Professional Design Project 

PDP‐12‐156

Industrial design and development of c arm physical body for c arm x ray device

MSME name -City -State -Zone -

Universal press tools & co.BangaloreKarnatakaSouthZone

Designer/Firm-

South

Uttejna technologies gCity -State -PROJECT CODE

j gBangaloreKarnataka

Approved cost :Start Date :Completion date :

Rs.100000001-01-201312-02-2014

PHASE 1 – RESEARCH

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C ARM INDUSTRIAL DESIGN

PHASE 1 REPORT

INDUSTRIAL DESIGN & DEVLOPMENT OF C ARM BODY FOR

C ARM X RAY DEVICE CLIENT : UNIVERSAL PRESS TOOLS AND CO

IMPORTANT NOTE : CONFIDENTIAL DOCUMENT CONTAINING PROPRIETARY INFORMATION

FIGURE 1

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1. OBJECTIVE OF THE PROJECT

The purpose of this document is to design and develop a generic C arm mechanics platform with unique features that can act as a platform for Indian companies to build their brand their product with distinct competitive advantage and user friendly features. This document covers Phase 1 deliverables for such a project.

2. PHASE 1 DELIVERABLES Following actions were performed and output generated to mark completion of phase I of the project

- Problem Space diagnosis - Task Workflow analysis - Market Survey - User feedback - Prioritize requirements - Chart Feature dependencies - Derive Customer specification sheet

Based on this, following deliverables have been achieved

- Process flow diagram - Survey report - Problem Space map - List of untapped potentials - System Specification document

3. PROBLEM SPACE DIAGNOSIS

3.1 Topology of a C - arm A C-Arm is an X Ray based real time Fluoroscopy device used in OT Rooms for imaging purposes.

C – ARM It has a ‘C’ shaped Arm that rotates and revolves around the patient to provide visibility of the area of interest within the patient from different angulations as per the diagnostic need of the doctor ...hence the name X ray tube

Imager

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A typical C- Arm has 6 degrees of motion:

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3.2 C ARM IN USE

Operator of C arm typically stands opposite to the doctor near the C Arm bucky and controls the C arm as per instructions of the doctor Doctor views the Fluoroscopy monitors mounted on a separate cart which may not be visible to the operator at all times.

C ARM placed from HEAD END

C ARM placed from SIDE END

Layout of a C arm OT room

Operator

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There are generally 2 fluoroscopy monitors, one to show the current view while other to review old or previous views 3.3 PROCESS FLOWCHART

The above indicates high level process flowchart for a process in a typical C Arm Operation Decision based paths in Green are often repeated and lead to lots of X ray Shots to get out of the loop. This lead to un-necessary X ray exposure to not only patient but also the doctors and his/her staff around him/her. Even taking an X ray Shot ( as represented by one process box above) has several decisions taken on case to case basis. This is illustrated below.

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3.3 SURVEY REPORT Places surveyed by Design Team St John’s Hospital, Bangalore OT Room Bangalore Kidney Foundation , Bangalore Kaveri Hospital , Trivandrum Orange City Hospital, Nagpur Narayana Hrudayalaya, Bangalore Manufacturers Surveyed by Design team Prognosys Medical Systems , Bangalore Skanray Technologies, Mysore Cura Healthcare, Chennai Philips Healthcare, Pune And others who need us to keep their names confidential

C ARM IN OT ROOM

DOCTOR GIVING PROCEDURE OVERVIEW

CROSS REFERENCE GIVEN BY LASER DEVICE

MONITOR TROLLEY

OPERATION IN PROGRESS

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SUMMARY OF ORAL INTERVIEWS WITH TECHNICIANS/DOCTORS

- Awareness Of Dangers of X Ray have improved. Technicians and Nurses are concerned about the X ray exposures they get and would like it to be minimized

