Nuvectra 4300 4300 User Manual

Algostim, LLC 4300

User Manual

Material Specification Title: IFU, Algovita SCS, Trial Stimulator Manual for Clinicians Document Number and Revision 0300-000026-06 Page 1 of 2 Prepared By: Amy Kosbau Approved By: QIG Group The information contained in this document is the sole property of QIG Group. Any reproduction in part or whole without the written permission of QIG Group is prohibited. Do not print the material specification notes pages when printing the literature piece. Do not count the material specification notes pages in the literature piece page count. 1.0 PURPOSE To define all parameters necessary to assure conformance to appropriate specifications. 2.0 SCOPE This specification describes the configuration and content for the IFU, Algovita SCS, Trial Stimulator Manual for Clinicians 3.0 RESPONSIBILITY It is the responsibility of the product development engineer, manufacturing engineer or labeling engineer to maintain this document in accordance with Algostim requirements. 4.0 MATERIAL CHARACTERISTICS 4.1 Content: The content of the instructions for use document shall be defined in the files and PDF provided by Algostim. 4.2 Material: The paper shall be: 4.2.1 Front/Back Cover: 80# uncoated cover 4.2.2 Inner Pages: 40# white smooth opaque text stock. 4.3 Color: 4.3.1 4-color 4.4 Physical Size: 4.4.1 All dimensions are in inches unless otherwise noted. 4.4.2 7.25 ± .20 length x 6.50 ± .20 width 4.5 Type of Binding: Perfect Bound 4.6 Other: 4.6.1 Literature Piece Page Count (including covers, excluding specification notes pages) 34 4.7 Language Translation Requirements & Configuration: 4.7.1 English (en) 5.0 STORAGE CONDITION Store in dry location.
Material Specification Title: IFU, Algovita SCS, Trial Stimulator Manual for Clinicians Document Number and Revision 0300-000026-06 Page 2 of 2 QIG Group The information contained in this document is the sole property of QIG Group. Any reproduction in part or whole without the written permission of QIG Group is prohibited. 6.0 QUALITY CHARACTERISTICS 6.1 Clarity of Text: The text shall be easily readable and free of smears and smudges. Graphics content, layout and text shall be consistent with that in the document (pdf) provided by the customer. 6.2 Workmanship: The booklet shall be uniformly cut along its edges and free of significant rough edges or paper slivers. 6.3 Color: Color shall be uniform throughout each lot. 6.4 Lot Quality: Any lot of material, which does not meet the requirements of this specification, is subject to return. Greatbatch Medical reserves the right to return entire lots of material which fail to meet the requirements of this specification. 7.0 PACKAGING/LABELING 7.1 Each package provided by the supplier shall be labeled with: Greatbatch part number, revision level of this specification document, quantity, supplier name, and date of manufacturing. 7.2 A Certificate of Conformance is required with each shipment to include quantity, material characteristics, Greatbatch part number, revision, PO, lot and date of manufacturing. NOTE: Graphics Content and Layout to be shown and per Algostim file.
Algovita™ Spinal Cord Stimulation System Trial Stimulator Model 4300External Pulse Generator (EPG)2014ONLYTrial Stimulator Manual for Clinicians
Refer to the Information for Prescribers Manual for indications, contraindications, warnings, pre-cautions, adverse events, clinical study results, and related information.Algovita™ is a trademark of QIG Group, LLCFCC Information (US Only) e following is communications regulation information about the Algovita Trial Stimulator and Pocket Programmer.Trial Stimulator FCC ID: 2ABU84300Pocket Programmer FCC ID: 2ABU84100ese devices comply with part 15 of the FCC Rules. Operation is subject to the following two con-ditions: (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 the products not authorized by Algostim, LLC could void the FCC certication and negate your authority to operate these products.
