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Reflotron User Manual - The University of Sydney

1. The data can also be copied directly from the memory by searching for the desired value using the keys shown on the left gt see also Storage and retrieval of results in Section 2 If the test results are not tagged with a patient identification only the respective value is displayed If the memory contains no further value for the respective para meter Reflotron Plus briefly displays NO ENTRY and then returns to the input prompt If a value is found it may be copied into the input line of the risk calculator After this the value has to be confirmed once again Search and copy can be exited at any time In this example the incidence is 8 0 incidence of infarction in per cent over 8 years and the patient s risk factor is increased 1 6 fold compared to people of the same age The risk here may be from to stands for low risk for moderate risk and for high risk After the result of the risk assessment has been displayed various parameters entered can be searched for and changed using these two cursor keys When you return to the result line the new risk values are displayed The calculation is performed using the Friedewald formula The Home key takes you directly back to the first input line The End key takes you directly to the risk assessment display 3 7 Printing out a record PATIENT HAME AH OTHER Export
2. The magnetic code was not completely read Remove the test strip as soon as the message appears insert it again correctly and close the flap once again If the same message appears repeat the test with a new test strip 2 19 os HEHT THTERRU Display of results 2 20 Eis B a T Eisis ED SEDENS HE is HO MAGHETIC CODE Note Keep the Reflotron test strip away from magnetic fields e g paper clip holders magnets magnetic stirrers as these can corrupt or delete the magnetic code This is how ever reliably recognized by the instrument The magnetic code has not been read Reason the test strip has not been inserted correctly In this case take a new test strip and insert it with its mag netic strip facing down wards and its test area at the front If necessary check the transporter and the magnetic head for soiling as described in Section 4 Cleaning and Quality Checking These messages appear if the flap was opened during measurement This stops the measurement and no result is therefore displayed If this happens close the flap remove the test strip and repeat the test with a new test strip Repetition of measurement with the same test strip returns unusable results The instrument displays the result along with the parameter abbreviation and the units In enzyme determinations the reference temperature is also displayed Checking result
3. Calling up the menu With the instrument in the CLOCK PRIHT EEP READY state press the but UNITS STRIPS _2 tons lt and gt simultaneously to call up the menu for indi vidual settings Reflotron Pie wl Use the lt or gt button to position the cursor under BEEP and confirm with J Select the desired frequency pitch or OFF no sound sig nal and confirm with 1 OFF FREQL FREQE Press the buttons lt and gt simultaneously to return the instrument to the measuring mode The Reflotron Plus is now ready to perform an analysis again See also Basic instrument settings in Section 6 Note The sound signal accompany ing important system messages cannot be switched off 2 35 Units and enzyme reference temperature Explanations Calling up the menu i CLOCK PRIHT BEEF UNITS STRIFS DELETE Refotron 2 36 This function is only active if a test has been performed since switching on the Reflotron Plus If this is not the case the mes sage NO PARAMETER appears in the display Only the unit or the temperature of the last parameter deter mined e g cholesterol can be changed The new setting is then valid for all cholesterol determinations performed after the change even if Reflotron Plus is switched off in between Results in this example choles terol which were determi
4. within this subfunction Scrolling in the functions F2 F3 F4 and F6 3 3 Explanation Input Terminating the input El Exit ii Displaying the identification F al 3 4 Entering a patient sample identification Each result can be tagged with a corresponding identification e g the patient s name If a patient sample is to be tested the identification must be entered before testing begins All test results ascertained afterwards are then automatically allocat ed to this identification The identification must be entered or corrected before the first result is displayed Proceed in the same way for each subsequent patient If no identification is required the test results in the memory are marked with consecutive numbers These numbers are not displayed but appear only in the printout of the result Simply start typing The text appears in the display immediately instead of the date and time The whole range of write functions is available for corrections The entry is stored together with the test result as it appears on the display at the time the result is displayed It is not necessary to terminate the input with the key shown on the left Note If the entry is terminated however overwriting of the first character deletes the whole line Date and time again appear in the first line The identification entered is of course preserved and will contin
5. 3 1 General keys Write functions i Zn m T E Letters are written in capitals If 3 symbols are imprinted on the key the upper symbol appears The sign in the lower right corner is printed The numerical block all keys with framed symbols is activated Switching from lower to upper case letters permanently Inserts a space into a series of characters The space may then be replaced by a new character Deletes the character above the cursor Moves the cursor back to the beginning of the line Moves the cursor to the end of the word Space bar produces a space Cursor keys move the cursor one character to the left or right Deletes the character to the left of the cursor Terminates an entry Special keys E aE CARDIAC RISK LDL ACC TO FRIEDEWALD CHOL HDL CHOL RATIO ADDITIONAL TEST INFO CREATININE CLEARANCE LABELING CONTROL MEASUREMENTS TRANSFER PROFILE II TRANSFER PROFILE PRINT PROFILE PRINT DISPLAYED TEXT Note Except for Prt Sc print screen and F7 these functions can only be called up if no test strip is being measured and the instrument is in READY mode Exits the currently activated function or the write mode Selects the subfunction Search and copy and scroll forwards within this subfunction Selects the subfunction Search and copy and scroll backwards
6. 6 15 10 11 12 13 Display Clock Accuracy Precision Linearity Required operating environment Transport conditions Data interfaces Power supply Mains Car battery optional Power consumption 6 16 Over 50 function controls ensure the working safety of the instru ment alphanumeric display 2 lines with 24 characters each LC display battery buffered real time clock 0 5 of the reflectance with respect to the mean for the instru ments delivered lt 0 2 of the reflectance 0 05 deviation Temperature 15 C to 34 C Rel humidity max 95 Temperature 20 C to 55 C when packed Rel humidity 5 to 95 when packed 1 RS 232 C serial interface DB 25 socket 1 keyboard interface 5 pin DIN socket 115 2380 VAC 22 Frequency 47 Hz to 63 Hz Permissible range 10 30 V DC reverse battery protection Permissible internal resistance max 100 mQ Recommended plug Cannon AXR 3 11 Connecting cable max 2 5 m 1 5 mm 45 VA 14 Weight 15 Dimensions 16 Language versions 17 Servicing approx 5 3 kg approx 300 x 350 x 210 mm The user can choose among 6 different languages which can be set by means of the input keys An additional language is possible The service engineer can test all major functions with a keyboard Reflotron Plus makes this work easier by means of service messages The modular design and the possi
7. CARDIAC RISK mardi CARDIAC RISK CARDIAC RISK VEARS CARDIAC RISE SMOKING Maximum and minimum values programmed into the instrument Cholesterol Triglycerides HDL cholesterol Age Syst BP Diast BP The following data are collected Total cholesterol Triglycerides HDL cholesterol mg dl mmol l mg dl mmol l mg dl mmol l mmHg kPa mmHg kPa Sex M male F female Age of the patient Does the patient smoke Does the patient suffer from diabetes mellitus Cardiovascular diseases minimum 130 3 362 1 0 0 011 23 0 595 30 95 0 12 664 10 0 1 333 maximum 340 8 792 400 0 4 572 99 2 56 74 190 25 327 190 25 327 3 9 CARDIAC ECG LUH CARDIAC RISK mmHg CARDIAC RISE Results MULT g g a Printing out a record Exporting a record Explanation 3 10 Left ventricular hypertrophy Systolic blood pressure sphygmomanometric Diastolic blood pressure sphygmomanometric Note The data marked with are meant for documentation purposes only They do not enter into the risk calculation The example on the left shows an incidence of 12 5 incidence of infarction in percent over 6 years The minimum and maximum inci dences range of the sex related age group are listed for better risk assessment The individual risk is elevated by the factor 5 5 over the minimum incidence of the sex relat
8. HO MAGHETIC uo MAGHETIC CODE MISRERD Other possible messages This means that the magnetic code has not been read by the instrument Insert the control strip again with its magnetic strip facing downwards and the test area at the front This means that the magnetic code has not been read fully by the instrument Insert the control strip with its grey area at the front If the same message appears again discard the strip and take a new one This indicates that the grey area has been scanned and its reflectance measured at the three measuring wavelengths The result is displayed Check the three results against the three ranges printed on the label to see if the optical system is working accurately If one or more of the three results obtained lie outside the specified range repeat the measurement with a new con trol strip If this also gives one or more results lying outside the specified range proceed as described under Cleaning and Quality Checking See also Reflotron Clean Check pack insert Opening the measuring chamber and removing the strip A Example The first figure displayed is 638 Comparison with the minimum and maximum printed on the label shows that the value lies within the confidence range The optical system is working reliably The result remains displayed until the flap is opened Lift the flap and remove the strip if necessary push the release l
9. LED 1 7 ae Result se who y l Surface of test area 2 A light emitting diode 1 flashes light of a defined wavelength onto the surface of the test area 2 The light that strikes the strip is reflected by the surface with varying intensity depending on the colour of the test area 6 1 6 2 The light beam emitted by an LED in the Ulbricht sphere is reflected several times by the white inside wall so that the light is diffusely dis tributed in the sphere Two photodiodes symmetrically positioned in the Ulbricht sphere serve as light detectors a sample photodetector D and a reference photodetector D The reference detector meas ures the intensity of this diffuse light while the sample detector meas ures the intensity of the light diffusely reflected by the test area and weakened through absorption by the indicator The ratio of the two intensities is proportional to the reflectance R The electrical signals from the detector are carried to an analog to digital converter 4 which converts the analog signals into digital values The reflectance is calculated in the microprocessor The concentration or activity of the test performed is then determined mathematically from the measured reflectance This is done using a test and lot specific function stored on a mag netic strip on the back of each test strip and transmitted to the instru ment automatically when the test strip is inserted The general formula for the
