Damaged Products Or Packaging; Terms And Defi Nitions; Product Information; Overview Of The Bloom System - Bloom Diagnostics Bloom Lab Manual De Instrucciones

2.7. Damaged products or packaging

Do not use Bloom products, including all element of the
Bloom System, if the products or their packaging appears
damaged or shows evidence of tampering.
Do not attempt to deconstruct, damage, or tamper with
any elements of the Bloom System as this can result in
malfunction and will void the product's warranty.
3. Terms and defi nitions
Safety notes: Safety-related information that warns users
about hazards and instructs on how to avoid them:
• Warning: A warning points out a situation where a
potentially hazardous condition exists that could result
in a critical or catastrophic situation such as death or
serious long-term injury if not avoided.
• Caution: A caution points out a situation where a
potentially hazardous condition exists that could result
in a serious situation such as short-term injury or
impairment requiring medical intervention to correct if
not avoided.
• Information: Information points out a situation where
a potentially hazardous condition exists that could
result in a non-serious situation such as a slight
inconvenience if not avoided.

4. Product information

4.1. Overview of the Bloom System

The Bloom System is a multi-part, testing system. It provides
quantitative screening and monitoring of target analytes
and health guidance. For this purpose, the Bloom System
combines lateral flow assay-based bodily fluid testing using
an established diagnostic technology (Bloom Test strips)
with an electronic reader for quantification of the test line
(Bloom Lab) and user-friendly software for displaying and
interpreting results (Bloom App). See visual N°1.
Warning
The Bloom System does not function as a diagnostic
device.
Using the information provided by the Bloom System
for diagnosis can lead to mistreatment and severe
consequences.
Do not use the Bloom System to diagnose or treat
medical conditions.
4-3-6-2 Bloom Lab IFU, 09.04.2020, V1.0
LED indication ring Strip insertion flap

Bloom Lab

Bloom Test strip
Visual N°1: Bloom System
4.2. Bloom Lab
The Bloom Lab is an electronic device, which contains an
optical measurement system to quantify the test line in-
tensities produced by the Bloom Test strip during use. The
Bloom Lab is intended to be used in combination with the
Bloom App and Bloom Tests.

4.3. Bloom Test

The Bloom Test (Visual N°2) contains disposables which
can be used for single-use blood sampling.
Visual N°2: Bloom Test
The Bloom Test strip (see Visual N°3) is sold as one in-
tegral part of the Bloom Test. The Bloom Test strip is a
handheld, disposable single-use assay, which is designed
to detect the concentration of a target analyte in a finger
pricked blood sample and produces qualitative results
in the form of a test line intensity. An additional control
line indicates the proper analytical function of the Bloom
Test strip.
EN
Read out
window
Sample
window
Bloom App
5