Product Catalog 2019 - Atos Medical · 2019-04-10 · Atos Medical - Who we are At Atos Medical, we are committed to giving a voice to people who breathe through a stoma, with design

Product Catalog 2019

Atos Medical - Who we are

At Atos Medical, we are committed to giving a voice to people who breathe through a stoma, with design solutions and technologies built on decades of experience and a deep understanding of our users.

Since the introduction of the first Provox® voice prosthesis in 1990, Atos Medical has become the world leader in laryngectomy care.

Our commitment and dedicated specialization in this field has allowed us to gain a deep understanding of the needs of our customers. This understanding drives our innovation process and we take pride in continuously bringing innovative solutions to our users.

Over the years, we have served the needs of approximately 100,000 people who have had a laryngectomy in over 70 countries. Our comprehensive laryngectomy care portfolio includes a complete range of Provox voice and pulmonary rehabilitation devices. Our broad range of high quality Provox products allows for a personalized combination of solutions for each user.

Atos Medical understands that being the leader in this field is more than product development. Supporting clinical research and educating both professionals and users is an integral part of our business. Our products are featured in over 150 peer-reviewed publications. We support and conduct hundreds of conferences and educational programs every year, along with over a thousand user events across the country.

We are proud of our history and accomplishments, and we continue to learn from our users; serving them with the best products, services and education we can provide in laryngectomy care.

All products in this catalog may not be licensed in Canada. Please refer to atosmedical.ca for approved products.

Patents and Trademarks:

Provox®, Provox® ActiValve®, Provox® FreeHands HME®, Provox® Luna®, Provox® XtraBase®, Provox® TruTone EMOTE®, Provox® TruTone Plus®, and Provox® Liberty® are registered trademarks owned by Atos Medical AB, Sweden.

Provox® Vega™, Provox® Vega™ XtraSeal™, Provox® NiD™, Provox® XtraMoist™ and XtraFlow™, Provox® Micron HME™, Provox® HME Cap™, Provox® XtraFlange™, Provox® ShowerAid™, Provox® LaryTube™, Provox® LaryClip™ and Provox® LaryButton™, Provox® FlexiDerm™, Provox® OptiDerm™, Provox® FreeHands FlexiVoice™, Provox® FreeHands Support™, Provox® StabiliBase™ and Provox® SolaTone Plus™ are trademarks of Atos Medical AB, Sweden.

For information about patents, please refer to www.atosmedical.us.

Contents4. Speaking

15. Breathing

23. Hands-free

27. Care

31. Continuum of Care

34. Supplemental Products

38. Jaw Mobility

41. Laryngectomy Illustrations

42. Selection of References

43. Contact Information

45. Order Information

In this catalog you will find products that will help you to speak, breathe well and take care of your skin.

4

Speaking

5

Provox Vega Rx Size REF#

Provox Vega 17Fr

Rx 4mm 8270

Provox Vega 17Fr

Rx 6mm 8271

Provox Vega 17Fr

Rx 8mm 8272

Provox Vega 17Fr

Rx 10mm 8273

Provox Vega 17Fr

Rx 12.5mm 8274

Provox Vega 17Fr

Rx 15mm 8275


Provox Vega 20Fr

Rx 4mm 8276

Provox Vega 20Fr

Rx 6mm 8277

Provox Vega 20Fr

Rx 8mm 8278

Provox Vega 20Fr

Rx 10mm 8279

Provox Vega 20Fr

Rx 12.5mm 8280

Provox Vega 20Fr

Rx 15mm 8281


Provox Vega 22.5Fr

Rx 4mm 8282

Provox Vega 22.5Fr

Rx 6mm 8283

Provox Vega 22.5Fr

Rx 8mm 8284

Provox Vega 22.5Fr

Rx 10mm 8285

Provox Vega 22.5Fr

Rx 12.5mm 8286

Provox Vega 22.5Fr

Rx 15mm 8287

Provox Capsules Quantity Rx REF#

Provox Capsules 17Fr 15 pcs Rx 7795

Provox Capsules 20Fr 15 pcs Rx 7796

Provox Capsules 22.5Fr 15 pcs Rx 7797

Non-sterile, for single use. For use with Provox Vega only.

Provox® Capsules and TwistLockDesigned to be used with the Vega Insertion System.

The Provox Capsule is a single-use accessory for anterograde insertion of a standard voice prosthesis by a clinician into the tracheoesophageal puncture. TwistLock makes folding the esophageal flange of the prosthesis into the Provox Capsule simple.

Contact your Atos Territory Sales Manager for TwistLock details.

For single use. Includes: 1 Provox Vega voice prosthesis with Insertion System (sterile) and 1 Provox Brush (non-sterile).

*Data on file.

For Clinician Insertion Only.

Provox® Vega™A voice prosthesis designed for good voice quality, low speaking effort, easy device maintenance and comfort.

Consistency, device life, voice quality and ease of voicing are important factors when choosing the right voice prosthesis. Clinical studies show that the Provox Vega has superior device life, provides the best voice quality (as it requires the lowest amount of effort to speak) and is the easiest to clean.*

• Less strained voice

• Less effort to speak

• Better voice quality

The Provox Vega voice prosthesis comes with an Insertion System that can provide more control and greater flexibility.

• Adapts to patient anatomy and clinician’s preferred insertion method

• Creates an ideal fold of the esophageal flange

• Intuitive and easy-to-use

For Clinician Use Only.

6

Provox® Vega™ XtraSeal™Combines the benefits of the Provox® Vega™ with a solution to manage leakage around the voice prosthesis.

• The enlarged esophageal flange is thin and flexible which allows it to conform to the tissue around the TE puncture

• The user can continue to speak, eat and drink while the leakage around is managed

Provox Vega XtraSeal

Rx Size REF#

Provox Vega XtraSeal 17Fr

Rx 4mm 8288

Provox VegaXtraSeal 17Fr

Rx 6mm 8289


Rx 8mm 8290


Rx 10mm 8291


Rx 12.5mm 8292


Rx 15mm 8293


Rx Size REF#


Rx 4mm 8294


Rx 6mm 8295


Rx 8mm 8296


Rx 10mm 8297


Rx 12.5mm 8298


Rx 15mm 8299

For single use. Includes: 1 Provox Vega XtraSeal voice prosthesis with Insertion System (sterile) and 1 Provox Brush (non-sterile).

Note: When determining the appropriate size of the XtraSeal for the patient, it is critical to consider the shaft of the Provox XtraSeal is approximately 1mm shorter than the size indicated due to the enlarged esophageal flange.



Rx Size REF#

Provox VegaXtraSeal 22.5Fr

Rx 4mm 8300

Provox Vega XtraSeal 22.5Fr

Rx 6mm 8301


Rx 8mm 8302


Rx 10mm 8303


Rx 12.5mm 8304


Rx 15mm 8305

The Provox Vega XtraSeal voice prosthesis comes with an Insertion System that can provide more control and greater flexibility.

• Adapts to patient anatomy and clinician’s preferred insertion method

• Creates an ideal fold of the esophageal flange

• Intuitive and easy-to-use

7

Provox ActiValve

Rx Size REF#

Provox ActiValveLight

Rx 4.5mm 7150

Provox ActiValve Light

Rx 6mm 7151

Provox ActiValveLight

Rx 8mm 7152


Rx 10mm 7153


Rx 12.5mm 7154

Provox® ActiValve®The voice prosthesis for people who experience early leakage with other voice prostheses.

• Increased device life – reduces the need of frequent replacements in most patients who experience short device life.

