D01564D 04/04 Beta-Cath™ 3.5F System U.S. Customer Training Program

D01564D 04/04

Beta-Cath™ 3.5F System U.S. Customer Training Program

Beta-Cath™ 3.5F System U.S. Customer Training Program

D01564D 04/04

AgendaAgenda

• Introduction

• Product System Review

• Procedural Use and Application Pointers

• Hands-on Applications Workshop

• Site Training Guidelines

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IntroductionIntroduction

The 3.5F System is a modification of the existing Beta-Cath™ System platform, designed to work with a smaller Jacketed Radiation Source Train (JRST) and 3.5F Delivery Catheter.

Key Benefits•Smaller 6F Guide Catheter Compatibility

•Integral Catheter Tool Eliminates Conventional “Dummy” Run

•Single Catheter Accommodates Multiple Source Train Lengths (30 mm, 40mm, and 60mm)

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IntroductionIntroductionIntroductionIntroduction

The objective of this training program is to

familiarize the user with the unique features of the

Novoste™ Beta-Cath™ 3.5F System via Novoste

didactic, work-shop and proctored training.

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AgendaAgenda

• Introduction

• Product System Review– Jacketed Radiation Source Train (JRST)

– β-Rail™ 3.5F Delivery Catheter (standard and XL lengths)

– 3.5F Transfer Device

• Procedural Use and Application Pointers

• Hands-on Applications Workshop

• Site Training Guidelines

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Product System Review Product System Review

• Jacketed Radiation Source Train (JRST)

• β-Rail™ 3.5F Delivery Catheter

• 3.5F Transfer Device

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Jacketed Radiation Source Train Jacketed Radiation Source Train

Miniature Sealed Sources: Sealed Source diameter is 0.38 mm (0.013”).

Jacketed Radiation Source Train (JRST):Jacket eliminates potential of source separation.

Allows easy verification of the JRST position- when across the injury and in the TD, while maintaining the desired flexibility needed to navigate the coronary anatomy.

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End Marker

Coil Jacket


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JRST Spec’s:

Isotope

Half-life

Source Outer Diameter

Source Length

Source Train Active Length

Radiopaque Markers

Strontium 90

28.8 years

0.38 mm (0.013”)

2.5 mm

30 mm, 40mm, and 60 mm

One 2.5 mm radiopaque marker at each end of the JRST


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JRST Spec’s:Source Train Activity (maximum)

Source Activity Range*

Manufacturer

ISO Classification

Source Train Model Number

48 mCi (30mm JRST)

64 mCi (40mm JRST)

96 mCi (60mm JRST)

2.7- 4.0 mCi/source

AEA Technology QSA (AEAT)

C53X11

SICW.2

*Note: Source design is evaluated and registered for up to 5 mCi for licensing purposes


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JRST Manufacturing Process:

• Sr-90 wire matrix inserted into stainless steel capsule and welded closed.

• Radioactive Sources are inserted into the stainless steel coil along with two radiopaque markers (one on each end).

• Coil is permanently attached to radiopaque markers at each end.


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Product System ReviewProduct System Review

• Jacketed Radiation Source Train (JRST)• β-Rail™ 3.5F Delivery Catheter• 3.5F Transfer Device

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β-Rail™ 3.5F Delivery Catheter β-Rail™ 3.5F Delivery Catheter

The Delivery Catheter was reduced from 5F (1.67 mm) to 3.5F (1.17 mm).

This permits use of a 6 F (ID 0.067”/1.7 mm) Guide Catheter. Standard and XL lengths.

Catheter placed across lesion prior to TD attachment.

Single catheter accommodates multiple source train lengths (30mm, 40mm and 60mm).

β-Rail™ 3.5F Delivery Catheter:

Delivery Catheter Placement:

Single Catheter:

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1 cm Distal rail:

Coaxial Design:

The 1 cm radiopaque distal rail tip allows visualization of the tip on Fluoro during the procedure.

