Posts Tagged ‘safety’

Systems Engineering In Medical Device Design – Production, Part 1

Sunday, February 24th, 2013
     Done any remodeling lately?  If you have, you’ve been faced with countless choices regarding design and materials.  Even a relatively simple decision such as putting in hardwood flooring requires many considerations.  What type of wood?  What grade?  How about the stain?  Should it be factory stained and sealed, or should the flooring be installed by single board, then stained and sealed in place?  Ultimately, your decision is based on your requirements with regards to cost, durability, and personal style.

     Now imagine the decision making process that is required to produce a medical device.  We’ve been discussing this complex process during our series on medical device design utilizing the systems engineering approach, a systemized approach to product development, design, and manufacture that is used within many manufacturing arenas.  Its objective is to relate the requirements for manufacture, regulatory compliance, sale, use, and maintenance of the product to specific design criteria for functionality, durability, and safety.  By doing so, the systems engineering approach ensures that the product meets or exceeds all requirements.

     Last time we wrapped up our discussion on the Development stage of systems engineering by discussing field testing of medical devices assembled during Preproduction.  Problems encountered during this phase result in a comprehensive review of the device design and instructions.  When all issues have been resolved, things move on to the manufacturing phase and full commercial production.

     During the Production stage, engineers make continual assessments of the manufacturing process and ongoing adjustments are made to the device design and manufacturing protocol as necessary, this due primarily to changing stakeholder requirements regarding cost reduction.  In the competitive marketplace, cost reduction is a never-ending quest to maintain profitability in view of changing economic and market conditions, and this must be done without compromising the quality, safety, and effectiveness of the device.

     For example, suppose a medical diagnostic imaging machine was designed to be fitted with a machined metal gear in one of its mechanisms.  The manufacturer specifies that a $10 decrease must be made in production costs so it can continue to be sold at an acceptable profit margin.  After reviewing the design, engineers discover that substitution of a molded plastic gear would reduce manufacturing cost per machine by $12.  This is a common scenario, as plastic parts are often substituted for metal to save on cost.

     Plastic versus metal?  How can that be an acceptable swap?  In many cases, it can be.  Mechanical stressors are analyzed, and if the plastic gears meet durability requirements as well as their metal counterpart, they are substituted.  During the Preproduction phase these plastic gears are used in both lab and field testing, where they are put through the rigors of real world use.  If they perform acceptably, they are made a permanent part of the device’s design and used in commercial production.

     Next time we’ll continue our look at the Production stage to discover another way that systems engineering can facilitate cost reduction to meet stakeholder requirements.


medical device design

Industrial Control Basics – Disconnect Switches

Sunday, March 25th, 2012
     Last week our kitchen ceiling fan and light combo decided to stop working.  We don’t like eating in the dark, so I was compelled to do some immediate troubleshooting.  As an engineer with training in the workings of electricity I have a great respect for it.  I’m well aware of potential hazards, and I took a necessary precaution before taking things apart and disconnecting wires.  I made the long haul down the stairs to the basement, opened the circuit breaker in the electrical panel, and disabled the flow of electricity to the kitchen.  My fears of potential electrocution having been eliminated, my only remaining fear was of tumbling off the ladder while servicing the fan.

     Just as I took the precaution to disconnect the power supply before performing electrical maintenance in my home, workers in industrial settings must do the same, and a chief player in those scenarios is the motor overload relay discussed last week.  It automatically shuts down electric motors when they become overheated.  Let’s revisit that example now.

Industrial Control System

Figure 1


     Our diagram in Figure 1 shows electric current flowing through the circuit by way of the red path.  Even if this line were shut down, current would continue to flow along the path, because there is no means to disconnect the entire control system from the hot and neutral lines supplying power to it, that is, it is missing disconnect switches.  Electric current will continue to pose a threat to workers were they to attempt a repair to the system.  Now let’s see how we can eliminate potential hazards on the line.

Disconnect Switches

Figure 2


     In Figure 2 there is an obvious absence of the color red, indicating the lack of current within the system.  We accomplished this with the addition of disconnect switches capable of isolating the motor control circuitry, thereby cutting off the hot and neutral lines of the electrical power supply and along with it the unencumbered flow of electricity.

    These switches are basically the same as those seen in earlier diagrams in our series on industrial controls, the difference here is that the two switches are tied together by an insulated mechanical link.  This link causes them to open and close at the same time.  The switches are opened and closed manually via a handle.  When the disconnect switches are both open electricity can’t flow and nothing can operate.  Under these conditions there is no risk of a worker coming along and accidentally starting the conveyor motor.

