Algovita® Spinal Cord Stimulation Clinician Programming Manual Mobile Clinician Programmer Application Model 4510 Bridge Communicator Model 4110-xx ONLY 0300-000176-001 Rev.2 SCS CP_Mobile.
Algovita® is a registered trademark of Nuvectra Corporation The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Nuvectra is under license. Refer to the Information for Prescribers Manual for indications, contraindications, warnings, precautions, adverse events, clinical summary, and related information. FCC Information (US Only) Refer to the Apple® iPad User Guide at support.apple.com for its communications regulation information.
Contents Packaging Symbols Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v Terminology. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .vi 1. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Replacement and Servicing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 12. Charging the Bridge Communicator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .51 13.
Algovita Spinal Cord Stimulation System Packaging Symbols Glossary Symbol Details Title: Catalog Number Standard: ISO 15223-1 Reference Number: 5.1.61 Description: Indicates the manufacturer’s catalog number so that the medical device can be identified. Title: Serial Number Standard: ISO 15223-1 Reference Number: 5.1.71 Description: Indicates the manufacturer’s serial number so that the medical device can be identified. Title: Batch Code Standard: ISO 15223-1 Reference Number: 5.1.
Terminology Symbol Details Title: Fragile, handle with care. Standard: ISO 15223-1 Reference Number: 5.3.11 Description: Indicates a medical device that can be broken or damaged if not handled carefully. Title: MR Unsafe Standard: ASTM F 2503-13 Reference Number: 7.3.33 Description: An item which poses unacceptable risks to the patient, medical staff, or other persons within the MR environment.
Algovita Spinal Cord Stimulation System 1. Introduction About this Manual This Clinician Programming Manual provides instructions on using the Algovita® Clinician Programmer Application and on using, charging, and caring for the Bridge Communicator. The Algovita® Spinal Cord Stimulation (SCS) System delivers mild electrical pulses to a specific area in the spinal cord. Patients may feel stimulation as a tingling sensation (paresthesia) that masks or covers their pain.
Related Documents The Clinician Programmer Model 4510 runs on an Apple® iPad®. The Clinician Programmer Application communicates with a stimulator via the Bridge Communicator. The Clinician Programmer Application communicates with the Bridge Communicator Model 4110-xx via Bluetooth®, and the Bridge Communicator communicates with the stimulator via Medical Implant Communication Service (MICS).
Algovita Spinal Cord Stimulation System • Pocket Programmer Quick Reference is a quick reference guide for patients for the Pocket Programmer, and includes information on selecting programs, adjusting stimulation strength, and turning stimulation on and off. • Algovita® Spinal Cord Stimulation System MRI Procedure Guidelines Manual provides complete instructions and information on contraindications, warnings, precautions, and instructions for MR conditions of use.
Related Documents 10 Clinician Programming Manual 0300-000176-001 Rev.2 SCS CP_Mobile.
Algovita Spinal Cord Stimulation System 2. Important Safety Information Warnings Programmer Interaction with Other Implanted Devices. Do not use the Clinician Programmer to change program settings when near a person who has a pacemaker or other implanted devices. The effects of the Algovita System Clinician Programmer on other implanted devices are unknown. Modification. Do not modify the Clinician Programmer, Bridge Communicator, or charging accessories.
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Algovita Spinal Cord Stimulation System 3. About the Clinician Programmer A program is a combination of settings for delivering stimulation to one or more pain sites. Using the Clinician Programmer, you configure programs before transferring them to the stimulator for a patient’s use. You assign (pair) a Pocket Programmer and Patient Programmer Charger with the patient’s Algovita System using the Clinician Programmer.
Using the Navigation Menu Using the Navigation Menu Use the items in the Navigation menu to configure and view patient programs and stimulator settings. Access the on the ribbon. Navigation menu by tapping The top list in the Navigation menu includes workflow tasks. The clinician advances through the workflow to configure components, and create and manage programs. The task in progress is blue. Completed In progress Workflow tasks Incomplete 1 - Stimulator Configure and view stimulator information.
Algovita Spinal Cord Stimulation System Stimulator Settings Configure and view stimulator settings. Refer to Stimulator Settings on page 43. Patient Directory View patients added to the Clinician Programmer. Refer to Using the Patient Directory on page 19. Add Bridge Comm Pair a Bridge Communicator with the Clinician Programmer. Refer to Pairing a Bridge Communicator to the Clinician Programmer on page 17.