10. Next the date the time shown here and MXX XX CXX XX will appear MXX XX CXX XX is coded information for the cus tomer service staff e g MO6 17 C06 02 If the instrument does not dis play the correct date and or time they can be adjusted See Individual settings in Section 2 for appropriate instructions The next step is warming up iii ANOS the duration of which depends on the inside temperature of the apparatus The time remaining until the system is ready for analysis is displayed at intervals of 1 sec 2 3 2 4 If the messages appear in the wrong language e g Ade REFLOTREON PRONTO or the time is not displayed in the desired format e g please see Basic instrument settings in Section 6 for infor mation on how to make the necessary adjustments Our customer service staff will be glad to help you change the settings Sometimes a different message appears instead of Ready This means that a test strip or control strio has been left in the measuring chamber In this case open the flap and remove the strip If you find that the measuring chamber is empty push the release lever upwards Close the flap Clean the measuring chamber and subsequently check the performance of the optical sys tem Please refer to Section 4 Cleaning and Quality Checking for the appropriate instructions 2 5 Printer 2 6 Standby function Re
11. a rotor suitable for the kind of tube used and centrifuge If nec essary use a Suitable insert for the centrifuge Observe the instructions given by the manufacturer of the centrifuge and the respective safety warnings Using the plasma Reflotron test Dispense the sample directly from the supernatant Ma h After centrifuging use the plasma immediately for the respective h p EM ij using the Reflotron Pipette If you do not wish to perform the determination at once the plasma has to be separated from the sediment For the use and storage of the plasma sample refer to the stability data for the respective parameter in plasma Storage and retrieval of results Reflotron Plus stores up to 60 results including the date and time of the respective measure ment and the patient sample identification If more than 60 measurements have been taken the oldest result is automatically deleted The values remain in the memory when the Reflotron Plus is switched off For deletion of results from memory see Individual settings in Section 2 2 29 Retrieval of results k Rellatros PR PA ss ajiaji ii ae a v d ic a i 2 30 When the Reflotron Plus is READY the results can be retrieved from memory Press the enter button 1 to retrieve the last value meas ured Then press the cursor button lt one or more times to see the preceding values
12. appears for only 2 seconds It was not possible to allocate the record transmitted to the computer system Important This display appears for 2 seconds only and only if permitted by the com puter software Check the measuring system with Reflotron Check gt Section 4 Cleaning and Quality Checking Repeat the test with prediluted urine 1 20 and repeat the cal culation of the creatinine clear ance Action Choose a better location for the instrument or lower the room temperature Check for obstruction of vents and fan outlet at the bottom of the instrument Allow the instru ment to cool down before switching it off Choose a better location for the instrument or raise the room temperature Let the instrument warm up while switched on Contact service staff Check cable Make sure that computer is ready to receive data Check the setting of the inter face Check patient identification DATA TRANSFER ERROR ERROR No display and green control lamp not illuminated The data transfer to the com puter was faulty Important This display appears for only 2 seconds Numerical errors have occurred No power supply or instrument out of order If the suggested corrective measures have no effect or if the fault occurs repeatedly please contact your nearest Roche Diagnostics subsidiary for advice Action see Section 6 Operation with RS 232 interface Switch th
13. cholesterol calculation Mains voltage Measuring chamber Measuring principle Memory Results storage of 3 14 2 17 2 26 6 3 2 12 2 24 6 6 6 7 6 10 1 7 3 3 18 6 4 3 10 1 3 6 16 4 1 6 1 2 29 7 1 1 2 Operating parts Paper feed Patient identification Pipette Power supply Printer Printer paper Printer ribbon Printer setting Printing patient profiles PROCAM Profile transfer Release lever Required values Results deletion of Results retrieval of Retrieving results Risk calculator Sample identification Search and copy Site Software Sound signal Standby mode Strip counter Technical data Temperature setting Tests Time setting Ulbricht sphere Units setting Warming up time Workstation fold out section 6 8 6 9 3 4 2 18 2 17 1 3 1 4 1 6 2 6 6 9 1 6 6 9 1 6 6 9 2 34 6 8 3 22 3 5 3 19 2 5 2 10 4 4 4 6 2 39 2 30 3 5 6 8 3 4 3 7 1 2 6 3 2 35 6 8 2 6 6 8 2 38 6 15 2 36 6 6 8 2 32 6 1 2 36 6 5 6 6 2 3 2 6 1 5 8 Reflotron Tests Tests Reflotron Alkal Phosphatase Reflotron Amylase Reflotron Bilirubin Reflotron Cholesterol Reflotron CK Reflotron Creatinine Reflotron GGT y GT Reflotron Glucose Reflotron GOT Reflotron GPT Reflotron HDL Cholesterol Reflotron Hemoglobin Reflotron K Reflotron Pancreatic Amylase Reflotron Triglyceride Reflotron Urea Reflotron Uric Acid Controls Reflotron Clea
14. measuring chamber was last cleaned Action Remove the test strip If you find the chamber empty gt push the release lever upwards Insert the test strip with the brown magnetic strip facing down and the test area pointing forward Insert the test strip with the brown magnetic strip facing down and the test area pointing forward Important Do not store the test strips near mag netic objects staple magnets magnetized paper clip holders etc Close the flap and wait for the next message Open the flap remove and discard the test strip Clean gt see Section 4 Cleaning and Quality Checking 5 3 pa an 4 TE ee rye CREATININE CLEARANCE URINE DIL 1 8 7 YES HO CREATININE CLEARANCE DILUTE SAMPLE Message INSTRUMENT TOO WARM Te io INSTRUMENT TOO COLD TLS C PRINTER HOT READY HO DATA TRANSFER UHEHOWH IDENTIFICATION 5 4 More than 7 days have elapsed or more than 100 measure ments have been performed since the measuring system was last checked The urine was not diluted before the creatinine was deter mined Error messages Meaning The temperature inside the measuring chamber is too high The temperature inside the measuring chamber is too low The printer is defective or inac tive Important This display appears for only 2 seconds The computer is not connected to the serial interface or is not ready to receive data Important This display
15. operation e g during the warming up phase during per formance checks or during a measurement you cannot access the menu immediately After pressing the two buttons please wait until the display switches over 2 31 2 82 Date and time Notes on operation The flashing dotted line cursor indicates the parameter select ed for setting here CLOCK date and time To select a different menu item move the cursor to the left or right by pressing the lt or gt button Confirm your selection by pressing J Position the cursor below the word CLOCK and press 1 The procedure for setting the date and time is described here as an example for the other settings Note The following instructions are based on the 24 hour format If the 12 hour format is used the submenu structure is slightly different See also Basic instrument settings in Section 6 The values that can be changed here 01 for the year 2001 is raised with the cursor button gt and lowered with the lt button Confirm your selec tion by pressing Returning to measuring mode MONTH bay BEEP DELETE The month then appears which is changed in the manner described above This is fol lowed by the day the hour and finally the minutes After confirmation of the min utes setting by pressing 4 the menu of the different items that can be set is displaye
16. or gt button to position the cursor under J DELETE and confirm by pressing 1 You can now use the cursor buttons gt or lt to position the cursor under YES If you confirm this selection by pressing 1 all results will be deleted from the memory DELETE RESULTS YES HO Press the two buttons lt and gt simultaneously to return to measuring mode The Reflotron Plus is now ready to perform an analysis again 2 39 3 Working with Reflotron Keyboard Reflotron Keyboard Working with 3 Working with Reflotron Keyboard Reflotron Keyboard ae s A scans Firas Slak i i CEFERE Symbols General instructions The connection of the keyboard to the instrument is described in gt Section 1 Keyboard Note Switch off Reflotron Plus before connecting the keyboard Reflotron Keyboard is in principle operated like a computer keyboard The following examples explain how the symbols are used in this section This symbol means that the key shown is to be pressed This combination means that the two keys shown are to be pressed simultaneously in this example that you must press 7 and A together The keys Caps Lock Num Lock and Scroll Lock are used to activate indicator lamp on or deactivate indicator lamp off a function CAPS LOCK for example switches from lower case to upper case letters and vice versa
17. passes between the ribbon and the body of the cassette 6 9 General information Data transfer 6 10 Operation with RS 232 C interface Reflotron Plus is equipped with the widely used DB 25 connection socket Cables to the respective computers should be ordered from the sup pliers of the computer equipment The computer must be equipped with appropriate software i e adjusted to Reflotron Plus to allow data transfer There are in principle two possibilities to transmit the test results O Automatic transfer of every single record For this purpose set the automatic data transfer to YES gt see Section 6 Basic instrument settings O Manual data transfer via Reflotron Keyboard by pressing the pro file key F8 or F9 gt see Section 3 Transfer of patient profiles to a computer system The following data transfer protocol applies when the func tion key F9 is used 1st line CR LF 2nd line date and time CR LF 3rd line sample patient identification CR LF Ath line result CR LF 5th line result related message CR LF e g NON LINEAR REACTION 6th line additional test information CR LF e g normal values 7th line CR LF CR Carriage Return OD hex LF Line Feed OA hex The line holds a maximum of 24 characters The composition of the lines is identical with the display message The display for enzymes and substrates differ in the result line PPPP v
18. strip out of the container Y A Take a Reflotron Check strip t q i out of the container and insert ea z it in the test strip holder Close a the test strip container at once to protect its contents from dust Do not touch the grey area on the control strip since this would alter its reflectance as do any dust particles on it 2 8 Inserting the control strip Closing the measuring chamber Insert the control strip with the brown magnetic strip facing downwards and the grey area pointing towards the instru ment Holding the strip horizontally place the front of the strip on the silver coloured lower heater and push forwards Push the strip forward until it locks into place This message indicates that the control strip has been correctly inserted If this message fails to appear the first time push the release lever upwards and insert the strip again horizontally until it locks into position Close the flap The magnetic code is read The parameter abbreviation CHEK in the display indicates that the control strip has been properly inserted and the microprocessor has correctly read and stored the data coded on the magnetic strip The number of seconds indi cates the amount of time remaining until the result is dis played 2 9 Comparing the results with the specified values CAER Reira il 2 10 i Bim uo CODE 85 84
19. test information is always printed out together with the result Press F5 After the key has been pressed Reflotron Plus asks for the function Enter EDITEXT Capital letters must be used This is followed by the first parameter e g urea Existing text can be altered or new text entered The input is terminated and the next parameter if available is offered Press Escape to exit the function The instrument is then ready to perform a measurement again Calculation of the creatinine clearance Explanation The creatinine clearance provides information about renal function Calling up the function Press F6 When determining the creatinine concentration with Reflotron Creatinine using urine as specimen material the sample must be prediluted in a ratio of 1 20 before performing the test Use of different dilutions will produce incorrect results in the subse quent calculation of the creatinine clearance As Reflotron Plus only recognizes the creatinine test strip as such and not the specimen material used it is advisable to enter an appropri ate label e g U for urine in the last position position 24 of the patient identification Enter the respective creatinine value measured in blood serum or CREATININE CLEARANCE plasma and confirm with the key on the keyboard CREA S maddi F If the value entered is above or below the limit values Reflotron Plus indicates this by placing the si
