Nuvectra 24082412 2408, 2412 User Manual

Algostim, LLC 2408, 2412

User Manual

Algovita™ Spinal Cord Stimulation System Stimulator Models 2408 and 2412For IPG replacementImplant Manual  for StimulatorIPG implant.indb   1 3/3/14   8:46 AM
Algovita™ is a trademark of QIG Group, LLCCoreGuard™ is a trademark of Greatbatch, Inc.Refer to the Information for Prescribers Manual for indications, contraindications, warnings, precautions, adverse events, and related information.FCC Information (US Only)e following is communications regulation information about the Algovita Implantable Pulse Generator (IPG).2408 and 2412 IPG FCC ID: 2ABU824082412ese devices comply with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) ese devices may not cause harmful interference, and (2) ese devices must accept any interference received including interference that may cause undesired operation.Important: Changes and modications to these products not authorized by Algostim, LLC could void the FCC certication and negate your authority to operate these products.IPG implant.indb   2 3/3/14   8:46 AM
Algovita Spinal Cord Stimulation System  Stimulator Model 2408 and 2412 Implant Manual    3ContentsExplanation of Symbols Used on Packaging   5Component Description  7Package Contents  8Component Sterilization  8About this IPG Replacement Manual  8Implant Procedure  8Preparing for Surgery  8Preoperative IPG Preparation  9Explanting the IPG   13Connecting the Leads or Extensions to the New IPG   13Checking System Integrity   16Implanting the New IPG  16Completing the Implant Procedure 17Patient Counseling Information  17SCS System Implant: IPG Replacement  17Registration Form and Temporary Patient ID Card  18Returning Explanted Components   18Algostim Customer Service  18Specications 19Wireless Information  20Algovita SCS System Component Compatibility  21IPG implant.indb   3 3/3/14   8:46 AM
4      Stimulator Model 2408 and 2412 Implant Manual IPG implant.indb   4 3/3/14   8:46 AM
Algovita Spinal Cord Stimulation System  Implant Manual for Stimulator    5Explanation of Symbols Used on Packaging Symbol Explanation20XXConformité Européenne (European Conformity). is symbol means that the device fully complies with European Directive AIMD 90/385/EEC.Caution: Federal Law (USA) restricts this device to sale on or by the order of a physician.Consult instructions for useCautionSerial numberCatalog numberModel numberAuthorized representative in EuropeUse by dateDistributed byManufacturerTemperature limitKeep drySterilized using ethylene oxideDo not resterilizeDo not reuseIPG implant.indb   5 3/3/14   8:46 AM
6      Implant Manual for StimulatorExplanation of Symbols Used on Packaging Symbol ExplanationKeep away from sunlightDo not use if package is damagedPhoneRecycleContentsIPG: 3 connector ports with 8 channels eachIPG: 2 connector ports with 12 channels eachIPG implant.indb   6 3/3/14   8:46 AM
Algovita Spinal Cord Stimulation System  Implant Manual for Stimulator    7Component Descriptione Algovita™ Stimulator Model 2408 or 2412 (Figure 1) is part of the Algovita Spinal Cord Stimulation (SCS) System, a rechargeable, 24-electrode, SCS system for the treatment of chronic pain. 12123,LLC ,LLCFigure 1.  Algovita Stimulator Model 2408 and Model 2412e Algovita Stimulator is the implantable pulse generator (IPG) for the Algovita SCS System. In addition to the IPG, the implanted components of the SCS system consist of percutaneous leads or paddle leads with optional extensions. During the intraoperative test, an external pulse generator (EPG) is used in place of the IPG. e clinician programs the IPG and the EPG using a Clinician Programmer. e patient adjusts the system using either of 2 patient programmers.Algovita IPGs are 24-channel rechargeable IPGs. Each channel allows the system 1 active electrode. e channels are distributed over 2 or 3 connector ports, depending on the IPG model.• Algovita Stimulator Model 2408 (3x8 channel)—ree connector ports accommodate 1 to 3 percutaneous leads, with each lead allowing up to 8 active electrodes. • Algovita Stimulator Model 2412 (2x12 channel)—Two connector ports accommodate 1 or 2 percutaneous or paddle leads, with each lead allowing up to 12 active electrodes.e IPG delivers stimulation using independent current distribution, a technology that allows variable amounts of current to be delivered to each active electrode. e IPG battery is a deep discharge recovery battery with CoreGuard™ technology. Even if the patient allows the battery to completely discharge, the battery can be recharged with the Algovita Programmer Charger.IPG implant.indb   7 3/3/14   8:46 AM
