HandUReader - E77 Elektronika
Contents
1. Please note that a vial of test strips and calibration are co related Always remember calibrating the equipment when opening a new pack of strips 4 4 2 Selecting measuring mode HandUReader can be operated in two different modes In Timer mode the equipment waits for the strip to incubate for 60 seconds before it reads the first pad In this case incubation is controlled by the instrument In Fast mode the test strip is measured directly after Start is pressed In this case it is up to the user to time the incubation period outside the analyzer You can switch between Fast and Timer mode in the Menu Service Mode sub menu A N Warning When performing serial measurements in Fast mode allow the strips to react for approximately 55 seconds before inserting them in the HandUReader and pressing Start False low or false negative results may be obtained for some parameters 1f the reaction time is too short Likewise false high results may be obtained for some parameters if the incubation time outside HandUreader is too long 4 5 Measurement 4 5 1 Setting a Patient ID for measurement You can identify a measurement by assigning a Patient ID to it You can enter the Patient ID before starting the belonging measurement or you may also enter the Patient ID later in the Memory sub menus see chapter 4 6 3 for details To assign a Patient ID for the upcoming measurement press the Set ID button in the Meas sub menu Use the key pad displ2. HandUReader in perfect condition never leave used strips in the strip holding tray HandUReader checks the tray before switching off and opens it to kindly remind you if you have left a strip inside The only needed maintenance activity is to rinse and wipe out the strip holder with a dry cotton cloth each day before switching off the equipment Warning Since urine is a fluid of human origin 1t may be infective and may bear the possibility of biological risks Handle used strips and urine contaminants with care Battery recharge HandUReader s portable Reader Unit is powered by 3 pcs of AA size rechargeable battery Their fully charged capacity is sufficient for about 300 test measurements securing about a half year of operational period Portable Reader Unit is operating from batteries only in stand alone mode Docking it in the Printer Station in its basic position the batteries are being recharged You can also power Reader Unit by connecting power adapter directly to its socket If batteries are discharged equipment will not turn on When batteries are getting discharged Battery low message appears on LCD In case you don t touch the screen for a while to save energy HandUReader switches off after 2 5 minutes if operated from batteries and 5 minutes if connected to mains 6 Error messages and troubleshooting During application the control program checks the operational conditions needed for proper execution of the functions If checkin
3. ID identifies the result reports Standard mode setting is 9600 Baud 8 bits with 1 Stop bit and no parity Other option can not be programmed For more information on serial port refer section 4 8 Figure 6 The serial setup menu T Note By disabling the serial port the printer will be disabled too In this case you can only study test results on the display 4 2 3 Setting the language Select Menu Setup Language menu to set the language The equipment is programmed to communicate with the user on the following languages English German or Hungarian The language can be selected with the UP and DOWN buttons or by directly checking the field nearby the desired language You can store your changes and return to main menu by pressing OK Other languages can be programmed on user s request for extra charge 4 3 Strip setup options Menu Strip 4 3 1 Setting the measurement Unit The Menu Strip Unit menu allows you to select measurement Units of test results on printed reports and on LCD Options are Conv SI Arbitrary Conv Arb SI Arb The unit can be selected with the UP and DOWN buttons or by directly checking the field nearby the desired unit type You can store your changes and return to main menu by pressing OK 4 3 2 Setting sensitivity attribute of the image processing program Select Menu Strip Sensitivity menu to adjust the sensitivity Measurement sensitivity in program can be adjusted in two levels in both direc
