Vitalograph Spirotrac Instructions for Use
IFU Part No.: 07402
Issue 22
_______________________________________________________________________________________________________________
Page 70 of 78 DT_0006-15
EN ISO 13485, FDA 21 CFR 820, CMDR
Minimum PC System Requirements
Processor Speed: 2GHz or greater
RAM: 2GB (Min), 4GB (Recommended)
Disk Space: If the .NET version 4.5.1
framework is not already installed this will
require an additional 2 Gigabyte of hard
disk space. If SQL Server Express is not
already installed this will require an
additional 1 Gigabyte of hard disk space
Operating System: Windows 7, Windows 8,
Windows 8.1, Windows 10
Monitor: 1280 x 800 pixel
Other:
• .Net framework 4.5.1
• USB Port for Pneumotrac or other
compatible devices
• Bluetooth Support for BT-12 ECG
13 Contraindications, Warnings, Precautions and Adverse Reactions
1. No modification of this equipment is allowed. Any unauthorised changes to the
Vitalograph 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. For the device to be used as intended, there is no requirement to clean the
supporting computer. If cleaning is required to remove any visible soiling, this
should be done as per the computer manufacturer’s instructions.
3. Vitalograph intends that a new Bacterial Viral Filter (BVF
TM
) be used for every
subject to prevent cross contamination. Using a new BVF provides a significant
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 is a valuable tool that provides important information to clinicians
which is used together with other physical findings, symptoms, and history to
reach a diagnosis (ATS/ERS 2019).
5. When using any compatible Vitalograph device ensure that the flowhead
connecting tube is not pinched or trapped as spirometry results may appear to
be inverted.
6. Take care not to block the mouthpiece with tongue or teeth during testing. A
'spitting' action or cough will give false readings.
To Next Page
Loading...
Need help?
General
