DT710 Semester 1 Final Report - Team3-CPR-Project

Dublin Institute of Technology
Department of Mechanical Engineering
Innovating the CPR Mask
Year DT710-4
Module title Team Design Project
Lecturer Name Graham Gavin, Claire Brougham,
Ken Keating
Students Names Sean Stack,
Morven Gannon,
Andrew O’Shaughnessy,
Safwan Alhadeedy
Student Number C12564907
C12760661
C08669252
D15123213

i
Abstract
The purpose of this report is to improve the design and the performance of the standard CPR
(Cardiopulmonary Resuscitation) pocket mask. This is a team design project that is to be
completed as part of a team with four members. This report has been carried out as part of the
Medical Device Innovation program (DT710-4) in the Dublin Institute of Technology.
The aim of this project if to improve the quality of air in a CPR mask from 16% oxygen to
the standard atmospheric quantity of 21% oxygen.

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Declaration
I hereby certify that this material, which I now submit for assessment on the programme of
study leading to the award of Bachelor of Science (Medical Device Innovation), is entirely
my own work and has not been submitted for assessment for any academic purpose other
than in partial fulfilment for that stated above.
Signed:
1. ............................................
2. ............................................
3. ............................................
4. ............................................
Date...............................................

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Table of Contents
Abstract.......................................................................................................................................i
Declaration.................................................................................................................................ii
Table of Contents..................................................................................................................... iii
Table of Figures .........................................................................................................................v
Table of Tables ..........................................................................................................................v
1.0 Introduction..........................................................................................................................1
1.1 The Statement of Intent....................................................................................................2
2.0 Literature Review.................................................................................................................3
2.1 For Who and where is CPR used? ...................................................................................3
2.2 How is CPR carried out?..................................................................................................3
2.3 An Existing Product.........................................................................................................3
2.3.1 The CPR Bag Valve..................................................................................................4
2.4 How will this benefit CPR? .............................................................................................5
2.5 Material Properties...........................................................................................................6
2.5.2 Silicone .....................................................................................................................6
2.5.1 PVC...........................................................................................................................6
2.5.3 Thermoplastics..........................................................................................................6
2.6 Market Research ..............................................................................................................7
2.6.1 Defining the Market:.................................................................................................7
2.6.2 CPR Providers Market Analysis ...............................................................................8
2.6.2.1 Interviews...........................................................................................................8
2.6.2.2 Research.............................................................................................................8
2.6.2.3 The Questionnaire..............................................................................................8
2.6.2.4 Conclusions........................................................................................................9

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3.0 Product Design Specifications...........................................................................................10
4.0 Concept Design..................................................................................................................12
4.1 Concept 1 “Bag Incorporating Attachment Device” .....................................................12
4.2 Concept 2 “Balloon Incorporating Attachment”............................................................13
4.3 Concept 3 “Diaphragm Incorporating Attachment Device”..........................................14
5.0 Calculations........................................................................................................................15
6.0 Final Design.......................................................................................................................16
7.0 Discussions and Conclusions.............................................................................................18
7.1 Marketing Plan...............................................................................................................18
7.1.2 Phase 1: Partial Market Entry or Full Market Exit .................................................18
7.1.3 Phase 2: Full Market Entry .....................................................................................18
7.2 AmbiValve “Ambient Air Attachment” ........................................................................19
7.3 Materials & Manufacturing............................................................................................19
7.4 Possible Changes ...........................................................................................................20
References................................................................................................................................21
Appendixes-A ..........................................................................................................................22
Appendixes-B ..........................................................................................................................27
Appendixes-C ..........................................................................................................................34
Appendixes-D ..........................................................................................................................42

v
Table of Figures
Figure 1: The Bag Concept......................................................................................................12
Figure 2: The Balloon Incorporating Intraoral Device ............................................................13
Figure 3: The Diaphragm Incorporating Attachment Device..................................................14
Figure 4: The Pugh design process model adapted and employed for the three selected
concepts....................................................................................................................................16
Figure 5: AmbiValve Ambien Air Attachment w/ Intraoral Mask..........................................19
Table of Tables
Table 1: Results for dimensions of the device.........................................................................15
Table 2: 2 Tiered design refinement matrix.............................................................................17

1
1.0 Introduction
The clients brief stated that there were a number of faults with the standard CPR mask along
with several unlisted faults.
In this report the key focal point of the project is to improve the quality of air being supplied
to the patient undergoing manual CPR with a first responder. By carrying out this
improvement it will inadvertently create a further barrier which will act as a seal between the
patient and operator to prevent the spread of contact pathogens.
Currently 1 in 12 patients that suffer a cardiac arrest and need CPR outside of the hospital
setting will survive. This low survival rate is due to the issue around the quality of the CPR
given to the patient i.e. with the strong chest compressions and quality of air. It has been
noted in reports that approximately 460,000 patients die in America each year from improper
use of CPR [1]. This can be due to people carrying out CPR incorrectly or by Emergency
Services personnel being unable to perform proper chest compression while in the back of the
ambulance [1].
At present, atmospheric air contains 21% Oxygen (O2) and 0.039% Carbon Dioxide (CO2)
[2]. On the other hand when a person exhales and breaths out these percentages change to
just 16% O2 and 4% CO2 [3]. This rise in CO2 is 100 times larger than what the human body
is used to. Therefore during the CPR process, whether the person is carrying out the process
using “mouth to mouth” or using a standard CPR mask, the air quality being delivered to the
patient is insufficient [4].

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1.1 The Statement of Intent
The aim of this project is to improve the quality of air being supplied to a patient undergoing
Cardiopulmonary Resuscitation (CPR). The quality of air being delivered can be improved by
supplying ambient air to the patient by using an add-on device that can be fitted onto a
regular CPR mask. This must be a purely manually operated system that is controlled by the
operator’s breath. By achieving this aim it will ensure that the new device will benefit the
patient and improve the CPR process and increase the survival rate.
This will be done by increasing the Oxygen levels from 16%-21% and decreasing the Carbon
Dioxide levels from 4%-0.04%. By creating an ambient air environment for the patient it will
also create a barrier between the operator and patient which will prevent the spread of
pathogens in either direction. This is particularly beneficial for immunocompromised
patients.
The final design must not only improve the air quality but it must also not slow the process
down. This means that the product itself should not need any excessive training.

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2.0 Literature Review
2.1 For Who and where is CPR used?
The proposed CPR device will focus on a bystander and first responder in the event of
cardiac arrest in various scenarios, namely heart attacks, strokes, drowning or sudden adult
death syndrome. The device will cater for all age groups and will not be hindered by facial
deformities or facial hair due to the intraoral construction.
The proposed device will be used following cardiac arrest in everyday situations primarily.
Further use in ambulances will be facilitated by the device to provide an influx in oxygen
levels for the patient.
Furthermore, in situations where the oxygen levels are low (factory conditions, high altitude
conditions) the device will facilitate release of oxygen stores through material or mechanical
means.
2.2 How is CPR carried out?
In this section the topic of discussion is based on how CPR is carried out. CPR is extremely
important and if it is not carried out immediately or in the correct manner it can be
detrimental to a patient’s survival.
CPR is carried out using two stages. The first and most important part of carrying out CPR is
the chest compressions. Chest compressions are imperative and any prolonged pause can
result in the death of the patient. Chest compressions are carried out by pushing down on the
chest in a strategic position to force the heart to start beating. When this process is carried out
it causes the blood to flow around the body and keep the brain oxygenated.
The second step carrying out is delivering the rescue breaths. Between 500- 600mL of air
should be exhaled out of the rescuers lungs and into the patient. This quantity of air should
cause a rise in the patient’s chest as their lungs begin to fill up with the exhaled air [5].
The ratio of chest compressions to rescue breaths is 30 compressions to 2 rescue breaths i.e. a
ratio of 30:2 [6]
2.3 An Existing Product
A similar product that works on the same principle of supplying ambient air to the patient as
well as creating a seal from pathogens is the CPR Bag Valve. The CPR Bag Valve is most

