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RR Mechatronics Interrliner XN1 FRL Instructions For Use Manual

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Instructions for Use
Interrliner
MRN-164_2-EN Version 2.02

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Summary of Contents for RR Mechatronics Interrliner XN1 FRL

  • Page 1 Instructions for Use Interrliner MRN-164_2-EN Version 2.02...

  • Page 3: Table Of Contents

    Contents Contents - Application..............Document history overview.
  • Page 4 Contents 5.2.1 - - Main screen sections..........5.2.2 - - Main screen with keyboard.
  • Page 5 Contents 6 - Operation............. . . 6.1 - - Quick start-up.
  • Page 6 Contents 8.2.4 - - Usage options........... 8.2.5 - - Quality control procedure.
  • Page 7 Contents 13.1 - - Daily............. 13.2 - - Weekly.

  • Page 8: Application

    Application Application This manual, MRN-164_2, is applicable for the following instruments: EHST109621 Interrliner XN1 FRL EHST109622 Interrliner XN2 FRL EHST109623 Interrliner XN3 FRL with Software version V6.xx MRN-164_2-EN Version 2.02 Interrliner...

  • Page 9: Document History Overview

    Document history overview Document history overview MRN-164_2-EN Published date Thursday, 26 August 2021 Issue No Date Revised Section(s) Changes Authorised • Options number of retry 2.02 Sept. 2021 Program H. Schavemaker aspiration and disable pipette added • Entering Reagent information mandatory •...

  • Page 10: Introduction

    Introduction Introduction 1.1 - Intended use of device Automated analyser for in vitro determination of the Erythrocyte Sedimentation Rate (ESR) of human blood samples in conformity with the Westergren standard. For professional use in medical laboratories only. To be used for all patient populations, not restricted by age or any other anatomical or physiological particulars.

  • Page 11: Explanation Of Symbols

    Introduction (2) ICSH review of the measurement of the Erythrocyte sedimentation rate / J. M. Jou, Int. Journal of Laboratory Hematology 2011 (33), p .125-132 Note: Some details are not described in this manual; if applicable, they might be found in the following manuals: Interrliner Installation manual MRN-023.

  • Page 12: Starrsed Line Of Esr Instruments

    Manuals are available in PDF and HTML-format and can be downloaded from support.rrmechatronics.com. 1.7 - EQAS EQAS is RR Mechatronics' comprehensive tool to periodically assess the performance of the Starrsed instrument at your lab. Through EQAS, the test results of the instrument, obtained with Starrsed Control are objectively compared with a worldwide peer group using the same type of instrument.

  • Page 13: Sedimentation Measurement Principle

    Introduction 1.8 - Sedimentation measurement principle The automatic reading of the Westergren sedimentation pipettes is performed by moving an optical sensor along the pipettes. While the sensor is moving, it is taking a reading every 0.25 mm. The sensor is reading the absorption of infrared light through the Westergren pipette filled with blood.

  • Page 14: Instrument Description

    Instrument description Instrument description The Interrliner consists of the following main modules: Start-pool ▪ Loading of racks through belt-driven transport system ▪ Capability of holding 21 Sysmex racks ▪ Keyboard (in drawer) Tube handling and transport ▪ Indexer unit, initialising racks and reading the barcode of the sample tubes and sample racks. ▪...

  • Page 15: Pc Operation And User Interface

    Instrument description Reagents cabinet ▪ Swing door for easy access ▪ Capable of storage of all needed reagents PC with touch screen LCD monitor ▪ Windows based platform ▪ Dedicated instrument software ▪ Optional network connections ▪ USB port Option: External barcode reader, which can be connected to the USB port of the ESR analyser unit.

  • Page 16: Technical Specifications

    Instrument description 2.2 - Technical specifications Model name Catalogue number (REF) Instrument models Interrliner XN1 FRL EHST109621 Interrliner XN2 FRL EHST109622 Interrliner XN3 FRL EHST109623 Westergren method ESR method ICSH J. M. Jou; Int. Journal of Laboratory Hematology 2011; 33: 125-132 CLSI Procedures for the Erythrocyte Sedimentation Rate Test;...
  • Page 17 Instrument description Most commonly used brands/types. Sample tube types Closed tubes with concentric cap only. Barcode reader: CCD. Barcode reader type Most common barcode labels Reading capabilities Code39, ITF, Industrial 2 or 5, CodaBar,EAN/UPC, CODE128 Environment: Less than 65 dBA Sound level 18 - 28 °C Environment temperature...
  • Page 18 Instrument description 63 kg Start pool Conveyer/robot unit incl. Front Return 160 kg unit 12 kg Protection hood 18 kg (single), 22 kg (double), 26 (triple) Back panels LIS connectivity: Ethernet and serial, bi-directional according various protocols Communication Data storage: Hard disk on external PC Storage medium approx.

  • Page 19: Used Reagents

    Instrument description 2.3 - Used reagents NOTE: The latest version of the Material Safety Data Sheet (MSDS) of the used reagents can be found on our web site rrmechatronics.com 2.3.1 - Starrsed Rinse solution Starrsed Rinse solution is a dedicated IVD product, developed exclusively for automatic rinsing of the Westergren pipettes in Starrsed ESR analyzers.

