(77 days)
The MX960 reusable pressure transducer is used to convert hemodynamic pressure waveforms via a piezoresistive bridge circuit into electrical signals which can then be displayed using separate monitoring equipment.
The MX960 reusable pressure transducer is a non-fluid pathway device. A pressure waveform is conveyed through a disposable dome which is coupled to the reusable pressure transducer during pressure monitoring. Both the transducer and dome have mutually exclusive diaphragms. Accordingly, fluid contact is limited to the dome portion of the system. The materials which comprise the MX960 have been aggressively tested per the ANSVAAMI/ISO 10993 "Biological Evaluation of Medical Devices" and the "Tripartite Biocompatibility Guidance for Medical Devices". All materials have successfully met these standards.
The Medex, Inc. MX960 Reusable Pressure Transducer underwent performance testing against the ANSI/AAMI BP22-1994 standard for blood pressure transducers.
Here's a breakdown of the acceptance criteria and the study details:
1. Acceptance Criteria and Reported Device Performance
| PARAMETER | AAMI SPECIFICATION (Acceptance Criteria) | MX960 Performance (Reported Device Performance) |
|---|---|---|
| Sensitivity - µV/V/mmHg | Disclosure | 5.0 Nominal |
| Unbalance - mmHg | 0 ± 75 | 0 ± 50 |
| Zero Drift - mmHg | Disclosure | ≤ 2 in 4 hrs after 5 min |
| Input Impedance - OHMS | 200 | 300 ± 10% |
| Calibration Requirement - mmHg | Not Specified | 100 ± 3 |
| Accuracy - mmHg |
§ 870.2850 Extravascular blood pressure transducer.
(a)
Identification. An extravascular blood pressure transducer is a device used to measure blood pressure by changes in the mechanical or electrical properties of the device. The proximal end of the transducer is connected to a pressure monitor that produces an analog or digital electrical signal related to the electrical or mechanical changes produced in the transducer.(b)
Classification. Class II (performance standards).