Fig 1.
The inflation of the system and the two tests, i.e., water leak tests and pressure drop tests, carried out in two conditions, i.e., open air and simulated working conditions.
Fig 2.
The setup of the open-air experiments: The condom filled with water and the flow-stopper that prevents the water from flowing back through the tube.
Fig 3.
The two positions of the uterus model during the water leak and pressure test.
Fig 4.
The proposed mechanism of the intrauterine balloon tamponade in treating postpartum haemorrhage.
When the water reservoir is emptied into the condom balloon, the balloon becomes inflated, applying pressure inside the uterus.
Fig 5.
The prototype system, with CAD images of parts for 3D printing: A-D valves of different design: A, rounded snap-fit valve, B, square snap-fit valve, C, fine threaded valve, D, coarse-threaded valve; E, modified bottle cap with plug and v seals, compatible with common soda bottles; F, flow stopper, a variety of globe valve preventing flow back of water down the tube.
Fig 6.
The modified bottle cap with the plug and v seals.
Fig 7.
The flow stopper, a variety of globe valve.
Fig 8.
The uterus model.
Fig 9.
The hourly water leakage for the 4 different types of valves.
Fig 10.
Bland-Altman plot showing the 95% limits of agreement (red lines) with the 95% confidence interval (red region) and the bias (blue) with its 95% confidence interval (blue region).
Table 1.
Risk assessment for our device.
PO stands for probability of occurrence, S stands for severity, and CN stands for critical number. †denotes hypothesized usability risk, as no usability study was performed. *denotes hypothesized clinical risks, as no clinical trial was performed (or if so, results were not published).
Table 2.
Risk assessment for Bakri balloon.
PO stands for probability of occurrence, S stands for severity, and CN stands for critical number.
Table 3.
Risk assessment for condom-based tamponade.
PO stands for probability of occurrence, S stands for severity, and CN stands for critical number.
Table 4.
Risk assessment for BAMBI device.
PO stands for probability of occurrence, S stands for severity, and CN stands for critical number. *denotes hypothesized clinical risks, as no clinical trial was performed (or if so, results were not published). ⌃denotes that there is not a clear costing of the device mentioned in the relevant publications. Supposedly the cost should be comparable to that of the condom-based tamponade, and less than 5 euro per kit.