ApolloBVM

Designing the Automated Bag Valve Mask:

Providing Ventilation for Low Resource Settings

Submitted to BIOE Senior Design

Take A Breather:
Carolina De Santiago
Natalie Dickman
Madison Nasteff
Tim Nonet
Aravind Sundaramraj
Karen Vasquez

April 29, 2019

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TABLE OF CONTENTS

Executive Summary 3

Introduction: The Need for a Better Bag Valve Mask 4

Design Strategy 6
Total cost of device 6
Time device can run without human intervention 6
Time from beginning of setup to first compression cycle 6
Size 6
Weight 6
Percent error of desired frequency settings 6
Power usage 7
Volume displacement of compression 7
Designing the TAB 7

Final Design 10
Attachment of BVM to device 11
Compression mechanism 13
Electronic Components 16

Labor, Burden and Materials 17

Regulations 19

Standards 21

Testing and Results 23

Summary and Recommendations 28

References 29

Appendices 30
Appendix A: Cost Breakdown 30
Appendix B: Picaxe Code 31
Appendix C: User Questionnaire 38
Appendix D: Past Iterations of Device 39

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Executive Summary
Take A Breather has designed the TAB, an add-on device to automate the bag valve mask
(BVM). This device will address medical concerns regarding ventilation of patients experiencing
respiratory distress in low resource settings, areas that lack funding and resources for health care.
The needs for this device as as follows:
● Patients with reversible respiratory compromise lack reliable method of continuous safe
ventilation
● Hand compressed ventilation must last the duration of the patients stay, ranging from a
day to weeks
● Lack of medical personnel results in family members performing this task resulting in
inconsistent ventilation

Due to the limited funds and resources available, the device must adhere to additional constraints
unrelated to its ability to effectively ventilate a patient, which include:
● Limited energy resources
● High durability due to unpredictable environmental conditions
● Limited access to transportation and replaceable parts

After consulting various physicians and experts in emergency medical training and respiratory
distress, several design objectives were identified and are listed below:
● Accurate ventilation volumes and frequencies for adults, children, and infants
● Ease of use with minimal medical training
● Versatility to various commercial BVMs
● Long lasting ventilation for over 6 hours
● Minimization of cost
● Small size and low weight

Ventilators are used to treat a wide range of patients with various different needs for long periods
of time; for this reason, the TAB must also be adjustable for all potential patients’ needs while
being inexpensive and reliable in low resource settings. Take A Breather has focused its efforts
on designing an add-on device that mimics hand compression of a BVM and that optimally
satisfies all of the objectives and constraints present. Currently, a functional prototype of the
TAB has been evaluated using an airflow transducer to determine volume compression,
frequency analysis to determine breaths per minute, and user testing to determine ease of use.
The design of the TAB will be improved and modified throughout longevity and power tests.
The final device will be fully encased to reduce exposure to environmental factors and
incorporate a fan to minimize heat to the motor.

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4
Introduction: The Need for a Better Bag Valve Mask

Respiratory distress is a severe medical condition, often caused by asthma, allergies, or

cardiac arrest, that prevents a person from receiving enough oxygen to perform all bodily
functions. This condition kills up to 3 million people​1​ every year. Two universal devices exist to
assist in ventilation and recovery. Bag Valve Masks (BVMs), as seen in Figure 1, are low cost
devices that require manual (hand-compressed) ventilation for 1-10 minutes to provide air to the
lungs. BVMs are present in most medical and hospital settings around the globe and are
responsible for saving millions of lives. The other common device is a ventilator, a large
personalized machine that uses power and attaches to a patient to supply them with oxygen for as
long as needed. Ventilators are normally preferred due to their higher efficiency and
performance, but are frequently isolated to central hospitals making them unusable during
transport and in resource limited settings​2​. Therefore, BVMs, which are more portable and
adaptable than ventilators, are often utilized by paramedics, nurses, respiratory therapists, or
physicians and have become an essential skill for international physicians and critical care
providers.

Figure 1: Diagram of a BVM

In resource-limited settings, ventilators are rare even in major hospitals because of their
high cost and fragileness​2​. Therefore, BVMs are used for most ventilation methods whether in
hospice or at home. Furthermore, some low resource settings such as Malawi normally only have
one nurse to fifty patients per shift​3​, resulting in family members having to ventilate their loved
ones when nurses aren’t available. Patients with sepsis, pneumonia, aspiration, seizures, or any
other type of respiratory distress​4​ must receive hand-compressed ventilation for the duration of

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the patient’s respiratory support which can range from 1 day up to 1 week​3​. This is a tiresome
activity with high inter-provider variability and fatigue, assuming providers are available to
perform the task at all. While BVMs are cheap to purchase, they can become very expensive to
operate for extended periods of time due to the labor needed. On the other hand, a ventilator is
very expensive but can have very low operating costs since they are completely hands free and
automated. Thus, if a BVM add-on device could be created to automate the process to relieve
strain on the body while also costing less than $150, an optimal cost after consulting physicians
working in low resource settings, a regular BVM could potentially gain many of the advantages
of a ventilator.
Our overall goal is the creation of an automated, reliable, and long-lasting attachment to
fit onto the standard bag valve mask and automate compression and air supply. The attachment
needs to function with relatively little human interference to free up medical care providers or
family members from the personnel requirements of BVM operation. The device will be reliable
so after initial setup and initialization the device requires no human oversight. The device will
also last long enough to act as a potential ventilator replacement, thereby saving the many
million lives that are lost from lack of efficient manpower. The TAB utilizes a simple rack and
pinion mechanism with a compression mechanism that is meant to mimic manual compression in
order to achieve our goals.

