AGE Reader mu Introduction
User Manual
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1 Introduction
AGEs play a pivotal role in the development of chronic age-related diseases such
as diabetes, renal failure and cardiovascular disease. The level of AGEs in long-
lived tissues (not in blood!) serves as a memory of glycometabolic and oxidative
stress and is a valuable predictor of cardiovascular complications.
Until now it has been complicated to measure tissue AGEs in patients because
existing methods are expensive, time consuming, lack specificity, are poorly
reproducible and/or are invasive. The AGE Reader mu is the answer to the need for
measuring AGEs without the disadvantages of the existing methods. This state of
the art device provides a simple non-invasive solution which allows users to
determine the AGE level within 12 seconds. The information from the AGE Reader
can assist physicians in focusing treatment on patients with the highest risk of
complications. This includes patients suffering from diabetes mellitus, renal failure
but also acute disorders like acute coronary syndromes and sepsis. Moreover it is
an excellent tool for researchers in various fields.
The AGE Reader mu was developed and is being commercialized by DiagnOptics
Technologies B.V, an innovative medical technology company in the Netherlands.
This user manual provides the instructions for use of the AGE Reader mu.
DiagnOptics Technologies B.V
AGE Reader mu Intended use
User Manual
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2 Intended use
When used as intended, the AGE Reader mu non-invasively gives an evaluation of
Advanced Glycation End products (AGEs) in tissue. Clinical evidence shows that
AGE levels may assist the physician in clinical practice to assess the risk of
cardiovascular disease.
The AGE Reader mu is intended to be used by trained personnel to assess the
level of auto fluorescence in human skin. Users are expected to be familiar with
standard medical practices as required for patient monitoring.
All instructions, procedures and information in this user manual and on the labelling
on the device are to be regarded as the “Intended Use” and will fully inform the user
about the correct and safe use and installation of the AGE Reader mu.
AGE measurements should be performed directly on intact healthy skin on the inner
side of the dominant lower forearm. The skin at the measuring area should be
healthy, homogeneous and free of birthmark, tattoos or excessive hair growth and
without recent exposure to skin creams or any substance that may have fluorescent
properties. Self-tanning agents should not be used for at least 2 days before
measurement. Sun-blockers and other skin care products should be removed
before measurement.
Pigmented skin
The device and its software have been validated in patients with skin reflection >8%
(Fitzpatrick class 1-4). If the UV reflectance is below 10%, the AGE Reader mu will
give a warning that the signal is too low for valid results.
Radiation safety
Using the guidelines of NEN-IEC 62471, it is concluded that AGE Reader mu
measurements, as intended, remain considerably below the maximum radiation
exposure levels for skin and for the eye of both the operator and patient.
2.1 Conditions for which the device is not to be used
This device is not intended to be used on patients where the skin at the measuring
area is:
• not healthy
• not homogeneous
• damaged or tattooed
• exposed to skin care creams or any other substance that may have fluorescent
properties
The measurement result can be influenced if situations mentioned above are
present.
