PROVOX GR-LARYNXPLUS TruTone Plus Electrolarynx User Manual

Electrolarynx

TruTone® Emote®           TruTone® Plus™

SolaTone® Plus™

SolaTone® Plus™

TruTone® Emote®
TruTone® Plus™

A

B

C

D

Patent and trademarks

Provox®, TruTone®, SolaTone® and Emote® are registered trademarks owned by Atos Medical AB.
For information about protective rights (e.g. patents), please refer to our web page www.atosmedical.com/patents

Electrolarynx Instructions

The Provox TruTone electrolarynx range is designed to increase intelligibility by giving you the option to add prosody, while Provox SolaTonePlus is monotone. Please read all instructions to learn all of the features, especially sections 4 & 11 regarding tone control & prosody.

Definitions: TTE = Provox TruTone Emote, TTP = Provox TruTone Plus, TTE/P = both Provox TruTone products, STP = Provox SolaTone Plus

1. Electrolarynx

A – Sound head (x2 TTE/P) (x1 STP) (including sound button and foam ring)
B – Sound head spacer (TTE/P)
C – Talk button (Emotion™ button in TTE/P)
D – Volume knob
E – Body
F – Battery
G – Battery cap
H – Battery connector (TTE/P)
I – Oral tube (2 + 2)
J – Oral adapter
K – Tone (pitch) adjustment knob
L – LED indicator light
M – MODE button (TTE/P)
U – USB dust cover (TTE/P)
V – USB charge jack

2. When your electrolarynx arrives

• Adjust the base-tone (Section 4)
• Set the mode (TTE/P) (Section 6)
• Choose your sound head (Section 5)
• Decide if the sound head spacer is to be used (Section 5b)
• Charge your battery the first night you receive it (Section 7)
• Read the General care/Troubleshooting (Section 8)
• Read the tips on using an electrolarynx (Sections 9-10)
• Use the Emotion™ button to be more intelligible (Section 11)
• Get more out of your Provox TruTone Emote (Section 12) (TTE/P)
• If you prefer a monotone voice, you can use the button to control your volume (Section 6) (TTE)
• Warranty & warnings are on the last pages.

3. Volume level

Set the volume by turning the volume knob (D). Do not force the knob. Turn it up towards the sound head for a higher volume. Turn it down towards the battery cap for a lower volume. All the way down is off, which is handy when you do not want to accidentally activate the device. Lower volume settings will help you be understood better.

4. Adjusting Tone

• The tone adjustment knob (K) is located to the left of the button.
• Turn it up towards the sound head for a higher tone.
• Turn it down towards the battery cap for a lower tone.
• A tip: Keep the talk button pressed while you make your initial adjustment.

5. Sound head (TTE/P)

5a. Optional extra sharp sound head – (With the gray sound button)
If you have hard neck tissue, the sharp sound head has a sharper sound, which may penetrate tissue better. This may also be helpful if you work in a loud environment. This cap is not as smooth sounding, so the voice may not be as pleasant.

5b. Sound head spacer
If you regularly use a higher tone, you may remove the sound head spacer (B);
Follow these steps (Illustration A)

1. Unscrew the sound head.
2. Remove the spacer.
3. Screw the sound head back on.
4. Test the device, listening to the tonal qualities. If you prefer the tonal qualities without the spacer, be sure to store the spacer in a safe place, such as the box your device came in.

6. Setting the mode: (TTE/P)

The mode button is inside, under the battery cap; M – MODE button (TTE/P) (No tools required)

6a Changing modes
To change the mode, press both the mode button and the talk button. (The timing is not critical.) The mode changes immediately, but if you continue to hold the talk button, the device will beep to indicate the new mode setting. The number of beeps and the tone of the beeps indicate which mode it is in.

6b Modes
Provox TruTone Emote has six modes 1-6 and Provox TruTone Plus has two modes 1-2.

Modes 1-4: Four preset ranges. #1 is nearly monotone, so if you are intentional, you will hear a variation, and modes #2 through #4 have increasing range on the button, depending on your tone setting.
Mode 1 – Nearly monotone                                      1 Beep
Mode 2 – Low tonal variations —1/2-octave range  2 Beeps
Mode 3 – Medium tonal variations                            3 Beeps
Mode 4 – High tonal variations—2-octave range      4 Beeps

Modes #5-6 (TTE): Volume mode lets you control the volume with the talk button, instead of the tone. This is for people who do not use the tone control, and it allows volume control without moving the knob. A very light touch let‘s you speak with your “whisper voice”, while pressing firmly emits sound at full volume. The volume control knob still limits your max volume. Changing into these modes creates a “Whoop” sound (with an increasing tone), rather than a steady tone beep.
Mode 5 – Low Sensitivity—full volume requires more pressure.2 “Whoops”
Mode 6 – High Sensitivity—full volume requires less pressure. 3 “Whoops”

7. Batteries & charging

Provox TruTone products:

1. Use only approved Li-Ion batteries. Contact distributers for more information.
2. Install battery (F) as shown; it only fits one way. The battery connector (H) alignment tab points up, with the red wire to the right.
3. Use until volume begins to fade, which is at 80% drained. You will still have up to another week or more of battery life (depending on your talk time), and battery life will be extended by volume reduction.