20. the Cyrillic alphabet As already described under Units and enzyme reference tempera ture gt see Section 2 Individual settings the substrate concen trations can be displayed as conventional units CON mg dl or as SI units mmol l The conversion is carried out by the instrument using a factor The basic setting selects one system of units which is to be used for all substrates Selection of UNCHANGED guarantees that any parameter specific alterations made under Individual settings are maintained 6 5 Presetting the enzyme reference temperature and the enzyme unit DEFAULT TEMPERATURE UR CHANGED 25 C ge co af Cc DEFAULT UNITS EHZYM UNCHANGED L pkatil Presetting the conventional hemoglobin unit DEFAULT COM HE Presetting the blood pressure unit DIMENSION PRESSURE Time format TIME FORMAT 24 h Mode Le h Mode 6 6 The values displayed for the enzyme activities depend on the tem perature and unit selected Conversion is carried out by the instru ment using a factor The basic setting specifies one system of units which is to be used for all substrates Selection of UNCHANGED guarantees that any parameter specific alterations made under Individual settings are maintained The result of the hemoglobin determination is displayed in the units g dl or g l depending on the selection made here In the cardiac risk calculator the blood pr
21. the result If the result appears implaus ible check whether insufficient or no sample material was applied If possible dilute the sample as specified See pack insert of Reflotron tests for details Record the result Repeat the test as directed possibly after diluting the sample pack insert of Reflotron tests Repeat the test as directed Determination of this sample may not be possible Repeat the test as directed possibly after diluting the sample Dilute sample as directed gt See pack insert of Reflotron tests Take a measurement Message 15 05 61 12109156 LEASE REMOVE STRIF 15 05 61 12109156 HO MAGHETIC CODE 10056 CODE MISREAD 15 05 01 12 09 56 MEASUREMENT INTERRU al followed by 15 05 81 12109158 izim Se THTERRUPTED followed by 45 81 PLEASE REMO 31 12 05 CLEAN AND CHECI Operator messages Meaning The measuring chamber has been opened A used test strip has been left in the measuring chamber Reflotron Plus received no data from the test strip after the measuring chamber was closed The data read from the test strip are incomplete or faulty The measurement has been interrupted because the meas uring chamber was opened too soon The measurement has been interrupted because the meas uring chamber was opened and closed too soon More than 7 days have elapsed or more than 100 measure ments have been taken since the
22. 0 i e no paper feed is the standard setting Printer setting Identical with Printer setting in Section 2 Individual settings PRIHTOUTS i The numbers stand for the desired number of printouts of each indi vidual result O switches off the printer Note The printout of profiles is not affected by this setting See Section 3 Printout of patient profiles Sound signal This menu item is identical with Sound signal in Section 2 Individual settings See there for explanations Risk calculator Selection of the cardiac risk calculator RISK CALCULATOR EROCAR FREMINGHAM Time to stand by This setting specifies the time in minutes after which Reflotron Plus TIME TO STANDBY automatically switches to the standby state HEUER F 6 8 Printer operation Insertion of paper Grasp the printer cover at the centre of the upper edge lift forwards and down onto the instrument Cut or fold the loose end of the paper roll diagonally and insert it straight into the slit pressing the paper feed button f at the same time Tear off the paper straight at the printing block Replace the printer cover and press the paper feed button The paper then automatically rethreads itself Changing the printer ribbon Press the ribbon cassette down on the narrow side marked PUSH When inserting the new ribbon cassette make sure that the paper
23. 1 1902091 The following Reflotron Workstations can also be ordered from Roche Diagnostics as accessories The pictures illustrate how the worksta tions can be filled All workstations are supplied without contents Workstation B REF 1 1248944 Workstation C REF 1 1248952 Integrated printer Reflotron Plus is fitted with an integrated printer If the first printout is blank or too faint the paper feed button must be depressed for some time The procedure for changing the printer ribbon and inserting a new roll of paper is described in Section 6 The printer ribbon Epson ERC 09 black is available from Roche Diagnostics under REF 10745235 The paper width 58 mm diameter of roll 60 mm is supplied by Roche diagnostics under REF 11268457 Connection to a computer system The serial interface allows the Reflotron Plus to be connected to a practice or laboratory computer system For further details see Section 6 Operation with RS 232 C interface Keyboard Reflotron Plus has additional functions which can only be used in combination with a keyboard A conventional IBM compatible key board may be used In this case the legal regulations for emission of interfering radiation must be observed The Reflotron Keyboard supplied by Roche Diagnostics is available in various versions for different countries Connecting the keyboard The keyboard is connected to the keyboard socket on the rear of the instr
24. 32 2 34 2 35 2 36 2 38 2 39 3 1 3 4 3 5 3 5 3 10 3 12 3 14 3 15 Labeling measurements performed with control material Transfer of patient profiles to a computer system Profile transfer Profile transfer Il Printout of patient profiles Printing out displayed text 4 Cleaning and Quality Checking Cleaning the instrument Checking the optical system with Reflotron Check Checking the whole system with control sera 5 Display Messages and What They Mean Routine messages Operator messages Error messages 6 Technical Information and Notes Measuring principle Software Basic instrument settings Printer operation Insertion of paper Changing the printer ribbon Operation with RS 232 C interface Temporary or permanent disuse Technical data and specifications Safety warning Guarantee General note 7 Index 8 Reflotron Tests Page 3 18 3 19 3 19 3 20 3 22 3 23 4 1 4 4 4 5 del 5 3 5 4 6 1 6 3 6 9 6 9 6 10 6 14 6 15 6 18 6 19 6 19 2 Start up and Practice 4 Cleaning and Quality Checking 6 Technical Information and Notes 8 Reflotron Tests 1 Unpacking and Installation Unpacking and Installation 1 Unpacking and Installation Checking for damage sustained during transport Reflotron Plus is delivered in two separate boxes If the contents have suffered any damage in transport please inform your supplier or the carrier at o
25. 93 HDL cholesterol mg dl 10 0 100 0 mmol l 0 259 2 586 The CHOL HDL ratio is calculated In the example shown here the ratio of cholesterol to HDL cholesterol is 5 78 The values can also be entered directly from the instrument s mem ory To search for values in memory use the keys shown on the left see also Searching and Copying page 3 7 This function is only available when the calculated CHOL HDL ratio is displayed PATIENT HARE Exporting a record E Exiting the function a The instrument asks for a patient identification or suggests an exist ing one After confirmation a record showing the values is printed out The record can also be exported to a computer system in a corre sponding manner gt see also Operating with RS 232 interface in Section 6 The function can be exited at any time by pressing the Escape key 3 13 Explanation Calling up the function a Function EPITET AOBITIOHAL TEST INFO UREA 2 7 8 3 mmol l Terminating the input Exiting the function ul 3 14 Entry of additional test information Additional parameter specific test information can be entered for every parameter that has been determined with Reflotron Plus before this function is called up This information can be for example the reference range The additional text remains stored even after Reflotron Plus has been switched off The additional
26. Components of the Reflotron Plus System Reflotron Plus Reflotron Tests Reflotron Precinorm U Reflotron Precinorm HDL Reflotron Precinorm HB Reflotron Accessories Reflotron Clean and Check Introduction The Reflotron Plus is an in vitro diagnostic device designed for the quantitative determination of clinical chemistry parameters using Reflotron test strips It works on the principle of reflectance photo metry and ensures rapid and reliable results while being simple to use Various additional components are also available for the Reflotron Plus These are items which are necessary or useful for per forming an analysis or which allow you to check the performance of the system The Reflotron tests are test strips designed for the specific determin ation of important clinical chemistry parameters using undiluted specimen material The incorporation of a plasma separating system makes it possible to use whole blood as well as serum and plasma Some tests can also be performed with prediluted urine The Reflotron tests have a long shelf life and with only few exceptions can be stored at room temperature On the back of each Reflotron test strip there is a magnetic strip con taining all test and lot specific data Control materials for checking the performance of the Reflotron system Useful additional items for use with the Reflotron Plus Used for cleaning and checking the optical system Contents 1 Unpac
27. Creatinine U mg dl 0 5 10 0 umol 44 2 884 Urine volume ml 100 9999 Collection interval urine h 3 99 Body weight kg 15 160 Height cm 80 220 The values can also be copied directly from the memory by search ing for the desired values using the keys shown on the left gt see also Searching and Copying on page 3 7 Press F10 This function can only be called up when the result is displayed The instrument asks you to enter a patient identification or suggests an existing one After confirmation with the Wl key on the keyboard a record of the values is printed out In analogy to printing out the record it is also possible to transfer a record to a computer system using the function keys F8 or F9 gt see also Operating with the RS 232 C interface in Section 6 The function can be exited at any time by pressing the escape key 3 17 Labeling measurements performed with control material Explanation It is possible to separately identify measurements performed with control materials e g with Check strips or with Reflotron Precinorm U This allows the selective transfer of these measurements to the print er or to a connected computer system Calling up the function Press F7 A C appears in the last 24th position of the first line to label a measurement with control material As with patient samples you can also enter additional data in this line e g the name of the co
28. DDDDD EEEEEEEEE Substrate PPPPvDDDDDEEEEEE DD C Enzyme P name of parameter D digits decimal points E characters for the unit DD C enzyme reference temperature v preceding sign e g lt gt space The arrangement is usually left adjusted e g GGT lt 2 80 UA 25 C Notes If there is no sample patient identification the consecutive number of the sample is transferred in the 3rd line in the automatic data transfer If there is no additional test information line 6 contains only CR LF If the result is not provided with a result related message line 5 consists only of CR LF Apart from the test results the calculated results such as cardiac risk or LDL cholesterol can be transferred manually gt see Section 3 The data protocols correspond to the outputs to the printer User instructions and error messages are not transferred They are only output to the printer The following transfer protocol applies when the function key F8 is used Each line corresponds to a record and is composed as follows Time and date Patient sample identification Result with parameter value and dimension Additional test information compiled by the instrument Additional parameter information compiled by the user CR LF 6 11 Data security Cable configuration 6 12 The parts between semicolons have 24 characters or are omitted in the case of lines
