REUSABLE GENERAL PURPOSE NEEDLE GUIDE Reference Guide

TRANSDUCER

CORRESPONDING NEEDLE GUIDE

C8-5

C8-5

3, 6.5, 10cm

C9-2

C9-2

3.5, 6.5, 8.5, 12cm

CENTER LINE CROSSING DEPTH

ClearVue C5-2

ClearVue C5-2

3, 6, 8.5, 12cm

ClearVue S4-1, Ergo S4-2, S5-2/S5-1

ClearVue S4-1, Ergo S4-2, S5-2/S5-1

3, 6.5, 10cm

Ergo C5-2

C5-2

3, 6, 8.5, 12cm

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Reusable General Purpose Needle Guide

Refer to separate insert for Symbol Glossary.

NEEDLE GUIDE INTENDED USE The bracket and integrated guide provide physicians with a tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers.

COVER INTENDED USE Protective cover or sheath placed over diagnostic ultrasound transducer / probe / scanhead instruments. The cover allows use of the transducer in scanning and needle guided procedures for body surface, endocavity, and intraoperative diagnostic ultrasound, while helping to prevent transfer of microorganisms, body fluids, and particulate material to the patient and healthcare worker during reuse of the transducer (both sterile and non-sterile covers). The cover also provides a means for maintenance of a sterile field (sterile covers only). CIVCO Poly Ultrasound Transducer Covers are furnished sterile & non-sterile; single use patient / procedure, disposable.

INDICATIONS FOR USE n n n

Abdominal - Biopsy, Fine-Needle Aspiration, Regional Anesthesia Injections. Regional Anesthesia - Nerve Block, Musculoskeletal Injections. Small Parts - Biopsy, Fine-Needle Aspiration, Regional Anesthesia Injections.

PATIENT POPULATION General Purpose Guidance Systems are intended for use with appropriately sized transducer intended for use on adults of all body habitus, including small or slight frame.

INTENDED USERS General purpose guidance systems should be used by clinicians medically trained in the use and interpretation of ultrasound for interventions. There are no other unique skills or user abilities required for Bracket and Needle Guide use. This may include, but is not limited to: Anesthesiologists, Interventional Radiologists, Nephrologists, Radiologists, Sonographers and Surgeons.

PERFORMANCE CHARACTERISTICS n

n

General purpose needle guidance system provides accurate needle path with on-screen guidelines, supports wide range of gauge sizes, and incorporates quick-release feature for detachment of guide. Cover serves as a viral barrier to protect patients, users, and equipment from cross-contamination.

NOTE: For a summary of clinical benefits for this product, visit www.CIVCO.com.

CAUTION Federal (United States) law restricts this device to sale by or on the order of a physician. WARNING n Before use, you should be trained in ultrasonography. For instructions on the use of your transducer, see your system's user guide. n Review product labeling for sterile symbol. If sterile symbol appears on label, cover is sterilized using ethylene oxide. n Sterile product is intended for single-use only. n Do not use if integrity of packaging is violated. n Do not use if expiration date has passed. n Do not reuse, reprocess or resterilize single-use device. Reuse, reprocessing or resterilization may create a risk of contamination of the device, cause patient infection or cross-infection. n Needle guide is packaged non-sterile and is reusable. To avoid possible patient contamination, ensure needle guide is properly cleaned, sterilized or disinfected before each use. n Do not use if needle guide is damaged or does not fit properly. n Use only water-soluble agents or gels. Petroleum or mineral oil based materials may harm cover. n For illustration purposes only, transducer and bracket may be shown without a transducer cover. Always place a cover over transducer and bracket to protect patients and users from cross-contamination. n Ensure no air bubbles are present prior to use. Air left between cover and transducer lens may cause poor image quality.

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Reusable General Purpose Needle Guide n

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English

If the product malfunctions during use or is no longer able to achieve its intended use, stop using the product and call CIVCO. Report serious incidents related to the product to CIVCO and the competent authority in your Member State or appropriate regulatory authorities.

NOTE: Product is not made with natural rubber latex.

NEEDLE PATH VERIFICATION n

n

Before using component for first time, perform needle path verification to verify system and biopsy guide relationships, as described in system user guide. Verify needle guide angle corresponds with system software before each use.

NOTE: Use appropriate needle length to reach target area.

USING NEEDLE GUIDANCE 1. Place an appropriate amount of gel inside cover and/or on transducer face. Poor imaging may result if no gel is used. 2. Insert transducer into cover making sure to use proper sterile technique. Pull cover tightly over transducer face to remove wrinkles and air bubbles, taking care to avoid puncturing cover. 3. Secure cover with enclosed bands. 4. Inspect cover to ensure there are no holes or tears. 5. With doors open, align needle guide with locating features on transducer.

6. Close doors around transducer.

7. Tighten thumbscrew, ensure needle guide is firmly attached.

SELECTING GUIDE ANGLE 1. Loosen angle thumbscrew.

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Reusable General Purpose Needle Guide

2. Rotate guide to desired angle slot.

3. Tighten angle thumbscrew securely into position.

ACTIVATING NEEDLE GUIDE QUICK-RELEASE 1. Press quick-release tab toward transducer to activate quick-release function.

REMOVING NEEDLE GUIDE 1. After each use, remove needle guide from transducer, discarding single-use, disposable components. Remove visible contaminants from needle guide surface using a small, soft instrument brush. Keep needle guide from drying out until complete cleaning can be accomplished.