• Valve and valve-seat consist of fluoroplastic which appears to be insusceptible to destruction by biofilm

• Valve closes with magnets which prevents inadvertent valve opening when the user breathes or swallows

• Available in three strengths – Light, Strong and XtraStrong

• 22.5Fr diameter

Provox ActiValve

Rx Size REF#

Provox ActiValve Strong

Rx 4.5mm 7160


Rx 6mm 7161


Rx 8mm 7162


Rx 10mm 7163


Rx 12.5mm 7164

Provox ActiValve

Rx Size REF#

Provox ActiValve XtraStrong

Rx 4.5mm 7165


Rx 6mm 7166


Rx 8mm 7167


Rx 10mm 7168


Rx 12.5mm 7169

Provox ActiValve Lubricant (replacement)

7149Non-sterile, for single use. Includes: 1 Provox ActiValve voice prosthesis with 1 single-use insertion tool (sterile) and2 Provox Brush (non-sterile), 1 Provox ActiValve Lubricant (non-sterile), 1 Provox Plug (non-sterile), 2 User Cards, 1 Emergency Card.

Caution: Provox ActiValve contains magnets that may cause serious harm if kept in situ during MRI or radiation therapy.


8

Provox® DilatorFor Provox® NiD (Non-Indwelling Prosthesis).

Used to upsize the diameter or to temporarily stent the TE puncture, irrespective of type and diameter of voice prosthesis used.

Provox Dilator Rx Quantity REF#

Provox Dilator, 17Fr Rx 1 pc 7122

Provox Dilator, 20Fr Rx 1 pc 7123

Non-sterile, reusable, sterilizable. 17Fr diameter is 11.5Fr at tip and increases to 19Fr.20Fr diameter is 13Fr at tip and increases to 22Fr.

Provox® NiD™ Non-IndwellingProven features and quality of a Provox device with the convenience of patient self-insertion, removal and cleaning.

The laryngectomee can insert, remove and clean this voice prosthesis themselves while preserving the key features and proven quality of a Provox device.

• With clinician guidance, patients may insert or remove the NiD prosthesis themselves

• Sturdy, durable materials and construction

• Attached to a wide safety medallion to prevent it from falling into the tracheostoma

• Low airflow resistance

• Using dedicated cleaning tools, prosthesis may be cleaned while inside puncture or it may be removed for cleaning

• Available in 17Fr and 20Fr diameters, in the most popular lengths

Provox NiD Rx Size REF#

Provox NiD 17 Rx 6mm 7101






Provox NiD Rx Size REF#







Non-sterile, for single patient use. Includes: Inserter of corresponding size.

9

Provox® BrushFor cleaning of the voice prosthesis.

• Easy and efficient cleaning

• Handle can be bent for individual adaptation

• Can be used to insert the Provox Plug or Provox Vega Plug

Provox Brush Quantity Size REF#

Provox Brush 6 pcs 4.5-10mm 7204

Provox Brush XL 6 pcs 12-18mm 7225

Non-sterile, reusable, for single patient use.

Provox® FlushFor flushing after brushing.

• Can be used with air or drinking water

• Can be bent for individual fitting

Provox Flush Quantity REF#

Provox Flush 1 pc 8109

Non-sterile, reusable, for single patient use.

Provox® DilatorFor upsizing the diameter of the TE puncture or to temporary block a TE.

Can be used irrespective of type and diameter of voice prosthesis used.

• The size can be increased from 15Fr to 24Fr in one device

• Each ring steps up the French size (18, 20, 22, 24Fr)

• A small circular ring helps to keep the Provox Dilator in place and reduces the tendency of it sliding out

Provox Dilator Quantity REF#

Provox Dilator 1 pc 7211

Non-sterile, reusable, sterilizable. Provox Dilator for dilating 15-24Fr.


10

Provox® GuideWireEnables retrograde insertion of all Provox indwelling prostheses.

• Tip contains a retainer slit that holds the safety strap of the prosthesis

Provox GuideWire Quantity REF#

Provox GuideWire 1 pc 7215

Sterile, for single use.


Provox® Plug and Provox® Vega™ PlugA temporary solution to stop leakage through the voice prosthesis.

• Allows continued eating and drinking while waiting for voice prosthesis replacement due to leaking through

• Can be inserted with non-bristled end of Provox Brush

• Speaking is not possible with a Plug in place

Note: The Provox Vega Plug fits into Provox Vega and Provox XtraSeal prostheses. The Provox Plug is for Provox2 and Provox ActiValve.

Provox® XtraFlange™A rapid solution to manage leakage around the voice prosthesis.

• Easy, quick, cost-effective solution to a common problem

• Can be used in combination with all Provox indwelling voice prostheses

• White material for good visibility

Provox Plug and Provox Vega Plug

Quantity REF#

Provox Plug 1 pc 7205

Provox Vega Plug, 17Fr 1 pc 8119

Provox Vega Plug, 20Fr 1 pc 8129

Provox Vega Plug, 22.5Fr 1 pc 8139

Non-sterile, reusable, for single patient use. Includes: Provox Brush.

Provox XtraFlange Rx Quantity REF#

Provox XtraFlange 22.5Fr Rx 1 pc 7275

Provox XtraFlange 20Fr Rx 1 pc 7276

Provox XtraFlange 17Fr Rx 1 pc 7277

Sterile, for single use.


11

Provox® MeasureA tool that can be used to approximate the length of TE punctures.

• For 20Fr and 22.5Fr punctures

Provox Measure Quantity REF#

Provox Measure 1 pc 7270

Provox Measure Flanges 5 pcs 7271

Provox Measure: Non-sterile, reusable, sterilizable. Includes: 5 pcs Provox Measure Flanges.Provox Measure Flanges: Non-sterile, for single use.


Provox® Vega™ Puncture SetA disposable surgical set for primary and secondary placement of the Provox Vega voice prosthesis.

• Sterile, all-in-one and disposable surgical set

• Creates a round puncture

• Pre-loaded with a Provox Vega voice prosthesis

• Rapid procedure with minimal preparation

• Designed to protect the pharynx during primary puncture

• Allows simultaneous voice prosthesis insertion with tracheoesophageal (TE) puncture

Sterile, for single use. Set Includes: 1 Pharynx Protector (made of transparent thermoplastic), 1 Puncture Needle (made of surgical stainless steel), 1 Guidewire (made of pre-colored fluoroplastic), 1 Puncture Dilator with 1 preloaded Provox Vega voice prosthesis.

Also included: 1 Provox Vega Plug (non-sterile), 1 Provox Brush (non-sterile) and 1 Emergency Card.


Provox Vega Puncture Set

Size REF#

Provox VegaPuncture Set 17Fr

8mm 8140US


10mm 8141US


12.5mm 8142US


15mm 8143US


8mm 8144US

Provox Vega Puncture Set

Size REF#

Provox Vega Puncture Set 20Fr

10mm 8145US

Provox Vega Puncture Set 20Fr

12.5mm 8146US

Provox Vega Puncture Set 22.5Fr

8mm 8147US

Provox Vega Puncture Set 22.5Fr

10mm 8148US

Provox VegaPuncture Set 22.5Fr

12.5mm 8149US

12

*Manufactured by Griffin Laboratories, an Atos Medical company.

Provox TruTone EMOTE Electrolarynx REF#

Provox TruTone EMOTE Electrolarynx K1000

Includes: USB Charger, Rechargeable Battery, Lanyard, Oral Adapter, Oral Tubes and Extra-Sharp Head Cap.

Provox® TruTone EMOTE® Electrolarynx*Our most advanced, premium-quality speech aid for more natural expression.

In addition to the features of the TruTone Plus, the TruTone EMOTE also features:

• Exclusive Emotion™ Button provides flexibility and control of pitch and volume

• Unique Whisper™ Mode allows smooth transition between normal and softer volumes with one-touch ease

• Masculine or feminine voicing options with pitch adjustment

• Ergonomic hourglass design for better grip and comfort

• Simple mode selection—no tools needed!

• Rechargeable lithium battery offers long battery life

• USB port for convenient, in-unit battery charging

• Smart indicator light shows low battery and full charge

• Atos Exclusive Five-Year Drop & Soak® Warranty

Provox® TruTone Plus® Electrolarynx*Proven, high-quality speech aid for natural expression with a wide range of frequencies for voicing.