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Algovita Spinal Cord Stimulation System 4. Getting Started Before using the Clinician Programmer, make sure that Bluetooth is on. Refer to the Apple iPad User Guide at support.apple.com for instructions. After you log in to the Clinician Programmer, pair the Bridge Communicator with the Clinician Programmer to enable communication between the Clinician Programmer and a stimulator.
Pairing a Bridge Communicator to the Clinician Programmer 2. On the Clinician Programmer, select Add Bridge Comm from the Navigation menu. The application begins scanning for a Bridge Communicator that is within 5 meters (16 feet) of the Clinician Programmer Application. The Clinician Programmer displays Bridge Communicators that are in range. 3. On the Clinician Programmer, tap the left or right triangles to scroll through the carousel of communicators if more than one is in range. 4.
Algovita Spinal Cord Stimulation System 5. Managing Patients To program stimulation for a patient, add the patient to the Patient Directory. For a new patient without an existing stimulator, you manually create the patient. For a patient with an existing stimulator, you import the information from their stimulator. Using the Patient Directory Add patients and select patients using the Patient Directory. To access the Patient Directory: 1.
Adding a Patient Adding a Patient Note: When you add a patient with an existing stimulator, the Clinician Programmer imports patient information stored on the stimulator. For patients with an existing stimulator, add a patient by importing information from their stimulator. For new patients with an empty stimulator, create the patient first, then add the stimulator. To add a patient from a stimulator: 1.
Algovita Spinal Cord Stimulation System 1. Tap Create Patient on the Patient Directory screen. 2. Enter patient information using the keyboard. The required fields are Last Name, First Name, and Date of Birth. The date of birth must be in the format yyyy-mmdd. 3. Tap Done. Clinician Programming Manual 0300-000176-001 Rev.2 SCS CP_Mobile.
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Algovita Spinal Cord Stimulation System 6. Configuring Stimulators and Leads When you create a patient, the Clinician Programmer prompts you to add a stimulator. For a patient already assigned a stimulator, you can access information about stimulators and leads through the Navigation menu. Adding a Stimulator To add a stimulator: 1. Select Stimulator from the Navigation menu. 2. Tap Scan. The Clinician Programmer scans for stimulators within range. 3.
Adding Leads Adding Leads To add a lead: 1. Select Leads from the Navigation menu. The Leads screen displays. 2. Tap ADD LEAD. 3. Tap the arrows to scroll through the carousel to find the patient’s lead type. Note: If the patient has a three port stimulator, the 8 Perc lead is the only lead available. 4. Tap Select. at any time to undo any changes made in the Leads screen. 5. Tap 24 Clinician Programming Manual 0300-000176-001 Rev.2 SCS CP_Mobile.
Algovita Spinal Cord Stimulation System 6. Tap the port number to which you want to connect the lead. 7. Optionally, select the electrode spacing. 8. Select the orientation of the lead by tapping the retrograde or anterograde arrow. 9. Tap Confirm. The lead displays on the spine image. The lead is colored and numbered according to its corresponding port. 10. Drag the lead to the location that represents the implant location. Deleting Leads Note: Removing a lead deletes programs associated with the lead.
Deleting a Stimulator Deleting a Stimulator To delete a stimulator: 1. Tap the Navigation menu and select Stimulator. 2. Tap Remove Stimulator. 3. Optionally, slide the Clear patient data from stimulator radio button on to clear the stimulator of any patient data, including programs. The default setting is off for implantable stimulators and on for trial stimulators. 4. Tap Delete. 26 Clinician Programming Manual 0300-000176-001 Rev.2 SCS CP_Mobile.
Algovita Spinal Cord Stimulation System 7. Programming Use the Programming screen to create and edit programs and subprograms. Patients can have up to ten programs. A program is made of one to four subprograms. The clinician can also run individual subprograms from the Programming screen. Note: The clinician can run subprograms or programs using the Clinician Programmer, but patients can only run programs. When a patient runs a program, the subprograms run sequentially.