  • Page 20: Installation

    Installation Installation The instrument must be unpacked, installed and checked by a trained engineer prior to first operation. Detailed installation instructions are given in the Interrliner Installation manual. Connect the instrument only to a properly earthed power connection. 3.1 - Main power connections The main switch for the ESR analyser unit is located at the left side of this instrument.

  • Page 21: General Safety Information

    General safety information General safety information The instrument described in this manual is designed to be used by properly trained personnel only. For the correct and safe use of this instrument it is essential that both operating and servicing personnel follow generally accepted safety procedures in addition to the safety precautions specified in this manual.
  • Page 22 General safety information To start the Sample mode: ▪ Close the cover and press button “Sample mode”. ▪ The cover is automatically locked and sample mode is switched ON ▪ If button “Sample mode” is pressed while the cover is still open, an audible and visible warning message is given, instructing the operator to close the cover.

  • Page 23: Starrsed Program

    Starrsed program Starrsed program The Interrliner is controlled via an external computer on which runs the Starrsed software. The software functions are grouped on six tabbed screens. The software is controlled by mouse pointer or directly via the touch screen. A virtual keyboard is automatically displayed on screen, when numerical or alphanumerical input is required.

  • Page 24: Software Version

    (is not explained in this manual) 5.1 - Software version The latest software and manuals for the Interrliner can be downloaded from the RR Mechatronics website; www.rrmechatronics.com. (Login-part) The following program description is valid for software from version 6.12.1 and up and up.

  • Page 25: Main Screen Sections

    Starrsed program Maintenance screen 5. Settings screen 6. Service screen The above picture is an example of the screen of the ESR analyser unit in the normal operation Sample mode. If the software is set to service mode is this indicated with a yellow bar next to the menu. When the ESR analyser unit is running in the Service mode all kinds of settings can be changed and the instrument will run with the changed settings.
  • Page 26 Starrsed program Rack: This is a representation of a rack in process. Empty positions indicate, that no sample tube was detected at that position. The combinations of the pictograms have the following meaning: Barcode could not be read (read failure). Barcode was read correctly, waiting for response from LIMS Barcode was read correctly, but ESR is not required for this sample.

  • Page 27: Main Screen With Keyboard

    Starrsed program Version information and help: Shows the version information of the software. Click on the question mark for Instructions for Use (normal mode) or the error list in case of an error message. When the Service mode is activated, extended user information is shown. Sample information: After measurement, the results of the sample are shown in this window.

  • Page 28: Pipette Information

    Starrsed program 5.2.3 - Pipette information The following information is shown: MRN-164_2-EN Version 2.02 Interrliner...
  • Page 29 Starrsed program ▪ Sample ID: The sample identification (barcode) of the sample tube. ▪ Dilution: The dilution rate of this sample as calculated during the aspiration process. ▪ Time filled: The date and time when the sample was aspirated. ▪ Time to go: The number of minutes to wait until the sample will be measured.

  • Page 30: History Screen

    Starrsed program 5.3 - History screen In History the following options can be selected: ▪ Display pipette data Use button to send the selected data to the printer. Print ▪ Display sample history ▪ Display full patient result In Display sample history are the following options available: Print: Send the selected result to the printer.

  • Page 31: Display Pipette Data

    Starrsed program 5.3.1 - Display pipette data This table shows information of the samples in the carousel during the selected ESR process time. After measuring the pipette, the pipette data is transferred to the sample history files. In the header of the table the names of the columns are shown. Double-click the header of any column to sort the table by this column in ascending order.

  • Page 32: Display Sample History

    Starrsed program 5.3.2 - Display Sample history In the window Select date to show results: double click on the file name to select the results of the selected date. Press Refresh to refresh the list of available files. In the window Sample ID, type the sample ID information and press Search. Press Options for the following search options: ▪...

  • Page 33: Display Patient Results

    Starrsed program 5.3.2.1 - Display patient results In the window Select date to show results: double click on the file name to select the results of the selected date. Press Refresh to refresh the list of available files. In the window Sample ID, type the sample ID information and press Search. Press Options for the following search options: ▪...

  • Page 34: Display Rack History

    Starrsed program Date / time Date and time of the measurement of the result. ESR time (min.) Actual duration of the ESR. Dilution % The calculated dilution rate after aspiration of the sample. Temperature (°C) Room temperature at the time of the measurement of the sample. Pipet number Pipette in which the sample was measured.

  • Page 35: Display Rack Status

    Starrsed program Barcode was read correctly, but ESR is not required for this sample. ESR is required and waiting to be done. Sample was aspirated successfully. Sample was aspirated, but with fill errors. If option "Read rack number" is "ON" (Service - General/Barcode), the rack number is shown under date/ time.

  • Page 36: Esr Statistics Screens

    Starrsed program The Clear rack history button will clear the contents of the rack history file and restart to build-up a new rack history file. 5.3.4 - ESR Statistics screens A statistical graph is produced over a selected period. Make a selection of the following graphs; ▪...

  • Page 37: Qc Normal Results (Table)

    Starrsed program When the Starrsed Control sample ID is used, results are only listed here. When Lab ID barcode is used, QC results are also listed in "Patient results". Note: This part of the software can only be used in combination with Starrsed Control as quality control material.