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Design Strategy

The desired design specifications are outlined below, with all specifications compiled in Table 1.

Total cost of device

The total cost of the device should be under $150. This number is a significant decrease from the
cost of a ventilator which falls around $5000 at a minimum​5​. The cost of a bag valve mask
device is around $25 6​​ and needs to be replaced after each use, meaning a lot of BVMs in low
resource settings are donated or bought in bulk. After discussing these details with physicians
from these settings we decided that $150 was an optimum price for automating the compression
process and still being affordable to the local hospitals.

Time device can run without human intervention

The device must provide reliable ventilation to patients when unmonitored for as long as the
patient needs assistance. In special cases, patients need up to 6 hours of bagging​4​. Therefore, our
device should be able to provide at least 6 hours of ventilation. Two failed compressions in any
ten breath window would result in ineffective ventilation​7​.

Time from beginning of setup to first compression cycle

While the ABVM is being set up, it cannot supply ventilation. Thus, the device must be able to
be set up in the time that a patient can safely survive without ventilation. This time was
determined to be 45 seconds from when the last breath was supplied manually by the BVM to
when the first autonomous breath is supplied.

Size
We would like the device to occupy the least amount of space possible so that it could be stored
easily in any setting. But since it fits around the BVM, it needs to be at least that size. Therefore,
the device should fit in a 12” by 9” by 9” box, which is the size of the BVM expanded by two
inches in each direction.

Weight
Since the device will be placed to the side of the patient, weight was not an important factor.
However, it would be effective for the device to be light weight as it would make it easier to
carry. Thus the weight of the device must be under 6 lbs.

Percent error of desired frequency settings

The device will be replacing trained medical personnel to compress the bag valve mask.
Therefore, the device must be able to accurately supply properly timed breaths. It was
determined that a human will change the rate at which they squeeze a bag by up to 20% over a

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20 minute window. This error does not cause any serious health complications, but more
accurate frequencies would supply the patient with the exact amount of oxygen they need and
provide them more comfort. Thus, to be more effective, the device must always supply breaths
with less than 10% error over a 20 minute window.

Power usage
The device should be portable and last at least an hour, so power usage must be minimized to
allow for a smaller power supply. It would be feasible to power the device with 4AA batteries or
a rechargeable battery of similar fashion that is available in low resource settings. Thus, the
power usage per hour should be less than 6W​.

Volume displacement of compression

The volume of the air supplied in a compression cycle is critical to the effectiveness of each
breath. According to the AHA, during bag-mask ventilation, it is necessary to provide an adult
with approximately 500 mL of tidal volume​8​ and approximately 6-8 mL/kg​9​ of tidal volume
children, resulting in 250 mL for a 35 kg child.

Table 1: Design Specifications

Specification Value

Total cost of device $150

Time device can run without human intervention More than 6 hours

Time from beginning of setup to first compression cycle Less than 45 seconds

Size Less than 12” x 9” x 9”

Weight Less than 6 lbs

Percent error of desired frequency settings Less than 10%

Power usage Less than 6W

Volume Displacement of Compression 500 mL for adult​8

250 mL for children​9
100 mL for infants​9

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Designing the TAB

In order to make brainstorming for an automation device more manageable, automation

of the bag valve mask was decomposed into five sub functions. These five sub functions were: 1)
Securing the Bag Valve Mask, 2) Powering the Device, 3) Controlling/Adjusting the Device, 4)
Compressing the Bag, and 5) Monitoring the Device. These five sub functions are outlined and
further broken down in our functional decomposition chart in Figure 2.
Securing the bag valve mask is the first goal that must be accomplished. The bag valve
mask must be properly secured to the patient for ventilation to be possible. Currently there are
two existing methods for securing the bag valve mask to the patient that we must consider. The
mask of the BVM may be held by provider to the patient. The patient may also be intubated and
the BVM can be used without the mask. In addition to securing the BVM to the patient, the
automation attachment device must be properly secured to the BVM in order to ensure for proper
ventilation and for no errors to occur while the BVM is being automated. Since we are using the
device in a stationary environment, we will not worry about excessive movement of the device
itself.
Next, the device must be powered in order to work. Several methods of powering the
device must be considered for this sub function which will provide energy to the other sub
functions such as the compression mechanism and the monitoring of the device. The amount of
energy needed will depend on the power consumed by the selected compression or monitoring
mechanisms.
The automation device will need a component that allows for the adjustment and control
of the compression. Adjustment can be broken down into the ability to adjust the frequency of
compressions, and the velocity and pressure of the air output. The adjustment of the frequency of
breaths is vital to be able to provide a safe amount of air to patients depending on their age and
condition. The volume of air provided must also be able to be adjusted based on the size of the
patient.
Compressing the bag is a key objective of automation. Automating the bag valve mask
will require a mechanism which is able to consistently and reliably compress and decompress the
bag valve mask.
Finally, automation would require the device to signal its operating status to the user
(EMS personnel or personnel in low resource settings). Monitoring the device would entail
alerting users when the device is low on power as well as detecting and indicating the force
applied on the bag. This ensures there are no errors while compressing the bag as this can be a
sign of other complications with the patient.

