CR220 User Guide Intraoperative Remote Assistant User Guide

User Guide

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File Name: Cochlear - CR220 User Guide Intraoperative Remote Assistant User Guide.pdf

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Page 1

Professional use only

User Guide

Nucleus® CR220 Intraoperative Remote Assistant

Note Important information or advice. Can save inconvenience. Warning (harmful) Potential safety hazards and serious adverse reactions. Could cause harm to person.

CI513 CI522 CI24RE (CA) CI24RE (ST) CI24RE H CI422

• • • • • • It is not compatible with ABI and double array implants

CI512

•

The Cochlear™ Nucleus® CR220 Intraoperative Remote Assistant is compatible with the following implants:

Compatibility

Symbols

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 fitting software...X Troubleshooting ...X

Checking processor status ...X Resolve processor errors if required ...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

Front view...X Back view...X Holding and operating the remote ...X Navigating through the screens...X Initial set-up ...X

Introduction ...X About the intraoperative remote ...X

Contents

Visual alerts ...X Displaying system details ...X Resetting the remote assistant ...X General care and precautions ...X Technical and legal information ...X Device specifications ...X Environmental conditions ...X Certification and applied standards ...X Equipment classification ...X Regulatory authority compliance ...X Labelling symbols ...X Legal statement ...X

CR220 User Guide - 5

The sound processor and the remote assistant are not sterilised and should be enclosed in sterile plastic bags during surgery.

The remote assistant is to be used for surgery only.

It is strongly advised that you familiarise yourself with the intraoperative remote assistant well in advance of your first scheduled surgery.

The purpose of this user manual is to guide clinicians through the functions and uses of the CR220 intraoperative remote.

The intra-operative remote assistant is compatible with the CP810 processor. It does not support bilateral functionality or accessories.

The Cochlear Nucleus CR220 Intraoperative Remote Assistant is a handheld remote control that enables a clinician to perform impedance and AutoNRT™ tests on a Cochlear implant in the operating theatre.

Introduction

Not used

OK button Right arrow

Left arrow Down arrow

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Note: buttons highlighted in orange do not perform any function.

Pin for attaching the remote assistant lanyard

Not used Home button

Up arrow

Lock or unlock slider

Not used

Remote assistant display

Not used

Front view

About the intraoperative remote

Hard reset button

Coil guides for pairing

Remote assistant speaker

Personal identification label

Back view

CR220 User Guide - 7

USB cable socket

Product information label

Not used

Features of the remote assistant

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 hold and operate the remote

CR220 User Guide - 9

4. To return to the eprevious menu or Home screen, use the 'Home' button

3. To select an option on a screen, press the 'OK' button

2. To move back through the screens, press the left arrow button

1. To scroll forward through the screens, press the right arrow button

How to navigate through the screens

Getting started

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CR220 Series USB cable

AND

Global power adaptor

CP900 series charging kit

CR220 User Guide - 11

Computer with Computer with a USB port a USB port

To charge the remote assistant battery, you will need:

Tools to charge the remote assistant battery

Ensure that you only use battery charging equipment supplied by Cochlear to charge the remote assistant battery.

It is recommended to fully charge the remote assistant battery before using the remote assistant for the first 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.

Charge the remote assistant battery

Initial set-up

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Charging with a computer

OR 3. Using a computer with a USB port

OR 2. Using the global power adaptor

1. Charge using the sound processor battery charger

When the battery is full, this screen will appear

When charging correctly, this screen will appear

Green indicator light on battery charger

When charging, the indicator light will be steady green

Three options for charging the remote assistant

Getting started

5. Home screen will appear

1. Selection screen will appear

2. Press up or down arrows to select preferred language

3. Press OK

When using the remote assistant for the first time, it will prompt you to select a language.

Selecting the language

1. Press and 2. Start up 3. surgery 4. Press hold OK screen will warning OK appear screen will button appear

To turn the remote assistant on:

Turning the remote assistant on

1. Press & hold OK

2. Press right arrow

3. Press OK

Up OK

4. Select 'Start' and press OK

5. Screen appears

2. Menu appears

Up OK

3. Select 'Practice Mode' and press OK

4. Menu appears

Up OK

5. Select 'Start' and press OK

6. Press OK

6. Screen 7. Press appears OK

If you wish to enter practice mode while a sound processor is paired:

1. Prompt screen appears

If there is no sound processor paired to the remote assistant:

No adjustments or changes to settings are saved or sent to the sound processor while in practice mode.

Practice mode allows you to familiarise yourself with the remote assistant before you start using it clinically.

Practice mode

1. Press & hold OK button

To cancel practice mode: 2. Menu appears

Up OK

3. Select 'Exit Practice Mode' and press OK

When using practice mode, a small white or black square will appear in the top left corner of the screen.

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1. Hold the processor coil on 2. 'Pair processor' the coil guides at the back of prompt screen the remote assistant will display

To pair the remote assitant with a sound processor:

3. Press OK and wait during initialisation

If there is already a sound processor paired, you can re-pair with a different sound processor at any time using the following instructions.

If there is no sound processor currently paired with the remote assistant, the following screen will prompt you to pair a sound processor:

Before you start, ensure that both the processor and the remote assistant are switched on.

Pairing allows the remote assistant to communicate with the processor.

