PMD RespiraSense RS Device User manual

RespiraSense™PDS-801-007 Revision 2 I
RespiraSense™
Instructions for Use
Instructions for Use
English
PDS-801-007
The Instructions for Use are intended to provide the necessary information for the correct operation
of the RespiraSense™Device.
General knowledge of respiratory rate, patient vital monitoring and qualifications in healthcare are
prerequisites for correct use of the RespiraSense™Device by an operator.
The primary function of the RespiraSense Device is Respiratory Rate monitoring. Associated
applications for monitoring Dysfunctional Breathing are included within this Instructions for Use.

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Instructions For Use
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The RespiraSense™, herein called the ‘RS Device’, Instructions for Use are intended to provide the
necessary information for the correct operation of the Medical Device.
General knowledge of respiratory rate and patient vital monitoring, qualifications in healthcare, and
the use of this Medical Device are prerequisites for correct use by an operator.
Do not operate the RS Device without fully reading and understanding these instructions.
Do not operate the RS Device without receiving training in its use from an authorised trainer.
The RS Device must only be installed and put into service in accordance with the information provided
in this documentation and referenced documentation.
Notice
Purchase or possession of this Medical Device does not carry any express or implied licence to use with
replacement parts which would, alone or in combination with this Medical Device, fall within the scope
of one of the relating patents.
This Medical Device is only for sale within the European Union.
For more information contact the legal manufacturer:
1639
Legal Manufacturer
PMD Solutions
Bishopstown House,
Model Farm Road,
Cork,
Ireland
T12 T922
Tel: [phone]
customerservice@pmd-
solutions.com
www.pmd-solutions.com

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Terminology
Table 1 provides a definition of the key terms used in this manual.
Table 1: Definitions of Key Terms
Term
Definition
Instructions for Use
Instructions for Use
Barcode
Rectangular optical machine-readable code for identification
bpm
Breaths per minute
dB
Decibel
ECG
Electrocardiogram
EMC
Electro Magnetic Compatibility
FPC
Flexible Printed Circuit
IP
Ingress Protection (ingress of dust and vertical dripping water)
IT
Information Technology
LED
Light Emitting Diode
Lobe
The electronic component of the RS Device
MAC
Medicare Administrative Contractor
MRN
Medical Record Number
QR code
Square matrix type barcode for product identification
RespiraSense™
Trade name of the medical systems manufactured by PMD Solutions and
intended for use as a medical device
RR
Respiratory Rate
Sensor
The sensing component that is affixed on the patient body
RS Device
The combination of Lobe and Sensor
RS App
RespiraSense™Application which has Accessory connectivity features
along with RR measurement
RR App
RespiraSense™Respiratory Rate Monitoring App
RS System
The complete combination of Lobe and Sensor in addition to an
associated mobile application
Trend line
Trend of respiratory rate values over time

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Indications for Use
●The RS Device is intended to act as a short-term continuous monitoring device. It assesses
respiratory performance over time by continuously recording, storing, and periodically
transmitting respiratory rate data.
●The RS Device does not perform a diagnostic function, the data that it collects simply displays
the patient’s respiratory rate. Clinicians use this data to help make or rule out possible
diagnoses.
●The RS Device can emit an audible alert if the measured respiratory rate exceeds pre-
determined thresholds.
●The respiratory rate information that the RS Device obtains must be evaluated by clinicians on
a case-by-case basis.
●The RS Device may record abnormal data. Any abnormal data must be evaluated by a clinician.
Clinicians should assess additional physiological parameters or run additional tests before
making a diagnosis and prescribing treatment.
●The RS Device can be used in the home environment as instructed by a clinician operator.
While in use in the homecare environment, the RS Device can be worn by a patient, including
while sleeping overnight. The device can monitor the patient’s respiratory rate and provide a
record for subsequent review by any healthcare practitioner.
●The RS Device can be used as a sleep apnoea monitor. Data must be evaluated by a clinician
before clinical intervention.
Contraindications
●It is not to be used on neonates or infants (as defined by the FDA: Paediatric subpopulations
are defined in Section 520(m)(6)(E)(ii) and adopted reference in Section515A of the FD&C Act).
The device will be for use on adolescents and adults only.
●Do not use the RS Device during defibrillation.
●Do not use the RS Device during MRI, X-Ray or other medical imaging procedures.
●Do not use the RS Device in an oxygen rich environment.

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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.

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Cautions
The RS Device is to be operated by qualified personnel only. This manual and all precautionary
information and specifications should be read before use.
The RS Device mobile medical software application does not record or centralise any clinical
information for the purpose of retaining patient records. Historical information is stored on the Lobe
for the purpose of reference; however, it is deleted when the Lobe is recharged.
Only use the RS Device in line with the instructions in this manual.
During application, operators must ensure that the RS Device alarm limits are set in accordance with
the clinical guidelines of the hospital.
The alarm signal of the RS Device reaches a nominal sound pressure level of 64 dB maximum at one
meter in front of monitor.
In cases of high or low respiratory rate readings, the clinical status of the patient should be assessed
by a healthcare professional and/or supplemented with additional physiological data.
Do not place the RS Device in any position that could cause it to fall on the patient.
Always remove the Lobe and Sensor from the patient and completely disconnect the RS Device from
the patient before bathing the patient.
Do not place the RS Device or any associated IT equipment where the controls or settings can be
changed by the patient unless required to e.g. self-care in community.
Do not place the RS Device on high powered electrical equipment as it could prevent the device
from working correctly.
Changes or modifications not expressly approved by the party responsible for compliance could void
the operator's authority to use the equipment.
Respiratory Rate is empirically calculated according to the displacement measurements the Sensor
detects in the chest and abdomen during breathing and other non-breathing movements (coughing,
sneezing, talking, motion). The accuracy of the RS Device is reduced during periods of excessive or
continuous motion by the patient.
Instruct patients to avoid heavy electrical equipment or other sources of electromagnetic
interference, such as electric blankets and heating pads while wearing the RespiraSense to ensure
the most accurate measurements. Equipment such as electric blankets and heating pads are
included as sources of interference.
Inaccurate respiratory rate measurements can be caused by:
-Motion artefact
-Electromagnetic radiation interference
-Apnoea events
-Misplacement
-Use of device beyond working life
Setting the alarm limits to extreme values may render the alarm functionality useless.
In cases where the Alarm LED and/or Sounder have been disabled, system feedback will be reduced.
Examine Patient Information to determine expected system feedback.

