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Appendix A:

Troubleshooting

| SPRINT

PNS System – Clinician Instruction for Use [L0090-MAN-000 Rev F]

Problem

Possible Causes

Actions to be Taken

Pulse Generator

Screen (Remote or
Clinical Programmer)
shows “Wireless
Error”

Hand-Held Remote or Clinician
Programmer out of range

Ensure the component is
within arm’s length of the
Pulse Generator;
Hand-Held Remote: Toggle
lock switch down to retry
connection
Clinician Programmer: Attempt
to re-connect

Bluetooth wireless connection issue

Hand-Held Remote: - Make
sure the Clinical Programmer
has disconnected and is OFF
- Wait for the Hand-Held
Remote to go to sleep and
then try again

Clinician Programmer: Attempt
to re-pair to retry connection
(turn OFF and restart the
Tablet Computer if necessary)

Stimulation sensation
changes

Mounting Pad in different place than
usual

Reposition Mounting Pad

Mounting Pad not sticking to skin well

See troubleshooting section
“Mounting Pad is not adhering
to skin”

MicroLead has moved

If desired response cannot be
obtained by adjusting stimulus
parameters, remove
MicroLead and replace with
new MicroLead

Stimulation is painful Stimulus intensity is too high

Decrease stimulus intensity

MicroLead has moved

Replace MicroLead

Session time
remaining not
decreasing

Stimulation paused or was not turned on
yet

Turn stimulation on; Note that
only therapies with 6hr session
times will display the session
time remaining

Содержание SPRINT PNS System

Страница 1: ...1 SPRINT PNS System Clinician Instruction for Use L0090 MAN 000 Rev F Clinician Instructions for Use...

Страница 2: ...nc registered in the U S and other countries The BLUETOOTH word mark and logos are registered trademarks owned by Bluetooth SIG Inc Information on patents can be found at www sprtherapeutics com paten...

Страница 3: ...ad Placement Target using the OnePass Introducer System 23 4 2 Testing Stimulation 25 4 3 Confirming Location Placing the MicroLead s 37 4 4 Establishing Therapy Settings 43 5 Patient Counseling 48 5...

Страница 4: ...arge delivered by the rectangular stimulus pulse The per pulse charge of a stimulus pulse in nanoCoulombs nC is equal to the product of Amplitude and Pulse Duration nC mA x s Cycle the period of time...

Страница 5: ...ulse stimulus charges that allows convenient control of the strength of stimulation Pulse Duration the length of time one stimulus pulse lasts Measured in microseconds sec See Figure G 1 Ramp Down the...

Страница 6: ...her implantable neuro stimulator whose stimulus current pathway may overlap with that of the SPRINT System Patients who require Magnetic Resonance Imaging MRI The SPRINT MicroLead and other SPRINT com...

Страница 7: ...result in burns at the site of the electrode at the tip barb of the MicroLead and or at the Mounting Pad Do not reuse the SPRINT PNS System the SPRINT PNS System is a single patient device Use of the...

Страница 8: ...ctly on top of the MicroLead exit site Electronic medical equipment The System may interfere with patient monitoring equipment or other physiological instruments Always turn off and disconnect the sti...

Страница 9: ...injury to the patient In all cases stimulation can be turned OFF by pressing the button on the Pulse Generator or by removing the Pulse Generator from the Mounting Pad or unplugging the cables to the...

Страница 10: ...skin that results in a retained lead fragment an MRI examination is safe to perform under the conditions described in the MR Conditional statement below A Retained Lead Fragment ONLY is MR conditiona...

Страница 11: ...ruction for Use L0090 MAN 000 Rev F 2 System Overview 2 1 System Components The SPRINT PNS System is made up of sterile and non sterile components Indicates that two 2 of each component will be includ...

Страница 12: ...connection between the MicroLead and the Pulse Generator Dual Lead Systems come with two MicroLead Connectors one with a light gray cable connector Light Gray and the other with a dark gray cable conn...

