(199 days)
The intended us of ProSim 4 is to test and verify the basic operation of patient monitoring devices or systems used to monitor various physiological parameters of a patient, including ECG, Respiration, Invasive blood pressure and Non-invasive blood pressure.
The ProSim 4 Vital Signs Simulator provides electronic and pneumatic simulation of physiological parameters for determining that patient monitoring devices or systems are performing within their operating specifications. The device includes the following physiological simulations:
- ECG adult or neonatal
- Invasive and non-invasive blood pressure
- Respiration
The intended us of ProSim 6 and ProSim 8 is to test and verify the basic operation of patient monitoring devices or systems used to monitor various physiological parameters of a patient, including ECG, Respiration, Invasive blood pressure, Non-invasive blood pressure and Cardiac output. Additionally, the devices provide an optical signal to verify that the electronics within the pulse oximeter probe are functional.
The ProSim 6 and ProSim 8 Vital Signs Simulators provide electronic and pneumatic simulation of physiological parameters for determining that patient monitoring devices or systems are performing within their operating specifications. The devices provide the following physiological simulations:
- ECG adult or pediatric
- Invasive and non-invasive blood pressure
- Respiration
- Temperature
- Cardiac Output
- Fetal Simulation includes fetal, maternal ECG, & uterine contractions (ProSim 8 only)
Additionally, the devices provide an optical signal to verify that the electronics within the pulse oximeter probe are functional
Fluke Biomedical's ProSim 4 (hereafter referred to as the ProSim) provides a basis to train, evaluate, and perform preventive maintenance for virtually all patient monitors found in the healthcare industry. This is accomplished with multiple physiological simulations for ECG electrical signals, respiration electrical signals, invasive blood pressure (IBP) electrical signals and non-invasive blood pressure pulses. The ProSim is a lightweight, battery powered unit that is portable enough to test a patient monitor anywhere the monitor is being used.
ProSim vital signs simulator consists of the following components:
- Printed Circuit Board Assemblies using surface mount components and firmware loaded in embedded processors.
- Plastic iniection molded case parts.
- Stepper Motor and piston pump for pneumatic simulation that makes reliable pressure pulses.
- Liquid Crystal Touch Screen Display for user interface. User interface follows modern and ergonomic concepts.
- Lithium Ion rechargeable battery for portable operation, giving user flexibility and portability.
Fluke Biomedical's ProSim 6 and ProSim 8 (hereafter referred to as the ProSim) provides a basis to train, evaluate, and perform preventive maintenance for virtually all patient monitors found in the healthcare industry. This is accomplished with multiple physiological simulations for ECG electrical signals, respiration electrical signals, invasive blood pressure (IBP) electrical signals, non-invasive blood pressure (NIBP) pressure pulses, temperature electrical signal, cardiac output electrical signal, and pulse oximetry SPO2 optical simulated light attenuation. The ProSim is a lightweight, battery powered unit that is portable enough to test a patient monitor anywhere the monitor is being used.
ProSim vital signs simulator consists of the following components:
l ) Printed Circuit Board Assemblies using surface mount components and firmware loaded in embedded processors.
- 2) Plastic injection molded case parts.
-
- Stepper Motor and piston pump for pneumatic simulation that makes reliable pressure pulses.
-
- Liquid Crystal Display for user interface. User interface follows modern and ergonomic concepts.
-
- Lithium Ion rechargeable battery for portable operation, giving user flexibility and portability.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Fluke Biomedical ProSim 4, ProSim 6, and ProSim 8 devices:
Executive Summary:
The Fluke Biomedical ProSim 4, ProSim 6, and ProSim 8 are vital signs simulators designed to test and verify the basic operation of patient monitoring devices. The devices function by providing electronic and pneumatic simulations of various physiological parameters. Extensive non-clinical bench testing was conducted to demonstrate that the ProSim devices perform within their published specifications and are substantially equivalent to their predicate devices (MedSim300B, Cufflink, and Index 2MF SPO2 for ProSim 6/8). Clinical testing was not performed, as the devices are intended for laboratory use for preventative maintenance and not for direct patient use or medical equipment calibration. The ground truth for the testing was the published specifications of the device itself, verified through laboratory measurements.
1. Table of Acceptance Criteria and the Reported Device Performance:
The document provides a detailed comparison table between the ProSim devices and their predicate devices, indicating various performance characteristics. Since the acceptance criteria are essentially the published specifications and the study aims to show the device performs within those specifications, the "reported device performance" is implicitly that the device met these specifications, thus demonstrating substantial equivalence.
