RespiraSense
™
Instructions For Use
RespiraSense
™
PDS-801-007 Revision 2
Page
65
of
77
S
ECTION
9
-
S
ERVICE AND
M
AINTENANCE
Introduction
This section provides information about how to clean the RS Device and obtain service. No part of the
RS Device should be cleaned or serviced while attached to the patient.
Cleaning
The Lobe should be cleaned and disinfected:
●
If any part of it becomes soiled.
●
After removal from a patient.
●
Before application to a new patient.
●
Before and after charging cycle, even if it is to be placed on the same patient after charging.
This requirement mandates that the maximum time between cleaning will be 4 days when the
Lobe is in use.
To clean and disinfect the Lobe:
1.
Remove the Sensor and Lobe from the patient.
2.
Disconnect the Sensor from the Lobe.
3.
Wipe the entire Lobe with a 70 % isopropyl alcohol pad, or with hospital equivalent.
4.
Allow to air-dry thoroughly before reuse.
In cases where the Sensor has also been soiled, discard Sensor and apply new Sensor as per Instructions
for Use.
CAUTION
Do not autoclave, pressure sterilise, or gas sterilise the RS Device.
CAUTION
Do not soak or immerse any part of the RS Device in any liquid.
CAUTION
Use cleaning solutions sparingly. Excessive solution can flow into the RS Device and
cause damage to internal components.
CAUTION
Do not touch, press, or rub the display panels with abrasive cleaning compounds,
instruments, brushes, or rough-surface materials, or bring them into contact with
anything that could scratch the panel.
CAUTION
Do not use petroleum-based or acetone solutions or other harsh solvents to clean
the RS Device. These substances affect the RS Device’s materials and device failure
can result.
Disposal
Used Sensors should be disposed of according to hospital procedure for medical waste. Sensors are
for single use only.
Functional Verification
Functional verification is carried out using one of the supported mobile medical applications.
See
PDS-801-001: RespiraSense Respiratory Rate Monitor Instructions for Use
for details on how to use
the functional verification features
built into the RespiraSense Respiratory Rate Application.
