Project



Meeting Purpose: The purpose of this meeting is to communicate the project deliverables to the client and provide a list of required components and feasibility analysis to support component choices. As well as get approval to begin ordering the required components so that we can start development.

Materials to be reviewed

• Project Summary

• Customer Needs

• Engineering Specifications

• Feature Set

• Component Breakdown

• PUGH Matrix’s

• Other Required Components

• Bill of Materials

• Test Plans

• Risk Assessment

• Product Design Rendering

Meeting Date: February 8, 2013

Meeting Location: 09-4435 (This room is located on the 4th floor of the Computer Engineering Building)

Meeting time: 9am – 11am

Timeline:

• Note: This time line is tentative, adjustments will be made as needed during presentation.

|Meeting Timeline |

|Start |Topic of Review |Required Attendees |

|time | | |

|9am |Project Summary |Customer |

|9:05 |Customer Needs |Customer |

|9:10 |Engineering Specifications |Customer |

|9:15 |Feature Set |Customer |

|9:35 |Component Breakdown |Customer |

|9:40 |PUGH Matrix’s |Customer |

|10:00 |Other Required Components |Customer |

|10:10 |Risk Assessment |Customer |

|10:30 |Bill of Materials |Customer |

|10:45 |Test Plans |Customer |

|10:50 |Risk Assessment |Customer |

|10:55 |Product Design Rendering |Customer |

|Project # |Project Name |Project Track |Project Family |

|P13026 |Portable Emergency Ventilator |Biomedical Systems and Technologies Track|Medical Device |

|Start Term |Team Guide |Project Sponsor |Doc. Revision |

|Winter 2012 |Edward Hanzlik |Jeff Gutterman |2 |

| | |Roman Press | |

Project Description

Project Background:

A Portable Emergency Ventilator (PEV) is a device that can provide positive pressure ventilation to a person who is incapable of breathing on their own. The current device was built in the late 1980s. The goal of this project is to update this model with current technology while still keeping the FDA 510k approval. This includes the redesigning of the outer case as well as replacement of the circuits, pump, and battery to decrease size and increase ease of use. Additions for a pulse oximeter, voice feedback, and the recording of vitals are also planned. The team will be divided into a few subgroups, all of which will be given different project tasks.

Problem Statement:

The primary goal of this project is to design a replacement PEV which is similar to the current device. Also, the addition of a few features will better help the EMTs and paramedics utilize the device.

Objectives/Scope:

1. Replace outdated components

2. Design a new outer case

3. Add new features

4. Test in different conditions

5. Maintain FDA 510k approval

6. Develop a competitive product concept for the market in 2 years.

Deliverables:

• Working prototype meeting the customer needs

• Test data showing correct operation

• Designs for other possible configurations or environments

• User’s guide for operation

Expected Project Benefits:

• Marketing benefit to RIT

• Practice our engineering abilities

• Possibility of saving lives

Core Team Members:

• Daniel Fenton – Project Manager

• Kennedy Kong

• Christopher Freeman

• David Engell

• Derek Zielinski

• Eric Welch

• Marie Revekant

• Melissa Harrison

• Roberto Castillo Zavala

• Ryan Muckel

Strategy & Approach

Assumptions & Constraints:

1. Team must first understand how CPR/resuscitation is performed.

2. Once that is completed, the team must then comprehend how the current PEV device aids in this process.

3. Working with an existing model will help the team understand its functions, and also help in the design of a new, updated model.

4. New features will be added to make the device easier to use and also competitive in the market.

5. Team will focus on design issues throughout the project that will help the transition from the current design to the new one.

6. Maintaining substantial equivalency in accordance with FDA 510k approval.

7. Proposed budget: $1,000.

Issues & Risks:

• Project Issues/Risks/Constraints

• This project is a new area of study for most, which brings with it a learning curve

• How to obtain both available and not readily available resources

• Where and which parts/hardware to order, which can lead to mistakes that can be costly regarding both money and time

• Lead time from part orders can be lengthy

• No one on the team has a strong vibrations background, so analysis of the effects of falling and hitting the device will require external consultation

• Customer Needs

[pic]

|Portable Emergency Ventilator |

|Engineering Specifications - Revision 5 - 2/8/13 |

|Specification Number |Importance |Source |Function |Specification (Metric) |

Below is a chart comparing the current features and requirements of the Mediresp III with the new ventilator. The portion of the chart just shows which Engineering Specifications will be present in the new ventilator and in instances where it makes sense values are provided to show what changes or improvements will be made, “x” denotes that that feature will be carried over into the new design as defined by the Engineering Specifications.

