Instructions For Use

Intended Purpose

QuickTalker Freestyle is a speech-generating device intended for people who cannot or have difficulties communicating on their own.

Clinical Benefits of the Device

Dynamic device to assist a patient with verbal communication. The benefit is to maximize the efficiency and effectiveness of communication for individuals who are unable to communicate via verbal speech.

Performance Characteristics and Information for Health Care Professional

iPad Technical Specifications

To determine your iPad model, go to Settings App > General > About > Model Name.

iPad 11: https://www.apple.com/ipad-11/specs/
iPad Mini 7: https://www.apple.com/ipad-mini/specs/

Risks, Warnings, and Contra-Indications

QuickTalker Freestyle is neither waterproof nor completely water resistant. Do not immerse QuickTalker Freestyle in water or any other liquid. Make sure that no liquids are spilled on QuickTalker Freestyle.

QuickTalker Freestyle is not recommended to be used as access to a call system.

Device Overview

The QuickTalker Freestyle and QuickTalker Freestyle Mini devices have several key components.

Front View

The front of the devices displays a touchscreen interface with various communication symbols and words. Numbered indicators point to:

• [1] On/Off Button
• [2] Volume Buttons
• [3] Charging Port
• [4] Battery Level Indicator
• [5] Carrying Handle

The QuickTalker Freestyle features a grid of communication symbols and words, including categories like "Home", "want", "eat", "drink", "apple", "banana", "orange", "grapes", "strawberry", "water", "milk", "juice", "coffee", "tea", "breakfast", "lunch", "dinner", "snack", and "more".

The QuickTalker Freestyle Mini also features a similar grid of communication symbols and words.

Back View

The back of the devices includes features for mounting and stability. Numbered indicators point to:

• [1] Kickstand
• [2] Threaded inserts for mounting plate

Use Instructions

Device First Time Use

1. Press and hold the on/off button for 3-5 seconds to turn your device on.
2. Tap the speech app icon to start using your speech app.
3. Charge your device overnight when it's not being used or when the battery is low.

Speech App

1. Tap the speech app icon to start using your speech app.
2. Follow on-screen instructions to configure your speech app.
3. For additional information about your speech app, visit https://support.ablenetinc.com/category/speech-apps/ or the website of the developer of the speech app you are using.

iPadOS

For additional information about iPadOS, visit https://support.apple.com/en-au/guide/ipad/welcome/ipados.

Charging Your Battery

1. Attach the included charging cable to the wall plug.
2. Plug the included wall plug into an appropriate wall outlet.
3. Attach the included charging cable to the charging port on the QuickTalker Freestyle.
4. The battery indicator on your QuickTalker Freestyle will tell you when the battery is fully charged.

Positioning the Kickstand

1. Pull the kickstand away from the back of the QuickTalker Freestyle.
2. Adjust the angle of the kickstand until it is suitable to the user.
3. When done using the QuickTalker Freestyle, push the kickstand back in so it is flush with the back of the QuickTalker Freestyle.

Adjusting the Volume

The volume buttons on QuickTalker Freestyle are dynamic and change based on the orientation of the device. Press one of the volume buttons repeatedly. On the screen of the device, the volume indicator will appear showing you if the volume is increasing or decreasing.

Turning the Device Off

1. Press the volume up button one time, then press the volume down button one time, then hold the power button until the "Slide to power off" message appears on the screen of the QuickTalker Freestyle.
2. Swipe from left to right on the screen of the QuickTalker Freestyle to turn off.
3. If you are charging your battery, your QuickTalker Freestyle is unable to be turned off. To turn off, you must unplug it from the included wall charger.

Multiple Methods of Device Access

QuickTalker Freestyle supports the following methods of device access:

• Direct physical contact to the touch screen with or without a keyguard
• Indirect selection with a specialized access device including switch, Bluetooth computer mouse, and head tracking

Multiple Methods of Message Formulation

QuickTalker Freestyle supports message formulation through the selection of letters, words, pictures, or symbols.

Support

For support using your QuickTalker Freestyle or warranty assistance, contact ableCARE at (651) 294-3101 or ablecare@ablenetinc.com. Additional support resources are available online at https://support.ablenetinc.com/.