REPROCESSING WARNING n Users of this product have an obligation and responsibility to provide the highest degree of infection control to patients, co-workers and themselves. To avoid cross-contamination, follow infection control policies established by your facility. n Dispose of single-use components as infectious waste. Clean and sterilize reusable components after each use. n See your ultrasound system's user guide for reprocessing transducer between use. n This procedure for reprocessing has been validated for effectiveness and compatibility. Device could be damaged or cross-contaminated due to improper reprocessing. n Inspect needle guide for damage such as cracks or breakage. If damage is evident, discontinue use of needle guide and contact your ultrasound system support representative.

CLEANING MANUAL CLEANING ®

NOTE: Manual cleaning efficacy of this process was proven using Enzol Enzymatic Detergent. 1. Rinse needle guide under cold running potable water for one minute to remove gross soil. During rinse, brush all surfaces with soft-bristled brush while actuating moveable parts. Ensure all cracks, crevices, and hard-to-reach areas are brushed. 2. Prepare detergent solution following manufacturer's instructions for use. 3. Fully immerse needle guide in prepared detergent solution and allow to soak at least the minimum contact time listed in manufacturer's instructions for use. Brush all surfaces with soft-bristled brush while actuating moveable parts. Ensure all cracks, crevices, and hard-to-reach areas are brushed. 4. If visible soil still exists, repeat Step 3. 5. Rinse needle guide under cold running potable water for one minute. 6. Dry with clean, lint-free cloth. Visually inspect to ensure all surfaces are clean and dry. 6

Reusable General Purpose Needle Guide

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AUTOMATED CLEANING ®

NOTE: Automated cleaning efficacy of this process was proven using neodisher Mediclean forte. 1. Rinse needle guide under cold running potable water for one minute to remove gross soil. During rinse, brush all surfaces with soft-bristled brush while actuating moveable parts. Ensure all cracks, crevices, and hard-to-reach areas are brushed. 2. Prepare detergent solution following manufacturer's instructions for use. 3. Fully immerse needle guide in prepared detergent solution and allow to soak at least the minimum contact time listed in manufacturer's instructions for use. Brush all surfaces with soft-bristled brush while actuating moveable parts. Ensure all cracks, crevices, and hard-to-reach areas are brushed. 4. If visible soil still exists, repeat Step 3. 5. Place needle guide onto rack system in washer, following hospital protocol for washer load requirements. 6. Proceed with appropriate phase cycles using parameters listed below: Detergent Type and Concentration (if applicable)

Phase

Recirculation Time (Minutes)

Temperature

Pre-wash 1

02:00

Cold potable water

N/A

Wash 1

01:00

43°C potable water (set point)

Rinse 1 Dry Time

01:00 07:00

43°C potable water (set point) 90°C

neodisher Mediclean forte - 9.9ML/L N/A N/A

®

7. Remove needle guide from washer. Visually inspect to ensure all surfaces are clean and dry.

STERILIZATION AUTOCLAVE STERILIZATION NOTE: Sterilization efficacy testing was performed using worst-case parameters for time, temperature and load density. Parameters listed in the tables are the minimum required to ensure a Sterility Assurance Level -6 (SAL) of 10 or better. 1. Place the cleaned needle guide in an approved autoclave pouch. 2. Autoclave using the following parameters. Parameter

Cycle Type 1

Cycle Type 2

Cycle Type 3

Sterilizer

Pre-vacuum

Pre-vacuum

Gravity

Preconditioning Pulses Temperature (Minimum)

4 132°C

4 134°C

N/A 132°C

Exposure Time (Minimum) Drying Time (Minimum) Package Configuration

4 Minutes 30 Minutes Pouch (19 x 33cm)

3 Minutes 30 Minutes Pouch (19 x 33cm)

15 Minutes 30 Minutes Pouch (19 x 33cm)

STORAGE CONDITIONS n n

Avoid storing product in areas of temperature extremes or in direct sunlight. Store in a cool, dry place.

NOTE: Guide is validated for 5-year product life. NOTE: For questions or to order additional CIVCO products, please call +1 319-248-6757 or 1-800-445-6741 or visit www.CIVCO.com.

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Australian Sponsor Address Meditron

MPS GmbH Borngasse 20 35619 Braunfels, Germany Fax: 49 6442 32578

Building C Level 3/12-24 Talavera Rd Macquarie Park NSW 2113

DEUTSCHER SICHERHEITSVERTRETER (Produktversagen, Körperverletzung oder Todesfall)

Accumed Sagl Viale Serfontana 10 6834 Morbio Inferiore Switzerland

CIVCO Medical Instruments Co., Inc. 102 First Street South, Kalona, IA USA 52247-9589 319.248.6757, 800.445.6741 Fax: 319.248.6660, 877.329.2482 COPYRIGHT © 2023 ALL RIGHTS RESERVED. CIVCO IS A REGISTERED TRADEMARK OF CIVCO MEDICAL SOLUTIONS. ALL OTHER TRADEMARKS ARE PROPERTY OF THEIR RESPECTIVE OWNERS. PRINTED IN USA. ALL PRODUCTS MAY NOT BE LICENSED IN ACCORDANCE WITH CANADIAN LAW.

WWW.CIVCO.COM 2023-06-14 043-699L