4. menu allows the user to control one of the operational or setup functions For detailed explanation of sub menus please find the accurate descriptions in following chapters By pressing the QUIT button you can always return to main menu The OK button is used to enter the edited data and quitting the function 4 2 Setup procedure Menu Setup 4 2 1 Setting the clock Select Menu Setup Clock menu to set date and time see figure 5 You can adjust the parameter which is selected with a frame around it by the UP and DOWN function keys To go on to the next parameter press the NEXT button By changing the SEQ parameter you can set the date display mode from Month Day Y ear to Year Month Day or Day Month Y ear When all the parameters are set you can store your changes and return to main menu by pressing OK Figure 5 Clock setting 4 2 2 Setting the serial output port You can set the serial output port in the Menu Setup Serial menu see figure 6 If enabled the equipment is programmed to communicate with host computer on two ways either by PC unidirectional or by networked mode You can choose between the two protocols with the UP and DOWN buttons or by directly checking the field nearby the desired protocol In networked mode information is sent in blocks The blocks also include an indicator prior set by user by selecting or unselecting the BI ID being able to sign 1f the sequence number Seq Nr or patient ID Pat
5. the reader then to the mains Figure 3 Installation of the batteries Switch the HandUReader on by pressing the button Power On In a few seconds the manufacturer s logo then Main menu appears on the LCD offering the Memory Meas Menu options T Note If during power on process the user keeps pressed touched any point of the screen boot up process will be interrupted and the actually displayed information can be studied serial number software version etc After releasing the screen setup process will continue printer paper holder see fig 4 Fit easily the W 4 paper in the paper feeder hole and close the cover T plate The printer paper will be pulled up 9 f al Take a roll of printer paper and load it into the automatically to its start position Now i HandUReader is ready to operate offering the Main Menu option see chapter 9 Figure 4 Loading the printer paper A N Note After installation you may check whether your equipment operates accurately There are control solutions available on the market for example Quantimetrix from Quantimetrix Co which can be used for testing Use the control solution on each pad and measure the moisturized strip with HandUReader The result should be in the range written on the control solution s box 4 Operational guide 4 1 Control Menu system Operation and functions of HandUReader can be studied by its menu system s chart see Appendix Each selected
6. to rescind the purchase agreement only exists if the replacement instrument is also found to be defective Claims other than these will not be entertained Damage caused by misuse maltreatment tampering human error and extreme force are excluded from this warranty This warranty is only valid if the date and the stamp and signature of the dealer are entered on the warranty card on the date of purchase The warranty period is not extended by any claim made under this warranty 1116 Budapest Fehervari ut 98 HUNGARY Tel 36 1 206 1480 Fax 36 1 206 1481 E mail sales e77 hu v1 0 2004 06 14
7. HandUReader Portable Urine Chemistry Analyzer Instruction for Use Index Table Ie INTRODUCTION sissseccrceadccoscesncronstesiansvnaeyoiievesiawiancvsartescvecieteveieid caacacavaass antes E e 3 1 1 METHODOLOGY OF URINE TESTING see eee eee 3 L TIER I 3 2 DESCRIP FION OF HANDUREADER icssesd cecnccestveseces ccassseecdecd Ene ia eeaeee e EuS er EAEE T ESA E EEr aana arek eiai Sorita 3 De ANSTALLA TION a a E EEE EA EES 4 4 OPERATION ADB GU ED ET Sricnunia e EE EEE ETENEE EE 5 4 1 CONTROL MENU SYSTEM recipiens S N IE O EE O ETATEN EA E ETEO 5 4 2 SETUP PROCEDURE oirun N N AE E I TEE EEA A EES 5 Ae D E TTT A E E A A DE MEST TT TTT 6 ADS SSCL VIC AMOI ata eid td aR Siu Goeth ONS aR Bu ican it US aR T lds 6 4 3 STRIP SETUP OP PIONS RES 6 ASN SCAS Me measurement UNU secccnuiscnlcnnie Htinals a E ail aaih ath S 6 4 3 2 Setting sensitivity attribute of the image processing program ccccccccccscccccscccsssscssceseccceeeeseeeeeeseeeeeeeeseeeeeees 6 c SCL ANC DUG SCOUCNCE IN DVINIOUL TT 7 4 4 HE SERVICE MENU OP TIONS eriei E E E E E O E caatevennts 7 ie Sd me 0011 0 00 re me eee ee ee en ene eee eee ere eee if AMD DUENE INCASUIING MOUE iae areca hada brated eee ore antes Suatemueks othatatanmaiaaiadeceane She K 4 5 MEASUREMENT acreana anra A do smmmesaaand Op adoaemissuanduts O E tenneaeauasdethaasenua unset ieioaniaaee 8 as Dene a Patient 1D fOr NCASUlCMCHL verpir n pects dec araw ca bee ota ands neaeiadaiameata
