Coronary Intravascular Lithotripsy (IVL) System

Coronary Intravascular

Lithotripsy (IVL) System

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Coronary Intravascular Lithotripsy (IVL) System Instructions for Use (IFU) For use with the Shockwave Medical, Inc. IVL Generator and Connector Cable Indication for Use The Shockwave C2 Coronary IVL System is indicated for lithotripsy-enhanced, low-pressure balloon dilatation of calcified, stenotic de novo coronary arteries prior to stenting. Contents: Shockwave C2 Coronary IVL Catheter (1)

o The following balloon diameters are available: 2.5mm, 2.75mm, 3.0mm, 3.25mm, 3.5mm, 3.75mm, 4.0mm

o Folded Balloon Diameters are: 0.043" max. for 2.5mm to 2.75mm, 0.044" max for 3.0mm to 3.5mm and 0.046" max. for 3.75mm to 4.0mm

o 12mm balloon working length o 138cm catheter working length o 6F guide catheter compatible o 0.014" (0.36mm) guidewire compatible,

(Rx 190cm - 300cm) How Supplied The IVL Catheter is supplied sterile via e-beam sterilization and is intended for single use only. Do not re-sterilize as this could damage the device and lead to patient injury. Do not reuse the device as this could result in crosscontamination that could result in patient injury. Carefully inspect all packaging for damage or defects prior to use. Do not use the device if there is any sign of breach of the sterile barrier, as this could indicate loss of sterility that could result in patient injury. Do not use the device if there is damage to the package, as this could lead to device malfunction and result in patient injury. Store the IVL Catheter in a cool, dark, dry place. Storage of the device in extreme conditions may damage the device and/or affect device performance that could lead to patient injury. Device Description The IVL Catheter is a proprietary lithotripsy device delivered through the coronary arterial system of the heart to the site of an otherwise difficult to treat calcified stenosis, including calcified stenosis that are anticipated to exhibit resistance to full balloon dilation or subsequent uniform coronary stent expansion. Energizing the lithotripsy device will generate intermittent sound waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a coronary artery stenosis using low balloon pressure. The IVL Catheter comprises integrated lithotripsy emitters for the localized delivery

of intermittent sound wave therapy. The system consists of the IVL Catheter, IVL Connector Cable and IVL Generator. The Shockwave C2 IVL Catheter is available in seven (7) sizes: 2.5x12mm, 2.75x12mm, 3.0x12mm, 3.25x12mm, 3.5x12mm, 3.75x12mm, and 4.0x12mm. The Shockwave C2 IVL Catheter is compatible with a 6F guiding catheter, has a working length of 138cm, with hydrophilic coating at the distal end, and shaft depth markers at the proximal end. Refer to Figure 1 below for Shockwave C2 IVL Catheter components.

Lithotripsy Balloon Catheter Shaft Rx Port

Dual Port Hub

Connector

Figure 1: Shockwave C2 IVL Catheter The catheter shaft contains an inflation lumen, a guidewire lumen, and the lithotripsy emitters. The inflation lumen is used for inflation and deflation of the balloon with 50/50 saline/contrast medium. The guidewire lumen enables the use of a 0.014" guidewire to facilitate advancement of the catheter to and through the target stenosis. The system is designed as `Rapid Exchange' (Rx), so a length (190cm - 300cm) guidewire is indicated. The emitters are positioned along the length of the balloon working length for delivery of lithotripsy therapy. The balloon is located near the distal tip of the catheter. Two radiopaque marker bands within the balloon denote the working length of the balloon to aid in positioning of the balloon during treatment. The balloon is designed to provide an expandable segment of known length and diameter at a specific pressure. The proximal hub has two ports: one for inflation/deflation of the balloon, and one for the connection to the IVL Connector Cable. Required Devices for the Coronary IVL Procedure The IVL Catheter is to be used exclusively with the IVL Generator, IVL Connector Cable and its accessories. The IVL Connector Cable is a remote actuator which connects the IVL Generator to the IVL Catheter and is used to activate the lithotripsy therapy from the IVL Generator. Refer to the IVL Generator and IVL Connector Cable Operator's Manual for preparation, operation, warnings and precautions, and maintenance of the IVL Generator and IVL Connector Cable. Devices Required But Not Supplied By Shockwave Medical, Inc.

? 6F guide catheter ? 0.014" (0.36mm) Guide Wire (190cm - 300cm Length) ? 5"x96" (13x244 cm) minimum Sterile Sleeve

Shockwave C2 Coronary IVL Catheter Balloon Compliance Chart

Pressure

2.5x 12mm

2.75x 12mm

3.0x 12mm

3.25x 12mm

3.5x 12mm

3.75x 12mm

4.0x 12mm

ATM - KPa ? (mm)* ? (mm)* ? (mm)* ? (mm)* ? (mm)* ? (mm)* ? (mm)*

4* - 405 2.4

2.6

2.9

3.2

3.4

3.7

3.8

5 - 507 2.4

2.7

2.9

3.2

3.4

3.7

3.8

6* - 608 2.5

2.7

2.9

3.2

3.4

3.7

3.9

7 - 709 2.5

2.7

3.0

3.3

3.5

3.8

3.9

8 - 811 2.5

2.7

3.0

3.3

3.5

3.8

4.0

9 - 912 2.5

2.8

3.1

3.3

3.5

3.9

4.1

10* - 1013 2.5

2.8

3.1

3.4

3.6

3.9

4.1

Note: *? (mm) is ? 0.10 mm; 4 ATM is IVL treatment balloon pressure, 6 ATM is nominal balloon pressure and post-treatment pressure and 10 ATM is RBP (Rated Burst Pressure) of the balloon.

Shockwave C2 Coronary IVL System Sequence Chart The following pulsing sequence must be followed during treatment. Do not utilize a pulsing sequence other than those outlined in the IVL System Sequence Chart below. Insertion of any size Shockwave C2 IVL Catheter will automatically program the IVL Generator with the following treatment sequence:

Treatment Frequency

1 Pulse per 1 Second

Maximum Number of Continuous Pulses (1 cycle)

10 Pulses

Minimum Pause Time

10 Seconds

Maximum Total Pulses Per Catheter 80 Pulses (8 Cycles)

In the event the user attempts to deliver more than the maximum number of continuous pulses allowed, the IVL Generator is designed to stop automatically. To resume pulsing, wait at least the minimum pause time before resuming therapy. The therapy button must be released and pressed again to resume therapy. For more information, refer to the IVL Generator and IVL Connector Cable Operator's Manual.