29. If there are no more results in the memory or if the memory is empty the message shown on the left appears If you press the button again you return to the previously displayed result From any memory position the next value measured can be called up by pressing the gt button until the latest result obtained appears After this the message shown on the left appears If no button is pressed for 10 seconds the instrument reverts to the READY state The instrument can also be returned to the READY state at any time by pressing the enter button 2 Pressing the 1 button again displays the last value mea sured pressing the lt button the preceding value measured Individual settings Calling up the menu Reflotron Pie CLOCE PRINT BEEP UNITS STRIPS DELETE Note The results with the additional information are shown exactly as they appeared when the result was first displayed Switch on the instrument and wait until READY appears in the display Press the two cursor buttons lt and gt simultaneously to call up the menu for the indi vidual settings If a result from the memory or the message NO ENTRY is displayed instead this means that you did not press the two buttons simultaneously Wait until READY appears and the press the two cursor buttons lt and gt simultaneously Note If the instrument is performing an
30. YES If you select YES and confirm with 1 the instrument will initiate the normal start up procedure If you answer NO and then confirm LANGUAGE appears again and the menu can be run through once more Setting the language The cursor marks the language currently set The abbreviations stand LANGUAGE USA GER ULE for FRANCE SPAIN ITALY USA American English GER German U K British English FRANCE French SPAIN Spanish ITALY Italian FREE open for other languages For more information please contact your Roche Diagnostics subsidiary or local agent 6 4 Adjusting the keyboard KEYBORED USA GER FRANCE SPAIN ITALY Selecting the font CHARACTER SET JAPIEYEILL DEFAULT DIMENSION UNECHANBED COH U K FREE Reflotron Keyboard is available in different versions for the respective countries gt see Keyboard in Section 1 If you want to work with Reflotron Keyboard British for example select U K For the meaning of the abbreviations see Setting the language above Other conventional IBM AT compatible keyboards can also be con nected FREE is available for special keyboard drives Please contact your local Roche Diagnostics subsidiary or authorized dealer for information The standard setting is the US ASCII character set by IBM The other alternative is intended for Japan or countries using
31. ation with 12 24 V DC voltage Reflotron Plus can be adapted for additional operation with 12 24 V DC voltage so that the instrument can be operated with a car battery for example Please contact your supplier or Roche Diagnostics for further infor mation on this option When operating a Reflotron Plus adapted for use with direct current attention should be paid to the following points Voltage fluctuations are permissible in the 10 30 V range Connect the battery to the DC socket making sure that polarity is correct Reflotron Plus does not function with false polarity It is how ever provided with reverse battery protection While operating Reflotron Plus with direct current it must be disconnected from the mains A connecting cable 1 5 m with the recommended Cannon AXR 3 11 plug can also be ordered from Roche Diagnostics under REF 11331582 If you want to connect Reflotron Plus to the electrical system of your car please consult a car electrician Do not start the engine while performing a measurement For further technical details see Section 6 Technical Information and Notes Reflotron Workstation Reflotron Workstation accommodates all other materials needed for the analysis so that they are always close to hand Reflotron Plus is supplied together with the Workstation A new without contents shown on the left The Reflotron Workstation A new without contents can also be ordered under REF
32. be should be filled up to the maximum mark This is facilitated by choosing an appropriately sized tube When blood collection has been completed the tube is sealed and the blood and anticoagulant immediately mixed thoroughly by inverting the tube or using an auto matic mixer Pipetting with the Reflotron Pipette The specimen can be pipetted with commercially available pipettes which deliver a volume of 30 ul Please follow the manufacturer s instructions for the pipette used The Reflotron Pipette allows blood to be aspirated from blood col lection tubes without air bubbles Should it nevertheless become necessary to discard a sample because of air bubbles a new pipette tip must be used Wipe off any sample material adhering to the out side of the pipette tip If the pipette becomes contaminated while drawing up the sample it must be disinfected For more details on the use of Reflotron Pipette see Working with Reflotron tests and blood serum or plasma in Section 2 2 25 Inserting the capillary pipette Filling the capillary pipette 2 26 Collection of capillary blood using capillary pipettes If capillary blood is to be obtained using capillary pipettes then coat ed capillary pipettes which deliver a volume of 30 ul should be used Please refer to the pack insert of the respective Reflotron test for the appropriate anticoagulant In the following paragraphs the procedure for use of the Reflotron App
33. bility of replacing individual components considerably shorten repair times The manufacturer reserves the right to modify the system 6 17 6 18 Safety warning This instrument has been constructed and tested in accordance with DIN EN 61010 1 Safety requirements for electrical equipment for measurement and left our factory in a safe condition To ensure that this remains so and to ensure safe operation the user must observe the instructions and warnings given in this operator s manual The instrument belongs to Protection Class it has a protective earth It meets the requirements of Overvoltage Class II and Pollution Class 2 Do not plug the power cord into any socket that is not properly earthed Do not use an extension cord that does not have an earth wire Warning Breaking the connection to earth inside or outside the instrument or disconnection of the earth lead can make operation of the apparatus dangerous Deliberate interruption of the earth connection is not allowed Do not open instrument covers or remove parts that cannot be Opened or removed by hand as doing so may expose live parts Connecting points may also be live Any adjustment maintenance or repair work on an opened instru ment with the power on should be undertaken only by trained per sons who are conversant with the dangers involved If you have any reason to believe that the instrument can no longer be operated safely switch if off and
34. d again To return to the measuring mode press the two cursor but tons lt and gt simultaneously The Reflotron Plus is now ready for performing an analysis again Note If you only want to change a specific setting e g the day it is not necessary to go through the entire submenu When you have confirmed the new setting with J press the two buttons lt and gt simultaneously to return to measuring mode 2 33 Setting the printer Calling up the menu i CLOCK PRIHT BEEF UNITS STRIPS DELETE Reflotron Pies FRIMTOUTS 2 34 When the instrument is READY press the two cursor buttons lt and gt simultan eously to call up the menu for the individual settings Use the lt or gt button to position the cursor under PRINT and confirm by press ing 2 Use lt or gt to select the desired number of consecutive printouts of results and confirm with 1 The setting 0 switch es the printer off The functions PRINT PROFILE and PRINT SCREEN are not affected by this setting Even if the printer is switched off these data can still be printed out Press the buttons lt and gt simultaneously to return the instrument to measuring mode The Reflotron Plus is ready to perform an analysis again See also Basic instrument settings in Section 6 Acoustic signal
35. determination of concentration for sub strate tests is C A A R AJ R Ayer For the line of best fit for determination of the enzyme activity U I A A AC CG concentration R reflectance A to As specific coefficients n specific exponent N gt 0 for sigmoid curves N lt O for hyperbolic curves U I enzyme activity in U l AC difference between 2 measured concentrations The respective factors for these functions were determined during manufacture by comparison of the measurements with Reflotron Plus with a reference method With the help of these functions Reflotron Plus calculates the con centration or activity of the desired parameter and shows this on the display or transmits the result to a printer or to a connected computer system General notes Calling up the menu Basic settings k Reflotron Flu LANGUAGE FRANCE SPA Software In addition to the software programmed into the instrument for the performance and evaluation of a test and the software for the auto matic checks performed by the instrument Reflotron Plus also con tains software that allows the operator to select various laboratory specific basic settings and recurring functions via display prompts and function keys and via an optional keyboard Details of the procedure for calling up and performing these functions are given in the various chapters These chapters also describe the individual display messages and how t
36. e Please note that the instrument may potentially be infectious It should therefore be decontaminated before disposal e g by clean ing the housing and the measuring chamber with 70 alcohol 1 Optical system Measuring principle Light source Wave lengths Light detectors Service life of the light source Automatic compensation Measuring range Temperature Time of preparation for a new parameter Accuracy of input Electronics Microprocessors Storage capacity in KBytes Control of the process Technical data and specifications Measuring the reflectance with the aid of an Ulbricht sphere using a reference beam for compensation Light emitting diodes LEDs 567 nm 642 nm 951 nm Photodiodes 2 Over 50 000 measurements For the zero point and changes in current frequency 2 5 to 90 diffuse reflectance 37 0 C 0 1 C All parameter specific data are encoded in the magnetic strip on the reverse side of the test strip The system either performs automatically or does not require the usual setting procedures needed in photometric practice such as zero point method factor standard concentration kinetic times measuring temperatures volumes aspirated incubation times etc The records received are checked for plausibility 6 or 7 including printer Master Controller EPROM 128 48 EEPROM 16 0 5 RAM 32 16 Display messages guide the user through the operation
37. e instrument off and on again If the error occurs again please contact your authorized dealer or your near est Roche Diagnostics sub sidiary Switch the instrument off and then on again If the error occurs again please check the following Does another instrument work from the same socket Is the power cable properly connected Is the power cable intact 5 5 6 Technical Information and Notes Information and Technical Notes 6 Technical Information and Notes Ulbricht sphere Measuring principle For measurement the test strip is fixed to a movable carriage the transporter When the flap of the measuring chamber is closed this transporter moves the test strip into the measuring position with the help of a motor After a certain individual waiting time depending on the test the so called Ulbricht sphere is lowered onto the test strip This brings the reagents contained in the test strip into contact with the sample if blood is used the erythrocytes have been separated from the plasma during the waiting time and starts the reaction Depending on the test the colour reaction is measured in different ways end point or kinetic analysis and at different times The Ulbricht sphere contains LEDs of different wavelengths and detectors The opto electronic determination is performed as shown in the following schema Detector Analog to digital converter Microprocessor 4 ae do 1 f pe ene l L a g 1
