Shailee rindani syringe pump design; detailed documentation

Graduation Project 2014

Design of a Syringe Pump Sponsor

Universal Designovation Lab LLP Student

Shailee Rindani Product Design

Industry Guide

Mr. Bhagvanji Sonagra

Faculty Guide

Mr. Dhimant Panchal

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The Graduation Project Evaluation Jury recommends NAME OF THE LEARNER - SHAILEE RINDANI to be awarded the Graduation Degree of the MIT Institute of Design, Pune IN INDUSTRIAL DESIGN (Product Design) herewith, for the project titled “Design of a Syringe Pump” MEMBERS: NAME

ORGANIZATION

on fulfilling the further requirements by * (*Subsequent remarks regarding fulfilling the requirements:)

GRADUATION PROJECT 2014 PROGRAMME : UG PROGRAMME

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Chairperson of the Jury

SIGNATURE

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ACKNOWLEDGMENT

I would sincerely like to acknowledge the contribution of individuals who have helped me build not only this project, but my confidence in design itself. Prof. Dhimant Panchal, my faculty mentor, whose feedback and guidance was of utmost importance.

Mr. Bhagvanji Sonagra, Industry mentor and head of Universal Designovation Labs, who gave and trusted me with this opportunity.

I also thank him for showing me through thick and thin of a design process, bringing concepts to reality. I would take this opportunity to thank my co-workers during the internship, Neha Srivastava, Nitin Chanchiya, Sujit Prasad and Rahul Gohil, for imparting valuable knowledge and making me feel comfortable.

I cannot thank my parents enough for all the support and wishes without whom I would not have reached this stage.

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CONTENTS

CHAPTER I About the Company About the Sponsor/ Client

...4 ...5

CHAPTER II Project Summary

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CHAPTER III Initial Brief Objectives Design Methodology Timeline and Schedule

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Visual Semantics NICU layout Ergonomic considerations Competitor analysis Experience mapping Problem identification Product positioning chart Opportunities Color strategy PDS

...39 ...40 ...41 ...44 ...48 ...53 ...55 ...56 ...58 ...61

CHAPTER VI - Design Parameter CHAPTER VII - Approach and Strategy CHAPTER VIII

CHAPTER IV About the product Where is it used In and around the syringe pump Parts of a syringe pump Procedure Map Stakeholders Construction study CHAPTER V

...14-19 ...20 ...22 ...24 ...25 ...26 ...30

Concept generation Comparative study of concepts Concept selection Final concept refinement Internal assembly Specifications Orthographic drawings Mock-up model Conclusion Bibliography

...69 ...82 ...84 ...85 ...98 ...111 ...113 ...117 ...121 ...122

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CHAPTER I

Universal Designovation Labs, Rajkot is an Industrial Design and Development firm also known as UDLab. The firm took off from February, 2013 with no more than two Industrial Designs and a Mechanical Engineer, now equipping itself with Machine designers, CAD experts, Industrial designers and many other collaborations signifying growth and network. The head office is based in Rajkot, Gujarat under Mr. Bhagvanji Sonagra and a branch in Bangalore under the supervision of Mr. Prassana.

The firm takes interest in new product development, taking up challenges mainly in the field of medicine and agriculture. Their recent projects showcases this interest and aim for the India Design Mark. They try and spread design awarness in sectors in and around Gujarat where design has barely reached, bringing together and achieving new business objectives.

UDLab is also associated with the government of Gujarat under the MSME scheme, which provides a strategic model for design intervention for established industry clusters.

Nature of business is flexible with the requirements of the clients. UDLab provides custom design solutions in various fields, and offers design training. Their facilities go hand-in-hand with their networking capability as they work with embedded circuit developers, manufacturing setups for prototype building and testing etc in and around Rajkot.

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Dev Bio Care pvt ltd is registered with Mr. Kishan Amipara and Mr Gautam Vamja. The Client company approached for developing new range of pediatric products and are willing to see it through with the help of their manufacturing units in Surat, Gujarat.

The company was established in 1913 for manufacturing, trading and distributing bio-medical products. They intend to launch new products that would enter the ever-increasing medical scenario in and around Gujarat. Hence they opened a local office in March, 2013 to start the preparation of launching thier new line of products for neonatal units.

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CHAPTER II

PROJECT SUMMARY Considering the rise in the number of specialized hospital units and their demand of medical equipments, seizing this opportunity in the market, designing a syringe pump was initiated. Based on the statics of the current scenario in the medical industry, there is a huge demand in instruments for dispensing intravenous solutions to critical-care patients. The project was very challenging right from its inception, not only for me as a designer, but for people involved at every level of making it enter the market.

Briefly, syringe pumps are designed to deliver/draw precise amounts of fluids over specific time. This process involves extremely low volume of fluids which is impossible to control manually.

It is evident that a syringe pump plays a crucial part in saving lives, hence it carries a seriousness with it in terms of performance and functionality. But what is generally overlooked is the experience of it’s stakeholders which also plays a role when overall performance is seen. A conscious effort needs to be made in order to increase its efficiency, and decrease the rate of mistakes as far as syringe pumps are concerned. This is one of the aims of my project.

A syringe pump comes with its own set of paraphernalia, thus keeping its universatality in mind, and other factors related to it, research was conducted at various levels. Understanding its contribution from inside-out will help in re-designing and building the project better. With the increase in use of concentrated technology, a balance of technology and human intervention was sought after. Thus, solving problems faced by various people who interact with a syringe pump and suggesting uses of technology in favour of safety of the product and the patient.

