Cochlear Kanso Halo User manual

Kanso®
Halo Accessory
User Guide
EN
EL
ES
PT
PT-BR
RO
HE

Contents
Kanso® Halo Accessory User Guide 1
EL Πρόσθετο εξάρτημα Kanso® Halo
Οδηγός χρήστη
20
ES
Accesorio Kanso® Halo Guía de usuario 39
PT
Guia do utilizador do Acessório
Kanso® Halo
58
PT-BR
Guia do usuário do Acessório
Kanso® Halo
77
RO
Accesoriu Kanso® Halo Ghid de utilizare 96
115 󰁪󰁬󰁶󰁲󰂋󰂌󰁺󰁽󰁮󰂋󰁶󰁷󰁺󰁽󰂌󰂎󰁽󰂌
HE

1Kanso Halo Accessory User Guide
Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . .2
Kanso Halo Accessory. . . . . . . . . . . . . . . . . . . . . 3
Use the Halo Accessory . . . . . . . . . . . . . . . . 7
Remove the Halo Accessory . . . . . . . . . . . . . . . . 10
Regular care . . . . . . . . . . . . . . . . . . . . . . . . . 11
Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Warnings. . . . . . . . . . . . . . . . . . . . . . . . 13
Other information. . . . . . . . . . . . . . . . . . . 15
Contents
Kanso® Halo Accessory User Guide 1
EL
Πρόσθετο εξάρτημα Kanso® Halo
Οδηγός χρήστη
20
ES
Accesorio Kanso® Halo Guía de usuario 39
PT
Guia do utilizador do Acessório
Kanso® Halo
58
PT-BR
Guia do usuário do Acessório
Kanso® Halo
77
RO
Accesoriu Kanso® Halo Ghid de utilizare 96
115 󰁪󰁬󰁶󰁲󰂋󰂌󰁺󰁽󰁮󰂋󰁶󰁷󰁺󰁽󰂌󰂎󰁽󰂌
HE

2Kanso Halo Accessory User Guide
Introduction
About this guide
This guide is intended for hearing implant recipients and their
carers using the Kanso® Halo Accessory.
Note
• Refer to the relevant sections for cautions and warnings
relating to the use of the Halo Accessory.
• Please also refer to your Important Information document
for essential advice that applies to Cochlear implant systems.
Symbols used in this guide
Note
Important information or advice.
Tip
Time saving hint.
Caution (no harm)
Special care to be taken to ensure safety and effectiveness.
Could cause damage to equipment.
Warning (harmful)
Potential safety hazards and serious adverse reactions.
Could cause harm to person.

3Kanso Halo Accessory User Guide
Kanso Halo Accessory
Eyelets
Rings
Short Notch
Long Notch

4Kanso Halo Accessory User Guide
The Halo Accessory is a retention accessory for your sound
processor. This accessory provides users of the
Off-the-Ear (OTE) Kanso 2 Sound Processor increased
retention during activity or improved security against
dropping the device. The users will require hairclips to use with
the Halo Accessory.
Note
There is an option to use double-loop safety lines to attach
hairclips to the Halo Accessory after removing the rings.
The Halo Accessory should be used by recipients who can
either remove the sound processor themselves if it’s causing
discomfort or who can indicate any discomfort to their parent
or caregiver.

5Kanso Halo Accessory User Guide
Intended purpose
The Halo Accessory is intended to be used to assist with
wearing the sound processor as part of a hearing implant
system.
Indications
The Halo Accessory is indicated for use with the Kanso 2 Sound
Processor.
Contraindications
The Halo Accessory is not indicated for use with sound
processors other than those listed in Indications.

6Kanso Halo Accessory User Guide
Intended patient population
The sound processor is intended for patients implanted with a
compatible Cochlear Nucleus implant. There are no
restrictions for the intended patient population of the sound
processor in terms of age, weight, health or other condition.
Benefits
The sound processor operates in conjunction with a
compatible Cochlear Nucleus implant system.
Potential benefits of receiving a Cochlear Nucleus implant
system include:
• Better understanding of speech in quiet.
• Better understanding of speech in noise.
• Increased satisfaction based on hearing capabilities.
Intended users
The devices listed in Indications are intended for the following
users:
• Recipients of a compatible Cochlear Nucleus implant.
• Carers of recipients, who carry out recipient functions as
needed. Carers may include parents of paediatric recipients
who are less than 12 years old, and nurses or other carers
of otherwise dependant recipients.
• Audiologists/clinicians.

7Kanso Halo Accessory User Guide
Use the Halo Accessory
1. Align the eyelets
and notches of the
Halo Accessory with
the Kanso 2 Sound
Processor.
i. Shorter notch aligns
with the top
ii. Longer notch aligns with
the base
2. Ensure that the Halo
Accessory is aligned
parallel to the sound
processor.
3. Push the Halo Accessory
until it slides into place
on the sound processor.
Ensure the sound
processor is secure.
ii
i

8Kanso Halo Accessory User Guide
4. Thread the hairclips to
the rings attached to
the Halo Accessory.
5. Mount the sound
processor on to the
implant, with hairclips
hanging from the rings.
6. Attach the hairclips to hair on either side of the sound
processor.
a. Hold the hairclip from
the edges and press in
the middle to open it.

9Kanso Halo Accessory User Guide
b. Thread the hair through
the hairclip.
c. Press the edges of the
hairclip to close.
7. Check if the hairclips
are secure and orient in
V-shape with the sound
processor.
Caution
To avoid damage to your sound processor, make sure the Halo
Accessory is properly secured.
Note
When the Halo Accessory is on your sound processor, a portable
charger can be attached.

