Norma Icon-5 - User Manual

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Summary

Step 1: Peristaltic pump tube replacement

Peristaltic pump tube replacement procedure

Details the process for replacing peristaltic pump tubes, explaining wear and consequences of failure.

Remove pump module

Instruction to remove the pump module by unscrewing it from the assembly plate.

Remove pump cassette

Guidance on detaching the pump cassette by pressing its sides.

Remove pump tubes

How to gently pull pump tubes off the adapters to release them from the groove.

Identify pump tube sets

Distinguishes between HAT800B (orange) and HAT800C (grey) pump tubes for different cassettes.

Install pump tubes correctly

Instructions for parallel installation of pump tubes and ensuring they sit properly over rollers.

Reinstall pump cassette

Steps for correctly reinstalling the pump cassette, ensuring it clicks and is level.

Reinstall pump assembly

Final step to reinstall the pump, cautioning against pinching tubes and cables between metal plates.

Step 2: Replacement of aperture rubber valve

Aperture rubber valve replacement procedure

Outlines replacing the aperture rubber valve, explaining its function in air prevention and liquid flow regulation.

Remove metal shield

Instruction to remove the metal shield before accessing the aperture module.

Detach aperture module

Guidance on pulling the aperture module away from the amplifier block.

Remove and install rubber valve

Steps for removing the old rubber valve with forceps and gently installing the new one.

Reinstall aperture module

How to correctly reinstall the aperture module, aligning pins and waste tube.

Reinstall metal shield

Final step to reinstall the metal shield after aperture module replacement.

Step 3: Replacement of the sealing silicon ring of the apertures

Sealing silicon ring replacement procedure

Details replacing the silicone sealing ring for the aperture, preventing leaks and contamination.

Prepare for aperture servicing

Advises preparing a paper sheet to avoid losing aperture components during work.

Open and disassemble aperture

Instructions for opening aperture halves and carefully removing the ruby from the silicone seal using tweezers.

Clean aperture housings

How to clean aperture housing sides with a damp cloth, ensuring all residuals are removed.

Install ruby in new seal

Guidance on removing the ruby and seating it into the new silicone seal correctly.

Assemble aperture halves

Steps for gently assembling the right and left aperture halves, ensuring ruby seating and screw tightening.

Check aperture gap

Instruction to ensure an even gap between aperture halves to prevent breakage.

Post-assembly check

Reinstall aperture module and check MCV value, performing calibration if needed.

Step 4: Cleaning of the sample rotor brake

Sample rotor brake cleaning procedure

Details cleaning the sample rotor brake to prevent vial position errors, emphasizing proper reassembly.

Mark brake position

Advises marking the brake's position before disassembly to ensure correct reassembly.

Disassemble and clean brake

Steps for loosening hex screws, unscrewing the brake, and cleaning its parts.

Reassemble brake

Guidance on reassembling the brake with O-rings and washer, securing it using marked lines.

Step 5: Replacement of piercing needle

Piercing needle replacement procedure

Explains replacing the piercing needle to avoid sampling errors and needle clogging.

Access piercing needle

Steps to access the needle by pushing the wash head away and securing it with a hex key.

Remove and install piercing needle

Instructions for using the UNF tool to remove the old needle and install the new one correctly.

Step 6: Leakage detector check

Leakage detector pin replacement

Instructions for replacing corroded or damaged leakage detector pins.

Step 7: Closed wash head check

Closed wash head inspection

Procedure for inspecting the wash head for dirt, lubricating its axis, and checking alignment.

Check wash head operation

Verifies wash head alignment, closing firmness, and sensor operation.

Step 8: UNF connectors check

UNF connector security check

Steps to ensure all UNF connections are secure and check for leaks indicated by salt deposits.

Clean and inspect UNF connectors

How to unscrew, clean, and inspect UNF connectors and related parts for damage or cracks.

Step 9: Check Injectors

Injector inspection

Visual check of injectors for salt deposits or cracks, indicating potential leakage.

Microinjector replacement

Procedure for replacing the microinjector if issues are found, referring to the service manual.

Step 10: Verify Mixer operation

Mixer operation verification

Accessing service level to check mixer functionality and replacing it if errors occur.

Step 11: Reagent sensors and connections

Reagent sensor tube placement

Ensures reagent tubes are properly seated in reagent sensors with an audible 'click'.

