1.4.1 Identification label
The label shows:
Serial number of the device
Product name
Name and address of the manufacturer
Electrical safety symbol
Warning symbol for the WEEE Directive
Mark of conformity with the Medical Device Directive
1.4.2 Electrical safety symbol
In accordance with IEC 60601-1 this product and its component parts are of type BF and therefore protected against the hazards
of direct and indirect contact with electricity.
1.4.3 Warning symbol for the WEEE Directive
This symbol is laid down in the 2002/96/EEC regarding the waste of electrical and electronic equipment (WEEE). At the end of
its useful life this device must not be disposed of as normal domestic waste. Instead it must be delivered to a WEEE authorised
collection centre.
As an alternative, the device may be returned without charge to the dealer or distributor, when it is replaced by another equivalent
device.
Due to the construction materials used for the device, disposing it as a normal waste product could cause harm to the environment
and/or health.
Failure to observe these regulations can lead to prosecution.
1.4.4 Mark of conformity with the Medical Device Directive
0476
This product is certified to conform to the Class IIa requirements of the 93/42/EEC Medical Devices Directive.
1.5 Product description
Smart One® is a spirometer and pulse oximeter, and is connected to a Personal Computer using a USB cable.
The device measures a range of respiratory parameters, and the saturation of oxygen in the blood and the heart beat.
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