Sterile / Single-Use Coeur Power Syringes to deliver contrast agents in high-pressure injection systems

• Made from clarified polypropylene to allow optimal detection of air bubbles
• Dual-seal plunger designed to prevent air aspiration or leakage
• Tapered luer tip for bubble removal
• Extra-long quick fill tube with “J” curve for filling syringe
• Extra-long protective cap to prevent contamination
• Syringes sized to fit a wide variety of injectors including:
• Liebel-Flarsheim Angiomat® 3000 and Angiomat® Illumena Injectors
• Medrad®, Mark II™, Mark III™, Mark IV™, Mark V™, Mark V Plus™, and CT 100 series

• Made from clarified polypropylene (or PET) to allow optimal detection of air bubbles
• Dual-seal plunger designed to prevent air aspiration or leakage
• Tapered luer tip for bubble removal
• Extra-long quick fill tube with “J” curve for filling syringe
• Extra-long protective cap to prevent contamination

Our syringes fit a wide variety of injectors including:

• Liebel-Flarsheim (CT 9000, Angiomat® 6000 CT and Angiomat Illumena™ Injectors)
• Medrad® (CT 200, MCT™ and MCT™ Plus and CT 100 series)

Coeur fluid delivery products for use in both low- and high-pressure injection systems.

• Coiled lines
• J-tubes
• Y-lines Coming Soon
• Fill spikes (Available Now!)
• High-pressure lines

Preventive Maintenance Coeur’s Preventive Maintenance program offers a number of services you will not find with other organizations. When you subscribe with Coeur’s annual PM program you receive:

• Complete visual inspection and cleaning
• Proactive replacement of specified components
• Mechanical lubrication and adjustments
• System performance and safety checks
• Complete system calibration to factory specifications

Q: How can I obtain a copy of my Filed Service Report?

A: A copy of your FSR will be left at your facility or mailed after your Coeur Service Representative performs on-site service.

Q: How do I schedule a PM?

A: Contact Customer Service at 1-877-547-2377 or use our online request form.

Q: When was my last PM?

A: Coeur typically provides PM’s annually. Please Contact Customer Service at 1-877-547-2377or use our online request form to determine when your last PM took place.

Q: When does my contract expire?

A: Please contact Customer Service at 1-877-547-2377 or use our online request form.

Q: How often should a PM be performed on our equipment?

A: Most customer accounts receive a PM annually. We will estimate the wear on your components and identify potential problems before they occur.

Q: How much does the Coeur Service Contract cost?

A: Coeur offers a number of Service Agreements to fit your specific needs. Please refer to our Service Packages section or contact Customer Service.

Q: Are Coeur Service Representatives certified?

A: With over 35 years of biomedical engineering experience and over 12 years of specialized service on Liebel-Flarsheim and Medrad contrast injectors, Coeur Service Representatives have the knowledge and certifications to keep your equipment up and running properly.

Series 1 Service – Full Service Contract

• Comprehensive Preventive Maintenance program to reduce downtime.
• No additional cost for travel, parts or repairs.
• Multi-year contracts available to further reduce your costs.
• Realistic contract pricing.
• Complete service documentation to fulfill regulatory requirements.
• To minimize impact on patient care, Preventive Maintenance can be done in the evenings or weekends with no extra cost.

Series 2 Service – PM Only Service Contract

• Comprehensive Preventive Maintenance program to reduce downtime.
• Reduced pricing for multiple injectors at location.
• Reduced hourly rate for any repairs needed during contract year.
• To minimize impact on patient care, Preventive Maintenance can be done in the evenings or weekends with no extra cost.
• Complete service documentation to fulfill regulatory requirements.

Series 3 Service – Flat-Rate Preventive Maintenance

• Lower cost on all Time and Materials Service.
• Complete service documentation to fulfill regulatory requirements.
• To minimize impact on patient care, Preventive Maintenance can be done in the evenings or weekends with no extra cost.

Coeur OEM’S engineering success is centered on three primary concepts:

• Applying a “keep it simple” approach to product development
• Utilizing appropriate technology
• Designing for manufacturability

Partnering with our customers and applying these concepts during the engineering-and-design phase of a project ultimately positions Coeur OEM to be the highest quality, lowest cost supplier.

Coeur OEM utilized Pro/Engineer and AutoCad, to provide full engineering support from concept to finished product. We routinely handle projects ranging from individual components to complex finished devices. We can be an integral part of the customer’s design team or provide turn key project management.

Coeur OEM excels at the design and manufacture of complex medical components, component sub-assemblies, and finished medical devices.

Coeur OEM provides its customers with fully integrated support including component design, material selection, mold design and build, assembly equipment, automation, and design of the final sterile package. Our engineering department manages projects using a network of “Supersuppliers” to ensure capacity of any size opportunity.

