CORONARY DILATATION CATHETER INsTRuCTIONs fOR usE ENgLIsH

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CAREfuLLY READ ALL INsTRuCTIONs PRIOR TO usE. OBsERVE ALL WARNINgs AND PRECAuTIONs NOTED THROugHOuT THEsE INsTRuCTIONs. fAILuRE TO DO sO MAY REsuLT IN COMPLICATIONs.

DEVICE DESCRIPTION The scoreflex Coronary Dilatation Catheter is designed for easy guidewire exchange. Balloon diameter is 2.0, 2.5, 3.0, 3.5 and 4.0mm, and the length is 10, 15 and 20 mm. The balloon material is made of a semi-compliant nylon material with a rated burst pressure of 16 atmospheres. The proximal shaft of the catheter is composed of a female luer connector bonded to a Pebax tube jacketed on stainless steel tube. The proximal shaft joins with a smooth transition to a distal shaft composed of an outer tube of nylon with a balloon, tip tubes and pulling wire welded at the distal tip, the pulling wire is laser welded to the stainless steel tube skive. The distal outer body distal end is welded to the balloon proximal leg and the pulling wire. The pulling wire cutting section is outside of the balloon. Two radiopaque platinum/iridium marker bands are aligned with the balloon shoulders. The lumen tip section of the catheter accepts a standard 0.014 inch PTCA guidewire. The guidewire enters the catheter tip and advances coaxially out the tip Rx port, thereby allowing both coaxial guidance and rapid exchange of catheter with a single standard length guidewire. Two marked sections, 3mm in length, are located on the proximal shaft indicating the catheter position relative to the tip of either a brachial or femoral guiding catheter. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements. The catheter is lubricated with hydrophilic coating on the tip and the distal outer body surface, the tip inner lumen and the balloon are lubricated with silicone coating.

HOW SUPPLIED Contents One (1) scoreflex Coronary Dilatation catheter,

one (1) Re-wrap tool, one (1) securement clip. sterile sterilized with ethylene oxide gas. Non-pyrogenic.

Do not use if the package is open or damaged. storage store in a dry, dark, cool place. • Thisdeviceisintendedforonetimeuseonly.

DO NOT resterilize and/or reuse.

INDICATIONS for balloon dilatation of a stenotic portion of a coronary artery in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion.

CONTRAINDICATIONS The use of the scoreflex Coronary Dilatation Catheter is contraindicated in the following patient types: • Patientswithanunprotectedleftmaincoronaryartery• Patientswithcoronaryarteryspasmintheabsenceofasignificant

stenosis • ScoreFlexiscontraindicatedforhand-crimpingofstentcomponentsor

as a stent delivery system.

WARNINGS When using this type of device, the following warnings should be observed: • Toreducethepotentialforvesseldamage,theinflateddiameterofthe

balloon should approximate the diameter of the vessel just proximal and distal to the stenosis.

• PTCAinpatientswhoarenotacceptablecandidatesforcoronaryartery bypass graft surgery require careful consideration, including possible hemodynamic support during PTCA, as treatment of this patient population carries special risk.

• Whenthecatheterisexposedtothevascularsystem,itshouldbemanipulatedwhileunderhighqualityfluoroscopicobservation.Donotadvanceorretractthecatheterunlesstheballoonisfullydeflatedunder vacuum. If resistance is met during manipulation, determine the cause of the resistance before proceeding.

• Balloonpressureshouldnotexceedtheratedburstpressure(RBP)indicated on the package. The RBP is based on results of in vitro testing. use of a pressure monitoring device is recommended to prevent over pressurization.

• PTCAshouldonlybeperformedathospitalswhereemergencycoronary artery bypass graft surgery can be quickly performed in the event of a potentially injurious or life-threatening complication.

• Useonlytherecommendedballooninflationmedium.Neveruseairoranygaseousmediumtoinflatetheballoon.

• Usethecatheterpriortothe“UseBy”datespecifiedonthepackage.

PRECAUTIONS • DonotreinsertthePTCAcatheterintothecoildispenserafter

procedural use. • Priortoangioplasty,thedilatationcathetershouldbeexaminedto

verifyfunctionalityandensurethatitssizeissuitableforthespecificprocedure for which it is being used.

• Thecathetersystemshouldbeusedonlybyphysicianstrainedinthe performance of percutaneous transluminal coronary angioplasty.

• Duringtheprocedure,appropriateanticoagulantandcoronaryvasodilator therapy must be provided to the patient as needed. After the procedure, anticoagulant therapy should be continued for a period of time as determined by the physician.

• Thedesignandconstructionofthesecathetersdonotprovidetheuser with distal pressure monitoring capability.

• Donottwistthecathetershaftinexcessof180degreeswhenthetip is constrained.