The coaxial design (versus the 3 lumen 5F design) allows down-sizing of the system and is more crush resistant than the 5F design. No need for an Arrow® Sheath.

NOTE: VBT is conducted post-PTCA, so access with a distal rail is not an issue as it might be for a distal rail used for primary PTCA.


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Guidewire

Radiopaque Tip

IC Coil

Delivery Catheter

Guidewire


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Robust Strain Relief

Depth Marker (100cm)

Guidewire Guidewire Exit PortExit Port

180 cm (standard length)

135 cm (working length)

Guidewire

267 cm (XL Length)

Integrated Integrated Communication Communication

(IC) Coil(IC) Coil

Radiopaque Radiopaque TipTip


Proprietary Connector

End of End of Working Working LengthLength

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Coaxial Design: The IC Coil and distal rail segment are radiopaque and provide a permanent reference marker for the Delivery Catheter during the procedure.


IC Coil

Radiopaque distal rail

IST inserted in JRST Lumen

60mm Marker (IST)

40mm Marker (IST)

30mm Marker (IST)

Stop Marker

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Indicator of Source Train (IST):

The β-Rail™ 3.5F Delivery Catheter incorporates a pre-loaded Indicator of Source Train (IST)- designed to ensure proper catheter placement across the interventional injury and aid in the JRST length selection.


2.5 mm Stand-off2.5 mm

Stand-off

Stop Marker (IST)

30mm Marker (IST)

40mm Marker (IST)

60mm Marker (IST)

Distal MarkerDistal

Marker IST HubIST Hub

Luer FittingLuer

Fitting

Thin flexible distal wire

Thin flexible distal wire

Stiffer pushable proximal

wire

Stiffer pushable proximal

wire

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IST Markers: Inside-to-inside radiopaque marker spacing on the IST reflects active source length

30mm JRST- 30mm IST spacing40mm JRST- 40mm IST spacing60mm JRST- 60mm IST spacing

The interventional injury should be positioned between the IST markers, with sufficient margin, to ensure adequate radiation coverage.

Once the IST is removed, the only remaining marker is the IC Coil/Tip of the Delivery Catheter.


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Active Source Train Length

Schematic layout for IST and JRST


30mm

40mm

60mm

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Fluoro Image with and without ISTFluoro Image with and without ISTβ-Rail™ 3.5F Delivery Catheter β-Rail™ 3.5F Delivery Catheter

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Distal Position Marker

Schematic layout for current IST and JRST

40mm JRST

Not to scale and shown without stainless steel coil


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Indicator of Source Train (IST) Dimensions:

Proximal Wire Segment (OD): 0.018” (0.46 mm)

Distal Wire Segment (OD): 0.006” (0.15 mm)

30mm, 40mm, and 60mm IST Markers:

OD: 0.014” (0.36 mm)

Length: 0.040” (1 mm)

Distal most IST Marker:

OD: 0.020” (0.51 mm)

Length: 0.100” (2.5 mm)


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The IST is also designed to simulate a Dummy Run during IST removal from a positioned Delivery Catheter:

• The distal marker on the IST is designed to be slightly larger than the JRST.

• Removal of the IST provides “tactile feel” of catheter lumen patency.

Simulated “Dummy Run”

with the IST:


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Catheter-Transfer Device Attachment:

Standard Length (180 cm Total Length):

XL Length (267 cm Total Length):

100 cm Depth Marker:

The 3.5F Transfer Device is brought to the patient and attached to the Delivery Catheter pre-positioned at the injury site.

The 3.5F Delivery Catheter has a total length of 180 cm (versus the5F Delivery Catheter’s 155 cm).

The 3.5F XL Delivery Catheter has a total length of 267 cm (versus the5F Delivery Catheter’s 155 cm).

A white 100 cm Depth Marker (versus a 90 cm Depth Marker) is used as a reference point during the Delivery Catheter insertion.


