Ref r esher / I n - Service Manual

DSUS/COD/0316/0702 5/2016 ©C odm an Neur o, a div isi on of DO I 2016. All rights reserved.

TRUFILL® n-BCA Liquid Embolic System Refresher / In-Service Manual

The purpose of this manual is to provide Codman Neuro Associates with guidelines for conducting a refresher in-service for Health Care Providers that have been previously trained to use the Codman Neuro TRUFILL® n-BCA Liquid Embolic System. This manual in no way replaces Signature product training offered by the DePuy Synthes Professional Education Dept. A refresher in-service is not a training course and does not provide a Certificate of Attendance.

Do not create Certificates for refreshers.

Questions regarding this program should be addressed to the Professional Education Manager or Marketing Product Director.

Table of Contents

1. Assembling the Codman Neuro AVM Flow Model System2. Preparing the AVM Flow Model for “glue” injection3. Tips for optimal product refresher / in-service4. Support visual aids: charts and schematics5. AVM Flow Model “System” Troubleshooting and First Aid6.7. AVM Flow Model Packing Checklist

Packing the AVM Flow Model for shipment

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Assembling the AVM Flow Model “System”

1. Remove drip tray bag and various pouches fromshipping case. Remove tray from bag. Save returnairbill, if included, and all packing materials for return.

2. Remove flow model cradle from case with parts andpumps inside. Cradle is packed upright.

3. Remove both pump blocks (with tubing) from thecradle. One pump backs-up the other pump.

4. Remove electric pump controller.

5. Set other model parts aside until needed.

6. Remove tan platen from cradle base by lifting theright side out over the platen shelf pins.

7. Clamp provides a built-in 10F pin gauge to verifyRHV bore size. RHV must be flush (see below). IfRHV is not flush on pin gauge, it’s too small. Useonly RHV’s shipped with this model for thisconnection. Smaller RHV’s are used with products.

8. Insert 10F RHV into cradle wall slot as shown; rockinto place. Position the sideport arm downward.

9. Place index finger under clamp. Hold cradle downwith your hand. Lift and rotate the clamp onto RHV.

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Assembling the AVM Flow Model “System”

10. Place pump block near LEFT wall of cradle withtubing closest to the rear. Insert short tubingthrough cradle sidewall hole.

11. Plastic reservoir sits flush against the LEFTcradle wall. Place filter in rear corner. Push shorttubing to the bottom of the filter to avoidpumping air.

12. Place the long tubing along the backside of thecradle. Connect luer fitting at the end of thistubing to RHV side port (RIGHT side of cradle).

13. Fill reservoir with pre-filtered sheep plasma tothe ridge line (~500 mL).

14. Set platen on shelf pins. Make sure the RHVopening looks like this.

15. Insert short tubing with gray elbow connectorand black flow restrictor into platen orifice abovethe plasma reservoir. Push tubing into reservoir.Elbow rests on platen.

16. Connect controller to small round socket on thepump block. Keep switches and FLOW off untilready to use.

17. Plug controller into 110V power outlet. Useoptional power strip, as needed.

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Preparing the AVM Flow Model for “Glue” Injection

1. Attach baggie to RHV (luer connection).Straighten neck so that flow is unrestricted.

2. Push gray baggie connector into gray plasticfitting. Baggie is loose but flat on the platen.

3. Open RHV; insert guiding catheter. Tip mustnot go past the RHV sidearm junction. Don’tkink guide tip by over-tightening RHV.

4. Connect a syringe (5 – 20mL) to GuidingCatheter hub. Pull back on plunger untilplasma is visible in tubing along rear of cradle.Remove syringe. The pump is now primed.

5. Connect a 6F or 7F RHV to the guidingcatheter hub. Close all RHV ports, as usual.

6. Place drip tray under catheter hubs / RHV’s.

7. Turn pump on. Power light is RED. Continuousflow is on when switch is in the bottom position(CONT.). Continuous flow volume is controlledby FLOW knob only.

(PULSE is the upper switch position; blinksgreen when on. RATE knob controls the pulseflow rate only). If green light is not on, thepump is still on but resting in the middle(neutral) switch position.

8. Test system for no fluidic leaks. Slowly turn thepump flow volume up until plasma fills thebaggie and returns to the reservoir.

9. Push pump switch to neutral.

10.Insert microcatheter tip to desired embolicinjection location. See baggie schematic. Usesteerable guidewire, as needed.

