ERBA Chem 5 v3 User Manual

Semi-automated clinical chemistry analyser

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Chem 5 v3

Semi-Automated Clinical

Chemistry analyser

USER MANUAL

INS00013

Erba Lachema s.r.o., Karásek 2219/1d, 621 00 Brno, CZ

Date of last revision:

CC/IFU/205/23/A 01/2023

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Page 1 Chem 5 v3 Semi-Automated Clinical Chemistry analyser USER MANUAL INS00013 Erba Lachema s.r.o., Karásek 2219/1d, 621 00 Brno, CZ Date of last revision: CC/IFU/205/23/A 01/2023...
Page 2 User Manual Chem 5 v3 Foreword This manual is organized in a progressive sequence for easy study and reference. It is an instructional aide to provide a reference for easy operation and general maintenance of this analyser. It contains detailed description of the analyser features and specifications.
Page 3 User Manual Chem 5 v3 Legal Information All rights are reserved by manufacturer of this product. Manufacturer is the copyright owner of this document. The contents of this document are subject to change without prior notice and without legal obligation.
Page 4 User Manual Chem 5 v3 Contact Us We welcome your feedback about the product. You can reach us at the following. Address Erba Lachema s.r.o., Karásek 2219/1d, 621 00 Brno, Czech Republic Phone +420 517 077 111 +420 517 077 077 Website www.erbalachema.com...
Page 5 User Manual Chem 5 v3 The following symbols are used on the device to help the user Device complies with the CE marking of Regulation (EU) 2017/746 conformity on IVD MD Attention (caution) Read all safety instructions and precautions See Instructions for Read the user manual before operation.
Page 6 1. The concerned device delivery to Erba Lachema will be paid by the CUSTOMER 2. Device dismantling sorting of parts and elimination of wastes will be supported by Erba Lachema according to the existing local regulation 3. In case of a sale to a third-party the first...
Page 7 User Manual Chem 5 v3 Document Conventions Warning Icons About Bio-hazard Electric Shock High Temperature Injury Warnings and Caution Biological Risks Batch Code and Serial Number Notes, Usage, Tips, and Additional information viii...
Page 8: Table Of Contents
User Manual Chem 5 v3 Content OVERVIEW OF ANALYSER ................1-1 INTENDED USE OF Chem 5 v3 .............. 1-1 INTRODUCTION ..................1-1 BASIC PRINCIPLES ................1-2 ANALYSER VIEW ................... 1-4 SAFETY ......................2-6 ANALYSER FEATURES ..................3-8 HARDWARE SPECIFICATIONS .............. 3-8 SOFTWARE SPECIFICATIONS ...............
Page 9 User Manual Chem 5 v3 5.1.2 ONE POINT LINEAR MODE ............5-1 5.1.3 TWO POINT LINEAR MODE ............5-1 5.1.4 RATE A LINEAR MODE ..............5-1 5.1.5 SAMPLE BLANK LINEAR MODE ............ 5-1 5.1.6 CONCENTRATION (NON-LINEAR) MODE ........5-1 5.1.7 COAGULATION MODE ..............
Page 10 User Manual Chem 5 v3 PARAMETER DEFINITIONS AND VALUES ..........6-7 6.5.1 MODE ................... 6-7 6.5.2 FILTER 1 ..................6-8 6.5.3 FILTER 2 ..................6-8 6.5.4 OPTICAL DENSITY OF REAGENTS - DISPLAYING AND SAVING ..6-8 6.5.5 FACTOR ..................6-9 6.5.6...
Page 11 User Manual Chem 5 v3 6.7.1 PUMP CALIBRATION ..............6-13 6.7.2 LOAD DEFAULT PARAMETERS ........... 6-14 6.7.3 FILTER CHECK MENU ..............6-14 6.7.4 THERMAL PRINTER TEST MENU ..........6-14 6.7.5 TRANSMISSION CHECK .............. 6-15 6.7.6 LAMP SAVER MODE ..............6-15 6.7.7...