8      Implant Manual for StimulatorPackage ContentsPackage Contents• Stimulator Model 2408 (3x8) or Model 2412 (2x12) • Torque wrench• Port plugs (3 for Model 2408, 2 for Model 2412)• Product literature• Temporary patient ID card• Implant registration form and business reply envelopeComponent Sterilizatione implantable and surgical accessory components were sterilized with ethylene oxide prior to shipment. e SCS system sterile components are intended for single use only and must not be resterilized. Caution: Do not resterilize a system component or reimplant an explanted system component because of risk of infection or malfunction. About this IPG Replacement Manualis manual provides the instructions for the replacement of an Algovita Stimulator Model 2408 or 2412. For complete instructions on implanting an IPG as part of a system implant, refer to the system manual packaged in the lead kit.Implant ProcedureImplanting clinicians should be thoroughly familiar with this manual and all other product labeling.Caution: Do not place the charging paddle on an unhealed wound. e charging paddle is not sterile. Contact with an unhealed wound may result in an infection. Preparing for SurgeryBefore opening the sterile pack, verify the following on the sterile pack label:• IPG—Model number and use-by dateIPG implant.indb   8 3/3/14   8:46 AM
Algovita Spinal Cord Stimulation System  Implant Manual for Stimulator    9Preoperative IPG PreparationCautions:  » To allow the surgical wound to heal before another charge is needed, charge the IPG in its shelf carton before implanting.   » To assure maximum IPG battery life, make sure the IPG and its packaging are at room temperature before charging the IPG.  » Charging at temperatures above 35°C (95°F) can impair charging paddle operation. » Do not implant the IPG if it has been dropped onto a hard surface. » 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 a component, which may cause component failure.Before implanting an IPG, verify that the IPG is fully charged, verify IPG function, and determine the IPG implant site. A fully charged IPG allows the wound to heal before a recharge is needed.Verify that the IPG is functioning by using the Clinician Programmer to read the IPG battery charge level. (Refer to the Clinician Programming Manual for instructions on how to read the battery charge level.)To charge the IPG and verify that the IPG is functioning:1.  If the Programmer Charger needs charging, connect the power cord and AC power adapter to the Programmer Charger, and plug the AC power adapter into a wall outlet.Note: To determine if the Programmer Charger needs charging, see the Patient System Manual.2.  Connect the charging paddle to the Programmer Charger.3.  Turn the Programmer Charger on by sliding and holding the power on/o button on the side of the Programmer Charger.4.  Li the ap on the top of the IPG shelf carton and place the charging paddle on the window over the IPG (Figure 2).IPG implant.indb   9 3/3/14   8:46 AM
10      Implant Manual for StimulatorImplant Procedure1          1212         2412,LLCFigure 2.  Preoperatively check the IPGIPG implant.indb   10 3/3/14   8:46 AM
Algovita Spinal Cord Stimulation System  Implant Manual for Stimulator    115.  When the Notication screen appears, select Cancel (Figure 3).NotificationNot able toconnect with IPGCancel RetryFigure 3.  Notication screen6.  When the Main screen appears, select   (Figure 4).PFigure 4.  Main screenIPG implant.indb   11 3/3/14   8:46 AM
