Exsurgo Axon 2 User manual

Instructions for Use
Axon 2

All product names and brand names in this document are
trademarks or registered trademarks of their respective
holders.
© Copyright Exsurgo Ltd 2023. All rights reserved.
No part of this document may be reproduced or transmitted
in any form or by any means, electronic, mechanical,
photocopying, recording, or otherwise, without the prior
written permission of Exsurgo Ltd.
Axon is manufactured by:
Exsurgo Ltd
45i William Pickering Drive
Rosedale
Auckland 0632
New Zealand
UK Responsible Person:
Brain Lady Limited
PO Box 80146
London
N22 9NW
United Kingdom
Email: [email protected]m
Phone: [phone]
Web: www.exsurgo.com
Document Properties
Document Name
Axon 2 Instructions For Use
Issue Date
November 2023
Document Number
ED1001098
Document Revision
5

Exsurgo Ltd ED1001098-5 Axon Instructions for Use
Copyright © 2023 Exsurgo Limited –All Rights Reserved
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Contents
1Symbol Definitions and Terminology..................................................................................... 5
2Introduction............................................................................................................................. 7
2.1 Product description............................................................................................................ 7
2.2 Indications for Use............................................................................................................. 7
3Contraindications, Warnings, and Precautions..................................................................... 8
3.1 Medical Contraindications.................................................................................................. 8
3.2 General Warnings.............................................................................................................. 9
3.3 General Precautions........................................................................................................ 10
4Getting Started...................................................................................................................... 11
4.1 Axon System Contents .................................................................................................... 11
4.2 Before each use .............................................................................................................. 11
4.2.1 Headset preparation............................................................................................. 11
4.2.2 Install the Axon App.............................................................................................. 12
4.3 Starting the Axon App for the first time............................................................................. 13
4.3.1 Adding an Account ............................................................................................... 13
4.4 Starting your first session................................................................................................. 15
4.4.1 Logging in to the App............................................................................................ 15
4.5 Wearing the headset........................................................................................................ 16
4.5.1 Turning on the headset......................................................................................... 16
4.5.2 Preparing the Sensors.......................................................................................... 17
4.5.3 Putting on the headset.......................................................................................... 17
4.6 Progress tracking questionnaires and diaries................................................................... 18
4.7 Welcome Page................................................................................................................ 20
4.8 Starting a Session............................................................................................................ 21
4.8.1 Headset Connectivity Check................................................................................. 21
4.8.2 Complete Pre-session baselines........................................................................... 21
4.8.3 Choose your Game .............................................................................................. 23
4.8.4 Rest Periods......................................................................................................... 25
4.8.5 Complete final Baseline........................................................................................ 25
4.8.6 Session Complete ................................................................................................ 25
4.8.7 After the Session is completed ............................................................................. 26
5Tracking Your Progress........................................................................................................ 27
6Help & Support...................................................................................................................... 28

Exsurgo Ltd ED1001098-5 Axon Instructions for Use
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7Brain Visualisation................................................................................................................ 29
8Maintenance & Cleaning....................................................................................................... 29
8.1 Cleaning the headset....................................................................................................... 29
8.2 Battery Life...................................................................................................................... 30
8.3 Battery Replacement....................................................................................................... 30
9Transporting, Storing and Disposing of your Headset....................................................... 31
9.1 Shipping .......................................................................................................................... 31
9.2 Storage............................................................................................................................ 31
9.3 Disposal........................................................................................................................... 31
10 Technical specifications....................................................................................................... 32
10.1Device specifications....................................................................................................... 32
10.2EMC guidance & Declaration........................................................................................... 32
11 Contact information.............................................................................................................. 32

Exsurgo Ltd ED1001098-5 Axon Instructions for Use
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1 Symbol Definitions and
Terminology
The table below explains the symbols used in these Instructions for
Use, and on Axon labels and packaging.
Symbol
Definition
Reference
Manufacturer details
Name and address of the manufacturer
ISO 15223
5.1.1
Country and Date of Manufacture
NZ (New Zealand)
Date format: YYYY-MM (Year-Month)
ISO 15223
5.1.11
Type BF Applied Part
Classification of protection against
electrical shock, complying with IEC 60601-
1.
IEC 60601-
1 Table D1
No. 20
Medical Device
Indicates this device is a Medical Device
ISO 15223
5.7.7
Serial Number
Manufacturer’s serial number to identify the
specific device
ISO 15223
5.1.7
Catalog Number
Manufacturer’s catalog number to identify
the medical device
ISO 15223
5.1.6
Unique Device Identifier
Unique code identifying the specific device
for traceability.
ISO 15223
5.7.10
Bluetooth identifier
Used by the Axon App to pair with the Axon
headset
No
regulatory
requirement
Consult Instructions for Use
Read Instructions for Use prior to using the
system
ISO 15223
5.4.3
BTID
NZ