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commonly used in the professional environment due to a high level of training needed to
operate it correctly without causing damage to the patient [7].
2.3.1 The CPR Bag Valve
A product that has the similar goal of reducing the C02 levels and increasing the oxygen
levels in the CPR mask is the CPR bag valve [7].
The CPR Bag valve has many key attributes such as:
 It supplies ambient air to the patient. The bag has a one way valve that allows the
operator to compress the bag. By compressing the bag it forces air into the CPR mask
and thus into the patients mouth. When the operator releases the bag it expands and
creates a vacuum that in turn draws the ambient air into the bag and the cycle
continues again. This aspect is a major selling point of the product as it ensures that
the patient is supplied with the correct levels of Oxygen and Carbon Dioxide [7].
 By removing the physical aspect of the operator having to exhale his/her breath into
the patient’s body it removes the possibility of transmitting an infection or disease
that the operator may have present in their system. By ensuring a supply of ambient
air it reduces the chances of cross contamination to the patient through the operator’s
breath [7].
 The operator uses his/her hands to compress the Bag Valve. This means that the
operator can monitor the situation more efficiently to assess the current state of the
patient. This means that as the operator is utilising the bag valve they can also monitor
the patient to ensure that the process is working by confirming that the patient’s chest
rises when the bag is being compressed. This will let the operator know that and
adequate amount of air is being delivered to the patients lungs [7].
By having the operator in a better position it also means that they can monitor the
patient to ensure that they have not regurgitated during the process. If the operator did
not notice that the patient regurgitated it would create serious problems for the patient
and it could result in a fatality [7].
However there can also be a number of drawbacks associated with the Bag Valve CPR mask:
 The lungs operate by flexing the Diaphragm in the body which in turn creates a small
vacuum in the lungs. This is what allows a person to draw in a sufficient amount of
air to breath. During CPR the operator changes this process by forcing air into the
lungs by compressing the Bag Valve [7].

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During the CPR process the operator may force air into the lungs at too high of a
pressure. By doing this the air is not only forced into the lungs but it also travels
through the oesophagus and into the stomach of the patient. This fault can result in
gastric inflammation which causes the patient to regurgitate which can be a hazard
during CPR [7].
Excess pressure can also lead to the stomach rupturing inside the patient causing a
fatality due to the stomach acids leaking out into the body [7].
2.4 How will this benefit CPR?
Two sets of pigs were compared and the effect of ventilation on acid-base
conditions and the result from cardiac arrest in a pig model of CPR was shown,
one group didn’t receive ventilation throughout the first 10 minutes of CPR and
the other one did, the study indicated that ventilation through the 10 minutes of
CPR after 6 minutes of untreated ventricular fibrillation was accompanied with
a considerably greater rate of ROSC compared with the set that didn’t receive
ventilation. The nonventilated set had considerably larger arterial and mixed
venous hypoxia and hypercarbic acidosis. These results propose that ventilation
is a vital element of CPR for the treatment of cardiac arrest and that hypoxia
and hypercarbia unfavorably affect resuscitation [8], both hypercarbia and
hypoxia individually had an opposing effect on resuscitation from cardiac arrest
[9]. Coronary perfusion pressure is identified to be one of the greatest factors of
effective resuscitation from cardiac arrest [10]. Studies using an isolated heart
model revealed that hypercarbia and hypoxia intensely reduce myocardial force
of contraction [11]. Other studies of the effects of P02, Pco2 and pH on the
success of defibrillation have stated that animals with greater hypoxia or
hypercarbic acidosis needed the uppermost dose of electrical energy for
defibrillation and failed resuscitation more often [12].
One study presented that ventilation with air throughout 6 mins of CPR caused
a return of spontaneous circulation in 10 of 12 animals compared with only 5 of
12 animals ventilated with exhaled gas (p<.04). Mixed-venous and Arterial Po2

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were considerably higher and Pco2 was considerably lower in the air ventilated
group. [13]
We can conclude from the previous studies that reducing carbon dioxide and
increasing oxygen to the ambient air percentages rather than the normal
exhalation can improve the CPR success rate.
2.5 Material Properties
In this section the topics of discussion are the materials that are most commonly used in a
CPR mask. By studying the material properties that make up the CPR mask it will give the
reader a better understanding of how the CPR mask operates and why these materials were
chosen (See Appendixes-A for full research on the materials and manufacturing of CPR
Masks).
2.5.2 Silicone
Silicone is ideal for use in a medical device as its formation is physiologically inert, making it
suitable across the three grades of medical device classification.
2.5.1 PVC
PVC is a polymer with a crystal clear appearance formulated for injection moulding and
extrusion. Its heat stability characteristics make it ideal for connectors, drip chambers and
medical catheters. [2]
2.5.3 Thermoplastics
Two thermoplastics polymers that are currently used in the manufacturing of CPR masks are
Polyethylene (PE) and Polypropylene (PP) due to their various material properties that make
them suitable for the purpose of this product [14].
A material classified as a thermoplastic polymers is a material that incorporates toughness,
resistance to chemical attack and recyclability. Thermoplastic polymers are an easy material
to mould and are relatively low in cost due to their wide availability and high demand.
Polyethylene (PE) is an inert material that is extremely resistant to acid wear and low in cost.
Polyethylene is also a very easy material to manufacture and mould, which can also be
manufactured in different colours [15].

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Polypropylene (PP) is a very similar material to PE as it contains the same material properties
such as it is resistant to acid wear. On the other hand PP is flammable but flame retardants
will ensure that the material is slow to burn in the event of a fire. To ensure that the PP has
stability “stabilizers” can be added to the material to increase the stability and can hold its
form correctly during operation [15].
All of these properties that are incorporated in the two thermoplastic materials (PE and PP)
are essential to the operation of the CPR mask and how it operates.
1. The materials resistance to acidic wear is imperative because it is not uncommon for
the patient undergoing CPR to regurgitate. As the patient regurgitates the fluid that is
excreted from their system contains acidic properties that is used in the breakdown of
food in the digestive system. If this resistance to acidic wear were not incorporated in
the material it could lead to premature failure of the material and a fatality with the
patient could be the end result [6].
2. As said previously thermoplastics in general are a very tough material. Toughness in a
material is its ability to withstand fracture [16]. The product itself is very flexible and
has a high elastic limit which means it will return back to its original shape. To create
an efficient seal on the patients face the operator has to push down and slightly
manipulate the CPR mask to get a correct seal prior to administering the rescue
breaths [5].
2.6 Market Research
2.6.1 Defining the Market:
It was determined early on in discussions, using SWOT analysis and initial market sector
analysis, that it would be more pragmatic to investigate CPR course providers within Ireland
than to investigate manufacturers of present CPR barrier device solutions for market
information (see Appendixes-B for full Market Research and Standrards). This would refine
our findings by:
 Eliminating confusing product promotion details
 Confine the research to the 271 course providers within Ireland
 Course providers having a greater grasp on the human element
 Course providers having a practical view of current equipment in use and could
point out any conflicts of use (i.e. defibrillator and possible fluids)
 Highlighting any blind spots in either the design or regulatory needs

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This would also offer a platform to introduce our product to the market sector.
2.6.2 CPR Providers Market Analysis
2.6.2.1 Interviews
Two emailed questionnaires where developed to target the CPR course providers. They were
sent to a limited number and made personal (distinguishable from junk mail) to try and
ensure an honest response, and designed not to be intrusive, leading or time consuming for
the responder:
2.6.2.2 Research
The first questionnaire email was sent to 18 course providers. Of which, there were 6
responses all with full answers (some in great detail). It was then decided that the questions
asked could be more direct in nature, so the questions where refined keeping these responses
in mind and amended to suit the current product specification.
The second questionnaire email was sent to 25 course providers, of which there were 7
responses. All of these responses where extensively detailed and used in modifying the
product specification.
2.6.2.3 The Questionnaire
The questions asked were:
1. How high would you rate CPR givers concerns over contact pathogens during mouth to
mouth resuscitation? - where 1 = low and 10 = high
 An average response of 8
2. How would you rate the ease of use of present CPR masks? - where 1 = low and 10 = high
 An average response of 6.5
3. What are your reservations regarding the use of a CPR bag valve mask by first aiders?
 All mentioned over application risks and lack of training
4. Are you aware of the difference in air quality between ambient air and exhaled breaths?
 All answered yes
5. What level of difference does air quality make in the outcome of a CPR event? - where 1 =
low and 10 = high
 An average response of 8
6. Do you think first aiders (excluding healthcare professionals) would commitment to a device
that put a greater distance between them and the CPR recipient?

