PH Paradise Hearing Aids User Guide
- June 3, 2024
- PHONAK
Table of Contents
- Paradise Hearing Aids
Phonak AudéoTM P-RL
User Guide
Phonak Audéo P-RL Phonak Audéo P-RL Trial Phonak Life Charger Phonak Charger
Case GoTM
This user guide is valid for: Wireless hearing aids Phonak Audéo P90-RL Phonak
Audéo P70-RL Phonak Audéo P50-RL Phonak Audéo P30-RL Phonak Audéo P-RL Trial
Charging accessories Phonak Charger Case Go Phonak Life Charger
Note that instructions for the activity tracking functions can be found in the
myPhonak User Guide.
2
Your hearing aid and charger details
If no box is checked and you do not know the model of your hearing aid or charging accessories, please ask your hearing care professional. The hearing aids described in this user guide contain a built-in and non-removable rechargeable lithium-ion battery. The charger contains a built-in and non- removable rechargeable lithium-polymer battery. Please also read safety information regarding handling rechargeable hearing aids (chapter 24).
Hearing aid models c Audéo P-RL (P90/P70/P50/P30) c Audéo P-RL Trial
Charging accessories c Phonak Charger Case Go c Phonak Life Charger
- incl. USB cable (< 3 m)
Earpieces c Dome c SlimTip c cShell
3
Your hearing aids and chargers have been developed by Phonak a world leader
in hearing solutions based in Zurich, Switzerland.
These premium products are the result of decades of research and expertise and
are designed with your well-being in mind. We thank you for making such a
great choice and wish you many years of listening pleasure.
Please read the user guide carefully to make sure that you understand and get
the best out of your device. Training is not required for handling of this
device. A hearing care professional will help set up this device according to
your individual preferences during the fitting consultation. For more
information regarding features, benefits, set up, use, maintenance or repairs
of your hearing aid and accessories, please contact your hearing care
professional or the manufacturer representative. Additional information can be
found in the datasheet of your product.
Phonak – life is on www.phonak.com
Contents
Your hearing aid and charger
1. Quick guide
7
2. Parts of the hearing aid and charger
9
Using the charger
3. Preparing the charger
12
4. Charging the hearing aids
13
Using the hearing aid
5. Left and right hearing aid markings
18
6. Putting on the hearing aid
19
7. Removing the hearing aid
20
8. Multi-function button
21
9. On/Off
22
10. Tap Control
23
11. Connectivity overview
24
12. myPhonak App overview
25
13. Initial pairing
26
14. Phone calls
28
15. Flight mode
33
16. Rebooting your hearing aid
36
5
Further information
17. Operating, transport and storage conditions
37
18. Care and maintenance
39
19. Exchanging the earwax protection
42
20. Service and warranty
53
21. Compliance information
55
22. Information and description of symbols
64
23. Troubleshooting
72
24. Important safety information
78
6
1. Quick guide
Charging your hearing aids
Before using your hearing aid for the first time, it is recommended to charge
it for 3 hours.
After placing your hearing aid in the charger, the indicator light on the
hearing aid will show the charging state of the battery until it is fully
charged. When fully charged the indicator light will be constantly on, i.e.
solid green light.
Left & right hearing aid markings
Blue marking for left hearing aid.
Red marking for right hearing aid.
7
Multi-function button with indicator light The button has several functions.
It functions as an on/off switch, a volume control and/or a program change
depending on the hearing aid programming. This is indicated in your individual
instructions. Phone calls: If paired with a Bluetooth® enabled phone, a short
press will accept and a long press will reject an incoming call. On/Off:
Firmly press the lower part of the button for 3 seconds until the indicator
light blinks. On: indicator light is solid green Off: indicator light is solid
red Enter flight mode: When device is off, press the lower part of the button
for 7 seconds until the solid orange light appears. Then release the button.
Tap Control (only available for models P90 and P70) If paired with a Bluetooth
enabled device, multiple functions can be accessed using Tap Control, please
refer to chapter 10. This is also indicated in your individual instructions.
To use Tap Control tap the top of your ear twice.
8
2. Parts of the hearing aid and charger
The following pictures show the hearing aid model and charger accessories
described in this user guide. You can identify your personal models by: ·
checking “Your hearing aid and charger details” on
page 3. · comparing your earpieces, hearing aid and charger with
the following models.
Possible earpieces
Audéo P-RL Audéo P-RL Trial
Tube
Dome
SlimTip
cShell
Multi-function button with built-in indicator light
Anchor (optional) Speaker (without earpiece attached)
9
Phonak Life Charger and Phonak Charger Case Go
Charger Case lid Cavity for earpieces Indicator light for internal battery
status:
0% – 25% 25% – 50% 50% – 75% 75% – 100% Hearing aid charging slots with
left/right indicators
only applicable for Charger Case Go
10
USB-C connection to external power supply
External power supply
Indicator light for power connection Reset button
only applicable for Charger Case Go
USB cable (< 3 m) Power supply
11
3. Preparing the charger
Connecting the power supply
a) Plug the larger end of
c
the charging cable
d
a
b
into the power supply. b) Plug the smaller end
into the USB port on
the charger.
c) Plug the power
supply into a power
The Charger Case Go may also outlet.
be used without an external d) The indicator light is
power supply.
green when the
charger is connected
to the power supply.
Power supply Specifications
Power supply input voltage 100-240 VAC, 50/60 Hz, current 0.25 A
Power supply output voltage 5 VDC +/-10%, current 1 A
Charger input voltage
5 VDC +/-10%, current 1 A
USB cable specifications
5 V min. 1 A, USB-A to USB-C, maximum length 3 m
12
4. Charging the hearing aids
The Charger Case Go contains a built-in and non-removable rechargeable
lithium-polymer battery. If the built-in battery is fully charged, the hearing
aids can be charged 3 times. Low power: You will hear two beeps when the
hearing aid battery is low. You will have approximately 60 minutes before you
have to charge the hearing aids (this can vary, depending on the hearing aid
settings). The hearing aid contains a built-in and nonremovable rechargeable
lithium-ion battery. Before using your hearing aid for the first time, it is
recommended to charge it for 3 hours. The hearing aid must be dry before
charging, see chapter 18. Please ensure to charge the hearing aid within
operating temperature range: +5° to +30° Celsius (41° to 86° Fahrenheit).
