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PRONTO Evolution - RANDOM ANALYSER


Valid for Instruments with S/N 09-0011 to 09-0______

TABLE OF CONTENTS
MAINTENANCE SCHEDULE.........................................................................................2 SECTION 1. INTRODUCTION.......................................................................................3
1.1 GENERAL DESCRIPTION.................................................................................................3 1.2 TECNICAL SPECIFICATIONS.......................................................................................5 1.3 INSTALLATION...................................................................................................................6 1.4 STARTING THE ANALYZER and the MAIN MENU......................................................7

SECTION 2. OPERATION - Routine..............................................................................8


2.1 ENTERING TEST REQUESTS MANUALLY..................................................................8 2.2 LOADING REQUESTS FROM LAB-COMPUTER........................................................12 2.3 PRINTING LOAD-LIST (PER PATIENT).......................................................................14 2.4 PRINTING WORKLISTS (PER TEST)...........................................................................15 2.5 CALIBRATION...................................................................................................................16 2.6 START ANALYZER ..........................................................................................................18 2.7 2.8 2.9 2.10 2.11 DILUTE & REPEAT TESTS..........................................................................................22 VERIFY RESULTS / ENTER MANUAL RESULTS..................................................24 REPORTING RESULTS................................................................................................26 PREDILUTING SAMPLES...........................................................................................29 QUALITY CONTROL ..................................................................................................30

2.12 IMMUNOCHEMISTRY....................................................................................................32

SECTION 3.
3.1

PROGRAMMING and FORMATTING...............................................36

PROGRAMMING CHEMISTRIES...............................................................................36

3.2 ASSIGNING AND MODIFYING METHODS................................................................37 3.3 PRINT METHODS............................................................................................................39 3.4 REARRANGING SEQUENCE OF METHODS.............................................................39 3.5 3.6 3.7 3.9 3.10 CONFIGURATING PROFILES.....................................................................................40 FORMATTING REPORT HEADER.............................................................................40 CONTROL SERA.............................................................................................................40 SETTING DATE AND TIME.........................................................................................42 DISK COPIES................................................................................................................42

3.8 SET-UP ON LINE CONNECTION .................................................................................41

SECTION 4.

MAINTENANCE & TROUBLESHOOTING.......................................42

4.1 SELECT SAMPLE TRAY..................................................................................................43

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4.2 ADJUST PERISTALTIC PUMP........................................................................................43 4.3 RINSING THE SAMPLING SYSTEM.............................................................................43 4.4 RINSING THE FLOW-CELL...........................................................................................44 4.5 CHECK FILTERS.............................................................................................................44 4.6 POSITION FILTER and READ O.D.................................................................................45 4.7 SELECT PRINTER.............................................................................................................45 4.8 MAINTENANCE................................................................................................................45 4.9 PASSWORD(2)...................................................................................................................46 4.10 4.11 4.12 4.13 4.14 SELECT SERIAL PORT.............................................................................................46 AUTOMATIC REPETITION IF BEYOND LINEARITY .........................................46 WATER LEVEL DETECTOR ON/OFF......................................................................47 REAGENTS COOLING SYSTEM..............................................................................47 TROUBLE SHOOTING.................................................................................................47 ................................................................................................................48

SYMPTOMS POSSIBLE CAUSES & ACTIONS..........................................................47


Erroneous autozero 4.15 MECHANICAL TESTS....................................................................................................49 Vertical movement sample arm ..................................................................................................49 4.16 SETTING AND STORING STEPS...............................................................................51

SECTION 5.

REMOVAL AND REPLACEMENTS..................................................55

5.1 DISASSEMBLING THE CABINET.................................................................................55 5.2 REPLACING THE SYRINGE...........................................................................................56 5.3 REPLACING THE LAMP/CALIBRATION...................................................................57 5.4 REPLACING A FLOW-CELL..........................................................................................58 5.5 REPLACING TUBING OF PERISTALTIC PUMP........................................................59

APPENDIX 6-A................................................................................................................60 APPENDIX 6-A................................................................................................................61 APPENDIX 6-A................................................................................................................62 APPENDIX 6-B................................................................................................................64 APPENDIX 6-B................................................................................................................65 APPENDIX 6-B................................................................................................................65 APPENDIX 6-C................................................................................................................66

MAINTENANCE SCHEDULE
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DAILY MAINTENANCE Perform washes of the sampling system before and after the daily job is performed.It's reccomended to use our cleaning agent C4010 diluted 1:5 with distilled water , instead of only distilled water into the water container, as it helps to keep clean and uncontaminated the instrument without any interference with the chemistries. Clean the aspiration needle with a soft cloth and ammonia or another degreaser liquid that doesn't leave deposits. Perform an extra wash of the flow cell using our Ipocleaning solution E5056 and our Extracleaning solution C4015.Proceed in the following way: Enter in Maintenance Menu, select the function WASHING CUVETTE and select again the option : WITH IPOCLEANING AND EXTRACLEANING, then press ENTER, the screen will prompt all the instructions to follow.In case of hard deposits or dirty,aspirate manually the Extracleaning and leave the solution into the flow cell 1 night long, then perform washings with distilled water. Check tubings of aspiration systemand of the peristaltic pumps, in case of leakages replace them. Check if waste pump works correctly, in case it's necessary perform a sampling system washing with Extracleaning, then wash perfectly with distilled water to eliminate every trace of cleaning agent. Replace tubing of peristaltic pumps Lubricate with thiny oil cylinders of rotor on peristaltic pumps and all axes of mechanical assemblies.Be careful to not leave oil deposits on the mechanics. Clean the inner and the outer parts of the waste well using a cotton stick, remove expecially the inner fungine deposit to avoid contaminations. Clean or eventually replace the plunger of the syringe pump.Check for the presence of a persistent air bubble into the syringe during aspiration. Replace the aspiration and sampling system tubings, replace the waste and water tubings too.

WEEKLY MAINTENANCE TWO WEEKS MAINTENANCE

QUARTERLY MAINTENANCE

YEARLY MAINTENANCE

SECTION 1. INTRODUCTION 1.1 GENERAL DESCRIPTION


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The PRONTO Evolution is a random access/patient selective batch analyzer: the philosophy of the system is patient by patient,and working in time sharing, it's possible to access different functions while equipment is running tests.System is composed by a compact instrument and an external computer with a control custom board installed in. Computer controls all functions of PRONTO Ev. and permits data handling typefunctions from requesting to reporting and quality control,without halting the instrument's routine in progress. Features of the instrument are also the on board cooling system, the reagent level detection system and the possibility of working with primary tubes. Furthermore we have full 180 reactions on line without interrupting the routine. Main parts of the PRONTO Evolution are: -REAGENT COMPARTMENT : with 15 positions for reagent containers 45ml each or monotest adapters 2,5 ml. Cooling system for all 15 positions -SAMPLING STATION : 1000 l Syringe with sample probe and flow through needle cleaner - Reagent/sample level detector inductive capacitive with software setting -SAMPLE TRAY : twin possibility of operations: 20 primary tubes + 18 serum cups or removable turn table with 58 positions for samples,10 standards and 2 controls -REACTION RING : a ring around the sample tray, solid body with it, containing 180 reaction wells (2 concentric rings of 90 each) grouped in 10 disposable SECTORS of 18 positions each (2 x 9) provided with electronic control heater at 37 C for incubation -ASPIRATOR : a robotic arm with a probe to aspirate reaction mixture,driven by peristaltic pump. Washing well heated with peristaltic filling system -PHOTOMETER : consisting of 1 Quartz-Tungsten Lamp in the center of a Filterwheel, 1 flow cell (50 l) and 1 photodiode. The filterwheel contains a set of 6 interference filters + 1 position free for option The equipment works in a Sip and Dip way, syringe pump is always filled up with water,then during sampling it aspirate reagent, sample and dispenses the mixture into reaction well.Between water and reagent, reagent and sample and after the sample, there are gaps of air to avoid any contamination..Results are printed in a patient report or can be listed on a per-test basis. Up to 200 patients can be either programmed manually or downloaded from a laboratory computer. Up to 50 different methods can be programmed.

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1.2 TECNICAL SPECIFICATIONS
: Continuous (Walk away) : Random access/selectable Batch : End-Point Initial Rate Kinetic Bichromatic Differential (sample blank) Turbidimetric : 1 - 2 different reagents can be programmed for each test : 50 tests / patient , 4000 reports in long time storage : 38/58 sample positions + 2 pos. for controls, 20 Primary tubes, 10 standards. Interchangeable sample holders

Type of access Way of working Types of analysis

Number of reagents Patient file Sample holders

Reagent compartment : 15 reagent containers 45ml each - Electronic cooling system Reaction compartment: 180 positions:10 sectors of 18 wells Photometer : 6 interference filters + 1 option - range 340 to 620 nm resolution 0.0001 Abs. - Quartz-Tungsten Lamp, 10 Watt 50l flow cell temperature control by peltier elements:37C 0.1 : variable from 50-900 ul : variable from 2-100 ul : External DOS-compatible 386/486 option : 14", color SVGA : alfanumeric Std US : std High Speed Graphic printer on-board, 40 characters optional External printer. : RS 232 C : Printer Centronics Compatible : alphanumeric, patient by patient, or test by test. Date, patient ID and patient name. : 68 x 55 x 41 cm (W x D x H) : 40 Kg. :220 V - 50 Hz optional : 110 V - 60 Hz :400 Watt

Reagent volume Sample volume Processing Video display Keyboard Printer Serial port Parallel port Reporting Dimensions Weight Power requirements Power consumption

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1.3 INSTALLATION
After unpacking, check: - the presence of water container - the presence of a powercable - if the power on site corresponds with the power specified on your machine (220V or 110V). - check the presence of a program diskette

! IMPORTANT
If the instrument must be powered with 110 V , please refer to APPENDIX D to perform the power voltage change. If Voltage is not changed, malfunctioning or more severe damages can occurr. For the power,use a "clean" line, with not too big variations in voltage, and provided with a ground. Avoid to place the instrument into direct sunlight. In case your PRONTO Evolution has been purchased with the computer, the custom interface board has been already installed into the computer, in this case you need only to connect the flat cable from the card mounted into computer, to the rear connector of PRONTO Ev. analyzer. NOTE - Its important to connect the ground wires of the flat cable to the chassis of the instrument and to the chassis of the computer. In case you have purchased PRONTO Evolution to be installed with your own computer, follow these instructions: 1. With PRONTO Ev. is supplied a Custom Interface Board to be installed into a slot of your computer's mother board.This PCB is electrostatic sensitive, so handle it with care and take it off its plastic bag just immediatly before installation. 2. Disassemble the case of your computer after having disconnected it from AC line. 3. Insert the PCB PRONTO Ev. interface Board into a slot of your computer's mother board. 4. It's not necessary to check the IRQ of other boards present into your computer and beware their IRQ numbers don't match IRQ of PRONTO interface board, as this PCB doesn't work in Interrupt. 5. Assemble cover of the computer and complete connections with PRONTO Ev. and other peripherals equipments.

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1.4 STARTING THE ANALYZER and the MAIN MENU
To switch on PRONTO Evolution, you must first switch on the computer, with the software disk inserted into the floppy disk slot.

! IMPORTANT
The software will detect automatically the presence of an hard disk and will ask you to install it onto the hard disk drive, in order to start it automatically at the boot. Once the software has been installed onto the Hard Disk and the computer has been rebooted or once the computer has been switched on with the floppy disk inserted into the drive, the program is loaded automatically, then the following message will be prompted on the screen: SWITCH ON THE INSTRUMENT Now you can switch on PRONTO Evolution by the main switch located on the rear of the instrument, after a while the MAIN MENU appears, with the 3 main selections: PATIENTS ANALYZER UTILITIES HELP 22-09-1997 12:10:54

Rev. 1.7

The option PATIENTS offers access to all patient data and results. The option ANALYZER offers access to all functions of the analyzer, from routine work and methodology till maintenance. The option UTILITIES offers access to all other functions.The option HELP it's just a brief comment to keyboard functions. With the cursor keys and it's possible to step from one selection to the other or, in case no menu' is selected, just type the letter that appears highlighted (i.e. ANALYZER).

