User Manual - Frank`s Hospital Workshop
Contents
1. Figure 4 Loading the printer paper N Note After installation check whether the instrument is operating accurately User Manual COMBILYZER Plus 7 22 4 OPERATION GUIDE 4 1 Control Menu System The operation and functions of the COMBILYZER Plus can be viewed in the menu system chart see Appendix Each selected menu allows the user to control one of the operational or setup functions For a detailed explanation of the submenus please see the detailed descriptions in following chapters Pressing the QUIT button will return to main menu The OK button is used to enter the edited data and quit the function 4 2 Setup Procedure Menu Setup 4 2 1 Setting the Clock Select Menu Setup Clock in the menu to set date and time see figure 5 By pressing the UP and DOWN function keys the parameters inside the frame can be set To go on to the next parameter press the NEXT button By changing the SEQ parameter the date display mode can be set from Month Day Year to Year Month Day or Day Month Year When all the parameters are set save the changes and return to the main menu by pressing OK Figure 5 Clock setting 8 22 User Manual COMBILYZER Plus f Human 4 2 2 Setting Serial Output Port The serial output port can be set in the Menu Setup Serial menu see figure 6 If enabled the instrument is programmed to communicate with a host computer in two ways either PC unidirectional or network mode Choose be2. Plus 0002760131444446 Figure 9a Figure 9b Example of COMBILYZER Plus Entering the code Calibration Card Note Always remember to enter the code when opening a new pack of strips 12 22 User Manual COMBILYZER Plus f Human 4 4 2 Selecting Measuring Mode The COMBILYZER Plus can be operated in two different modes In Timer mode the instrument 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 In the Menu Service Mode submenu it is possible to toggle between Fast N mode and Timer mode Warning When performing serial measurements in Fast mode allow the strips to react for approximately 55 seconds before inserting them into the COMBILYZER Plus and pressing Start If the reaction incubation time is too short or too high false results my be obtained Refer also to the package insert of the COMBINA 11S test strips 4 5 Measurement 4 5 1 Setting Patient ID for Measurement A measurement can be identified by assigning a Patient ID to it The Patient ID can be entered before starting the corresponding measurement or it is also possible to enter the Patient ID later in the Memory submenus see chapter 4 6 3 for details To assign a Patient ID for the upcoming measureme
3. strip should be discarded by the operator The testing corresponds with the reaction time of the chemical reagents about 60 seconds The COMBILYZER Plus works using the reflectance photometry 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 digitised using analogue digital conversion The digitised image is processed by a built in program it locates the pads and based on the reflected light calculates the results The results together with the current date time and patient ID are 4 22 User Manual COMBILYZER Plus f Human stored and can be printed out by connecting the reader to the Printer Station The instrument is designed specifically for in vitro diagnostic professional use and to meet the requirements of medical professionals The measurement capacity is up to 80 test strip evaluations per hour User Manual COMBILYZER Plus 5 22 3 INSTALLATION The COMBILYZER Plus is shipped in a cardboard box Prior to unpacking clear the area where the instrument is to be operated a 30 x 50 cm size space will be needed Please note the 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 Prepare the accessories power adapter rechargeable batteries and printer paper Place COMBILYZER Plus in its
4. the COMBILYZER Plus needs to be connected to the host computer PC via the interface cable included and the serial output line needs to be enabled User Manual COMBILYZER Plus 17 22 5 MAINTENANCE Cleaning To keep your COMBILYZER Plus in perfect condition never leave used strips in the strip holding tray The COMBILYZER Plus checks the tray before switching off and opens it to remind the user when there is a strip left inside The only required maintenance activity is to rinse and wipe out the strip holder with a dry cotton cloth each day before switching off the instrument Warning Since urine is a fluid of human origin biological risks cannot be ruled out Handle used strips and urine contaminants