(91 days)
The Philips Medical Systems Integrated Patient Monitoring System (IPMS) is intended to monitor the heart rhythm and other vital signs for a patient undergoing an MRI procedure and to provide signals for synchronization for the MRI scanner.
The Philips Medical Systems Integrated Patient Monitoring System (IPMS) is a significant modification of the Invivo Research Omni-Trak™ 3150/3155 Series Patient Monitoring System. This device has been integrated into the Philips Physiotrak patient gurney used with the Philips MRI System. The Philips Medical Systems Integrated Patient Monitoring System is intended to monitor the heart rhythm and other vital signs for a patient undergoing an MRI procedure and to provide signals for synchronization for the MRI scanner. The IPMS works on DC (battery) power supplies and monitors ECG, non-invasive blood pressure, SPO2, respiration and temperature. This information can be displayed either at the monitor or remotely. The monitor sounds an alarm if any monitored parameter falls outside the range indicated by the alarm limits. The alarm limits is programmable either manually or programmally based on the current value of the parameter(s). This monitoring system is MRI-compatible. It utilizes technology from the Invivo Research Omni-Trak™ 3150/3155 Series Patient Monitoring System and the Invivo Research Millennia Patient Monitor. The IPMS consists of three major component parts; the MCB (Patient Connector Box), MEB (Monitoring Electronics Box), and MDCU (Monitoring Display and Control Unit) which are integrated into the Phillips Physiotrak patient gurney.
The provided text describes the acceptance criteria and a summary of performance testing for the Philips Medical Systems Integrated Patient Monitoring System (IPMS). However, it does not include a detailed study description with information like sample sizes for test and training sets, data provenance, number or qualifications of experts, adjudication methods, or MRMC comparative effectiveness studies. This document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing full clinical study details.
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1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria / Specification (Stated) | Reported Device Performance (Implied by "Validation and Verification Testing confirmed that this device operates as designed and intended") |
|---|---|---|
| ELECTRICAL AND MECHANICAL CHARACTERISTICS | ||
| Line Voltage | 115 VAC +/- 10%, 50/60 Hz | Meets specification |
| Power Sources Available | AC Power, or internal battery power with remote charger | Meets specification |
| Power Consumption | 8 hours with 4 batteries | Meets specification |
| Electrical Safety | Per EN 60601-1 | Meets specification |
| Electromagnetic Compatibility | Per EN 60601-1-2 | Meets specification |
| PERFORMANCE REQUIREMENTS | ||
| Heart Rate Monitor | ||
| Range/Resolution | 0 to 250 BPM / 1 BPM | Meets specification |
| Rate Accuracy | 0.5% of reading, +/- 1BPM | Meets specification |
| Defibrillator Protection | Accepts and recovers from a defibrillator discharge up to 5 KV | Meets specification |
| 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, 4 Hrs | Meets specification |
| Pop-Off Pressure Level | 270 +/- 14 mmHg | Meets specification |
| Cuff Inflation Time | 3 to 20 seconds | Meets specification |
| Pulse Oximetry | ||
| Range | 0 to 100% saturation | Meets specification |
| 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).