  • Page 38: Qc Abnormal Results (Table)

    Starrsed program 5.3.5.2 - QC abnormal results (table) The results from Starrsed Control level A are shown. Display Results (table) QC sample ID: Read from the barcode. The original Starrsed Control barcode (=batch number) Linked lab ID: The Lab ID is given if it is linked to the Starrsed Control sample ID Sampling date: The date and time when the QC sample was aspirated.

  • Page 39: Qc Abnormal Results (Graph)

    Starrsed program Error/Warning: Only special QC errors are mentioned here, general ESR warnings/errors are mentioned in the next column (ESR error/Warning). After these columns additional data is shown: pipette number, dilution rate, ESR30, ESR time and Aspect. Scroll to the right. Results are always shown with and without Temperature correction, independent of the setting Temp.

  • Page 40: Qc Abnormal Results Screen Extended

    Starrsed program Display Statistics (graph): All QC results from the chosen Starrsed Control batch are shown in a chart. Shown in the graph: ▪ QC results (red) = values of measurements per date ▪ Calculated mean (yellow) = mean value of all QC results of the specific batch ▪...

  • Page 41: Display Sample History (Qc)

    Starrsed program 5.3.5.5 - Display sample history (QC) This screen shows all patient results that have been measured after the selected QC result and up to the following QC result. The results are presented in the layout of the "Display sample history "...

  • Page 42: Qc Result Analysis

    Starrsed program Use this screen to link the Starrsed Control sample ID with a Lab ID or to check which links are active. 1. "Starrsed Control sample ID": Enter the lot number or scan the barcode from the original Starrsed Control tube label.

  • Page 43: Set Start/End Date

    Starrsed program 5.3.6 - Set start/end date Enter the Start/End date and time. 5.3.7 - History sample analyse option MRN-164_2-EN Version 2.02 Interrliner...
  • Page 44 Starrsed program Make a selection for all or today's results between start time and end time or make a selection for: 1. A specific number of past days. 2. A specific date. 3. A range of days from start date to end date. MRN-164_2-EN Version 2.02 Interrliner...

  • Page 45: History Analyse Results

    Starrsed program 5.3.8 - History analyse results Dilution error The dilution error detection is a user setting and can be changed in - dilution error detection to 0 ... Settings 25 %. In this example, the dilution error detection is set to 10% and limit errors set to YES. By selecting Dilution >= 110 all the samples with a dilution rate >= 110 are displayed in the table.

  • Page 46: Reagents Screen

    Starrsed program Warning By selecting one of the warning codes, all the samples with this warning code are displayed in the table. In the header of the table the names of the columns are shown. Double-click the header of any column to sort the table by this column in ascending order.

  • Page 47: Display Reagent History

    Starrsed program 5.4.1 - Display reagent history This screen shows the history of the used reagents. Select the reagent type on the right side. For external use of the information all the logged reagent data can by exported to EXCEL .CSV format by clicking Export to Excel (CSV).

  • Page 48: New Reagent Input

    Starrsed program 5.4.2 - New reagent input Note: Only the Rinse solution input screen is shown. The input screens are the same for all reagents. Input screen for new reagents. Make a selection to add new (default setting) or delete the current information and continue with "Next".

  • Page 49: Maintenance Screen

    Starrsed program 1. First enter / read the Article number 2. Enter/ read Lot number. 3. Enter / read the Expiration date (if barcode reader is used: cursor has to be in one of the two boxes) 4. If necessary, adjust the date when the reagent was placed. 5.

  • Page 50: Prime / Clean

    Starrsed program 5.5.1 - Prime / Clean All maintenance functions for the fluid system are grouped under button Prime / Clean. After each reagent change, the fluid system must be primed to fill the relevant tubes with reagent and remove air. This is also part of the daily start-up. Use the applicable button to perform the automatic priming cycle for this reagent: Prime: ▪...

  • Page 51: Fill And Clean Screen

    Starrsed program ▪ Wash each pipette: When the pipette belt turns one position, the pipette at the rinse position will be rinsed and dried, regardless if it was filled or not. ▪ Wash all pipettes: Before executing this function, check carefully if there are samples in the pipette belt that need to be measured.

  • Page 52: End-Of-Day-Wash Procedure

    Starrsed program 5.5.1.2 - End-of-day-wash procedure ▪ End-of-day wash: All pipettes will be washed once and needle, fill-nozzle and rinse-nozzle (wash station) are primed. 5.5.2 - Check sensors When there is a sensor alarm, an alarm indicator is shown in the tab Maintenance. All functions to check the status of the sensors are grouped under button Check sensors.
  • Page 53 Starrsed program Press the button Measure. The pipette currently at the measure position will be measured. The results are displayed in graphical form: Measure head start position correct Measure head start position wrong When a test pipette is installed at the measuring position the result of the test pipette is displayed in the field "ESR (mm)".

  • Page 54: Display Error History

    Starrsed program 5.5.3 - Display error history When there is a sensor alarm, an alarm indicator is shown in the tab Maintenance. All errors that occurred during operation are logged automatically This list can be used by field engineers to check the status of the instrument and locate possible problems. This log can be saved e.g.