Qualitative products are finding their way into the medical units, design intervention will help build a new identity and better functionality of the product and for the client company.

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CHAPTER III

INITIAL BRIEF FROM THE CLIENT Design and Development of a Syringe Infusion Pump

OBJECTIVES TO BE ACHIEVED: Application of design thinking and processes Understand the product from inside-out, including its attachments, counterparts, and the enviroment around it To learn and adapt new methods of research Enhance aesthetic appeal that also includes overall nature of the product Achieve a level of uniqueness by making it more intuitive Improve interaction with the product (product handling) To recognize the intended ecosystem in which the product operates

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DESIGN METHODOLOGY

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Research

Methods such as the following were employed: - Internet research, literature survey, contextual inquiries.

- Interviewing stakeholders and users looking for social and emotional condition, stress factors, demands and problems faced etc - Ethnographic observation - Observational research, device usage conditions, congregation of other products in the environment - Patient and staff movement tracking/ study - Contruction study of the product (assembly-disassembly, technology, mechanisms, processes etc.)

Analysis & Synthesis

- Categorising client requirements, user requirements and design requirements.

- Competitor study - Market trend analysis - Experience mapping (from visits to the hospitals) - Recognizing areas of opportunity - Comparison between Essential and Desirable features - Designing for assembly/ disassembly - Problem exploration and identification - Exploring methods like Contradiction Matrix for better understanding of the product and developing decisive knowledge.

Ideation

Validation

Design Engineering Phase

Concept Generation stage: - keeping in mind the nature of function and inducing safety features - performance at par with the competent parallel products in the market - improving handling and interaction with the product, beyond it’s intended function.

- unique identity for the client with the help of advanced features, technology and overall form complementing the original function.

- showcasing opportunities to make a mark in the competitive market

Validating and testing of initial concepts is of utmost importance, giving a taste of how the concept will look at feel.

- setting design and mechanical specifications - mechanism placement understanding, in order to filter tangible concepts - mockups to test and feel grips for better interaction and ergonomics - understanding placement of electronics into concepts via CAD models - orthographic drawings

Preliminary engineering stage helps build an almost final concept, with many feedback loops for better understanding of the final concept: - detailing of the concept chosen by the firm and approved by the client - preliminary understanding and explorations of how the product will be manufactured (number of parts, placement of parting lines etc) - final design for manufacturing (Engg support will be provided by UDLab)

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TIMELINE AND SCHEDULE

July - August

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September - October - mid November

December - ongoing

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CHAPTER IV INTRODUCTION

Infusion Pumps An infusion pump infuses fluids, medication or nutrients into a patient’s circulatory system, generally intravenously.

‘To infuse’ is to introduce a substance directly into a vein or tissue of a patient. One of the greatest technological advances in the medical field has been that of intravenous medicine-the ability to feed, hydrate, medicate and replace blood lost to sick and injured patients directly, through the use of needles. These devices deliver controlled amounts of nutrition, blood and medication directly to a person’s circulatory system, or even just under the skin, or directly to the Central Nervous System.

Monitoring and delivering such precise amounts of life-saving medication is almost impossible manually by the nursing staff. Large volume pumps can pump nutrient solutions large enough to feed a patient. Small-volume pumps infuse hormones, such as insulin, and other medicines. Over the years of development and research, many types of pumps with varying mechanisms fitted were used to infuse patients with vital fluids.

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Basic infusion pumps use the force of gravity and pressure systems to regulate and control the flow of fluid into the patient. As technology and demand increased, this basic function was equipped with safety features, embedded systems etc carefully designed so that no single cause of failure can harm the patient.

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Ambulatory Pump These pocket-sized pumps are meant for immediate care of patients while being trasported. Portability and their small footprint plays an important role. A broad range of therapy options are provided.

Multi-channel Pumps Permits simlutaneous administration of many fluids. Many permutations and combinations of such pumps are available the market as per the requirements of the buyer. Infusing/ Withdrawing or Infusing at same rate to different patients etc.

These are now several multi-channel pumps available which permit simultaneous administration of 2 or 3 infusions. However, one potential problem with such a system is the possibility of incompatible mixing.

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Volumetric Pumps Volumetric infusion pumps are widely used for intravenous infusions.

These pumps deal with continuous infusion and also intermittent infusions that require a higher volume of drug which can be regulated and observed. It acts as a “drop-based� pump, meaning the pump is equipped to calculate the volume of fluid, taking into account the size of a drop too. These are a part of safety features so that the patient goes through no pain and no harm.

The running expenses of these pumps are exorbitant because they require special IV infusion sets of a standard size. And for an increasing market and demand of medical care in India, it becomes an expensive choice for hospitals.

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Syringe Pump A syringe pump is generally used to infuse drugs into a pateint with an extremely low volume/ rate over a period of time, which is impossible to control manually.

History The first recorded attempt at intravenous medicine dates to 1492, this branch of medical science gained real momentum in the 17th century.

The first working IV infusion device was invented by the famous English architect Christopher Wren in 1658. After conducting ever-increasing experiments on humans which led to some deaths, the practise was banned. After the ban was lifted, key elements of intravenous transfusion which are still observed today were established: a slow infusion process, awareness and prevention of risks from air embolism, and avoiding volume overload. The 20th century saw huge advances in intravenous medicine including IV pumps. The two World Wars spurred medical advances across the board - needles were refined, rubber tubing was replaced by plastic, and vacuum bottles that reduced the risk of air embolism were designed. Vacuum bottles themselves were replaced by plastic bags in the 1950s.