• Single, pressure-sensitive button for natural expression


• Lightweight and extremely durable

• High-capacity, rechargeable 9V battery operation


• Smart indicator light shows low battery and full charge

• Atos Exclusive Three-Year Drop & Soak® Warranty

Provox TruTone Plus Electrolarynx REF#

Provox TruTone Plus Electrolarynx K120

Includes: USB Charger, Rechargeable Battery, Lanyard, Oral Adapter, Oral Tubes, Adjustment Tool and Extra-Sharp Head Cap.

Not available in Canada.

13

Provox® SolaTone Plus™ Electrolarynx*Easy-to-use, single-tone, button-activated speech aid with a wide range of frequencies for voicing.


• Lightweight and durable

• Quality sound and voice range

• Rechargeable, long-lasting AA batteries


• Atos Exclusive Three-Year Drop & Soak® Warranty

Provox SolaTone Plus Electrolarynx REF#

Provox SolaTone Plus Electrolarynx K355

Includes: USB Charger, Rechargeable Batteries, Lanyard, Oral Adapter and Oral Tubes.

Provox® Liberty® Electrolarynx*Value-priced, easy-to-use speech aid.

• Simple volume and pitch control

• Alkaline AA battery operation

• Lightweight and durable

• Three-Year Manufacturer Warranty

Provox Liberty Electrolarynx REF#

Provox Liberty Electrolarynx K306

Includes: Batteries, Lanyard, Oral Adapter and Oral Tubes.



14

SoniVox® Plus Voice Amplifier Kit*Portable voice amplifier with slim design.

• Superior sound quality with reduced feedback

• Powerful and lightweight

• USB port for convenient in-unit battery charging

• Auxiliary Input for music

• Available in two versions—ClearVoice microphone or SlimVoice microphone

SoniVox Plus Voice Amplifier Kit REF#

SoniVox Plus Waistband Amplifier Kit with ClearVoice microphone (in black)

K620

SoniVox Plus Waistband Amplifier Kit with SlimVoice microphone (in beige)

K621

Includes: Protective Carrying Case, USB Charger, Rechargeable Batteries, Lanyard, Auxiliary Cable, Microphone and Pencil/Lapel Microphone.

HandsFree™ TruTone Plus® Holder*Allows you to work with your hands while talking with Provox TruTone Plus electrolarynx.

HandsFree TruTone Plus Holder REF#

HandsFree TruTone Plus Holder KH100

Note: Holder is only compatible with TrueTone Plus.

Batteries REF#

Rechargeable 9V High-Capacity Battery S50439

TruTone EMOTE Lithium Battery S50444

Rechargeable Batteries*

Oral Adapter and Tubes REF#

Oral Adapter 50445

Oral Adapter And Tube 4 Pack S50460-4

White and Clear Tubes - 4 pack S50450

Single patient use, reusable.

Oral Adapter Accessories*For use with all Provox® Electrolarynges.


15

Breathing

16

Provox XtraHME Quantity REF#

Provox XtraMoist HME 30 pcs 7290

Provox® XtraMoist™ HMEThis Heat and Moisture Exchanger (HME) makes the air more humid. Use it during the day, when you’re taking it easy.

• High humidification

• Comfortable breathing

• Reduces coughing and mucus production*

• Easy stomal occlusion for voicing

• Low-profile design

Provox® XtraFlow™ HMEThis HME helps make it easier to breathe. Use it during the day when you’re physically active.

• Low breathing resistance

• Reduces coughing and mucus production*

• Easy stomal occlusion for voicing

• Low-profile design

Provox XtraHME Quantity REF#

Provox XtraFlow HME 30 pcs 7291

Provox Luna Quantity REF#

Provox Luna HME 30 pcs 8013

Provox Luna Adhesive 15 pcs 8014

Non-sterile, for single use.

Note: Do not use skin barrier, wipe, cream, alcohol or any other skin prep prior to applying Provox Luna.

Provox Luna is meant to be used as a system and is not interchangeable with other Provox products.

See page 30 for Provox Luna accessories.

*Data on file.

Provox® Luna®A nighttime solution designed to help sleep comfortably, soothe the skin and improve lung health.

• Soft and smooth for nighttime comfort

• Adhesive made of hydrogel to soothe and cool the skin

• Excellent humidification compared to other HMEs*

• Low breathing resistance for easy nighttime breathing

• Side openings to prevent occlusion while sleeping


*Data on file.


*Data on file.

17

Provox® XtraBase®For speaking with finger occlusion or hands-free.

• For a flat or somewhat deeper stoma

• Sticks well to the skin

• Convex shape with more durable and rigid center for better adhesion

Provox XtraBase Quantity REF#

Provox XtraBase 20 pcs 7265


Provox® StabiliBase™Provides superior seal and support for the stoma when speaking hands-free.

• Also for frequent speaking with finger occlusion


• For a deep stoma

• Provox StabiliBase OptiDerm is suitable for sensitive skin

Provox StabliBase Quantity REF#

Provox StabiliBase 15 pcs 7289

Provox StabiliBase OptiDerm 15 pcs 7318


Provox® Micron HME™Not only an HME, but also an effective bacteria, virus and dust filter.

• A highly-effective bacterial and viral filter (≥99% efficiency)

• Reduces coughing and mucus production

Provox Micron HME Rx Quantity REF#

Provox Micron HME Rx 5 pcs 7247

Provox Micron HME Rx 30 pcs 7248


Note: Provox Micron filtration capacity may vary depending on the size, shape and speed of airborne particles.

18

Provox OptiDerm Quantity REF#

Provox OptiDerm Round 20 pcs 7255

Provox OptiDerm Oval 20 pcs 7256

Provox OptiDerm Plus 20 pcs 7332


Provox® OptiDerm™ A daytime adhesive for when the skin feels sore or irritated.

• For sensitive skin

• Use after surgery

• Use after radiotherapy

Provox® FlexiDerm™ Provides a good seal around the stoma during the day.

• For speaking with finger occlusion

• Soft and flexible with strong adhesive properties

• Ideal for when the area around the stoma is flat

Provox FlexiDerm Quantity REF#

Provox FlexiDerm Round 20 pcs 7253

Provox FlexiDerm Oval 20 pcs 7254

Provox FlexiDerm Plus 20 pcs 7331


Round

Oval

Plus

Illustration is to scale but is not actual size.

Color for illustration purposes only.

Compare options to get a good seal: Round, Oval and Plus(FlexiDerm and OptiDerm Only)

19

Provox® LaryTube™ with RingTo be secured with Provox Adhesive.

With Ring Rx ID OD L REF#

Provox LaryTube 8/36

Rx 9.5 12.0 36 7624


Rx 9.5 12.0 55 7625


Rx 10.5 13.5 36 7626


Rx 10.5 13.5 55 7627

With Ring Rx ID OD L REF#


Rx 12.0 15.0 36 7628


Rx 12.0 15.0 55 7629


Rx 13.5 17.0 36 7630


Rx 13.5 17.0 55 7631

Provox® LaryTube™ FenestratedTo be secured with Provox LaryClip or Provox TubeHolder.

Fenestrated Rx ID OD L REF#


Rx 9.5 12.0 36 7637


Rx 9.5 12.0 55 7638


Rx 10.5 13.5 36 7640


Rx 10.5 13.5 55 7641

Fenestrated Rx ID OD L REF#


Rx 12.0 15.0 36 7643


Rx 12.0 15.0 55 7644


Rx 13.5 17.0 36 7646


Rx 13.5 17.0 55 7647

Standard Rx ID OD L REF#


Rx 9.5 12.0 27 7601


Rx 9.5 12.0 36 7602

ProvoxLaryTube 8/55

Rx 9.5 12.0 55 7603


Rx 10.5 13.5 27 7605


Rx 10.5 13.5 36 7606


Rx 10.5 13.5 55 7607

Standard Rx ID OD L REF#


Rx 12.0 15.0 27 7609


Rx 12.0 15.0 36 7610


Rx 12.0 15.0 55 7611


Rx 13.5 17.0 27 7613


Rx 13.5 17.0 36 7614


Rx 13.5 17.0 55 7615

Provox® LaryTube™For maintaining the opening of the tracheostoma while supporting the use of a Provox HME, available in Standard, Fenestrated and with Ring. ID = inner diameter (in mm)OD = outer diameter (in mm) L = length (in mm)

Provox® LaryTube™ StandardTo be secured with Provox LaryClip or Provox TubeHolder.

