Related Manuals for Boston Scientific RELIANCE 4-FRONT DF4-LLHH
Summary of Contents for Boston Scientific RELIANCE 4-FRONT DF4-LLHH
- Page 1 PHYSICIAN’S LEAD MANUAL ™ RELIANCE 4–FRONT Pace/Sense and Defibrillation Lead Integrated Bipolar DF4-LLHH and DF4-LLHO Connectors Extendable/Retractable Fixation REF 0657, 0658, 0675, 0676, 0692, 0693, 0695, 0696...
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Page 3: Table Of Contents
Table of Contents INFORMATION FOR USE ................Device Description ..................Related Information..................Indications and Usage................. Contraindications ..................Warnings ..................... Precautions ....................Potential Adverse Events ................PRE- IMPLANT INFORMATION..............Surgical Preparation.................. Items Included................... Accessories....................Vein Pick ....................Radiopaque Suture Sleeve..............Stylets ..................... Lead Cap .................... - Page 4 DF4-LLHH Dual coil models, DF4–LLHH connector, extendable/retractable fixation DF4-LLHO Single coil models, DF4–LLHO connector, extendable/retractable fixation 1. Distal steroid-eluting pace/sense electrode (cathode) 2. Proximal pace/sense coil (anode), distal defibrillating coil 3. Proximal defibrillating coil (dual coil models only) 4. Suture sleeve 5.
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Page 5: Information For Use
INFORMATION FOR USE Device Description This lead family has the following characteristics: • Endocardial cardioversion/defibrillation and pace/sense lead—intended for chronic delivery of cardioverting/defibrillating shocks, and bipolar pacing and sensing capabilities; implanted within the superior vena cava, right atrium, and right ventricle. •... -
Page 6: Related Information
• Steroid-eluting—upon exposure to body fluids, the steroid elutes from the lead to help reduce tissue inflammation response at the distal electrode. The steroid suppresses the inflammatory response believed to cause threshold rises typically associated with implanted pacing electrodes. Lower thresholds are desirable because they can increase pacing safety margins and reduce pacing energy requirements, potentially increasing pulse generator longevity. -
Page 7: Indications And Usage
Indications and Usage This Boston Scientific lead is indicated for use as follows: • Intended for pacing, rate-sensing, and delivery of cardioversion and defibrillation shocks when used with a compatible pulse generator Contraindications Use of this Boston Scientific lead is contraindicated for the following patients: •... - Page 8 Handling • Excessive flexing. 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. • Do not kink leads. Do not kink, twist, or braid the lead with other leads as doing so could cause lead insulation abrasion damage or conductor damage.
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Page 9: Precautions
• Proper connections. When connecting the lead to the pulse generator, it is very important that proper connections are made. The terminal pin must be inserted beyond the setscrew block to enable a proper connection. Visualization of the terminal pin insertion indicator beyond the setscrew block may be used to confirm that the terminal pin is fully inserted into the pulse generator port. - Page 10 • Chronic repositioning. Optimum threshold performance might not be achieved if the lead is chronically repositioned because the steroid can be depleted. • Protect from surface contamination. The lead uses silicone rubber which can attract particulate matter, and therefore, must always be protected from surface contamination.
- Page 11 • Tools applied to distal end. Do not apply tools to the distal end of the lead because lead damage could occur. Avoid holding or handling the distal tip of the lead. • Curving the stylet. Do not use a sharp object to curve the distal end of a stylet.
- Page 12 • Electrode distance from pacemaker. 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 defibrillator pulse generator and the pacemaker.
- Page 13 Hospital and Medical Environments • Electrocautery. Electrocautery may induce ventricular arrhythmias and/or fibrillation, and may cause asynchronous pacing, inhibited pacing, inappropriate shocks, and/or a reduction in pulse generator pacing output possibly leading to loss of capture. If electrocautery is medically necessary, observe the following to minimize risk to the lead.