Reagent sensor cleaning and connection check

Cleaning sensors for liquid detection issues and checking/reconnecting loose reagent tubes.

Step 12: CMOS battery replacement

CMOS battery replacement procedure

Explains replacing the CMOS battery every 2-3 years to maintain system clock operation, with safety precautions.

Battery replacement precautions

Notes on avoiding metal tools, touching the battery surface, and using gloves for safety.

Set date and time

Reminds to set the correct date and time after battery replacement to ensure accurate operation.

Step 13: Fluidics cleaning

Fluidics cleaning procedure

Details the cleaning procedure for analyzer fluidics using Norma-iHClean solution for maintenance.

Norma-iHClean steps

Specific steps for using Norma-iHClean, including prime cycles, stress cycles, and rinsing.

Step 14: QC, performance check and scatter calibration

QC and calibration procedure

Steps for performing QC, scanning controls, calibration, and checking CV% and NEU XY values.

Scatter calibration

Performing scatter calibration if necessary and adjusting digital gain values for accuracy.

Step 15: Software upgrade

Software upgrade procedure

Instructions for upgrading software via USB drive, referring to the Norma website for downloads.

The Norma Icon-5 is an automated hematology analyzer designed for efficient and accurate blood cell analysis. This document outlines its maintenance procedures and key components.

Function Description:

The Icon-5 performs automated hematology analysis, providing comprehensive blood cell counts and related parameters. It utilizes various fluidic and optical systems to process samples and generate results. The analyzer is designed for routine use in clinical laboratories, offering reliability and precision in diagnostic workflows.

Important Technical Specifications:

The maintenance kit (HAT827A) is designed for a 1-year/10,000 sample period. Key components include:

Aperture maintenance kit (HAT809A): 1 pc.
Peristaltic pump tube set: HAT800B (for orange pumps) and HAT800C (for gray pumps), 1 pair of each.
Lubricants (in small containers):
- Shell Retinax lubricant (red) (HAT829A): 1 pc.
- Teflon based grease (white) (HAT829B): 1 pc.
- Silicone grease (clear) (HAT829C): 1 pc.
Piercing needle with UNF screw and "O" ring (HAT165A): 1 pc.
Greiner BIO Vacutainer NO add w/o rubber in cap (White) (HAT823B): 1 pc. A special UNF tool (not included in the kit) is required for certain maintenance tasks. The analyzer's High Voltage board (HVDCDC) produces 180VDC.

Usage Features:

The Icon-5 is operated through a user interface that allows access to various modes, including QC mode for quality control, and service level for maintenance and calibration. The system uses specific reagents and controls, such as NormaCont5+, for accurate operation and calibration. The analyzer can perform both WBC and RBC measuring channel hard cleaning options using Norma-iOptiClean and Norma-iHClean cleaning solutions. Software upgrades can be performed via a USB drive.

Maintenance Features:

Regular maintenance is crucial for the Icon-5's performance and longevity. All maintenance steps must be performed by a trained service engineer.

