Staying Connected - March 2009

Cable and Wire Labeling, Marking Requirements and Options

Marking requirements
for ECG cables and leads
are specified in EC13

Medical cables and wires require labeling and marking for identification and to comply with regulatory standards.  Labeling and marking requirements are established in CFR Title 21 Sec. 820.120 “Device labeling.”  “Each manufacturer shall establish and maintain procedures to control labeling activities.”  Sub paragraph (a) specifies: “Labels shall be printed and applied so as to remain legible and affixed during the customary conditions of processing, storage, handling, distribution, and where appropriate use.”

Additional labeling requirements for ECG cables and lead sets are detailed in ANSI/AAMI EC13, EC53 and IEC 60601-2-47.  Details include color coding and designations for patient electrode connections.

At Affinity, we work with our customers to establish and document labeling to meet regulatory requirements early in the design process.  A variety of labeling and marking options are available.  Commonly used labeling and marking options include:

Custom nameplate permanently
attached into cable yoke

Nameplates and Inserts

Nameplates are generally designed to fit into recessed pockets molded into the cable yoke or connector.  Nameplate labels are printed on a durable material such as polycarbonate which resists cleaning agents and scratching.  The recessed pocket helps prevent the nameplate from being removed either accidentally or intentionally.  When attached using an appropriate adhesive, the nameplate is virtually permanent.

High quality branding is possible
using a custom nameplate

One of the advantages of a nameplate system is the ability to print brands and logos with intricate detail and in multiple colors.  The material and process used to produce nameplates lends itself to high quality printing.  A well designed nameplate can not only convey necessary information, but can connect the cable to the manufacturer’s brand.


Preprinted nameplates with durable
stain textured polycarbonate surface

AHA and IEC designations
on cable yoke

One of the methods that Affinity uses to label leadwires is to use pre-printed inserts, similar to nameplates.  These colorful labels are inserted into pockets molded into snaps or banana plug connectors using a permanent adhesive.  Affinity’s proprietary inserts offer a convenient way to comply with AHA and IEC labeling requirements.

Molded-In Markings

Color coded, pre-printed inserts
comply with AHA and IEC labeling
requirements for patient leads

Example of AHA lead designation
molded into leadwire snap

Lead markings, logos, and other designations can be molded into a finished part.  This type of marking is most commonly used on leadwire snaps but is also used on cable connectors and yokes.  Leadwires can conform to AAMI EC53 labeling requirements by molding lead designations into appropriately colored leadwire snaps.

One advantage of molding a logo or designation into a cable or leadwire is that the markings are permanent and adds no additional cost to the product.  One disadvantage is that molded printing is not as easy to read due to it being the same color as the material it is molded into.

Color coded bead markers permanently
attached to leadwires conform
to AHA marking requirements

Bead Markers

Plastic Bead markers are often attached to individual ECG lead wires.  They are color coded and printed to conform to AHA and IEC marking requirements.  Bead markers slip over the wire and are then attached using a specially formulated adhesive and are virtually permanent.

Flag Label

Flag labels are labels that are wrapped around and then extend outward from a cable like a flag from a flagpole.  The labels are commonly vinyl or polypropylene with a high-adhesion permanent acrylic adhesive.  They are abrasion and smudge resistant and hold up well to normal cleaning solutions.  This type of label can be printed on-demand on either blank or pre-printed label stock.   It is common to print date codes, lot numbers and serial numbers along with graphic indications.

Pre-printed flag label with date
of manufacture added

Flag label printed on-demand with
customer specified information

Flag labels typically wrap around the cable and extend one or more inches to offer a larger printable area than a wrap-around label.  Flag labels are available in a variety of sizes and if pre-printed, can include complex graphics and multiple colors.

Wrap-Around Cable Labels

Wrap-around cable labels are a common and effective way to apply labels directly to cables.  This type of label typically features an aggressive acrylic adhesive on a printable polypropylene carrier making it virtually permanent.