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• 0.014” Guidewire compatibility

• Hydraulic sending and returning of the sources

• Use of Sterile Water for Irrigation

• Packaged sterile, single use only


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Bell Luer Bell Luer

Accommodates 30mm, 40mm, or the 60mm JRST

Accommodates 30mm, 40mm, or the 60mm JRST

Sensing occurs at Proximal end of Source Chamber

Sensing occurs at Proximal end of Source Chamber

Logo Label Logo Label

3.5F Transfer Device3.5F Transfer DeviceStandard Model Exchangeable Battery Model

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3.5F Transfer Device3.5F Transfer DeviceStandard Model: 6-Month Service Cycle

Simplified Source Sensing:

3.5F Proprietary Connector (PC):

125 Uses:

Bell Luer:

Complete Visualization of the JRST:

The 3.5F Transfer Device (TD) utilizes a simple photo-reflectance sensing system (at the proximal end of the Source Chamber) that senses whether the JRST is IN or OUT.

The 3.5F PC is only compatible with the 3.5F Transfer Device.

The 3.5F battery provides for 125 uses with treatment counter.

The Bell Luer is inserted around the Syringe Luer to prevent fluid entry into the TD.

The 3.5F TD shell is light grey and is labeled: “Beta-CathTM 3.5F System”.

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3.5F Transfer Device3.5F Transfer Device

Simplified Source Sensing:

3.5F Proprietary Connector (PC):

Exchangeable Battery:

Bell Luer:

Complete Visualization of the JRST:

The 3.5F Transfer Device (TD) utilizes a simple photo-reflectance sensing system (at the proximal end of the Source Chamber) that senses whether the JRST is IN or OUT.

The 3.5F PC is only compatible with the 3.5F Transfer Device.

A 6-volt Lithium Battery powers the TD to allow for easy exchange of the power source.

The Bell Luer is inserted around the Syringe Luer to prevent fluid entry into the TD.

The 3.5F TD shell is light grey and is labeled: “Beta-CathTM 3.5F System”.

Exchangeable Battery Model: 12-Month Service Cycle

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• Pre-Procedure Surveillance

• 3.5F Delivery Catheter (Standard and XL Lengths)– Catheter Unpacking– Catheter Inspection and Preparation– Catheter Placement and JRST Selection

• IST Lumen Check and Removal

• TD Preparation

• PC to TD Attachment and Priming– DC Positioning

• JRST Delivery and Return– Troubleshooting Tips

• Delivery Catheter Withdrawal

• Optional Instructions: IST Reinsertion

Procedural Use and Application PointersProcedural Use and Application Pointers

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Pre-Procedure SurveillancePre-Procedure Surveillance

Determine which Transfer Device you are using and refer to the appropriate Instructions for Use.

• Standard (6-month Service Cycle) Model

• Exchangeable Battery (12-month Service Cycle) Model– Battery must be installed in the Transfer Device before the TD can be operational.

* Operation and treatment with both Transfer Devices is identical; the major differences between the two models is the power source

• Do not use without leak test after six months

• Remove Calibration Certificate from Shipping Container and identify Effective Use period(s)

• Inventory the Source Train within the TD

• Conduct a Radiation Survey of the Transfer Device and note results for future reference as TD baseline reading.

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• Soft pack contains sterile catheter which comes in a hoop.

• Carefully remove catheter from package, especially if hub is not fixed to the hoop.

• Assure that the hub does not hang up at the package.

Catheter UnpackingCatheter Unpacking

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• Examine the Delivery Catheter upon removal for bends or kinks or other signs of damage.

• Flush guidewire lumen with 1 ml heparinized saline.• May use blunt Flushing Cannula or syringe

• Visually confirm that the IST is seated against the internal distal catheter marker/stop.

Catheter Inspection and PreparationCatheter Inspection and Preparation

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Attach syringe filled with Sterile Water for Irrigation to the IST hub and flush the inner (RST) lumen of the Delivery Catheter (DC) with 2-3 ml while observing the tip of the Delivery Catheter for leakage.

