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Instructions for Use 
Version 1.0
Doc. nr.: DI-C-01-008.5
 
 
 
 
 
 
 
AGE Reader mu
User Manual
Contents
1 Introduction .......................................................................................................... 1
2 Intended use ........................................................................................................ 2
2.1
Conditions for which the device is not to be used ....................................................... 2
3 Warnings and precautions ................................................................................... 3
4 Description of the AGE Reader mu ...................................................................... 4
5 Installing the AGE Reader mu ............................................................................. 5
6 Instructions for use ............................................................................................... 6
6.1
Starting the AGE Reader mu ....................................................................................... 6
6.2
Main screen ................................................................................................................. 7
6.3
Measurement............................................................................................................... 8
6.4
Settings screen .......................................................................................................... 15
7 Background on AGE values ............................................................................... 19
8 Cleaning & maintenance .................................................................................... 22
8.1
Cleaning instructions ................................................................................................. 22
8.2
Maintenance instructions ........................................................................................... 22
9 Problems & solutions ......................................................................................... 23
9.1
Power supply problems ............................................................................................. 23
9.2
Problems during operation ........................................................................................ 23
10 Technical specifications ................................................................................... 24
11 Marking on the AGE Reader mu ...................................................................... 25
11.1 The rear label ............................................................................................................ 25
11.2 The serial label .......................................................................................................... 26
11.3 Power button ............................................................................................................. 27
11.4 Packaging label ......................................................................................................... 28
12 Spare parts & accessories ............................................................................... 29
12.1 Spare Parts................................................................................................................ 29
13 Liability & warranty ........................................................................................... 30
13.1 Liability....................................................................................................................... 30
13.2 Warranty .................................................................................................................... 30
13.3 Declaration of Conformity .......................................................................................... 30
14 Electromagnetic compatibility .......................................................................... 31
14.1 Essential performance ............................................................................................... 31
14.2 Electromagnetic emissions ........................................................................................ 31
14.3 Electromagnetic immunity ......................................................................................... 32
14.4 Distances between RF equipment ............................................................................ 34
Contents
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Summary of Contents for Diagnoptics Age Reader

  • Page 1: Table Of Contents

    Conditions for which the device is not to be used ............2 3 Warnings and precautions ................... 3 4 Description of the AGE Reader mu ..............4 5 Installing the AGE Reader mu ................5 6 Instructions for use ....................6  ...
  • Page 2: Introduction

    The AGE Reader mu is intended to be used by trained personnel to assess the Until now it has been complicated to measure tissue AGEs in patients because level of auto fluorescence in human skin. Users are expected to be familiar with existing methods are expensive, time consuming, lack specificity, are poorly standard medical practices as required for patient monitoring.
  • Page 3: Warnings And Precautions

    The AGE Reader mu consists of a small enclosure (considered as applied part) and The AGE Reader mu is intended for static use! It is not intended to be a portable device. its detachable silicone mat for the patient to rest his arm on during the Transportation must be done with great care at own risk.
  • Page 4: Installing The Age Reader Mu

    ‘power on’ state. not be lit. Part of this initialization is a self-test of the AGE Reader mu’s internal light sources. Notice that some light will be emitted from the measurement window for a The dedicated AGE Reader mu Software is preinstalled and will start short period during this phase this is completely harmless.
  • Page 5: Main Screen

    The patient’s dominant forearm should be placed on the AGE Reader mu as The last twenty measurement results are stored by the AGE Reader mu. A list of indicated in figure 6. Ensure that the arm these measurement is available on the Measurement Results Screen. This screen...
  • Page 6 Figure 11. One single measurement result Upon a successful measurement the AGE Reader mu will advance to the The AGE Reader measurement result is displayed at the centre of the row in large Measurement Results screen (figure 9). This screen will show the last font.
  • Page 7 Problems during measurement Age input buttons If the AGE Reader mu is not able to successfully perform the measurement it will abort the measurement and indicate the problem to the user. Three problem indications exist and will be explained subsequently: Confirm button ...
  • Page 8 Low-signal error indication External error indication If the measured fluorescence signal from the arm is too low, the AGE Reader mu is The External error indication is shown (figure 16) when any of the measurement unable to perform a reliable measurement. It will then abort the measurement and parameters has an out of bound value that cannot be directly related to the use of raise a low-signal error (figure 15).
  • Page 9: Settings Screen

     Brightness screen: Change the LCD display brightness  Information screen: Show information about the AGE Reader mu  The year (YYYY) is shown as a four digit number  The day (DD) is shown in bold text. ...
  • Page 10 Using a lower LCD display brightness setting will reduce the power-consumption of AGE Reader mu hardware version number the AGE Reader mu and prolongs the operating time of the battery. AGE Reader mu firmware version number The Manufacturer information displays the DiagnOptics Technologies B.V. company Return button homepage URL and the email address of the DiagnOptics Technologies B.V.
  • Page 11: Background On Age Values

    Age is the most important factor determining the level of Advanced Glycation End- products (AGEs) in tissue. The AGE value as measured by the AGE Reader is also No reliable AGE values can be given with the current AGE Reader mu software if correlated with age.
  • Page 12: Cleaning & Maintenance

    Risk Group III: Definite CV risk The measurement window should always be kept clean! If the AGE Reader measurement result is 2.9 or above, the subject has a definitely In the design of the AGE Reader mu, special attention was given to allow high cardiovascular risk.
  • Page 13: Problems & Solutions

    Problems during operation  Storage & Transport Conditions: When the AGE Reader mu is turned on, the software will initialize the system. If a o Temperature range: Lower limit - 40ºC - Upper limit + 70°C fault condition occurs in this start-up phase a fault code is presented by red blinking...
  • Page 14: Marking On The Age Reader Mu

    11.1 The rear label Figure 24. Serial label The rear label is located at the back of the housing of the AGE Reader mu. This label shows all necessary information for installation, use and applicable warnings. The rear label contains two connector inlets (figure 23), one inlet for the accompanying power supply, one connector inlet for the USB connection and will Table 4.
  • Page 15: Power Button

    11.4 Packaging label CE-Mark & Notified body number (6 mm high) Each AGE Reader mu together with a user manual and power supply will be Identifies DiagnOptics Technologies B.V. as its packed in protective packaging right after production. This packaging should be manufacturer with name and contact information.
  • Page 16: Spare Parts & Accessories

    (collectively “Damage”) if or where the Damage is If any doubt exists that damage has been done to the AGE Reader mu itself, please caused by or arises in connection with (a) improper use of the AGE Reader mu, (b) contact DiagnOptics or its representatives.
  • Page 17: Electromagnetic Compatibility

    The AGE Reader mu is intended for use in the electromagnetic environment specified below. output lines output lines The customer or the user of the AGE Reader should assure that it is used in such an environment. 1 kV 1 kV...
  • Page 18: Distances Between Rf Equipment

    14.4. Distances between RF equipment The AGE Reader is intended for use in the electromagnetic environment specified below. The customer or the user of the AGE Reader mu should assure that it is used in such an environment. Recommended separation distances between portable...
  • Page 19 DiagnOptics Technologies B.V. Aarhusweg 4-9 9723 JJ Groningen The Netherlands Tel.: +31(0)50 589 0612 Email: info@diagnoptics.com http: www.diagnoptics.com...

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