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TRUFILL n-BCA Liquid Embolic System Refresher Set-up Tips

1. Review the product IFU and In-service brochure before starting.

2. Thaw plasma in lukewarm water, if not already thawed. Warm plasma is preferred.

3. Pre-filter plasma with the large mesh filter in the supply case. Use measuring cup forease of pouring into reservoir.

4. Remove TRUFILL Tantalum Powder vial from pouch.

5. Make certain baggie lies flat on the platen. Untwist neck by rotating the RHV luerfitting before filling with plasma.

6. If TRUFILL n-BCA System mixtures are flying through the baggie to the reservoirunpolymerized, slow down the flow rate by turning FLOW knob to the left. Don’t useRATE knob.

7. If glue mixtures are still not “working”, check to make certain the black flow restrictor is stillattached at the end of the elbow tube in the reservoir. If not, replace the elbow tube with afunctional elbow tube (look in the “parts” container). Remove clogs from tube.

As a last resort, push the guiding catheter slightly past the RHV Y-junction. This will alsoslow down the flow rate by partially blocking plasma flow into the baggie. Adjust guidedepth to optimize flow for your mixture.

8. Observe plasma level in reservoir occasionally. Plasma accumulating in drip tray can bemoved back to the reservoir via the large syringe barrel in the parts container.

9. If pump aspirates air, bubbles / FOAM will appear in pump tubing and the baggie. Re-fill theplasma reservoir via opening at the left front corner of the cradle.

10. If you think you may run out of plasma before your refresher ends, dilute small batch ofremaining plasma with saline. Adjust your flow rate accordingly, if used.

11. Prepare a separate table for mixing TRUFILL n-BCA System components. Keep extrasterile gloves on the table. If gloves become contaminated with contrast, saline or blood,change BEFORE mixing components so polymerization time is not affected.

12. 1cc (non-polycarbonate) syringes used for injection of TRUFILL n-BCA System mixtures:use 1cc non-sterile syringes provided in supply case (Merit or Covidien Monoject – longbarrel). If you must use other syringes, do NOT use hard, clear plastic Merit Medallionsyringes. These are polycarbonate and cautioned against use by the IFU multiple times.Translucent B-D syringes are acceptable but only available with a luer lock in the 3ccsize and up. B-D does not offer a 1cc luer lock non-polycarbonate syringe.

13. Place 3cc, 5cc and 10cc syringes on the mixing table for use in withdrawing TRUFILLEthiodized Oil, flushing D5W (dextrose 5% in water) and withdrawing contrast for comparison.

14. Place 16 gauge needles on the table used for withdrawing TRUFILL Ethiodized Oilfrom the glass vial. The TRUFILL Ethiodized Oil vial is non-sterile. Hold the vial while

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the physician withdraws oil; practice sterile technique. Usually, a larger syringe works best, depending on how much TRUFILL Ethiodized Oil will be used in the mixture.

15. Smaller gauge needles (21g) are used to aspirate the final mixture of TRUFILLEthiodized Oil and TRUFILL n-BCA into an injection syringe from the mixing bowl. Thishelps filtrate the mixture, especially if optional TRUFILL Tantalum Powder is used.

16. Some physicians prefer to mix TRUFILL n-BCA and TRUFILL Ethiodized Oil in theinjection syringe directly, which eliminates a step and reduces the possibility of anyglassware contamination. For this technique, physicians aspirate the cyanoacrylatemonomer directly from the TRUFILL n-BCA Vial into the injection syringe followed by the desired amount of TRUFILL Ethiodized Oil. The syringe is then slowly mixed by rocking back and forth several times.

17. Place either a sterile glass vial / beaker or shot glass on the table for mixing the TRUFILL n-BCA System components. If the refresher involves the use of the facility’s glassware, wipe the container with alcohol prior to adding TRUFILL n-BCA or TRUFILL Ethiodized Oil. Soap residue may affect polymerization rates. Discard all glassware used for mixing after use.

18. A self piercing white cap comes with each vial of TRUFILL n-BCA in the productpouch or refresher supply zip-bag. Follow the IFU for syringe attachment instructions toavoid spraying.

19. Protect garments and shoes, as desired.

20. Make certain everyone wears eye protection before refresher begins. Safety glasses areprovided in the supply case. These should be worn over Rx glasses also.

TRUFILL n-BCA Liquid Embolic System Refresher Packing Tips

1. USE FLOW MODEL CHECKLIST & packing instructions to re-pack shipping cases. DoNOT co-mingle parts. Please make certain all model parts are flushed, cleaned and dry.

2. Pack all remaining supplies for return EXCEPT plasma, TRUFILL Tantalum Powder, opened D5W & opened TRUFILL Oil Vials. Retain TA locally - don’t fly with it. Plasma can be refrozen once. Discard opened TRUFILL Ethiodized Oil Vials – do not try to save any of this oil.