• Discardalldisposibledevicesusedduringthisprocedureperlocalrequirements for medical device waste disposal.

• Donotuseoil-basedcontrastmedium,organicsolventsoralcohols;there is a possibility of catheter leak, damage or lubrication loss.

POTENTIAL COMPLICATIONS AND ADVERSE EFFECTS Potential complications and adverse effects due to the use of this product include, but are not limited to, the following: • Death• Acutemyocardialinfarction• Totalocclusionofthecoronaryartery• Coronaryvesseldissection,perforation,ruptureorinjury• Hemorrhageorhemotama• Restenosisofthedilatedvessel• Unstableangina• Arrhythmias,includingventricularfibrillation• Drugreactions,allergicreactiontocontrastmedium• Hypo/hypertension• Infection• Coronaryarteryspasm• Arteriovenousfistula• Embolism• Balloonburstduetolesioncharacteristics

MATERIALS REQUIRED • ArterialSheath• Femoralorbrachialguidingcatheterintheappropriatesizeand

configuration• Hemostaticvalve(s)• Contrastmediumdiluted1:1withnormalsaline• Sterileheparinizednormalsaline• 20ccLuer-locksyringe• Inflationdevice• Guidewirediameternottoexceed0.014";seeproductlabel• Guidewireintroducer• Guidewiretorquedevice

PREPARATION FOR USE Prior to use, examine all equipment carefully for defects. Examine the dilatation cathe ter for bends, kinks, or other damage. Do not use any defective equipment. Prepare equipment to be used following manufacturer’s instructions or standard procedure. Complete the following steps to prepare the PTCA catheter for use: 1. slide the protective sheath off the balloon. 2. Remove the protective mandrel from the catheter tip. 3. Prepareaninflationdevicewiththerecommendedcontrastmedium

according to the manufacturer’s instructions. 4. Gentlyflushtheguidewirelumenwithsterile,heparinizedsaline

solution (the solution will exit at the distal end of the balloon). 5. Evacuate air from the balloon segment using the following

procedure: 6. Filla20ccsyringeortheinflationdevicewithapproximately4ccof

the recommended contrast medium. 7. Afterattachingthesyringeorinflationdevicetotheballooninflation

lumen, orient the dilatation catheter with the distal tip and the balloon pointing in a downward vertical position.

8. Applynegativepressureandaspiratefor15seconds.Slowlyreleasethepressuretoneutral,allowingcontrasttofilltheshaftofthedilatation catheter.

9. Disconnectthesyringeorinflationdevicefromtheinflationportofthe dilatation catheter.

10.Removeallairfromthesyringeorinflationdevicebarrel.Reconnectthesyringeorinflationdevicetotheinflationportofthedilatationcatheter. Maintain negative pressure on the balloon until air no longer returns to the device.

11. slowly release the device pressure to neutral. 12.Disconnectthe20ccsyringe(ifused)andconnecttheinflation

devicetoinflationportofthedilatationcatheterwithoutintroducingair into the system.

Caution: All air must be removed from the balloon and displaced with contrast prior to inserting into the body. Otherwise complications may occur.

INSTRUCTIONS FOR USE 1. Insert a guidewire through the hemostatic valve that is on the

guiding catheter, following the manufacturer’s instructions. 2. Advance the guidewire carefully into and through the guiding

catheter. Withdraw the guidewire introducer, if used. 3. Attach a torque device to the guidewire, if desired. under

fluoroscopy,proceedwithacceptedPTCAtechniquestoadvancetheguidewire to and across the lesion.

4. Backload the distal tip of the dilatation catheter onto the guidewire ensuring that guidewire exits the notch located distal to the balloon.

Note: When backloading the catheter onto the guidewire, the catheter should be supported, ensuring that the guidewire does not wrap around the balloon.5. Advance the dilatation catheter over the guidewire until it

approaches the hemostatic valve. 6. Open the hemostatic valve. Insert the dilatation catheter while

maintaining guidewire position and tighten the hemostatic valve. Tofacilitateinsertion,theballoonmustbefullydeflatedtonegativepressure.

7. Tighten the hemostatic valve to create a seal around the dilatation catheter without inhibiting movement of the dilatation catheter. This will allow continuous recording of proximal coronary artery pressure.

Note: It is important that the hemostatic valve be closed tightly enough to prevent blood leakage around the dilatation catheter shaft, yetnotsotightthatitrestrictstheflowofcontrastintoandoutoftheballoon or restricts guidewire movement. 8. Advancethedilatationcatheteruntiltheappropriateproximal

marker aligns with the hemostatic valve hub. This indicates that the dilatation catheter tip has reached the guiding catheter tip.

