PACKING TRANSPORT AND STORAGE 4 1 General Warnings Instrument has to be decontaminated before packing for transportation 4 2 Packing Packaging is needed whenever it is to be transported or shipped by courier or other means Ee To pack the instrument follow the instructions as described below 1 Decontaminate the instrument as explained in chapter No 12 Decontamination of this manual 2 Place the instrument into the original packaging box Instrument has to be properly protected by plastic protective material Put copy of safety clearance certificate copy of Safety Clearance certificate is attached at the end of this manual 3 Mark the package with address instrument identification and warning labels 4 3 Instrument Transportation The transportation of the instrument in unpacked condition must be limited with in the room where it isused to avoid damage 4 4 Storage of the Instrument Before storing the instrument for along period pack it
5. Gloved hands should be considered contaminated at all times and must be kept away from eyes mouth and nose at all times Mucous membranes are considered prime entry routesfor infectious agents Wear eye protection and a surgical mask when there is a possibility of aerosols Eating and drinking while decontaminating instrumentsisnot advisable 12 4 Procedure e Asolution of 5 Sodium Hypo Chlorite NaOCL solution Bleach is used Commercial bleach is 5 NaOCL household bleach is 3 NaOCL When using commercial bleach use a 10 1 mixture if using household bleach a 6 1 mixture is required This is a caustic solution It isimportant to wear gloves and eye protection when handlingit e Wipe down the carrier and all exposed surfaces of the unit with the bleach solution Remove the top shroud of the instrument and wipe down the top surface of the instrument base as well asthe inside of the top shroud Reassemble the unit and discard the used gloves and towels Version No 02 Effective Date JAN 2013 Page 38 of 39 URICHA BF 3 4 Printer ON OR Errien o N r renin rE EE one meu N ETEY 30 8 3 5 DAte MING sorene prac a n aa ea e a e N maa EEE Er NEEE 30 8 45 Data MANTEN sire venais r A AA EANES I NAVAT NN 31 8 4 1 Data Transfer Through USB iva ccacseceesgmvmnisecievateorqeewndend iE EE EE EEREN 31 8 4 2 Data Transfer Through Serial Cabl ripiirsrenennai an araon nep T E TATARER 32 BLO Data sai ineen E A T T AAE a E E E VAE eE ATT
6. MESSAGES CAUSES O CORRECTIVE ACTION Delete records and then run strip If not deleted next tests will be overwritten on earlier records in sequence MEMORY FULL If Number of saved records exceeds RECORD the memory limit Before running the IN SEQ DELETE next test this message will displayed pl Ent This is an initial message after B on f neer selecting Test option for entering AECA INEO the sample details i 7 Test strip is not placed Place the Test strip in the STRIP ABSENT in the strip holder Strip holder a j If the previous strip is not removed Remove the test strip from REMOVE STRIP from the Strip holder the Strip holder Suppose after entering all the Sample Details if user selects RUN option without saving the parameters then it will display the message string Please Save Sample Details Select Batch Info for entering the sample details Therefore after entering the sample details one must save the test parameters amp then select the RUN option Please Save Sample Details Batch means bunch of samples amp max Samples per batch is 25 User can enter maximum 25 samples in each Do not enter sample details batch If you try to add more samples more than 25 in a single batch then it will display the message string BATCH FULL Batch Full BATCH EMPTY is displayed when the Batch Empty batch is empty without any sample details