Page 12 User Manual Chem 5 v3 MAINTENANCE ..................11-1 11.1 DAILY MAINTENANCE ................ 11-1 11.2 QUATERLY MAINTENANCE ..............11-2 11.3 REPLACEMENT OF TUBING ..............11-2 11.3.1 ASPIRATION TUBE REPLACEMENT ..........11-2 11.3.2 REPLACEMENT OF PERISTALTIC PUMP TUBINGS ....... 11-4 11.4 REPLACEMENT OF LAMP ASSEMBLY ..........11-5 11.5...
Page 13: Overview Of Analyser
1.2 INTRODUCTION The Chem 5 v3 (hereafter referred as an analyser) is a low cost, low power, compact, high performance 32-bit micro controller based Biochemistry analyser, which is used for Routine Chemistries, Electrolytes, Hormones and Drug tests.
Page 14: Basic Principles
User Manual Chem 5 v3 1.3 BASIC PRINCIPLES Semi-automated clinical biochemistry analyser based on the principle of photometry, it measures light transmittance at various wavelengths White light as we see it is actually composed of several colours. This becomes evident, when we pass a beam of white light through a prism.
Page 15 User Manual Chem 5 v3 Lambert’s Law The light absorbed by the coloured solution is directly proportional to the light path of the colour solution (diameter of the cuvette): that is if the cuvette diameter is doubled, the light absorbed will be doubled.
Page 16: Analyser View
User Manual Chem 5 v3 1.4 ANALYSER VIEW PHOTOMETER COVER PRINTER DISPLAY KEYPAD ASPIRATION TUBE ASPIRATION SWITCH...
Page 17 User Manual Chem 5 v3 ON/OFF SWITCH INCUBATOR CONNECTOR PERISTALTIC PUMP COVER PC INTERFACE PORT EXTERNAL USB PRINTER EXTERNAL PC/AT KEYBOARD PORT PORT DC INPUT SUPPLY SERIAL NUMBER PLATE FUSE...
Page 18: Safety
User Manual Chem 5 v3 2 SAFETY This section provides safety information about analyser. Use this product properly and safely to prevent injuries and or damage to property. User must read these safety precautions before installation/use and follow the directions.
Page 19 User Manual Chem 5 v3 Take immediate corrective measures including shutdown of operation when ⚫ any malfunction is detected in the analyser. In the event of trouble, do not play with the analyser and leave any repair work ⚫ to an authorized expert.
Page 20: Analyser Features
User Manual Chem 5 v3 3 ANALYSER FEATURES 3.1 HARDWARE SPECIFICATIONS SYSTEM TYPE Open, Flow cell. MEASUREMENT Colorimetry (Rate/End Point) PRINCIPLE APPLICABLE ANALYTES Photometric assays – Substrates, Enzymes, Lipid, Protein, Sugar, Inorganic Substances SETUP Benchtop. LIGHTSOURCE Quartz Halogen Lamp, 12V, 20 Watts.
Page 21: Software Specifications
User Manual Chem 5 v3 PROCESSOR 32-bit Cortex M4 Microcontroller. MEMORY Built-in1MB Flash, 136KB SRAM, 16KB EEPROM and 64 KB ROM. REAL TIME CLOCK Built in. REPLACEABLE BATTERY Lithium Battery CR2032 (3V) ON PCB WASTE COLLECTION Waste collected in closed container.
Page 22 User Manual Chem 5 v3 ▪ ▪ Both by Date and I.D Graphic presentation of Non Linear calibration curves ⚫ QC (QC Data available for three controls per test) ⚫ ▪ Daily QC ▪ Monthly QC Rate calculation by least square regression method.
Page 23: Keyboard Description
User Manual Chem 5 v3 3.3 KEYBOARD DESCRIPTION DESCRIPTION These are multi-function keys. Each key is used for entering a number seen on the key, and upto three alphabets in upper and lowercase. E.g. The numeric key ‘1’ is used to select or enter an alphabet or the number ‘1’...