12      Implant Manual for StimulatorImplant Procedure7.  While the IPG is charging, the Charge Status screen is displayed (Figure 5).>Charge StatusOKCharge StatusCharging inProgressOKFigure 5.  Charging in progress.8.  When the Charge Status screen shows that charging is complete, select OK (Figure 6).Charge StatusCharging completeOKFigure 6.  IPG charging completeIPG implant.indb   12 3/3/14   8:46 AM
Algovita Spinal Cord Stimulation System  Implant Manual for Stimulator    13Explanting the IPG 1.  Turn o the IPG.2.  Place the patient in a position that will allow access to the IPG.3.  Use standard sterile technique to prepare and drape the patient.4.  Administer prophylactic antibiotics according to an infection control protocol.Caution: To help prevent infection, use prophylactic antibiotics. An infection may require the removal of the entire SCS system.5.  Using standard surgical technique, open the IPG pocket.6.  Remove the IPG from the pocket.7.  Use the Algovita torque wrench to unscrew the setscrews. 8.  Remove the leads or extensions from the IPG header. 9.  Return the explanted IPG components to Algovita as instructed in the Returning Explanted Components on page 18.Connecting the Leads or Extensions to the New IPG 1.  Prepare the lead or extension for connection to the new IPG.a.  Wipe the lead or extension contacts dry with sterile gauze.Note: Wipe gloves dry before drying or cleaning components.   b.  If the contacts came in contact with body uids or saline, thoroughly clean the contacts with sterile deionized or sterile water, then dry them completely.Caution: Before connecting a lead or extension to the IPG, wipe o any body uids and dry the connections. Fluids in the connections may result in stimulation at the connection site, intermittent stimulation, or loss of stimulation. c.  Inspect the lead or extension for any evidence of damage or corrosion. Explant and replace any damaged or corroded component.2.  Fully insert each lead into the appropriate connector port.Caution: Do not use saline or other ionic uids at connections. Ionic uids in the connection may cause in a short circuit. a.  Grasp the lead or extension in the middle of the contacts.IPG implant.indb   13 3/3/14   8:46 AM
14      Implant Manual for StimulatorImplant Procedureb.  Slowly insert the lead or extension into the appropriate connector port (Figure 7), stopping when the lead or extension begins to meet resistance or your ngers touch the connector port.12,LLC12,LLCFigure 7.  Insert the lead or extension into the connector port.c.  Grasp the lead or extension near the setscrew ring (Figure 8).12,LLC12,LLCFigure 8.  Grasp near setscrew ring.d.  Using a steady force, continue inserting the lead or extension into the connector port.e.  When the lead is fully inserted, you will see the end of the lead move to the back of the connector port and feel it stop against the back of the connector port. e setscrew ring will be aligned with the setscrew.f.  Repeat the insertion steps for additional leads or extensions.IPG implant.indb   14 3/3/14   8:46 AM
Algovita Spinal Cord Stimulation System  Implant Manual for Stimulator    153.  Insert a port plug into any connector port not being used for this implant (Figure 9). 12,LLCFigure 9.  Insert a port plug into any unused port.4.  Using the torque wrench provided in the IPG package, tighten each lead, extension, and port plug.Cautions: » Use only the torque wrench that is part of the Algovita SCS System. Using another torque wrench may damage the lead, and may result in stimulation at the connection site, intermittent stimulation, or loss of stimulation.  » e torque wrench is single use only. Do not resterilize the torque wrench because of risk of infection or device malfunction.a.  Fully insert the torque wrench into the grommet in the IPG header until it stops in the setscrew socket. Caution: Make sure the torque wrench is fully inserted into the grommet before tightening because the setscrew may be damaged, resulting in intermittent stimulation or loss of stimulation.b.  Turn the torque wrench clockwise until it clicks once (Figure 10). If you continue to turn, the wrench will continue to click, but the additional turns do not tighten the setscrew further.IPG implant.indb   15 3/3/14   8:46 AM
