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Label Symbols

Symbol

Description

Classified by CSA with respect to safety

!USA Rx ONLY

For USA audiences only

Caution: US Federal law restricts this device for sale by or on the order of a physician

Refer to instructions for use (Consult accompanying documents)

Temperature limitation

Humidity limitation

Pressure limitation

Do not use if package is damaged

Authorized representative in the European community

IP57

Protection from the amount of dust that would interfere with the opera-
tion of the device. Protection against temporary immersion in water.

R-NZ

This device complies with all applicable Australian Communications and
Media Authority (ACMA) regulatory arrangements and electrical equipment
safety requirements

FCC ID

US Federal Communications Commission device identification

Содержание Model 2301

Страница 1: ...Axonics SNM System Remote Control Modulation Technologies Remote Control User Manual Model 2301 USA Rx ONLY ...

Страница 2: ...xonics Sacral Neuromodulation System and r SNM are trademarks of Axonics Modulation Technologies Inc registered or pending registration in the U S and other countries Caution The Axonics Sacral Neuromodulation System should be used only on the order of a doctor ...

Страница 3: ... Recommended Use and Care 9 How to Use Your Remote Control 11 Summary of Buttons and Lights 12 How Your Remote Control Communicates with Your Stimulator 14 Use Scenarios 15 1 Connect to Your Stimulator 16 2 View Stimulator Status 18 3 Turn Down Your Stimulation Level 22 4 Turn Up Your Stimulation Level 24 ...

Страница 4: ...Status Permanent Stimulator Only 30 8 Change Your Stimulation Program Trial Stimulator Only 32 9 See a System Error 34 10 Turn Off Your Remote Control 36 Troubleshooting 38 Additional Information 43 Replacement and Disposal 44 Specifications 45 Axonics Contact Information 48 Label Symbols 49 ...

Страница 5: ... to relieve the symptoms of fecal dysfunction Patients are given a Remote Control to monitor the battery status and settings of their Axonics SNM System This manual describes how to use the Remote Control Axonics recommends you read this manual before using your Remote Control ...

Страница 6: ...sing your Remote Control Troubleshooting Remote Control issues Additional information about the Remote Control Note The Remote Control may behave differently when communicating with the Trial Stimulator TS and the Permanent Stimulator PS This manual will highlight when certain behavior is specific to the TS or PS Otherwise both stimulators are referred to commonly as the Stimulator ...

Страница 7: ...following Therapy Guides which are provided by your doctor for more information regarding your system Trial System Guide for more information about the trial stimulation period Patient Therapy Guide for more information about permanent SNM therapy ...

Страница 8: ...rom the Remote Control This will help avoid and or reduce unwanted audible clicks Some equipment may generate signals called Electromagnetic Interference or EMI EMI can block the Remote Control s signals to the Stimulator If you have issues using your Remote Control move away from such sources This includes computer monitors cellular telephones and other electronic equipment Warning Do not attempt...

Страница 9: ...ust your stimulation or check the battery status of your Stimulator 9 9 If you need to store your Remote Control put it in a cool dry place away from direct heat and light 9 9 Clean your Remote Control with a damp soft cloth as needed 9 9 Bring your Remote Control to all visits with your healthcare provider ...

Страница 10: ...the Remote Control in liquid or clean it with harsh cleaners Do not drop the Remote Control or mishandle it in a way that causes damage Do not use the Remote Control near flammable or explosive gases Do not allow other people to use your Remote Control ...

Страница 11: ...stimulation level Turn up or turn down your stimulation level Turn your stimulation on and off Monitor charging of your Stimulator PS only Change your stimulation program TS only Receive notice of errors in your Remote Control or Stimulator Note Do not make stimulation changes regularly Your doctor should change your stimulation settings if needed Axonics recommends you only change your stimulatio...

Страница 12: ...12 12 Summary of Buttons and Lights Stimulation Level Connect System Error Up Down Stimulator Battery Status Active Program ...

Страница 13: ...o the Stimulator Down Turn down stimulation level or Turn off stimulation Active Program Shows which stimulation program is active System Error Shows there is an error in the Remote Control or Stimulator Stimulator Battery Status For TS shows how long until the battery is depleted For PS shows if the battery needs charging Note For a detailed description of the lights see the section View Stimulat...