Page 24: Aspiration Switch
User Manual Chem 5 v3 For Linear test, CALIB key is used when factor is to be calculated by running sample as standard. For nonlinear test it is used to calibrate curve. This key is used to enter the negative sign. This key is...
Page 25: Installation
User Manual Chem 5 v3 4 INSTALLATION 4.1 INSPECTION The analyser is tested before shipment and is packed carefully to prevent any shipping damage. It is user’s responsibility to inspect all cartons upon arrival and notify the carrier of any apparent damage. Follow the steps described in the paragraphs below to install the analyser.
Page 26: Storage And Transportation
User Manual Chem 5 v3 4.3 STORAGE AND TRANSPORTATION Instructions for storage, transport and handling the analyser: Analyser is a precision instrument and must be handled by trained personnel only to avoid damage. Improper handling may cause improper functionality. It is fully inspected and carefully packed before leaving the factory to withstand shocks in transit.
Page 27: Electrical Requirements
User Manual Chem 5 v3 4.5 ELECTRICAL REQUIREMENTS Voltage and Single phase continuous stabilized AC 115/230 volts ± 10%, 50 / 60 Hz Frequency Grounding Perfect earthing must be provided at power source with all applicable local requirement (A grounded, power plug only should be used).
Page 28: Installation Procedure
User Manual Chem 5 v3 4.6 INSTALLATION PROCEDURE 1. Unpack the accessory box. 2. Remove the waste bottle and place it on the table. 3. The analyser comes equipped with an external AC power adapter and one three/two pin power cord (with earth terminal) for external AC power adapter.
Page 29: External Printer Installation
NOTE: In case of error at external printer get the error corrected, restart the printer and reissue PRINT command. 4.7.3 PC COMMUNICATION Chem 5 v3 can be connected to PC through USB for online result transmission. NOTE: USB Connectivity to PC requires operating system 2000/XP or above. 4.8 EXTERNAL KEYBOARD INSTALLATION Switch off the analyser before connecting PS2 keyboard.
Page 30: Principles Of Operation
User Manual Chem 5 v3 5 PRINCIPLES OF OPERATION 5.1 MODES OF OPERATION The analyser is capable of performing analysis using the following modes. 5.1.1 ABSORBANCE MODE The optical density in the range of 0 – 3 O.D. can be obtained directly on the analyser selecting appropriate wavelength.
Page 31: Coagulation Mode
User Manual Chem 5 v3 Two Point Non-Linear ⚫ Rate A Non-linear ⚫ Sample Blank Non-linear ⚫ 5.1.7 COAGULATION MODE This mode is used for performing common Coagulation tests like PT (Prothrombin Time) PT or aPTT (activated partial thromboplastin time). The final result is obtained in seconds.
Page 32: Aspiration Volume
User Manual Chem 5 v3 5.3 ASPIRATION VOLUME The aspiration volume is programmable from 100 – 2997 μl. After aspiration of sample an air aspiration of 30 μl has been provided. For Rate A and Two Point mode, if the aspiration volume value is between 100 –...
Page 33: Additional Cuvette Holder
User Manual Chem 5 v3 5.5 ADDITIONAL CUVETTE HOLDER The analyser’s main cuvette holder can accommodate 3 types of cuvettes. 33 µl flowcell ⚫ Rectangular Polystyrene Cuvette ⚫ 6 mm round Glass Tube with adapter for Coagulation and Elisa tests ⚫...
Page 34: Settings
User Manual Chem 5 v3 6 SETTINGS 6.1 HARDWARE CHECK Turn ‘ON’ the analyser. It will automatically check all the important devices and will show the status on display. If any of the parameter is not ok, then the following message will be displayed PROCEED…<YES>.