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0.50

Recommended Mixtures Listed volumes based on a total volume of 1.0 mL - actual total volumes may vary.

Intranidal injections without AV fistulae or high flow rates, in order to more deeply penetrate the nidus

0.75 0.25

0.67 0.33

Conditions TRUFILL Ethiodized Oil : n-BCA Ratio

(EO: n-BCA)

TRUFILL Ethiodized Oil Volume (mL)

TRUFILL n-BCA Volume (mL)

Feeding pedicle injections close to the nidus, at high flow rates where venous opacification occurs on contrast injections within 0.5 second

0.50*

3:1 (75% EO / 25% n-BCA)

2:1 (67% EO / 33% n-BCA)

1:1 (50% EO / 50% n-BCA)

1:2 (33% EO / 67% n-BCA) 0.33 0.67*

*TRUFILL Tantalum Powder may also be added to ethiodized oil toaugment radiopacity. Tantalum powder should not be used alone with n-BCA. At higher n-BCA concentrations (>50%), addition of up to 0.5g tantalum powder is advised.

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Source: Codman Neuro TRUFILL n-BCA Liquid Embolic System Directions for Use, 10/13

Warning: Polymerization time, viscosity, and injection technique are interrelated and affect the progress of embolization. The appropriate formulation of any additives is dependent upon the expert evaluation of the relationship of anatomy, hemodynamics, and the catheter system. Figure 1 illustrates the polymerization rates obtained during in vitro testing in static bovine plasma.

Warning: A 0:1 ethiodized oil to n-BCA ratio should never be used. Refer to the “Recommended Mixtures” section for recommended ratios.

TRUFILL n-BCA Liquid Embolic System: IFU Warnings

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Source: Codman Neuro TRUFILL n-BCA Liquid Embolic System Directions for Use, 10/13

0123456789

101112131415161718

5:1

Appr

oxim

ate

Pol

ymer

izat

ion

Tim

e (s

ec)

0:1 1:1 2:1 3:1 4:1

Approximate Polymerization Time(in vitro testing in static bovine plasma)

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Figure 1Ethiodized oil : n-BCA Ratio

Sources: Codman Neuro TRUFILL n-BCA Liquid Embolic System Directions for Use, 10/13; Cordis Neurovascular, Inc. R&D notebook.

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Source: Cordis Neurovascular, Inc. R&D Notebook

PROWLER® 10 Microcatheter Total length (cm) 175 155 75 Dead Space (cc) 0.34 0.32 0.23

PROWLER® 14 MicrocatheterPROWLER SELECT® LP-ES Microcatheter

Total length (cm) 175 155 75 Dead Space (cc) 0.38 0.35 0.25

PROWLER® PLUS Microcatheter PROWLER SELECT® PLUS Microcatheter

Total length (cm) 175 155 140 105 90 75 Dead Space (cc) 0.55 0.50 0.46 0.39 0.34 0.30

RAPIDTRANSIT® Microcatheter Total length (cm) 175 155 140 105 90 75 Dead Space (cc) 0.55 0.50 0.46 0.39 0.34 0.30

Codman Neuro Microcatheter Deadspace

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Source: Codman Neuro Infusion Catheter Product Line Instructions for Use

Codman Neuro AVM Flow Model Troubleshooting Guide

1. The AVM Flow Model does not function after it is plugged in.

- Verify that the source outlet OR power strip is ON by plugging in another device to test it.

- Verify Power Switch is turned ON. FlowTek controller light is RED and fan is on when powered.

- Verify Pump connector is plugged into the pump block securely.

- Switch Pump controller to either PULSE or CONT. If neither GREEN light appears, unplug power.

- If controller is hot to the touch, let it cool down and try again. Do not block air flow around the unit.

- If power outlet is functional but the Controller will not power on, call for a replacement.

NOTE – pump controller has no fuse to change

2. The AVM Flow Model leaks.

- Determine source of the leak visually, then turn the pump controller to neutral (green light off).

- If the pump or pump tubing is leaking, turn the Power completely off. Unplug the controller from the pump.Replace with the spare pump that shipped with the Flow Model.

- If the AVM model baggie is leaking at the RHV luer connection, make sure the fittings are well connected. Twist together until secure. Straighten the neck of the baggie by turning the luer.

- If the AVM model baggie is leaking at the gray elbow snap-fit connection, make sure the fittings are well connected. If the baggie is preventing a tight fit, replace baggie. Baggies should not be stretched too tightly across the platen prior to plasma introduction.