     To add yet another level of safety, disconnect switches are often tagged and locked once de-energized.  This prevents workers from mistakenly closing them and starting the conveyor while maintenance is being performed.  Brightly colored tags alert everyone that maintenance is taking place and the switches must not be closed.  The lock that performs this safety function is actually a padlock.  It’s inserted through a hole in the switch handle, making it impossible for anyone to flip the switch.  Tags and locks are usually placed on switches by maintenance personnel before repairs begin and are removed when work is completed.

     Now let’s see how our example control system looks in ladder diagram format.

Control System Ladder Diagram

Figure 3


     Figure 3 shows a ladder diagram that includes disconnect switches, an emergency stop button, and the motor overload relay contacts.  The insulated mechanical link between the two switches is represented by a dashed line.  Oddly enough, engineering convention has it that the motor overload relay heater is typically not shown in a ladder diagram, therefore it is not represented here.

     This wraps up our series on industrial control.  Next time we’ll begin a discussion on mechanical clutches and how they’re used to transmit power from gasoline engines to tools like chainsaws and grass trimmers.



Industrial Control Basics – Electric Motor Control

Sunday, February 19th, 2012
     Electric motors are everywhere, from driving the conveyor belts, tools, and machines found in factories, to putting our household appliances in motion.  The first electric motors appeared in the 1820s.  They were little more than lab experiments and curiosities then, as their useful potential had not yet been discovered.  The first commercially successful electric motors didn’t appear until the early 1870s, and they could be found driving industrial devices such as pumps, blowers, and conveyor belts.

      In our last blog we learned how a latched electric relay was unlatched at the push of a button, using red and green light bulbs to illustrate the control circuit.  Now let’s see in Figure 1 how that circuit can be modified to include the control of an electric motor that drives, say, a conveyor belt inside a factory.

Motor Control Relay

Figure 1


    Again, red lines in the diagram indicate parts of the circuit where electrical current is flowing.  The relay is in its normal state, as discussed in a previous article, so the N.O. contacts are open and the N.C. contact is closed.  No electric current can flow through the conveyor motor in this state, so it isn’t operating.  Our green indicator bulb also does not operate because it is part of this circuit.  However current does flow through the red indicator bulb via the closed N.C. contact, causing the red bulb to light. 

     The red and green bulbs are particularly useful as indicators of the action taking place in the electric relay circuit.  They’re located in the conveyor control panel along with Buttons 1 and 2, and together they keep the conveyor belt operator informed as to what’s taking place on the line, such as, is the belt running or stopped?  When the red bulb is lit the operator can tell at a glance that the conveyor is stopped.  When the green bulb is lit the conveyor is running.

     So why not just take a look at the belt itself to see what’s happening?  Sometimes that just isn’t possible.  Control panels are often located in central control rooms within large factories, which makes it more efficient for operators to monitor and control all operating equipment from one place.  When this is the case, the bulbs act as beacons of the activity taking place on the line. Now, let’s go to Figure 2 to see what happens when Button 1 is pushed.

Electric Motor Control

Figure 2


     The relay’s wire coil becomes energized, causing the relay armatures to move.  The N.C. contact opens and the N.O. contacts close, making the red indicator bulb go dark, the green indicator bulb to light, and the conveyor belt motor to start.  With these conditions in place the conveyor belt starts up.

     Now, let’s look at Figure 3 to see what happens when we release Button 1.

Industrial Control of Motors

Figure 3


     With Button 1 released the relay is said to be “latched” because current will continue to flow through the wire coil via one of the closed N.O. contacts.  In this condition the red bulb remains unlit, the green bulb lit, and the conveyor motor continues to run without further human interaction.  Now, let’s go to Figure 4 to see how we can stop the motor.

Motor control relay unlatched.

Figure 4


     When Button 2 is depressed current flow through the relay coil interrupted.  The relay is said to be unlatched and it returns to its normal state where both N.O. contacts are open.  With these conditions in place the conveyor motor stops, and the green indicator bulb goes dark, while the N.C. contact closes and the red indicator bulb lights.  Since the relay is unlatched and current no longer flows through its wire coil, the motor remains stopped even after releasing Button 2.  At this point we have a return to the conditions first presented in Figure 1.  The ladder diagram shown in Figure 5 represents this circuit.

Motor Control Ladder Diagram

Figure 5


     Next time we’ll introduce safety elements to our circuit by introducing emergency buttons and motor overload switches.