Algovita Spinal Cord Stimulation System Trial Stimulator Manual 1ContentsExplanation of Symbols Used on Packaging and Trial Stimulator 3Introduction 5Package Contents 5Important Safety Information 6Contraindications 6Warnings 6Precautions 7Adverse Events 8EPG Description 10Turning the EPG On or Off 11Quick Stimulation Off 12Using the EPG During Intraoperative Test Stimulation 13Connecting the Trial Cable to the EPG 13Disconnecting the Trial Cable from the EPG 14Stimulation Trial 15Preparing the EPG for a Stimulation Trial 15After the Stimulation Trial 15Changing the EPG Batteries 16Checking the Battery Charge Status 16Changing the Batteries 17EPG Care and Storage 18General EPG Cleaning 18Cleaning the EPG After Use 18Cleaning the EPG Battery Contacts 18
EPG Service and Replacement 19Disposal 19Troubleshooting 20Algostim Customer Service 21Specications 22Electromagnetic Compatibility Declaration 24Wireless Information 28
Algovita Spinal Cord Stimulation System Trial Stimulator Manual 3Explanation of Symbols Used on Packaging and Trial StimulatorSymbol Explanation2014Conformité Européenne (European Conformity). is symbol means that the device fully complies with European Directive AIMD 90/385/EEC and R&TTE Directive 1999/5/ECONLYCaution: Federal Law (USA) restricts this device to sale on or by the order of a physicianis device complies with Part 15 of the Federal Communication Commission rulesAuthorized representative in EuropeCautionConsult instructions for useSerial numberManufacturerDate of manufactureCatalogue numberModelTemperature limitHumidity limitation
4 Trial Stimulator ManualExplanation of Symbols Used on Packaging and Trial StimulatorSymbol ExplanationFragile, handle with careKeep dryAtmospheric pressure limitationKeep away from sunlightDo not use if package is damagedNon-ionizing radiationType BF equipmentBatteryClass II equipmentNot for general wasteRecycleContentsTelephone
Algovita Spinal Cord Stimulation System Trial Stimulator Manual 5Introductione Algovita™ Trial Stimulator Model 4300 (Figure 1) is part of the Algovita Spinal Cord Stimulation (SCS) System, a rechargeable, 24-electrode, SCS system for the treatment of chronic pain.Figure 1. Algovita Trial Stimulator Model 4300 e trial stimulator is the external pulse generator (EPG) for the Algovita SCS System. e EPG is used by the physician during intraoperative test stimulation and is used by the patient as part of the Algovita Trial Stimulation System. e EPG allows the physician to program system congurations identical to either the Algovita Stimulator Model 2408 (3x8 channel) or the Stimulator Model 2412 (2x12 channel).e EPG is programmed using the Clinician Programmer. During a stimulation trial, the patient controls the EPG using the Pocket Programmer.Package Contents• Trial Stimulator Model 4300• Trial Stimulator Pouch• AAA Batteries (2)• Product Literature
6 Trial Stimulator ManualImportant Safety InformationImportant Safety InformationContraindicationsDiathermy. Shortwave, microwave and/or therapeutic ultrasound diathermy must not be used on SCS patients. e energy generated by diathermy can be transferred through the SCS system, causing tissue damage at the lead site which may result in severe injury or death.WarningsElectrocautery. Electrocautery devices should not be used in close proximity to an SCS trial system. Contact between an active electrode and an implanted SCS system component can cause direct stimulation of the spinal cord, which may result in severe injury to the patient If use of electrocautery is necessary:1. Turn the EPG o.2. Use bipolar cautery.3. Verify system and therapy function aer electrocautery use.Electromagnetic Interference. Strong electromagnetic elds can potentially turn stimulation o or change the strength of stimulation, which may cause an uncomfortable or jolting sensation. If uncomfortable stimulation occurs, advise patients to move away from the area or turn stimulation o.Patients should also exercise care around: • e detectors or security screeners such as those used at entrances or exits of department stores, libraries, and other public establishments, and airport security screening devices. Patients should exercise caution when approaching such a device and should request assistance to bypass the device. If the patient must proceed through the device, the patient should turn the EPG o and proceed with caution, moving through the center of the screener as quickly as possible.• Power lines or power generators• Electric steel furnaces and arc welders• Large, magnetized stereo speakers• erapeutic magnets