The Shockwave C2 Coronary IVL Catheter will deliver a maximum of 80 pulses or 8 cycles as noted above. If this count is reached, the catheter shall not be used any further. If further therapy is needed, discard this catheter and obtain a new one. Caution: Do not exceed 80 pulses in the same treatment segment.

Contraindications for Use The Shockwave C2 Coronary IVL System is contraindicated for the following: 1. This device is not intended for stent delivery. 2. This device is not intended for use in carotid or

cerebrovascular arteries.

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Warnings 1. This device is intended for single (one) time use only.

DO NOT re-sterilize and/or reuse. 2. Do not use a device past the expiration date on the

label. Use of expired product may result in patient injury. 3. Percutaneous transluminal IVL should only be

performed at hospitals with adequate emergency surgical support. 4. Inspect all product components and packaging prior to use. Do not use the device if the device or the packaging has been damaged or if sterility has been compromised. Damaged product could result in patient injury. 5. Do not use the device if the balloon protective sheath cannot be removed easily prior to use. If excessive force is used the catheter could be damaged. Damaged product could result in patient injury. 6. For preparation, operation, warnings and precautions, and maintenance of the IVL Generator and its accessories refer to the IVL Generator Operator's Manual. 7. IVL Connector Cable is non-sterile and must be enclosed in a sterile sleeve prior to and during use. 8. Use only an appropriately sized balloon for the vessel to be treated. 9. Inflate the balloon according to the balloon compliance chart. Balloon pressure should not exceed the rated burst pressure (RBP). 10. Perform all device manipulations under adequate fluoroscopic guidance. 11. Do not advance or retract the catheter unless the balloon is fully deflated under vacuum. If resistance is met during manipulation, determine the cause of the resistance before proceeding. 12. Do not use, or attempt to straighten, a catheter if the shaft has become bent or kinked. Instead, prepare a new catheter. 13. Do not use excessive force or torque on the catheter as this could result in damage to the device components and result in patient injury. 14. Use only one (1) catheter of any given size. If a second catheter of the same size is necessary, DO NOT re-use the first catheter. Discard it before preparing the second catheter. 15. This device should only be used by physicians trained in angiography and intravascular coronary procedures. 16. Physicians must read and understand these instructions prior to use of the device. 17. Treat patients per standard medication or interventional procedures in the event of complications associated with the procedure or device. Precautions 1. Use only the recommended 50/50 contrast/saline balloon inflation medium. 2. During the procedure, appropriate anticoagulant therapy must be provided to the patient as needed. Anticoagulant therapy should be continued for a period of time to be determined by the physician after the procedure.

3. Inflate the balloon according to the compliance chart. DO NOT overinflate balloon as this may cause patient injury.

4. Use the IVL Generator in accordance with recommended settings as stated in the IVL Generator Operator's Manual. DO NOT deviate from recommended settings as this may cause patient injury.

5. If an inability to inflate or maintain balloon pressure occurs, remove the catheter and use a new device.

6. If the IVL Catheter appears not to deliver lithotripsy therapy, remove and replace it with another catheter.

7. Ensure that the IVL Catheter is used with a 0.014" guidewire and is inserted through a 6F guiding catheter at least 0.068" (1.72mm) ID. Failure to do so could result in inadequate device performance or patient injury.

8. Precaution should be taken when handling device after exposure to patient, e.g. contact with blood. Used product is considered biohazardous material and should be disposed of properly as per hospital protocol.

9. Precaution should be taken when treating patients with previous stenting within 5mm of target lesion.

Adverse Effects Possible adverse effects are consistent with standard catheter-based cardiac interventions and include, but are not limited to, the following: ? Abrupt vessel closure ? Access site pain ? Allergic reaction to contrast medium, anticoagulant

and/or antithrombotic therapy ? Arrhythmia ? Arteriovenous fistula ? Bleeding complications ? Cardiac tamponade or pericardial effusion ? Coronary artery occlusion, perforation, rupture

or dissection ? Coronary artery spasm ? Death ? Emboli (air, tissue, thrombus or atherosclerotic emboli) ? Emergency or non-emergency coronary artery

bypass surgery ? Emergency or non-emergency percutaneous coronary

intervention ? Entry site complications ? Fracture of the guide wire or any component of the

device that may or may not lead to device embolism, serious injury or surgical intervention ? Hematoma at the vascular access site(s) ? Hemorrhage ? Hypertension/Hypotension ? Infection/sepsis ? Myocardial Infarction ? Myocardial Ischemia or unstable angina ? Peripheral Ischemia ? Pseudoaneurysm ? Renal failure/insufficiency

? Restenosis of the treated coronary artery ? Shock/pulmonary edema ? Stroke ? Vascular complications which may require surgical repair

(conversion to open surgery) In addition, patients may be exposed to other risks associated with coronary interventional procedures, including risks from conscious sedation and local anesthetic, the radiographic contrast agents used during angiography, the drugs given to manage the subject during the procedure, and the radiation exposure from fluoroscopy. Risks identified as unique to the device and its use: ? Allergic/immunologic reaction to the catheter material(s)

or coating ? Device malfunction or failure ? Excess heat at target site ? Premature ventricular contraction Procedural Steps Caution: Refer to the IVL Generator and IVL Connector Cable Operator's Manual for preparation, operation, warnings and precautions, and maintenance of the IVL Generator and IVL Connector Cable. Preparation 1. Prepare the insertion site using standard sterile

technique. 2. Achieve preferred vascular access and place

a guidewire and guide catheter. 3. Select a lithotripsy balloon catheter size that is 1:1

based on balloon compliance chart (above) and reference vessel diameter. 4. Remove the IVL Catheter from the package. 5. Prepare the lithotripsy balloon using standard technique. Fill a 20cc syringe with 5cc of 50/50 saline/ contrast medium. Attach syringe to inflation port on catheter hub. Pull vacuum at least 3 times, releasing vacuum to allow the fluid to replace the air in the catheter. 6. Fill indeflator device with 10cc of 50/50 saline/contrast medium. Disconnect syringe and connect indeflator to inflation port of catheter hub ensuring no air is introduced to the system. 7. Remove the protective sheath and shipping mandrel from the IVL Catheter. Warning: Do not use the device if the protective sheath or shipping mandrel are difficult to remove or cannot be removed. 8. Flush the guidewire port with saline. 9. Wet the lithotripsy balloon and distal shaft with sterile saline in order to activate the hydrophilic coating. 10. Insert the IVL Connector Cable into the sterile sleeve or probe cover.

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11. Remove the cap from the proximal end and attach the IVL Catheter Connector (see Fig 1) to the IVL Connector Cable.