- If the AVM model baggie is leaking anywhere in a major fluidic path either due to pinhole or small rupture, “glue” the pinhole OR replace the baggie. Continuing to use it unattended may cause a mess.

3. The AVM Flow Model has no flow.

- Verify power is on and the pump controller is set to CONT. or PULSE. The green light is ON.

- If pump is on CONT. and there is still no flow, verify there is enough fluid (plasma or water) in thereservoir to circulate through the fluidic path. o If not, verify short pump tubing is all the way to the bottom of the basket filter.

o Verify short pump tubing OR elbow tube’s flow restrictor are not blocked. Clear blockage.o Refill reservoir so that short pump tubing is submersed. IF YOU SEE FOAM, REFILL!o Circulate fluid to remove residual air bubbles.

- If there is still no flow, verify that the pump was primed with the syringe aspiration technique (attach to hub of Guiding Catheter with tip at 10F RHV Y-junction and pull negative).

- Verify there are no leaks in the fluidic path. Correct them, if there are. This includes ALL RHV’s, stopcocks and end caps.

- Still no flow? Turn power off and change the pump block. Remember to prime it.

- If the pump overheats and shuts off, change the block and prime the replacement.

IMPORTANT: the pump block has no user replaceable parts, including tubing. Replace in its entirety. FIRST-AID MEASURES

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EXCERPTS from US SDS 914670, 914855, 914872 – 2013. Refer to product MSDS for additional information.

TRUFILL n-BCA Liquid Embolic Agent Inhalation Move injured person into fresh air and keep person calm under observation. Get medical attention if any discomfort continues.

Skin contact If adhesive bonds skin, flush with water and seek medical assistance. Do not attempt to force skin apart if bonded. Peel or roll the surfaces apart with the aid of a blunt edge, e.g. a spatula or a teaspoon handle; then remove adhesive from the skin with soap and water. Upon solidification cyanoacrylates produce heat, in rare cases, large drops generate enough heat to cause burns. Burns should be treated normally after the adhesive has been removed from the skin.

Eye contact If adhesive bonds eyelids, flush with water and seek medical assistance. Do not attempt to force bonded skin apart. In the event that eyelids are stuck together or bonded to the eyeball, wash thoroughly with warm water and apply a gauze patch. The eye will open without further action, typically in 1 - 4 days. There will be no residual damage. Do not try to open the eyes by manipulation.

Ingestion It is almost impossible to swallow cyanoacrylates. The adhesive solidifies and adheres in mouth. Lips may become stuck together. If lips are accidentally stuck together, apply lots of warm water to the lips and encourage maximum wetting and pressure from saliva inside the mouth. Peel or roll lips apart. Do not try to pull the lips with direct opposing action.

Most important symptoms/effects, acute and delayed Lachrymation (discharge of tears). Visual disturbances including blurred vision. May cause redness and pain.

General information Cyanoacrylate adhesive is a very fast setting and strong adhesive. It bonds human tissue including skin in seconds. Experience has shown that accidents due to cyanoacrylates are handled best by passive, non-surgical first aid.

TRUFILL Ethiodized Oil Inhalation Move to fresh air. Call a physician if symptoms develop or persist.

Skin contact Remove contaminated clothing. Wash with soap and water. Unforeseen allergic reactions may occur in some people particularly sensitive. Get medical attention if irritation develops and persists.

Eye contact Flush eyes thoroughly with water for at least 15 minutes. Get medical attention if irritation develops or persists.

Ingestion Drink 1 or 2 glasses of water. Get medical attention if any discomfort continues. Do not induce vomiting. If vomiting occurs, the head should be kept low so that stomach vomit doesn't enter the lungs.

Most important symptoms/effects, acute and delayed Irritant effects. Irritation of eyes and mucous membranes.

TRUFILL Tantalum Powder Inhalation Move to fresh air. If breathing is difficult, give oxygen and monitor closely. Get medical attention if discomfort persists.

Skin contact Contact with dust: Wash with soap and water. Get medical attention if irritation develops and persists.

Eye contact Do not rub eyes. Flush eyes thoroughly with water for at least 15 minutes. Make sure to remove any contact lenses from the eyes before rinsing. Get medical attention if irritation develops and persists.

Ingestion Immediately rinse mouth and drink plenty of water. Keep person under observation. If person becomes uncomfortable take to hospital along with these instructions. Only induce vomiting at the instruction of medical personnel. Get medical attention if any discomfort occurs.

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Most important symptoms/effects, acute and delayed Irritation of eyes and mucous membranes. Irritation of nose and throat.

All components Indication of immediate medical attention and special treatment needed Treat symptomatically.

