Tabla De Contenido; Importante; General Information; Intended Use - Bloom Diagnostics AHM test Manual De Instrucciones

IMPORTANT: Dear user, to avoid hazards and confusion, please read these instructions for use carefully before attempting to use the
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Bloom AMH Test. RETAIN INSTRUCTIONS FOR USE FOR FUTURE REFERENCE AND WARRANTY.
um Gefahren zu vermeiden und Unklarheiten zu beseitigen, lesen Sie diese Bedienungsanleitung sorgfältig durch, bevor Sie versuchen, den
Bloom AMH Test zu verwenden. BEWAHREN SIE DIE BEDIENUNGSANLEITUNG ZUM NACHLESEN UND FÜR DEN GARANTIEFALL AUF.
IMPORTANT: Chère utilisatrice, cher utilisateur, pour éviter des dangers et une confusion, veuillez lire attentivement ce mode d'emploi
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avant d'essayer d'utiliser le Bloom AMH Test. CONSERVEZ LES INSTRUCTIONS D'UTILISATION POUR RÉFÉRENCE FUTURE ET GARANTIE.
IMPORTANTE: gentile utilizzatore, per evitare pericoli e confusione si prega di leggere attentamente le presenti istruzioni per l'uso prima
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di tentare di usare il Bloom AMH Test. CONSERVARE LE ISTRUZIONI PER L'USO A SCOPO DI RIFERIMENTO FUTURO E PER GARANZIA.
Estimado/a usuario/a, para evitar peligros y confusión, lea detenidamente estas instrucciones antes de intentar utilizar el Bloom AMH Test.
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CONSERVE LAS INSTRUCCIONES PARA FUTURA REFERENCIA Y A EFECTOS DE LA GARANTÍA.
AMH-REF-1-1.X (1 test)
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 AMH Test ..................................................4
2.2.1. Principle of the method ..................................4
2.2.2. Test performance ...........................................4
2.2.3. Cross reactivity and interferents .......................4
2.2.4. Components .................................................5
3. Safety Regulations ..................................................5
3.1. Disclaimers .........................................................5
3.2. General notes on safety .......................................5
3.3. Limitations of use .................................................5
3.4. Use-by-date ........................................................6

1. General information

Anti-Müllerian hormone (AMH) is a hormone produced by
cells surrounding the egg in the ovarian follicles, or egg sacs.
It is of interest for reproductive medicine, as it can reflect
the number of eggs present in the ovaries, i.e. the ovarian
reserve. Besides a strong correlation with age, AMH levels
stay relatively stable throughout a woman's menstrual cycle,
and thus can be measured at any time. For more information
please visit www.bloomdiagnostics.com.
AMH-REF-3-1.X (1 test)
4. Operating steps ......................................................6
5. Storage .................................................................9
6. Bloom Lab LED indications .......................................9
7. Troubleshooting ....................................................10
8. Symbol information ..............................................13
9. Contact information ..............................................13

1.1. Intended use

The Bloom AMH Test is a single-use testing kit for quanti-
tative in-vitro diagnostic examination of AMH in capillary
blood, using lateral flow technology. It is intended for women
between 18 and 51, interested in estimating their individual
ovarian reserve as an ancillary screen of fertility. To be used
in a home environment or store setting.

1.2. Terms and definitions

• Warning: Points out a situation where a potentially
WICHTIG: Sehr geehrter Nutzer,
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AMH-REF-2-1.X (5 tests)
4.1. Preparation .........................................................6
4.2. Blood sample collection .......................................6
4.3. Process sampling and report collection ..................8
4.4. Device cleaning ...................................................9
6.1. Proper function ....................................................9
6.2. Error case .........................................................10
7.1. Bloom Lab ........................................................10
7.2. Bloom App ........................................................12
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AMH-REF-4-1.X (5 tests)
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