12. Attach the other end of the same IVL Connector Cable to the IVL Generator.

Caution: Care must be taken to avoid applying lithotripsy therapy, i.e. pressing the therapy button of the IVL Connector Cable while lithotripsy balloon is dry and/or un-inflated, as this may damage the balloon. Delivering the Shockwave C2 IVL Catheter to the Treatment Site 1. Using a guidewire and guiding catheter, position

catheter proximal of the treatment site. 2. Advance the 0.014" guidewire across the

treatment site. 3. Select a balloon catheter size that is 1:1 with the

reference vessel diameter. 4. Load the IVL Catheter over the exchange length

(190 - 300cm) 0.014" guidewire and through a guiding catheter and advance balloon to the treatment site. 5. Position the lithotripsy balloon at the treatment site using the marker bands to aid in positioning. Treating the Site with Intravascular Lithotripsy 1. Once the IVL Catheter is in place, record position using fluoroscopy. 2. If position is incorrect, adjust the lithotripsy balloon to the correct position. 3. Inflate lithotripsy balloon to 4.0 atm. 4. Deliver IVL treatment sequence per the Shockwave C2 IVL Catheter Sequence Chart by pressing the therapy button on the IVL Connector Cable.

5. Inflate lithotripsy balloon to reference size per balloon compliance chart and record lesion response on fluoroscopy.

6. Following IVL treatment, deflate lithotripsy balloon and wait 30 seconds to re-establish blood flow.

7. Repeat steps 3, 4, 5, and 6 to complete a single treatment of 20 pulses.

8. Additional treatments can be performed if deemed necessary. If multiple inflations are required due to a lesion length greater than the lithotripsy balloon length, the recommended balloon overlap is at least 2 mm to prevent geographic miss. However, care must be taken not to exceed 80 pulses maximum in the same treatment segment.

9. Perform a completion arteriogram to assess post intervention result.

10. Deflate the device and confirm that the balloon is fully deflated prior to removing the IVL Catheter.

11. Remove the IVL Catheter. If there is difficulty in removing the device through the hemostatic valve due to the lubricity, gently grasp the IVL Catheter with sterile gauze.

12. Inspect all components to ensure that the IVL Catheter is intact. If a device malfunction occurs or any defects are noted on the inspection, flush the guidewire lumen and clean the outer surface of the catheter with saline, store the IVL Catheter in a sealed plastic bag, and contact Shockwave Medical, Inc. at complaints@ for further instructions.

Note: IVL generates mechanical pulses and may cause singular ectopic impulses on the electrocardiogram. In patients with implantable pacemakers and defibrillators, these ectopic impulses may interact with the sensing capabilities. Monitoring of the electrocardiographic rhythm and continuous arterial pressure during IVL treatment is required. Caution: IVL Catheter once pulled out of the body should not be reinserted for additional inflation or lithotripsy treatments. Balloon can be damaged in the process. Patient Information Physicians should instruct patients to seek medical attention immediately for signs and symptoms of recurrent ischemic heart disease. There are no known limitations to normal daily activities. Patients should be instructed to comply with the medication regimen as prescribed by their physician. Return of Devices If any portion of the Shockwave IVL System fails prior to or during a procedure, discontinue use and contact your local representative and/or email complaints@. Patents: patents

Symbol

Definition Do not re-use Use by date Sterilized using irradiation Caution Manufacturer Do not use if package is damaged Keep dry

Authorized Representative in the European Community

Keep away from heat Batch code Catalogue number Do not resterilize

Symbol

UL

PAT IVL

Definition Non-pyrogenic Consult instructions for use Contains 1 unit (Contents: 1) Recommended Guidewire Recommended Guide Catheter Balloon Diameter Balloon Working Length Catheter Working Length (Usable Length, UL) Conformit? Europ?enne Patents. Refer to patents Intravascular Lithotripsy

Shockwave Medical, Inc. 48501 Warm Springs Blvd., Suite 108 Fremont, CA 94539, USA MedPass SAS 95 bis Boulevard Pereire 75017 Paris France

0086

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N?vod k pouzit? koron?rn?ho intravaskul?rn?ho litotriptick?ho (IVL) syst?mu K pouzit? s IVL gener?torem a propojovac?m kabelem spolecnosti Shockwave Medical, Inc. Indikace k pouzit? Koron?rn? IVL syst?m Shockwave C2 je indikov?n k n?zkotlak? bal?nkov? dilataci kalcifikovan?ch de novo stenotick?ch koron?rn?ch tepen rozs?en? o litotripsii ped implantac? stentu. Obsah: Koron?rn? IVL kat?tr Shockwave C2 (1)

o K dispozici jsou n?ze uveden? prmry bal?nk: 2,5 mm, 2,75 mm, 3,0 mm, 3,25 mm, 3,5 mm, 3,75 mm, 4,0 mm

o Prmry slozen?ch bal?nk: 0,043" (1,092 mm) max. pro 2,5 mm az 2,75 mm, 0,044" (1,118 mm) max. pro 3,0 mm az 3,5 mm a 0,046" (1,168 mm) max. pro 3,75 mm az 4,0 mm

o Pracovn? d?lka bal?nku 12 mm o Pracovn? d?lka kat?tru 138 cm o Kompatibiln? s vodic?m kat?trem 6 F o Kompatibiln? s vodic?m dr?tem 0,014" (0,36 mm)

(rychl? v?mna [Rx] 190 cm ? 300 cm) Stav pi dod?n? IVL kat?tr se dod?v? steriln?, je sterilizovan? elektronov?m paprskem (e-beam) a je urcen pouze k jednor?zov?mu pouzit?. Neprov?djte optovnou sterilizaci, protoze by to mohlo v?st k poskozen? prostedku a porann? pacienta. Prostedek nepouz?vejte opakovan, protoze by to mohlo v?st ke k?zov? kontaminaci, kter? by mohla zpsobit porann? pacienta. Ped pouzit?m pecliv zkontrolujte vsechny obaly, zda nejsou poskozen? nebo vadn?. Prostedek nepouz?vejte, pokud zjist?te jakoukoli zn?mku porusen? steriln? bari?ry, protoze by to mohlo znacit ztr?tu sterility, kter? by mohla v?st k porann? pacienta. Prostedek nepouz?vejte, pokud zjist?te jakoukoli zn?mku poskozen? obalu, protoze by to mohlo v?st k chybn? funkci prostedku a n?sledn k porann? pacienta. IVL kat?tr skladujte na chladn?m, tmav?m a such?m m?st. Skladov?n? v extr?mn?ch podm?nk?ch mze v?st k poskozen? prostedku a/nebo nep?zniv ovlivnit jeho funkci, coz by mohlo v?st k porann? pacienta. Popis prostedku IVL kat?tr je vlastnicky chr?nn? litotriptor zav?dn? syst?mem koron?rn?ch tepen srdce na m?sto jinak obt?zn l?citeln? kalcifikovan? sten?zy, vcetn kalcifikovan? sten?zy, u n?z se pedpokl?d?, ze bude kl?st odpor pln? bal?nkov? dilataci nebo n?sledn?mu jednotn?mu rozvinut? stentu. Zapnut?m litotriptoru se v c?lov?m m?st l?cby generuj?

