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26-0002-0005/0 (en) (2022)

Signal “off” time

—Interval between stimulations when there is no stimulation; measured in

minutes.

Signal “on” time

—Length of time the programmed output current is delivered; measured in

seconds.

SAPS (Stroke Application & Programming Software)

—Software that allows the physician or

therapist to set the VNS parameters and initiate stimulation paired with rehabilitation tasks.

Train

—Duration (in seconds) that the signal frequency is output from the IPG.

Vagus nerve

—Either of the pair of tenth cranial nerves arising from the medulla and supplying

mainly the viscera, especially with autonomic sensory and motor fibers.

Vivistim

—Trade name of MicroTransponder’s Paired VNS

™

System for motor deficits

associated with stroke.

VNS

—Vagus Nerve Stimulation

WT (Wireless Transmitter)

—An RF device that connects via a USB plug to the laptop’s USB

port and provides communication with the IPG; used in conjunction with SAPS.

19.2 Symbols

This manual and accompanying non-implantable device labeling use these symbols and
definitions. Refer to the

Microtransponder

Vivistim

Paired VNS

™

System Implantable

Device Manual for Healthcare Professionals

for symbols relating to the implantable

components of the Vivistim

System.

Caution, pay special attention to the information following the symbol

For USA audiences only

Rx Only

For Prescription use only

Communication Distance

Non-ionizing Radiation

Date of Manufacture

Do Not Use if Package is Damaged

Authorized Representative in the European Union

Содержание 2100

Страница 1: ...als for the Vivistim Paired VNS System and its component parts nor does this represent full disclosure of all pertinent information concerning use of this product potential safety complications or efficacy outcomes Copies of all Vivistim Paired VNS System manuals are included with the system for full disclosure copies are also available from MicroTransponder Inc This manual contains information th...

Страница 2: ... ID in the software to avoid inadvertently misidentifying a patient Therapist Trigger Mode enables the therapist to trigger stimulation using the push button trigger Magnet Mode enables the patient to trigger stimulation using a magnet swipe To treat a patient 1 Connect and Program the IPG p 17 2 Start and Deliver Treatment p 20 3 Implement Magnet Mode Before Sending Patient for At home Therapy p ...

Страница 3: ...ring Therapy Overview 15 3 3 3 Patient Log File Overview 16 4 PROGRAMMING THE IMPLANT 17 4 1 Connecting to a Specific IPG 17 4 2 Patient Information Optional 20 4 3 Implant Settings 20 4 4 Therapy Modes 23 4 4 1 Stim Test Mode 23 4 4 2 Therapist Trigger Mode 25 4 5 Impedance 26 5 DELIVERING PAIRED VNS 29 5 1 Therapist triggered therapy 29 5 1 1 Select VNS Pairing Therapy Menu 29 5 1 2 Select Task ...

Страница 4: ...1 14 DEVICE LIFETIME 51 14 1 IPG Lifetime Removal and Replacement 51 14 1 1 Signs of End of Life for the Vivistim System 51 14 1 2 Replacement Based on Battery Status Indicators 51 15 DEVICE DISPOSAL 52 16 VIVISTIM SYSTEM DEVICES 53 16 1 Conventions 53 16 2 Communication Signals 53 16 3 Wireless Transmitter 53 16 4 Stroke Application Programming Software SAPS 54 16 5 Other Applicable MicroTranspon...

Страница 5: ... 20 Figure 4 11 Implant Setting Parameters 21 Figure 4 12 Amplitude 21 Figure 4 13 Frequency 22 Figure 4 14 Train Duration 22 Figure 4 15 Pulse Width 23 Figure 4 16 Stim Test Mode 24 Figure 4 17 Implant Settings 24 Figure 4 18 Therapist Trigger Mode 25 Figure 4 19 Implant Settings 26 Figure 4 20 Lead Impedance Check 27 Figure 4 21 High Lead Impedance Notification 27 Figure 4 22 Low Lead Impedance ...

Страница 6: ... Declaration Electromagnetic Emissions 55 Table 17 2 Guidance and Manufacturer s Declaration ESD and Power Fluctuations 56 Table 17 3 Guidance and Manufacturer s Declaration Radiated Electromagnetic Fields 57 Table 17 4 Recommended Separation Distance Between Portable and Mobile RF Communication Equipment and the Wireless Transmitter 58 ...