  • Page 55: Display Maintenance History

    Starrsed program 5.5.4 - Display maintenance history When there is a sensor alarm, an alarm indicator is shown in the tab Maintenance. All performed maintenance functions are logged automatically. This log can be saved e.g. to a memory stick by clicking button Save As ... 5.5.5 - Maintenance info MRN-164_2-EN Version 2.02 Interrliner...

  • Page 56: Close

    Starrsed program This screen is divided in 6 maintenance level sections. For maintenance levels 1 to 4, the status is monitored and flagged if it is overdue. Press the button Info to open the work instruction for a specific maintenance level. When this maintenance is done press the button Done to log the completed work in the maintenance log file.

  • Page 57: End-Of-Day-Wash Schedule Settings

    Starrsed program ▪ Weekdays: The function runs only on defined working days (default: monday till friday) at the selected time. Other days can be set with "Custom" ▪ Daily: The function runs on a daily base at the selected time. ▪...

  • Page 58: Operation

    Operation Operation 6.1 - Quick start-up This section describes a quick start-up procedure and a general description of what to do before starting a large batch of samples to run through the system. The Interrliner can only handle tubes with correct closed caps and correct labeling. 6.1.1 - Check list Run this checklist before each large batch of samples.

  • Page 59: Esr Unit Check

    Operation ▪ Observe the Robotic arm movement during the start-up, after finishing the reset sequence the ESR analyser unit is ready for use. ▪ Switch the Interrliner. The system becomes operational when the lines "HST Version X.XX" and "Lab Comm On (or OFF)" are shown in the display. ▪...

  • Page 60: Liquid Levels

    Operation 6.2.1 - Liquid levels Liquid containers levels are checked with liquid level sensors before processing new racks. When the level sensor alarm appears, replace reagent as soon as possible. 6.3 - Checks during operation ▪ Perform regularly visual checks for air bubbles in the sample pipettes, see Air bubbles ▪...

  • Page 61: Turn Off Sequence

    Operation 6.4.2 - Turn off sequence ▪ Close the Interrliner software. ▪ Switch the Interrliner OFF. ▪ Switch (optional) printer OFF. ▪ Switch the ESR analyser unit OFF. ▪ Switch the Interrliner rack system OFF. MRN-164_2-EN Version 2.02 Interrliner...

  • Page 62: Reporting

    Reporting Reporting The Interrliner is able to handle different types of protocols. The selection is made in -LIMS-settings. Service A protocol is a set of rules governing the communication and the transfer of data between machines, as in a computer system. It is also a formal set of rules and procedures to be followed during a request for information before data is transferred between machines and computer systems.

  • Page 63: Report 60-Minute Mode

    Reporting 6. Pip.=Sedimentation pipette number (number on the pipette belt). 7. Time=Actual sedimentation time in minutes. 8. T=Temperature (in degrees Centigrade). 9. Error=Error message (if the Analyser detects an error). EDTA mode 7.1.1 - Report 60-Minute mode + REPORT EXAMPLE +(Not to scale) -- StaRRsed-- Date 25/04/2019...

  • Page 64: Report 30 Minute Mode

    Reporting 7.1.2 - Report 30 Minute mode + REPORT EXAMPLE +(Not to scale) - StaRRsed-- Date 25/04/2019 Time: 15:28 915001 CLEAR EDTA 7.2 - ESR Error Error messages can be found on the printout in column 10. If errors are found during the measurement, the ESR analyser unit will give an audible alarm. The Error message is displayed on the main screen.

  • Page 65: Limit Error Settings

    Reporting 7.3 - Limit error settings When an option (at Limit error settings) is set to and this limit error occurs, results will be printed/send to the LIMS. Together with the sedimentation time and dilution rate (which are still printed at the usual position), the operator/analyst can see what caused the error and may or may not use the ESR values which are preserved in the error message.
  • Page 66 Reporting Graphic showing typical absorption values of a sample The 'sedimentation' value is the distance in millimeters between the cells/plasma level (87.5% absorption) and the meniscus. If there is no haze, the absorption drops quickly to a value below the 75% level. If the distance between the 87.5% and the 75% level is less then 3mm, the report will state 'CLEAR'.

  • Page 67: Quality Control

    Quality control Quality control 8.1 - Control pipettes The correct function of the hardware and software of the Interrliner measurement unit should be checked at regular intervals with the aid of Mechatronics Control Pipettes (Order nr. QTST049000). More information can be found in the Control Pipette User Manual (MRN-019).

  • Page 68: Temperature Correction

    Quality control 8.2.3 - Temperature correction The assayed values are based on an 60 minutes ESR, with dilution and temperature correction . Therefore, using temperature correction . The the measured ESR value should be compared with the expected value calculation of a 30 minute measurement to a 60 minute ESR result with temperature correction influences the QC result due to rounding.

  • Page 69: Qc Results

    Quality control When using LAB ID: Link the Lab ID with Starrsed Control Sample ID, see chapter Linked QC IDs. Attach the lab ID label on the tube on top of the original Starrsed Control label 2. Rub the Starrsed Control tube between hands until packed cells have been completely re-suspended. (See also video instruction https://portal.rrmechatronics.com/whatiseqas/) 3.