Non-sterile, for single patient use, reusable. Includes: 5 XtraFlow HMEs and Provox Brush.

Non-sterile, for single patient use, reusable. Includes: 5 XtraFlow HMEs.

Non-sterile, for single patient use, reusable. Includes: 5 XtraFlow HMEs.

20

Provox® TubeBrushUsed to clean the Provox LaryTube and Provox LaryButton.

• Soft bristles, cotton tip and ergonomic handle designed for comfort

• Looped handle allows brush to be easily hung on a hook for drying

Provox TubeBrush Quantity Size* REF#

Provox TubeBrush 6 pcs 8mm 7660

Provox TubeBrush 6 pcs 12mm 7661

Non-sterile, reusable. For single patient use.* 8mm TubeBrush for use with LaryTube sizes 8 and 9 12mm TubeBrush for use with LaryTube sizes 10 and 12

Provox® LaryButton™ For maintaining the opening of the stoma while supporting use of Provox HME.

Provox LaryButton

Rx OD L REF#

Provox LaryButton 12/8

Rx 12 8 7671


Rx 14 8 7672


Rx 16 8 7673


Rx 18 8 7674

Provox LaryButton

Rx OD L REF#


Rx 12 18 7685


Rx 14 18 7686


Rx 16 18 7687


Rx 18 18 7688

Non-sterile, for single patient use, reusable.

Barton-Mayo™ Button Provox® LaryButton™

Size Diameter Length Diameter Length REF#

9 Short RegularLong

13.513.513.5

152230

1212

818

76717685

10 Short RegularLong

15.015.015.0

152230

1414

818

76727686


171717

152230

1616

818

76737686


191919

152230

1818

818

76747688

Conversion ChartThe below chart is meant to be a guide as to which LaryButton to try if you are converting from a Barton-Mayo button. Atos Medical makes no claims that the specifications of the suggested LaryButton are identical to those of the corresponding Barton-Mayo button. Please consult your clinician to help determine the best size button for you.

21

Provox BasePlate Adaptor Quantity REF#

Provox BasePlate Adaptor 1 pc 7263

Non-sterile, for single patient use.

Provox® BasePlate AdaptorMakes it possible to attach a 15mm connector to a Provox attachment.

• Designed for use with a Provox attachment (e.g. an adhesive, LaryTube or LaryButton) to attach a device with an ISO 15mm standard connector.

Provox® TubeHolderSuitable for users with sensitive skin around the stoma.

• Designed exclusively for use with Provox LaryTube and LaryButton to help with retention

• Integrated clip connectors allow for optimal fit with less stress on the wings of the Provox LaryTube or LaryButton

• Also well suited for those who have sensitive skin around the tracheostoma and cannot tolerate an adhesive

Provox TubeHolder Quantity REF#

Provox TubeHolder 1 pc 7668


Provox® LaryClip™An alternative to Provox TubeHolder.

• A two-piece system designed to discreetly attach Provox LaryButton and/or Provox LaryTube to the stoma

Provox LaryClip Quantity REF#

Provox LaryClip 1 set 7669

Non-sterile, for single patient use.Includes: 8 pcs LaryClip, 40 pcs LaryClip Base.

22

Provox® LaryButton™ Sizer Kit and Provox® LaryTube™ Sizer KitTo allow for proper selection and sizing.

• Each kit contains sterilizable and reusable tubes/buttons for individual fitting

• The products can be secured with Provox LaryClip and Provox TubeHolder

Provox LaryButton Sizer Kit REF#

Provox LaryButton Sizer Kit 7690

Non-sterile, reusable, sterilizable.

(Sizer Buttons and inner box). Outer tray can be cleaned in instrument washer. Includes: REF#: 7671, 7672, 7673, 7674, 7685, 7686, 7687, 7688.

Provox LaryTube Sizer Kit REF#

Provox LaryTube Sizer Kit 7648

Non-sterile, reusable, sterilizable.

(Sizer Tubes and inner box). Outer tray can be cleaned in instrument washer. Includes: REF#: 7601, 7637, 7638, 7640, 7641, 7643, 7644, 7647.


Provox® FenestrationPunchUsed to make small holes in the Provox LaryTube.

• Allows air to flow to the voice prosthesis

Provox FenestrationPunch Quantity REF#

Provox FenestrationPunch 1 pc 7654

Non-sterile, reusable.


Provox HME Cassette Adaptor

Quantity REF#

Provox HME Cassette Adaptor 1 pc 7246


Provox® HME Cassette AdaptorEnables use of a Provox HME Cassette to any tracheostomy tube.

• Designed for a tracheostomy tube with a 15mm ISO connector

23

Hands-free

24

Provox® FreeHands FlexiVoice™Gives the freedom to speak hands-free.

More than 90 % of the participants in a clinical study were able to speak hands-free with Provox FreeHands FlexiVoice. About half of the users used it every day.*

• Available in four membranes: Light, Medium, Strong, XtraStrong

• Allows the flexibility of speaking hands-free or with finger occlusion when necessary

• Use different membranes for different situations

• Can lock during physical activity so membrane remains open

• Reduces mucus production and coughing*

Provox FreeHands FlexiVoice Rx REF#

Provox FreeHands FlexiVoice Set Plus: 1 Light, 1 Medium, 1 Strong, 2 Arches, 1 Removal Aid, 20 FreeHands Moist HME, 10 FreeHands Flow HME

Rx 7757

Provox FreeHandsFlexiVoice Set: 1 Light, 1 Medium, 1 Strong, 2 Arches, 1 Removal Aid

Rx 7760

Provox FreeHands FlexiVoice Rx REF#

Provox FreeHands FlexiVoice Light: 1 Light, 1 Arch, 1 Removal Aid

Rx 8161

Provox FreeHands FlexiVoice Medium: 1 Medium, 1 Arch, 1 Removal Aid

Rx 8162

Provox FreeHands FlexiVoice Strong:1 Strong, 1 Arch, 1 Removal Aid

Rx 8163

Provox FreeHands FlexiVoice XtraStrong:1 XtraStrong, 1 Arch, 1 Removal Aid

Rx 8166

Provox® FreeHands Support™Designed to reduce stomal movement and improve voice quality when speaking hands-free with Provox FreeHands FlexiVoice.

Provox FreeHands Support Quantity REF#

Provox FreeHands Support Starter Set*:1 Support Flat, 1 Support Medium, 1 Support Deep

1 set 8020

Provox FreeHands Support Flat*

1 pc 8021

Provox FreeHands Support Medium*

1 pc 8022

Provox FreeHands Support Deep*

1 pc 8023

Provox FreeHands Support Adhesives

15 pcs 8024

*FreeHands Support Adhesive sold separately

FreeHands Support: Non-sterile, for single patient use, reusable.

FreeHands Adhesive: Non-sterile, for single use.

FreeHands FlexiVoice: Non-sterile, for single patient use, reusable.

Provox FreeHands FlexiVoice is meant to be used with Provox FreeHands HMEs and is not interchangeable with other Provox products.

*Data on file.

25

Provox® FreeHands FlexiVoice™ ArchTo prevent fabric from accidentally occluding the opening of the FlexiVoice speaking valve.

