Axonics SNM System 1401 User manual

Modulation
Technologies
Charging SystemUser Manual
Ladesystem-Handbuch
Manuel d’ulisaon du système
de chargement
Manual del usuario del sistema de carga
Manuale d’uso del sistema di ricarica
Handleiding van het oplaadsysteem
Axonics SNM System®
ChargingSystem
!USA Rx ONLY
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English .............................................................................. 1
Deutsch .......................................................................... 41
Francais .......................................................................... 81
Espanol......................................................................... 121
Italiano ......................................................................... 161
Nederlands ................................................................... 201
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Languages
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1
Modulation
Technologies
User Manual
Models 1401, 9005, 9008
EN
!USA Rx ONLY
Axonics SNM System® Charging System
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Axonics®, Axonics Modulaon®, Axonics Modulaon
Technologies®, and Axonics Sacral Neuromodulaon System®
are trademarks of Axonics Modulaon Technologies, Inc.,
registered or pending registraon in the U.S.
and other countries.
Cauon: The Axonics Sacral Neuromodulaon System should be
used only on the order of a doctor.
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3
Contents
Introducon ........................................................................................ 5
Manual Overview.......................................................................... 7
Refer to Your Paent Therapy Guide............................................. 8
Charging System Components ...................................................... 9
Precauons ................................................................................. 10
Recommended Use and Care...................................................... 11
HowtoUseYourChargingSystem................................................... 13
Charger Buons and Lights......................................................... 14
Charger Sounds and Vibraons................................................... 16
Inial Set-up................................................................................ 17
Where to Place the Charger........................................................ 18
How to Charge .................................................................................. 19
1) Turn the Charger On ............................................................... 20
2) Choose How to Charge ........................................................... 21
2A) Aach the Carrier........................................................... 22
2B) Aach the Belt ............................................................... 23
3) Place the Charger Over the Smulator................................... 24
4) Complete Charging ................................................................. 25
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4
Contents
Troubleshoong................................................................................ 26
Troubleshoong Scenarios.......................................................... 27
Addional informaon..................................................................... 30
Replacement and Disposal.......................................................... 31
Care Instrucons......................................................................... 32
Specicaons .............................................................................. 33
Axonics Paent Support.............................................................. 37
Label Symbols ............................................................................. 38
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5
Introducon
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6
The Axonics Sacral Neuromodulaon (SNM) therapy is provided to
relieve the symptoms of urinary and fecal dysfuncon. Paents are
given a Charging System to charge their Smulator baery.
This manual describes how to use the Charging System. Axonics
recommends you read this manual before using your Charging
System.
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7
Manual Overview
This manual describes how to use your Charging System.
The manual includes:
■Overview of Charging System buons, lights, and funcons
■Steps for using your Charging System
■Troubleshoong Charging System issues
■Addional informaon about the Charging System
If you have issues with your Charging System, ask your doctor for
assistance.
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8
Refer to Your Paent Therapy Guide
Refer to the Paent Therapy Guide that was provided by your doctor
for addional informaon about your Axonics SNM System, including:
■Indicaons for Use
■Contraindicaons
■System Warnings
■System Precauons
■Paent Acvity Precauons
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9
Charging System Components
Charger
Charges the
Smulator
Charge Belt
Holds the
Charger over the
Smulator
Dock
Stores and charges
the Charger
Carrier
Holds the Charger
over the
Smulator
Power Supply
Connects the Dock
to a power source
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10
Precauons
■If you have other acve implants (such as a pacemaker), the
Charger may cause issues with such implant(s). Contact your
doctor if you experience issues or have any quesons.
■Some equipment may generate signals, called Electromagnec
Interference or EMI, that block the Charger’s signals to the
Smulator. If you have issues using your Charger, move away from
such sources, including computer monitors, cellular telephones,
and other electronic equipment.
■Do not use the Charger over an open wound. The Charger, carrier,
and charge belt are not sterile. Contact with an open wound could
cause an infecon.
■Do not use the power supply near water. Use in these condions
could result in shock or serious injury.
■If you experience skin irritaon, redness or heang at the site of
charging, do not connue charging.
■Do not sit or lie on the Charger during charging as this may apply
unwanted pressure at the charge site. Consult your doctor if you
have irritaon or discomfort during charging.
Warning: Do not aempt to modify or service this product. If
there is an issue with the product, please consult your doctor.
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11
Recommended Use and Care
DO
9Develop a habit for charging that ts your schedule (e.g., every
Sunday while watching your favorite TV show). You do not need to
wait for the Smulator baery to be low to charge.
9Store your Charger on the Dock between uses. Keep the Dock
plugged in so the Charger will be ready when you want to charge.
9Clean your Charger and Dock with a damp, so cloth as needed.
9Only use the power supply provided with the Dock.
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12
Recommended Use and Care
✕Do not let your Smulator stay at a low baery level for long
periods of me (e.g., weeks).
✕Do not drop the Charger in liquid or clean it with harsh cleaners.
✕Do not use the Charger near ammable or explosive gases.
✕Do not place the Charger over clothes when charging. It will take
longer to charge.
✕Do not use the Charger under a blanket or heavy clothing. This
may cause the charger to heat up.
DO NOT
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13
How to Use Your Charging System
The Charging System allows you to easily and comfortably recharge
your Smulator baery. When the Charger is placed on the skin over
the implanted Smulator, the Charger will charge the Smulator
baery. Charging a low Smulator baery will take 1 to 4 hours
depending on the depth of the Smulator and how the Charger is
placed over the Smulator. A Carrier or a Belt can be used to hold
the Charger in place while charging. This secon shows you the
Charger’s buons, lights, and sounds. It also shows you the ideal
placement of your Charger over your Smulator.
Note: If you noce a change in device performance or when you reach 15
years of implantaon, please consult your physician to discuss your opons.
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14
Charger Buons and Lights
The Charger has a buon and two lights that help you use the
Charger.
Power Buon Turns on or o the Charger
PowerLight Shows if the Charger has enough baery to
charge your Smulator
Error Light Shows if the Charger has an issue
1Power Buon PowerLight
2
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15
Charger Buon and Lights
1. The power buon can be pressed to turn the Charger on and o.
When ON, the power light will come on.
2. The power light will be
■Green: this means you can fully charge the Smulator.
■Solid Orange: this means you may not be able to fully charge
the Smulator. If you need to recharge the Smulator, you
should charge your Charger rst.
■Flashing Orange: this means you need to charge the Charger.
■Red: this means there is an error. Turn the Charger o then
back on. If the red light is sll on, call your doctor and ask for a
newCharger.
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16
Charger Sounds and Vibraons
What you hear or feel: What it means:
One long tone Charger is over the Smulator and
charging has started.
3 beeps + vibraon
(repeats)
Charging has been interrupted and is
not complete.
Three rising tones Smulator baery is fully charged.
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