Introduction, Intended use – Fluke Biomedical ProSim 6 User Manual

Page 13

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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

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