7. NIT POS KET NEG GLU TRACE PH 5 SG 1 030 LEU NEG TEST READ STRIP MANUAL MODE PID PATH_02 SEQNO 2 ESC BATCH INFO HOME READ STRIP LOAD STRIP REMOVE STRIP Page 22 of 39 Similarly select the Appearance of the particular sample SAMPLE DETAILS PID PATH_04 NAME AJ AY COLOR VOLUME 0 ML SAMPLE DETAILS PID PATH_04 NAME AJ AY COLOR LIGHT YELLOW APPEARANCE CLOUDY VOLUME 0 ML Enter VOLUME of the Sample in mL milliliters SAMPLE DETAILS PID PATH_04 NAME AJ AY COLOR LIGHT YELLOW APPEARANCE CLOUDY APPEARANCE HAZY TURBID APPEARANCE CLEAR HAZY CLOUDY TURBID MILKY CLOUDY Numeric Values 25 123 45 6 7890 SAMPLE DETAILS PID PATH_04 NAME AJ AY COLOR LIGHT YELLOW APPEARANCE CLOUDY VOLUME 25 ML URICHA User can enter max 250 ml of volume Note Limit Set for the Test Parameters Version No 02 Effective Date JAN 2013 Page 19 of 39 URICHA Upto 250 ML milliliters Samples Per Batch 25 samples Motor Rotation 65000 rotations After entering all the test parameters select SAVE option present on the screen On selecting this option it will display following sub screens SAMPLE DETAILS BATCH INFO PID PID PATH_04 TSWE F PATH_01 NAME AJ AY COLOR LIGHT YELLOW APPEARANCE CLOUDY VOLUME 25 ML WAIT LOADING PATH_02 PATH_03 BATCH INFO PID PATH_01 PATH_02 PA
8. PVT LTD A 374 TTC MIDC Industrial Area MAHAPE NAVI MUMBAI 400710 INDIA Tel 91 22 67829700 Fax 91 22 67829701 Email sales robonikindia com Website www robonik in Version No 02 Effective Date JAN 2013 Page 4 of 39 11 URICHA CLEANING AND MAINTENANCE Danger of Infection Urine and used test sticks bare the danger of infection Always use protective gloves during handling and disposal The disposal of used test sticks should be Performed according to the regulations for the handling of potentially infectious material Cleaning 11 2 1 How to Clean the Housing The instrument housing may be wiped with a cloth Mild cleaning agents or disinfectants may be used Ensure that no moisture permeates the equipment 11 2 2 How to clean the Strip Holder Wipe off Urine residues from the strip holder with a lint free cloth after each measurement This prevents crustification and drying of Urine residues The strip holder can be removed from its mechanism and should be cleaned with water and when necessary with cleaning agent or disinfectant Make sure that the instrument isturned off before removing the strip holder After cleaning the strip holder should be put back on to its mechanism carefully The circular notch of mechanism and strip holder must be placed on top of each other Strip Holder Mechanism Version No 02 Effective Date JAN 2013 Page 37 of 39 URICHA 10 TROUBLE SHOOTING ERROR
9. STRIP MEMORY FULL RECORD IN SEQ DELETE 3 Suppose after entering all the Sample Details if user select RUN option without saving the parameters then it will display the message string Please Save Sample Details as shown below SAMPLE DETAILS PID PATH_04 NAME AJ AY COLOR LIGHT YELLOW PLEASE SAVE SAMPLE DETAILS APPEARANCE CLOUDY VOLUME 25 ML Version No 02 Effective Date JAN 2013 Page 23 of 39 URICHA After reading the strip the strip holder move to the load position and the result is displayed on the screen as shown below RESULT 12 12 12 10 42 25 SEQNO1 PID PATH_01 BLD NEG UBG NORM BIL NEG PRO NEG NIT POS KET NEG GLU TRACE PH 5 SG 1 030 LEU NEG User can take the print of the displayed Result by selecting PRINT option present on the screen RESULT 12 12 12 10 42 25 SEQNO1 PID PATH_01 BLD NEG UBG NORM BIL NEG PRO NEG NIT POS KET NEG GLU TRACE PH 5 SG 1 030 LEU NEG After selecting ESC option it will display following screen where next sample is ready to take its readings RESULT 12 12 12 10 42 25 SEQNO1 PID PATH_01 BLD NEG UBG NORM BIL NEG PRO NEG NIT POS KET NEG GLU TRACE PH 5 SG 1 030 LEU NEG Version No 02 Effective Date JAN 2013 RESULT URICHA 10 10 42 25 12 12 12 SEQ NO 1 PID PATH_01 NAME AJ AY COLOR LIGHT YELLOW APPEARANCE CLOUDY ORO AAR EE BLD NEG UBG NORM BIL NEG PRO NEG
10. Yes option DIAGNOSTICS DIAGNOSTICS LAMP AMPLITUDE LAMP AMPLITUDE PRINTER TEST PRINTER TEST MOTOR TEST P MOTOR TEST WAIT MEMORY CLEAR DIAGNOSTICS DIAGNOSTICS LAMP AMPLITUDE LAMP AMPLITUDE PRINTER TEST PRINTER TEST MOTOR TEST MOTOR TEST CLEAR MEMORY CLEAR MEMORY CLEAR MEMORY YES NO MEMORY NOT CLEAR Version No 02 Effective Date JAN 2013 Page 28 of 39 URICHA 6 INSTALLATION AND START UP INSTRUCTIONS 6 1 Unpacking Instructions Check accessories as per packing list 6 1 1 Packing List Instrument Adapter with power cord Paper Roll Paper Roll Rod Touch Pen Uricha 10Test Strips User Manual NAOHBWNE Note Read the operating manual for URICHA carefully before the first startup De in order to ensure an error free operation Kindly store all packing materials so as to use it to re pack and ship for maintenance or servicing E 6 2 Placing the Instrument i The instrument hasto be placed on a hard even surface level bench 2 Room temperature has to be between 18 C and 35 C with a relative humidity below 85 3 Do not place the instrument near strong electromagnetic fields 4 Do not place the instrument near heating plates ovens or radiators 5 Do not expose the instrument to strong light sources i e direct sunlight 6 Maintain the instrument in a clean relatively dust free environment to ensure maximum Performance Version No 02 Effective Date JAN 20