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 83.33% said yes
7. Do you think first aiders (excluding healthcare professionals) would commitment to a device
that delivers a higher quality of air?
 83.33% said yes
8. If these problems were overcome, would you be prepared to amend your course content to
accommodate alternative methodology?
 83.33% said yes
 16.67% said it depended on complexity of device usage
9. What extra cost would your clients be willing to incur for solutions to these problems?
 33.33% said very little
 16.67% said not sure
 33.33% said €5.00
 16.67% said €10.00
2.6.2.4 Conclusions
This process benefitted the analysis by:
 Giving us contact to the market sector and a potential client base
 Defining the problem in practical user friendly terms
 Finding out if our solution is a requirement within the market sector
 Informing us of new developments within the sector (especially with regards
to new ILCOR guidelines which have been mentioned several times). Further
research will be directed towards ILCOR COSTR (International Liaison
Committee on Resuscitation) guidelines published on Friday 16th
October
2015.

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3.0 Product Design Specifications
At the beginning of any design project, it is imperative that the designer creates a product
specification list. A product specification list is essentially a “wish list” that the designer has
created from their research. This list would incorporate all the key aspects of the design to
ensure the product would meet all of its goals.
In this design project the key aims to accomplish are:
1. Increase the oxygen levels in the mask from 16% to 21%. At present the current
ambient percentage of oxygen in the air is 21%, while the air being supplied to a
patient undergoing CPR is 16% as it is exhaled from the operator into the patient’s
lungs.
2. Reduce the Carbon Dioxide levels from 4% to 0.04% (ambient level). As the operator
exhales their breath into the patient it causes an increase in Carbon dioxide of 100
times the normal value for humans on earth. Carbon Dioxide is a poisonous gas to
humans, this increase in the CO2 levels are extremely negative in the hope of survival
for the patient.
3. The product should act as a barrier to prevent the possibility of passing a disease
between the patient and operator. The current CPR mask allows for direct contact
between the patient and the operator through the air being transferred. By creating a
product that supplies ambient air to the patient through a design that used the breath
of the operator, it should create a barrier that prevents cross contamination between
the operator and patient.
4. It should fit directly onto a CPR mask i.e. a connecting device. By creating a
component that attaches onto the standard CPR mask it will be sold as a separate item
that increases the survival rate of the patient.
5. It should function using the operator’s breath and it should be strictly mechanical. No
electronic parts should be required.
6. Quick and easy to use. This means that the finished product should not hinder or slow
down the CPR process. If the finished product were to hinder the process it would
have extremely negative ramifications. The product should also be easy to use and
would not need extensive training beyond the standard level for first responders at an
emergency scene.

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7. Attempt to adhere to ISO 10993-Should be strictly manufactured using biomaterials.
Failing to use biomaterials could be catastrophic to the finished product. Biomaterials
must be used to ensure that the materials do not irritate or cause damage to the
person’s skin.
8. Attempt to adhere to ISO 10651-4 2002 specifications:
a. Connection Ports
b. Operational Requirements
c. Ventilator Requirements
d. Storage and Operation Conditions
e. Marking Information and Instruction
ISO 10651 is the standard for CPR masks and how they operate.
9. Adhering to the recently released ILCOR 2015 Guidelines to satisfy the market
requirements (CPR course providers). ILCOR are the regulatory body for all CPR
trainers in Ireland. They have a strict procedure format for how CPR should be
administered.

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4.0 Concept Design
Three concept designs were chosen to further study and analyse as possible products. The
form will incorporate dimensions to achieve an optimum volume of air for the patient to fully
gain the effects of the ambient air. Appendixes-C incorporates all of the conceptual designs
that were designed for this report.
4.1 Concept 1 “Bag Incorporating Attachment Device”
Figure 1: The Bag Concept.
This concept utilises the principle of air pressures to obtain ambient air from the external
environment and delivering them to the patient (see Figure 1). The Bag incorporating concept
essentially uses a bag to draw in ambient air (at 21% Oxygen and 0.04% Carbon Dioxide
concentration) into the device hollow, which can then be delivered to the patient through
rescue breaths. The device utilises a lightweight internal bag which will inflate and deflate
that will provide the rescue breaths through the device. Ambient air will be drawn into the
bag, through the one way valve, when the operator inhale’s. The pressure from the exhale
cycle of their breath will then force the bag to compress and deliver the ambient air to the
patient.
Pros
 16% to 21% oxygen increase is achieved.
 Intuitive use would require little if any training.
Cons
 The operator needs to exhale to create the vacuum within the device to draw air in
prior to exhaling, which creates the pressure to force the air out of the device and into
the patient. This can lead to complications and the device will be no longer intuitive.

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 Bag will need to be of a material that will change shape under pressure delivered from
breaths, this may be expensive to manufacture.
 Use of internal bag may lead to instances of failure in the mechanical operation of the
device.
 Additional time needed to attach device before CPR commencement.
4.2 Concept 2 “Balloon Incorporating Attachment”
Figure 2: The Balloon Incorporating Intraoral Device
This concept utilises the principle of air pressures to obtain ambient air from the external
environment and delivering them to the patient (see Figure 2). The concept achieves this by
incorporating a balloon which, as it is inflated/deflated creates a pressure change inside the
device. This pressure change will draw ambient air in that can be delivered to the attached
CPR device. The concept itself will take the form of an attachment which can be combined
with both intra-oral masks and pocket mask valves for ease of use.
Pros
 Ambient air delivery is achieved.
 Little additional training required, use remains the same.
 Less mechanical moving parts which leads to a lower risk of failure.
 Operator only needs to exhale into the device for it to operate.
Cons

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4.3 Concept 3 “Diaphragm Incorporating Attachment Device”
Figure 3: The Diaphragm Incorporating Attachment Device
The Diaphragm Incorporating Attachment Device using the same mechanical principle as
Concept 1 and 2, draws in ambient air through changes in air pressure within the device (see
Figure 3). This concept however replaces the balloon feature with a mechanical diaphragm
which is operated through the users rescue breaths. Due to the spiral spring, the diaphragm
naturally draws the ambient air into the device. As the user exhales, the pressure from this,
forces the diaphragm component down, delivering the ambient air to the patient. The
diaphragm is also contained within a plastic casing, to retain its shape and the ambient air.
Once the operator stops exhaling into the device the spring will return to its natural position
and draw the ambient air back into the system and ready for its next cycle.
Pros
 Attachment does not add bulk to the overall operation of the device.
 Little additional training required, use remains the same.
 Operator only needs to exhale into the device for it to operate.
Cons
 Use of semi-complex internal mechanism may lead to device failing.

