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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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

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Changing Password ............................................................................................................................ 48
Password Complexity......................................................................................................................... 48
Set Result Screen Timeout................................................................................................................. 48
System Check ..................................................................................................................................... 48
Tablet Restrictions ............................................................................................................................. 49
Installing Application from Distribution Service ................................................................................ 49
Default Settings.................................................................................................................................. 49
Section 6 –Troubleshooting and App Messages .................................................................................. 51
Application Messages ........................................................................................................................ 51
Troubleshooting................................................................................................................................. 52
Patient Registration ........................................................................................................................... 52
Reading Respiratory Rate Data from Lobe......................................................................................... 54
Alarm Scenario and Red LED.............................................................................................................. 56
Section 7 –Product Specification.......................................................................................................... 58
Physical............................................................................................................................................... 58
Environmental.................................................................................................................................... 58
Battery................................................................................................................................................ 58
Sounder.............................................................................................................................................. 58
Compliance......................................................................................................................................... 59
Respiratory Rate Measurement Limits .............................................................................................. 59
Non-Invasive and Continuous Respiratory Rate Monitoring Compared to Electrocardiogram and
Nurse Evaluation............................................................................................................................. 59
Sensor Specification........................................................................................................................... 60
Alarm Generation Criteria.................................................................................................................. 61
Alarms ................................................................................................................................................ 61
Display/Indicators .............................................................................................................................. 61
CE Notice............................................................................................................................................ 62
Section 9 - Service and Maintenance.................................................................................................... 65
Introduction ....................................................................................................................................... 65
Cleaning.............................................................................................................................................. 65
Disposal.............................................................................................................................................. 65
Functional Verification....................................................................................................................... 65
Service and Repair.............................................................................................................................. 66
Repair Policy ................................................................................................................................... 66
Expected Service Life.......................................................................................................................... 66

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Shelf Life (Sensor)............................................................................................................................... 66
Section 10 –Associated IT Equipment .................................................................................................. 67
Section 11 –Associated Mobile Medical Applications.......................................................................... 69
Description of the RS App Air Mode .................................................................................................. 69
Air Dashboard ................................................................................................................................. 69
Section 12 –Warranty and Agreements ............................................................................................... 72
PMD Solutions Limited Warranty....................................................................................................... 72
Sales and End-User Licence Agreement............................................................................................. 72
Warranty ............................................................................................................................................ 72
Exclusions........................................................................................................................................... 72
End-User Licence................................................................................................................................ 73
Restrictions......................................................................................................................................... 73
Section 13 –Requesting IFU.................................................................................................................. 74

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SECTION 1-OVERVIEW
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.

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Figure 1 Sensor in Packaging Figure 2 Lobe
Figure 3 RS Device with Sensor and Lobe together
The RespiraSense is used with the following associated IT equipment:
A portable hand-held device, typically a tablet computer, onto which the Associated Mobile Medical
Applications are installed and operated . The main Associated Mobile Medical Applications are show
in Table 2. These Instructions for Use will concentrate on the Respiratory Rate Monitoring application.
The instructions for Use for the other available applications can be found in Section 11 –Associated
Mobile Medical Applications. There may be minor visual differences between the applications when
used on different devices.

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Table 2 List of Associated Mobile Medical Applications
Name of Application
Clinical Indication
RespiraSense RS App
Continuous and motion tolerant monitoring of
respiratory rate
Product Description
The RS Device is a non-invasive, wireless, Respiratory Rate (RR) monitor that is worn on the body of
the patient. It is internally powered and enables continuous RR monitoring from a single application.
It is designed to enhance the ability of medical staff to reliably measure respiratory rate.
The Lobe can emit an audible alert if a physiological alarm condition is met. This occurs if the measured
respiratory rate exceeds either lower or upper threshold limits. These limits are defined by the
operator during the setup of the RS Device and can be redefined by the user by connecting to a RS
Device in use.
The RespiraSense™Respiratory Rate Monitor is comprised of the RS Device and the RS App. The RS
Device is assembled then placed on the left-hand side of the patient’s torso. The RS App is used to
communicate with the Lobe and Sensor during patient registration and while in use. This is supplied
on a portable hand-held device that allows easy data retrieval and display.
The RS App is compatible with mobile computers that comply with EN IEC 60950-1 and have the
appropriate software and hardware specifications. These specifications are detailed in Section 7 –
Product Specification of this manual.
Position of Users
During normal use, the RS Device is attached using a medical grade adhesive patch to the Patient.
The Operator, a trained medical professional, registers a RS Device to a patient using the RS App and
subsequently monitors them using the app. The Operator comes into contact withthe RS Device during
registration and attachment to the patient, and during removal and disposal.
Features and Benefits
The following are the key features and benefits of the RR Monitor:
●Clinically proven technology
●Motion tolerant monitoring
●Continuous respiratory rate monitoring
Indications for Use
It is important to note the following:
●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 as the data that it collects simply
indicates the patient’s respiratory rate. Clinicians use this data to help make or rule out
possible diagnoses.

