Staying Connected - June 2007

EC53 Basics – the ANSI/AAMI standard for ECG Cables and Leadwires

When we work with customers to design new cable or leadwire systems one of the typical requirements is that the design must “meet EC53.”  What is EC53 and how does it affect medical cable and leadwire designs?

The goal of EC53 was to promote patient safety by helping prevent inadvertent connection of patient leads to a power source, as well as allowing more rapid transfer of a patients requiring continuous monitoring during emergency care through standardization.


Fully shielded
leadwire connector
fits all AAMI/DIN
style cables

Prior to the adoption of the standard, rare but serious incidents occurred when patient leads with exposed male pin connectors were inadvertently plugged into power outlets.  The primary way that EC53 addresses safety is by defining cable and leadwire connections with no exposed electrical contacts.

To facilitate continuous monitoring, EC53 compliant cables and leadwires from any manufacturer should be interchangeable with cables and leadwires from any other manufacturer.  This allows a patient to be transferred into a clinical setting more quickly by using the same leadwires attached by emergency responders.

The voluntary standard goes beyond unexposed electrical contacts to promote safety and reliability by defining minimum physical and electrical requirements for compliant cables and leadwires.  Labeling and packaging requirements are also formalized.

Physical requirements

To achieve both safety and interchangeability goals for leadwire connection to a cable, EC53 specifies that DIN 42-802 be followed.  The DIN reference specifies pin and socket (plug and jack) dimensions as well as electrical contact setback to achieve a “touch proof” connector.


Unshielded DIN plug with
recessed contact
s

AAMI/DIN style shielded yoke
with recessed pins

To establish minimum physical performance of cables and leadwires the standard contains requirements for the number of mate/unmate cycles, connector retention force, flex life of components and tensile strength.  Cleaning, disinfection, and sterilization minimums are also called out.

Electrical requirements

Minimum performance standards for several critical electrical requirements are defined in EC53.  One requirement is for defibrillation withstand.  When a patient connected to a monitor is defibrillated, the ECG cable should limit current flowing back to the monitor, ensuring the effectiveness of the defib pulse to the patient.  The cable should also protect the monitor from defib pulses so that heart monitoring may resume following defibrillation.

Noise in an ECG signal may make accurate diagnosis difficult.  Cable and leadwire movement in emergency care situations such as transporting a patient is particularly problematic.  The issue is addressed in EC53 by establishing both a standard test method and a maximum cable noise level of 50µV peak to peak.

Other electrical requirements are for dielectric (Hipot) withstand, sink current, contact resistance, and patient leadwire resistance.

Testing

Finally, EC53 provides test methods and procedures by which compliance of the device to the standard can be verified.  Test equipment, circuits, and specific procedures are provided and allow uniform and consistent testing.

Affinity Medical and EC53

Affinity Medical Technologies is a custom OEM medical cable manufacturer.  One of our core competencies is designing and manufacturing cables and leadwires that meet and exceed the ANSI/AAMI EC53 standard.


Affinity engineering technician
Bob Evans performing Hipot
testing on medical cable

While ANSI/AAMI EC53 only pertains to ECG cables and leadwires, it is often used as the basis to establish performance requirements for other medical cables.  Part of the design and development process at Affinity is to work with our customers to review and apply applicable electrical and mechanical requirements of EC53 to their medical cable design.

Affinity Medical’s in-house engineering lab has the ability perform all tests associated with the EC53 standard, except for ETO pre-conditioning.  We routinely verify that cables we manufacture meet the requirements of EC53.

At Affinity, we understand AAMI/ANSI EC53 well.  Bob Frank, Affinity Medical Technologies Director of Engineering, was a member of the AAMI Working Group that developed the standard

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MEET CINDY OLDNYSKI - Manager of Quality Assurance


Cindy Oldynski – Always smiling

Cindy Oldynski joined Affinity Medical as the Quality and Distribution Supervisor in 2001. Soon after, she accepted the Manager of Quality Assurance position reporting directly to the President and CEO, Mary Phillipp.  Cindy’s previous background in Quality, Documentation Control, Distribution Management, Regulatory Affairs, Customer Service and Production allowed her to utilize her extensive skills and draw from many years of experience in the medical manufacturing industry to transition into her new role at Affinity.