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5.0 Calculations
In this section we shall discuss the calculations of the dimensions and the volume of the
AmbiValve. The criteria which our choice of dimensions is based on to deliver the right
amount of volume.
The tidal volume will restrict the volume of the cylinder to 500 ml
𝑣 = 𝑡𝑖𝑑𝑎𝑙 𝑣𝑜𝑙𝑢𝑚𝑒 ≅ 500 𝑚𝑙
And for calculating the radius of the cylinder
𝑃1 ∗ 𝑉1 ∗ 𝑅1 = 𝑃2 ∗ 𝑉2 ∗ 𝑅2
 𝑃1 ∶ 𝑃𝑟𝑒𝑠𝑠𝑢𝑟𝑒 𝑖𝑛 𝑡ℎ𝑒 𝑡𝑟𝑎𝑐ℎ𝑒𝑎 𝑃2 ∶ 𝑃𝑟𝑒𝑠𝑠𝑢𝑟𝑒 𝑖𝑛 𝑡ℎ𝑒 𝑎𝑚𝑏. 𝑣𝑎𝑙𝑣𝑒
 𝑉1 ∶ 𝑣𝑒𝑙𝑜𝑐𝑖𝑡𝑦 𝑖𝑛 𝑡ℎ𝑒 𝑡𝑟𝑎𝑐ℎ𝑒𝑎 𝑉2 ∶ 𝑣𝑒𝑙𝑜𝑐𝑖𝑡𝑦 𝑖𝑛 𝑡ℎ𝑒 𝑎𝑚𝑏. 𝑣𝑎𝑙𝑣𝑒
 𝑅1 ∶ 𝑅𝑎𝑑𝑖𝑢𝑠 𝑜𝑓 𝑡ℎ𝑒 𝑡𝑟𝑎𝑐ℎ𝑒𝑎 𝑅2 ∶ 𝑅𝑎𝑑𝑖𝑢𝑠 𝑜𝑓 𝑡ℎ𝑒 𝑎𝑚𝑏. 𝑣𝑎𝑙𝑣𝑒
Due to the too many unknowns in the equation it makes it quite difficult to generate a
solution or in other words we can have too many solutions to pick from. However, if we want
to deliver the tidal volume which is 500 ml as shown in the equation above the optimum
design would be the one with the radius of the trachea (1 to 1.25 cm) but that would result in
a height of a 159 cm in length which wouldn’t serve our purpose. For this very reason the
most suitable method of determining the dimensions of the AmbiValve is through the design.
In other words the dimensions of the device are design driven.
The table below (see Table 1) shows a range of possible solutions for the delivery of the tidal
volume by calculating the height for every given radius using the following equation:
ℎ =
500
𝜋. 𝑟2
The choice of parameters is driven by design, the most realistic model will have a radius of 3
cm to 3.4 cm, since it is desired to keep the radius at it a minimum.
Table 1: Results for dimensions of the device (see Appendixes-D for the full table).
Radius(cm) Height(cm) Volume Cubic cm(ml)
1 159.1549 500
3 17.6839 500
3.2 15.5425 500
3.4 13.7677 500
6.4 3.8856 500

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6.0 Final Design
Using the linear elements of ‘Pugh’s Total Design’ model to control the design process and
reach a higher product specification, we ran each of the three principle concepts through the
mode as shown in Figure 4.
We omitted the ‘Sell’ phase and replaced the ‘Manufacture’ phase with a ‘Prototyping’ phase
to fit the brief:
Figure 4: The Pugh design process model adapted and employed for the three selected concepts
The initial product specification was defined by the marketing analysis (completed at this
stage), the requirements of regulatory bodies (valve dimension etc.) and the function of the
product as defined by the team.
This was done in conjunction with a weighted scoring criteria as seen in Table 2, we used the
second tier of selection to re-write the product specification where required.
The first tier required all specifications to be met to move onto the second tier.
For example, product specification 6 regarding ease of use was re-worded when looking at
the response time factors and mechanical robustness of the device in the tier 2 selection and
discussing the concept images number 1 and 3.
The second tier has a greater emphasis on qualitative variables in order to assist product
specification development and to refine the perception of the product.
Prototyping
Derived from specifications in the detailed design
Detailed Design
Derived from the Concept Design
Ammended for problems encountered within the
prototyping process
Concept Design
Derived from the Product Specificaitons
Detailed Design
Product Specification
Derived from the product and market research
information
Concept Design
Market
Information gathered from all product and market research

17
Table 2: 2 Tiered design refinement matrix
Tier 1 Selection Criterion (Yes or No) – Defined by the Product Specification
Concepts: Con 1 Con 2 Con 3
Increased O2 Y Y Y
Lower CO2 Y Y Y
Create a Barrier Y Y Y
Fitting on existing CPR masks Y Y Y
Operator Breath Y Y Y
Efficiency Y Y Y
Biomaterial - ISO10993 Compliant Y Y Y
CPR Device - ISO 10651 Compliant Y Y Y
CPR Course Provider Regulatory Body - ILCOR 2015 Y Y Y
Intuitive and Simple to use Y Y Y
Tier 2 Selection Criterion (1 = low/5 = high)–Defines the Product Specification and the Detailed
Design
Key Aspects: Weight Given Con 1 Con 2 Con 3
Elegance 0.2 2 4 3
Added Value to service provided 0.8 4 4 4
Robustness 0.8 1 4 2
Aesthetic 0.2 2 3 2
Affordability 0.5 1 3 2
Resources Available 0.7 1 5 1
Response Time Factors 0.7 3 4 2
Safety 0.9 1 4 4
Calculated Weighted Totals: 9 19.2 12.5
Moving from a concept design to a detailed design went against concept 2 both in the
weighted score and in trying to design a reliable, affordable and returnable diaphragm.

18
7.0 Discussions and Conclusions
7.1 Marketing Plan
For a product within the medical market sector, the first phase is to provide free units to the
first point of reference for CPR in the general public, who are the instructors of CPR in
Ireland. This would promote an adoption, awareness and an identity of the product and
ensure a better share of the public market.
It would also act as a test market to further refine the product and an opportunity to
investigate other opportunities. Although this would incur great cost at first, it would provide
a solid foundation for long term sales.
7.1.2 Phase 1: Partial Market Entry or Full Market Exit
Batch manufacture 300+ AmbiValve units.
Contact all CPR course providers in Ireland (271 course providers in 2015) informing them
that they will receive an AmbiValve unit via the mail. It will incorporate instructions for use
and documentation detailing the benefits of the product with emphasis on the air quality
delivered.
After a 2 month period we will contact the CPR course provider with a detailed questionnaire
to further refine the product and assess the market.
The results of which will determine if:
a. We leave the market.
b. We stay in the market.
c. We stay in the market and further develop and improve the product.
We repeat the process after 4 months, and then 6 months.
The potential cost of the product will be assed at each 2 month stage.
7.1.3 Phase 2: Full Market Entry
If we have decided to stay in the market after 6 months, and depending on the scale of market
response, we will approach the top 40 manufacturers of First Aid kits in Europe that would
include a CPR mask (scaled to the relevant ISO standard) and negotiate the inclusion of our
product along with their CPR mask units.
All manufacturing will be lean and to a larger batch scale.
The final cost of the unit will be addressed at this stage.