  • Page 70: Qc Result Analysis

    Quality control Messages when the general setting "Temperature Correction" is switched ON: ▪ "E116: QC is out of acceptable range!" The Sample mode is switched OFF automatically. Remaining filled pipettes are processed in the normal manner. Messages when the general setting "Temperature Correction" is switched OFF: The software always calculates a temperature corrected result because only temperature corrected results can be compared with the Assay mean value.

  • Page 71: Waste Disposal

    Waste disposal Waste disposal The waste container has a level sensor and as soon as the level sensor generates a waste error, the waste container must be emptied. The waste must be treated as potentially infectious (biohazardous) material and disposed of according to local regulations. Preferably, discard the complete waste container and replace it with a cleaned one.

  • Page 72: Data Safety Management

    Data safety management Data safety management The Interrliner has its own external PC. This means that all collected data is stored on the hard-disk of the external computer. This means that all raw data and results are kept, irrespective of a power failure or if the instrument is un- intentionally turned off.

  • Page 73: Troubleshooting

    Troubleshooting Troubleshooting Occasionally small faults may cause major problems. This chapter may help to solve the most common faults and explain why a specific problem occurs. A lot of the problems or errors are due to a lack of maintenance. Remember that this instrument operates with a considerable amount of whole blood, virtually undiluted, stores it in a pipette for one hour and then cleans pipettes for re-use.

  • Page 74: Errors 181-185 And 193-201

    Troubleshooting 1. Check that the rack transport unit is switched ON. 2. Clear the error by pressing button. Clear error 3. When the error occurs again: 4. Close the Starrsed software. 5. Switch the ESR analyser unit OFF. 6. Switch the rack transport unit OFF. 7.

  • Page 75: Separator Error

    Troubleshooting 11.6 - Separator error If it takes too long for the waste pump to empty the waste separator, the system generates a separator error. Separator error may be caused by: Extensive foam build-up in the waste Check the separator assembly and connections for possible separator.

  • Page 76: Hazy Reports

    Troubleshooting 1. Blood clots or rubber debris from the tube cap in the sample. ▪ Check the condition of the outer needle. 2. Filling procedure stopped by operator. 3. Insufficient sample volume. ▪ Should be at least 1.4 ml. 4. Faulty filling nozzle or filling nozzle O-ring. ▪...

  • Page 77: Leaking Pipettes

    Troubleshooting 11.9 - Leaking pipettes 1. Check for particles like specks of dirt or hairs in the pipette valve. 2. If no particles are found, replace the valve tube and valve body. 11.10 - Liquid level sensor not sensing 1. Liquid in the container is not detected. This occurs sometimes with the bottle and is De-ionized water caused by a very low conductivity.

  • Page 78: Foam In Column

    Troubleshooting 11.11.1 - Foam in column A layer of air bubbles that is concentrated on top of the blood column does not affect the sedimentation process itself. The sedimentation develops normally below the bubbles. However, too many bubbles bring about a shortening of the effective blood column, which is a deviation from the Westergren method.

  • Page 79: One Air Bubble About 5 Mm Under Meniscus

    Troubleshooting 11.11.3 - One air bubble about 5 mm under meniscus The filling (aspiration) speed is not critical but should be within certain limits. 1. If just one air bubble is found about 5mm below the meniscus, the filling speed may be too high.

  • Page 80: Small Air Bubbles Rising In Pipette

    Troubleshooting 11.11.5 - Small air bubbles rising in pipette Usually this is caused by a dirty or damaged fill nozzle. ▪ Observe the maintenance schedules. ▪ Clean the fill nozzle. ▪ Check the fill nozzle for damage. If necessary, replace the fill nozzle. Sample tube is leaking on the fill nozzle side.
  • Page 81 Troubleshooting ▪ Try new QC sample tube (normal samples will be Result is out of range, the applicable values for the finished) acceptable range depend on the user setting. E116 is shown in the status line of the Sample screen and the QC ▪...
  • Page 82 Troubleshooting QC result out of range! ▪ Perform a new QC sample, normal samples will be finished ▪ If this error persists check/clean instrument QC sample expired! Use a new batch of Starrsed Control It is not possible to link this Lab ID. Lab ID is already linked! The "Linked QC IDs"...
  • Page 83 Troubleshooting ▪ Check/clean instrument and perform a new QC The measured control values change abruptly up- or sample downwards. ▪ If these errors persist perform maintenance step Do not compare 30 minute method with 60 minute ▪ Compare only results from one batch. method result.

  • Page 84: Troubleshooting Interrliner Transport

    Troubleshooting Interrliner transport Troubleshooting Interrliner transport Errors which are not explained in this section can usually not be solved by the operator. Refer to the Service manual for more information (available only in English). The following numbers are the 2 rightmost digits of the error numbers which are displayed on the display of the rack transport system.

  • Page 85: General Maintenance

    General Maintenance General Maintenance Interrliner is an analyzer that operates with considerable amounts of whole blood virtually undiluted, and stores it in a pipette for one hour. For this reason instrument maintenance is of the utmost importance. To maintain the maximum reliability of the instrument, the maintenance procedures must be strictly followed.