38. ed age group In addition to the data entered and the result of the risk assessment the printout also includes LDL Friedewald and the CHOL HDL ratio These are not taken into consideration in the risk calculation but are meant as additional information only As well as printing out a record it is also possible to export the record to the computer system gt see also Operation with RS 232 inter face in Section 6 Press the Escape key to return to analysis mode Calculation of LDL according to Friedewald Reflotron Plus calculates the value of LDL cholesterol from the values cholesterol triglycerides and HDL cholesterol on the basis of the Friedewald formula Calling up the function LOL ACC TO FPRIEDEWALE CHOL maddi f LOL ACC TO FRIEDEMALD LEL 163 06 mafdl Exiting the function a Press F3 Reflotron Plus displays the first parameter to be entered Use a decimal point when entering decimals Every entry has to be terminated by pressing enter Certain limits have to be observed The next parameters asked for are TG and HDL If a value entered is above or below the limits programmed into the instrument Reflotron Plus indicates this by placing the sign lt or gt before the respective maximum or minimum value and performs the calculation using the programmed limit value Maximum and minimum values programmed into the instrument minim
39. ensure that it cannot be used accidentally It must be assumed that safe operation is no longer possible if the instrument e shows visible signs of damage e fails to operate e has been stored under unfavorable conditions for a prolonged period or e has been transported under rough conditions The Reflotron Plus should only be used by appropriately qualified persons Guarantee The statutory guarantee provisions governing the sale of consumer goods in the country of purchase shall prevail General note The data and information provided in this manual are current as of issue Any substantial changes will be incorporated in the next edition If there is any conflict of information the package insert included with the product in question shall invariably prevail 6 19 7 Index 7 Index Additional information entering Application of sample Applicator Basic settings Blood collection Blood pressure unit Cable configuration Cardiac risk calculation Capillary blood Capillary plasma Checking the display Checking the optical system Cholesterol HDL chol ratio Clean and Check Cleaning Computer interface 12 24 V connection Control sera Data transfer Date Deleting data Deletion of results Display check Display messages Disposal Error messages Framingham Friedewald Hemoglobin unit Interface configuration of Installation Keyboard Labeling control measurements Language LDL
40. er Transfer of patient profiles to the computer system This function can be exited at any time Printing out displayed text Explanation The result of a measurement is printed out The number of printouts depends on the number previously set gt see Individual settings in Section 2 or Section 6 Technical Information and Notes Printout of a test result is also possible with the printer switched off Calling up the function jp Even when the printer is switched off Printout 0 the result shown in the display can be printed out by pressing the Prt Sc key on the keyboard Exiting the function This function is automatically exited after the printout has been completed 3 23 4 Cleaning and Quality Checking Cleaning and Quality Checking 4 Cleaning and Quality Checking Opening the measuring chamber Cleaning the instrument Note Always switch off the instrument prior to cleaning Do not allow fluids to enter the instrument Some parts of the instrument can become contaminated with infec tious material Please observe the pertinent safety regulations The Reflotron Plus needs no maintenance The exterior parts of the instrument can be cleansed as required using mild detergents or disinfectants preferably 70 alcohol After 100 measurements or 7 days after being cleaned last Reflotron Plus automatically asks the user to clean the measuring system and subsequently to check
41. essure can be entered either in conventional units mmHg or in Sl units kPa see Section 3 Calculation of cardiac risk You can choose between the 24 hour and 12 hour format for the time display Note The choice made here influences the prompt for Date and time See Section 2 Individual settings Date format FORMAT OF DATE ciel mim WH mitt gida wu Configuration of the serial interface BLOCK CHECE HOHE ENEH AUTOMATIC DATA TO RS Let us take 15 May 2001 as an example If you choose the format dd mm ww the display will show 15 05 01 In the format mm dd ww the month is shown first thus 05 15 01 If a computer system is to be connected to Reflotron Plus the supplier of the software must configure the serial RS 232 C interface For the meaning of the individual menu items see Operation with RS 232C interface in this Section Note BLOCK CHECK CHARACTER appears only if STX ETX FRAME has been answered with YES YES means that all test results are immediately transferred to the computer This does not apply to results that originate from calculations e g LDL acc to Friedewald gt See section 3 Working with Reflotron Keyboard NO is the standard setting 6 7 Number of blank lines after a printout This setting results in a paper feed of the corresponding number of blank lines after a printout
42. ever upwards 2 11 Working with Reflotron tests and blood serum or plasma When working with blood plasma serum urine or con trol samples always observe the guidelines regulations and precautions for handling potentially infectious ma terial which apply in your practice or laboratory Collect venous blood or anticoagulated venous blood or serum using commercially available specimen collection vessels Switching on the instrument Switch on the Reflotron Plus as described under Switching on the Reflotron Plus and wait for the display message READY to appear Notes on the sample material The parameter specific stability data for whole blood serum or plasma given in the inserts in the individual Reflotron test strip packs must be observed 2 12 Reflotron Pipette Correct application of the sample material When working with Reflotron test strips a specimen volume of 30 ul must be applied with a commercially available precision pipette The Reflotron Pipette is also suitable for this purpose Reflotron Pipette has been developed for general use with undiluted blood serum and plasma It delivers precisely 28 5 31 5 ul the volume needed for correct functioning of the Reflotron Plus system In the case of capillary blood certain precautions with respect to the specimen collection must be observed see so Working with capillary blood 2 13 Mounting the pi
43. f the receiving soft ware ignores the CTS and DCD signals 2 Other EDP units acc to DIN 66020 Reflotron Plus Computer DB 25 plug DB 25 plug GND 1 1 GND protective TD 2 ae O 2 TD RD 3 rg RD RTS 4 4 RTS CTS 5 5 CTS DSR 6 6 DSR DTR 20 a 99 DTR GND 7 7 GND signal The following settings are predetermined by the software O BAUD RATE 300 9600 O STOP BITS 1 2 O PARITY NONE ODD EVEN O SIX ETX NO YES O BCC NONE EVEN ODD For the settings see Basic instrument settings in this Section If Start of TeXt End of TeXt is selected the above records look as follows STX 02 hex Record ETX 03 hex When using an STX ETX frame an additional BCC Block Check Character may be sent DIN 66219 to improve data security The modulo 2 sum after STX up to and including ETX must be O with EVEN and 255 with ODD The word length is 8 bits The character set corresponds to the standard ASCII character set by IBM 6 13 6 14 Temporary or permanent disuse If Reflotron Plus is not going to be used for a prolonged period of time the instrument should be disconnected from the mains It is advisable to cover the instrument with a dust cover to prevent it from becoming soiled If the instrument is to be taken out of operation entirely and disposed of it must be disposed of in conformity with the relevant legal regu lations and in co ordination with your local authority if appropriat
44. flotron Plus prints out all important data results error messages and the message MEASURE MENT INTERRUPTED The procedure for switching off the printer and altering the printer settings is described in Section 2 under Individual set tings and in Section 6 under Basic instrument settings If you do not want to take a measurement for a longer period of time you may put the Reflotron Plus into standby The difference between this and switching off the instrument with the on off switch is that you save the warm up time after restarting the instrument For information on setting this function please refer to Basic instrument settings in Section 6 In this setting the green indica tor lamp indicates that the instrument is still switched on As soon as you lift up the flap or enter data via the keyboard the Reflotron Plus is ready to perform a measurement again Practice with Reflotron Check The Reflotron Check control strip has a grey area with a defined reflectance value It is used for checking the perform ance of the optical system of Reflotron Plus Reflotron Check is suitable for preliminary practice with the apparatus Start Reflotron Plus as de scribed under Switching on the Reflotron Plus After the warming up period the instrument displays READY 2 1 Opening the flap Lift up the flap on the measur ing chamber Taking a
45. g off the foil as this could damage the test area Carefully insert the test strip into the strip holder of the Reflotron Plus Applying the sample A Measuring zone Application zone Adhesive strip Note on working with the Reflotron Pipette The Reflotron Pipette has three stops To aspirate the sample depress the plunger to the first stop and slowly release the plunger to the ori ginal position If necessary remove any sample material adhering to the outside by wip ing with a swab To apply the sample hold the pipette vertically and depress the plunger to the second stop Do this gently but firmly so that no spraying occurs but the tip is completely emptied Then depress the plunger com pletely to discard the pipette tip Draw up the sample material with the Reflotron Pipette avoiding the inclusion of air If it is necessary to expel the sample material because of air bubbles a new pipette tip has to be used If the same tip is used the volume dispensed might exceed the required amount Apply the sample material to the centre of the mesh covered application zone making sure that only the drop of specimen and not the pipette tip touches the application zone The adhesive strip is not part of the application zone Support the right forearm with the left hand or vice versa while pipetting The test zone will immediately absorb the sample 2 17 Inserting the test s
46. gn lt or gt before the respective maximum or minimum value If the entry is not corrected Reflotron plus then performs the calcu lation with the respective limit value This also applies to the following entries Enter the creatinine value measured in the urine and confirm with the CREATININE CLEARANCE 3 key on the keyboard PRG MIYAT The determination must have been performed with urine diluted 1 20 Enter the result obtained with this prediluted urine do not multiply the result by 21 Values obtained with undiluted urine or with different dilutions will lead to an incorrect result Enter the volume of the timed urine collection in ml CREATINIME CLEARANCE VOLUME URINE ml F Press the 1 key on the keyboard to confirm that the specimen used Gre INE O ACE for determination of the creatinine in urine was diluted 1 20 URINE DIL 4 20 s 3 15 CREATININE CLEARANCE URTHE DIL 1 207 Ves CREATININE CLEARANCE DILUTE SAMPLE CREATININE CLEARANCE COLLECT URTHE CREATIHIHE CLEARANCE BODY HEIGHT ko F CREATININE CLEARANCE HEIGHT om CREATININE CLEARANCE CREA 3 16 CLEAR LLS mifmin Ho If this was not the case use the key to place the cursor under No and confirm with the 1 key on the keyboard The two displays shown on the left will then alternate In this case press the escape key Esc to exit the creatinine clear ance functio
47. he corresponding value must be entered Certain limits have to be observed 3 5 CARDIAC RISE mardi CARDIAC RISE YEARS F CARDIAC RISK INFARCT IN FAM Ne SHORTS CARDIAC RISE DIABETES A decimal point must be used for decimals With YES NO answers the cursor can be positioned under the cor rect answer using the cursor keys Every entry must be confirmed by pressing the Enter key If the value entered is outside the specified limits Reflotron Plus performs the calculation with the limit values programmed into the instrument This also applies to the following entries Limit values programmed into the instrument minimum maximum Cholesterol mg dl 110 405 mmol l 2 845 10 473 Triglycerides mg dl 50 0 400 0 mmol l 0 572 4 572 HDL cholesterol mg dl 25 75 mmol l 0 647 1 94 Age 40 65 Blood pressure syst mmHg 100 225 kPa 13 33 29 993 The following data are asked for next TG is the abbreviation for the parameter triglycerides Enter the value for HDL cholesterol Enter the patient s age SYST B P stands for the systolic blood pressure measured by sphygmomanometry Is there a history of myocardial infarction in first degree relatives Does the patient suffer from angina pectoris Does the patient smoke Does the patient suffer from diabetes mellitus Searching and copying Result THD FACTOR RISE HA m 1 6 Changing existing values
