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Table 8. Symbols on packaging

(continued)

Symbol

Description

Consult instructions for use

CE mark of conformity with the identi

cation of the

noti

ed body authorizing use of the mark

Opening instruction

Authorized Representative in the European
Community

Manufacturer

Australian Sponsor Address

Outdated version. Do not use.

Version überholt. Nicht verwenden.

Version obsolète. Ne pas utiliser.

Versión obsoleta. No utilizar.

Versione

obsoleta. Non utilizzare.

Verouderde

versie. Niet gebruiken.

Föråldrad

version. Använd ej.

Παλιά

έκδοση

Μην

την

χρησιμοποιείτε

Versão obsoleta. Não utilize.

Forældet version. Må ikke anvendes.

Zastaralá verze. Nepoužívat.

Utdatert versjon. Skal ikke brukes.

Zastaraná verzia. Nepoužíva

Elavult verzió. Ne használja!

Wersja nieaktualna.

Nie u

ywa

Содержание RELIANCE 4-FRONT DF4-LLHH

Страница 1: ... l i z a r V e r s i o n e o b s o l e t a N o n u t i l i z z a r e V e r o u d e r d e v e r s i e N i e t g e b r u i k e n F ö r å l d r a d v e r s i o n A n v ä n d e j Π α λ ι ά έ κ δ ο σ η Μ η ν τ η ν χ ρ η σ ι μ ο π ο ι ε ί τ ε V e r s ã o o b s o l e t a N ã o u t i l i z e F o r æ l d e t v e r s i o n M å i k k e a n v e n d e s Z a s t a r a l á v e r z e N e p o u ž í v a t U t d a t...

Страница 2: ... i e t g e b r u i k e n F ö r å l d r a d v e r s i o n A n v ä n d e j Π α λ ι ά έ κ δ ο σ η Μ η ν τ η ν χ ρ η σ ι μ ο π ο ι ε ί τ ε V e r s ã o o b s o l e t a N ã o u t i l i z e F o r æ l d e t v e r s i o n M å i k k e a n v e n d e s Z a s t a r a l á v e r z e N e p o u ž í v a t U t d a t e r t v e r s j o n S k a l i k k e b r u k e s Z a s t a r a n á v e r z i a N e p o u ž í v a ť E l...

Страница 3: ...g the Lead 28 POSTIMPLANT 30 Postimplant Evaluation 30 Explantation 30 SPECIFICATIONS 31 Specifications Nominal 31 Lead Introducer 33 Symbols on Packaging 33 d a t e d v e r s i o n D o n o t u s e e r s i o n ü b e r h o l t N i c h t v e r w e n d e n V e r s i o n o b s o l è t e N e p a s u t i l i s e r V e r s i ó n o b s o l e t a N o u t i l i z a r V e r s i o n e o b s o l e t a N o n u ...

Страница 4: ... n ü b e r h o l t N i c h t v e r w e n d e n V e r s i o n o b s o l è t e N e p a s u t i l i s e r V e r s i ó n o b s o l e t a N o u t i l i z a r V e r s i o n e o b s o l e t a N o n u t i l i z z a r e V e r o u d e r d e v e r s i e N i e t g e b r u i k e n F ö r å l d r a d v e r s i o n A n v ä n d e j Π α λ ι ά έ κ δ ο σ η Μ η ν τ η ν χ ρ η σ ι μ ο π ο ι ε ί τ ε V e r s ã o o b s o l...

Страница 5: ...hich may improve pacing performance Lower and more consistent pacing thresholds may increase the pacing longevity of the pulse generator Coil electrodes the distal coil electrode and the proximal coil electrode for dual coil models serve as the anode and cathode during cardioversion defibrillation shocks The distal coil also serves as the anode for pacing and sensing GORETM expanded polytetrafluor...

Страница 6: ...parate lumens within the silicone rubber lead body A second layer of silicone covers the lead body to provide additional insulation and a uniform body diameter A layer of polyurethane covers the proximal area of the lead body to provide additional abrasion protection in the implantation pocket The suture sleeve and terminal boot molding are fabricated from molded silicone rubber Lubricious coating...

Страница 7: ...ing If not terminated in a timely fashion an induced ventricular tachyarrhythmia can result in the patient s death External source rescue shocks Do not use any component of the lead system to assist in delivery of external source rescue shocks or extensive tissue damage could occur Resuscitation availability Ensure that an external defibrillator and medical personnel skilled in CPR are present dur...

