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Slide 1

Supporting parental contact for preterm infants

MAE 156B – Fall / Winter 2024-2025

Mayah Carlton, Reuven Reyman, Parissa Teli, Mike Zhang , Jeffrey Keppler

Primary Design Review

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Problem Definition

Slide 2

10% of Pregnancies – result in preterm births
Skin to Skin Contact – Proven to benefit preterm infants
Challenge – Jet Ventilator cable is extremely short and can easily be pulled out from baby

Mayah

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2^nd Mock Trial Completed

Slide 3

Reuven

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Final Design

Slide 4

Locking mechanism

Alignment Linkage

Support Linkage

Linear Slider

Ventilator Clamp

Accessory Plate

Reuven

Accessory Shelf

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Project Objectives Satisfied

Slide 5

High Level Objective	Specific Want	Design Feature
Effectively decrease risk associated with Kangaroo Care	Prevent dislodgement of endotracheal tube	Designed with slight “give” so the arm can follow the infant
Effectively decrease risk associated with Kangaroo Care	Provide stable surface for Ventilator Auxiliary Box	Velcro strap to secure box Movable feet hold box in place Parallel linkage ensures box remains horizontal
Improve ergonomics of transfer process and parental holding time	Flexible arm that moves easily	Unlocking joints allows arm to slide and pivot smoothly
	Rigid arm that supports vital equipment	Locking joints keep the arm in place

Reuven

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Ventilator Clamp

Slide 6

Reuven

Functional Requirements

Support full weight of arm and payload ~ 8lbs
Support moment at worst-case orientation (fully extended)
Locking pivot joint

Constraints

Snug fit over 2” diameter ventilator stand
< 2” between pivot point and ventilator stand

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Locking Joints

Slide 7

Parissa

Functional Requirements

Must interface with linear slider and support linkages
Must have a controlled release mechanism
Must have the ability to lock in place
Must support weight of linkages and accessory plate (~ 6 lbs)

Constraints

Diameter of gear should be no larger than 2.5"

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Linear Slider

Slide 8

Mayah

Functional Requirements

Support minimum 3.25 kg (~6 lb)
Support worst-case moment of 13.57 Nm
Extend 9” from base of ventilator
Slider can be locked in place

Constraints

Cannot exceed 12" from base of the ventilator

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Support Linkage

Slide 9

Jeffrey

Functional Requirements

Interface with locking joint
Support design load with no deformation
Handle many rotations with minimal ware

Constraints

66° Max & Min Angle
Ease of Fabrication
Material Selection

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Accessory Plate

Slide 10

Functional Requirements

Support 50kg (10kg minimum with deformation)
Rotating parts lockable, ~240° rotation
Provide ample locations to mount tubes and equipment
Secure auxiliary ventilator box

Constraints

Close proximity to infant
Slight movement of parent during contact time
Vibrations from auxiliary ventilator box

Reuven

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Applicable Standards

Slide 11

Standard	Title	Compliance Measures
ISO 14971	Risk Management for Medical Devices	Produce documentation for Risk management plan, Hazard Identification, Risk Evaluation, Risk – Benefit Analysis, and Post Market Surveillance.
		Maintain these documents and conduct internal and external audits.
ISO 13485	Quality Management System for Medical Devices	Produce documentation for Quality management system, Supplier Management, Document control, Production and Process control, Corrective and Preventive Actions, Complaint Handling and reporting.
		Maintain a quality manual and standard operating procedure.
		Apply for ISO 13465 certification for market access.
IEC 62366	Usability Engineering to Ensure Safe Design	Produce Documentation for all usability activities, Formative testing, User and environment analysis.
		Produce evidence of usability validation and design validation.

Mayah

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Design Validation Plan

Slide 12

NICU Mock Trials	Component Testing	Maximum Load Validation	Verify that the device mounted as designed can support expected load
	Component Testing	Device Integration	Verify that the device properly integrates into NICU environment
	Operation Testing	Standard Operating Procedure Test	Verify that the device can be used as intended
	Operation Testing	User Interaction Test	Verify that the device has a positive effect on the safety and ergonomics of kangaroo care time

Parissa

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Final Project Plans

Slide 13

Mayah

Task	To Do	Deadlines
Finish First Product	Finish updating CAD Manufacture all updated components Improve aesthetics	March 4
Present to NICU Task Force	Present Product 1 to task force Gather final feedback and adjustments	March 4
Develop Manufacturing Documentation	Organize CAD and manufacturing files Build-out website Assembly manual	March 19
Build Second Product	Build second device (Sponsor wants two) Write User Manual	March 19

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Remaining Concerns

Slide 14

Meet with NICU Task Force (March 4) Questions:

What can we do to make the parents feel more comfortable using the device?
Would you like us to incorporate blue and pink colors into the design of the device?
Would you like us to move the knob to adjust the device toward the locking joint

Jeffrey

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Gantt Chart

Slide 15

MAE 156 Gantt Chart Preterm Infant Holding.xlsx

Parissa

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Schedule Flowchart

Slide 16

Parissa

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Cross Functional Diagram

Slide 17

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For Internal Use Only. Do not Distribute. Slide 18

Thank You

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stuff

An overview of the project and team's objectives.
A description of the final design and how it meets the project objectives
A description of each component of the design
A plan for completing the design by the Final Design Review
A detailed to-do list of all aspects required in completion of the project. Show:
A plan for testing the design
List any concerns that need to resolved

Slide 19

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Risk Management

Slide 20

Key Problem Area: Failure of locking joints
Failure Cause	Mitigation
Gears fail to interlock – arm moves unexpectedly	Spring loaded mechanism ensures gears are pushed together automatically
Teeth breakage – arm moves unexpectedly	Consider material choice for gears (injection molding high-density plastic)
Force required to separate gears too intense – arm won’t move	Incorporate gear-ratio into the user knob to transmit greater force to pull back
Loosening of steel wire overtime leading to inability to pull gear back – arm won’t move	Design anchor point with adjustable tension of steel wire (see appendix #25)

Reuven

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List of Design Validation Tests

Slide 21

Mayah

Test	Description	Testing Procedure	Deliverable Date
Maximum Rated Load Validation	Verify that the device mounted as designed can support expected load	Mount device to ventilator and increase supported weight until maximum rated load is exceeded	Week 9
Operational Procedure Test	Verify that the device can be used as intended	Allow users to operate device in appropriate setting
Customer Satisfaction Test	Verify that the device has a positive effect on the safety of kangaroo care time	Run mock trials and gather feedback from nurses

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Fusion FEA Design Justification – Ventilator Clamp

Slide 22

Factor of Safety > 15
Minimum Deformation
Tested with ONE clamp, but final design includes TWO

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Fusion FEA Design Justification – Support Linkage

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Factor of Safety > 15
Minimum Deformation
Tested with ONE clamp, but final design includes TWO

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Rail Mount

Medical Standard Guide 19054

Rail Clamp and T slot clamps are compliant with medical standards
Material – Anodized Aluminum or Stainless Steel

Slide 24

Devices to integrate with

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Past Key Design Decisions

Found pre-existing patented arm using pistons
Rail Mount Joint Redesigned
Mount to connect arm to handle on the jet ventilator

Slide 25

LOCKING RELEASE MECHANISM FOR AN ARTICULATED SUPPORT ARM

Pub . No . : US 2017 / 0314731 A1

Applicant : GCX Corporation , Petaluma , CA

Filed : Apr . 29 , 2016

Pub . Date : Nov . 2 , 2017

https://patentimages.storage.googleapis.com/d5/db/00/37fbc3e0ea5933/US20170314731A1.pdf

Jeff