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DIESTRO 103APV4R ELECTROLYTE ANALYZER

7

JS Medicina Electrónica

the results issued by the Analyzer. Do not process samples without having carried out a quality
control and verified the correct functioning of the Analyzer.

If the equipment is not used in the manner specified by the manufacturer, the protection
provided by the equipment may be affected.

2. SYMBOLOGY

Different safety instructions are given in each chapter of the manual and on the analyzer, to
highlight aspects related to safe operation.

Note: Identify references to information in other sections of the manual

Press on the touch screen.

DANGER. There may be damage if the equipment or its parts are handled without
due care. Consult the manual and documentation before use.

Biohazard. There are parts of equipment, accessories or supplies that can cause
damage and biological infections if not handled with due care.

WEAR GLOVES

WHENEVER WORKING WITH THE EQUIPMENT, ITS PARTS AND SAMPLES,
AS THEY ARE POTENTIALLY INFECTIOUS.

Batch information

Serial Number

Reference/Catalog Number

In Vitro Diagnostic Equipment

Authorized
Representative in the
European Union

Read the manual before use.

For indoor use only

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Summary of Contents for 103APV4R

Page 1: ...ELECTROLYTE ANALYZER OPERATOR AND SERVICE MANUAL DIESTRO 103APV4R V 1 0 MARCH 2022 RE 0851 CONTENT ...

Page 2: ...ANCE 21 6 PACK REPLACEMENT 21 5 SERUM PLASMA WHOLE BLOOD MEASUREMENT 24 1 OVERVIEW 24 2 SAMPLE LOADING 24 3 MEASUREMENT 25 4 PRINTING RESULTS 28 5 PH CORRECTED CALCIUM MEASUREMENT 29 6 URINE MEASUREMENT 30 1 OVERVIEW 30 2 SAMPLE LOADING 31 3 MEASUREMENT 31 7 CALIBRATION 32 1 OVERVIEW 32 2 1 POINT CALIBRATION OF IONS AND PH 32 3 TWO POINT CALIBRATION OF IONS AND PH 33 4 TCO2 CALIBRATION 33 5 CALIBR...

Page 3: ...CTRODES AND UNIT SELECTION 59 3 AUTOMATIC SAMPLE LOAD 59 4 RESULT VISUALIZATION TIME 59 5 NORMAL VALUES 60 6 CONNECTIONS 60 7 INTERNAL PRINTER 61 8 DETECTION THRESHOLDS 61 9 INSTITUTION NAME 61 10 LANGUAGE 62 15 SERIAL PORT OUTPUT CONFIGURATION FOR LIS INTERFACE 63 16 INSTALLATION OF BARCODE READER AND OR EXTERNAL KEYBOARD OPTIONAL 67 17 ERROR MESSAGES 68 1 ANALYZER STATUS 68 2 ERROR MESSAGES 69 1...

Page 4: ...25 AUTOSAMPLER OPTIONAL 92 1 OVERVIEW 92 2 INSTALLATION 92 3 MEASUREMENT USING THE AUTOSAMPLER 95 4 WAYS TO LOAD THE SAMPLE INTO THE AUTOSAMPLER 97 5 CONFIGURATION 99 6 BAR CODE SPECIFICATIONS 100 7 SPECIFICATIONS OF PRIMARY TUBES AND CUPS 101 8 MAINTENANCE 104 9 HOW TO REMOVE THE TUBE HOLDER DISC FROM THE SAMPLER 104 10 CHANGE SAMPLER DISC SEPARATORS 107 26 DIAGRAMS 108 27 TECHNICAL SPECIFICATION...

Page 5: ... No 15964 ANMAT AUTHORIZATION IN PROCESS Exclusive sale to PROFESSIONALS Apple tree s a 53 Boulevard Général Wahis 1030 Brussels BELGIUM Phone 32 2 732 59 54 Fax 32 2 732 60 03 E Mail mail obelis net JS Medicina Electrónica Diestro Diestro 103APV4R and its images are a registered trademark of JS Medicina Electrónica S R L The contents of this manual hardware and firmware are protected by intellect...

Page 6: ...nt o Damage caused by falling equipment in water or splashing water on it o Any type of error message or alarm on the equipment loss of liquids or damaged pipes o Any other type of anomaly Do not allow the equipment or its flexible power cord to be exposed to surfaces that are too hot to the touch Do not place anything on top of the equipment Do not drop or place anything in any of the openings of...

Page 7: ...ed to safe operation Note Identify references to information in other sections of the manual Press on the touch screen DANGER There may be damage if the equipment or its parts are handled without due care Consult the manual and documentation before use Biohazard There are parts of equipment accessories or supplies that can cause damage and biological infections if not handled with due care WEAR GL...

Page 8: ...sdiction Manufacturer s details Date of Manufacture Connector Polarity Ground Connection Temperature limits Expiration date Install before this date If the component is not installed from this date the warranty time begins to elapse GUARANTEE Number of months warranty of the component or input Fragile Box orientation European Compliance Maximum number of boxes that can be stacked Standard A calibr...

Page 9: ...DIESTRO 103APV4R ELECTROLYTE ANALYZER 9 JS Medicina Electrónica For more information about the analyzer press the INFO button INFO Menu Contents To exit press the back arrow ...

Page 10: ... with pH electrode Pipe Kit for Pack connection CD with user manual Quick start guide Power supply 15V 4A Only models with External Source Peristaltic pump head Tip for the capillary Capillary Adapters Ground cable Pack Tray For more detailed information see sections TECHNICAL SPECIFICATIONS and DIAGRAMS 2 INSTALLATION REQUIREMENTS 2 1 Supply Voltage 100 240 V 50 60 Hz 1A The supply voltage and ou...