One of the major developments in infusion pumps was the invention in the early 1970s of a wearable infusion pump, by Dean Kamen. This was the first ambulatory pump. It not only gave patients freedom to move when receiving treatment, it meant they could receive their medication on an outpatient basis. This advancement was a godsend to patients, such as diabetics, who need round the clock injections. The invention automatically administered precise doses at regularly timed intervals, ushering in many advances in infusion pumps and other medical equipment, such as portable dialysis machines.

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What is a Syringe pump?

A syringe pump is a small infusion pump, used to gradually administer small amounts of fluid to a patient over a period of time. This type of a pump is much more precise as it delivers small amounts of medication slowly over a long period of time.

The mordern syringe pump that is extensively used clinically is combination of mechanical and electronic components that manipulate a standard syringe. It must accommodate the syringe’s length, the smallest syringe pumps are the size of a standard television remote. A small computer controls a continually running motor, the latter applying a continuous force upon the plunger end of the syringe. This continuous administration of a drug differentiates the syringe pump from similar devices such as an insulin pump, the latter only administering insulin when a patient presses certain buttons on the device. After flowing through a short length of plastic tubing, the drug enters the body intravenously.

The pump is equipped with many essential features to let the doctor and/or the nurse control the medical processes that occur.

A syringe pump has a host of advantages over other forms of intravenous drug administration. Infants, especially those born premature, may need a variety of medications to survive. Yet their small size requires smaller amounts of medication. A properly programmed syringe pump can accurately administer medication, lowering the chances of an accidental overdose.

Advantages Cheaper than drip rate pumps • Precise control of total volume infused • Suited for small volume • Low cost of disposables • Pressure maintains rate inspite of resistance • Delivery of air impossible • Portable •

Disadvantages • Unsuitable for large volume • Comprehensive alarm system not usually provided

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WHERE IS A SYRINGE PUMP USED? - Palliative care; to continuously administer pain killers etc. Keeps medication level in the blood almost constant.

- patients who show difficulty in swallowing - carrying out microfluid applications i.e. slow incorporation of a fixed volume - delivering medications or nutrients to adult patients and neonates- such as insulin, hormones, antibiotics, analgesics, blood etc.

- intravenous delivery of common medications, such as inotropic agents, vasodilators, aminophylline, insulin, heparin etc.

- now-a-days syringe pumps are also used in epidural infusions (surface of the Central Nervous System). For example, infusing local spine anaesthesia during childbirth.

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A syringe pump is a combination of mechanical and electronic components that manipulate a standard syringe. It is composed of the following things:

Environment

External attachments SYRINGE PUMP

Stakeholders

Mechanical parts

Electronics

Logistics and Packaging

Common practices

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IN AND AROUND THE PUMP Babies’ lives will depend on the environmental conditions and life-support systems in each nursery,

Specific equipment/service requirements Each cot space requires within the space itself: a) an incubator; b) space for a supplies trolley and dressing trolley; c) a dripstand (although this may be mounted on the medical supply unit); d) four computer ports; e) a staff/staff call system; f) WiFi capability (based on local decision); g) a whiteboard. h) ventilation and humidification equipment; i) two infusion pumps; j ) six to eight syringe pumps; Equipment that might be used intermittently around the cot includes: • EEG machine; • ECG machine; • mobile imaging equipment.

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Neo-natal units Most babies are, and remain, healthy and receive routine care at their mother’s bedside before going home with their family. However, approximately 10% of babies require some form of specialist support at birth, with 1–3% requiring neonatal intensive care (NICU). Increasing numbers of very small premature babies are being born alive and surviving, owing to the increasing capability of technology and development of healthcare expertise. These babies may require quite prolonged periods of supportive care over several weeks.

A NICU is typically directed by one or more neonatologists and staffed by nurses, nurse practitioners, pharmacists, physician assistants, resident physicians, and respiratory therapists. Babies are nursed in cots or incubators in an area or type of unit appropriate to their need for lifesupport systems, intensive care and treatment, monitoring and observation or isolation. A mixture of multi-cot rooms and single-cot rooms are usually provided.

Common Diagnosis in the NICU: - Anemia - Apnea (stops/forgets to breathe) - Bradycardia (slow heart rate) - Chronic lung diseases - Hydrocephalus (collection of cerebro-spinal fluid) - Hemorrhages - Jaundice

- Necrotizing enterocolitis (most common intestinal condition in newborns) - Respiratory syndrome - Sepsis (infections) - Reflux

Such a list was obtained by talking to various neonatologists and doctors who work for established hospitals in and around Rajkot, Gujarat.

This list will help formulate a specified regional and global DRUG LIBRARY for the new syringe pump design that will increase safety and reduce errors.

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Guide rod with flexible cover EXTERNAL PARTS OF A SYRINGE PUMP

Syringe barrel clamp

Plunger clamp

Place syringe here

Release lever syringe pusher

EL

OL

R NT

N PA

CO

Handle Display screen Syringe flange groove

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Visual Alarm Display

Plunger

Syringe barrel flange

PROCEDURE MAP

Storage space

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STAKEHOLDERS

Resposible for providing safe products and good servicibility Not easily approachable

Choosing the correct equipments

Life saving expectations Conducting process improvement surveys

Remains unavailable for comment

Doctors: Diagnosis and treatment periodic visits writes prescriptions

Surveys the market and word of mouth while picking out equipments for the hospital

Nurses/ Attendents: Round the clock service makes sure prescriptions are followed maximum attachment First responder to alarms

“We trust brands outside of India�

Cleaners/ Caretakers: unknowingly careless

Answerable to many

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Immobile

MEDICAL PROCESSES

Occlusion:

An obstruction or a closure of a passageway, vessel, pipe or tubing. When the IV line attached to the syringe is kinked or obstructed, fluid accumulates raising the pressure inside the line. When the nurse/ attendant sets it right the increse in pressure results in extra fluid being forced inside the patient’s vein which can be harmful or even fatal.