perusovan? zvukov? vlny, kter? narus? v?pn?k v l?zi a umozn? n?slednou dilataci sten?zy koron?rn? arterie pomoc? n?zkotlak?ho bal?nku. IVL kat?tr je osazen integrovan?mi litotriptick?mi emitory k lokalizovan? l?cebn? aplikaci perusovan?ch zvukov?ch vln. Syst?m se skl?d? z IVL kat?tru, IVL propojovac?ho kabelu a IVL gener?toru. IVL kat?tr Shockwave C2 je k dispozici v sedmi (7) velikostech: 2,5 ? 12 mm, 2,75 ? 12 mm, 3,0 ? 12 mm, 3,25 ? 12 mm, 3,5 ? 12 mm, 3,75 ? 12 mm a 4,0 ? 12 mm. IVL kat?tr Shockwave C2 je kompatibiln? s vodic?m kat?trem 6 F, m? pracovn? d?lku 138 cm, hydrofiln? povrchovou ?pravu na dist?ln?m konci a hloubkov? znacky na tubusu na proxim?ln?m konci. Souc?sti IVL kat?tru Shockwave C2 jsou zn?zornny na obr. 1.

Litotriptick?

Port pro rychlou

bal?nek Tubus kat?tru

v?mnu

?st? se dvma porty Konektor

Obr. 1: IVL kat?tr Shockwave C2 Tubus kat?tru obsahuje plnic? lumen, lumen vodic?ho dr?tu a litotriptick? emitory. Plnic? lumen se pouz?v? k plnn? bal?nku sms? kontrastn? l?tky a fyziologick?ho roztoku (1:1) a n?sledn?mu vyprazdov?n?. Lumen vodic?ho dr?tu umozuje pouz?t vodic? dr?t o prmru 0,014" (0,36 mm) k posouv?n? kat?tru k c?lov? sten?ze a skrze ni. Tento syst?m je zkonstruov?n ,,pro rychlou v?mnu" (rapid exchange, Rx), a proto je indikov?na d?lka vodic?ho dr?tu (190 cm ? 300 cm). Emitory jsou k l?cebn? aplikaci litotripsie rozm?stny po cel? pracovn? d?lce bal?nku. Bal?nek se nach?z? pobl?z dist?ln?ho hrotu kat?tru. Dv rentgenokontrastn? znacky na bal?nku vyznacuj? jeho pracovn? d?lku a pom?haj? zajistit spr?vnou polohu bal?nku pi v?konu. Bal?nek je zkonstruov?n tak, aby pi specifikovan?m tlaku zajistil expandovan? segment o zn?m? d?lce a prmru. Proxim?ln? ?st? m? dva porty: jeden k naplnn? a vypr?zdnn? bal?nku a jeden k pipojen? IVL propojovac?ho kabelu. Prostedky potebn? k proveden? koron?rn?ho IVL v?konu IVL kat?tr se sm? pouz?vat v?hradn s IVL gener?torem a IVL propojovac?m kabelem a jeho p?slusenstv?m. IVL propojovac? kabel je d?lkov? aktiv?tor, kter? propojuje IVL gener?tor s IVL kat?trem a slouz? k aktivaci litotriptick? l?cby z IVL gener?toru. Informace o p?prav, provozu a ?drzb a varov?n? a bezpecnostn? opaten? pro IVL gener?tor a IVL propojovac? kabel naleznete v uzivatelsk? p?rucce k IVL gener?toru a IVL propojovac?mu kabelu. Potebn? prostedky nedod?van? spolecnost? Shockwave Medical, Inc.

? Vodic? kat?tr 6 F ? Vodic? dr?t 0,014" (0,36 mm)

(d?lka 190 cm ? 300 tcm) ? Steriln? n?vlek min. 5" ? 96" (13 ? 244 cm)

Tabulka plnn? bal?nku koron?rn?ho IVL kat?tru Shockwave C2

Tlak

2,5 ? 2,75 ? 3,0 ? 3,25 ? 3,5 ? 3,75 ? 4,0 ? 12 mm 12 mm 12 mm 12 mm 12 mm 12 mm 12 mm

atm?kPa ? (mm)* ? (mm)* ? (mm)* ? (mm)* ? (mm)* ? (mm)* ? (mm)*

4*?405 2,4

2,6

2,9

3,2

3,4

3,7

3,8

5?507 2,4

2,7

2,9

3,2

3,4

3,7

3,8

6*?608 2,5

2,7

2,9

3,2

3,4

3,7

3,9

7?709 2,5

2,7

3,0

3,3

3,5

3,8

3,9

8?811 2,5

2,7

3,0

3,3

3,5

3,8

4,0

9?912 2,5

2,8

3,1

3,3

3,5

3,9

4,1

10*?1 013 2,5

2,8

3,1

3,4

3,6

3,9

4,1

Pozn?mka: *? (mm) je ? 0,10 mm; 4 atm je tlak bal?nku pro IVL l?cbu, 6 atm je jmenovit? tlak bal?nku a tlak pro angioplastiku po l?cb a 10 atm je jmenovit? tlak prasknut? bal?nku.

Tabulka sekvenc? koron?rn?ho IVL syst?mu Shockwave C2 Pi l?cb je nutn? dodrzovat n?sleduj?c? pulzn? sekvenci. Nepouz?vejte pulzn? sekvence jin? nez definovan? v n?ze uveden? tabulce pulzn?ch sekvenc? IVL syst?mu. Pi vlozen? IVL kat?tru Shockwave C2 libovoln? velikosti se IVL gener?tor automaticky naprogramuje na tuto l?cebnou sekvenci:

L?cebn? frekvence

1 pulz za 1 sekundu

Maxim?ln? pocet kontinu?ln?ch pulz (1 cyklus)

Minim?ln? pozastaven?