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Page 14: Potential Adverse Events
Follow-up Testing • Unsuccessful conversion testing. Following an unsuccessful high-energy shock, miscounting of cardiac rate, delayed detection, or nondetection due to low amplitude VF signals, it may be necessary to reposition the lead. • Lead performance in chronic state. For some patients, lead performance at implant may not predict performance in the chronic state. -
Page 15: Pre- Implant Information
• Lead insulation breakage or abrasion • Lead tip deformation and/or breakage • Malignancy or skin burn due to fluoroscopic radiation • Myocardial trauma (e.g., cardiac perforation, irritability, injury) • Myopotential sensing • Oversensing/undersensing • Pericardial rub, effusion • Pneumothorax •... -
Page 16: Surgical Preparation
Surgical Preparation Consider the following prior to the implantation procedure: • Instrumentation for cardiac monitoring, imaging (fluoroscopy), external defibrillation, and lead signal measurements must be available during implant. Always isolate the patient from potentially hazardous leakage current • when using electrical instrumentation. •... -
Page 17: Lead Cap
Table 1. Stylet stiffness and knob color Stylet Stiffness Knob Color Soft Green Firm White a. The stylet stiffness is imprinted on the knob. Table 2. Stylet length and cap color Stylet Length (cm) (Imprinted on cap Cap Color of the knob) Yellow Green Black... -
Page 18: Implantation
IMPLANTATION NOTE: Select the appropriate lead length for a given patient. It is important to select a lead that is long enough to avoid any sharp angles or kinks and to allow for a gentle curve of excess lead in the pocket. Typically, a minimum of 5 to 10 cm of excess lead is sufficient to achieve this configuration in the pocket. -
Page 19: Handling The Fixation Helix
gentle curve is less likely to straighten than a sharp bend as the stylet is used. CAUTION: Do not use a sharp object to curve the distal end of a stylet. Do not curve a stylet while it is in the lead. If a curved stylet is preferred, gently curve a straight stylet before inserting it into the lead to avoid damage to the stylet and lead. -
Page 20: Inserting The Lead
NOTE: The expected and maximum number of turns to extend or retract the helix are provided in the specifications (Table 6 on page 31). Any curves introduced into the stylet could increase the number of turns needed to extend or retract the helix. CAUTION: Do not overextend or over-retract the helix. - Page 21 CAUTION: The vein pick is not intended either for puncturing the vein or for dissecting tissue during a cutdown procedure. Be sure that the vein pick does not puncture the insulation of the lead. This could prevent proper lead function. Figure 6.
- Page 22 Identify points St (sternal angle) and Cp (coracoid process) (Figure 7 on page 18). [1] Subclavius muscle [2] Costocoracoid ligament [3] Costoclavicular ligament Figure 7. Entry point for percutaneous subclavian venipuncture Visually draw a line between St and Cp, and divide the segment into thirds.
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Page 23: Positioning Lead In Right Ventricle
Figure 8. Location of thumb and needle entry Feel with the thumb the pressure from the passage of the needle through the superficial fascia; direct the needle deep into the tissues toward the subclavian vein and the underlying first rib. Fluoroscopic guidance will reduce the chance that the needle would pass below the first rib and into the lung. -
Page 24: Lead Fixation
[1] Proximal coil electrode [2] Distal coil electrode Figure 9. Suggested electrode position within the heart Verify under fluoroscopy that the distal coil electrode is situated in the right ventricle, below the tricuspid valve, and that the proximal coil electrode (in dual-coil models) is situated in the superior vena cava and high right atrium. -
Page 25: Checking For Lead Stability
When data are acceptable and the correct position has been achieved, proceed with lead fixation. NOTE: Maintain the stylet in a partially retracted position when placing the lead in the RV apex or RV free wall to minimize tip stiffness. Remove the pacing system analyzer (PSA) alligator clips from the Connector Tool. -
Page 26: Repositioning The Lead
CAUTION: To prevent dislodgment, avoid rotating the terminal pin after fixating the lead. Check the stability of the lead using fluoroscopy. Do not tug on the lead. If possible, have the patient cough or take several deep breaths. When the electrode position is satisfactory, withdraw the stylet beyond the right atrium. - Page 27 • Attach the PSA cable alligator clips to the Connector Tool cathode (–) spring contact and anode spring contact (+). Use of the Connector Tool will protect the terminal pin from alligator clip damage and prevent bridging between terminal contacts. Fully engage the alligator clips on the cathode and anode spring contacts to avoid inaccurate baseline measurements (Figure 10 on page 23).