- Greater depth of C and free space are appreciated but making the C too big affects manoeuvrability. Doctors may switch between AP and Lateral frequently and very big Cs can slow things down

- Motorization of C movements was proposed as an advantage but was not accepted by Orthopaedic operators since motorized movements cannot be more than 10-12 degrees per second due to various regulatory constraints. This is a great impediment since doctors switch between AP and lateral frequently and slow response from operators tends to irritate doctors

- Instead an easy to use , properly counterbalanced C arm is preferred as it aids efficient positioning for orthopaedic applications

- Laser aiming as a positioning technique was found useful by doctors - The frequent positioning errors leading to extra X ray shots ( shown in Green boxes in process

chart) was found to be avoidable and both doctors and operators appreciated improved efficiency of positioning as well as reduced X ray exposure due to laser aiming

- Operators need to run between the C (while positioning it) and controls which are on the rear of the C arm. This was not efficient and also doctors tend to get irritated by delays and errors. Probably means to have controls and movement access more closer was need of the hour

- Operators need access to control from either side of C arm but the controls are only at the rear in most C arms. This was found cumbersome

- Sometimes the operators need to view monitor while positioning or collimation but monitors face the doctor and hence there is a positional delay as operators don’t have clear view and work on instructions from someone else without direct view. This reduces efficiency.

- Some imported C arm have very high lateral height (see figures in 3.1). As a result , shorter doctors need to stand on a stool at times to operate…which is grossly inconvenient

- When moving device down a ramp, operator needs to be more careful else he or she may lose control of the device

- Fitment of the device in lifts is difficult. Especially in some low end C arms , the wire between monitor trolley and Bucky is not separable so it becomes difficult to move the device between floors.

- When device is moved around, it tends to ride on wires of other equipment. Good C arms have ‘‘Cable pushers” and these are important for the C arm

- Doctors in training have ambition of having their own Ortho Clinic with a C-Arm. Since the scenario is competitive, doctors have a taste for more aesthetically appealing and feature rich C arms at entry segment costs. As market is getting crowded, this is getting more prominent.

ALLENGER’S C-ARM IN ACTION

GENERAL C ARM LAYOUT ( USA )

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SUMMARY OF DISCUSSIONS WITH EQUIPMENT MANUFACTURERS - As market gets competitive, Indian manufacturers of C arm are open to more feature rich

systems at competitive costs at entry level. Hence they are ready to experiment to be better than others

- Tender specifications were very important in lot of specifications that were defined for the product. Companies with depth of C even 5 mm more use that leverage to exclude others by manipulating tender specs. Over a period, some tender specs have frozen for the entry segment and whole industry seems to adhere to this as bare minimum . Some of these important specs are

SPECIFICATION (Ortho) VALUE STANDARDIZED ACTUAL REQUIREMET Vertical column movement 450mm movement NO one uses more than

250mm movement but because of tenders, everyone provides 450mm movement

System width Less than 800mm Varies between 780 to 800 as most tenders exclude C arms wider than 800 due to door width and Lift opening issues

Horizontal carriage movement

200mm This is more than sufficient from usability perspective

Free space 750mm-800mm Most entry segment C arms are at 750mm while others give 800mm

Depth of C 580mm -620mm While most are at about 580mm, a trend has begun where OEM manufacturers want to build 700and even 750 Depth of C to be able to exclude others from certain tenders. This affects manoeuvrability but no one cares as sales in India happens on tender spec, not user requirements.

Wig Wag motion 10-12 degree range This is sufficient for doctor to access region of interest without C arm interference

- A single spec that satisfies all Manufacturers is not feasible as everyone has his/her own definition of what spec is critical and how they want to use it to position themselves. Hence our architecture needs to have sufficient flexibility to cater to different users.