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●In default configuration, the RS Device can emit an audible and visible alert if the measured
respiratory rate exceeds pre-determined thresholds. The user can override the default settings
to suppress Sounders and visible alerts.
●The respiratory rate information that the RR Monitor 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 is not to be used for neonatal or infant monitoring.
●Do not use the Device during defibrillation.
●Do not use the Device during MRI, X-Ray or other medical imagining procedures.
●Do not use the Device in Oxygen Rich environments.
Principles of Operation
The Device provides a continuous, non-invasive method of monitoring patient’s respiratory rate.
Respiratory Rate
Respiratory Rate (RR) is the number of breaths taken within a set amount of time, typically 60 seconds.
This is also known as respiration rate, respiration frequency, ventilation rate, ventilation frequency,
pulmonary ventilation rate or breathing frequency. Respiratory rate is a vital sign and can help in the
assessment of the health status of a patient. Respiratory rates can change with fever, illness, or other
medical conditions.
For ventilation to occur, some sort of mechanical displacement of the thoracic and/or abdominal
region must take place.
The respiratory rate is the effect of the intercostal muscles across the ribcage contracting. This causes
the sternum to lift and expand outwards across the ribs. These mechanical actions create a vacuum in
the thoracic region of the body, which is compensated by air flowing from the environment into the
lungs via the facial cavities –the nose and the mouth.
Ventilation also occurs mechanically when the abdomen displaces and creates a vacuum and/or drop
of the diaphragm. The diaphragm is a band of muscle under the lungs that separates the thoracic
regions from the abdominal region. The displacement of the abdomen has the same result as the
displacement of the ribcage: air flows into the lungs through the nose and mouth.
If any problems are indicated by circulatory condition or skin integrity, remove the Sensor from the
patient.
CAUTION
Do not use damaged Sensors.
CAUTION
Do not immerse the Sensor in water, solvents, or cleaning solutions (the Sensors and
connectors are not waterproof).
CAUTION
Do not sterilise Sensors by irradiation, steam, autoclave, or ethylene oxide (unless
otherwise indicated on the Sensor directions for use).
CAUTION
Do not attempt to reprocess, recondition, or recycle Sensors as these processes
could damage the electrical components, and lead to patient harm.

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CAUTION
Single patient use. Do not use the sensor on more than one patient after application
Monitoring during Motion
The RS Device measures respiratory rate during motion. However, the method of monitoring also
detects non-breathing motions that can occur during talking, walking, limb movement or other similar
actions. Note there is a decrease in accuracy during patient movement. In cases of extreme or
prolonged motion the RS Monitor will refrain from providing a RR data point if the result is determined
to be of insufficient certainty.
Declaration of Essential Performance
The following Essential Performance criteria have been declared for RS Device:
●Measurement of Respiratory Rate within specified accuracy/error limits.
●Sounding of the Alarm on respiration limit violations.
Specific details on the accuracy limits and alarm generation criteria can be found in Section 7 –
Product Specification.
Intended Users
The RS Device is intended to be used by trained medical personnel only.

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SECTION 2-SYSTEM DESCRIPTION
In this section a description of the main features of the RespiraSense™ Device and associated mobile
medical applications available. Detailed instructions on the use of the RS APP are found in Section 3–
Patient Monitoring.
1. RespiraSense Lobe and Sensor
Figure 4 shows the Lobe and Sensor assembly and operational features.
Figure 4 RespiraSense Lobe and Sensor Assembly and Underside

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2. RespiraSense Device Charging Station
Figure 5: Multi Charger Dock
Table 3 Feature of the Multi Charger Dock
Referenc
e
Name
Description
1
Lobe charging slot
The resting place of the Lobe during charging and
storage
2
Power indicator
Green LED to indicate power is supplied to the
Charger
3
Micro suction Pad
A non-adhesive based material used to secure the
Lobe in the charging Slot
4
Power Plug
The port for the power adapter
5
Auxiliary USB Charger
A USB charging port for associated equipment

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3. RS App
RS App is the RespiraSense RS Application that allows a user to register RS device with a patient and
monitor RR data.
Figure 5 shows the RS App Dashboard. This is the default screen displayed when the application is first
started.
Accessing the Dashboard displays a list of all nearby RS Devices which are monitoring patients. A
summary of up to four RS Devices are shown, with more available using a scroll interface when
required. The device list can then be scrolled by holding a finger on the screen and dragging it up and
down the screen. An overview of the Dashboard is shown in Figure 5 below. Details of the Patient
Information Panel are presented later.
The Dashboard also allows access to patient registration interfaces and the help and settings options.
Figure 6: RS App Dashboard
2
1
4
3
6
1
7
5
1
8