Page 35: Runtest
User Manual Chem 5 v3 This screen is also referred to as the “Home screen” of the analyser. Select any option by pressing any one of the alphanumeric keys (1-6) corresponding to the desired option. The options on the opening screen are described below: 6.2.1 RUNTEST...
Page 36: Setting The Date
User Manual Chem 5 v3 NOTE: System setup details are printed below the header in test print taken through thermal and external printers. Sections 6.3.1 to 6.3.6 cover each of the above options in detail. 6.3.1 SETTING THE DATE The analyser incorporates a built-in calendar function, which is maintained by a battery, and once set, the Date and Time will be printed when the analyser prints result data on the printer.
Page 37: Setting The Data Output Mode
User Manual Chem 5 v3 HOUR: Enter an hour from 00 to 23. MINUTE: Enter minutes from 00 to 59. SECONDS: Enter seconds from 00 to 59. Each entry is separated by a ‘:’ sign, which appears automatically after the entry of the 2 digit.
Page 38: Blank Deduction
User Manual Chem 5 v3 Item Description Each key can be used for entering three alphabets in upper and lowercase. And followed by the number seen on the key, e.g. ‘A’, ‘B’, ‘C’, ’a’, ’b’, ’c’, ‘1’ ‘Y’, ’Z’, ’y’, ’z’, ’-‘, ’9’...
Page 39: Test Parameters
User Manual Chem 5 v3 If Air Purge is enabled extra 150 μl air is aspirated after displaying the result. If Air Purge is disabled, extra 150 μl air will not be aspirated. 6.4 TEST PARAMETERS The analyser is pre-programmed for the test codes (Test Names and parameters).
Page 40: Parameter Definitions And Values
User Manual Chem 5 v3 parameter. For the other parameters the user can use the numeric keys to enter the appropriate data. Press <HELP> again to exit “Help Screen”. After making the changes press <fn> to save the changes. Wrongly entered parameters will not be accepted and the cursor will be positioned on the wrong entry and a message will pop up.
Page 41: Optical Density Of Reagents - Displaying And Saving
User Manual Chem 5 v3 Key ‘8’ – SAMP_BK - For Sample Blank chemistries. Key ‘9’ – SAMP_BK_NL - For nonlinear Sample Blank chemistries 6.5.2 FILTER 1 It is the primary filter at which measurements are made. The available wavelengths 340, 405, 505, 546, 578, and 630 nm.
Page 42: Factor
User Manual Chem 5 v3 For Rate A, and Rate A Nonlinear. D RG OD/m (Delta Reagent Optical density per minute) field will be displayed, which is the Rate of change of absorbance for reagent blank. The D RG O.D and D RG O.D/m are also known as self-reactivity of reagent.
Page 43: Delay T (Delay Time)
User Manual Chem 5 v3 6.5.10 DELAY T (delay time) It is the lag time or delay time (in seconds), for the reaction to reach equilibrium. (Please refer to the reagent manufacturer specification). In case of End-Point test, it is the time (in seconds) required for the solution to stabilize in the Flowcell/Cuvette.
Page 44: Lin.lim (Linearity)
User Manual Chem 5 v3 During the test performance, For decreasing reaction if the absorbance of reaction mixture during read time ⚫ is lower than the value that has been set, the analyser gives a warning of “RX ABSORBANCE UNDER”.
Page 45: Sample Vol (Μl)
User Manual Chem 5 v3 6.5.17 SAMPLE VOL (µl) This volume is displayed in the RUNTEST screen and helps the operator in pipetting correct volume of Sample. 6.5.18 R1/R2 VOL (µl) This volume is displayed in the RUNTEST Mode and helps the operator in pipetting correct volume of Reagent.
Page 46: Changing The Test Name And Description
User Manual Chem 5 v3 6.6 CHANGING THE TEST NAME AND DESCRIPTION In TEST PARAMETER page, press <↑> Key (Up arrow key) when the cursor is at mode parameter to position the cursor on the test name and type the required name and description and press <fn>...
