Frequently Asked Questions
Frequently asked questions
A laboratory setting in which a patient is simulated by a reproducible experimental procedure. A so-called tissue haemoglobin phantom is a mix of several ingredients (such as blood, saline, intralipid) in a container and looks like human tissue to the sensors. In this material, you can control the oxygenation and blood content, and you can cover a much wider range than in-vivo. With this procedure, you can compare different devices to each other across the full range of oxygen levels, and especially also in the dangerous oxygen levels which is not possible using in-vivo validation. The phantom method has also been established in the new ISO standard on cerebral oximetry (ISO 80601-2-85:2021).
In normal validation, the procedure is done in healthy adults, which are not at all representative of patient groups like newborn children. Also, it is unethical to expose them to dangerous oxygen levels, so the really relevant oxygen range cannot be tested. Using the phantom method, you can create a measurement environment that is representative of the conditions in a newborn baby, and also you can validate the device's behaviour at dangerous oxygen levels.
If you are on the 24- or 48-month subscription model and your subscription is still active, we will send you a fresh sensor. If you have purchased OxyPrem equipment and have expired sensors, we will provide the first fresh sensor free of charge if you have purchased 2 or more of them. If you have purchased 6 or more, we will also provide the second needed fresh sensor free of charge. All other sensors need to be purchased normally.
There are several other promising fields with important markets where NIRS brings clinical benefit, such as angiology or cardiac surgery. We are in contact with professionals from those areas to evaluate the potentials and the resources required to tap into those fields. We are focusing on the areas with high medical need and large markets.
We provide free trial sessions via videocall or in your NICU. If you want to have a device in your hospital, we offer a 6-month Trial program at a very attractive price. You can use this program to evaluate OxyPrem for your clinical application with very limited risk and at your own pace. We are happy to make suggestions how you could test the device.
There is no such thing as a "normal" oxygenation range, but the SafeBoosC consortium currently sees a tissue saturation of 47% as the lower acceptable value in preterms. They do not impose an upper limit, but research and experiences from Japanese clinical care in the past have shown that too much oxygenation in the brain leads to blindness.
The fingerclips are pulse oximeters, which measure a different kind of oxygenation. They just measure how well the lungs and the circulatory system work together, but they do not measure if the oxygen levels are OK in a specific location of the body, for example in the brain. To give you an example: A fingerclip oximeter would be a device in your basement which tells you that your heating is successfully making warm water for the heating system. A tissue oximeter (such as OxyPrem) would be upstairs in your bedroom and tell you if the room is warm enough. If a pipe is broken on the way between the basement and the bedroom, the device in the basement would not know, whereas the one in the bedroom knows. This is how OxyPrem watches over, for example, the brain.
The brain is the most sensitive organ in the human body when it comes to oxygen supply, and undersupply can have severe consequences such as death and life-long disabilities. Since brain oxygenation is not visible from the outside, clinicians need equipment which measures this oxygenation and provides them with this information for their clinical decisions. The standard monitors (ECG, EEG, and pulse oximetry) cannot provide that information.