Frequently
asked
questions
Find key information about neonatal jaundice, Picterus® Jaundice Pro and Picterus® Calibration Card.
Neonatal jaundice, or hyperbilirubinemia, occurs when a newborn’s blood contains high levels of bilirubin, a yellow substance produced from the breakdown of haemoglobin in red blood cells.
Adults generate about 2.4 million red blood cells every second, producing a substantial amount of bilirubin. The liver processes and removes this bilirubin from the body. In adults, some bilirubin in the blood is normal and not harmful due to lower levels and a fully developed blood-brain barrier preventing bilirubin from entering the brain.
In newborns, however, the situation is completely different. In the womb, fetuses use a special kind of haemoglobin (fetal haemoglobin) to extract oxygen from the mother’s blood efficiently. This fetal haemoglobin becomes unnecessary after birth when the baby starts breathing independently. Consequently, the baby’s body rapidly breaks down red blood cells to replace fetal haemoglobin with adult haemoglobin, increasing bilirubin production. However, since the liver is not fully developed in some newborns, their ability to process bilirubin is limited. The blood-brain barrier might also be underdeveloped, allowing bilirubin to enter the brain, which can be harmful.
While neonatal jaundice is a common and usually temporary condition in newborns, affecting 60 to 80% of them (84 to 112 million cases annually worldwide), it typically appears within 48 to 72 hours after birth and resolves within 3 to 7 days. However, about one in ten newborns affected by jaundice may develop significant jaundice, necessitating close monitoring and treatment. Failure to detect and manage high bilirubin levels can lead to brain damage or even death, as excessive bilirubin might cross the underdeveloped blood-brain barrier.
Picterus® Jaundice Pro is a jaundice screening device approved for clinical use by healthcare professionals and caregivers of newborns (e.g. parents)
Picterus® Jaundice Pro can only be used on newborns who:
- Are born with gestational age between 37-42 weeks.
- Have a birth weight between 2500-4500 gr.
- Are between 1-14 days old.
- Have parents with skin colour, according to Fitzpatrick, scale 1 to 4 in Figure 1. The six Fitzpatrick skin types and associated hair and eye colour are classified from very light (1) to very dark skin (6), as shown below. The Picterus® Jaundice Pro app is only valid for skin types 1 to 4.
Figure 1 Fitzpatrick skin type scale
Picterus® Jaundice Pro app must not be used on newborns who:
- Have pathological jaundice.
- Are highly likely to develop pathological jaundice because of incompatible blood type or haemolytic jaundice.
- Have other medical conditions that require medical treatment.
- Have received phototherapy.
- Have had the chest region exposed to sunlight over the last 24 hours. Sunlight changes the relationship between the amount of bilirubin in the blood and the skin and can thus make the measurements less accurate.
Yes, pictures must only be taken on the infant’s chest, as shown in the instructions for use. The skin must be clean, undamaged, and dry. The skin must not have been lubricated with moisturizing cream, oil, etc. The skin must not be affected by any skin condition or disease other than jaundice.
Please seek medical advice. Values given from this equipment should not be used for diagnosis. It does not replace the need for follow-up of healthcare professionals. Healthcare professionals shall perform actions according to national guidelines for follow-up and treatment of neonatal jaundice. Moreover, do not rely solely on the results and always consider the baby’s overall condition.
Download Picterus® Jaundice Pro from Google Play or App Store on your mobile phone. Follow the instructions as stated in Google Play and App Store.
Picterus® Jaundice Pro is compatible with all phones that have not previously reported any problems. If you attempt to use the app on a phone with known issues identified by Picterus AS, an error will be reported.
For an updated list of compatible devices and known issues, click here.
For the best results, please refer to section 4.2 in the instructions for use and consider the following practical tips:
- The measurements are easier to perform when the baby is calm, for example, by using the app after feeding.
- Babies often move with their arms. Ask someone to gently hold their hands.
- Take the photos in good light conditions and avoid shadows.
- Place the Picterus® Calibration Card on a flat part of the baby’s chest, avoiding shadows.
Failure messages are often shown due to the rejection of a measurement. This is a safety measure to avoid inaccurate measurements. Rejection of a measurement can happen due to low image quality, e.g., too little light. If you get a failure message, try again by turning on an extra light or measuring the newborn in a different place. Make sure your camera lens is clean. Moreover, shadows should be avoided when doing the measurement. You can also try some of the suggestions stated in question 9.
As stated in the instructions for use, the camera should be positioned to point towards the chest, ensuring that the flash is not directed at the newborn’s eyes. This approach has been shown to be safe. Additionally, no undesirable side effects have been reported in the relevant literature or found in the clinical studies of the Picterus® Jaundice Pro, which involves using a smartphone to capture images of the newborn’s skin.
Picterus AS does not collect or process personal or sensitive personal information other than your email adress which is needel for logging in. For further details, please read the Picterus AS privacy policy.
The image below is an example of what Picterus AS receives from measurements. The background of the image is blacked out, only the Picterus® Calibration Card and the imaging window are retained to make the measurement. As shown in the sample below, the app only processes anonymous calibration data for functionality. Personal photos are not retained
For further details, please read the Picterus AS privacy policy.
One Picterus® Calibration Card can be used for multiple screenings on a single newborn and needs to be disposed of after use.
The sticker on the back of the Picterus® Calibration Card is intended and approved for use on the skin. Please note that the sticker is only present on an old version of the card which is no longer in use. From the 12th of June 2024, Picterus ® Calibration Cards do not come with a sticker on the back anymore.