• Hold PC and IST hub together when flushing.

• Do not use excessive pressure or force when flushing. • Lumen is small• Risk of bending or kinking of DC

• You will see fluid exit at the IST hub vent.


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• Visually confirm that the IST is seated against the internal distal marker/stop in the Delivery Catheter.

If the IST is not properly seated:

• Check that the IST hub has been fully inserted onto the Delivery Catheter PC.

• If a gap still exists between the distal marker of the IST and the internal stop of the Delivery Catheter, select another Delivery Catheter and return the original to Novoste.


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• Advance the β-Rail™ 3.5F Delivery Catheter over the .014” guidewire to the interventional injury site.

– Insert with IST in position– Do not advance over floppy portion of wire– Depth marker is at 100 cm– Catheter working length is 135 cm

Delivery Catheter AdvancementDelivery Catheter Advancement

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• The handling requirements of a “Distal Rail” catheter, such as the Novoste™ β-Rail™ 3.5F Delivery Catheter , differ from those of traditional “rapid exchange” or “monorail” designed catheters.

• Always handle the β-Rail™ 3.5F Delivery Catheter with the IST in place to avoid kinking.

• Be aware that 3.5F Delivery Catheter Standard length is 180 cm vs. 155 cm. The XL catheter length is 267cm and permits TD attachment inside or outside the sterile field.

• Once the Delivery Catheter is positioned and the IST has been removed, slight advancement and retraction of the Delivery Catheter can be done without kinking.


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• In case of crossing problems, the IST can be retracted a few centimeters to improve trackability.

• Excessive pushing to advance the catheter may increase the risk of Delivery Catheter kinking.

• Tips to avoid kinking at the guidewire exit area during advancement: – Use extra support wire– Improve alignment of the guiding catheter– Deep intubations of the guiding catheter


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• Observe tracking or kinking of the guide catheter under fluoroscopy during positioning.- Guide catheter curve and tortuous Ao-iliac bifurcation

• When using the Novoste™ β-Rail™ 3.5F Delivery Catheter, care must be exercised during insertion and removal of the system.

• Always insert and remove the DC slowly and observe under

fluoroscopy. If any resistance is felt, stop immediately and determine cause of resistance.

• The distal rail segment of the β-Rail™ 3.5F Delivery Catheter is radiopaque, to allow visualization of catheter tip position on the guidewire.


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• Observe the position of the distal rail and floppy segment of the guide wire in order to avoid getting the distal rail onto the floppy segment of the guidewire.

• Distal rail designs may cause guide wire prolapse if advanced onto the floppy segment of the guidewire.


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If prolapsing of Guidewire is seen on fluoroscopy – readvance the Delivery Catheter while retracting the Guidewire to eliminate prolapseIf prolapsing of Guidewire is seen on fluoroscopy – readvance the Delivery Catheter while retracting the Guidewire to eliminate prolapse

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Balloon and IST Marker PositionBalloon and IST Marker Position

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Catheter Placement and Treatment Position

Catheter Placement and Treatment Position

• Under fluoroscopy, carefully position the Delivery Catheter, placing the Interventional Injury Length between the distal marker of the IST and either the 30mm,40mm, or the 60mm IST marker. Ensure adequate 5 mm margins for 30mm RST; 10 mm margins for 40mm or 60mm JRST.

• Ensure that the IST hub has been fully seated onto the Delivery Catheter PC and no gap is visible under fluoroscopy.

• Transfer Device (JRST) is selected based upon Interventional Injury Length which is determined by the IST markers.

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IST Position in DCIST Position in DC

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• Once the Delivery Catheter is properly positioned with adequate margins, gently close the hemostatic valve.

• Gently withdraw the IST into the guiding catheter to approximately the aortic arch and readvance x 2.

