Fluke Biomedical ProSim 8 - Introduction and Safety; Intended Use and General Safety Precautions

1
Introduction
The Fluke Biomedical ProSim™ 8 Vital Signs Simulator (hereafter the Product) is
a full-featured, compact, portable simulator, used to measure the performance of
patient monitors.
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 SpO
2
, 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
SpO
2
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.