Maxim?ln? celkov? pocet pulz na kat?tr

10 pulz 10 sekund 80 pulz (8 cykl)

Pokud se uzivatel pokus? aplikovat vts? nez maxim?ln povolen? pocet kontinu?ln?ch pulz, IVL gener?tor se automaticky zastav?. Ped dals? aplikac? pulz a pokracov?n?m v l?cb pockejte nejm?n po dobu minim?ln?ho pozastaven?. Chcete-li pokracovat v l?cb, mus?te uvolnit a znovu stisknout tlac?tko l?cby. Dals? informace viz uzivatelsk? p?rucka k IVL gener?toru a IVL propojovac?mu kabelu.

Koron?rn? IVL kat?tr Shockwave C2 aplikuje maxim?ln 80 pulz nebo 8 cykl, jak je uvedeno v?se. Po dosazen? tohoto poctu jiz kat?tr nelze d?le pouz?vat. Pokud je poteba pokracovat v l?cb, kat?tr zlikvidujte a pouzijte nov?. Pozor: Neaplikujte v?ce nez 80 pulz v jednom l?cebn?m segmentu.

Kontraindikace pouzit? Koron?rn? IVL syst?m Shockwave C2 je kontraindikov?n v n?sleduj?c?ch p?padech: 1. Tento prostedek nen? urcen k zaveden? stentu. 2. Tento prostedek nen? urcen k pouzit? v karotid?ch ani

mozkov?ch tepn?ch.

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Varov?n? 1. Tento prostedek je urcen pouze pro jednor?zov?

(jedno) pouzit?. NEPROV?DT optovnou sterilizaci ani nepouz?vat opakovan. 2. Prostedek nepouz?vejte po datu exspirace uveden?m na st?tku. Pouzit? prostedku po datu exspirace mze zpsobit porann? pacienta. 3. Perkut?nn? translumin?ln? IVL se sm? prov?dt pouze v nemocnic?ch s odpov?daj?c?m z?zem?m pro esen? nal?hav?ch situac?. 4. Ped pouzit?m zkontrolujte vsechny souc?sti v?robku i balen?. Pokud jsou prostedek nebo obal poskozen? nebo pokud byla narusena sterilita, prostedek nepouz?vejte. Poskozen? v?robek mze zpsobit zrann? pacienta. 5. Prostedek nepouz?vejte, pokud ochrann? pouzdro bal?nku nelze ped pouzit?m snadno odstranit. Kat?tr by se mohl pouzit?m nadmrn? s?ly poskodit. Poskozen? v?robek mze zpsobit zrann? pacienta. 6. Informace o p?prav, provozu a ?drzb a varov?n? a bezpecnostn? opaten? pro IVL gener?tor a jeho p?slusenstv? naleznete v uzivatelsk? p?rucce k IVL gener?toru. 7. IVL propojovac? kabel nen? steriln? a ped pouzit?m mus? b?t vlozen do steriln?ho n?vleku, ve kter?m mus? bhem pouzit? zstat. 8. Pouz?vejte pouze bal?nek, jehoz velikost vyhovuje osetovan? c?v. 9. Bal?nek naplte podle tabulky plnn? bal?nku. Tlak bal?nku nesm? pekrocit jmenovit? tlak prasknut?. 10. Veskerou manipulaci s prostedkem prov?djte pod odpov?daj?c? skiaskopickou kontrolou. 11. Neposouvejte kat?tr vped ani vzad, pokud nen? bal?nek zcela vypr?zdnn pomoc? podtlaku. Pokud pi manipulaci naraz?te na odpor, zjistte p?cinu odporu a teprve potom pokracujte. 12. Nepouz?vejte kat?tr, pokud je tubus ohnut? nebo zalomen?; nepokousejte se ho ani narovn?vat. Nam?sto toho pipravte nov? kat?tr. 13. Nevyv?jejte na kat?tr nadmrnou s?lu ani kroucen?, protoze by mohlo doj?t k poskozen? souc?st? prostedku a n?sledn k porann? pacienta. 14. Pouz?vejte pouze jeden (1) kat?tr dan? velikosti. Pokud je nutn? pouz?t druh? kat?tr stejn? velikosti, NEPOUZ?VEJTE prvn? kat?tr opakovan. Zlikvidujte ho pedt?m, nez piprav?te druh? kat?tr. 15. Tento prostedek mohou pouz?vat pouze l?kai vyskolen? v angiografii a intravaskul?rn?ch koron?rn?ch v?konech. 16. L?kai si mus? ped pouzit?m tohoto prostedku prostudovat tento n?vod. 17. V p?pad komplikac? spojen?ch s v?konem nebo prostedkem osetete pacienty standardn?mi farmakologick?mi nebo intervencn?mi postupy. Bezpecnostn? opaten? 1. K plnn? bal?nku pouz?vejte pouze doporucenou sms kontrastn? l?tky a fyziologick?ho roztoku (1:1).

2. Bhem v?konu mus? b?t pacientovi podle poteby poskytov?na vhodn? antikoagulacn? l?cba. V antikoagulacn? l?cb je teba pokracovat i po v?konu po dobu stanovenou l?kaem.

3. Bal?nek naplte podle tabulky plnn?. Bal?nek NEPEPLTE, protoze by to mohlo zpsobit porann? pacienta.

4. IVL gener?tor pouz?vejte pi dodrzen? doporucen?ch nastaven? uveden?ch v uzivatelsk? p?rucce k IVL gener?toru. NEODCHYLUJTE se od doporucen?ch nastaven?, protoze by to mohlo zpsobit porann? pacienta.

5. Pokud nelze bal?nek naplnit nebo udrzet tlak, kat?tr vyjmte a pouzijte nov? prostedek.

6. Pokud se zd?, ze IVL kat?tr neaplikuje litotriptickou l?cbu, vyjmte ho a nahrate jin?m.

7. IVL kat?tr se mus? pouz?vat s vodic?m dr?tem o prmru 0,014" (0,36 mm) a zav?dt vodic?m kat?trem 6 F o vnitn?m prmru nejm?n 0,068" (1,72 mm). Nedodrzen? tohoto pokynu by mohlo v?st k sn?zen? funkcnosti prostedku nebo k porann? pacienta.

8. Pi manipulaci s prostedkem po expozici pacientovi, nap. po kontaktu s krv?, je teba dodrzovat bezpecnostn? opaten?. Pouzit? v?robek je povazov?n za biologicky nebezpecn? materi?l a mus? b?t n?lezit zlikvidov?n v souladu s protokolem zdravotnick?ho za?zen?.

9. Bezpecnostn? opaten? je teba pijmout pi l?cb pacient, jimz byl jiz d?ve implantov?n stent ve vzd?lenosti do 5 mm od c?lov? l?ze.

