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INFORMATION FOR USE

1

INFORMATION FOR USE

Device Description

The ENDOTAK RELIANCE™ (Models 0157/0158), the ENDOTAK
RELIANCE™ S (Model 0138), the ENDOTAK RELIANCE™ G (Models
0184/0185/0186/0187), and the ENDOTAK RELIANCE™ SG (Models
0180/0181/0182/0183) are active fixation, endocardial cardioversion/
defibrillation, and integrated bipolar pace/sense leads with an extendable/
retractable helix and a steroid-eluting collar. The silicone lead body has a
lubricious coating. The electrode coils of the ENDOTAK RELIANCE G and
the ENDOTAK RELIANCE SG are covered with GORE™ expanded
polytetrafluoroethylene (ePTFE). The ENDOTAK RELIANCE and the
ENDOTAK RELIANCE G (dual-coil leads), and the ENDOTAK RELIANCE
S and the ENDOTAK RELIANCE SG (single-coil leads) are for use as an
integral part of an ICD automatic implantable cardioverter defibrillator
system with DF-1

1

and IS-1

2

ports.

Instructions in this manual should be used in conjunction with other
resource material, including the applicable ICD physician’s manual, and
instructions for use on any implant accessories or tools.

This literature is intended for use by professionals trained or experienced in
device implant and/or follow-up procedures.

Indications

The ENDOTAK RELIANCE leads provide pacing and rate-sensing and
deliver cardioversion and defibrillation shocks for ICD automatic
implantable cardioverter defibrillator systems.

Contraindications

Use of this Boston Scientific active fixation lead is contraindicated for the
following patients:

• Patients who have a unipolar pacemaker.

• Patients with a hypersensitivity to a maximum single dose of 1.1 mg

dexamethasone acetate.

• Patients with mechanical tricuspid heart valves.

Warnings

In the following list of warnings, page numbers are indicated for those
warnings that are specific to other areas of the manual. Refer to the
indicated pages for information relevant to the warning.

1.

DF-1 refers to the international standard ISO 11318:2002.

2.

IS-1 refers to the international standard ISO 5841.3:2000.

GORE is a trademark of W. L. Gore and Associates.

358988-001 EN Europe.book Page 1 Monday, November 24, 2014 11:17 AM

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Содержание 0138

Страница 1: ...RELIANCE Steroid Eluting Extendable Retractable Helix Endocardial Defibrillation Leads ENDOTAK RELIANCE 0157 0158 ENDOTAK RELIANCE G 0184 0185 0186 0187 ENDOTAK RELIANCE SG 0180 0181 0182 0183 358988 001 EN Europe book Page 1 Monday November 24 2014 11 17 AM ...

Страница 2: ...358988 001 EN Europe book Page 2 Monday November 24 2014 11 17 AM ...

Страница 3: ...IANCE and ENDOTAK RELIANCE G only 4 Suture Sleeve 5 Second Suture Sleeve Models 0183 and 0187 only 6 Yoke 7 Distal defibrillating electrode terminal cathode 8 Proximal and distal pace sense electrode terminal 9 Proximal defibrillating electrode terminal anode ENDOTAK RELIANCE and ENDOTAK RELIANCE G only 2 8 9 ENDOTAK RELIANCE S Lead REF 0138 ENDOTAK RELIANCE Lead REF 0157 0158 ENDOTAK RELIANCE is ...

Страница 4: ...358988 001 EN Europe book Page 4 Monday November 24 2014 11 17 AM ...

Страница 5: ...Symbols on Packaging 6 DEVICE FEATURES 7 Detailed Device Description 7 LEAD EVALUATION 10 Implant Information 10 Included Items 10 Opening Instructions 11 Sterilization 11 Surgical Preparation 11 Accessories 11 Suture Sleeves 11 Fixation Tool 12 Stylets 12 Stylet Guide 12 Transvalvular Insertion Tool 12 Vein Pick 13 Lead Caps 14 Handling the Lead 14 IMPLANTATION 15 Inserting the Stylet 15 Handling...

Страница 6: ...ulse Generator 23 Evaluating with the PRM 24 Conversion Testing 24 Securing the Lead 25 Percutaneous Implant Technique 25 Venous Cut Down Technique 26 Abdominal Implants 27 Tunneling the Lead to the Abdominal Pocket 27 Connection to a Pulse Generator 28 POST IMPLANT EVALUATION 29 Follow Up Testing 29 Explantation 29 SPECIFICATIONS 30 358988 001 EN Europe book Page 2 Monday November 24 2014 11 17 A...

