7
6
System description
1.5 Safety information
See “Safety and compliance information” for detailed safety and compli-
ance information.
Correct use: Any disregard of the instructions in the User Manual may
result in a safety risk. Use DocUReader 2 Pro to analyzer urine samples
only. The device is not intended for any other application.
Environmental conditions: The DocUReader 2 Pro analyzer is approved
for indoor use only. See “12 Maintenance” and “Appendix B Technical
specifications” for further environmental limitations.
All components of the urine test strip analyzer may come into contact
with human urine and are therefore possible sources of infection. Urine
specimens should be handled at Biosafety Level 2. To prevent accidental
contamination in a clinical laboratory, always wear disposable surgical
gloves when handling reagents, fluids or any part of the device. Use
universal precautions and consult relevant sections of the Centers for
Disease Control and Prevention manual, Biosafety in Microbiological
and Biomedical Laboratories (BMBL) 6th Edition and the World Health
Organisation’s Laboratory biosafety manual, Fourth edition.
1.6 Approvals
The DocUReader 2 Pro system meets the requirements laid down in:
Regulation (EU) 2017/746 of the European Parliament and of the Council of
5
th
April 2017 on in vitro diagnostic medical devices and repealing Directive
98/79/EC and Commission Decision 2010/227/EU.
Restriction of hazardous substances. The DocUReader 2 Pro system
meets the requirements laid down in: Directive 2011/65/EU of the European Par-
liament and of the Council of 8
th
June 2011 on the restriction of the use of certain
hazardous substances in electrical and electronic equipment.
Compliance with the applicable regulation and directive(s) is provided by means
of the Declaration of Conformity.
2 System description
2.1 Principle of operation
A motor moves the test strip tray (a slide with a central channel and an embed-
ded reference pad) that carries the test strip under a fixed measurement unit. The
analyzer reads the reference pad first, then each of the test pads on the strip in
turn.
The optical unit contains four LEDs that emit light at various discrete wave-
lengths.
