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
ECG
Respiration
IBP
NIBP
Simulation Type
Electrical
Electrical
Electrical
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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