Coeur OEM offers full contract injection molding and insert molding for most thermoplastic engineering resins. We work with polycarbonate, ABS, nylons, PVC, PET and SAN, as well as filled polypropylenes and other engineering resins.

To ensure consistent molded part quality, our injection molding department is equipped with microprocessor-controlled molding machines and a “real time” process monitoring system. Key process parameters are constantly monitored and evaluated using SPC/SQC tools.

Components are kept clean through the use of localized HEPA systems, which have been shown to be more effective than conventional clean molding areas.

Coeur Extruded Tubing is committed to developing effective, timely solutions to meet and exceed our customers’ needs.

Tubing Specifications

We extrude tubing as small as .030 and up to 1.250 OD in funnel (pulse tubing), multi-lumen, co-joined, co-extruded, dual-color, ribbed, Silicone-coated, stripped, printed, angle cut, tinted, colored, radio opaque, inline printing, inline angle cut, and inline auto coiling. All of our tubing is processed through X/Y axis laser gauge systems with close loop systems to minimize operator interface while maximizing the quality of the tubing. All process data is electronically archived and available to our customers upon request.

At Coeur OEM, we remain very flexible in our approach to servicing our customers. Because we offer all the disciplines you may require with your new project, we can answer each of your various manufacturing needs. With extrusion, injection molding, complete assembly, and packaging, we provide you with the complete package.

The Coeur facility in Washington, North Carolina is the site of one of our controlled-environment manufacturing areas (CEMA), controlling 0.5 micron and larger particles for the assembly of Class I and Class II Medical devices. A wide range of secondary, post-molding services including sonic welding, pad printing, heat staking, and foil transfer printing. Solvent bonding is also offered.

Our Washington, NC location, a registered FDA facility, is ISO 9002/EN46001 certified and QSR (cGMP) compliant. In addition, the company also maintains its listing with Underwriter’s Laboratories (UL) as a manufacturer of fabricated plastic parts.

Packaging

Coeur OEM is committed to providing our customers with a multitude of customized packaging solutions. Some of our packaging materials and containers include:

• Bags and pouches
• Trays, Shrink packaging
• Form/Fill/Seal Machines
• Rigid and Flexible Packaging

Dispenser Coils

Dispenser Coils displayed We are committed to providing our guidewire and micro-catheter customers with custom designed dispenser coils that exceed their expectations. We control the components we use, extruding all of our own tubing through laser-gauged and closed-looped systems and injection molding our own clips and luers. We injection mold our clips because they provide up to 30% more holding power over an extruded clip, and they remain the same, clip after clip. Because we have spent years co-developing over 400 different dispenser coil designs with our customers, we have the expertise to help you with the design of your new coil.

Coeur, Inc. partners with leading industry experts to ensure sterility assurance and regulatory compliance. We can meet our customers’ compliance needs for AAMI\ANSI\ISO 11135 and EN550 requirements.

Coeur, Inc. guides our clients through the sterilization process:

• Identifying the cycle appropriate for specific products/materials.
• Reviewing customer products for grouping into families.
• Assisting the customer through the validation progression.
• Ensuring the product is sterilized by a process and equipment that is capable of reliably and consistently sterilizing products to a minimum sterility assurance level of 10-6.

• Defining requirements for:
• Cycle Parameters
• Test Sample Preparation
• Biological Indicator (BI) Placement
• Load Configuration
• Defining Applicable Acceptance Criteria
• Microbiological
• Residual
• Performance
• Monitoring routine sterilization processes for product release We also maintain documentation to support regulatory compliance.

Coeur OEM is registered with the FDA as a manufacturer, a contract manufacturer, and a re-packager/re-labeler of medical devices. Coeur Medical meets the current requirements of FDA’s QSR (Quality System Regulation), formerly the cGMP (Current Good Manufacturing Practices) and has a CEMA (Controlled Environment Manufacturing Area) that controls 0.5 micron and larger particles.

Coeur OEM is an ISO 9002/EN46001 Certified Assembler of Medical Devices, and our Quality System has been recommended for ISO 9002 Certification as an Injection Molder of Medical Components.

Coeur OEM provides regulatory support (including 510(k) submissions and sterilization) to the medical marketplace. Coeur Medical can also coordinate material testing for biocompatibility or physical properties.

Coeur OEM provides a full range of inspection and testing capabilities including:

• Dimensional inspection using calipers, micrometers, an optical comparator and other measuring equipment
• Custom designed and built go/no go gauges for improved inspection consistency.
• A laminar flow station that allows component and product inspection without contamination
• Custom-built test equipment that allows for functional product testing and data collection for statistical analysis, including trending and product capability
• “Real time” SPC/SQC process monitoring