13
4.1 Using the charger Please refer to chapter 3 for how to set up the charger.
- Insert the hearing aid into the charging slots and the earpieces in the
large cavity. Make sure the left and right hearing aid markings match the left
(blue), right (red) indicators next to the charging slots. The hearing aids
will automatically be switched off when inserted into the charger.
14
2. The indicator light on the hearing aid will show the charging state of the
battery until the hearing aid is fully charged. When fully charged the
indicator light will remain on, i.e. solid green light.
The charging process will automatically stop when the batteries are fully
charged, so the hearing aids can be safely left in the charger. It can take up
to 3 hours to charge the hearing aids. The charger lid can be closed while
charging.
Charging times
Indicator light
Charging state 0 10%
11 80%
81 99% 100%
Approx. charging times
30 min (30%) 60 min (50%) 90 min (80%)
3 h
15
3. Remove the hearing aids from the charging slots by simply lifting them out
of the charger.
Do not hold the tubes to remove the hearing aids from the charger as this can
damage the tubes Turn off your hearing aid before inserting it in the
disconnected charger to store it.
The hearing aid switches on automatically when removed from the charger. The
indicator light starts blinking. The solid green light indicates the hearing
aid is ready for use.
16
4.2 Battery Capacity in the Phonak Charger Case Go
To check the remaining battery capacity of the internal battery, open the lid
of the Charger Case Go. The indicator lights will show the status for 10
seconds.
Indicator light for internal battery status:
0% – 25% 25% – 50% 50% – 75% 75% – 100%
The lowest indicator light will light up in red when the internal battery is
depleted and cannot charge the hearing aids any more.
The internal battery of the Charger Case Go is not charged while the hearing
aids are charging.
17
5. Left and right hearing aid markings
There is a red or blue marking on the back of the hearing aid and on the
speaker. This will tell you if it is a left or a right hearing aid. Blue
marking for left hearing aid. Red marking for right hearing aid.
18
6. Putting on the hearing aid
1. Place the hearing aid behind your ear.
2. Insert the earpiece into your ear canal.
3. If there is an anchor attached to the earpiece, tuck it into the bowl of
your ear to secure your hearing aid.
19
7. Removing the hearing aid
Pull on the bend of the tube and remove the hearing aid from behind the ear.
20
8. Multi-function button
The multi-function button has several functions.
It functions as an on/off switch, a volume control and/or a program change
depending on the hearing aid programming. This is indicated in your individual
“Hearing aid instructions”. Please ask your hearing care professional for a
printout.
If the hearing aid is paired with a Bluetooth® enabled phone, a short press on
the upper or the lower part of the button will accept an incoming call and a
long press will reject an incoming call refer to chapter 14.
21
9. On/Off
Switch on hearing aid The hearing aid is configured to switch on automatically when removed from the charger. If this function is not configured, firmly press and hold the lower part of the button for 3 seconds until the indicator light blinks. Wait until the solid green light indicates the hearing aid is ready.
Switch off hearing aid Press and hold the lower part of button for 3 seconds until the solid red light indicates the hearing aid is off.
Blinking green
Hearing aid is switching on
Solid red for 2 seconds Hearing aid is switching off
When you switch on the hearing aid you might hear a start-up melody.
22
10. Tap Control
Tap Control is only available for models P90 and P70. If paired with a
Bluetooth® enabled device, multiple functions can be accessed using Tap
Control e.g. accept/end phone call, pause/resume streaming, start/stop voice
assistant. This is indicated in your individual “Hearing aid instructions”. To
use Tap Control tap the top of your ear twice.
23
11. Connectivity overview
The illustration below shows the connectivity options available for your
hearing aid.
Bluetooth® enabled device, e.g. cell phone
Roger**
TV Connector connected to TV*
- The TV Connector can be connected to any audio source such as a TV, PC or hi-fi system. ** Roger wireless microphones can be connected to your hearing aids as well.
24
12. myPhonak app overview
Compatibility information The myPhonak app can be used on:
· Phones with Bluetooth® Low Energy (LE) capability · iPhone® 5s and newer
running iOS® Version 12.0 or
newer · Google Mobile Services (GMS) certified AndroidTM
devices supporting Bluetooth 4.2 and AndroidTM OS 7.0 or newer
Please find the Instruction for Use on www.phonak.com/myphonakapp. or scan the
code
Install myPhonak app for iPhone users, please scan the code
Install myPhonak app for Android OS users, please scan the code
iPhone® is a trademark of Apple Inc., registered in the U.S. and other
countries. IOS® is a registered trademark or trademark of Cisco Systems, Inc.
and/or its affiliates in the United States and certain other countries.
AndroidTM is a trademark of Google LLC.
25
13. Initial pairing
13.1 Initial pairing to a Bluetooth® enabled device
It is only necessary to perform the pairing procedure once with each device
featuring Bluetooth® wireless technology. After the initial pairing, your
hearing aids will connect automatically to the Bluetooth® enabled device.
Initial pairing can take up to 2 minutes.
1. On your device (e.g. a phone), ensure that Bluetooth wireless technology
is enabled and search for Bluetooth enabled devices in the connectivity
setting menu.
2. Switch on both hearing aids. You now have 3 minutes to pair your hearing
aids with your device.
26
3. Your Bluetooth® enabled device shows a list of other Bluetooth® enabled
devices. Select the hearing aid from the list to simultaneously pair both
hearing aids. A beep confirms successful pairing.
For more information about pairing instructions for Bluetooth wireless
technology, specific to some of the most popular phone manufacturers, go to:
https://www.phonak.com/com/en/support.html
13.2 Connecting to the device
After your hearing aids have been paired to your device, they will
automatically connect again when switched on.