19
7.2 AmbiValve “Ambient Air Attachment”
Figure 5: AmbiValve Ambien Air Attachment w/ Intraoral Mask
The chosen concept, the AmbiValve, utilises the principle of air pressures to deliver ambient
air from the external environment to the patient, thus increasing the Oxygen concentration
from 16% to 21% whilst decreasing Carbon Dioxide levels also.
The attachment achieves this by incorporating a balloon component which can deflate to
draw in ambient air, and force this air out through the valve into the attached CPR mask. One
way valves are fitted both at the ambient air inlet, and the tapered outlet, to create the
pressure differences that create the increase in pressure and the vacuum, for this device to
operate.
The final product takes the form of a CPR mask attachment and is designed to fit any ISO
10651 – 4 (2002 Specification) standard valve, using a tapered outlet, creating an interference
fit. Markings on the top and bottom of the device will be applied to indicate the correct
orientation for first time users.
7.3 Materials & Manufacturing
The attachment, along with its internal components, will be made from different grades and
formulations of the polymer PVC. PVC was chosen for its crystal clear appearance, ideal for
determination of the internal balloons successful operation, and ability to be manufactured
both by extrusion, and injection moulding methods, the latter being used in the manufacturing
of the AmbiValve. The internal balloon is also to be made from PVC, formulated and
manufactured in the same way as IV bags to achieve appropriate shape and required

20
characteristics. All materials follow ISO 10993 standards for Biomaterials being used in a
Grade I medical device.
7.4 Possible Changes
Although the design of the AmbiValve has been a success and all of the criteria of the
product specification has been met, the design itself still has room for improvement.
1. In the event of the patients airway being blocked there is no pressure relief valve. This
is a vital component to have on the device. In the event of the patients airway being
blocked the air being supplied can be forced down the wrong path into the stomach
leading to gastric inflammation.
2. A CPR mask in the professional setting could be used quite regularly. To avoid this
product being disposed of after each use, the balloon mechanism should be designed
that it can be easily replaceable.
The AmbiValve’s concept design as shown in this report has been a success. The main aim of
the design was to improve the patient’s chances of survival by supplying ambient air instead
of poor quality recycled air. By utilising the one-way valves it allows the design to do this
similar to that of the Bag Valve which was discussed previously in the report. The major
advantages the AmbiValve has over the Bag Valve on the market is that the pressure being
applied to the patients lungs is significantly lowered thus preventing any further accidents
such as gastric inflammation.
The other major advantage is that the AmbiValve is designed to deliver 500 ml of ambient air
which is the correct tidal volume needed to see a visible chest rise in the patient. This is a
major advantage as it ensures that the patient is being supplied with the correct quantity of
quality ambient air.

21
References
[1] S. Jeffery, “PARAMEDIC: No Advantage for Mechanical vs Manual CPR,” Medscape,
2016 November 2014. [Online]. Available:
http://www.medscape.com/viewarticle/835008#vp_1. [Accessed 08 October 2015].
[2] P. Shakhashir, “GASES OF THE AIR,” Scifun, November 2007. [Online]. Available:
http://scifun.chem.wisc.edu/chemweek/pdf/airgas.pdf. [Accessed 08 October 2015].
[3] M. O'Callaghan, Biology Plus, The Educational Company of Ireland, 2013.
[4] D. P. Keseg, “The Merits of Mechanical CPR,” JEMS, 29 August 2012. [Online].
Available: http://www.jems.com/articles/2012/08/merits-mechanical-cpr.html.
[Accessed 08 October 2015].
[5] P. J. K. R. O. T. V. John M. Field, “The Textbook of Emergency Cardiovascular Care
and CPR,” in The Textbook of Emergency Cardiovascular Care and CPR, Philidelphia,
Lippincott Williams and Wilkns, 2009, p. 180.
[6] C. Robert A. Berg, R. Hemphill, B. S. Abella, T. P. Aufderheide, D. M. Cave, M. F.
Hazinski, E. B. Lerner, T. D. Rea, M. R. Sayre and R. A. Swor, “Part 5: Adult Basic Life
Support,” American Hearts Association, 2010. [Online]. Available:
http://circ.ahajournals.org/content/122/18_suppl_3/S685.full#sec-1. [Accessed 08
October 2015].
[7] M. a. M. L. M. Ann M. Weiss, “Focus On - Bag-Valve Mask Ventilation,” ACEP News,
01 September 2008. [Online]. Available: http://www.acep.org/Clinical---Practice-
Management/Focus-On---Bag-Valve-Mask-Ventilation/. [Accessed 06 November 2015].
[8] B. L. F. R. W. V. R. W. M. R. O. D. Idris AH1, “Pubmed,” Department of Surgery,
(Division of Emergency Medicine), University of Florida College of Medicine,
Gainesville 32610-0392., 12 1990. [Online]. Available:
http://www.ncbi.nlm.nih.gov/pubmed/7994855.

22
[9] W. V. B. L. B. M. O. D. Idris AH, “Pubmed,” 1995. [Online]. Available:
[10] M. G. R. E. G. M. A. T. F. M. N. R. Paradis NA, “Pubmed,” Feb 1990. [Online].
Available: http://www.ncbi.nlm.nih.gov/pubmed/2386557#.
[11] B. R. G. H. Weisfeldt ML, “Pubmed,” 1975. [Online]. Available:
[12] M. G. B.-J. P. L. W. M. N. B. M. J. F. M. N. A. MD M von Planta, crit care, Feb 1992.
[Online]. Available: http://www.annemergmed.com/article/S0196-
0644%2805%2980471-8/abstract.
[13] I. AH, “Pubmed,” Crit Care Med, 28 Nov 2000. [Online]. Available:
[14] Dongguan City Risen Medical Products Co., Ltd, “Promotional Mouth to Mouth CPR
Mask for First Aid,” Dongguan City Risen Medical Products Co., Ltd, 01 Novemeber
2015. [Online]. Available: http://risenmedical.en.made-in-
china.com/product/RKOJsmzGgqhr/China-Promotional-Mouth-to-Mouth-CPR-Mask-
for-First-Aid.html. [Accessed 06 November 2015].
[15] CES Edupack 2015, “CES Edupack 2015,” Granta Design Limited, Cambridge, 2015.
[16] W. H. J. S. W. A. W. N. R. Dietmar Gross, Engineering Mechanics 1, Dordrecht:
Springer, 2013.
[17] Continence Product Advisor, “Indwelling Catheters,” Continence Product Advisor,
[Online]. Available:
http://www.continenceproductadvisor.org/products/catheters/indwellingcatheters.
[Accessed 02 10 2015].
Appendixes-A
Current Device Specifications

23
Manufacturing:
The selection of the materials in the manufacturing of a CPR pocket masks lies in its
biocompatibility as well as the ease of which this material can be manufactured to create the
required shape, regardless of its complicated structure (e.g hollow air filled structure). Indeed
the fore mentioned structure is the most complicated part along with the one way valve,
primarily made from PC + Silicone Rubber. The manufacturing methods used in the creation
of the hollow structure is explained below:
Hollow-Air Filled Structure:
The manufacturing method is outlined in the United States Patent1
No: 8,852,480 B2
“Method For Manufacturing Hollow Structure For Breathing Mask”. The patent references a
manufacturing method that “…includes producing an open hollow structure of a first
material, positioning the open hollow structure on a tool adapted to hold the open hollow
structure, filling the open hollow structure with a filler medium, and closing the filled open
hollow structure with a second material ”. This method produces the hollow on existing
Pocket CPR Masks. The hollow itself can have a varying wall thickness2
, with a thicker
second material closing off the vacuum and also being in contact with the patients face.
Mask:
The most important aspect of a “pocket” CPR mask is its portability combined with its ability
to actually function properly. These functions come from both its material selection and
manufacturing selection. The material must be flexible, transparent, form-retaining and most
likely a plastic such as PVC, Polystyrene or Polyurethane. The resilience of the material also
needs to be such as that it can be flexed into a hollow for its intended purpose and then

