Vitalograph micro 6300 - Indications for Use; Contraindications Warnings Precautions and Adverse Reactions

ENG
4Page of 44 DT_0006 Issue 16
A Global Leader in Respiratory Solutions
1. Indications for Use
The device is a spirometer which measures patient respiratory
parameters including FVC, FEV1, FEV6, PEF, MVV and VC. The
Vitalograph micro is a handheld spirometer designed for lung
function testing for use on adults and paediatrics, 5 years and
older, in a variety of environments such as hospital wards,
health centres and private homes under the supervision of a
healthcare provider.
2. Contraindications, Warnings, Precautions and Adverse
Reactions
1. Nomodicationofthisequipmentisallowed.Any
unauthorised changes to the device may compromise product
safety and/or data and as such Vitalograph cannot be held
responsible and the device will no longer be supported.
2. The micro is not designed as a sterile device. Always follow the
safety guidelines given by the manufacturer of cleaning and
disinfectant chemicals.
3. Vitalograph intends that a new Bacterial Viral Filter (BVF™) be
used for every subject to prevent cross contamination. Using
anewBVFprovidesasignicantlevelofprotectionofthe
subject, the device, and the user against cross contamination
during spirometry manoeuvres. A BVF is for single use only.
4. Spirometry may support or exclude diagnosis, but it cannot
make one (ATS/ERS 2019
1
).
5. The device is marked as “Rx Only” and therefore may only be
sold in the USA by or on the order of a physician.
6. Whenusingtheremoteowheadensurethattheowhead
connecting tube is not pinched or trapped as spirometry results
may be affected, or a false reading may be detected.
7. The USB cable supplied with the device has the potential to be
a strangulation hazard and therefore should be kept out of the
reach of children and pets.
8. The device is rated to IP22 which protects it from solids
>12.5mm and dripping water however it is not designed
tobewaterproof.Donotgetthedevicewetoruseinitawet
environment (e.g., in the rain, in a shower). If the device does
1 ATS/ERS Standardisation of Spirometry Eur Respir J 2019