8. a measuring cycle lasts around 60 seconds from pressing the Start button To get the results in printed report form the printer prior need to be enabled see chapter 4 8 and Reader Unit should be docked or it should be in a visible distance from Printer Station 8 Now you can discard the used test strip after opening the strip holder tray by pressing Start After you can either finish your testing job by pressing the Quit control button or if you still have urine samples to be tested place the new moisturized test strip on the strip holder as previously you did then press the Start control button Strip holder tray closes automatically and the equipment starts a new measuring cycle 9 Finishing your work with HandUReader press the Quit button in main menu After asking confirmation of your request the equipment will turn off automatically If you leave the equipment without control more then 2 5 minutes it will turn off automatically if operated from batteries and 5 minutes if connected to mains 4 6 Memory data management 4 6 1 Result printout Enter the Memory Print sub menu if you gaia G would like to print out records stored in the of printed range of printed range memory You can select a memory range to be printed out The limits of the memory 2004 6 11 10 16 range that is selected for printing are ID MR SMITH displayed in the top right corner see figure neg 10 You can select one of them by simply norm pointing on it The se
9. ayed on LCD for typing the Patient ID and store it by pressing the OK button You may now start the measurement which will identified by the previously entered Patient ID 4 5 2 Performing a measurement A N Note To have accurate results never use stored or accidentally contaminated urine Use only LabStrip U11 Plus strips with HandUReader If your Hand U Reader has already been set up for normal operation you need to follow the instructions listed below no 1 9 if not follow the instructions listed in chapters 4 1through 4 4 1 Have the urine test sample tubes prepared 2 Enter Patient ID by using the Meas SetID sub menu if your working system needs it see chapter 4 5 1 for details 3 Press the Start control button on LCD The strip holder tray opens automatically 4 Dipa test strip into the urine sample for 2 sec and then remove the excess urine from strip by teasing its edge on the test tube rim or on a tissue paper 5 Place the moisturized test strip with the pads up on the strip holder Take care of the strip ending edge to be pushed against the strip bumper 6 Press the Start control button on LCD again The strip holder tray closes automatically and the measuring cycle starts now 7 From this phase test process is controlled automatically by HandUReader if you have previously selected Timer measuring mode see chapter 4 4 2 Results are stored and they will be printed out by default In Timer measuring mode default
10. becsean haute meenneneme ake 8 dda PETON AM CASUF CINCH i ar T T E tek aha ea eter e aerate 8 4 6 MEMORY DATA MANAGE MEINE lt hisereaicact ost avaepiuiwd Bacbuee de baieau bla tubvapnansedethonubeeeeonae det ateauesmenetsthatuadeeven seins tueee 9 L bls ROSUL PIOU ari are ae thie adits satin aR eS olin Ah oat OS E cM cae keh nals kas el Uae aio na teed ene Amn as 9 402 E T SCHAING 10 HOSE COMPULCR sets te estahet cc meee nes eatie eet eh outa au toate he E te ehoate tue cs 10 4 6 3 Enter Patient ID for a memory PrecOrd 10 4 6 4 Clearing test data JV OM MCINOTY L 10 4 7 TOE PRUNE RSS DA ON oen a T e R O E T E T 10 4 8 Poe SE R Eie esata td aa eens Bad alta ead T A 10 3 IVEATINTEEENANCE saantia E EEEE EE EEE N E E 11 6 ERROR MESSAGES AND TROUBLESHOOTING sesesessssssscccsesssssocccccesssoccccsssssosoooccecesssooocesesssssocessssesssooee 11 Ta TECHNICAL PEA TURES visas ssestecesscsiratuctuctestiniaresteutacdstiscuet a e r a 12 3 PACKING LIS cri e i a r e e E OE EEE Eai 12 Dic SYMBOLS conseua E E E EE 12 10 APPENDIN iror O EE E die tadeoveaes 13 11 MANUFACTURER S WARRANTY cusoon eoat da aan a ea ai eaa iS 14 Warning Important precautions to users Read this before using the equipment Always read and follow the instructions described in this manual and in the LabStrip U11Plus manual Never use the equipment power adapter or test strips others than are shipped or supplied by the manufacturer or its accredited distr
11. caused by individual handling habits of the user or different light conditions may happen Urine analyzer urine strip reader equipments are designed specifically to improve accuracy and security of urine strip evaluation by using light and photometric reader in order to detect the colour changes on test strips The analyzers also help in test data handling and report generation by offering data storage and automated data processing features in medical laboratories 1 2 Test strips Good quality dry reagent urine multi strips are the basis of urine analysis These strips have separated pads for each tested parameter A pad contains certain chemicals which develop colour changes reacting with the tested parameter according to its concentration in urine HandUReader is working with LabStrip U11Plus urine multi strips which provide accurate results Tested ingredients are as follow Billirubin Urobilinogen Ketones Ascorbic Acid Glucose Protein Blood pH Nitrite Leucocytes Specific Gravity 2 Description of HandUReader printer station HandUReader is designed for urine dipstick reading The equipment includes two main functional Units portable battery operated Reader Unit for urine analysis bench top AC powered Printer Station docking the portable Reader Unit and providing the printed report reader unit Figure 1 Parts of HandUReader LCD Serial Comm cable socket The Reader is menu driven so the opera
