St. Jude Medical Protege Clinician Manual
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St. Jude Medical Protege Clinician Manual

Implantable pulse generator
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Protege
Implantable Pulse Generator
Clinician's Manual
37-4832-01A.indd A
37-4832-01A.indd A
1/30/2014 4:39:11 PM
1/30/2014 4:39:11 PM

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  • Page 1 ™ Protege Implantable Pulse Generator Clinician’s Manual 37-4832-01A.indd A 37-4832-01A.indd A 1/30/2014 4:39:11 PM 1/30/2014 4:39:11 PM...
  • Page 2 CAUTION: Federal law restricts this device to sale by or on the order of a physician. 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, Inc.

  • Page 3: Table Of Contents

    Directions for Use ........15 Protege IPG Clinician’s Manual 37-4832-01A.indd i...
  • Page 4 Protege IPG ........

  • Page 5: Prescription And Safety Information

    This neurostimulation system is indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome and intractable low back and leg pain. Protege IPG Clinician’s Manual 37-4832-01A.indd 1 37-4832-01A.indd 1 1/30/2014 4:39:16 PM...

  • Page 6: Contraindications

    Diathermy is further prohibited because it may also damage the neurostimulation system components. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. Injury or damage can Protege IPG Clinician’s Manual 37-4832-01A.indd 2 37-4832-01A.indd 2...
  • Page 7 (1) verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system and (2) avoid programming either device in a unipolar mode (using the device’s can as an anode). Protege IPG Clinician’s Manual 37-4832-01A.indd 3 37-4832-01A.indd 3...
  • Page 8 A physician should determine whether or not a patient may have an allergic reaction to these materials before the system is implanted. Protege IPG Clinician’s Manual 37-4832-01A.indd 4 37-4832-01A.indd 4 1/30/2014 4:39:17 PM...

  • Page 9: Precautions

    Implantation of two systems. If two systems are implanted, ensure that at least 20 cm (8 in) separates the implanted IPGs to minimize the possibility of interference during programming. Protege IPG Clinician’s Manual 37-4832-01A.indd 5 37-4832-01A.indd 5 1/30/2014 4:39:17 PM...
  • Page 10 Mobile phones. The effect of mobile phones on neurostimulation systems is unknown; patients should avoid placing mobile phones directly over the system. Protege IPG Clinician’s Manual 37-4832-01A.indd 6 37-4832-01A.indd 6...
  • Page 11 Care and handling of components. Use extreme care when handling system components prior to implantation. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components. Protege IPG Clinician’s Manual 37-4832-01A.indd 7 37-4832-01A.indd 7 1/30/2014 4:39:17 PM...
  • Page 12 High-output ultrasonics and lithotripsy. The use of high-output devices, such as an electrohydraulic lithotriptor, may cause damage to the electronic circuitry of an implanted IPG. If lithotripsy must be used, do not focus the energy near the IPG. Protege IPG Clinician’s Manual 37-4832-01A.indd 8 37-4832-01A.indd 8 1/30/2014 4:39:17 PM...
  • Page 13 Electromagnetic interference (EMI). Certain commercial electrical equipment (for example, arc welders, induction furnaces, and resistance welders), communication equipment (for example, microwave transmitters, linear power amplifi ers, and high power amateur transmitters), and high voltage Protege IPG Clinician’s Manual 37-4832-01A.indd 9 37-4832-01A.indd 9 1/30/2014 4:39:17 PM...

  • Page 14: Adverse Effects

     Seroma (mass or swelling) at the IPG site  Allergic or rejection response to implant materials  Implant migration or skin erosion around the implant Protege IPG Clinician’s Manual 37-4832-01A.indd 10 37-4832-01A.indd 10 1/30/2014 4:39:17 PM 1/30/2014 4:39:17 PM...
  • Page 15  Battery failure Protege IPG Clinician’s Manual 37-4832-01A.indd 11 37-4832-01A.indd 11 1/30/2014 4:39:17 PM 1/30/2014 4:39:17 PM...

  • Page 16: Product Description

    Product Description The Protege™ IPG is a rechargeable, electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation.

  • Page 17: Contents Of Package

    Contents of Package In addition to the product documentation, the Protege™ IPG kit (Model 3789) contains the following items:  1 IPG  1 pocket sizer  1 torque wrench (Model 1101)  2 port plugs (Model 1111)  1 tunneling tool (Model 1112) Protege IPG Clinician’s Manual...

  • Page 18: Identifying The Ipg

    IPG in the header of the IPG. For the Protege™ IPG, the code is SJM ZNN, where Z designates Model 3789 and NN designates the last two digits of the year of manufacture. For example, SJM Z14 designates a Protege IPG (Model 3789) manufactured in 2014.

