FAQs
FAQs about Ruma Digital-System Pro are available in the login area at Professional Resoorces RD-S Pro.
General Questions About the Marker
What is the Ruma Marker?
The marker belongs to the group of low-molecular-weight polyethylene glycols (PEGs). The PEGs we use are not metabolised, meaning they pass through the body without undergoing a reaction and are completely excreted in the urine. The marker is neither a medical device nor a medicinal product. Further information on assessments by the EMA (European Medicines Agency) and FDA (Food and Drug Administration) can be found here.
What substances does the liquid marker contain?
The liquid marker consists of a combination of different low-molecular-weight polyethylene glycols in water.
What does the marker capsule contain?
The capsule contains a combination of monodisperse polyethylene glycols. The food colouring Brilliant Blue has also been added. The capsule shell consists of vegan hard gelatin.
What does the marker do in the body?
Polyethylene glycol markers are inert substances. This means they do not interact with the body and are excreted unchanged through the kidneys into the urine.
Which colouring agent does the capsule contain?
The colouring agent used is Brilliant Blue (E133), which is also commonly used as a food colouring.
How should the marker be stored?
The marker can be stored at room temperature. Refrigerated storage is also possible, although the polyethylene glycols will solidify at lower temperatures. Once removed from the refrigerator, they return to their liquid state after some time at room temperature.
How long must I wait after taking the marker capsule before collecting my urine specimen?
You must wait at least 60 minutes after taking the capsule.
Can I wait longer than 60 minutes before collecting my urine specimen?
Yes. This is not a problem, provided you collect the first urine passed after taking the marker.
Can I take the marker in the evening and collect my urine specimen the following morning?
Yes. The important thing is to collect the first urine passed after taking the marker. The marker remains in the bladder until you empty it.
Why do I have to chew the effervescent sweets?
Chewing the effervescent sweets stimulates saliva production, helping the capsule dissolve quickly in the mouth. This also helps reveal attempts to conceal the capsule in the mouth for later introduction into a clean urine specimen. If someone attempts to hide the capsule in their mouth, the tongue and oral cavity turn blue.
How should I store my urine specimen until I hand it over to my doctor or send it to the laboratory?
The urine specimen should be refrigerated or frozen until it is sent.
What should I do if I cannot urinate after 60 minutes?
You may collect the urine specimen later. The important thing is that the laboratory receives the first urine passed after taking the marker.
I went to the toilet after taking the marker but forgot to collect the urine. What should I do?
In this case, the marker intake procedure must be repeated.
I made a mistake while recording the video. What should I do?
Please contact your healthcare professional to discuss how to proceed.
Why am I not allowed to drink anything after taking the marker?
Drinking excessive amounts of fluid during the waiting period dilutes the urine and may reduce the marker concentration below the detection limit.
Why should I empty my bladder before taking the marker?
If your bladder is already full when you take the marker, the resulting dilution may reduce the marker concentration below the detection limit.
What happens if a patient stores their urine specimen incorrectly?
Incorrect storage may make the specimen unsuitable for analysis. Bacterial overgrowth or other processes may adversely affect the laboratory analysis. However, the marker itself remains unaffected.
Once the patient has collected the urine specimen, what prevents subsequent manipulation?
Attempts to manipulate the specimen are detected through laboratory testing. Marker analysis, creatinine and pH measurements, and specific tests for interfering substances (oxidant testing, sample checks and tests for synthetic urine) are used to reliably detect manipulation attempts.
The effects of interfering substances on urine analysis have been extensively investigated in scientific studies. These investigations included substances intended to produce false-negative results and substances intended to interfere with the analysis itself. The study found that only a small number of interfering substances significantly affect GC-MS results, and these are detected by the selected specimen validity tests.
Ruma Digital-System (Patient Application) – Hardware and Technology
What requirements must my smartphone meet to use the Ruma Digital-System app?
Your smartphone must have front and rear cameras with a minimum resolution of 720p. The operating system must be at least Android 5.0 or iOS 12. Please ensure that sufficient storage space is available for recording a video.
Do I need an internet connection to use the app?
Yes. The app requires a stable internet connection.
I cannot scan the QR code on the marker packaging. What should I do?
