Question 1

What is OxyPrem?

Accepted Answer

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

Question 2

What is a phantom validation?

Accepted Answer

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).

Question 3

How long can you use OxyPrem 1.4?

Accepted Answer

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

Question 4

How do I attach the OxyPrem sensor?

Accepted Answer

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.

Question 5

Do you have any OxyPrem NOAH info material that you can give to me?

Accepted Answer

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.

Question 6

Does OxyPrem's higher quality come from the hardware or from the software side?

Accepted Answer

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.

Question 7

How does OxyPrem 1.4 work?

Accepted Answer

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.

Question 8

How does OxyPrem NOAH work?

Accepted Answer

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.

Question 9

What is the difference between phantom validation and normal validation?

Accepted Answer

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.

Question 10

Do you have a Bluetooth version?
Why is there no Bluetooth version?

Accepted Answer

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.

Question 11

What happens after I reach the end of the sensor lifetime?

Accepted Answer

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.

Question 12

Can I extract raw data from OxyPrem 1.4?

Accepted Answer

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.

Question 13

Can I extract physiological data from OxyPrem NOAH?

Accepted Answer

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

Question 14

What happens when OxyPrem malfunctions?

Accepted Answer

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.

Question 15

Can I run the OxyPrem software off my own tablets/equipment?

Accepted Answer

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.

Question 16

Can I have a sample of the .csv data which is recorded with OxyPrem 1.4?

Accepted Answer

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

Question 17

How many wavelengths does OxyPrem 1.4 have?

Accepted Answer

OxyPrem 1.4 has 8 wavelengths.

Question 18

How many wavelengths does OxyPrem NOAH have?

Accepted Answer

OxyPrem NOAH has 13 wavelengths.

Question 19

How deep is the tissue sensitivity of OxyPrem 1.4?

Accepted Answer

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

Question 20

Is it a problem when the patient has a lot of hair / birthmarks / other skin irregularities?

Accepted Answer

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.

Question 21

Does skin colour matter?

Accepted Answer

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.

Question 22

Does OxyPrem use any laser technology? / Isn't it dangerous to operate a laser so close to the head?

Accepted Answer

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

Question 23

Which other applications are you looking at besides neonatology?

Accepted Answer

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.

Question 24

Can I have a free device for testing?

Accepted Answer

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.

Question 25

What is the normal oxygenation range? / What oxygenation range is the normal range in SafeBoosC-III?

Accepted Answer

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.

Question 26

Can you give me any references of people using OxyPrem already in clinical practice?

Accepted Answer

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

Question 27

Do I have to buy the device, or can I also rent it?

Accepted Answer

You can do both.

Question 28

Will I be able to connect OxyPrem NOAH to other connective device, e.g. Philips monitor?

Accepted Answer

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.

Question 29

How bad is it if the oxygen levels are not good for a short time?

Accepted Answer

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.

Question 30

I heard you are working on a new OxyPrem version. Will I be able to upgrade mine if I buy a current one now?

Accepted Answer

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

Question 31

Why do I need OxyPrem if I can use those easy-to-use fingerclips to know about oxygenation?

Accepted Answer

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.

Question 32

Can I get a demonstration on a live patient?

Accepted Answer

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.

Question 33

What device class does OxyPrem have under MDR?

Accepted Answer

IIa.

Question 34

How do you disinfect OxyPrem sensor equipment?

Accepted Answer

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

Question 35

Can I disinfect OxyPrem by immersing it in disinfectant?

Accepted Answer

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.

Question 36

Is OxyPrem chlorine disinfectable?

Accepted Answer

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

Question 37

Is the on-screen software available in other language?

Accepted Answer

Currently the OxyPrem software is only available in English language.

Question 38

I forgot to press an event marker. Can I do that later on?

Accepted Answer

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.

Question 39

Is looking into the LEDs / light sources / "lasers" dangerous?

Accepted Answer

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.

Question 40

What is your regulatory roadmap?

Accepted Answer

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.

Question 41

Why is it so relevant to monitor oxygen in the brain?

Accepted Answer

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.

Question 42

What is the sampling frequency is of OxyPrem 1.4?

Accepted Answer

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.

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