12. data of the prior selected memory range will be printed out in clinically meaningful see chapter 4 3 1 units by the built in thermo paper printer with a speed of 2 lines per sec A N Note The printer is operating only 1f it is connected to mains 4 8 The Serial port The HandUReader serial communication protocol offers two options either the PC Unidirectional protocol when upon a Start signal the selected data of the test measurement is sent to the receiver computer or Network protocol can be used You can select the communication protocol in the Menu Setup Serial sub menu By checking the BI ID field you can determine whether the uploaded serial data should be identified by Patient ID or by Sequence ID In this sub menu you can also disable all serial data flow and the printer as well 10 Note Use only the serial port on the Reader Unit for uploading your data to host PC The serial port on the Printer station is an input for manufacturer calibration If you uncheck the Enable field no test result will be printed out neither will be sent through serial port In this case you can only study test results on LCD screen PC unidirectional protocol does not apply control sum checking When sending uploading result data to a computer the HandUReader needs to be connected to the host computer PC via interface cable included and the serial output line needs to be enabled 5 Maintenance Cleaning To keep your
13. g ends with indication of malfunction an error message will be displayed Below you can find the list of error messages and suggestions how to eliminate them Error message Action to be done 1 Tray moving error check the tray opening route 2 Memory is full clear some memory addresses 3 Battery low recharge the batteries 4 Netw comm error check the serial com synchronism 5 Serial disabled enable the serial output 6 There is no strip load a strip into the strip holder 7 Remove the strip remove the strip from holder 8 Wrong calibr code re enter valid calibr Code 9 Expiry date error enter valid calibration code 10 Is not meas number enter valid calibration code 11 Need calibration code enter valid calibration code Note If you cannot solve a problem or you experience malfunctioning not listed above please contact your distributor immediately 11 7 Technical features technology colour image processing detection CCD image processing max throughput 50 strip hour memory last 200 results display touch screen LCD printer 57 mm thermal printer 2 lines sec size 480 x 290 x 165 mm weight 850 gr external power adapter 7 5 VDC 1 5A Interfaces RS232 serial port Op temperature 15 30 C Relative humidity 20 80 8 Packing list HandUReader equipment l pC Power adapter with power cord l pe Rechargeable battery 3 pcs Strip tray l pC Serial communication cable l pC Printer paper l pe Instructions for Use l pe 9 Sy
14. he requirements raised by medical professionals Measuring output is up to 50 test strip evaluations per hour 3 Installation Important Check the packing list section 8 if the shipment is complete If it is complete follow the instructions below otherwise please contact your distributor immediately HandUReader is shipped in card board box Prior to unpacking clear the area where the instrument is to be operated a 30 x 50 cm size table will be needed Please take care of shipping marks on the box while handling Open the box Cut the tape only leave the carton material intact It is recommended to keep the packaging materials for a while Prepare the accessories power adapter the rechargeable batteries and printer paper Check also the packing list 1f the shipment is complete see section 8 If it is complete follow the instructions below otherwise please contact your distributor immediately Place HandUReader to its working position cover plate rechargeable batteries Remove the Reader Unit from its docked position find its battery holder on the bottom and remove the cover plate and load the batteries included as shown on figure 3 Reconnect the Reader Unit to its docked position Using the standard RS232 serial cable included connect the Reader Unit s serial port see figure 2 to your computer s serial port if you want to upload and collect data in a database Connect power adapter first to DC socket on