At Affinity, we often use printable wrap-around labels for marking round and flat cable.  Printed on demand, these labels include information specified by the customer.  Due to size constraints, wrap-around labels typically offer room to print only a few lines of text and are commonly used to print a part number and lot number.  Occasionally more than one label is used on a single cable in order to include additional information.

Wrap-around label on cable

Close-up of print-on-demand label
wrapped around cable with Lot Number


A wide variety of options is available for medical cable and wire labeling.  Affinity can help with labeling and marking schemes that both meet regulatory requirements and also enhance product identification and branding.  By establishing labeling and marking requirements early in the design process, time can often be saved and also help speed product launch.

Whatever your cable labeling and marking requirements are, we can help.  Let Affinity Medical Technologies become part of your design team.  Contact Affinity Customer Care at 1+ 949-477-9495 or email to

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Meet Hank Mancini – Affinity Medical Business Development Manager

Hank Mancini –
Affinity Medical Technologies
Business Development Manager

If With his broad smile, upbeat personality, infectious laugh and sometimes weird sense of humor, Hank Mancini found a home at Affinity Medical Technologies in 2007.

Hank brings with him more than thirty years of experience in the medical industry.  While managing a Tyco plant in Huntington Beach, California he worked with many current Affinity team members.  “Joining Affinity was like coming home,” Hank said.

Although Hank’s title is Business Development Manager, he enjoys being involved in all aspects of the company.  In addition to selling, Hank oversees marketing including trade shows, periodic card mailings, Affinity’s web site, and our Staying Connected electronic newsletter.  “I like to keep busy and one way to do that is to always be working on multiple projects at the same time.  That way if there is any down time, I always have something else productive that I can be doing” said Hank.

When asked what he likes most about his position with Affinity, Hank replied, “I appreciate the customer focus that our President, Mary Phillipp, insists on.  Mary understands that without our customer partners, there is no need for Affinity.  Mary has assembled a wonderful and talented group of people which makes Affinity a great place to work.”

Much of Hank’s time is spent traveling to visit customers across the country.  “Mary Phillipp, Bob Frank and I often travel together.  We feel that it is vitally important to meet with customers and prospective customers face to face,” said Hank.  “While travel is expensive in terms of both time and money, there’s no substitute for personal contact.”

Hank and Teresa at Staples
Center the night Kobe Bryant
received his MVP award

Gumby (the bird) and Dexter
checking each other out

Hank and his wife, Teresa, live in Huntington Beach, California, share six grown children and have three grandchildren.  They are huge Los Angeles Lakers fans attending most home games.  Besides the Lakers, Hank enjoys digital photography, reading, and home improvement.  Hank is a big fan of the TV reality show “The Amazing Race.”

Hank and Teresa also share their home with Kobe, their 6-year old pug, Dexter their 1-year old white cat, and Gumby their 8-year old Eclectus parrot.

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Announcements and Information

Visit Affinity at HRS 2009 in Boston

Affinity will once again exhibit at the annual Heart Rhythm Show. The Heart Rhythm 2009 Technical Exhibits will be held May 14-16, 2009 at the Boston Convention & Exhibition Center 415 Summer Street, in Boston Massachusetts.  Affinity will be located in booth 260.

March Trivia – there’s more to March than St. Patrick’s Day!

March 1st is National Pig Day.  It was started by Texas art teacher Ellen Stanley in 1972 to honor this four-legged creature!  Many feel that pigs are intelligent and clever animals. It is said that they can easily be taught to do tricks by those who keep them as pets.

March is National Peanut Month – enjoy some peanut trivia:

  • The peanut is not a nut, but a legume related to beans and lentils
  • There are four types of peanuts grown in the USA — Runner, Virginia, Spanish and Valencia
  • Presidents Thomas Jefferson and Jimmy Carter were both peanut farmers
  • The average American consumes more than six pounds of peanuts and peanut butter products each year

March is also Women’s History Month, National Sauce Month, National Noodle Month and National Caffeine Awareness Month as well as 12 other designations.

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: +1 949 477 9495
Fax: +1 949 477 9499