The connection will be maintained as long as the device remains ON and within
range. Your hearing aid can be connected to up to two devices and paired to up
to eight devices.
27
14. Phone calls
Your hearing aids connect directly with Bluetooth® enabled phones. When paired
and connected to your phone, you will hear the caller’s voice directly in your
hearing aids. Your voice is picked up by the hearing aid microphones and
transmitted to the phone.
Your voice
Caller’s voice
28
14.1 Making a call Enter the phone number and press the dial button. You will
hear the dialing tone through your hearing aids. Your voice is picked up by
the hearing aid microphones and transmitted to the phone.
29
14.2 Accepting a call When receiving a call, a calling notification will be
heard in the hearing aids. The call can be accepted by tapping the top of your
ear twice (only available for models P90 and P70), a short press on the upper
or lower part of the multi-function button on the hearing aid (less than 2
seconds) or directly on your phone.
short press < 2 sec
tap ear twice
30
14.3 Ending a call A call can be ended by tapping the top of your ear twice
(only available for models P90 and P70), a long press on the upper or lower
part of the multi-function button on the hearing aid (more than 2 seconds) or
directly on your phone.
long press > 2 sec
tap ear twice
31
14.4 Rejecting a call An incoming call can be rejected by a long press on the
upper or lower part of the multi-function button on the hearing aid (more than
2 seconds) or directly on your phone.
long press > 2 sec
32
15. Flight mode
Your hearing aids operate between 2.4 GHz2.48 GHz frequency range. When
flying some operators require all devices to be switched into flight mode.
Entering flight mode will not disable normal hearing aid functionality, only
the Bluetooth® connectivity functions. 15.1 Enter flight mode To disable the
wireless function and enter flight mode in each hearing aid:
33
If the hearing aid is turned off,
proceed to Step 2.
If the hearing aid is on, turn it off
by pressing and holding the lower
part of the button for 3 seconds,
until the indicator light turns solid
red for 2 seconds, signifying that
the hearing aid is switching off.
Press and hold the lower part of
the button. The green indicator
light blinks when the hearing aid
starts up.
Keep pressing the button for
7 seconds, until the indicator light
is solid orange, then release the
button.
The solid orange light indicates the
hearing aid is in flight mode.
In flight mode, your hearing aid cannot connect directly to your phone.
34
15.2 Exit flight mode To enable the wireless function and exit flight mode in
each hearing aid: Switch the hearing aid off and then on again – refer to
chapter 9.
35
16. Rebooting your hearing aid
Use this technique if your hearing aid is in an error state. This will not
remove or delete any program or settings.
1. Press the lower part of the button for at least 15 seconds. It does not
matter if the hearing aid is switched on or off before you start pressing the
button. There is no light or acoustic notification at the end of the 15
seconds.
2. Place the hearing aid in the power-connected charger and wait until the
indicator light blinks green. This can take up to 30 seconds. The hearing aid
is now ready to use.
36
17. Operating, transport and storage conditions
The product is designed such that it functions without problems or
restrictions if used as intended, unless otherwise noted in these user guides.
Please ensure to use, charge, transport and store the hearing aids and the charger according to the following conditions:
Temperature
Maximum range
Use
Charging
Transport
Storage
+5° to +40°C +5° to +30°C -20° to +60°C -20° to +60°C (41° to 104°F) (41° to 86°F) (-4° to 140°F (-4° to 140°F)
Recommended +5° to +40°C +7° to +22°C 0° to +20°C 0° to +20°C
range
(41° to 104°F) (45° to 72°F) (32° to 68°F) (32° to 68°F)
Humidity
Maximum range
0% to 85% (non condensing)
0% to 85% (non condensing)
0% to 70%
0% to 70%
Recommended 0% to 60%
range
(non
condensing)
0% to 60% (non condensing)
0% to 60%
0% to 60%
Atmospheric 500 hPa to
pressure
1060 hPa
500 hPa to 1060 hPa
500 hPa to 1060 hPa
500 hPa to 1060 hPa
37
Please ensure to charge the hearing aids regularly during long-term storage.
If the device has been subject to storage and transport conditions outside of
the recommended use conditions, wait 15 minutes before starting the device.
38
18. Care and maintenance
Diligent and routine care of your hearing aid and charger contribute to
outstanding performance and a long service life. To ensure a long service
life, Sonova AG provides a minimum of a five year service period after phase
out of the respective hearing aid, charger and essential components.. Please
use the following specifications as a guideline. Further information regarding
product safety, see chapter 24.2.
39
General information Before using hair spray or applying cosmetics, you should
remove your hearing aid from your ear, because these products may damage it.
Your hearing aids are resistant to water, sweat and dust under the following
conditions: · After exposure to water, sweat or dust, the hearing aid
is cleaned and dried. · The hearing aid is used and maintained as described in
this user guide.
Always make sure that the hearing aids and charger are dry and clean before
charging.
40
Daily Hearing aid: Inspect the earpiece for earwax and moisture deposit and
clean the surfaces with a lint-free cloth. Never use cleaning agents such as
household detergents, soap, etc. for cleaning your hearing aid. It is not
recommended to rinse with water. If you need to clean your hearing aid
intensively, ask your hearing care professional for advice and information on
filters or drying methods. Charger: Make sure that charger inserts are clean
and clean the surfaces with a lint-free cloth. Never use cleaning agents such
as household detergents, soap, etc. for cleaning your charger.
Weekly Hearing aid: Clean the earpiece with a soft, damp cloth or with a
special cleaning cloth for hearing aids. For more in-depth maintenance
instructions or for more than basic cleaning, please see your hearing care
professional. Clean the charging contacts on the hearing aid with a soft, damp
cloth. Charger: Remove dust or dirt from the charger inserts with a lint-free
cloth.
Always make sure that the charger is disconnected from the power mains before
cleaning.
41
19. Exchanging the earwax protection
Your hearing aid is equipped with an earwax protection to protect the speaker
from earwax damage.
Please check the earwax protector regularly and exchange it if it looks dirty
or if the hearing aid volume or sound quality is reduced. The earwax
protection should be replaced every four to eight weeks on a regular receiver,
and once a week on the ActiveVentTM Receiver.