Provox FreeHandsFlexiVoice Arch

Quantity REF#

Provox FreeHandsFlexiVoice Arch

5 pcs 8165


Provox® FreeHands HME® MoistFor extra humidification when relaxing.

• To be combined with Provox FreeHands FlexiVoice when speaking hands-free

Provox FreeHandsHME Moist

Quantity REF#

Provox FreeHands HME Moist 30 pcs 8220


Provox® FreeHands HME® FlowFor humidification when being active.

• To be combined with Provox FreeHands FlexiVoice when speaking hands-free

Provox FreeHandsHME Flow

Quantity REF#

Provox FreeHands HME Flow 30 pcs 8221


Provox HME Cap Quantity REF#

Provox HME Cap 1 pc 7730


Provox® HME Cap Makes it possible for the Provox FreeHands HMEs to be used also during sleep.

• Used with the FreeHands HMEs

• Cap can be occluded manually for speech

• Matte titanium

26

Removal AidTo remove the HME from the FlexiVoice speaking valve.

Removal Aid Quantity REF#

Removal Aid 2 pcs 7745

Non-sterile, reusable.

Provox® XtraBase®For speaking with finger occlusion or hands-free.

• For a flat or somewhat deeper stoma


• Convex shape with more durable and rigid center for better adhesion

Provox XtraBase Quantity REF#

Provox XtraBase 20 pcs 7265


Provox® StabiliBase™Provides superior seal and support for the stoma when speaking hands-free.

• Also for frequent speaking with finger occlusion


• For a deep stoma

• Provox StabiliBase OptiDerm is suitable for sensitive skin

Provox StabliBase Quantity REF#

Provox StabiliBase 15 pcs 7289

Provox StabiliBase OptiDerm 15 pcs 7318


27

Care

28

Provox® Adhesive RemoverTo help remove adhesive.

Provox Skin Barrier Quantity REF#

Provox Skin Barrier 50 pcs 8011


Provox® Skin BarrierTo leave a protective layer on the skin.

Provox Adhesive Remover Quantity REF#

Provox Adhesive Remover 50 pcs 8012


Provox® Cleaning Towel To clean the skin before putting on an adhesive.

Provox Cleaning Towel Quantity REF#

Provox Cleaning Towel 200 pcs 7244

Non-sterile, for single use.Includes: 20 resealable pouches of 10.

Provox Wipes Set Quantity REF#

Provox Wipes Set 1 set 8243

Non-sterile, for single use. Includes: 6 Skin Barrier, 6 Adhesive Remover and 10 Cleaning Towel.

Provox® Wipes SetTo care for skin when using adhesives.

29

Skin Tac Quantity REF#

Skin Tac Wipe 50 pcs MS407W


*Manufactured by Torbot Group Inc.

Skin Tac™ Wipe*Improves adhesion of appliances and adhesive to the skin.

• Works as a barrier between adhesive and skin to reduce irritation

Provox ShowerAid Quantity REF#

Provox ShowerAid 1 pc 7260

Non-sterile, for single patient use. Includes: 1 Provox FlexiDerm Oval Adhesive.

Provox® ShowerAidProtects the stoma from water when showering.

• Replace your HME with this while enjoying a shower and switch back when you have finished

Provox® Silicone Glue Improves the adhesion between the skin and the adhesive.

• 30mL bottle

Provox Silicone Glue Quantity REF#

Provox Silicone Glue 1 pc 7720

Non-sterile. Bottle with brush cap, for multiple applications. Single patient use.

30

Provox Adhesive Strip Quantity REF#

Provox Adhesive Strip 10 pcs 8015


Provox® Luna™ ShowerAidProtects the stoma from water while showering with Provox Luna.

Provox Luna ShowerAid Quantity REF#

Provox Luna ShowerAid 1 pc 8016

Showering with Provox Luna requires the use of Provox Adhesive Strip.


Provox Luna is meant to be used as a system and is not interchangeable with other Provox products.

Provox® Adhesive Strip™Designed to protect Provox Luna Adhesive while showering.

31

Continuum of Care

32

Provox® Laryngectomy Pulmonary Kit (LPK)Immediate post-operative pulmonary care system enhances patient outcomes.*

Provox Laryngectomy Kits provide all-in-one packaging for immediate post-operative 24/7 pulmonary rehabilitation and the option for ready-to-use surgical placement of the Provox Voice Prosthesis. The kits feature Provox Heat and Moisture Exchangers (HMEs) – approved for 24 hour use even while sleeping!

Clinical studies have shown that most laryngectomized patients who use a Provox HME twenty-four hours a day, even while sleeping, experience reductions in:

• Mucus production

• Coughing and forced expectoration

Immediate post-operative use of the HME also lowers costs as compared to the use of an external humidifier.

Provox Laryngectomy Pulmonary Kits provide convenient all-in-one packaging supporting pulmonary care as well as communication needs.

Contact your Atos Medical Representative for LPK details.

Contact your Atos Medical Representative for LPK details.

Provox Standard Laryngectomy Pulmonary Kit

Provox XtraFlow HME Provox LaryTube StandardProvox TubeHolderProvox TubeBrush Provox ShowerAidDry Erase Board


*Data on file.


33

Provox® Coming HomeAn intuitive tool designed to help with the transition from hospital to home for patients who have had a laryngectomy.

The tool includes a durable carrying case with selected products and information in several languages and a removable carrying case to take with you when you go out.

Provox Coming Home introduces the products step-by-step, explaining in an easy-to-understand way what the products are for and when and why to use them.

Provox Coming Home

Provox XtraFlow HMEProvox FlexiDerm AdhesiveProvox OptiDerm AdhesiveProvox Luna AdhesiveProvox Luna HMEProvox SkinBarrierProvox Adhesive RemoverProvox Cleaning TowelProvox Shower AidProvox Luna Shower AidProvox StabiliBase AdhesiveTravel FlashlightMirror


Provox Coming Home is available through clinicians only.

Adhesives and Heat and Moisture Exchangers (HMEs) designed to use during the day.

A nighttime system designed to help take care of the skin, improve lung health and sleep more comfortably.

Products designed to help take care of the skin surrounding the stoma.

A cover designed to help prevent water from entering the stoma while showering.

An adhesive designed to provide additional stability when speaking.

A carrying case for products needed when going out.

Each kit includes:

34

Supplemental Products

35

Polyester Stoma Covers*• 100% Polyester 4-ply fabric

• Discreet coverage

• Available in several colors

• Easily adjustable neck strap from 13 1/4 to 18 inches

• Machine washable

• Dimension: Approx. 9 1/2 inches wide and 8 1/4 inches long

4-Ply Polyester Stoma Cover REF#

Polyester Stoma Cover, White RSCWH

Polyester Stoma Cover, Black RSCBL

Polyester Stoma Cover, Navy RSCNA

Polyester Stoma Cover, Beige RSCBE

Non sterile, for single patient use. Reusable.

Foam Stoma Covers*• Lightweight medical-grade foam

• Beige color

• One adhesive strip

• Dimensions: 65 x 65mm, 2mm thick

Foam Stoma Covers Quantity REF#

Foam Stoma Cover, Beige 30 pcs RFFFL02

Non sterile, for single use.

Mock Turtle Neck Stoma Covers*• Mock turtle neck style for discreet coverage

• Comfortable 80/20 poly/cotton blend resists shrinkage and fading

• Machine washable

• Two colors available

• Adjustable neck collar from 12 to 21 inches

• Dimensions: approx. 10 inches wide and 8 inches long

Mock Turtle Neck Covers REF#

Mock Stoma Cover, White RTNSCWH

Mock Stoma Cover, Navy RTNSCNA

Non sterile, for single patient use. Reusable.

*Manufactured by Fountain Head Marketing, Inc.™

36

Kapi-Gel Tracheostoma Spacer Quantity REF#

Kapi-Gel 8mm ID, 3mm Thick 10 pcs LATNG2008





*Manufactured by Kapitex Healthcare Ltd.