11. prior to returning the instrument to the manufacturer or your local distributor for servicing repairs or return Thank you for your co operation Customer J Contact Address Position Dept Tel Country Se Fax Post Code Model No ___ Serial No Accessories Returned Date of Purchase if known Complaint Has the equipment been exposed to any of the following delete as applicable a Blood body fluids pathological specimens YES NO If YES please specify b Other Biohazard YES NO if YES Please specify Version No 02 Effective Date JAN 2013 Page 39 of 39 URICHA 12 DECONTAMINATION 12 1 Decontamination Procedure If the instrument is to be shipped after being exposed to potentially hazardous material it should be decontaminated The following procedure outlines how to decontaminate the instrument before packaging and shipment 12 2 Purpose of Decontamination Decontamination minimizes the risk to all who come in contact with the instrument duringshipping handling and servicing 12 3 General Considerations e Any laboratory instrument that has been used for clinical analysis is considered a biohazard and should be decontaminated prior to handling Intact skin is generally considered an effective barrier against infectious Organisms however small abrasions and cuts may not be always visible Prophylactic gloves must be worn when handling instruments that have not been decontaminated
12. 13 Page 13 of 39 URICHA 6 3 Power Supply Instrument is directly run on AC DC switching adaptor Use only recommended adapter An adapter should be CE marked Earthing Point in adapter is must The specifications of AC DC switching adapter is INPUT 100 240V 50 60 Hz 0 5A Min OUTPUT 12V DC 1 50A Min Use locally available approved plugin cable power cord to give the input voltage to Adapter It should be CE CSAor ULapproved 6 4 Protective Grounding Warning Make sure that electrical power source is properly grounded 6 5 START UP Instructions 1 Switch on the instrument 2 The instrument initializes all the parameters internally and carries out a power on self test and then displays the following screen ROBONIK INDIA PVT LTD PLOT NO A 374 TTC MIDC INDUSTRIAL AREA MAHAPE NAVI MUMBAI URICHA URINE CHEMISTRY ANALYSER VERSION 2 3 CT 3 If printer is enabled Model Name will be printed along with Clinic Name Date amp Time 4 And by default if Printer flap is not closed then it will display the following screen after the initial address screen FLAP ERROR Version No 02 Effective Date JAN 2013 Page 14 of 39 URICHA URICHA comes with a built in 20 column Thermal Printer User has to take proper care to handle this delicate instrument TIPS FOR CAREFUL USAGE OF PRINTER Do not pull the paper when loaded 1 Lift the paper lid carefully and load the paper 2 Keep the instr
13. EN 32 8 Sela RESU a as rn aa eNe Sak a Oee VN e eae en NE N 33 BLS Dede EISE IRESUIE Sireasa a E Sait Mai NE E E OA NE A E EN 33 8 5 E2 Seano MBYPID airan n e E AERA EE AE E E E A A E T 34 QEIPREGAU TIONS A E E E E E tems sbi itnana 35 LO TROUBLESHOOTING ALIN A E R A R E sm ae ooh rere E 36 TINCLEANINGAND MAINTENANCE roi iae raare a eA R AE a E AAAA A E A iam acheles 37 LDL Danget OF Infection sanjar en ae a iaai UE E A 37 AES ET ATA AEE A A E T E A E E E T 37 112 1 HOW toclean the HOUSING vi secssiscswinerades teen ae eE aoia e a Ea Aaaa EAAS 37 11 2 2 How to clean the Strip Holder 37 12 DECONTAMINATION ssena cago ke 12 1 Decontamination Procedure 38 12 2 Purpose of DECONTAMINATION sccsccicccscanertesicaceascrasnactarecscunaebednesseabanensecaastastessapessans 38 12 3 General Considerati nS aseissa seu ces dav IE E A Raia ETE en TEES DIE RNAAR 38 LDA Proced nes sscoicecicendicenodrusadansiahresans RERE E Ea E ATE R ASE a 38 T3 SARE mYAGCLEARANGESCERTIFIGATE ne a aaea e EEE ate ee A AT 39 Version No 02 Effective Date JAN 2013 Page 3 of 39 1 1 L2 1 3 1 4 URICHA GENERAL INFORMATION Warranty Information Each Instrument is completely tested and guaranteed for twelve months from delivery The warranty applies to all the mechanical and electrical parts It is valid only for proper installation use and maintenance in compliance with the instructions given in this manual ROBONIK will at its disc