Understanding the Programming Screen Understanding the Programming Screen Use the Programming screen to configure electrodes and set stimulation parameters for a subprogram. A subprogram requires at least one anode and one cathode. You can configure the implantable stimulator enclosure or trial stimulator ground pad as an electrode by tapping the can icon on the Programming screen. You can use a commercially available ground pad for the trial stimulator.
Algovita Spinal Cord Stimulation System Indicates an electrode. Gray is inactive, yellow is a cathode, blue is an anode. • • • • Percentage is the percentage of the subprogram amplitude allocated to the electrode. The electrode number is in the lower right. Electrode polarity is in the lower left. The can displays at the bottom right of the right-most lead. You can program the can like an electrode. Port Indicator. The port (lead) on which the program stimulates.
Using Programming Functions Using Programming Functions Access different programing functions through the programming tabs. • Subprogram: configure electrodes and adjust their amplitude, pulse width, and frequency. Refer to Configuring the Subprogram on page 30. • Shifting: shift amplitude allocation up and down a lead. Refer to Shifting the Amplitude on page 32. • Impedance: conduct an impedance check. Refer to Performing Impedance Checks on page 33.
Algovita Spinal Cord Stimulation System 5. Tap the Subprogram tab. 6. Set the stimulation parameters (amplitude, pulse width, and frequency) for the subprogram by tapping on the left and right arrows for each stimulation parameter. Note: Adjusting the frequency for a subprogram adjusts the frequency for all subprograms within the program. The amplitude of the pulse in milliamps (mA). • The amplitude for an electrode cannot exceed 15 mA. • The total amplitude for a subprogram cannot exceed 30 mA.
Shifting the Amplitude Shifting the Amplitude Shifting moves the amplitude allocation between and across leads. To shift the electrode configuration: 1. Tap the Shifting tab on the Programming screen. 2. Tap the desired rate for the Shifting Increment. 3. Use the up, down, left, or right arrows to shift the amplitude allocation. Note: Shifting arrow availability is determined by lead placement. Optionally, lock an electrode from shifting by tapping the electrode on the Programming screen.
Algovita Spinal Cord Stimulation System Performing Impedance Checks Check the impedance between the stimulator and the electrodes by performing an impedance check. To perform an impedance check: 1. Tap the Impedance tab on the Programming screen. Impedance bar 2. Tap an electrode or the can (stimulator housing) on the Programming screen, then tap to assign the electrode or can as the sink (the direction of the current flow). If you do not select another electrode, the default sink is the can. 3.
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Algovita Spinal Cord Stimulation System 8. Managing Programs Manage programs from the Summary screen. Running a program runs the subprograms consecutively. You can adjust the strength, frequency, and pulse width for a program from the Summary screen when stimulation is turned on. Program parameters Subprogram parameters Add a program. Add a subprogram. Program number and name. A run time indicator displays around the circle of the program number.
The subprogram strength. The green bar is a visual indicator of the subprogram strength. Delete a program or subprogram. A popup window displays that allows you to choose the programs and subprograms to delete. Turn stimulation on to start stimulation for the selected program. Stimulation ramps to the amplitude value for the program. Displays the Stimulator Settings screen. Displays the Leads screen. Pair the Pocket Programmer and Patient Programmer Charger to a stimulator.
Algovita Spinal Cord Stimulation System Adding a Program To add a program: 1. Tap . The Create New Program popup displays. 2. Tap Create New on the popup. - To copy a program: 1. Tap . The Create New Program popup displays. 2. Tap a program dot to select an existing program to copy. 3. Tap Create from Copy. Clinician Programming Manual 0300-000176-001 Rev.2 SCS CP_Mobile.
Adding a Subprogram Adding a Subprogram If a program already has four subprograms, you cannot add another subprogram. To add a subprogram: 1. Tap in an open subprogram column. The Create New Subprogram popup displays. 2. Tap Create New on the popup. To copy a subprogram: 1. Tap in an open subprogram column. The Create New Subprogram popup displays. 2. Tap a subprogram dot to select an existing subprogram to copy. 3. Tap Create from Copy. 38 Clinician Programming Manual 0300-000176-001 Rev.
