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Servicing and calibration
The unit has been calibrated by the manufacturer for a period of two years’ use.
In
the case of commercial use
, the unit must be serviced and recalibrated at least
once every two years. This calibration will be charged for and can be carried out by
an appropriate authority or an authorised service centre - in accordance with the
regulations for users of medical equipment.
6.2. Disposal
This product must not be disposed of together with domestic waste.
All users are obliged to hand in all electrical or electronic devices, regardless of
whether or not they contain toxic substances, at a municipal or commercial collection
point so that they can be disposed of in an environmentally acceptable manner.
Please remove the batteries before disposing of the device / unit. Do not dispose of old
batteries with your household waste, but at a battery collection station at a recycling
site or in a shop.
Consult your municipal authority or your dealer for information about disposal.
6.3. Guidelines / Standards
Device standard: Device corresponds to the requirements of the standard for non-
invasive blood pressure monitors:
AAMI/ ANSI/ IEC 80601-2-30
IEC 60601-1
IEC 60601-1-2
- Bluetooth system to V3.0
- FCC Part 15C
Electromagnetic compatibility: Device fulfills the stipulations of the International
standard IEC 60601-1-2
Clinical trial results:
Clinical trials for this unit were carried out in the USA according to ANSI/AAMI
standard.
The B.H.S. (British Hypertension Society) clinical protocol was used to measure the
accuracy of this product. Blood pressure units using the same measurement technology
are graded "AA" for systolic/diastolic accuracy by independent investigators using the
BHS protocol (Use the same algorithm as B.H.S. grade"AA" model number 3BT0-1).
This is the highest grading available for blood pressure monitors. Please see bhsoc.org
for more information.
Electromagnetic compatibility:
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