PMD RespiraSense RS Device, Инструкция по эксплуатации

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RespiraSense
™
Instructions For Use
RespiraSense
™
PDS-801-007 Revision 2 Page 12 of 77
S
ECTION
1 - O
VERVIEW
About This Manual
This manual describes how to set up and use the RS Device system with its associated equipment.
Important safety information relating to can use of the system appears before this overview. Other
important safety information is located throughout the manual where appropriate.
WARNING Read the entire safety information section before you operate the RS Device
Failure to follow instructions may result in serious injury and/or failure to monitor
breathing. If in doubt, contact issuing organisation or authorised dealer.
WARNING Refer to Section 12 for details on how to access IFU on the website.
Notification of Warnings, Cautions, and Notes
Please read and follow any warnings, cautions and notes that appear in this manual.
The following table provides descriptions of these.
WARNING Provided when actions can result in a serious outcome such as injury or death to
the patient or operator. The text in a warning is in bold. Harm associated with
warning is also presented.
CAUTION Provided when special care needs to be exercised by the patient or operator to avoid
patient injury or damage to the product.
Note Provided when additional general information is required.
Respiratory Rate Monitor Overview and Terminology
Product Overview
RS Device Description
The RS Device is comprised of the RespiraSense
™
Lobe (hereafter the Lobe), the reusable component
that houses the RS Device’s electronics, and a single use adhesive RespiraSense
™
Sensor (hereafter the
Sensor). The Lobe and Sensor connect via a secured FPC and are mechanically fastened together using
a plastic Cradle. The Lobe and Sensor are placed on the left-
hand side of a patient’s torso. The RS
Device is intended to be used with a supported mobile medical application to monitor a patient’s RR
status.
The Lobe is rechargeable. It is designed to be charged using the supplied Charging Station. Charging
must be done outside of the immediate patient environment.
The separated RS Device components are shown in Figure 1 and Figure 2. A detailed description of the
components and the interactions between components will be presented later in this IFU. The
components are as follows:
● The Sensor : An adhesive, single-patient, single-use sensor array.
● The Lobe : A reusable electronics module, housing data processing, Bluetooth communication
module, LEDs and sounder.