3.4 COMPETITON BENCHMARKING Products for Orthopaedic applications by different companies were reviewed to verify specifications and a common minimum specification was derived

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SIEMENS ACARDIC VARIAC

PHILIPS BV PULSERA L&T VISION

PHILIPS SURGICO

GE STENOSCOP

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ALLENGERS

ZHEIM

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3.4 PROBLEM SPACE MAP

PROBLEM (USER) : Require a portable and flexible tool to get real time diagnostic images of internal body anatomy from different angulations.

PROBLEM (OEM BUYER) : Need a C arm Mechanics platform at competitive cost and unique features to position their product competitively in the market

ENVIRONMENT

- Used in Controlled atmosphere in Air conditioned OT rooms

- Subject to fumigation & sterilization chemicals

- Parked on pathways and aisles

- Transport and storage between -10C to 50C

DEMOGRPAHICS

- Used by Doctors and Technicians of all ages

- Well educated & technologically aware users professionally trained in healthcare

- Aspirational value (to become independent Ortho hospital owners one day)

PSYCHOGRAPHICS

- Friendly and helpful

- Rugged and strong

- Flexible and portable

- Technologically advanced

- Sleek and smart

- Awe and pride

- Sterile & hygienic

UNTAPPED POTENTIAL ( USERS) :

- Reduction in Iterative positioning processes

- Lowered lateral height and better counterbalance for ease of use

- Lowered X ray dose by better means to collimate and position virtually

- Better depth of C without compromise in overall size

- Better Styling and design using new technologies to become an aspirational product

- Better access to controls – both mechanical as well as Control panel from either side

- Easy of movement and improved transfer between OT rooms

- Better access to info on monitor to both doctors and operators/technicians

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MECHANICAL SPECIFICATIONS FROZEN BASED ON MARKET & USER INPUTS No Specification Range available Comments

1 System Length 1800-2000 mm Depends on C size 2 System width 796 mm <800 Basic lift widths 3 Vertical Column Movement 450mm or more 4 C rotation +/- 180 5 Orbital Under scan At least 90 degrees Special requests possible 6 Orbital Over scan At least 35 degrees Special requests possible

with effect on C size 7 C motion Counterbalanced in all axes 8 SID 950 -1000mm <=1000 recommended` 9 Free Space Sid – 200mm (regulatory requirement)

10 Depth of C 580-800 mm range Around 600-700 recommended

11 Extent of non iso-centricity 100-125mm range Depends on C size 12 Wig Wag +/- 12 degrees Customizable 13 Horizontal carriage travel 200mm 14 Lateral C Height 1000mm or less Affected with C size 15 Steering Rear Wheel steering

indexed at 90 degrees

16 Control panel mounting option To be designed . 17 Monitor Cart To be designed .

DELIVERABLES INCLUDED IN BASIC MECHANICS: The Basic mechanics shall contain following - Base Chassis - Steering assembly and Steering handle with rear wheels steerable and front free floating castor wheel - Vertical column running on 24VDC with limit switch feedback of extreme positions - Wig Wag Assembly with +/- 12 degrees wig wag (manual) with brake - Horizontal Carriage movement of 200mm with brake - Yoke Rotation of 360 degrees with brake - Yoke Bearings and C Brake Assembly - Welded C with suitable flanges and Cable Input opening as per your spec - Basic Handles ( common to all devices) - Basic Sheet metal “boxy” covers ( Common to all devices) - Imager cover and tube cover - Monitor cart body Other specifications shall be frozen after CONCIEVE PHASE ( Phase II)

UNTAPPED POTENTIAL (OEM BUYERS) :

- Flexible architecture to allow customization and base platform for several products

- Reasonable cost to allow better positioning vis a vis features

- Unique identity and distinct physical attributes to create differentiation

- Unique User friendly features

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High level Architecture

CONCLUSION: The above terms comply with the general spirit of design & development and associated risks and depict dedicated effort required for success from both ends.

RATANJIT SINGH SOHAL

PHASE 2 – CONCEPTS

PHASE 3 – DRAWINGS

FINAL PRODUCT