Algovita Spinal Cord Stimulation System Trial Stimulator Manual 7Interaction with Implanted Sensing Stimulators and Other Implanted Devices. SCS systems may interfere with the operation of implanted sensing stimulators such as pacemakers or cardioverter debrillators (ICDs). If other implanted devices are indicated for the patient, careful screening is required to determine if safe results can be achieved before permanently implementing concurrent electrical therapies. e eects of implanted SCS systems on other implanted devices are unknown.Magnetic resonance imaging (MRI). Patients with the Algovita SCS system must not be exposed to MRI. e electromagnetic eld generated by an MRI may forcefully dislodge the IPG or leads, damage the IPG electronics, and induce voltage through the lead that may cause an uncomfortable or jolting sensation or serious injury. e Algovita SCS System components have not been tested for heating or migration in the MR environment. Introducing an Algovita SCS patient into an MRI scanner may result in severe patient injury, death, or device malfunction.Modication. Do not modify the EPG. Modication of any SCS system component may result in damage to the system, compromised system integrity, and harm or injury to the patient. Radio-frequency or microwave ablation. Safety has not been established for radiofrequency (RF) or microwave ablation in patients who have an SCS system. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage.PrecautionsSystem Interaction with Other Medical Treatments and Procedures. An IPG may interact with the following therapies or procedures:• Diagnostic x-rays. e eects of diagnostic x-rays on a stimulator are typically transient because interference occurs only during the time of x-ray exposure. In some cases, the EPG may need to be reprogrammed.e following therapies or procedures may turn your stimulation o or may cause permanent damage to your stimulator, particularly if used in close proximity to the EPG.• Radiotherapy• Lithotripsy• External debrillation • Radiation therapy• Ultrasonic scanning• High-output ultrasound
8 Trial Stimulator ManualImportant Safety Information• CT scans may damage the EPG if stimulation is on. CT scans are unlikely to damage the EPG if stimulation is turned o.If any of the therapies or procedures listed above are required by medical necessity:• Adjust stimulation to its lowest level before the procedure or application then turn the EPG o.• All equipment, including ground plates and paddles, must be used as far away from the EPG as possible.• Every eort should be taken to keep elds, including current, radiation, or high-output ultrasonic beams, away from the EPG. • Set equipment to the lowest energy setting clinically indicated. • Verify SCS system and therapy function following treatment.Component Compatibility. Use only the Clinician Programmer, or an Algovita patient programmers and accessories in your Algovita SCS System to adjust stimulation. e eects of non-Algovita components on an Algovita SCS System are unknown. Flammable Atmospheres. Avoid using the EPG in ammable or explosive environments (eg, an anesthetic mixture with air, oxygen, or nitrous oxide). Using a battery-powered device near ammable or explosive atmospheres can produce a spark which may cause injury..Adverse Eventsere are potential risks involved with any surgery. e possible risks of using a trial stimulation system are similar to the risks that can occur with other spinal procedures. ese risks include:• e most common risks are temporary pain at the incision or infection.• ere is a small possibility of developing a cerebral spinal uid (CSF) leak.• In rare cases bleeding (epidural hemorrhage), a blood clot (hematoma), or a pocket of uid (seroma) may develop at the location where leads are placed.• In rare cases, injury to the spinal cord may occur, resulting in paralysis.• e use of blood thinners may increase the risk of complications such as blood clots (hematomas), which may produce paralysis.e possible risks of using a trial stimulation system to evaluate a treatment for chronic pain include:• e leads may shi or move from the location where they were originally implanted. Such a change in location may cause changes in stimulation, sometimes unpleasant, and/or reduce
Algovita Spinal Cord Stimulation System Trial Stimulator Manual 9the pain relief provided by the SCS system.• e SCS system may fail at some point, due to a random component or battery failure. Examples of failure include lead or lead insulation break, loose connection, electrical short, or component malfunction. A failure may reduce or stop the pain relief provided by the SCS system.• A patient may have an allergic reaction or become irritated by materials that are used to manufacture the SCS system components. Signs of a negative reaction are persistent redness, swelling, or warmth at the area where the system is implanted• A patient may have ongoing pain in the area where a lead or extension is located.• A patient may have unpleasant or painful stimulation. Such changes in stimulation may occur if stimulation settings are changed too quickly, a lead moves or breaks, or there is a loose electrical connection in your SCS system.• A patient may experience weakness or numbness in areas below your SCS system location.• A patient may experience changes in stimulation, painful stimulation, or problems with the operation of the SCS system due to electromagnetic interference from other electrical devices, medical equipment, or medical procedures.