Preparation for Maintenance: Before starting maintenance, the analyzer must be shut down. Reagent pickup tubes should be pinched using clamps from the reagent pickup tube set, and both side covers removed for access to inner components.
Peristaltic Pump Tube Replacement (HAT800B or HAT800C): Recommended annually or every 10,000 samples. Worn tubes can lead to leaks, reduced liquid movement, and errors in sample processing. The procedure involves removing the pump module, detaching the pump cassette, pulling off old tubes from adapters, installing new tubes (HAT800B for orange cassette, HAT800C for grey cassette), reinstalling the cassette (ensuring it clicks and is level), and finally reinstalling the pump, being careful not to pinch external silicone tubes or cables.
Aperture Rubber Valve Replacement (HAT809A): Recommended annually or every 10,000 samples. A contaminated valve can lead to improper closing, air entry, and erroneous measurements. The process includes removing the metal shield, pulling the aperture module from the amplifier block, removing the black screw cap and old rubber valve, installing the new rubber valve with the flat side down, and screwing in the cap (avoiding overtightening). Reinstallation requires careful alignment of the waste tube within the waste collector.
Sealing Silicon Ring Replacement (HAT809B): Recommended every 24 months or if necessary. A worn ring can cause leaks and contamination. This involves taking out the aperture module (following steps for rubber valve replacement), opening the aperture halves, carefully removing the ruby from the old seal, cleaning the housings, seating the ruby into the new seal, and reassembling the aperture halves. The ruby is asymmetrical; the spherical side must face the LEFT side aperture housing, and the flat side must face up. The two screws should be tightened gradually and evenly with "two fingers" torque to avoid deforming the silicon. A small, even gap between the aperture halves is critical. After replacement, MCV values should be checked with a control sample, and calibration performed if needed.
Sample Rotor Brake Cleaning (N/A): Recommended annually or every 10,000 samples. A tight or dirty brake can cause "Sample rotor errors." The procedure involves marking the brake's position for reassembly, loosening hex screws, unscrewing the brake from the axle, removing the white plastic part, and cleaning all components (including O-rings) with a clean cloth and alcohol-based cleaner. Reassembly requires aligning with the pre-marked line and tightening screws. Sample Rotor test functions should be used to verify operation.
Piercing Needle Replacement (HAM165AE): Mandatory annually or every 10,000 samples. A worn needle can cause sampling errors or clogging. The process involves using a 2mm hex key to push and secure the wash head in its open position, then using the Norma UNF tool to unscrew and remove the old needle. The new needle must be installed with its opening facing the right side, towards and into the wash head, to ensure proper waste capture.
Leakage Detector Check (HAE053A): Recommended annually or every 10,000 samples. This involves checking and replacing corroded or damaged pins in the shear valve waste collector.
Closed Wash Head Check (N/A): Recommended annually or every 10,000 samples. The wash head should be cleaned with a brush, and the axis lubricated with white grease. Alignment of the needle within the wash head should be checked and adjusted if necessary. The wash head's closing mechanism and the closed state sensor operation also need verification.
UNF Connectors Check (N/A): Recommended annually or every 10,000 samples. All UNF screws should be checked for tightness using fingers or the UNF tool. Visible white salt deposits indicate leakage, requiring unscrewing, cleaning, and checking the condition of the UNF screw and other parts. Damaged connectors or valve manifolds must be replaced.
Injectors Check (N/A): Recommended annually or every 10,000 samples. Inspect for salt deposits around the bottom fixing plate of all injectors, which may indicate leakage. Check the injector piston for cracks. If issues arise with the microinjector, replace the complete part (HAM151A) and refer to the service manual for addressing the new injector.
Mixer Operation Verification (N/A): Recommended annually or every 10,000 samples. Access service level to check mixer operation and replace if any errors occur.
Reagent Sensors and Connections (N/A): Recommended annually or every 10,000 samples. Ensure all tubes "click" into reagent sensors. Clean sensors with a brush if liquid detection problems occur, and run a priming sequence. Check reagent pickup tube connections; if loose or damaged, cut 10mm from the tubing end and reconnect.
CMOS Battery Replacement (HAT809A): Recommended every 2-3 years or 20,000 samples. The RTC battery maintains the system clock. Replace the battery on the Liliom board, avoiding metal tools to prevent short circuits. Do not touch the new battery's surface with bare fingers to prevent contamination. Use rubber gloves. After replacement, set the actual date and time. If the battery is drained, the date will default to May 1st, 2009.
Fluidics Cleaning (N/A): Recommended annually or every 10,000 samples. Perform hard cleaning for both WBC and RBC channels using Norma-iOptiClean and Norma-iHClean. For older SW versions, use Norma-iHClean (or hypochlorite) solution. This involves immersing the diluent pickup tube into the cleaning solution, running diluent prime multiple times, performing stress cycles, rinsing the pickup tube, and running more stress cycles until PLT background decreases to near 0.
QC, Performance Check, and Scatter Calibration (N/A): Recommended annually or every 10,000 samples. Use NormaCont5+ controls. Access QC mode, scan the control LOT QR code, run all control levels (at least normal), and perform calibration if needed. Recheck with controls. Run normal control in stress mode 10 times to check CV% values. Perform scatter calibration if necessary. Check NEU XY parameter on the results technical screen against the control assay sheet. If the difference is outside ±3, use the "Calc. Opt. Amp." button to accept new digital gain values.
Software Upgrade (N/A): Recommended annually or every 10,000 samples. Download SW upgrades from the Norma website to a USB drive (in a folder named "nectar"), connect to the analyzer, and run the upgrade procedure from the System - About menu.

Norma Icon-5 Specifications

General

Brand	Norma
Model	Icon-5
Category	Medical Equipment
Language	English