Страница 13: ...Clinical Programmer Charger USB cord and AC adapter plug used to recharge the Clinical Programmer 20 Patient Case Includes Recharging Base and Power Supply recharges the Rechargeable Batteries for th...

Страница 14: ...r The Clinical Programmer is a tablet that allows the clinician to operate and program the Pulse Generator The Clinical Programmer is not intended for use by patients and is non sterile If the clinici...

Страница 15: ...pter 2 System Overview 15 SPRINT PNS System Clinician Instruction for Use L0090 MAN 000 Rev F NOTE When stored for extended periods of time the Clinical Programmer should be stored in a cool dry locat...

Страница 16: ...that the Pulse Generator is in a location that is comfortable and easily accessible by the patient or caregiver Consider if the MicroLead or the stimulation it delivers will be susceptible to postura...

Страница 17: ...nsion s Dual Lead Adapter for two lead configuration MicroLead Connector s Magnetic Coupler s 3 3 Assemble Additional Supplies and Set up a Sterile Procedure Tray Sterile surgical towels 2 packs or si...

Страница 18: ...as necessary 2 If desired administer local anesthetic around the planned insertion site s for the MicroLead Local anesthesia may be provided at the discretion of the clinician Anesthesia may be applie...

Страница 19: ...t into the chest may cause rhythm disturbances to the heart which could be lethal Do not place the Mounting Pad on the head or on the front of the throat Stimulation in these areas may cause severe mu...

Страница 20: ...endix G Lead Placement in Proximity to Peripheral Nerves for example lead placements 2 Insert the Stimulating Probe into the Percutaneous Sleeve Align hub components and rotate the Stimulating Probe c...

Страница 21: ...3 Insert the Percutaneous Sleeve with Stimulating Probe through the skin in a location that provides access to the target nerve using ultrasound or fluoroscopic guidance as appropriate 4 Connect the...

Страница 22: ...ssociated with 100 For 12 Hz the goal is generally to induce a sense of tension in the muscle At 100 Hz the goal is generally to produce a comfortable tingling sensation See Appendix G for additional...

Страница 23: ...ultrasound guidance it may be beneficial to assess several different locations and stimulation intensities around the nerve until the optimal response is achieved In some cases it may be beneficial t...

Страница 24: ...c cycling will then be presented Switching between Fast Cycling and Slow Cycling can be done as many times as desired Press No to continue to the next screen If all settings are correct press the butt...

Страница 25: ...robe instead of the lead press to proceed to the next screen When on the next screen press the button 3 times to return to test stimulation through the probe Dual Lead Dual Lead Systems Only Ensure th...

Страница 26: ...et The startup screen will briefly display Select Connect to Pulse Generator to pair the Clinical Programmer with the Pulse Generator DUAL LEAD SYSTEM Follow the instructions below testing the first M...

Страница 27: ...e shown select start scan To confirm that the appropriate Pulse Generator is available for pairing match the displayed serial number with the number displayed on the back of the Pulse Generator Select...

Страница 28: ...0Hz appropriate for the therapeutic application For 12 Hz the goal is generally to induce a sense of tension in the muscle At 100 Hz the goal is generally to produce a comfortable tingling sensation E...

Страница 29: ...al response is achieved In some cases it may be beneficial to advance the stimulating probe across the axis of the nerve to initiate stimulation at a low intensity It may also be useful to withdraw th...

Страница 30: ...n by pressing the Stop Stim button and select Next to continue NOTE If desired response cannot be obtained stop stimulation set the intensity as low as possible and adjust position as needed before te...

Страница 31: ...mum possible intensity If the intensity if set to 0 stimulation is OFF During Test Stimulation intensity is adjusted in increments of 2 When stimulation is on the icon will appear on each side of the...

Страница 32: ...e L0090 MAN 000 Rev F Select Next to continue with testing the second lead if performing a Dual Lead Placement or Select Set Min Max for establishing therapy settings see Section 4 4 2 Establishing Th...

Страница 33: ...rcutaneous Sleeve Retracting a MicroLead once its barb has been deployed in tissue will damage the barb If a lead must be retracted remove it from the body completely and insert a new MicroLead Do not...

