Precautions And Warnings; Test Preparation And Sampling; Delayed Analysis; Test Procedures - Dräger DrugTest 5000 STK Instrucciones De Uso

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2.5

Precautions and warnings

NOTICE
i i
For hygienic reasons, use gloves when handling the Dräger
DrugTest 5000 test system and all samples. Do not touch
the sampler with bare hands before and after sampling and
observe current hygiene rules.
Follow proper handling and disposal procedures.

Open the foil pouch only immediately before use to prevent

contamination of the sampler.
Do not use the Dräger DrugTest 5000 STK if the foil pouch is

damaged.
Do not use the Dräger DrugTest 5000 STK beyond the expiry date

printed or embossed on the pouch. The expiry date is formatted as
YYYY-MM, e.g. 2011-01 means the Dräger DrugTest 5000 STK
should not be used after the end of January 2011.
The Dräger DrugTest 5000 STK can be processed only with the

Dräger DrugTest 5000 Analyzer.
3 Testing
3.1

Test preparation and sampling

Ensure that the test subject has not had any substances like

e.g. food, chewing gum or tobacco in the mouth for at least
10 minutes before sampling.
Make sure that the ambient temperature is between +5 °C to

+ 40°C and the relative air humidity is between 5% and
95% relative humidity.
Make sure that the packaged test cartridges are at ambient

temperature (wait for 15 minutes to achieve temperature
equalisation if necessary).
1. Remove the safety cap with cartridge from the sampler of the test
cassette (Fig. 1) and give the test cassette to the test subject.
Keep the safety cap with cartridge.
2. Instruct the test subject to place the sampler in the cheek and
move it carefully from one side of the mouth to the other (Fig. 2).
The test subject must not chew or suck on the sampler.
Watch the sampling process!
A sufficient sample will be collected within 4 minutes. If the sample

volume indicator shows blue before the 4 minutes have passed,
the sampling can be ended (Fig. 3).
If the sample is not analysed immediately after it has been taken, make
sure to follow the instructions in Section 3.1.1 "Delayed analysis".
3.1.1

Delayed analysis

NOTICE
i
i
Results may be invalid or incorrect if maximum storage
times are not observed.
If the saliva is not analysed immediately after the sample has been
taken, the Dräger DrugTest 5000 STK can be stored at room
temperature up to a max. of 4 hours (confirmation of THC) or 8 hours
(confirmation of all other drugs). The safety cap must be placed back
onto the sampler holder in this case. Remove the safety cap from the
sampler holder again before analysis.
Dräger DrugTest 5000 STK
3.2

Test procedures

NOTICE
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Observe the Instructions for use of the
Dräger DrugTest 5000 Analyzer.
3. Take the test cassette with the sample from the test subject.
Open the Analyzer door and insert the test cassette into the
bottom slot of the Analyzer until it audibly clicks into position
(Fig. 4).
4. Remove the cartridge from the safety cap and insert the cartridge
into the top slot of the Analyzer until it audibly clicks into position
(Fig. 5).
5. Close the door
The Analyzer automatically starts the analysis.
On completion of the analysis, the Analyzer displays the results for
every tested substance on the screen.
Note the display.
6. Remove the test cassette with the cartridge after the analysis and
dispose of it (Fig. 6).
3.3

Confirmation of results

The Dräger DrugTest 5000 test system is a qualitative measurement
procedure. For a confirmed result, a second sample must be taken and
analysed by an accredited laboratory.
Take the second sample with a collection system suitable for saliva
®
samples (e.g. Dräger DCD 5000 (order no. 83 19 910)).
4 Interpretation of results
On completion of the analysis, the Analyzer displays the results for
every tested substance on the screen. See the Instructions for Use for
additional details on the operation of the Analyzer.
Data management
After the analysis, the test results are shown on the Analyzer display
and saved in the Analyzer memory. All data can be printed out with the
Dräger Mobile Printer. For more information on the data management
options of the Analyzer see the Technical Manual for the Dräger
2)
DrugTest 5000 test system .
5

Quality control

Regular quality control is part of a good analytical practice and may be
required by the responsible authority. Always contact the responsible
authorising and accreditation bodies to ensure that the applied quality
control programme corresponds to the applicable standards.
Internal control
An integrated process control is conducted with every analysis (see
also Section 2.4 "Test principle"). If the analysis was run without errors
and the result safe to interpret, a control signal is generated. If the
control signal is not generated, the Analyzer does not interpret the
analyses but shows "invalid" as the result. Depending on the
configuration, the Analyzer display may differ if a result is invalid
(e.g. "not interpretable").
External control
The properties of the test allow a quality control to be run on site by
taking a drug-free sample and processing it. The result for all analyses
of this sample must be "negative".
When using positive controls, ensure that they are suitable for the
Dräger DrugTest 5000. For information on suitable positive controls,
please contact DrägerService
2) The Technical Manual can be downloaded free of charge from the Dräger
home page (www.draeger.com).
®
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Testing
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