Page 11: ...tion free place that support the weight of the equipment and allows the operator to stand in front of it without any obstacle with sufficient place in front of the analyzer so that when opening the front cover it is fully supported and without any objects touching the sides of the analyzer Dimensions Height 280 mm Width 470 mm Depth 210 mm 470 mm with pack included Auto Basic and Auto Plus models ...

Page 12: ...placed use spare parts provided or recommended by the manufacturer Connect the ground wire to the grounding terminal of the analyzer to a ground connection duly verified by qualified personnel Connect the external power supply to the analyzer connector Don t connect the power supply to the outlet yet uChip connector Power supply connector External Power Supply Grounding terminal Power supply conne...

Page 13: ...eir corresponding couplings in the analyzer Keep the caps that you removed to cover the bottles of the Pack at the time of discarding it Observe color coding and text on your analyzer and Pack Pipe Kit for Pack Connection Open the front of the analyzer by turning the clamp screw a quarter turn and tilt the front forward Cleaning Solution uChip Pack Caps Analyzer couplings ...

Page 14: ... Electrónica Clamp screw Clamp screw Take the Cleaning Module open the transparent packaging and remove the safety seal from the Sample Taking Cleaner as indicated in the figure 1 Opening front Clamp screw 2 Opening front 3 Opening front 4 Opening front ...

Page 15: ...tops against the bottom Make sure the Cleaning Module is in the correct position labeled Front Front towards the operator Placing the cleaner step 1 Placing the cleaner step 2 For more details see the section INSTALLATION REPLACEMENT OF THE DIESTRO SAMPLING CLEANER Return the fill port to the original position raise the front and turn the clamp screw to lock position Connect the power supply to th...

Page 16: ...trónica See the section CALIBRATION AND PURGE When the calibration is complete the analyzer displays the following screen Check that the date and time of the analyzer are correct 4 RETRACTABLE FILL PORT The analyzer with the fill port in the resting position ...

Page 17: ...ng capillary well with ISE Cleaning Solution Solution ISE REF IN 0400 The Capillary Adapter is specially made to adapt the sample needle of the analyzer to a Capillary Place the sample in the capillary position Connect the adapter to the end of the capillary that has the sample loaded Hold the end of the fill port and connect the adapter with the capillary and press Load Once the sample is loaded ...

Page 18: ...dicina Electrónica 1 2 Capillary Adapter 1 Capillary Adapter 2 BIOHAZARD Capillary samples and adapters are potentially infectious Handle with gloves Before starting to measure capillaries clean the fill port with ISE Cleaning Solution REF IN 0400 ...

Page 19: ...er These tubes are reusable and always connected to the analyzer There are different types of Pack according to the country region and distributor where the analyzer was purchased The type of Pack is independent of the model The type of Pack your analyzer needs can be identified by pressing the INFO button at the top left of the screen If the pack type is not appropriate the analyzer will display ...

Page 20: ...f the operator 4 CONSUMPTION OF CALIBRATOR SOLUTIONS The analyzer electronically discounts doses from the uChip When the pack is empty the analyzer will display the message Pack Empty and will stop working with that pack When the pack is empty you will need to discard it and install a new one The red cap and associated tubing of the Analyzer may contain potentially infectious residues use caution ...

Page 21: ... the Pack If opened it loses the Guarantee and you run biological risks The consumption of Standard A and Standard B will never be equal Therefore there will always be a non proportional surplus of one of them The analyzer will display the message Pack Empty when any of the solutions runs out 6 PACK REPLACEMENT JS Medicina Electrónica recommends the simultaneous replacement of the Fill Port Cleane...

Page 22: ...the new Pack 3 Unscrew the green and orange caps of the Pack and pierce the aluminum seals Keep the caps that you removed to cover the bottles at the time of discarding them 4 Unscrew the special connection caps of the old pack and screw them into the new pack respecting the corresponding colors and place the original caps of the Pack to be discarded so that it does not lose liquid 5 Screw the cou...

Page 23: ...O 103APV4R ELECTROLYTE ANALYZER 23 JS Medicina Electrónica See the section CALIBRATION and PURGE Once the calibration process is complete the analyzer will display the following screen and be ready to measure ...

Page 24: ...ntrifuge the samples and measure the serum Do not mix serum and urine samples 2 SAMPLE LOADING BIOHAZARD Samples capillaries and adapters are potentially infectious Handle with gloves After removing the sample clean the sampling capillary well with ISE Cleaning Solution ISE REF IN 0400 The sample can be loaded from a tube syringe or from a capillary with an adapter Load from a capillary Loading fr...

Page 25: ...s any buttons 3 2 In the measurement menu you can select whether to measure TCO2 if installed IONS or both In this step lift the lever if you hadn t done it before Loading will start automatically 1 second later configurable If this option is not configured press Load to load the sample For samples in a tube or syringe simply move the lever in the first position 45º For samples from a capillary mo...

Page 26: ...ed remove the tube or capillary and lower the lever If the lever is not brought to the resting position the analyzer will not continue with the measurement and start emitting an audible signal 3 5 The analyzer will display the following screen The analyzer automatically positions the sample in the measuring chamber and performs the measurement ...

Page 27: ...at the results stays on screen is configurable If the Sodium result is lower than expected and you have a Sodium Glass Electrode perform a Sodium conditioning wash See section Sodium Conditioner 3 6 Loading patient data You can enter the data by hand by pressing on each of the fields or directly by scanning the label of the tube The data you can enter are id number Name letters and numbers Sex Age...

Page 28: ... 154 5 mmol l Sodium Measured Value Flagged above maximum K 3 64 mmol l Potasium Measured Value Cl 107 2 mmol l Chlorine Measured Value Flagged above maximum Ca 0 37 mmol l Calcium Measured Value Flagged below minimum Li 0 38 mmol l Lithium Measured Value Tmeas 20 2 C Actual Temperature of pH measurement pH 37 7 740 Corrected pH at 37 C Flagged above maximum Ca 7 40 0 43 mmol l Corrected Calcium p...