48. he transporter and the heaters see Section 4 repeat the measurement with an unused dust free control strip If the values now lie within the specified confidence limits the system can be used If this is not the case and the value for the same wavelength is still outside the confidence range the optical system must be checked before further measurements are carried out In this case please contact the Technical Service Department of the nearest Roche Diagnostics subsidiary or your authorized dealer Reconstituting the control material Checking the whole system with control sera The following control sera are available for checking the Reflotron Plus the Reflotron tests and operation of the instrument Reflotron Precinorm U the universal system control Reflotron Precinorm HB a special control material for Reflotron Hemoglobin Reflotron Precinorm HDL a special control material for Cholesterol HDL Control sera should be handled as potentially infectious materials Observe the relevant regulations and safety measures applicable to your laboratory or practice Carefully read the pack insert accompanying the control material Open the bottle carefully avoiding any loss of lyophilized material and in accordance with the pack insert add exactly the amount of distilled water specified using a suitable pipette 4 5 Evaluation 4 6 Close the bottle carefully and dissolve its c
49. ing a record na Explanation Calling up the function 3 CARDIAC K CHOL mardi 3 8 Press F10 A record can only be printed out from the risk assessment display The instrument asks for a patient identification or suggests an existing one After confirmation a record showing all the values is printed out A record can be transmitted to the computer system in analogy to the printout of the record gt see Operation with RS 232 C interface in Section 6 The risk calculator can be exited at any time by pressing Escape The instrument is then ready to perform a measurement again Calculation of cardiac risk according to FRAMINGHAM In the FRAMINGHAM study performed in the USA the incidence of myocardial infarction in dependence of defined risk factors was ascertained in 30 to 74 year old women and men Press F2 See also Basic instrument settings in Section 6 The data are entered as described under Calculation of cardiac risk according to PROCAM All the functions described above are available here and are handled in the same manner If a value entered is above or below the limits programmed into the instrument Reflotron Plus indicates this by placing the sign lt or gt before the respective maximum or minimum value and performs the calculation using the programmed limit value CARDIAC RISE mardi CARDIAC RISE mardi iz
50. king and Installation Checking for damage sustained during transport Checking that the consignment is complete Proper siting Connection to the mains Operation with 12 24 V DC voltage Reflotron Workstation Integrated printer Connection to a computer system Keyboard 2 Start up and Practice Switching on the Reflotron Plus Standby function Practice with Reflotron Check Working with Reflotron tests and blood serum or plasma Notes on result displays in special cases Working with capillary blood Collection of blood using capillary blood collection tubes Pipetting with the Reflotron Pipette Collection of capillary blood using capillary pipettes Obtaining capillary plasma Storage and retrieval of results Individual settings Date and time Setting the printer Acoustic signal Units and enzyme reference temperature Strip counter Deleting the results from memory 3 Working with Reflotron Keyboard General instructions Entering a patient sample identification Calculation of cardiac risk Calculation of cardiac risk according to PROCAM Calculation of cardiac risk according to FRAMINGHAM Calculation of LDL according to Friedewald Calculation of the cholesterol HDL cholesterol ratio Entry of additional test information Calculation of the creatinine clearance Page From NNOORWNHHA bok 1 2 1 2 6 2 1 2 12 2 21 2 24 2 25 2 25 2 26 2 28 2 29 2 31 2
51. licator a dispensing aid for capillary pipettes and the corre sponding Capilette capillary pipettes is described as an example of the collection and application of capillary blood Insert the dark colored end of the capillary tube into the applicator until it meets resistance When using capillary pipettes let the capillary blood flow up to the coloured ring of the tube by capillary action holding the pipette at a slightly downward angle Do not aspirate the blood into the tube as can lead to contamination of the applicator and carries the risk of inclusion of air bubbles which would falsify the volume Wipe off any sample material adhering to the outside of the capillary pipette Interim storage of the specimens Applying the sample Discarding the capillary pipette If several determinations are to be carried out on the same patient several capillary pipettes containing capillary blood can be stored for a few minutes prior to commencing the respective measurements The capillary pipettes contained in the Accessory Kit are coated with lithium heparinate Please note that not every test can be performed with this anticoagulant gt See the pack insert of the respective Reflotron test The dispensing button of the applicator has two stops By pressing the button until the first stop is reached the sample is applied to the centre of the mesh covered application zone see also illustration on page 2 17 Hold the a
52. lotron Clean and Check Then check the correct position of the lower heater springing free moving parallel to the transporter surface If this is not the case contact the service department of Roche Diagnostics Return the black shield to its original position Leave the instrument to dry for at least 10 minutes with the measur ing chamber flap open Close the flap After every cleaning operation the optical system of Reflotron Plus should be checked using Reflotron Check REF 1 1142577 4 3 CHEK CHEK CHER nm DE 4 4 ETE A deve Eos oe Baa Eor are m Checking the optical system with Reflotron Check Reflotron Check is designed for checking the optical system of Reflotron Plus The procedure has already been described gt see Practice with Reflotron Check in Section 2 Note on evaluation Reflotron Plus measures the amount of light diffusely reflected by the strip at each of the three wavelengths and displays the reflectance values per mil o The meanings of the three numerical values displayed are as follows First number 638 reflectance in o 63 8 at 642 nm Second number 639 reflectance in o 63 9 at 567 nm Third number 633 reflectance in o 63 3 at 951 nm The values must lie between the minima and maxima specified on the label X being the target value If one or more values are outside the confidence limits proceed as follows clean t
53. marked with if there is no additional information General information on the RS 232 interface A prerequisite for the data transfer is that the computer system is ready to receive the data active DSR on the Reflotron Plus instru ment After being switched on Reflotron Plus is in principle ready to transmit data active DTR on computer Data transfer can be interrupted by an X OFF signal 13 hex Reflotron Plus immediately stops the data transfer The readiness to receive data must be restored by an X ON signal 11 hex or any other signal If the computer is not ready to receive data or is not connected the message NO DATA TRANSFER is displayed for approx 2 seconds If the transfer is interfered with or the computer sends an NAK sig nal 15 hex Reflotron Plus interrupts the transfer with the message DATA TRANSFER ERROR If the record received cannot be allocated the computer may send a DC4 signal 14 hex to the Reflotron Plus Reflotron Plus indicates this by displaying UNKNOWN IDENTIFICATION for about 2 sec onds This can be very helpful if for example the patient name entered in the instrument is unknown to the computer system 1 IBM AT and compatible PCs Reflotron Plus PC DB 25 plug DB 9 plug TxD 2 2 RxD RxD 3 3 TxD DSR 6 4 DTR GND 7 5 GND DTR 20 6 DSR 7 RTS 1 DCD 8 CTS Interface configuration The bridges between 1 7 and 8 can be omitted i
54. n Check Reflotron Precinorm U Reflotron Precinorm HB Reflotron Precinorm HDL 30 Tests 15 Tests 30 Tests 30 Tests 15 Tests 30 Tests 30 Tests 30 Tests 30 Tests 30 Tests 30 Tests 30 Tests 30 Tests 15 Tests 30 Tests 15 Tests 30 Tests 15 Reflotron Check 16 Wipes 4x2ml 4x2ml 4x2ml REF 11622773 11200658 10905321 10745065 11126695 10886874 10745081 10744948 10745120 10745138 11208756 10744964 11208764 11126679 10745049 11200666 10745103 11142577 10745154 10745189 11183893 Reflotron Tests Customer s address and location of the Reflotron Plus Warranty If the warranty card was not filled out at the time of purchase please submit the original receipt with your claim The statutory guarantee provisions governing the sale of consumer goods in the country of purchase shall prevail Serial No o E a xe E iv D p 5 ou E D fo o pa 2 sv a together with the instrument to your local Roche Diagnostics subsidiary or Date of purchase Please complete your warranty card and in the case of a claim send it Reflotron Plus Warranty Card
55. n and perform the creatinine measurement with predilut ed urine 1 20 The start the calculation again If you have confirmed that the urine was prediluted 1 20 before the measurement enter the length of the urine collection interval in whole hours and confirm with the 1 key on the keyboard Enter the patient s body weight in kg and confirm with the 4 key on the keyboard If you confirm with the 1 key without making an entry here the creatinine clearance will be calculated without taking into account body weight or height If you have entered and confirmed the patient s body weight you are then asked to enter the patient s height Enter the height in cm and confirm with the 1 key on the keyboard The result of the creatinine clearance calculation is displayed e g 115 ml min The creatinine clearance is calculated according to the formula Creatinine clearance ml min 1 73 m U x Uvol x 1 73 S x tx BSA BSA BW x H x 71 48 x 10 U Creatinine concentration in urine Uvol Volume of timed urine collection t Collection interval for urine BSA Body surface area BW Body weight H Height Searching and copying J Pa un Pa Oni ia i Printing out a record ATIEHT HAME F aHa OTHER d Exporting the record E Exiting the function Fl Maximum and minimum values programmed into the instrument minimum maximum Creatinine S mg dl 0 5 10 0 umol 44 2 884
56. nce Checking that the consignment is complete The main box contains the Reflotron Plus reflectance photometer a Reflotron Workstation A new a printer ribbon and printer paper The following items are also supplied 1 connecting cable 1 instruction manual and other items such as the following if ordered 1 Reflotron Pipette 1 applicator incl 50 capillary pipettes 1 Accu Chek Softclix Pro incl Accu Chek Softclix Pro Lancets 1 Reflotron Clean and Check If any items are missing please inform your supplier at once Proper siting Do not expose Reflotron Plus to direct sunlight Do not put the instrument near sources of heat such as radiators heaters or instruments radiating heat To ensure trouble free performance keep the Reflotron Plus in a room with a temperature between 15 C and 34 C and a relative humidity of not more than 95 Operate the Reflotron Plus at a distance of at least 4 m from diathermy units as these can interfere with the functioning of elec tronic instruments Checking the mains voltage Connecting the mains cable Connection to the mains Reflotron Plus covers a voltage range of 115 V to 230 V 22 Before plugging in Reflotron Plus please check that your mains voltage lies within the range covered by the instrument If it does not please contact your supplier As soon as the mains cable is plugged in Reflotron Plus is ready for use Leads of the socket Oper
