Inhaltsverzeichnis; General Information; Intended Use; Who Should Use The Bloom System - Bloom Diagnostics Bloom Lab Bedienungsanleitung

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

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.
4-3-6-2 Bloom Lab IFU, 09.04.2020, V1.0
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

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
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