To acquire Picterus® Calibration Cards, please talk to your healthcare professional.
For general questions, please contact Picterus AS at contact@picterus.com
Neonatal jaundice, or hyperbilirubinemia, occurs when a newborn’s blood contains high levels of bilirubin, a yellow substance produced from the breakdown of haemoglobin in red blood cells.
Adults generate about 2.4 million red blood cells every second, producing a substantial amount of bilirubin. The liver processes and removes this bilirubin from the body. In adults, some bilirubin in the blood is normal and not harmful due to lower levels and a fully developed blood-brain barrier preventing bilirubin from entering the brain.
In newborns, however, the situation is completely different. In the womb, fetuses use a special kind of haemoglobin (fetal haemoglobin) to extract oxygen from the mother’s blood efficiently. This fetal haemoglobin becomes unnecessary after birth when the baby starts breathing independently. Consequently, the baby’s body rapidly breaks down red blood cells to replace fetal haemoglobin with adult haemoglobin, increasing bilirubin production. However, since the liver is not fully developed in some newborns, their ability to process bilirubin is limited. The blood-brain barrier might also be underdeveloped, allowing bilirubin to enter the brain, which can be harmful.
While neonatal jaundice is a common and usually temporary condition in newborns, affecting 60 to 80% of them (84 to 112 million cases annually worldwide), it typically appears within 48 to 72 hours after birth and resolves within 3 to 7 days. However, about one in ten newborns affected by jaundice may develop significant jaundice, necessitating close monitoring and treatment. Failure to detect and manage high bilirubin levels can lead to brain damage or even death, as excessive bilirubin might cross the underdeveloped blood-brain barrier.
Picterus® Jaundice Pro is a jaundice screening device approved for clinical use by healthcare professionals and caregivers of newborns (e.g. parents)
Picterus® Jaundice Pro can only be used on newborns who:
- Are born with gestational age between 37-42 weeks.
- Have a birth weight between 2500-4500 gr.
- Are between 1-14 days old.
- Have parents with skin colour, according to Fitzpatrick, scale 1 to 4 in Figure 1. The six Fitzpatrick skin types and associated hair and eye colour are classified from very light (1) to very dark skin (6), as shown below. The Picterus® Jaundice Pro app is only valid for skin types 1 to 4.
Figure 1 Fitzpatrick skin type scale
Picterus® Jaundice Pro app must not be used on newborns who:
- Have pathological jaundice.
- Are highly likely to develop pathological jaundice because of incompatible blood type or haemolytic jaundice.
- Have other medical conditions that require medical treatment.
- Have received phototherapy.
- Have had the chest region exposed to sunlight over the last 24 hours. Sunlight changes the relationship between the amount of bilirubin in the blood and the skin and can thus make the measurements less accurate.
Yes, pictures must only be taken on the infant’s chest, as shown in the instructions for use. The skin must be clean, undamaged, and dry. Skin must not have been lubricated with moisturising cream, oil, etc. The skin must not be affected by any skin condition or disease other than jaundice.
Please seek medical advice. Values given from this equipment should not be used for diagnosis. It does not replace the need for follow-up of healthcare professionals. Healthcare professionals shall perform actions according to national guidelines for follow-up and treatment of neonatal jaundice. Moreover, do not rely solely on the results and always consider the baby’s overall condition.
Download Picterus® Jaundice Pro from Google Play or App Store on your mobile phone. Follow the instructions as stated in Google Play and App Store.
Picterus® Jaundice Pro is compatible with all phones that have not previously reported any problems. If you attempt to use the app on a phone with known issues identified by Picterus AS, an error will be reported.
For an updated list of compatible devices and known issues, click here.
For the best results, please refer to section 4.2 in the instructions for use and consider the following practical tips:
- The measurements are easier to perform when the baby is calm, for example, by using the app after feeding.
- Babies often move with their arms. Ask someone to gently hold their hands.
- Take the photos in good light conditions and avoid shadows.
- Place the Picterus® Calibration Card on a flat part of the baby’s chest, avoiding shadows.
Failure messages are often shown due to the rejection of a measurement. This is a safety measure to avoid inaccurate measurements. Rejection of a measurement can happen due to low image quality, e.g., too little light. If you get a failure message, try again by turning on an extra light or measuring the newborn in a different place. Make sure your camera lens is clean. Moreover, shadows should be avoided when doing the measurement. You can also try some of the suggestions stated in question 9.
As stated in the instructions for use, the camera should be positioned to point towards the chest, ensuring that the flash is not directed at the newborn’s eyes. This approach has been shown to be safe. Additionally, no undesirable side effects have been reported in the relevant literature or found in the clinical studies of the Picterus® Jaundice Pro, which involves using a smartphone to capture images of the newborn’s skin.
Picterus AS does not collect or process personal or sensitive personal information other than your email adress which is needel for logging in. For further details, please read the Picterus AS privacy policy.
As shown in the sample below, the app only processes anonymous calibration data for functionality. Personal photos are not retained.
For further details, please read the Picterus AS privacy policy.
One Picterus® Calibration Card can be used for multiple screenings on a single newborn and needs to be disposed of after use.
The sticker on the back of the Picterus® Calibration Card is intended and approved for use on the skin. Please note that the sticker is only present on an old version of the card which is no longer in use. From the 12th of June 2024, Picterus ® Calibration Cards do not come with a sticker on the back anymore.
To acquire Picterus® Calibration Cards, please talk to your healthcare professional.
For general questions, please contact Picterus AS at contact@picterus.com