Page 29: ...t the same temperature as the instrument Do not use control solutions or samples freshly taken from the refrigerator first allow them to stabilize at room temperature The remaining Ions are measured simultaneously with the corrected Ca and pH up to a maximum of 7 measured parameters Always handle the sample in anaerobiosis BIOHAZARD Samples capillaries and adapters are potentially infectious Handl...

Page 30: ...e quality control menu are always reported at 37 C The Quality Control of Corrected Ca is carried out in the same way as the other Ions For more details see section QUALITY CONTROL 6 URINE MEASUREMENT 1 OVERVIEW Ensure the correct functioning of the analyzer by servicing it correctly and performing a quality control See the sections QUALITY CONTROL and MAINTENANCE Always dilute urine samples The d...

Page 31: ...g Solution Solution ISE REF IN 0400 Urine samples are always loaded from a tube always DILUTE with the provided urine diluent 3 MEASUREMENT Pressing X at any time of the measurement will be aborted The measurement can be started from the main screen by pressing Urine The analyzer will show the dilution and in case you want to modify it press the Dilution button From now on the measurement continue...

Page 32: ...ctrodes Green Ready to Measure Black Present on the analyzer and Disabled will not measure that parameter Red Not Calibrated will not measure that parameter If the electrode is not displayed on this bar it implies that the Analyzer did not detect it Check the connections and whether the Analyzer has that electrode enabled 2 1 POINT CALIBRATION OF IONS AND PH It is performed automatically by the an...

Page 33: ...an be performed on demand To do this navigate to the Calibration screen Route HOME screen Calibration Then press Electrolyte Calibration to begin calibration If the analyzer is not able to load Std A or Std B will show a Not Filled error and calibration will not be performed View maintenance errors 4 TCO2 CALIBRATION The calibration of TCO2 is carried out in the factory and in special situations m...

Page 34: ...n Follow the on screen instructions Use only the TCO2 calibration solution provided by the manufacturer 5 CALIBRATION RESULT Once the Calibration is completed the Analyzer will print a ticket with the result If the calibration was executed manually the results will be displayed on the screen The analyzer will display the status gain and balance If any result is not valid the electrode will say Unc...

Page 35: ...int button The legend Calibrated indicates that the electrode is ready to measure See the ELECTRODE GAIN section for gain ranges If the sodium or pH gain is less or greater than expected perform a wash with sodium conditioner For more details see the section SODIUM PH CONDITIONER The legend Not Calibrated indicates that the electrode will not be able to measure View the ERROR MESSAGES section ...

Page 36: ...PV4R S N 1 Analyzer Model and Serial Number UI 1 0 uISE 1 57 UI Firmware Versions Pack LOT 8 Pack Lot Number Expires 2023 09 01 Expiration Date Std A 87 B 34 A B Reagents Level Na Calibrated Ion Name Calibration Status Slope 71 2 Slope Balance 24 84 mV Balance K Calibrated Slope 63 6 Balance 4 98 mV Cl Calibrated Slope 58 2 Balance 21 77 mV Ca Calibrated Slope 29 9 Balance 7 97 mV Li Calibrated Sl...

Page 37: ...rom there you can also print that result 8 CALIBRATION OPTIONS To access the options navigate to the Calibration Options menu Route HOME screen Calibration Options 8 1 Enabling Disabling Electrodes Units The electrodes connected to the Analyzer can be enabled or disabled Disabling an Electrode implies that it will not be calibrated nor measured To access this menu navigate to Route HOME screen Con...

Page 38: ...8 2 Configuring the measurement correction The correction equation allows you to fine tune the values measured by the analyzer in such a way that they coincide with those obtained with other equipment internal and external quality controls or with the desired Standard Before using Corrections verify the correct operation of the analyzer and perform quality control Never apply Corrections if the eq...

Page 39: ...trode to which you want to apply the correction Then press a to modify the quadratic term b for the linear term and c for the delta Corection equation y ax2 bx c The Correction equation is typical of the equipment and is maintained when changing the Pack or electrodes Verify the need to maintain correction values with the change of the pack or electrodes ...

Page 40: ...ements Urine measurements ISE Cleaning Solution Normal washes Sodium washes This way you can check the status of the electrodes To access this information navigate to Route HOME screen Calibration ION Options Then select the electrode you want to display You can print the information by pressing the print button 10 PACK HISTORY Overview This menu contains all the data related to the use of the pac...

Page 41: ...rmation click on the pack status indicator from any menu 11 STANDBY FUNCTION After 10 minutes of inactivity the analyzer automatically goes into standby While in this mode automatic calibration and washing operations are suspended In this mode two types of operations will be executed A B wetting performed every 8 hours after the last calibration Wetting A performed every 3 hours after the last cal...

Page 42: ...asurement It also forces the execution of a rinse before measuring when the analyzer was not used in the last 10 minutes 3 ON DEMAND RINSE To access this menu navigate to Route HOME screen Rinse 3 1 Regular Rinse It consists of a washing of the ion chamber and the needle using Std A 3 2 TCO2 Rinse only analyzers with TCO2 option It consists of a rinse of the TCO2 chamber using Stda A 3 3 Intensive...

Page 43: ...trode the equipment will automatically ask for a pH Sodium rinse after a week of the last one You must place the pH Na cleaning solution at the time the equipment requires it It can also be started manually by pressing the corresponding button At the end of the rinsing process a calibration will be carried out automatically ...

Page 44: ...ottle If the equipment has not been used for a long time you must also perform a purge After the purge is complete a TCO2 wash is carried out automatically 3 AUTOMATIC PURGE It is performed automatically when a new pack is installed in the analyzer The analyzer will first purge the reagent from the stdB bottle and then the reagent from the stdA bottle When the process is finished a calibration wil...