Kapi-Gel® Tracheostoma Spacer*Intended to help create a better seal around tracheostoma support devices and are suitable for uneven stomal anatomy.

• A 43mm diameter, 3 or 5mm thick circular, tacky, laminated silicone gel spacer

• Available in two inner diameter openings to accommodate different diameter tubes and buttons (8mm opening fits tubes or buttons with <14mm OD; 12mm opening fits tubes or buttons with >12mm OD)

• Can improve tracheostoma device fitting, act as a cushion behind tubes and buttons during digital occlusion and may help reduce air leakage

Barton-Mayo Tracheostoma Button

Size Models Diameter (mm)

Length (mm)

Rx REF#


9 Short RegularLong

13.5 152230

Rx ENBMB091ENBMB092ENBMB093



15.0 152230




17.0 152230




19.0 152230


Barton-Mayo Sizing Kit Includes trial buttons for each available Barton-Mayo Button

ENBMBKIT



*Manufactured by Medical Innovations.

Barton-Mayo™ Tracheostoma Button*Developed to provide leak-proof tracheostoma valve retention for total laryngectomy patients.

• Can be used with an Heat and Moisture Exchanger (HME)

• Enhances speech with “hands-free” stomal occlusion

• Another option for positive stoma sealing

• Wide range of sizes available

37

Servox® Digital XL Electrolarynx*Quality, reliable and simple-to-operate speech aid.

• Digital XL uses four standard, commercially available, AAA batteries (NiMH rechargeable or regular alkaline)

• Includes eight rechargeable NiMH batteries and a110v battery charger that charges batteries in about 4 hours

• Titanium housing

• Buttons can be set for various volumes and pitches enabling individual setting

• Rocker switch for individual volume adjustment

• Convenient hip bag for traveling/storage

• 2-Year Warranty

Servox Digital Electrolarynx REF#

Servox Digital XL Electrolarynx 37575

Servox Coin Battery 20ZU1015

Servox Oral Adapter with 5 tubes 20ZU1010

includes: AAA NiMH rechargeable batteries, VARTA NiMH charger, international plug adapter, battery holders, oral adapter, oral tubes, attachable hand cord, belt holster, neck cord, standard and soft tone screw caps.

Not available in Canada.*Manufactured by Servona, Inc.

Tracho-Foam®Double-sided adhesive foam discs.

• For patients who are having difficulty maintaining a good seal with adhesive alone

• May provide a comfortable, airtight seal that conforms to the irregular contours of the stoma

• May be used with Provox XtraBase, StabiliBase or FlexiDerm adhesives as a temporary solution when a good seal is difficult to achieve due to irregularly shaped stoma

Trach-Foam Discs Quantity REF#

Tracho-Foam Discs Large0.125 x 1 in. ID x 2.625 In. OD

20 pcs TF258

Tracho-Foam Standard0.125 x 1 in. ID x 2.25 In. OD

20 pcs TF214


38

Jaw Mobility

39

TheraBite® Jaw Motion Rehabilitation System™ For restoring jaw mobility after trismus and mandibular hypomobility.

The TheraBite® Jaw Motion Rehabilitation System™ is a clinically proven, anatomically correct and portable system designed to restore mobility after trismus and mandibular hypomobility. The patient controlled system utilizes repetitive passive motion to stretch connective tissue, strengthen weakened muscles and mobilize joints. The average sustainable gain in jaw opening is around 1–1.5mm per week. The TheraBite® Jaw Motion Rehabilitation System™ can also help to reduce muscle pain by reducing joint inflammation and prevent reduced muscle strength during (chemo) radiation in the head and neck area. The TheraBite Jaw Motion Rehabilitation System is available in both adult and pediatric versions.

Bite Pads

The self-adhesive Bite Pads spread the force across the teeth and can be trimmed for customized protection. The Bite Pads come in adult, pediatric and edentulous (toothless) versions.

Range of Motion Scales The disposable Range of Motion Scales allows the patient and his/her clinician to monitor the progress of the treatment. Includes a Range Setting Arm.

Hand-Aid The Hand-Aid assists the patient in maintaining constant opening during stretching or strengthening programs

Exercise Log The daily and monthly Exercise Log enables the user and his/her treating clinician to log the daily and monthly progress

40

TheraBite Jaw Motion Rehabilitation System Quantity REF#

Adult TheraBite® Jaw Motion Rehabilitation System™ 1 System TH001

Pediatric TheraBite® Jaw Motion Rehabilitation System™ 1 System TH002

TheraBite® ActiveBand 1 pc 8260

TheraBite® Range of Motion Scales 150 pcs SC001

TheraBite® Bite Pads, Regular 4 pcs PA001

TheraBite® Bite Pads, Edentulous 4 pcs PA002

TheraBite® Bite Pads, Pediatric 4 pcs PA003

TheraBite® ActiveBand™ TheraBite® ActiveBand™ is an addition to the TheraBite® Jaw Motion Rehabilitation System™ providing resistance to mouth closure. It is used as a part of the Pharyngocise protocol for patients undergoing head and neck radiation therapy. The device is designed to increase muscle strength and endurance of the muscles of mastication (the masseter, temporalis, medial and lateral pterygoid muscles). The active exercise can be used for patients compromised by cerebral lesions after stroke or that have neuromuscular disorders.

TheraBite® System

TheraBite Jaw Mobilizer: Non-sterile, reusable.

Adult Includes: Jaw Mobilizer, 4 Regular Bite Pads, Hand-Aid, 30 Range of Motion Scale, Carrying Bag, Instructions for Use, Patient Progress Log

Pediatric Includes: Jaw Mobilizer, 4 Pediatric Bite Pads, Hand-Aid, 30 Range of Motion Scale, Carrying Bag, Instructions for Use, Patient Progress Log

TheraBite Bite Pads: Non-sterile, for single patient use.

41

Laryngectomy Illustrations

Speaking with the Provox voice prosthesis: Manual occlusion of the Provox XtraHME attached

with Provox Adhesive.

Before total laryngectomy After total laryngectomy

Speaking with the Provox voice prosthesis: Hands-free with Provox FreeHands FlexiVoice

attached with Provox Adhesive.

© K

. Va

nder

po

ol

MC

06

96

42

Provox® Voice Prostheses• Timmermans AJ, Harmsen HJ, Bus-Spoor C, Buijssen

KJ, van As-Brooks C, de Goffau MC, Tonk RH, van den Brekel MW, Hilgers FJ, van der Laan BF. Biofilm formation on the Provox ActiValve: Composition and ingrowth analyzed by Illumina paired-end RNA sequencing, fluorescence in situ hybridization, and confocal laser scanning microscopy. Head Neck. 2016 Apr;38 Suppl 1:E432-40.

• Kress P, Schäfer P, Schwerdtfeger FP, Rösler S. Are modern voice prostheses better? A lifetime comparison of 749 voice prostheses. Eur Arch Otorhinolaryngol. 2014 Jan;271(1):133-40.

• Hancock KL, Lawson NR, Ward EC. Device life of the Provox Vega voice prosthesis. Eur Arch Otorhinolaryngol. 2013 Mar;270(4):1447-53.

• Hilgers FJ, Lorenz KJ, Maier H et al. Development and (pre-) clinical assessment of a novel surgical tool for primary and secondary tracheoesophageal puncture with immediate voice prosthesis insertion, the Provox Vega Puncture Set. Eur Arch Otorhinolaryngol. 2013 Jan;270(1):255-62.

• Hancock K, Ward E, Lawson N, van As-Brooks CJ. A prospective, randomized comparative study of patient perceptions and preferences of two types of indwelling voice prostheses. Int J Lang Commun Disord. 2012 May-Jun;47(3):300-9.

• Ward EC, Hancock K, Lawson N, van As-Brooks CJ. Perceptual characteristics of speech production using the new indwelling Provox Vega voice prosthesis: A randomized controlled cross-over trial. Head & Neck. 2011 Jan;33(1):13-9.

