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3 4-3-6-2 Bloom Lab IFU, 09.04.2020, V1.0
EN
1. General information
1.1. Intended use
The Bloom Lab is intended for optically measuring Bloom
Test strips and sharing the results with other Bloom devices,
such as the Bloom App, for display and further analysis.
1.2. Who should use the Bloom System?
The Bloom Lab only works together with the Bloom App and
Bloom Tests. These form the “Bloom System”.
The Bloom System is intended to be used by those inter-
ested in preventative health tracking, self-optimisation, and
tracking of medical conditions.
The Bloom System should only be used and operated by
persons aged 18 years and over. No prior training is necessary.
1.3. Standards and legal requirements
The Bloom Lab is classifi ed as an IVD according to the EC
Council Directive 98/79/EC (IVDD), and conforms to the
relevant provisions of the IVDD in accordance with Annex
III. It further complies with the European directives 2011/65/
EU (RoHS), 2012/19/EU (WEEE) and 2014/53/EU (RED). The
Bloom Lab has been developed in accordance with the
IEC 61010-1:2010+AMD1:2016, IEC 61010-2-101:2018, EN
61326-1:2013, EN 61326-2-6:2013, EN 60601-1-2:2014, EN
60601-1-11:2015 and EN 13532:2002.
2. Safety regulations
2.1. Disclaimer
The results obtained from using the Bloom System should
not be regarded as a medical assessment.
The Bloom System provides the user with health guidance.
It is not a diagnostic device. Despite all eff orts taken to avoid
Quick start guide
3
report report
EN Dear user, in order to avoid hazards and confu-
sion, please read these instructions for use carefully
before attempting to use the Bloom Lab. RETAIN
INSTRUCTIONS FOR USE FOR FUTURE REFERENCE
AND WARRANTY. DE Sehr geehrter Nutzer, um
Gefahren zu vermeiden und Unklarheiten zu
beseitigen, lesen Sie diese Bedienungsanleitung
sorgfältig durch, bevor Sie versuchen, das
Bloom Lab zu verwenden. BEWAHREN SIE DIE
BEDIENUNGSANLEITUNG ZUM NACHLESEN UND FÜR DEN GARANTIEFALL AUF. FR Cher utilisateur, afi n d’éviter tout danger et confu-
sion, veuillez lire ces instructions d’utilisation attentivement avant toute tentative d’utilisation du Bloom Lab. CONSERVEZ LA NOTICE
D’UTILISATION POUR RÉFÉRENCE FUTURE ET À TITRE DE GARANTIE. IT Gentile utente, al fi ne di evitare pericoli e confusione, leggere
attentamente le presenti istruzioni per l’uso prima di utilizzare Bloom Lab. CONSERVARE LE ISTRUZIONI PER L’USO PER FUTURO
RIFERIMENTO E GARANZIA. ES Estimado usuario, para evitar riesgos y confusión, lea detenidamente estas instrucciones de uso antes
de intentar utilizar el Bloom Lab. CONSERVE LAS INSTRUCCIONES DE USO PARA FUTURAS REFERENCIAS Y GARANTÍAS. HU Kedves
felhasználó, a veszélyek és a félreértések elkerülése érdekében kérjük, olvassa el fi gyelmesen ezt a használati útmutatót, mielőtt
megpróbálná használni a Bloom Lab-et. ŐRIZZE MEG A HASZNÁLATI UTASÍTÁST A KÉSŐBBI HIVATKOZÁS ÉS A GARANCIA ÉRDEKÉBEN.
What’s in the box
1 instructions for use
EN
See operating steps in the Bloom Test quick start guide.
DE Siehe Schritte in der Bloom Test Kurzanleitung.
FR Veuillez vous référer au guide de démarrage rapide Bloom Test pour connaître les étapes à suivre.
IT
Osservare le fasi operative nella guida rapida del Bloom Test.
ES
Vea los pasos operativos en la guía de inicio rápido de Bloom Test.
HU Lásd a Bloom Test gyorsindítási útmutatójának működési lépéseit.
2
1 USB-C cable 1 power supply 1 Bloom Lab
1
BL-REF-2
2022-02-09, 4-3-6-8 Bloom Lab IFU EU Prof. V1.4
Table of contents
1. General information .............................................. 3
1.1. Intended use .................................................................. 3
1.2. Who should use the Bloom System? .......................... 3
1.3. Standards and legal requirements ............................. 3
2. Safety regulations .................................................. 3
2.1. Disclaimer ...................................................................... 3
2.2. General notes on safety ............................................... 4
2.3. How to handle the Bloom Lab correctly..................... 4
2.4. Handling of bodily fl uids .............................................. 4
2.5. Use of second-hand Bloom products ......................... 4
2.6. Use of non-Bloom parts with the Bloom System ...... 4
2.7. Damaged products or packaging ................................ 4
3. Terms and defi nitions ............................................ 4
4. Product information .............................................. 5
4.1. Overview of the Bloom System ................................... 5
4.2. Bloom Lab ..................................................................... 5
4.3. Bloom Lab components ............................................... 5
5. General operating steps ....................................... 5
6. Store-use operating steps ..................................... 7
7. Cleaning the Bloom Lab ......................................... 7
8. Maintenance ........................................................... 8
8.1. Updating a Bloom Lab .................................................. 8
8.2. Setting up an administrator for a Bloom Lab ............ 8
8.3. Changing the administrator of a Bloom Lab ............. 8
9. Storage and transport ........................................... 8
10. Disposal ................................................................. 8
11. LED indications and error handling .................... 8
11.1. Proper function ........................................................... 8
11.2. Error case ...................................................................10
12. Troubleshooting ................................................. 10
13. Technical details ................................................. 12
13.1. Technical specifi cations............................................12
13.2. Operating principle ...................................................13
13.3. Performance ..............................................................14
13.4. Trademarks ................................................................14
14. Warranty ............................................................. 14
15. Symbol information ........................................... 14
16. Contact information ........................................... 14