The multi color columns titled “Worst Case”, “Nominal”, “Best Case”, and “2015” are intended to give an idea of what can be expected for features given different scenarios. The goal of team P13026 will be to provide a combination of “Worst Case” and “Nominal” features in their project demonstration at Imagine RIT in May. The other categories will be used to help define the PRP for upcoming teams as well as give an idea of what should be included in a 2015 concept in order for it to be competitive in the market.

| | | |New Ventilator | |

| |Features |Mediresp III |Worst Case |Nominal |Best Case |2015 |

| |BPM |x |  |x |  |x |

| |peak flow |x |  |x |  |x |

| |air assist |x |  |x |  |x |

| |high pressure alarm |x |  |x |  |x |

| |DC input |6V-16V |  |9V-24V |  |9V-24V |

| |DC internal battery |x |  |x |  |x |

| |battery operation time |2-hr |  |1-hr |  |2-hr + |

| |elapsed time meter |x |  |x |  |x |

| |pump life |x |  |x |  |x |

| |2nd pressure relief |x |  |x |  |x |

| |time to back-up |x |  |x |  |x |

| |blood oxygen level |  |  |x |  |x |

| |CO2 |  |  |  |  |x |

| |Operation temperature |  |  |0-30 deg. C |  |wider range |

| |dimensions |11inx13inx7in |  |>current |  |~500 cubic in. |

| |weight |~23lbs. |  |>17lbs. |  |5-10lbs. |

| |drop height |~ 1m |  |  |  |1m |

| |screen color |analog |b/w |color |color |color |

| |screen size |1in x 2.5in. |3.5in |4.3in |6-7in |>8in. |

|Displa|BPM |  |not shown |cycle screen |all values shown |all values shown with |

|ys | | | | | |moving displays and |

| | | | | | |animations |

| |blood oxygen level | | | | | |

| |pulse | | | | | |

| |pressure level |shown with controls |only values shown on |all values shown |all on same screen|having option to |

| | |and incremental |screen | | |customize values shown |

| | |displays | | | |on screen |

| |mode of operation | | | | | |

| |BPM setting | | | | | |

| |flow | | | | | |

| |CPR count | | | | | |

| |charge |LED |no indicator |default charge LED's via|display on screen |display on screen with |

| | | | |window | |graphic |

| |CPR |breaths set with dial|monitor compressions |beat count |CPR audio |Audio and pictorial |

| | | | | |instructions | |

| |CPAP |  |  |  |  |x |

| |Alarms |LED and beep |LED and beep |LED and beep |message on screen |audio/ visual display |

|Housin|shape |square |square |panel design |form fitted w/ |geometric |

|g | | | | |custom mount | |

| |material |metal |sheet metal |styrene |styrene |composite |

| |Data |  |no storage |displayed so can be |SD or USB |internal storage w/ |

| | | | |recorded | |Bluetooth communication|

PUGH Matrix

A PUGH matrix is a method that helps determine which solutions are better than others. It is a scoring matrix used for concept selection. Therefore we will be using this methodology to choose the main components in the portable ventilator system. The components we will be presenting in our presentation are listed below.