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 Figure 2: Functional Decomposition

After breaking the problem into subfunctions, the team worked on each of these sub
functions in a parallel manner. This allowed the prototype to be brought to fruition faster. Much
of our time was spent on brainstorming ideas, trying out different ideas, and iterative prototyping
before deciding on our final design, the rack and pinion device.

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Final Design

Figure 3: Final CAD assembly of TAB

The TAB is an add on device that attaches to the BVM in order to automate compression as
shown in Figure 3. The TAB takes user input to control the breaths per minute, compresses the
bag, and provides ventilation to the patient. First, the BVM is attached using the front and back
attachment mechanisms. Then, the user inputs the desired settings using the buttons. Next the
compression mechanism, composed of the pushers and rack and pinion, compresses the bag.
Finally, the air flows out of the tube into the patient’s mouth. The following text describes how
each of these components work in more detail.

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Attachment of BVM to device

Front End
To secure the front end of the BVM, we utilize a peg system that can adjust for various BVM
lengths as there is no standard length for the bag as seen in Figure 4. The front attachment was
designed to fit the output valve of the BVM as this is the one of the two standardized
components of the BVM, the other being the size of the bag for volume.

Figure 4: Front end attachment system

Back end
To secure the back end of the BVM, the hard circular portion of the back end must be inserted
into the slightly flexible U shaped holder as shown in Figure 5. Next, use the adjustable zip tie to
tighten the back end in place. To adjust for various BVM lengths the telescoping piece, at the
bottom of the back attachment, is used to adjust accordingly by either pulling out the back
attachment further or bringing it closer.

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 Figure 5 : Back end attachment mechanism

Tubing
The extended tubing of the device can be attached to the patient to allow for the device to sit out
of the way while compressing as seen in Figure 6. First, the BVM, is attached to the extending
tube then the extending tube is attached to a black connector. This connector is attached to an
expiratory valve that prevents dead space. Finally this expiratory valve is connected to the
patient's mouth through a mask or endotracheal tube (ETT) in order to supply oxygen. The tube
is 2 feet which allows the BVM to be set behind or next to the patient.

Figure 6: Tubing connection from BVM to patient via an expiratory valve

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Compression mechanism

Sliders
The sliders are the subcomponents that interface between the moving mechanism and the BVM.
The 2 sets of orthogonal slider rails, that are on the compressor, slide through the slider rails
found on the base as seen in Figure 7. The rack on the compressor connects with the pinion that’s
attached to motor. The screws found on the bottom are used to limit the range of motion of the
compressor in conjunction with the limit switches, which will be discussed in more detail in the
electronic control section.

Figure 7 : Sliders and rail

Pusher
The triangular portion that extends upwards, as seen in Figure 8, is responsible for compressing
the bag. As the 2 pushers approach each other, the black triangles will start squeezing the bag,
making air flow through the tube and into the patient. As the 2 pushers move away from each
other, the BVM is allowed to expand with new air. The triangle shape was chosen since it was
able to provide more than 600 mL of air with the least amount of effort from preliminary testing.
A point force is located in the center portion of the triangle as a way to break initial tension in the
bag and allow the bag to be more easily compressed.

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 Figure 8: Pushers attached to sliders

Rack and Pinion with Motor

This subcomponent, shown in Figure 9, is responsible for moving the compressors with enough
force to compress the bag. The 3D printed black “base” is used to house all the other components
such as the motor, slider rails etc. The servo motor HSR-2645CRH has a pinion attached to it
through a “converter”. As the motor spins, the gear will cause the pinions to move in an
antiparallel fashion.To ensure that the racks move in a ordered fashion, sliders and slider rails
were incorporated. As the rack moves, the slider and slider rail only allow movement in that
direction, increasing the efficiency of the design. A second set of sliders/slider rails were
incorporated to prevent the compressor from twisting.

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Figure 9: Bird’s eye view of the rails and pinion, motor is hidden by gear, limit switches seen
above the gear in green

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Electronic Components

Control via PICAXE

The device is controlled via a PICAXE 20x2 microcontroller as shown in Figure 10. This
controller has 20 pins, 16 of which are input/output pins. Of these pins, the device utilizes 6 for
the LEDs, 3 for the user interface buttons, 2 for the limit switches, and 1 for the motor. To
prevent the compressors (rail) from sliding off the rail, limit switches (not pictured) are used as
feedback devices for the motor as the motor does not have built in feedback. There are two limit
switches that are activated when screws attached to the bottom of the compressors touch the
switches, indicating that the compressors are at the far end of their stroke. The PICAXE was
chosen as to reduce cost when compared to the Arduino.