19.1 Regular receiver with dome
19.1.1 Removing the earpiece from the speaker
1. Remove the earpiece from the speaker by holding the speaker in one hand
and the earpiece in the other.
42
2. Gently pull off the earpiece to remove.
3. Clean the speaker with a lint-free cloth.
43
19.1.2 Exchanging the earwax protection with CeruShieldTM Disk
1. Gently rotate the CeruShieldTM Disk in the direction indicated by the
arrows until a free opening appears under the bin icon.
2. To remove a used earwax protector carefully insert the speaker into the
free opening (under bin icon) until it clicks. After the click you will see
the used earwax protector in the opening below the bin icon.
44
3. To insert a new earwax protector carefully insert the speaker into the
opening where the new earwax protector is visible (opposite the bin icon)
until it clicks. After the click you will see the opening below is empty and
the new earwax protector is now inside the speaker.
45
19.1.3 Attaching the earpiece to the speaker 1. Hold the speaker in one hand
and the earpiece in the other.
2. Slide the earpiece over the speaker sound outlet.
3. The speaker and the earpiece should fit perfectly together.
46
19.2 ActiveVentTM Receiver with SlimTip
19.2.1 Parts Explanation
wax filter dispenser
a
a) rotating disk
b
c
b) new filter
c) dispensing slot for used filters
changing tool
a) screw end
for removing used filter
a
b
b) forked end
for inserting new filter
47
19.2.2 Removing the used wax filter (HF3 Filter) 1. Hold the earpiece firmly
and secure the rear of the speaker with your finger.
2. Insert the screw end of the changing tool into the speaker of the hearing
aid.
48
3. Rotate the changing tool clock-wise runtil some resistance is felt. Pull
the changing tool out of the speaker with the used wax filter attached to the
end.
4. Insert the used wax filter into the dispensing slot in the middle of the
wax filter dispenser.
49
5. Slide the changing tool to either side of the dispensing slot. Lift the
changing tool up, leaving the used wax filter in dispensing slot.
19.2.3 Inserting a new wax filter
1. After removing the used wax filter from the speaker of the hearing aid,
brush away any remaining debris. Rotate the ridged disk of the wax filter
dispenser until a new wax filter is visible in the window of the disk.
50
2. Now use the opposite end of the changing tool (i.e. forked end) to pick up
a new wax filter.
3. Insert the forked end of the changing tool down and pull up
51
4. Insert the new wax filter into the speaker of the hearing aid. Make sure
to secure the rear of speaker with your finger.
5. Once the new filter is securely placed in the speaker, lift the changing
tool a way in a slight tilted angle. Reattach the changing tool to the wax
filter dispenser
52
20. Service and warranty
Local warranty Please ask the hearing care professional where you purchased
your hearing aids and charger about the terms of the local warranty.
International warranty Sonova AG offers a one year limited international
warranty, valid from the date of purchase. This limited warranty covers
manufacturing and material defects in the hearing aid and charger
respectively, but not accessories such as tubes, earpieces, external
receivers. The warranty only comes into force if a proof of purchase is shown.
The international warranty does not affect any legal rights that you might
have under applicable national legislation governing sale of consumer goods.
53
Warranty limitation This warranty does not cover damage from improper handling
or care, exposure to chemicals or undue stress. Damage caused by third parties
or non-authorized service centers renders the warranty null and void. This
warranty does not include any services performed by a hearing care
professional in their office. Serial numbers Hearing aid left side: Hearing
aid right side: Charger: Date of purchase: Authorized hearing care
professional (stamp/signature):
54
21. Compliance information
Europe: Declaration of Conformity for the hearing aid Hereby Sonova AG
declares that this product meets the requirements of the Medical Device
Regulation (EU) 2017/745 as well as the Radio Equipment Directive 2014/53/EU.
The full text of the EU Declaration of Conformity can be obtained from the
manufacturer or the local Phonak representative whose address can be taken
from the list on www.phonak.com/us/en/certificates (Phonak worldwide
locations).
Australia/New Zealand: Indicates a device’s compliance with applicable Radio
Spectrum Management’s (RSM) and Australian Communications and Media Authority
(ACMA) regulatory arrangements for the legal sale in New Zealand and
Australia. The compliance label R-NZ is for radio products supplied in the New
Zealand market under conformity level A1.
55
The wireless models listed on page 2 are certified under:
Phonak Audéo P-RL (P90/P70/P50/P30) Phonak Audéo P-RL Trial Phonak Charger
USA Canada
FCC ID: KWC-PRL IC: 2262A-PRL
56
Notice 1: This device complies with Part 15 of the FCC Rules and with RSS-210
of Industry Canada. Operation is subject to the following two conditions: 1)
this device may not cause harmful interference, and 2) this device must accept
any interference received, including interference that may cause undesired
operation.
Notice 2: Changes or modifications made to this device not expressly approved
by Sonova AG may void the FCC authorization to operate this device.
Notice 3: This device has been tested and found to comply with the limits for
a Class B digital device, pursuant to Part 15 of the FCC Rules and ICES-003 of
Industry Canada. These limits are designed to provide reasonable protection
against harmful interference in a residential installation. This device
generates, uses and can radiate radio frequency energy and, if not installed
and used in accordance with the instructions, may cause harmful interference
to radio communications. However, there is
57
no guarantee that interference will not occur in a particular installation. If
this device does cause harmful interference to radio or television reception,
which can be determined by turning the equipment off and on, the user is
encouraged to try to correct the interference by one or more of the following
measures: · Reorient or relocate the receiving antenna. · Increase the
separation between the device
and receiver. · Connect the device into an outlet on a circuit
different from that to which the receiver is connected. · Consult the dealer
or an experienced radio/TV
technician for help.