Bolus:

A syringe that is placed into a pump whilst connected to the patient is highly likely to deliver an infusion bolus. Syringes should always be inserted into pump mechanisms before being attached to patients. The infusion line should also be temporarily disconnected from the patient if a pump is changed during a procedure. Lifting the syringe up will inevitably cause an inadvertent bolus.

In case of an emergency, the doctor prescribes a sudden increase in dosage to set the treatment going, it can be applied manually or even via a syringe pump.

Siphonage/ Free flow: When pressure in the IV line falls, the liquid pressure inside the body forces the liquid/ blood through the tube and out of the vein by gravity. Syringe pumps should be placed at the level of the patient with the syringe securely located in the mechanism and with an anti-siphon valve in the line.

Keep Vein Open(KVO): As the name suggests, it is a slow drip rate providing enough fluid flow to keep the end of the catheter from clotting off. The normal rate for an IV would be 1mL per minute.

Air embolism:

Stiction:

Venous air embolism can result from the introduction of air through intravenous lines, and can prove to be fatal if not attended immediately. Most pumps are equipped with Air-in-line detectors to ensure no mistakes while filling the syringe with medication.

The friction between the syringe barrel and plunger may sometimes give rise to an unwanted bolus if pressed with sudden pressure/ jerk. This can also happen when the drug being infused is very viscous (like for example stem cells).

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FLOW OF MEDICATION II .

3 way valv e

(Adults and Neonates)

I. Clamped syring

IV .

IV lin e

V. Winged cathete r

III. Manifold

VI .

Cannul a

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I. 10-60 ml syringes which are recognized by the pump sensors.

II. 3-way valve/stop cock: regulates the flow of fluids, secures the patient from siphoning.

III. Manifold: in one embodiment, it provides multiple ports for different functions; making it easy for the operator to locate different IV lines from different syringes.

IV. Intravenous extention line: kink-resistant tubing, thick medical grade walls that ease the process of infusion from syringe to vein.

V. Catheter: functionally, the bevelled needle is temporarily kept inside the vein for administration of fluids VI. Cannula: an intravenous cannula is used to give medical personnel access to a patient’s vein for the withdrawal or insertion of medicine or other fluids.

VII. Hypodermic needle: hollow needles basically to inject or extract substances in the body.

e

* Additional attachments for increased efficiency during infusion

Attaches 2-3 Iv lines allowing to regulate their flows, and to titrate them when needed.

Prevents siphoning and acts as a backup incase the pump fails to function.

: allows the needle to be twisted and locked in place, this prevents accidental removal of the needle while injecting.

: the needle is pushed onto the protruding part, close fit is maintained.

Eccentric placement helps the user to get closer to the patient’s skin.

: remains inside the vein throughout the infusion time and more Flexible (medical grade) plastic avoids needlestick injury ‘wings’ on either side provide much needed stability while insertion.

Polyurethane catheter remains firm during insertion but softens at body temperature, minimising vessel trauma.

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DISASSEMBLING EXISTING SYRINGE PUMP ( TM-1509 SYRINGE PUMP)

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This model is meant for table top use, no pole clamp

testing various functions after connecting to AC mains via power cord provided.

testing alarms; syringe holder dislodged

creating OCCLUSION by keeping the nozzle of syringe pressed, hence artificially creating pressure to understand audio and display responses.

battery pack accessibile externally

opening pusher block, which is connected to the main mechanism by a hollow rod.

Syringe sizer mechanism: easy to access but takes time to re-assemble. Self-check required. Positioned beside the lead screw assembly.

Removing the main lead screw assembly is extremely difficult and time consuming. Unscrewing the chassis is not ergonomic as the flange bends inside the mechanism.

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DISASSEMBLING EXISTING SYRINGE PUMP ( EMCO Infusor 850 )

Screen inclination helps servicing of PCB

Dirt accumulation and breakage of parts

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Briefly witnessed the repair and serving of this pump. It had an automatic linear displacement system, hence the stepper motor was directly connected to the lead screw. Aesthetics were compromised and so was the quality to reduce the cost.

Pusher block

Display and controls

Potentiometer

Rack and pinion

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PRINCIPLES OF OPERATION A Syringe Pump system comprises of a rotatable threaded lead screw shaft and a plunger which directly engages the threaded shaft such that rotation of the shaft drives the plunger into the syringe body, pushing out fluid/ medication. Safety features are added and this system further comprises of a guide system to secure the plunger and avoid it’s rotation.

Engage-disengage (as needed) Display Unit

Syringe barrel clamp

Syringe size sensor

Driver Block assembly Pressure sensor A

stepper motor

Opto switch

Structural competance

Power supply (AC)

Buzzer

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sensor

Gears

Feedback loop

Lead Screw Assembly Length of rod: 135mm

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Syringe Sizing Assembly Sizes recognized: 10-60 ml Brands used: Dispo-Van, MediKit

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ELECTRONICS - OPERATION OVERVIEW

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CHAPTER V

ANALYSIS AND SYNTHESIS This chapter plays an important role in mentally concluding the factors that will influence the design and development of concepts. It shall lay down certain specifications and standards that will create a benchmark in itself.