Страница 14: ...ator Your Remote Control must be near the Stimulator to send and receive signals Only the Remote Control given to you by your doctor can send and receive signals to and from your Stimulator To use your Remote Control hold it comfortably in front of you The Remote Control should be held on the same side of the body as the Stimulator ...

Страница 15: ... Turn up your stimulation level 5 Turn your stimulation off 6 Turn your stimulation on 7 Monitor battery charge status PS only 8 Change your stimulation program TS only 9 See a system error 10 Turn off your Remote Control Note If you have issues using your Remote Control please refer to the Troubleshooting section of this manual For more help please contact your doctor ...

Страница 16: ...16 16 1 Connect to Your Stimulator 1 2 3 ...

Страница 17: ...nnect to the Stimulator 3 Watch for the stimulation level lights to stop flashing and the stimulator battery light to turn on This means the Remote Control is communicating with the Stimulator If no light is visible connection has failed See Troubleshooting Note The most common issue is not having your Remote Control close enough to the Stimulator If your initial connection attempt fails move the ...

Страница 18: ...18 18 2 View Stimulator Status Stimulation Level Stimulator Battery Status Active Program ...

Страница 19: ...ry will last for 4 or more days Flashing green PS only Stimulator battery is charging Solid orange Stimulator battery will last for 2 to 4 days Flashing orange Stimulator battery will last for 2 days or less Stimulation Level lights No stimulation Default level set by your doctor Maximum level ...

Страница 20: ...20 2 View Stimulator Status Active Program Program 1 is active Program 2 is active TS only ...

Страница 21: ......

Страница 22: ...22 3 Turn Down Your Stimulation Level 1 2 ...

Страница 23: ...see Connect to Your Stimulator 1 Press the Down button one time 2 A Permanent Stimulator Watch for the stimulation level lights to decrease by one The Remote Control will vibrate This may take 3 seconds B Trial Stimulator The Remote Control will vibrate and the stimulation level lights will flash After multiple adjustments the stimulation level may change This may take 3 seconds ...

Страница 24: ...24 4 Turn Up Your Stimulation Level 1 2 ...

Страница 25: ...rate This may take 3 seconds B Trial Stimulator The Remote Control will vibrate and the stimulation level lights will flash After multiple adjustments the stimulation level lights may change This may take 3 seconds Note Stimulation level can only be turned up by one level at a time It may take up to 30 seconds for the stimulation level to fully increase depending on your stimulation settings Make ...

Страница 26: ...26 5 Turn Your Stimulation Off 1 2 HOLD ...

Страница 27: ...stimulation The Remote Control must be connected to the Stimulator see Connect to Your Stimulator 1 Press and Hold the Down button for 5 seconds 2 Watch for the stimulation level lights to all turn off The Remote Control will vibrate This may take 3 seconds 5 Turn Your Stimulation Off ...

Страница 28: ...28 6 Turn Your Stimulation On 1 2 HOLD ...

Страница 29: ...Up button for 5 seconds 2 Watch for the stimulation level lights to light up The Remote Control will vibrate This may take 3 seconds Note Stimulation level will be at the level set before turning the Stimulator off Note You should not need to regularly turn your stimulation off and on Your doctor should adjust your stimulation if needed ...

Страница 30: ...n Battery Status light will flash green when your Stimulator is charging When charging is done or if charging stops for any reason the Stimulation Battery Status light will stop flashing See the Charging System manual for more information about charging your Stimulator ...

Страница 31: ......

Страница 32: ...32 1 2 3 8 Change Your Stimulation Program Trial Stimulator Only ...

Страница 33: ...ton for at least 5 seconds 2 The Remote Control will vibrate and you will see either i The active program light change from 1 to 2 or vice versa to indicate that the program has changed or ii The currently active program light flashes for 4 seconds and does not change to the other program This indicates that the Stimulator was unable to change programs see Troubleshooting 3 Press and release the U...

Страница 34: ...ator is still connected to the cable coming from your back Connect the Stimulator to the cable if not already connected Turn off the Remote Control Next turn on the Remote Control and try to increase the stimulation level If the red light is still on try changing the stimulation program If the red light is still on call your doctor Red light flashes Ask for a new Remote Control Red light is on at ...

Страница 35: ......

Страница 36: ...36 10 Turn Off Your Remote Control 1 2 ...

