01/ Product video
Fenom PRO product video will be launched soon.
03 / FAQ
When is the device available?
The Fenom PRO™ system is currently available in Germany, Switzerland and the UK. Additional market launches are planned for 2018.
Does the device have a CE mark?
Yes, Spirosure received a CE Mark for its Fenom PRO™ point-of-care breath analyser in August 2016.
Does the device have FDA clearance?
No. Spirosure is planning to pursue FDA clearance for the Fenom PRO™ point-of-care breath analyser in the near future.
How soon after conducting a test will you get the FeNO result?
Results are ready in 28 seconds and automatically uploaded to Fenom CONNECT™.
Are the Fenom PRO™ results reproducible?
The reproducibility of Fenom PRO is summarized in the device specifications section of the Instructions for Use (IFU) – See Chapter 13, Technical Info:
- Precision for NO concentrations below 50ppb: 5ppb
- Precision for NO concentrations greater than 50ppb: 10% of the concentration
Please refer to the website Support section for a copy of the IFU.
Why do I need a FeNO device if I already measure FEV1?
Fractional Exhaled Nitric Oxide (FeNO) measurements are an objective measurement of airway inflammation substantiated by several respiratory societies including ATS, ERS and NICE. FEV1 (Forced Exhaled Volume in 1 second) is an assessment of the degree of airflow obstruction. FeNO and FEV1 are two distinct domains of asthma that provide different information to the clinician. By way of example, a patient could have low lung function yet airway inflammation is controlled and FeNO is low. This is typically seen in a chronic moderate or severe asthmatic where there is irreversible decreased lung function and yet airway inflammation is treated effectively by inhaled steroids. In contrast to this, a patient could have increased airway inflammation (elevated FeNO) but their lung function is normal. This is commonly seen in children. In summary, measuring both FEV1 and FeNO provides a more comprehensive assessment of a patient’s asthma.
How often do I need to change the sensor?
The sensor is not changed or exchanged in the way FeNO users may be accustomed to. Spirosure provides the device and the service to conduct FeNO measurements by using Fenom PRO and Fenom CONNECT. Any customer of Spirosure can expect regular visits from a Spirosure representative to ensure superior customer service. The connected aspect of the device will be used to ensure appropriate delivery of consumables and licensed tests so the customers do not experience any down-time.
Can results be stored on the device?
No, results are not stored on the Fenom PRO device. If a patient uses Fenom CONNECT, results are stored securely in our cloud server. The Fenom CONNECT web software can then be used by the physician to view each patient’s FeNO history and trend. A physician should also record results in their electronic or paper-based records system, for their own records.
How is data on the Fenom PRO™ device and Fenom CONNECT™ app being secured to ensure patient privacy?
The Fenom PRO™ device does not store patient data. Fenom CONNECT™ uses secure cloud storage with encryption at rest, daily security patches, and intrusion detection. It is hosted on Heroku Private Spaces, which is purpose-built for storage of sensitive information.
All data is protected by the Advanced Encryption Standard (AES) used by the U.S. Government and meets the General Data Protection Regulations (GDPR) for data protection and privacy within the EU.
Is it possible to connect to an EMR?
It is not currently possible to connect to an Electronic Medical Record (EMR) system.