15. ibutors Never use IVD products either if their expiration date is over or if the product is damaged Always follow the storage shipment installation and operational instructions indicated on both the packaging material and in the users manual Before installing the equipment always consult with a qualified health care professional in order to avoid malfunction or misrepresentation of the measurement results The equipment provides the accuracy specified in its technical features only under the required and permanently maintained operational temperature range 15 30 C If there is a significant difference in temperature between the place where the equipment was stored and the place where you would like to operate it wait 20 30 minutes before starting measurements with the instrument The equipment s changing temperature may influence test result 1 Introduction 1 1 Methodology of urine testing ci The urine analysis is part of the medical diagnosis methods frequently used by medical doctors in laboratories in order to reveal diseases The most cost effective device used to screen urine is paper or plastic dipstick This micro chemistry system has been available for many years and allows quantitative and semi quantitative analysis within one minute by simple but careful observation The colour change occurring on each segment of the strip is compared to a colour chart to obtain result However misreading or misinterpreting of results
16. lected limit can be hee adjusted with the help of the UP and nora DOWN arrows The lower limit can not be neg higher than the upper limit therefore HE E a re pr 5 increasing the minima will increase the neg ne maxima also and decreasing the maxima ae L JA will decrease the minima as well if their value was the same The selected range can be printed out by pressing PRINT Figure 10 Selecting a memory range for printing For example on figure 10 39 is the minima and 41 is the maxima of the printed range Therefore by pressing the PRINT button three records will be printed out 39 40 41 4 6 2 Data sending to host computer In the Memory Send sub menu you have the possibility to send the records of a selected memory range to a host computer In memory send function the selected range of measurement data located in the selected range of memory addresses will be sent to the receiver serial port on a preprogrammed speed Refer section 4 6 1 for details about setting the memory range to be sent For setting the parameters of the serial port see section 4 2 2 A N Note You can enter a new patient ID or modify an existing one for a selected memory record both in Memory Print and in Memory Send sub menu with the Set ID function button 4 6 3 Enter Patient ID for a memory record You can enter a new Patient ID or modify the old one for an existing memory record Enter the Memory Print or the Memory Send sub menus and cho
17. mbols In vitro diagnosticum A Warning ci Information inside SN Serial number aaa Manufacturer Biological risks 12 10 Appendix Appendix A The menu structure DISPLAYING LOGO ON LED Ea PLAUTO E SE 2 STRIP ON HOLDER T InSUCHOr executan START TMED 60 TIMER MODE REASURERE NT enabled E o gt Appendix B Results Table LabStripU 11Plus Bilirubin Conv neg l 2 4 mg dl Bil SI neg 17 35 70 umol l robilinogen Conv norm 2 4 8 12 mg dl bg SI norm 35 70 140 200 umol I Ketone Conv neg 15 50 150 mg dl Ket SI neg Es 5 15 mmol l sc Acid Conv neg 20 40 mg dl SC SI neg 0 2 0 4 g l Glucose Conv norm 50 150 500 1000 mg dl Glu SI norm 3 10 30 50 mmol l Protein Conv neg 30 100 500 mg dl Pro SI neg 0 3 l 5 g l Blood Conv Neg ca 5 10 50 300 Ery ul H Conv SI 5 6 q 8 9 itrite Conv SI neg pos Leukocytes Conv SI neg 25 FE 500 Leu ul Spec Grav Conv SI 1 000 1 005 1 010 1 015 1 020 1 025 1 030 1 035 13 11 Manufacturer s warranty 77 Elektronika Ltd warrants HandUReader against defects in materials and workmanship for a period of one year from the date of purchase The warranty ceases to apply if the instrument has been misused poorly maintained or tampered with Liability under this warranty is limited to the repair of defective parts or at the discretion of 77 Elektronika Ltd to the issue of a replacement instrument A right
18. ose a data record by adjusting the minima of the memory range see figure 10 After pressing the Set ID button you can enter a new Patient ID for the selected record or you may also modify an existing one Use the key pad for typing the Patient ID and store it by pressing the OK button 4 6 4 Clearing test data from memory All data in the memory or only a specified record can be deleted in the Memory Clear sub menu Upper limit of storage place is 200 records The memory address s lower and upper limits can be set by using the UP and DOWN arrows in top right corner of the LCD refer section 4 6 1 for details about setting the memory range to be cleared After setting the limits of the memory range that should be erased press the CLEAR button The address pointer returns to lower address of the field after execution of the memory clear function By pressing CLR ALL button all existing records in the memory will be cleared 4 7 The Printer Station The Printer Station connects the equipment to mains voltage and also provides power supply for the Reader Unit while it is placed in its basic position If you would like to send measurement data either to the printer or to a computer via serial communication output first make sure the Reader Unit is connected to the Printer Station Data communication 1s executed through infrared IR transmission line either docking the Reader Unit or holding it in a visible distance from the Printer Station Test
