Search Results

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:

1. Printed Circuit Board Assemblies using surface mount components and firmware loaded in embedded processors.
2. Plastic iniection molded case parts.
3. Stepper Motor and piston pump for pneumatic simulation that makes reliable pressure pulses.
4. Liquid Crystal Touch Screen Display for user interface. User interface follows modern and ergonomic concepts.
5. 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.
• 3. Stepper Motor and piston pump for pneumatic simulation that makes reliable pressure pulses.
• 4. Liquid Crystal Display for user interface. User interface follows modern and ergonomic concepts.
• 5. 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)

ProSim 6 & 8 (compared to MedSim 300B, Index 2, and Cufflink)

Ask a specific question about this device

The 6004 NIBP monitor is a portable NIBP monitor for spot checking or monitoring of a patient's systolic, diastolic and mean arterial (MAP) blood pressures, and pulse rate, with optional SpO2 and/or integral printer. The device will provide fast, reliable measurements on patients ranging from children (pediatric) to adults when using the appropriate BCI blood pressure cuff. The oximetry option works with all BCI oximetry probes, providing SpO2 and pulse rate on all patients from neonate to adult. The device is intended for use in both clinical and ground EMS environments by health care professionals. It is not intended for home use. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals.

The BCI 6004 NIBP monitor with optional pulse oximetry (SpO2) and printer is a new monitor with the same parameters as existing devices legally marketed by BCI International. This device is designed to provide full featured monitoring capabilities in a light weight, transportable design. The system consists of a small table top non-invasive blood pressure monitor with a desk top charger. The system features an NIBP cuff hose connection, an SpO2 probe interface, the optional internal printer, display of patient data via an LED display (Systolic, Diastolic, & Mean arterial pressure, Interval timer, SpO2, Pulse Rate, Pulse Strength), system status LEDs (Battery, Probe, Alarm Silence, Alarm, & Alert), and the function keypad area consisting of eleven keys (O/I (off/on), START, CANCEL, STAT, Up and Down Arrows, INTRVL, RECALL, MANUAL/AUTO, ALARM SET, & Alarm Silence). The monitor has a serial port that is used for data communication. The model 6004 has two parameters, NIBP and SpO2 plus the integrated printer.

Here's a breakdown of the acceptance criteria and the study details for the BCI 6004 NIBP Monitor, extracted from the provided text:

Acceptance Criteria and Device Performance

Ask a specific question about this device