Axonics 1101 User manual

1
Sacral Neuromodulation System
Neurostimulator Implant Manual
Model 1101 Neurostimulator
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.

2
Axonics Modulation Technologies, Inc.
26 Technology Drive
Irvine, CA 92618 (USA)
www.axonicsmodulation.com
Tel. [phone]
Fax [phone]

3
LABEL SYMBOLS
This section explains the symbols found on the product and
packaging.
Symbol
Description
Axonics Neurostimulator
Axonics Torque Wrench
Neurostimulator default
waveform with 14 Hz
frequency, 0 mA amplitude
and 210 µs pulse width
Neurostimulator
default electrode
configuration:
Electrode 0:
negative (-)
Electrode 1: Off (0)
Electrode 2: Off (0)
Electrode 3:
Positive (+)
Case: Off (0)
Product Serial Number

4
Symbol
Description
Manufacturer
Product Model Number
Manufacturing Date
Non ionizing
electromagnetic radiation
Conformité Européenne
(European Conformity).
This symbol means that the
device fully complies with
AIMD Directive 90/385/EEC
(Notified Body reviewed)
and RED 2014/53/EU (self-
certified)
Refer to instructions for
use (Consult accompanying
documents)
Temperature limitation
Humidity limitation
Pressure limitation

5
Symbol
Description
Do not reuse
Sterilized using Ethylene
oxide
Use by
Do not use if package is
damaged
Do not re-sterilize
Authorized representative
in the European
community
Open here
For USA audiences only
Caution: U.S. Federal law
restricts this device for sale
by or on the order of a
physician
󱛻󱛼󱛽
Warning / Caution
Product Literature

6
Symbol
Description
Magnetic Resonance (MR)
Conditional
IC Industry Canada
certification number
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

7
TABLE OF CONTENTS
LABEL SYMBOLS....................................................... 3
TABLE OF CONTENTS ............................................. 7
INTRODUCTION........................................................ 9
INDICATIONS, WARNINGS, AND
PRECAUTIONS........................................................... 9
DEVICE DESCRIPTION ..........................................10
Package Contents............................................................. 10
System Registration Form and Patient Identification
Card ................................................................................. 11
STORAGE AND USAGE ..........................................12
Sterilization...................................................................... 13
SPECIFICATIONS ....................................................14

8
X-RAY IDENTIFICATION ......................................16
NEUROSTIMULATOR IMPLANT
PROCEDURE.............................................................17
Procedure Supplies........................................................... 17
Neurostimulator Preparation ........................................... 17
Creating the Neurostimulator Pocket................................ 18
Connecting the Lead to the Neurostimulator .................... 19
Implanting the Neurostimulator ....................................... 22
Completing the Implant Procedure ................................... 24
Post-Surgery Treatment ................................................... 24
Replacing the Neurostimulator......................................... 24
WIRELESS COMMUNICATION ............................26
CUSTOMER SERVICE .............................................28

9
INTRODUCTION
This manual provides information about the Axonics Sacral
Neuromodulation (SNM) System Neurostimulator (Model
1101), which is a part of the Axonics SNM System. The
Neurostimulator is connected to the Axonics Tined Lead
(Model 1201 or 2201).
Indications, Warnings, and
Precautions
•Refer to Indications for Use insert for indications and
contraindications
•Refer to Information for Prescribers booklet for warnings,
precautions, adverse events, patient selection and clinical
summary.
•Refer to MRI Physician Guidelines for MRI specific conditions
and contraindications.

10
DEVICE DESCRIPTION
The Axonics Neurostimulator (Figure 1) is part of the
Axonics SNM System. The Neurostimulator is a
programmable device that is connected to the Axonics
tined lead, which conducts stimulation pulses to the sacral
nerve.
Package Contents
The Neurostimulator package contains the following:
• Neurostimulator
• Torque wrench
• System registration form
• Patient identification card
• Neurostimulator Implant Manual (this document)
The contents of the inner package are STERILE. The
contents of the Neurostimulator package are intended for
single use only.
Figure 1: Axonics Neurostimulator.

