The Interrliner is an in vitro diagnostic medical device designed for the automated determination of the Erythrocyte Sedimentation Rate (ESR) in human blood samples. It adheres to the Westergren method, conforming to CLSI approved standard H02-A51 and recommended by the ICSH. This instrument is intended for professional use in medical laboratories for screening and follow-up of patients with suspected inflammatory conditions, and is applicable to all patient populations without restriction by age or physiological particulars.
The Interrliner system consists of several main modules:
- Start-pool: This section facilitates the loading of racks via a belt-driven transport system and can hold up to 21 Sysmex racks. It also includes a keyboard in a drawer for user interaction.
- Tube handling and transport: This module features an indexer unit for initializing racks and reading barcodes of sample tubes and racks. A sample robot unit mixes the sample tubes and places them onto the ESR analyser unit for aspiration. A conveyor belt transports racks from the Start-pool, and a front return line moves racks back to the Sysmex HST-XN line after sampling. A protection hood ensures safety during operation.
- ESR analyser unit: This is the core measuring instrument, equipped with a belt holding 84 precision-bore glass Westergren pipettes. It performs automated aspiration of sample tubes, automated dilution of EDTA blood samples with citrate, and automated ESR measurement after 30 or 60 minutes. The pipettes are also automatically cleaned and dried.
- Reagents cabinet: This cabinet has a swing door for easy access and is capable of storing all necessary reagents.
- PC with touch screen LCD monitor: The entire operation is driven by a personal computer running a Windows operating system. The user interface is intuitive and can be controlled via the keyboard or an optional touch screen. A virtual keyboard is automatically displayed for numerical or alphanumerical input. An optional external barcode reader can be connected to a USB port for reagent handling and ID input in sample history searches.
Function Description:
The Interrliner automates the Westergren method, ensuring pipettes are always filled to the correct level. It uses closed sample tubes to minimize contamination risk. Measurements are corrected to a constant temperature of 18 °C. Sample IDs are read by a barcode reader and linked to each sedimentation measurement, eliminating the need for manual worksheets. In EDTA mode, the dilution of EDTA blood with citrate is highly accurate. The instrument automatically washes and dries used sedimentation pipettes. This model integrates with the Sysmex HST-XN line and uses Sysmex sample racks. The advanced software communicates with Sysmex Lab Comm host computer systems.
The sedimentation measurement principle involves an optical sensor moving along the pipettes, taking readings every 0.25 mm. This sensor measures the absorption of infrared light through the blood-filled pipette. Absorption values, relative to the darkest (100%) and lightest (0%) readings, determine levels such as cells/plasma separation (87.5%), hazy detection (75.0%), and meniscus detection (50.0%).
The dilution principle is unique, involving the addition of Diluent to whole blood. The Interrliner monitors air displacement during aspiration, using an airflow sensor and calculating syringe speed to achieve a diluter accuracy of ± 3%. The 4:1 citrate dilution reduces hematocrit (Hct) influence on sedimentation, bringing Hct levels from 0.45 (normal) to 0.36, aligning with ICSH recommendations for EDTA samples with Hct of 0.35 or less. Dilution errors up to 25% result in only a 5% variation in Hct, which does not significantly impact ESR measurement accuracy.
Important Technical Specifications:
- Instrument Models: Interrliner XN1 FRL, XN2 FRL, XN3 FRL (Catalogue numbers: EHST109621, EHST109622, EHST109623).
- ESR Method: Westergren method, conforming to ICSH and CLSI standards.
- Temperature Compensation Method: R.W. Manley: J. clin Path (1957), 10, 354.
- 30 Minute Method: R. Rogers: Medical Laboratory World 1994.
- Allowed Blood Specimen Types: For EDTA mode: Whole blood with < 1% EDTA anticoagulant.
- Automatic Dilution: 4 vols. blood + 1 vol. Starrsed Diluent.
- Reported Result: mm after 1 hour.
- Throughput (100% filled):
- 30 minute method: Single 140/hour, Double 240/hour, Triple 360/hour.
- 60 minute method: Single 75/hour, Double 140/hour, Triple 215/hour.
- Reagents Used: Starrsed Diluent (QRR 010931), Starrsed Disinfectant (QRR 010947), Starrsed Saline (QRR 010933), Starrsed Rinse Solution (QRR 010934), De-ionized water.
- Aspirated Blood Volume per Sample: 1.4 ml in EDTA mode.
- Rack Type: Sysmex sample rack (low profile).
- Sample Tube Types: Most commonly used brands/types, closed tubes with concentric cap only.
- Barcode Reader Type: CCD, reading Code39, ITF, Industrial 2 or 5, CodaBar, EAN/UPC, CODE128.
- Environment: Sound level < 65 dBA, Temperature 18-28 °C, Relative humidity 10-90%.
- Mains Voltage: 115/230VAC, 50/60 Hz.