Страница 7: ...uding the applicable ICD physician s manual and instructions for use on any implant accessories or tools This literature is intended for use by professionals trained or experienced in device implant and or follow up procedures Indications The ENDOTAK RELIANCE leads provide pacing and rate sensing and deliver cardioversion and defibrillation shocks for ICD automatic implantable cardioverter defibri...

Страница 8: ...thmia nondetection or over sensing of rate possibly resulting in inappropriate delivery of a pulse generator shock or inadequate delivery of converting energy Although pliable the lead is not designed to tolerate excessive flexing bending or tension This could cause structural weakness conductor discontinuity and or lead dislodgment Page 14 Take care to obtain appropriate electrode position Failur...

Страница 9: ...esterilization may also create a risk of contamination of the device and or cause patient infection or cross infection including but not limited to the transmission of infectious disease s from one patient to another Contamination of the device may lead to injury illness or death of the patient Precautions It has not been determined whether the warnings precautions or complications usually associa...

Страница 10: ...ath Electrolyte imbalance dehydration Elevated thresholds Erosion Excessive fibrotic tissue growth Extracardiac stimulation muscle nerve stimulation Fluid accumulation Foreign body rejection phenomena Formation of hematomas or seromas Heart block Hemorrhage Hemothorax Inability to defibrillate or pace Inappropriate therapy e g shocks and antitachycardia pacing ATP where applicable pacing Incisiona...

Страница 11: ...chyarrhythmias which include acceleration of arrhythmias and early recurrent atrial fibrillation Thrombosis thromboemboli Valve damage Venous occlusion Venous trauma e g perforation dissection erosion Warranty A limited warranty certificate for the lead is available For a copy contact Boston Scientific using the information on the back cover Refer to the Contraindications Warnings Precautions and ...

Страница 12: ...ns for use Sterilized using ethylene oxide Reference number Use by Date of manufacture Lot number Serial number CE mark of conformity with the identifica tion of the notified body authorizing use of the mark Manufacturer Authorized Representative in the Euro pean Community Do not use if package is damaged Australian Sponsor address 358988 001 EN Europe book Page 6 Monday November 24 2014 11 17 AM ...

Страница 13: ...ectrode The extendable retractable helix serves as the cathode for intracardiac right ventricular electrogram rate sensing and pacing The helix is extended retracted using a terminal pin mechanism Fluoroscopic Markers The lead has radiopaque markers near the distal tip that can be seen under fluoroscopy These markers show when the helix is fully retracted or fully extended Coil Electrodes The dist...

Страница 14: ...ubricious The lubricious coating reduces both the static and dynamic coefficients of friction making the lead surface feel and handle like polyurethane while providing the time tested reliability of silicone Terminals The ENDOTAK RELIANCE and ENDOTAK RELIANCE G leads have three terminals two DF 1 shock and one bipolar IS 1 pace sense The ENDOTAK RELIANCE S and ENDOTAK RELIANCE SG leads have two te...

Страница 15: ... is 18 cm Figure 1 ENDOTAK RELIANCE G 0184 0185 0186 0187 59 cm 64 cm 70 cm 90 cm ENDOTAK RELIANCE SG 0180 0181 0182 0183 59 cm 64 cm 70 cm 90 cm ENDOTAK RELIANCE 0157 0158 59 cm 64 cm ENDOTAK RELIANCE S 0138 64 cm Figure 1 Electrode spacing for the ENDOTAK RELIANCE lead is measured from the distal tip base to the distal end of the proximal coil electrode 18 cm 358988 001 EN Europe book Page 9 Mon...

Страница 16: ...onversion In some cases reliable arrhythmia conversion may not be obtained with any leads at the available ICD energy levels Bipolar pacemakers may be used with the ENDOTAK RELIANCE lead family and ICD pulse generator as long as the pacemaker and ICD pulse generator do not interact causing ICD pulse generator nondetection or false detection Refer to the section Minimizing Pacemaker Interaction on ...

Страница 17: ...ation electrically isolate the patient from potentially hazardous current leakage Boston Scientific also recommends availability of sterile duplicates of all implantable items in case of accidental damage or contamination Accessories Suture Sleeves Suture sleeves are adjustable tubular reinforcements positioned over the outer lead insulation Figure 2 They are designed to secure and protect the lea...