Once the menu name is selected with the arrow keys, hit ENTER and the sub-menu of the selected option is being displayed: PRONTO Evolution USERS MANUAL
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PATIENTS ANALYZER UTILITIES HELP 22-09-1997 12:10:54

1-ENTER PATIENTS E REQUESTS 2-PRINT PATIENT REPORTS 3-PRINT RESULTS PER TEST 4-LIST PATIENTS 5-WORKLISTS 6-ENTER MANUAL RESULTS 7-RECEIVE PATIENTS 8-TRANSMIT RESULTS

PATIENTS

ANALYZER

UTILITIES

HELP

22-09-1997

12:10:54

1-START ANALYZER 2-CALIBRATION 3-METHODS PROGRAMMING 4-MAINTENANCE 5-MECHANICAL TESTS 6-QUALITY CONTROL 7-PREDILUTION 8-REPEAT TESTS 9-IMMUNOCHEMISTRY

PATIENTS

ANALYZER

UTILITIES

HELP

22-09-1997

12:10:54

1-SET DATE 2-SET TIME 3-COPY DISK 4-SET REPORT HEADER 5-SET PROFILES 6-SET ASSAY VALUES CONTROLSERA 7-TEST-CODES for ON-LINE 8-COPY PREVIOUS PATIENTS

Each of the sub-options can be selected by going there with the cursor keys and hitting ENTER, or by just typing the corresponding number.

SECTION 2. OPERATION - Routine 2.1 ENTERING TEST REQUESTS MANUALLY


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This option offers 2 suboptions: DELETE PATIENTS ENTER PATIENTS that can be selected with the cursor keys and hitting ENTER at the selected option. Patients are stored with a patient number 1-200. In fact this is a position number, corresponding with the position on the sample tray. The sample tray however can be selected in Maintenance Menu; we can operate with both serum cups and primary tubes, in this case we select Sample Tray = 38. In case we want to operate with serum cups only, then we select Sample Tray = 58, in this case the normal sample tray of PRONTO can be used. So the relation can be as follows ( when sample tray = 38 is selected ): Pat.No. 1 2 . 20 21 . 38 39 etc. Position No. 1 2 . 20 21 . 38 1 Sample Container primary tube primary tube Serum cup Serum cup primary tube 2nd tray

And so on till reaching the patient number 200. Of course in this case the second or third tray are virtual as physically we do not change the tray. In case we select the sample tray = 58 the relation becomes the following : Pat.No. Position No. 1 1 . . 58 58 59 1 2nd tray . . 116 58 117 1 3rd tray . . Of course in this case we use only serum cups and not primary tubes too.

The patient number is set to 1, when the active patient record is being cleared and increments automatically every time a new patient is entered, either manually or on-line. Furthermore every patient has a field for a Patient ID of 8 characters (alpha- numeric). This patient ID can be the same as the patient number, or in case of a bigger labcomputer, it can correspond to the patient number in the labcomputer. This is PRONTO Evolution USERS MANUAL
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specially useful by on line connection to this lab computer. An extra 30-char.field is available for the patients name. DELETE PATIENTS At the beginning of the routine (or at the end of it !) the active patient record should be cleared. The patients cleared away this way can however be saved on the diskette in the long- time storage file (4000 patients). If needed later they can be retrieved from this file with the option PRINT PATIENT REPORTS. When all patients are cleared the patient counter is reset to 1. There is however the possibility to save patients that are not completely ready and rearrange them in the active file, starting at number 1. Refer to this flow chart for the available selections and the effects obtained : DELETE PATIENTS SAVE PATIENTS (Y=1) YES results saved in longtime storage. SAVE PENDING TESTS NO active file is cleared and patient number reset to 1 YES ALL completed patients are deleted. All patients with pending tests are regrouped starting at no 1. The program jumps to the option ENTER PATIENTS as described below. HOWEVER: the patient number will be different.When e.g. 11 patients of the former day were with results missing they will be assigned the new numbers 1 - 11 and the next free number will be 12.

ENTER PATIENTS This option shows the following fields:


PATIENTS ANALYZER UTILITIES HELP PATIENT 12-06-1997 Esc=Exit

Patient number ?1

Position on sample tray : 1 Page 10 of 67

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Pat. ID Pat. Name

TEST:

A) TP K) CHE U) HDL e) IGG

B) BUN L) LDH V) CPK f) IGM

C) CHO M) FAL W) PH g) TRF

D) GOT N) BIT X) MG h) APA

E) TRI O) BID Y) FAP I) APB

F) GPT P) UA Z) PHL j) C3

G) GLU Q) CA a) BIL k) C4

H) GGT R) FE b) FEF l) PCR

I) CRE S) AMY c) ALB m) PCL

J)FAC T) CL d) IGA

F1=Next F2=Stat

F3=C1

F4=C2

F5=Patient

F6=GO TO F8=Copy until n.

F9=Preceeding

Entering Patient no.: XXX Here the current patient no. is displayed.With F1 and F9 you can page through the patients already entered. Patient ID. : Up to 8 alphanumeric characters corresponding to a hospital or laboratory ID.

Patient Name : Up to 30 alphanumeric characters for pat. demographics. Both fields will appear on the patient report. TEST : You can select it with: - a Test-ID letter as displayed in the block below - a number of a profile as configurated in the Profiles ( Sec. 3.5 ) - a test can be deleted by typing it again.

Selected tests 'light up' in the block below.

TEST-BLOCK

Here the test-ID of all configurated chemistries are being displayed. Each test selected is displayed in inverse-mode. An alternative mode to select tests, is to go into the test to be selected by means of the cursor keys and hitting the ENTER key. By hitting the ENTER-key again a test can be defeated.

Once a patient is ready, hit F1 to go to the next number.Hitting F9 you go to previous patient.When the last patient has been entered, hit ESC to return to the main menu. PRONTO Evolution USERS MANUAL
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F8 KEY With this key it is possible to copy the last patient entered into the next numbers, until a user selectable number. It is used for long series of tests (research). F2 KEY Pressing this key it's possible to select urgent patients to be executed in random way with priority.It is possible to enter patients with different characteristics of execution by typing a different function key: a normal patient it's executed as normal random, an urgent entering is executed with priority all over other patients, a control entering (C1,C2)is executed as a control and sample is picked up into C1 or C2 position. According to selection made, will change the entering status bar on the upper part of the screen (Patient-Stat etc.). F3 - F4 KEYS By Pressing one of these two keys, it's possible to execute a control test in between two consecutive patients, in this case, request of control will be entered as a normal patient, but the instrument will pick up serum in position C1 or C2. F6 KEY With this function key is possible to skip some patients number and to go directly to a selected patients number. It can be useful working with primary tubes only, as their positions are from 1 to 20, then after this entering its possible to select GO TO N. 39, which as explained above corresponds again to position 1 on sample tray, when 38 is selected. By this, when working in continuous access, its possible to perform tests for the first sample, then replace its primary tube, while the instrument is testing the second one, with a new sample which will be numbered 39.

2.2 LOADING REQUESTS FROM LAB-COMPUTER


As an alternative to manual entering, the patients and test requests can be downloaded from a computer. After tests are completed its possible to send back the results associated with the patients to the host computer via a serial connection to be implemented between the host computer and the PRONTO Evolution. The options which are used to perform the downloading from and to the host computer are RECEIVE PATIENTS and TRANSMIT PATIENTS in the PATIENT MENU.

When we select this option, we have the following mask on the screen: PATIENTS ANALYZER UTILITIES HELP 22-09-1997 12:10:54

RECEIVING PATIENTS No. of patients & controls present : 10 RECEIVING PATIENTS


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DELETE PATIENTS
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Rev. 1.7

At this moment we can select the two options displayed; if we select RECEIVING PATIENTS, we will add these patients to the patients which are already present in the instrument, if we select DELETE PATIENTS, the effect will be exactly the same described in the section ENTERING PATIENTS, by resetting the progressive number to 1 and deleting all the patients present. Once we select RECEIVE PATIENTS, the system will contact the host computer by sending an enquire for connection, if there is contact with the host computer the PRONTO Evolution displays: >> COMPUTER ON LINE << When patients are received they are being displayed.When nothing appears, it means that the computer is either not ready or there are no new patients to be loaded. You can escape from this program any time with the key ESC. NOTE - The patients received from a lab computer can be resent to the lab computer, after the tests have been completed, with the option TRANSMIT RESULTS, but if we want to send to the computer also some patients which have not been downloaded from the lab computer, but have been entered directly into the PRONTO, we must use the option UNIDIRECTIONAL, in order to send to the lab computer also the patients entered directly on the PRONTO (i.e. URGENCIES).

For any further information about this operations, refer to your lab data handling software operations manual.For any data implementation with an existing lab software refer to appendix 6-B of this manual for transmission and data protocol description. When all the tests have been completed for all the patients, then its possible to send back the results to the host computer by the selection of the TRANSMIT RESULTS function. The screen will display : PATIENTS ANALYZER UTILITIES HELP 22-09-1997 12:10:54

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TRANSMITTING RESULTS Rev. 1.7 By selecting TRANSMITTING RESULTS we can send back all the patients previously downloaded from the host computer with associated results for the tests requested. With the sub option UNIDIRECTIONAL we can send to the host computer also the patients which have not been downloaded, but have been entered directly on the PRONTO Evolution, as the urgencies. NOTE - Its not possible to send to the host computer with the TRANSMITTING RESULTS function, the patients which have not been received from the host computer, as the instrument will collate a code for each patient received from the host computer. In case we want to send to the host computer also some patients, as the urgencies, that have been entered directly on the instrument, we must use the UNIDIRECTIONAL option. UNIDIRECTIONAL

2.3 PRINTING LOAD-LIST (PER PATIENT)


Once the patients have been entered, a loadlist for the sample trays is to be printed. The option LIST PATIENTS from the PATIENTS-menu list all patients with their position no., Pat.ID, and tests requested. According to this list the sample tray has to be loaded. Selecting LIST PATIENTS this mask will appear on the screen: PATIENTS LIST VIEW PRINT

By selecting the option PRINT, all patients' list is printed by the internal printer. PRONTO Evolution USERS MANUAL
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By selecting the option VIEW, is displayed on the screen the following mask:
PATIENTS NUM. 1) 2) 3) 4) 5) 6) 7) 8) 9) 10) ANALYZER ID. 001 002 003 004 005 006 007 008 009 010 UTILITIES NAME P. Smith A. Red HELP 12-06-1995 Esc=Exit

TEST - PATIENT N.: 2 GLU = 0 BUN = 25 CHO = 0

By selecting the patient number using the arrow key, selected patient will be lighted up and on the right column will be displayed all results and tests related to that patient.To escape from this menu press the ESC key.

2.4 PRINTING WORKLISTS (PER TEST)


The option WORKLISTS from the PATIENTS-menu offers the possibility to list the work to be done on a per test basis. It is NOT necessary to print these lists to run the routine but it may serve other purposes, e.g. a REST-LIST, to see which tests are not finished yet.Selecting this option the following screen will be displayed:
WORKLIST SELECT TEST ALL TESTS

By the choose of ALL TESTS, a complete worklist for all tests will be printed, by selecting SELECT TEST option, will appear this screen:
PATIENTS ANALYZER UTILITIES HELP WORKLIST EXISTING TESTS: 12-06-1995 Esc=Exit

A) TP K) CHE U) HDL e) IGG

B) BUN L) LDH V) CPK f) IGM

C) CHO M) FAL W) PH g) TRF

D) GOT N) BIT X) MG h) APA

E) TRI O) BID Y) FAP I) APB

F) GPT P) UA Z) PHL j) C3

G) GLU Q) CA a) BIL k) C4

H) GGT R) FE b) FEF l) PCR

I) CRE S) AMY c) ALB m) PCL

J)FAC T)CL d)IGA

Select the tests you need worklist for and press ESC key to start printing. PRONTO Evolution USERS MANUAL
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Here is a sample of WORKLIST printout :

WORKLISTS on date : 22-09-1997 TEST : BUN - UREA R 1414 NUM. PAT. ID. PAT. TOT. TESTS : 6 *********************************************** 3) 01002 ..................... 5) 01050 ..................... 6) 01051 ..................... 8) 01053 ..................... 9) 01054 ..................... 10) 01055 .....................