with care Battery recharge The COMBILYZER Plus s portable Reader Unit is powered by 3 AA size rechargeable batteries Their fully charged capacity is sufficient for about 300 test measurements sufficient for about a half year of operation The Portable Reader Unit operates on batteries only in stand alone mode Docking it with the Printer Station will recharge the batteries The Reader Unit can also be powered by connecting the power adapter directly to its socket If batteries are discharged the instrument cannot be switched on When batteries are low a Battery low message appears on the LCD In case the screen hasn t been touched for a while the COMBILYZER Plus will shut down to save energy after 2 5 minutes if operated on b
5. the right shows the pad to be selected in default sequence Figure 8 depicts the display showing the default settings of the pad sequence function menu URINALYSIS MENU STRIP PADSEQ 1 2 3 4 5 6 7 8 9 0 1 i Figure 8 Changing the pad sequence Pad names can be marked in the list on the right with the help of the UP and DOWN control buttons When the desired pad name is marked select it by pressing CHOOSE The selected pad name will be removed from the list on the right and appear in the first position in the list on the left The next pad can now be chosen from the list of remaining pads on the right following the same procedure Each succeeding pad will appear in the list on the left one position lower until there are no more pads left in the list on the right Store the changes and return to main menu by pressing the OK button User Manual COMBILYZER Plus 11 22 AN 4 4 Service Menu Options Menu Service 4 4 1 Code Card Entering encoded test strip related information allows the COMBILYZER Plus to control the measurement process precisely This coded information describes the maximum number of measurements being allowed with the given code When opening a new vial of strips select the Menu Service Calibration submenu from the menu system Find the Calibration Card in the strip package and enter its code see figure 9 URINALYSIS 9 39 MENU SERVICE CALIBR Code OOO2760131444446 COMBILYZER
6. User Manual COMBILYZER Plus N Human CONTENTS 1 INTRODUCTION 1 1 Methodology of Urine Testing 1 2 Test Strips 2 DESCRIPTION OF COMBILYZER PLUS 3 INSTALLATION 4 OPERATION GUIDE 4 1 Control Menu System 4 2 Setup Procedure Menu Setup 4 2 1 Setting the Clock 4 2 2 Setting Serial Output Port 4 2 3 Setting the Language 4 3 Strip Setup Options Menu Strip 4 3 1 Setting Measurement Unit 4 3 2 Setting the Sensitivity Attribute of the Image Processing Program 4 3 3 Setting Pad Sequence in the Printout 4 4 Service Menu Options Menu Service 4 4 1 Code Card 4 4 2 Selecting Measuring Mode 4 5 Measurement 4 5 1 Setting Patient ID for Measurement 4 5 2 Performing Measurement 4 6 Memory Data Management 4 6 1 Result Printout 4 6 2 Sending data to Host Computer 4 6 3 Enter Patient ID for Memory Record 4 6 4 Clearing Test Data from Memory 4 7 Printer Station 4 8 Serial Port 5 MAINTENANCE 6 ERROR MESSAGES AND TROUBLESHOOTING 7 TECHNICAL FEATURES 8 PACKING LIST 9 SYMBOLS 1 0 APPENDIX O O000X00X00 AOD AUU W ma This page left blank 2 22 User Manual COMBILYZER Plus f Human 1 INTRODUCTION 1 1 Methodology of Urine Testing Urinalysis is one of the medical diagnosis methods frequently used by medical doctors in laboratories in order to reveal diseases This micro chemistry system has been available for many years and allows qualitative and semi quantitative analysis within one minute by simple but caref
7. atteries and after 5 minutes if connected to mains 18 22 User Manual COMBILYZER Plus f Human 6 ERROR MESSAGES AND TROUBLE SHOOTING The control program checks the operational conditions needed for proper execution of the instrument s functions If the check ends with the indication of a malfunction an error message will be displayed The list of error messages below includes suggestions on how to eliminate problems Error message Action to be done 1 Tray moving error check the tray opening path 2 Memory is full clear some memory addresses 3 Battery low recharge the batteries 4 Netw comm error check the serial com synchronisation 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 a valid calibration code 9 Expiry date error 10 Is not meas number 11 Need calibration code enter a valid calibration code enter a valid calibration code enter a valid calibration code Note If a problem cannot be solved or a malfunction is experienced that is not listed above please contact your HUMAN distributor immediately User Manual COMBILYZER Plus 19 22 7 TECHNICAL FEATURES Technology colour image processing Detection CCD image processing Max throughput 50 strips hour Memory last 200 results Display touch screen LCD Printer 57 mm thermal printer 2 line
