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Protego DF-1 S
Tripolar ICD lead with active fixation
Technical Manual
414086
Revision: E (2015-05-28)
© BIOTRONIK SE & Co. KG
All rights reserved.
Specifications subject to modification, revision and improvement.
0123 2015
Index 414086Technical ManualProtego DF-1 S
®
BIOTRONIK SE & Co. KG
Woermannkehre 1
12359 Berlin · Germany
Tel +49 (0) 30 68905-0
Fax +49 (0) 30 6852804
sales@biotronik.com
www.biotronik.com
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Summary of Contents for BIOTRONIK ProMRI Protego DF-1 S
- Page 1 ® Tripolar ICD lead with active fixation Technical Manual 414086 Revision: E (2015-05-28) © BIOTRONIK SE & Co. KG All rights reserved. Specifications subject to modification, revision and improvement. BIOTRONIK SE & Co. KG Woermannkehre 1 12359 Berlin · Germany...
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Page 2: Table Of Contents
Table of Contents Table of Contents Table of Contents Description ........... 3 About this Technical Manual . -
Page 3: Description
Description Description Description1414086Technical ManualProtego DF-1 S About this Technical Manual Target group This technical manual is targeted at medical personnel and cardiologists who are familiar with the following topics: • The use of ICDs and the respective leads, tachycardia therapy •... -
Page 4: Design And Properties Of The Lead
Description Design and Properties of the Lead Product name Protego DF-1 S Model Length Protego DF-1 S 60 61 cm Protego DF-1 S 65 65 cm Protego DF-1 S 75 75 cm Features at a glance • Fixation: Extendable/retractable fixation screw, electrically active •... -
Page 5: Intended Use, Indications And Contraindications
Description Intended Use, Indications and Contraindications Intended use and indications In combination with a compatible ICD, this lead is designed for the following: • Permanent sensing and pacing in the right ventricle • Delivery of defibrillation / cardioversion therapies With its active fixation screw, this lead is especially suitable for patients with degenerated trabeculae in the ventricle for whom passive fixation with silicone or polyurethane tines is not possible. -
Page 6: Packaging, Sterility, Storage, And Disposal
Description Packaging, Sterility, Storage, and Disposal Box and label The lead is delivered in a box bearing a quality control seal and a product information label. The label contains the following information about the lead: • Name of model • Technical properties and data •... -
Page 7: Safety
Safety Safety Safety2414086Technical ManualProtego DF-1 S Medical and Technical Complications Medical complications Potential medical complications of using implantable pacemakers or ICDs include the following: • Formation of fibrotic tissue • Thrombosis, embolism • Elevated pacing thresholds • Foreign body rejection phenomena •... -
Page 8: Risky Therapeutic And Diagnostic Procedures And Environmental Influences
• Please contact the responsible authorities or BIOTRONIK beforehand to determine whether these products are actually certified "MR conditional" in your country or region. - Page 9 Safety Risky procedures The table below provides an overview of procedures that present a risk to patients with an implanted lead or a device system. Take appropriate precautionary measures and observe the specific instructions listed in the table. Procedure Type of danger Recommendations for risk mitigation Therapeutic ultra-...
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Page 10: Electrical And Electromagnetic Safety
Diagnostic Procedures and Environmental Influences, p. 8). Additional information For further information about this topic and possibilities of risk mitigation, refer to the manuals for BIOTRONIK active devices. Preventing leakage currents Leakage currents to the active device, the lead or directly to the myocardium must be prevented, as they can trigger lethal arrhythmias. -
Page 11: Handling And Implantation
Handling and Implantation Handling and Implantation Handling and Implantation3414086Technical ManualProtego DF-1 S Implantation: Basic Instructions and Safety Measures • Always implant the lead using X-ray monitoring. • Monitor the ECG carefully during implantation and keep external defibrillation equipment and a pacing system analyzer on standby. •... -
Page 12: Information On The Steroid Collar
Handling and Implantation Information on the Steroid Collar Intended medical use The lead tip has a steroid collar in the form of a silicone rubber ring that contains dexamethasone acetate. The intended effect is the reduction of the inflammatory processes after implantation and the inflammation-related post-operative threshold increase (lead maturation behavior). -
Page 13: Opening The Package
Handling and Implantation Opening the Package Packaging composition The lead and its accessories are sealed in two blisters, one within the other, and sterilized with ethylene oxide. As a result, the inner blister is also sterile on the outside. You can remove the inner blister by using a standard aseptic technique and place it in the sterile field. -
Page 14: Checking The Function Of The Fixation Screw Before Implantation
Handling and Implantation Checking the Function of the Fixation Screw before Implantation Function Use the enclosed fixation tool to extend the fixation screw (turn right, clockwise) and retract it (turn left, counterclockwise). When fully extended, the fixation screw protrudes a maximum of 1.8 mm from the lead body. -
Page 15: Accessing The Vein And Inserting The Lead
Handling and Implantation Accessing the Vein and Inserting the Lead Preparing the lead After all implantation preparations have been made, proceed as follows: Step Action Ensure that the fixation screw is completely retracted. Move the premounted lead fixation sleeve close to the lead connector. -
Page 16: Positioning And Fixating The Lead
Handling and Implantation Positioning and Fixating the Lead Prerequisite Access to the vein has been obtained through incision of the cephalic vein or puncture of the subclavian vein, and the lead tip has been inserted. Positioning the lead Proceed as follows to position the lead in the ventricle: Step Action Carefully advance the lead tip through the tricuspid valve into the... - Page 17 Handling and Implantation CAUTION Damage to the lead in the event of defective screw mechanisms Do not operate the screw mechanism if one of the following problems arises: • The screw mechanism has become sticky due to coagulated blood or bodily fluids.
