Cochlear CR310 Remote Assistant for Cochlear Implant System User Manual Users guide

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Document ID	3342663
Application ID	rOa1tsjje2DqR6jTU7OKVg==
Document Description	Users guide
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Document Type	User Manual
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Date Submitted	2017-04-03 00:00:00
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DRAFT ONLY FOR CLINICAL TESTING
Nucleus® 7
Remote Control
User Guide
CR310
DRAFT ONLY FOR USABILITY TESTING
The Cochlear™ Nucleus® 7 Remote Control (model number:
CR310) is a hand-held device for controlling the commonly used
functions of your Cochlear Nucleus 7 Sound Processor (model
number: CP1000).
The remote control allows you to:
•
change programs
•
turn volume or sensitivity (if available) up and down
•
turn True Wireless™ Accessories on and off
•
turn telecoil on and off.
If you have two Nucleus 7 Sound Processors (bilateral), your
remote control can communicate with both processors at once.
This guide is intended for Cochlear implant recipients and their
carers using the Nucleus 7 Sound Processor. For more
information, refer to the Nucleus 7 Sound Processor User Guide.
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.
ii
NUCLEUS® 7 REMOTE CONTROL USER GUIDE
DRAFT ONLY FOR USABILITY TESTING
Nucleus 7 Remote Control
Volume or
sensitivity
Program
Processor(s)
paired
On/Off
switch
Telecoil
button
Next
program button
Volume or
sensitivity up
button
Previous
program button
Volume or
sensitivity down
button
Pin for
attaching
lanyard
Other indicators on your remote control
Telecoil on
Low battery in
remote control
NUCLEUS® 7 REMOTE CONTROL USER GUIDE
Accessory on
DRAFT ONLY FOR USABILITY TESTING
Battery
CAUTION
Use ONLY disposable CR2032 or 5004LC 3V standard lithium
coin cell batteries in your remote control.
NEVER use rechargeable coin cell batteries or other battery
types.
NUCLEUS® 7 REMOTE CONTROL USER GUIDE
DRAFT ONLY FOR USABILITY TESTING
Travel
Your remote control transmits high frequency radio waves
when switched on. Switch it off before takeoff and landing.
NUCLEUS® 7 REMOTE CONTROL USER GUIDE
DRAFT ONLY FOR USABILITY TESTING
Pair
Pairing allows two devices to communicate with each other.
Your clinician may have already paired your remote control
with your processor. If not, you will need to pair it the first
time you use it.
If your remote control is not
paired to any processor, it
displays dashes (shown left)
and “blinks” when you press
buttons.
Pair your processor and remote control
1. Turn on your processor
and remote control.
They must both be
“awake” and on at all
times while pairing.
2. Place the coil on the
back of your
remote control.
NUCLEUS® 7 REMOTE CONTROL USER GUIDE
DRAFT ONLY FOR USABILITY TESTING
3. The remote control
will show pairing in
progress.
4. The remote control
then shows
successful pairing of
either left (L) or
right(R) processor.
5. If you have two
processors (bilateral),
repeat steps 2-4 for
your second processor.
NUCLEUS® 7 REMOTE CONTROL USER GUIDE
DRAFT ONLY FOR USABILITY TESTING
Wireless accessories
If you use Cochlear True Wireless™ Accessories with your
processor, your remote control can be used to control the
wireless accessory and monitor its status.
NOTE
Before you can stream audio, you must first pair the wireless
accessory to your processor. See the True Wireless Accessories
User Guide for details.
To use a Mini Microphone or TV Streamer
1. To start streaming audio,
long-press the telecoil button.
The accessory icon will appear.
TIP
You can long-press the telecoil button again to select the
next paired wireless accessory.
2. To stop streaming audio,
short-press the telecoil button.
The accessory icon will
disappear.
NOTE
You use the controls on the Phone Clip to make and receive
calls.
NUCLEUS® 7 REMOTE CONTROL USER GUIDE
DRAFT ONLY FOR USABILITY TESTING
Telecoil
Your clinician can set up your processor with manual telecoil
so you can listen to room hearing loops.
You can not use telecoil at the same time as a wireless
accessory.
NOTE
We recommend you use a Cochlear Wireless Phone Clip to
make phone calls. See the True Wireless Accessories User Guide.
Turn telecoil on (if set up)
1. Short-press the telecoil button
once.
The telecoil icon will appear.
Turn telecoil off
1. Short-press the telecoil button
once.
The telecoil icon will disappear.
NUCLEUS® 7 REMOTE CONTROL USER GUIDE
DRAFT ONLY FOR USABILITY TESTING
Other information
Physical configuration
The remote control comprises:
• analogue and digital integrated circuits based on a
micro-processor design, with bidirectional wireless
communication capabilities
• buttons and a switch for operation of unit
• buttons for remote control of sound processor”
• a display for indicating system status and activity
• in-built coil sensor
• lanyard pin.
Materials
The remote control housing and buttons are made of
polycarbonate and acrylonitrile butadiene styrene (ABS). The
display is made of ABS.
Environmental conditions
CONDITION
MINIMUM MAXIMUM
Storage & transport temperature -10° C (14° F) +55° C (+131° F)
Storage & transport humidity
0% RH
Operating temperature
+5° C (+41° F) +40° C (+104° F)
Operating relative humidity
0% RH
90% RH
Operating pressure
700 hPa
1060 hPa
90% RH
NUCLEUS® 7 REMOTE CONTROL USER GUIDE
DRAFT ONLY FOR USABILITY TESTING
Dimensions
COMPONENT
LENGTH WIDTH
DEPTH
Nucleus 7 Remote Control
66.0 mm
10.6 mm
36.5 mm
Weight
COMPONENT
WEIGHT
Nucleus 7 Remote Control (with battery)
35 g
Operating characteristics
CHARACTERISTIC
VALUE/RANGE
Wireless technology
Proprietary low power
bidirectional wireless link
RF frequency
2.4 GHz
Battery type
One disposable CR2032 or
5004LC lithium coin cell battery
Operating battery voltage
2.12 – 3.00 V
Button and switch functions
Remote control lock and unlock,
telecoil/wireless accessories on
and off, program adjust, volume or
sensitivity settings adjust
Remote communication range
Up to 2 m
Display
Custom, icon based monochrome
LCD
NUCLEUS® 7 REMOTE CONTROL USER GUIDE
DRAFT ONLY FOR USABILITY TESTING
Wireless communication link
The remote control wireless communication link operates in
the 2.4 GHz ISM band using GFSK (Gaussian frequency-shift
keying) on 4 channels. The link uses a proprietary bidirectional
communication protocol and operates over a distance of up
to 2 metres from the processor. The wireless communication
link continuously switches between the 4 channels to avoid
interference on any specific channel. The remote control
indicates via its display when the processor is out of operating
distance (or switched off) or when the link is interrupted due
to broad spectrum interference (see page 7).
Environmental protection
Your remote control contains electronic components subject
to the Directive 2002/96/EC on waste electrical and
electronic equipment.
Help protect the environment by not disposing of your
remote control or batteries with your unsorted household
waste. Please recycle your remote control and batteries
according to your local regulations.
10
NUCLEUS® 7 REMOTE CONTROL USER GUIDE
DRAFT ONLY FOR USABILITY TESTING
Certification and applied standards
The Nucleus 7 Remote Control fulfils the essential
requirements listed in Annex 1 of the EC directive 90/385/EEC
on Active Implantable Medical Devices as per the conformity
assessment procedure in Annex 2.

