St. Jude Medical Optisure LDA220 User Manual

St. Jude Medical Optisure LDA220 User Manual

Defibrillation leads
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Optisure™
Defibrillation leads
Models LDA220, LDA230, LDA210, LDA220Q, LDA230Q, LDA210Q, LDP220, LDP230,
LDP220Q, LDP230Q, LDP210Q
User's Manual

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Summary of Contents for St. Jude Medical Optisure LDA220

  • Page 1 Optisure™ Defibrillation leads Models LDA220, LDA230, LDA210, LDA220Q, LDA230Q, LDA210Q, LDP220, LDP230, LDP220Q, LDP230Q, LDP210Q User's Manual...
  • Page 2 Unless otherwise noted, ™ indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service marks of St. Jude Medical, LLC and its related companies.
  • Page 3 Description Optisure™ Models LDA220, LDA230, LDA210, LDA220Q, LDA230Q, LDA210Q, LDP220, LDP230, LDP220Q, LDP230Q, and LDP210Q transvenous tachyarrhythmia leads are steroid- eluting, active or passive fixation leads, and are designed for long-term attachment to an implantable cardioverter defibrillator (ICD). All leads have two defibrillation electrodes except for models LDA210, LDA210Q, and LDP210Q which have one.
  • Page 4 Distal defibrillation St. Jude Medical IS-1 lead connectors conform to the international connector standard ISO 5841-3. St. Jude Medical DF-1 lead connectors conform to the international connector standard ISO 11318/Amd. 1. MP35N is a trademark of SPS Technologies. 35N LT and 35N LT DFT are registered trademarks of Fort Wayne Metals.
  • Page 5 Tip to distal defibrillation electrode (mm) Tip to proximal defibrillation electrode (cm) Connector type St. Jude Medical IS-1 lead connectors conform to the international connector standard ISO 5841-3. St. Jude Medical DF-1 lead connectors conform to the international connector standard ISO 11318/Amd. 1.
  • Page 6 Table 2. Passive fixation lead technical specifications LDP220 LDP230 LDP220Q LDP230Q LDP210Q Sense/pace 1 IS-1 bipolar(3.2 mm) connector Defibrillation 2 DF-1 unipolar(3.2 mm) connectors Sense/pace/defibrillation n/a DF4-LLHH DF4-LLHH DF4-LLHO Materials Body Fast-Pass™ Conductors 35N LT and 35N LT DFT Connectors MP35N and stainless MP35N steel...
  • Page 7: Mr Conditional Icd System

    The lead is not designed, sold, or intended for use other than as indicated. MR Conditional ICD System The St. Jude Medical™ MR Conditional lead is part of the St. Jude Medical MR Conditional ICD system. An MR Conditional lead is conditionally safe for use in the MRI environment when used in a complete MR Conditional ICD system and according to the instructions in the MRI Procedure Information document for the St.
  • Page 8: Warnings And Precautions

    MR Conditional LDA220Q Warnings and Precautions Testing has demonstrated that the St. Jude Medical™ MR Conditional ICD system is  conditionally safe for use in the MRI environment when used according to the instructions in the MRI Procedure Information document.
  • Page 9: Instructions For Use

    Additional quantities of all sterile implantable devices should be available in case of accidental contamination or damage. Package Inspection St. Jude Medical packages all leads under clean conditions and sterilizes them using ethylene oxide gas before shipment. If the lead package and seal are intact, the lead and accompanying...
  • Page 10 If the package is wet, damaged, or punctured, or if the seal is broken, contact St. Jude Medical. St. Jude Medical does not recommend use of the product after its expiration date. If the lead package has been breached outside a sterile field or the expiration date has passed, contact St.
  • Page 11 Stylet Guide (Funnel, IS-1 models only) Use the stylet guide (funnel) to assist the insertion of a stylet into the lead's IS-1 connector pin. Insert the stylet guide over the IS-1 connector pin prior to introducing the stylet. Preparing the Active Fixation Lead Test the extension and retraction of the helix before implanting the lead.
  • Page 12 Extra stylets are packaged with each lead. To avoid damage to the lead or to body tissue, do not use excessive force or surgical instruments to insert a stylet into a lead. Attempt to keep the lead straight when inserting a stylet; do not insert the stylet into a severely bent lead.
  • Page 13 and attach the clip-on tool to the connector pin. For instructions on using the clip-on tool, see Preparing the Active Fixation Lead (page 9). While keeping the lead as straight as possible, grasp the connector boot with one hand and with the other hand, rotate the clip-on tool clockwise to extend the helix.
  • Page 14 directly on the lead is not recommended because they may damage the lead. Positioning the Passive Fixation Lead Under fluoroscopic guidance, advance the lead into the right atrium. To aid in passing the lead through the tricuspid valve and into the right ventricle: remove the stylet from the lead shape the distal end of the stylet into a gentle curve carefully reinsert the stylet into the lead...
  • Page 15 acceptable values. Note For DF4 leads, use a sterile patient cable with a plunger clip (such as Models 4160 or 4161) or the IS4/DF4 Connector Sleeve (Model EX3151). The use of alligator clips directly on the lead is not recommended because they may damage the lead. IS4/DF4 Connector Sleeve The IS4/DF4 connector sleeve is designed for use with an IS4 or a DF4 lead.
  • Page 16 Testing Defibrillation Efficacy Once acceptable sensing and pacing performance have been verified, defibrillation lead testing may be performed to determine the voltage/energy requirements for reliable defibrillation, and to ensure that those requirements are well within the output capabilities of the pulse generator. If defibrillation is performed, ensure that the stylet has been withdrawn from the implanted lead.
  • Page 17 tightly, or otherwise creating excessive strain at the insertion site. Never tie a ligature directly to the lead body. Be careful not to dislodge the lead tip during suturing. Always use heavy, nonabsorbable suture. If desired, a second suture sleeve may be utilized for additional security: Carefully open the slit in the sleeve and position the sleeve on the lead body.
  • Page 18: Post-Implantation Follow-Up

    If the lead or any portion of it is extracted, handle it according to local regulations. Clean the extracted lead with disinfectant and return it to St. Jude Medical for investigation and safe disposal. For safety reasons, it is recommended that all used leads be enclosed in a protective cover.
  • Page 19: Technical Support

    Technical Support St. Jude Medical maintains 24-hour phone lines for technical questions and support: 1 818 362 6822  1 800 722 3774 (toll-free within North America)  + 46 8 474 4147 (Sweden)  + 61 2 9936 1200 (Australia) ...
  • Page 20 Symbol Description Sterilized using ethylene oxide Accessories Product literature Contents Caution, Consult Accompanying Documents Consult instructions for use Follow instructions for use on this website Date of Manufacture Reorder number Country of manufacture; BE- Belgium, MY- Malaysia, US- United States Do not use if package is damaged Do not reuse Manufacturer...
  • Page 21 Symbol Description Affixed in accordance with European Council Directive 90/385/EEC. Hereby, St. Jude Medical declares that this device is in compliance with the essential requirements and other relevant provisions of these Directives. Made in USA...
  • Page 24 +32 2 774 68 11 Manufacturing Site: Manufacturing Site: St. Jude Medical Puerto Rico LLC St. Jude Medical Operations (M) Sdn. Bhd. Lot A Interior - #2 Rd Km. 67.5 Plot 102, Lebuhraya Kampung Jawa, Santana Industrial Park Bayan Lepas Industrial Zone...

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