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Page 18: Intraoperative Measurements And Tests
Handling and Implantation Intraoperative Measurements and Tests Connecting the leads For a qualitative evaluation of the lead position, it is necessary to measure pacing temporarily thresholds, intracardiac potentials and the defibrillation threshold. For this purpose, temporarily connect the patient cable to the lead connectors using alligator clips. - Page 19 Handling and Implantation Suitable measuring devices BIOTRONIK provides measuring devices calibrated to the properties of the active devices for measuring pacing threshold, defibrillation threshold and intracardiac potentials. The input filter characteristics of the measuring device must be as close as possible to those of the active device, especially when evaluating the intracardiac signal amplitude.
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Page 20: Fixating The Lead At The Lead Incision Point
Handling and Implantation Fixating the Lead at the Lead Incision Point Purpose Fixating the lead at the incision point in the vein or in the muscle minimizes the risk of dislodgment. The lead fixation sleeve enables secure and smooth fixation of the lead at its incision point and decreases the risk of damaging the insulation or coil during fixation. -
Page 21: Connecting The Lead To The Active Device
Position of the set screws In BIOTRONIK ICDs, the set screw(s) of the DF-1 connector port(s) are accessible from the labeled side of the housing and the set screw(s) of the IS-1 connector port(s) are accessible from the unlabeled side of the housing. - Page 22 Handling and Implantation Connector allocation The lead connectors are connected based on the diagram on the ICD housing. The connectors are allocated as follows: DF-1 connector • Connect the DF-1 connector for the ventricular shock coil to IS-1 connector • Connect the bipolar IS-1 connector for the ventricle to P/S V. Connecting the ICD lead to the Proceed as follows for each individual connector: device...
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Page 23: Lead Placement
Handling and Implantation Lead Placement Depending on the implantation site and patient's anatomy, the lead may be longer than required to connect the active device and position the lead in the heart. In this case, we recommend placing the excess lead length around the active device in loose loops. -
Page 24: Appendix
Appendix Appendix Appendix4414086Technical ManualProtego DF-1 S Technical Data Scale drawing Schematic diagram: Product name Protego DF-1 S Model Length Protego DF-1 S 60 61 cm Protego DF-1 S 65 65 cm Protego DF-1 S 75 75 cm Basic data Polarity, overall Tripolar Polarity for pacing and sensing In the ventricle: bipolar... - Page 25 Appendix Fixation and tip electrode Fixation principle Active fixatin Fixation design Extendable/retractable fixation screw, electrically active Penetration depth, extended length Max. 1.8 mm Typical number of rotations for 5 to 10 rotations extension or retraction Maximum number of rotations for 20 rotations extension or retraction Electrically active surface of ...
- Page 26 Appendix Conductor RV shock coil Design Cable DFT wires per cable 7 x 7 Material of conductor MP35N*) - DFT Material of insulation Teflon PFA Outer diameter 0.28 mm (including insulation) Conductor resistance Length 61 cm or 65 cm Max. 1.6 Ω Length 75 cm Max.
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Page 27: Disclaimer
The buyer/user bears the entire risk associated with the use of the lead. complications and BIOTRONIK shall not be liable for any loss, damage, or injury of any nature, whether consequential damage direct, indirect, or consequential, that may occur in connection with the leads and accessories or their use. -
Page 28: Legend For The Label
Appendix Legend for the Label Symbol Meaning Manufacturing date Use by Storage temperature BIOTRONIK order number Serial number Lot number Sterilized with ethylene oxide Do not resterilize Single use only. Do not re-use! Non-sterile STERILE Follow the instructions for use... - Page 29 Appendix Symbol Meaning Bipolar, endocardial active fixation lead with extendable and retractable screw Unipolar coronary sinus lead, fixation using preformed Bipolar coronary sinus lead, fixation using preformed tip Unipolar coronary sinus lead, fixation in vessel using silicone thread Bipolar coronary sinus lead; fixation using electrically passive, preshaped tip;...
- Page 30 Appendix Symbol Meaning Positioning the lead in the coronary venous system for left ventricular pacing Coronary sinus Pace Pacing Sense Sensing Shock Shock Dexamethasone acetate as steroid eluant...
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