2.5 CALIBRATION
As PRONTO Evolution is a random access analyzer, it's not necessary to enter all patients before performing calibration, but it's possible to calibrate up to 10 tests before entering any patient. Furthermore it's possible to perform calibration against standard or use the factor obtained with a previous calibration. To carry out all calibrations required select the option CALIBRATION from the ANALYZER-menu. The following screen is displayed:
PATIENTS ANALYZER UTILITIES HELP 12-06-1997 Esc=Exit

ANALYZER OPERATING CALIBRATE ? *(CALIBRATED) A) TP B) BUN C) CHO D) GOT E) TRI F) GPT G) GLU H) GGT I) CRE 67 J)FAC

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K) CHE U) HDL e) IGG L) LDH V) CPK f) IGM M) FAL W) PH g) TRF N) BIT X) MG h) APA O) BID Y) FAP I) APB P) UA Z) PHL j) C3 Q) CA a) BIL k) C4 R) FE b) FEF l) PCR S) AMY c) ALB m) PCL T)CL d)IGA

F1 = Continue F4 = Delete Calibration

F2 = View

F3 = Print * ( Calibrated)

In the lower block the tests that can be calibrated are being displayed, together with the number of samples for each. To select tests to be calibrated it's possible to proceed in different ways: 1- Typing letter or capital letter beside test to be calibrated, remember that a small letter and a capital letter are not indicating the same test. 2- Selecting profile number to calibrate all test grouped in that number 3- Moving with arrow keys and typing Enter key to select tests When tests to be calibrated are selected, press F1 to continue and execute calibration. Beside test codes, in square parenthesis are indicated the number of samples per test. NOTE* If calibration of a test has never been performed, it will not be possible to run that test, if no test is calibrated,the instrument will not start operations, even if patients and requests are entered. By this is necessary to run at least a first time a calibration, then the calibration frequency will be up to the end user only. The instrument keeps in memory the calibration factor and indicates it with an * beside the test.

Another point to remark is that to operate with PRONTO Evolution, you don't need necessarily to enter patients, as working in true random mode, it's possible to enter patients while instrument is running. Here there are three choices, F1 to continue the calibration, F2 to view and F3 to print the previous calibration datas ( i.e. the calibration factors of yesterday). NOTE* that all test marked with an asterisk ( * ) are already calibrated ! After having pressed F1 Key, will be prompted the following screen:
PATIENTS ANALYZER UTILITIES HELP 12-06-1997 Esc=Exit

EXECUTE TEST
TEST GLU GOT CHO BUN STD POS. 1 1 1 REAG.POS. 15 2 6 12 REAG.VOL.ml REAG.VOL.ml (Exist.) 42 38 32 18 00 00 00 00 STD 290 150 46 FACTOR 323.2 1768 612 1210 CONTROLS C1 C2 C1 C1C2 C1

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F1=CONTINUE

F8=ALL WITHOUT CALIBRATION

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F10=CONTROLS Y/N

Pressing F9 Key it's possible to change value of the standard concentration and carry out calibration against standard. Pressing F8 Key it's possible to change the factor and carry out tests against factor without any calibration. In case you choose F8 option, select factor and press F1 to go on with test.Calibration will run only for blank reagent O.D. reading, then it will go back on main men and will be possible to go into start analyzer option. When calibration is completed, the instrument goes back to main menu. NOTE* Calibrations must be executed before starting the routine, positions for standards are the same position for samples going from n. 44 to n. 58, when sample tray=58 is selected, and for samples going from 21 to 35 when sample tray=38 is selected, but normally these positions are used only in case of multistandard calibrations, in clinical chemistry the use of a single multistandard to calibrate more test is the most diffused, in this case beside the position of the standard is displayed an asterisk (*); when calibrations are completed, replace standards with sera if necessary. If a test is calibrated already, it will be prompted on the screen with an asterisk (*) beside to indicate it.

2.6 START ANALYZER


Selecting this option, the equipment starts the routine, as PRONTO Evolution works in time sharing, true random capabilities are available, so without stopping the routine, it's possible to execute other functions, entering new patients, adding reagents and others, as well it's possible to stop the routine to execute urgent patients and print immediatly results. The first choice before starting routine is for the mode of operation, that can be selected to be BATCH or RANDOM TEST. The next screen presents a list of the work to be done, e.g.:
PATIENTS ANALYZER UTILITIES HELP 12-06-1997 Esc=Exit

EXECUTE TEST TEST REAG. POS. REAG. VOL.ml FACTOR ............................................................................................................................... GLUCOSE R1250 15 >2 308.4 UREA R1414 7 8 2424.2 CHOLESTEROL 5 15 442.39 TRIGLYCERIDS 3 8 600 GOT/AST 2 10 1768 GPT/ALT 4 10 1768 CREATININE 11 >2 113.51 N. 6 6 8 6 6 6 6 67

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F1=EXEC.RANDOM F4=EXEC.BATCH F5=SELECT TEST SAMPLE TRAY 1 PATIENTS (1-38) F7=CHANGE TRAY

By pressing F1 or F4 you can start operations either in random or batch mode, by pressing option F5 it's possible to select which test should be executed, by pressing F7 the instrument is paused to change sample tray to be executed. Fill the reagent containers with the amount of reagent needed and place them in the proper positions in the reagent tray. NOTE - When the Reagents level detector is activated, in Maintenance Menu, and the function CK INITIAL VOLUME is enabled, before starting the operations, the instrument will always check all the reagents for the tests to be performed and will display directly on the screen the existing volume of reagent. In this case the operator is not allowed to type any number into the VOLUME field. In case the reagent wont be enough to perform all the existing samples, then a symbol > will appear beside the reagents volume and the instrument will not start the routine. Then it will be necessary to add reagent or if this is not possible, to deselect the test whose reagent is not enough.

At the moment we select the option F1 or F4 to start the routine, the screen will display the following :
PATIENTS ANALYZER UTILITIES HELP 12-06-1997 Esc=Exit

EXECUTE TEST TEST REAG. POS. REAG. VOL.ml FACTOR ............................................................................................................................... GLUCOSE R1250 15 10 308.4 UREA R1414 7 8 2424.2 CHOLESTEROL 5 15 442.39 TRIGLYCERIDS 3 8 600 GOT/AST 2 10 1768 GPT/ALT 4 10 1768 1) Check water container is full 2) Check waste bottle is empty 3) Place Reagents into reagent compartment 4) Place Samples, Standards and Controls into positions N. 6 6 8 6 6 6

5) Check the probes of Sampler and Aspiration system 6) Check if segments have been inserted !! OPERATIONS TIME hh:mm START ANALYSER Now, by pressing the ENTER key, the routine will start. PRONTO Evolution USERS MANUAL
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On the lower part of the central mask, is displayed the time the instrument requests to perform all the tests which are already entered, of course if we enter other samples and tests during the routine, the time requested will not be effective anymore. Once the instrument starts the operations, in the order it will perform several rinses of the sampling system and of the aspiration system with the flow cell. Then it will perform the AUTOZERO operation in order to set all filters level to 0 Abs. On the screen it will be displayed : Alt+F1= Abort CHECKING FILTERS At this moment the instrument is zeroing the filters levels. At any moment of the routine, its possible to abort all the operations by pressing Alt+F1. If there are problems with the lamp or with the flow cell, the system will display an alarm ( refer to the Maintenance section ). If everything is right, then the system will start sampling and reading operations.

During all the routine operations the screen will display the following mask: ANALYSER IN OPERATION SAMPLING GL - PAT. 5 GOT AZ GL AZ PAT. PAT. PAT. PAT. 1 1 1 2 I.D.: I.D.: I.D.: I.D.: 1st O.D.: 1.2524 FIT: 1.00 O.D.: 1.1021 1.0240 O.D.: 0.2421 O.D.: 0.9521 0.9012 READING GOT- PAT. 2 RES. : 15 RES. : 52 RES. : 150 RES. : 40 P P

F1=ENTER PATIENTS F3 = REAGENT BLANK F5=REPEAT F6=REPEAT WITH DILUTION F7=REPORT PRINTOUT F8=STOP ON PAT. N. F9=MENU F10=ADD REAGENT Alt+F1=Abort

On the screen the function being executed on each moment is being displayed immediately. On the lower part of the screen, we have several options that can be executed without stopping the routine in course. These options can be called and executed while the instrument is operating, as the system works in time sharing, so we can enter new patients to be executed in random mode, as patients, urgencies (stat) or controls, we can program repetitions with F5 and F6, we can stop the operation at a certain patient (i.e. pat. 8) by pressing F8.With F7 is possible to select a normal printout, a screen dump during routine work, or a REPORT PRINTOUT PRONTO Evolution USERS MANUAL
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to have a complete report, with the laboratory header, for each patien completed. Here are the functions descriptions : F1=ENTER PATIENTS : By pressing this key we can enter the Entering Patients Menu, the mask its exactly the same as described in section 2.1 and we have the same possibilities. : With this key its possible to run a Reagent Blank reading. This is particularly useful when we have to run a test already calibrated in a previous day, we can use the factor obtained with this previous calibration, but its better to run a new reagent blank to be subtracted from the reactions absorbance, in order to avoid any error. : When this key is depressed, we can select a test and a sample to be repeated without predilution.

F3 = REAGENT BLANK

F5=REPEAT

F6=REPEAT WITH DILUTION: With this key we can select a test and a sample to be repeated with dilution. In this case the dilution factor used is the one programmed in the test parameters, the dilution is performed by changing the Reagent/sample ratio and result is automatically multiplied by the dilution factor. F7=NORMAL PRINTOUT : This is a toggle function, it can switch between NORMAL PRINTOUT and REPORT PRINTOUT. In normal mode we have the printout of all the informations related to the test, as absorbance, FIT and so on. In report mode, we have a complete report patient by patient, with patient name, units, normal range and all the other informations normally written on a report. : During normal routine of the instrument, this function allows the operator to select a sample on which the routine will stop. Then, when this sample is reached, we can press ENTER to restart the routine. In case we add some reagent with function F10, because the system has calculated there is no enough reagent, i.e. for GGT, normally the system halt the sampling. Once reagent is addedd, the key changes into F8=CONTINUE, by depressing it the sampling for that test is restarted. : With this key we can go back to the main menu, once the routine has been completed, without stopping in stand by mode.
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F8=STOP ON PAT. N.

F9=MENU

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F10=ADD REAGENT : When during the execution of a test, reagent for a certain test is not enough to complete tests required (i.e. GGT), a warning will appear on the upper part of the screen:

WARNING GGT-NOT ENOUGH REAGENT And the system will stop sampling for that test, then operator must press the key F10,the instrument asks which reagent must be added (GGT) and the amount of reagent added, on the lower part of the screen F8 option changes to F8=CONTINUE, at the moment that reagent for GGT has been added, operator must press F8 key to continue sampling for that test. NOTE - When the operator wants to execute for a sample, a test which has not been previously selected, its enough to press the key F5, the instrument will ask for the test to be repeated, then the operator must enter the test he wants to add for that sample and the number of the sample. The instrument will add the test to the patient automatically. The only necessary condition is that the test requested must be already calibrated, otherway the system will not accept it.