• If resistance is felt, stop immediately and determine cause of resistance.

• If resistance is felt due to patient anatomy, remove the DC and optimize intervention and/or guiding catheter.

IST Lumen Check and RemovalIST Lumen Check and Removal

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• If resistance is believed to be due to the DC, remove the DC and replace with new catheter

• Gently withdraw IST to the end of the Delivery Catheter.

• Reinsert a few centimeters to ensure patency of proximal end of catheter, then remove entirely.

• Visually inspect the IST to ensure the delivery catheter did not kink.

• Secure Delivery Catheter to ensure that catheter position remains stable.

• Coil IST and loop ends to stabilize. Store on sterile table.

• Verify correct catheter position under fluoroscopy.

IST Lumen Check and RemovalIST Lumen Check and Removal

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• The Delivery Catheter must be handled carefully once IST support has been removed.

• Wet O-rings with Sterile Water for Irrigation before inserting the

PC into TD.

• Keep the PC end of the catheter straight while connecting to the TD and throughout the procedure!!

PC to TD Connection OrientationPC to TD Connection Orientation

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• The Delivery Catheter PC should be held only by the skirt when attaching it (the PC) to the Transfer Device.

• Holding the PC and the adjoining catheter just distal of the PC (at the strain relief), can result in an internal kink to the Delivery Catheter and an inability to transport the JRST.

• The β-Rail™ 3.5F Delivery Catheter and 3.5F Transfer Device should be connected and maintained throughout the procedure in an “in-line” orientation- to avoid any possibility of catheter kinking just distal of the PC.

• The proximal end of the DC must not be placed at an angle approaching 85-90º. (Data on file at Novoste)

PC to TD Connection OrientationPC to TD Connection Orientation

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• Ensure sufficient sterile water-filled syringe volume (14 ml).

• Open the hemostatic valve.

• Move the Fluid Control Lever to SEND.

• While observing under fluoroscopy, depress the syringe to transport the source train to the interventional injury site. All three pressure indicator lights should be illuminated during transport.

• Once sent, confirm JRST placement under fluoroscopy approximately every 15-30 seconds and obtain cine films to confirm placement.

• The first fluid pressure indicator light should be illuminated throughout radiation treatment.

Delivery of the JRSTDelivery of the JRST

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JRST in Treatment PositionJRST in Treatment Position

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Blood flow around the DCBlood flow around the DC

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• Open the hemostatic valve.

• Move the Fluid Control Lever to RETURN.

• Provide sufficient pressure to illuminate the three pressure indicator lights when returning the JRST.

• The source sensing system is located at the proximalend of the quartz chamber.

- Always visually confirm return of the JRST

• Difficulty returning sources:– Ensure hemostatic valve is open.– Send JRST a few cms in the opposite direction.– Use high pressure (3 lights) again to return JRST.

• NOTE: Withdraw the entire 3.5F System, if 15 seconds have elapsed and the JRST has not reached the treatment site or been returned to the TD.

Returning the JRSTReturning the JRST

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• Exercise care when withdrawing the Delivery Catheter through any area of increased restriction, such as a stent, guide catheter tip or hemostatic valve. Always withdraw the Delivery Catheter slowly and observe under fluoroscopy.

• Never withdraw the Delivery Catheter against resistance. If resistance is felt, stop immediately and determine the cause of resistance before proceeding.

• Distal rail designs may cause guide wire prolapse upon withdrawal. If prolapse persists and cannot be resolved, withdraw the Delivery Catheter and guidewire together as one unit.

Delivery Catheter WithdrawalDelivery Catheter Withdrawal

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Delivery Catheter tip “catch” on Guide Catheter during withdrawal:

• Observe the DC & Guidewire under fluoroscopy as it enters the Guiding catheter.

• Assess for resistance.

• If resistance is felt, readvance the DC and slowly retract the D/C again.

Delivery Catheter tip “catch” on Guide Catheter during withdrawal:

• Observe the DC & Guidewire under fluoroscopy as it enters the Guiding catheter.