Страница 34: ...Use one hand to hold the Percutaneous Sleeve in place to maintain its position for optimal MicroLead placement 3 With the anchoring barb facing up and nested within the needle bevel insert the MicroLe...

Страница 35: ...mmer Tablet to confirm that the MicroLead location delivers desired results Advance the MicroLead as desired or adjust stimulation settings as required to optimize results Retracting the MicroLead Int...

Страница 36: ...eve with Introducer leaving the MicroLead implanted 8 Re insert the loose end of the MicroLead into the entry site on the hinged side of the MicroLead Connector assuring that adequate lead length exis...

Страница 37: ...xcess MicroLead wire 11 Slide the MicroLead Connector into the Mounting Cradle then adhere the Mounting Cradle to the skin The Mounting Cradle should be placed close enough to the lead exit site that...

Страница 38: ...e center portion of the Waterproof Bandage leaving the plug end of the MicroLead Connector exposed 13 Connect the Magnetic Coupler to the Pulse Generator using a long or short extension cable if neede...

Страница 39: ...tion 2 3 Operating the Hand Held Remote To switch to the Clinical Programmer tablet select Yes and see Section 4 4 2 Establishing Therapy Settings with the Clinical Programmer To continue establishing...

Страница 40: ...ulation intensity level press the button To decrease stimulation press the button To increase stimulation press the button Once the desired maximum stimulation level is reached turn stimulation OFF by...

Страница 41: ...ers for the second dark MicroLead repeats the steps used to set the parameters for the first MicroLead When all settings are as desired press the button to enable the Hand Held Remote for patient use...

Страница 42: ...w selected View Edit Program can be skipped Select View Edit Program to begin setting stimulation minimum and maximum levels Single Lead Select Start Stim to begin setting minimum and maximum stimulat...

Страница 43: ...up to 3 favorites To remove a favorite tap on the box of the favorite you wish to delete When the desired settings have been entered tap the Save Finish button in the bottom right Note To adjust the...

Страница 44: ...fety Card provided on the back of the Patient Instructions for Use 5 2 MicroLead Exit Site Care and Bandaging Instructions Instruct the patient on proper care of the MicroLead exit site s and protecti...

Страница 45: ...eir Patient Instructions for Use which explains the purpose and nature of their system 5 4 Usage Log The Pulse Generator will keep a log of the amount time of stimulation used the average intensity of...

Страница 46: ...nents 3 If desired cut the MicroLead close to the MicroLead Connector between the skin and the MicroLead Connector ensuring that the potion of MicroLead that remains exposed may be easily grasped 4 Ap...

Страница 47: ...s Rechargeable Batteries and the Hand Held Remote must never be disposed of in a fire because they contain batteries It is possible that a fragment or fragments of the MicroLead could break off and re...

Страница 48: ...mer shows Recharge Battery Rechargeable Battery is low Replace the Rechargeable Battery Hand Held Remote buttons are not working Lock Switch is on Move switch to unlocked up position Screen Remote or...

Страница 49: ...to sleep and then try again Clinician Programmer Attempt to re pair to retry connection turn OFF and restart the Tablet Computer if necessary Stimulation sensation changes Mounting Pad in different pl...

Страница 50: ...rator Magnetic Coupler not fully connected to Short or Long Extension Check connection between cables Magnetic Coupler not fully connected to MicroLead Connector Check connection between Magnetic Brea...

Страница 51: ...ve the MicroLead from the MicroLead Connector Move the MicroLead Connector approximately 1 cm closer to the MicroLead exit site then close the MicroLead Connector connecting the MicroLead again MicroL...

Страница 52: ...ontrol will allow you to directly change the Amplitude and Pulse Duration and to use those parameters to set the minimum and maximum allowed values Direct parameter controls for setting maximum and mi...

Страница 53: ...parameter control intensity adjustment only press the icon and select Standard Parameter Control Fine Resolution Standard Resolution Selecting Fine Resolution will increase the resolution of the inte...

