1 - product overview, Introduction, Terminology – Welch Allyn SureTemp PlusModule - User Manual User Manual

Page 7: Intended use, Introduction terminology intended use

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SureTemp Plus Module OEM Implementation

Product Overview

Welch Allyn OEM Technologies

Confidential

7

1 - Product Overview

Introduction

Temperature is a critically important vital sign that most often affects patient treatment decisions.
Various therapies and studies are initiated or withheld based on a patient’s temperature.
Therefore, determining a correct temperature is vital to patient care. SureTemp® Plus
thermometry provides fast and accurate temperature readings.

The Welch Allyn SureTemp Plus module is a fully integrated, microprocessor-based thermistor
thermometer design. This proprietary Welch Allyn predictive technology provides fast, accurate
readings. Oral/axillary and rectal probes utilize single-use disposable probe covers that help to
reduce cross-contamination.

The SureTemp Plus module is designed to control and acquire data from an external Welch Allyn
proprietary thermometer. The SureTemp Plus module calculates temperature measurements
and outputs this data to a host system via a serial communications interface.

Terminology

Patient temperature can be measured via an oral/axillary or rectal probe. A proprietary Welch
Allyn predictive algorithm in conjunction with the thermistor based thermometer is used for fast
predictive-mode temperature measurement or monitor-mode temperature measurement.

Predictive temperature measurement: Thermometers that render a temperature reading before
steady state is achieved are classified as Predictive Thermometers. Predictive Thermometers
reduce the time required for measurement by using algorithms to predict what the temperature
would be if the probe were left in place until steady state is achieved.

Monitor-mode temperature measurement: A function or mode of an electronic thermometer used
to continuously monitor temperature until it reaches the thermal steady state (unchanging). The
thermal steady state is achieved through an oral or rectal measurement in approximately 3
minutes and through an axillary measurement in approximately 5 minutes.

Intended Use

The Welch Allyn SureTemp Plus module is intended for use as a subsystem within a medical
instrument or device. It is designed for use on adult (18 years and older) and pediatric (17 years
and younger) patients. The module and its accessories should always be used as described in
the Host system operator’s manual and only for the purpose(s) intended.

The most common user is a nurse or skilled health-care professional (EMT, paramedic,
respiratory therapist, clinical engineer, and so on).

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