Pump Selection PUGH Matrix

|Pump Selection |

|  |Option #1 |Option #2 |Option #3 |Option #4 |

| | Diaphragm |Articulated Piston |Rotary Vane |Centrifugal |

|Selection Criteria |Score |Score |Score |Score |

|Pulsations |0 |0 |- |- |

|Pump Life |0 |0 |0 |0 |

|Resistance to Environment |0 |0 |0 |0 |

|Durability |0 |0 |0 |0 |

|Weight |0 |- |- |- |

|Cost |0 |0 |- |- |

|DC Input |0 |- |- |- |

|Sum +'s |0 |0 |0 |0 |

|Sum 0's |7 |5 |3 |3 |

|Sum -'s |0 |2 |4 |4 |

|Net Score |0 |-2 |-4 |-4 |

|Rank |1 |2 |3 |3 |

Diaphragm Pump Sub-Selection PUGH Matrix

[pic]

[pic]

[pic]

[pic]

[pic]

Mass Flow Sensor Selection PUGH Matrix

|Mass Flow Sensor Selection |

|  |Option #1 |Option #2 |Option #3 |Option #4 |

| |(Honeywell) AWM2300V |(Honeywell) AWM2100V |Sensirion |TSI Incorporated |

|Selection Criteria |Score |Score |Score |Score |

|Weight |0 |0 |- |0 |

|Cost |0 |+ |0 |+ |

|Physical Durability |0 |0 |0 |0 |

|Accuracy |0 |+ |+ |+ |

|Range |0 |-- |-- |-- |

|Operating Temperature |0 |0 |- |- |

|Size |0 |0 |- |- |

|Sum +s |0 |2 |2 |3 |

|Sum 0s |8 |5 |3 |0 |

|Sum -s |0 |2 |4 |3 |

|Net Score |0 |0 |-2 |0 |

|Rank |1 |2 |3 |2 |

[pic]

[pic]

Mass Flow Sensor Analysis:

The mass flow sensor juncture consists of two different paths: the main path, which goes straight through the T-joints and completely bypasses the mass flow sensor, and the path which goes through the mass flow sensor. In order to simplify the calculations (and the assembly of the final product), the main path uses the same diameter tubing as the pump outlet (3/8”) while the mass flow sensor path uses tubing that matches the outer diameter of the flow sensor (1/8”).

The driving factor in this process is the pressure drop across each path, which has to be equal. The following equation was used:

[pic]

Assuming constant height and that the initial and final velocities (outside of the control volume in the original flow) are constant:

[pic] (1)

In this equation, the head loss is driven by the bends in the mass flow tubing, the expansion and contractions at the T-joints and the length of tubing in the main section. Assuming that velocities, minor and major head losses are not changing, the only factor that does get changed is the pressure drop across the flow sensor. This pressure drop, combined with the head losses in the mass flow path, has to equal that across the main path without exceeding the flow rate limit in the mass flow sensor.

The control volumes over which the pressure drops occur begins after the first T-joint inlet to before the second T-joint outlet. This means the mass flow has head loss at the contraction into the smaller section of the T-joint, the expansion into the 1/8” tubing, the first tubing bend, the mass flow pressure drop, the second tubing bend, the contraction into the small T-joint and the expansion into the original stream. The main stream just has the expansion from the T-joint to the 3/8” tubing, the frictional losses across the tubing length and the compression back into the T-joint.

From here on out, a number with no subscript represents the original path, a 1 represents the main path and a 2 represents the flow sensor path.

Main Flow Calculations

The main tubing minor head loss values are taken from Figure 8.15 (Pritchard, 363) and the friction factors are taken from Figure 8.13 (Pritchard, 359). The values found in those tables (which will not change, since they are based on the velocity of the flow), were used in the following calculations:

Major head loss – Length is driven by the length of the mass flow sensor

[pic]

Minor Head Losses – Minor head losses occur at expansion and compression through T-joint (2 times total, represented by an E and C)

[pic]

Subbing these two equations (with values plugged in) to equation one, the pressure drop is:

[pic]

Mass Flow Calculations

The mass flow calculations use the same formula and figure for the minor head loss, but there are 2 contractions and 2 expansions to be dealt with, along with two curved sections (which are approximated as 90 degree bends for simplification). It is assumed that the lengths of the straight sections of the curve are negligible. Figure 8.17b (Pritchard, 366, the following equations and laminar flow assumptions were used for the curve calculation:

[pic]

The minor head loss calculations for the bend and the compressions/expansions are all iterative calculations, since they are dependent on the flow rate (which is the unknown). The pressure drop across the mass flow sensor is also dependent on the flow rate, as shown in the figure below:

[pic]

Source:

The flow is assumed to be between 200-400 sccm (from educated guesses), so the pressure drop can be guessed by linear interpolation:

[pic]

An initial flow rate of 300 sccm was used, and then the Solver feature on excel (with all of these equations mentioned above) was used to minimize the pressure drop different between each stream.