11
System Registration Form and Patient
Identification Card
The system registration form registers the device and
creates a record of the device in Axonics’ implant data
system.
The patient identification card is also packaged with this
device. The patient should carry the identification card at
all times.

12
Storage and Usage Environment
Component Packaging – Any component that has been
compromised in any way should not be implanted. Do not
implant the component if any of the following have
occurred:
•The storage package or sterile pack has been
damaged, pierced, or altered, as sterility cannot be
guaranteed, which may lead to infection.
•The component itself shows any signs of damage.
The component may not function
properly.
•The use-by date has expired. In this case,
component sterility cannot be guaranteed and
infection may occur.
•The sterile component was dropped onto a non-
sterile surface. In this case, the sterility cannot be
guaranteed and infection may occur.
Usage Environment:
The following lists the appropriate temperature, humidity,
and pressure usage conditions for use of the
Neurostimulator:
•Temperature: 20 °C to 45 °C
•Pressure: The Neurostimulator should function at up
to 10 m (33 feet) underwater (200 kPa) and at
altitudes up to 3000 m (10,000 feet) associated with
activities like hiking and skydiving (as low as 70 kPa)
Shipping and Storage Environment:
The following lists the appropriate temperature, humidity,
and pressure conditions for shipping and storing the
Neurostimulator:
•Temperature (short term: 3 days): -10 oC to 55 oC

13
•Temperature (long term): 20oC to 30 oC
•Humidity (short term: 3 days): 15% to 95%
•Humidity (long term): 30% to 85%
•Pressure (short term): 57 kPa to 106 kPa
•Pressure (long term): 70 kPa to 106 kPa
If the
Neurostimulator is exposed to extreme
temperatures, it may be permanently damaged and should
not be used, even if it has returned to a temperature that
is within the specified operating range.
Sterilization
The contents of this package have been sterilized using
ethylene oxide. This device is for single use only and should
not be re-sterilized.

14
SPECIFICATIONS
Table 1shows the Neurostimulator physical specifications.
For detailed descriptions and specifications for other
components and accessories, refer to the product
literature packaged with those devices.
Table 1: Neurostimulator Specifications.
Physical
Attributes
Height
42 mm
Length
22 mm
Thickness
6 mm
Weight
11 grams
Volume
5.5 cc
Radiopaque identifier
AXA
Stimulation
Characteristics
Frequency
2-130 Hz
Pulse Width
60-450 µs
Amplitude
0-12.5 mA
Minimum Amplitude
Step Size
0.05 mA
Ramping
0-30 s
Stimulation Mode
Continuous or Cycling
Mode of Operation Current-Controlled
Power Source
Battery
Rechargeable
Power Source
50 mAh (3.6V)
Battery life
15 years (open-ended)*

15
Note: All dimensions are approximate.
*Battery life estimated at nominal and worst case stimulation settings.
Nominal: 1 mA, 14 Hz, 210 µs, continuous stimulation, impedance = 1,600 Ohms.
Worst case: 4 mA, 14 Hz, 210 µs, continuous stimulation, impedance = 1,600
Ohms.
Table 2 shows the materials used in the Neurostimulator kit
components that come in contact with human tissue.
Table 2: Human-Contact Materials.
Device
Component
Material
Neurostimulator Neurostimulator
case
Titanium-Ceramic
Neurostimulator
header
Epoxy
Septum and strain
relief
Silicone
Setscrew
Titanium
Adhesive
Silicone
Torque wrench Torque wrench
handle
Polyetherimide
Torque wrench shaft
Stainless steel
Note: The Neurostimulator case, which contains the
electronics and power source, is hermetically sealed.