The year in which authorisation to affix the CE mark was
granted was 2016.
It also fulfils the essential requirements listed in the EC
directive 1999/5/EC on Radio and Terminal
Telecommunication Equipment as per the conformity
assessment procedure in Annex IV.
Equipment classification
Your remote control is an accessory to a medical device as
described in the international standard IEC 60601-1:2005,
Medical Electrical Equipment – Part 1: General Requirements
for Basic Safety and Essential Performance.
NUCLEUS® 7 REMOTE CONTROL USER GUIDE
11
DRAFT ONLY FOR USABILITY TESTING
Radio compliance for Japan
This device is granted pursuant to the Japanese Radio Law (
) and the Japanese Telecommunications Business Law
).
This device should not be modified (otherwise the granted
designation number will become invalid).
202
L S B003
Radio compliance for Korea
1. Equipment name/model name:
2. Registration number: MSIP-CRM-COH-CR310
3. Company name: Cochlear Limited
4. Manufactured date: 2016
5. Manufacturer/Country of Origin:
Cochlear Limited/Australia
WARNING
This radio equipment has the possibility of radio interference
during operation.
This equipment is suitable for electromagnetic equipment for
home (Class B) and it can be used in all areas.
FCC (Federal Communications Commission)
and Canadian IC compliance
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:
• This device may not cause harmful interference.
• This device must accept any interference received,
including interference that may cause undesired operation.
12
NUCLEUS® 7 REMOTE CONTROL USER GUIDE
DRAFT ONLY FOR USABILITY TESTING
Changes or modifications made to this equipment not
expressly approved by Cochlear Limited may void the FCC
authorisation to operate this equipment.
This equipment has been tested and found to comply with the
limits for a Class B digital device, pursuant to Part 15 of the
FCC Rules. These limits are designed to provide reasonable
protection against harmful interference in a residential
installation.
This equipment 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 no guarantee that
interference will not occur in a particular installation. If this
equipment 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 equipment and
receiver.
• Connect the equipment 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.
FCC ID: WTO-CR310
IC ID: 8039A-CR310
NUCLEUS® 7 REMOTE CONTROL USER GUIDE
13

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