Staying Connected - June 2014

Medical Cable and Leadwire Labeling and Marking Requirements

Medical cables and wires require labeling and marking for identification and to comply with regulatory standards.  Labeling and marking requirements for the United States 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.

To ensure that labeling meets all applicable regulatory requirements requires that Quality and Regulatory resources be involved in the product development process.  Examples of compliant labeling and markings include:

Nameplates and Inserts

Nameplates are generally designed to fit into recessed pockets molded into the cable yoke or connector.  Nameplate labels are commonly 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 for low-energy surfaces, the nameplate is virtually permanent.


Custom nameplate permanently
adhered to cable yoke

High quality branding is possible
using a custom nameplate

One of the advantages of a nameplate system is the ability to print logos and branding information 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 promote the manufacturer’s brand.


Preprinted nameplates in roll form
with durable stain-resistant textured
polycarbonate surface

Cable yoke label with both AHA
and IEC designations


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

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 are extremely durable and offer a convenient way to comply with AHA and IEC labeling requirements.

 

Molded-In Markings



Example of lead designations
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 markings may not be as easy to read because they are the same color as the material it is molded into.

Bead Markers

Plastic Bead markers may be 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, are then attached using a specially formulated adhesive and are virtually permanent.


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

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

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.

Printed on demand, wrap-around 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.

Flag Labels



Pre-printed flag label with
date of manufacture added

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.

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.


Medical cable assemblies often
require multi-language instructions
to be included with packaging


Instructions for Use

Instructions for use, also referred to as IFUs, are an important and required part of labeling.  IFU’s can range from instructions printed on an insert card to multi-page booklets printed in a variety of languages.

Writing instructions for use and translating to other languages is the responsibility of the device manufacturer.  Cable manufactures, such as Affinity and Molex, will often produce instructions after receiving finished artwork files for the document from the device maker.

Summary

A variety of options is available for medical cable and leadwire labeling.  The Affinity engineering team can help with labeling and marking that meet regulatory requirements and also enhance product identification and branding.  Labeling and marking requirements should be addressed early in the design process so that any recessed areas in tooling to hold labeling will be considered in tool design and fabrication.

Contact your local Molex Sales Engineer, Affinity Customer Care at 1+ 949-477-9495 or email to custcare2@molex.com.

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Meet Beatriz “Betty” Navarrete – Cell Champion Material Handler



Betty Navarrete -
always has a smile on her face


Betty started her career as a manufacturing associate at Affinity in July 2004, almost ten years ago!  Six years ago, she was given increased job responsibilities including the important job of releasing orders for production.  In addition to releasing work orders, Betty oversees Affinity’s warehouse and cable cutting.

“One of the most important parts of my job is making sure production orders are kitted, staged and ready to be pulled by the appropriate work cell,” said Betty.  “Every product that we manufacture has a default work cell assigned, but most products can be manufactured in several work cells.  We are always looking ahead to see what products need to be manufactured and which work cells have the trained people and equipment to manufacture the product.  When a work cell finishes a job, we need to have their next job ready to pull so that there is no down time.  That helps us meet our delivery commitments to our customers.”

Affinity will be transitioning from its current MRP system to SAP on October first and Betty has been part of the SAP Core Team preparing for the transition.  “Learning what SAP is and how we will use it to improve our business processes has been a big challenge,” said Betty.   “But, I like challenges.  We have been working and training for months and we will be ready by October first.”

Betty reports to Affinity Materials Supervisor, Sue Alessi.  “Betty is one of our strongest team members,” commented Sue.  “She always gives 100%.  Betty has taken on an important role in our transition to SAP.  She is learning all the transactions necessary to manage materials.  She will really be a key to our success.”


Betty releases customer orders
for kitting and manufacturing


When asked what she likes most about working at Affinity, Betty replied; “There are always opportunities to learn new things and to grow and develop.  Mary Phillipp provided the leadership for Affinity to grow and now Molex is helping us grow even faster by providing more people, space and new equipment.”

Before immigrating to the United States from Mexico and joining Affinity, Betty completed her studies in Psychology and received a university degree.  After graduation, Betty worked for the National Statistical and Geographic Information Systems of Mexico, and organization that compiles information about companies and their employees for the national census.  Betty was also trained and employed as an early childhood counselor in the Psychology department at the university where she earned her degree.

Betty lives in nearby Tustin.  Asked about her interests outside of work, she replied, “I love to read.  I also love music and going out with my friends to listen to music and enjoy each other’s company.

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Announcements, Information and Trivia



The World Cup is the most
widely viewed sporting
event in the world


The Affinity soccer ball
is definitely not the
official World Cup ball


Brazil hosted the World Cup
for the first time in 1950

World Cup Trivia

Copa do Mundo da FIFA – The month-long World Cup is hosted by Brazil from June 12th to July 13th, 2014.

Official Match Ball – The Adidas Brazuca if the official match ball of the 2014 FIFI World Cup.  While the ball carries the Adidas brand, it is manufactured by Forward Sports in Pakistan.

New Technology – The 2014 World Cup is the first to use “goal-line technology.” The system being used for the 2014 World Cup was developed by the German company, GoalControl.  No special sensors, nets or balls are required as seven cameras are focused on each goal and can accurately detect a ball crossing the goal line.

64 Years Ago – 2014 is the second time that Brazil has hosted the World Cup and the fifth time the event has been held in South America.  Brazil hosted the 1950 World Cup, “IV Campeonato Mundial de Futebol,” 64 years ago.

31 plus 1 – Thirty one national teams have advanced through qualification rounds that began in 2011 to participate in the 2014 World Cup.  As the official host, the national team of Brazil automatically qualifies and it’s team rounds-out the 32 teams to compete.