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2. Responsibility of the operator
The operator is responsible for ensuring that only trained users work with the Plusoptix
Vision Screener.
Training
Training must at least include reading the user manual and a briefing on the operation of the
device. The briefing on the operation of the device is provided by Plusoptix, by Plusoptix
authorised dealers, or can be carried out by a previously trained user.
Electrical safety and electromagnetic compatibility
The operator is responsible for ensuring that external equipment connected to the device
meets the standards IEC 60601-1 and IEC 60601-1-2 in respect to electrical safety and
electromagnetic compatibility together with the equipment.
Attention
:
The device may not be opened. Opening the device runs the risk of receiving an
(invisible) electric shock, and it will invalidate its approval as a medical device.
The operator is responsible for ensuring that the device is sent to Plusoptix or an
authorised Plusoptix dealer for service or warranty cases.
Attention (only S12C)
:
If you insert batteries other than the supplied rechargeable batteries, only use
rechargeable Nickel Metal Hydride NiMH/AA HR6 batteries with a capacity of
1,900 to 2,100 mAh and a quick-charge rate of at least 1 A. When inserting the
batteries, check for the correct polarity.
In accordance with Standard IEC 60601-1-2, we are required to provide the following
warnings:
Attention:
The use of accessories, transducers and cables that have not been approved or
provided by the manufacturer may result in increased electromagnetic emission
or reduced electromagnetic immunity of the device resulting in faulty operation.
Attention:
Avoid use of the device next to or in conjunction with other equipment, as this
could result in faulty operation. If such a use is required, the devices should be
monitored to ensure correct function.