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Axonics 1601, Manual

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Sacral Neuromodulation System

Trial Stimulator Manual

Model 1601

Rx only 

Axonics®, Axonics Modulation®, Axonics Modulation Technologies® and 

Axonics Sacral Neuromodulation System® are trademarks of Axonics Modulation Technologies, Inc., 

registered or pending registration in the U.S. and other countries.

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Summary of Contents for 1601

Page 1: ...ly Axonics Axonics Modulation Axonics ModulationTechnologies and Axonics Sacral Neuromodulation System are trademarks of Axonics ModulationTechnologies Inc registered or pending registration in the U S and other countries 110 0078 001 rev D_output indd 1 1 10 20 11 28 AM ...

Page 2: ...Axonics ModulationTechnologies Inc 26Technology Drive Irvine CA 92618 USA www axonicsmodulation com Tel 1 877 929 6642 Fax 1 949 396 6321 110 0078 001 rev D_output indd 2 1 10 20 11 28 AM ...

Page 3: ...dust and splashing water that would interfere with the operation of the device Product Serial Number Do not use if package is damaged Manufacturer Authorized representative in the European community Product Model Number USA Rx ONLY For USA audiences only Caution U S Federal law restricts this device for sale by or on the order of a physician Manufacturing Date Warning Caution Non ionizing electrom...

Page 4: ... the product Refer to instructions for use Consult accompanying documents IEC 60601 1 EN60601 1 Type BF Equipment Temperature limitation Classified by CSA with respect to safety Humidity limitation R NZ This device complies with all Australian Communications and Media Authority ACMA regulatory arrangements and electrical equipment safety requirements Pressure limitation FCC ID US Federal Communica...

Page 5: ...IONS 9 Clinician programming 9 Electromagnetic interference EMI 10 Patient activities 12 Patient programming and Remote Control 13 Storage and Usage Environment 13 Sterilization 14 System implant 14 POTENTIAL ADVERSE EVENTS SUMMARY 14 INDIVIDUALIZATION OF TREATMENT 15 PATIENT COUNSELING INFORMATION 16 SPECIFICATIONS 17 ACTIVATING THE TRIAL STIMULATOR 18 CONNECTING THE TRIAL STIMULATOR TO THE TINED...

Page 6: ...ary electrical stimulation For an advanced trial the TS connects to a tined lead to deliver temporary electrical stimulation Purpose of the trial system The Axonics SNMTrial System is used for a test period to evaluate if a subject should be treated with the Axonics SNM System DEVICE DESCRIPTION The Axonics TS Figure 1 is part of the Axonics SNM System The TS is a programmable device that is worn ...

Page 7: ...formed on patients implanted with the Axonics SNM System Diathermy can transmit energy through the implanted system potentially causing tissue damage at the location of the implanted electrodes resulting in severe injury Magnetic Resonance Imaging MRI An MRI should not be conducted on an individual undergoing a trial period of SNM therapy utilizing the externalTS Other Medical Procedures Thefollow...

Page 8: ...ize their exposure by not lingering in the immediate area of the security systems Some anti theft detectorsmaynotbevisible Ifpatientsfeelpoorly theyshouldwalkawayfromtheareaandanti theftdetectorsandsecurityscanners Case Damage TheTrial Stimulator contains battery chemicals that could cause severe burns if the case were ruptured or pierced Effects on other implanted devices The effect of the Axonic...

Page 9: ...tosensethetelemetrysignalsassociated with reprogramming Programmer interaction with a cochlear implant Patients with cochlear implants should keep the external portion of their cochlear implant as far from the Clinician Programmer CP or Remote Control as possible This will help minimize unintended audible clicks or other sounds Programmer interaction with flammable atmospheres The CP is not intend...

Page 10: ... external coils of bone growth stimulators should be kept at least 45 cm 18 in away from the Axonics SNM System Do not use a bone growth stimulator if it is not working as intended Dental drills and ultrasonic probes The drill or probe should be kept 15 cm 6 in away from the Neurostimulator The Neurostimulator should be turned off Electrolysis The electrolysis wand should be kept at least 15 cm 6 ...

Page 11: ... high radiation exposure may not be immediately evident and exposure should be limited using appropriate measures including shielding and adjusting the beam angle to avoid exposure to the Neurostimulator Transcutaneous electrical nerve stimulation TENS TENS electrodes should not be placed in locations where the TENS current passes over any component of the Axonics SNM System Discontinue using TENS...