Page 45: ...quality control of their equipment The Control Ampoules Diestro Control and Diestro Trilevel come in 3 levels low medium the normal value and high Do not use calibrator solutions as a control Do not use calibrating solutions or controls for flame photometer Use controls for DIRECT ISE Contact the manufacturer distributor or technical service to make sure which controls are the most appropriate and...

Page 46: ...s and have the equipment in optimal maintenance conditions The statistical calculations are Mean value Standard Deviation Ca Li pH and Coefficient of percentage variability Na K Cl 2 QUALITY CONTROL MEASUREMENT LEVEL 1 2 AND 3 Route HOME screen Quality Control Level 1 Level 2 ó Level 3 To measure the quality control samples we must press the button corresponding to the level to be measured and pro...

Page 47: ...lyte shows a graph where you can see the evolution of the measurements the limits for that control and the standard deviations represented with horizontal dotted lines for 1 2 and 3 standard deviations With the drop down list you can choose the number of samples that will be used to make the graph It can be the last 6 20 30 40 or 50 measurements ...

Page 48: ...ght of the chart which will make a table appear indicating if the criterion for each rule is met if you press again the bar the table will be hidden 4 RANGES Route HOME screen Quality Control Ranges The Ranges menu allows us to edit the limits for each control in each analyte These are the values used to mark the limits in the evolution graph of the measurements ...

Page 49: ...x and a keyboard will appear that will allow us to enter a new value Finish by pressing Enter The average level will be calculated automatically 5 MEMORY Route HOME screen Quality Control Memory The Memory menu allows us to see the quality control measurements The Delete Memory button deletes all stored measurements use it carefully ...

Page 50: ...ck on it and a new screen will open with the results The Delete button allows us to remove only this measurement from the list of control measurements 6 BRAND AND LOT Route HOME screen Quality Control Brand and Lot Here we will enter the brand and batch of controls used for quality control ...

Page 51: ...YZER 51 JS Medicina Electrónica 11 CLOCK 1 DEFINITION The analyzer keeps the date and time despite being turned off 2 CLOCK ADJUSTMENT To access your analyzer s date and time setting navigate to Route HOME screen Settings Date and time ...

Page 52: ...RO 103APV4R ELECTROLYTE ANALYZER 52 JS Medicina Electrónica 12 MEMORY 1 OVERVIEW It allows the operator to have access to the results of the measurements and calibrations carried out ordered chronologically ...

Page 53: ...and name Once the study we want to bring has been selected the results will be displayed and it will be allowed to print if necessary by pressing the Printer button Also if enabled you can send the result to the LIS by pressing the corresponding button 3 SAMPLER RESULTS HISTORY Route HOME screen Memory Sampler Results History Here we find grouped the measurements made with the sampler a session nu...

Page 54: ... repetition the value shown will be the average of the n measurements made The values shown in red indicate that the expected maximum CV or SD for that ION pH TCO2 has been exceeded Pressing on the row of a given tube will display the measurements of that tube along with the calculated statistics This is very useful for the control of the equipment using calibrated solutions ...

Page 55: ...ibration History Here we can select the calibration that we want to see Ions or TCO2 they appear ordered chronologically indicating order number date time and type of calibration As with the measurements you can print a ticket with the results of the calibration by pressing the Printer button TCO2 Calibration report ...

Page 56: ...e analyzer Error Not Filled The operator can position the sample manually to perform the measurement 2 MANUAL POSITIONING 2 1 Faced with a Not Filled error the analyzer displays the following window If you press CANCEL the analyzer will run a rinse and the sample will be lost After rinsing the analyzer will be ready to measure again If you want to position manually 2 2 Open the front of the analyz...

Page 57: ... 2 5 The measurement will begin and the Analyzer will continue normally The operator is responsible for positioning the sample correctly Position it from the reference electrode covering as many electrodes as possible with the amount of sample it counts Remember that the sample has to be in contact with the reference electrode Beware of electrodes that are not in contact with the sample The result...

Page 58: ... menu is accessed from Route HOME Configuration As there are more options than those that fit on a screen you must make a vertical scroll of the menu using the scroll bar located on the right to access the options that are hidden Screen when entering the Configuration menu Screen after scrolling vertically ...

Page 59: ...se whether the value shown is the one measured at room temperature or the one calculated at 37 degrees Celsius 3 AUTOMATIC SAMPLE LOAD Allows you to enable or not the Automatic Loading of the Sample When enabled the analyzer starts loading the sample automatically after a delay specified in this menu usually 1 or 2 seconds This avoids having to press Load while holding the sample on the input port...

Page 60: ... or up arrow depending on whether it is below or above the limit 6 CONNECTIONS Here you can enable serial output choose the port to use and the speed and protocol used Serial output RS232 via a USB SERIAL converter attached to the USB port on your analyzer allows you to connect the analyzer to a printer or other type of device for example a PC or LIS data network See chapter SERIAL PORT OUTPUT CON...

Page 61: ...TECTION THRESHOLDS Allows you to edit the values used in the detection of the various liquids used IT IS NOT RECOMMENDED TO MODIFY THEM UNLESS REQUIRED BY THE TECHNICAL STAFF OF THE COMPANY 9 INSTITUTION NAME Pressing on the current name opens a keyboard that allows you to configure the name that will appear on the tickets and on the top line of the screen when the analyzer is in the main menu ...

Page 62: ...E ANALYZER 62 JS Medicina Electrónica 10 LANGUAGE To change the language press the square with the current language and choose the required one from the list The analyzer must be turned off and back on for it to become effective ...

