MacuLogix AdaptDx Pro M-1 - Table of Contents; Introduction; Intended Use; Limitations of Use

2 3
1. Introduction 3
2. Intended Use 3
3. Limitations of Use 3
4. Authorized European Representative 3
5. Essential Performance 3
6. Device Components and Operation 4
7. Cleaning 18
8. Troubleshooting 19
9. Customer Support 19
10. Repair 20
11. Disposal 22
12. Specications 22
13. Electrical Safety and EMC 24
14. Symbol ID 34
1. Introduction
Dark adaptation is the process of the eyes adjusting to low levels of illumination. During dark adaptation,
the sensitivity of the eye to light is increased. The two major components of dark adaptation are dilation
of the pupil and photochemical alterations of the retina.
The AdaptDx Pro™ device includes a headset that is worn over the eyes and a controller that is held
in the patient’s hand during a dark adaptation test. The patient dons the headset to create a complete
light seal and then is exposed to a bright ash followed by a dim adaptation stimulus. The intensity of the
adaptation stimulus is gradually extinguished. The just-detectable stimulus intensity and the time at which
it is detected are periodically recorded to generate a dark adaptation threshold curve. The speed of dark
adaption recovery is characterized by a proprietary parameter called the Rod Intercept,™ (RI™) which is
displayed as the result of the dark adaptation test.
2. Intended Use
The AdaptDx Pro is a battery-powered, head-mounted automated dark adaptometer intended
to evaluate the time for retinal adaptation after exposure to an adapting light. It is intended for use
as a diagnostic device to aid in the detection, monitoring, and management of age-related macular
degeneration (AMD) and for measurement of dark adaptation speed.
3. Limitations of Use
The AdaptDx Pro is not suitable for use with patients who are unable to follow simple instructions,
operate a response button, or maintain attention for the anticipated duration of the test. The AdaptDx
Pro is not suitable for use with patients who are unable to perform the Test Tutorial (See Section 6).
4. European Authorized Representative
Medspace Medical Devices BV +31 43 306 3320
Il Fiore Building B, 3rd Floor +31 43 306 3338
Avenue Ceramique 227
6221 KX Maastrich
The Netherlands
5. Essential Performance
When the AdaptDx Pro headset is properly connected to the handheld controller with the supplied
connection cable, the AdaptDx Pro has no features that would be deemed an unacceptable risk if it
malfunctions. Therefore, there is no essential performance associated with the AdaptDx Pro.
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