10 Trial Stimulator ManualEPG Description EPG Description Figure 2. EPG button and status lightse button on the EPG (Figure 2) allows you to turn the EPG on and o and turn stimulation o. Turn stimulation on using the Clinician Programmer or one of the patient programmers. e lights on the EPG allow you to verify if the EPG or stimulation is on or o. • EPG On/O —Turn the EPG on or o by pressing the button for 5 seconds.• Quick Stimulation O —Turns stimulation o by pressing the button for 2 seconds.• Stimulation On/O Light —Check if stimulation is on or o. • EPG Battery Status Light —Check if the EPG is on and the battery charge level is above 25% (ashes green) or below 25% (ashes red).• Ground Pad Connector Port—is port is used to connect an optional (electrophysiology) ground pad to the EPG. e ground pad is required with the use of the Algostim Computer Aided Stimulation Programming (CASP) feature. See the Clinician Programming Manual for instructions on using CASP.Ground Pad Connector PortEPG On/Off and Quick Stimulation OffEPG Battery Status Light Stimulation On/Off Light
Algovita Spinal Cord Stimulation System Trial Stimulator Manual 11Turning the EPG On or OffFigure 3. Turning the EPG on or oBefore turning stimulation on, the EPG must be on (Figure 3). To turn the EPG on:• Press the EPG On/O button (Figure 3) and hold for approximately 5 seconds. Aer a short delay, the EPG turns on, and the EPG Battery Status light ashes green. When the EPG turns on, stimulation is o.Notes: » If the EPG Battery Status light ashes red, replace the EPG batteries. For instructions, see Changing the EPG Batteries on page 16. » Turn stimulation on using the Clinician Programmer or one of the patient programmers.To turn the EPG o:• Press the EPG On/O button (Figure 3) and hold for approximately 5 seconds. e EPG Battery Status light turns o.Note: e EPG On/O button and Quick Stimulation O button are the same button. Pressing and holding the EPG On/O button for approximately 2 seconds turns stimulation o.EPG On/OffEPG OffEPG On (ashing)
12 Trial Stimulator ManualQuick Stimulation OffQuick Stimulation OffFigure 4. Quickly turning stimulation oTo quickly turn stimulation o using the EPG:• Press the Quick Stimulation O button (Figure 4) and hold for approximately 2 seconds. Aer a short delay, stimulation turns o, and the Stimulation On/O light turns o.Notes: » e Clinician Programmer includes a Quick Stimulation O icon on stimulation screens, and a Quick Stimulation O button on the top of the Clinician Programmer. » If you are unable to turn stimulation o, press the tabs on either side of the trial cable connector, and disconnect the trial cable from the EPG. » e Quick Stimulation O button and the EPG On/O button are the same button. Pressing and holding the Quick Stimulation O button for approximately 5 seconds turns the EPG o. » Turn stimulation on using the Clinician Programmer.Stimulation OffStimulation On (ashing)Quick Stimulation Off
Algovita Spinal Cord Stimulation System Trial Stimulator Manual 13Using the EPG During Intraoperative Test StimulationAer placing the leads and connecting the leads to the trial cable, connect the trial cable to the EPG, turn the EPG on, then turn stimulation on using the Clinician Programmer. During intraoperative test stimulation, use the Clinician Programmer to program the EPG. For additional procedural instructions, see the system implant manual packaged with the lead. For programming instructions, see the Clinician Programming Manual.Connecting the Trial Cable to the EPGCaution: e trial cable is a single-use component; do not resterilize the trial cable because of risk of infection.To connect the trial cable to the EPG:1. Check that stimulation is o. Caution: Connecting the trial cable to the EPG with stimulation on may cause an uncomfortable or jolting sensation.2. To prevent the lead from pulling out from the spine, secure the trial cable to the drape before passing the end of the cable o the sterile eld. 3. Aer the cable end is passed o the sterile eld, tape the non-sterile end on top of the sterile drape, to prevent the non-sterile cable end from falling back into the sterile eld.4. With the arrow on the trial cable end and the Algovita logo facing the same direction, connect the trial cable to the EPG (Figure 5). Caution: Maintain adequate slack on the trial cable. Do not pull the trial cable taut. Pulling on the cable may dislodge the lead, which may result in loss of stimulation.Figure 5. Connecting the trial cable to the EPG5. Turn the EPG on.6. Turn stimulation on using the Clinician Programmer.