Страница 8: ...llator pulse generator that uses the metallic housing as a defibrillation electrode Use fluoroscopy to verify lead position Use fluoroscopy to verify that the lead tip is directed toward the apex when implanted Other positions may result in lead movement which could affect defibrillation efficacy Only use Connector Tool for electrical connections For DF4 LLHH or DF4 LLHO leads only use the Connect...

Страница 9: ...ontents are sterilized with ethylene oxide gas before final packaging When the pulse generator and or lead is received it is sterile provided the container is intact If the packaging is wet punctured opened or otherwise damaged return the pulse generator and or lead to Boston Scientific Storage temperature Store at 25 C 77 F Excursions are permitted between 15 C to 30 C 59 F to 86 F Transportation...

Страница 10: ... connector and or result in potential adverse consequences such as undersensing of cardiac activity or failure to deliver necessary therapy Line powered equipment Exercise extreme caution if testing leads using line powered equipment because leakage current exceeding 10 µA can induce ventricular fibrillation Ensure that any line powered equipment is within specifications Do not bend the lead near ...

Страница 11: ...is necessary to avoid inadvertent tissue trauma and accidental fixation and to release the electrode helix if tissue snagging has occurred Do not implant lead under clavicle When attempting to implant the lead via a subclavian puncture do not insert the lead under the medial one third region of the clavicle Damage or chronic dislodgment to the lead is possible if the lead is implanted in this mann...

Страница 12: ...not suture directly over lead Do not suture directly over the lead body as this may cause structural damage Use the suture sleeve to secure the lead proximal to the venous entry site to prevent lead movement Tunnel the lead Tunnel the lead from the chest area to the pulse generator implant site Never tunnel the lead from the pulse generator implant site to the chest area because this can damage th...

Страница 13: ...erve the following to minimize risk to the lead Also refer to pulse generator labeling for device programming recommendations and additional information about minimizing risk to the patient and system Avoid direct contact between the ablation catheter and the pulse generator and leads RF ablation close to the lead electrode may damage the lead tissue interface Keep the path of the electrical curre...

Страница 14: ...Conductor coil fracture Death Elevated thresholds Erosion Excessive fibrotic tissue growth Extracardiac stimulation muscle nerve stimulation Formation of hematomas or seromas Hemorrhage Hemothorax Inability to defibrillate or pace Inappropriate therapy e g shocks and antitachycardia pacing ATP where applicable pacing Incomplete lead connection with pulse generator Infection Lead dislodgment Lead f...

Страница 15: ...system prove ineffective Various factors such as disease state or drug therapy may necessitate repositioning of the defibrillation leads or substitution of one lead system for another in order to facilitate arrhythmia conversion In some cases reliable arrhythmia conversion may not be obtained with any leads at the available defibrillation or pulse generator defibrillation energy levels Bipolar pac...

Страница 16: ...nch and slide it over the lead until it is in the desired position The window feature is designed to aid compression of the sleeve onto the lead during suturing NOTE A radiopaque suture sleeve is pre loaded on the lead and is also available in a slit form as an accessory Model 6403 The accessory slit suture sleeve is intended to be used as a replacement for the pre loaded suture sleeve in the even...

Страница 17: ...the stylet funnel Rotates the terminal pin clockwise or counterclockwise to extend or retract the helix 1 Fixation knob disengaged 2 Stylet funnel 3 Rotation mark 4 Terminal boot levers 5 Indicator arrows 6 Anode spring contact 7 Cathode spring contact Figure 1 Connector Tool 13 d a t e d v e r s i o n D o n o t u s e e r s i o n ü b e r h o l t N i c h t v e r w e n d e n V e r s i o n o b s o l ...

Страница 18: ...Indicator arrows 2 Terminal boot molding 3 Terminal molding Figure 2 Lead fully inserted into Connector Tool Inserting the Stylet Follow the steps below to insert a stylet 1 Remove any preinserted stylet before inserting a different one 2 Select a stylet according to the function and to the preferred firmness If desired gently curve the stylet with any sterile smooth surfaced instrument e g 10 cc ...

Страница 19: ... molding To engage the fixation knob on the terminal pin push the fixation knob toward the Connector Tool body to close the gap Rotate the fixation knob clockwise to extend the helix or counterclockwise to retract it Visually observe the helix extending and retracting Figure 4 on page 15 Figure 4 Connector Tool fixation knob engaged 15 d a t e d v e r s i o n D o n o t u s e e r s i o n ü b e r h ...