24
returned to its collapsed shape to aid in portability. Resilience is explained as “….the
property of returning to the original shape after distortion within elastic limits." Hackk's
Chemical Dictionary Fourth Edition p. 578, column 23
.
Valve:
Commonly made of PVC, the valve used in the construction of these masks is a “multi-stage
mouth-to-mouth resuscitation valve in combination with a first valve to allow exhaled breath
from a mouth of an operator to pass through the first valve to the mouth of a victim”4
. The
second valve assumes the role of ensuring exhaled air from the victim does not reach the
operator.
Materials:
The project doesn’t require a complete overhaul of the material selection, but the re-design of
an existing product to solve problems. I have not identified any issues using the existing
materials at this stage so have decided a brief overview is adequate:
Polyvinyl Chloride:
 “Crystal clear, with high melt flow and excellent heat stability characteristics for
connectors, drip chambers and accessories to medical bags and catheters. Formulated
for injection moulding or extrusion”.
Silicone:
 “Resistant to ultra-violet light, ozone and weathering”
 “Silicone rubber is physiologically inert, thus making it the preferred choice of the
medical, pharmaceutical and food processing industries”.
1
patent available in Dropbox
2
a thinner degree wall thickness could perhaps solve bearded patient problem.
3
patent included in Dropbox folder
4
patent available in Dropbox folder
CPR Facts and Statistics

25
• About 75 percent to 80 percent of all out-of-hospital cardiac arrests happen at home, so
being trained to perform cardiopulmonary resuscitation (CPR) can mean the difference
between life and death for a loved one.
• Effective bystander CPR, provided immediately after cardiac arrest, can double a victim’s
chance of survival.
• CPR helps maintain vital blood flow to the heart and brain and increases the amount of time
that an electric shock from a defibrillator can be effective.
• Approximately 95 percent of sudden cardiac arrest victims die before reaching the hospital.
• Death from sudden cardiac arrest is not inevitable. If more people knew CPR, more lives
could be saved.
• Brain death starts to occur four to six minutes after someone experiences cardiac arrest if no
CPR and defibrillation occurs during that time.
• If bystander CPR is not provided, a sudden cardiac arrest victim’s chances of survival fall 7
percent to 10 percent for every minute of delay until defibrillation. Few attempts at
resuscitation are successful if CPR and defibrillation are not provided within minutes of
collapse.
• Coronary heart disease accounts for about 550,000 of the 927,000 adults who die as a result
of cardiovascular disease.
• Approximately 335,000 of all annual adult coronary heart disease deaths in the U.S. are due
to sudden cardiac arrest, suffered outside the hospital setting and in hospital emergency
departments. About 900 Americans die every day due to sudden cardiac arrest.
• Sudden cardiac arrest is most often caused by an abnormal heart rhythm called ventricular
fibrillation (VF). Cardiac arrest can also occur after the onset of a heart attack or as a result of
electrocution or near-drowning.
• When sudden cardiac arrest occurs, the victim collapses, becomes unresponsive to gentle
shaking, stops normal breathing and after two rescue breaths, still isn’t breathing normally,
coughing or moving.
Experts say CPR is a lifesaver, and with good reason. Each year, more than 350,000 people in
the United States — one every 90 seconds — experience cardiac arrest. The vast majority of

26
these do not occur at a hospital, and those who receive CPR from a bystander are up to three
times more likely to survive than someone who doesn’t receive such assistance.
Additional Problem Identification
“The air a person normally breathes contains approximately 21 percent oxygen. The
concentration of oxygen delivered to a victim through rescue breathing is 16 percent,
therefore the oxygenation levels supplied by a pocket CPR mask is insufficient.”
“When administering CPR the patient may experience vomiting or other discharge from
the mouth. In this case, CPR must be stopped to administer suction, and as a consequence
the patient does not receive adequate oxygenation. Additional readjusting of the mask in
this instance will also hinder recovery.”
*how will this work with an in mouth piece?
This problem is also significant in CPR recovery but is only mentioned in passing in most
documentation. Statistics are obviously hard to come by on how often an occurrence this is
but I feel it could be important to look at and allow for a bit of creativity in how it is
approached with regards to material use. There are materials that shrink when wet/moist,
could be useful in this case?
The detection of the resumption of breathing in a patient is not always evident when
bystander CPR is performed, resulting in additional CPR being performed that may cause
unnecessary trauma (chest bruising, fractures of the ribs etc.) This problem is in
conjunction with the problem in actually detecting that oxygen levels have returned to the
patient.
The pocket mask is made transparent for to make the identification of oxygenation status in
patients. However, even with this, a bystander performing CPR without adequate training
will make no sense of the indicators (blue lips, the actual sound of breathing etc.). A way of
counteracting this would be to introduce elements that act as indicators of factors such as
oxygenation (material that indicates oxygen levels), C02
release (again by indicator).
Shape of the mask creating an appropriate seal that does not need constant readjustment
Conceptual Research

27
Idea:
“Utilizing a One-Way Permeable Membrane to recover oxygen from the ambient air, storing
it, and then delivering it to the patient through CPR recovering breathing”
Explanation:
Inflatable tube material that will increase in volume through inhaling through a one-way
permeable membrane. Inhale to increase the volume from the ambient air; the one-way
membrane will prevent leaking of said air back to the external air. Exhaling during CPR
method using intraoral device will then force the increased ambient air into the patient. This
in turn will increase oxygen intake from 16% to 21%.
Backup research:
One-way oxygen permeable membranes are used in the construction of certain type of “rigid
gas permeable” contact lenses. The materials used are various but the principle of the
material permeability is the same when applied to the idea.
Oxygen Absorbing Crystals
Idea:
“The use of so called “Aquaman Crystal”, which can steal oxygen from the air and store it to
be used later, could be used in the construction of the CPR device to deliver an increased
oxygen dose to the patient”
Explanation:
The use of oxygen absorbing material in the construction of the facemask or intraoral device
could allow for storage of oxygen to be used in situations where the ambient air is not
sufficient to be drawn in for use. The material, albeit in its infancy, has been tested and
described as a technical synthetic “hemoglobin”.
Backup research:
Oxygen Chemisorption/Desorption in a Reversible Single-Crystal-To-Single-Crystal
Transformation
McKenzie, Christine; Sundberg, Jonas; Cameron, Lisa; Southon, Peter D.; Kepert, Cameron
J. Published in: Chemical Science
Appendixes-B

