Operating Principle; Performance; Trademarks; Warranty - Bloom Diagnostics Bloom Lab Manual De Instrucciones

15.2. Operating principle

The Bloom Lab is an electronic device, which contains an
optical measurement system (optical reader) to quantify
the test line intensities produced by the Bloom Test strip
during use. It captures the Bloom Test strip read-out
window, automatically detects the test and control line
and calculates the mean intensity value for each line
by image analysis. This mean value, in connection with
further image analysis, corresponds to the concentration
of the captured target analyte. The actual concentration
of the target analyte is calculated differently for each
batch of Bloom Tests using the Bloom App, thus enabling
measurements with the Bloom Lab for a wide variety of
analytes.

15.3. Performance

For the analyte specific performance please see the in-
structions for use of each Bloom Test.

15.4. Trademarks

The Bluetooth® word mark and logos are registered
trademarks owned by Bluetooth SIG, Inc. and any use of
such marks by Bloom Diagnostics is under license. Other
trademarks and trade names are those of their respective
owners.

16. Warranty

For consumers, who are covered by consumer protection
laws or regulations in their country of purchase or, if dif-
ferent, their country of residence, the benefits conferred by
Bloom Diagnostics' Limited Warranty are in addition to all
rights and remedies conveyed by such consumer protection
laws and regulations, including but not limited to these
additional rights.
For further information on the rights provided by consum-
er law visit: www.bloomdiagnostics.com.
4-3-6-2 Bloom Lab IFU, 09.04.2020, V1.0

17. Symbol information

Manufacturer
Do not dispose of
waste of electrical and
electronic equipment as
unsorted municipal waste
Fragile, handle with care
Keep away from sunlight
Humidity exposure limits
80%
between 30% and 80%
30%
for device operation
Atmospheric pressure
1060 hPa
exposure limits between
700 hPa to 1060 hPa
700 hPa
for device operation
Temperature exposure
60°C
limits between -20°C
and +60°C for transport
-20°C
and storage
In vitro diagnostic
medical device
Serial Number

18. Contact information

Bloom Diagnostics AG
Susenbergstrasse 185
8044 Zürich, Switzerland
For assistance or technical support contact:
Email - support@bloomdiagnostics.com
Web - www.bloomdiagnostics.com/contact
CE Mark
Consult instructions
for use
Keep dry
Do not use if package
is damaged
Temperature exposure
limits between +15°C
40°C
and +40°C for device
15°C
operation
Humidity exposure
85%
limits between 30%
and 85% for transport
30%
and storage
Atmospheric pressure
exposure limits
1060 hPa
between 700 hPa
to 1060 hPa for
700 hPa
transport and storage
IP51 (dust and
IP51 dripping water
protected)
Catalog number
EN
15