The product is CE marked as a Class IIa product (permission to use on human patients within EU only).
The Samba Gyn 420 is currently available in a version compatible with the Samba 3200 Control Unit.
The Samba Gyn 420 catheter is not FDA approved.
| Sensor diameter | 0.42 mm (1.3 F) | |
| Fiber diameter | 0.25 mm (0.75 F), incl. standard coating 0.40 mm (1.2 F), incl. radiopaque coating |
|
| Calibration | Factory calibration (on-site calibration not needed) | |
| Tolerated bend radius | 10 mm (0.4 in) | |
| Pressure range | -50 to 350 cm H2O | |
| Accuracy | ±0.5 mbar and ±2.5% of reading (-50 to 250 cm H2O) or ±4% of reading (250 to 350 cm H2O) |
|
| Temperature coefficient | <0.2 cm water/ºC (20-45ºC/ 68-113ºF) | |
| Long term stability | <0.5% of range | |
| Storage temperature | -40 to +80ºC (-40 to 176ºF) | |
| Total transducer length | 4 m (13,1 ft) | |
| Bare fiber length | 10 cm (0.4 in), or 14.5 cm (5.7 in) |
|
| Length of loose PTFE tubing | 10 cm (0.4 in), or 15 cm (5.9 in) |
|
| Coating | Radiopaque (visible under X-ray) | |
| Regulatory approval | CE, class IIa | |
| Compatible Samba system | Samba 3200 Control Unit |