Страница 7: ...t upper extremity motor deficits associated with a stroke by pairing rehabilitation movements with Vagus Nerve Stimulation The Lead electrodes are attached to the left vagus nerve in the neck The Lead is tunneled from the neck to the chest where it is connected to the Implantable Pulse Generator IPG and the IPG is placed subcutaneously or sub muscularly in the pectoral region The SAPS is delivered...

Страница 8: ...der Vivistim Paired VNS System Manual for Patients and an additional copy is on the last page of this manual Software capabilities include Use of SAPS with the WT by a rehabilitation therapist or neurologist or other physician to interrogate and program an IPG s parameters and assess IPG function Use of SAPS with the WT by a rehabilitation therapist or neurologist or other physician to initiate a ...

Страница 9: ...uthorization of MicroTransponder WARNING The use of any software other than that specified herein will violate safety effectiveness and design controls of the programmable devices and such use may result in an increased risk to users and patients 1 3 SAPS Package Contents The SAPS package contains the following Software installed on commercially available laptop Documentation 1 4 WT Package Conten...

Страница 10: ...he proper setup 1 Connect the power cord to the power port on the laptop and connect the other end to the wall outlet 2 Connect the WT to a USB port on the laptop 3 Optional Connect the push button to a USB port on the laptop A Power Button B Power Cord C Push Button D Wireless Transmitter Figure 2 1 SAPS Hardware Set up Overview ...

Страница 11: ...h SAPS see Section 13 Troubleshooting If this does not correct the issue or you have additional problems please contact MicroTransponder per Section 18 Information and Support 4 The SAPS loaded onto the laptop will then launch to the Startup Menu Screen Welcome menu see Figure 2 22 Before proceeding to the next section ensure that you have arrived at this Startup Menu Screen Figure 2 22 Startup Me...

Страница 12: ...6 0002 0005 0 en 2022 12 when the WT is connected properly red when the WT is disconnected and alternating white green when SAPS is communicating see Figure 2 Figure 2 3 WT Interface Connected Indicator ...

Страница 13: ...the physician or therapist to assign a task and perform a therapy session To access the rest of the program features the Log In button must be selected see Figure 3 1 Figure 3 1 Log In To log in and access all other SAPS screens select the Log In button upper right menu bar 4th button from the right and type the password provided into the pop up shown in Figure 3 1 At this point the program is unl...

Страница 14: ...f desired the user may select the Log Out button and once again remove access to the additional SAPS screens After a period of 15 minutes the Log In will time out and you will need to log back in to continue the session 3 1 Buttons Versus Tabs Within the SAPS there are two types of clickable elements buttons and tabs see Figure 3 3 Figure 3 3 Buttons Versus Tabs ...

Страница 15: ...erapy Each tab at the top of the SAPS screen corresponds to a particular capability of the system denoted by the tab s name NOTE See Figure 3 3 for the location of the menus and the corresponding buttons used to access the menus described in this section CAUTION New parameters and therapy modes are not input into the IPG and remain blue in color until the Test function or the Download Settings to ...

Страница 16: ...rapist triggered therapy for more detail or 3 3 3 Patient Log File Overview The third tab Patient Log File allows the physician or therapist to review on the computer screen or print out specific saved settings that were utilized during the rehabilitation session For example the therapist can review each stimulation usage for a given task See Section 8 Patient Log File for more detail ...

Страница 17: ...lant 4 1 Connecting to a Specific IPG Perform these six steps before therapy for each patient to connect to their specific IPG 1 Select the Disconnect button to disconnect any IPG that is connected to SAPS that is different from your patient s IPG Serial see Figure 4 2 Select Continue when prompted to confirm Figure 4 2 Disconnect 2 Verify there is no Serial displayed in SAPS you will see 3 dashes...

Страница 18: ...d Figure 4 5 Figure 4 4 Interrogate Button on Screen Figure 4 5 Contact Implant 4 A pop up menu will appear Select the IPG whose Serial matches the one on the patient s Patient Identification Card by clicking on their specific IPG and then pressing the Select button circled in Figure 4 6 Figure 4 6 Select Button ...

Страница 19: ...5 Impedance Figure 4 7 Serial and Battery Status 6 You may also want to verify that the IPG date and time are synched with the computer See the steps below a Press the Time button circled in Figure 4 8 Figure 4 8 Time Button b A window appears showing the Current Device Time and Current PC Time see Figure 4 9 Generally the Set with PC Time button on the right hand side is used to synchronize time ...