Page 12: ...hichtheyparticipateandinformthemoftheneedforrestrictingandminimizingactivities during the trial stimulation period Componentmanipulationbypatient Twiddler ssyndrome Cliniciansshouldadvisepatientstorefrainfrommanipulating thecomponentsoftheAxonicsSNMSystem Manipulationmaycausedevicedamage leadmigration skinerosion oruncomfortable stimulation Scubadivingorhyperbaricchambers Patientsshouldnotscubadiv...

Page 13: ...clean the device with damp soft cloth Remote Control use Patients should avoid operating the Remote Control when near flammable or explosive gases Storage and Usage Environment Component packaging Do not use the component if any of the following have occurred The storage package has been damaged pierced or altered In this case sterility cannot be guaranteed and infection may occur The component it...

Page 14: ...y time Failures such as electrical shorts open circuits and insulation breaches are unpredictable Also the TS battery will eventually run out and can provide no more than 60 days of stimulation Component handling Handle the components of the Axonics SNM System with extreme care They may be damaged by excessive force or sharp instruments Such damage can lead to intermittent stimulation or loss of s...

Page 15: ... surgical procedure follow up responsibilities andself carerequirements Inordertoachieveoptimalbenefitsfromthetherapy theAxonicsSNMSystemrequires a long term commitment to post surgical management Patient selection Select the patients carefully to ensure they meet the following criteria The patient is an appropriate surgical candidate Give special consideration for the lead length implant depth an...

Page 16: ...care professionals including their primary doctor and dentist that they have a trial SNM system PatientsshouldbringtheirPatientTherapyGuidetoallmedicalanddentalappointments Thiswillhelpresolveanyquestionsthat their healthcare professional may have regarding any precautions to take to avoid potential device problems PatientsshouldalwayscarrytheirRemoteControl Thisallowspatientstochangethestimulatio...

Page 17: ...A Minimum Amplitude Step Size 0 05 mA Ramping 0 30 s of Programs 2 Mode of Operation Current Controlled Power Source Battery Lithium ion non rechargeable Size 27 mm x 25 mm x 5 2 mm Weight 4 5 grams Expected Battery life Nominal 60 days Worst case 45 days Note All dimensions are approximate Battery life estimated at nominal and worst case stimulation settings Nominal 1 mA 14 Hz 210 µs continuous s...

Page 18: ... from the CP the green light will not be on However theTS will remain active b IfaCPdoesnotconnecttotheTS theTSwillreturntohibernatemode Itcanbeturnedonagainbypressingthebuttononthe back of theTS Notes IfaredlightflashesthereisanerrorwiththeTS ConnecttheCPfordetailederrorinformation RefertotheCPmanualfordetailed troubleshooting information Ifthereisnoflashinglightwhenyoupressthebutton trypressingt...

Page 19: ... will not be any gap between the connectors when fully inserted Use the CP to check the electrode impedances to confirm that the cables are connected Figure 3 Align the raised grey bar on theTS with the raised bar on the BasicTrial Cable shown or the grey line on the PE not shown Plug the BasicTrial Cable or PE fully into the extension of theTS INSERTING TS INTO THE BELT Thefollowingsectiondescrib...

Page 20: ...sibly damaged or not working the patient should contact their physician to get a newTS Disposal At the end of a trial stim period the patient should return theTS to their physician If return is not possible the patient should follow local government rules to dispose of theTS Warning Do not throw theTS in a fire as the battery may explode 110 0078 001 rev D_output indd 20 1 10 20 11 29 AM ...

Page 21: ...the Medical Device Radio communication 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 ICCompliance This device complies with Industry Canada license e...

Page 22: ...he TS for successful communication Wireless Security The TS can only communicate with a single Remote Control that is paired to it using the Clinician Programmer Any Axonics Clinician Programmer can communicate with aTS Additional mechanisms exist to ensure the integrity of radio data CUSTOMER SERVICE For questions regarding the Axonics SNM System call our Customer Support Center toll free at 1 87...

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Page 24: ...ope Services BV DeTweeling 20 22 5215 MC s Hertogenbosch The Netherlands All Rights Reserved Copyright 2019 Axonics ModulationTechnologies 11 14 2019 110 0078 001 rD 110 0078 001 rev D_output indd 24 1 10 20 11 29 AM ...

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