14 Trial Stimulator ManualUsing the EPG During Intraoperative Test StimulationDisconnecting the Trial Cable from the EPGTo disconnect the trial cable from the EPG:1. If you want to save battery power, turn the EPG o.2. While squeezing both tabs on the trial cable connector (Figure 6), gently disconnect the cable from the EPGCaution: Do not pull directly on the trial cable. Pulling on the trial cable may break a wire or dislodge the lead. A broken wire or dislodged lead may result in loss of stimulation and may require another trial procedure to replace the lead.Figure 6. Disconnecting the trial cable
Algovita Spinal Cord Stimulation System Trial Stimulator Manual 15Stimulation Trial e patient uses the EPG during the stimulation trial. For detailed instructions on preparing the patient for a stimulation trial and evaluating a stimulation trial, see the system implant manual packaged with the leads.Preparing the EPG for a Stimulation TrialBefore beginning a new stimulation trial:• Inspect the EPG and make sure it is not damaged.• Clean the EPG. Follow your healthcare facility’s procedures in the cleaning of medical devices or use the procedure Cleaning the EPG Aer Use on page 18.• Make sure the EPG has new batteries installed.• Make sure the EPG has been cleared of previously stored data. See the Clinician Programming Manual for instructions on clearing data from the EPG.After the Stimulation TrialAer the stimulation trial, the patient returns the trial stimulation system to the physician. When returned, clean the EPG. Follow your healthcare facility’s procedures in the cleaning of medical devices or use the procedure Cleaning the EPG Aer Use on page 18.If you and the patient determine that an Algovita SCS system will be implanted, and you want to move the program settings from the EPG to an IPG, see Swapping an EPG for an IPG in the Clinician Programming Manual for information.
16 Trial Stimulator ManualChanging the EPG BatteriesChanging the EPG Batteriese EPG is powered by two AAA batteries. Replace the EPG batteries before each stimulation trial or when the batteries are low or depleted. If the EPG loses power, the program settings remain at the settings last programmed, whether set by the clinician or changed by the patient. Caution: Do not leave depleted batteries in the EPG. e batteries may corrode and cause damage to the electronic components. If the EPG is not to be used for several weeks, remove the batteries. Checking the Battery Charge Statuse EPG has a ashing EPG Battery Status Light (Figure 7).• When the battery charge level is above 25%, the light ashes green. • When the EPG battery charge level is at or below 25%, the light ashes red. If the light is ashing red, change the EPG batteries in order to maintain stimulation.• If the EPG battery is depleted, the EPG will not turn on.Figure 7. EPG Battery Status LightNote: e Clinician Programmer may also be used to check the EPG battery charge status. See the Clinician Programming Manual for detailed information.EPG On (ashing) and EPG Battery Above 25%EPG On (ashing) and EPG Battery Below 25%EPG Off
Algovita Spinal Cord Stimulation System Trial Stimulator Manual 17Changing the Batteries1 243Figure 8. Replacing the EPG batteriesTo change the EPG batteries (Figure 8):1. Using a Phillips screwdriver, loosen the screw on battery compartment cover.2. Remove the battery compartment cover and batteries.3. Insert the new batteries following the polarity diagram in the battery compartment.4. Replace the battery compartment cover, then insert and tighten the screw.