Exsurgo Ltd ED1001098-5 Axon Instructions for Use
Copyright © 2023 Exsurgo Limited –All Rights Reserved
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Symbol
Definition
Reference
Warnings
Actions or situations that could lead to
personal injury. Take note of all warnings
before using the device.
No
regulatory
requirement
Cautions
Actions or situations that could damage the
equipment or other property, or interfere
with operating the device.
No
regulatory
requirement
Notes
Contains advisory information about some
aspects of operation.
No
regulatory
requirement
EU Only:
Do not dispose of Axon as unsorted
municipal waste.
To arrange for return or collection contact
your Axon supplier for disposal information.
EU directive
2012/19/EU
US Only:
Prescription Only
CAUTION: U.S. Federal law restricts this
device to sale by or on the order of a
licensed physician.
21 CFR
801.109
Keep dry
keep away from rain and in dry condition
ISO 15223
5.3.4
Temperature Limitation
Acceptable upper and lower limits of
temperature for transport and storage
ISO 15223
5.3.7
Humidity Limitation
Acceptable upper and lower limits of
relative humidity for transport and storage
ISO 15223
5.3.8
UK Conformity Assessed
UK product marking indicating compliance
with relevant UK regulations.
UK Medical
Devices
Regulations
2002
WARNING
CAUTION

Exsurgo Ltd ED1001098-5 Axon Instructions for Use
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2 Introduction
2.1 Product description
Axon uses Exsurgo’s custom-designed EEG headset to read and
record the unique EEG signature and brain activity patterns
associated with each user, which are then transmitted to the app,
enabling them to interact with these signals in real time.
The user learns to modulate their activity through neurological
exercises in the form of simple animated games, using positive
reinforcement to redirect brain activity towards frequencies
associated with relaxation and calm focused attention.
Axon facilitates changes in brain activity by harnessing neuroplastic
processes, thus reducing symptoms and introducing new patterns of
brain activity, in a process known as operant conditioning. As the
user progresses and completes the required sessions, the brain
learns to regulate itself through neuroplastic (Hebbian) learning.
2.2 Indications for Use
Axon is an EEG-based Neurofeedback system that uses the
principles of operant conditioning to enable users to self-regulate and
optimize their own brain activity via a brain computer interface,
allowing personalized treatments for a range of conditions.
Axon is indicated foruse by adults in both a professional (e.g. clinical)
and/or home environment, and can function as an adjunctive
treatment to improve symptoms related to chronic pain and anxiety.

Exsurgo Ltd ED1001098-5 Axon Instructions for Use
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3 Contraindications, Warnings, and
Precautions
We recommend you consult with your primary healthcare
provider/clinician before using Axon.
3.1 Medical Contraindications
Please do not use Axon unless you have discussed with your
clinician, if you have had any of the following:
•Head injury or concussion within the past 6 months
•History of seizures (e.g. epilepsy).
•Diagnosis of a neurological disorder.
•Hospitalization for psychiatric treatment.
•Undergone treatment for a serious disease (e.g. cancer),
within the past 6 months
•Using an electronic implanted device (e.g. pacemaker,
loop recorder)
WARN
WARNING

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3.2 General Warnings
Please take note of all warnings before operating. Failure to do so
may result in ineffective treatment or personal injury.
•DO NOT drink any beverages high in sugar (e.g. soda /
fizzy drinks), or any caffeine (including tea, coffee, and
energy drinks) for at least one hour prior to a training
session.
•DO NOT use under the influence of alcohol.
•DO NOT use under the influence of mind-altering
prescription drugs not approved by your doctor, and/ or
illicit drugs.
•DO NOT expose to any flames, sources of ignition or
incandescent material.
•DO NOT use in presence of strong heat, magnetic or
electrical field.
WARN
WARNING

Exsurgo Ltd ED1001098-5 Axon Instructions for Use
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3.3 General Precautions
Please take note of the following precautions for optimal use of Axon,
and to avoid possible damage to the equipment or other property.
•Dreadlocks, beads, or any other hairstyle or head covering
that cannot be removed may interfere with the headset
sensors.
•Store the headset in its case when not in use.
•DO NOT smoke while using Axon.
•DO NOT use outdoors.
•DO NOT leave exposed to sunlight for long periods of time
•DO NOT use harsh solvents to clean the device.
•DO NOT immerse in water or any other liquid.
•DO NOT dispose of improperly or expose to fire in any way
for disposal.
CAUTION