9. Advance the dilatation catheter over the guidewire and into the stenosis.Continueunderfluoroscopyandusetheradiopaquemarker band(s) to position the usable (dilating) section of the balloon within the stenosis.

10.Itisrecommendedthattheballooninflationprotocolinthissectionis followed. However, at the discretion of the physician, an alternate inflationtechniquemaybeemployed:a. Begininflationat2atm(or203kPa)andholdatthispressure

for 10-20 seconds. b. Increasetheinflationpressureatarateof1atmevery

10-20 seconds until the indentation in the balloon disappears. Hold at this pressure for 10 seconds.

c. Aftertheindentationhasdisappeared,increasetheinflationpressure at a rate of 1 atm (101 kPa) every 10 seconds until the targetballoondiameterisachievedbyfluoroscopicassessment.Holdatthefinal(maximum)pressurefor20seconds.

d. Ifthecontinousballooninflationintheabovestepsresultsinpatient discomfort or sT segment changes, the physician may modifytheinflationprotocolasfollows:• Deflatetheballoonandallowtheischemiatoresolve• Resumetheinflationprotocol,startingatthehighestpressure

achievedduringthepreviousinflation.Inflatetheballoonfrom zero to the new pressure using an incremental increase in pressure.

e. Afterthetargetballoondiameterisachieved,additionalinflationsmay be performed at the discretion of the physician. Maintain negativepressureontheballoonbetweeninflations.

11. To remove the dilatation catheter, apply negative pressure using the inflationdeviceandconfirmthattheballoonisfullydeflated.

12.Withdrawthedeflateddilatationcatheterthroughthehemostaticvalve. If insertion of another catheter is desired, the guidewire may be kept in place.

13. Reseal the hemostatic valve per its instructions for use.14. The catheter may be coiled once using the securement clip provided

in the package (attached to the bottom left of the compliance card). Care should be taken not to kink or bend the shaft upon placement or removal of the securement clip. Only the proximal shaft should besecuredwiththesecurementclip;itisnotintendedforthedistalend of the catheter.

15. The balloon may be re-folded once (after expansion) using the balloon re-wrap tool provided in the package (attached to the upper right of the compliance card). Care should be taken not to damage the balloon upon placement or removal of the re-wrap tool.

EXCHANGE PROCEDURE TECHNIQUE ThePTCAcatheterhasbeenspecificallydesignedforrapid,singleoperator balloon exchanges. To perform a dilatation catheter exchange: 1. Loosen the hemostatic valve. 2. Hold the guidewire and hemostatic valve in one hand, while

grasping the balloon shaft in the other hand.

3. Maintain guidewire position in the coronary artery by holding the wire stationary, and begin pulling the dilatation catheter out of the guiding catheterwhilemonitoringthewirepositionunderfluoroscopy.

4. Withdrawthedeflateddilatationcatheteruntiltheguidewirelumenisreached.Carefullypullbacktheflexible,distalportionofthedilatationcatheter out of the rotating hemostatic valve while maintaining the guidewire’s position across the lesion.

Note: If resistance is felt, remove PTCA catheter, guidewire and guiding catheter together from the vasculature. 5. slide the distal tip of the dilatation catheter out of the hemostatic

valve, and tighten valve onto the guidewire to hold it securely in place. 6. Prepare the next dilatation catheter to be used, as previously

described in the Preparation for use section. 7. Backload another dilatation catheter onto the guidewire as previously

described under the Instructions for use section, step 4, and continue the procedure accordingly.

REFERENCES The physician should consult recent literature on current medical practice on balloon dilatation, such as that published by ACC/AHA.

DISCLAIMER OF WARRANTY AND LIMITATION OF REMEDY DescriptionsorspecificationsinOrbusNeichMedicalprintedmatter,including this publication, are meant solely to generally describe the product at the time of manufacture and do not constitute any express warranties. OrbusNeich Medical will not be responsible for any direct, incidental, or consequential damages resulting from the misuse of the product.

Manufacturer:OrbusNeich Medical, B.V.Drs. W. van Royenstraat 53871ANHoevelakenThe Netherlands

EU Authorized Representative:Quality first International LimitedSuites317-318Burford Business Centre11 Burford Road stratford, London E15 2sTunited Kingdom

©2008OrbusNeichMedicalscoreflex is a registered trademark of OrbusNeich Medical

EXPLANATION OF SYMBOLS

Description Symbol

Catalog Number REF

Lot Number LOT

Balloon Diameter

Balloon Length BALLOON

sterilized using Ethylene Oxide STERILE EO

use By

Do Not Reuse

Read Instructions Prior to use

Do Not Resterilize

Conformity to the Council Directive 93/42/EEC Concerning Medical Devices

C 0, M 0, Y O, K 100

C 0, M 0, Y 0, K 50