18 Trial Stimulator ManualEPG Care and StorageEPG Care and Storagee following recommendations are made for the care and storage of the EPG:• Keep new batteries available.• Replace low or depleted batteries.• Do not drop the EPG. Protect the EPG from sharp objects and physical shocks. Mishandling can permanently damage the EPG.• e sensitive electronics of the EPG can be damaged by temperature extremes, particularly high heat. » Do not expose the EPG to excessively hot or cold conditions, including leaving the EPG in your car or outdoors for extended periods of time. » If the EPG is to be stored for a period of time, be careful that the storage temperature is not less than -20°C (-4°F) or greater than 60°C (140°F).General EPG Cleaning• e EPG is not waterproof. Do not immerse the EPG in liquid or allow moisture to get inside the case.• If the EPG is dirty, clean the outside with a slightly damp cloth. Do not clean the EPG with bleach, nail polish remover, or similar substances.Cleaning the EPG After UseAer using the EPG for intraoperative test stimulation, clean the EPG before giving it to a patient for a stimulation trial. Also clean the EPG when a patient returns the EPG aer a stimulation trial. Follow your healthcare facility’s procedures in the cleaning of medical devices. If your healthcare facility does not have a cleaning procedure:1. Inspect the EPG for any dirt, debris or residue.2. Clean the EPG, as appropriate, with hospital-grade isopropyl alcohol (IPA).3. Before using the EPG, make sure it is clean and dry.Cleaning the EPG Battery Contactse EPG battery contacts may be cleaned periodically with a cotton swab dampened with alcohol. Do not use a pencil eraser or sandpaper.
Algovita Spinal Cord Stimulation System Trial Stimulator Manual 19EPG Service and Replacemente components have no user-serviceable parts. Only Algostim, LLC should service or repair the EPG. Do not attempt to open or repair the EPG. Unauthorized repairs will void the warranty. If the EPG needs service or repair, contact Algostim Customer Service. When contacting Algostim Customer Service, have the EPG serial numbers available. e serial number is located on the back of the EPG.Note: e Limited Warranty does not cover loss or the of the EPG or damage caused by misuse. For additional information, refer to the Limited Warranty packaged with this manual.DisposalTo dispose of the EPG, consult local regulations for proper disposal of AAA batteries and electronic devices. Return explanted leads, extensions, anchors to Algostim, LLC. Do not autoclave the components or expose them to ultrasonic cleaning. Dispose of unreturned components according to local environmental regulations.
20 Trial Stimulator ManualTroubleshooting Troubleshooting e following tables cover stimulation and EPG troubleshooting. If you are having a problem with your EPG and do not nd an answer in these tables, contact Algostim Customer Service.Table 1. Stimulation and EPG TroubleshootingIndication Possible Cause Possible SolutionYou want to turn stimulation o quickly, but stimulation will not turn o.You are not holding the Quick Stimulation O button down for the correct amount of time.Make sure you are holding the Quick Stimulation O button down for 2 seconds. e EPG has malfunctioned. Press the tabs on either side of the trial cable connector, and disconnect the trial cable from the EPG.e patient no longer feels stimulation.e strength of the active program is too low.Increase the strength of the active program.e EPG is turned o. Turn your EPG on.Stimulation is o. Although unlikely, stimulation may have been turned o by EMI from security gates or other electronic devices. Verify that stimulation is on. e EPG batteries are depleted. Check the EPG battery charge level, and change the batteries if needed. A lead has moved or lead has become disconnected from the trial cable. 1. Turn the EPG o.2. Inspect the trial stimulation system connections and lead location.e EPG Battery Status Light or the Stimulation On/O Light are ashingTo conserve battery power, when the status lights are on, they always ash. e EPG will not turn on. You are not holding the EPG On/O button down long enough.Make sure you are holding the EPG On/O button down for 5 seconds.e EPG batteries are depleted. Check the EPG battery charge level, and change the batteries if needed.
