Atos TruTone Emote ProVox Battery-Powered Artificial Larynx User Manual

Atos TruTone Emote ProVox Battery-Powered Artificial Larynx

Descriptive information

Intended use
An electrolarynx is a battery-powered artificial larynx that is externally applied and intended for use in the absence of the ability to use 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.
Contraindications
The device should only be used in accordance with the Instructions for Use. Users without the physical, cognitive, or mental ability required to operate the device themselves, should not use the device independently and should only use it if they are under sufficient supervision of a clinician or a trained caregiver. The device should not be directly applied over frail neck tissue with weak blood  vessels. This can cause tissue damage or bleeding. Patients with this conditionshould only use the device when they have been specifically instructed by their clinician about how to use the device and where to safely apply it.
Description of the device
An electrolarynx is a battery-powered artificial larynx that is externally applied on undamaged skin and intended for use in the absence of the larynx or the inability to use the larynx to produce sound.
Warnings

• Failure to follow the safety instructions could result in personal injury, or damage the device. Read all safety information below before using the device.
• Incorrect use of the device or not following instructions in this IFU can cause personal injury and/or damage the device.
• Do not use the device between persons, this can cause cross-contamination. The device is intended for single patient use only.
• Do not turn on, or use, or charge the device if it has been exposed or dropped in water or other liquids, as it can cause personal injury and/or damage the device.
• Before charging inspect the charger for damage. A damaged or nonfunctioning charger shall no longer be used, as it can cause fire, personal injury or damage the device.
• Only use approved chargers, as usage of unapproved chargers can cause fire, personal injury, or damage to the device.
• Do not attempt to charge non-rechargeable batteries, as this could result in personal injury or damage the device.
• Do not replace rechargeable batteries with non-rechargeable batteries, as this could result in personal injury or damage the device.
• Do not physically damage the batteries, as this could result in personal injury or damage the device.
• Do not store batteries in a pocket, purse, box or drawer etc. where they may short-circuit each other, or be short-circuited by conductive materials such as coins or keys, as this could result in personal injury or damage the device.
• Do not use a leaking battery as it could result in personal injury or damage the device.
• Do not expose the lithium battery to temperatures outside the temperature ranges specified on the label, as it could result in personal injury or damage the device.
• Use caution when replacing the batteries. Incorrect installation of the batteries may result in a hazardous situation, such as extreme heat or fire, as this could result in personal injury or damage the device or other property.
• The device contains a magnet that generates magnetic and electromagnetic fields that may interfere with pacemakers or other implantable devices as well as certain procedures or treatments. Maintain a minimum distance of 6″/15 cm between the device and any medically implanted devices. Consult with your physician before any medical procedure or treatment. If interference between the device and any medically implanted device is suspected, discontinue use and consult with your physician.
• Do not insert any part of the device or accessories into the stoma, as this could result in personal injury.
• Do not modify the device, as it could result in personal injury or damage the device.
• The device contains small parts that may become dislodged and present a choking hazard. Keep away from small children.

Precautions

• Be careful not to damage the battery wiring when opening/closing the battery cap.
• Failure to follow maintenance instructions could result in personal injury and/or damage the device.
• Never use a broken, modified or altered device; or charge a broken, modified or altered device, as this could result in personal injury and/or damage the device.
• The device and batteries may become warm (up to 45 °C/113 °F) during charging. Allow the device to cool down before use.
• The device may become warm during use. Take necessary precautions when placing on neck for use.
• With extensive use, vibrations can cause discomfort for some sensitive users.
• The device may malfunction or stop working due to electromagnetic field interference from other devices.
• Be careful not to chew/bite on the oral tube as it could cause dental damages.
• Be careful not to drop the device, as it could cause damage to the device.
• The device may cause sense of effort and fatigue in the shoulder/arm for individuals who experiences shoulder dysfunction.

Instructions for use

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

Content

Box content

• Electrolarynx
• IFU – Instructions for use
• Oral adapter
• Oral tube variety pack
• Micro USB-cable
• Extra sharp sound head (TTE/P)
• 2 AA NiMH rechargeable batteries (STP)
• Lanyard

Part specification (Illustration 1)

• Sound head (x2 TTE/P) (x1 STP) (including sound button and foam ring)
• Sound head spacer (TTE/P)
• Power button (Emotion™ button in TTE/P)
• Volume knob
• Body
• Battery
• Battery cap
• Battery connector (TTE/P)
• Oral tube (2 + 2)
• Oral adapter
• Tone (pitch) adjustment knob
• LED indicator light
• MODE button (TTE/P)
• USB dust cover (TTE/P)
• USB charge jack

Operating instruction

Volume level and power

• The volume knob (D) all the way down is off.
• Turn the device on and adjust the volume by turning the volume knob upwards (D).

Adjusting tone

• Adjust the tone by turning the tone adjustment knob (K).
• Keep the power button (C) pressed while making your initial adjustment to hear the differences.
• Using the tone knob (K) without holding the power button (C) still changes the tone without the ability to hear it.