Page 47: Load Default Parameters
User Manual Chem 5 v3 6.7.2 LOAD DEFAULT PARAMETERS Press < > > key on the Pump Calibration screen to display the next page. Press <fn> to download default Test parameters from the memory. Press <>> key to go to the next page or <<> to go back to the previous page.
Page 48: Transmission Check
User Manual Chem 5 v3 Press <PRINT> key to obtain Test printout from Thermal printer. Press < > > key to display the next page or <<> to go back to the previous page. 6.7.5 TRANSMISSION CHECK Press <fn> to check the transmission.
Page 49: Keypad Check Menu
User Manual Chem 5 v3 Press <>> key to go to the next page or <<> to go back to the previous page. 6.7.7 KEYPAD CHECK MENU Test all the 25 keys in this menu by pressing each key on the keypad. The key legend should disappear from the LCD on successful press of the particular key.
Page 50: Modes Of Operation
User Manual Chem 5 v3 7 MODES OF OPERATION Biological hazard: When using the analyser, when handling the analyzed samples or wastes, follow the appropriate safety measures. Use protective equipment such as a lab coat, protective gloves or safety glasses.
Page 51: 1-Point Linear Mode
User Manual Chem 5 v3 8. After all readings are taken remove the Polystyrene cuvette, and press <RESET>key to exit this screen. 9. When the display changes to the “Home screen” wash the flowcell, using the “fn/WASH” Key. NOTE: In absorbance mode the unit automatically gets converted to ABS hence if...
Page 52 User Manual Chem 5 v3 REAGENT BLANK” and “PRESS NO TO SKIP” alternately. Press <NO> to skip reagent blank. If <NO> is pressed, then previously stored reagent blank OD will be used for calculation of factor. Aspirate standard solution (RGT + STD), when the analyser displays “ASPIRATE STANDARD”...
Page 53: 2-Point Linear Mode
User Manual Chem 5 v3 the “fn” key. (Follow the on screen instructions.) 12. To wash the flowcell with distilled water, hold tube containing distilled water under the aspiration tube and press <fn> to start the wash action and after proper wash press <fn>...
Page 54: 1-Point Non Linear Mode
User Manual Chem 5 v3 this delta ABS of reagent is subtracted to obtain a final delta ABS. of reaction mixture. The graphical representation of the reaction can be displayed on the screen by pressing <ENTER> key. The printout of result and graph can be obtained by pressing the <PRINT>...
Page 55 User Manual Chem 5 v3 2. Press < fn > to toggle between POINT TO POINT and SPLINE methods. Press < 1 > FOR CALIBRATION. Press < 2 > FOR GRAPH. Press < 3 > FOR SAMPLE RUN. NOTE: Non-linear chemistries can be performed by directly entering the absorbance values of the standards in the absorbance column of the calibration table.
Page 56 User Manual Chem 5 v3 a. When the analysers display “ASPIRATE WATER”, then Aspirate distilled water and wait for a few seconds. (The Analyser automatically zero’s the ABS) b. In the calibration table, the standards for which the concentration is entered, only those standards can be run.
Page 57: 2-Point Non Linear Mode
User Manual Chem 5 v3 analyzed will be stored in memory for QC Data. When the screen displays “ASPIRATE SAMPLE” & “UP->C1 DOWN-> C2” alternately, one can enter appropriate patient ID and then Aspirate reaction mixture (RGT + SMP). The analyser will automatically start incubation countdown (entered as Delay time in parameters).
Page 58 User Manual Chem 5 v3 concentration of the standards to be run. A minimum of 3 and a maximum of 6 standards can be used. If the number of standards is less than six, zero values must be entered against the corresponding standard number. Press <...
Page 59: Rate A Linear Mode
User Manual Chem 5 v3 countdown (entered as Delay time in parameters) followed by Read Time countdown. At the end of Read time the analyser will give the results interpolated directly from the previously plotted graph using the delta absorbance read by the photometer.