28
Relevant ISO 10651 Points:
4.3 Face mask connectors
If provided with the resuscitator, face masks shall have either a 22 mm female connector or a 15 mm male connector which shall mate with
the corresponding connectors specified in EN 1281-1.
4.7 Oxygen tube connector and pressure gauge connector
The oxygen tube connector, if provided, shall comply with EN 13544-2:2000. The pressure gauge connector (if provided) shall not be
compatible with tubing fitting the oxygen tube connector.
5.2 R) Dismantling and reassembly
A resuscitator intended to be dismantled by the user, e.g. for cleaning, etc. should be designed so as to minimize the risk of incorrect
reassembly when all parts are mated. The manufacturer shall recommend a functional test of operation to be carried out after reassembly
6.1 R) Supplementary oxygen and delivered oxygen concentration
When tested by the method described in A.4.6 in accordance with the requirements of its classification (see 6.7.1)
a resuscitator shall provide a minimum delivered oxygen concentration of at least 35 % (V/V) when connected to an oxygen source
supplying not more than 15 l/min and, in addition, shall be capable of providing an oxygen concentration of at least 85 % (V/V) (see note).
The manufacturer shall state the range of delivered oxygen concentrations at representative flows, i.e. 2 l/min, 4 l/min, 6 l/min, 8 l/min, etc.
6.2 R) Expiratory resistance
In the absence of positive end-expiratory pressure devices, and when tested by the method described in A.4.7, the pressure generated at the
patient connection port shall not exceed 0,5 kPa (_ 5 cmH20). (See also 10.2 c) 8)).
6.3 R) Inspiratory resistance
When tested by the method described in A.4.8, the pressure at the patient connection port shall not exceed 0,5 Kpa (_ 5 cmH20) below
atmospheric pressure. (See also 10.2 c) 8)).
6.4 R) Patient valve malfunction
When tested by the method described in A.4.9, an inadvertent positive expiratory pressure greater than 0, 6 Kpa
(_ 6 cmH2O) shall not be created at an added input flow of up to 30 l/min when this flow is added in accordance with the manufacturer’s
instructions.
6.5 R) Patient valve leakage - Forward leakage. If forward leakage is a design feature, it shall be so stated in the instruction manual.
6.6 R) Resuscitator dead space and rebreathing. When tested by the method described in A.4.10, the resuscitator dead space shall not
exceed 5 ml + 10 % of the minimal delivered volume specified for the classification of the resuscitator. Excessive rebreathing should not
occur during spontaneous breathing.
6.7.1 R) Minimum delivered volume (Vdel) When tested as described in A.4.11 using the compliance, resistance, frequency and I:E ratio
given in Table 1, the minimum delivered volume shall be as given in Table 1.
6.7.2.1 For resuscitators designated for use with a body mass less than 10 kg, a pressure-limiting system shall be provided so that the airway
pressure does not exceed 4, 5 Kpa (_ 45 cmH20) under the test conditions described in A.4.12. However, it shall be possible to generate an
airway pressure of at least 3 Kpa (_ 30 cm H2O).
NOTE: An override mechanism can be provided.
6.7.2.2 If a pressure-limiting system is provided for a resuscitator designated for use with patients of over 10 kg body mass, the pressure at
which it operates shall be stated in the instruction manual [see 10.2 c)9)]. Any pressure-limiting device provided that limits pressure to
below 6 Kpa (_ 60 cmH20) shall be equipped with an override mechanism. If provided with a locking mechanism, pressure override
mechanisms shall be so designed that the operating mode, i.e. on or off, is readily apparent to the user by obvious control position, flag, etc.
7.2 R) Operating conditions
When tested by the method described in A.4.13, the resuscitator shall comply with clause 6 throughout the range of relative humidity from
15 % r.h. to 95 % r.h either:
- throughout the temperature range from - 18 °C to + 50 °C ; or
- If a specific operating range is given (see 9.2 and 10) throughout the temperature range declared by the manufacturer.
9 Marking
9.1 General
Marking of resuscitators, or parts if applicable, packages, inserts and information to be supplied by the manufacturer shall comply with EN
1041.
9.3 Indication of pressure-limiting system setting
If the resuscitator is supplied with a pressure-limiting system set at one fixed pressure, the nominal pressure setting
at which the system is activated shall be marked on the resuscitator.
10 Information to be provided by the manufacturer in operating and maintenance instructions
10.1 General

29
The manufacturer shall provide instructions for use and maintenance. The size and shape of these instructions for
use should be such that they can be enclosed with or attached to the resuscitator container.
10.2 Contents
In addition of EN 1041 the instructions for use and maintenance shall include the following information, where
applicable :
a) a warning to the effect that incorrect operation of the resuscitator can be hazardous ;
b) instructions on how to make the resuscitator operational in all intended modes of operation ;
c) a specification detailing the following information for the resuscitator and its recommended accessories if
applicable :
A.4.7 Expiratory resistance
For resuscitators suitable for use with patients with a body mass of up to 10 kg, connect the patient connection port
to an air source and introduce air at a flow of 5 l/min. Record the pressure generated at the patient connection port.
For all other resuscitators, connect the patient connection port to the air source and introduce air at a flow of
50 l/min. Record the pressure generated at the patient connection port.
For resuscitators suitable for use with patients with a body mass of up to 10 kg, connect the patient connection port
to a vacuum source producing an air flow of 5 l/min. Record the pressure generated at the patient connection port.
For all other resuscitators, connect the patient connection port to a vacuum source producing an air flow of
50 l/min. Record the pressure generated at the patient connection port.
A.4.10.1 Principle
Ventilation by the resuscitator of a “bag-in-bottle” reservoir with 100 % (V/V) oxygen as tracer gas. Calculation of
the total deadspace of the resuscitator from the volume of ventilation and the oxygen concentration of the inspired
gas captured inside the bag.
The standard goes on to detail testing procedures:
Relevant ILCOR 2015:
 Nothing has changed since the ILCOR guidelines published in 2010 regarding pulmonary resuscitation, but these passages are
relevant to our product. This is the document that every CPR training professional refers to for regulatory and procedural
guidelines throughout the world (governing bodies are: CoSTR ERC - Europe, CoSTR AHA – U.S.A and JRC – Asia)
Page 89:
Rescue Breaths:
In non-paralysed, gasping pigs with unprotected, unobstructed airways, continuous-chest-compression CPR without artificial ventilation
resulted in improved outcome.140Gasping may be present early after the onset of cardiac arrest in about one third of humans, thus facilitating
gas exchange.48During CPR in intubated humans, however, the median tidal volume per chest compression was only about 40 mL,
insufficient for adequate ventilation.141In witnessed cardiac arrest with ventricular fibrillation, immediate continuous chest compressions
tripled survival.142Accordingly, continuous chest compressions may be most beneficial in the early, ‘electric’ and ‘circulatory’ phases of
CPR, while additional ventilation becomes more important in the later, ‘metabolic’ phase.39During CPR, systemic blood flow, and thus
blood flow to the lungs, is substantially reduced, so lower tidal volumes and respiratory rates than normal can maintain effective
oxygenation andventilation.143–146When the airway is unprotected, a tidal volume of 1 L produces significantly more gastric inflation than a
tidal volume of 500 mL.147Inflation durations of 1 s are feasible without causing excessive gastric
insufflation.148Inadvertenthyperventilation during CPR may occur frequently, especially when using manual bag-valve-mask ventilation in a
protected airway. While this increased intrathoracic pressure149and peak airway pressure, 150a carefully controlled animal experiment
revealed no adverse effects.151From the available evidence we suggest that during adult CPR tidal volumes of approximately 500–600 mL
(6–7 mL kg−1) are delivered. Practically, this is the volume required to cause the chest to rise visibly.152CPR providers should aim for an
inflation duration of about 1 s, with enough volume to make the victim’s chest rise, but avoid rapid or forceful breaths. The maximum
interruption in chest compression to give two breaths should not exceed10 s.153These recommendations apply to all forms of ventilation
during CPR when the airway is unprotected, including mouth-to-mouth and bag-mask ventilation, with and without supplementary oxygen.
Page 92:

30
Disease transmission:
The risk of disease transmission during training and actual CPR performance is extremely low.255–257Wearing gloves during CPR is
reasonable, but CPR should not be delayed or withheld if gloves are not available.
Barrier devices for use with rescue breaths:
Three studies showed that barrier devices decrease transmission of bacteria during rescue breathing in controlled
laboratorysettings.258,259No studies were identified which examined the safety, effectiveness or feasibility of using barrier devices (such as a
face shield or face mask) to prevent victim contact when per-forming CPR. Nevertheless if the victim is known to have a serious infection
(e.g. HIV, tuberculosis, hepatitis B or SARS) a barrier device recommended. If a barrier device is used, care should be taken to avoid
unnecessary interruptions in CPR. Manikin studies indicate that the quality of CPR is superior when a pocket mask is used compared to a
bag-valve mask or simple face shield.260–262Foreign
CPR Course Trainers Interview 1:
Questions:
Would you prioritise finding a defibrillator unit over administrating chest compressions?
In what instance would you not administer mouth to mouth resuscitation and why?
Are you aware of the difference in air quality between ambient and exhaled air?
Would you be prepared to amend your course content to address this issue?
What is the biggest problem addressing mouth to mouth resuscitation?
Dear ....
I am a student at DIT Bolton Street completing a course in Medical Device Innovation.
I'm conducting market analysis for a course project aimed at improving devices used in the mouth to mouth resuscitation
process.
It would be of great help to us if you could answer the following 5 questions.
Your response does not need to be detailed but I do need to use the answers by next Monday.....
Would you prioritize finding a defibrillator unit over administrating chest compressions?
In what instance would you not administer mouth to mouth resuscitation and why?
Are you aware of the difference in air quality between ambient and exhaled air?
Would you be prepared to amend your course content to address this issue?
What is the biggest problem addressing mouth to mouth resuscitation?
Your help would be greatly appreciated
Many thanks
Morven Gannon
Initial Risk Assessment for the Problem Definition Phase:
Risks & Failures Identified and Solutions Offered:
Risk I.D Number Potential Risk/Failure Solution