10 Kanso Halo Accessory User Guide
Remove the Halo Accessory
Caution
Always remove the Halo Accessory before charging your sound
processor in the Home Charger. If the Halo Accessory is attached
to your sound processor in the Home Charger, charging could be
slow or may not work.
1. Detach hairclips from your hair.
2. Remove your sound processor from the implant.
3. Support the Halo Accessory on either side with your
fingers.
4. Push the sound processor through with your thumbs.

11Kanso Halo Accessory User Guide
Regular care
Caution
Do not use cleaning agents or alcohol to clean your processor or
Halo Accessory.
Caution
To avoid deformation or breakage of your Halo Accessory, do not
wring or twist it.
• Check the Halo Accessory for dirt or moisture regularly.
Wipe the Halo Accessory with a soft dry cloth.
• Check if the Halo Accessory is becoming loose or showing
signs of wear. Replace as needed.

12 Kanso Halo Accessory User Guide
Cautions
• The Halo Accessory is a retention device. Do not use it for
any other purpose.
• Always use the Halo Accessory with a compatible sound
processor.
• If your Halo Accessory appears damaged or worn, replace
it with a new one.

13Kanso Halo Accessory User Guide
Warnings
• If your sound processor becomes warmer than usual,
remove it immediately and seek advice from your clinician.
Parents/caregivers: if your recipient indicates discomfort,
check if their sound processor is warmer than usual.
• Sound processors and related accessories contain small
parts that alone or in combination may pose a hazard of
inhalation, choking or ingestion. Swallowing or inhaling
small parts can cause severe or fatal injuries. Use the
tamper-resistant locks to keep small parts attached to the
processing unit where available. Always supervise children
under 3 years of age and others who may be at risk of
inhalation, choking or ingestion of small parts when they
use the sound processor and related accessories. When not
in use, keep small parts, and combinations of small parts,
out of reach from children. If small parts are swallowed or
inhaled, seek immediate medical attention.
• The Halo Accessory and sound processor should be
protected from excessive heat sources such as prolonged
exposure to bright sunlight. Before wearing the Halo
Accessory and sound processor, check the surface to
ensure it is not too hot to wear without discomfort to skin.
• Exposure of the sound processor and Halo Accessory to
temperatures above the operating range (+5° C/+41° F
to +40° C/+104° F) could lead to increased risk of sound
processor shutdown or malfunction due to overheating.

14 Kanso Halo Accessory User Guide
• If you experience tightness or pain at the implant site, or
develop significant skin irritation, stop using your sound
processor and contact your clinician.
• If the coil magnet is too strong, pressure sores may
develop at the implant site. If this happens, or if you
experience any discomfort in this area, contact your
clinician.
• No modification of this equipment is allowed.
• Use only as intended.
• Report unexpected problems to your clinician.

15Kanso Halo Accessory User Guide
Other information
ITEM MATERIAL
Halo Accessory Nylon
Rings 316 Stainless Steel
Product component measurements
Typical values.
ITEM WEIGHT WIDTH LENGTH
Halo Accessory 1 g 38.9 mm 40.1 mm
Environmental conditions
CONDITION MINIMUM MAXIMUM
Storage and transport temperature -10° C (+14° F) +55° C (+131° F)
Storage and transport humidity 0% RH 90% RH
Operating temperature (sound
processor) +5° C (+41° F) +40° C (+104° F)
Operating relative humidity 0% RH 90% RH
Operating pressure 700 hPa 1060 hPa
Disposal
Help protect the environment by not disposing of your Halo
Accessory with your unsorted household waste. Please recycle
your Halo Accessory according to your local regulations.

16 Kanso Halo Accessory User Guide
Warranty
The use of the Halo Accessory will not impact your Nucleus
Global Limited Warranty for your sound processor, if used in
accordance with the Halo Accessory instructions.

17Kanso Halo Accessory User Guide
Labelling symbols
The following symbols may appear on your sound processor or
accessories and/or packaging:
Consult
instructions for use
Consult instructions for use
Specific warnings or precautions associated with the
device, which are not otherwise found on the label
Manufacturer
Compatible sound processors
Authorised representative in the European Community
UDI
Unique Device Identification
Catalogue number
Medical device
Date of manufacture
+55°C
-10°C
(+14°F) (+131°F)
Temperature limits
Ingress protection
rating
Protected against failure from dust penetration
Protected against failure from continuous immersion in
water up to 3 metres deep for up to 2 hours
CE registration mark with notified body number
CE registration mark
Recyclable packaging

18 Kanso Halo Accessory User Guide
Serious incidents
Whilst serious incidents in relation to medical devices are
rare, it is acknowledged that incidents may happen. As an
organisation, Cochlear recognises the potential for harm and
will respond to any reported serious incident.
What is a serious incident?
A ‘serious incident’ means any event that directly or indirectly
has caused or could have caused an unexpected or unwanted
event including any of the following:
• The death of a patient, user or other person,
• The temporary or permanent serious deterioration of a
patient’s, user’s or other person’s state of health,
• A serious public health threat.
Reporting a serious incident
There is no definitive list of events/incidents that constitute a
serious incident, however all serious incidents should be
reported to:
• your local Cochlear office
www.cochlear.com/intl/contact/global-offices
• For users within the European Union, you should also report
serious incidents to your National Competent Authority,
http://ec.europa.eu/growth/sectors/medical-devices/
contacts_en
• For users outside of the European Union, if applicable, report
serious incidents to your National Competent Authority,
• For users within Australia, report serious incidents to the
Therapeutic Goods Administration https://www.tga.gov.au