Страница 20: ... using one of the following methods via the cephalic vein or through the subclavian or internal jugular vein Via cutdown through the left or right cephalic vein Only one incision over the deltopectoral groove is required to access the right or left cephalic vein in the deltopectoral groove The vein pick packaged with this lead can be used to aid access during the cutdown procedure Isolate the sele...

Страница 21: ...apment by the subclavius muscle or ligamentous structures associated with the narrow costoclavicular region 6 It is recommended to introduce the lead into the subclavian vein near the lateral border of the first rib The syringe should be positioned directly above and parallel to the axillary vein to reduce the chance that the needle will contact the axillary or subclavian arteries or the brachial ...

Страница 22: ...is apparent the thumb should project about 2 centimeters below the clavicle because the subclavius muscle should be hypertrophied as well Figure 8 on page 19 18 d a t e d v e r s i o n D o n o t u s e e r s i o n ü b e r h o l t N i c h t v e r w e n d e n V e r s i o n o b s o l è t e N e p a s u t i l i s e r V e r s i ó n o b s o l e t a N o u t i l i z a r V e r s i o n e o b s o l e t a N o n...

Страница 23: ...pex of the right ventricle WARNING Use fluoroscopy to verify that the lead tip is directed toward the apex when implanted Other positions may result in lead movement which could affect defibrillation efficacy WARNING Take care to obtain appropriate electrode position Failure to do so may result in higher defibrillation thresholds or may render the lead unable to defibrillate a patient whose tachya...

Страница 24: ...ator pulse generator that uses the metallic housing as a defibrillation electrode Lead Fixation The lead helix is electrically conductive to allow mapping measuring pacing and sensing thresholds of potential electrode positions without extending the helix into the tissue Mapping prior to lead fixation is recommended as it can reduce the potential need for multiple lead positionings 20 d a t e d v ...

Страница 25: ...markers under fluoroscopy to identify when the fixation helix is fully extended Full extension is achieved when the radiopaque markers are joined and the fixation helix is extended outside the distal fluoroscopy markers Table 3 on page 21 Table 3 Fluoroscopic view of helix electrode Fully Retracted Fully Extended 6 Once the lead is affixed in the desired location hold the proximal end of the lead ...

Страница 26: ...tion of the lead body during lead removal is necessary to avoid inadvertent tissue trauma and accidental fixation and to release the electrode helix if tissue snagging has occurred 3 Reaffix the electrode using the previous procedures for handling positioning and checking for lead stability CAUTION The helix can become unintentionally extended if the Connector Tool fixation knob is engaged on the ...

Страница 27: ... due to signal filtering Baseline measurements should fall within the recommended values indicated in the table Lower intrinsic potentials longer durations and higher pacing threshold may indicate lead placement in ischemic or scarred tissue Because signal quality may deteriorate reposition the lead if necessary to obtain a signal with the largest possible amplitude shortest duration and lowest pa...

Страница 28: ...nd duration measurements are not inclusive of current of injury and are taken during the patient s normal baseline rhythm Over rotation of the terminal pin may increase local tissue trauma and cause temporarily high voltage thresholds 4 Once acceptable measurements are obtained remove the pacing system analyzer connections and remove the stylet 5 Pinch the terminal boot levers and slide the Connec...

Страница 29: ...e a suture around the lead cap to keep it in place 4 Giving consideration to patient anatomy and pulse generator size and motion gently coil any excess lead and place adjacent to the pulse generator It is important to place the lead into the pocket in a manner that minimizes lead tension twisting sharp angles and or pressure Electrical Performance 1 Evaluate the lead signals using the pulse genera...

Страница 30: ... state against the availability of the pulse generator energy settings and the patient s ability to tolerate multiple arrhythmia inductions If a patient s arrhythmia s cannot be reliably converted with the lead supplementary implantation of an alternate lead system will require additional conversion testing WARNING Do not use any component of the lead system to assist in delivery of external sourc...

Страница 31: ...the suture sleeve and the lead to the fascia For additional stability the sleeve may be secured to the lead first before securing the sleeve to the fascia 3 Check the suture sleeve after tie down to demonstrate stability and lack of slippage by grasping the suture sleeve with fingers and trying to move the lead in either direction Venous Cutdown Technique 1 Slide the suture sleeve into the vein pa...