31
1
Failure to achieve the time allotted for the
entire project
Clearly achieve all the set objectives required for the
course content within the set time
2
Individually returning personally assigned
tasks behind schedule
Ensure that all participants are up to date and have
clearly defined, achievable objectives set each week
3
Unable to attain the correct resources Make realistic material or technological demands in the
design process
4
Failure to id/quantify the customers’ needs
or priorities
Make a detailed analysis of the market sector with
specific attention paid to the end user
5
Poor project planning and scheduling Ensure that all individually assigned tasks are relevant,
realistic and in line with the expectations of the module
6
Product will not work or is of poor quality Deliver a basic tried and tested assembly system utilising
available components
7
User safety concerns and customer
acceptance problems
Detailed analysis of market and end user requirements
8
Inability in design to fulfil regulatory
criteria
Consistently refer to the relevant regulatory bodies
(FDA/ISO)
9
Competitive market sector and high risk of
obsolesce
Extensive analysis of the existing client base with
reference to potential shortfalls in the market
10
Production requirements are too excessive Keep an eye on materials, production systems and costs
in the design process
11
Environmental impact failures Include a factor of fatigue/failure testing sequence in the
product testing stage
12
Other teams on the module delivering the
same idea
Keep quiet while in the development stage
Risks Calculations:
To ask: Should a RPN be introduced or will this basic risk calculation be enough?
Risk = (RP) x (RM)
Where:
RP = Probability of the risk occurring with a natural range of 0% - 100% (0.00 to 1.00)
RM = Magnitude of the risk occurring, where 0% means there is no impact on the project and 100% assures project failure (0.00 – 1.00)
The following table is only the opinion of team member Morven Gannon.
Risk I.D Probability of Risk Occurring Magnitude of Impact on Project (RM) Quantitative Value of RISK (RP

32
Number (RP) x RM)
1 0.3 0.8 0.24
2 0.4 0.6 0.24
3 0.1 0.4 0.04
4 0.4 0.6 0.24
5 0.4 0.4 0.16
6 0.5 0.8 0.40
7 0.2 0.3 0.06
8 0.5 0.5 0.25
9 0.4 0.2 0.08
10 0.2 0.6 0.12
11 0.3 0.5 0.15
12 0.5 0.3 0.15
The top 5 prioritised risks:
Risk 6: Product will not work or is of poor quality
Risk 8: Inability in design to fulfil regulatory criteria
Joint third:
Risk 1: Failure to achieve the time allotted for the entire project
Risk 2: Individually returning personally assigned tasks behind schedule
Risk 4: Failure to id/quantify the customers’ needs or priorities

33
STRENGTHS
OPPERTUNITIES
WEAKNESSES
THREATS
 3 successful DIT engineering students
and 1 international engineer
specialising in medical devices
 A strong reservoir of experience to
draw on within the module and at DIT
 A well considered problem with
enough space in the market to bring
innovation to
 Enough time to allot each facet of the
project in extensive detail
 Potential to be adopted by other
facets of emergency response, not
just a first aid kit user
 Add to the whole field of assisted
breathing technology
 The market seems to have hit a ceiling
in product development
 The other teams on the module
coming up with the same idea
 Loss of intellectual property
 Undiscovered regulatory restrictions
 No clear strategic direction
 Inexperience in medical device
product development and design
 No educated understanding of
regulatory procedure as of yet
 Untested team dynamic
 Potentially conflicting information
from advisory bodies

34
Appendixes-C
Concept Generation
Concept Ideation
Concept 1 “Oxygen Absorbing Attachment”
Explanation
This concept revolves around the newly formulated material, which essentially “absorbs”
oxygen from the air, releasing it later under certain stimulus (heat, electricity, movement).
The material itself comes in a crystalline form at present but further research in the area
means its applications could be widespread, especially in the rescue mask and deep sea
diving areas.
The concept mask and attachment uses this material to achieve optimum oxygen delivery in a
patient who has suffered cardiac arrest. The mask itself is made of a porous silicone with the
ability to allow oxygen through its membrane. The attachment has the “oxygen absorbing”
material encased in a similar membrane allowing delivery of the stored oxygen into the
hollow between mask and patient. The material releases its stored oxygen when the rescuer
applied pressure and heat with the hands to the mask attachment. The mask is then used
normally by applying rescue breaths.
Pros
 Attachement does not add bulk to the overall operation of the device.
 No additional training required, use remains the same
Cons
 “Oxygen absorbing” material still in its infancy stage of implementation.
 Cost of this material would likely push the product into an unafforable range.
 Sterilisation for multiple uses would cause an issue.
Concept 2 “Two Way Oxygen Delivery Mask”

35
Explanation
This concept also boarders on the conceptual side, also utilizing the “oxygen absorbing
material” mentioned in Concept 1. The mask itself is formed by both an over the nose CPR
pocket mask, combined with an intra oral mask. The idea behind this concept is that air will
be directed both through the mouth, and through the nose, the latter being delivered oxygen

36
through the “oxygen absorbing” material, activated once again by the rescuers hand position.
Normal rescue breaths are initiated through the intra oral mask also.
Pros
 Oxygen delivery through two airways may aid faster recovery.
Cons
 “Oxygen absorbing” material still in its infancy stage of implementation.
 Cost of this material would likely push the product into an unafforable range.
 Although shape is familiar, in pressure situations, mask may not be intuitive to use.
 Use of material in a cold environment may render additional mask useless.
Concept 3 “Intra Oral Accordion”

37
Explanation
The accordion concept essentially uses a “pump” mechanic to draw in ambient air (at 21%
oxygen concentration) into the device hollow, which can then be delivered to the patient
through rescue breaths. The device utilizes a porous silicone which allows oxygen to pass
through when the rescuer performs an inhale breath. Once an exhale is applied, the internal
cylinder pushes down, along with compressing the silicone accordion shape, and delivers the
higher concentration of oxygen.
Pros
 Intuitive “pump-like” use would require little if any training.
Cons
 Uses materials which may price the device out of competing in the market.
 Use of porous silicone may lead to instances of failure in the mechanical operation of
the device.

38
Additional Concept Ideation

41
Additional Final Design Iterations

42
Appendixes-D
Radius(cm) Height(cm) Volume Cubic
cm(ml)
1 159.1549 500
1.2 110.5243 500
1.4 81.2015 500
1.6 62.1699 500
1.8 49.1219 500
2 39.7887 500
2.2 32.8833 500
2.4 27.6311 500
2.6 23.5436 500
2.8 20.3004 500
3 17.6839 500
3.2 15.5425 500
3.4 13.7677 500
3.6 12.2805 500
3.8 11.0218 500
4 9.9472 500
4.2 9.0224 500
4.4 8.2208 500

43
4.6 7.5215 500
4.8 6.9078 500
5 6.3662 500
5.2 5.8859 500
5.4 5.458 500
5.6 5.0751 500
5.8 4.7311 500
6 4.421 500
6.2 4.1403 500
6.4 3.8856 500

DT710 Semester 1 Final Report - Team3-CPR-Project

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