2.7

DILUTE & REPEAT TESTS

At the end of the routine the PRONTO Evolution produces an acoustical signal to draw the attention of the operator. This signal lasts for a few seconds, then is silenced automatically and the instrument stays in stand by mode, waiting for new samples or repetitions or controls (Continuous Access Mode): ANALYSER IN OPERATION SAMPLING WORK COMPLETED GOT PAT. 8 AZ PAT. 10 GL PAT. 10 I.D.: I.D.: I.D.: 1st O.D.: 1.2524 FIT: 1.00 O.D.: 1.1021 1.0240 O.D.: 0.2421 READING RES. : 15 RES. : 52 RES. : 150

P P

F1=ENTER PATIENTS F3 = REAGENT BLANK F5=REPEAT F6=REPEAT WITH DILUTION F7=REPORT PRINTOUT F8=STOP ON PAT. N. F9=MENU F10=ADD REAGENT Alt+F1=Abort

At this point, basing on results obtained, we can decide to run some repetitions of tests with or without dilutions. To repeat these tests whose results are not affordable, select option F5 or F6 in case of repetition with a dilution (Remember that dilution factor is that preprogrammed in the method ), the screen will display the following : PRONTO Evolution USERS MANUAL
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ANALYSER IN OPERATION SAMPLING WORK COMPLETED GOT PAT. 1 AZ PAT. 1 GL PAT. 1 I.D.: I.D.: I.D.: 1st O.D.: 1.2524 FIT: 1.00 O.D.: 1.1021 1.0240 O.D.: 0.2421 REPETITIONS TEST - ID: GOT Patient Number ? : 2 READING RES. : 15 RES. : 52 RES. : 150

P P

How to repeat: - pressing F5 or F6 key, the instrument asks for Test to be repeated and sample number. - type the test code and the sample number to be repeated followed by ENTER. The instrument will start the repetition of the sample immediately. - in case repetition with dilution is requested type the F6 key and proceed as described above. Note that all numbers of sample will report the flag indicated in routine beside results, as L or P or *, to indicate their necessity to be repeated with dilution. Dilution factors as programmed for the chemistry in question will be used. Dilution in this case means e.g. if normally 10l of sample are used, and the dilution factor equals 4, the sample will be repeated with 2.5 l. Once all repetitions have been performed and/or all the samples have been completed, press F9 key to return to the main menu. The system will perform some rinsing of the sampling and of the aspiration systems and then will stop giving an acoustical alert and displaying the following screen : ATTENTION !! Remove the used segments : From 1 to N YES NO

N represents the last used segment. If we replace all the used segments, also if not all the reaction wells have been used, then we select YES. In case the instrument didnt use all the wells of the last segment, then we can select NO. In this case the instrument will keep in memory the last reaction well used and will start over from the next immediately available. In addition to the repetitions inside the routine, it's possible to repeat tests and samples directly from the main men, by selecting the option REPEAT TESTS from the Analyzer Menu, in this case it's just necessary to select the test and the samples to be repeated and specify if the repetition must be simple or with dilution. The mask displayed is the following : PRONTO Evolution USERS MANUAL
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PATIENTS ANALYZER UTILITIES HELP 12-06-1997 Esc=Exit REPETITIONS TEST : GOT 1 2 3 4 5 6 7

NUMBER OF PATIENT : F1 : delete result and continue; F8=All (Toggle : Insert/Remove) To dilute and repeat type (d or D) after no. of patient

To select the patients to be repeated, type the number of patient as listed in the upper part of the screen and press Enter to select it. Consider that performing this operation once will select the patient, performing it twice will deselect it (Toggle mode). Once a patient is selected its number will appear highlighted. To select a repetition with dilution, type the number of the patient followed by a d or D, (i.e. 5d or 5D) then press enter, in the upper part of the screen the number followed by a d will appear highlighted.Then once all patients to be repeated have been selected, press F1 to perform the repetitions. *STAT (Emergencies)* As explained in section 2.1 we can estabilish at the moment of entering a patient if its execution must be normal,a control or a Stat.In case we enter the patient with the "label" Stat, obtained by pressing F2 key, this sample will be executed with priority over the other samples.When we work in random mode, we can however enter a new patient with Stat option, pressing F2 key (Enter Stat) whenever we have this necessity.The normal routine never stops and it is possible to execute urgencies as normal part of routine.

2.8

VERIFY RESULTS / ENTER MANUAL RESULTS

The first level at which the results must be verified is on the test protocol that is being printed during the analysis. This check may lead to the conclusion that complete tests has to be repeated when e.g. the standard or the reagent wasn't good. Also samples may be detected that have to be diluted and then repeated. The option MANUAL RESULTS of the PATIENTS-menu serves two purposes: 1. To view the results before printing patient by patient and scrutinize them for clinical plausibility . Modifications can be made. 2. To enter the results of off-line chemistries, i.e. chemistries that are not determined on the PRONTO Evolution, like e.g. Na and K. This way a more complete test report can be achieved.Typing this option the following choice is displayed:
ENTERING MANUAL RESULTS

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ENTER RESULTS DELETE RESULTS

By selection of DELETE RESULTS item, the instruments displays the following mask:
DELETE RESULTS EXISTING PATIENTS: 4 First Patient n. : Last Patient n. :

You are requested to enter the first patient and the last patient numbers you want delete results, then type ENTER key to confirm and all patient numbers indicated will be deleted. Note that every time a repetition is performed, old results are deleted automatically. Otherway if option ENTER RESULTS is selected, the following choice will be displayed:
ENTERING MANUAL RESULTS BY PATIENT BY TEST

Selecting BY PATIENT option will ask the number of patient to be entered:


Number of Patients: (1-4) N: 2

Number of patients will display how many patients are present and in the lower left part of the screen must be entered the number of the patient whose we want to enter or modify the results.Once ENTER key is pressed to confirm the patient whose results we want to modify, on the screen will appear the following mask:
ENTERING RESULTS - 2 PATIENT ID : NAME :

GLU : 112

GOT : 24

BUN : 39

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By moving with the arrow keys all fields can be modified, results can be added or deleted, every modification or entering of new data, must be confirmed with the ENTER key.When ready go back with ESC.

If instead of the option " Enter results by Patient", you choose BY TEST, on the screen will appear :
ENTER MANUAL RESULTS
EXISTING PATIENTS : 4

First Patient : Last Patient :

The operator has to select the range of pat.numbers in which he wants to enter the results.After this on the screen will be displayed the following:
ENTER RESULTS - TEST ID ?

Type in the box the test-ID you want to modify or enter results. The patients are displayed one after the other and the results can be typed in as displayed below:
N. 2) 3) 4) PAT. ID PAT. NAME 002 BROWN 003 SMITH 004 PORTER TEST RESULT GLU : 95 GLU : 125 GLU : 300

When ready go back with ESC. This option offers the possibility to delete results without deleting the tests requests. It may be useful after a run with bad results.

2.9

REPORTING RESULTS

Results can be printed in two ways: - as patient reports PRONTO Evolution USERS MANUAL
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- on a per test basis PRINTING PATIENT REPORTS With this option of the PATIENTS-menu the collated reports can be printed, both of todays patients as well as patients from former days (long time storage).

Selecting ths option REPORT RESULTS on PATIENTS MENU, the screen will prompt:
REPORT RESULTS OF TODAY OLDER DATES

Selecting the option OLDER DATES will be possile to print reports of patients stored in the long time storage memory (Floppy Disk drive or H.D.D.), the screen will show all preceeding dates present on the disk:
PRECEEDING DATES 20-06-95 22-06-95 23-06-95

then it's necessary to select the date we are interested in , on the screen will be displayed the following request:

REPORT RESULTS VIEW PRINT

the option PRINT will display the criteria of selection of the patient, (refer to report results for today). The option VIEW will display all patients presents in that date with ID, NAME and tests associated:
NUM. 1) 2) 3) 4) 5) 6) 7) 8) 9) 10) | | | | | | | | | | | ID. 001 002 003 004 005 006 007 008 009 010 | NAME | P. Smith | A. Red | | | | | | | | TEST - PATIENT N.: 2 GLU = 95 CHO = 165 BUN = 25

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By selecting the patient with the up and down arrow keys, all tests and results for each patient will be displayed.

In case we choose OF TODAY, will be prompted on the screen:

REPORT RESULTS - From N. Till N. - Selectively by number - All - By name - By Patient ID.

With the option From n. till n. the screen will show:


REPORT RESULTS EXISTING PATIENTS: 4 From Patient n. : Till Patient n. :

then enter the number of the first patient and the of the last patient whose reports must be printed and push ENTER;the print will start for all patients included in the defined range. In the same way we can select the patient whose report we want by typing the patient number, the name or the ID.Of course selecting ALL, we will print all patients of today reports.The same selection mask will be displayed also when we choose PRINT in OLDER DATES reports program. PRINTING RESULTS PER TEST With this option of the PATIENTS-menu the results can be listed for the individual tests.The first option mask that is displayed on the screen is:

PRINT RESULTS BY TEST CHOOSE TEST ALL TEST

Selecting ALL TEST option, all test present will be printed, selecting CHOOSE TEST, will be displayed the Test Block Mask, where we will be able to choose test to be printed, using the arrow keys or the capital letters code as explained in the Calibration section. PRONTO Evolution USERS MANUAL
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2.10

PREDILUTING SAMPLES
the the the the the

The option PREDILUTION of the ANALYZER-menu offers the possibility to use PRONTO Evolution to predilute automatically samples.It's important to note that Predilution function is to be used for all samples that need to be diluted before analysis, as the urine samples and serum samples for some immunochemistry tests. This dilution is not to be confused with the post dilution function performed by instrument in the repetition with dilution function. Selecting predilution function on Analyzer Men, you enter in a screen which asks for the following data:
PREDILUTION Number of Samples (1 to 6) : Sample volume (l) Diluent volume(l) : :

Position of diluent (1 to 15) : F1 = Continue

First enter all parameters requested,remember that the max quantity of reaction mixture that can be contained into the reaction vessels cannot exceed the amount of 800 l. Then hit F1 key and will be prompted another screen in which is possible to modify the sample/diluent volume ratio sample by sample, i.e.:
PREDILUTION DILUENT POSITION (1-15) : 1 DILUENT VOLUME l SAMPLE VOLUME l 1) 200 200 2) DILUENT VOLUME l SAMPLE VOLUME l 150 250

hitting F1 again will be prompted operation mode and all checks to be done before operation starts, then press Enter to execute predilution. Place up to 29 samples into the odd-numbered positions: 1, 3, 5, 7, ........., 57. Place empty sample cups into the even-numbered positions: 2, 4, 6, 8, ...........58. Sample 1 will be diluted into cup 2, sample 3 into 4 etc. PRONTO Evolution USERS MANUAL
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2.11

QUALITY CONTROL

This option of the ANALYZER-menu offers 2 sub-options when we are running the software from the floppy disk : MONTHLY QC CALCULATE

In case we are running the software fron an hard disk drive C:\, we will have these options : MONTHLY QC CALCULATE KINETIC CURVES

Options related to the Quality Control Program are the following : - MONTHLY QC, statistics and graphics on values stored on daily basis. - CALCULATE , a simple CV-program for values to be entered manually. When we select the option MONTHLY QC, we have the following choices : MODIFY SD DELETE MONTH

MODIFY : For both 2 controls of each test an average value can be entered for each day of the month. S.D. : Mean, S.D., and C.V.% are calculated over the values stored automatically in the routine. DELETE MONTH : All values of the month can be deleted, either for all chemistries at the same time, or for individual chemistries. It is important to know that only if controlsera C1 and/or C2 are programmed in the methods of the test, will be performed during the calibration and the associated results will be stored in the monthly QC calculation memory, to perform this function, running controlsera in the normal routine, gives only a simple indication if the controls are within the estabilished range, but will not be used for the monthly QC calculation.

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Selecting the option CALCULATE displayed the following screen: in the Quality Control option mask, will be

CALCULATE S.D.
35 35 36 35 36 34 35 34 35 35 34

ENTER DATA (NEGATIVE TO DELETE)

36

It's just necessary to type the values and press ENTER after each value, in case we want to remove an erroneous data, we have just to type it with the minus (-) sign before (i.e. -16) and entering it the wrong value will be deleted. Once all values have been entered, press ESC key, on the screen will be prompted the following: CALCULATE S.D.
35 35 36 35 36 34 35 34 35 35 34 36

TOT. DATA 12 F1 = CONTINUE

MEAN 34.5 S.D. F9 = PRINT

0.674

C.V.