Страница 32: ...or upper extremity movement Figure 13 Strain relief loop 28 d a t e d v e r s i o n D o n o t u s e e r s i o n ü b e r h o l t N i c h t v e r w e n d e n V e r s i o n o b s o l è t e N e p a s u t i l i s e r V e r s i ó n o b s o l e t a N o u t i l i z a r V e r s i o n e o b s o l e t a N o n u t i l i z z a r e V e r o u d e r d e v e r s i e N i e t g e b r u i k e n F ö r å l d r a d v e ...

Страница 33: ...AUTION After tunneling re evaluate the lead to verify that no significant change in signals or damage to the lead has occurred during the tunneling procedure Reattach the Connector Tool and repeat the steps in Evaluating Lead Performance NOTE If the tunneling procedure must be delayed cap the lead terminal and form a temporary pocket for the coiled lead Capping the terminal protects it and prevent...

Страница 34: ...patient Contact Boston Scientific when any of the following occur When a product is removed from service In the event of patient death regardless of cause along with an autopsy report if performed For other observation or complications reasons NOTE Disposal of explanted pulse generators and or leads is subject to applicable laws and regulations For a Returned Product Kit contact Boston Scientific ...

Страница 35: ...rminal Fixation Extendable retractable helix Expected number of rotations to fully extend retract the helixa 11 turns Maximum number of rotations allowed to extend retract the helixa 20 turns Maximum fixation helix penetration depth 1 9 mm Electrode Distal coil surface area 450 mm2 31 d a t e d v e r s i o n D o n o t u s e e r s i o n ü b e r h o l t N i c h t v e r w e n d e n V e r s i o n o b ...

Страница 36: ...roid 0 96 mg dexamethasone acetate Maximum Lead Conductor Resistance From low voltage terminal pin to distal tip electrode 80 Ω From low voltage proximal terminal ring contact to distal coil electrode 80 Ω 32 d a t e d v e r s i o n D o n o t u s e e r s i o n ü b e r h o l t N i c h t v e r w e n d e n V e r s i o n o b s o l è t e N e p a s u t i l i s e r V e r s i ó n o b s o l e t a N o u t i...

Страница 37: ...r Date of manufacture Sterilized using ethylene oxide Do not resterilize Do not reuse Do not use if package is damaged 33 d a t e d v e r s i o n D o n o t u s e e r s i o n ü b e r h o l t N i c h t v e r w e n d e n V e r s i o n o b s o l è t e N e p a s u t i l i s e r V e r s i ó n o b s o l e t a N o u t i l i z a r V e r s i o n e o b s o l e t a N o n u t i l i z z a r e V e r o u d e r d ...

Страница 38: ...i s e r V e r s i ó n o b s o l e t a N o u t i l i z a r V e r s i o n e o b s o l e t a N o n u t i l i z z a r e V e r o u d e r d e v e r s i e N i e t g e b r u i k e n F ö r å l d r a d v e r s i o n A n v ä n d e j Π α λ ι ά έ κ δ ο σ η Μ η ν τ η ν χ ρ η σ ι μ ο π ο ι ε ί τ ε V e r s ã o o b s o l e t a N ã o u t i l i z e F o r æ l d e t v e r s i o n M å i k k e a n v e n d e s Z a s t a ...

Страница 39: ... i e t g e b r u i k e n F ö r å l d r a d v e r s i o n A n v ä n d e j Π α λ ι ά έ κ δ ο σ η Μ η ν τ η ν χ ρ η σ ι μ ο π ο ι ε ί τ ε V e r s ã o o b s o l e t a N ã o u t i l i z e F o r æ l d e t v e r s i o n M å i k k e a n v e n d e s Z a s t a r a l á v e r z e N e p o u ž í v a t U t d a t e r t v e r s j o n S k a l i k k e b r u k e s Z a s t a r a n á v e r z i a N e p o u ž í v a ť E l...

Страница 40: ... l t N i c h t v e r w e n d e n V e r s i o n o b s o l è t e N e p a s u t i l i s e r V e r s i ó n o b s o l e t a N o u t i l i z a r V e r s i o n e o b s o l e t a N o n u t i l i z z a r e V e r o u d e r d e v e r s i e N i e t g e b r u i k e n F ö r å l d r a d v e r s i o n A n v ä n d e j Π α λ ι ά έ κ δ ο σ η Μ η ν τ η ν χ ρ η σ ι μ ο π ο ι ε ί τ ε V e r s ã o o b s o l e t a N ã o u...

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