Cochlear R200FF Remote Assistant User Manual 369388 ISS4 01 CR220UG LM

Cochlear Limited Remote Assistant 369388 ISS4 01 CR220UG LM

User Guide

Nucleus® CR220
Intraoperative Remote Assistant
User Guide
Professional use only
Contents
Introduction .......................................................................................................X
About the intraoperative remote ..................................................................X
Front view .....................................................................................................X
Back view ......................................................................................................X
Holding and operating the remote .........................................................X
Navigating through the screens ...............................................................X
Initial set-up .......................................................................................................X
Charging the remote assistant battery ..................................................X
Turning the remote assistant on ..............................................................X
Selecting the language ..............................................................................X
Practice mode .............................................................................................X
Pairing the remote assistant .....................................................................X
Setting remote assistant beeps ................................................................X
Turning the remote assistant off .............................................................X
Day before surgery ...........................................................................................X
Checking remote assistant battery status .............................................X
Recharge batteries if required ..................................................................X
Checking processor status ........................................................................X
Resolve processor errors if required ........................................................X
Immediately before surgery ...........................................................................X
Repeat battery status checks ...................................................................X
Locking & unlocking the remote assistant keypad ..............................X
Placing the remote assistant in a sterile bag .........................................X
During surgery ...................................................................................................X
Impedance testing ......................................................................................X
AutoNRT testing .........................................................................................X
After surgery ......................................................................................................X
Cleaning the remote assistant .................................................................X
Uploading results to fi tting software ......................................................X
Troubleshooting ................................................................................................X
Symbols
Note
Important information or advice. Can save
inconvenience.
Warning (harmful)
Potential safety hazards and serious
adverse reactions.
Could cause harm to person.
Compatibility
The Cochlear Nucleus® CR220 Intraoperative Remote Assistant is
compatible with the following implants:
CI512
CI513
CI522
CI24RE (CA)
CI24RE (ST)
CI24RE H
CI422
It is not compatible with ABI and double array implants
Visual alerts .................................................................................................X
Displaying system details ..........................................................................X
Resetting the remote assistant ................................................................X
General care and precautions ........................................................................X
Technical and legal information ....................................................................X
Device specifi cations ..................................................................................X
Environmental conditions .........................................................................X
Certifi cation and applied standards ........................................................X
Equipment classi cation ...........................................................................X
Regulatory authority compliance ............................................................X
Labelling symbols .......................................................................................X
Legal statement ..........................................................................................X
Introduction
The Cochlear Nucleus CR220 Intraoperative Remote Assistant is a hand-
held remote control that enables a clinician to perform impedance and
AutoNRT™ tests on a Cochlear implant in the operating theatre.
The intra-operative remote assistant is compatible with the CP810
processor. It does not support bilateral functionality or accessories.
The purpose of this user manual is to guide clinicians through the
functions and uses of the CR220 intraoperative remote.
It is strongly advised that you familiarise yourself with the intraoperative
remote assistant well in advance of your fi rst scheduled surgery.
The remote assistant is to be used for surgery only.
The sound processor and the remote assistant are not sterilised
and should be enclosed in sterile plastic bags during surgery.
© Cochlear Limited 2012 CR220 User Guide - 5
About the intraoperative remote
Front view
Note: buttons highlighted in orange do not perform any function.
Not used
Not used
Not used
Not used
Home button
Right arrow
Left arrow
Up arrow
Down arrow
OK button
Lock or unlock slider
Remote assistant display
Back view
Personal identifi cation label
Remote assistant speaker
Hard reset button
Coil guides for pairing Product information label
USB cable socket
Not used
Pin for attaching the remote assistant lanyard
© Cochlear Limited 2012 CR220 User Guide - 7
6 - CR220 User Guide © Cochlear Limited 2012
Features of the remote assistant
How to hold and operate the remote
Hold the remote assistant in the palm of your hand. Keep it within 2
metres (about six feet) of the sound processor (about six feet) of each
other. Operating it at a greater distance may cause increased delay
between the sound processor and the remote assistant response time or
loss of communication all together.