58
Radio information of your wireless hearing aid
Antenna type
Resonant loop antenna
Operation frequency
2.4 GHz 2.48 GHz
Modulation Radiated power Bluetooth®
GFSK, Pi/4 DPSK, GMSK < 2.5 mW
Range Bluetooth® Profiles supported
~1 m 4.2 Dual-Mode HFP (Hands-free profile), A2DP
Wireless Power Transfer information of your Charger
Operation frequency
135 kHz
Radiated power
less than 45 dBuV/m
59
Emissions Test Compliance Electromagnetic environment guidance
RF emissions CISPR 11
Harmonic emissions
Group 2 Class B
The medical device uses RF energy only for its internal function. Therefore, its RF emission are very low and are not likely to cause any interferences in nearby electronic equipment
Complies
Voltage fluctuations /
flicker emissions
Complies
Compliance with emission and immunity standards
Emission standards
EN 60601-1-2:2015+A1:2021 IEC 60601-1-2:2014+A1:2020 EN 55011:2016/A2:2021 CISPR11:2015+A1:2016+A2:2019 CISPR32. CISPR32:2015+A1:2019 ISO 7637-2:2011 CISPR25:2016
60
Electromagnetic interference immunity tests
IEC 60601 test level Compliance levels
Electromagnetic environment guidelines
Electrostatic discharges ± 8 kV contact (ESD) IEC 61000-4-2
± 2, ± 4, ± 8, ± 15 kV air
± 8 kV contact
± 2, ± 4, ± 8, ± 15 kV air
Floors should be made from wood or concrete or covered with ceramic tiles. If the floor covering consists of synthetic material, the relative humidity should be at least 30 %.
Electrical fast transients/bursts according to IEC 61000-4-4
Surges according to IEC 61000-4-5
± 2 kV for power lines
Repetition frequency 100 kHz
± 2 kV for power lines
Repetition frequency 100 kHz
The quality of the supply voltage should be the same as the voltage of a typical business or hospital environment.
±1 kV line(s) to line(s)
±1 kV line(s) to line(s)
The quality of the supply voltage should be the same as the voltage of a typical business or hospital environment.
61
Electromagnetic interference immunity tests
IEC 60601 test level Compliance levels
Electromagnetic environment guidelines
Blackouts, brownouts, 0 % UT; 0.5 cycle
0 % UT; 0.5 cycle
Magnetic fields of the
and fluctuations of the
power supply
At 0°, 45°, 90°, 135°,
according to IEC
180°, 225°, 270° and
61000-4-11
315°
At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°
mains power frequency should comply with the typical values of business and hospital
0 % UT; 1 cycle and 70 0 % UT; 1 cycle and 70 environments.
% UT; 25/30 cycles % UT; 25/30 cycles
Single phase: at 0° Single phase: at 0°
0 % UT; 250/300 cycles 0 % UT; 250/300 cycles
Supply frequency (50/60 Hz) magnetic field IEC 61000-4-8
30 A/m
30 A/m
Magnetic fields of the mains power frequency should comply with the typical values of business and hospital environments.
Conducted RF
3 Vrms
3 Vrms
IEC 61000-4-6
0.15 MHz to 80 MHz 0.15 MHz to 80 MHz
6 Vrms in ISM bands 6 Vrms in ISM bands
between 0.15 MHz and between 0.15 MHz and
80 MHz
80 MHz
80 % AM at 1 kHz
80 % AM at 1 kHz
Transients RF IEC 61000-4-3
10 V/m 80 MHz to 2700 MHz
10 V/m 80 MHz to 2.7 GHz
80 % AM by 1 kHz 80 % AM by 1 kHz
62
Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment
Test Frequency
Band
Service Modulation Maximum power
MHz
MHz
W
385
308 TO 390 TETRA 400
Pulse
1,8
modulation
18 Hz
450
430 TO 470 GMRS 460, Pulse
2
modulation
FRS 460
217 Hz
710
Pulse
modulation
745
704 to 787 LTE Band 13, 17 18 Hz
0,2
780
810
GSM 800/900, Pulse
TETRA 800, modulation
870
800 to 960
iDEN 820, CDMA 850,
217 Hz
2
LTE Band 5 930
1720
GSM 1800; Pulse
CDMA 1900; modulation
1845 1700 to 1990 GSM 1900; 217 Hz
2
DECT;
1970
LTE Band 1, 3,4,
25; UMTS
Distance m 0,3 0,3
0,3
0,3
0,3
Immunity Test Level
V/m 27 28
9
9
28
Bluetooth, Pulse
WLAN 802.11 modulation
2450 2400 to 2570 b/g/n,
217 Hz
2
RFID 2450,
LTE Band 7
0,3
28
5240 5100 to 5800 WLAN 802.11 Pulse
02
0,3
9
a/n
modulation
217 Hz
63
22. Information and description of symbols
With the CE symbol, Sonova AG confirms that this product including
accessories meets the requirements of the Medical Devices Regulation (EU)
2017/745 as well as the Radio Equipment Directive 2014/53/EU. The numbers
after the CE symbol correspond to the code of certified institutions that were
consulted under the above-mentioned directives and regulations.
This symbol indicates that the products described in these user instructions
adhere to the requirements for an applied part of Type B of EN 60601-1. The
surface of the hearing aid is specified as an applied part of Type B.
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Indicates the medical device manufacturer, as defined in Medical Device
Regulation (EU) 2017/745.
Indicates the date when the medical device was manufactured
Indicates the Authorized representative in the European Community. The EC REP
is also the importer to the European Union.
This symbol indicates that it is important for the user to read and take into
account the relevant information in these user guides.
This symbol indicates that it is important for the user to pay attention to
the relevant warning notices in these user guides.
65
This symbol indicates that it is important for the user to pay attention to
the relevant warning notices related to batteries in these user guides.
Important information for handling and product safety.
This symbol confers that the electromagnetic interference from the device is
under limits approved by the US Federal Communications Commission.
Indicates a device’s compliance with applicable Radio Spectrum Management’s
(RSM) and Australian Communications and Media Authority (ACMA) regulatory
arrangements for the legal sale in New Zealand and Australia
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The Bluetooth® word mark and logos are registered trademarks owned by
Bluetooth SIG, Inc. and any use of such marks by Sonova AG is under license.