Algovita Spinal Cord Stimulation System Deleting a Program or Subprogram Deleting a program deletes all its subprograms. To delete a program or subprogram: 1. Tap Delete in the bottom right of the Summary screen. The Delete Program popup displays. 2. Tap a program or subprogram dot. 3. Tap Delete in the popup. Managing a Disabled Program If a program has an orange triangle dispalyed next to its number on the Summary screen, the stimulator has disabled the program, and it can no longer run.
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Algovita Spinal Cord Stimulation System 9. Patient Report You can generate a PDF report that contains information on a patient’s system and programs. The bottom of every page displays the user identification, the generation date, and the software version of the Clinician Programmer. To generate a report: 1. Select Report from the Navigation menu. Note: Report becomes active only when viewing the Summary screen. 2. Select which method you want to save the report information from the popup.
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Algovita Spinal Cord Stimulation System 10. Stimulator Settings Use the Stimulator Settings to view information about the stimulator, configure background impedance checks, and turn on advanced patient adjustments. Accessing Stimulator Settings To access stimulator settings: 1. Select a patient from the Patient Directory. 2. Select Stimulator Settings from the Navigation menu. View battery information. Refer to Stimulator Battery on page 44. View a diagnostic message generated by the stimulator.
Stimulator Battery Enable the stimulation options the patient can adjust. Refer to Patient Adjustments on page 47. Restore the stimulator’s internal settings and calibrations with an option to generate a calibration report. Restore Settings is not available to all users. Displays the Stimulator Settings screen. Displays the Leads screen. Pair the Pocket Programmer and Patient Programmer Charger to a stimulator. Refer to Patient Devices on page 48.
Algovita Spinal Cord Stimulation System Auto Tune Auto Tune optimizes the communication between the stimulator and the Patient Programmer Charger. Auto Tune the stimulator if you or the patient experience reduced communication between the stimulator and the Patient Programmer Charger. This may happen when the tissue surrounding the stimulator changes, such as after healing from surgery or a significant weight change. • Tap Tune to start the Auto Tune.
Impedance Check Impedance Check Turn on background impedance checks to enable an implantable stimulator to check impedance each time stimulation stops, or the trial stimulator to check impedance when stimulation starts. If the stimulator detects high impedance for an electrode, the stimulator disables the program and all other programs that use that electrode. Note: A patient cannot run a disabled program.
Algovita Spinal Cord Stimulation System Patient Adjustments Enable the stimulation options the patient can adjust within the assigned range. The patient uses the Patient Programmer Charger to make the adjustments. Subprogram Strength Frequency Pulse Width Patient can adjust stimulation strength for individual subprograms. Patient can adjust the frequency for a program. Patient can adjust the pulse width for individual subprograms. Clinician Programming Manual 0300-000176-001 Rev.2 SCS CP_Mobile.
Patient Devices Patient Devices For a patient to use their Programmer Charger or a Pocket Programmer, pair the Programmer Charger or Pocket Programmer to the stimulator. To pair programmers to the stimulator: 1. Tap 2. Tap the serial number space and enter the serial numbers located on the label on the back of the programmer. The programmers need not be present when adding them to a stimulator. 3. Tap Confirm to send the programmer serial numbers to the stimulator. 4.
Algovita Spinal Cord Stimulation System 11. Care, Cleaning, Replacement, and Servicing Care and Handling For information about care, handling, and storage of the Apple iPad, refer to the Apple iPad User Guide available at support.apple.com. Handle the Algovita System components and accessories with care. Do not drop them or submerge them in water. Avoid all sources of water that can come into contact with the devices.
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Algovita Spinal Cord Stimulation System 12. Charging the Bridge Communicator The Bridge Communicator has rechargeable batteries. You can charge the batteries any time the battery level is below 100%. Routinely check your battery levels, and charge a device when needed. Note: • For instructions on how to recharge the iPad on which the Clinician Programmer Application resides, refer to the Apple iPad User Guide available at support.apple.com.
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Algovita Spinal Cord Stimulation System 13. Troubleshooting If the instructions in this chapter do not solve your problem, contact Nuvectra Customer Service. Nuvectra Customer Service If you have any questions about the Algovita System, call Nuvectra Customer Service toll-free at 1-844-727-7897 within the United States or 1-214-618-4980. Clinician Programmer Troubleshooting Problem Patient does not feel stimulation.