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VISUAL SEMANTICS

Form has a frame that makes it look lighter, and balances weight.

Broader base, seens heavy and stable.

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Internal relationships within a neonatal unit (General layout of an NICU)

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• Reach – How far is the user supposed to reach?

• Sight – How much is the user able to see?

• Placement of product – Is it located in a convenient place? Is it accessible and within the user’s reach?

• Body position – Is the user in an uncomfortable position? Is the user in the appropriate zones?

Visual Viewing angle Avg height Readability ease of operation

Haptic Hand measurements Grip analysis/ test

Handling

Auditory Alarms and signals

Placement of buttons/keypad Grips safety of various functions hand-eye coordination Intuitive to use

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Standing height range : 5 - 6.4 ft [25 th percentile (Japanese women) to 97.5 th percentile (US men)]

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Handle and control ergonomics: Intuitive and easy to use. Should not start other functions. Some individuals are not able to grip tightly, hence force applied should also be taken into consideration.

Readability Depends on a number of variables including distance, illumination, and angle, not to mention the acuity of the viewer. One should also consider that viewing distance is not more than 750mm and should never be less than 330mm, to avoid straining eyes.

Suggestion

Adjustable screen; pivoted from the middle so the user can tilt it.

In addition, if screen was rotatable and floating, the adjustable angle should be -5째~+15째;

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COMPETITOR ANALYSIS - I

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COMPETITOR ANALYSIS - II

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EXPERIENCE MAPPING: within product environment

[ Senior Pediatrician Dr. Sonwani and Head Nurse Mr. Pranav ]

Loading/ Unloading a syringe pump from pole

New admission/ under treatment periodic visits by the doctor PRE-PREPARATION administering the prescribed dose monitoring round the clock

visiting doctor nurses, helpers cleaning staff authorized personnel

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Removal of pump; single handed loading pumps stored on IV pole itself even when not in use

space behind the setup is rendered useless

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Avg height does not permit comfortable interaction with the product, increasing cognitive load.

Support for other hand while preparing for the infusion, other unwanted buttons might be presses in the process.

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Individuality of each product Intuitive Spacious enough; yet strategically allows no crowding Space planning and management Product positioning

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- Dr. Patel

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- Dr. Mehta

PROBLEM AREA IDENTIFICATION

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ERROR CHART

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PRODUCT POSITIONING Trendy

Boxy

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OPPORTUNITIES

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According to a Forbes article: By 2020, medical decisions will be based on better data. The technology will improve our clinical decision making.

So where does the OPPORTUNITY lie?

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COLOR STRATEGY

Color can either make or brake the outlook of a product. In medical product design, color needs to achieve three main objectives: - Increase functionality by making the device easier and more intuitive to use.

- Encourage the desired emotional response from the onlooker.

- Recognition of the company’s brand.

One can gain the attention of the user by highlighting with color the areas of the device that the user needs to interface with and what are the most important controls to interface with such as the major touchpoints.

It also helps organizing the system, and division of various functions.

Understanding the overall effect that a device/ color should be on a patient or on an onlooker is essential to determine it’s color.

Should it have a sense of fun about it so it’s less intimidating to a child in a pediatric setting?

For example, orange is a happy color. As such, it can also be comforting. As with yellow, too much can be overpowering.

Visual perception It has been observed that we perceive light-colored objects to weigh less than dark-colored objects. Using a lighter color around the periphery, a darker color at the interior makes the device appear smaller. Finally, lighter-toned objects encourage that they be kept clean – it’s easy to see when they’re dirty! That’s one reason why light colors and pastels predominate in medical devices.

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As mentionaed earlier, color is very powerful in providing a system of organization. Hence while visiting NICU and child care hospitals, we looked into the environment around which constitutes these pumps so as to get a fair idea where and how the product is placed.

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Prominent, vibrant, colors that do not build up stress, and colors that stood out were picked from each environment for the final product. This deduction helps in blending the final product outcome into the intended environment and yet giving it it’s own identity.

PRODUCT DESIGN SPECIFICATION

PDS generated as per client’s requirement and various feedbacks

Installation and Use

- Table top - Clamped on an IV pole - To be stored clamped on poles or placed on shelves.

- Form - To blend-in with the NICU environment - Delicate and damagable parts should be protected within the walls of the pump - To provide adequate space for smooth operation - Increasing the usability of the handle - To make disassembling easier and quicker

Aesthetics

- Color - The machine should have colors according to the environment - Helps differentiating the functions and highlights the major touchpoints of the pump.

- Versatality - Should be able to operate in various conditions. eg- vertical mounting in case of very viscous fluids.

- Establishing connectivity to the hospital network and being able to download the history of the pump for further analydis and legal use.

Size

- Box dimensions : 400 x 135 x 135 mm

Safety features

- Displacement sensor - Self test routines - Set of audio visual alarms

- Occlusion sensor - Buzzer - Engage- diengage sensor

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Usability

- Screen LCD screen display Optimize the viewing of the screen during on going infusion Adjustable screen angle, better and comfortable ergonomics Indication of alarm/ on going infusion at the back of the pump that faces the attendant - Syringe Covering the syringe as it may seem intimidating to the onlooker, specially the parents.