Page 63: ...ORT OUTPUT CONFIGURATION FOR LIS INTERFACE The analyzer has the option to send data according to the LIS communication protocol A USB to RS232 adapter will be required Connection cable Pins DB9 Female USB to RS 232 Adapter Pins DB9 Female PC 1 1 2 3 3 2 4 4 5 5 6 6 7 7 8 8 9 9 ...

Page 64: ...ng options Validate Each time a measurement is completed the operator must press the send data icon to send the data or press the back arrow to exit without sending it Do Not Validate Each time a measurement is completed it will be sent automatically Validate on Error Each time the measurement is finished and if there is an error the operator must acknowledge the transmission by pressing the send ...

Page 65: ...te and time there are 2 separation spaces Serum Na measurement result Na XX X mmol v Error Z Z Measurement Error Flag SCLQuU v Result outside the established normal range Calcium units can be mmol mgr or meq l W W measurement result in serum K X XXmmol in Error Z Serum Cl measurement result Cl XXX X mmol v Error Z Serum Ca measurement result Ca X XX mmol v Error Z Result of Li measurement in serum...

Page 66: ...45 3mmol E u K 4 16mmol E Q Cl 105 7mmol Ca 0 85mmolv Li 0 51mmol Urine measurements in the analyzer with Na K Cl Ca Li configuration Urine measurements without errors without patient ID All units of the ions are in mmol 8 2012 10 13 16 39 57 NaO 251 0 mmol l KO 21 20 mmol l ClO 251 0 mmol l Note In urine measurements a letter O is added after the measured ion Only Sodium Potassium and Chlorine ar...

Page 67: ...cina Electrónica 16 INSTALLATION OF BARCODE READER AND OR EXTERNAL KEYBOARD OPTIONAL The equipment allows you to connect an external USB barcode reader and or an external USB keyboard in one of the two USB ports that it has on the back of the cabinet ...

Page 68: ...lashing Green You can measure with certain considerations i e Some electrode is not calibrated reagent level is low etc Red There are errors you can t measure it 2 Reagent Pack Level Indicates the remainder percentage of the reagent with the lowest content By clicking on the indicator you can access the pack window 3 Electrode Status By clicking on the status bar of the electrodes you can access t...

Page 69: ... not calib In measurement The result is reported but will not be valid Repeat calibration measurement Check plugs on pipes and electrodes Eliminate any possible sources of interference Check the valves and peristaltic pipe In the case of electrodes with glass capillary Na pH pass sodium conditioner Possible electronic failure Change electrode If the problem persists call technical support ADC out ...

Page 70: ...odes or plugged pipe circuit Peristaltic pipe or faulty valves The ongoing operation is aborted Missing Pack It does not recognize the uChip uChip not connected Failure of electronic components It does not calibrate It doesn t measure No lava Connect a uChip Turn off and back on Contact the Technical Service Error Description Possible Cause Effect Action Expired Pack Pack Expired Pack out of date ...

Page 71: ...ltic pipe Change electrodes Investigate possible interference from other equipment or appliances Contact technical support L The balance during 1 point calibration differs from the last 1 point calibration Q Sharp differences during the measurement process In the Sharp differences during sample stabilization Measures low sodium Dirty sodium electrode Low sodium electrolyte measurement values Pass ...

Page 72: ...erformed daily the analyzer will not allow to continue working until one is completed See sections ISE CLEANING AND RINSING 2 WEEKLY MAINTENANCE 2 1 Sodium conditioning solution Once a week perform an intensive wash with the sodium conditioning solution See section SODIUM CONDITIONER 2 2 Internal cleaning of the equipment Clean the surface that says keep clean and any splashes of biological substa...

Page 73: ...ervice Maker Electrodes According to the need they have an estimated shelf life of one year Trained operator Distributor Technical Service Maker Capillary sampling Every 6 months Trained operator Distributor Technical Service Maker Standard and valve pipes Every 1 year Distributor Technical Service Maker Stack According to the need Distributor Technical Service Maker Fill Port According to the nee...

Page 74: ...ica 4 OPEN THE FRONT 4 1 Loosen the clamp button using a screwdriver or coin 4 2 Open the front by tilting it forward 5 MOUNT THE FRONT 5 1 Close the front 5 2 Adjust the clamp button using a flat screwdriver or coin Front Clamp Button Opening Front Clamp button ...

Page 75: ...Note that if a wash is carried out without the Sample Taking Cleaner the analyzer will drip on the area below the sample collection Note that if whole blood is passed then the time in which the washing of the sample is effective may be decreased by the detachment of clots or fibrins in the cleansing dressing 6 1 With the analyzer turned off open the front 6 2 Carefully lift the capillary sample un...

Page 76: ...OSAL OF SUPPLIES 6 4 Open the transparent packaging and remove the safety seal from the new Sample Taking Cleaner as shown in the figure 6 5 Present the DIESTRO cleaning module on the front of the position guides and slide smoothly until you stop against the bottom Make sure the Cleaning Module is in the correct position labeled Front Front towards the operator 6 6 Introduce the capillary sample i...

Page 77: ...ic Acid if present and waste 2 Disconnect the analyzer 3 Close the bottles of the Pack tightly 4 Do not tilt the equipment 5 If it is necessary to pack it for transport use the box in which the equipment was delivered along with the parts that prevent bumps and movements If such a box is not available use one of similar sizes and fill the sides of the equipment well 6 Install by following the inst...

Page 78: ...ratory is located As a guideline we suggest Close the bottles of the Pack well and consider as pathological residue Close any bottle of solutions tightly and consider them as special residue Used spare parts that probably had contact with biological samples and were not properly disinfected were considered as pathological residues 9 FINAL DISPOSITION OF THE EQUIPMENT For the final disposal of the ...

Page 79: ...ca 19 SERVICE 1 OVERVIEW The Analyzer has a menu for use by the manufacturer or authorized personnel which allows to evaluate the operation of the hydraulic circuit and the state of the electrodes Analyzer hydraulic circuit without TCO2 Analyzer connection diagram ...