How to navigate through the screens
3. To select an option on
a screen, press the 'OK'
button
4. To return to the eprevi-
ous menu or Home screen,
use the 'Home' button
1. To scroll forward
through the screens, press
the right arrow button
2. To move back through
the screens, press the
left arrow button
© Cochlear Limited 2012 CR220 User Guide - 9
Getting started
Initial set-up
Charge the remote assistant battery
It is recommended to fully charge the remote assistant battery before
using the remote assistant for the fi rst time. It may take approximately
2 to 4 hours to fully charge a completely empty battery. A fully charged
battery should provide you with enough battery life to last a full surgery.
However, battery life varies depending on amount of usage.
Ensure that you only use battery charging equipment supplied by
Cochlear to charge the remote assistant battery.
Tools to charge the remote assistant battery
To charge the remote assistant battery, you will need:
Computer with
a USB port
CR220 Series USB cable
Computer with
a USB port
Global power
adaptor
CP900 series
charging kit
AND
OR
OR
© Cochlear Limited 2012 CR220 User Guide - 11
10 - CR220 User Guide © Cochlear Limited 2012
Three options for charging the remote assistant
Turning the remote assistant on
To turn the remote assistant on:
Selecting the language
When using the remote assistant for the fi rst time, it will prompt you to
select a language.
When charging, the
indicator light will be
steady green
1. Charge using the
sound processor battery
charger
3. Using a computer
with a USB port
2. Using the global
power adaptor When charging correctly,
this screen will appear
When the battery is full,
this screen will appear
3. surgery
warning
screen will
appear
1. Press and
hold OK
button
4. Press
OK
5. Home
screen will
appear
2. Press up or down
arrows to select
preferred language
1. Selection
screen will
appear
3. Press
OK
2. Start up
screen will
appear
OR
OR
Up
Dn
Green indicator
light on battery
charger
Charging with a
computer
OK
OK
OK
12 - CR220 User Guide © Cochlear Limited 2012
Getting started
When using practice mode, a small white or black square will appear in
the top left corner of the screen.
To cancel practice mode:
Practice mode
Practice mode allows you to familiarise yourself with the remote
assistant before you start using it clinically.
No adjustments or changes to settings are saved or sent to the
sound processor while in practice mode.
If there is no sound processor paired to the remote assistant:
If you wish to enter practice mode while a sound processor is paired:
2. Press right
arrow
3. Press
OK
4. Select 'Start'
and press OK
1. Prompt
screen appears
2. Menu
appears
3. Select
'Practice Mode'
and press OK
1. Press &
hold OK
4. Menu
appears
5. Select
'Start' and
press OK
1. Press & hold
OK button
2. Menu
appears
3. Select 'Exit Practice
Mode' and press OK
6. Press
OK
7. Press
OK
5. Screen
appears
6. Screen
appears
Up
Dn
OK
Up
Dn
OK
Up
Dn
OK
Up
Dn
OK OK
Rt OK OK
OK
OK
When pairing is complete, the 'Processor Paired' screen will appear,
followed by the 'Home' screen
Setting remote assistant beeps
You can adjust the remote assistant beeps from the Settings screen.
Pairing the remote assistant
Pairing allows the remote assistant to communicate with the processor.
Before you start, ensure that both the processor and the remote
assistant are switched on.
If there is no sound processor currently paired with the remote assistant,
the following screen will prompt you to pair a sound processor:
If there is already a sound processor paired, you can re-pair with a
different sound processor at any time using the following instructions.
To pair the remote assitant with a sound processor:
1. Hold the processor coil on
the coil guides at the back of
the remote assistant
3. Press OK
and wait during
initialisation
1. From the 'Home' screen, use the right arrow key to scroll to
the Settings menu
2. Press OK 3. Use up and down arrows to
select 'Soft', 'Loud' or 'Off'
4. Press OK
2. 'Pair processor'
prompt screen
will display
OK
RtRt RtRt
Up
Dn
OK
OK
Rt
© Cochlear Limited 2012 CR220 User Guide - 17
16 - CR220 User Guide © Cochlear Limited 2012
Getting started Getting started
Day before surgery
Checking the remote assistant battery status
To check the remote assistant battery status, watch for the battery level
indicator screen when the remote assitant is switched on.
You can also view the battery status by locking the keypad (see p.21).
Checking the processor status
To check the status of the processor and processor battery:
1. Press the OK button quickly from Home screen. The status screen
will display
If the remote assistant receives an error from the processor, or the
processor battery is low, a visual alert will display .