Body of syringe can be covered so photosensitive drugs can be administered without pre-peparation.

- Handling To provide the user with a better grip while operating the pump Providing support for the free hand of the medical personnel Can act as a frame around the syringe, hence protecting it against any jerks/ damage.

To give the syringe pump a new and unique look and feel.

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Materials

- The main body of the syringe pump needs to be made from ABS plastic.

- Parts of the internal mechanism are cast aluminium, treated Al sheets, assembling standard parts.

Ports (external communication)

- USB - RS232 serial cable connector with PC interface protocol. Drug protocol- for installing a personalized drug library - Mains inlet

Mechanism

Linear displacement : lead screw mechanism Stepper motor : accurate motor rotation sensor- opto switch Syringe sizer mechanism : Rack and Pinion attached to a potentiometer

ELECTRICAL AND ELECTRONIC PARTS OF A SYRINGE PUMP

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SAFETY FEATURES

Alarms : the pump is equipped with specific and categorized alarm sounds and colors to help the user understand what is wrong distinctly, avoiding human error.

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CHAPTER VI

DESIGN PARAMETERS Simplistic approach with a trustworthy and unique design solution. Refining usability to provide the user with optimum service.

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CHAPTER VII

APPROACH

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CHAPTER VIII

Visual Language:

Concept Generation

Friendly Less intimidating Soothing Reliable Competent Clean

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CONCEPT I Integrating the benefits of Top-loading the syringe with increased use of the handle, which otherwise remains in the background for most of the functional time.

Objectives: - Wire management while storage - Defining the form with the help of interface and graphics - Protection against jerks and accidents with the help of a handle

- handling and storing made easier.

- two angles of viewing possible - can protect pusher block in case of fall/jerks - may provide easy disassembly

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- not much ergonomic support - blocks view

- handle hinders view of pusher block - fragile/ breakage point

Wire management

Different angles of viewing at different heights

screen plcement just below the syringe barrel

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CONCEPT II These explorations include placing the syringe at different positions, within the body cavity of the pump to accomodate certain photo-sensitive drugs.

Objectives: - Minimum two-part mould - Keeping the usability and ergonomics of the handle - Simple yet crisp form - Exploring grips and clamps that provide maximum syringe visibility, yet ensuring safety.

- IV line - no protecsecured tion in case - handle gives of fall good grip while operating

- two part assembly - better accessibility

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- readability decreases when placed at height

two part body with handle opposite the pusher block, for better grip while loading syringe

Concept- houses the syringe at the base of the pump.

For photosensitive drugs and protection against jerks.

NOT a safe placement in case of human error.

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CONCEPT III Highlighting the display and encasing the pusher block assembly without any structural hinderance to enable easy accessibility.

Objectives: - Top-loading syringe placement - Usability of handle which also balances the weight while pump is being carried - Basic form, needs more character

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CONCEPT III

-pusher block exposed - no hinderance in visibility

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CONCEPT IV Changing the orientation of the handle, integrating it with a curvilicious form that provides a good grip while moving the pusher block assembly and secures the emerging IV line from the syringe barrel.

Objectives: - Integrating strong points of previous concepts - Providing grip for hand while operating so that no other buttons are touched accidently - Extra space also serves as a board to stick drug name, titration quantities for staff of the next shift.

- Unique looking form from many viewing angles.

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CONCEPT V This concept aims to achieve safety and modularity of internal parts.

Objectives: - Compacting the structure - Syringe visibility and providing enough space for external attachments - Exploring snap-fit plastic moulded part to house the PCB, for easy disassembly - Sturdy and stable looking form - Material exploration: collapsible stainless steel handle; to be taken out when required.

- syringe - stackability visibility - form allows external attachments - readability - new at a height method of disassembly

78

79

145

135

“Prominance of a handle”

385

80

81

Touchpoints USABILITY AESTHETICS TYPE

Top-loading syringe position

82

Front-loading syringe position; with 45 degree tilt

- Assymetric handle position - two part body

FEATURES

PROS

Top-loading syringe position

- multiple use of handle - fragile parts protected behind handle frame - two viewing angles

- handle serves as a holder for IV line - ergonomic support

- provides space for labelling drugs - minimalistic and sleek form - handle provides ergonomic support

CONS

- handle hinders while operating pusher block

- may be difficult to use while handling syringe barrel clamp

- readability may decrease when placed at a height

ATTRIBUTES

Multi-functional Clarity Minimalistic

Soft Blended Casual

Sleek Soothing Professional

Top-loading syringe position

Top-loading syringe position

- screen just below syringe barrel - screen and few buttons highlighted - no hinderance for pusher block - can be more aesthetic - moulding can be costly - pusher block is exposed

- unique form - provides ergonomic support

- modular arrangement for PCB -accomodates external attachments - collapsible handle occupies less space

- handle provides character and ergonomic support to the user - stackability - stable and sturdy form

- material wastage

- aesthetic appeal - stackability

- moulding a 3D handle increases cost

Stand-out Robust Easy

Spacious Heavy Soft

Top-loading syringe position

Technical Boxy Stable

Industrial Usability

Top-loading syringe position

Handy Complex Protected

Professional Sturdy

83

CONCEPT SELECTION

84

Client Requirement

Company feedback

Designer’s requirement

Aesthetics Costing Ease of manufacturing

Improving form/ outer structure Unique identity Team feedback and analysis

Ergonomics Better functionality Aesthetics

FINAL CONCEPT REFINEMENT : MODULARITY Modularity is the degree to which a system’s components can be separated and recombined. This concept forms the stratergy for design for disassembly.

