For Your Safety; Intended Use - Dräger DrugTest 5000 Instructions For Use Manual

For Your Safety

Strictly follow the Instructions for Use
Strictly observe these instructions when using the Dräger
®
DrugTest 5000 Analyzer. Any disregard may cause errone-
ous measuring results and damage the device.
The Dräger DrugTest 5000 Analyzer is only to be used for
purposes specified herein.
Maintenance
Maintenance jobs may only be carried out by trained spe-
cialists. We recommend commissioning Dräger Safety for
servicing the device.
Only genuine Dräger parts may be used for maintenance.
The Dräger DrugTest 5000 Analyzer does not contain any
parts serviceable by the user. Unauthorised opening of the
device voids any guarantee claim.
We recommend an annual inspection of the device ( see
also chapter "Maintenance" on page 8).
No use in areas subject to explosion hazards
The device is not approved for use in a potentially explosive
atmosphere.
Connection of electrical devices
Do not connect electrical devices not mentioned in this
manual before contacting Dräger Safety.
Shipping Damages
If there are any damages upon receipt of the device, imme-
diately demand a check from the haulier and the local ser-
vice representative.
Dräger Safety is not responsible for damages caused dur-
ing transport. However, Dräger Safety will be helping with
clarifying the incident with the haulier.
Dräger Safety AG & Co. KGaA
______________
® Dräger DrugTest is a registered trademark of
Dräger Safety AG & Co. KGaA.

Intended Use

The Dräger-DrugTest 5000 Analyzer is a device for detect-
ing drugs in oral fluid samples collected with the Dräger
DrugTest 5000 Test-Kit (In-Vitro Diagnostic Medical
Device). The mea-surement is based upon an optical evalu-
ation of the immunochemical test strips contained in the
Test-Kit.
The system is an easy and quick test procedure for detect-
ing amphetamines, benzodiazepines, cannabinoides,
cocaine metabolites, metamphetamines and opiates. Test
results are displayed immediately after finishing the analy-
sis and can be stored in the analyzer, printed with the
Dräger Mobile Printer or transferred to a PC via the inte-
grated USB interface.
The system is suited for stationar y as well as for mobile use.
System Components
The following components are provided with the Dräger
DrugTest 5000 Analyzer:
Quan- Designation
tity
1 Dräger DrugTest 5000 Analyzer
1 Power supply unit (12 V DC) with line cord
1 Instructions for Use
Additional Accessories
For extending the system, Dräger Safety offers additional
accessories like printer, keypad, bar code reader, carrying
bag, 12 V car cable, separate Test-Kits and transport
cases. Refer to the order list (see page 9) for more informa-
tion.
Carrying through a Drug Test
The Dräger DrugTest 5000 Analyzer is immediately usable.
There is no assembly or installation required before com-
missioning.
Preparation
Place the Dräger DrugTest 5000 Analyzer onto a plane,
solid and horizontal base.
Keep all ventilation slots open and clean.
Make sure that the specific ambient conditions are es-
tablished:
o
ambient temperature between 5 C and 40
o
104 F); relative humidity between 5 % and 95 %.
Connect the external keyboard, align printer etc., if re-
quired.
When using an external power supply, e.g. with insufficient
battery charge:
Connect battery charger.
Switching on the analyzer
Keep button OK pressed for approx. 3 seconds until an
acoustic signal sounds and the start screen is displayed.
– After successful completion of the automatic self check
the device displays readiness for operation » READY «.
Collecting the oral fluid sample
The oral fluid sample is collected using the Dräger DrugTest
5000 Test-Kit (order no.: 83 19 830). For detailed informa-
tion on the Test-Kit, refer to the Instructions for Use
for Dräger DrugTest 5000 Test-Kit, which is enclosed in the
Test-Kit units.
Wait at least 10 minutes following intake of sub-
stances through mouth or nose before collecting a
sample.
Ensure that the test cassettes and cartridges in the
pouch are at ambient temperature (if necessary,
wait 15 min. for temperature compensation) .
Only open pouches immediately before use, remove
test cassette from the pouch.
Remove the protective cap of the test cassette from oral
fluid collector and give the test cassette to the subject –
figure 1.
Instruct the subject to place the oral fluid collector inside
the cheeks and and move it carefully from one side of the
mouth to the other – figure 2.
Do not chew or suck on the oral fluid collector.
Observe the collection!
Once the sample adequacy indicator changes colour to
blue, normally after approx. one minute, an adequate
sample amount has been collected – figure 3.
Performing the evaluation
Take the test cassette from the subject, open the door of
the Analyzer and insert the test cassette into the lower
compartment, until it engages audibly – figure 4.
Insert the cartridge into the upper compartment of the
Analyzer, until it engages audibly – figure 5.
Close the door of the Analyzer and follow the instructions
shown on the screen.
Do not move the unit during the test execution!
A status bar on the display indicates the progress of the
evaluation process. After completed analysis the results
are displayed for each substance.
If desired:
Data of the subject and user can be entered, the test re-
sult can be printed and the data can be saved by select-
ing the menu items in accordance with the notes shown
o o on the screen.
C (41 F and
7