Introduction, Intended use – Fluke Biomedical ProSim 4 User Manual

Page 11

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Introduction

The ProSim

 4 Vital Signs Simulator (the Product) is a portable vital signs

monitor functional tester.
The product simulates:

ECG

Functions

Respiration

Invasive and non-invasive Blood Pressure

When the term simulation is used in connection with ECG, respiration, IBP, or

NIBP, the simulation type shown in Table 1 is used in this Product.

Table 1. Simulation Types

Parameter Simulation

Type

ECG Electrical

Respiration Electrical

IBP Electrical

NIBP Pneumatic

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, and

non-invasive blood pressure.
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 and is not

intended for use on patients, or to test devices while connected to patients. This

Product is not intended to be used to calibrate medical equipment. It is intended

for over the counter use.

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