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Dräger DrugTest 5000 STK User Manual

Dräger DrugTest 5000 STK
22 pages
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Dräger DrugTest
®
5000 STK
WARNING
To properly use this product, read and comply with these
instructions for use.
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Gebrauchsanweisung
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Instructions for Use
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Notice d’utilisation
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Instrucciones de uso
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Instruções de utilização
16
NOTICE
Not for medical use.
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www.draeger.com/IFU
9300124
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Dräger DrugTest 5000 STK Specifications

General IconGeneral
Detection MethodImmunoassay
Sample TypeOral fluid (saliva)
Result TimeWithin 8 minutes
CalibrationPre-calibrated, no user calibration required
Drugs DetectedAmphetamines, Benzodiazepines, Cocaine, Opiates, Methamphetamines, Cannabis (THC)
Detection TimeframeUp to 24-48 hours after drug use
Operating Temperature5°C to 40°C
Test DurationApproximately 5-10 minutes

Summary

For your safety

Strictly follow the Instructions for Use

Ensures safe and correct use by requiring full understanding and strict adherence to instructions.

Description

Product overview

Details the components of the Dräger Drug Test 5000 STK and packing unit contents.

Intended Use

Specifies the system's purpose for qualitative detection of analytes in oral fluid for forensic use only.

Explanation of symbols

Clarifies the meaning of various symbols used throughout the product instructions for better comprehension.

Test principle

Explains the immunoassay principle of competitive inhibition used in the qualitative detection of substances.

Testing

Test preparation and sampling

Covers pre-test requirements, ambient conditions, and the process of collecting saliva samples.

Test procedures

Provides step-by-step instructions for inserting the test cassette and cartridge into the Analyzer.

Confirmation of results

Outlines the requirement for a second sample for confirmed results via an accredited laboratory.

Interpretation of results

Data management

Describes how test results are displayed, saved, printed, and managed by the Analyzer.

Quality control

Emphasizes the importance of internal and external quality control for ensuring test accuracy and validity.

Limitations of procedure

Addresses potential sources of false results and the need for professional assessment for accurate interpretation.

Performance features

Influence of food and beverages

Examines the impact of consuming food, beverages, or stimulants on the accuracy of test results.

Analytical performance

Discusses the analytical specificity and potential cross-reactivity of the test system with similar compounds.

Diagnostic performance

Summarizes the clinical performance metrics of the test system based on comparative studies.

Storage

Disposal

Bibliography

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