  • Page 19: Directions For Use

    To ensure a fl at area is selected, you can mark a fl at area prior to the surgical procedure while the patient is in a sitting position. Protege IPG Clinician’s Manual 37-4832-01A.indd 15 37-4832-01A.indd 15...
  • Page 20 3. Insert and remove the pocket sizer to ensure that the pocket is large enough to accommodate the IPG, allowing enough extra room for a strain relief loop for each lead or extension. Protege IPG Clinician’s Manual 37-4832-01A.indd 16 37-4832-01A.indd 16...

  • Page 21: Tunneling To The Pocket

    NOTE: The tunneling tool is malleable and can be bent to conform to the contour of the patient’s body. 1. With the cannula sleeve in place on the tunneling tool, create a subcutaneous tunnel between the lead anchor site and the IPG pocket. Protege IPG Clinician’s Manual 37-4832-01A.indd 17 37-4832-01A.indd 17 1/30/2014 4:39:19 PM...
  • Page 22 Figure 2: Suggested tunnel to the IPG pocket 2. Withdraw the tunneling tool from the cannula sleeve, leaving the cannula sleeve in the subcutaneous tunnel. Protege IPG Clinician’s Manual 37-4832-01A.indd 18 37-4832-01A.indd 18 1/30/2014 4:39:19 PM 1/30/2014 4:39:19 PM...
  • Page 23 Patients with nonadjacent leads may experience changes in perceived stimulation from theft detectors and metal screening devices. The correct way to route multiple leads is as follows: Legend: 1. Correct 2. Incorrect Protege IPG Clinician’s Manual 37-4832-01A.indd 19 37-4832-01A.indd 19 1/30/2014 4:39:20 PM 1/30/2014 4:39:20 PM...
  • Page 24 Figure 3: Sequence of tunneling steps for SCS 4. Withdraw the cannula sleeve from the subcutaneous tunnel by passing it over the lead or leads, taking care not to cause traction on them. Protege IPG Clinician’s Manual 37-4832-01A.indd 20 37-4832-01A.indd 20...

  • Page 25: Connecting A Lead Or Extension To The Ipg

    Do not loosen the setscrew in the connector more than a quarter turn at a time while trying to insert the lead. Retracting the setscrew too far can cause the setscrew to come loose and make the connector assembly unusable. Protege IPG Clinician’s Manual 37-4832-01A.indd 21 37-4832-01A.indd 21 1/30/2014 4:39:24 PM...
  • Page 26 Legend: 1. Fully inserted 2. Not fully inserted Figure 4: Insert the lead fully into the IPG header Protege IPG Clinician’s Manual 37-4832-01A.indd 22 37-4832-01A.indd 22 1/30/2014 4:39:24 PM 1/30/2014 4:39:24 PM...
  • Page 27 Figure 5: Tighten the setscrew clockwise 4. Remove the torque wrench and check the septum to ensure that it closed. If the septum did not close, gently reseat the septum flaps. Protege IPG Clinician’s Manual 37-4832-01A.indd 23 37-4832-01A.indd 23 1/30/2014 4:39:26 PM...
  • Page 28 5. If implanting two leads, repeat the previous steps. If implanting a single lead only, insert the header port plug into the unused port, and use the torque wrench to tighten the setscrew until it clicks. Figure 6: Insert the port plug Protege IPG Clinician’s Manual 37-4832-01A.indd 24 37-4832-01A.indd 24 1/30/2014 4:39:28 PM...

  • Page 29: Implanting The Ipg

    IPG separately. 1. Place the IPG into the IPG pocket, at a depth not to exceed 2.25 cm (0.9 in), with the label facing the skin surface. Protege IPG Clinician’s Manual 37-4832-01A.indd 25 37-4832-01A.indd 25...
  • Page 30 2. Carefully coil any excess lead or extension behind the IPG in loops no smaller than 2.5 cm (1 in) in diameter to provide strain relief for the lead or extension and IPG connection. Protege IPG Clinician’s Manual 37-4832-01A.indd 26 37-4832-01A.indd 26...
  • Page 31 6. Ensure that the patient programmer achieves effective communication with the IPG and that the system is operational. NOTE: IPG output may not be identical to that of the trial stimulator at the same settings. Protege IPG Clinician’s Manual 37-4832-01A.indd 27 37-4832-01A.indd 27...
  • Page 32 7. Ensure that the IPG is away from the pocket incision suture line, close the pocket incision, and apply the appropriate dressings. Figure 8: Close the pocket incision Protege IPG Clinician’s Manual 37-4832-01A.indd 28 37-4832-01A.indd 28 1/30/2014 4:39:31 PM...

  • Page 33: Replacing The Ipg

    4. Gently remove the lead or extension from the IPG header; then clean and dry all connections, ensuring they are free of fluid and tissue. Protege IPG Clinician’s Manual 37-4832-01A.indd 29 37-4832-01A.indd 29...

  • Page 34: Disposing Of Explanted Components

    To return an explanted component, place it in a container or bag marked with a biohazard label and coordinate the return with your St. Jude Medical representative or Customer Service. Protege IPG Clinician’s Manual 37-4832-01A.indd 30 37-4832-01A.indd 30 1/30/2014 4:39:33 PM...