Pairing the remote assistant

Getting started

2. Press OK

3. Use up and down arrows to select 'Soft', 'Loud' or 'Off'

CR220 User Guide - 17

4. Press OK

1. From the 'Home' screen, use the right arrow key to scroll to the Settings menu

You can adjust the remote assistant beeps from the Settings screen.

Setting remote assistant beeps

When pairing is complete, the 'Processor Paired' screen will appear, followed by the 'Home' screen

Getting started

Press and hold the OK button until the menu screen displays.

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.

2. Select Switch Off from the menu selection to turn the remote assistant off.

To turn the remote assistant off:

Turning the remote assistant off

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 .

To check the status of the processor and processor battery:

Checking the processor status

You can also view the battery status by locking the keypad (see p.21).

To check the remote assistant battery status, watch for the battery level indicator screen when the remote assitant is switched on.

Checking the remote assistant battery status

Day before surgery

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Getting started

2. The 'Locked' or 'Unlocked' screen will appear

CR220 User Guide - 21

The remote assistant cannot be turned off while the keypad is locked.

The 'Locked' and 'Unlocked' screens also display the remote assistant battery status.

1. Slide the lock/unlock slider down to lock or up to unlock

The remote assistant keypad can be locked to prevent pressing keys accidentally.

Locking & unlocking the remote assistant keypad

We recommend repeating the battery and processor checks again on the day of the surgery. (See pages 19-20)

Repeat battery and processor checks

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 3133 to resolve the errors.

Immediately before surgery

Recharge batteries and resolve processor errors

Getting started

22 - CR220 User Guide

Do not sterilise the remote assistant.

3. Press OK to start continuous impedance measurement

CR220 User Guide - 23

5. 'Stopping' screen will display, followed by results screen

2. Impedance screen will display

4. When you are satisfied wih the impedance results, press OK to stop the test

1. From the Home screen, press the right arrow

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.

Impedance test

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.

Remote assistant in a sterile plastic bag

During surgery

Before entering the operating theatre, place the remote assistant in a sterile bag and seal the bag.

Getting started

Place the remote assistant in a sterile bag

Getting started

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Impedance not found

Currently being measured

Open circuit

Impedance OK

Not yet tested/skipped

Electrode definitions for impedance test

2. AutoNRT screen will display

CR220 User Guide - 25

8. Number of electrodes successfully measured will also display

3. Press 4. AutoNRT 5. Press OK launch screen OK will display

7. On successful completion, AutoNRT complete screen will display

6. AutoNRT will run

1. Use right arrow to reach AutoNRT screen

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.

AutoNRT test

Using the remote assistant

Graph view

Trace view

Press any button to pause the process and display the AutoNRT Paused screen.

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2. If you choose to cancel the AutoNRT test prior to successful measurements, the screen displays a cancelled message.

You can pause the AutoNRT results while the test is running.

Pausing AutoNRT

Electrode view

Neural response not found

Currently being measured

Open circuit

NRT OK

Not yet tested/skipped

Electrode definitions for AutoNRT

CR220 User Guide - 27

The results screen displays the most recent tests for the currently detected implant. The results are displayed in the following screens:

Viewing final AutoNRT results

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.

Using the remote assistant

Viewing results while AutoNRT is running

Using the remote assistant

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Using the remote assistant

Turn it off

CR220 User Guide - 29

You will need to upload the results from the remote assistant to the cochlear implant fitting software (CustomSound or NFS). Refer to the user guide for your fitting software for full instructions.

Uploading results to fitting software

Do not use an oven or microwave or any other electrical or heating device to dry the remote assistant.

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.

3. Leave out to dry for approximately 12 hours.

2. Wipe it with a soft dry cloth

If the remote assistant gets wet:

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.

Cleaning the remote assistant

After surgery

Using the remote assistant

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Using the remote assistant

Text

Coil cable fault

Can't find processor

Text

Incorrect coil type

CR220 User Guide - 31

Troubleshooting information Text

Screen display

Processor error

Error

Visual alerts

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 rectified before testing can continue.

Troubleshooting

Using the remote assistant

Switch on processor error

Remote assistant battery low

32 - CR220 User Guide

Charge remote error

Processor battery low

Processor battery empt

Charge processor error

Remote assistant battery empty

Error

Coil off implant

Troubleshooting information Text

Processor and implant error

Screen display

Coil fault

Incorrect implant

Error

Using the remote assistant

Screen display

CR220 User Guide - 33

This alert may display during impedance or AutoNRT testing

Text

Troubleshooting information

Using the remote assistant

3. 'Beeps on remote' 4. Press right 5. 'Remote info' menu will display arrow screen will display

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Rt Hm

6. Press 7. 'Processor info' 8 Press Home button to return to setright screen will display tings menu and 'Home' screen arrow

2. Press OK

CR220 User Guide - 35

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.

You can view the remote assistant serial and version numbers from the Settings menu. 1. From the 'Home' screen, use the right arrow key to scroll to the Settings menu

Resetting the remote assistant

Displaying system details

Using the remote assistant

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 films 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.

• •

•

• • •

General care and precautions

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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 firmware.

• • • • • • •

CR220 User Guide - 39

The remote assistant housing, including non-metallic buttons/keys, is made of polycarbonate.

Materials

Custom analogue and digital integrated circuits based on a microprocessor design, with bi-directional wireless communication capabilities.

•

The remote assistant comprises:

Physical configuration

Specifications

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 find 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.

Technical information

Technical and legal information

Other information

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CR220 User Guide Intraoperative Remote Assistant User Guide