(191 days)
The 3160 MRI Patient Monitoring System is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner.
The 3160 MRI Patient Monitoring System is intended for use by health care professionals.
The 3160 MRI Patient Monitoring System is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner. It is designed to assist clinicians in monitoring patient vital signs in the midst of the dynamic and evolving Magnetic Resonance environment. A combination of wireless communication, radio frequency (RF) shielding, digital signal processing (DSP), and adaptable mounting technologies address the challenges associated with patient monitoring in the MRI area. Built on Invivo's strong heritage in MRI patient vital signs monitoring, the 3160 orovides accurate, continuous, and reliable performance during all phase of MRI applications.
Here's a summary of the acceptance criteria and study information for the K050399 device, based solely on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Parameter | Acceptance Criteria (Specification) | Reported Device Performance |
|---|---|---|
| ELECTRICAL AND MECHANICAL CHARACTERISTICS | ||
| Operating Voltage | 90 to 264 VAC | Passed all tests (implied by "met the performance requirements") |
| Power Consumption | 30 Volt-Amperes with Charged batteries (48 VA maximum during charging) | Passed all tests (implied by "met the performance requirements") |
| Battery Capacity | > 8 hours (Lithium Ion) | Passed all tests (implied by "met the performance requirements") |
| Electrical Safety | Per EN 60601-1 | Passed all tests (explicitly stated in "Summary of Performance Testing") |
| Electromagnetic Compatibility | Per EN 60601-1-2 | Passed all tests (explicitly stated in "Summary of Performance Testing") |
| Heart Rate Monitor | ||
| Range/Resolution (Adult) | 30 to 249 BPM / 1 BPM | Met performance requirements (accuracy and precision) |
| Range/Resolution (Neonate) | 30 to 300 BPM / 1 BPM | Met performance requirements (accuracy and precision) |
| Rate Accuracy (30-200 BPM) | ± 1% | Met performance requirements (accuracy and precision) |
| Rate Accuracy (201-250 BPM) | ± 1.5% | Met performance requirements (accuracy and precision) |
| Rate Accuracy (251-300 BPM) | ± 2% (Neonate only) | Met performance requirements (accuracy and precision) |
| Defibrillator Protection | Accepts and recovers from discharge up to 5 KV | Met performance requirements (accuracy and precision) |
| Non-Invasive Blood Pressure Monitoring | ||
| Auto Mode Set Intervals | OFF, 1, 2, 2.5, 3, 5, 10, 15, 20, 30, 45 Min, or 1, 2 and 4 Hrs | Met performance requirements (accuracy and precision) |
| Pop-Off Pressure Level | 285 +/- 14 mmHg | Met performance requirements (accuracy and precision) |
| Cuff Inflation Time | 3 to 20 seconds | Met performance requirements (accuracy and precision) |
| Pulse Oximetry | ||
| Range | 0 to 100% saturation | Met performance requirements (accuracy and precision) |
| Accuracy |
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).