Turning the remote assistant off
To turn the remote assistant off:
1. Press and hold the OK button until the menu screen displays.
2. Select Switch Off from the menu selection to turn the remote
assistant off.
The remote assistant automatically goes into standby mode if it
has been inactive for an extended period. Press any button to 'wake' the
remote assistant from standby mode.
OK
OK
Up
Dn
OK
OK
Recharge batteries and resolve processor errors
Recharge batteries if they are not fully charged. Refer to pages 9-10 for
instructions to recharge the batteries.
If the remote assistant displays any processor errors, refer to pages 31-
33 to resolve the errors.
Immediately before surgery
Repeat battery and processor checks
We recommend repeating the battery and processor checks again on
the day of the surgery. (See pages 19-20)
Locking & unlocking the remote assistant keypad
The remote assistant keypad can be locked to prevent pressing keys
accidentally.
The 'Locked' and 'Unlocked' screens also display the remote assistant
battery status.
The remote assistant cannot be turned off while the keypad is locked.
1. Slide the lock/unlock slider down
to lock or up to unlock
2. The 'Locked' or
'Unlocked' screen
will appear
© Cochlear Limited 2012 CR220 User Guide - 21
20 - CR220 User Guide © Cochlear Limited 2012
Getting started Getting started
Remote assistant in a sterile
plastic bag
During surgery
During surgery, the intraoperative remote assistant can be used
to perform impedance and AutoNRT tests. When performing
intraoperative tests, ensure the processor is placed over the implant to
get accurate measurements.
Impedance test
The impedance test indicates the electrical status of the intra-cochlear
electrodes. It loops continuously through the 22 electrodes, displaying
which electrode is being tested, and the status of all electrodes already
tested.
1. From the Home
screen, press the
right arrow
3. Press OK to start
continuous impedance
measurement
2. Impedance
screen will
display
4. When you are satisfi ed wih
the impedance results, press
OK to stop the test
5. 'Stopping' screen will display,
followed by results screen
Place the remote assistant in a sterile bag
Before entering the operating theatre, place the remote assistant in a
sterile bag and seal the bag.
Do not sterilise the remote assistant.
OK
Rt
OK
© Cochlear Limited 2012 CR220 User Guide - 23
22 - CR220 User Guide © Cochlear Limited 2012
Getting started Getting started
AutoNRT test
Neural Response Telemetry (NRT) measures neural activity within
the cochlea in response to electrical stimulation from the implant.
An AutoNRT test provides a quick, non-invasive, objective measure of
peripheral neural function.
Electrode defi nitions for impedance test
Not yet tested/skipped
Impedance OK
Open circuit
Currently being measured
Impedance not found
1. Use right
arrow to reach
AutoNRT screen
2. AutoNRT
screen will
display
7. On successful comple-
tion, AutoNRT complete
screen will display
8. Number of electrodes
successfully measured
will also display
5. Press
OK
4. AutoNRT
launch screen
will display
3. Press
OK
6. AutoNRT
will run
OK
Rt OK
© Cochlear Limited 2012 CR220 User Guide - 25
24 - CR220 User Guide © Cochlear Limited 2012
Using the remote assistant
Viewing nal AutoNRT results
The results screen displays the most recent tests for the currently
detected implant. The results are displayed in the following screens:
Electrode defi nitions for AutoNRT
Not yet tested/skipped
NRT OK
Open circuit
Currently being measured
Neural response not found
Viewing results while AutoNRT is running
While the AutoNRT test is running, you can press the right and left
arrow buttons to switch between the following results views: Electrode
view, graph view and trace view.
Pausing AutoNRT
You can pause the AutoNRT results while the test is running.
1. Press any button to pause the process and display the AutoNRT
Paused screen.
2. If you choose to cancel the AutoNRT test prior to successful
measurements, the screen displays a cancelled message.
Electrode view Graph view Trace view
L R
L R
L R
© Cochlear Limited 2012 CR220 User Guide - 27
26 - CR220 User Guide © Cochlear Limited 2012
Using the remote assistant Using the remote assistant
After surgery
Cleaning the remote assistant
To keep the remote assistant clean, wipe it with a soft dry cloth. Do
not use alcohol, household cleaners or abrasive materials to clean the
remote assistant.