First, check that you are using the correct camera. Please use the rear camera to scan the QR codes on the marker packaging and container. Another possibility is that your smartphone camera does not meet the minimum requirements. Your smartphone must have front and rear cameras with a resolution of at least 720p and run Android 5.0 or iOS 12 or later. The QR code may also have been damaged after the marker was assigned by your healthcare professional. In either case, please contact your healthcare professional. They can assign a new marker or supervise marker intake directly at the healthcare facility.
What happens if I open the marker container beforehand?
The container has a tamper-evident security seal. If the seal is broken, it indicates that the container has already been opened. Using a container with a broken seal during the intake video may be considered an attempt at manipulation.
Can I record a video without an internet connection?
No. Recording the marker intake video with the app requires a stable and continuous internet connection. The app checks the connection before recording begins.
What should I do if my smartphone battery is running low?
Please ensure that your smartphone battery is charged to at least 25%. Otherwise, the marker intake video cannot be recorded.
The QR code scanning process is not working, and I cannot reach anyone at the healthcare facility. What can I do?
Please try again later. If the problem persists, contact your healthcare professional as soon as possible.
I have lost my smartphone, or it is no longer working. What should I do?
You can easily pair a new smartphone with your healthcare professional's tablet or phone.
What is blockchain technology?
The Ruma app uses modern blockchain technology for tamper-resistant documentation. When a data record (block) is created, it is encrypted and added to a chain of records (blockchain). Each new record contains information from the previous record, creating a data chain whose complete history can be traced back to its origin. Individual records cannot be manipulated without changing the entire chain. Such changes are detected by the software. In addition, all data is stored redundantly across multiple decentralised servers.
Ruma Digital-System (Patient Application) – Using the App
How do I pair my smartphone with my healthcare professional's tablet?
You can only pair your smartphone with your healthcare professional's tablet at the healthcare facility. After starting the app, select "Pair Healthcare Professional". Then scan the QR code displayed on your healthcare professional's tablet.
What is the purpose of the "Messages" button?
This function provides an overview of the messages your healthcare professional has sent you through the app.
What should I keep in mind when recording the video?
The video must be recorded at a clear table so that nothing obstructs the view of your actions. Your forearms must also remain uncovered. Please follow the instructions in the user manual or instructional video. Both are available in the app.
How will I know whether my marker intake was assessed as correct?
Only your treating healthcare professional can inform you whether your video was accepted as valid.
When is marker intake classified as an unsuccessful attempt?
Your video is classified as an unsuccessful attempt if an unintentional error occurs during capsule intake or if the procedure cannot be completed correctly for reasons beyond your control.
When is marker intake classified as "manipulated"?
Your healthcare professional carefully assesses your actions during the video-documented marker intake. Any deviation from the prescribed procedure that conceals your actions may be considered an attempt at manipulation.
I have changed healthcare professionals. How can my new healthcare professional view my intake videos? Will they have access to previous videos?
You can easily pair your smartphone with your new healthcare professional's tablet. The connection to your previous healthcare professional is automatically removed. Your new healthcare professional can view newly recorded videos as usual but will not have access to previous videos.
Ruma Digital-System (Patient Application) – Data Protection
Are the marker intake videos stored on my smartphone?
The videos are stored temporarily on your smartphone for approximately 3–4 seconds while encryption takes place.
Who can view my videos?
Only your treating healthcare professional has access to your videos. Neither Ruma nor the laboratory or your healthcare professional's staff can access them.
What happens to my data, and where is it stored?
Only your treating healthcare professional has access to your videos. Neither Ruma nor the laboratory or your healthcare professional's staff can access them.
When is my data deleted?
The data is not deleted. It remains securely encrypted in the blockchain.
Can I watch my video again?
No. The video is encrypted immediately after recording and deleted from your smartphone after transmission.
Can my healthcare professional forward my video to other healthcare professionals?
No.
Can I delete the video after recording it?
No.
Can my healthcare professional delete videos I have recorded?
No.
How is my data encrypted, and how secure is the encryption?
Patient data is encrypted using the Advanced Encryption Standard (AES-256), while videos are encrypted using AES-128.
