AccuCARE Reference Guide

Notes

6

Multi-Purpose Workstation™ Stabilizer

English

INTENDED USE The equipment is intended to provide fixation, support and manipulation of transrectal ultrasound imaging probes during insertion and final placement.

ASSEMBLING FLOORSTAND 1.

2.

3.

4.

USING FLOORSTAND I. II. III. IV. V.

Vertical Adjustment Knob Arm locking knob Hex shaft attachment Vertical Adjustment Shaft Wheel Locking Lever

WARNING n

For illustration purposes only, device may be shown without a cover. Always place a cover over device to protect patients and users from crosscontamination.

1

English

Multi-Purpose Workstation™ Stabilizer

1. Unlock all wheel locking levers to move workstation floorstand into optimal working position. 2. When optimal working position, push wheel locking levers down to secure. 3. To adjust optimal working height for horizontal swivel joint, first loosen vertical adjustment knob then lift vertical adjustment shaft to desired height. Tighten vertical adjustment knob to secure. WARNING n

Ensure mounting system is secure.

4. Attach desired accessory to hex shaft. 5. Loosen arm locking knob to position arm. 6. Tighten arm locking knob to secure position.

2

Multi-Purpose Workstation™ Stabilizer LP (Single-Sided Mount)

English

INTENDED USE The equipment is intended to provide fixation, support and manipulation of transrectal ultrasound imaging probes during insertion and final placement.

SETTING UP ARM (SINGLE-SIDED MOUNT) 1. Loosen rail clamp levers on table mount. Slide table mount onto table rail and tighten rail clamps levers to secure. Center Y adjustment. I. II. III. IV. V. VI. VII. VIII.

Stabilizer quick connect knob Knob Y Rail clamp Table rail Rail clamp levers Stabilizer mounting plate Hex shaft attachment Arm locking knob

2. Fit dovetailed mounting plate to mating stabilizer mounting plate on table mount. Secure with stabilizer quick connect knob.

FUNCTIONAL PREUSE CHECKS PRIOR TO USE n n n

Attach table mount at a suitable clasping point on table rails to ensure it remains securely in position. Ensure stabilizer moves freely when locking knob is loosened and secures firmly when locking knob is tightened. Perform table clearance check. Before indexing the table, make sure stabilizer and table mount do not interfere.

1

Notes

18

Multi-Purpose Workstation™ Stepper

English

GE Healthcare ERB Hitachi Aloka Medical C41L47RP, EUP-U533, UST-672-5/7.5 Siemens Endo-PII Terason 8B4S, 8BP4

I. II. III. IV. V. VI. VII. VIII. IX. X. XI. XII. XIII. XIV.

BK Medical 8558, 8658, 8808, 8808e, 8818, 8848, E14CL4b

Mindray 6LB7s SonoScape BCL10-5

1

Grid Locking Levers Transducer Positioning Locator (not included on all models) Transducer Positioning Notch (not included on all models) Cradle latch Cradle Cradle Knob Scale Marker Carriage Scale Locking knob Hex Shaft Connection Carriage Knob Grid Locking Knob Adjustable Platform Cradle Extension Handle (not included on all models)

English

Multi-Purpose Workstation™ Stepper

INTENDED USE The equipment is intended to hold and manipulate ultrasound imaging probes during prostate brachytherapy, cryotherapy, transperineal template-guided biopsy, and/or fiducial marker placement procedures (including volume determination of the prostate gland), and/or the application of radionuclide source(s) into the body during brachytherapy.

SETTING UP STEPPER

I. Stabilizer II. Hex Shaft Connection III. Locking knob

1. Attach stepper to stabilizer using hex shaft connection. Secure by tightening locking knob. NOTE: Connection may be inserted into either side of stepper. 2. 3. 4. 5. 6.

Open the cradle latch. Place and orient validated transducer into the cradle. Close cradle latch and tighten knob. Loosen grid rail locking knobs and pull back on grid rail handle so grid platform is out of the way for initial transducer positioning. Center stepper using longitudinal movement knob.

I. Cradle Extension II. Cradle

7. Insert cradle extension into cradle, if required.

ADJUSTING THE STEPPER 1. 2. 3. 4.

Grasp the transducer handle and loosen locking control knob on stabilizer. Install sterile drape (See Drape instruction). Install grid (See Grid instruction). Obtain satisfactory transducer position and starting image.

WARNING n

Before using assembled equipment, verify needle position is correctly aligned with grid display on the ultrasound monitor. If needle position is not correctly aligned with display, adjust grid platform.

ADJUSTING AND SECURING GRID PLATFORM 1. Loosen Vertical Adjustment Screws with the provided hex wrench (3/32"). Align needle with the grid display on ultrasound monitor by turning the Vertical Adjustment Knob until the vertical needle position is correctly aligned with display. Tighten Vertical Adjustment Screws. 2. Loosen Horizontal Adjustment Screw with the provided hex wrench (3/32"). Align needle with the grid display on ultrasound monitor by turning the Horizontal Adjustment Knob until the horizontal needle position is correctly aligned with display. Tighten Horizontal Adjustment Screw.