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The System is not to be interfaced with any Network or IT equipment not specified in these
Instructions for Use.
In environments with a large number of Bluetooth devices, updates to the Respiratory Rate
Application may be delayed.
Notes
The mode of operation of the RS Device system is continuous.
Guide to Packaging and Labelling Symbols
The following table defines the symbols that are found on the packaging and labelling of the Device.
Symbol
Caution Symbol Description
NAME AND ADDRESS OF LEGAL MANUFACTURER
DATE OF MANUFACTURE
LOT OR BATCH NUMBER
DO NOT USE IF PACKAGE IS DAMAGED
KEEP DRY
UPPER AND LOWER TEMPERATURE LIMITS
HUMIDITY LIMITATION
SINGLE USE
USE BY
DECLARATION OF CONFORMITY (MDD 93/42/EEC) ANNEX II
DECLARATION OF CONFORMITY (FCC)
TYPE BF APPLIED PART IEC 60601-1
Ingress Protection against the ingress of dust and vertical dripping water ingress. (IP
54)
Identifies electrical equipment designed primarily for indoor use
Non-ionizing electromagnetic radiation
Serial number

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Electronic instructions for use available on the software application
Consult Instructions for Use
Direct Current (DC) Input/output
Caution
WEEE Symbol

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TABLE OF CONTENTS
Terminology ......................................................................................................................................... 2
Indications for Use ............................................................................................................................... 3
Contraindications................................................................................................................................. 3
Warnings .............................................................................................................................................. 4
Cautions ............................................................................................................................................... 5
Notes.................................................................................................................................................... 6
Guide to Packaging and Labelling Symbols.......................................................................................... 6
Section 1 - Overview.............................................................................................................................. 12
About This Manual............................................................................................................................. 12
Notification of Warnings, Cautions, and Notes.................................................................................. 12
Respiratory Rate Monitor Overview and Terminology...................................................................... 12
Product Overview ........................................................................................................................... 12
RS Device Description ..................................................................................................................... 12
Product Description ........................................................................................................................... 14
Position of Users............................................................................................................................. 14
Features and Benefits..................................................................................................................... 14
Indications for Use.......................................................................................................................... 14
Principles of Operation ...................................................................................................................... 15
Respiratory Rate ............................................................................................................................. 15
Monitoring during Motion.............................................................................................................. 16
Declaration of Essential Performance................................................................................................ 16
Intended Users................................................................................................................................... 16
Section 2 - System Description.............................................................................................................. 17
Dashboard –Patient Information Panel ............................................................................................ 20
Respiratory Rate Measurement - Function Screen............................................................................ 21
Threshold Alteration and Indicator Alteration Interface ................................................................... 23
Settings Change Acknowledgment Screen......................................................................................... 24
Addition of an Accessory.................................................................................................................... 25
Alarm Function................................................................................................................................... 25
Lobe - Low Battery Warning............................................................................................................... 26
Checking Battery Levels.................................................................................................................. 26
Connection Selection Section ............................................................................................................ 27
Rename Confirmation Screen ............................................................................................................ 28

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Side Menu .......................................................................................................................................... 29
Section 3–Patient Monitoring .............................................................................................................. 33
Introduction ....................................................................................................................................... 33
Preparation for Monitoring................................................................................................................ 33
Step 1: Registration of a Lobe............................................................................................................ 34
Step 2: Assembling the Lobe and Sensor........................................................................................ 35
Step 3: Attaching the RS Device to the Patient............................................................................... 35
Step 4: Multiple Patient Monitoring through Dashboard.................................................................. 36
Step 5: Priority Patients ..................................................................................................................... 37
Step 6: Obtaining Detailed Respiratory Rate Measurements............................................................ 37
Step 7: Dealing with Alarm Events..................................................................................................... 38
Step 8: Alter Respiratory Rate Thresholds during Monitoring........................................................... 39
Step 9: Alter LED and Sounder Settings ............................................................................................. 39
Step 10: Removal, Disposal, and Recharging..................................................................................... 40
Using the RS Device in the Home Healthcare Setting........................................................................ 41
Limitations of Respiratory Rate Monitoring Outside of a Clinical Environment ............................ 41
Setup for Home Use........................................................................................................................... 41
Home User Maintenance ................................................................................................................... 41
Environmental Considerations........................................................................................................... 41
Degradation of Device........................................................................................................................ 42
Children and Pets............................................................................................................................... 42
Movement.......................................................................................................................................... 42
Electromagnetic Interference ............................................................................................................ 42
Section 4 - Alarms and Indicators.......................................................................................................... 43
LED Function ...................................................................................................................................... 43
Sounder Function............................................................................................................................... 44
Alarm Condition ................................................................................................................................. 44
Alarm Limits ....................................................................................................................................... 44
Alarm Pause ....................................................................................................................................... 44
Alarm Function................................................................................................................................... 44
Alarm Notification.............................................................................................................................. 46
Section 5 –Configuration and Advanced Features............................................................................... 47
Accessing the Settings Menu ............................................................................................................. 47
Set Default Thresholds....................................................................................................................... 47