16      Implant Manual for StimulatorImplant Procedure12,LLCFigure 10. Tightening the setscrews.Checking System Integrity 1.  To ensure the leads or extensions have been properly connected to the IPG and to rule out a short or open circuit, use the Clinician Programmer to program the basic stimulation parameters, check the battery charge level, and check the electrode impedances.2.  If the system integrity test results are not acceptable, check the connections made in Connecting the Leads or Extensions to the New IPG on page 13.Implanting the New IPG1.  Making sure of the following, place the IPG into the subcutaneous pocket (Figure 11):  » IPG is parallel to the skin and the Algovita logo is facing outward  » Lead or extension is loosely coiled behind the IPG with no sharp bends in the coils » IPG is placed no deeper than 1.5 cm below the skinCaution: Ensure that the IPG is placed deep enough to avoid dehiscence or erosion. Also ensure that the IPG is placed no deeper than 1.5 cm (0.59 in) below the skin and is parallel to the skin. If the IPG is too deep or is not parallel to the skin, communication with the programmers and recharge connection may be inecient or unsuccessful.IPG implant.indb   16 3/3/14   8:46 AM
Algovita Spinal Cord Stimulation System  Implant Manual for Stimulator    1712,LLCFigure 11. Place the IPG in the pocket.2.  Secure the IPG in the pocket with a suture through each suture hole in the header.Completing the Implant Procedure1.  Close and dress all wounds. 2.  Complete the implant registration form and return the documents to Algostim, LLC in the business reply envelope supplied in the packaging.3.  Fill out the temporary patient identication card.Patient Counseling InformationProvide the patient with the appropriate information applicable to the SCS surgical procedure.SCS System Implant: IPG Replacement• Provide your patient with postoperative care cautions that include the following: » Not drive any vehicles or operate any other dangerous equipment (for example, power tools) with stimulation on » Not engage in rigorous physical activity such as twisting, bending, or climbing » Not stretch or reach the arms above the head » Not li objects weighing more than 5 pounds (2 kilograms) » Not to place the charging paddle on an unhealed woundIPG implant.indb   17 3/3/14   8:46 AM
18      Implant Manual for StimulatorRegistration Form and Temporary Patient ID Card  » Keep metal objects away from charging paddle »  Call your oce: » If patient notices redness around an incision, at any signs of bleeding, pus-like drainage, persistent drainage, redness, excessive swelling, or excessive pain » At any signs or symptoms of extreme nausea or persistent headache » At any signs of sudden severe pain, leg weakness, spasm, loss of bladder and/or bowel function  » If patient notices redness at the charging site » If patient is not receiving adequate pain reliefRegistration Form and Temporary Patient ID Card At the time of implantation, complete the implant registration form in the product package and return it to Algostim, LLC. Registration initiates the system warranty. A temporary patient identication card is packaged with the IPG. A permanent identication card will be mailed to the patient when Algostim, LLC receives the implant registration form.Returning Explanted Components Return explanted leads, extensions, IPGs, and anchors to Algostim, LLC. e IPG should be explanted before cremation. e cremation process may cause the IPG battery to explode. Do not autoclave the components or expose them to ultrasonic cleaning. Dispose of unreturned components according to local environmental regulations. Algostim Customer ServiceIf you have any questions about an Algovita SCS System, call Algostim Customer Services at XXX-XXX-XXXX. Algostim Customer Service is available 24 hours a day, 7 days a week.IPG implant.indb   18 3/3/14   8:46 AM