Clinician Programmer Troubleshooting Problem Possible Cause and Solution Cannot increase or decrease the strength, Increasing or decreasing the value is outside the allowed range. amplitude, frequency, or pulse width for Adjust the maximum value for the range. Refer to Subprogram on page 30. a program. The amplitude may be exceeding maximum values; an electrode cannot exceed 15 mA and a subprogram cannot exceed 30 mA. Adjust the electrode configuration for optimal stimulation.
Algovita Spinal Cord Stimulation System Clinician Programmer Messages Some messages may include an error code. If provided, reference the error code when contacting Nuvectra Customer Service. Message Description/Possible Action Communications problem. Unable to communicate with stimulator. Verify that the Clinician Programmer and the Nuvectra Bridge Communicator are within range of the stimulator. The message includes an error code.
Charging a Fully Discharged Implantable Stimulator Charging a Fully Discharged Implantable Stimulator A patient may need assistance to charge a fully discharged implantable stimulator. To charge a fully discharged implantable stimulator: 1. Move the Patient Programmer Charger within 1 meter (3 feet) of the implantable stimulator and turn on the Patient Programmer Charger. The Not Able to Connect screen displays. 2. Tap Cancel to display the Home screen. 3.
Algovita Spinal Cord Stimulation System 14. System Specifications iPad Specifications For non-therapy related precautions and Regulatory Statements regarding the use of the iPad, on which the Clinician Programmer application resides, refer to the Apple iPad resources available at support.apple.com.
Bridge Communicator Specifications Guidance and manufacturer’s declaration – electromagnetic emissions The Bridge Communicator is intended for use in the electromagnetic environment specified below. The customer or the user of the Bridge Communicator should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance RF emissions CISPR 11 Group 1 The Bridge Communicator uses RF energy primarily for its internal function.
Algovita Spinal Cord Stimulation System Guidance and manufacturer’s declaration – electromagnetic emissions The Bridge Communicator is intended for use in the electromagnetic environment specified below. The customer or the user of the Bridge Communicator should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level 3 Vrms 150 kHz to 80 MHz 3 Vrms 150kHz to 80 MHz Radiated RF IEC 61000-4-3 10 V/m 80 MHz to 2.7 GHz 10 V/m 80 MHz to 2.
Wireless Information Wireless Information Wireless Specifications and Safety Bridge Communicator wireless technology operating characteristics The Bridge Communicator interacts with the stimulator using MedRadio Band: 402 to 405 MHz. The effective radiated power is below the limits as specified in: Europe: Radio Equipment Directive 2014/53/EU USA: FCC 47 CFR Part 95 The Bridge Communicator interacts with the stimulator using 2.45 GHz.
Algovita Spinal Cord Stimulation System Wireless Quality of Service Medical Implant Communication Service (MICS) Medical Implant Communication Service (MICS) is a wireless radio band operating at 402 to 405 MHz. It is used between the Bridge Communicator and the stimulator. MICS has a range of approximately 1 meter (3 feet). Bluetooth Wireless Technology Bluetooth wireless technology, a wideband transmission system operating in the 2.4 to 2.
Compliances and Authorizations Compliances and Authorizations For compliance with the limits for a Class B digital device, refer to the Apple iPad resources available at support.apple.com/manuals/ipad. This 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.
Algovita Spinal Cord Stimulation System 15. Glossary Term Definition balancing The automatic allocation of the total amplitude for a polarity of a program to equal 100%. EPG External Pulse Generator. Also known as the trial stimulator. IPG Implantable Pulse Generator. Also known as the implantable stimulator. program A combination of stimulation settings used to deliver stimulation to one or more sites in a patient. A program consists of one or more subprograms.
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0300-000176-001 Rev.2 SCS CP_Mobile.
Nuvectra Corporation 10675 Naples St. NE Blaine, MN 55449 Tel 1 844 727 7897 Tel +1 214 618 4980 Fax +1 716 759 5069 www.nuvectramed.com Emergo Europe B.V. Prinsessegracht 20 2514 AP The Hague The Netherlands Tel +31 70 345 8570 © 2019 Nuvectra All Rights Reserved Part Number 0300-000176-001 Rev 02 2019-07 0300-000176-001 Rev.2 SCS CP_Mobile.