Page 60 User Manual Chem 5 v3 Aspirate the Reagent Blank when the analyser displays “ASPIRATE REAGENT BLANK” & “PRESS NO TO SKIP” alternately. Wait for a few seconds. The analyser will automatically start incubation countdown (entered as delay time in parameters) followed by the Read time countdown. The end of the analysis is signalized by an acoustic beep.
Page 61: Rate A Non Linear Mode
User Manual Chem 5 v3 mixture (RGT + SMP). The analyser will automatically start incubation countdown (fed as Delay time in parameters) followed by the Read time countdown. The display continuously shows the change in ABS as the reaction proceeds. The countdown shows the time elapsed since the start of the reaction.
Page 62 User Manual Chem 5 v3 4. Using the vertical cursors numeric keys enter concentration of the standards to be run. A minimum of 3 and a maximum of 6 standards can be used. If the number of standards is less than six, zero values must be entered against the corresponding standard number.
Page 63: Sample Blank
User Manual Chem 5 v3 countdown (entered as Delay time in parameters) followed by Read Time countdown. At the end of Read time the analyser will give the results interpolated directly from the previously plotted graph using the delta absorbance read by the photometer. If in the system setup thermal printer is activated then the result will be printed out automatically, otherwise user has to press <...
Page 64: Sample Blank Non-Linear
User Manual Chem 5 v3 absorbance of the Reagent Blank Solution after the programmed delay time is over & then gives prompt of “ASPIRATE SAMPLE BLANK”. Now aspirate the Sample solution. Wait for a few seconds, to allow the solution to stabilize in the flowcell.
Page 65 User Manual Chem 5 v3 4. Using the vertical cursors numeric keys enter concentration of the standards to be run. A minimum of 3 and a maximum of 6 standards can be used. If the number of standards is less than six, zero values must be entered against the corresponding standard number.
Page 66: Coagulation Mode
User Manual Chem 5 v3 6. Aspirate Sample Blank or Control 1 Blank or Control 2 Blank when the display shows “ASPIRATE SAMPLE BLANK” or “ASPIRATE CONTROL 1 BLANK” or “ASPIRATE CONTROL 2 BLANK” respectively. After this aspirate Sample or Control 1 or Control 2 when the display shows “ASPIRATE SAMPLE”...
Page 67 User Manual Chem 5 v3 2. Add desired sample volume in the tube. 3. Press <fn> for incubation. Analyser will start incubation countdown entered as delay time in parameters. 4. In one reagent chemistry, READ TIME will be set to 0 whereas in two reagent chemistry, READ TIME field should have some value.
Page 68: Index Mode
User Manual Chem 5 v3 9. When the display changes to the “Home screen” wash the flowcell, using the “fn” key. (Follow the instructions on the display.) 7.11 INDEX MODE This mode is used for calculating test results based on the index formula entered by the user.
Page 69 User Manual Chem 5 v3 2. The RUN TEST screen will now be displayed with the parameters that are necessary for the analyser to operate in this mode. 3. Aspirate Distilled Water when “ASPIRATE WATER” is displayed on the screen.
Page 70 User Manual Chem 5 v3 7. In the next screen, the ABS will be displayed along with the concentration as per the value calculated by Index Formula. This result will be printed along with the Index formula on the Thermal Printer as well.
Page 71: Quality Control
User Manual Chem 5 v3 8 QUALITY CONTROL Quality control of a calibrated biochemistry analyser is the periodic monitoring of the system performance by use of specimens both in the normal and abnormal range for comparison. The obtained data is compared with previously obtained data.
Page 72: Daily Quality Control
User Manual Chem 5 v3 8.1.1 DAILY QUALITY CONTROL It is a plot of Standard Deviation (Y-axis) vs. the number of controls run (X- axis). Data for each run (QC) is graphically plotted on QC DATA control chart for the each chemistry for rapid or early identification of trends.
