Frequently Asked Questions

OxyPrem 1.4 and OxyPrem NOAH are non-invasive sensors used to measure brain oxygen in newborn children.

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).

OxyPrem 1.4 can be used for 100 patients or 2 years, whichever is reached first.

The two most common ways are to attach the OxyPrem sensor underneath a CPAP hat or by wrapping a self-adhesive bandage around it. The bandage also works well for body parts other than the head.

At this point, we have an Info Sheet as well as a Pricing Information Sheet which we can leave with you. Once more material becomes available after approval/registration of the device, we will let you know.

Actually both: The reusable profile allows us to use more and much higher-quality hardware components than disposables, and we have very advanced algorithms in our software.

OxyPrem 1.4 is a non-invasive tissue oximeter using NIRS. Its sensor is equipped with 8 different wavelengths at two light source locations and has 4 light detectors. OxyPrem 1.4 is most sensitive to tissue in the range of 0.5 to 1.5cm.

OxyPrem NOAH is a non-invasive tissue oximeter using NIRS. Its sensor is equipped with 13 different wavelengths at 3 light source locations and has 6 light detectors.

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.

We have worked to create a Bluetooth version in the past, but found that the interferences in an intensive care environment were too strong to create a reliable signal. Additionally, it is a problem to put a battery close to the patient and would need frequent replacement for continuous monitoring.

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.

You can retrieve all your measurement data in a 1-second resolution from our secure online webspace. Currently, there is no direct connection (RS232 etc.) to extract data during operation of OxyPrem.

Yes, you will be able to extract measurement data to a USB stick.

Please contact our support either via e-mail to support@oxyprem.com or telephone to your local hotline. We will decide together on the best course of action.

Since OxyPrem is a medical device, you can only use it with the Monitor provided with the system. However, OxyPrem NOAH will have Philips patient monitor connectivity, and interfaces to other patient monitors are planned.

Of course. We will gladly send a sample of it to you via email if you like.

OxyPrem 1.4 has 8 wavelengths.

OxyPrem NOAH has 13 wavelengths.

OxyPrem 1.4 is most sensitive in tissue depth of 0.5 to 1.5cm while being insensitive to superficial layers.

Hair, birthmarks and skin irregularities or other macroscopical inhomogeneities may affect the readings. OxyPrem 1.4's algorithm and sensor reduce the effect of some of these challenges, nevertheless they should be avoided.

The superficial tissue layers are not considered for OxyPrem's readings. Melanin in the skin is located very close to the surface, therefore skin colour does not affect the measurement.

OxyPrem uses regular, low-powered LEDs. Almost no heat is created, and you could look into the LEDs the whole day without any damage.

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.

Of course. Please contact our service team to put you in touch with them. Just write a quick request to support@oxyprem.com.

You can do both.

You will be able to extract the measurement data of OxyPrem NOAH to a USB stick for use in whichever way you like. Additionally, there will be a connection to Philips patient monitors, and more connections to other monitors will follow.

A change in trend over time or more acute reactions to haemodynamic or clinical interventions are the most important considerations overall when evaluating NIRS. A reduction in cerebral hypoxic events leading to brain injury and other complications is aided by maintaining these normal StO2 ranges.

If you buy OxyPrem 1.4 equipment now, we will upgrade you to OxyPrem NOAH systems when they become available, at no cost.

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.

We will be sure to inform you in due time when we are close to your area, and we are happy to arrange a meeting. In the meantime, please check our homepage to see which symposia / conferences we will be attending. Please reach out to ensure we can reserve enough time for you.

IIa.

The OxyPrem 1.4 Sensor can be disinfected using regular alcoholic wipes.

The current OxyPrem 1.4 sensors are only designed for wiping disinfection, which most users require. We are however always collecting suggestions (so thank you if you are suggesting this) and if it turns out that many users would like immersion disinfection, we will consider implementation.

Chlorine affects the soft silicone surface of the OxyPrem sensor, therefore disinfection is limited to alcoholic disinfectants at the moment.

Currently the OxyPrem software is only available in English language.

Please let us know when this happens; we will be able to add your missing data point in the secure data portal according to your description.

Not at all. First, they are no lasers but regular LEDs, and their intensity is so low that you could look into them the whole day without any damage.

OxyPrem 1.4 has the CE mark according to the MDD framework, annex IV. OxyPrem NOAH will receive CE marking under the new MDR framework, with an FDA 510(k) submission to follow. Local registrations (e.g. CFDA, MDSAP) will be pursued as appropriate.

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.

The display shows an updated value each second but this value is actually computed from rolling data of the last 5 seconds. The system's internal sampling rate is approximately 42 Hz.

We are a medical device manufacturer from Zurich that specializes in near-infrared technology. Our current product OxyPrem 1.4 and our upcoming product OxyPrem NOAH are non-invasive sensors used to measure brain oxygen in newborn children.

We have office and lab space in a business center close to Zurich, as well as registered offices at the Neonatology department of the University Hospital Zurich.

"Oxy" is for "oxygen", "Prem" is for "premature" as in premature babies. (Fun fact: in Hindi, "prem" means "love"!)

The brain is highly sensitive to oxygen undersupply, and in vulnerable patients such as preterm babies, oxygen levels have to be monitored using suitable equipment. However, the equipment which is available is often not reliable and precise enough for preterm children. These devices may cause clinical decisions to be based on wrong information, which bears a high risk of life-long damage or even death for the patient. OxyPrem offers new-generation, high-quality devices which solve this problem.