Provox SolaTone Plus:
Two 1.5V Nickel Metal Hydride (NiMH) rechargeable AA cells.

7a. Indicator light, battery low:
Provox TruTone products:
The LED light turns on if the battery is 80% drained (or more) when you press the talk button to let you know it is fully functioning, but approaching time to charge.

Provox SolaTone Plus:
No indicator.

7b. Charging
Provox TruTone products:
You may charge on a schedule, proactively; i.e. once a week, or once every two weeks.

To charge, pull the USB dust cover (U) out at the top end, revealing the USB charge jack (V).
Plug in a micro-USB cord into the USB charge jack (V).

Provox SolaTone Plus:
USB charging: Insert micro-USB cord into port ensuring proper orientation.

Charger specifications: 5v, 750mA minimum (or .75A minimum).

7c. Indicator light, charging:

• When charging, the LED indicator light turns on solid.
• When charging is complete, the LED indicator light flashes.
• Unplug the unit when the charging is complete to conserve power.

Caution: Do not attempt to charge alkaline or other “non-rechargable” batteries. Batteries must be disposed of properly. Recycle batteries according to local requirements.

8. General care and troubleshooting

Cleaning

• Wipe with a damp cloth.
• Do not use oils, electrical contact cleaner, or other chemicals as they may cause damage. Isopropyl alcohol (rubbing alcohol) is safe.
• Do not use a soaking wet cloth. Use of an overly wet cloth may allow excess liquid to penetrate the device and cause damage.

Water damage
DO NOT ACTIVATE THE DEVICE!

• Remove the caps and USB dust cover (TTE/P) from the body and unplug the battery.
• Place into a sealed container with dry rice for two days before testing.

Low volume or muffled sound

• Try using or removing the sound head spacer. (TTE/P)
• Charge the battery.
• Verify the diaphragm is properly located, see page 4, Image C

Excessive buzzing

• Ensure you have a complete seal between the device and the neck, all the way around the flat surface of the sound head.
• Try different positions – 1/8” (3mm) can make a very big difference.
• Adjust the tone and volume level.
• Try the oral adapter.

Unsteady tone

• Try a mode with a lower sensitivity (TTE/P)

Unsteady volume

• Try a mode that is not a volume mode. (TTE/P)

9. Electrolarynx neck placement

• Place the sound head (A) against your neck and activate the talk button. Do not cover the stoma.
• Speak as sound is carried into your mouth. Do not force air out.
• Ensure an airtight seal between the sound head and your neck.
• Try different positions until you get the best sound. NOTE: Even a 1/8” (3mm) position change can have a great impact on the sound volume.
• Try cheek placement, or use the oral adapter in cases of a tender neck or excess buzzing.
• Adjusting the base tone up or down may produce a better voice.
• Mid-range tones are easier to hear for most people.

10. Optional oral adapter and oral tubes

Installation (Illustration B)

1. Insert oral tube (I) into top of oral adapter (J). NOTE: Do not insert oral tube beyond stop. Ensure that the tube does not protrude into the cap area.
2. Place oral adapter over sound head (A) (Do not twist it on)
3. Place oral tube into mouth, at corner of mouth.
4. Activate electrolarynx. Speak around oral tube.

• NOTE: The tube is optional. You may also hold the device with the oral adapter to the corner of your mouth!

10a. Oral adapter use tips

• The larger rigid oral tubes do a very good job of getting sound into your mouth, but can be more difficult to speak around.
• The soft clear oral tubes are easier to speak around, but may not get as much sound into your mouth. If your tongue blocks the sound, you may want to cut an angle on the end to prevent blockage.
• You may hear excess “buzzing” (soft clear tubes). Try getting a better seal between the oral adapter and the tube. Remove the oral tube from the oral adapter and push it back in again.
• Practice talking with the oral tube. Form words around the tube before turning on the electrolarynx.
• A good position for many people is found by placing the tip of the tube just behind your front teeth, and to one side, or toward the back of the mouth just ahead of where the tongue touches the roof of your mouth when you make the “G” sound (i.e. “GO”).
• Oral adaptor use may require reduced volume settings.
• To keep the device clean and moisture free, an extra-large finger cot or a large unlubricated condom may be placed on the sound head before installing the oral adapter. Alternatively, a small square of kitchen plastic wrap, approximately 3” x 3” (75mm x 75mm), can be placed on the sound head and smoothed down before installing the oral adapter.

