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Guidelines, Temperature site indication, Oral mode – Welch Allyn SureTemp PlusModule - User Manual User Manual

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Guidelines

SureTemp Plus Module OEM Implementation

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Confidential

Welch Allyn OEM Technologies

Guidelines

Welch Allyn strongly recommends that you follow these guidelines for making the SureTemp Plus
technology consistent across all implementations.

The Host system should consider the advantages that the SureTemp Plus handheld device offers
as a standard in predictive thermometry. User recognition is an important factor when selecting a
technology to include in a Host system.

The Welch Allyn handheld devices have been setting expectations as to how the technology is
used in other products. It is in the best interest of Welch Allyn and the OEM customer to make
the look, feel, and usage consistent for this technology when integrated into other medical
devices.

To assure consistency, consider the following topics:

Temperature Site Indication

Audible Signals

In-Progress Indication

Algorithm Indication

Temperature Site Indication

Always provide an indicator to inform the user as to which measurement site is selected in the
device. Options for displaying the temperature-taking sites are described below.

Note: If icons are used, the FDA requires that they be described in English. This can be
accomplished by adding a label to the finished device that defines the icons.

Oral Mode

Figure 5. Ways to Display the Oral Mode

Preferred

To indicate the oral mode, display an upright body icon with a flashing
head (Figure 5) and the word ORAL.

Acceptable

If a graphical display cannot be accomplished, display the word ORAL
or the abbreviation ORL.

Not acceptable

To provide no indication, or to use any other abbreviation (such as O,
OR, OL) or other inappropriate indicator, is not acceptable.

ORAL

ORL