14. ER WAIT DATA SENDING DATA SENDING OVER TOTAL RECORDS 197 TOTAL RECORDS 197 MAIN SCREEN Version No 02 Effective Date JAN 2013 Page 31 of 39 URICHA 8 3 3 Comm Mode USB Serial Communication Mode is a toggle between USB amp Serial Communication UTILITIES AUTO START OFF CLINIC DETAILS PRINTER ON DATE TIME 8 3 4 Printer ON OFF It is a toggle key between Printer On amp Printer Off If user wants to take the print of the result then switch to Printer On option or else select Printer Off UTILITIES AUTO START OFF CLINIC DETAILS COMM MODE DATE TIME 8 3 5 Date Time It displays the Date Time screen where user can enter the Date Time with the help of numeric screen UTILITIES AUTO START OFF 27 12 06 CLINIC DETAILS TME RSM AMIN SEC COMM MODE 13 46 40 PRINTER ON To enter change the date and time touch on the shaded zones accordingly A numeric submenu screen will be displayed Enter the current date and time On completion Touch ESC to escape Version No 02 Effective Date JAN 2013 Page 30 of 39 B Rear View URICHA 7 DC Power Input 4 On Off Switch I O 6 USB Interface Parts 4 On Off Switch 1 0 5 Serial Interface 6 USB Interface 7 DC Power Input Version No 02 Effective Date JAN 2013 5 Serial Interface Function Turning the equipment on and off Connection of a computer Conn
15. Enter the sample details before running the samples To avoid this message connect proper data cable select the same communication medium ie USB on computer data receiving application which you have selected on instrument Communication Setting Using data receiving application on computer If you have not connected the data cable i e USB cable correctly you will get this message Connect USB cable This command appears for selecting Start Logging button in the Application screen If paper is not loaded in the printer Load the paper in the printer Flap Error If Printer flap is not closed Close the Printer flap before giving any Print command Keep printer flap properly closed or load the paper REFER Thermal printer Select Start Logging button in the Application screen Wait for Start command PAPER ERROR OR If Printer flap not closed and FLAP ERROR paper not loaded Invalid PID Entry while searching the Avoid entering Invalid PID while Test Results wrt Patient s Identity searching the Test Results No Records Found Version No 02 Effective Date JAN 2013 Page 36 of 39 URICHA 2 GENERAL SAFETY WARNINGS 2 1 Danger Warnings Symbols The following symbols are used to inform the user of the safety rules This symbol indicates Direct current This symbol indicates that mains switch of instrument is ON This symbol indicates that m
16. TH_03 PATH_04 Select Back to go back to the Sample Details screen Whereas NEXT amp PREV options are used for the browsing purpose Remember in a single batch one can enter maximum 25 Sample Details SAMPLE DETAILS TEST READ STRIP MANUAL MODE PID PID PATH_01 NAME A SEQNO 1 ESC COLOR BATCH INFO HOME APPEARANCE READ STRIP LOAD STRIP VOLUME 0 ML PLEASE ENTER BATCH INFO Version No 02 Effective Date JAN 2013 Page 20 of 39 URICHA When we select Test option by default the strip holder is already in the load position Now dip a test stick into the urine sample for approx one second Hold by touching the edge of the strip to a paper towel to remove excess sample Slide or push the strip to the end of the strip holder Do not touch the reagent Pads on the test strip TEST READ STRIP MANUAL MODE SEQNO 1 ESC Select READ STRIP PID HOME READ STRIP LOAD STRIP After selecting Read Strip strip holder will remain in the Load position for 30 sec READING WAIT 30 And again it will wait for the next 30 sec in READING the Home position for taking the readings WAIT 30 READING OVER Version No 02 Effective Date JAN 2013 Page 21 of 39