  • Page 35: Maintaining The Ipg Battery

    2. Time 3. Battery fully charged 4. Recharge notice 5. Stimulation stops 6. Recharge within 30 to 90 days Figure 9: IPG battery depletion over time Protege IPG Clinician’s Manual 37-4832-01A.indd 31 37-4832-01A.indd 31 1/30/2014 4:39:33 PM 1/30/2014 4:39:33 PM...
  • Page 36 NOTE: The model used to predict device longevity was generated by fi tting a mathematical model to three years of real-time cycling data, which was then used to extrapolate device battery capacity at the end of ten years. Protege IPG Clinician’s Manual 37-4832-01A.indd 32 37-4832-01A.indd 32...

  • Page 37: Recharging The Ipg Battery

    1. Recharge the battery to its maximum capacity before turning off the IPG. 2. Recharge the battery to its maximum capacity every 3 months while it is not in use. Protege IPG Clinician’s Manual 37-4832-01A.indd 33 37-4832-01A.indd 33 1/30/2014 4:39:35 PM...

  • Page 38: Customer Service Information

    For help with a St. Jude Medical neuromodulation product, including technical service or repairs, contact Customer Service using the following information: St. Jude Medical 6901 Preston Road Plano, TX 75024 800 727 7846 972 309 8000 972 309 8150 Fax Protege IPG Clinician’s Manual 37-4832-01A.indd 34 37-4832-01A.indd 34 1/30/2014 4:39:35 PM 1/30/2014 4:39:35 PM...

  • Page 39: Appendix A: Product Specifications

    Appendix A: Product Specifications Protege IPG The Protege™ IPG (Model 3789) has the following physical specifi cations. Table 1: IPG specifi cations Height 4.8 cm (1.89 in) Length 5.3 cm (2.09 in) Thickness 0.95 to 1.1 cm (0.37 to 0.43 in) Weight 29.0 g (1.0 oz)
  • Page 40 The Protege IPG has the following operating parameters. Table 2: Operating parameters for the IPG Parameter Range Steps Pulse width 50–500 μs Alternating 12 and 13 μs (starting with 12 μs) Frequency 2–200 Hz 2 Hz 200–500 Hz 10 Hz 500–1200 Hz...

  • Page 41: Appendix B: Regulatory Statements

    Reorient or relocate the receiving antenna.  Increase the separation between the equipment and receiver.  Connect the equipment into an outlet on a circuit different from that to which Protege IPG Clinician’s Manual 37-4832-01A.indd 37 37-4832-01A.indd 37 1/30/2014 4:39:37 PM 1/30/2014 4:39:37 PM...
  • Page 42 This device must accept any interference received, including interference that may cause undesired operation. Modifications not expressly approved by the manufacturer could void the user’s authority to operate the equipment under FCC rules. Protege IPG Clinician’s Manual 37-4832-01A.indd 38 37-4832-01A.indd 38 1/30/2014 4:39:38 PM...

  • Page 43: Appendix C: Symbols And Definitions

    (1) minor or moderate injury or (2) damage to the equipment or other property. This symbol advises the reader to consult this document for important safety-related information. Protege IPG Clinician’s Manual 37-4832-01A.indd 39 37-4832-01A.indd 39 1/30/2014 4:39:38 PM 1/30/2014 4:39:38 PM...
  • Page 44 Denotes temperature limits for storage conditions Denotes humidity limits Denotes pressure limits Denotes do not use if the product sterilization barrier or its packaging is compromised Denotes catalog number Denotes manufacturer Protege IPG Clinician’s Manual 37-4832-01A.indd 40 37-4832-01A.indd 40 1/30/2014 4:39:38 PM 1/30/2014 4:39:38 PM...
  • Page 45 Denotes for prescription use only Denotes ethylene oxide gas sterilization Denotes authorized European representative Denotes European conformity Denotes the EU notifi ed body number for AIMD Protege IPG Clinician’s Manual 37-4832-01A.indd 41 37-4832-01A.indd 41 1/30/2014 4:39:47 PM 1/30/2014 4:39:47 PM...
  • Page 46 Protege IPG Clinician’s Manual 37-4832-01A.indd 42 37-4832-01A.indd 42 1/30/2014 4:39:56 PM 1/30/2014 4:39:56 PM...
  • Page 47 Protege IPG Clinician’s Manual 37-4832-01A.indd 43 37-4832-01A.indd 43 1/30/2014 4:39:56 PM 1/30/2014 4:39:56 PM...
  • Page 48 ATRIAL FIBRILLATION CARDIAC RHYTHM MANAGEMENT CARDIOVASCULAR NEUROMODULATION St. Jude Medical, Inc. St. Jude Medical St. Jude Medical St. Jude Medical Global Headquarters 6901 Preston Road Coordination Center BVBA Australia Pty. Limited One St. Jude Medical Drive Plano, Texas 75024 The Corporate Village 17 Orion Road St.

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