Product Information; Overview Of The Bloom System; Bloom Lab; Bloom Lab Components - Bloom Diagnostics Bloom Lab Bedienungsanleitung

• 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 poten-
tially 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

The Bloom Lab only works together with the Bloom App and
Bloom Tests. These form the "Bloom System". To get started,
download and install the Bloom App on your smartphone.
Warning
Do not use the Bloom System as a diagnostic
device. Using the information provided by the
Bloom System for diagnosis can lead to mis-
treatment and severe consequences. Results
should be reviewed by a medical practitioner.

4.1. Overview of the Bloom System

NFC tag
Read out
window
Sample
window
Bloom Test packaging Bloom Test strip
Bloom System
The Bloom System is a medical testing system. It provides
screening and monitoring of target markers and medical
guidance. It combines lateral fl ow immunoassays (Bloom
Test strips), an established diagnostics technology, with an
electronic reader for test strip analysis (Bloom Lab) and an
app for displaying and interpreting results (Bloom App).

4.2. Bloom Lab

The Bloom Lab is an electronic device, which contains
an optical measurement system to quantify the test line
intensities 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. More information on this can
be found in chapter 5.
4-3-6-2 Bloom Lab IFU, 09.04.2020, V1.0
LED indication ring Strip insertion flap
Bloom Lab
Bloom App

4.3. Bloom Lab components

Caution: Only use equipment specifi ed by Bloom Diagnos-
tics to guarantee the proper function of the device.
The Bloom Lab package includes (required):
• 1 x Bloom Lab
• 1 x Power supply (model no RYS518050150UE)
• 1 x USB-A to USB-C cable (150cm)
• 1 x Instructions for use
See the following images for reference.
Bloom Lab
Power supply
Not included (required):
• Bloom Test
• Bloom App
Visit www.bloomdiagnostics.com to learn more.

5. General operating steps

Caution: Exceeding or not meeting the specifi ed conditions
can cause damage to the device.
Caution: Do not use the Bloom Lab in rooms with high
humidity such as the bathroom, as this could lead to fail-
ures regarding the evaluation of the retrieved sample.
Caution: Do not use the Bloom Lab for self test without
proper guidance from a healthcare professional.
In order to use the Bloom System, you must have a smart-
phone with a working internet connection and the installed
Bloom App ready, as well as a Bloom Test. Check the Bloom
Lab package components for completeness and any damage
to the Bloom Lab.
EN
USB-C cable
Instructions for use
5