Propaq m indications for use, Ecg monitoring, Non-invasive blood pressure monitoring – ZOLL Propaq M Rev B User Manual

Page 14: Temperature monitoring, Monitoring

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9650-0803-01 Rev. B

Propaq M Indications for Use

The Propaq M is intended for use by trained medical personnel who are familiar with basic
monitoring, vital sign assessment, and the use of the Propaq M. The Propaq M is also intended
for use by (or on the order of) physicians at the scene of an emergency or in a hospital
emergency room, intensive care unit, cardiac care unit, or other similar areas of a hospital. The
usage may be in an ambulance or at the scene of an emergency. It is also intended to be used
during the transport of patients. The Propaq M will be used whenever it is required to monitor
any of those functions that are included (as options) in the device. The Propaq M unit can be
used on pediatric patients (as described in the following table) and on adult patients (21 years of
age or older) with and without heart dysfunction.

ECG Monitoring

The Propaq M is intended for use to monitor and/or record 3-, 5-, or 12-lead ECG waveform
and heart rate, and to alarm when heart rate is above or below limits set by the operator. The
patient population will range from newborn (neonate) to adult, with and without heart
dysfunction.

Non-Invasive Blood Pressure Monitoring

The Propaq M is intended for use to make non-invasive measurements of arterial pressure and
heart rate, and to alarm if either parameter is outside of the limits set by the user. Measurements
are made using an inflatable cuff on the patient's arm or leg. The patient population will range
from newborn (neonate) to adult.

Temperature Monitoring

The Propaq M is intended for use to make continuous temperature measurements of rectal,
esophageal, or surface temperatures, and to alarm if the temperature is outside of the limits set
by the user. The patient population will range from newborn (neonate) to adult.

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Monitoring

The Propaq M is intended for use to monitor pulse rate and oxygen saturation of arteriolar
hemoglobin, and to alarm if either parameter is outside of the limits set by the user.
Measurements are made non-invasively at remote sites such as a finger, toe, ear lobe, bridge of
nose, etc. The patient population will range from newborn (neonate) to adult.

Pediatric Patient Subpopulation

Approximate Age Range

Newborn (neonate)

Birth to 1 month of age.

Infant

1 month to 2 years of age.

Child

2 to 12 years of age.

Adolescent

12 to 21 years of age.

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