8. he following way first make sure the Reader Unit is connected to the Printer Station Data communication is executed through the infrared IR transmission line either docking the Reader Unit or placing it in a direct sight line with the Printer Station Test data of the previously selected memory range will be printed out on the built in thermo paper printer at a speed of 2 lines per sec N Note The printer will operate only if it is connected to mains 4 8 Serial Port The COMBILYZER Plus 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 the communication protocol can be selected in the Menu Setup Serial submenu By checking the BI ID field it can determined whether the uploaded serial data should be identified by patient ID or by sequence ID In this submenu all serial data flow and the printer itself can be disabled Note Use only the serial port on the Reader Unit for uploading data to the host PC The serial port on the Printer Station is an input only for manufacturer calibration If the Enable field is unchecked no test result will be printed out or sent through serial port In this case test results can only be viewed on the LCD The PC unidirectional protocol does not apply control sum checking When sending uploading result data to a computer
9. mory Print and Memory Send submenus with the Set ID function button 4 6 3 Enter Patient ID for Memory Record New patient IDs can be entered or a existing IDs modified Enter the Memory Print or the Memory Send submenu and choose a data record by adjusting the low limit of the memory range see figure 10 After pressing the Set ID button a new patient ID for the selected record can be set or an existing ID can be modified Use the key pad to enter 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 specific record can be deleted in the Memory Clear submenu The maximum number of stored records is 200 The lower and upper limits of the memory address 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 the next lower address field after execution of the memory clear function By pressing CLR ALL button all existing records in the memory will be cleared 16 22 User Manual COMBILYZER Plus f Human 4 7 Printer Station The Printer Station connects the instrument to the mains voltage and also provides power for the Reader Unit if it is docked Sending measurement data either to the printer or to a computer via serial port can be done t
10. nt press the Set ID button in the Meas submenu Use the key pad displayed on LCD to type in the Patient ID and store it by pressing the OK button The results of the measurement will be stored under the Patient ID 4 5 2 Performing Measurement Note To have accurate results never use urine that has been stored for a longer period of time or contaminated Use only COMBINA 11S strips with the COMBILYZER Plus Refer also to the package insert of the COMBINA 11S test strips User Manual COMBILYZER Plus 13 22 lf your COMBILYZER Plus has already been set up for normal operation please follow the instructions listed below no 1 9 if not follow the instructions in chapters 4 1through 4 4 eel Prepare the urine test sample tubes Enter the Patient ID by using the Meas SetID Press the Start button on the LCD The strip holder tray opens automatically Dip a test strip into the urine sample for 2 sec and remove the excess urine from strip by drawing its edge across the rim of the test or blotting it on a paper towel Place the moistened test strip with the pads facing up on the strip holder Make sure that the leading edge of the strip is pushed against the stop Press the Start button on the LCD again The strip holder will close automatically The device will check if there is a strip on the strip holder and if so the strip holder case will open half way to allow the strip to evaporate freely When the incubation time is over the