2

Multi-Purpose Workstation™ Stepper

I. II. III. IV.

English

Vertical Adjustment Screws Vertical Adjustment Knob Horizontal Adjustment Screw Horizontal Adjustment Knobs

DEVICE INSPECTION 1. Stepper should hold transducer securely, allow smooth rotation and precise movement along longitudinal axis of the transducer.

FUNCTIONAL PREUSE CHECKS WARNING n

Prior to each use perform the following checks to ensure optimal stepper performance.

1. Rotate carriage knob to ensure carriage moves freely through full range of linear travel and performs stepping function. 2. Rotate cradle to ensure movement through full range of rotational travel.

3

Notes

52

Reprocessing & Maintenance

English

- Floorstand - Arm - Stepper REPROCESSING WARNING n

n n 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. Do not soak or immerse electrical components. Do not place in a mechanical washer. Do not use ethylene oxide or autoclave to sterilize.

1. Manually soak non-electrical parts of stepper with mild detergent, such as ENZOL® Enzymatic Detergent (Johnson & Johnson) following the manufacturers recommendation for use. 2. Disinfect all surfaces with common germicidal or antiseptic wipe, such as alcohol or hydrogen peroxide. 3. Wipe dry with lint-free cloth or allow to air dry prior to reassembly and use.

- Cradle Extension Handle CLEANING, DISINFECTING AND STERILIZING WARNING n

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. The recommended protocol for reprocessing the items listed above has been evaluated for effectiveness and compatibility. If choosing to use a reprocessing protocol other than those listed, a validation must first be completed to ensure effectiveness and compatibility.

CLEANING 1. Remove visible contaminants using a small, soft instrument brush. Keep from drying out until complete cleaning can be accomplished. 2. Soak for minimum of five minutes in neutral pH, low foaming enzymatic detergent, such as ENZOL® Enzymatic Detergent (Johnson & Johnson). While immersed, use instrument brush to remove trapped contaminants from surfaces and features. If visible contaminants cannot be easily removed, repeat soaking procedure for an additional five minutes. Remove from cleaning solution and remove any remaining residue with dry wipe. Follow cleaning solution manufacturer’s directions for use and recommendations for concentration.

DISINFECTING AND STERILIZING 1. Sterilize using steam (autoclave) at 132-138°C for 15 to 30 minutes. 2. High-level disinfect using CIDEX OPA® ortho-Phthalaldehyde Solution (Johnson & Johnson) or equivalent .55% ortho-phthalaldehyde-based solution. Follow manufacturer’s instructions and recommendations for concentration, time of contact and post-process procedure. 3. High-level disinfect or sterilize using CIDEX® or CIDEX® Plus Activated Dialdehyde Solution (Johnson & Johnson) or equivalent glutaraldehydebased solution. Follow manufacturer’s instructions and recommendations for concentration, time of contact and post-process procedure.

DISPOSAL WARNING n

Dispose of single-use components as infectious waste.

MAINTENANCE NOTE:

n n

Device should be stored to keep all components together and secure. If device does not function per instructions, contact CIVCO.

SHIPPING AND TRANSPORTATION NOTE: All product to be returned must be in its original packaging. Contact CIVCO for further instructions as needed.

1

Notes

20

Accessories

English

Endocavity Balloon INTENDED USE The transducer standoff device can be used to perform scanning and needle guided procedures for body surface and endocavity diagnostic ultrasound.

CAUTION Federal (United States) law restricts this device to sale by or on the order of a physician. WARNING n n

Before use, you should be trained in ultrasonography. For instructions on the use of your transducer, see your system's user guide. 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.

APPLYING BALLOON TO TRANSDUCER 1. Place an appropriate amount of gel inside endocavity balloon and/or on transducer face to aid in scan quality, application and removal of balloon. 2. Insert transducer into balloon with fill tube oriented in top-center of transducer. Pull balloon tightly over transducer face to remove wrinkles and air bubbles. 3. Visually orient balloon so lateral seams are symmetrical distance from longitudinal array. 4. Tape balloon securely making sure to attach around plastic tabs (Tape not included). 5. Fill syringe with 30cc of saline solution. Fill balloon through luer lock port holding prove tip down; fill and aspirate with 10-20cc until all air is removed. Do not over inflate balloon. 6. Deflate balloon leaving 25-30cc syringe connected.

2

1

DISPOSAL WARNING n

Dispose of single-use components as infectious waste.

1

English

Accessories

System Drape INTENDED USE Drape is to be used as an instrument cover for medical devices and helps to prevent transfer of microorganisms, body fluids and particulate material.