Страница 20: ...ed Therapy Mode is selected and turned on 1 Turn on your desired Therapy Mode to adjust the Implant Settings 2 Each of the implant setting parameters available in the Implant Settings menu has a box next to the setting see Figure 4 11 Select the box to display all available parameters in a drop down box 3 Select the appropriate value for each parameter and program the parameters into the IPG using...

Страница 21: ...eters CAUTION Programming the output current to very low levels may result in ineffective therapy CAUTION Programming the output current to excessively high levels may result in patient discomfort Always verify that settings are tolerable Figure 4 12 Amplitude ...

Страница 22: ...26 0002 0005 0 en 2022 22 Figure 4 13 Frequency Figure 4 14 Train Duration ...

Страница 23: ...es 3 therapy modes Stim Test Mode see Section 4 4 1 Stim Test Mode Therapist Trigger Mode see Section 4 4 2 Therapist Trigger Mode and Magnet Mode see Section 7 2 Magnet Mode 4 4 1 Stim Test Mode The Stim Test Mode see Figure 4 16 is used to test the parameters displayed in the Implant Settings menu ...

Страница 24: ... On see Figure 4 16 2 Optionally you may change the stimulation parameters displayed in the Implant Settings menu see Figure 4 17 For each of the settings Amplitude Frequency Train Duration Pulse Width click the button next to the setting and a menu will drop down containing all available parameters for that setting Then select the appropriate value for ...

Страница 25: ...sing the Test function This sequence can be repeated until the patient s IPG is programmed to appropriate parameters In the scenario where a Test is not performed the Download Settings to IPG button must be selected to program the IPG with the therapy parameters displayed in the Implant Settings menu CAUTION If the Test function is not performed new parameters are not input into the IPG until the ...

Страница 26: ... implant Initiation of Paired VNS using Therapist Trigger Mode is detailed in Section 5 Delivering Paired VNS 4 It is recommended to verify that the VNS settings chosen are tolerable for the patient See Section 4 4 1 Stim Test Mode for details 4 5 Impedance In the Impedance portion of the Patient Information area of the Program Implant menu the Lead impedance can be checked by selecting the Check ...

Страница 27: ...gure 4 21 or less than 250 Ω see Figure 4 22 the Warning screen informs the patient to contact their physician or therapist to see if any further action needs to be taken CAUTION Changes in Lead impedance are common therefore changes of even several thousand ohms occur normally over time Refer to the Microtransponder Vivistim Paired VNS System Implantable Device Manual for Healthcare Professionals...

Страница 28: ...26 0002 0005 0 en 2022 28 Figure 4 22 Low Lead Impedance Notification Figure 4 23 Lead Impedance Displayed ...

Страница 29: ... Pairing Therapy menu see Figure 5 to initiate a therapy session and trigger stimulation Figure 5 1 VNS Pairing Therapy Menu 5 1 2 Select Task Select the specific task see Figure 5 from the drop down menu by selecting the task drop down menu button and selecting the appropriate task that the patient is going to perform for rehabilitation see Figure 5 The patient log file associates this selected t...

Страница 30: ...st Trigger Mode for on demand therapy verify all laptop connections see Figure 2 1 and verify that the WT is an appropriate distance from the patient see Section 16 2 Communication Signals Select the Start Task button see Figure 5 This enables the system to start a rehabilitation task and allows you to trigger the delivery of stimulation ...

Страница 31: ...lishes a communication session with the device Notice that both the Stimulate and the End Task buttons are now available and that the Status window is updated to Ready to Stimulate see Figure 5 At any time you may select the End Task button to end the rehabilitation task Figure 5 4 Communication Established and Ready to Stimulate ...

Страница 32: ...for at least 0 5 seconds after the train duration ends Figure 5 5 Stimulate Selected Status Stimulating The message Refractory appears in the Status window for a length of time equal to the programmed stimulation train duration immediately following the Stimulating message see Figure 5 Figure 5 6 Status Refractory No Stimulation Allowed The value in the Stimulation Counter window increases by one ...

Страница 33: ... and the system is ready to select a new task and or begin a new session see Figure 5 NOTE The SAPS automatically ends the task if the session is inactive for more than 10 minutes When the SAPS automatically ends a task it displays a message that The IPG is no longer in Therapy Session see Figure 5 The task can be started where it ended by selecting the Start Task button again Figure 5 8 Ten Minut...