57. ned before the change of setting and are stored in the memory see Storage and retrieval of results in Section 2 are not altered Note The procedure for generally changing the unit or tempera tures is described under Basic instrument settings in Section 6 When the instrument is READY press the two but tons lt and gt simultaneous ly to call up the menu for the individual settings UC Use the lt or gt buttons to position the cursor under UNITS and confirm with J Changing the enzyme reference temperature Changing the substrate unit UNITS UNITS TRIG pkatll mmol sd If the last test performed was an enzyme determination e g GPT the desired temperature can be selected using the lt and gt keys After confirmation with 1 the prompt for the desired unit appears ukat I stands for microkatals litre U I for units per litre Use the lt or gt key to posi tion the cursor under the desired unit and confirm with J If the last test performed was a substrate measurement e g TRIGLYCERIDE the desired unit can be selected with the keys lt and gt Confirm by pressing 1 Press the two buttons lt and gt simultaneously to return to measuring mode The Reflotron Plus is now ready to perform an analysis again See also Basic Instrumen
58. new pack of test strips Use new control material and or another test to check the perfor mance of the system again In case of doubt or frequent accuracy problems please contact the customer service department of your local Roche Diagnostics sub sidiary or your authorized dealer 4 7 5 Display Messages and What They Mean Display Messages and What They Mean 5 Display Messages and What They Mean Message READY Ba ma 5 0 42 PLEASE INSERT STRIF PLEASE CLOSE The messages appearing in the display window serve to guide the operator and also give useful indications of possible causes for a malfunctioning of the system Further possible display texts and their meanings may be found in Sections 2 and 3 see Startup and Practice and Working with Reflotron Keyboard Routine messages Meaning Checking the display Checking the internal functions of the instrument The measuring unit is being brought to the required temper ature The instrument is operational The flap is open The strip has been correctly inserted or the release lever is in the wrong position The magnetic code is being read The data of the magnetic code have been correctly read Action When you switch on the Reflotron Plus this picture appears for about 2 seconds with the cursor flashing under all segments If any of the seg ments is incomplete or if there is no flashing cursor the
59. ntrol material and the lot number for documentation purposes FHU Fis Then perform the measurement ir mafdl The results are then displayed printed out or exported to a computer system together with this c If you wish to print out or transfer to a computer all results labeled in this manner after calling up the export function or the profile printout simply press F7 when the instrument asks for the patient name and confirm with the 1 key on the keyboard 3 18 Transfer of patient profiles to a computer system Profile transfer Explanation All test values belonging to one patient identification gt see Entering a patient sample identification in this section can be transferred to a computer system en bloc The computer must be connected and be ready to receive the data gt see Operation with RS 232 C interface in Section 6 Calling up the function TRANSFER PROFILE is displayed for about 1 second Automatically the current identification is suggested If necessary it can be overwritten or another name can be copied using the search and copy function HARE ALM OTHER Terminating the input J The profile is transferred Searching and copying The procedure used for copying a name is the same as that described for copying results from memory gt see Calculation of cardiac risk according to PROCAM Copy the name instead of the test result I
60. o work with these programs Basic instrument settings The basic instrument settings are carried out by Roche Diagnostics or your supplier before delivery However if circumstances change e g in the case of a general change in the system of units to be used for displaying the results or if the standby mode is changed or if the Reflotron Plus is connected to a computer system it may become necessary to alter the basic settings Switch off the instrument Press the two cursor buttons lt and gt simultaneously and hold them down Then switch on the instrument with the ON OFF switch continuing to hold down the cursor buttons lt and gt until the menu appears in the display The menu starts with LANGUAGE 6 3 Procedure Position the cursor flashing broken line under the desired setting by u wl moving it to the left or right with the cursor button lt or gt Press the 1 button to confirm the selection and to proceed to the next menu item If you only press I the old setting is maintained The menu can be exited at any time by pressing the cursor buttons lt and gt simultaneously In this case the instrument initiates the normal start up procedure The menu can also be exited by switching off the instrument You can also exit the menu by means of the prompt shown on the left which appears at the end of the menu SET UF OF HO
61. on of cardiac risk acc to PROCAM Copy the name instead of the result 3 20 Selective data transfer ALM OTHER PATIENT HARE H OTHER Exiting the function Ese L It is also possible to exclude specific results from transfer e g in the case of duplicate measurements To do this label the record concerned by placing an in the first position of the patient sample identification and exit with the Esc key This label can be removed by entering again The function can be exited at any time by pressing the escape key 3 21 Explanation Calling up the function Terminating the input Searching and copying Selective data printout Exiting the function Esc L 3 22 Printout of patient profiles All test results belonging to one patient identification gt see Entry of patient sample identification can be printed out en bloc Press F10 PRINT PROFILE is displayed for about 1 second Automatically the current identification is suggested and can be overwritten if necessary If you wish you can also copy in another name using the search and copy function The profile is printed out Proceed as described for the function Transfer of patient profiles to the computer system It is possible to exclude certain test values from being printed out e g duplicate determinations gt See Selective data transfer und
62. ontents completely by occasionally swirling and inverting the bottle as described in the pack insert avoiding the formation of foam Wait until the stated reconsti tution time has elapsed The solution is then used for the analysis as a sample For stability see the pack insert Compare the result with the values specified in the table supplied with the control material If it lies outside the specified confidence limits proceed as follows Check the expiry date of the test strips and the lyophilized or recon stituted control material Check that you are handling the pipette or applicator and the test correctly Clean the measuring chamber Check the performance of the optical system with Reflotron Check Repeat the test with the control serum Batch specific table of values If the result is outside the confidence limits even though there is no fault in the instrument there are various possible causes Please check whether the respective test strip pack contains a flyer with a separate table of specified values The control material cannot be used because it was not dissolved or stored properly Use a new bottle The test strips from the current pack have expired prematurely This may be because the container was not closed for some time and the capacity of the desiccant has been exhausted the atmos pheric moisture or the temperature have spoilt the test strips Use a
63. pette tip Taking a test strip out of the container 2 14 The Reflotron Pipette should only be used with high grade pipette tips e g Pipette Tips Roche Diagnostics REF 1 0140023 Make sure that the tip is sitting firmly on the cone of the pipette Important rules for working with Reflotron tests The following description of a glucose determination with Reflotron Glucose illustrates use of the test strips You should always have read the appropriate pack insert before performing a test Do not use test strips beyond their date of expiry After removing a test strip close the container at once Otherwise the specified expiry date is no longer valid The desiccant in the cap of the test strip container protects the test strips from moisture Removing the protective foil Keep the test strips away from strong magnetic fields Magnetic fields can corrupt the magnetic code This is indicat ed by the display message MAGNETIC CODE MISREAD In almost all the test strips the test area is covered by an aluminium foil This foil must be removed before use Take hold of the loose end of the protective foil as shown Peel off the protective foil made of aluminium plastic right over the perforation and discard in accordance with the waste disposal guidelines applicable in your practice or laboratory 2 15 2 16 Note Be careful not to bend the test strip when peelin
64. pplicator vertically while dis pensing and perform the action slowly in order to avoid splattering The volume of the capillary pipettes is such that sufficient sample is applied to the test strip After the sample has been dispensed the capillary tube can be eject ed by depressing the dispensing button until the second stop is reached Dispose of potentially infectious material according to the regulations applicable in your practice or laboratory 2 27 Collecting the specimen Centrifuging the specimen 2 28 Obtaining capillary plasma Capillary plasma may be obtained using commercially available ca pillary blood collection tubes microcollection tubes and an appropri ate centrifuge In this case the manufacturer s specifications on the proper use of the collection tubes should be observed After preparing the puncture site see above and wiping off the first drop collect the capillary blood into a collection tube containing an anticoagulant that is suitable for the requested test Fill the tube up to the upper mark select a proper size according to the sample volume required Avoid pressing or squeezing the punc ture site as this may lead to hemolysis and could influence the test result Having filled the collection tube seal it and immediately mix the blood with the anticoagulant by repeatedly inverting the tube or using a mixer To obtain plasma insert the collection tube and a counterbalance into
65. results may be displayed incorrectly In this case contact your dealer or the service department of Roche Diagnostics Wait until instrument is opera tional Tests can be performed Insert test strip or close flap Close the flap measurement will start Push the release lever upwards Wait for the test result 5 1 15 035 81 11080 36 GLU 128 8 mardi 15 053 81 11080 GLU 18 8 mafedl 15 05 61 izim gg GLU E88 mafdl HO PARAMETER HO ENTRY 5 2 12 09 56 Display of the result substrates The result is below the measurement range The result is above the measurement range Display of result for enzymes The chosen reference tempera ture is also displayed The reaction kinetics has slightly deviated from the linear course The reaction kinetics has considerably deviated from the linear course It was not possible to check the reaction kinetics for linearity Reason very high enzyme activ ity concentration or intense intrin sic colour of sample material The concentration enzyme activity is too high or the intrin sic colour of the sample mate rial too intense The unit or enzyme reference temperature cannot be altered as no test strip has been mea sured Indicates that no further record has been found when retrieving results from memory when using the search and copy function or in the transfer or print profile functions see Section 8 Record
66. s Note If you wish you may change the units or the enzyme reference temperature gt See Individual settings in Section 2 If results are obtained which are clinically implausible please refer to Section 4 Cleaning and Quality Checking Notes on result displays in special cases mardi Boido ee CTION The result is below the lower limit of the measuring range The test strip was measured without application of a sample Repeat the test The result is above the upper limit of the measuring range If necessary dilute the sample See pack insert of the Reflotron test The enzyme activity is too high or the colour of the sample is too intense In either case the sample must be diluted and the analysis repeated gt See pack insert of the Reflotron test An asterisk in front of the result indicates that the reaction kinetics were slightly non linear Repetition of the test and or dilution of the sample is recom mended See pack insert of the Reflotron test 2 21 In the case of non linear kinetics and a value at the lower end of the measuring range there is no purpose in diluting the sample The reaction kinetics were a psal JLG strongly non linear INVALID RESU Repeat the test OTe a ee However it is possible that the REACTION HONLIHERE sample cannot be determined with Reflotron Opening the measuring chamber and removing the
