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HemoCue Glucose 201 User Manual

HemoCue Glucose 201
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HemoCue Glucose 201 with Plasma Conversion
Operating Manual

Questions and Answers:

HemoCue Glucose 201 Specifications

General IconGeneral
Measurement MethodPhotometric
CalibrationFactory calibrated
DisplayLCD
Sample TypeCapillary, venous, or arterial whole blood
Operating Conditions10-90% relative humidity (non-condensing)
Measuring Range0-400 mg/dL
Power SourceBattery
Measurement Time40-240 seconds
Operating Temperature15-30°C
Battery LifeApproximately 1000 measurements
Sample Volume5 µL

Summary

Introduction to the HemoCue Glucose 201 System

System Overview and Safety

Introduces the analyzer's capabilities and highlights safety design.

HemoCue Glucose 201 System Components

HemoCue Analyzer

The main analytical device for glucose measurement.

AC Adapter

Power supply for the HemoCue Glucose 201 Analyzer.

Batteries

Alternative power source for the analyzer.

HemoCue Glucose 201 Microcuvettes

Consumables for performing glucose measurements.

Operating Manual and Quick Reference Guide

Documentation for system operation and quick reference.

HemoCue Cleaner

Tool for cleaning the analyzer's optical parts.

HemoCue Glucose 201 Analyzer Start-up

Powering the Analyzer

Connecting via AC adapter or installing batteries.

Preparing the Analyzer

Positioning cuvette holder and powering on the device.

Analyzer Self-Test Process

The analyzer conducts internal checks and displays status.

Ready for Use Confirmation

Indicates analyzer readiness with 'READY' and flashing dashes.

Configuring Audio Signal

Activating Audio Signal

Pressing and holding the on/off button to show a bell icon.

Audio Signal Ready State

Waiting for 'READY' display before analysis when audio signal is on.

Measuring Capillary Blood

Preparing the Analyzer for Measurement

Ensuring the analyzer is in 'READY' state before sampling.

Patient Finger Preparation

Ensuring the patient's hand is warm and relaxed for sampling.

Finger Cleaning and Stimulation

Cleaning the finger with disinfectant and stimulating blood flow.

Capillary Blood Sampling

Fingertip Sampling Technique

Sampling at the side of the fingertip for best blood flow.

Puncturing the Finger

Using a lancet to puncture the finger while applying pressure.

Wiping Initial Blood Drops

Wiping away the first 2-3 drops of blood.

Second Blood Drop Collection

Re-applying pressure to obtain another blood drop.

Microcuvette Filling and Preparation

Filling the Microcuvette

Filling the microcuvette with blood in one continuous process.

Wiping Excess Blood

Wiping excess blood from the microcuvette's outer surface.

Checking for Air Bubbles

Inspecting the filled microcuvette for air bubbles.

Performing the Glucose Measurement

Inserting Microcuvette and Starting Measurement

Placing the microcuvette into the holder and pushing it to the measuring position.

Measurement Indicator

Display shows 'X' during the measurement process.

Displaying Measurement Results

Glucose value displayed after 40-240 seconds in mg/dL and mmol/L.

Handling Measurement Results

Result remains on display; analyzer auto-turns off. Result can be retrieved.

Measuring Venous and Arterial Blood

Blood Sample Preparation

Ensuring blood is well mixed before measurement.

Blood Drop Application

Placing a blood drop onto a hydrophobic surface for collection.

Microcuvette Filling and Wiping

Filling the microcuvette and wiping off excess blood.

Air Bubble Check

Checking the filled microcuvette for air bubbles.

Daily Maintenance of the Analyzer

Cuvette Holder Removal

Pulling out the cuvette holder to its loading position.

Cuvette Holder Detachment

Rotating and removing the cuvette holder from the analyzer.

Cleaning the Cuvette Holder

Cleaning the detached cuvette holder with alcohol or detergent.

Maintenance of Optical Parts

Accessing the Optic Unit

Showing the analyzer's optic unit with the cuvette holder removed.

Using the HemoCue Cleaner

Inserting and moving the cleaner in the optic unit opening.

Cleaning Cover Glasses

Cleaning the upper and lower cover glasses with the cleaner.

Troubleshooting Guide

Analyzer Error Codes

Troubleshooting common error codes (900-930) displayed by the analyzer.

No Display or Erroneous Display

Resolving issues with no characters or erroneous characters on the display.

Troubleshooting Measurement Issues

Display Status Errors

Troubleshooting issues with display indicators like '---' or incorrect state transitions.

Control Material Measurement Errors

Addressing out-of-range results when using control materials.

Patient Sample Measurement Discrepancies

Investigating patient sample results that are higher or lower than expected.

System Specifications and Theory

General System Description

Overview of the HemoCue Glucose 201 system's functionality and calibration.

Intended Use of the System

Details on the quantitative determination of glucose in whole blood.

Measurement Theory and Reagents

Explanation of the enzymatic method, reagents, and wavelengths used.

Specimen Collection and Preparation

Guidelines for collecting and preparing capillary, venous, or arterial blood samples.

Storage, Quality Control, and Results

Storage and Handling of Microcuvettes and Analyzer

Guidelines for storing microcuvettes and the analyzer under specified conditions.

Quality Control Procedures

Information on the analyzer's internal quality control and verification methods.

Measurement Range and Results Interpretation

Details on the measuring range, high values, and expected glucose levels.

System Limitations and Expected Values

Information on In Vitro Diagnostic use and reference glucose ranges.

Technical Details and Support

Technical Specifications

Physical dimensions, weight, power requirements, and compliance standards.

AC Adapters and Essential Performance

Approved AC adapters and the essential performance of the system.

Warranty and Service Information

Details on the analyzer's warranty period and service contacts.

Service, Disposal, and Spare Parts

Guidance on cleaning, disposal, and available spare parts.

Electromagnetic Compatibility (EMC) - RF Separation

RF Interference Guidance

Guidelines for maintaining minimum separation distances from RF transmitters.

Separation Distance Calculation

Formulae for calculating separation distances based on transmitter power and frequency.

Electromagnetic Immunity

Electrostatic Discharge (ESD) Immunity

Test levels and compliance for electrostatic discharge.

Electrical Fast Transient/Burst Immunity

Test levels and compliance for electrical fast transients/bursts.

Surge Immunity

Test levels and compliance for surge events on power supply lines.

Voltage Fluctuations Immunity

Test levels and compliance for voltage dips and interruptions.

Electromagnetic Emission and Immunity

Conducted RF Immunity

Test levels and guidance for conducted radio frequency interference.

Radiated RF Immunity

Test levels and guidance for radiated radio frequency interference.

Electromagnetic Emissions

Recommended Cables

Specifications for USB and Serial shielded cables to be used with the system.

RF Emissions Compliance

Information on RF emissions and their electromagnetic environment guidance.

Harmonic Emissions and Voltage Fluctuations

Compliance for harmonic emissions and voltage fluctuations.

Symbols, References, and Contact Information

Symbols Used in Manual

Explanation of common symbols used throughout the operating manual.

References and Citations

List of scientific references and publications related to the system.

Manufacturer and Distributor Contact Details

Contact information for HemoCue AB and HemoCue America.

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