Other trademarks and trade names are those of their respective owners.
The Compliance Identification Mark indicates that the device is in accordance
with Brazilian conformity assessment requirements for equipment under health
surveillance system. OCP indicates the certification body.
Japanese mark for certified radio equipment.
Indicates the manufacturer’s serial number so that a specific medical device
can be identified.
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Indicates the manufacturer’s catalogue number so that the medical device can
be identified. Indicates that the device is a medical device.
This symbol indicates that it is important for the user to read and take into
account the relevant information in this user guide. Ingress Protection
Rating. IP68 rating indicates that the hearing aid is water and dust
resistant. It survived continuous immersion in 1 meter of water for 60 minutes
and 8 hours in a dust chamber as per the IEC60529 standard.
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Temperature during transportation and storage: 20° to +60° Celsius (4° to
+140° Fahrenheit). Humidity during transportation and storage: 0% to 70%, if
not in use. See instruction in chapter 24.2 regarding drying the hearing aid
after use. Atmospheric pressure during transportation and storage: 500 hPa to
1060 hPa During transportation keep dry.
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The symbol with the crossed-out garbage bin is to make you aware that this
hearing aid as well as the charger may not be thrown away as normal household
waste. Please dispose of old or unused hearing aids and charger, at waste
disposal sites intended for electronic waste, or give your hearing aid and
charger to your hearing care professional for disposal. Proper disposal
protects the environment and health.
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Symbols applicable to the European power supply only Power supply with double
isolation. Device designed for indoor use only. Safety isolating transformer,
short circuit proof.
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23. Troubleshooting
Problem
Causes
Hearing aid not
Speaker/earpiece blocked
functioning
Hearing aid switched off
Battery fully discharged
Hearing aid whistles
Hearing aid not inserted correctly into ear
Cerumen in ear canal
Hearing aid too loud
Volume too loud
Hearing aid not loud
Volume too low
enough or distorted
Low battery
Speaker/earpiece blocked
Hearing has changed
Hearing aid plays two
Indication for low battery
beeps
Hearing aid will not
Battery fully discharged
switch on
Button was inadvertently deactivated by
pressing the button longer than 15 seconds
Indicator light on hearing Hearing aid not inserted correctly
aid does not light up when into charger
hearing aid placed in charging slots
Hearing Aid battery fully discharged
Lowest indicator light on Charger Case error Charger Case Go constantly red
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What to do Clean speaker opening/earpiece Press lower part of multi-function
button for 3 seconds (chapter 9) Charge hearing aid (chapter 4) Insert hearing
aid correctly (chapter 6) Contact your ENT/GP or hearing care professional
Decrease volume if volume control available (chapter 8) Increase volume if
volume control available (chapter 8) Charge hearing aid (chapter 4) Clean
speaker opening/earpiece Contact your hearing care professional Charge hearing
aid (chapter 4)
Charge hearing aid (chapter 4) Perform step 2 of the rebooting process
(chapter 16)
Insert hearing aid correctly into charger (chapter 4)
Wait three hours after placing hearing aid in charger, regardless of LED
behavior
Push reset button for min. 8 seconds
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Problem
Causes
Indicator light on hearing Hearing aid is out of its operating
aid is solid red while
temperature range
hearing aid is in the
Faulty battery
charger
Indicator light on hearing “Auto On” feature is disabled
aid switches off when
hearing aid is removed
from charger
Hearing aid with
Vent in wrong position (e.g. closed)
ActiveVentTM Receiver is not Wax
working properly
Other
ActiveVent speaker feels loose in earpiece or has
Speaker dislodged from earpiece (i.e during exchange of earwax protection)
separated completely from earpiece
Indicator light on hearing Indicator light on hearing aid was red when
aid remains solid green hearing aid was placed into the charger after removal from charger
Battery does not last the Shortened battery life
whole day
Phone call function does Hearing aid is in flight mode
not work
Hearing aid not paired to the phone
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What to do Warm hearing aid up. Operating temperature range is +5° to +40°
Celsius (+41° to +104° Fahrenheit) Contact your hearing care professional
Switch on the hearing aid (chapter 9)
Press upper part of multi-function button for 3 seconds Clean the speaker
opening and / or change the wax filter (chapter 19.2) Contact your hearing
care professional Push the speaker back into the earpiece. If the speaker is
still loose contact your hearing care professional.
Reboot the hearing aid (chapter 16)
Contact your hearing care professional. A battery replacement may be required
Switch hearing aid off and then on again (chapter 15.2) Pair hearing aid to
the phone (chapter 13)
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Problem
Causes
Charging does not start Hearing aid not inserted correctly into
(when charger connected charger
to power supply)
Charging does not start Internal battery of charger discharged
(when charger not connected to power supply)
Hearing aid not inserted correctly into
charger (only applicable for Charger Case
Go)
If the problem persists, contact your hearing care professional for
assistance.
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What to do Insert hearing aid correctly into charger (chapter 4.1) Connect
charger to power supply (chapter 3) Remove the hearing aid from the charger
and insert again as described in chapter 4.1
Please check https://www.phonak.com/com/en/support.html for further
information.
77
24. Important safety information
Please read the relevant safety information and limitationsof-use information
on the following pages before using your hearing aid.
Intended use The hearing aid is intended to amplify and transmit sound to the
ear and thereby compensate for impaired hearing.
The Phonak Tinnitus Balance software feature is intended for use by people
with tinnitus who also desire amplification. It provides supplementary noise
stimulation which can help defocus the user`s attention from their tinnitus.
The chargers are intended to charge the battery of the rechargeable hearing
aid.
Intended patient population: Hearing aids: This device is intended for
patients with unilateral and bilateral, mild to profound hearing loss from 36
months of age. The tinnitus software feature is intended for patients with
chronic tinnitus from 18 years of age.