Страница 18: ...nsertion of a stylet into the pace sense terminal of the lead Figure 4 Transvalvular Insertion Tool The Transvalvular Insertion TVI tool is a sterile disposable nontoxic plastic device designed to allow the use of tear away hemostatic introducers with the ENDOTAK RELIANCE G and ENDOTAK RELIANCE SG lead families The TVI tool is used to temporarily dilate the hemostatic valve thereby allowing the e ...

Страница 19: ...e the introducer pull the TVI tool out of the hemostatic valve The TVI tool may be temporarily left on the body of the lead to facilitate repositioning Once the lead is in position the TVI tool must be peeled away Vein Pick The vein pick is a sterile disposable nontoxic nonpyrogenic plastic device designed to assist the physician during entry of the lead s electrode tip into the vein To use the ve...

Страница 20: ...ctrode in fluid Such treatment will reduce the amount of steroid available when the lead is implanted Chronic repositioning may adversely affect the lead s low threshold performance because the steroid may be depleted Do not attempt to alter the electrodes Do not apply pressure to the tip of the electrode The conductor insulation is silicone rubber which can attract particulate matter and must alw...

Страница 21: ...he helix extending and retracting The helix can be extended or retracted by rotating the terminal pin clockwise to extend the helix or counterclockwise to retract it Note Refer to the Lead Fixation section on Page 19 for additional information on how to fixate the helix and to the Specifications section on Page 30 for the expected and maximum number of turns to extend or retract the helix CAUTIONS...

Страница 22: ...c tear away introducer size is 9 5F 3 17 mm for ENDOTAK RELIANCE G and ENDOTAK RELIANCE SG models CAUTION The TVI tool should always be used in conjunction with a hemostatic tear away introducer ENDOTAK RELIANCE G and SG models only 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 to the lead is possible i...

Страница 23: ... entry point and define the course of the needle toward the subclavian vein where it crosses the first rib Figure 9 Landmarks identify the entry point for a percutaneous subclavian venipuncture 1 Referring to Figure 9 identify points St sternal angle and Cp coracoid process 2 Visually draw a line between St and Cp and divide the segment into thirds The needle should pierce the skin at the junction...

Страница 24: ...e lung Positioning the Lead Under fluoroscopy and with the helix retracted and a stylet in the lead advance the lead as far as possible so the tip electrode is in the apex of the right ventricle Figure 11 and Figure 12 Also verify under fluoroscopy that the distal coil electrode is situated in the right ventricle below the tricuspid valve and that the proximal coil electrode ENDOTAK RELIANCE and E...

Страница 25: ...on electrode CAUTION For patients with bipolar cardiac pacemakers the lead pace sense electrode the tip electrode and distal coil electrode should be placed as far as possible from the pacemaker electrodes to avoid cross sensing between the ICD and the pacemaker Lead Fixation The ENDOTAK RELIANCE ENDOTAK RELIANCE S ENDOTAK RELIANCE G and ENDOTAK RELIANCE SG active fixation lead s helix is electric...

Страница 26: ...e 30 for the expected number of turns to extend or retract the helix CAUTION Do not rotate the terminal pin clockwise more than the maximum number of turns indicated for each model number in the Specifications section on Page 30 Continuing to rotate the terminal pin once the helix is fully extended or retracted as indicated by fluoroscopy can damage the lead cause lead dislodgment and or cause acu...

Страница 27: ...to verify that the helix is retracted and disengaged completely from the heart wall before attempting to reposition the lead Reaffix the electrode helix using the procedures previously discussed in the Positioning the Lead Lead Fixation and Checking for Lead Stability sections Do not rotate the fixation tool more than the maximum number of turns indicated in the Specifications Page 30 Continuing t...

Страница 28: ...der programming the pacemaker to 1 the lowest amplitude allowable for safe capture in the chronic state 2 the maximum sensitivity and 3 the minimum cardiac rate acceptable for the patient Also consider using pacemaker leads with close interelectrode spacing e g 1 2 cm Taking Baseline Measurements Connect the terminal pins to a pacing system analyzer PSA and evaluate the placement by determining th...