17. TRANSFER TEST READ STRIP MANUAL MODE PID NONAME SEQNO 0 ESC BATCH INFO HOME READ STRIP LOAD STRIP PLEASE ENTER BATCH INFO Since it displays the message string Please Enter Batch Info one must first select BATCH INFO option present on the screen On selecting BATCH INFO it will display following sub screen through which user can enter the PID Name Patient Name Color Appearance and Volume of the sample TEST READ STRIP MANUAL MODE PID NONAME SEQ NO 0 ESC HOME READ STRIP LOAD STRIP PLEASE ENTER BATCH INFO SAMPLE DETAILS PID NAME COLOR APPEARANCE VOLUME 0 ML Select PID option from the Sample Details screen patient by providing the alphanumeric screen SAMPLE DETAILS COLOR APPEARANCE VOLUME 0 ML Version No 02 Effective Date JAN 2013 Page 17 of 39 t helps the user for the identity of the BCDEFG ENTR IJ KLMN PQRSTU WXYZ _ 12345 78 90 SAMPLE DETAILS PID PATH_04 NAME COLOR APPEARANCE VOLUME 0 ML URICHA Similarly on selecting NAME it will display Alpha numeric screen where user must enter the Patient s Name SAMPLE DETAILS PID PATH_04 APPEARANCE VOLUME 0 ML BC DEFG ENTR IJ KLMN PQRSTU WXYZ _12345 78 90 SAMPLE DETAILS PID PATH_04 NAME AJ AY COLOR APPEARANCE VOLUME 0 ML The next parameter helps to specify the color of the samp
18. USER MANUAL URICHA TABLE OF CONTENTS 1 GENERAL INFORMATION csceesseseeeseeseeveeeuee NOONAN Dono E o AAN E 4 1 1 Warranty Information cceczavsccscusdevaeseigeunednteetaneacense cup n Ea E E EE Ea ERE E E K a a EEA 4 1 2 Technical Service 4 1 3 Disposal Instruction 4 TA ContactS arrarnta anea EEE E EEEN a a EEA 4 2AGENERALSARENWARNING S ETE EE E EE 5 2 1 Danger Warnings Symbol asemenea E AAA E EE AAE DEEE EEES 5 2 2 USE Of The IMSEFUMEMEE siooni ea eE EAEE a aa 6 BSMINTRODUCTIO NEA nooonononoDoconcadoonooNoONCoHSCONOoUoCONORAOoNIDONEOOION 7 3 1 Description 7 3 2 Salient Feat UFES i cibsecsisrssscaizisierrneitvoiipiinigrt wasnt aA bins ieinlea s nes E AAEE ENRETE E 7 3 3 Technical Specitications URICHA cressoni enese DNIA aks 20a 8 ATPACKINGATRANSEORRANDISTORA GE TE e EEEE EEN 9 4 l General WanningS seniade aa AV eE O E E DEAE 9 42 PACKING eieae E D E AE a E EE EES 9 4 3 Instrument Transportation wniannciinnanninscn nah nan odin a a o e EEE AN 9 4 4 Storage of the Instrument sale nae ua AT PE TT iieeonvin 9 SMINSTRUMENMDESCRIPTIO NETAS a r 10 Bid Perspective VEW wissen asenaeu manne niiuaatanlednnbalnoninbnnenmarintampamiaaanidardiaaatiauitasteoled ESE 10 5 2 iinstrument Working PRMCIDICS winch winwaracaanvanainwsiausidlonnlnaiaesie wiidinenaaniaaSn 05 eE ENEG 12 52l Block Diagram eeoa sen tees ohn A EE R 12 Bok FURCHOMAN PRIMI IOs ccecsndsicdandaninininanlaimitan
19. ains switch of instrument is OFF This symbol indicates generic danger It means that serious damage can occur to the operator if described precautions are not observed This symbol indicates HIGH ELECTRIC VOLTAGE It is dangerous to touch any part having this label Only qualified operators can access these components after unplugging the instrument from the Supply This symbol indicates that the instrument involves the handling of samples which can be infected urine or human serum In this condition infection or contamination might occur Pay attention to the general safety warnings when in presence of such biological substances Use Protective clothes gloves and glasses This symbol in the user manual indicates that damages to the instrument or erroneous results could occur if the given warnings are not followed This symbol indicates a portion which is particularly important and should be studied carefully This symbol indicates a Protective Earth or Ground terminal Se PE o General Symbols Symbol for Manufacturer 5 E Symbol for IN VITRO DIAGNOSTIC MEDICAL DEVICE Version No 02 Effective Date JAN 2013 Page 5 of 39 URICHA 2 2 Use of the Instrument The instrument has to be used for the designed purposes under specified conditions following proper procedures and safety rules to be follow by qualified personnel THIS MANUAL CONTAINS INSTRUCTIONS FOR OPERATION BY QUALIFIED PERSONNEL ONLY
20. carefully as described above and store indoors Relative humidity hasto be lessthan 85 and temperature between 02c and 50 c Version No 02 Effective Date JAN 2013 Page 9 of 39 5 INSTRUMENT DESCRIPTION 5 1 Perspective View A Front View Parts 1 Printer Flap 2 Touch Screen DISPLAY 3 Test Strip holder Version No 02 Effective Date JAN 2013 URICHA i z ip 1 Printer Flap 2 Touch Screen 3 Test Strip holder Function Opening the printer flap for paper replacement Control of equipment functions Test strip holder Page 10 of 39 URICHA ESC option present on the Utilities screen will help the user to come out of the Utilities screen to the Main menu screen 8 4 Data Transfer Select Data Transfer option from the Main menu It will display the data transfer screen which asks the user Send data via USB Select Yes if you want to send the data through USB If USB cable is not connected then it will display the string Connect USB cable Connect the cable and select Yes option present on the Data Transfer screen Similarly you can transfer the data through Serial cable 8 4 1 Data Transfer through USB DATA TRANSFER DATA TRANSFER SEND DATA VIA USB CONNECT USB CABLE TOTAL RECORDS 197 TOTAL RECORDS 197 DATA TRANSFER DATA TRANSFER WAIT FOR START COMMAND USB CABLE CONNECTED TOTAL RECORDS 197 TOTAL RECORDS 197 DATA TRANSFER DATA TRANSF