Страница 37: ... to Your Stimulator 1 Press and release the Connect button 2 Watch for all the lights on the Remote Control to turn off This means the Remote Control has stopped communicating with the Stimulator and is off Note The Remote Control will automatically turn off after 12 seconds of no activity by the user ...

Страница 38: ...octor if you need help Summary of issues addressed in this section Remote Control will not communicate to Stimulator System Error light is on Cannot change stimulation level Cannot change stimulation program Damaged Remote Control Discomfort or pain due to stimulation Troubleshooting ...

Страница 39: ...ontrol lights scroll then turns off Battery Status indicator is not on Move Remote Control closer to Stimulator and retry connection For the PS only try charging the Stimulator If issue persists contact your doctor Remote Control does not respond when Connect button is pressed Contact your doctor for a new remote ...

Страница 40: ...o check if they are stuck Reconnect to Stimulator If you have 2 programs available try switching to the other program If issue persists contact your doctor Red error light is on all the time If you have a TS check to make sure the Stimulator is connected to the cable coming from your back Try to adjust stimulation on the Remote Control If the red light is still on call your doctor If you have a PS...

Страница 41: ... or turned down Contact your doctor Remote Control lights are scrolling or Remote Control lights are not on Reconnect and retry adjustment Contact your doctor Unable to adjust stimulation program The currently active program light flashes for several seconds when attempting to change the active program Only 1 program may be set for your Stimulator Contact your doctor ...

Страница 42: ...ctor to discuss replacement Discomfort or pain due to stimulation Constant pain or discomfort in the groin or buttocks Turn down stimulation level If issue persists turn off stimulation and contact your doctor Remote Control will not turn off Light s will not turn off Retry turning the Remote Control off press and release Connect button Contact your doctor for replacement ...

Страница 43: ...43 Additional Information ...

Страница 44: ...he Remote Control battery is expected to last up to 5 years When the battery runs out you should get a new Remote Control Disposal Follow your local government rules to dispose of the Remote Control If you no longer need a working device return it to your doctor Warning Do not throw the Remote Control in fire as the battery may explode ...

Страница 45: ... Storage Shipment Conditions Short Term 3 days or less Temperature 25 C 70 C 13 F 158 F Pressure 57kPa 106kPa Humidity 15 95 Storage Shipment Conditions Long Term over 3 days Temperature 20 C 30 C 68 F 86 F Pressure 70kPa 106kPa Humidity 30 85 Power source Lithium ion battery non rechargeable Size 7 1 x 3 8 x 1 6 cm Weight 60g ...

Страница 46: ...ective radiated power is below the limit of 25 µW ERP EIRP as specified in EU EN ETSI 301 839 and USA FCC 47 CFR Part 95 Subpart I The Remote Control has to be within 1 meter from the Stimulator for successful communication Wireless Security The Remote Control is uniquely paired to a specific Stimulator Additional mechanisms exist to ensure the integrity of radio data Expected battery life based o...

Страница 47: ...ical 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 IC Compliance This device complies with Industry Canada license exempt ...

Страница 48: ...ealth or the Axonics SNM therapy Axonics Patient Support Axonics located in Irvine CA USA can help answer questions or concerns about your Axonics SNM therapy Please note that Axonics cannot discuss or comment on your medical condition Call 1 877 929 6642 Hours M F 6 00 am 6 00 pm Pacific Time ...

Страница 49: ... Model Number Manufacturing Date IEC 60601 1 EN60601 1 Type BF Equipment Non ionizing electromagnetic radiation Conformité Européenne European Conformity 2019 This symbol means that the device fully complies with AIMD Directive 90 385 EEC Notified Body reviewed and RED 2014 53 EU self certified IC Industry Canada certification number ...

Страница 50: ...ty limitation Pressure limitation Do not use if package is damaged Authorized representative in the European community IP57 Protection from the amount of dust that would interfere with the opera tion of the device Protection against temporary immersion in water R NZ This device complies with all applicable Australian Communications and Media Authority ACMA regulatory arrangements and electrical eq...

Страница 51: ......

Страница 52: ...ology Drive Irvine CA 92618 USA www axonicsmodulation com Tel 1 877 929 6642 Fax 1 949 396 6321 HealthLink Europe Services BV De Tweeling 20 22 5215 MC s Hertogenbosch The Netherlands All Rights Reserved Copyright 2019 Axonics Modulation Technologies Inc 110 0125 001 rA ...

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