If the remote assistant gets wet:
1. Turn it off
2. Wipe it with a soft dry cloth
3. Leave out to dry for approximately 12 hours.
4. Turn it on again after it is dry. If the remote assistant no longer
functions, return it to your Cochlear representative. Cochlear cannot
guarantee that it can repair a water-damaged remote assistant.
Do not use an oven or microwave or any other electrical or
heating device to dry the remote assistant.
Uploading results to fi tting software
You will need to upload the results from the remote assistant to the
cochlear implant fi tting software (CustomSound or NFS). Refer to the
user guide for your fi tting software for full instructions.
© Cochlear Limited 2012 CR220 User Guide - 29
28 - CR220 User Guide © Cochlear Limited 2012
Using the remote assistant Using the remote assistant
Troubleshooting
The remote assistant displays visual alerts when errors occur. Some
alerts mean that the testing processes cannot continue (e.g. if the
processor coil has moved off the implant). In these cases, the problem
will need to be rectifi ed before testing can continue.
Visual alerts
Error Screen display Troubleshooting information
Processor error Text
Incorrect coil
type
Text
Coil cable fault Text
Can't fi nd
processor
Text
© Cochlear Limited 2012 CR220 User Guide - 31
30 - CR220 User Guide © Cochlear Limited 2012
Using the remote assistant Using the remote assistant
Error Screen display Troubleshooting information
Remote
assistant
battery empty
Text
Processor and
implant error
This alert may display during
impedance or AutoNRT testing
Charge
processor error
This alert may display during
impedance or AutoNRT testing
Charge remote
error
This alert may display during
impedance or AutoNRT testing
Switch on
processor error
This alert may display during
impedance or AutoNRT testing
Error Screen display Troubleshooting information
Incorrect
implant
Text
Coil fault
Coil off implant
Processor
battery low
Remote
assistant
battery low
Processor
battery empt
© Cochlear Limited 2012 CR220 User Guide - 33
32 - CR220 User Guide © Cochlear Limited 2012
Using the remote assistant Using the remote assistant
Displaying system details
You can view the remote assistant serial and version numbers from the
Settings menu.
Resetting the remote assistant
If the Home button does not work or the remote assistant display
freezes, you can reset the remote assistant by inserting a pointed
object into the reset socket located on the back of the remote. This
will reset the remote to its original settings, including language, pairing
information, remote beeps and remote alerts.
2. Press
OK
3. 'Beeps on remote'
menu will display
4. Press right
arrow
OK
1. From the 'Home' screen, use the right arrow key to scroll to
the Settings menu
RtRt RtRt Rt
Rt
5. 'Remote info'
screen will display
8 Press Home button to return to set-
tings menu and 'Home' screen
6. Press
right
arrow
Rt
7. 'Processor info'
screen will display
Hm Hm
© Cochlear Limited 2012 CR220 User Guide - 35
34 - CR220 User Guide © Cochlear Limited 2012
Using the remote assistant
General care and precautions
Only use the intraoperative remote assistant while the recipient is
under anaesthetic.
Do not use or store the device in dusty or dirty areas, extreme high
or cold temperatures (e.g. Do not store in direct sunlight, behind a
window or in a car for extended periods of time)
Take care when placing the remote assistant in a bag or pocket
with other objects as the display may scratch. Commercially
available protective fi lms may be used to protect the remote
assistant display from scratches.
Do not use alcohol, household cleaners or abrasive materials to
clean the remote assistant.
Do not use any commercial or household appliance to dry the
remote assistant.
Only use the CR200 Series Global Power Adaptor, the CP900
Series Global Power Adaptor (if using the CP900 Series Battery
Charger) or the CR200 Series Global charging kit when charging
your remote assistant from mains power.
Do not bend or compress the display on the remote assistant.
Do not use excessive force when connecting or disconnecting the
USB cable or when using the buttons on the keypad.
Do not disassemble, deform or immerse in water. If the remote
assistant is not working, return it to your clinician. Warranty will be
void if opened.
Do not use the remote assistant if it becomes unusually warm.
Inform your Cochlear representative immediately.
Dispose of electrical components in accordance with your local
regulations.
When charging the remote with a computer, ensure the computer
conforms to IEC 60950 standards.
Technical and legal information
Technical information
The remote assistant wireless communication link operates in the 2.4
GHz ISM band using GFSK (Gaussian Frequency Shift Keying) on 10
channels. The link uses a proprietary bi-directional communication
protocol and operates over a distance of up to 2m from the
CP810 series processor. When interference is present, the wireless
communication link switches between the 10 channels to fi nd a
channel where the interference least affects the operation of the link.