21. ection of a computer Contact for the provided Adapter DC voltage Page 11 of 39 URICHA URICHA 5 2 Instrument Working Principle 8 3 Utilities 5 2 1 Block Diagram URINE ANALYZER 5 5 11 UTILITIES The diagram representing the main functional elements of the instrument TEST MENU AUTO START OFF DIAGNOSTICS HOME CLINIC DETAILS COMM MODE USB N gl g O a a RGB SENSCR DATA TRANSFER PRINTER ON wv i DATE TIME Pi 8 3 1 Auto Start ON OFF A It is a toggle key between Auto Start ON amp Auto Start OFF To run the instrument in Auto mode select Auto Start ON UTILITIES CLINIC DETAILS ETENI COMM MODE USB PRINTER ON The test stick moves below a fixed measuring head on a slide with an embedded reference DATE TIME pad The reflectometric analysis of the test stick and the reference field take place during withdrawal and release of the slide The stick is illuminated with an LED and a detector registersthe intensity of light reflected by the test stick at three different wavelengths Using 8 3 2 Clinic Details an internal calibration the results are calculated from the reflection values Whenever On selecting Clinic Details it will display the alphanumeric screen in order to enter the samples are strongly alkaline a density correction is automatically conducted Clinic Name UTILITIES 5 3 Functional Principle A measurement is started by placing a strip on the holder The measurement is
22. hat the electromagnetic environment should be evaluated prior to operation of the device electromagnetic radiation e g unshielded international RF sources as these d Warning Do not use this device in close proximity to sources of strong may interfere with the proper operation Version No 02 Effective Date JAN 2013 Page 6 of 39 URICHA 9 PRECAUTIONS Precautions Keep the place dry and clean Use original packaging for transportation Refer to the instructions provided by reagent manufacturer gt If the display shows error messages instead of a result then please read the chapter 10 and repeat the measurement Make sure to remove excess urine by blotting the test strip carefully ona lint free cotton cloth Version No 02 Effective Date JAN 2013 Page 35 of 39 URICHA User can take the printout of the Result by selecting Print option present on the screen ESC option will help the user to come out of the screen to the Result screen But if the Printer is set to its disabled mode then on selecting Print option it will display the following screen which will ask the user whether to Enable or Disable the Printer ENABLE PRINTER YES ENABLE PRINTER ENABLE PRINTER PRINTER ENABLE ENABLE PRINTER PRINTER DISABLE 8 5 1 2 Search by PID Select Search by PID it will display alphanumeric screen through which user can enter the PID This option helps the user to search the
23. inneinnnasietasinesia ea AE TEEN OENES 12 6 INSTALLATION AND START UP INSTRUCTIONS sssssssssesnssnsnnnnnnnennnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 13 6 1 Unpacking INSEFUCHIONS cacsncsiis cin see sescevieeien 13 6 1 1 Packing List 13 6 2 PLACING the IMstrume ni eneee E AAE a EVRE eE 13 6 3 Power SUD DIY Orriaren enr N E AAEE E E ERA 14 6 4 Protechive Ground NO ennie Ar a EEEE E AE AES 14 6 5 Start Up INSET UIONS secsnusncdnianursua iupainrrinweinciaie E A A AEE E EEEE 14 PAELOWICHARMRERRESENTATION DATES tries fete nleles este settitelsteelets teteeleteleteitrletestee ine estesistetenieiciaeistentsteste 16 8 START UP SCREEN co els Bi M TOSte E E E ieee earn Giasinnsin atonal ane sielnsaibcns Sasine eaves tisha into ceai aie ible israts bay dntvarne 17 1B 2y DIG QIOSIICS erde rarene ARE AEE E A A E a A 24 8 2 1 Lamp AMP RUGS u erena cement nE a E AAA A eee E NEN 25 8 22 Printer TEST ornini E NEER EAA ET EAEE 26 8 2 3 Motor TEE Kretane aD se ease AOE EEIE EENAA EAAS 28 82A Clear Memory vaain eere a a aS EE A EE EE 28 8 3 UCINEES cic ecesitiateciae saan 29 8 3 1 Auto Start ON OFF 29 8 3 2 CLINIC Detail Sidnei neee e EE ed s Aa HRs aale TAi 29 8 3 3 COMM ModE USB Serial ccivecciasicesateseaincisinesinsisinaeindemaviessesicnssiesiveuisauliie siya netteiadiisisnigsiensecuiaed 30 Version No 02 Effective Date JAN 2013 Page 2 of 39 URICHA 13 SAFETY CLEARANCE CERTIFICATE Please complete all information requests on this form