1.95%

By depressing the F9 key, you'll print the numerical data of the SD and CV, by pressing F1 key, a Levey-Jennings chart will be visualized:
GOT - GOT/AST QUALITY CONTROL - GOT/AST CONTROL SERUM : 1 + + + 10 15 20 25 30

250 200

+ ++ 150 + + + + 1 5

+ + + + +

++ + +

F1=CONTINUE

F9=TO PRINT

In the same way, by depressing F9 it's possible to print the Levey-Jennings chart.

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KINETIC CURVES By selecting this option, after we have performed some kinetic tests, we can visualize the kinetic curves on the display. Once selected, the option will ask : TEST ? At this point simply type the test code (i.e. GOT) and press enter. The screen will display the kinetic curve of the first patient with a GOT test : GOT - GOT/AST PAT. 1 1.1250 GOT RES.= 25 FIT= 1.00 Esc=Exit

0 25 F1=CONTINUE F5=PRINT

By pressing F1 its possible to display the curve of the next patient for the same test, by pressing F5 its possible to obtain a printout of the curve. Once all the curves have been displayed, the system will ask again whose test the curves are to be displayed. To return to the QC menu, at this stage press ESC.

2.12 IMMUNOCHEMISTRY
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With this option of the ANALYZER menu it's possible to calibrate and run immunoturbidimetric tests with the PRONTO Evolution instrument.By selecting this item, will be displayed on the screen the following choice:

IMMUNOCHEMISTRY RUN TEST CALIBRATION VIEW AND PRINT CURVES

RUN TEST will perform the routine of immuno, CALIBRATION will perform the single or multi point calibration of the immuno test and the last option, VIEW AND PRINT CURVES, will display and print on an external printer, the last calibration curve for each test of immunochemistry. Of course the calibration of each test of immuno, must be performed before running the test with samples. To perform the calibration of the tests requested, simply select the option CALIBRATION. On the screen will appear :
CALIBRATION TEST IMMUNOCHEMISTRY

A) F) K) P) U) Z)

IGA [0 ] C4 [0 ] LAM [0 ] HP [0 ] ACT [0 ] IAL [0 ]

B) G) L) Q) V)

IGG ORO PCR CE

[0 [0 [0 [0

] ] ] ]

C) IGM H) ALB M) APA R) B2M W) A1

[0 ] [0 ] [0 ] [0 ] [0 ]

D) I) N) S) X)

TRF [0 ] TRF [0 ] APB [0 ] MAB [0 ] ACF [0 ]

E) C3 [0 J) KAP [0 O) LPA [0 T) A1A [0 Y) GCF [0

] ] ] ] ]

F1 = CALIBRATE F4 = DELETE CALIBRATION

F2 = VIEW

F3 = PRINT * = TESTS CALIBRATED

So far the steps and the functions available are exactly the same we can have in the General Chemistry calibration menu. Beside each test is indicated the number of samples to be executed. Once tests to be calibrated have been selected, press F1 key to start the calibration routine. NOTE - Its always necessary to run a new calibration whenever a new Antiserum lot is used.

Once F1 key has been depressed, on the screen will appear the following :
PATIENTS ANALYSER UTILITY HELP 12-06-1995 Esc = Exit

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CALIBRATION IMMUNOCHEMISTRY TEST TEST IgA IgG IgM REAG.POS. 15 15 15 2 3 4 REAG.VOL. ml 10 10 10 5 5 5 LOT. DATE OF LAST CALIB. 2254 2705 1152 24/04/97 24/04/97 24/04/97 N. CAL. 4 5 4

F1=Continue

Press F1 to continue, then will appear the request if the operator wants to deduct predilution of the calibrator. Thi is useful when a single calibrator is available, in this case this function allows the operator to build a calibration curve automatically using a single calibrator only.
PATIENTS ANALYSER UTILITY HELP 12-06-1995 Esc = Exit

CALIBRATION IMMUNOCHEMISTRY TEST TEST IgA IgG IgM REAG.POS. 15 15 15 2 3 4 REAG.VOL. ml 10 10 10 5 5 5 LOT. DATE OF LAST CALIB. 2254 2705 1152 24/04/97 24/04/97 24/04/97 N. CAL. 4 5 4

TO DEDUCT PREDILUTION ? YES F1=Continue NO

By selecting YES, on the screen, below the Reagents positions, will appear the diluent position, normally 15 common to all the tests, then the instrument will give the instructions to proceed for the predilution.

DEDUCTING PREDILUTION

PREDILUCTION - ATTENTION Place: Diluent in Position : 15 Calibrator in Position : S6 Empty cups in the Positions : (S1 - S5)

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START

F1=Continue

Perform all instructions indicated on the screen and press ENTER, the instrument will execute an automatic dilution of the calibrator in position S6 in the empty cups from S1 to S5 according to the following ratios : 1:2 - 1:4 - 1:8 - 1:16 - 1:32 to build the necessary calibration curve. The diluent container is always 15 for all the tests. Once the curve has been built, the instrument will perform the autozeroing of all the filters with distilled water and then will proceed to the calibration in the following order of process : 1. CALIBRATORS PREDILUTION ACCORDING TO THE METHOD 2. SAMPLING OF THE CALIBRATORS BLANK ( Prediluted): Calibrator + R1 Incubation Reading 3. SAMPLING OF THE CALIBRATOR ( Prediluted ): Calibrator + R1 + R2 ( Antiserum ) Incubation Reading 4. RESULTS CALCULATION

Once the instrument has completed the reading of all the calibrators selected, on the screen appears the calibration curve obtained with the mathematical model (Algorythm) used, the given concentration and the recalculated one for each point of calibration., with the Delta % between the given concentration and the recalculated one, flagged if out of the specified maximum value allowed as programmed in method.

IGA - IGA
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MODEL (1-6) : 1

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0.2200 0.1850 0.1052 0.0980 3 0.0600 2 0.0250 1


CAL 1 2 3 4 5 6 OD 0.0250 0.0600 0.0980 0.1052 0.1850 0.2200 CONC.(Given) 0.0000 0.5000 1.0000 2.0000 4.0000 8.0000

5 4

CONC.(Calc.) 0.0030 0.4890 1.2000 1.9900 4.0500 8.5400

CONC.(%) 0.24 - 0.84 1.10 - 0.90 0.25 2.10 F6=DELETE POINT

F1=STORE F8=RESTORE POINT

F3=CHANGE MODEL F9=PRINT

Now , before storing the curve in the memory, its possible to modify it by changing the mathematical model or deleting one calibration point, this in order to achieve the best fitting of the curve with the minimum Delta between the given and calculated concentrations. Once the curve is satisfactory, press F1 to store it.

SECTION 3. 3.1

PROGRAMMING and FORMATTING

PROGRAMMING CHEMISTRIES

Up to 50 chemistries can be programmed on one diskette. To program or modify a method, select the option METHODS PARAMETERS from the ANALYZER-menu. There are 3 sub-options, wich can be selected with the cursor keys and the ENTER-key: PRONTO Evolution USERS MANUAL
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MODIFY METHODS

PRINT METHODS

REARRANGE METHODS

With the option MODIFY METHODS, it's possible to modify or create your own methods for clinical chemistry, immunochemistry one point and immuno multi point, with the option PRINT METHODS, you can print a single test's parameters or all test's parameters, finally, with the option REARRANGE METHODS, it's possible to modify the visualization order of all tests.

3.2

ASSIGNING AND MODIFYING METHODS

With this option we can select the class of the test to be modified or creted, we have displayed three choices:

MODIFY METHODS CLINICAL CHEMISTRY IMMUNO 1 POINT MMUNO MULTIPOINT

By selecting the CLINICAL CHEMISTRY option, we enter in the parameters mask, were, moving the cursor on all the various fields using the arrow keys and the ENTER key to confirm the data entering, we can modify the various parameters to define a clinical chemistry test.

These are the parameters we have: TEST-ID: - if an unknown test-ID is entered(3char.),the program asks you to confirm if a new test is to be made. - if a known test-ID is entered, the program allows you to change the ID or leave it as it is.Subsequently all parameter fields are being displayed. - if a test-ID is selected that already has been assigned in another class, the program will warn the operator and ask for confirmation : 0: Off-line test, not be analyzed by the ELECTA.This offers you the option to collate tests like Na or K into the report.
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TYPE of Reaction (1-5)

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1: Endpoint 2: Kinetic - enzymatic tests 3: Initial Rate 4: Bichromatic endpoint 5: Serum Blank - 2 reaction vessels are being used for each sample Full Name of test Units Normal value - lower limit Normal value - upper limit Lower limit Reag.O.D. Upper limit Reag.O.D. Reag.Blank correction (1=y) Number of reagents (1-3) Linearity limit Sample Volume (l) Volume Reagent-I (l) Position Reag.-I (1-15) Volume Reagent-II (l) Position Reag.-II (1-15) Standard Concentration Pos. of Standard (1-6)* Factor Stabilization time (sec.) Incubation time (sec,) Time elapse for 2nd Reag. Time elapse for 3rd Reag. Number of Decimals (0-4) Save calibration factor Reaction Incr.(0)/Decr.(1) Substrate expletion (O.D.) : (15 char.) : ( 6 char.) : : : Limits for reagent blank O.D. : considered normal and reliable : : Up to 3 reagents per test. : Above this value, result of test can be uncorrect : : : : : : : When this number is followed by an *, a multicalibration serum is used and this n. position can be the same for other tests : : Time in seconds for the liquid into the flow-cell to stabilize before the first reading : Time between adding start-reagent and aspirating the mixture into the flow-cell. : Time passing by before addition of 2nd reagent : : : Calibration factors of substrates can (1=yes) be saved, to avoid too many calibrations. : enter 1 for kinetic reactions with a decreasing absorbtion : Warning level for substrate expletion. This level is relative to the reagent absorbtion as measured in the reagent cuvet. : factor for automatic dilution when a test is being repeated : : - (in case of bichromatic)
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Dilution factor 1st filter (nm) 2nd filter (nm)


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No. of random washes No.of washes sampler (1-9) Correction Factor : No. of washes in random mode : - (at the end of the test) : temperature factor, to calculate results to 25C or 30C.

No.of washes aspirator(2-4) : - (at the end of the test) NOTE: In case of typing errors, use BACK SPACE to return to the beginning of the list without storing the modifications. If a modification has been made in the middle of the list, use ENTER to store the modification and to exit the method.

3.3

PRINT METHODS

By this selection there are two options of printing tests: PRINT ALL :To obtain a printout of all programmed chemistries with parameters

PRINT SELECTIVE :Individual tests can be selected. After the selection hit ESC to start printing.

3.4

REARRANGING SEQUENCE OF METHODS

This option displays the mask with all programmed tests: TP BUN CHO GOT TRI GPT GLU 1 2 3 4 5 6 7 GGT CRE FAC CHE LDH FAL BIT 8 9 10 11 12 13 14 BID UA CA FE AMY CL HDL 15 16 17 18 19 20 21 CPK PH MG FAP PHL BIL GUV 22 23 24 25 26 27 28

By entering a number beside each test code, it defines the test's position on the screen arrays and so it offers the possibility to change the sequence of the methods, without having to enter all the parameters from the beginning. PRONTO Evolution USERS MANUAL Page 39 of 67
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Near each test the sequential number is displayed.

3.5

CONFIGURATING PROFILES

Profiles are groups of tests that can be composed by the user and serve to speed up the manual entering of test-requests. With the option PROFILES of the UTILITIES-menu up to 9 profiles can be selected (19). Each profile can have as many tests as there are in the test file.

