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Diagnoptics Age Reader - 3 Warnings and Precautions; 4 Description of the AGE Reader Mu

Diagnoptics Age Reader
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AGE Reader mu Warnings and precautions
User Manual
3
3 Warnings and precautions
The following warnings and precaution are essential for correct and safe functioning
of the AGE Reader mu as is intended by the manufacturer.
The AGE Reader mu is intended for static use! It is not intended to be a portable device.
Transportation must be done with great care at own risk.
Protect against falls and mechanical shocks.
Do not use the device if there is visible damage and/or sharp edges.
This device emits UV-A radiation.
Measurements should be done on the inner side of the lower forearm on healthy undamaged
skin without birthmarks or excessive hair growth. 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.
Only use the accompanying external power supply (part.nr.: CFR51000 or CFR52000).
The mains plug of the power supply is the separator that connects or disconnects the AGE
Reader mu and its power supply from the mains. Avoid positioning the equipment such that
access to the coupler, plug, etc. is limited (so that disconnection becomes difficult).
Do not use excessive force or sharp objects on the touchscreen.
To avoid risk of electric shock, this equipment must only be connected to a supply mains with
protective earth.
Always make sure that with the use of a computer or laptop approved for medical use, the
system complies with IEC 60601-1-1 for medical systems. The USB-port should be a limited
circuit with a maximum current of 8A.
This device meets all requirements for electromagnetic compatibility of IEC 60601-1-2. If the
user however notes unusual device behaviour, particularity if such behaviour is intermittent and
associated with nearby usage of portable and mobile RF communications equipment, this
could be an indication of electromagnetic interference. If such behaviour occurs, the user
should try moving the interfering equipment further from this device. Failure to do so could
result in the equipment not functioning properly.
The use of accessories, transducers and cables other than those specified, with the exception
of replacements parts sold by DiagnOptics, may result in increased emissions or decreased
immunity of the AGE Reader mu.
The AGE Reader mu should not be used adjacent to or stacked with other equipment and that
if adjacent or stacked use is necessary, the AGE Reader mu should be observed to verify
normal operation in the configuration in which it will be used.
The measurement window should always be kept clean.
Never place anything else than intended on top of the device.
Maintenance and repairs should only be done by DiagnOptics or authorized representatives.
Correct positioning of the arm over the window is essential and the arm should be maintained
steady during the measurement process.
Do not let fluids ingress.
The USB port is protected by a cover which can only be removed with a tool (small
screwdriver, toothpick). Always place it back after use!
Table 1. Warnin
g
s &
p
recautions
AGE Reader mu Description of
User Manual AGE Reader mu
4
Figure 1. AGE Reader mu front side
4 Description of the AGE Reader mu
The AGE Reader mu is a proprietary device to assist a physician in assessing
cardiovascular risk. This way of non-invasive monitoring uses auto fluorescence
excited by ultraviolet A light in human tissue.
The AGE Reader mu consists of a small enclosure (considered as applied part) and
its detachable silicone mat for the patient to rest his arm on during the
measurement. The AGE Reader mu is operated from a touchscreen with LED
backlight, and controlled by an internal micro controller running dedicated AGE
Reader mu Software. This software allows the user to change his preferences and
calculates the AGE Reader measurement result. Results of the measurements are
presented as an absolute value numerical and can be displayed in a graph on the
screen. The AGE Reader mu is powered by an accompanying medically approved
external power supply connected to the mains. The AGE Reader mu can also be
powered from the internal rechargeable Lithium ion battery.
Contents of packaging:
AGE Reader mu
User manual
External power supply part number CFR51000 or CFR52000
Mains plug set to comply with regulations for use in country of usage
The AGE Reader mu (figure 1) has the following external features:
Enclosure with detachable silicone mat.
3,5” touchscreen from which the device is operated and all necessary
information during use is presented visually to the user.
Measuring window on the upper side of the AGE Reader mu.
Power button to turn the device on and off.
Rear panel at the back of the device (figure 2) with:
o Power inlet for the medically approved power supply.
o USB port for firmware upgrades (protected by a cover).
o Blue LED to indicate when the internal battery is charging.
Power button
Touch
screen
Measurement
window
Detachable
silicone mat