Tabla De Contenido; General Information; Safety Regulations - Bloom Diagnostics Bloom Lab Manual De Instrucciones

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 fluids ................................. 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 ..................... 5
3. Terms and defi nitions ......................................... 5
4. Product information ........................................... 5
4.1. Overview of the Bloom System ......................... 5
4.2. Bloom Lab ..................................................... 5
4.3. Bloom Test ..................................................... 5
4.4. Bloom App .................................................... 6
5. Bloom Lab components ...................................... 6
6. Using the Bloom System for the fi rst time .............. 6
7. General operating steps .....................................6
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 de-
vices, such as the Bloom App, for display and further
analysis.
1.2. Who should use 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
8. Store-use operating steps ...................................8
9. Cleaning the Bloom Lab .....................................9
10. Maintenance ...................................................9
10.1. Updating a Bloom Lab ..................................9
10.2. Setting up an administrator for a Bloom Lab .......... 9
10.3. Changing the administrator of a Bloom Lab ....9
11. Storage and transport ......................................9
12. Disposal .........................................................9
13. LED indications and error handling ...................9
13.1. Proper function ...........................................10
13.2. Error case ..................................................11
14. Troubleshooting .............................................11
15. Technical details ............................................13
15.1. Technical specification .................................13
15.2. Operating principle ....................................15
15.3. Performance ...............................................15
15.4. Trademarks ................................................15
16. Warranty ......................................................15
17. Symbol information .......................................15
18. Contact information .......................................15
1.3. Standards and legal requirements
The Bloom Lab is classified 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.
EN
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