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Charger: The intended patient population is the user of the compatible hearing
aids
Intended user: Hearing aids: Intended for people with hearing loss using a
hearing aid and their caregivers. A hearing care professional is responsible
for adjusting the hearing aid. Charger: Intended for people with hearing loss
using the compatible rechargeable hearing aid and their caregivers, hearing
care professional
Indications: General clinical indications for the use of hearing aids, charger
and Tinnitus software feature are:
· Presence of hearing loss · Uni- or bilateral · Conductive, sensorineural or
mixed · Mild to profound · Presence of a chronic tinnitus (only applicable for
devices which provide the Tinnitus software feature)
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Contraindications: General clinical contra-indications for the use of hearing
aids and Tinnitus software feature are:
· Hearing loss is not in the fitting range of the hearing aid (i.e. gain,
frequency response)
· Acute tinnitus · Deformity of the ear (i.e. closed ear canal; absence of
the auricle) · Neural hearing loss
The primary criteria for the referral of a patient for a medical or other
specialist opinion and / or treatment are as follows:
· Visible congenital or traumatic deformity of the ear; · History of active
drainage from the ear in the previous
90 days; · History of sudden or rapidly progressive hearing loss in
one or both ears within the previous 90 days; · Acute or chronic dizziness; ·
Audiometric air-bone gap equal to or greater than 15
dB at 500 Hz, 1000 Hz and 2000 Hz;
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· Visible evidence of significant cerumen accumulation or a foreign body in
the ear canal;
· Pain or discomfort in the ear; · Abnormal appearance of the eardrum and ear
canal
such as: · Inflammation of the external auditory canal · Perforated eardrum ·
Other abnormalities which the hearing care professional believes are of
medical concern
The hearing care professional may decide that referral is not appropriate or
in the best interests of the patient when the following applies:
· When there is sufficient evidence that the condition has been fully
investigated by a medical specialist and any possible treatment has been
provided;
· The condition has not worsened or changed significantly since the previous
investigation and / or treatment.
· If the patient has given their informed and competent decision not to accept
advice to seek a medical opinion, it is permissible to proceed to recommend
appropriate
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hearing aid systems subject to the following considerations:
· The recommendation will not have any adverse effects on the patients health
or general well being;
· The records confirm that all necessary considerations about the patient´s
best interests have been made If legally required, the patient has signed a
disclaimer to confirm that the referral advice has not been accepted and that
it is an informed decision. Charger: Please note, contraindications are not
derived from the charger, but from the compatible hearing aids.
Clinical benefit: Hearing aid: Improvement of speech understanding Tinnitus
feature: Tinnitus feature provides supplementary noise stimulation which can
help defocus the user`s attention from their tinnitus. Charger: The Charger
itself does not provide a direct clinical benefit. An indirect clinical
benefit is provided by enabling
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the parent device (rechargeable hearing aids) to achieve their intended
purpose.
Side effects: Physiological side-effects of hearing aids like tinnitus,
dizziness, wax build up, too much pressure, sweating or moisture, blisters,
itching and/or rashes, plugged or fullness and their consequences like
headache and/ or ear pain, may be resolved or reduced by your hearing care
professional.
Conventional hearing aids have the potential to expose patients to higher
levels of sound exposure, which might result in threshold shifts in the
frequency range affected by acoustic trauma. Charger: Please note, side
effects are not derived from the charger, but from the compatible hearing
aids.
The hearing aid is suitable for the home healthcare environment and due to
their portability it may happen that it is used in professional healthcare
facility environment like
83
physician offices, dental offices etc. A hearing aid will not restore normal
hearing and will not prevent or improve a hearing impairment resulting from
organic conditions. Infrequent use of a hearing aid does not permit a user to
attain full benefit from it. The use of a hearing aid is only part of hearing
habilitation and may need to be supplemented by auditory training and
instruction in lipreading. Feedback, poor sound quality, too loud or too soft
sounds, inadequate fitting or problems when chewing or swallowing, can be
resolved or improved during the fine-tuning process at the fitting procedure
by your hearing care professional.
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Any serious incident that has occurred in relation to the hearing aid, should
be reported to the manufacturer representative and the competent authority of
the state of residence. The serious incident is described as any incident that
directly or indirectly led, might have led or might lead to any of the
following: a) the death of a patient, user or other person b) the temporary or
permanent serious deterioration of
a patient’s, user’s or other person’s state of health c) a serious public
health threat To report an unexpected operation or event, please contact the
manufacturer or a representative.
85
24.1 Hazard warnings
The rechargeable hearing aids and the charger contain lithium-ion batteries
that can be taken onto airplanes as carry-on luggage. They cannot be placed in
the checked-in baggage and can only be placed in the carry-on luggage.
Your hearing aids operate between 2.4 GHz -2.48 GHz frequency range. When
flying please check if flight operator requires devices to be switched into
flight mode, see chapter 15.
The hearing aids (specially programmed for each hearing loss) must only be
used by the intended person. They should not be used by any other person as
they could damage hearing.
Changes or modifications to the hearing aid that were not explicitly approved
by Sonova AG are not permitted. Such changes may damage your ear or the
hearing aid
86
. Do not insert objects other than the hearing aids into the charging slots of
the Charger Case. These objects could absorb the inductive charging energy and
become hot.
Do not use the hearing aids and charging accessories in explosive areas (mines
or industrial areas with danger of explosions, oxygen rich environments or
areas where flammable anesthetics are handled) The device is not ATEX
certified.
If you feel pain in or behind your ear, if it is inflamed or if skin
irritation and accelerated accumulations of earwax occur, please check with
your hearing care professional or physician.
Titanium shells of custom hearing aids and earpieces can contain small
quantities of acrylates from adhesives. People who are sensitive to such
substances may potentially experience an allergic skin reaction. Please stop
using the device immediately if such a reaction occurs and check with your
hearing care professional or physician.
87
In very rare cases, the dome can remain in your ear canal when removing the
hearing tube from the ear. In the unlikely case that the dome does get stuck
in your ear canal, it is strongly recommended to see a physician for safe
removal.
Hearing programs in the directional microphone mode reduce background noises.
Please be aware that warning signals or noises coming from behind, e. g. cars,
are partially or entirely suppressed.
