Table 1.
The characteristics of cuff-based devices for non-invasive continuous monitoring of blood pressure.
| Device, company name, country | Measurement technology, device location | Disadvantages | Validation* | Status of the device |
|---|---|---|---|---|
| CNAP, CNSystems, Austria | Volumetric clamp technique plethysmography, finger | The occurrence of “blue finger syndrome,” limitations in patients with vascular diseases, and finger pathology | ISO 81060-2, ISO 81060-3, ISO/TS 81060-5 | Approved FDA and commercialized |
| ClearSight (Nexfin), Edwards Lifesciences, United States | Volumetric clamp technique plethysmography, finger | After 8 h of continuous monitoring on a single finger, the finger cuff should be reapplied to another finger. | ISO 81060-2, ISO 81060-3, ISO/TS 81060-5 | Approved FDA and commercialized |
| Lidco Hemodynamic Monitor, Lidco Group Plc, England | Volumetric clamp technique, Finger | Alternating between the two cuffs, limiting hand movement | ISO 81060-2, ISO 81060-3, ISO/TS 81060-5 | Approved FDA and commercialized |
| Finapres/Finometer, Finapres Medical Systems, Netherlands | Volumetric clamp technique plethysmography, finger | Alternating between the two cuffs, limiting hand movement | ISO 81060-2, ISO 81060-3, ISO/TS 81060-5 | Approved FDA and commercialized |
| The VitalStream, Caretaker Medical, United States | Pulse decomposition analysis, finger | Alternating between the two cuffs, limiting hand movement | ISO 81060-2, ISO 81060-3, ISO/TS 81060-5 | Approved FDA and commercialized |
*https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm. **ISO 81060-2 Third edition 2018-11 Non-invasive sphygmomanometers – Part 2: Clinical investigation of intermittent automated measurement type [Including: Amendment 1 (2020)]; ***ISO 81060-3 First edition 2022-12 Non-invasive sphygmomanometers – Part 3: Clinical investigation of continuous automated measurement type; ****ISO/TS 81060-5 First edition 2020-02 Non-invasive sphygmomanometers – Part 5: Requirements for the repeatability and reproducibility of NIBP simulators for testing of automated non-invasive sphygmomanometers.