Nez?douc? ?cinky Mozn? nez?douc? ?cinky jsou stejn? jako u standardn?ch katetrizacn?ch kardiologick?ch intervenc? a pat? k nim mimo jin? n?sleduj?c?: ? N?hl? uzaven? c?vy ? Bolest m?sta p?stupu ? Alergick? reakce na kontrastn? l?tku, antikoagulant

a/nebo antitrombotickou l?cbu ? Arytmie ? Arterio-ven?zn? p?stl ? Krv?civ? komplikace ? Srdecn? tampon?da nebo perikardi?ln? v?potek ? Okluze, perforace, ruptura nebo disekce

koron?rn? arterie ? Spasmus koron?rn? arterie ? Smrt ? Embolie (vzduchov?, tk?ov?, trombov? nebo

aterosklerotick? embolie) ? Nal?hav? nebo nenal?hav? bypass koron?rn? arterie ? Nal?hav? nebo nenal?hav? perkut?nn? koron?rn?

intervence ? Komplikace v m?st vstupu ? Zlomen? vodic?ho dr?tu nebo souc?sti v?robku,

kter? p?padn mze v?st k embolizaci prostedku, v?zn?mu porann? nebo chirurgick? intervenci ? Hematom m?sta (m?st) c?vn?ho p?stupu ? Krv?cen? ? Hypertenze/hypotenze

? Infekce/sepse ? Infarkt myokardu ? Myokardi?ln? ischemie nebo nestabiln? angina pectoris ? Perifern? ischemie ? Pseudoaneurysma ? Ren?ln? selh?n?/insuficience ? Resten?za l?cen? koron?rn? arterie ? Sok/plicn? ed?m ? Mozkov? p?hoda ? Vaskul?rn? komplikace, kter? mohou vyzadovat

chirurgickou n?pravu (pechod na oteven? chirurgick? z?krok) Pacienti nav?c mohou b?t vystaveni dals?m rizikm souvisej?c?m s koron?rn?mi intervencn?mi v?kony, vcetn rizik spojen?ch se sedac? pi vdom? a s lok?ln?m anestetikem, rentgenokontrastn?mi l?tkami pouz?van?mi pi angiografii, l?ky pod?van?mi pacientovi bhem v?konu a radiacn? expozic? ze skiaskopie. Rizika identifikovan? jako jedinecn? pro prostedek a jeho pouzit?: ? Alergick?/imunitn? reakce na materi?l(y) nebo povrchovou ?pravu kat?tru ? Chybn? funkce nebo selh?n? prostedku ? Nadmrn? zah?t? c?lov?ho m?sta ? Pedcasn? komorov? stahy Postup v?konu Pozor: Informace o p?prav, provozu a ?drzb a varov?n? a bezpecnostn? opaten? pro IVL gener?tor a IVL propojovac? kabel naleznete v uzivatelsk? p?rucce k IVL gener?toru a IVL propojovac?mu kabelu. P?prava 1. Standardn? steriln? technikou pipravte m?sto vstupu. 2. Zajistte preferovan? c?vn? p?stup a zavete vodic? dr?t a vodic? kat?tr. 3. Zvolte bal?nkov? kat?tr o velikosti 1:1 na z?klad tabulky plnn? bal?nku (v?se) a referencn?ho prmru c?vy. 4. Vyjmte IVL kat?tr z balen?. 5. Standardn? technikou pipravte litotriptick? bal?nek. Naplte 20 ml st?kacku 5 ml smsi fyziologick?ho roztoku a kontrastn? l?tky (1:1). Pipojte st?kacku k plnic?mu portu na ?st? kat?tru. Nejm?n 3? vytvote natazen?m podtlak; zrusen?m podtlaku se vzduch v kat?tru nahrad? tekutinou. 6. Naplte plnic? za?zen? 10 ml smsi fyziologick?ho roztoku a kontrastn? l?tky (1:1). Odpojte st?kacku a k plnic?mu portu na ?st? kat?tru pipojte plnic? za?zen?. Dbejte pitom, aby do syst?mu nepronikl vzduch. 7. Sejmte ochrann? pouzdro z IVL kat?tru a vyjmte pepravn? mandr?n z IVL kat?tru. Varov?n?: Prostedek nepouz?vejte, pokud je odstrann? ochrann?ho pouzdra nebo pepravn?ho mandr?nu obt?zn? nebo nemozn?. 8. Propl?chnte port vodic?ho dr?tu fyziologick?m roztokem.

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Strana 6 ze 48

9. Navlhcete litotriptick? bal?nek a dist?ln? tubus steriln?m fyziologick?m roztokem, aby se aktivovala hydrofiln? povrchov? ?prava.

10. Zasute IVL propojovac? kabel do steriln?ho n?vleku nebo krytu sondy.

11. Sejmte krytku z proxim?ln?ho konce a pipojte konektor IVL kat?tru (viz obr. 1) k IVL propojovac?mu kabelu.

12. Druh? konec tohoto IVL propojovac?ho kabelu pipojte k IVL gener?toru.

Pozor: Dbejte, abyste litotriptickou l?cbu neaplikovali, tj. nestiskli tlac?tko l?cby na IVL propojovac?m kabelu, kdyz je litotriptick? bal?nek such? a/nebo nenaplnn?, protoze by se t?m bal?nek mohl poskodit. Zaveden? IVL kat?tru Shockwave C2 na m?sto l?cby 1. Pomoc? vodic?ho dr?tu a vodic?ho kat?tru um?stte

kat?tr proxim?ln od m?sta l?cby. 2. Vete vodic? dr?t o prmru 0,014" (0,36 mm)

m?stem l?cby. 3. Zvolte bal?nkov? kat?tr o velikosti 1:1 vci referencn?mu

prmru c?vy. 4. Nasute IVL kat?tr na v?mnn? vodic? dr?t

(190?300 cm) o prmru 0,014" (0,36 mm), vete vodic?m kat?trem a posouvejte bal?nek na m?sto l?cby. 5. Litotriptick? bal?nek na m?st l?cby uvete do spr?vn? polohy; k oven? spr?vn? polohy slouz? znacky na bal?nku. L?cba m?sta pomoc? intravaskul?rn? litotripsie 1. Po zaveden? IVL kat?tru na m?sto zaznamenejte skiaskopicky jeho polohu.