• Hilgers FJ, Ackerstaff AH, Jacobi I, Balm AJ, Tan B, Van den Brekel MW. Prospective clinical phase II study of two new indwelling voice prostheses (Provox Vega 22.5 and 20Fr ) and a novel anterograde insertion device (Provox SmartInserter). Laryngoscope. 2010 Jun;120(6):1135-43.

• Hilgers FJ, Ackerstaff AH, van RM et al. Clinical phase I/feasibility study of the next generation indwelling Provox voice prosthesis (Provox Vega). Acta Otolaryngologica. 2010 April; 130(4):511-9.

• Soolsma J, van den Brekel MW, Ackerstaff AH, Balm AJ, Tan B, Hilgers FJ. Long-Term Results of Provox ActiValve, Solving the Problem of Frequent Candida- and “Underpressure”-Related Voice Prosthesis Replacements The Laryngoscope. 2007 The American Laryngological, Rhinological and Otological Society, Inc.

• Hancock K, Houghton B, Van As-Brooks CJ, Coman W: First clinical experience with a new nonindwelling voice prosthesis (Provox NID) for voice rehabilitation after total laryngectomy. Acta Otolaryngologica. 2005 Sep;125(9):981-90.

• Hilgers FJ, Ackerstaff AH, Balm AJ, Van den Brekel MW, Bing Tan I, Persson JO: A new problemsolving indwelling voice prosthesis, eliminating the need for frequent Candida- and “underpressure”-related replacements: Provox ActiValve. Acta Otolaryngologica. 2003 Oct;123(8):972-9.

• Free RH, Van der Mei HC, Elving GJ, Van Weissenbruch R, Albers FW, Busscher HJ: Influence of the Provox Flush, blowing and imitated coughing on voice prosthetic biofilms in vitro. Acta Otolaryngologica. 2003 May;123(4):547-51.

• Op de Coul BMR, Hilgers FJM, Balm AJM, Tan IB, van den Hoogen FJA, van Tinteren H: A decade of post-laryngectomy vocal rehabilitation in 318 patients: A single institution’s experience with consistent application of Provox® indwelling voice prostheses. Archives of Otolaryngology- Head & Neck Surgery. 2000 Nov;126(11):1320-8.

• Balle VH, Rindsø L, Thomsen JC. Primary speech restoration at laryngectomy by insertion of voice prosthesis – 10 years experience. Acta Otolaryngologica 2000; Suppl 543:244-245.

• Ackerstaff AH, Hilgers FJ, Meeuwis CA, van der Velden LA, van den Hoogen FJ, Marres HA, Vreeburg GC, Manni JJ: Multi-institutional assessment of the Provox®2 voice prosthesis. Archives of Otolaryngology - Head & Neck Surgery.1999 Feb;125(2):167-73.

• Hilgers FJM, Ackerstaff AH, Balm AJM, Tan IB, Aaronson NK, Persson JO. Development and clinical evaluation of a second-generation voice prosthesis (Provox®2) designed for anterograde and retrograde insertion. Acta Otolaryngologica. 1997 Nov;117(6):889-96.

• Hilgers FJM, Schouwenburg PF. A new low-resistance, self-retaining prosthesis (Provox®) for voice rehabilitation after total laryngectomy. Laryngoscope. 1990 Nov;100(11):1202-7.

References*Provox® HME and Provox FreeHands HME• Lansaat L, de Kleijn BJ, Hilgers FJ, van der Laan BF,

van den Brekel MW. A prospective multicenter clinical feasibility study of a new automatic speaking valve for postlaryngectomy voice rehabilitation. Eur Arch Otorhinolaryngol. 2017 Feb;274(2):1005-1013.

• Macri GF, Bogaardt H, Parrilla C, Minni A, D’Alatri L, de Vincentiis M, Paludetti G. Patients’ experiences with HMEs and attachments after total laryngectomy. Clin Otolaryngol. 2016 Dec;41(6):652-659.

• van den Boer C, Muller SH, van der Noort V, Olmos RA, Minni A, Parrilla C, Hilgers FJ, van den Brekel MW, van der Baan S. Effects of heat and moisture exchangers on tracheal mucociliary clearance in laryngectomized patients: a multi-center case-control study. Eur Arch Otorhinolaryngol. 2015 Nov;272(11):3439-50.

• Parrilla C, Minni A, Bogaardt H, Macri GF, Battista M, Roukos R, Pandolfini M, Ruoppolo G, Paludetti G, D’Alatri L, de Vincentiis M. Pulmonary Rehabilitation After Total Laryngectomy: A Multicenter Time-Series Clinical Trial Evaluating the Provox XtraHME in HME-Naïve Patients. Ann Otol Rhinol Laryngol. 2015 Sep;124(9):706-13.

• van den Boer C, Muller SH, Vincent AD, van den Brekel MW, Hilgers FJ. Ex vivo assessment and validation of water exchange performance of 23 Heat and Moisture Exchangers for laryngectomized patients. Respir Care. 2014 Aug;59(8):1161-71.

• van den Boer C, Muller SH, Vincent AD, Züchner K, van den Brekel MW, Hilgers FJ. Ex vivo water exchange performance and short-term clinical feasibility assessment of newly developed heat and moisture exchangers for pulmonary rehabilitation after total laryngectomy. Eur Arch Otorhinolaryngol. 2014 Feb;271(2):359-66

• Herranz J, Espiño MA, Morado CO. Pulmonary rehabilitation after total laryngectomy: a randomized cross-over clinical trial comparing two different heat and moisture exchangers (HMEs). Eur Arch Otorhinolaryngol. 2013 Sep;270(9):2479-84.

• Brook I, Bogaardt H, van As-Brooks C. Long-term use of heat and moisture exchangers among laryngectomees: medical, social, and psychological patterns. Ann Otol Rhinol Laryngol. 2013 Jun;122(6):358-63.

• Hilgers FJ, Dirven R, Wouters Y, Jacobi I, Marres HA, van den Brekel MW. A multicenter, prospective, clinical trial evaluating a novel adhesive baseplate (Provox StabiliBase) for peristomal attachment of postlaryngectomy pulmonary and voice rehabilitation devices. Laryngoscope. 2012 Nov;122(11):2447-53.

• Scheenstra RJ, Muller SH, Hilgers FJ. Endotracheal temperature and humidity in laryngectomized patients in a warm and dry environment and the effect of a heat and moisture exchanger. Head Neck. 2011 Sep;33(9):1285-93.

• Scheenstra RJ, Muller SH, Vincent A, Ackerstaff AH, Jacobi I, Hilgers FJ. A new heat and moisture exchanger for laryngectomized patients: endotracheal temperature and humidity. Respir Care. 2011 May;56(5):604-11.

• Scheenstra RJ, Muller SH, Vincent A, Hilgers FJ. Heat and moisture exchange capacity of the upper respiratory tract and the effect of tracheotomy breathing on endotracheal climate. Head Neck. 2011 Jan;33(1):117-24.

• Scheenstra RJ, Muller SH, Vincent A, Sinaasappel M, Hilgers FJ. Influence of breathing resistance of heat and moisture exchangers on tracheal climate and breathing pattern in laryngectomized individuals. Head & Neck. 2010 Aug;32(8):1069 78.

• Scheenstra RJ, Muller SH, Vincent A, Ackerstaff AH, Jacobi I, Hilgers FJM. Short term endotracheal climate changes and clinical effects of a heat and moisture exchanger with an integrated electrostatic virus and bacterial filter developed for laryngectomized individuals. Acta Otolaryngologica. 2010 Jun;130(6):739-46

• Bien S, Okla S, van As-Brooks CJ, Ackerstaff AH. The effect of a Heat and Moisture Exchanger (Provox HME) on pulmonary protection after total laryngectomy: a randomized controlled study. European Archives of Otorhinolaryngology. 2010 March;267(3):429-35.

