10-7002-0 Rev 2
June 2019
Page 1 of 7
DPP® Micro Reader
For use with the DPP® HIV-Syphilis System
Read this user guide completely before using the product.
Storage conditions: 10 - 35°C (50 - 95°F)
NAME AND INTENDED USE
The DPP Micro Reader is for use with the DPP® HIV-Syphilis System.
SUMMARY AND EXPLANATION
The DPP® HIV-Syphili s Micro Reader is a reflectance reader used to interpret test results usi ng the DPP® HIV-Syphili s test devices. The
DPP Micro Reader minimizes human errors due to subjective visual interpretation; hence, the results of DPP HIV-Syphilis System device
should be read exclusively with the DPP Micro Reader.
PRINCIPLES OF THE PROCEDURE
The DPP Micro Reader for use with the DPP HIV-Syphilis System is a portable, battery-powered instrument that captures an image of
the test strip surface, verifies the presence and intensity of the control line and measures the line intensity at each of th e test line
positi ons. It reports a reactive (R), non-reactive (NR), or inval id result (INV) after approxi mately 3 seconds . A 14-segment l iquid crystal
display (LCD) located on the top of the instrument shows the status of the instrument and displays the test results to the op erator.
The DPP Micro Reader is maintenance-free, not configurable by the user and is operated with a single button.
MATERIALS PROVIDED
Each kit contains:
1 DPP Micro Reader
3 Lithium-ion, type CR2032 (3 V/230 mAh), coin cell batteries (installed)
1 DPP Test Device Holder
1 USB Wall Power Adapter (5v / 1000 mA) with cable
1 Microfiber cloth
1 User Manual
WARNINGS AND PRECAUTIONS
•For In Vitro Diagnostic Use.
•DPP HIV-Syphilis System test results must be read using the DPP Micro Reader and cannot be visually interpreted.
•The DPP Micro Reader is calibrated and checked before shipping under strict quality control measures, to guarantee a high degree
of quality. Do not attempt to open, re-configure or re-cal ibrate the DPP Micro Reader.
•Protection provided by this instrument may be impaired if the equipment is used in a manner not consistent with the instructions
in this manual.
•To operate, the DPP Micro Reader requires three (3) CR2032 (3 V/230 mAh) batteries , or be powered through the USB power
cable using the port located above the battery compartment. The power cable must be connected to the supplied USB adapter
or a 5V USB power source like a powered USB hub.
•Do not use the DPP Micro Reader in direct sunlight or exposed to bright light while reading results.
•The DPP Micro Reader i s designed for use on a clean, fl at, horizontal surface.
•Always ensure that the DPP Micro Reader is positioned correctly in the DPP Test Device Holder. Incorrect positioning may lead to
incorrect results.
•The DPP Micro Reader can be operated at temperatures between 10 and 35°C (50 to 95°F) and between 20% and 85% humidity.
Ensure that the DPP Micro Reader is brought to operating temperature before use.
•Protect the DPP Micro Reader from liquids. Any liquid entering the Reader may damage itpermanently.
•Please follow the instructions in the product insert provided with the test kit regarding the disposal of DPP devices containing
hazardous or infectious material.