24. le These colors can vary from sample to sample SAMPLE DETAILS PID PATH_04 NAME AJ AY APPEARANCE VOLUME 0 ML SAMPLE DETAILS PID PATH_04 NAME AJ AY COLOR LIGHT YELLOW APPEARANCE VOLUME 0 ML Version No 02 Effective Date JAN 2013 COLOR K veo DARK YELLOW AMBER gt BROWN RED ORANGE PINK COLOR LIGHT YELLOW YELLOW DARK YELLOW AMBER Em BROWN RED ORANGE PINK LIGHT YELLOW Page 18 of 39 URICHA Since it displays the message string REMOVE STRIP one has to remove the previous strip and then load new strip Now it is ready to take the readings for the next sample Continue the running process as mentioned above By default the Test Result is saved which cannot be deleted It can be erased through Clear Memory option present in the DIAGNOSTICS screen Note 1 Remember that if you change the setting of AUTO START in Utilities for instance if you set AUTO START ON then instrument will start in its Auto mode and will display the Test screen as follows TEST READ STRIP AUTO MODE PID NONAME SEQNO 0 ESC BATCH INFO LOAD STRIP PLEASE ENTER BATCH INFO 2 If storage capacity is full then after selecting Test option from the main menu it will display the message MEMORY FULL RECORDS IN SEQ DELETE at the bottom of the Test screen TEST READ STRIP MANUAL MODE PID PAT_25 SEQ NO 25 ESC BATCH INFO HOME READ STRIP LOAD
25. linic Name And if printer is in disabled mode then it will not print any of the details related to the instrument DIAGNOSTICS LAMP AMPLITUDE MOTOR TEST CLEAR MEMORY The printout will be displayed as follows URICHA VERSION 2 2 CT ABCDEFGH Version No 02 Effective Date JAN 2013 Page 26 of 39 URICHA 5 And by default if Printer paper is not loaded then it will display the following screen after the initial address screen PAPER ERROR 6 START UP Screen appears URICHA 12 12 12 MEDICARE 10 18 25 TEST DATA DIAGNOSTICS UTILITIES DATA TRANSFER 7 START UP screen consists of following menus 1 TEST 2 DIAGNOSTICS 3 UTILITIES 4 DATA TRANSFER 5 DATA Version No 02 Effective Date JAN 2013 Page 15 of 39 URICHA 7 FLOWCHART REPRESENTATION START UP SCREEN DIAGNOSTICS UTILITIES DATA TRANSFER SEND DATA VIA USB SERIAL LIST SEARCH RESULT BY PID RESULT TOTAL RECORDS 250 AUTO START cuinic COMM MODE ON OFF DETAILS SERIAL USB DATE TIME LAMP PRINTER CLEAR AMPLITUDE TEST MEMORY APPEARANCE VOLUME Version No 02 Effective Date JAN 2013 Page 16 of 39 URICHA 8 2 1 LAMP AMPLITUDE On selecting Lamp Amplitude it will display the following screen DIAGNOSTICS LAMP AMPLITUDE GREEN 1701 5 START PRINT PRINTER TEST RED 1574 6 STOP PRINT MOTOR TEST BLUE 2274 4 ESC CLEAR MEMORY On selecting
26. retion repair or replace parts which may be found defective in the warranty period The warranty does not include any responsibility for direct or indirect personal and material damages caused by improper use or maintenance of the instrument Parts that are inherently subject to deterioration are excluded from the warranty In case of defects due to misuse of the instrument any travel and man hour expenses will be charged extra Technical Service ROBONIK is always accessible to the customers for any kind of information about installation use maintenance etc When asking for service please refer to this manual and report the data reported on the identification label serial number Only qualified technicians are entitled to fix the instrument the user as described in this manual should carry out ordinary maintenance ROBONIK technical service or an authorized service center with specialized technicians with suitable instrumentation and original spare parts only are always available for extraordinary maintenance repair under a yearly maintenance contract or on specific demand Disposal Instruction In case of removal or disposal of instrument following instructions need to be followed e Donot dispose in municipal waste follow local regulations for instrument disposal e Plastic Parts Electronic PCB s and components can be recycled so return it back the instrument to manufacturer Contacts Manufacturer ROBONIK INDIA