Figure 10: Close up on PICAXE and voltage regulators

Power
The device is currently powered by a 12V outlet and has an on/off switch. The voltage needed
for the components of the system are 5V and 7.5V which are achieved using two voltage
regulators, seen in Figure 10.

User interface
The user interface consists of three buttons and six LED indicators, as seen in Figure 11. One
button controls the frequency: slow, medium, or fast. Three options were chosen so that
providers could provide the breathing frequency that is needed. The other button controls the
distance travelled based on the patient’s age: adult, child, or infant. The LEDs cycle through the
options when the corresponding buttons are pressed, allowing the user to easily identify the
current setting. This was chosen over an LCD display in order to reduce cost. While using the

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user interface, breaths per minute will decrease as the age of the patient increases meaning the
infant setting must always be used with the fast frequency and the adult setting will be used with
either the slow or medium frequency.

Figure 11: Close up of User Interface

Limit Switch
The limit switches are used as feedback devices for the motor as the motor does not have built in
feedback, as seen in Figure 9. There are two limit switches that are activated when screws
attached to the bottom of the compressors touch the switches, indicating that the compressors are
at the far end of their stroke. This would help prevent the device from inadvertently breaking due
to conditions making the compressor (rail) move out of position.

Program sequence
The first step of the programming sequence is the calibration of stroke length. The device fully
opens and closes, changing direction as each limit switch is pressed. This allows the system to
know the distance that the compressor arms will need to travel for each stroke. The next portion
of the sequence is the user interface. The user selects the frequency and patient age (adult, child,
or infant) by pressing the corresponding buttons. The LEDs cycle to indicate the current
selection. When the correct LEDs are illuminated, the user presses the on/off button. This will
begin compression at the desired speed and desired stroke length corresponding to the amount of
volume necessary for the specified age. When the user wants to stop compression, they must
hold the on/off switch and then the device will stop compressing. The user can then change the
settings and begin compression again.

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Labor, Burden and Materials

The Labor, Burden and Materials costs were calculated for low (0-500 devices) , medium
(500-1000 devices) and high volumes (>1000) of device manufacturing. The materials and labor
costs were divided into 7 subsections including: Encasing, User Interface, Compression system,
Electronics, Attachments, Tubing/Connectors, and the Base. For low and medium volumes, all
custom designed STL parts were 3D printed. For High Volume Estimates, these custom parts
were assumed to be injection molded instead of 3D printed. In addition, we assumed we would
need more employees for the medium and high volumes than the volume. The breakdown of cost
for low, medium and high can be seen in Figures 12-14.

Figure 12: Low Volume LBM with a total cost of $525.33

Figure 13: Medium Volume LBM with a total cost of $602.85

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 Figure 14: High Volume LBM with a total cost of $676.00

Regulations

The FDA has a series of regulations that a medical device must follow depending on its
classification. The automated bag valve mask (ABVM) has been identified to be a Class II
medical device. The ABVM exists in a capacity between a BVM and a ventilator both of which
are previously defined as Class II medical devices, thus the ABVM is naturally a class II device.
In order for a Class II medical device to be approved to be on market, there are a few basic
regulatory requirements. These include Establishment registration, Medical Device Listing,
Premarket Notification 510(k), unless exempt, or Premarket Approval (PMA), Investigational
Device Exemption (IDE) for clinical studies, Quality System (QS) regulation, Labeling
requirements, and Medical Device Reporting (MDR). There are many more regulations that
apply to specific devices. These regulations are outlined by the Code of Federal Regulations
(CFR). In Table 1 below we have specified the most important regulations that apply to the
Automated Bag Valve Mask.

Table 2: FDA Regulations

Regulation Description

R 21 CFR 820 Quality Management System

21 CFR 822 Postmarket Surveillance

21 CFR 870.5210 CPR Aid

21 CFR 861 Procedures for Performance Standards Development

21 CFR 803 Medical Device Reporting

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21 CFR 820
According to this regulation, the team must have a management structure that is in charge of the
quality system. The quality system itself includes design control, document control,
identification and traceability of devices, production control, Corrective Action Preventative
Action (CAPAs), and risk management procedures. When designing our device, we will
carefully document our process such that our reasonings can be traced and explained in the
future.

21 CFR 822
According to this regulation, once our product is in the market, we must have postmarket
surveillance in place since we are a Class II device. We will likely send out surveys to
hospitals/EMS personnel and gather information on the device’s use. Such information may
include usability scores, percent failure rate, how long the device lasts in certain settings, etc.
During the testing of our device, we can establish this surveillance system based on our
experience.

21 CFR 870.5210
According to this regulation, because we are providing real time information to the medical
professional regarding the quality of CPR administered, we are creating a device that gives CPR
aid with feedback. This subsection also classifies our device as Class II and as such, we have to
perform nonclinical testing to prove performance, have proper labeling on the device, prove
electronic safety, software validation, biocompatibility, and human factors testing. This testing
will occur after our device has been constructed, and we will plan these tests when we have a
better idea of our final device.