- Fuses (20 x 5 mm): Per ESR Unit: Slow blow 230V 2.5 Amp / 115V 5 Amp; Transport Unit: Slow blow 230V 1.6 Amp / 115V 3.15 Amp.
- Power Consumption: Standby 90 VA (XN1), 2x90VA (XN2), 3x90VA (XN3); Maximum 650 VA (XN1), 2x1000 VA (XN2), 3x1500 VA (XN3).
- Heat Output: Standby 86 Watt (XN1), 2x86 Watt (XN2), 3x86 Watt (XN3); Operation 460 Watt (XN1), 2x460 Watt (XN2), 3x460 Watt (XN3).
- Dimensions (Width x Height x Depth): XN1 FRL: 1400 x 1530 x 1150 mm; XN2 FRL: 2500 x 1530 x 1150 mm; XN3 FRL: 3600 x 1530 x 1150 mm.
- Total Weight (empty): XN1 FRL: 238 kg; XN2 FRL: 519 kg; XN3 FRL: 740 kg.
- Weight (components): ESR analyser unit 45 kg, Start pool 63 kg, Conveyer/robot unit incl. Front Return unit 160 kg, Protection hood 12 kg, Back panels 18 kg (single), 22 kg (double), 26 kg (triple).
- LIS Connectivity: Ethernet and serial, bi-directional according to various protocols.
- Data Storage: Hard disk on external PC, approx. 5 Mb per 1000 samples (results and raw data).
Usage Features:
The Interrliner software is controlled via six tabbed screens: Sample, History, Reagents, Maintenance, Settings, and Service.
- Sample Screen: Displays pipettes in use, sample number, status, and "time to go" for each pipette. A graphical representation of the pipette and optical density graph are shown. The carousel graphically represents pipette filling (position B), measurement (position C), and washing (position D). Blue dots indicate successfully filled pipettes, flashing red dots indicate failures. Rack status pictograms indicate barcode read failures, successful reads awaiting LIMS response, successful reads where ESR is not required, ESR required and pending, successfully aspirated samples, and samples with fill errors.
- History Screen: Allows selection of display options for pipette data, sample history (including full patient results, rack history, ESR statistics, and QC results with Starrsed Control), and linked QC IDs. Results can be printed or sent to LIMS. Search options include today's results, results from a selected time frame, past days, or a specific date range. Detailed information for selected Sample IDs includes aspect code (e.g., Hazy <10), ESR 30 min, ESR 60 min (measured or calculated), and temperature-corrected ESR 60 min T.Corr.
- Reagents Screen: Shows reagent levels and logs reagent replacement. Sensor alarms are indicated by a flashing red-to-yellow mark for empty containers. Reagent information must be correctly entered; failure to do so will trigger an alarm and prevent sample aspiration. The software checks reagent status before starting a new rack and will finish aspirating the current rack (max 10 samples) if an alarm occurs during processing. Reagents alarm is also set if the expiry date is exceeded or if opened for more than three months.
- EQAS: RR Mechatronics' External Quality Assessment Scheme (EQAS) allows periodic performance assessment of the Starrsed instrument. Test results with Starrsed Control are compared with a worldwide peer group.
Maintenance Features:
Maintenance functions are grouped under the "Maintenance" screen, which has sub-screens for Prime/Clean, Check sensors, Display Error history, Display Maintenance hist., and Maintenance Info.
- Prime/Clean: Used after reagent changes to fill fluid systems and remove air. Includes functions to prime pipettes, needle/nozzle, diluter, nozzle with water, and waste system. "Prime all units" performs all priming functions sequentially. Cleaning functions include "Wash each pipette," "Wash all pipettes," "Wash only sample pipettes," "Fill & Clean," and "End-of-day wash."
- Check Sensors: Allows checking the status of various sensors, including Fill stop sensor, Temperature sensor, Diluter start sensor, Diluent flow sensor, Separator sensor, and Measure sensor.
- Display Error History: Logs all errors that occurred during operation, which can be saved for troubleshooting.
- Display Maintenance History: Logs all performed maintenance functions.
- Maintenance Info: Provides information on maintenance levels and their overdue status.
- End-of-day Wash: Recommended daily procedure to keep the instrument clean and prevent bacterial growth. Options include "No End-of-day wash," "Immediately," "Only once," "Weekdays," and "Daily" at a selected time.
- General Maintenance: Procedures are based on a number of samples and include daily, weekly, and various level maintenance tasks (Level 4, Level 3, Level 2, Level 1). These tasks involve cleaning external parts, checking sensors, inspecting sample needles, replacing pump tubing, bacterial filters, fill-nozzle O-rings, and performing fill and clean procedures using Starrsed Cleaning Agent.
- Troubleshooting: Provides guidance for common errors, including communication errors, motor timeouts, liquid flow issues, reagent alarms, separator errors, fill time-out errors, hazy reports, leaking pipettes, liquid level sensor issues, and air bubbles. It also includes quality control troubleshooting for expired or out-of-range QC samples.
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