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Page 28: Connection To A Pulse Generator
• Changes in the defibrillation electrode surface area, such as changing from a TRIAD configuration to a single coil configuration, can affect the impedance measurements. Baseline defibrillation impedance measurements should fall within the recommended values indicated in the table. CAUTION: R-wave amplitudes of less than the recommended value can cause inaccurate rate counting in the chronic state, possibly resulting in failure to sense a tachyarrhythmia or misdiagnosis of a normal rhythm as abnormal. -
Page 29: Electrical Performance
Grasp the lead body in the labeled area distal to the terminal ring contacts and fully insert the lead terminal into the pulse generator port until the terminal pin is visible beyond the setscrew block. If the terminal pin is difficult to insert, verify the setscrew is completely retracted. -
Page 30: Conversion Testing
Conversion Testing After obtaining acceptable signals, use the pulse generator to demonstrate ability to reliably convert ventricular fibrillation (VF) and, when appropriate to the patient, ventricular tachycardias. This testing involves inducing arrhythmias and shocking the patient with high-voltage pulses delivered from the pulse generator, through the defibrillation electrodes of the lead, to the heart. -
Page 31: Securing The Lead
Securing the Lead After the electrodes are satisfactorily positioned, use the suture sleeve to secure the lead to achieve permanent hemostasis and lead stabilization. Suture sleeve tie-down techniques can vary with the lead insertion technique used. Consider the following warning and precautions while securing the lead. WARNING: Do not kink, twist, or braid the lead with other leads as doing so could cause lead insulation abrasion damage or conductor damage. -
Page 32: Tunneling The Lead
Figure 12. Example of suture sleeve, venous cutdown technique Use at least two grooves to secure the sleeve to the lead. Secure the lead and suture sleeve to the adjacent fascia. 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. - Page 33 WARNING: For DF4-LLHH or DF4-LLHO leads, use caution handling the lead terminal when the Connector Tool is not present on the lead. Do not directly contact the lead terminal with any surgical instruments or electrical connections such as PSA (alligator) clips, ECG connections, forceps, hemostats, and clamps.
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Page 34: Postimplant
POSTIMPLANT Postimplant Evaluation Perform follow-up evaluation as recommended in the applicable pulse generator physician’s manual. CAUTION: For some patients, lead performance at implant may not predict performance in the chronic state. Therefore, it is strongly recommended that post-implant follow-up EP testing be performed should any change occur in lead performance. -
Page 35: Specifications
• Wash, but do not submerge, the pulse generator and leads to remove body fluids and debris using a disinfectant solution. Do not allow fluids to enter the pulse generator’s lead ports. • Use a Boston Scientific Returned Product Kit to properly package the pulse generator and send it to Boston Scientific. - Page 36 Table 6. Specifications (Nominal) (continued) Nominal Characteristic 660 mm Proximal coil surface area (dual-coil models) Fixation helix surface area 5.7 mm Tip to proximal coil electrode length 18 cm (dual-coil models) Tip to distal coil electrode length 12 mm Diameter: Insertion 2.7 mm (8F) Isodiametric lead body...
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Page 37: Lead Introducer
Table 6. Specifications (Nominal) (continued) Nominal Characteristic From (high voltage) middle terminal ring 2.5 Ω contact to distal coil electrode From (high voltage) distal terminal ring 2.5 Ω contact to proximal coil electrode (dual coil models) a. Use fluoroscopy markers for verification of full extension/retraction of the helix. Lead Introducer Table 7. - Page 38 Table 8. Symbols on packaging (continued) Description Symbol Consult instructions for use CE mark of conformity with the identification of the notified body authorizing use of the mark Opening instruction Authorized Representative in the European Community Manufacturer Australian Sponsor Address...
- Page 40 Boston Scientific 4100 Hamline Avenue North St. Paul, MN 55112-5798 USA Guidant Europe NV/SA; Boston Scientific Green Square, Lambroekstraat 5D 1831 Diegem, Belgium 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)
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