Alere Dds ® 2 Test Kit: Instructions For Use - Alere DDS 2 Manual Del Usuario

Alere DDS 2 Test Kit Instructions for Use | EN
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Alere DDS ® 2 test procedure
A
Set up the cartridge
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Press the power button to switch the analyser on. Wait for the initialising process to complete.
2
Remove a new Alere DDS2 Test Cartridge
3
Check that the silica gel pack is present, intact and is yellow. If the silica gel is missing, open or is green,
discard the test and start again with a new cartridge. Report the problem to Product Support.
4
When prompted by the analyser screen, insert the test cartridge. The analyser will check that the
cartridge is valid.
Make sure to keep the analyser horizontal
B
Collect the donor sample
5 Ask the donor to unwrap a new Alere DDS2 Oral Fluid Collection Device
Ensure that they hold the collection device by the plastic stem, and then place it in the mouth.
6 The sample donor must actively swab the collection device around gums,
7 Continue swabbing until the sample presence indicator
C
Run the test
8 Insert the collection device into the test cartridge
cartridge to the stop position.
9 The analyser will now test the sample. The test time will be displayed on the screen. Make sure to keep the
analyser horizontal and still at all times.
10 The results will be displayed on the analyser screen. If it has been enabled, a donor questionnaire will begin
after pressing 'OK'. If required, the results can be printed.
11 Please ensure that the printer is connected to the analyser and has been
To skip this step press 'NO'.
12 The test cartridge and collection device can now be removed from the analyser.*
Do not remove the test cartridge by pulling the collection device and do not attempt to remove the
collection device from the test cartridge.
* Take care when removing the test cartridge as the underside of the cartridge may be hot.
Handle the test cartridge by the side edges.
Open out cover
2
from its foil wrapper.
and still at all times.
from the packaging.
tongue and inside the
starts to turn blue.
(in the analyser). Gently push all the way into the
switched on before printing.
Precautions
DO NOT use the test cartridge or oral fluid collection device after the expiry date printed on the pouch label.
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n DO NOT open the foil pouch until ready to test.
DO NOT use the kit if the collection device, test cartridge or their packaging is marked, wet, dirty or damaged.
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DO NOT pull the test cartridge apart.
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DO NOT use the test cartridge if the silica gel pack within the foil pouch is green: the crystals should be yellow.
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n DO NOT use the test cartridge if the silica gel pack within the foil pouch is missing or has burst.
n DO NOT use oral fluid collection device if indicator shows blue or has started to turn blue.
DO NOT ingest the silica gel pack.
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DO NOT leave donor unobserved during sample taking.
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n DO NOT use the test cartridge if it has been dropped on the floor after removal from the foil pouch.
n Handle all specimens as if they were potentially infectious. It is advisable to wear protective gloves throughout
the sample collection and testing process.
n DO NOT allow the donor to chew or suck the collection device.
n DO NOT place the collection device in the mouth after it has been in contact with the sample buffer solution
contained within the test cartridge.
n The test cartridge and collection device are designed for single use only and should be discarded in accordance
cheek.
with local or national regulations.
n Ensure the analyser is kept horizontal and as still as possible following insertion of the cartridge.
n DO NOT remove the collection device until the test is complete.
When removing the test cartridge at the end of the test, the underside of the cartridge may be hot. Handle the
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test cartridge by the side edges.
Hazard information for the components under applicable European Community (EC) Directives is as follows:
Test Conjugate Pad:
Buffer: Warning: Contains methanol.
n P309+P311: If exposed or if you feel unwell: Call a POISON CENTRE or doctor/physician.
n Please note each test cartridge contains 1.3 mL of buffer containing methanol.
Safety Data Sheet (SDS) is available for the professional user on request.
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Sample collection
A sample should be obtained using the Alere DDS2 Oral Fluid Collection Device.
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Following oral fluid collection best practices, we recommend no eating, drinking or smoking 10 minutes prior to
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sample collection as this reduces the risk of contaminants impacting the test result.
The donor must collect the sample.
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The sample should be processed immediately.
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Alere DDS
H319: Causes serious eye irritation.
H371:
May cause damage to organs.
2 Test Kit Instructions for Use | EN
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