  • Page 86: Daily

    General Maintenance 13.1 - Daily The purpose of the daily maintenance is to keep the instrument clean and contamination as low as possible. Clean all parts that are exposed to blood, wipe the outer surface and the stainless steel plate below the pipette belt.

  • Page 87: Level 4 Maintenance

    General Maintenance Detailed instructions of this procedure can be found in the Work Instruction Cleaning waste separator . Symptoms of a dirty separator: 1. Separator errors. 2. Foam in the separator. 3. Waste pump cannot sufficiently remove the waste from the separator. 13.3 - Level 4 maintenance The purpose of level 4 maintenance is to carry out the daily / weekly maintenance and replace the pump tubing, bacterial filters and the Fill nozzle O-ring.

  • Page 88: Replace Bacterial Filters

    General Maintenance 13.3.2 - Replace bacterial filters Detailed instructions of this procedure can be found in WI Cleaning waste separator . As part of the Cleaning waste separator procedure the bacterial Hepa filter QWLV040002 is replaced with a new one. 13.3.3 - Fill-nozzle O-ring replacement As the fill nozzle O-ring (QWLV050004) ages, it looses its flexibility and air-bubbles may occur in the Westergren pipettes, the O-ring needs to be replaced.
  • Page 89 General Maintenance Start Fill and clean procedure: 1. Select button OK. 2. The needle goes down and the process is started. 3. When all the pipettes are filled, the needle goes back to the home position. 4. After the Fill & clean process is finished, a notification is given to stop the procedure. 5.

  • Page 90: Level 3 Maintenance

    General Maintenance 1. The needle comes down. 2. Fill a container with 150 ml hot (80 °C) de-ionized water. 3. Add 15 ml cleaning agent. (QRR 010905) 4. Stir the prepared solution. 5. Put the container close to the needle location. 6.

  • Page 91: Check Or Replace Sample Probe Or Outer Needle

    General Maintenance Be careful, as there may be blood in the cassette. First, prepare some disinfectant and put this in the waste separator. Press to pump disinfectant through the pump cassette. Prime Disinfectant Symptoms for a bad or faulty waste pump cassette: ▪...

  • Page 92: Reagents Installation

    General Maintenance 13.6 - Reagents installation Note: since november 2015 a 5 liter bottle (including a specific level sensor) is delivered for storage of Deionized water. Use only the Mechatronics bulk reagent cubitainers on the Interrliner. For storage of deionized water, a plastic 5l bottle is delivered (including a specific level sensor and adapter).

  • Page 93: Cleaning Touch Screen Display

    General Maintenance The sensors and the reagents have the following color codes: Reagent Color code Starrsed Rinse solution Green Starrsed Saline Yellow Starrsed Diluent Grey Deionized water Blue Starrsed Disinfectant White Notes Deionized water Add one or two drops of Starrsed Saline to the deionized water to avoid Reagent alarm.

  • Page 94: Appendix For Interrliner

    Appendix for Interrliner Appendix for Interrliner Appendix section MRN-164_2-EN Version 2.02 Interrliner...

  • Page 95: Appendix - Error List Interrliner Esr Analyser Unit

    Appendix for Interrliner 14.1 - Appendix - Error list Interrliner ESR analyser unit last updated: 01-09-2014 Error Extra explanation Reason/Solution • Power cable not connected E2: Communication error! (Board: Communication lost after 3 retries on the communication PCB %s (%x), Command: %x, TWSR: between Computer and Interrliner.
  • Page 96 Appendix for Interrliner • Check for leakage on the E9: Air flow failure! ESR analyser unit was not able to pipette or fill nozzle. get a stable reading during the vacuum test before aspiration the sample. • Check if outer needle is E10: Sample probe was jammed.
  • Page 97 Appendix for Interrliner • Check and/or clean the E24: "Diluter Start" sensor out of The Diluter Start sensor has Diluter Start sensor. If cleaning range. Check/clean this sensor ! reached a critical level. fails, replace sensor Continuing could result in filling errors.
  • Page 98 Appendix for Interrliner E37: NACK received from host Did not receive ACK from Host See E30 after sending 'Sample result after sending 'Sample result string' string'! 3 times. • Configuration file maybe E40: Position settings error. Position settings in Eeprom do not corrupted.
  • Page 99 Appendix for Interrliner ▪ Faulty EEPROM (24C01) on E158: Read error serial EEPROM There was a communication error Elevator or Indexer board. on Elevator or Indexer board! between the serial EEPROM (on Elevator or Indexer board) and the ▪ EEPROM not mounted on main processor (keyboard) during Elevator or Indexer board.
  • Page 100 Appendix for Interrliner • No power on the Elevator E166: I2C communication error There was a communication error board. between PC and Elevator board! between the Elevator board and the main processor during an I2C ▪ I2C cable(s) not connected. operation.
  • Page 101 Appendix for Interrliner E181: Barcode rotator up / down The Barcode vertical motor didn’t ▪ Check up and down sensors. motor timeout! reach its up or down position ▪ Faulty Barcode vertical motor. within a certain time limit. ▪ Barcode rotator unit mechanically blocked.
  • Page 102 Appendix for Interrliner E195: Sample unit in / out motor The Sample arm unit in / out didn’t ▪ Check sample arm out and timeout! reach the in (= needle) or out (= home sensors. rack) position within a certain time ▪...
  • Page 103 Appendix for Interrliner E211: Unknown command from The communication was OK, but ▪ Check RS232 cable between Input-pool! an unknown command was Elevator board and Interrliner received from the Input-pool. Transport board. ▪ If there are I2C errors in the ESR analyser unit: check the I2C cable(s).