Algovita Spinal Cord Stimulation System  Implant Manual for Stimulator    19SpecicationsTable 1.  Operating Values for Stimulator Model 2408 and 2412Programmable parameter  Operating range and resolutionaNumber of programs  1 to 10Number of pulses per sub-program 1 to 4Electrode conguration  2 to 24 electrodes and IPG can as anode, cathode, or oAmplitude 0 to 15 mA per channel (IPG pulse maximum 30 mA) (Max 17 V)Pulse width  20 to 1500 μs (20 μs resolution)Frequency 2 to 2000 Hz (64 frequency options)Ramp on/o  O, On: 1, 2, 4, or 8 second durationa.  e Algovita SCS System includes programmable coverage areas with each individual electrode contact limited to 15 mA. A programming interlock is enforced to limit the coverage area output current to 30 mA or less. Table 2.  Component Materials for Stimulator Model 2408 and 2412Components   Material Material Contacts Human TissueIPGCaseHeaderTitaniumPolysulfonePolyurethaneSiliconeSilicone rubberYe sYe sYe sYe sYe sSetscrews  Titanium Ye sTorque wrenchHandleShaPolyether ether ketoneStainless steelYe sYe sPort plugs Polyurethane Ye sIPG implant.indb   19 3/3/14   8:46 AM
20      Implant Manual for StimulatorSpecificationsTable 3.  Specications for Stimulator Model 2408 and 2412Description  ValueConnectorTypeDiameter3-Octapolar in-line 2.54 mm (0.100 in) spacing – Model 24082-Dodecapolar in-line 2.54 mm (0.100 in) spacing – Model 24121.4 mm (0.05 in)Height  55.0 mm (2.2 in)Length  58.0 mm (2.3 in)icknessCase 9.5 mm (0.4 in)Weig ht 40.0 g (1.4 oz)Volume  20.5 cm3 – 2408, 19.5 cm3 – 2412 (1.25 in3 – 2408, 1.19 in3 – 2412)Battery life  10 yearsPower source  Lithium ion rechargeable battery – fully recoverable batteryStorage temperature  –35° to 55°C (-31° to 131°F)Radiopaque Identication (ID) code  ALG24Lead retention strength Meets EN45502-1 requirementsWireless Informationis transmitter is authorized by rule under the Medical Device Radiocommunication Service (in part 95 of the FCC Rules) and must not cause harmful interference to stations operating in the 400.150–406.000 MHz band in the Meteorological Aids (ie, transmitters and receivers used to communicate weather data), the Meteorological Satellite, or the Earth Exploration Satellite Services and must accept interference that may be caused by such stations, including interference that may cause undesired operation. is transmitter shall be used only in accordance with the FCC Rules governing the Medical Device Radiocommunication Service. Analog and digital voice communications are prohibited. Although this transmitter has been approved by the Federal Communications Commission, there is no guarantee that it will not receive interference or that any particular transmission from this transmitter will be free from interference.IPG implant.indb   20 3/3/14   8:46 AM
Algovita Spinal Cord Stimulation System  Implant Manual for Stimulator    21Algovita SCS System Component CompatibilityOnly Algovita SCS System components should be used as part of an implanted Algovita SCS System.Table 4.  Algovita SCS System Component CompatibilityStimulator Model 2408 (3x8)Extension Model 5208 (1x8)Stimulator Model 2412 (2x12)Extension Model 5212 (1x12)Trial  Stimulator Model 4300Clinician Programmer Model 4500Programmer Charger Model 4200Pocket Programmer Model 4100 For Placing 1–3 8-electrode Leads   Percutaneous LeadModels 1081-xx1, 1084-xx, 1086-xx █ █ █ █ █ █Trial LeadModels 1081-xxT, 1084-xxT(Percutaneous)█ █ █ █ █ For Placing 1–2 12-electrode Leads Percutaneous LeadModels 1121-xx, 1124-xx, 1126-xx█ █ █ █ █ █Paddle LeadModel 3000-xx(3-4-3-2)█ █ █ █ █ █Paddle LeadModel 3101-xx(2x6)█ █ █ █ █ █Trial Lead Models 1121-xxT, 1124-xxT (Percutaneous)█ █ █ █ █1. Denotes lengthIPG implant.indb   21 3/3/14   8:46 AM
22      Implant Manual for StimulatorAlgovita SCS System Component CompatibilityIPG implant.indb   22 3/3/14   8:46 AM
IPG implant.indb   23 3/3/14   8:46 AM
©Algostim, LLC 2014All Rights ReservedPart Number 10069770300-000021-05Revision 5March 2014Algostim, LLC10675 Naples St. NEBlaine, MN 55449763.786.7400www.algostim.comAuthorized Representative in EuropeEmergo EuropeMolenstraat 152513 BH The Hague The Netherlands (31) (0) 70 345-8570IPG implant.indb   24 3/3/14   8:46 AM

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