Setting the mode (TTE/P)
To change the mode, first remove the battery cap, then press both the mode button (M) and the power button (C). The mode changes immediately, but if you continue to hold the power 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. Provox TruTone Emote (TTE) has six modes 1-6 and Provox TruTone Plus (TTP) has two modes 1-2.

• Modes 1-4: Four preset ranges.
• 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 powerbutton (C), instead of the tone (K). This is for people who do not use the tone control, and it allows volume control without moving the knob. A very light touch lets 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“

Choosing sound head
If you have hard neck tissue or are in a loud environment. The grey sound head can be used because of its sharper sound. (See 2.3.2 Replacing the sound head)
Using the sound head spacer (B) – (TTE/P)
If you regularly use a higher tone and prefer the tonal qualities without a sound head spacer you may remove it. (See 2.3.3 Add/remove sound head spacer)
Charging battery

• Pull the USB dust cover (U) out at the top end. (TTE/P)
• Insert micro-USB into the USB charge jack (V).with an approved plug for wall charging.
• Check that the LED indicator light (L) is lit.
• Unplug the unit when the charging is complete to conserve power. Use until volume begins to fade, which is at 80% drained. LED indicator light (L)
• Low battery (TTE/P) – The light turns on when you press the power button signaling that it is approaching time to charge.
• Charging – Solid light
• Complete charging – Flashing light

Electrolarynx neck placement

• Place the sound head (A) against your neck and activate the power button (C). Do not insert any part of the device or accessories into 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 that even a 3 mm / 1/8″ position change can have a great impact on the sound volume.
• If you are unable to achieve sound transmission through your neck or are unable to place the device against your neck for medical reasons, try cheek placement or use the use the oral adapter (See installing/using optional oral adapter/tube 2.3.4).
• Adjusting the base tone up or down may produce a better voice.
• Mid-range tones are easier to hear for most people.

Optional oral adapter and oral tubes
If neck placement does not suit you because of a tender neck or excess buzzing you can use the oral adapter. (Installing/using oral adapter/tube 2.3.4)
Guidelines for demonstration use
Warning!
The oral adapter, oral tube and sound head are for single-patient use only, and must not be reused between patients.
Precaution!
Maintain the device after each patient and demonstration use according to the maintenance instructions.

• Demonstration use is intended to determine patient suitability for the device.
• The users shall clean and disinfect their hands with isopropyl alcohol (IPA) or with another suitable disinfectant, or use gloves.
• The sound head (A) (including the sound button and foam ring) shall be replaced and discarded between each patient (2.3.2 Replacing the sound head).
• The device shall be wiped off before and after each patient according to 2.3.1 of device.

Maintenance and part changing

Maintenance of device

• Maintenance actions are the responsibility of the user. Maintenance should be performed after each use.
• Wipe the device with a clean, dry cloth or if necessary, a slightly damp cloth (not dripping wet). Use water with mild soap or isopropyl alcohol 50-75%.
• Be careful not to get moisture inside the device
• Do not use electrical or spray cleaners

Replacing the sound head (Illustration 5)
Contact your local representative for replacement sound heads.

1. Wipe down the device according to 2.3.1. Maintenance. Be sure to apply light pressure and wipe the power 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. Make sure that the sound head spacer (B) is still installed. Replace it if it is broken or missing before installing the new sound head (A) (TTE/P) (See. 2.3.3 Add/remove sound head spacer).
4. Install a new sound head (A).

Precaution: Do not 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 3)
Precaution: Do not to twist the coil/actuator. The wires should wind smoothly around the coil/actuator. (Illustration 3)

Add/remove sound head spacer (Illustration 2)

1. Unscrew the sound head.
2. Add/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.

Installing/using oral adapter/tube (Illustration 3)

1. Insert oral tube (I) into top of oral adapter (J).
   Precaution: 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).
   Precaution: Do not twist it on.

3. Place oral tube into mouth, at the corner of the mouth.

4. Activate electrolarynx. Speak around oral tube.

Changing battery
STEP
Two 1.5 V Nickel Metal Hydride (NiMH) rechargeable AA cells.

• Install battery (F) by following the arrows placed inside of the STP (Illustration 1)

TTE/P:
Use only approved Li-Ion batteries. Contact distributors for more information.

• Install battery (F) as shown (Illustration 1); it only fits one way. The battery connector (H) alignment tab points up, with the red wire to the right. (Illustration 1)

Troubleshooting guide

Not satisfactory intelligibility during phone use

1. Place the phone microphone up by the nose, not below the mouth. This will get microphone away from stoma and electrolarynx sound.
2. Reduce the volume of the electrolarynx so the volume level is as quiet as it can be, while still generating a tone.