  • Page 104: Maintenance Schedule

    Appendix for Interrliner 14.2 - Maintenance schedule Maintenance performed periodically or after number of samples Maintenance Schedule Interrliner (Example) Sample volume: 350 per day (5 working Daily Weekly Level 4 Level 3 Level 2 Level 1 Parts Total days) (monthly) (quarterly) (halfyearly) (yearly)
  • Page 105 Appendix for Interrliner Run Fill and clean Replace Waste cassette assembly ESRI090921 Replace Blotting washer waste pump ESRI090026 Replace Pinch valve tube ESRI010246 Replace Blue disc filter QWLV040003 Check needle condition Replace teflon tips (diluter syringe repair QWLV030901 set)* Replace Waste pump motor ESRI090920 Replace Fill block washer ESRI030906...
  • Page 106 Appendix for Interrliner ESRI070924 Fill tube assembly to regulator ESRI070924 Fill tube assembly from regulator QWLV030021 Diluter Syringe QWLV080002 Quad Ring MRN-164_2-EN Version 2.02 Interrliner...

  • Page 107: Work Instruction Interrliner

    Work instruction Interrliner Work instruction Interrliner Work instruction section MRN-164_2-EN Version 2.02 Interrliner...
  • Page 108 Work instruction Interrliner Work instruction Number Page 1 of 1 Purpose: Daily maintenance Safety: Bio Hazard area Instrument: Interrliner Revision: 001, 2019 Prepare disinfectant: (if not already prepared). This disinfectant is for cleaning of all external parts that are exposed to blood. 1.
  • Page 109 Work instruction Interrliner Work instruction Number Page 1 of 3 Purpose: Weekly maintenance Bio Hazard area Safety: Instrument: Interrliner Revision: 001, 2019 Clean Fill nozzle Clean fill nozzle The use of a toothbrush and detergent is recommended. ▪ Carefully scrub the fill nozzle inner part. ▪...
  • Page 110 Work instruction Interrliner Cleaning A. Clean all parts with hot water and a brush. B. Use some acid free vaseline on the screw-thread of the glass jar, the top rim of the glass jar, the O-ring for the HEPA filter and the black PVC pipe on the back. Replacing C.
  • Page 111 Work instruction Interrliner Check sensors Vacuum pressure check ▪ Go to tab -> sensor. Select box. Maintenance Check Check Flow sensor Flow: 0980 ± 60 Abs: 0320 ±10 If the flow is not in range there might be a blockage in the vacuum flow line to the flow sensor. Fill Stop sensor check ▪...
  • Page 112 Work instruction Interrliner 6. If trapped air bubbles are found, go to tab click button and perform the [Maintenance], [Prime / Clean] [Prime function. Diluent/Diluter] 7. Wipe outer surface and stainless steel plate below the pipettes with disinfectant. 8. Check (or replace if needed) two drip trays (ESRI010318) MRN-164_2-EN Version 2.02 Interrliner...
  • Page 113 Work instruction Interrliner Work instruction Number 1215 Page 1 of 4 Purpose:Maintenance level 4 Safety: Bio Hazard area Instrument: Interrliner Revision: 003, 2019 Clean Fill nozzle and exchange O-ring Fill Nozzle 6. Clean fill nozzle The use of a toothbrush and detergent is recommended.
  • Page 114 Work instruction Interrliner Clean waste separator and exchange filters Removing Cleaning A. Clean all parts with hot water and a brush. B. Use some acid free vaseline on the screw-thread of the glass jar, the top rim of the glass jar, the O-ring for the HEPA filter and the black PVC pipe on the back.
  • Page 115 Work instruction Interrliner C. If applicable replace the bacterial HEPA filter (For Maintenance Level 4: Exchange filter QWLV040002) On waste bottle (If used): Exchange bacterial filter QWLV040001 on the waste bottle assembly. Exchange Rinse and Saline tube assembly New rinse pump tube assembly ESRI090902. New saline pump tube assembly ESRI090903 New tube replacement:...
  • Page 116 Work instruction Interrliner Fill and clean Starrsed Cleaning Agent preparation Interrliner ESR analyser unit: Fill and clean: This cycle takes about 90 minutes. 1. Fill the clean adapter EHST110907 with hot de-ionized water. (+/- 150 ml, 80 °C) 2. Add 15 ml Starrsed Cleaning Agent (QRR 010905) to the hot water in the adapter.
  • Page 117 Work instruction Interrliner The instrument is ready for normal operation. Sensor Check Vacuum pressure check ▪ Go to tab -> sensor. Select box. Maintenance Check Check Flow sensor Flow: 0980 ± 60 Abs: 0320 ±10 If the flow is not in range there might be a blockage in the vacuum flow line to the flow sensor. Fill Stop sensor check ▪...
  • Page 118 Work instruction Interrliner 6. If trapped air bubbles are found, go to tab click button and perform the [Maintenance], [Prime / Clean] [Prime function. Diluent/Diluter] 7. Wipe outer surface and stainless steel plate below the pipettes with disinfectant. 8. Check (or replace if needed) two drip trays (ESRI010318) MRN-164_2-EN Version 2.02 Interrliner...