19. pad name is selected by pressing CHOOSE the previously selected pad name will be the first in the left column and at the same time it will be removed from the list on the right Now you can choose one pad again from the pads remaining in the right column to be next in line in the left column which will be the new sequence of pads on printouts Repeat this procedure until the new sequence of pads is compiled in the left column and there are no pads in the right column Pressing the OK button stores the changes and the program automatically returns to main menu 4 4 The service menu options Menu Service 4 4 1 Calibration Entering encoded test strip related information allows HandUReader to control the measurement process precisely This coded information describes the strip lot expiry date lot number and maximum counts of measurements being allowed with the given calibration When opening a new vial of strips select the Menu Service Calibration sub menu from the menu system Find the Calibration Card in the strip package and enter its code numeric digits using the touch screen see figure 9 URINALYSIS 9 39 MENU SERVICE CALIBR Code HandUReader 0002760131444446 Figure 9a Example of HandUReader Calibration Card Figure 9b Entering the calibration code Figure 9 Calibrating HandUReader after opening a new vial of strips Note A A The calibration is needed for the proper operation of the reader
20. tions for each pad On figure 7 you can see the display showing the default setting for sensitivity You can change the sensitivity of each pad separately At one time you may only 6 change the sensitivity of the selected pa with the help of the UP and DOWN control buttons When the desired sensitivity value of the prior selected test pad appears then by pressing the NEXT button the newly selected value is set After the last pad adjustment is over by pressing the OK button changes will be stored and the program will automatically return to main menu q URINALYSIS 9 37 0 MENU STRIP SENSITIVITY U seccessesst Figure 7 Setting pad sensitivity T Note When the reader is adjusted different from manufacturer setting it will be indicated by asterisks in the footer of the printout 4 3 3 Setting the pad sequence in printout Select Menu Strip Padseq sub menu to change the pad sequence in printout Entering this function menu the left column on the LCD indicates the actually set pad sequence while the list of pads on the right offers the pads to be selected in default sequence Figure 8 depict the display showing the default setting of this function menu URINALYSIS 9 35 54 MENU STRIP PADSEQ L BIL BG 1 2 3 4 5 6 7 8 9 0 1 Figure 8 Changing the pad sequence You can select one of the pad names from the list on the right with the help of the UP and DOWN control buttons When the desired
21. tor needs first to set up the Reader Unit according to the operational conditions with the help of functional menus then only to feed the me Power on button equipment by placing the moisturized test strip on the holder the rest reading evaluating the strips is done automatically by the device DC power in sockel test strip holder Figure 2 The Reader Unit The urine test strip containing chemical reagents 1s positioned under the reader s sensor After the pads colours have been evaluated the strip should be discarded by the operator Timing controlled by the device is adequate to the needs of chemical reactions time about 60 seconds HandUReader works by reflectance photometer method Inside the reader the strip is illuminated by white light and the light reflected from the strip is detected by a colour CCD sensor The RGB signals are digitalized by analogue digital conversion The digitalized image is processed by built in program it locates the pads then based on the reflected light wave information the urine component parameter values as the result of evaluation will be calculated The results together with the actual date time and patient ID are stored and can be printed out by connecting the reader to the Printer Station The equipment is designed specifically for professional use In basic installation the Reader Unit and the Printer Station is connected Its physical design including colour meets t
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