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Human HumaStar 600 User Manual

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HumaStar 600
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User Manual
Cat No. 16660/001

Table of Contents

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Human HumaStar 600 Specifications

General IconGeneral
BrandHuman
ModelHumaStar 600
CategoryLaboratory Equipment
LanguageEnglish

Summary

1 SAFETY INSTRUCTIONS

1.1 INTRODUCTION

Introduction to the user manual and its importance for accurate operation and maintenance.

1.2 USER WARRANTY

Details regarding the manufacturer's warranty for the instrument and its limitations.

1.3 INTENDED USE OF THE INSTRUMENT [IVD]

Specifies the intended diagnostic application and user qualifications for the instrument.

1.5 DISPOSAL MANAGEMENT CONCEPT

Guidelines for the proper disposal of instrument components and waste materials.

1.6 INSTRUMENT DISINFECTION

Procedures for disinfecting the instrument and its parts, especially after contact with biological fluids.

1.7 BIOHAZARD WARNING

Highlights the presence of biohazardous materials and associated warning labels.

1.8 ADDITIONAL LABELS

Explains the meaning and importance of various warning labels used on the instrument.

1.4 GENERAL SAFETY WARNINGS

Provides essential safety precautions for operating the instrument, including electrical and environmental hazards.

2 INTRODUCTION

3 SYSTEM DESCRIPTION

3.1 UNPACKING

Instructions for carefully unpacking the instrument and verifying all included components.

3.2 INSTALLATION

Detailed steps and requirements for installing the instrument, including electrical and hydraulic connections.

3.3 PARTS OF THE INSTRUMENT

Identification and description of the main physical components of the instrument.

3.4 SOFTWARE FUNCTIONS OVERVIEW

Overview of the instrument's software capabilities, including sample and patient management.

4 GET READY FOR OPERATION

4.1 AUTOMATIC OPERATION

Description of the automatic measuring procedure, including system checks and operational cycles.

5 ROUTINE TASKS

5.1 REAGENTS

Procedures for managing reagents, including loading, removing, and refilling reagent bottles.

5.2 SAMPLES

Steps for defining sample data, loading samples, and managing sample sectors on the tray.

5.3 TEST RESULTS

How to inspect, accept, reject, and print test results, including pending and historical data.

5.4 CALIBRATION

Process for defining, requesting, and accepting calibration sets and individual calibrations.

5.5 REAGENT BLANK

Procedures for measuring and managing reagent blanks, including automatic requests.

5.6 QUALITY CONTROL

Steps for setting up, requesting, and processing quality control samples and analyzing results.

5.7 TWIN QC

Information on Twin QC operation, Youden plots, and correlated Levy-Jennings plots.

5.8 WORKING WITH LIS

Details on integrating the instrument with Laboratory Information Systems (LIS).

5.9 DEFINITION AND USE OF SAMPLE PROFILES

Creating and using sample profiles to define predefined patterns of tests for ordering.

6 DEFINITION OF METHODS

6.1 METHOD TYPES AND CALCULATIONS

Overview of different method types (Endpoint, Kinetics) and their calculation formulas.

6.2 METHOD PARAMETERS

Configuration of various parameters for defining methods, including common and specific data.

6.3 SOLUTIONS

Setting up system solutions, diluents, and cleaning agents required for instrument operation.

6.4 OPTIONS

Adding or deleting reference classes and measurement units for method definitions.

6.5 CALCULATED METHODS

Creating and defining new calculated tests using existing methods and mathematical operators.

6.6 EXTERNAL METHODS

Adding, modifying, or printing external methods, often used for constants in calculations.

6.7 UNITS AND LIMITS

Modifying units and limits for methods without direct access, setting lab-specific parameters.

6.8 DEVELOPEMENT OF A METHOD

Accessing to review reactions in real-time for method development and optimization.

7 ISE MODULE CAT.-NO. 16663-03

8 MAINTENANCE

8.1 SCHEDULER

Managing and accessing the maintenance schedule for daily, weekly, and monthly tasks.

8.2 DAILY MAINTENANCE

Recommended daily operations, including probe inspection, cleaning, and solution checks.

8.3 WEEKLY MAINTENANCE

Procedures for weekly maintenance, such as intensive cuvette and washer cleaning.

8.4 MONTHLY MAINTENANCE

Monthly maintenance tasks, including photometer and washer volume calibration.

8.5 MAINTENANCE ON DEMAND

Tasks performed when indicated by the instrument, such as cuvette or lamp replacement.

9 TROUBLESHOOTING

9.1 MESSAGES AND WARNINGS

Explanation of instrument-related messages and warnings, and their corresponding causes and actions.

9.2 VISIBLE FAULTS

Identification of visible issues with the instrument and their corrective actions.

10 APPENDIX

10.1 TECHNICAL SPECIFICATION

Detailed technical specifications of the HumaStar 600 instrument, including throughput and dimensions.

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