2. Pokud je poloha nespr?vn?, pesute litotriptick? bal?nek do spr?vn? polohy.

3. Naplte litotriptick? bal?nek na 4,0 atm. 4. Stisknut?m tlac?tka l?cby na propojovac?m kabelu

aplikujte l?cebnou sekvenci IVL podle tabulky sekvence IVL kat?tru Shockwave C2. 5. Naplte bal?nek na referencn? velikost podle tabulky plnn? bal?nku a skiaskopicky zaznamenejte odezvu l?ze. 6. Po proveden? IVL l?cby litotriptick? bal?nek vypr?zdnte a pockejte 30 sekund na obnoven? toku krve. 7. Opakov?n?m krok 3, 4, 5 a 6 provete jeden l?cebn? v?kon s 20 pulzy. 8. V p?pad poteby lze prov?st dals? l?cebn? v?kony. Pokud je teba prov?st nkolik plnn? vzhledem k tomu, ze d?lka l?ze pesahuje d?lku litotriptick?ho bal?nku, doporucuje se k prevenci vynech?n? urcit? oblasti pekryv bal?nku alespo 2 mm. Dbejte vsak, abyste v jednom l?cebn?m segmentu neaplikovali v?ce nez maxim?ln? pocet 80 pulz. 9. Angiograficky zkontrolujte v?sledn? stav po intervenci. 10. Vypr?zdnte prostedek a ped vytazen?m IVL kat?tru ovte, ze je bal?nek zcela vypr?zdnn?. 11. Vyt?hnte IVL kat?tr. Pokud je obt?zn? prostedek vzhledem ke kluznosti vyt?hnout hemostatick?m ventilem, setrn IVL kat?tr uchopte steriln? g?zou. 12. Kontrolou vsech souc?st? ovte, ze nedoslo k poskozen? IVL kat?tru. Pokud dojde k poruse funkce prostedku nebo pokud pi kontrole zjist?te poskozen?, fyziologick?m roztokem propl?chnte lumen vodic?ho dr?tu a ocistte vnjs? povrch kat?tru, vlozte IVL kat?tr do plastov?ho s?cku, s?cek uzavete a vyz?dejte si od spolecnosti Shockwave Medical, Inc. na adrese complaints@ dals? pokyny.

Pozn?mka: IVL generuje mechanick? pulzy a na elektrokardiogramu mze produkovat ojedinl? ektopick? impulzy. U pacient s implantabiln?mi kardiostimul?tory a defibril?tory mohou tyto ektopick? impulzy interagovat se senzory. V prbhu IVL l?cby je nutn? elektrokardiograficky monitorovat rytmus a sledovat prbzn? arteri?ln? tlak. Pozor: IVL kat?tr vytazen? z tla pacienta se jiz nesm? znovu zav?dt k dals?mu naplnn? ci litotripsii. Mohlo by pitom doj?t k poskozen? bal?nku. Informace pro pacienty L?kai pacienty pouc?, aby v p?pad zn?mek a p?znak recidivy ischemick? choroby srdecn? okamzit vyhledali l?kaskou p?ci. Nejsou zn?ma z?dn? omezen? bzn?ch kazdodenn?ch cinnost?. Pacienty je teba poucit, aby dodrzovali l?kov? rezim stanoven? l?kaem. Vr?cen? prostedk Pokud kter?koli souc?st IVL syst?mu spolecnosti Shockwave selze ped v?konem nebo v jeho prbhu, pestate ho pouz?vat a kontaktujte m?stn?ho z?stupce a/nebo zaslete e-mail na adresu complaints@. Patenty: patents

Znacka

Definice Nepouz?vat optovn Pouz?t do data Sterilizov?no oz?en?m Pozor V?robce Nepouz?vat, jestlize je balen? poskozeno Chr?nit ped vlhkem

Zplnomocnn? z?stupce v Evropsk?m spolecenstv?

Chr?nit ped teplem K?d d?vky Katalogov? c?slo Neprov?dt optovnou sterilizaci

Znacka

UL

PAT IVL

Definice Apyrogenn? Ctte n?vod k pouzit? Obsahuje 1 jednotku (obsah balen?: 1) Doporucen? vodic? dr?t Doporucen? vodic? kat?tr Prmr bal?nku Pracovn? d?lka bal?nku Pracovn? d?lka kat?tru Conformit? Europ?enne (Evropsk? shoda) Patenty. Viz patents Intravaskul?rn? litotripsie

Shockwave Medical, Inc. 48501 Warm Springs Blvd., Suite 108 Fremont, CA 94539, USA MedPass SAS 95 bis Boulevard Pereire 75017 Pa?z Francie

0086

LBL 61361 Rev C, N?vod k pouzit? (kvten 2018)

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System til koronar intravaskul?r lithotripsi (IVL) Brugsanvisning Til brug med Shockwave Medical, Inc. IVL-generatoren og IVL-forbindelseskablet Indikation for anvendelse Shockwave C2 IVL-system til koronararterierne er indiceret til lithotripsi-forst?rket ballondilatation under lavt tryk af forkalkede, stenotiske de novo koronararterier inden stentning. Indhold: Shockwave C2 IVL-kateter til koronararterierne (1)

o F?lgende ballondiametre er tilg?ngelige: 2,5 mm, 2,75 mm, 3,0 mm, 3,25 mm, 3,5 mm, 3,75 mm, 4,0 mm

o Diametrene p? sammenfoldede balloner er: Maks. 1,092 mm (0,043 tomme) for 2,5 til 2,75 mm, maks. 1,118 mm (0,044 tomme) for 3,0 mm til 3,5 mm og maks. 1,168 (0,046 tomme) for 3,75 til 4,0 mm

o 12 mm ballonarbejdsl?ngde o 138 cm arbejdsl?ngde p? kateter o Kompatibelt med 6F guidingkateter o Kompatibelt med en 0,36 mm (0,014 tomme)

guidewire, (wire til hurtig udskiftning 190-300 cm) Levering IVL-kateteret leveres sterilt, steriliseret med e-str?lesterilisation og er kun beregnet til engangsbrug. Det m? ikke resteriliseres, da det kan beskadige enheden og medf?re patientskade. Enheden m? ikke genbruges, da der kan ske krydskontaminering, som kan medf?re patientskade. Inspic?r omhyggeligt al emballage for eventuel beskadigelse eller defekter inden brug. Brug ikke enheden, hvis det ser ud til, at den sterile barriere er brudt. Det kan v?re tegn p? manglende sterilitet, som kan medf?re patientskade. Brug ikke enheden, hvis emballagen er beskadiget. Det kan f?re til, at enheden fejlfungerer, og medf?re patientskade. Opbevar IVL-kateteret p? et k?ligt, m?rkt og t?rt sted. Opbevaring af enheden under ekstreme forhold kan beskadige enheden og/eller p?virke enhedens funktion, hvilket kan medf?re patientskade. Beskrivelse af enheden IVL-kateteret er en patentbeskyttet lithotripsi-enhed, der f?res igennem hjertets koronararteriesystem til stedet med forkalket stenose, der ellers er vanskelig at behandle, herunder forkalket stenose som forventes at vise modstand over for fuld ballondilatation eller efterf?lgende ensartet udvidelse af en koronarstent. Tilf?ring af energi til lithotripsi-enheden genererer intermitterende lydb?lger ved m?lstedet for behandlingen, hvorved kalk spr?nges inden i l?sionen og efterf?lgende dilatation af en stenose