Exsurgo Ltd ED1001098-5 Axon Instructions for Use
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4 Getting Started
4.1 Axon System Contents
1 x Axon 2 headset
1 x Axon 2 headset case
1 x Quick Start Guide
4 x spare sensors
1 x water pen
4.2 Before each use
4.2.1 Headset preparation
Check the general condition of the Axon headset visually to ensure
there are no signs of damage to:
•Any of the plastic housing
Do not use the headset if the plastic housing is damaged, and
contact Exsurgo Support.
•The silver coating on the sensors
Replace the sensors if the silver coating is damaged, exposing

Exsurgo Ltd ED1001098-5 Axon Instructions for Use
Copyright © 2023 Exsurgo Limited –All Rights Reserved
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the uncoated area underneath; see examples below.
4.2.2 Install the Axon App
Install the Axon App by:
•visiting our website at
https://exsurgo.com/products/axon
•scanning the QR Code below,
•or searching for Exsurgo Axon on the Apple
App Store or Google Play Store.
Follow the prompts in the App to log in, using the Email address and
Password you entered when you registered.
Axon
A smartphone or tablet is required to run the Axon App,
with compatibility for iOS 16 or later, or Android 9 or later.

Exsurgo Ltd ED1001098-5 Axon Instructions for Use
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4.3 Starting the Axon App for the first time
4.3.1 Adding an Account
To add a user account for the first time select ‘Add an account’
Enter your email address you provided when you completed the
account registration, then press ‘Next’
Your Username
will be the email
address that you
provided.

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Enter your Password (case sensitive), then press ‘Next’.
Create a four-digit PIN to be used for future log-ins. You will be
asked to confirm your PIN by re-entering it.
Use the eye
icon to check
the password
is correct.

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4.4 Starting your first session
4.4.1 Logging in to the App
Select your user account from the user list and enter your four-digit
pin or password.

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4.5 Wearing the headset
4.5.1 Turning on the headset
Press the power button on the top of the headset to turn the headset
on.The Status Indicator on the headset will flash blue, indicating the
headset is powered on and waiting for a Bluetooth connection.
Once switched on, the Axon app will detect the Axon headset and
display the headset’s Bluetooth ID.
Power
button
Status
Indicator
You can find your
headset’s unique
Bluetooth ID by
referring to the
on the
headset label.
BTID
Hold the power
button down to
turn off

Exsurgo Ltd ED1001098-5 Axon Instructions for Use
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Confirm your headset’s Bluetooth ID by selecting it, to connect to your
headset.
Once successfully connected, the Status Indicator on the headset will
stop flashing and light up a steady blue.
4.5.2 Preparing the Sensors
The signal quality can also be improved by wetting the sensors with
water. Using the included water pen, lightly brush water over the
sensor surface.
Use deionised or distilled water to avoid mineral residue building up
on the sensors.
4.5.3 Putting on the headset
Position the headset in the correct orientation - facing down on a flat
surface, with the earpiece sensors at the top (the left earcup on your
left).
Pick up by holding the earpieces, and place over your ears. Adjust
While some users may be able to get good signal quality without needing
to wet the sensors, we recommend you start by using the water pen to
obtain a good connection quickly and easily.

Exsurgo Ltd ED1001098-5 Axon Instructions for Use
Copyright © 2023 Exsurgo Limited –All Rights Reserved
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the earpieces by sliding them up or down, to ensure a firm,
comfortable fit.
Try to move as much hair as
possible away from underneath the
sensors to ensure good skin contact.
Massage the sensors into the scalp
to dislodge any hair that may be
trapped, and to ensure good contact
with the scalp.
4.6 Progress tracking questionnaires and diaries
The Axon app will prompt you to complete Progress Tracking
Questionnaires and a Medication Diary. This will help you monitor
your overall progress throughout your training period.
Give your best recollection of how you felt over the last 24 hours, and
your daily medication.
The Axon headset should now sit comfortably, evenly, and firmly over
the middle of the head.
All four sensors should have direct connection to the skin, unobstructed
by hair.
Ensure the sensors remain
symmetrical across the middle of
your head by adjusting the
earpieces on both sides to the
same setting, indicated by the
arrow and numbers on the side of
the earcup sliders.

Exsurgo Ltd ED1001098-5 Axon Instructions for Use
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Press the forward arrow to proceed to the next page, or the back arrow
if you want to change your previous answers.

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4.7 Welcome Page
This is the main page where you can Start your Neurofeedback
training session.
You can also navigate to the following sections of the Axon app:
Your Progress
Track your training progress.
(Refer to Section 5)
Help & Support
View instructional videos and support
documentation.
(Refer to Section 6)
Brain Visualisation
View a representation of your neuronal
activity.
(Refer to Section 7)