3.6

FORMATTING REPORT HEADER

The heading of a patient report consists out of 4 lines, that can be adapted to the laboratory in question. Select the option REPORT-HEADER of the UTILITIES-menu. The program offers the option to just VIEW the header (without danger to change it accidentally) or to MODIFY. In case of MODIFY: Select the line to be modified with the UP and DOWN-cursorkeys. Use the other cursor keys and the Back-Space to modify the line.
REPORT HEADER LABORATORY *********************************************************** BPC BioSED srl T.sa del Grillo Km 0.6 - Castelnuovo di P. - Roma ***********************************************************

3.7

CONTROL SERA

With the option CONTROL-SERA of the UTILITIES-menu the assay values of the control sera can be entered. Once selected , this option asks if we want to DEFINE the control sera values or we want to PRINT them. Selecting either DEFINE or PRINT, the instrument offers the choice for SELECT TEST or ALL TESTS. The choice SELECT TEST, will visualize the test code block, as in calibration mode, then we can select all tests we want to modify the values of the control sera.Once all test required are selected, press the ESC key to continue, will e displayed the following:
ENTERING VALUES OF CONTROL SERA TEST : GPT CONTROL 1 CONTROL 2
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With the option ALL TESTS the upper and lower limits of the 2 control sera of the first chemistry in the list are being displayed and can be modified.

3.8 SET-UP ON LINE CONNECTION


The PRONTO Evolution can be linked online to a laboratory datahandling computer anytime. See Appendix 6-B. In communicating with a datahandling the chemistries are defined by a test-ID. Test-ID's are normally dictated by the analyzer.The PRONTO Evolution however has the special option to assign test-ID's only for the purpose of communicating with a LabEDP.This way the communication protocol may use the ID of the lab- computer. This test-ID may be 3 or 6 characters long and may be any alphanumerical string. Furthermore a certain test may have more than one communication ID's assigned. This offers a special possibility that few analyzers have: the many Glucoses to be determined during a working day may chemically be the same test, organizationally they consist out of different tests, like: gluc.before breakfast gluc.p.p. glucose profile: 8.00 h. 12.00 h. 16.00 h. Glucoses of different types may be available for analyzing at the same time. Into the PRONTO Evolution they may be downloaded with different ID's, still the PRONTO Evolution will recognize them all as a Glucose, run them in one batch and send the results back with the proper ID. The program shows the options MODIFY and PRINT. The option MODIFY lets you select: 6 Characters or 3 Characters

after which the table of the PRONTO Evolution tests is shown. In the left column the PRONTO Ev. Codes may be entered, in the right column the communication ID's, for example: PRONTO Code GOT GLU GLU GLU GLU LDH COMPUTER Code GOT GLU8 GLUpp GLU12 GLU16 ... etc.
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3.9 SETTING DATE AND TIME

With the options 1 and 2 of the UTILITIES-menu the date or the time can be adjusted. As the computer has got a battery operated clock on board, the date and time should always be right after switching on and off.

3.10

DISK COPIES

With these options, COPY DISK and COPY PATIENTS ON DISK, its possible to perform several operations involving the floppy disk drive. The option COPY DISK, allows the operator to copy from a program disk onto another new program disk, all the methods and the settings of the source disk. Its important that the target disk is a brand new software disk. The option COPY PREVIOUS PATIENTS is available only when the software is installed onto an hard disk, and allows the operator to copy patients from a floppy disk into the hard disk, to filed for future uses.

SECTION 4.

MAINTENANCE & TROUBLESHOOTING

Before, during and after the routine the PRONTO Evolution rinses according to a programmed schedule probes, syringe, tubing and flow-cells and also checks the interference filters. The operator has however the possibility to: start a complete rinsing and checking cycle as a daily maintenance execute one specific step of this cycle in case a certain part of the system is suspect

The option MAINTENANCE of the ANALYZER MENU offers the following suboptions: SELECT SAMPLE TRAY (38/58) = 38 ADJUST PERISTALTIC PUMP CHECK ASPIRATION SYSTEM PRIME DILUTER WASHING CUVET CHECKING FILTER (Autozero) POSITIONING FILTER / O.D. READING USE OF PRINTER - ADJUST DAILY MAINTENANCE PRONTO Evolution USERS MANUAL
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PASSWORD (2) TO SELECT SERIAL PORT 1 or 2 AUTOM. REPETIT. IF BEYOND LINEARITY YES/NO WATER LEVEL DETECTOR ON/OFF REAGENT LEVEL DETECTOR ON/OFF CK INITIAL VOLUME ON/OFF

4.1 SELECT SAMPLE TRAY


By this option its possible to select which sample tray must be used for operating the instrument. In case we select Sample Tray=38, then we can use both primary tubes, from position 1 to position 20, and serum cups on the ring adapter, from position 21 to position 38. On this ring adapter will be placed also two controls and 16 standards. In case we select Sample Tray=58, then we can use only serum cups from position 1 to position 58, with two positions for the controls. When we select Sample Tray=38, then the reagent level detector, if active, will be used also to detect the sample level only on primary tubes.

4.2 ADJUST PERISTALTIC PUMP


The adjustment of the peristaltic pump determines the volume of reaction mixture being aspirated through and into the flow-cells before measurement takes place. The volume must be enough to rinse the flow-cell sufficiently but not higher than the total reaction mixture (sample vol. + reag.vol.) If the volume is too high, air will be sucked into the cell. If the volume is too low, more liquid then normal stays behind in the reaction wells. As the tubing of the peristaltic pump gets older, it looses some of its elasticity and the volume may get lower too. With this option the operator may adjust the volume: - the current number of steps is displayed in the frame - the number of steps can be increased or decreased by entering a new number between 100 and 999 and confirming it with the ENTER-key

4.3 RINSING THE SAMPLING SYSTEM


With this option the sampling system - syringe and tubing - can be rinsed (primed) upto 9 times. Enter the number (1-9) in the window and hit the ENTER-key to execute the rinsing. The actions taken are being displayed on the monitor. Its important to carry out this operation whenever the instrument has not been in use for a long time or at the first installation, as the system is completely empty and must be filled up with cleaning solution. To perform this operation, connect reservoire filled up with a solution of BPC cleaning agent and clean distilled water to the instrument, then enter in maintenance PRONTO Evolution USERS MANUAL
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menu and select this option. If no cleaning fluid is present in the reservoire the system will be emptied.

4.4 RINSING THE FLOW-CELL


With this option the flow-cell with tubing are being rinsed. When we select this item, we have displayed 2 options on the screen : WASHING CUVETTE AUTOMATIC WITH IPOCLEANING AND EXTRACLEANING

The normal function AUTOMATIC rinses the flow cell with cleaning fluid. Selecting the AUTOMATIC mode, we have other 2 options : WASHING CUVETTE AUTOMATIC MANUAL

In automatic mode water (or eventually cleaning agent) from water container is deposited into the washing well, where is heated, and it is aspirated through the flow-cell. In MANUAL mode the system will prompt only to activate the peristaltic pump. In this case its necessary to extract the aspiration probe from the aspiration arm, dip it into a vial containing the solution we want to aspirate into the flow cell and activate the peristaltic pump. With the option WITH IPOCLEANING AND EXTRACLEANING, the system demands to put the cleaning solutions in Reagent Positions 1 and 2, then perform the maintenance cycle automatically. Do not forget to perform another rinse cycle after the maintenance cycle.

4.5 CHECK FILTERS


At the start of calibration or test routine, the filters going to be used for reading are being checked and 'auto-zeroed'. This means that with water in the flowcell the 0-Abs. (= 100% Transmission) is being adjusted.The electronic values (voltage) of these settings are stored and applied during this single routine. If the voltages found exceed factory-set limits, a warning is displayed at the monitor for the filter in question. If all filters show a warning, there is a general problem (e.g. no water in the flow-cell or lamp burned).If there is a warning for one filter, the flow-cell can be dirty (depending on wavelength) or a filter can be bad or dusty. After having rectified the problem this option offers the possibility to check cuvet and PRONTO Evolution USERS MANUAL Page 44 of 67
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filters off-line (without starting a routine).

4.6 POSITION FILTER and READ O.D.


This option permits to read the O.D. of a liquid at the wavelength of one of the filters present in the PRONTO Evolution. The program prompts you to: -select a wavelength -auto-zero the cuvet (with water being present) -disconnect the aspirating probe from the aspirator arm and put this probe manually into the mixture to be measured. -aspirate the liquid -read the O.D. (Remember to execute Autozero before measuring)

4.7 SELECT PRINTER


Standard the PRONTO Evolution has got an High Speed Graphic thermal printer 'onboard'. It is however possible to replace the on-board printer with an external printer. Eventually it is possible to work without a printer, e.g. in case of an on-line connection to a lab-computer. This however is not recommended. With this option of the maintenance programs one of the three situations can be selected: - ON BOARD : the on-board printer is activated - NO PRINTER : - EXTERNAL : a parallel printer must be connected to the 25-pins connector (male) on the rear of the computer. NOTE - When On Board printer is selected, the system will ask for the printout intensity. Its necessary to type a number between 1 and 10 to select the darker the printout will be performed. NOTE - When EXTERNAL printer is selected, on the screen will appear the request if the operators wants the FORM FEED on reports printout, in order to print a report on a single page. In this case is necessary to consider that the default for the single page is intended to be 11 in size.

4.8

MAINTENANCE

Daily Maintenance Although the system is rinsed automatically during the routine, the operator should apply an extra cleaning at the end of the working day.The option DAILY MAINTENANCE of the MAINTENANCE menu executes the rinsing of the sampler, the aspirator and flowcell and performs a filter check.Water must be present in the water container. Weekly Maintenance Once a week the system may be washed with a detergent or in extreme cases with an PRONTO Evolution USERS MANUAL
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active solution of Hypocleaning agent BPC.This wash can be executed in manual aspiration or with the automatic maintenance cycle in WASHING CUVETTE function. Quarterly Maintenance Once every 3 months it is recommended to replace the tubing of the peristaltic pump as described in 5.4. The exact interval depends on the workload of the laboratory and has to be determined by experience. For a complete maintenance schedule, refer to the page MAINTENANCE SCHEDULE of this manual, it's suggested to copy the page and to put the copy on the instrument or near to it, to have always an immediate reference for periodic maintenance.Consider that the Hypocleaning is a deproteinizing agent and the EXTRAcleaning is an acid Ph strong cleaner and degreaser.

4.9

PASSWORD(2)

With this option it's possible to lock the access to any men and sub-men of the PRONTO Evolution fixing a Password to allow the access to locked Items. To install this password, select item password(2) and press ENTER key, you are prompted to entry a 2 letter password, i.e. JR, then you can move on all items to be locked and when item is selected, press ENTER key to confirm access denied. When all menues to be locked have been selected, press ESC key to return to normal operations. Now to access to locked items, you are prompted to enter the Password. In case it is necessary to delete the password, proceed as follows: select again password (2) item in maintenance men, then enter the password, i.e. JR, then system will prompt the choice:
MODIFY DELETE

MODIFY DELETE

: will ask you a new password to protect items already selected : will delete completely the password and selection made of items to be protected

4.10

SELECT SERIAL PORT

This option of maintenance menu, allows you to change via software the serial port 1 or 2, on the computer of the instrument, to be connected to another lab computer for on line data transfer.When selected, this option just asks for COM 1 or COM 2, you have only to select which one you choose and hit Enter key to confirm.

4.11

AUTOMATIC REPETITION IF BEYOND LINEARITY

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the instrument during the normal routine will give a result on whatever test, which is beyond the linearity limit programmed in the method, the sample will be repeated with dilution one more time, in order to verify the exact value of the result. When beside the item there is a NO, then the function is disabled.

4.12

WATER LEVEL DETECTOR ON/OFF

On this item you can switch to on or off the water level detector, connected to the water container if presetted for this use. If your water container is provided with the level detector, connect the jack plug to the socket located on the right side of the PRONTO Evolution, just above the water input nipples.With this option you can choose if you want the level detector activated or deactivated.

4.13

REAGENTS COOLING SYSTEM

The PRONTO Evolution is provided with a cooling system for the reagent compartment. This cooling system is based on Peltier elements and is electronically controlled to switch between two differents adjustable temperatures. These temperatures are factory set at the same level, but its possible to adjust them refering to the Service Manual - Reagents Cooling Temperatue adj. section.