21 CFR 803
According to this regulation, whenever a patient gets seriously injured or dies due to our device,
we must file a Medical Device Report, MDR, to the FDA.

21 CFR 861
According to this regulation, we will create standardized tests to validate various
aspects/processes surrounding our device, including but not limited to: performance,
components, manufacturing, and sales.

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Standards

Standards for medical devices are outlined by several international organizations such as the
International Organization for Standardization (ISO) and the International Electrotechnical
Commission (IEC).

Table 3: ISO and IEC Standards

Standard Description

ISO 13485:2016 7.1 Requirements for how to ensure quality management

when manufacturing production parts

ISO 13485:2016 8.5.1 Requirements for a comprehensive quality

management system specifically relating to how to
make changes to the device.

IEC 60601-1 General Safety of Medical Electrical Equipment

IEC 60601-1-6 Usability Safety Requirements

IEC 60601-1-8 Alarm Systems in Medical Equipment

IEC 60601-1-12:2015 Requirements for medical electrical equipment and

medical electrical systems used in the emergency
medical services environment

IEC 60812 Failure Modes, Effects, and Criticality Analysis

(FMECA)

ISO 13485:2016 General

This standard refers to the level of ​quality management required in the stages of medical device
creation. Those include design and development, production,​ storage, distribution, installation,
and servicing and design and development, or provision of associated activities (e.g.technical
support). This standard is also used by third parties who supply materials and components.
This standard generally applies to the entire process of senior design documentation and tests. In
addition, it applies to any of the materials that are created or used in the final device.

IEC 60601-1
The general requirements for basic safety and essential performance for medical electrical
equipment are outlined in IEC 60601-1. This includes but is not limited to reducing the potential

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for electrical shock, radiation, fire, and excessive energy output hazards. Power supply standards
are also specified and will be important for our device. The ABVM will need to undergo several
tests and will need to comply with these standards in order to be approved to be on the market. It
is important that early in the design process, the critical components are identified. Additionally,
spec sheets of all parts used in the device must be referenced and compiled. Test plans should
also be drafted early in the design process.

IEC 60601-1-6
This standard refers to the safety of the device when it is in use. It specifies a procedure (the
usability engineering process) for manufacturers to analyze and validate usability and its effect
on basic safety and essential performance of medical electrical equipment.

The standard requires that manufacturers assess and mitigate any risks caused by the user. These
risks are anything associated with both correct and incorrect use. During our analysis, it is
important to identify possible user errors and the risks associated with them. Additionally it is
important to identify and mitigate risks associated with abnormal use of the device. This process
must be detailed and documented and validated.

IEC 60601-1-8
It is important for the alarms on the device to be up to standard. The ABVM has the potential to
have several alarms to notify the user when problems arise. The IEC 60601-1-8 outlines general
requirements, tests, and guidelines for alarm systems in medical electrical equipment. There are
several auditory and visual conventions. For the visual arms, some conventions surrounding
indicator lights and controls are outlined. Frequency range and harmonic conventions are
outlined for auditory alarms.

IEC 60601-1-12:2015
There are additional standards for medical devices which are not used in a controlled indoor
environment. Devices that will be used in emergency situations will likely be used by EMS
personnel and will be subject to a mobile environment due to ambulance transport. The ABVM
will be in use in the EMS environment therefore will need to comply by these standards.

IEC 60812
According to this standard, an analysis for system reliability must be conducted. This is called a
Failure Modes and Effect Analysis (FMEA). In an FMEA, a system must be systematically
analyzed to find potential modes of failure. The procedure of analysis must be included. We
must have a failure modes, effects and criticality analysis (FMEA) worksheet. We have already
created this worksheet which is included in our cycle 1.5 documents.

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Testing and Results

Volume Testing
Before creating the calibration mechanism for the device we needed to determine how far to
compress the bag to deliver a certain volume. To measure volume displacement while using the
device, we used the Biopac available in Ryon Lab. The Biopac is a data acquisition system for
physiology measurement and interpretation. First, the BVM was attached to the device through
the attachment mechanism. Then, a 2 foot tube was attached from the BVM and into the Biopac.
Next, under each of the possible patient settings (infant, child, adult) and the breathing settings
(slow, medium, fast ventilation), 20 compressions were recorded by the Biopac. With the Biopac
data, we measured the volume of each compression. For each condition, we calculated the mean
volume being compressed. Success was achieved if the mean volume was =500 mL for adult,
=250 mL for child, and =100 mL for infant. Figure 15 shows the results of our most recent tests
for the volume testing. Testing was done over 10 cycles and the error bars represent one standard
deviation. As shown, we were able to achieve the desired volumes for Infant, Child, and Adult
categories.

Figure 15: Volume Testing Results, Dashed Box represents Target Volume

Frequency Testing
Next we needed to validate how well our device can deliver a certain compression frequency
without error as the number of breaths provided in a period of time is a crucial factor for patients
under respiratory distress. In order to calculate frequency, we measured the amount of
compressions done in a minute at each speed and at each patient size. Frequency error was then
calculated by Equation 1.