Page 80: ...E ANALYZER 80 JS Medicina Electrónica Analyzer hydraulic circuit with TCO2 Notes The Sampler is Optional The number of electrodes depends on the configuration of the equipment the image shows the widest available electrode train ...

Page 81: ...able to see the conductivity in the selected detector see map A StdA B StdB C Sample by FP Sampler It is not advisable to open more than one valve at the same time as this can cause air to enter the hydraulic circuit If necessary purge the analyzer after testing Do not keep the valves open for too long Pressing Esc does not close the open valves To modify threshold values navigate to Route HOME sc...

Page 82: ...ample from the FillPort requires fill port out FI Move loaded sample to the ION chamber VA Empty ION Camber RI Normal Rinse I2T Move sample from the electrode chamber to the TCO2 reactor VAT Empty TCO2 reactor RIT TCO2 Reactor Rinse SMP Select Sampler Mode DWN Lower the sampler needle until liquid is found UPP Raise the Sampler needle 2 3 To access the sampler maintenance menu navigate to Only ava...

Page 83: ...le electrodes it is necessary to wait a stabilization time 15 seconds from when the sample is loaded Electrode Gain Differences between the voltages generated by the StdA and the StdB In some cases it may be useful to determine the voltage generated by certain samples in the measuring chamber The positioning of each calibrator solution or sample in the measuring chamber can be done both manually m...

Page 84: ...d in the equipment The mV shown mV difference between the electrode in question and the reference electrode are proportional to the concentration of each ION Interpretation of the results obtained The result obtained for the Std A and the Std B allow to verify the gain of each electrode in mV See section TECHNICAL SPECIFICATIONS Electrode Gain Range ...

Page 85: ...rew on its back 1 4 Unplug the connector from the electrode to be replaced 1 5 Loosen the terminal s of all the electrodes to the right of the one to be changed move them all a little to the right the electrodes are joined with silicone couplings that join them under pressure 1 6 Remove the defective electrode 1 7 Place the new electrode with the couplings and attach them to those that correspond ...

Page 86: ...DIESTRO 103APV4R ELECTROLYTE ANALYZER 86 JS Medicina Electrónica Fig 41 Removing the electrode cover Fig 42 Separating the electrode train ...

Page 87: ...place the thermal paper roll perform the following sequence 1 Open the lid of the roll holder gently pulling from the slot out Roll door opening 2 Replace the roll and remove the end of the paper as described in the image Changing the paper roll 3 Close the lid of the roll holder Closed roll holder ...

Page 88: ...CEMENT After the change of the peristaltic head it will be necessary to perform a purge 1 On the back of the equipment disconnect the peristaltic pipes from both couplings Remove the head pressing at the same time on its side locks LOCKS REMOVE WHILE THE LOCKS ARE PRESSED REMOVE PUMP PIPES ...

Page 89: ...DIESTRO 103APV4R ELECTROLYTE ANALYZER 89 JS Medicina Electrónica View of the peristaltic without head 3 Place the new head by pressing towards the equipment and connect the pipes 4 Perform a purge ...

Page 90: ...en the front of the analyzer 2 2 Remove the pipe from the stainless steel capillary 2 3 Loosen without removing the screw fastening the stainless steel capillary and take it out 2 4 Insert the tip at the tip of the new stainless capillary leaving at the lower end that protrudes approximately 1 5Cm 2 5 Put the new stainless steel capillary verifying that it matches the slot of the Teflon bracket an...

Page 91: ...DIESTRO 103APV4R ELECTROLYTE ANALYZER 91 JS Medicina Electrónica Needle sampling with Tip placed ...

Page 92: ...If an Intensive Wash is used at the end of the measurement it is reduced to 38 positions When using Prime I also reduce one position leaving 37 positions If a Quality Control is performed depending on whether it runs 1 2 or 3 levels the positions will be reduced to 36 35 or 34 In the case of using the Autosampler to perform only a Quality Control the 3 positions of the controls and the Normal Wash...

Page 93: ... connector in the side of the analyzer Do the same with the tubing 4 Stick the flat cable to the analyzer s cabinet with the provided double sided tape Screw the plastic piece to the analyzer s cabinet 5 Bring the sampler close to the analyzer Align the plastic piece with the sampler and screw them together Plastic piece ...

Page 94: ...DIESTRO 103APV4R ELECTROLYTE ANALYZER 94 JS Medicina Electrónica 6 Put the needle cover and screw it ...

Page 95: ...Now plug the power supply and perform a purge NEEDLE COVER 3 MEASUREMENT USING THE AUTOSAMPLER To access the Autosampler menu press the Sampler button on the HOME screen The equipment has three ways to make the measurement with the autosampler a Easy Serum b Easy Urine ...

Page 96: ...d At the end of the scanning of all the tubes will be positioned again in those that did not have or could not read the label there the following screen will appear with the following options MAN Manual It allows you to enter an ID manually with the on screen keyboard or an external keyboard scanner SKIP Skip that tube CANCEL Aborts the scan MEASURE The measurement of the scanned tubes begins c Ma...

Page 97: ...out mixing the order with each other in order to achieve a better measurement MAN Manual It allows you to enter an ID manually with the on screen keyboard or an external keyboard scanner SKIP Skip that tube CANCEL Aborts the scan MEASURE The measurement of the scanned tubes begins PREV Position sampler on previous tube 4 WAYS TO LOAD THE SAMPLE INTO THE AUTOSAMPLER The sample can be loaded from a ...

Page 98: ...DIESTRO 103APV4R ELECTROLYTE ANALYZER 98 JS Medicina Electrónica Loading from a tube into the sampler Loading from sample cup ...