Below is a summarized table consolidating key features and their performance (or range of performance), with the acceptance criteria being that the ProSim meets or improves upon the predicate device's comparable specification or meets its own stated specifications if it's a new feature or different range.
ProSim 4 (compared to MedSim 300B and Cufflink)
| Feature | Predicate Devices (Range/Specification) | ProSim 4 (Reported Performance/Specification) | Acceptance Criteria |
|---|---|---|---|
| Display | 2x24 char LCD (MedSim); 8x20 char alpha & 64x240 graphics (Cufflink) | ¼ VGA graphic LCD Touch Color Display | More display, Touch Screen, and Color – Met/Exceeded |
| IBP Channels | 4 channels (MedSim) | 1 channel | Reduced per market requirements and use – Met |
| Comm Port | RS232 | USB | Advancement in technology – Met |
| Battery Test | Limited low battery indication (MedSim); No battery (Cufflink) | Multiple levels of battery life indication | Predicate checks at one level, ProSim checks at multiple levels – Met/Exceeded |
| Power | 2x9V alkaline (MedSim); AC line (Cufflink) | Li-Ion rechargeable battery w/ low battery indicator; battery eliminator (115VAC) | Longer operating life with modern battery technology – Met/Exceeded |
| Amplitude accuracy (ECG) | +/- 5%, 2Hz @ 1.0 mV p-p SQ wave Lead II (MedSim) | +/- 2% setting lead II | More accurate on newer devices – Met/Exceeded |
| NSR rates (ECG) | 30 to 300 BPM (MedSim) | 30 to 320 BPM | Wider range due to market preferences – Met/Exceeded |
| NSR amplitudes (ECG) | 50 uV to 5.5mV (MedSim) | 1mV | Limited amplitude for basic simulation – Met |
| Pacemaker | 0.1 to 2.0 ms width, -700 to +700 mV (MedSim) | 1 ms width, 3mV | Basic simulation for targeted market – Met |
| Impedance variation (Resp) | 0 to 3 ohms (MedSim) | 1.0 ohm | Basic simulation for targeted market – Met |
| Respiration rates | 15, 20, 30, 40, 60, 120 brpm (MedSim) | 10, 20, 30, 40, 50, 60, 70, 80, 90 & 100 brpm | More Respiration rates – Met/Exceeded |
| Apnea (Resp) | Off, Continuous, momentary, 12 & 32 s (MedSim) | Off & Continuous | Less apneas for basic simulation – Met |
| Transducer Sensitivity (IBP) | 5 or 40 uV/V/mmHg (MedSim) | 5 uV/V/mmHg | Fewer selections for basic simulation – Met |
| Static pres. Selection (IBP) | Manual and automatic (MedSim) | Manual | Limited selection mode per target market and use – Met |
| Dynamic BP selections (IBP) | Arterial, left and right ventricle, pulmonary artery, pulmonary wedge, Swan-Ganz (MedSim) | Arterial and left ventricle | Fewer selections for basic simulation – Met |
| Static BP selections (IBP) | -10, -5, 0, 20, 30, 40, 80, 100, 200, 250 & 300 mmHg (MedSim) | 0, 80, 160 & 250 mmHg | Fewer selections for basic simulation – Met |
| Manometer (NIBP) | N/A (MedSim); Max. 499.75 mmHg (Cufflink) | 0 to 400 mmHg | Lower range per market requirements – Met |
| Simulation (NIBP) | N/A (MedSim); Systolic/Diastolic simulations. Adult 60/30 to 255/195 (Cufflink) | Systolic/Diastolic Adult – 60/30, 120/80, 150/100 & 200/150; Neonatal 35/15 & 70/40 | Fewer selections for basic simulation; Adult and Neonatal – Met |
| Synchronization to ECG (NIBP) | N/A (MedSim); 30 to 240 BPM (Cufflink) | Up to 150 BPM | Limited for basic simulation – Met |
ProSim 6 & 8 (compared to MedSim 300B, Index 2, and Cufflink)
| Feature | Predicate Devices (Range/Specification) | ProSim 6 & 8 (Reported Performance/Specification) | Acceptance Criteria |
|---|---|---|---|
| Intended Use | MedSim: ECG, Resp, BP, Temp, CO; Index 2: SpO2; Cufflink: NIBP | ECG, Resp, IBP, NIBP, Temp, CO, SpO2 (Fetal Sim for ProSim 8) | Additional functions of noninvasive blood pressure and pulse oximetry simulation. – Met/Exceeded |
| Display | MedSim: 2x24 char LCD; Index 2: 2x24 char LCD; Cufflink: 8x20 char alpha & 64x240 graphics | ¼ VGA graphic LCD Color Display | More display, Color. – Met/Exceeded |