Page 73 User Manual Chem 5 v3 8.1.1.2 DAILY QC REPORT FOR C2 This display for Daily QC report for C2 is obtained after the numeric key < 2 > is pressed. Printout of the Daily Quality Control Report for C2 can be obtained using the <PRINT>...
Page 74: Monthly Quality Control
User Manual Chem 5 v3 NOTE: Similarly daily QC report for C3 can be obtained 8.1.2 MONTHLY QUALITY CONTROL It is a plot of Standard Deviation (Y-axis) versus the number of days in a month (X- axis). Data for each run (QC) is graphically plotted on QC DATA control chart for the each chemical and for rapid or early identification of trends.
Page 75 User Manual Chem 5 v3 Press <fn> key to erase the QC data. 8.1.2.2 MONTHLY QUALITY CONTROL FOR C2 This display is obtained after the numeric key < 4 > is pressed: The monthly Mean and Standard Deviation 2SD is displayed on the screen. Printout of the Monthly Quality Control Report for C2 can be obtained using the <PRINT>...
Page 76 User Manual Chem 5 v3 However, taking monthly QC report print is possible only if valid SD and Mean values are defined. NOTE: Similarly monthly QC report for C3 can be obtained. NOTE: 1. In Daily QC and Monthly QC, flag will get displayed along with control data...
Page 77: Patient Reports
User Manual Chem 5 v3 9 PATIENT REPORTS Reports can be obtained by pressing the numeric key <4> in the “Home screen”. It allows the printing of the results obtained in the analysis for each patient. The Patient Report can be obtained by: Date, I.D. and by Date and I.D.
Page 78: Collated Report By I.d
User Manual Chem 5 v3 arrow keys to scroll the page UP and DOWN to view the remaining results. 9.2 COLLATED REPORT BY I.D The screen for Collated Report by ID is as follows: Enter Sample ID using alphanumeric keys. Use right and left arrow keys to move the cursor.
Page 79 User Manual Chem 5 v3 Enter date in DD/MM/YY format and ID. Press <fn> to toggle between Date and ID. Press <ENTER> to confirm. The following screen is displayed: arrow keys to scroll the page UP and DOWN to view the remaining...
Page 80: Qc Rules
User Manual Chem 5 v3 10 QC RULES Criteria for Evaluation : The algorithm will calculate the SD values of different controls based on which the respective rules will be implemented, depending on this the user would decide whether the RUN is to be accepted or Rejected.
Page 81 User Manual Chem 5 v3 2) Westgard 1:2S Rule: This refers to the control rule that is commonly used with a Levey-Jennings chart when the control limits are set as the mean plus/minus 2s. In the original Westgard multirule QC procedure, this rule is used as a warning rule to trigger careful inspection of the control data by the following rejection rules.
Page 82 User Manual Chem 5 v3 4) Westgard R:4S Rule: Reject when 1 control measurement in a group exceeds the mean plus 2s and another exceeds the mean minus 2s. This rule should only be interpreted within- run, not between-run. The graphic below should really imply that points 5 and 6 are within the same run.
Page 83 User Manual Chem 5 v3 6) Westgard 10x Rule: Reject when 10 consecutive control measurements fall on one side of the mean. This would be applied across five controls and across different run (on the same day) Each of the rule would be validated when the run for control is being performed,...
Page 84 User Manual Chem 5 v3 is to be rejected considering the Westgard rules then it would be the user who would decide whether the samples are to be rejected or are to be Accepted, what it means is that the analyser would proceed with the sample run despite of the failure in QC rules and none of the samples would be flagged for the QC failures.
Page 85: Maintenance
3. Always leave the flowcell filled with distilled water. Never leave any reaction mixture in it. 4. At the end of each day, aspirate Erba cleaning solution into the flowcell and leave it filled overnight. Every morning aspirate distilled water 5-6 ml to thoroughly rinse the flowcell.