• Assess for resistance.

• If resistance is felt, readvance the DC and slowly retract the D/C again.


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Guidewire “wrapping” around Delivery Catheter:

• Observe the DC and guidewire under fluoroscopy prior to withdrawal.

• If guidewire “wrapping” is suspected, withdraw the DC and guidewire as one unit.

Guidewire “wrapping” around Delivery Catheter:

• Observe the DC and guidewire under fluoroscopy prior to withdrawal.

• If guidewire “wrapping” is suspected, withdraw the DC and guidewire as one unit.


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Delivery Catheter tip “catch” on Hemostatic Valve during withdrawal:

Ensure that the hemostatic valve is completely opened and assess for any resistance.

If resistance is felt, immediately stop, re-check the hemostatic valve and assess for other causes of restriction.

Delivery Catheter tip “catch” on Hemostatic Valve during withdrawal:

Ensure that the hemostatic valve is completely opened and assess for any resistance.

If resistance is felt, immediately stop, re-check the hemostatic valve and assess for other causes of restriction.


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• Conduct standard Post-Procedural Radiation Checks.

• Dry and store the Transfer Device in the appropriate storage container.

System Removal and DisassemblySystem Removal and Disassembly

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This procedure is only used to reposition the DC- Not for additional radiation treatments

• Remove DC from patient

• Place PC Cover over PC and take to sterile table

• Put on second pair of sterile gloves

• Uncoil IST

• Hold PC with sterile gauze pad and discard PC Cover

Optional Instructions: IST ReinsertionOptional Instructions: IST Reinsertion

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• Reinsert IST into DC over non-absorbent backed sterile gauze pads.

Approximately 4 drops of displaced non-sterile water will drip from PC.

Verify that IST is firmly against the distal marker/stop of the DC (IST may not reach distal marker stop).

• Remove non-sterile gloves.

• Reinsert DC over guidewire.

• Conduct IST lumen check and removal (with a sterile gauze pad) as previously described.

Discard the Discard the non-sterilenon-sterile IST IST

Optional Instructions: IST ReinsertionOptional Instructions: IST Reinsertion

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• Introduction• Product System Review• Procedural Use and Application Pointers• Hands-on Application Workshop• Site Proctoring Guidelines

AgendaAgenda

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Hands-on experience with:

• Standard Procedure Flow

• Key Product Sensitivities– Catheter handling & mishandling

• Review of Trouble-shooting and Emergency Source Recovery Procedures

• Questions & Answers

Hands-on Applications WorkshopHands-on Applications Workshop

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• Introduction• Product System Review• Procedural Use and Application Pointers• Hands-on Application Workshop• Site Training Guidelines

AgendaAgenda

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Beta-Cath™ 3.5F System specific training is required of VBT clinicians at each site, with requisite training sign-offs.

– Each member of the VBT Team must complete a didactic review of the Beta-Cath™ 3.5F System.

– A Mock Training Procedure is required at each site which has not received basic Beta-Cath™ (5F) System training.

– Each clinician is to be proctored for their initial 3-5 Beta-Cath™ 3.5F System procedures by a qualified Novoste Representative.

– The Novoste Representative will determine clinician 3.5F proficiency and will authorize the award of a Beta-Cath™ 3.5F System Training Certificate.

Site Training GuidelinesSite Training Guidelines

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Beta-CathTM 3.5F System SummaryBeta-CathTM 3.5F System Summary

Smaller diameter source train and 3.5F catheter design provides additional clinical benefits, while building on the key advantages of the original Beta-CathTM 5F System:

• Ideal low, user-friendly maintenance Sr-90 Isotope

• Small, portable, hand-held device uniquely designed for the Cath Lab

• Minimally restrictive, passive-centered catheter design

Documents

D01564D 04/04 Beta-Cath™ 3.5F System U.S. Customer Training Program