Страница 34: ...t further communication from the SAPS NOTE During a patient s first therapy session give the patient the magnet and review this section and the Microtransponder Vivistim Paired VNS System Quick Start Guide for Patients with them 4 Remove the magnet cover if applicable see Figure 5 9 below Figure 5 9 Magnet with Cover Attached A and Detached B 5 To begin stimulation swipe the magnet across the pati...

Страница 35: ...26 0002 0005 0 en 2022 35 Figure 5 10 Magnet Swipe ...

Страница 36: ...t has been removed from the patient s chest the magnet must be placed back over the patient s chest where the IPG is located to stop stimulation The magnet should be held in place and the patient s physician contacted for further instruction Stimulation will be stopped as long as the magnet is held in place NOTE During a patient s first therapy session verify that the patient can terminate stimula...

Страница 37: ...0002 0005 0 en 2022 37 Figure 6 1 Reset Button 3 When prompted as shown in Figure 6 2 enter the password provided Figure 6 2 Password Prompt 4 Select the Accept button to complete the reset see Figure 6 3 ...

Страница 38: ...ent 0 0 mA NOTE All settings and device history are preserved After a successful reset the IPG stimulation output may be reprogrammed from 0 0 mA as appropriate for the patient to resume operation at their previously programmed settings 5 The IPG must now be reprogrammed to the appropriate mA setting for the patient ...

Страница 39: ... let you know when they are scheduled to have an MRI The patient should always let you know if they have a lifestyle change For example the patient could start playing a sport or start smoking In a patient s first visit make sure to discuss Section 12 Precautions Warnings Contraindications and Hazards and Section 5 2 Magnet Mode in addition to the Microtransponder Vivistim Paired VNS System Quick ...

Страница 40: ...lements the ability to initiate stimulation with a magnet The button adjacent to Magnet Mode must be toggled to On and programmed to enable this function Off must be selected and programmed to terminate this capability The amount of Therapy performed Start Date and the Session History are displayed as shown circled in Figure 7 2 Figure 7 1 Magnet Mode ...

Страница 41: ... toggle to On see Figure 7 1 2 When this mode is turned on you are prompted to set the Magnet Mode Duration and reminded to save changes as shown in Figure 7 3 Select OK Figure 7 3 Magnet Mode Prompt 3 Optionally you may change the stimulation parameters displayed in the Implant Settings menu See Section 4 3 Implant Settings ...

Страница 42: ...plant Once the IPG is programmed to respond to the magnet it is no longer necessary for the patient to be in close proximity to the WT as there is no longer communication required between SAPS and the IPG to trigger stimulation during a task To trigger stimulation in Magnet Mode the magnet must be swiped across the patient s chest where the IPG is located ...

Страница 43: ...om the device to a file that can be used later To export the IPG statistics select the Read Statistics button circled in Figure 8 1 These are saved in csv format to the hard drive of the laptop To export the SAPS log select the Export Log button These are saved in txt format to the hard drive of the laptop You may choose a particular date range for export or choose to Export All circled in Figure ...

Страница 44: ...26 0002 0005 0 en 2022 44 Figure 8 2 Patient Log File Export Log ...

Страница 45: ...26 0002 0005 0 en 2022 45 9 INTENTIONALLY BLANK ...

Страница 46: ... button to save these settings to the IPG 4 Following the MRI procedure program the IPG to the appropriate settings to resume stimulation Figure 10 1 IPG Settings for MRI Procedures CAUTION All non implantable components of the Vivistim System including the WT SAPS software and any off the shelf accessories such as the magnet are considered MR Unsafe and are also to be left outside of the MRI scan...

Страница 47: ...mperatures in the range of 20 C to 70 C Humidity up to and including 100 has no effect on the WT Additionally To clean the WT wipe it down with a mixture of water soap and alcohol The WT is standard lab type equipment and is reusable Please return the WT to MicroTransponder in the case of malfunction for evaluation and disposal ...

Страница 48: ...ivistim System should be moved typically at least 1 8 m 6 ft away from equipment with which it may be interfering Programming or interrogating the IPG may momentarily interfere with other sensitive electronic equipment nearby Communication The IPG listens for a communication signal from the WT Communication usually takes less than 2 seconds but may be prolonged or interrupted in the presence of el...