11. operating position Remove the Reader Unit from its docked position locate its battery holder on the bottom remove the cover plate and load the batteries included as shown in figure 3 Reconnect the Reader Unit in its docked position Using the standard RS232 serial cable included to connect the Reader Unit s serial port see figure 2 to the computer s serial port if you intend to upload data to an external device i e Computer Connect the power adapter first to the DC socket on the reader then to the mains Switch the COMBILYZER Plus on by pressing the Power On button In a few seconds the HUMAN logo will appear on the LCD followed by the main menu which offers the Memory Meas Menu options cover plate rechargeable batteries Figure 3 Installation of the batteries 6 22 User Manual COMBILYZER Plus A 7N Human Note If during power on process the user keeps any part of the LCD pressed touched the boot up process will be interrupted and the system information can be viewed serial number software version etc After releasing the screen the boot up process will continue Take a roll of printer paper and load it into the printer paper holder see fig 4 Insert the paper into the paper feeder slot and close the cover plate The printer paper will be feed automatically to its start position Now the COMBILYZER Plus is ready to operate using the Main Menu options see chapter 9 all d AR
12. or by directly marking the field near the desired unit type Store the changes and return to main menu by pressing OK 4 3 2 Setting the Sensitivity Attribute of the Image Processing Program Select the Menu Strip Sensitivity menu to adjust the sensitivity Measurement sensitivity in the program can be adjusted on two levels in both directions for each pad In figure 7 the display shows the default setting for sensitivity The sensitivity change of each pad can be adjusted separately Only one selected pad sensitivity can be changed at one time with the help of the UP and DOWN control buttons When the desired sensitivity value of the previously selected test pad appears the newly selected value is set by pressing the NEXT button After the last pad adjustment is complete store changes and return to the main menu by pressing the OK button URINALYSIS 9 MENU STRIP SENSITIVITY 2 Figure 7 Setting pad 37 07 mi x zi Note When the reader has been adjusted to settings different from the standard HUMAN settings this will be indicated by asterisks in the footer of the printout 10 22 User Manual COMBILYZER Plus 7N Human 4 3 3 Setting Pad Sequence in the Printout Select the Menu Strip Padseg submenu to change the pad sequence in the printout In this function menu the left column on the LCD indicates the previously set pad sequence while the list of pads on
13. s sec Size 480 x 290 x 165 mm Weight 850 g External power adapter 7 5 V DC 1 5A Interfaces RS232 serial port Op temperature 15 30 C Relative humidity 20 80 8 PACKING LIST COMBILYZER Plus instrument 1 pc Power adapter with power cord 1 pc Rechargeable battery 3 pcs Strip tray 1 pc Serial communication cable 1 pc Printer paper 1 roll User manual 1 pc 20 22 User Manual COMBILYZER Plus f Human 9 SYMBOLS according to EN 980 In vitro diagnostic medical device Warning Information inside Serial number ESR Manufacturer User Manual COMBILYZER Plus 21 22 10APPENDIX The Menu Structure SUTEHNG ON DISPLAYING LOGO ON LCD STRIP SERVICE SETUP SET NER SET SET AAEM ADDR RANGE ADDR RANGE ADDR RANGE edition LANGU SETTING CALBRATION CLOCK CODE SETTING SERIAL SETTING instruction execution TINED 665 MEASUREMENT performing PRINT y enabled 22 22 User Manual COMBILYZER Plus Human Gesellschaft f r Biochemica und Diagnostica mbH Max Planck Ring 21 e D 65205 Wiesbaden Germany Telefon 49 6122 9988 0 Telefax 49 6122 9988 100 eMail human human de Internet http www human de 02 2005 05
14. splayed in the top right corner see figure 10 They can be selected simply tapping them The selected limit can be adjusted with the help of the UP and DOWN arrows The lower limit can not be higher than the upper limit therefore increasing the low limit will increase the high limit and decreasing the high limit will decrease the low limit if the value was the same The selected range can be printed out by pressing PRINT f Human minima maxima of printed range of printed range 2004 06 11 19 16 ID MR SMITH BIL UBG KET ASC GLU PRO ERY pH NIT LEU neg norm neg neg norm neg neg 5 neg neg SG 1 0800 Figure 9 Selecting a memory range for printing For example on figure 10 the low limit is 39 and 41 is the high limit of the range to be printed Pressing the PRINT button will therefore print three records 39 40 41 User Manual COMBILYZER Plus 15 22 4 6 2 Sending data to Host Computer In tne Memory Send submenu it is possible to send records from the memory to a host computer The selected range of measurement data located in the selected range of memory addresses will be sent to the receiver serial port at the pre programmed speed Refer to 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 Note Entering a new patient ID or modifying an existing one for a selected memory record is possible both in the Me
