We offer our “Detalo Performance” blood volume analyser that we clarify is not a medical device. The device does not serve a medical purpose and does not diagnose, treat or monitor illnesses or disease. The intended use of this product is to monitor cardiovascular performance and evaluate effect of training and other interventions in athletes.
We aim to offer a FDA approved and CE marked medical device “Detalo Clinical” in the near future.
The assessment of blood volumes using the carbon monoxide (CO) rebreathing technique has been around for more than 100 years. Despite the immense importance for blood volume in exercise performance the measurement has not become a routine measurement. One reason here fore is that the common/ manual approach is very much prone to human errors.
Our system limits these since the main source of error, the application of a very precise bolus of CO gas is performed fully automated. Also the administration of O2 is automated as this is applied on a demand basis. The system hence allows the operator to focus on the investigated subject in much greater detail than with the manual method which also provides a safety aspect. The handling of the CO gas cylinder is guided by the software which also provides an additional safety benefit. We normally encourage all new users to return a usability questionnaire and ease of use and simplicity are always rated very high. We focus on improving guidance and process help even further in corporation with customers.
Non-radioactive Blood Volume Measurement
The blood volume measurement is performed with the use of non-radioactive substances. The CO method offers the potential of easy, simple and cheap blood volume measurement as required blood analysis can be performed on standard blood gas analysers which are usually already available within most research institutions. Also, the organization does not need to store expensive radioactive test kits or hire specialized staff in order to perform the CO rebreathing routine.
Cases and References
The Detalo Performance is being used for athlete evaluation by multiple Olympic sport federations already. The blood volume analyser has also been used in clinical settings as well as in research institutions for scientific purposes. These have resulted in a number of scientific publications. Specific references can be obtained on request.
The Detalo Performance analyser has been taken and tested at high altitude in various scientific studies/ expeditions. One of the scientific studies tested the effects of four week altitude training at Sierra Nevada (2350 m) in Spain, while two physiological expeditions have successfully used the device at the Jungfraujoch Research Station at 3450 m altitude in Switzerland. In 2019 and 2020 the device was brought to the Peruvian Andes and +80 measurements were completed at 5100 m altitude in La Rinconada (the highest city of our planet). Lastly, the device is being used for one year under extreme conditions on the Antarctic continent at altitudes up to 3400 m (Concordia and Dumont d’Urville research stations) in collaboration with the French Polar Institute and the European Space Agency (ESA). Going a bit higher, the analyser has furthermore been tested and used during zero gravity flights as part of ESA’s parabolic flight campaigns. It should thus be safe to state that the device is robust and suitable for travel.
Reliability and Accuracy
The stated reliability and accuracy values are based on scientific studies available at PubMed (PMID: 27633742; PMID: 28381454; PMID: 28135764 and PMID: 29704889). In these the %TE is reported between 0.8 and 1.6%.
Functionality of Software Provided
The software is meant to guide the test operator through the process of performing a measurement test. Test subject information is gathered, and the operator is able to select the needed CO dose. A measurement screen helps the operator to have an overview of the steps involved as well as to control each step of the process. Reminders and warnings help guide the operator to remember important elements such as blood samples and patient safety. There is an input screen for blood data that also shows the BV results from the test. Results can be printed directly or saved in Excel format. Software updates are free of charge for all customers and downloadable. Detalo Health are gathering customer feedback at all times and are constantly improving software and features accordingly. Customer specific requirements can be supported if feasible but will billed according to a separate agreement.
Configuration and Reporting
Patient reports contain test subject information, measured blood volume related data (BV, PV, RBCV and hemoglobin mass). Blood volume predictions according to Nadler formula is also included in report. Everything is saved in a raw excel format that cannot be changed and in a modifiable format to enter blood data at a later point. Reports can also be printed.
Software and Hardware Requirements
Our software requires the customer to provide a PC/ laptop (no Apple computer) running Windows 7 or later. PC should be connected to the internet to allow Detalo Health to monitor device functionality and need for maintenance. PC should be 2 GHz Intel processor launched 2012 or later. Screen resolution 1024×768 or better. PC must be under full control and maintenance from customer’s Cyber Security guidelines and control.