The remote assistant indicates via its display when the processor is not
within operating distance, and when the link has been interrupted due
to interference.
Specifi cations
Physical confi guration
The remote assistant comprises:
Custom analogue and digital integrated circuits based on a micro-
processor design, with bi-directional wireless communication
capabilities.
Push-buttons/keys and a slider for control of processor features
and its own system features.
A display for indicating system status and activity.
A speaker for sounding an audible alert.
In-built coil sensor to check if the processor’s coil is receiving
sound signals from the processor and for pairing.
On-board battery charging circuit.
A temperature sensor for battery safety.
A micro USB connector for charging the remote assistant and
updating the fi rmware.
Materials
The remote assistant housing, including non-metallic buttons/keys, is
made of polycarbonate.
© Cochlear Limited 2012 CR220 User Guide - 39
38 - CR220 User Guide © Cochlear Limited 2012
Other information
Dimensions
Length Width Depth
110 mm 46.1 mm 13.35 mm
Weight
The remote assistant weighs 65 g.
Operating characteristics
Characteristic Range
Wireless technology Proprietary Low Power Bidirectional
Wireless Link
RF frequency 2.4 GHz
Operating battery voltage 3. 7 V
Battery charging voltage 4.2 V
Battery capacity 680 mAh (Internal Lithium-ion
battery)
Push-key functions Remote assistant on and off and
remote assistant settings change
Wireless transmission range Up to 2 m
Display 128 x 128 pixels, colour LCD
Environmental conditions
Condition Minimum Maximum
Storage temperature -40 ºC (-40 ºF) +50 ºC (+122 ºF)
Storage relative
humidity
0% RH 90% RH
Operating
temperature
+5 ºC (+41 ºF) +50 ºC (+122 ºF)
Operating relative
humidity
0% RH 90% RH
Certifi cation and applied standards
The CR220 Remote Assistant fulfi ls the essential requirements listed in
Annex 1 of the EC directive 90/385/EEC on Active Implantable Medical
Devices as last amended by EC Directive 2007/47/EEC.
Equipment classifi cation
Your remote assistant is internally powered equipment Type B as
described in the international standard IEC 60601-1:2005, Medical
Electrical Equipment - Part 1: Basic Safety and Essential Performance.
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.
Changes or modifi cations made to this equipment not expressly
approved by Cochlear Limited may void the FCC authorization to
operate this equipment.
0197
© Cochlear Limited 2012 CR220 User Guide - 41
40 - CR220 User Guide © Cochlear Limited 2012
Other information Other information
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: WTOR200FF
IC ID: 8039A-R200FF
Labelling symbols
The symbols below are found on your remote assistant components
and packaging
Consult instructions for use
Storage temperature limits
Relative humidity limits
Disposal - do not dispose in fi re
Disposal – dispose of electrical
components in accordance with your
local regulations
Certifi cation - Japan
Certifi cation - Australia
Certifi cation - New Zealand
Serial number
Date of manufacture
Type B applied part
This device restricted to sale by or on the
order of a physician.
Recycle
0197
CE Registration Mark
Legal statement
The statements made in this guide are believed to be true and correct as
of the date of publication. However, specifi cations are subject to change
without notice.
Nucleus® cochlear implant systems are covered by one or more
international patents.
© Cochlear Limited 2011
42 - CR220 User Guide © Cochlear Limited 2012
Other information
Printed in Australia
369388 Iss4 APR12
Cochlear implant systems are protected by one or more international patents.
The statements made in this guide are believed to be true and correct in every detail as of the date of publication. However,
specifi cations are subject to change without notice.
Nucleus is a registered trademark of Cochlear Limited.
AutoNRT, Cochlear and the elliptical logo are trademarks of Cochlear Limited.
© Cochlear Limited 2012
Cochlear implant systems are protected by one or more international patents.
The statements made in this guide are believed to be true and correct in every detail as of the date of publication. However,
specifi cations are subject to change without notice.
Nucleus is a registered trademark of Cochlear Limited.
AutoNRT, Cochlear and the elliptical logo are trademarks of Cochlear Limited.
© Cochlear Limited 2012
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