15. strip holder will close again and the measuring cycle will start From this step on the test process is controlled automatically by the COMBILYZER Plus if the Timer measuring mode has been previously selected see chapter 4 4 2 Results are stored and will be printed out by default In Timer measuring mode default a measuring cycle lasts around 60 seconds from pressing the Start button To get the results in printed report form the printer has to be enabled in advance see chapter 4 8 The Reader Unit should be docked or be short distance from Printer Station To start a new measuring cycle place a new strip on the strip holder and touch the Start button Quit operation is accepted in such case only if there is no strip left in the strip holder otherwise the device will continue to display a warning message until the used strip has been removed When you are finished working with the COMBILYZER Plus press the Quit button in main menu After asking for confirmation of your request the instrument will shut down automatically If the instrument is left without input it will shut down automatically after 2 5 minutes if operated on batteries and after 5 minutes if connected to mains 14 22 User Manual COMBILYZER Plus 4 6 Memory Data Management 4 6 1 Result Printout Enter the Memory Print submenu to print out records stored in the memory A range of stored records can be selected for printing The limits of the selected range are di
16. tween the two protocols with the UP and DOWN buttons or by directly selecting the circle next to the desired protocol In network mode information is sent in blocks The blocks are arranged either by sequence number Seq Nr or by patient ID Figure 6 The serial setup menu set by the user in advance by selecting or unselecting the B1 ID identifies the result reports The standard mode setting is 9600 Baud 8 bits with 1 Stop bit and no parity Other options can not be programmed For more information on the serial port refer to section 4 8 Note By disabling the serial port the printer will be disabled too In this case the test results will appear only on the display 4 2 3 Setting the Language Select the Menu Setup Language menu to set the language The instrument is programmed to communicate with the user in the following languages English German or Hungarian The language can be selected with the UP and DOWN buttons or by directly marking the field next to the desired language Store the changes and return to main menu by pressing OK User Manual COMBILYZER Plus 9 22 A 4 3 Strip Setup Options Menu Strip 4 3 1 Setting Measurement Unit The Menu Strip Unit menu allows the measurement units of the test results to be selected for printed reports and the LCD Options are Conventional Sl Arbitrary Conventional Arbitrary SI Arbitrary The units can be selected with the UP and DOWN buttons
17. ul observation The colour change occurring on each segment of the strip is compared to a colour chart to obtain the result However misreading or misinterpreting of results may happen caused by individual handling habits of different users or different light conditions 1 2 Test Strips The COMBILYZER Plus works with COMBINA 11S urine test strips Tested parameters are as follows Bilirubin Urobilinogen Ketones Ascorbic Acid Glucose Protein Blood pH Nitrite Leucocytes Specific Gravity User Manual COMBILYZER Plus 3 22 2 DESCRIPTION OF COMBILYZER Plus The COMBILYZER Plus is designed for urine test strip reading The instrument includes two main functional units portable battery operated Reader Unit for urine analysis bench top AC powered Printer Station which docks with the portable Reader Unit and produces printed reports Figure 1 Parts of COMBILYZER Plus LCD Serial Comm cable socket The Reader is menu driven so DC power insocket the operator needs to set up the Reader Unit first according to the Power on button operational conditions with the help of the function menus After placing the moistened urine strip on the strip holder the instrument reads and evaluates the strips automatically test strip holder Figure 2 The Reader Unit The urine test strip containing chemical reagents is positioned under the reader s sensor After the pads colours have been evaluated the
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