PlenOptika QuickSee - Screening Environment

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7P/N 2018 - 10 B Rev A 6 – Release

PlenOptika QuickSee

Screening Environment

The QuickSee can be used indoors or outdoors. Be sure to eliminate or block any

sources of sunlight and/or incandescent light from reﬂecting directly into the sub-

ject’s ﬁeld of view.

NOTE: A minimum pupil size of 2 mm is required for screening to occur and may

be difﬁcult to achieve in a room or environment with a bright light source. For best

results, subject’s pupils should be 2 mm or greater.

The device is designed to work in the following environmental conditions:

• Ambient temperature range: -10ºC to +40 ºC. (with battery charging, 0 to 50 ºC)

• Relative humidity range: 30-90%

• Atmospheric pressure: 800 to 1060 hpa

5. The device, if used as speciﬁed, shall not require any special maintenance func-

tions to ensure basic safety with regard to electromagnetic disturbances during

its lifetime. However, if the user suspects any damage in the device that may

result in EMI problems, contact Plenoptika Support.

6. The device contains a rechargeable Lithium Ion Polymer Battery cell (IEC62133:

2012 certiﬁed, Ratings: 3.7 V, 8000 mAh, 29.6 Wh). Replacement or substi-

tution of this battery may only be performed by PlenOptika service engi-

neers. If you experience an issue with the battery contact please PlenOptika

Support.

NOTE: If the device is used continuously in environmental conditions in which

the temperature is 40 ºC or higher, some parts of the device may surpass 41

ºC. During such situations, the expected maximum temperature of the follow-

ing parts (as determined by IEC 60601-1 testing) are:

• Thumb wheel: Maximum expected temperature < 48 ºC

• Grips: Maximum expected temperature < 52 ºC

• Eyecup: Maximum expected temperature < 55 ºC

Under these conditions, the device does not represent a safety risk for the

patient, operator, or environment. However, it is recommended to reduce the

temperature of the device in order to avoid an unpleasant experience for the

patient. To accomplish this we recommend:

• Turning off the device until the temperature of these parts is reduced.

• Avoiding exposure to a heat source (i.e. sunlight) to reduce the temperature

of the aforementioned parts.

NOTE: The measurement time is 10 to 25 seconds (According to IEC 60601-1

the exposure limit is 60 ºC for 60 seconds or less).