R E P R O C E S S E D V A S C U L A R D E V I C E S

Product Description: EP cables are sterile extension cables that provide

a conduit/connection between each diagnostic or ablation catheter and the

corresponding equipment console.

Program Overview: Stryker has FDA 510(k) clearance to reprocess single-use

cables and validated cycles for reusable diagnostic and ablation cables,

including Carto® 3 cables. Stryker’s comprehensive EP cable reprocessing

program includes:

• Validated device-specific cleaning processes

• Electrical performance testing

• Additional high-voltage safety performance testing (ablation cables)

• Individual device packaging and labeling

• Ethylene oxide sterilization

• Complete device tracking and management

• Up to 60% cost savings as compared with original pricing

Sterile extension cables for use with:

Diagnostic EP Catheters

Ablation Catheters

Carto® 3 Systems

Product Summary:

EP CABLESSINGLE-USE & REUSABLE DIAGNOSTIC/ABLATION

sustainability.stryker.com • 888.888.3433

PRODUCT INFORMATION

Decontamination and Cleaning: All cables undergo a thorough

decontamination process that includes manual cleaning, brushing and

visual inspection under magnification. Stryker adheres to all cleaning

protocols provided in the original manufacturers’ instructions for use.

Performance Testing: All cables are tested for electrical performance

through end-to-end testing (continuity), lead-to-lead testing (isolation),

and high potential current leakage. All ablation cables undergo performance

testing to ensure proper functionality.

Packaging & Labeling: Each cable is individually coiled and sealed in a

mylar/Tyvek® pouch to allow for sufficient ethylene oxide exchange during

sterilization. Cables are packaged and labeled by item number for easy and

accurate identification.

Sterilization: Ethylene oxide sterilization is validated as per ANSI/AAMI/

ISO 11135 to a sterility assurance level of 10-6. Ethylene oxide residuals

do not exceed maximum allowable limits of ANSI/AAMI/ISO 10993-7.

Device Tracking: Serialized tags allow for comprehensive device history

and life cycle tracking, ensuring cables are never reprocessed beyond their

maximum number of cleared cycles.

ABLATION

CARTO 3

DIAGNOSTIC

The third-party trademarks used herein are trademarks of their respective owners.

MKT8008B

Cable Type Average Annual Usage

Average (OM) Acquisition Cost

Savings Estimate

Savings Percentage*

300Diagnostic $83 $12,450 50%

175Ablation $269 $23,537 50%

225Carto $370 $41,625 50%