CAUTION Federal (United States) law restricts this device to sale by or on the order of a physician. WARNING n n

n

Before use, you should be trained in ultrasonography. For instructions on the use of your transducer, see your system's user guide. Disposable components are packaged sterile and are single-use only. Do not use if integrity of packaging is violated or if expiration date has passed. 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.

APPLYING DRAPE NOTE: To ensure sterile procedure, drape unit after transducer is accurately positioned in rectum and radiation planning is completed. Taped Drape 1. Using sterile technique, remove drape from package. 2. Unfold drape with edge markings up. Tear tab on cut side. 3. Place drape over stepper with cut side open toward patient. 4. Secure with tape strips under transducer. 5. Align paired holes in drape with holes in grid platform. 6. Securing grid to grid platform will secure drape in position.

DISPOSAL WARNING n

Dispose of single-use components as infectious waste.

2

Accessories

English

Template Grid 14GA INTENDED USE This device is intended to be used to aid in the percutaneous positioning and placement of needles or needlelike therapeutic probes.

CAUTION Federal (United States) law restricts this device to sale by or on the order of a physician. WARNING Before use, you should be trained in cryotherapy. For instructions on preparation, safe operation and care of your transducer and cryotherapy system, see your user's manual. 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

n

NOTE:

n

n n n n

Disposable components are packaged sterile and are single-use only. Do not use if integrity of packaging is violated or if expiration date has passed. Percutaneous Instrument Guide (guide) cannot be resterilized after use. Do not use guide if it appears to be damaged. Ensure guide is fully engaged and fits securely to the platform. Guide to be used with 2.4mm therapeutic probe. Only to be used with compatible CIVCO Steppers.

ASSEMBLING GRID 1. 2. 3. 4. 5.

Using sterile technique, remove guide from package. Configure guide for desired mode, one plate or two (Refer to illustrations). Disengage clip to remove plate for Mode F only (Refer to illustration I). Mount guide to platform (Refer to illustration II). Ensure guide is secured to stepper platform (Refer to illustration II). MODE D - TWO PLATES

MODE F - ONE PLATE

1 4 GA I.

1 4 GA II.

REMOVING PLATE

MOUNTING GUIDE TO PLATFORM

1 4 GA

1 4 GA

DISPOSAL WARNING n

Dispose of single-use components as infectious waste.

3

English

Accessories

Template Grid 17/18GA INTENDED USE Grid accepts and guides needles up to 1.3 mm (18 gauge) in diameter and provides coordinates as an aid to needle loading and positioning during radioactive seed implantation, cryotherapy, transperineal template-guided biopsy, and/or fiducial marker placement.

CAUTION Federal (United States) law restricts this device to sale by or on the order of a physician. WARNING n

n

n

n n n n

Before use, you should be trained in brachytherapy. For instructions on preparation, safe operation and care of your transducer and brachytherapy system, see your system's manual. Disposable components are packaged sterile and are single-use only. Do not use if integrity of packaging is violated or if expiration date has passed. 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. Do not use grid if it appears to be cracked or broken. Grid cannot be resterilized after use. Ensure graphics on ultrasound monitor match graphics on grid. Take care when inserting needles into grid to avoid breaking needle.

ASSEMBLING GRID 1. Using sterile technique, remove grid from package. 2. Select appropriate graphics on grid to match ultrasound monitor. 3. Tighten locking knobs. o o

BK Medical 8558, 8658, 8808e, 8818, 8848, E14CL4b Hitachi Aloka Medical C4IL47RP, EUP-U533

o o o o o o o o

17/18GA

17/18GA

DISPOSAL WARNING n

Acuson ER7B Best® Sonalis™ TRT TriView GE Healthcare ERB Hitachi Aloka Medical UST-672-5/7.5 Mindray 6LB7s Siemens Endo-PII Terason 8B4S, 8BP4 SonoScape BCL10-5

Dispose of single-use components as infectious waste.

4

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

SCANMEDICS Unit 6, 15-17 Gibbes St. St. Chatswood, NSW 2067 Australia

DEUTSCHER SICHERHEITSVERTRETER (Produktversagen, Körperverletzung oder Todesfall)

CIVCO Medical Instruments Co., Inc. 102 First Street South, Kalona, IA 52247-9589 319.248.6757, 800.445.6741 Fax: 319.248.6660, 877.329.2482 COPYRIGHT ©2019 ALLRIGHTS RESERVED. CIVCO IS AREGISTERED TRADEMARK OF CIVCO MEDICALSOLUTIONS. MULTI-PURPOSE WORKSTATION IS ATRADEMARK OF CIVCO MEDICALSOLUTIONS. ALLOTHER TRADEMARKS ARE PROPERTY OF THEIR RESPECTIVE OWNERS. PRINTED IN USA. ALL PRODUCTS MAY NOT BE LICENSED IN ACCORDANCE WITH CANADIAN LAW.

WWW.CIVCO.COM 043-626P