Intended Use And General Description; Intended Purpose; General Description; Installation And Power-On - Cortexa Technology DermaLab Mini Instructions For Use Manual

2 Intended use and general description

2.1 Intended purpose

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The DermaLab Mini is an investigational laboratory instrument for measuring skin parameters.
Several probes can simultaneously be connected to the main unit to measure skin-related param-
eters such as TEWL, ultrasound, elasticity, hydration, pH, temperature, sebum, and skin color. In
addition, a Dermascope can be connected to the Windows-based computer system using a USB
connector to capture optical images of skin.
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The DermaLab Mini is intended to be connected using a USB cable to a Windows-based com-
puter system.
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The DermaLab Mini does not serve a medical purpose and is not intended for diagnosis, preven-
tion, monitoring, prediction, prognosis, treatment, or alleviation of disease. The DermaLab
not covered by annex XVI of the MDR (EU 2017/745).

2.2 General description

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The DermaLab Mini system consists of the main-unit, a Windows-based computer system,
probes, and a medical grade power supply to provide power to the main-unit. The system is not a
medical device and is designed to meet international safety requirements for measurement, con-
trol, and laboratory equipment (IEC 61010-1).

3 Installation and power-on

To ensure trouble-free and safe operation of the DermaLab
use and maintenance as laid down in this document. Power supply
The power supply must be connected to a wall outlet providing a protective ground terminal to en-
sure electrical safety. It may be connected to input voltages from 100 - 240 VAC, 50/60 Hz. Do
not use any other power supply than supplied by Cortex Technology (Adapter Tech., ATM036T-
P120).

3.1 Main unit

Connect the main unit to the +12 V output cable from the power supply. The power input is
located on the rear panel of the main unit (see Figure 1 - connector 7).
To obtain the most stable readings it is advisable to let the unit and probes warm up for approx. 5
minutes prior to use.

3.2 Connection between the computer and the main unit

The main unit is connected to the computer with the supplied USB cable (see Figure 1 - connector
8).

3.3 Connection of probes

The TEWL, Skin Color, Ultrasound, Hydration, Elasticity, pH and Temperature probes can be con-
nected to the rear panel of the DermaLab
When inserting the connectors: insert the connector and gently turn it. When the pins are cor-
rectly aligned it clicks into the socket. To disconnect the probe, gently pull the outer ring of the
connector and it will disengage (do not turn).
The Dermascope is to be connected to a USB port on the Windows-based computer system.
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Mini please follow the instructions for
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Mini using various types of connectors.
CORTEX TECHNOLOGY ApS
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Mini is
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