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Directions for use
Introduction 7
CAUTION Within the patient environment, only connect the equipment
(the RetinaVue 100 Imager) to computers or laptops that have passed the
safety standard for information technology equipment IEC 60601-1, EN
60601-1, ANSI/AAMI ES 60601-1 to ensure the safety of the USB electrical
connection. Outside the patient environment, only connect the equipment
(the RetinaVue 100 Imager) to computers or laptops that have passed the
safety standard for information technology equipment IEC 60950-1, EN
60950-1, UL 60950-1 to ensure the safety of the USB electrical connection.
CAUTION Do not turn off the device while saving data from a patient test.
Turning off the device while saving patient data may delete the data.
CAUTION Do not use the device adjacent to or stacked with other
equipment. If the device is used adjacent or stacked with other equipment,
the device should be observed to verify normal operation in the
configuration in which it will be used.
CAUTION Do not submerge the device in liquid or allow liquid to enter the
interior of the device.
CAUTION Do not use automatic cleansing machines or sterilization.
CAUTION Consult the cleaning agent and germicidal cleaner agent
manufacturer instructions for their proper use and germicidal efficacy prior
to their use.
CAUTION Only use the cleaning or germicidal cleaner agent types listed or
damage may occur.
Note
The RetinaVue 100 Imager can be used on patients with eye implants and
intraocular lenses. While the RetinaVue 100 Imager can be used on
patients with cataracts and other eye opacities, the use of the RetinaVue
100 Imager may result in a lower quality image due to the increased
reflection of the flash off the patient's intraocular lens.
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