Introduction, Intended use – Fluke Biomedical ProSim 6 User Manual
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1
Introduction
The Fluke Biomedical ProSim™ 6 and ProSim™ 8 Vital Signs Simulators (hereafter the
Product) are full-featured, compact, portable simulators, used to measure the performance
of patient monitors. The Fluke Biomedical ProSim™ 8 is shown in all illustrations.
The Product simulates:
•
ECG Functions
•
Respiration
•
Invasive and Non-Invasive Blood Pressure
•
Temperature
•
Cardiac Output
When the term simulation is used in connection with ECG, respiration, temperature, IBP,
NIBP, cardiac output, or SpO2, the simulation type shown in Table 1 is used in this
Product. Additionally, the Devices provide an optical signal to verify that the electronics
within the pulse oximeter probe are functional.
Table 1. Simulation Types
Parameter Simulation
Type
ECG Electrical
Respiration Electrical
Temperature Electrical
IBP Electrical
NIBP Pneumatic
Cardiac Output
Electrical
SpO2 Light
Emission
Intended Use
The Product is intended to be used 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, Temperature, and Cardiac output. Additionally, the Devices provide an optical
signal to verify that the electronics within the pulse oximeter probe are functional.
The intended user is a trained biomedical equipment technician who performs periodic
preventative maintenance checks on patient monitors in service. Users can be associated
with hospitals, clinics, original equipment manufacturers and independent service
companies that repair and service medical equipment. The end user is an individual,
trained in medical instrumentation technology.
This Product is intended to be used in the laboratory environment, outside of the patient