RespiraSense
™
Instructions For Use
RespiraSense
™
PDS-801-007 Revision 2
Page
4
of
77
Warnings
Do not modify the RS Device
without the authorisation of the manufacturer. Modification of the
device can lead to serious personal injury and/or failure to monitor patient.
The RS Device
measurement results should be scrutinised in light of the condition of the specific
patient. Any results that are inconsistent with the clinical status of the patient should be
rechecked and/or supplemented with additional physiological data. Failure to adequately assess
the patient can lead to unnoticed adverse events.
The RS Device
should be considered as an early warning device. Failure to adequately assess the
patient can lead to unnoticed adverse events.
The RS Device
is not to be used on infants or neonates. Use of the RS Device on infants or neonates
can result in misdiagnosis, failure to monitor patient and tearing of skin.
Do not interface RS Device
with any equipment, accessory or device not described in these
Instructions for Use. Interface with non-authorised equipment can lead to breakage of Device,
battery explosion and failure to monitor patient. Check with authorised distributor if in doubt of
any component.
Do not use RS Device
on patients who are acutely ill or clinically unstable in the home healthcare
environment. Use in this way will lead to failure to monitor the patient. Check with issuing
organization if in doubt.
Do not use the RS Device
adjacent to or stacked with other equipment as this may impede the
correct operation of the Device. If such use is necessary, this equipment and the other equipment
should be observed to verify that they are operating normally.
Use of portable accessories, transducers and cables other than those specified or provided by the
manufacturer of this equipment could result in increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in incorrect operation.
Do not use portable Radio Frequency communications equipment (including peripherals such as
antenna and external antennas) within 30 cm (12 inches) to any part of the RS Device. Otherwise,
degradation of the performance of this equipment could result.
Do not use any part of the RS Device
during magnetic resonance imaging (MRI) scanning, or other
medical imaging procedures. Induced current could potentially cause burns, tearing of skin and
damage to equipment. The RS Device can affect the imaging procedure, and the MRI can affect
the accuracy of the RS Device measurements.