(T rue f requency − Desired f requency)/ Desired f requency ​Equation 1

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Success was achieved if frequency error fell between plus or minus 10% of the wanted
frequency. Figure 16 shows the most recent results from this testing. Each frequency was tested
for 5 cycles and the average was taken for analysis. Overall, we were able to achieve precise
frequency control for all the possible settings.

Figure 16: Frequency Testing Results

User Interface and Attachment Testing

The TAB must be simple enough to use such that it does not interfere with normal medical
procedure and can be used quickly enough to bring benefit to the patient. To test the usability of
the device twenty subjects were shown a demonstration of how the BVM is attached to the TAB
as well as how to begin ventilation. Next, each subject was timed on how quickly they could
attach the bag themselves. The subjects were a mix of emergency medical technicians and
engineering students. Each subject was told this was a life or death situation and needed to finish
the task as swiftly and effectively as possible.
Afterwards, the subjects were questioned on the ease of use (Appendix C) and were
asked to rank the user interface, device attachment mechanisms and the overall device from 1-5,
1 being poor and 5 being excellent (Table 4). The average time to being ventilation was 38
seconds with the fastest time being 24 seconds and the slowest being 61 seconds. This shows that
subjects with or without medical background can operate our device in a timely matter that is
under our objective of 45 seconds. Along with this the device on averaged was ranked at 4
indicating that it is a simple enough device that can be understood after one demonstration.

Table 4: User Interface Results

Average Time
(s) User Interface Rating Attachment Rating Tube Rating Entire Device

38.6 4.4 3.6 3.5 4.1

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Size and Weight
The TAB weighs 3.6 lbs which is under our 6 lb goal and therefore meets the weight restrictions
set. The device is also able to fit within a 12” by 9” by 9” box we had defined for our size as seen
in Figure 17.

Figure 17: The TAB in a 12” by 9” by 9” box

Total Cost
After calculating the price for each part of our device for bulk ordering, we added up the cost for
each section (Table 5) and had a total cost of $117.20. This is below our specification goal of
$150 and will therefore be affordable in many low resource settings. Furthermore, because we
utilized 3D printing for most of our support pieces our device will be able to be repaired and
managed in most locations at very low repair costs. A further detailed cost breakdown for each
particular part used in the TAB can be found in the appendix.

Table 5: Total Cost

Attachment $19.71

Compression $43.63

Electronics $35.05

Base $6.18

Casing $13.17

Total Cost $117.20

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Device Lifetime
In order to test the lifetime of our device, we set up the TAB with a BVM and started the
motor at patient setting adult with frequency slow which is about 500 mL at 10 bpm. We set a
timer and video recorded the device for as long as it continued to work. When we first attempted
this test the device ran for 1 hr 21 min and then a limit switch broke off from physical strain. We
corrected this by adding a spring system to prevent this damage and retested the longevity. The
second test ran for 45 minutes when the motor broke. We determined that this was because we
had used this motor for several weeks and had overheated due to usage. It was decided we
needed a new motor to accurately test the device lifetime. We also created a ventilation system to
address the overheating as seen in Figure 18. For the final longevity test, the device was able to
run unassisted for 11 hours until the motor overheated. A timelapse of this test can be found
here​. From these results we were able to ascertain the maximum lifetime for our motor and
observed that the motor is the limiting factor in our device’s lifetime.

Figure 18: Prototype ventilation system added to the TAB

Power Usage:
In order to test the power usage of the device, we set the device to three most commons
settings; 1) Adult Slow (500 mLs at 10 bpms) , 2) Child Medium (250 mLs at 20 bpms), and 3)
Infant Fast (100 mLs at 30 bpms) and recorded the current and voltage draw over several cycles.
The device was powered by an external power supply with digital readouts of voltage and
current. These readouts were recorded with a camera while the device ran and the numbers were
recorded by averaging current and voltage over every frame. The data had a low signal to noise
ratio so to reduce noise the power usage data was fit to a sinusoidal wave (see Equation 2) and
plotted below in Figure 16.

27
 P (t) = A * sin(wt) + B ​Equation 2

Figure 19: Power Usage over Time

The recorded average power usage for each setting is found in Table 6 below. From these
tests we were able to determine that power usage for all common settings was to high for our
design specification. Unfortunately, we don’t believe this can be lowered in an efficient manner
and a larger power budget would be necessary for ventilation using BVMs.

