26
Other:
•
.Net Framework 4.6.1
•
USB Port
•
Bluetooth Support
•
PDF Viewer
Notes:
•
All values displayed are expressed as BTPS values.
•
Take care not to block the mouthpiece with tongue or teeth. A
‘spitting’
action or coughing will give false readings.
•
Time zero is determined using the back-extrapolated method, from the
steepest part of the curve. The operating conditions specified apply to the
device plus accessories.
•
The device, flowhead and SpiroSafe filter are classified as type BF applied
parts.
•
An applied part is a part of the equipment, that in normal use necessarily
comes into physical contact with the subject for equipment or system to
perform its function.
14. CE Notice
Marking by the symbol
indicates compliance of the Model MD6300
Micro Spirometer to the Medical Devices Directive of the European
Community.
The Model MD6300 Micro Spirometer is intended for use in a variety of
healthcare environments, e.g., primary care, hospital wards and private
homes, except for near active high frequency surgical equipment and the
RF shielded room of an ME system for magnetic resonance imaging,
where the intensity of electromagnetic disturbance is high. The customer
or the user of the Micro Spirometer should assure that it is not used in
such an environment.
The Model MD6300 Micro Spirometer has been tested in accordance
with:
EN 60601-1:2006 + A1:2013 Medical electrical equipment. General
requirements for basic safety and essential performance.
EN 60601-1-2:2015 + A1:2021 Medical electrical equipment - Part 1-2:
General requirements for basic safety and essential performance
–
Collateral Standard: Electromagnetic disturbances
– Requirements and
tests.