11. Using the pressure sensitive Emotion™ button to increase

intelligibility—it’s easy! (TTE/P)

Why learn this? By increasing and decreasing pressure on the button you will be able to add emotion to your speech. This can help your voice sound more natural, and can help the listener understand you better, so you will have greater intelligibility—a benefit proven in a study by the University of Minnesota. Small changes in tone are enough to remove the “robotic edge” to your voice, and will help your listener connect to you better.

How? Follow these easy steps to get started:

• It is recommended to use either mode #3 or mode #4 for the exercises on Provox TruTone Emote and mode #2 on Provox TruTone Plus. (See “Setting the mode”)
• Press the talk button lightly to activate the base tone.
• Hold the electrolarynx in the air to practice at first.
• Increase pressure slightly to increase the tone. Decrease pressure to come back down to the base tone.
• Practice a smooth up and down transition, slowly increasing and decreasing pressure on the button. Be aware of the bezel around the button as you release pressure, so your voice does not cut out unitentionally.

GREETING: While still buzzing the device in the air, mouth the greeting “How ARE you?” which should mimic the slow up and down tone. Once you have the timing accurate, speak using the device. Practice this a few times.

RESPONSE: Now, practice the response “How are YOU?” with the tone raised on the word ‘you’. First, practice in the air while you mouth the words, holding steady for the first two words, then increasing pressure for the final word “YOU”, and finally, snap your thumb off of the talk button so you don’t drag on. Once you have the timing down, speak using the device.

BORED: Finally, practice the less common bored phrase “HOW ARE you?”, where you snap the talk button down quickly, then slowly reduce pressure for the final word, “you”. This one is tricky because you don’t want to release before you are finished speaking. Practice until you get the timing accurate.

When?

• Just remember to press the talk button as light as possible, and increase the pressure when you want to show emotion or emphasis. Place your emotions into the talk button.
• You do not need to use the intonation in each word, but you will naturally add some to emphasize individual syllables, words or phrases as needed.
• Do not worry about sounding perfect—you will get better, and at least you will not be monotone.
• Only press as hard on the button as your personal health and comfort allow.
• Even if you do not consciously use the Emotion™ button, you may still achieve some natural vocal inflection with natural changes in pressure on the button.

Some practice phrases
woOOow. vs. wow. (Note: excited vs. bored)
I LOVE you. vs. I love YOU.
How ARE you? vs. How are YOU? (greeting vs. response)
BYE bye, vs. Bye BYE.

Then, practice on some phrases that you commonly say—phrases that are a part of your personality. You might have a friend or family member suggest phrases that they are accustomed to hearing you say. Just increase and decrease pressure slightly with the rhythm of each changing word and syllable. Don‘t think about it too hard while you are in conversation—eventually, it will come naturally.

12. Getting more out of your electrolarynx

Phone use – For telephone use, these two tips go a long way towards improving communication:

• Turn the volume down! Turn the device as quiet as it can be, and still make a tone. This way, your articulation is as loud or louder than the tone from the device. Otherwise, the tone may be overpowering.
• Mic placement: Position the phone mic up by the nose. This maximizes the distance between the microphone and the electrolarynx and stoma, so it does not pick up stoma blast and electrolarynx buzzing.

13. Guidelines for demonstration use

The electrolarynx device is intended for use by a single patient. If the device is to be used with multiple patients for demonstration and/or evaluation purposes, the following precautions should be taken to reduce the risk of cross-infection.

13a. General guidelines

• Demonstration use of the device is intended for topical use on uninjured skin for the purpose of identifying patient needs and preferences. It is intended for short-term in-clinic use, and not for long-term use at home.
• The oral adapter and oral tubes are single-patient use only, and are not to be reused between patients.
• The patient shall clean their hands and disinfect their hands with isopropyl alcohol (IPA), or other suitable disinfectant.
• The sound head (including the sound button and foam ring) shall be replaced between patients.
• The electrolarynx device shall be wiped down with 70% IPA before and after use by a patient. Note that wiping down the device is never 100% safe from cross-infection, but the risks are negligible when the device is used with uninjured skin.

13b. Replacing the sound head:
Follow theses steps: (Illustration D)

1. Use a cloth moistened with disinfectant to wipe down the device. The wipe should be moist, but not dripping with disinfectant. Begin wiping down the body of the device. Be sure to apply light pressure and wipe the talk button with a circular or twisting motion. After wiping down the body, wipe down the sound head cap, being careful to not apply excess pressure that would cause the top sound button to be dislodged.
2. Remove the sound head by unscrewing it.
3. The sound head should then be discarded.
4. Install a new Sound head to prepare the device for its next use.