Page 99: ...andle with gloves After removing the sample clean the sampling capillary well with ISE Cleaning Solution Solution ISE REF IN 0400 Correct tube placement BIOHAZARD Samples capillaries and adapters are potentially infectious Handle with gloves 5 CONFIGURATION In the configuration menu of the Autosampler you will find the following options ...

Page 100: ...fore moving on to the next tube To modify the number of repetitions click on the number and an editing window will open c Times to measure the same tube You can program the number of times you want to measure the same tube To modify the number of repetitions click on it and an editing window will open d ION and TCO2 Selection of type of measurement You can enable either or both of them 6 BAR CODE ...

Page 101: ...ELECTROLYTE ANALYZER 101 JS Medicina Electrónica The following photos indicate the correct way to glue the code to the tube 1 2 3 Barcode pasted correctly Fig 62 7 SPECIFICATIONS OF PRIMARY TUBES AND CUPS 10mm 45mm max ...

Page 102: ...ubes 1 Tube 12 x 86mm round bottom for 5ml 2 Tube 12 x 75mm round bottom for 5ml For this tube change the separators of the sampler disc See section 10 of this chapter 3 Tube 12 x 56mm round bottom for 3ml 5 Tube 12 x 100mm round bottom for 5ml Type of glasses for sample 4 Cup 10 x 22mm 1 2 3 4 5 ...

Page 103: ...YZER 103 JS Medicina Electrónica Pediatric Primary Tube Type 6 Pediatric primary tube 11 x 42mm for 0 5ml For better utilization of the pediatric primary tube place it inside an adult primary tube as shown in the following photo 1 2 6 ...

Page 104: ...f a spill of liquids inside the sampler it will be necessary to remove the disc to be able to clean it correctly Wear gloves To be carried out by trained and authorized personnel Disconnect the power outlet from the analyzer and remove all tubes that are in the disc Take the Allen wrench provided with the analyzer This is located on the inside of the front Allen Wrench Unfit the two screws at the ...

Page 105: ...E ANALYZER 105 JS Medicina Electrónica 10 1 5 Remove the center screw Remove the disc using the previously unadjusted screws Removing the tube holder disc Fig 65 Clean the residues that are inside the sampler Screws to be loosen ...

Page 106: ...TRO 103APV4R ELECTROLYTE ANALYZER 106 JS Medicina Electrónica Replace the disc by matching the sampler hole to the shaft lock Adjust the center screw Adjust the two screws at the top Sampler hole Shaft lock ...

Page 107: ... SEPARATORS In the case of using tubes of 75mm long or shorter it is recommended to change the separators of the sampler disc for the shorter ones provided with the analyzer To make this change perform the following sequence Remove the sampler disc as indicated in the previous section Remove the bottom disc with the supplied Allen M2 5 wrench Remove and replace the long separators with the shorter...

Page 108: ...DIESTRO 103APV4R ELECTROLYTE ANALYZER 108 JS Medicina Electrónica 26 DIAGRAMS Touch keyboard Printer Pack Screen Sampling Barcode reader Tray door pack Front view Sampling drive lever Side view ...

Page 109: ...DIESTRO 103APV4R ELECTROLYTE ANALYZER 109 JS Medicina Electrónica Pack Rear View Cable Uchip ...

Page 110: ...DIESTRO 103APV4R ELECTROLYTE ANALYZER 110 JS Medicina Electrónica Printer Pack Clamping button Sampling Barcode reader Autosampler Front view Pack Pack tray Autosampler Side view ...

Page 111: ...DIESTRO 103APV4R ELECTROLYTE ANALYZER 111 JS Medicina Electrónica Autosampler Pack ...

Page 112: ...DIESTRO 103APV4R ELECTROLYTE ANALYZER 112 JS Medicina Electrónica Rear view detail ...

Page 113: ...DIESTRO 103APV4R ELECTROLYTE ANALYZER 113 JS Medicina Electrónica Front View with Open Lid ...

Page 114: ...DIESTRO 103APV4R ELECTROLYTE ANALYZER 114 JS Medicina Electrónica Electrode cable Electrode lock Electrode chamber ...

Page 115: ...ution g 120 1 1 Size and Weight of the analyzer box Height 270 mm Width 420 mm Depth 470 mm 103APV4R Weight 6 7 kg Box with equipment 1 pack Urine Thinner Source ISE Cleaning Solution and accessories Weight with battery 7 2 kg 103APV4R w AutoSampler Option Weight without battery 9 kg Box with equipment 1 pack Urine Diluent source ISE Cleaning Solution barcode reader and accessories Weight with bat...

Page 116: ...rical protection 4 POWER SUPPLY SPECIFICATIONS INCLUDED Internal source optional Input voltage 100 240 VAC 50 60 Hz 1 0 A Output voltage 15V 3 4A External source standard Input voltage 100 240 VAC 50 60 Hz 1 5 A Output voltage 15V 4 0A 5 SAMPLES TIME Up to 48 samples hour for serum measurements without TCO2 determination Up to 29 samples hour for serum measurements with TCO2 determination 6 MAXIMU...

Page 117: ...L S D 0 06 1 1 5 mmol L SD 0 01 7 0 7 6 CV 3 5 15 50 Urine Repeatability N 20 C V 10 C V 5 C V 5 N A N A N A N A 10 ELECTRODES Maintenance free selective ion electrodes 11 ELECTRODE GAIN RANGE Electrode gain Electrode Na K Cl Ca Li pH TCO2 Gain 60 85 55 65 45 65 24 34 30 50 50 65 175 215 Note This is the gain range of new electrodes with the use this value may vary and the electrode will continue ...

Page 118: ...RNAL CLOCK 3V Lithium Battery CR1220 13 BACKUP BATTERY OPTIONAL Pack Batteries NiMh 14 4V 2400 mAh provided by the manufacturer of the equipment 14 EXTERNAL BARCODE READER AND KEYBOARD SPECIFICATIONS A barcode reader or keyboard can be connected to the USB connector The analyzer accepts the following barcode standards UPC EAN JAN UPC A UPC E EAN 8 EAN 13 JAN 8 JAN 13 ISBN ISSN Code 39 Codabar Code...