Final Solution

This produced a final value for the flow rate—278.73 sccm. This flow rate is only met by the AWM2300V series mass flow sensor.

Mass Flow Data Tables:

See attached excel file to e-mail for these Data Tables.

Pressure Sensor Selection PUGH Matrix

|Pressure Sensor Selection |

|  |Option #1 |Option #2 |Option #3 |Option #4 |

| |136PC01G2 (Honeywell) |Honeywell Models |4525DO-SS5AI015AP (MS)|NPC-1210 (GE) |

|Selection Criteria |Score |Score |Score |Score |

|Cost |0 |+ |- |+ |

|Physical Durability |0 |0 |0 |0 |

|Accuracy |0 |+ |+ |+ |

|Operating Temperature |0 |- |0 |+ |

|Size |0 |0 |+ |+ |

|Pressure Range |0 |+ |+ |+ |

|Sum +s |0 |3 |3 |5 |

|Sum 0s |6 |2 |2 |1 |

|Sum -s |0 |1 |1 |0 |

|Net Score |0 |2 |2 |5 |

|Rank |3 |2 |2 |1 |

[pic]

[pic]

Control System Selection PUGH Matrix

[pic]

Feature Analysis:

10 low-power modes to provide power optimization based on application requirements Allows different power states while being powered on.

• Standby state if the device is not running the ventilation cycle

• General-purpose input/output Allows sensors with analog outputs to communicate through common digital logic

Display Technology

• K70 was able to support larger LCDs

Two 16-bit SAR ADCs

• We might be able to use these to read from the analog sensors.

• 16bit resolution is pretty good

Programmable gain amplifier (PGA)

• Similar to an OP AMP circuit, this would control the gain digitally.

Two I2C modules

• Some of the sensors have I2C output

Storage Features

• This has a SD card controller so it can write to data to SDHC (High capacity SD cards) devices.

Power System Design Plan

[pic]

Integration of power system with inputs and outputs

[pic]

PUGH chart for specific battery selection

PowerStream Universal Specifications

Cost: $172 battery + $8 car adapter

Operating temperatures: -10° C to 60° C

Charging temperatures: 0° C to 45° C

No capacity vs. temperature information

[pic]

[pic]

Tekkeon battery pack specifications

[pic][pic]