Requirements for Installation
The analyser should be placed either on a table, workbench or wheeled cart which should be available for installation along with the needed blood gas analyser. Customer must acquire O2 and CO gas cylinders (O2 from wall outlets will also work) that should be installed according to local regulations. CO gas must be 99.997% pure, have a maximum size of 2 liters and compressed to maximally 30 bar. The later is to limit hazard in case of accident.
The CO gas cylinder must fit one of the following standards (other standards available upon request):
- Britsh Standard BS341#4 connector.
- French Standard AFNOR NF E
- European Standard DIN 477/1#5 connector
- US Standard CGA 350 connector
The Oxygen gas must be medical grade and fit on of the following standards:
- British Standard BS341#3 connector.
- French Stadard AFNOR NF F
- European Standard DIN 477/1#9 or #6 connector
- US Standard CGA 540 or 870 connector
We recommend an O2 gas cylinder with a volume of 10-50 liters compressed to 200 bar. Neither gas nor blood gas analysers are included in the offerings from Detalo Health Aps.
There is a regular inspection that should be performed by the operator to ensure that system components have not been compromised, damaged or removed. The drying procedure as described in the manual must be performed after each measurement. The 2-valve mouthpiece should be disassembled and cleaned after each use.
There is a monthly maintenance requirement that needs to be performed by an operator to perform a pressure check to detect potential leaks from the rebreathing system (10 min). In case of transportation there will be a need to flush the CO chamber with CO gas as will be guided by software.
Machine data (not person or measurement data) will automatically be send to the manufacturer as a part of our cloud intelligence solution. Manufacturer will inspect these and normally, manufacturer will identify potential device issues well before these may affect measurement results. For the sake of safety, we strongly advice the customer to support these efforts and ensure relevant internet access from PC from the start.
The manufacturer will monitor metrics from the cloud intelligence and will coordinate with customer contact if required. The analyser does not require additional calibration. In case of needed repairs these will either be conducted on-site or when needed at the production facilities of the manufacturer.
We offer a one year warranty for the device excluding consumables such as sodalime canisters, mouth pieces and anti-bacterial filters.
All parts of the instrument and workmanship are guaranteed after acceptance. Any defect in design, construction or materials will be repaired, or the part(s) concerned will be replaced – excluding consumables. All costs connected with warranty actions, excluding the cost of consumables are covered.
Warranties cover all required maintenance, service and support for the period. Warranties can be upgraded up to 5 years of full warranty cover.
Safety and Certifications
Detalo Performance is a non-medical blood volume measurement device intended to be used for athletes to evaluate performance. The device is regulated as a non-medical device in accordance with EU Court ruling C-219/11 and we confirm that the equipment meets the regulatory requirements as such.
The Product is CE marked as consumer electronics and complies with Electromagnetic compatibility: DIN EN 60601-1-2 and Electrical Safety test: LVD 2014/35/EU.
The device is designed to use carbon monoxide which is toxic to humans as it binds to haemoglobin and thereby limits O2 transport to organs. While the bolus of CO applied for the measurement can be compared to what is inhaled if smoking ne cigarette, a %HbCO level of over 50% may result in seizure, coma, and fatality. The device also uses oxygen which comes with the risk of fire. The device is re-used across multiple test persons, which come with the risk of viral or bacterial infection (hence the need of using anti-bacterial filters). The customer should be aware of local regulations and safety requirements for supply, storage, use and disposal of CO and O2.
The device has gone through a detailed risk management process in accordance with ISO 14971 and a number of safety features are included: It’s designed to minimise the amount of CO present in the system at any time and the use of a manually operated “push-to-open” button on the CO supply is mandatory . There is a built-in safety controller that monitors valve configuration and the CO delivery mechanism. Each CO dose needs to be manually confirmed on the device every time and only a dose of maximal 150 ml can be applied. In case of a device failure, power-out or similar, all valves automatically shut down. There is a redundancy of valves to minimise risk unwanted release of CO. There is a redundancy of pressure sensors in the CO chamber to ensure precision of CO dose determination.
Software is built in accordance with IEC 62304 and final certification is in progress. There is a cloud based intelligence solution in place to monitor device functionality when appropriately connected to the internet.