67. side of the centre of the finger pad In infants or small children heel or big toe Warm up site prior to puncture The blood flow can be increased by rubbing or massaging or by warming the site e g with a warm moist towel Cleanse the site prior to puncture with 70 alcohol Wipe off residual alcohol to prevent hemolysis The first drop may contain a lot of tissue fluid and should there fore be wiped off with a swab Do not milk the site as this increases hemolysis and introduces excess tissue fluid When using capillary pipettes the drop of blood should be suffi ciently large as otherwise small air bubbles may be aspirated An entrapped air bubble has to be expelled together with the sample material below it and the tube then refilled avoiding the aspiration of air bubbles Collection of blood using capillary blood collection tubes The blood is collected into a capillary blood collection tube Please ensure that the collection tube is coated with an anticoagulant suit able for the test selected For full details of suitable anticoagulants for the various parameters please consult the package insert accom panying the respective Reflotron test Your supplier will inform you where to obtain tubes suitable for the collection or storage of capil lary blood These tubes are coated either with Li heparin or EDTA and are available in different sizes for example Microvette CB 300 or Microtainer The tu
68. strip The result remains displayed until the flap is opened Note It is possible to have a second look at the results later on see Storage and retrieval of results in Section 2 Remove the used test strip and inspect the colour development of the test area 2 22 Inspection of the colour development The entire test area should be coloured Small colour variations are compensated by the integrating technique used for evaluation of the test area A different colour around the edges does not affect the result Note Dispose of the test strip according to the regulations for potentially infectious material applicable in your practice or laboratory 2 23 2 24 Working with capillary blood When working with blood plasma serum or control samples always observe the guidelines regulations and precautions for handling potentially infectious material which apply in your practice or laboratory For specimen collection the usual laboratory equipment such as alco hol swabs cotton swabs lancets and collection tubes are required Capillary blood is collected with the aid of commercially available lancets or a lancing device such as Accu Chek Softclix Pro and the matching Accu Chek Softclix Pro Lancets and commercially available blood collection tubes or capillary pipettes When collecting capillary blood please observe the following points Puncture site In adults a little to the
69. t Settings in Section 6 2 37 Strip counter Calling up the menu i CLOCE PRIHT BEEP UNITS STRIPS DELETE reflatrom piit a A mi En pres ke o p ina J 1 1 MOUNTS CREA COUNTS CREA COURTS TRIG TOTAL COUNTS Printout of strip counter 2 38 When the instrument is READY press the two but tons lt and gt simultan eously to call up the menu for the individual settings Use the lt or gt button to position the cursor under STRIPS and confirm with J If the printer is switched off the respective numbers of tests performed for each parameter are displayed one after the other for about 2 seconds Then the sum of all parameters together is shown TOTAL COUNTS XX If the printer is switched on the individual counts are printed out elo The buttons lt or gt can be used to call up the individual counts again one at a time Press the two buttons lt and gt simultaneously to return to measuring mode The Reflotron Plus is now ready to perform an analysis again Deleting the results from memory Calling up the menu When the instrument is 1 CLOCK PRINT EEP READY press the two but UNITS STRIPS _2 tons lt and gt simultan eously to call up the menu for Reflotren j iiih the individual settings E Mal a i Use the lt
70. t is also possible to exclude certain test results from the transfer e g in case of duplicate assays For this purpose label the record concerned by entering in posi NAME tion 1 of the patient sample identification and exit with the ESC key ZH OTHER This label can be deleted by keying in once again Exiting the function le The function can be exited at any time by pressing the escape key 3 19 Profile transfer Il Explanation The data transfer described above can also be performed in a differ ent format Each record then contains the following information separated by semicolons Date Time Patient name identification if entered Result line Additional text if entered Example 20 10 01 15 51 44 A N OTHER TG 180 mg dl additional text These records e g also of control measurements can then be further processed e g with a conventional software program Calling up the function Profile transfer Il is displayed for about 1 second The current identification is automatically offered and can be over PATIENT MAME written if desired AH OTHER If you wish you can enter another name using the Search and copy function Terminating the input J Press the 1 key to transfer the profile Searching and copying The procedure for copying an identification is the same as that Paun Pron described for copying results from memory gt Calculati
71. the optical system see also Display Messages and What They Mean Improper excessive application of the sample can make it necessary to carry out cleaning at considerably shorter intervals Allow Reflotron Plus to stand for at least 10 minutes after completion of the cleansing operations before switching on again Do not spray disinfectants into the measuring chamber Open the flap to clean the measuring chamber If there is still a test strip in the measuring chamber this should be removed If it cannot be removed easily lift up the release lever and then remove the test strip 4 1 4 2 Lift the black shield forwards as far as it will go Clean the upper heater especially the aperture with a gentle rotary action e g using an alcohol moistened wipe preferably 70 alco hol e g from Reflotron Clean and Check A cotton bud moistened with water can also be used In this case wipe dry with a dry cotton bud Then check to see that no strands of cotton wool have been left behind Hold the black shield forwards and pull upwards pulling the bridge upwards at the same time Also wipe the transporter especially the lower heater and the mag netic head e g with an alcohol moistened wipe or a moist cotton bud In the latter case dry with a dry cotton bud If cotton buds are used for cleaning contaminated parts can be dis infected by subsequent cleaning with a wet wipe 70 alcohol e g from Ref
72. trip 2 18 Lift the flap The test strip must be inserted into the measuring chamber horizontally within 15 seconds for the exact time see pack insert after applying the sample see Practice with Reflotron Check in Section 2 The message PLEASE CLOSE FLAP confirms that the test strio has been properly locked into position If this message does not appear when the test strip has been inserted proceed as follows O remove the test strip O if necessary push the release lever upwards O insert the test strip again Display PLEASE CLOSE FLAP This must take place within the given time limit approx 15 sec see above Otherwise a new test strip must be used and the process repeated Closing the flap Other messages MAGH EPS TIL CODE MISRERD Close the flap The magnetic code is read The appearance of the parame ter abbreviation GLU confirms that the Reflotron Glucose test strip has been correctly inserted and the data of its magnetic code have been read by the microprocessor The same abbreviation in this case GLU also appears on the label of the test strip con tainer and on the handle of each Reflotron test strip for purposes of identification The time remaining before the result appears is displayed in seconds If the instrument displays one of the following messages instead of GLU RESULT IN 143 SEC then something is wrong
73. ue to be allocated to the respective results The entry which remains in the background after the function has been exited again appears on the display Explanation Calling up the function CARDIAC RISE mardi Calculation of cardiac risk The cardiac risk of the individual patient can be calculated on the basis of prospective studies This helps the doctor to set up and assess the patient s risk profile With Reflotron Plus the individual cardiac risk can be calculated according to either the PROCAM study or the FRAMINGHAM study Reflotron Plus has been preset by the manufacturer to PROCAM This setting can be altered to FRAMINGHAM see Basic instru ment settings in Section 6 These calculations can of course not replace the doctor s decision Calculation of cardiac risk according to PROCAM In the PROCAM study Prospective Cardiovascular M nster Study the incidence of myocardial infarction in relation to defined risk factors was ascertained in 40 to 65 year old men Strictly speaking therefore the calculation can only be used with male patients In the sense of an extended interpretation of the PROCAM data it is also permissible to use this cardiac risk calculator for women after the menopause Press F2 Reflotron Plus displays the first parameter to be entered Depending on the setting mmol l might be displayed instead of mg dl Now t
74. um maximum Cholesterol mg dl 100 999 99 mmol l 2 586 25 86 Triglycerides mg dl 1 0 400 0 mmol l 0 011 4 572 HDL cholesterol mg dl 25 0 75 0 mmol l 0 647 1 940 The following functions can be performed now Searching and copying Changing existing values Printout of a record Export of a record gt See also Calculation of cardiac risk according to PROCAM in this Section Press the Escape key to return to analysis mode 3 11 Explanation Calling up the function E CHOL mardl CHOLSHDL RATIO DHOLSHOL RATIO mardi Searching and copying Paue Pg One Printing out a record F10 3 12 Calculation of the cholesterol HDL cholesterol ratio CHOL HDL ratio The cholesterol HDL ratio in combination with other parameters provides information about a disturbance of the lipid metabolism Press F4 Enter the patient s cholesterol value and confirm with the 1 key on the keyboard If the value is above or below the limit values Reflotron Plus indicates this by displaying the sign lt or gt before the respective maximum or minimum value If the entry is not corrected Reflotron Plus per forms the calculation with the programmed limit value Enter the HDL cholesterol value and confirm with the 1 key on the keyboard Maximum and minimum values programmed into the instrument minimum maximum Cholesterol mg dl 100 500 mmol l 2 586 12
75. ument with the Reflotron Plus switched off 2 Start up and Practice 9911981d pue dn J1815 2 Start up and Practice Switching on the Reflotron Plus Plugging in the mains cable When the mains cable has been plugged in or an appropri ately adapted Reflotron Plus has been connected to a suit able DC source the instrument is ready for operation Attention Never obstruct the vents on the top of the apparatus or the fan outlet at the bottom The prerequisites described under Proper siting gt see Section 1 must be satisfied 2 1 2 2 Preliminary remarks The meanings of the various display messages are explained below Display messages indicating correct operation appear on a neutral back ground messages indicating differing procedure appear on a light grey back ground Display messages on a dark grey background indicate either incorrect operation or instrument faults For a detailed description of display messages see Section 5 Display Messages and What They Mean Switching on the instrument After switching on the Reflotron Plus using the on off switch all segments of the dis play appear for about 2 sec onds Check that the display appears exactly as shown on the left The lines under the segments should be flashing If any dots or segments are missing the result shown may be incorrect In this case please contact your supplier

Reflotron User Manual - The University of Sydney

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