27. started by AUTO START OFF ce DET Ss LENTR pressing the LOAD STRIP and READ STRIP on startup screen The result is shown on the display J K LMN printed out and released via the interfaces after the measurement has been completed All PQRSTU user inputs are performed viathe touch screen COMM MODE USB WXYZ PRINTER ON 123435 78 9 0 DATE TIME Version No 02 Version No 02 Effective Date JAN 2013 Page 12 of 39 Effective Date JAN 2013 Page 29 of 39 URICHA 8 2 3 MOTOR TEST On selecting Motor Test it will check whether the motor is moving smoothly or not DIAGNOSTICS MOTOR TEST LAMP AMPLITUDE START PRINTER TEST ROTATION COUNTER 0 STOP CLEAR MEMORY ESC The rotation counter count the cycles of motor movement in and out position of the strip holder resemble one cycle To start the counter select START option present on the screen Similarly select STOP option for terminating the process 8 2 4 Clear Memory Clear Memory helps the user to clear the memory Results from the RAM Before clearing the memory it will ask the user whether to clear the memory or not by displaying the message string Clear Memory Yes No If you want to clear the memory then select Yes option present on the DIAGNOSTICS screen otherwise select No option Memory not cleared message string appears if selected No option whereas Memory Cleared message string appears if selected
28. test with the help of patient s identity But if we enter wrong PID then it will display the message NO RECORD FOUND in the next screen RESULT BC DEFG ENTR J KLMN PQRSTU WXYZ LIST RESULT _ 12345 TOTAL RECORD 82 678 90 Version No 02 Effective Date JAN 2013 Page 34 of 39 URICHA 3 INTRODUCTION 3 1 Description URICHA isareflection photometer for the analysis of urine test sticks The measurements are performed under standardized conditions measured values will display printed and can be transferred to a computer The UR ICHA is designed for in vitro DIAGNOSTICS use IVD and should be used by Qualified and healthcare professionals only 3 2 Salient Features Urine Chemistry analyzer is an easy to use low power Urine analyzer designed for field use with following salient features v Easy to use handheld low power analyzer Finger touch operation makes easy to interface Large memory to save 250 Results with date Convenient computer interface via USB to back up the results Single input voltage 12 VDC Large display for clear view Results for all 10 parameters are conveniently displayed on one page Alphanumeric Input possible Instrument can be connected to Laboratory information systems and also to PC using USB RS232 interfaces amp software gt Built inthermal printer with 24 characters v VV VV V v v Version No 02 Effective Date JAN 2013 Page 7 of 39
29. ument clean and dust free How to insert the paper Insert the thermal paper roll by placing the sensitive side facing down The sensitive paper side is recognizable by its smoother face User may operate the instrument by disabling the printer from the utility menu If the printer is in its Disabled mode then it will display following screen asking the user whether to enable or disable the printer ENABLE PRINTER ENABLE PRINTER ENABLE PRINTER PRINTER ENABLE ENABLE PRINTER PRINTER DISABLE Version No 02 Effective Date JAN 2013 Page 27 of 39 URICHA On selecting Stop Print option the printer must stop printing the Lamp Amplitudes It displays the msg string Print Stop after selecting the Stop Print option LAMP AMPLITUDE GREEN 1701 5 START PRINT RED 1574 6 STOP PRINT BLUE 2274 4 PRINT STOP ESC option of the Lamp Amplitude screen will help the user to come out of the Lamp Amplitude screen to the DIAGNOSTICS screen Remember that if the printer is in its Disabled mode then after selecting START PRINT it must display following screen ENABLE PRINTER ENABLE PRINTER On selecting YES option it will start taking the printout of Lamp Amplitudes whereas on selecting NO option it will continue with its Disabled mode 8 2 2 PRINTER TEST To check the printer select Printer Test option On selecting Printer Test it will print the Model Name Version no amp the C

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