Connections from battery to external power supply

| |Current (A) | Voltage (V) |Power (W) |

|Pump* |3.8 |12 |22.8 |

|MCU (K70P256M120SF3) |0.3 |3.8 |1.14 |

|NEC 4.3" LCD (NL4827HC19-05B) |0.2764 |5 |1.382 |

|Total | | |25.322 |

*This assumes pump is running at 50% duty cycle

|Battery voltage (V) |12 |

|Battery capacity (Ah) |5 |

|Battery capacity (Wh) |60 |

|Expected battery life (Hours) |2.37 |

Power calculation for determining expected battery run time

|Battery capacity (Wh) |60 |

|Power draw (Wh) |25.322 |

|Battery capacity after 300 charge cycles |70% |

|Number of charge cycles |550 |

|New expected battery life (Hours) |1.07 |

|Average number of uses per week |5 |

|Battery lifetime (years) |2.12 |

Battery lifetime use case for 1 hour run time and 5 uses/week

User Interface Selection PUGH Matrix

|User Interface Selection |

|  |Option #1 |Option #2 |Option #3 |Option #4 |

| |LCD |LED |Analog |e-ink |

|Selection Criteria |Score |Score |Score |Score |

|Cost |0 | - |+ | - |

|Weight |0 |0 |0 |0 |

|Physical Durability |0 | - |+ | + |

|Size |0 |0 |- |0 |

|Functionality |0 |0 |- | + |

|Definition |0 | + |- | + |

|Power Usage |0 |- |+ | + |

|Response Time |0 |0 |+ |- |

|Sum +'s |0 |1 |4 |4 |

|Sum -'s |0 |3 |3 |2 |

|Sum 0's |8 |4 |1 |2 |

|Net Score |0 |-2 |1 |2 |

|Rank |1 |4 |2 |2 |

Housing Selection PUGH Matrix

|Housing Selection |

|  |Option #1 |Option #2 |Option #3 |Option #4 |

| |Sheet Metal |Wood |Plastic |Composite Material |

|Selection Criteria |Score |Score |Score |Score |

|Cost |0 | + | + | - |

|Weight |0 | - | + | + |

|Durability |0 | - |+ | + |

|Water Proofing |0 | - | + | + |

|Ease of Construction |0 |0 | - | - |

|Time Commitments of Construction |0 | + | - | - |

|Sum +'s |0 |2 |4 |3 |

|Sum -'s |0 |3 |2 |3 |

|Sum 0's |6 |1 |0 |0 |

|Net Score |0 |-1 |2 |0 |

|Rank |3 |4 |1 |2 |

[pic]

Controls Selection PUGH Matrix

|Controls Selection |

|  |Option #1 |Option #2 |

|Speaker |Type- magnetic |[pic] |

|CUI Inc.- CDMG16008-03-ND |Frequency range- 600Hz~20kHz | |

| |Impedance- 8 Ohms | |

| |Sound pressure level- 82 dB | |

| |Power- rated- 0.3W | |

| |Power- Max- 0.5W | |

| |Height- 2.75mm | |

| |Size- 16mm Diameter | |

|Settings Knobs |Series- PKJ | |

|TE Connectivity-SWITCH KNOB STRGHT 0.76" |Style- cylindrical with pointer |[pic] |