Algovita Spinal Cord Stimulation System Trial Stimulator Manual 21Table 1. Stimulation and EPG TroubleshootingIndication Possible Cause Possible Solutione EPG will not turn o. You are not holding the EPG On/O button down long enough.Make sure you are holding the EPG On/O button down for 5 seconds. Holding this button down for 2 seconds, turns stimulation o.e EPG has malfunctioned. Press the tabs on either side of the trial cable connector, and disconnect the trial cable from the EPG. Algostim Customer ServiceIf you have any questions about an Algovita SCS System, call Algostim Customer Service toll-free at 1-844-727-7897 within the United States. Outside of the United States, call your product distributor for assistance. If additional assistance is needed, contact Algostim Customer Service +1-214-618-4980.
22 Trial Stimulator ManualSpecificationsSpecicationsTable 2. Operating Values for Model 4300Description ValueNumber of programs 1 to 10Number of sub-programs per program 1 to 4Electrode conguration Up to two 12 electrode leads or three 8 electrode leads Amplitude – upper patient limit ±15.0 mAAmplitude – lower patient limit ±0.017 mAPulse width 20 to 1500 μs (20-μs resolution)Frequency – upper patient limit 2000 HzFrequency – lower patient limit 2 HzTable 3. Physical Characteristics for Trial Stimulator Model 4300Description ValueLength 86.4 mm / 3.4 inWidth 51 mm / 2.0 inickness 22 mm / 0.85 inCable Connector 24 pin contact cable connector
Algovita Spinal Cord Stimulation System Trial Stimulator Manual 23Table 4. Electrical and Operating Characteristics for Trial Stimulator Model 4300Description ValuePower source 2 AAA alkaline batteries 1.5vOperating Type ContinuousNote: e Ground Pad port may be connected to a standard electrophysiology ground pad using a DIN 42-802 1.5mm touch-proof connector, and is analogous to using the hermetic enclosure of the IPG in stimulation.Table 5. Storage and Operating Conditions for Trial Stimulator Model 4300Parameter ValueOperating temperature 10 to 40° Celsius (50-104°F)Storage temperature -20 to 60° Celsius (-4 to 140°F)Maximum humidity 10% to 85% non-condensingMinimum atmospheric pressure 70 kPaMaximum atmospheric pressure 106 kPaTable 6. Component Materials for Trial Stimulator Model 4300Component MaterialEPG Acrylonitrile butadiene styrenePolycarbonate
24 Trial Stimulator ManualElectromagnetic Compatibility DeclarationElectromagnetic Compatibility Declarationis section lists the EMC Declaration tables. e EPG is intended for use in the electromagnetic environment specied below. e customer or the user of the EPG should assure that it is used in such an environment. e EPG contains RF transmission and receiving capabilities; consequently, it is possible that other portable and mobile RF communications equipment may interfere with the EPG. e trial cable (maximum length 213 cm [84 in]) and ground pad (maximum length 200 cm [79 in]) were included in the system testing to demonstrate compliance with the requirements of IEC 60601-1-2 2007. Use of accessories and cables other than those specically listed may result in increased emissions or decreased immunity of the EPG.e EPG should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the EPG should be observed to verify normal operation in the conguration in which it will be used.Table 7. Guidance and manufacturer’s declaration – electromagnetic emissionse EPG is intended for use in the electromagnetic environment specied below. e customer or the user of the EPG should assure that it is used in such an environment.Emissions test Compliance Electromagnetic environment - guidanceRF emissionsCISPR 11Group 1 e EPG uses RF energy primarily for its internal function. erefore, its RF emissions are very low and are not likely to cause interference in nearby electronic equipment.RF emissionsCISPR 11Class B e EPG is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.Harmonic emissionsIEC 61000-3-2Class AVoltage uctuations /icker emissionsIEC 61000-3-3Complies
Algovita Spinal Cord Stimulation System Trial Stimulator Manual 25Table 8. Guidance and manufacturer’s declaration – electromagnetic emissionse EPG is intended for use in the electromagnetic environment specied below. e customer or the user of the EPG should assure that it is used in such an environment.Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidanceElectrostatic discharge (ESD) IEC 61000-4-2 ± 6 kV contact± 8 kV air± 8 kV contact ± 15 kVe EPG is a portable device intended for use in hospital or home environments as well as being carried by ambulatory patients.Electrical fast transient/burst IEC 61000-4-4 ± 2 kV for power supply lines± 1 kV for input/output lines Not applicable Not applicable – Battery powered deviceSurge IEC 61000-4-5 ± 1 kV line(s) to line(s)± 2 kV line(s) to earthNot applicable Not applicable – Battery powered deviceVoltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11<5% UT(>95% dip in UT) for 0.5 cycle40% UT(60% dip in UT) for 5 cycles70% UT(30% dip in UT) for 25 cycles<5% UT(>95% dip in UT) for 5 sNot applicable Not applicable – Battery powered devicePower frequency (50/60 Hz) magnetic eld IEC 61000-4-83 A/m 3 A/m Power frequency magnetic elds should be at levels characteristic of a typical location in a typical commercial or hospital environment.Note: UT is the A.C. mains voltage prior to application of the test level.