Table 6: Average Power Usage

Setting Average Power Usage (W)

Infant Fast (100 mLs at 30 bpm) 6.5

Child Medium (250 mLs at 20 bpm) 7.7

Adult Slow (500 mLs at 10 bpm) 10.5

28
Summary and Recommendations
Currently, our design is able to attach to the BVM securely and automatically provide
ventilation for infants and children. Additionally, we have a robust user interface which allows
the user to choose the appropriate settings required and stop ventilation when needed; the user
interface is also easy to use, as tested by our user interface testing. The front and back end
attachment mechanisms can reliably secure the BVM in place allowing the TAB to compress the
bag with no extra movement. Lastly, the rack and pinion mechanism is able to give consistent
volume and frequency for all the settings as shown by the volume and frequency tests.
There are three main areas for improvement: 1) the device needs to be plugged into a wall
2) the motor breaks after extended use 3) the device has openings to the environment. For 1), an
appropriate sized battery must be found and/or make the compression mechanism more efficient.
The problem with the battery is that the current motor drew too much current, making the battery
die much faster than expected. Inadequate voltage then led to motor being weaker, causing
inadequate ventilation therefore a better quality motor must be chosen. Last, the device encasing
needs to be optimized to be durable in harsh conditions, this includes closing off all crevices to
the device while allowing for ventilation.
We recommend in future iterations for this device, to put less emphasis on the size and
weight constraints of the device. At the beginning the team believed that the target audience was
going to be EMS personnel therefore the device would have had to be placed on the patient’s
chest in order to accommodate for space in an ambulance. This resulted in the limitation of size
and weight of the device so that it would be more portable. However as we progressed, we
realized, through testing, that the device could just be placed to the patient’s side using an
extension tubing and act as a replacement ventilator. The limited space forced us to use a smaller
motor, which was prone to overheating; a bigger motor would be able to dissipate the heat much
better and last longer. A future team can also try to diagnose why the current motor fails and act
accordingly. While having the device portable is still a useful aspect, size and weight need not be
limiting factors to the device and focus must be placed on the motor and the ventilation
capabilities of the TAB.
Smaller improvements can also be made to optimize the current prototype. First the
device needs to have rubber padding on the bottom of the encasing and th pushers to prevent the
device from moving during operation and from damaging the BVM. From our user testing, we
also recommend that the back attachment be made larger and easier to use (e.g. including
grooves to indicate where back of bag should be placed). Finally, a fan for the motor may need
to be incorporated into the new prototype if the new motor still experiences overheating.
In terms of testing, the device still needs to be tested thoroughly once the new prototype
is developed. The device must be tested for accuracy of volume and frequency over long periods
of time so that it can be used in life saving situations. Currently the TAB is at a promising start,
but with modifications, we believe that this device can be implemented worldwide to help
patients undergoing respiratory distress.

29
References

[1] Mzungu, Watipaso. “Ticking Time-Bomb in Malawi Health Sector.” The Nation, NPL, 30
May, 2015.

[2] ​Cox, Lawrence A., and John D. Smethers. "Lung ventilators." U.S. Patent No. 4,206,754. 10
Jun. 1980.

[3] Forum of International Respiratory Societies. The Global Impact of Respiratory Disease –
Second Edition. Sheffi eld, European Respiratory Society, 2017.

[4] ​Force, ARDS Definition Task, V. M. Ranieri, and G. D. Rubenfeld. "Acute respiratory
distress syndrome." ​Jama3​07.23 (2012): 2526-2533.

[5] ​“Allied Healthcare AHP300 Transport Ventilator.”, 2018

[6] “AMBU Bag SPUR II Adult Resuscitator w/Adult Mask, Oxygen Reservoir, PEEP Valve.”,
2018

[7] J​esudian, M. C., et al. "Bag-valve-mask ventilation; two rescuers are better than one:
preliminary report." ​Critical care medicine​13.2 (1985): 122-123.

[8] ​Neumar, Robert. “2010 American Heart Association Guidelines for Cardiopulmonary
Resuscitation and Emergency Cardiovascular Care.” ​American Heart Association​, American
Heart Association, 2 Nov. 2010.

[9] “Pediatric Ventilation Guidelines.” ​Ministry of Health and Medical Services,​Pediatric

Intensive Care Unit, 2010.

30
Appendices
Appendix A: Cost Breakdown

31
Appendix B: Picaxe Code

init:
symbol strokeval = b0
symbol speedval = b1
symbol stroke = b2
symbol increment = b3

symbol strokebutton = pinB.3

symbol speedbutton = pinB.2
symbol onoffbutton = pinB.4

symbol limitopen = pinB.5

symbol limitclose = pinB.6

symbol pulsecal = w3

symbol strokeper = w4
symbol strokepulse = w5

symbol waittime = w6
symbol stroketime = w7
symbol timecorrect = w8

symbol highspeedled = C.0

symbol medspeedled = C.1
symbol lowspeedled = C.2

symbol longstrokeled = C.4

symbol medstrokeled = C.3
symbol shortstrokeled = C.5

symbol speedopen = 200

symbol speedclose = 400
symbol speedstop = 300

symbol lowspeedwaitadult = 1650

symbol medspeedwaitadult = 500
symbol highspeedwaitadult = 0

32
symbol lowspeedwaitchild = 2100
symbol medspeedwaitchild = 975
symbol highspeedwaitchild = 475

symbol lowspeedwaitinfant = 2550

symbol medspeedwaitinfant = 1300
symbol highspeedwaitinfant = 800

strokeval = 1
speedval = 1
pulsecal = 0

;use limit switch to determine distance

;low speed
do while limitopen = 0
pulsout B.7, speedopen
pause 20
high highspeedled
high medspeedled
high lowspeedled
high longstrokeled
high medstrokeled
high shortstrokeled
loop
do while limitclose = 0
pulsout B.7, speedclose
pause 20
low highspeedled
low medspeedled
low lowspeedled
low longstrokeled
low medstrokeled
low shortstrokeled
pulsecal = pulsecal + 1
loop