Page 119: ...y or metabolic alkalosis Increased plasma insulin Forced diuresis Treatment with diuretics Hypercalcemia Diabetes mellitus Lower potassium intake Diet low in potassium Alcoholism Anorexia nervosa Increased gastrointestinal losses Diarrhea Vomiting Fistulas Gastrointestinal drainage tubes Malabsorption Abuse of laxatives or enemas Increased urinary losses Primary or secondary hyperaldosteronism Adr...

Page 120: ... about 140 mmol L depend on the content of sodium and water in plasma and intracellular potassium However elevated plasma sodium may be due to low aqueous content and vice versa It accounts for approximately 90 of the inorganic cations in plasma being responsible for almost half of the osmolarity of plasma 3 Reference range cNa aP reference range adults 135 148 mmol L 4 Clinical interpretation 4 1...

Page 121: ...P adults 98 109 mmol L 4 Clinical interpretation The cCl as a single parameter is of minor importance in every way However decreased values can cause muscle cramps apathy and anorexia Increased values can lead to hyperchloremic metabolic acidosis 5 Considerations The importance of the cCl is in relation to the calculation of the anion gap Calcium Concentration cCa 1 Definition cCa P is the concent...

Page 122: ...first hour of being taken Whole blood samples taken in tubes with Li or Na heparinate yield cCa values lower than those obtained with the same sample without heparin This is because heparin complexes Ca and decreases it There are commercially heparins with calcium balance that would decrease this effect If the amount of heparin added to the tube or syringe can be decreased then this error would de...

Page 123: ...ffects such as tremors or confusion with even lower doses pH value 1 The pH indicates pH is a measure of acidity or alkalinity of an aqueous solution indicating the concentration of hydrogen ions 2 Reference range For optimal function of enzymes and cellular metabolism the pH in the blood must be maintained at values between 7 35 7 45 3 Clinical interpretation Acid base balance disorders can inter...

Page 124: ...JS Medicina Electrónica its minimum expression the influence of pH and it is not necessary to apply the correction formula since there will be no change in pCO2 which will cause the pH not to change and consequently the Calcium is not modified ...

Page 125: ...salt during the diuretic effect of saluretics and other similar preparations in certain acute nephropathies tubular necrosis in the polyuric phase following anuria in chronic nephropathies pyelonephritis chronic glomerulonephritis or polycystic kidney with saline incontinence syndrome in adrenal insufficiency of Addison s disease hypernatriria appears in Schwartz Bartter syndrome excessive secreti...

Page 126: ...ity in the following clinical situations 1 A decreased urinary sodium concentration indicates that there is an extrarenal loss of sodium while a high urinary sodium concentration indicates the existence of renal salt loss or adrenal insufficiency 2 In the differential diagnosis of acute renal failure in conjunction with other additional diagnostic elements 3 In hyponatremia a reduced urinary sodiu...

Page 127: ...f proteins and or lipids However the result is traditionally called concentration This conversion is based on recommendations from the IFCC Expert Panel on pH and Bood Gases in order to avoid the confusion of having two types of electrolyte results This technology is typically used in Blood Gas Analyzers and Point of Care Analyzers The reported result is independent of the solids content of the sa...

Page 128: ...asured ion s R General gas constant T Temperature n Valence of the measured ion s F Faraday constant ci concentration of the ion s measured fi Activity Coefficient of the measured ion s Stating the equation in terms of the operation of the Equipment 0 ln i i E E P f c P Slope of the Electrode Calibration Curve for the working temperature It is determined by the analyzer by measuring the Calibratio...

Page 129: ...rbon Dioxide gas Water Sodium Lactate The reaction is aided by a magnetic stirrer that mixes the L A and the sample in a constant volume reactor for a certain time The gaseous CO2 released in the reactor produces an increase in pressure that is measured with a sensor connected to it This pressure increase is directly proportional to the amount of NaHCO3 in the sample The equipment is previously ca...

Page 130: ...ge for 24 hour URINE Sodium mmol L 120 135 148 158 75 200 Potassium mmol L 2 8 3 7 5 3 6 2 40 80 Chloride mmol L 75 98 109 156 140 250 Calcium mgr 3 4 5 6 6 4 Not applicable Lithium mmol L 0 5 1 0 2 0 Toxic Not applicable pH 7 35 7 40 7 45 Not Applicable TCO2 mmol L 23 29 Not Applicable The normal values of urine samples are relative it depends largely on the diet and treatment to which the patien...

Page 131: ...or Electrode indefinite 12 months EL 0008D Digital pH electrode 6 months 6 months IN 0100 ISE Calibration Pack Use before expiration date IN 0106 TCO2 Calibration Solution Use before expiration date IN 0300 ISE Urine Diluent Use before expiration date IN 0400 ISE Cleaning Solution Use before expiration date IN 0600 Sodium Conditioner Use before expiration date IN 0050 Fill Port Cleaner indefinite ...

Page 132: ...anual Diestro 103APV4R Español RE 0851 Manual Diestro 103APV4R English RE 0905 Power Supply 15V 4A Indefinite 6 months RE 1000 Ground Cable Indefinite RE 0952 NiMh Battery 6 months 12 months Install before Install before the defined date If the component was not installed from this date the warranty time begins to elapse ...

Page 133: ...hat are spent or consumed before the operational and normal use of the referred product In these cases the warranty period will be as indicated in the operator s manual as install before or expiration date They will be causes of cancellation of this guarantee if the product has been subjected to blows or accidents of any nature improper use excesses or drops of electrical voltage that imply use in...

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