| High level ECG | ¼" standard phone jack w/ lead II waveform at .2V/mV (MedSim) | BNC jack for 0.5V/mV output into 50 Ohm impedance | Output to oscilloscope via BNC is preferred by customers. – Met/Exceeded |
| IBP Channels | 4 independent BP channels (MedSim) | 2 channels | Number of channels reduced per market requirements and use. – Met |
| Comm Port | RS232 (all predicates) | USB | Change from RS232 to USB data port with advancement in technology. – Met/Exceeded |
| Battery Test | Limited low battery indication (MedSim, Index 2); No battery (Cufflink) | Multiple levels of battery life indication | Predicate devices only check at one level. ProSim checks battery status at multiple charge levels. – Met/Exceeded |
| Amplitude accuracy (ECG) | +/- 5%, 2Hz @ 1.0 mV p-p SQ wave Lead II (MedSim) | +/- 2% setting lead II | More accurate on newer devices due to market preferences and technology improvements. – Met/Exceeded |
| NSR rates (ECG) | 30 to 300 BPM (MedSim) | 30 to 360 BPM | Wider range due to market preferences. – Met/Exceeded |
| Square and/or Pulse waves | Square at 2 Hz and 0.125 Hz (MedSim) | Square at 2.5, 2 & 0.125 Hz. Pulse at 60ms / 60 and 30 BPM | More choices. – Met/Exceeded |
| Sine waves | 0.05 to 100 Hz (MedSim) | 0.05 to 150 Hz | More choices. – Met/Exceeded |
| Triangle wave | 2 Hz (MedSim) | 0.125, 2 and 2.5 Hz | More choices. – Met/Exceeded |
| R Wave detector | Yes (MedSim) | Yes | None. – Met |
| QRS Detection and Tall T-wave rejection | No (MedSim) | Yes | Improved capability. – Met/Exceeded |
| Impedance variation (Resp) | 0 to 3 ohms (MedSim) | 0 to 5 ohms | Expanded capability to meet new market requirements. – Met/Exceeded |
| Respiration rates | 15, 20, 30, 40, 60, 120 brpm (MedSim) | 15 to 120 brpm in incremental steps | More Respiration rates due to market requirements and use. – Met/Exceeded |
| Apnea (Resp) | Off, Continuous, momentary, 12 & 32 s (MedSim) | Off, Continuous, momentary, 12, 22 & 32 S | Additional apneas. – Met/Exceeded |
| Blood temperatures (CO) | 36C to 38C and user programmable (MedSim) | 36C to 38C in incremental steps | User programmable not included due to market requirements and use. – Met |
| Injective temp (CO) | Chilled (2C) (MedSim) | Chilled (0C) or 24 C | More selections per market requirements. – Met/Exceeded |
| Fixed blood flow rate (CO) | 3, 5, 7 L/min (MedSim) | 2.5, 5, 10 L/min | Different selections per market requirements. – Met |
| Output trend (CO) | 1 normal, 2 defective (MedSim) | No | Not included due to market requirements and use. – Met |
| Exciter range (IBP) | 2 to 16 V/DC to 4 kHz (MedSim) | 2 to 16 V/DC to 5kHz | Higher frequency range driven by market trend and technology. – Met/Exceeded |
| Static pres. Selection (IBP) | Manual and automatic (MedSim) | Manual | Limited selection mode per target market and use. – Met |
| Dynamic BP selections (IBP) | Arterial, left and right ventricle, pulmonary artery, pulmonary wedge, Swan-Ganz (MedSim) | Arterial, radial artery, left and right ventricle, pulmonary artery, pulmonary wedge, right atrium, left atrium and Swan-Ganz | More selections. – Met/Exceeded |
| Static BP selections (IBP) | -10, -5, 0, 20, 30, 40, 80, 100, 200, 250 & 300 mmHg (MedSim) | -10 to 300 mmHg in incremental steps | More selections. – Met/Exceeded |
| Temperature (Sim) | 0, 24, 37 and 40C (MedSim) | 30C to 42C in incremental steps | Different selections per market requirements. – Met |
| SpO2 Accuracy | Select 50% to 100% in 1% increments - accuracy: 75%to 100% ± 1% plus the accuracy of the pulse oximeter under test. 50%-75%, ± 2% plus accuracy of the oximeter under test. Under 50%, unspecified. (Index 2) | Select 30% to 100% in 1% increments w/ oximeter manufacturer's R-curve or Fluke Biomedical R-curves (91-100% ±(3 counts + UUT accuracy), 81-90% ±(5 counts + UUT accuracy), 71-80% ±(7 counts + UUT 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).