The cooling system provides a temperature which is max 10C less than environmental temperature. The switching between the two temperatures is provided via software in the Mechanical Test menu. Its a toggle function and the only visible effect of this operation is the change in the colour of the LED lamp located on the left side of the instrument : when its green colour the temperature selected is the n. 1, when its yellow colour the temperature selected is the n. 2, when its red the cooling system is off. To switch on the cooling system use the cooling unit switch whch is located on the rear of the instrument, near to the main switch. NOTE - Never switch on the cooling system while the unit is already switched on or its operating, as this can cause malfunctionings or more severe damages. Always switch it on before switching on the instrument.

4.14

TROUBLE SHOOTING

SYMPTOMS POSSIBLE CAUSES & ACTIONS PRONTO Evolution USERS MANUAL


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Computer does not load - is proper program disc present in slot? - is the computer provided with Hard Disk Drive ? - check the setup BIOS of the computer if the floppy disk set is correct (1.44Mb 3,5") Reagent and/or water not being aspirated - Sampling probe clogged ? - Syringe assembly not functioning ? - Tubing not properly connected or damaged? - Electrovalve not moving ? Reagent and/or water not being dispensed - Sampling probe clogged ? - Syringe assembly not functioning ? Sample not being aspirated - Check piston and powering of syringe - Tubing not properly connected or damaged? - Air bubbles in the syringe - Replace the O ring - Sampling arm descends too much into the sample cup Aspiration arm descends but liquid is not aspirated - Rotor of the peristaltic pump is too tight or too loose - Tubing of wrong diameter being installed on peristaltic pump - Silicon tubing on pump damaged , leaky or stretched - Aspiration arm descends too much into reaction vessels and tip strucks on the bottom The waste well is not emptying - Malfunction of the waste pump - Tubing disconnected or broken - Magnetic valves for needle washing don't operate correctly Autozero of filterwheel gives 0 V. on all filters - Lamp of photometer burned out - Connector of lamp assembly disconnected - Filterwheel locked Erroneous autozero - Flow-cell not properly filled with water - Flow-cell dirty (to be cleaned) - Little air bubbles building up in the cuvet (to be cleaned) - Tubing disconnected,leaky or clogged. Erroneous autozero - Peristaltic pump malfunctioning - Dirty wash water in container - Erroneous positioning of filter wheel - No water in water container PRONTO Evolution USERS MANUAL
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Erroneous,non-reproducible results - Check the presence of water with cleaner into the container - Check for little air bubbles in the cuvet (clean the cuvet) - Check aspirating system - Check the peristaltic pump tubing if smashed - Clean reaction sectors being used ? - Check temperature of reaction ring - Check temperature into the flow cell Some mechanical movements are not correct - Check the mechanical settings in mechanical test menu - Note if there is a warning because EEPROM doesnt store the settings or it needs to be replaced Initial Communication Problem with C alarm at the switching on - Check contact of the connector at the rear of the instrument - Check contact of interface PCB into the computers slot - Diluter module locked up or motor malfunctioning

4.15 MECHANICAL TESTS


The program MECHANICAL TESTS of the ANALYZER MENU allows to check any single mechanical movement of the analyzer and some electronic functions as well. It displays the FUNCTIONS TEST menu: - Vertical movement sample arm - Sample Holder - Horizontal movement sample arm - Emptying the Waste Well - Diluter - Vertical movement Aspirator - Horizontal movement Aspirator - Peristaltic Pump - Filters and O.D. - Autozero and wash - Total Reset - Set and Store Steps - Switch Reagents temperature - Level detector sensitivity adjust. - Reagent volume check - Store values of EEPROM on disk Each of the options - when selected - shows its own submenu, consisting of the particular functions the moving part in question is supposed to execute. Most functions are selfexplaining. Each function may be selected with the cursor keys and enabled hitting ENTER. Vertical movement sample arm
RESET DESCEND ON WASTE WELL DESCEND ON REACTION VESSEL
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DESCEND ON SAMPLE CUP DESCEND ON REAGENT VERTICAL MOVEMENT STEP ADJ. ( 8) FINE ADJ. UP. MOV. SAMP. PROBE (0-9) cleaner UPWARD MOVEMENT FROM SAMPLE CUP : >> self explaining << : : Fine positioning of probe in serum cup : Fine positioning of probes tip from probe : Test for probes tip positioning : returns to zero-position : enter a sample number and hit ENTER. The sample tray should move to the selected position. : enter a number to indicate reaction vessel where : the reaction mixture will be dispensed or aspirated

Sample Tray
RESET SAMPLE POSITION REACTION VESSEL FOR DISPENSATION REACTION VESSEL FOR ASPIRATION

Horizontal movement sample arm


RESET POSITION OVER OUTER REACTION VESSEL POSITION OVER INNER REACTION VESSEL POSITION OVER OUTER SAMPLE POSITION OVER INNER SAMPLE POSITION OVER REAGENT POSITION OVER OUTER WASTE WELL POSITION OVER WASTE WELL : : : : : :

>> self explaining << :

Empty Waste Well


START STOP WASHING VALVE OFF WASHING VALVE ON : waste pump starts to empty waste well : pump stops : select aspiration to empty waste well : select aspiration to flush into needle cleaner

Diluter
RESET LOAD DILUTER VALVE OFF VALVE ON : returns to home position : enter a number (ul) and push ENTER.The selected amount of reagent will be aspirated. : deactivates the valve : activates the valve on top of the syringe

Vertical movement Aspirator


RESET DESCEND FOR WASHING DESCEND FOR ASPIRATING : returns to home position : the probe descends in one movement : the probe descends in several steps

Vertical movement Aspirator


RESET ON OUTER REACTION VESSEL ON INNER REACTION VESSEL : return to home position : self explaining : self explaining

Peristaltic Pump
WASH ASPIRATE

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PUMP FOR FILLING UP THE WELL : fill up the aspiration system washing well

Filters and O.D.


RESET FILTER POSITION READING ADC OFFSET : reset filterwheelo to home position : moves filter to selected position : displays on screen selected item : offset selection

Autozero and wash


WASH AUTOZERO : performs a complete wash cycle : performs autozero and displays the voltages of all filters

Total Reset Set and Store Steps Switch Reagents Temperature Level Detector Sensitivity Adjust. Reagent Volume Check Store Values of EEPROM on Disk

: performs a resettting on all mechanincs

: refer section 4.16 : Toggle switch the cooling temperature : refer section 4.16 : perform a check of level detector : copy of values of EEPROM on disk

4.16

SETTING AND STORING STEPS

In PRONTO Evolution, all the mechanical and electronic settings to operate correctly, are stored into an EEPROM. This in order to reduce the necessity of the operator to perform any adjustment before operating the instrument. Due to different causes, as the connection of the instrument to its computer when this is already on, or any problem occurring on the power line, these settings on EEPROM can be damaged or partially erased. In this case its necessary to set once more the mechanics and the operating sets of the instrument. The same situation can be necessary if we replace a mechanical assembly, then its also necessary to adjust the steps to center the mechanics in relation one to each other. This operation must be performed every time we have the following alarm when we switch on the system : PROBLEM WITH EEPROM OR SOME SETTINGS MISSING

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OK Rev. 1.7 In this case press Enter to confirm ( it can be necessary to perform this operation several times before the software will skip this message. When this situation occurs, its necessary to perform the following settings : Set and Store Steps Level Detector Sensitivity Adjust. Vertical Movement Step Adj. ( 8) Fine Adj. Up. Mov. Sampl. probe (0-9) Select Sample Tray (38/58) Adjust Peristaltic Pump Use of Printer - Adjust To Select Serial Port 1 or 2 Autom. Repetit. if beyond linearity Water level detector Reagents level detector - in the Mechanical Test Menu - in the Mechanical Test Menu - in the Mechanical Test Menu - in the Mechanical Test Menu - in the Maintenance Menu - in the Maintenance Menu - in the Maintenance Menu - in the Maintenance Menu - in the Maintenance Menu - in the Maintenance Menu - in the Maintenance Menu

4.16.1 Set and Store Steps Enter in Mechanical Test Menu and in Set and Store Steps function, sequentially will be displayed on the screen the settings to be performed. Use the + and - keys to set the positions forward or backward in simgle step mode, then press the Enter key, once the positioning has been completed, to jump to the next setting.

Here are listed the settings and the meaning related :


SAMPLE HOLDER PRESS + OR - KEYS

This is to center the position of reaction vessel under the aspiration probe
POSIT. OVER INNER SAMPLE PRESS + OR - KEYS POSIT. OVER OUTER SAMPLE PRESS + OR - KEYS

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This to center the positioning of sampling probe over the inner and outer samples ; if the sample tray=38 has been selected the positioning will be on the primary tube for the inner sample and on the ring adapter for the outer sample, otherway on the inner sample cup
POSIT. OVER INNER REACTION VESSEL PRESS + OR - KEYS POSIT. OVER OUTER REACTION VESSEL PRESS + OR - KEYS

Basically the same principle of positioning and centering as above described, but on the reaction vessels

SAMPLE HOLDER PRESS + OR - KEYS

Centering of the reaction vessel under the sampling probe


POSITION OVER WASTE WELL PRESS + OR - KEYS POSIT. OVER OUTER WASTE WELL PRESS + OR - KEYS

Positioning of the sampling probe over the inner and the outer parts of the waste well
POSITION OVER REAGENT PRESS + OR - KEYS

Centering the sampling probe position over the reagents container ( Default position 1 )
HORIZ. MOVEMENT OF ASPIRATOR PRESS + OR - KEYS VERT. MOVEMENT OF ASPIRATOR PRESS + OR - KEYS

Horizontal and vertical positioning of aspiration probe over the outer reaction vessel
HORIZ. MOVEMENT OF ASPIRATOR PRESS + OR - KEYS VERT. MOVEMENT OF ASPIRATOR PRESS + OR - KEYS

Horizontal and vertical positioning of aspiration probe over the inner reaction vessel

Once this has been completed, press Enter key and the system will store the values on EEPROM and then return to Mechanical Test Menu. In case there are problems on the EEPROM and this need to be replaced, the following message will be displayed : ATTENTION : VALUE ON EEPROM HASNT BEEN STORED , TRY AGAIN OK In this case try again by pressing Enter. Considering that after a certain number of times the warning will disappear, check if the system operates correctly, if the mechanical settings have not been stored correctly or certain problems persist call the service PRONTO Evolution USERS MANUAL Page 53 of 67
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organization in order to replace the EEPROM. 4.16.2 Sampling Probe Settings These settings are for the fine positioning of sampling probe in relation to the sample cup and to the needle cleaner. Enter in Mechanical Test Menu, then select the function Vertical Movement of Sampling Arm. Perform the settings as follows : Put an empty cup in pos. 38 (sample tray=58) and select in Mechanical Test - Positioning over outer sample. Select VERTICAL MOVEMENT STEP ADJ. ( 8) and type in the number of steps necessaries to meet the specifications Sampling Probe Serum Cup 2 mm 0.2 Verify by selecting the option DESCEND ON SAMPLE. Its important to have a clearance between the tip of the probe and the bottom of the sample cup. Reset the Horiz. Movement of Sampling Arm, then enter in Vertical Movement of Sampling probe. Remove the sample tray . Select the option FINE ADJ. UP. MOV. SAMPLING PROBE (0-9) and type in the number of steps to meet the specs : Sampling Probe Needle Cleaner 0.8 mm Check with the option Upward Movement From Sample Cup. 4.16.3 Level Detector Sensitivity Adjust. To perform this adjustment its necessary to put an empty reagent container in position 8 on reagents tray. Provide fresh and clean distilled water and a mouth pipette of 10 ml. Enter in Mechanical Test menu - LEVEL DETECTOR SENSITIVITY ADJUST., on the screen will be prompted the following : LEVEL DETECTOR SENSITIVITY ADJUST. REAGENT IN POS. 8 ENTER NUMBER OF ml = 5 Using the pipette put 5 ml of distilled water in container in pos. 8 and press Enter, the system will automatically calibrate for this quantity on the quantity pipetted into the container. After this on the screen will be prompted in sequence the request of pipetting 10 ml time by time till the container will contain 45 ml. At every step the system will calibrate on the quantity of liquid pipetted into the container. NOTE - Of corse more accurate is the pipetting more accurate wil be the calibration of the system. PRONTO Evolution USERS MANUAL Page 54 of 67
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Once this step is completed, verify the calibration with the option REAGENT VOLUME CHECK.