do while limitopen = 0
pulsout B.7, speedopen

33
 pause 20
loop

stroketime = 20*pulsecal
pulsout B.7, speedstop

low highspeedled
low medspeedled
high lowspeedled
low longstrokeled
low medstrokeled
high shortstrokeled

main: ; make a label called ‘main’

if strokebutton = 1 then strokeset ; jump if the input is on
if speedbutton = 1 then speedset ; jump if the input is on
if onoffbutton = 1 then motor
debug
goto main ; else loop back around

strokeset:
if strokeval = 1 then
low shortstrokeled
high medstrokeled
strokeval = 2
do while strokebutton = 1
loop
goto main
elseif strokeval = 2 then
low medstrokeled
high longstrokeled
strokeval = 3
do while strokebutton = 1
loop
goto main
elseif strokeval = 3 then
low longstrokeled
high shortstrokeled
strokeval = 1

34
 do while strokebutton = 1
loop
goto main
endif
goto main

speedset:
if speedval = 1 then
low lowspeedled
high medspeedled
speedval = 2
do while speedbutton = 1
loop
goto main
elseif speedval = 2 then
low medspeedled
high highspeedled
speedval = 3
do while speedbutton = 1
loop
goto main
elseif speedval = 3 then
low highspeedled
high lowspeedled
speedval = 1
do while speedbutton = 1
loop
goto main
endif

motor:
do while onoffbutton = 1
loop

;stroke length will determine percent of stroke (strokeper)

if strokeval = 1 then
strokepulse = pulsecal*16/100
elseif strokeval = 2 then

35
 strokepulse = pulsecal*39/100
elseif strokeval = 3 then
strokepulse = pulsecal*100/100
endif

;speed
if speedval = 1 then
if strokeval = 1 then
waittime = lowspeedwaitinfant
elseif strokeval = 2 then
waittime = lowspeedwaitchild
elseif strokeval = 3 then
waittime = lowspeedwaitadult
endif
elseif speedval = 2 then
if strokeval = 1 then
waittime = medspeedwaitinfant
elseif strokeval = 2 then
waittime = medspeedwaitchild
elseif strokeval = 3 then
waittime = medspeedwaitadult
endif
elseif speedval = 3 then
if strokeval = 1 then
waittime = highspeedwaitinfant
elseif strokeval = 2 then
waittime = highspeedwaitchild
elseif strokeval = 3 then
waittime = highspeedwaitadult
endif
endif

debug

;compression cycles
do while onoffbutton = 0

do while limitopen = 0
pulsout B.7, speedopen

36
 pause 20
if onoffbutton = 1 then
exit
endif
loop

pulsout B.7, speedstop

if onoffbutton = 1 then
exit
endif

pause waittime

for increment = 1 to strokepulse

pulsout B.7, speedclose
pause 20
if onoffbutton = 1 then
exit
endif
next
increment = 1

pulsout B.7, speedstop

if onoffbutton = 1 then
exit
endif

pause waittime

loop

;reset sequence
do while onoffbutton = 1
pulsout B.7, speedstop
pause 20
high highspeedled
high medspeedled

37
 high lowspeedled
high longstrokeled
high medstrokeled
high shortstrokeled
loop

low highspeedled
low medspeedled
low lowspeedled
low longstrokeled
low medstrokeled
low shortstrokeled
pulsout B.7, speedstop

do while limitopen = 0
low highspeedled
low medspeedled
low lowspeedled
low longstrokeled
low medstrokeled
low shortstrokeled
pulsout B.7, speedopen
pause 20
loop

pulsout B.7, speedstop

strokeval = 1
speedval = 1
low highspeedled
low medspeedled
low lowspeedled
low longstrokeled
low medstrokeled
low shortstrokeled
high lowspeedled
high shortstrokeled

goto main

38
Appendix C: User Questionnaire
User Interface Testing Questionnaire

It was easy to understand how to change the patient age (Infant, Child, Adult)
1 2 3 4 5
Strongly Disagree Strongly Agree

It was easy to understand how to change the stroke speed (Slow, Medium, Fast)
1 2 3 4 5
Strongly Disagree Strongly Agree

It was easy to start the compressions

1 2 3 4 5
Strongly Disagree Strongly Agree

It was easy to stop the compressions

1 2 3 4 5
Strongly Disagree Strongly Agree

The buttons were easy to press and responsive

1 2 3 4 5
Strongly Disagree Strongly Agree

The interface was an appropriate size

1 2 3 4 5
Too Small Just Right Too Large

Overall, it was easy to use this device

1 2 3 4 5
Strongly Disagree Strongly Agree

Further comments:

39
Appendix D: Past Iterations of Device

Proof of Concept for rack and pinion mechanism

Low fidelity prototype

40
 Medium fidelity prototype

CAD Assembly of Medium fidelity TAB

41