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

ACUNAV ™

DIAGNOSTIC ULTRASOUND CATHETERS

Performance Verification: Material characteristics, electrical profile and

mechanical designs are identified and compared to predicate original

manufacturer devices. Torsion, deflection and tensile strength testing establish

the mechanical functionality and reliability of reprocessed AcuNav™ catheters.

Decontamination and Cleaning: Accepted AcuNav™ catheters undergo

comprehensive cleaning that incorporates prolonged soaking, cleaning and

rinsing in pH-neutral enzymatic cleansers and sanitizers that are compatible

with all device materials. Stryker restores AcuNav™ catheters by removing

bacterial endotoxins and bioburden using a final rinse process to prepare

the catheters for sterilization. Residual levels of organic materials, such as

protein, carbohydrate, hemoglobin and total organic carbon are quantified and

compared with acceptable standards. Stryker’s standards are based on

AAMI TIR30, a series of processes, materials, test methods and acceptance

criteria for cleaning medical devices.

Cleaning Validations: Stryker’s design control process incorporates

independent third-party validation of internal cleaning systems. Numerous

validation tests are performed to evaluate the catheters’ ability to withstand stress

during introduction or withdrawal, bioburden removal and biocompatibility.

During cleaning validations, Stryker utilizes FDA-recognized standards for

soiling devices to worst-case scenarios.

Visual Inspection: All reprocessed AcuNav™ catheters are thoroughly inspected

under magnification to evaluate each device component for cleanliness and

surface defects.

Uses a longitudinal side-fire imaging plane that displays anatomy and deployed devices in standard ultrasound format

Contains a 64-element phased array transducer that provides high resolution 2D imaging

Product Summary:

Comprehensive cleaning of AcuNav™ diagnostic ultrasound catheters

sustainability.stryker.com • 888.888.3433

PRODUCT INFORMATION

Acoustic Performance: During validation, reprocessed catheters were

tested in the M-mode and Doppler Mode and no significant difference was

detected between reprocessed ultrasound catheters and original

catheters. During reprocessing, testing is performed to evaluate the

transducer and acoustic signal strength.

Transducer Integrity: Within each transducer, Stryker evaluates element

sensitivity (volts p-p), Capacitance (pF), Pulse width (ns), Center frequency

(MHz), and Fractional bandwidth (%). Data are carefully interpreted and

evaluated against Stryker’s strict acceptance criteria.

Articulation Integrity: The diameter of the curve created by the tip

deflection is measured against accepted tolerance specifications.

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.

VISUAL INSPECTION

ACOUSTIC PERFORMANCE

TRANSDUCER INTEGRITY

*Savings estimates are based on average annual usage of 75 units at an original manufacturer acquisition cost of $2,500. A hospital’s true savings potential is not realized immediately; rather, savings may increase over time as reprocessing is continuously embraced by staff as a standard best practice.

**These AcuNav and SoundStar 2D part numbers offer equivalent functionality.

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

Model# French Size Device Type Length Indicator

LabelConsole

Type

08255790** 10F AcuNav™ 90 cm Acuson/ Siemens

10135936 8F AcuNav™ 90 cm Acuson/ Siemens

10135910 8F AcuNav™ 90 cmGE Vivid I

Ultrasound System

10043342** 10F AcuNav™ 90 cmGE Vivid I

Ultrasound System

SNDSTR10-2D** 10F SoundStar 2D 90 cm Acuson/

Siemens

SNDSTR10G** 10F SoundStar 2D 90 cm

GE Vivid I Ultrasound

System10F

10F

10F

8F

10F

8F

75BioSense Webster $2,500 $93,750 50%

Manufacturer Average Annual Usage

Average (OM) Acquisition Cost

Savings Estimate

Savings Percentage*

MKT20141105B