4.16.4 Other Settings Perform these other settings in the Maintenance Menu : Select the sample tray to be used Adjust the number of steps of the peristaltic pump in order to comply the following specifications :

Level of liquid after aspiration (Allowed Range) Flow Cell

Aspiration Probe

Check the if specifications are met using the Check Aspiration System option Select the printer to be used with the eventual settings related (i.e. Printout Intensity) Select the serial port to be used for the On-Line connection to an host computer Select wether or not perform the automatic repetition if beyond linearity Activate or deactivate the water level detector and the reagents level detector NOTE - Also if the setting is already the one wanted, select another item and then select again the one wanted, this in order to store it again.

SECTION 5.

REMOVAL AND REPLACEMENTS

5.1 DISASSEMBLING THE CABINET First of all it's always necessary to disconnect the main plug from AC outlet before performing any replacement or disassembling the cabinet of the instrument. To perform all replacements described into this section, will be enough to disassemble only the upper part of the cabinet. Proceed as follows: Pull up the printer ass'y from its housing and disconnect the printer cables Unscrew the two screws located on both sides of the upper cover Pull up the entire upper cover carefully to PRONTO Evolution USERS MANUAL
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avoid damages to the tubing

5.2 REPLACING THE SYRINGE


For the syringe the following situations may occur: - the piston has to be replaced, because it is leaking. In this case drops of liquid leak down along the piston. This situation may occur after the system has been in use for a very long time. - the syringe has to be replaced because of a major damage . - The piston of the syringe must be replaced as the useful time has reached expiration. Its important to replace the piston also every time we can see some air bubbles persisting into the upper part of the syringe. These bubbles can lead to erroneous results as to low reproducibility. The phenomena is however less evidenced when the system works with a greater quantity of sample than when it works with 5 l of sample. To Replace the syringe proceed as follows: Enter in Mechanical Test menu - Dilutor and select Load Dilutor item, enter 400 ul and press ENTER key to perform the function

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Once the Piston moves down, loosen the screw fixing the piston to the moving bar of dilutor

Remaining into Mechanical Test menu, select again other 500 ul into Load Dilutor item and let the moving bar descending more until it stops (be careful that maximum volume allowed for the Load Dilutor Function is 1000 ul, in case you exceed this volume, it can damage the dilutor module) Unscrew the syringe from its header block and pull down the syringe with the piston,at this stage the piston can be removed and replaced, be careful to the O' Ring sealing the head of the syringe. Repeat inverse items to reassemble the syringe into the dilutor, check always that the piston's lower edge must be overlapping the moving bar of about 8 mm, to avoid it can break the syringe head. To avoid this trouble it's really better to tighten the moving bar screw on the piston, only when you are sure it doesn't touch the upper inside of the syringe (reset position).

5.3 REPLACING THE LAMP/CALIBRATION


The lamp assembly consists of a lamp, fixed in its fitting, with wires and plug. To replace the lamp assembly:

- switch off the instrument - Remove the cover of the photometer. - Disconnect the plug of the lamp from main PCB - unscrew the fitting of the lamp - pull out the lamp - put in the new lamp and assembly in reverse PRONTO Evolution USERS MANUAL
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order WARNING: always avoid to touch the bulb with your fingers, as the human skin-excretions will be burned into the quartz and destroy the characteristics of the U.V. emission. After having installed a new lamp, the photometer have to be recalibrated in the following way: make sure that the flow cell is filled with clean distilled water. This is the normal situation at the end of the routine. In case of doubt use the function WASHING CUVETTE - AUTOMATIC select MECHANICAL TEST :POSITIONING FILTER /O.D.READING a submenu is displayed: FILTER POSITION READ ADC OFFSET select FILTER POSITION, enter 340 and push ENTER select READ ADC and push ENTER, the system makes a reading and displays the result: Filter 340 Volt x.xxx D.O. y.yyyy

adjust the potentiometer GAIN on the photodiode amplifier PCB, and repeat the ADC-reading until you'll have : VOLTS=8.5 push ESC to exit select OFFSET and hit ENTER, then again select READ ADC and press ENTER again, the offset value displayed must be between 0.0020 and 0.0060. (typ. 0.003),it can be adjusted with the trimmer marked OFFSET, after which the reading has to be repeated.

NOTE - It's not important that the filter of highest transmission (it can be the 340 or 620 it's not important), is perfectly set to 8.5 V, it's important that performing an autozero, all filter's voltages are within estabilished range of 3.5 to 9.5 V. It's suggested that the mean of the filters is far about 1-1.5 V from the extreme limits of the allowed range (3.5 9.5).

5.4 REPLACING A FLOW-CELL


The flow cell can be easyly removed or replaced. It can just be pulled out of its sockets and put back. Be careful that the flow cell must be always disconnected from the cable going to the main board, only when the instrument it's switched off.Be careful when you disconnect tubings going to aspiration needle and to the peristaltic pump, to avoid water or liquid PRONTO Evolution USERS MANUAL Page 58 of 67
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spilling out into the flow cell body, as it can damage the internal temperature sensor. After the replacement, is necessary to adjust the temperature into the flow cell. Ref to the service personnel for this operation.

5.5 REPLACING TUBING OF PERISTALTIC PUMP


The tubing in the peristaltic pump is pressed by a semi-circular leader to the rotor of the pump. This leader is mounted on a plate, which in turn is kept in position by a screw tightened by hand.

To replace the tubing: untighten the screw remove the old tubing put in the new tube press the leader by hand against the tubing

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tighten the screw Perform the setting as described in section 1.16.4

NOTE - On the opposite side of the leader of the pump there is a locking plate, which is factory set in the correct position. This is necessary to avoid the leader can press too much the tubing leading to shorte life of the tubing itself. Never attempt to adjust this plate otherway problems can occurr.

APPENDIX 6-A
TYPES OF CALCULATION OF THE PRONTO Evolution The calculation types 1 - 5 can be used either with FACTOR or with STANDARD. Type of Calculation = 1 ENDPOINT Conc.Standard Conc.Sample = Abs. sample Abs. Standard Conc.Standard The Calibration Factor Abs. Standard I case of endpoint determinations with factor or with 'stored calibration' the formula becomes: Conc.Sample = Abs. sample F Type of Calculation = 2 KINETIC
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can be stored as F.

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During the reading interval programmed for the test every 250 ms the absorption is measured. At the end of the time span a straight line is calculated through the points of measurement, using the linear regression method. The coefficient of correlation is used as a check on the linearity (must be > 0.90). The calculated slope, expressed in Abs./min. is used to calculate the activity: U/l = Abs./min. F Results are FLAGGED: in case of increasing (+) reactions: if the first reading > Start-Absorbance as programmed for the method in question. if the first reading < (RB + SE) where: RB =Abs.Reagent Blank as measured at start of batch. SE =O.D. for Substrate Expletion as programmed for method in question.

in case of decreasing (-) reactions: if the first reading < (RB - SE)

APPENDIX 6-A
Type of Calculation = 3 INITIAL RATE

This corresponds to fixed-time-kinetics. The calculation is based on the delta absorbance over the reading interval : one reading at the start (= end of incubation time) the second at the end. In this case we use the Abs. between 1st and 2nd Abs. instead of the simple Abs. Type of Calculation = 4 BICHROMATIC

The calculation is based on the delta Abs. between 2 wavelengths. Formula like in End Point. Type of Calculation = 5 SERUM BLANK

This type of calculation is based on the delta Abs. of a sample with reagent and a serum blank (sample + diluent). To this end 2 reaction wells are being used for each sample. Calculations as for Endpoint. For the calculation of the non-linear standard curves the operator may choose out of 6 mathematical models (Algorythmes). PRONTO Evolution USERS MANUAL
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MODEL 1: 4-Parameter Log-Logit 1 R = R0 + K c 1 + exp [-(a+b.lnC)]

MODEL 2:

5-Parameter Log-Logit 1

R = R0 + K c 1 + exp [-(a+b.lnC+c.C)]

APPENDIX 6-A
MODEL 3: 5-Parameter Exponential

R = R0 + K exp [ a.lnC + b.(lnC)2 + c.(lnC)3]

MODEL 4:

5-Parameter Polynomial (R - R0) (R - R0)2 +c 100 1002 +d 1003 (R - R0)3

ln C = a + b

MODEL 5:

4-Parameter Logit 1

R = R0 + K c 1 + exp [-(a+b.C)]

MODEL 6:

Linear with offset

C = a + b.R

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APPENDIX 6-B
ON-LINE PROTOCOL AND DATA FORMAT INTERFACE The standard serial port for the connection to an lab-computer is located on the back of the computer of the PRONTO Evolution. Pin 2: transmit Pin 3: receive Pin 7: signal ground

Word format: 1200 BAUD 8 databits 1 stopbit no parity

STRING FORMAT each data string consists of : STX .... data.....BCC ETX The data consist of readable ASCII characters only, between ASCII 32 to 255. The BCC consists of 2 ASCII characters, representing the sum of the characters not including STX and BCC and ETX, expressed in hexadecimal notation. BCC = ? (ASCII characters) % 256 (%) It is modulus or remainder operator

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APPENDIX 6-B
PROTOCOL: If the computer wants to send data to the PRONTO Evolution, it must send an ENQ. If the PRONTO Evolution is in the receive mode it will answer with an ACK and the computer can start sending its strings.
COMPUTER ENQ PRONTO Evolution (Receive mode)

ACK (connection established) (status string) (may be neglected)

request string

if not acceptable resend on NAC next string on ACK or EOT if no more strings.

ACK NAC

if string accepted

If the PRONTO Ev. wants to send results to the computer, it first sends an ENQ to establish the connection. The computer should answer with an ACK. If no answer is received, the PRONTO Evolution sends an ENQ every 10 sec. COMPUTER PRONTO Evolution (transmit mode)
ENQ (connection established) result string if acceptable if not accept resends on NAC next string on ACK when finished

ACK ACK NAC

EOT

APPENDIX 6-B
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Request string: STX Pat.ID Demographics TEST1 TEST2 TEST3..... BCC ETX (8) (30) (n) (n) (n) (2) Note: no spaces between the 3-character testcodes. Result string: STX Pat.ID Demographics TEST1 Result TEST2 result ..... BCC ETX (8) (30) (n) (6) (n) (6) (2) NOTES: - no spaces between testcodes and results. - results contain the proper decimal point. - n is the the value 3 or 6 as assigned in the set-up. Table of ASCII codes used in the Comunication STX ETX EOT ENQ ACK NAC ASCII ( 2 decimal) ASCII ( 3 decimal) ASCII ( 4 decimal) ASCII ( 5 decimal) ASCII ( 6 decimal) ASCII ( 21 decimal)

APPENDIX 6-C
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ON SCREEN FLAG CODES LIST L P * Beyond linearity limit fixed in methods Dilution is needed Out of normal values range fixed in method If first O.D. (in kinetics reaction as GOT and GPT) is minor than blank reagent O.D. -Substrate expl. limit O.D. as programmed in method.It means reagent not working properly or activity of sample is extremely high . repeat with dilution In immunochemistry means the sample is out of calibration curve. Near reagent Blank O.D. it means O.D. out of range programmed in method.Check reagent. Near C1,C2,C3 it means control serum value is out of the range programmed in Control Sera Assay. Valid only if control sera value are programmed.

FC CK CK

ERROR MESSAGES ON SCREEN WARNING PROBLEM ON EEEPROM - SOME SETTINGS MISSING Check all the settings as described in section 4.16 or replace the EEPROM. WARNING COMMUNICATION PROBLEM WITH CONTROLLER 1 (2, 3) Problems of motor or electronic controllers.(Refer service manual, contact your dealer) FILTERS OUT OF RANGE Check if lamp is burned out, flow cells dirty or clogged, in case this message does not disappear, contact your dealer.

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