16
X-RAY IDENTIFICATION
The radiopaque marker allows physicians to identify the
manufacturer and model number under standard x-ray
procedures. For the Axonics Neurostimulator, the
designated code is AXA, which appears as light characters
on a black background (Figure 2).
Figure 2: The Axonics Neurostimulator radiopaque
marker, “AXA”.

17
NEUROSTIMULATOR IMPLANT
PROCEDURE
The following section describes the procedure for
implanting the Axonics Neurostimulator. This procedure
should be performed when an Axonics tined lead has
already been implanted.
Procedure Supplies
In addition to the general surgical tools required by the
physician, the following supplies are needed for the
preparation, implantation, programming, and Remote
Control pairing of the Neurostimulator:
•Axonics Neurostimulator (Model 1101)
•Axonics Charging System (Model 1401)
•Axonics Clinician Programmer (CP) (Model 2501)
•Axonics Remote Control (Model 2301)
⚠Caution: The user should avoid damaging the
Neurostimulator and be especially cautious using sharp
instruments as damage to the Neurostimulator may
require a surgical replacement.
Neurostimulator Preparation
Use the Charger to activate the Neurostimulator. Before
opening the sterile Neurostimulator package, the Clinician
Programmer (CP) should be used to communicate with the
Neurostimulator to verify the ability to communicate and
to check battery status. If the Neurostimulator battery is
low, the device should be charged through the box before
implantation by using the Charger. Refer to the CP and
Charging System Manuals for further instructions.

18
Creating the Neurostimulator Pocket
1. The Neurostimulator will be placed in a subcutaneous
pocket at the anterior surface of the muscle in the upper
buttock area. Create a small incision, slightly larger than
the smaller dimension of the Neurostimulator, and then
bluntly dissect a subcutaneous pocket.
Notes:
•The Neurostimulator should be placed no deeper
than 3.0 cm (about 1 in) below the skin and should be
parallel to the skin. If the Neurostimulator is too deep
or is not parallel to the skin, charging and/or
programming the device may be unsuccessful.
•The Neurostimulator should be implanted
horizontally (Figure 3) with the ceramic side farthest
from the patient’s midline to facilitate charging and
programming.
•For a patient with another neurostimulator already
implanted, the neurostimulators should be placed as
far away as practical and separated by a minimum of
20 cm (8 in).
⚠Cautions:
•The Neurostimulator implant site should be irrigated
with antibiotic solution, and it is recommended that
IV antibiotics be administered perioperatively. Do not
soak the Neurostimulator in antibiotic solution as this
may affect lead connections.
•The Neurostimulator has been sterilized. The
Neurostimulator should not be placed on any non-
sterile surface. The Neurostimulator should not be
placed on skin. An infection may require surgical
removal of the implanted system.

19
2. Use the tunneling tool to create a tunnel from the lead
incision site to the neurostimulator pocket. Refer to the
Tined Lead Manual for detailed tunneling and lead implant
instructions.
Connecting the Lead to the Neurostimulator
1. The components should be wiped and dried to remove any
fluids before making the connections. If necessary, use
sterile water or a non-ionic antibiotic solution, then wipe
dry.
⚠Caution: Failure to completely dry the components could
lead to undesired stimulation, intermittent stimulation, or loss of
therapy.
2. Ensure that the Neurostimulator connector block is dry and
clean.
Figure 3: Axonics Neurostimulator Implantation
Position.

20
3. Use the torque wrench to turn the setscrew
counterclockwise to back up the setscrew. Do not
remove the setscrew from
the connector block (Figure
4).
4. Insert the lead into the Neurostimulator connector block
until fully seated and the lead cannot be inserted further.
Marker D on the lead should be inside the Neurostimulator
strain relief (Figure 5).The retention sleeve on the tined
lead should be positioned under the Neurostimulator
setscrew.
Figure 4: Use the Torque Wrench to Turn the Setscrew
Counterclockwise to Back up the Neurostimulator
Setscrew and Allow for Insertion of the Lead.