Proclaim™ DRG Implantable Pulse Generator Model 3664 Clinician's Manual
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Contents Prescription and Safety Information ........................................................................... 1 Intended Use .................................................................................................................... 1 Indications for Use ............................................................................................................ 1 Contraindications............................................................................................................
Prescription and Safety Information Read this section to gather important prescription and safety information. Intended Use This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. The system is intended to be used with leads and associated extensions that are compatible with the system. Indications for Use This neurostimulation system is indicated for the management of chronic, intractable pain.
Computerized tomography (CT). If the patient requires a CT scan, all stimulation should be turned off before the procedure. If stimulation is not turned off, the patient may experience a momentary increase in stimulation, which may be uncomfortable. After the procedure, stimulation should be turned back on and the system should be checked for proper function. Diathermy therapy.
information on radiation effects is available. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. Damage to the system may not be immediately detectable. Restricted areas.
Patient selection. It is extremely important to select patients appropriately for neurostimulation. Thorough psychiatric screening should be performed. Patients should not be dependent on drugs and should be able to operate the neurostimulation system. Infection. Follow proper infection control procedures. Infections related to system implantation might require that the device be explanted. Implantation of multiple leads.
Device modification. The equipment is not serviceable by the customer. To prevent injury or damage to the system, do not modify the equipment. If needed, return the equipment to St. Jude Medical for service. Component disposal. Return all explanted components to St. Jude Medical for safe disposal. Hospital and Medical Environments High-output ultrasonics and lithotripsy.
Escalating pain Bleeding where the needle has been inserted Headache Infection Localized collection of serous (clear) fluid at the injection site Discomfort during the treatment Allergic or rejection response to implant materials Contact pain at the lead site Stimulation in unwanted places (such as stimulation of the chest wall) Lead migration (movement) causing changes in stimulation or pain from understimulation Implant migration (movement), local skin br
The following image shows how the major system components are intended to interact. Figure 1. Interaction among main system components 1. Clinician programmer or patient controller 2. IPG 3. Leads 4. Patient magnet NOTE: This manual provides instructions for implanting the IPG. For instructions for using other components, see the applicable manuals for those components.
Identifying the IPG Before implanting the IPG, you can view the model number engraved on the IPG. After implantation, you can identify the IPG using a radiopaque identification tag that you can view with standard X-ray procedures. The tag, which is located in the lower left corner of the IPG when the logo side of the IPG is facing toward you, contains a code in the following format: SJMLN. SJM designates St.
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. Connecting a Lead or Extension to the IPG The following steps outline the suggested guidelines to connect a lead or extension to the IPG: CAUTION: Do not connect a lead or extension with body fluid or saline residue on its contacts because corrosion can occur and cause failure of the system. 1.
Figure 4. Tighten the setscrew clockwise 4. If implanting multiple leads, repeat the previous steps for each lead. If implanting fewer than the maximum number of leads, insert port plugs into any unused header ports, and use the torque wrench to tighten the setscrews until the wrench clicks. Figure 5. Insert the port plug Implanting the IPG The following steps outline the suggested procedure to implant the IPG: 1.
5. Use the clinician programmer app to communicate with the IPG and perform intraoperative testing to confirm that the system is operational. See the clinician's manual of the clinician programmer app for instructions. NOTE: IPG output may not be identical to that of the trial stimulator at the same settings. 6. Ensure that the IPG is away from the pocket incision suture line, close the pocket incision, and apply the appropriate dressings.
Technical Support For technical questions and support for your St. Jude Medical™ neuromodulation product, use the following information: +1 972 309 8000 +1 800 727 7846 (toll-free within North America) For additional assistance, call your local St. Jude Medical representative. Appendix A: Product Specifications NOTE: Not all models are available in all countries. Contact your local representative for more information. Storage Specifications Store the components according to the following conditions.
Connector strength Exceeds EN 45502-1 requirements Program storage capacity 16 programs with 1 stim set per lead Upgradeable features Yes MRI status MR Conditional * Battery longevity was estimated using the following nominal settings for a dual-lead system 24 hours per day: 20-Hz frequency, 300 μs pulse width, and 800-μA amplitude at 1600-ohms impedance. For information on how additional settings may impact the longevity of the device, please contact Technical Support.
Leads and Extensions MN20450-series implant leads (standard and SlimTip™ leads) MN20550-50 Lead extension kit, 50-cm Lead and Extension Accessories MN22050 MN22150 MN23650 MN23850 MN23950 MN24000 MN25000 Lead accessories kit Small curve delivery sheath kit, 22 cm Big curve delivery sheath kit, 22 cm Axium™ small curve delivery sheath, 22 cm Axium™ big curve delivery sheath, 22 cm 14G curved delivery needle, 4.
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 the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. Operation is subject to the following two conditions: This device may not cause harmful interference. This device must accept any interference received, including interference that may cause undesired operation.
Table 6. Bluetooth Smart wireless technology information Channel 40 logical channels Bandwidth 2 MHz per channel Data flow Bi-directional Protocol Bluetooth Smart wireless technology *EIRP = Equivalent isotropically radiated power Radio Transmitter, Cables, Transducers The device contains a radio transmitter/receiver with the following parameters. Radio transmitter parameters: Frequency (range): 2.4000 to 2.4835 GHz Bandwidth (-15dB): 2.398 to 2.
Wireless Security Measures The wireless signals are secured through device system design that includes the following: The generator will encrypt its wireless communication. Only one patient controller may communicate with the generator at the same time. A unique key for each unit that is checked during each transmission. Built-in pairing that specifies valid and legitimate pairing among units.
Manufacturing facility Temperature limits for storage conditions Do not use if the product sterilization barrier or its packaging is compromised Catalog number Manufacturer Contents quantity Pulse generator Accessories Serial number Batch code Prescription use only Ethylene oxide gas sterilization Authorized European representative European conformity, affixed in accordance with the relevant provisions of AIMD directive 90/385/EEC and R&TTE directive 1999/5/EC. Hereby, St.
Appendix E: CE Mark Date The following table lists the year in which the CE mark was awarded from the applicable notified body by model number. Table 9.
Manufacturer: St. Jude Medical 6901 Preston Road Plano, Texas 75024 USA +1 972 309 8000 European Authorized Representative: St. Jude Medical Coordination Center BVBA The Corporate Village Da Vincilaan 11 Box F1 1935 Zaventem Belgium +32 2 774 68 11 Manufacturing Site: St. Jude Medical Puerto Rico LLC Lot A Interior - #2 Rd Km. 67.5 Santana Industrial Park Arecibo, PR 00612 USA Manufacturing Site: St. Jude Medical Operations (M) Sdn. Bhd.