i koronararterien med lavt ballontryk muligg?res. IVL-kateteret er udstyret med integrerede lithotripsisendere til levering af lokaliseret intermitterende lydb?lgebehandling. Systemet best?r af IVL-kateteret, IVL-forbindelseskablet og IVL-generatoren. Shockwave C2 IVL-kateteret f?s i syv (7) st?rrelser: 2,5 x 12 mm, 2,75 x 12 mm, 3,0 x 12 mm, 3,25 x 12 mm, 3,5 x 12 mm, 3,75 x 12 mm og 4,0 x 12 mm. Shockwave C2 IVL-kateteret er kompatibelt med et 6F guidingkateter, og har en arbejdsl?ngde p? 138 cm med hydrofil coating p? den distale ende og dybdemark?rer p? skaftets proksimale ende. Se Figur 1 herunder for Shockwave C2 IVLkateterdele.

Lithotripsi-ballon Kateterskaft

Rx-port

Muffe med dobbeltport Forbindelse

Figur 1: Shockwave C2 IVL-kateter Kateterskaftet indeholder et fyldningslumen, et guidewirelumen og lithotripsi-senderne. Fyldningslumenet bruges til fyldning og t?mning af ballonen med 50/50 saltvand/kontrastmiddel. Guidewirelumenet g?r det muligt at bruge en 0,36 mm (0,014 tomme) guidewire til at lette fremf?ringen af kateteret til og igennem m?lstenosen. Systemet er designet til hurtig udskiftning, (`Rapid Exchange' - Rx), s? en l?ngdeguidewire (190 cm-300 cm) er indiceret. Senderne er placeret langs l?ngden p? ballonens arbejdsl?ngde til levering af lithotripsi-behandling. Ballonen sidder n?r kateterets distale spids. To r?ntgenfaste mark?rb?nd inden i ballonen angiver ballonens arbejdsl?ngde som en hj?lp til placering af ballonen under behandlingen. Ballonen er designet til at give et ekspanderbart segment af kendt l?ngde og diameter ved et specifikt tryk. Den proksimale muffe har to porte: en til fyldning/t?mning af ballonen og en til forbindelse til IVL-forbindelseskablet. N?dvendige enheder til IVL-proceduren i koronararterierne IVL-kateteret m? udelukkende anvendes sammen med IVL-generatoren, IVL-forbindelseskablet og tilbeh?r. IVL-forbindelseskablet er en fjernstyret aktiveringsenhed, som forbinder IVL-generatoren med IVL-kateteret, og det bruges til at aktivere lithotripsi-behandlingen fra IVL-generatoren. Se brugervejledningen til IVLgeneratoren og IVL-forbindelseskablet for klarg?ring, betjening, advarsler og forholdsregler samt vedligeholdelse af IVL-generatoren og IVLforbindelseskablet. N?dvendige enheder, der ikke leveres af Shockwave Medical, Inc.

? 6F guidingkateter ? 0,36 mm (0,014 tomme) guidewire

(190 cm-300 cm i l?ngde) ? Et sterilt overtr?k p? minimum 13 x 244 cm

(5 x 96 tommer)

Shockwave C2 IVL-kateter til koronararterierne Complianceskema for ballon

Tryk

2,5 x 2,75 x 3,0 x 3,25 x 3,5 x 3,75 x 4,0 x 12 mm 12 mm 12 mm 12 mm 12 mm 12 mm 12 mm

ATM - kPa ? (mm)* ? (mm)* ? (mm)* ? (mm)* ? (mm)* ? (mm)* ? (mm)*

4* - 405 2,4

2,6

2,9

3,2

3,4

3,7

3,8

5 - 507 2,4

2,7

2,9

3,2

3,4

3,7

3,8

6* - 608 2,5

2,7

2,9

3,2

3,4

3,7

3,9

7 - 709 2,5

2,7

3,0

3,3

3,5

3,8

3,9

8 - 811 2,5

2,7

3,0

3,3

3,5

3,8

4,0

9 - 912 2,5

2,8

3,1

3,3

3,5

3,9

4,1

10* - 1013 2,5

2,8

3,1

3,4

3,6

3,9

4,1

Bem?rk: *? (mm) er ? 0,10 mm; 4 ATM er ballontrykket under IVL-behandling, 6 ATM er det nominelle ballontryk og tryk efter behandling, og 10 ATM er ballonens RBP-tryk (Rated Burst Pressure - nominelt spr?ngtryk).

Shockwave C2 IVL-system til koronararterierne Sekvensskema F?lgende impulssekvens skal f?lges under behandlingen. Brug ikke en anden impulssekvens end den, der er vist i nedenst?ende sekvensskema for IVL-systemet. Is?tning af et Shockwave C2 IVL-kateter i enhver st?rrelse vil automatisk programmere IVL-generatoren med f?lgende behandlingssekvens:

Behandlingsfrekvens Maksimalt antal kontinuerlige

impulser (1 cyklus) Minimum pausetid Maksimalt antal impulser

pr. kateter

1 impuls pr. 1 sekund

10 impulser

10 sekunder 80 impulser (8 cyklusser)

IVL-generatoren er designet til at stoppe automatisk, hvis brugeren fors?ger at give mere end det maks. tilladte antal kontinuerlige impulser. Vent mindst den minimale pausetid, inden behandlingen med impulser genoptages. Brugeren skal slippe og trykke p? behandlingsknappen igen for at genoptage behandlingen. Se brugervejledningen til IVL-generatoren og IVL-forbindelseskablet for yderligere information.

Shockwave C2 IVL-kateteret til koronararterierne vil maks. tilf?re 80 impulser eller 8 cyklusser som anf?rt ovenfor. Hvis dette antal n?s, m? kateteret ikke anvendes yderligere. Hvis det er n?dvendigt med yderligere behandling, skal det p?g?ldende kateter bortskaffes og et nyt tages i brug. Forsigtig: Overstig ikke 80 impulser i det samme behandlingssegment.

Kontraindikationer Shockwave C2 IVL-systemet til koronararterierne er kontraindiceret til f?lgende: 1.Denne enhed er ikke beregnet til anl?ggelse af

en stent. 2. Denne enhed er ikke beregnet til anvendelse

i halspuls?ren eller de cerebrovaskul?re arterier.

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