2016TRUFILL n-BCA System in-service / refresherSupply Kit Contents (fluoro (yes or no), # physicians, # injections ea, # max)CHECK ITEM QTY

TRUFILL n-BCA Vials ("glue" tubes & piercing caps)

TRUFILL Tantalum Powder vials in DG shipping box

TRUFILL Ethiodized Oil ampules (glass vials)

Simulated AVM Models ("plastic baggies")

6F Guides STR - 20" length = 2; full length = 4 in hoops

Codman Neuro Microcatheters (P-10 & P-14)

SGW's: A-14 / A-10

Emerald wire (for use with the guiding catheters)

D5W (dextrose) 500mL bag

1cc non-polycarbonate syringes

3cc syringes - BD

5cc & 10cc syringes - BD

21g Needles

16g Needles

Glass vials

4 x 4 gauze pads

Absorbant table pads

Stopcocks for small bore RHV's

Rotating Hemostatic Valves (RHV's) - 6F and 7F for use with GC/MC

Safety Glasses

Gloves, 1 bag medium (for set-up & tear-down)

Gloves, 1 bag large (for set-up & tear-down)

500mL sheep plasma

Sharps container

D5W bowl / plastic organizer tray

Marker and vial labels for glassware

strainer for plasma

Codman Neuro AVM Flow Model & supplies in P-1560 case

Instructions Manual for refresher (incl. w/ AVM FM)

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Codman Neuro AVM / "Glue" Flow Model System Packing List Please verify that each item has been repacked in Pelican 1560 Case

Return Item QTY Packed

Cradle (bronze acrylic) 1

Platen (tan plastic) 1

Plasma reservoir container (clear plastic) 1

Reservoir filter (gold mesh / blue plastic) 1

Pump blocks with tubing attached (black) 2

10F (large bore / blue o-ring) RHV's* 2 - 3

Elbow tubes with black flow restrictors 2

Large capacity syringe (rinsed well) 1

Extension power cord, black 6ft or 8ft 1

Capped cylinder w/ 20" Guides 1

FlowTek pump controller 1

Foam block - fills packing gap in cradle 1

Drip Tray in Drip Tray Bubble Pak 1 each

Tie wrap in container to seal the case lock 1

Instruction manual w/ lab posters 1

AVM glue baggies in large zip pouch 1

* Do NOT return RHV's that have been used with plasma & glue

DO NOT ADD ANY OTHER materials to this crate. Use the supply crate.

Packed by & Date:

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1. Turn Pump Controller power OFF. Verify red light is off. Unplug from outlet.2. Disconnect Controller from the black pump block. DO NOT remove any tubes.3. Remove used “glue” baggie connected to the 10F RHV from the Flow Model

platen. Discard both. DO NOT discard the gray elbow fitting.4. Take cradle and pump block to sink. Discard sheep plasma. Wash cradle, elbow

tube, platen, reservoir & filter with disinfectant liquid soap - NO ALCOHOL. Rinsethoroughly with warm water and dry completely before packing.

5. Flush pump tubing with water to remove all sheep plasma from the lines.DO NOT SUBMERSE THE PUMP BLOCK. Wipe exterior with soapy towel. Rinseby hand with warm water & paper towel. Dry surface before packing.

6. Wipe surface of Pump Controller with soft damp cloth to remove plasma.DO NOT SUBMERSE THE PUMP CONTROLLER. Dry surface carefully. Wrapcords around body as shown below. Insert into Left front shipping case foam slot.

7. Place the cradle UPRIGHT in the rear foam cut-out. Place the platen in thebottom of the cradle. Reservoir and filter go on the RIGHT. Both pumps with ALLtubing still attached lie flat in the base of the cradle as shown, side by side. MAKECERTAIN the tubing is wrapped horizontally around the two pump blocks tocreate space between the blocks and the cradle’s platen holder pins. Thelarge foam block is placed between the pumps and reservoir to hold them inplace. The large desiccator pack goes here.

8. Return operating and spare parts to the plastic container with the lid. Close andplace in the RIGHT side cut-out at the front of the case.

9. Extension cord lays flat on the LEFT ledge of the foam.10.Mid-length guides lay on the REAR ledge of the foam behind cradle.11.Return cleaned and dry drip tray to its protective bag. Place on top of the cradle.

This bagged tray holds all the equipment in place for shipment. Place baggiepouch, if included, and manual on top of this bag.

12.Case lid is padded with convoluted foam. Don’t remove this foam. Close casesecurely – double latch with no materials in o-ring seal. Tie wrap at least one lockport next to latch to prevent accidental content spills.

Packing the AVM Flow Model “System” for Transit

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