Instructions for Use: GEV019-100
Page 57
10.3
Ventilator Accuracy Testing
Components Used:
The following components (diagram and table below) and circuitry were utilised for conducting Ventilator Accuracy and
Performance Testing as per ISO 80601-2-12
Medical electrical equipment
–
Part 2-12:
Particular requirements for basic safety and
essential performance of critical care ventilators.
The Citrex H4 flow sensor was within its calibration period (before first use). A
“Zero Offset” calibration
was conducted on each test and an Oxygen Calibration completed before use. The sensor was also used
for data logging.
Item
Item
Description
1
Inspiration Hose
22 mm corrugated tubing equivalent to tubing supplied by Fairmont Medical Solutions Pty Ltd (refer to
Section 11)
2
Y-Piece
22 mm corrugated tubing equivalent to tubing supplied by Fairmont Medical Solutions Pty Ltd (refer to
Section 11)
3
Heat and Moisture Exchange Filter
Standard HME Filter equivalent to that supplied by Fairmont Medical Solutions Pty Ltd (refer to
Section 11)
4
Expiration Hose
22 mm corrugated tubing equivalent to tubing supplied by Fairmont Medical Solutions Pty Ltd (refer to
Section 11)
5
Bacterial Filter
Standard Bacterial Filter equivalent to that supplied by Fairmont Medical Solutions Pty Ltd (refer to
Section 11)
6, 7
Pneumotachograph and Tubing
22 mm with 8 mm orifice with 3/16-inch tubing for differential pressure
8
GeVentor Expiration Valve
GeVentor Expiration Valve; 3D printed by 3DMEDiTech for Gekko Medical Pty Ltd