This hearing aid is not for children below 36 months. The usage of this device
by children and individuals with cognitive impairment should be supervised at
all times to ensure their safety. The hearing aid is a small device and
contains small parts. Do not leave children and individuals with cognitive
impairment unsupervised with this hearing aid. If swallowed, consult a
physician or hospital immediately as the hearing aid or its parts can cause
choking!
88
Only authorized personnel are allowed to open the charger due to possible
electrical hazard.
The following is only applicable for persons with active implantable medical
devices (i.e. pacemakers, defibrillators, etc.): · Keep the wireless hearing
aid and the charging device at least 15 cm (6 inches) away from the active
implant. If you experience any interference, do not use the wireless hearing
aids and contact the manufacturer of the active implant. Please, note that
interference can also be caused by power lines, electrostatic discharge,
airport metal detectors etc. · Keep magnets (i.e.battery handling tool,
EasyPhone magnet, etc.) at least 15 cm (6 inches) away from the active
implant.
Use of this equipment adjacent to or stacked with other equipment should be
avoided because it could result in improper operation. If such use is
necessary, this equipment and the other equipment should be observed to verify
that they are operating normally.
89
Use of accessories, transducers and cables other than those specified or
provided by the manufacturer of this equipment could result in increased
electromagnetic emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.
Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches)
to any part of the hearing aids, including cables specified by the
manufacturer. Otherwise, degradation of the performance of this equipment
could result.
The USB port of the charger is to be used for the described purpose only.
For charger, use only IEC 62368-1 and/or IEC60601-1 certified equipment with
an output rating of 5 VDC. Min. 1 A.
90
Hearing aids should not be fitted with domes / wax protection systems when
used by clients with perforated eardrums, inflamed ear canals or otherwise
exposed middle ear cavities. In these cases, we recommend the use of a custom
earpiece. In the unlikely case that any part of this product should remain in
the ear canal, it is strongly recommended to see a medical specialist for safe
removal.
Avoid strong physical impacts to the ear when wearing a hearing aid with
customized earpiece. The stability of customized earpieces is designed for
normal use. A strong physical impact to the ear (e.g. during sports) may cause
the customized earpiece to break. This may lead to perforation of the ear
canal or eardrum.
After mechanical stress or shock to the customized earpiece, please ensure
that it is intact before placing it in the ear.
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The majority of hearing aid users have a hearing loss for which a
deterioration in hearing is not to be expected with regular use of a hearing
aid in everyday situations. Only a small group of hearing aid wearers with
hearing loss, may be at risk of deterioration in hearing after a long period
of use. During streaming of phone calls or music to the hearing aid, the
signal from the other side (binaural pair of hearing aids) or a CROS device is
no longer transmitted to the hearing aid, which may result in unawareness of
acoustical situations indicating danger. Do not remove receiver cables from
the hearing instruments. If removal or exchange is required it is recommended
to contact the hearing care professional.
92
WARNING: This device uses a lithium button/coin battery. These batteries are
hazardous and can cause severe or fatal injuries in 2 hours or less if they
are swallowed or placed inside any part of the body, whether the battery is
used or new! Keep out of the reach of children, individuals with cognitive
impairment, or pets. If you suspect that a battery was swallowed or placed
inside any part of the body, immediately consult your physician without any
delay!
Your charger should not be used inside of a motor vehicle. Using the charger
inside of a motor vehicle may interfere with the vehicle’s electronic systems.
Both your hearing aid(s) and Charger Case Go contain lithium-ion batteries,
both with a Watt hour rating <20 Wh which have been tested according to UN
38.3 of the “UN Manual of Tests and Criteria” and should be shipped in
accordance with all the rules and regulations on the safe shipment of lithium-
ion batteries.
93
24.2 Information on product safety
Protect your hearing aid and charging accessories from heat (never leave near
a window or in the car). Never use a microwave or other heating devices to dry
your hearing aid or charging accessories (due to risk of fire or explosion).
Ask your hearing care professional about suitable drying methods.
Do not place the hearing aids and the charger accessories close to an
induction cooking surface. Conductive structures inside the charging
accessories could absorb inductive energy resulting in thermal destruction.
The dome should be changed every three months or when it becomes stiff or
brittle. This is to prevent the dome from detaching from the tube spout during
insertion into or removal from the ear.
Do not drop your hearing aid or charging accessories! Dropping onto a hard
surface can damage your hearing aid or charging accessories.
94
Charger and power supply must be protected against shocks. If the charger or
power supply is damaged after a shock, the devices must not be used anymore.
If you are not using your hearing aid for a long period of time, store it in a
box with a drying capsule or in a well ventilated location. This allows
moisture to evaporate from your hearing aid and prevents a potential impact on
its performance.
Special medical or dental examination including radiation described below, may
adversely affect the correct functioning of your hearing aids. Remove and keep
them outside the examination room/area before undergoing: · Medical or dental
examination with X-ray (also CT scan). · Medical examinations with MRI/NMRI
scans, generating magnetic fields. Hearing aids don’t need to be removed when
passing security gates (airports etc.). If X-ray is used at all, it will be in
very low doses, and will not affect the hearing aids.
Do not use your hearing aid or charger in areas where electronic equipment is
prohibited.
95
The hearing aids have to be dry before charging. Otherwise the charging
reliability cannot be guaranteed. Only use approved charger described in this
user guide for charging your hearing aids, otherwise the devices may be
damaged. Make sure that you always completely dry your hearing aid after use.
Store the hearing aid in a safe, dry and clean place.
96
Notes
97
Notes
98
Notes
99
Your hearing care professional:
029-0903-02/V1.00/2022-01/PM © 2022 Sonova AG All rights reserved
Sonova Deutschland GmbH
Max-Eyth-Strasse 20 70736 Fellbach-Oeffingen Germany
Australian Sponsor: Sonova Australia Pty Ltd Locked Bag 5006 Norwest, NSW, 2153 Australia
Manufacturer: Sonova AG Laubisrütistrasse 28 CH-8712 Stäfa Switzerland www.phonak.com
References
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