  • Page 119 Work instruction Interrliner Work instruction Number 224 Page 1 of Purpose: Maintenance level 3 Bio Hazard area Safety: Instrument: Interrliner Revision: 004, 2019 Clean Fill nozzle and exchange O-ring Fill Nozzle 6. Clean fill nozzle The use of a toothbrush and detergent is recommended.
  • Page 120 Work instruction Interrliner Exchange bacterial filter On waste bottle (If used): Exchange bacterial filter QWLV040001 on the waste bottle assembly. Exchange Rinse and Saline tube assembly New rinse pump tube assembly ESRI090902. New saline pump tube assembly ESRI090903 New tube replacement: 1.
  • Page 121 Work instruction Interrliner 6. Place one end of the tube in the pump plate holder. 7. Pull the new tube over the peristaltic pump rotor. 8. Pull pump tube slightly downwards and at the same time towards the back of the Interrliner. Fill and clean Starrsed Cleaning Agent preparation Interrliner ESR analyser unit: Fill and clean:...
  • Page 122 Work instruction Interrliner 1. Select button OK. 2. The needle goes down and the process is started. 3. When all the pipettes are filled, the needle goes back to the home position. 4. After the Fill & clean process is finished, a notification is given to stop the procedure. 5.
  • Page 123 Work instruction Interrliner Clean waste separator and exchange Waste cassette assembly Be careful, as there may be blood in the cassette. First, make up some disinfectant and put this in the waste separator. Press to pump disinfectant through the pump cassette. Prime Disinfectant Clean Separator The waste system must be cleaned before replacing the waste...
  • Page 124 Work instruction Interrliner Exchange Waste Cassette and blotting washer 1. Disconnect the two tubes from the waste pump cassette. 2. Press levers (at three o'clock and nine o'clock positions) and pull at the same time. 3. Remove the old blotting washer ESRI090026 around the motor shaft.
  • Page 125 Work instruction Interrliner 1. Go to tab and perform the procedure. [Maintenance] [End-of-day wash] 2. Check system for leakage. ▪ Inspect the peristaltic pump tubes and connections for leaks. ▪ Check that liquid does not run back after the pumps have stopped. 3.
  • Page 126 Work instruction Interrliner Work instruction Number Page 1 of Purpose: Cleaning diluent system Bio Hazard area Safety: Instrument: Interrliner Revision: 001, 2015 Step 1 1. Remove the suction-tube from the diluent pinch valve. Disconnect the tube and connect a new tube 2.
  • Page 127 Work instruction Interrliner Work instruction Number Page 1 of 1 Purpose: Cleaning waste separator (Version 2) Bio Hazard area Safety: Instrument: Interrliner Revision: 003, Dec. 2015 Removing Cleaning A. Clean all parts with hot water and a brush. B. Use some acid free vaseline on the screw-thread of the glass jar, the top rim of the glass jar, the O-ring for the HEPA filter and the black PVC pipe on the back.
  • Page 128 Work instruction Interrliner Work instruction Number Page 1 of Purpose: Fill and Clean Bio Hazard area Safety: Instrument: Interrliner Revision: 001, 2019 Applicable for Software version 6.12 and up. Starrsed Cleaning Agent preparation Interrliner ESR analyser unit: Fill and clean: This cycle takes about 90 minutes.
  • Page 129 Work instruction Interrliner 1. Select button OK. 2. The needle goes down and the process is started. 3. When all the pipettes are filled, the needle goes back to the home position. 4. After the Fill & clean process is finished, a notification is given to stop the procedure. 5.
  • Page 130 Work instruction Interrliner Work instruction Number Page 1 of 1 Purpose: Sample probe or outer needle replacement Bio Hazard area Safety: Instrument: Interrliner Revision: 002, January 2019 Lift the robotic protection hood. Needle exchange: 1. Unscrew sample probe manually. 2. Mark each tube for easier reconnecting to the correct nipple. 3.

  • Page 131: Glossary Of Terms

    Glossary of Terms Glossary of Terms Bidirectional communication means that there is two-way communication from the Interrliner to the HOST (sample requests and results) and from the HOST to the Interrliner (confirmation or denial of sample requests). pre-diluted samples collected in tubes with sodium citrate anticoagulant-diluent . Citrate mode is used for not diluted on the Interrliner during aspiration.

  • Page 132: Index

    Index Errors 183 and 193....Errors 24-26, 38, 42-43, 62, 67, 70-75, 80. . . bubbles......Errors 33 and 37.
  • Page 133 Results......QC Results screens....Leaking pipettes.
  • Page 134 Usage options..... . . Used reagents..... . Waste disposal.

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