26 Trial Stimulator ManualElectromagnetic Compatibility DeclarationTable 9. Guidance and manufacturer’s declaration – electromagnetic emissionse EPG is intended for use in the electromagnetic environment specied below. e customer or the user of the EPG should assure that it is used in such an environment.Immunity test IEC 60601 test levelCompliance levelElectromagnetic environment - guidanceConducted RFIEC 61000-4-6Radiated RFIEC 61000-4-33 Vrms150 kHz to 80 MHz3 V/m80 MHz to 2.5 GHzNot applicable3 V/mPortable and mobile RF communications equipment should be used no closer to any part of the EPG, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance Not applicable – Battery powered deviced=1.2 80 MHz to 800 MHzd= 2.3 800 MHz to 2.5 GHzwhere P is the maximum output rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).Field strengths from xed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol.Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.Note 2: ese guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and reection from structures, objects, and people.a Field strengths from xed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to xed RF transmitters, an electromagnetic site survey should be considered. If the measured eld strength in the location in which the EPG is used exceeds the applicable RF compliance level above, the EPG should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the EPG.b Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3V/m.
Algovita Spinal Cord Stimulation System Trial Stimulator Manual 27Table 10. Recommended separation distances between portable and mobile RF communications equipment and the EPGe EPG is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. e customer or the user of the EPG can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the EPG as recommended below, according to the maximum output power of the communications equipment.Rated maximum output power of transmitter WSeparation distance according to frequency of transmitter m150 kHz to 80 MHz d=1.2 80 MHz to 800 MHz d=1.2 800 MHz to 2.5 GHzd=2.3 0.010.11101000.120.381.23.8120.120.381.23.8120.230.732.37.323For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.Note 2: ese guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and reection from structures, objects, and people.
28 Trial Stimulator ManualWireless InformationWireless InformationTable 11. Wireless Specications and Safety Programmer wireless technology operating characteristicse Clinician Programmer interacts with the EPG using MedRadio Band: 402-405 MHz. e eective radiated power is below the limits as specied in: Europe: EN ETSI 301 839-2 USA: FCC 47 CFR Part 95; 95.601-95.673 Subpart E, 95.1201-95.1219e Clinician Programmer interacts with the EPG using 2.45 GHz. e eective radiated power is below the limits as specied in:Europe: EN ETSI 300 328USA: FCC part 15.24Stimulator wireless technologye EPG complies with emissions requirements per R&TTE Standard EN 301 839-2 v13.1 (402MHz to 405MHz).Wireless integrity e Algovita SCS System employs mechanisms to ensure integrity of the communication area. e EPG will not respond to any device to which it is not linked.Note: is equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. ese limits are designed to provide reasonable protection against harmful interference in a residential installation. is equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment o and on, the user is encouraged to try to correct the interference by one or more of the following measures:• Reorient or relocate the receiving antenna.• Increase the separation between the equipment and receiver.• Connect the equipment into an outlet on a circuit dierent from that to which the receiver is connected.• Consult the dealer or an experienced radio/TV technician for help.
Algovita Spinal Cord Stimulation System Trial Stimulator Manual 29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 (i.e., 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.
30 Trial Stimulator ManualWireless Information
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