Unit “dead“, “broken” or “just stopped working”

1. Make sure that the volume knob (D) is not turned all the way down which turn the device off.
2. Turn the volume knob (D) all the way down to off.
3. Lightly press the power button (C) and increase pressure. If the device activates and deactivates in the process the device needs to be sent in for replacement. (See 2.5.1 Service & assistance)
4. If the LED turns on every time the power button (C) is pressed, the device is low on battery and needs to be charged. (TTE/P)
5. Plug a known-good micro USB cable, that is powered, into the device. If the device powers on and the LED flashes then the device battery is unplugged. Remove the battery cap and press battery cable connector (black plastic where the black and red wires go) further into the housing.

Charging light (L) does not turn on while charging

1. Test power outlet with a lamp.

2. Make sure the micro USB cable is fully plugged into the power supply and the device.

3. Try a different micro USB cable.

4. Try a different power supply (USB power outlet).

5. Test charger & cable on a cell phone or other device.
   STP

6. Make sure the battery (or batteries) is rechargeable. Device will not charge non-rechargeable batteries.

7. Make sure the batteries are inserted correctly. Check to make sure the batteries have proper orientation with the battery + going to the device +.
   TTE/P:

8. Plug a known-good micro USB cable that is powered into the device and activate the power button (C), if the device powers on and the LED light flashes then the device battery is unplugged. Remove the battery cap (G) and press battery connector (H) further into the housing.

Unit “has too much buzzing” “sounds funny“, “is muffled“ or “not clear“

1. Make sure the sound head (A) is in full contact with the skin on the neck.
2. Try a different location on the neck. (See 2.2.7 Electrolarynx neck placement)
3. Reduce the volume (D).
4. Adjust the tone (K).
5. Use the oral adapter (See Installing/using the oral adapter and oral tube 2.3.4).
6. Inspect the cap. If the sound button seems loose or has move slightly or the foam ring seems damaged the device might need a new foam ring.
7. Remove the sound head (A) and look inside.
   • Is there a small rubber piece glued in place in the center of the sound head (A)? If not, the unit needs a replacement sound button. (See 2.5.1 Service & assistance)
   • Make sure the diaphragm is attached to the coil’s post. Make sure the coil bounces freely when touched, and does not have any gritty feel (Illustration 4)

TTE/P:

1. Try the optional extra sharp sound head (2.3.2 Replacing the sound head) (Illustration 5)

“Sound head (A) came apart” or the sound button has been pushed out of the cap

1. Check if foam ring is damaged.
2. If it was not damaged, the original foam ring may be reused and assembled back together.
3. If it is damaged, it needs to be changed.

TTE/P:
The sensitivity of the button-sensor may be too sensitive. Try a different MODE, typically a lower mode.
Button “sticks“

1. Read general cleaning advice (2.3.1 Maintenance of device)
2. Use q-tip or cotton swab with a small amount of recommended alcohol (2.3.1 Maintenance of device) to clean around the power button 5-6 times, then press power button 5-6 times.
3. Alternate pressing power button and cleaning around button with q-tip or cotton swab. Continue until no longer sticking.
4. Use a thicker piece of paper to remove debris stuck in power button crevice.

7 Unsteady tone (TTE/P)
Try a mode with a lower sensitivity. (See 2.2.3 Setting the mode)
Unsteady volume (TTE/P)
Try a mode that is not a volume mode. (See 2.2.3 Setting the mode)
Unit causing interference to radio or TV reception

1. Reorient or relocate the receiving antenna.
2. Increase the separation between the equipment and receiver.
3. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
4. Consult the dealer or an experienced radio/TV technician for help.

Service

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.
Disposal
Always follow medical practice and national requirements regarding biohazards when disposing of a used medical device.

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

Technical specifications

+41 °F to +77 °F

Storage and transport temperature

(to maintain optimal battery life)

|

-20 °C to +25 °C

-4°F to +77 °F

Operating humidity

(to maintain optimal battery life)

| 15% to 93% relative humidity,

700 hPa to 1060 hPa

Storage humidity

|

0% to 45% relative humidity

Expected service life| 1-5 years
Applied part| Type BF Applied Part (entire device)

Mode of operation

| 30 minutes of activation during a 24 hour period
Power source| Internally powered

Dimensions

|

Provox SolaTone Plus 118 mm (4.6 inch); Provox TruTone Emote 113 mm (4.5 inch); Provox TruTone Plus 113 mm (4.5 inch)

Weight

|

Provox SolaTone Plus 130 g (0.29 pounds); Provox TruTone Emote 130 g (0.29 pounds); Provox TruTone Plus 131 g (0.29 pounds)

Charge specification

|

5 V, 750 mA minimum (or 0.75 A minimum)

Compliance

Device is tested and conforms to the IEC 60601-1-2 with test level adopted for domestic environment.

Limited warranty

For international warranty contact your local distributer.
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

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
No. 12100, 2021-11-29
© Atos Medical AB, Sweden

References

• Patents | Atos Medical

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