Bloom Diagnostics Lab, Instructions For Use Manual, Page: 3 / 56

3
EN
EN IMPORTANT: Dear user, to avoid hazards and confusion, please read these instructions for use carefully before attempting to use the
Bloom Thyroid Test. RETAIN INSTRUCTIONS FOR USE FOR FUTURE REFERENCE AND WARRANTY.
DE
WICHTIG: Sehr geehrter Nutzer,
um Gefahren zu vermeiden und Unklarheiten zu beseitigen, lesen Sie diese Bedienungsanleitung sorgfältig durch, bevor Sie versuchen, den
Bloom Thyroid Test zu verwenden. BEWAHREN SIE DIE BEDIENUNGSANLEITUNG ZUM NACHLESEN UND FÜR DEN GARANTIEFALL AUF.
FR IMPORTANT: Chère utilisatrice, cher utilisateur, pour éviter des dangers et une confusion, veuillez lire attentivement ce mode d’emploi
avant d’essayer d’utiliser le Bloom Thyroid Test. CONSERVEZ LES INSTRUCTIONS D’UTILISATION POUR RÉFÉRENCE FUTURE ET GARANTIE.
IT IMPORTANTE: gentile utilizzatore, per evitare pericoli e confusione si prega di leggere attentamente le presenti istruzioni per l’uso prima
di tentare di usare il Bloom Thyroid Test. CONSERVARE LE ISTRUZIONI PER L’USO A SCOPO DI RIFERIMENTO FUTURO E PER GARANZIA.
ES IMPORTANTE: Estimado/a usuario/a, para evitar peligros y confusión, lea detenidamente estas instrucciones antes de intentar utilizar el
Bloom Thyroid Test. CONSERVE LAS INSTRUCCIONES PARA FUTURA REFERENCIA Y A EFECTOS DE LA GARANTÍA.
1. General information
Thyroid stimulating hormone (TSH) is produced by the pitui-
tary gland, a small gland located in the brain. TSH stimulates
the thyroid to release thyroid hormones triiodothyronine
(T3) and thyroxine (T4). These thyroid hormones play an
important role in the function of tissues and organs and are
also involved in the regulation of body temperature and
metabolism. As the release of TSH is very sensitive to small
changes of thyroid hormone levels, a TSH test can be used to
assess the status of the thyroid.
1.1. Intended use
The Bloom Thyroid Test is a single-use testing kit for manual
in-vitro diagnostic quantitative measurement of thyroid
stimulating hormone in capillary blood, used to screen for
hypothyroidism. It is intended for professional testing for
individuals 18 years old and above.
1.2. Terms and definitions
• Warning: Points out a situation where a potentially
hazardous condition exists that could result in a critical or
TSH-REF-1-1.X; TSH-REF-3-1.X (1 test) TSH-REF-2-1.X; TSH-REF-4-1.X (5 tests)
Table of contents
1. General information ...............................................3
1.1. Intended use .......................................................3
1.2. Terms and definitions ..........................................3
2. Bloom System .........................................................4
2.1. Overview of the Bloom System ..............................4
2.2. Bloom Thyroid Test...............................................4
2.2.1. Principle of the method ..................................4
2.2.2. Test performance ...........................................4
2.2.3. Interferents ....................................................4
2.2.4. Components .................................................4
3. Safety Regulations ..................................................5
3.1. Disclaimers .........................................................5
3.2. General notes on safety .......................................5
3.3. Limitations of use .................................................5
4. Operating steps ......................................................5
4.1. Preparation .........................................................6
4.2. Blood sample collection .......................................6
4.3. Process sampling and report collection ..................8
4.4. Device cleaning ...................................................8
5. Storage .................................................................8
6. Bloom Lab LED indications .......................................9
6.1. Proper function ....................................................9
6.2. Error case .........................................................10
7. Troubleshooting ....................................................10
7.1. Bloom Lab ........................................................10
7.2. Bloom App ........................................................11
8. Symbol information ..............................................12
9. Contact information ..............................................12