Page 86: Quaterly Maintenance
User Manual Chem 5 v3 11.2 QUATERLY MAINTENANCE Replace the aspiration tubing and peristaltic pump tubing once every THREE months (as explained below) or earlier if it shows signs of wear and tear. NOTE: Failure to change the peristaltic pump tubing in time can cause serious errors of aspiration volumes and can also damage the analyser due to the leakage of corrosive reagents through torn tubing.
Page 87 User Manual Chem 5 v3 3. Unscrew the aspiration tubing from the flow cell. 4. Slide out the washer and ‘O’ ring of the old aspiration tubing. 5. Discard the old aspiration tubing onto an appropriate location, as it is bio- hazardous.
Page 88: Replacement Of Peristaltic Pump Tubings
User Manual Chem 5 v3 Biological hazard: Dispose of all waste in accordance with local regulations. It is recommended to inactivate the waste by adding a disinfectant. 6. Slide the washer and ‘O’ ring into the new aspiration tubing. 7. Lock it to the flow cell with the plastic screw available.
Page 89: Replacement Of Lamp Assembly
User Manual Chem 5 v3 5. Insert the one end of new peristaltic tubing assembly into the tubing coming from the flow cell. 6. Position the new tubing around the rotor. 7. Insert the other end of peristaltic tubing into the waste tube and direct the waste tube towards waste bottle.
Page 90 User Manual Chem 5 v3 5. Unscrew the thumbscrew provided on the lamp holder. 6. Pull out the lamp. 7. Place a new lamp and connect the lamp terminals and fix thumbscrews. 8. Refit the lamp cover. 9. Close Photometer Cover.
Page 91: Replacement Of Printer Paper
User Manual Chem 5 v3 11.5 REPLACEMENT OF PRINTER PAPER Warning: THE REPLACEMENT OF PRINTER PAPER SHOULD BE PERFORMED BY THE TRAINED PERSON ONLY. Before starting the instrument, make sure that enough printer paper is on the roll. The paper roll is located under the printer cover. To check and / or replace the paper roll lift off the printer cover.
Page 92: Disinfection Procedure For Flowcell And Tubing
User Manual Chem 5 v3 6. Press PAPER FEED key provided on the keypad to advance the paper. Warning: BE CAREFUL – SHARP PAPER CUTTER. Warning: SWITCH OFF THE POWER SUPPLY BEFORE REMOVING THE COVER. 11.6 DISINFECTION PROCEDURE FOR FLOWCELL AND...
Page 93 User Manual Chem 5 v3 8. Once the flow cell and the tubing gets saturated with 70% IPA solution. 9. Press the Wash button again to stop the aspiration. 10. Allow 70% IPA solution remain inside the flow cell and tubing for about 2 minutes.
Page 94: Troubleshooting Guide
User Manual Chem 5 v3 12 TROUBLESHOOTING GUIDE SYMPTOM LIKELY CAUSE/CORRECTIVE ACTION 1. Check if peristaltic pump tubing is connected properly, if not reconnects correctly. Liquid is not aspirated 2. Perform pump calibration again. when the <fn/WASH> key <ASP> switch is pressed 3.
Page 95 User Manual Chem 5 v3 SYMPTOM LIKELY CAUSE/CORRECTIVE ACTION 1. The initial absorbance of reagent is less than the RG. The result printout is ABS Lim. Value test parameters. accompanied by the warning “CRITICAL REAGENT 2. Check if the “RG. ABS LIM.” Value has been correctly ABSORBANCE”...
Page 96: List Of Consumables
User Manual Chem 5 v3 13 LIST OF CONSUMABLES For continuous and trouble free working of analyser, it is a recommended to keep certain spare consumables handy. One set of the items mentioned below is also supplied along with the instrument as standard accessories.
Page 97 Instrument or service complaint: www.erbalachema.com/service/en/instrument-complaint Erba Lachema is a part of global Erba Mannheim GmbH Group. In case of technical problems, contact our service: service@erbamannheim.com Any serious incident that has occurred in relation to the device shall be reported to the manufacturer and the competent authority of the Member State in which the user and / or the patient is established.

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