The outer form is made into three main parts, namely: (1) front cover (2) back cover (3) battery compartment

Separate core to come in and make a hole for the battery attachments as it is not in the same direction as the main core-cavity.

Feedback: battery can be accomodated within the main body; extra mould unnecessary

85

SELECTED CONCEPT VARIATION : 3D HANDLE

- Subtle color combination that blends with the environment - Moldable handle fails to enhance the overall form of the syringe pump.

- Stackability is the drawback, as not enough space for hand to operate in between the pumps

86

SELECTED CONCEPT VARIATION : 2D HANDLE, BATTERY COMPARTMENT AND SYRINGE SIZING ASSEMBLY

space for lead screw assembly

Action: pull out and snaps onto the syringe barrel

87

SELECTED CONCEPT REFINEMNET : Change in handle, parting line and internal assemblies.

The concept is changed such that the handle and the battery compartment are included within one mould. This was done to save tooling costs and material.

Sub-assemblies were placed in a modular way, to allow easy disassembly and reduce servicing time.

390

88

Parting line is chosen such that it divides the hole encasing the main shaft of the lead screw assembly. Hence making the system more modular and easier to disassemble.

89

10:10

AM

[i]

DOPAMINE

DISPLAY AND CONTROL

5

Vol.

[?]

3.0

ml

1:34

Time Elapsed

s

[ ]

ml/h

OK

10:10

AM

[i]

DOPAMINE 5

Vol.

ml

1:34

Time Elapsed

s

[?]

3.0

ml/h

[ ]

OK

10:10

AM

[i]

DOPAMINE Vol. Time Elapsed

5

[?]

3.0

ml

1:34

s

ml/h

[ ]

OK

10:10 AM

[i]

DOPAMINE Vol. Time Elapsed

5

ml

1:34

s

[?]

3.0

ml/h

[ ]

OK

10:10 AM

[i]

DOPAMINE Vol. Time Elapsed

5

[?]

3.0

ml

1:34

s

ml/h

[ ]

OK

10:10 AM

[i]

DOPAMINE Vol. Time Elapsed

5

[?]

3.0

ml

1:34

s

ml/h

[ ]

OK

10:10

AM

[i]

DOPAMINE

90

Vol. Time Elapsed

5

1:34

ml s

[?]

3.0 OK

10:10 AM

[ ]

[i]

DOPAMINE Vol.

ml/h

Time Elapsed

5

1:34

ml s

[?]

3.0 OK

10:10 AM

[ ]

[i]

DOPAMINE Vol.

ml/h

Time Elapsed

5

1:34

ml s

[?]

3.0 OK

ml/h

[ ]

10:10

AM

[i]

DOPAMINE Vol. Time Elapsed

5

1:34

ml s

[?]

3.0 OK

ml/h

[ ]

INTERFACE EXPLORATIONS 10:10 AM

[i]

EPINEPHRINE 5

Vol. Time Elapsed

1:34

[?]

3.0

ml s

ml/h

[ ]

10:10

AM

[i]

ALERT !!!!!!

DOPAMINE Vol.

5

ml

[?]

3.0

Infusion stopped. Pump on standby Time

Elapsed

OK

ml/h

[ ]

OK

Priority given to Drug Name. Volume, Time Elapsed and Rate of flow shown.

10:10

AM

DOPAMINE

Vol. Rate

5

3.8

ml

s

Total time Time Elapsed

10:10

8

24.3

AM

hr

s

Press [ i ] for info on the step taken/ alarm.

91

10:10

AM

[i]

DOPAMINE OCCLUSION !!!!

Remove kinks from line, press 5 ml Restart to continue infusing.

Time

3.0

Vol.

Elapsed

[?] ml/h

[ ]

OK

Press MUTE to silence the alarm, to avoid building up cognitive load and disturbing the neonate.

10:10

AM

[i]

DOPAMINE Input Password:

5

Vol.*******345ml Time Elapsed

1:34

s

[?]

3.0 OK

92

ml/h

[ ]

10:10

AM

[i]

DOPAMINE

Default K.V.O. Rate Occlusion Pressure Setting Vol.Drug Library 5 ml Set 1:34 time and date Time s Elapsed Pump Temperature

[?]

3.0

BACK

OK

ml/h

[ ]

SELECTED CONCEPT REFINEMENT : VARIATION IN FORM

Front

Back

93

94

95

INTERACTION Use of graphics has been kept simple and intuitive that also goes with the form of the product.

Syringe sizer Spring-loaded action keeps the syringe barrel in place while measuring its diameter

Pusher block Press button to move to and fro, so as to accomodate the syringe plunger.

LED Indicator

Mute alarm LED indication, different for different function

Pause/ Restart Infusion Soft keys (for specific functions only)

96

Navigation keys

Manual Bolus option Brand name This is used in case of an emergency, when a sudden high dose is required to be given to the patient

ON/ OFF

Pole Clamp - Detachable pole clamp is kept attached that rests the syringe pump onto the IV pole in any hospital environment.

- Screw head ( textured plastic) is made to insert at an angle so that the palm movement is not too close to the pump body, making the process more comfortable.

IV pole Groove to rest syringe flange ( frontal visibility maintained)

Handle - Used for lifting and moving the pump from place to place - Used for support while using the pusher block - Encases delicate pump body and mechanism in case of jerks/ fall.