As Manager of Quality Assurance, Cindy oversees the daily QA activities necessary in the production of over molded patient medical cables and lead wires. In addition to assisting with final inspection, her activities include complaint handling, internal quality audits, preventative and corrective actions, quarterly management review meetings as well as continuous training of all personnel in quality related procedures.  She organizes and participates regularly in external audits with customers and suppliers.

Cindy is also responsible for improving and maintaining effective quality systems that support manufacturing, sales, and engineering while remaining in compliance with FDA regulations.  In addition, Cindy is committed (along with Affinity’s Management team) to meet or exceed the highest levels of worldwide quality standards such as ANSI/AAMI EC53 and to adhere to the requirements of the international standard of manufacturing ISO 13485.  In order to maintain ISO 13485 certification, Cindy continues to monitor all company quality activities to ensure each employee meets or exceeds these stringent requirements.


Cindy helps in production
with cable testing

Most days, you will find Cindy out on the production floor or in receiving and inspection where she is available to answer questions and advise team members about quality issues, always with a smile on her face. When asked what she likes most about her job at Affinity Cindy replied, “The people.  I also appreciate the great support I receive from upper management.  Mary Phillipp, our president and CEO expects everyone to take responsibility for quality.  After all, quality is every employee’s job.  Our culture at Affinity truly reflects this philosophy.”

Cindy volunteers her free time in an animal rescue organization that assists in finding good homes for abandoned cats and kittens.  She also enjoys spending long weekends with her husband and family at their new vacation home near St. George, Utah.

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Overmolded Electronics

One of the unique capabilities of Affinity Medical Technologies is to overmold electronics as part of a cable assembly.


Miniature circuit with battery

Circuit in bottom half of ABS case

If the need arises to add electronic circuitry to a medical device without redesigning the device itself, consider adding the electronics as part of a cable assembly.  Or, if extra capabilities need to be added to a legacy device, consider an external solution.


Medical cable with above circuit
overmolded into cable yoke


Overmolded electronics package
allows two cables to interconnect
via D-sub connectors

Affinity can help you design an electronics package that can be incorporated into a custom medical cable.  Photos show our capability to overmold electronics, but we can also do various cam-shell designs that are sonically welded, depending upon the application and customer requirements.

Our experience can help shorten your product development cycle.  We know what materials to use and how to position components to survive the temperatures and pressures of injection molding.

If you would like to see a sample of electronics that have been incorporated into a cable and overmolded, contact Affinity Medical Customer Care at 949-477-9495 or email to customercare2@affinitymed.com.

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Affinity Medical Technologies Celebrates 10 Years!

Affinity Medical Technologies is now in its eleventh year of operation and recently celebrated with a ten year anniversary party for employees and members of the Affinity “family.” We look forward to an exciting future as the company develops its resources and expands into new markets.   The entire Affinity team is constantly working to accomplish the same goal: to achieve excellence in everything we do.


Group photo at Affinity 10 year anniversary picnic

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Announcements and Information

Upcoming Holidays

  • National Flag Day is June 14th – Display our flag

  • Fathers Day is June 17th – Remember your father!

  • Independence Day - Affinity will be closed Wednesday, July 4th in celebration of Independence Day.


Suzann Sitka and Candy Golding
the Affinity Customer Care team

Affinity Customer Care - Hours of Operation

Affinity Medical Technologies customer care specialists are available from 7:00 A.M. until 4:00 P.M. Pacific time.

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Affinity Medical Technologies

1732 Reynolds Ave
Irvine, CA 92614  USA
Phone: 949-477-9495
Fax: 949-477-9499
Contact Us