Страница 49: ...or more of the following measures Reorient or relocate the receiving antenna Increase the separation between the equipment and receiver Connect the equipment to 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 EMI interference Programming in the presence of an EMI signal can be difficult or impossible bu...

Страница 50: ...rror message such as the Telemetry Lost message shown in Figure 13 1 during interrogation checking impedance programming stimulation parameters or while performing any other therapy required communications The most common causes of communication problems are connection issues Performing these steps may restore communication 1 Verify that the WT is properly connected to the laptop The USB plug from...

Страница 51: ...unicate with the IPG After trying all other remedies verifying all connections restarting the computer etc please contact MicroTransponder for assistance in resetting the IPG Contact information is provided in Section 18 Information and Support 14 DEVICE LIFETIME 14 1 IPG Lifetime Removal and Replacement All MicroTransponder IPGs eventually require surgical replacement as a result of battery deple...

Страница 52: ...5 0 en 2022 52 15 DEVICE DISPOSAL Return the SAPS and the WT to MicroTransponder for examination and safe disposal Please contact MicroTransponder for additional instructions see Section 18 Information and Support ...

Страница 53: ...etary and secure protocol that implements the Medical Implantable Band MICS 403 MHz This ensures that the IPG is not programmable by other MICS programmers and that the WT cannot program other MICS based devices The communication portion of the Vivistim System is designed to minimize the possibility of mis programming or phantom programming with the IPG Phantom programming is the inadvertent progr...

Страница 54: ...cian to check the Lead impedance Allows the physician to record the rehabilitation task information Stores the therapy session history for review at a later time Requires the physician to use a SAPS password to access implant programming and therapy functions Allows users without the SAPS password but with the laptop password to access patient log and therapy information The software is delivered ...

Страница 55: ...Nearby electronic equipment may be affected RF emissions Class B The Wireless Transmitter is suitable for use in all establishments other than domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonics emissions IEC 61000 3 2 Not Applicable1 Voltage fluctuation flicker emissions IEC 61000 3 3 Not Applicable1 1 T...

Страница 56: ... typical commercial or hospital environment 2 kV common mode 2 kV common mode 1 25 50 μs Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT For 0 5 cycle 40 UT 60 dip in UT For 5 cycles 70 UT 30 dip in UT For 25 cycles 5 UT 95 dip in UT For 5 s 5 UT 95 dip in UT For 0 5 cycle 40 UT 60 dip in UT For 5 cycles 70 UT 30 dip in UT For 25...

Страница 57: ...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 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and p...

Страница 58: ...S Band telemetry in the frequency range 402 405 MHz 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 transmitters and receivers used to communicate weather data the Meteorological Satellite or the Earth Ex...

Страница 59: ...nication it is recommended that the WT connection be verified and the laptop and SAPS be restarted Other technical solutions are detailed in Section 13 Troubleshooting If issues continue please contact MicroTransponder MicroTransponder Inc 2802 Flintrock Trace Suite 226 Austin TX 78738 www microtransponder com info microtransponder com ...

Страница 60: ...rve during surgery Lead fracture Lead disconnection from the IPG or high battery impedance approaching end of life EOL IPG Implantable Pulse Generator The stimulator portion of the Vivistim System typically implanted in the chest below the clavicle The IPG provides stimulation to the vagus nerve through a connected Lead and Lead electrode Lead An implantable part of the Vivistim System delivers el...

Страница 61: ...roTransponder s Paired VNS System for motor deficits associated with stroke VNS Vagus Nerve Stimulation WT Wireless Transmitter An RF device that connects via a USB plug to the laptop s USB port and provides communication with the IPG used in conjunction with SAPS 19 2 Symbols This manual and accompanying non implantable device labeling use these symbols and definitions Refer to the Microtranspond...

Страница 62: ...onsult Instructions for Use Reference Number Batch Code Manufacturer Magnetic Resonance Unsafe MR Conditional Serial Number Temperature Limitation Storage and Transport Number of Radio Frequency RF Communication Channels Keep Dry ...

Страница 63: ...st until your therapy session end time 3 4 If you lose your magnet you will need to contact your clinician for a new one or replace it with a magnet that is strong enough A commercial magnet with a pull force rated at 4 5 kg or greater is sufficient Magnet Force 4 5 kg 5 The magnet provided to you may damage TVs computer disks credit cards and other items affected by strong magnetic fields Please ...

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