Preparatory Treatment

Cleaning and disinfecting your QuickTalker Freestyle between uses is essential to the health and safety of the user. To help fight against the spread of germs, here are some helpful steps to cleaning and disinfecting your device.

Always be sure to wear the appropriate personal protective equipment such as protective gloves and safety glasses.

Cleaning Your Device

Before disinfecting your device, remove any dirt or debris that may be on the device.

1. Turn the device off.
2. Remove any large chunks, visible heavy dirt, or debris that is attached to the device.
3. Wipe down the device with cleaning wipes.
4. Use a cotton swab soaked with cleaner to get into any tight areas that were not accessible with the cleaning wipes.
5. Let the device completely dry.

Disinfect Your Device

Now that the device is clean, it is time to disinfect it. Changing protective gloves may be required before disinfecting the device to ensure no dirt or debris is transferred back to the device.

1. Make sure the device is still turned off and that the batteries are removed.
2. Use a clean towel or wipes with Virucidal, Bactericidal, Pseudomonacidal, Tuberculocidal, or Fungicidal to disinfect the surfaces of the device. It is important to note that these chemicals only disinfect when they are wet and should be left wet on the device for at least 4-minutes.
3. Use a cotton swab soaked with Virucidal, Bactericidal, Pseudomonacidal, Tuberculocidal, or Fungicidal to disinfect the tight areas that were not accessible with the towel or wipes. Make sure the chemical stays wet on the device for at least 4-minutes.
4. Let the device air-dry entirely before using it.

Troubleshooting

QuickTalker Freestyle does not turn on

Plug the QuickTalker Freestyle into its wall charger and let the battery re-charge for 1-hour. If the device does not turn on after charging, contact ableCARE at (651) 294-3101 or ablecare@ablenetinc.com.

QuickTalker Freestyle has low volume

The volume buttons on QuickTalker Freestyle are dynamic and change based on the orientation of the device. Press one of the volume buttons repeatedly. On the screen of the device, the volume indicator will appear showing you if the volume is increasing or decreasing. If the volume does not increase, contact ableCARE at (651) 294-3101 or ablecare@ablenetinc.com.

The speech app will not open

Contact ableCARE at (651) 294-3101 or ablecare@ablenetinc.com for assistance updating your speech app.

The glass screen on my QuickTalker Freestyle is cracked.

Immediately stop using your QuickTalker Freestyle and contact ableCARE at (651) 294-3101 or ablecare@ablenetinc.com to request a replacement device.

Preventative and Regular Maintenance

Clean the QuickTalker Freestyle if necessary. No scheduled maintenance is required.

Reusable

If the device is intended to be reused, it must be cleaned and disinfected between uses in accordance with standard infection control procedures. Reuse is appropriate only if the device remains in good working condition and shows no signs of material degradation.

Cleaning and Disinfection Prior to Reuse

Refer to the PREPARATORY TREATMENT section, above.

Inspection Prior to Reuse

Before each reuse, inspect the device for:

• Physical damage or wear
• Corrosion, cracking, or discoloration of components

Discontinuation of Use

Discontinue use and dispose of the device according to local regulations if:

• Any signs of material degradation are present
• The device fails to operate reliably

Where appropriate, devices may be reused if they are reconditioned by the manufacturer, in accordance with applicable safety and performance requirements.

Devices Used Together With

QuickTalker Freestyle may be used with the following AbleNet products:

• Blue2 FT
• One Mount

The above AbleNet products are not required to use QuickTalker Freestyle.

Proper Disposal

QuickTalker Freestyle contains electronic components and should not be disposed of in your normal home or business waste collection. QuickTalker Freestyle should be disposed of with a licensed electronics recycler. Clear all private information off your device before recycling. Contact ableCARE at (651) 294-3101 for assistance clearing all private information off of your device.

When to Contact a Healthcare Professional

If you have difficulty accessing your QuickTalker Freestyle or need assistance with device placement.

Change in your condition.

Notice of Serious Incident

Notice - If any serious incident has occurred while using this device, seek medical attention and then please report to AbleNet, Inc and your competent authority of the member state in which you are in.