|W/SPIN |Type- knurled, straight |[pic] |

| |Shaft size- 0.250in. | |

| |Diameter- 0.760in. | |

| |Height- 0.555in. | |

| |Indicator- line of side | |

| |Material- plastic | |

| |Color- black | |

| | | |

|Kilo International- KNOB BLK |Series- ML | |

|GLOSS.625"DIA.125"SHAFT |Style- cylindrical | |

| |Type- smooth | |

| |Shaft size- 0.125in. | |

| |Diameter- 0.625in. | |

| |Height- 0.625in. | |

| |Indicator- dot on top | |

| |Material- metal | |

| |Color- black gloss | |

| | | |

|Kilo International- KNOB BLK MATTE.50"DIA |Series- JD | |

|6MM SHAFT |Style- cylindrical | |

| |Type- knurled, straight | |

| |Shaft size- 0.236in. | |

| |Diameter- 0.500in. | |

| |Height- 0.625in. | |

| |Indicator- line on top and side | |

| |Material- metal | |

| |Color- black matte | |

|Mode Switch |Series- HD |[pic] |

|Kilo International- KNOB BLK MATTE.50"DIA |Style- cylindrical, wedged | |

|.125"SHAFT |Type- smooth | |

| |Shaft size- 0.125in. | |

| |Diameter- 0.500in. | |

| |Height- 1.00in. | |

| |Indicator- line on top and side | |

| |Material- metal | |

| |Color- black matte | |

|Reset Button |Switch Function- on-mom |[pic] |

|Grayhill Inc.- SWITCH PUSH SPST-NC 1A 115V|Current rating- 1A(AC) | |

| |Voltage rating (AC)- 115V | |

| |Actuator type- round, plunger | |

| |Color- black | |

| |Mounting type- panel mount, rear | |

| |Termination style- solder lug | |

| |Operating temp.- -40C~85C | |

| |Electrical life- 1,000,000 cycles | |

|Manual Button |Switch Function- on-mom |[pic] |

|NKK Switches- SWITCH PUSHBUTTON DPDT 3A |Current rating- 3A(AC/DC) | |

|125V |Voltage rating (AC)- 125V | |

| |Voltage rating (DC)- 30V | |

| |Actuator type- round, button, flush | |

| |Color- clear | |

| |Illumination color- LED, green | |

| |Illumination Voltage- 3.5 VDC | |

| |Mounting type- panel mount, front | |

| |Termination style- solder 0.110in | |

| |Features- epoxy sealed terminals | |

| |Operating temp.- -25C~50C | |

| |Electrical life- 100,000 cycles | |

| |Mechanical life- 1,000,000 cycles | |

|Power Switch |Switch Function- on-off |[pic] |

|TE Connectivity- SWITCH ROCKER SPST 20A |Current rating- 20A(AC) | |

|125V |Voltage rating (AC)- 125V | |

| |Actuator type- concave (curved) | |

| |Color- black | |

| |Mounting type- panel mount, snap in | |

| |Termination style- screw | |

| |Features- epoxy sealed terminals | |

| |Operating temp.- -20C~85C | |

| |Electrical life- 6,000 cycles | |

| |Mechanical life- 100,000 cycles | |

Other Required Components:

Top of Form

ENM Hour Meter, LCD, 2-Hole Rectangular

|Grainger Item # |2PAR5 |  |

|Price (ea.) |$33.25 | |

|Brand |ENM |  |

|Mfr. Model # |T1121BB |  |

|UNSPSC # |39121523 |  |

|Ship Weight (lbs.) |0.15 |  |

|Availability |Ready to Ship  |  |

|Country of Origin |USA |  |

|(Country of Origin is subject to change.) | | |

|  | |  |

| |

| |

|Item | |Hour Meter |

|Type | |LCD |

|Time Range (Hours) | |0 to 99,999 |

|Bezel Face (In.) | |2.12 x 1.25 |

|Bezel Face Type | |2-Hole Rectangular |

|Elapsed Time To | |99999.9 |

|Voltage | |4.5 to 28VDC |

|Number of Digits | |6 |

|Display Units | |Hours and Tenths |

|Bezel to Back Length (In.) | |0.82 |

|Depth (In.) | |0.51 |

|Length (In.) | |1.22 |

|Width (In.) | |2.12 |

|Ambient Temp. Range (F) | |-22 a 149 |

|Material of Construction | |ABS |

|Reset Type | |Remote Signal |

|Temp. Range (F) | |-22 to 149 |

|Fits | |1.45"x0.95" |

|Mounting Method | |Flange |

|Terminal Type | |Spade |



Top of Form

Pulse Oximeter:

This external device will allow for an EMT to monitor a patient’s Blood Oxygen level as well as their pulse. The Pulse Oximeter chosen for this prototype will be the Nellcor DS-100A Reusable Finger Clip. This device will interface with the Freescale MED-SPO2 development board via a DB9 connection. The MED-SPO2 is a MOD that can be attached to the K-70 tower to allow the data being created by the Pulse Oximeter to be displayed on the screen of the K-70.

This particular Pulse Oximeter has been chosen because there is clear documentation on how to interface it with the Freescale hardware we will be using for the control system.

[pic]

DB9 Board Connections to Sensor

[pic]

Pulse Oximeter Sensor

[pic][pic]

Pulse Oximeter and Freescale MED-SPO2 interface MOD

More reference material on how this will all interface and interact can be found at:



Bill of Materials

• The “Price/each” items with a gray background will possibly be free; we are just waiting to hear back from Freescale about our proposal.

• In the “Status” column, a “Green” box means the part is what we need and once we are given the “Okay” to buy should be ordered right away.

• The “Yellow” boxes mean there is still some reservation do to pricing, lack of engineering specs, or lead times.

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Basic Test Plans

Power System Test Plan:

Specifications Tested

|Tested Specification |Description |Critical Value |Nominal Value |

|S6 |Battery must be able to be charged with a range of voltages |12 to 24 V |6 to 24 V |

|S7 |Battery must output a voltage of 12V to power the pump and 5V to |11 to 13V and 5V |12V and 5V |

| |power the MCU | | |

|S8 |Battery must power the unit for at least 1 hour |>1 hour |>2 hours |

|S15 |Battery must be able to operate in all temperature situations | ................
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