Mains inlet

USB port RSS-232 communication port

Battery compartment; external access

97

INTERNAL ASSEMBLY

98

Front cover Main PCB

99

1

5

4 2

3 100

Part

1

2

3

4

5

Funtion

Material

ABS - cool grey

Rear cover

Houses the main mechanisms, external battery and the handle

Front cover

Holds the main PCB and the interface, with keypad and LCD screen

Lead screw chassis

Positive Linear displacement and speed reduction of the stepper motor by the gears that indirectly pushes the fluid out of the syringe.

Pusher block cover

Houses the mechanism and flexible circuit that connects to the lead screw assembly

ABS - white (matt)

Syringe sizer mechanism

The spring-loaded outer plastic holder snaps into position holding the syringe barrel in place, and registering it’s diameter with a rack and pinion mechanism.

ABS - blue (matt)

ABS - white (gloss finish and matt)

Aluminium sheet, cast Aluminium, plastic, and other standard parts available in the market

101

Disassembling made easier and more modular Grooves to pull out the syringe barrel holder

Countersunk screws at the back of the pump

External Communication

102

Alternating grooves (within the mould) that secures the IV line. Prevents Siphoning and detects early signs of Occlusion.

An appearance that: Blends Soothes the eye Calms the nerves Does not jump out And is the client’s choice.

103

104

105

106

107

108

109

110

SPECIFICATION

Name:

SYRINGE PUMP

Type:

Single channel, positive displacement syringe pump

Compatible brands:

Dispovan, Seruvan

Syringe capacity:

2, 3, 5, 10, 20, 30, 50/60 ml

Insulation:

CF Type, Class II (recommended)

External battery:

Rechargeable

Dimensions:

420mm x 136mm x 176mm (l x b x h)

Space occupied:

420mm x 150mm x 176mm (l x b x h)

Weight:

< 2.5 kg

Input parameters:

Volume, time, set pressure when required.

Infusion range:

0.1 - 999 ml/hr

111

112

Occlusion pressure level:

Levels 1- 5; 180 -1250 mm Hg

K.V.O rate :

0.05 - 2 ml/hr

Bolus dose rate:

(manual application) 0.1 - 800 ml/hr

Types of alarms:

End of infusion, Occlusion, Disengagement of plunger, Battery usage, Volume limit reached, etc.

Alarm volume:

> 65 dBA

Screen/ display:

Backlit black LCD; monochrome

Power supply:

230 V; 50/60 Hz

Accessories:

Pole clamp, AC power cable, Instruction manual, USB cord, RSS cable.

Shell material:

Injection molded ABS plastic

Bought out components:

Stepper motor, Lead screw, Bearings, Power plug, Rechargeable batteries, LCD screen and electronics.

ORTHOGRAPHIC DRAWINGS

Front View

Back View

113

Top View

Side View 114

Pusher block housing

Syringe plunger holder

115

Syringe sizer

116

MOCK-UP MODEL

117

118

119

120

CONCLUSION

“Satisfaction is the death of desire.” There is no doubt that this statement is applicable here. From electronics development, software development, structural changes etc need to be done simultaneously and tested. After the client and user study, it was concluded that the client’s product line needs to be branded too, and there is no standardisation in the form language of different models.

This concept, if developed further will be fully equipped and ready to compete the Indian market that is dominated by international products and change the way medical personnel look at equipments made in India. Scope involves accepting trends and current scenarios like use of Bluetooth or wireless technologies for safer and later options.

I am grateful to have been given this huge learning opportunity that has enabled me to develop as a product designer. It has widened my horizon, taught me patience and instilled self-confidence.

I’ve learnt how to interact with clients, engineers, and fellow colleagues and live in a symbiotic environment.

121

BIBLIOGRAPHY http://www.medicalbuyer.co.in/index.php?option=com_content&task=view&id=1804&Itemid=41 http://www.ebme.co.uk/articles/clinical-engineering/101-vascular-infusion-systems http://www.frankshospitalworkshop.com/equipment/infusion_pumps_user_manuals.html http://www.medicaldesignbriefs.com/ http://cms.allsteeloffice.com/SynergyDocuments/ErgonomicsAndDesignReferenceGuideWhitePaper.pdf http://www.fda.gov/downloads/MedicalDevices/.../ucm094461.pdf http://ceaccp.oxfordjournals.org/content/4/3/81/T2.expansion.html http://ergo.human.cornell.edu/conferences/nece05/ah-best%20practices%20for%20site-wide%20hospital%20ergonomics.pdf http://www.mhra.gov.uk/home/groups/dts-iac/documents/publication/con007322.pdf http://techcenter.lanxess.com/scp/americas/en/docguard/Part_and_Mold_Design_Guide.pdf?docId=77015 http://www.vygon.co.uk/pdf/upload/Vygon-Neonatal-Paediatric-Full.pdf http://www.google.it/patents/US6645177 http://www.digikey.com/Web%20Export/Supplier%20Content/MallorySonalert_458/PDF/MallorySonalert_AudibleAlarmBasics.pdf?redirected=1 http://www.designingforhumans.com/idsa/design-critique/ http://www.wipro.com/Documents/whitepaper/Whitepaper%20-%20Medical%20Devices%20Isolation%20-%20%C3%B4How%20safe%20 is%20safe%20enough%C3%B6.pdf

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http://www-edc.eng.cam.ac.uk/books/gooddesignpractice2/requirements%20capture.pdf http://library.iyte.edu.tr/tezler/master/endustriurunleritasarimi/T000449.pdf