• Be careful not to remove the silicone diaphragm underneath the sound head. The silicone diaphragm should be retained in the groove on the coil’s/ actuator’s stem. (Illustration C)
• Be careful not to twist the coil/actuator. The wires should wind smoothly around the coil/actuator. (Illustration C)
• If applicable: Make sure that the sound head Spacer is still installed. Replace it if it is broken or missing, by installing it onto the device before installing the new Sound-Head. (TTE/P)

Contact your local representative for replacement sound heads.

Service & assistance
The electrolarynx does not contain any serviceable parts other than those removable by the patient. Service parts include batteries, sound head, sound head spacer, foam ring, oral adapter and oral tubes. Contact your local representative for assistance in using or maintaining your electrolarynx and for ordering available parts.

Limited Warranty
For international warranty contact your local representative.

Electrolarynx speech aid information

Intended use: An electrolarynx is a battery-powered artificial larynx that is externally applied and intended for use in the absence of the larynx to produce sound. When held against the skin in the area of the voicebox, or by insertion of a tube in the oral cavity (with an oral adapter), the device generates mechanical vibrations which resonate in the oral and nasal cavities and can be modulated by the tongue and lips in a normal manner, thereby allowing the production of speech. This device is intended for multiple uses by a single patient.
Intended operator: The patient is the intended operator.
Applied part: The entire device is considered a Type BF Applied Part
Environmental conditions for operation: +5°C to +25°C; 15% to 93% relative humidity; 700 hPa to 1060 hPa
Environmental conditions for transportation and storage: To maintain optimal battery life, maintain the following environmental conditions: -20°C to +25°C; 0% to 45% relative humidity.
Mode of operation: 30 minutes of activation during a 24 hour period
Power source: Internally powered.
Expected service life: The expected service life is 1-5 years depending on use frequency and care taken to prevent wear and damage.

Magnetic and electromagnetic fields:

• This device complies with part 15 of the FCC rules. 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.
• Note: 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.
• This device complies with CAN ICES-3(B)/NMB-3(B)

Warnings:

• Do not insert any part of the electrolarynx or tube or any accessories into the stoma.
• Do not burn or physically damage the battery.
• Do not charge non-rechargeable batteries.
• Devices and batteries may become warm (up to 45°C) during charging. Allow the device to cool before use if it becomes too warm.
• Do not short-circuit a cell or battery. Do not store cells or batteries haphazardly in a pocket, purse, box or drawer where they may short-circuit each other or be short-circuited by conductive materials such as coins or keys.
• Use caution when replacing the battery. Incorrect installation of the battery may result in a hazardous situation, such as extreme heat or fire.
• Electrolarynx devices contain a magnet that generate magnetic and electromagnetic fields that may interfere with pacemakers or other implantable devices as well as certain procedures or treatments. Consult with your physician before any procedure or treatment. Maintain a minimum distance of 6” / 16 cm between your electrolarynx and any implanted devices. If interference between the devices is suspected, discontinue use and consult with your physician.
• No modification of this equipment is allowed. Modifying your electrolarynx or using it with other equipment not described in the instructions may result in unsafe operation.
• Electrolarynx devices contain small parts that may become dislodged and present a choking hazard. Keep away from small children.
• Used electrical and electronic products should not be mixed with general household waste. For proper treatment, recovery and recycling, please take this product to a local collection point or recycling location. Recycle as dispose of the battery according to local regulations for batteries.
• Disposing of this product correctly will help save valuable resources and prevent any potential negative effects on human health and the environment, which could otherwise arise from inappropriate waste handling.

For a larger print version, visit www.atosmedical.com/IFU

Reporting:
Please note that any serious incident that has occurred in relation to the device shall be reported to the manufacturer and the national authority of the country in which the user and/or patient resides.

Manufacturer

Date of manufacture

Single Patient – multiple use

Keep away from sunlight and keep dry

Medical Device

Instructions for use

Waste electrical and electronic equipment

Type BF Applied Part

Refer to instruction Manual

No. 12100, 2021-03-30

Australian sponsor:
Atos Medical Pty Ltd
6/174-180 Pacific Highway
North Sydney NSW 2060
Australia
Tel: +61 1800 286 728

Brazil Registration Holder:
Atos Medical Brasil Ltda
Rua Joaquim Nabuco, 47
Cj. 92- Brooklin
04621-000 Sao Paulo, SP
Brasil
Tel: +55 11 2305 2022

Canadian distributor:
Atos Medical Canada Inc
20 Simona Drive, Unit 5
Bolton, ON L7E 4K1
Canada
Tel: +1 833 514 2867

Atos Medical AB
Kraftgatan 8,
SE-242 35 Hörby, Sweden
Tel: +46 (0)415 198 00
Email: info@atosmedical.com

© Atos Medical AB, Sweden.

References

• IFU – Instructions For Use | Atos Medical
• IFU – Instructions For Use | Atos Medical
• Patents | Atos Medical

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