Страница 54: ...nstruction for Use L0090 MAN 000 Rev F APPENDIX C Contacting SPR Therapeutics Via Mail SPR Therapeutics Inc 22901 Millcreek Blvd Suite 110 Cleveland OH 44122 USA Via Telephone Toll Free 844 378 9108 V...

Страница 55: ...as the product as stored by the clinician or patient between uses All the components of the SPRINT System are suitable for use under the following operating conditions a temperature range of 5 C 41 F...

Страница 56: ...echargeable Battery REF 9612 Parameter Specification Dimensions Approximately 6 2cm X 3 7cm X 1 4cm Mass Approximately 30g Controls Indicators Control and multicolor Visual Indicator is a Momentary Pu...

Страница 57: ...th 1 channel stimulating at 100Hz 20mA 80 s 100 duty cycle into a 1 500 patient circuit resistance IEC 60601 1 classification and designations Type BF equipment Internally powered NOT suitable for use...

Страница 58: ...equired Mains Power 90VAC 264VAC 50Hz or 60Hz SPRINT Mounting Pad REF 9618 Parameter Specification Size Approximately 7 9cm X 5 4cm X 3 9cm Skin Contacting Material Hydrogel SPRINT Hand Held Remote RE...

Страница 59: ...cations UL Listed FCC Part 15 class B Output 5 2V at up to 2 0A DC max power output 10W Mains Power Input 100 240VAC 50 60Hz SPRINT MicroLead Connectors REF 9650 9655 Parameter Specification Colors Li...

Страница 60: ...touchproof keyhole connector SPRINT Long Extensions REF 9685 9686 Parameter Specification Colors Light Gray REF 9680 Dark Gray REF 9681 Connector Proximal end touchproof keyhole connector Distal end t...

Страница 61: ...o home screen Lock switch is off buttons are enabled Lock switch is on buttons are disabled Intensity being set will be the minimum available Intensity being set will be the maximum available Intensit...

Страница 62: ...Flashing Yellow light Stimulation stopped due to a low battery OR stimulation stopped due to an error OR internal error Flashing Blue light Pulse Generator is in BLUETOOTH pairing mode Short beep Seq...

Страница 63: ...ecrease or increase the displayed value typically the stimulation intensity Return to the Pulse Generator home screen Menu for optional programming features Minimum intensity value set for the MicroLe...

Страница 64: ...s Information displayed relates to the Dark Gray MicroLead MicroLead connected to the Dark Gray MicroLead Connector and cables Table D explains the symbols on products and packaging related to the SPR...

Страница 65: ...t should be used before the specified day Keep dry IP 22 The degree of protection from water and dust offered by the Pulse Generator and Hand Held Remote unintentional and limited duration exposure to...

Страница 66: ...ort use an appropriate length Extension Cable 5 Follow instructions in Section 4 2 Testing Stimulation 6 Once an optimal position has been identified disconnect the Stimulating Needle from the Pulse G...

Страница 67: ...to the indented lock sites on the underside of the MicroLead Connector until the snap closure of the MicroLead Connector can be opened Once opened withdraw the MicroLead from the MicroLead Connector 1...

Страница 68: ...ation The patient s report of comfortable stimulus evoked sensations can provide guidance for lead placement Lead placement may be guided by imaging e g ultrasound Considerations for Percutaneous Inse...

Страница 69: ...as close to the nerve as the needle is for application of anesthesia during a nerve block positioning the electrode 5 15 mm from the nerve is typical The lead should be placed in the optimal location...

Страница 70: ...Desired sensations may be achieved in this region using a single MicroLead To target this location position the patient in a comfortable prone position Insert the Stimulating Probe approximately 2 cm...

Страница 71: ...n the environment of the human body will not fail or the human body will not react adversely to the use or implantation of the Product Suitability of the Product for a particular patient is solely a m...

Страница 72: ...22901 Millcreek Blvd Suite 110 Cleveland OH 44122 USA Call 844 378 9108 Fax 216 803 0777 www sprtherapeutics com support sprtherapeutics com 2018 SPR Therapeutics Inc...

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