Страница 29: ...ously discussed Verify that measurements fall within the recommended values If testing results are unsatisfactory further lead system repositioning or replacement may be required Electrical Performance Make the lead connections and evaluate the lead signals using either the pulse generator or a Boston Scientific PRM WARNING When connecting the lead to the ICD pulse generator it is very important t...

Страница 30: ...m because greater separation may cause the signal from the leads to exceed the refractory period of the ICD pulse generator resulting in oversensing in normal rhythm or undersensing in polymorphic rhythm In addition a wide pace sense electrode separation may contribute to oversensing by introducing a large repolarization signal T wave thereby causing false fulfillment of the rate criteria WARNING ...

Страница 31: ... 10 J safety margin cannot be obtained by other less invasive means consider placing an additional defibrillation lead Note If after prolonged and repeated inductions of VF a thoracotomy is to be performed consider performing it at a later date Securing the Lead After the electrodes are satisfactorily positioned and conversion testing has been performed secure the lead to the vein to achieve perma...

Страница 32: ...bility and lack of slippage by grasping the suture sleeve with fingers and trying to move the lead in either direction WARNING Do not kink twist or braid the lead terminal with other leads as doing so could cause lead insulation abrasion damage CAUTIONS When ligating the vein avoid too tight a stricture A tight stricture might damage the silicone rubber insulation or sever the vein Avoid dislodgin...

Страница 33: ...a Boston Scientific lead tunneler do not cap the leads CAUTIONS 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 This could damage the electrodes or lead body or both by permanently stretching the lead When tunneling the lead take precautions not to place excessive tension on the lead This could ca...

Страница 34: ...n the lead connector must be capped before closing the pocket incision Place a suture around the lead cap to keep it in place Plug any unused DF 1 lead port on the pulse generator with the DF 1 port plug ENDOTAK RELIANCE S or ENDOTAK RELIANCE SG lead only The pace sense terminal is inserted into the ICD lead port identified as the pacing sensing port The defibrillation terminals are inserted into ...

Страница 35: ...sensing integrity If programmed accordingly placing and holding a magnet over an active implanted pulse generator elicits tones synchronously with the R wave of the pace sense electrodes If a problem exists with the pace sense electrodes or their interface with the pulse generator it may be revealed by evaluating the beeping tones of the device Refer to the applicable ICD system manual for specifi...

Страница 36: ...LIANCE G Expected number of rotations to fully extend retract the helixa 0138 0180 0181 0182 11 turns 0183 15 turns 0157 0158 0184 0185 0186 11 turns 0187 15 turns Maximum number of rota tions allowed to extend retract the helix 0138 0180 0181 0182 20 turns 0183 25 turns 0157 0158 0184 0185 0186 20 turns 0187 25 turns Terminal sizes 1 IS 1 bipolar 1 DF 1 1 IS 1 bipolar 2 DF 1 Tip to proximal coil ...

Страница 37: ...86 1 9 Ω 0187 2 5 Ω Maximum lead conductor resistance from DF 1 Proximal terminal pin to proximal electrode NA 2 0 Ω Material External insulation Silicone rubber DF 1 terminal pin Titanium IS 1 terminal pin Stainless steel Pace sense conductor MP35N nickel cobalt alloy PTFE sleeve Shocking conductor Drawn brazed strand cable PTFE coated Tip electrode helix Platinum iridium Coil electrode covering ...

Страница 38: ...ucer 9F 3 0 mm All single and dual coil models 10 5F 3 5 mm All single and dual coil models Hemostatic introducer 9F 3 0 mm Models 0138 0157 58 10 5F 3 5 mm Models 0138 0157 58 Hemostatic introducer and TVI tool 9 5F 3 17 mm Models 0180 87 11F 3 67 mm Models 0180 87 358988 001 EN Europe book Page 32 Monday November 24 2014 11 17 AM ...

Страница 39: ...358988 001 EN Europe book Page 1 Monday November 24 2014 11 17 AM ...

Страница 40: ...ed 2002 358988 001 Boston Scientific Australia Pty Ltd PO Box 332 BOTANY NSW 1455 Australia Free Phone 1 800 676 133 Free Fax 1 800 836 666 www bostonscientific com 1 800 CARDIAC 227 3422 1 651 582 4000 2014 Boston Scientific Corporation or its affiliates All Rights Reserved 358988 001 EN Europe 2020 01 358988 001 EN Europe book Page 2 Monday November 24 2014 11 17 AM ...

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