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The ESA615 Electrical Safety Analyzer is an electronic signal source and measurement device for verifying the electrical safety of medical devices. The ESA615 also provides ECG simulation and performance waveforms to verify patient monitors are performing within their operating specifications. The ESA615 provides following function categories: ECG Functions, ECG-Performance Testing.

Fluke Biomedical's ESA615 Electrical Safety Analyzer (hereafter referred to as the ESA615) provides a basis for verifying the electrical safety of medical devices. The Product also provides ECG simulation and performance waveforms to verify patient monitors are performing within their operating specifications. The ESA615 can be controlled by a suitably equipped computer to carry out tests, via either a cable or wirelessly. The ESA615 consists of the following components: 1) Printed Circuit Board Assemblies using surface mount components and firmware loaded in embedded processors. 2) Plastic injection molded case parts. 3) Liquid Crystal Display for user interface. 4) Power cord for powering the unit at 120V and 60Hz.

The ESA620 Electrical Safety Analyzer is an electronic signal source and measurement device for verifying the electrical safety of medical devices. The ESA620 also provides ECG simulation and performance waveforms to verify patient monitors are performing within their operating specifications. The ESA620 provides following function categories: - ECG Functions . - ECG-Performance Testing ●

Fluke Biomedical's ESA620 Electrical Safety Analyzer (hereafter referred to as the ESA620) provides a basis for verifying the electrical safety of medical devices. The Product also provides ECG simulation and performance waveforms to verify patient monitors are performing within their operating specifications. The ESA620 consists of the following components: 1) Printed Circuit Board Assemblies using surface mount components and firmware loaded in embedded processors. 2) Plastic injection molded case parts. 3) Liquid Crystal Display for user interface. 4) Power cord for powering the unit at 120V and 60Hz.

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.

The MPS450 Multiparameter Simulator is an electronic signal source for determining that patient monitors are performing within their operating specifications. The MPS450 provides the following function categories: ECG Functions Arrhythmia Functions ECG-Performance Testing Respiration Blood Pressure Temperature Cardiac Output (Optional) Fetal/Maternal ECG & IUP (Optional)

Fluke Biomedical's MPS450 Multiparameter Simulator (hereafter referred to as the MPS450) 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, blood pressure, respiration, temperature, artifact, and arrhythmia conditions. The MPS450 is a lightweight, battery powered unit that is portable enough to test a patient monitor anywhere the monitor is being used.

The Impulse 7010 is used to determine that a defibrillator is performing within its operating specifications by providing multiple loads of 25, 50, 75, 100, 125, 150, 175 and 200 Ohms. The Impulse 7010 is used in conjunction with the Impulse 7000DP Defibrillator Analyzer.

The Impulse 7010 Defibrillator Selectable Loads is an optional accessory to the Impulse 7000DP to simulate 25 to 200 Ohm thoracic impedance. Four 50 Ohm resistors are switched in combinations to make series or parallel circuits of 25, 50, 75, 100, 125, 150, 175 and 200 Ohms. Defibrillator output energy is measured by the Impulse 7000DP Defibrillator Tester.

The Impulse 6000D/7000DP is used to determine that defibrillators and transcutancous pacemekers are performing within their performance specifications through the measurement of energy output.

The Impulse 600013/7000DP is a portable, rechargeable, battery-operated defibrillator tester. The Impulse 7000DP also functions as a transcutaneous pacemaker tester. The device's defibrillator input is connected to the output of a defibrillator under test which provides a 50-Ohm test load, approximately the impedance of the human body. The Impulse 6000D/7000DP simulates patient electrocardiogram signals to trigger automated defibrillation when a ventricular fibrillation waveform is presented, and the device tests that the automated defibrillator does not advise shock when a normal sinus rhythm electrocardiogram is presented. The energy output delivered by the defibrillator under test is measured. The Impulse 7000DP also tests transcutaneous pacemaker outputs by presenting a low level electrocardiogram at various pulse rates and measures the response of the pacemaker under testing rate and amplitude. For pacemaker testing, the device incorporates inputs of 50 to 1500 Ohm impedance test loads. The Impulse 6000D is a defibrillator tester only without the pacemaker test option. Both models have 10 electrocardiogram outputs to simulate patient milli-volt level electrocardiogram signals to test combination patient monitors/defibrillators/pacemakers. The Impulse 7000DP has a USB type "B" interface to a PC to allow data download to a PC. It is electrically isolated from the measurement circuitry and allows remote control of the test from a PC. A BNC type connector on the rear panel also allows an oscilloscope to record the waveform output from the defibrillator under test, attenuated to a lower voltage level, and also electrically isolated from the measurement circuitry. Another BNC connector outputs a higher level signal (greater amplitude) to view the electrocardiogram signal on a second oscilloscope channel. The accessories for the Impulse 6000D/7000DP include an external power supply to operate and re-charge the internal battery. Optional adapters to connect defibrillators marketed by different manufacturers to the standard 4 mm banana style input jacks are available. Waveform analysis determines the characteristics of a defibrillator discharge pulse. Peak voltage amplitude, current, timing, overall energy and the refractory period of a pacemaker are recorded. Measurement is done by attenuating the high voltage signal to a lower voltage level, which is then input into an analog to digital converter. A digital signal processor calculates the measurements and corrects hardware error sources with mathematical calibration constants for any offset and gain errors.