• Lorenz KJ, Huverstuhl K, Maier H. [Finger-free speech with the Provox FreeHands HME Automatic Tracheostoma Valve system. Clinical long-term experience]. HNO. 2009 Nov;57(11):1090-8.

• Zuur JK, Muller SH, Vincent A, Sinaasappel M, de Jongh FH, Hilgers FJ. The influence of a heat and moisture exchanger on tracheal climate in a cold environment. Medical & Biological Engineering & Computing. 2009 Sep;31(7):852-7.

• Lorenz KJ, Maier H. [Pulmonary rehabilitation after total laryngectomy using a heat and moisture exchanger (HME)]. Laryngorhinootologie. 2009 Aug;88(8):513-22.

• Scheenstra RJ, Muller SH, Vincent A, Sinaasappel M, Zuur JK, Hilgers FJ. Endotracheal temperature and humidity measurements in laryngectomized patients: intra- and inter-patient variability. Medical & Biological Engineering & Computing. 2009 Jul;47(7):773-82.

• Zuur JK, Muller SH, Vincent A, Sinaasappel M, de Jongh FH, Hilgers FJ. Assessment of tracheal temperature and humidity in laryngectomized individuals and the influence of a heat and moisture exchanger on tracheal climate. Head & Neck. 2008 Aug;30(8):1072-1082.

• Hilgers FJ, Soolsma J, Ackerstaff AH, Balm FJ, Tan IB, van den Brekel MW. A thin tracheal silicone washer to solve periprosthetic leakage in laryngectomies: direct results and long-term clinical effects. Laryngoscope. 2008 Apr;118(4):640-5.

• Zuur JK, Muller SH, Sinaasappel M. Hart GA, Van Zandwijk N, Hilgers FJ. Influence of heat and moisture exchanger respiratory load on transcutaneous oxygenation in laryngectomized individuals: a randomized cross-over study. Head & Neck. 2007 Dec;29(12):1102-1110.

• Lorenz KJ, Ackerstaff AH, Hilgers FJM, Maier H. Hands-free speech after surgical voice rehabilitation with a Provox® voice prosthesis: experience with the Provox® Freehands™ HME tracheostoma valve system. European Archives of Otorhinolaryngology. 2007 Feb; 264(2):151-157.

• Hilgers, F. J. & Ackerstaff, A. H. Development and evaluation of a novel tracheostoma button and fixation system (Provox LaryButton and LaryClip adhesive) to facilitate hands-free tracheoesophageal speech. Acta Otolaryngologica. 2006 Dec;126(11):1218-1224.

• Hamade, R., Hewlett, N., & Scanlon, E. A quantitative and qualitative evaluation of an automatic occlusion device for tracheoesophageal speech: the Provox FreeHands HME. Clin Linguist Phon. 2006 Apr-May;20(2-3):187-93.

• Zuur JK, Muller SH, de Jongh FH, van Zandwijk N, Hilgers FJ: The physiological rationale of heat and moisture exchangers in post-laryngectomy pulmonary rehabilitation: a review. European Archives of Otorhinolaryngology. 2006 Jan;263(1):1-8.

• Tervonen H, Back L, Juvas A, Rasanen P, Makitie AA, Sintonen H, Roine RP, Vilkman E, Aaltonen LM: Automatic speaking valve in speech rehabilitation for laryngectomized patients. European Archives of Otorhinolaryngology. 2005 Oct;262(10):816-20.

• Op de Coul BM, Ackerstaff AH, van As-Brooks CJ, van den Hoogen FJ, Meeuwis CA, Manni JJ, Hilgers FJ. Compliance, quality of life and quantitative voice quality aspects of hands-free speech. Acta Otolaryngologica. 2005 Jun;125(6):629-37.

• Ackerstaff AH, Fuller D, Irvin M, Maccracken E, Gaziano J, Stachowiak L: Multicenter study assessing effects of heat and moisture exchanger use on respiratory symptoms and voice quality in laryngectomized individuals. Otolaryngology Head & Neck Surgery. 2003 Dec;129(6):705-12

• Hilgers FJ, Ackerstaff AH, Van As CJ, Balm AJ, Van den Brekel MW, Tan IB: Development and clinical assessment of a heat and moisture exchanger with a multi-magnet automatic tracheostoma valve (Provox FreeHands HME) for vocal and pulmonary rehabilitation after total laryngectomy. Acta Otolaryngologica. 2003 Jan;123(1):91-9

• van As CJ, Hilgers FJM, Koopmans-van Beinum FJ, Ackerstaff AH. The influence of stoma occlusion on aspects of alaryngeal speech. Acta Otolaryngologica. 1998 Sep;118(5):732-8.

The above references represent a selection. For more information contact Atos Medical AB or your local representative.

43

ContactBelow you will find our global addresses and contact information. Find your country and reach out to us. We are always here to help you!

Head Office/Manufacturer:Atos Medical AB Tel. +46 (0)415 198 00 [email protected] www.atosmedical.com

Australia:Atos Medical Pty Ltd Tel. +61 1800 286 728 [email protected] www.atosmedical.com.au

Belgium: Atos Medical BVBA / SPRL Tel. +32 (0)2 218 55 50 [email protected] www.atosmedical.be

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Canada:Atos Medical Canada Inc Tel. +1 833 514 2867 [email protected] www.atosmedical.ca

France:Atos Medical S.A.S. Tel. +33 (0)1 49 08 01 00 [email protected] www.atosmedical.fr

Germany:Atos Medical GmbH Tel. +49 (0)800 53 53 667 [email protected] www.atosmedical.de

Hungary:Atos Medical AB Magyarorszagi Tel. + 36 70 377 2414 www.atosmedical.com

Italy:Atos Medical Srl Tel. +39 049 775 522 [email protected] www.atosmedical.it

Japan: Atos Medical Japan Inc. Tel. +81 (0)3 4589 2830 [email protected] www.atosmedical.jp

The Netherlands: Atos Medical B.V. Tel. +31 (0)79 593 5000 [email protected] www.atosmedical.nl

New Zealand:Atos Medical Ltd Tel. +64 (0)4 576 2100 [email protected] www.atosmedical.co.nz

Nordic Countries:Tel. +46 (0)415-19820 [email protected] www.atosmedical.com

Poland:Atos Medical Poland Sp. z o.o Tel. +48 22 295 00 16 [email protected] www.atosmedical.com

Portugal:Atos Medical Spain S.L. Sucursal em Portugal Tel. +351 212 539 281 [email protected] www.atosmedical.pt

Spain:Atos Medical Spain S.L. Tel. +34 93 323 91 95 [email protected] www.atosmedical.es

Switzerland: Atos Medical, Switzerland Tel. +41 (0)44 380 60 90 [email protected] www.atosmedical.ch

UK:Atos Medical UK Tel. +44 (0)115 784 1899 [email protected] www.atosmedical.co.uk

US:Atos Medical Inc. Tel. +1 800 217 0025 [email protected] www.atosmedical.us

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When I got my first Provox voice prosthesis I could make myself heard again. It was an enormous relief. - Anna

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The Atos Medical Insurance and Reimbursement Team is committed to helping you navigate through the process to make it as smooth and easy as possible, getting the most from your benefits. We are also working to get in-network with more insurance companies which may mean easier access to products and better reimbursement options for you!

Forms and Insurance InformationAtos Medical Inc. will file claims for durable medical equipment (DME) orders upon request. For an insurance claim to be filed, the following needs to be completed and returned to our office:• Front and back copies of all insurance cards• Detailed Written Order/Prescription Form• Patient Insurance Information Form (PIIF)• Patient Service Agreement (PSA) and HIPAA Signature Form • MCF if ordering a voice prosthesis (Medicare Only)

The type of DME equipment ordered, laryngectomy supplies or jaw motion rehabilitation supplies, will determine which forms are to be completed.

Insurance forms are available at:www.atosmedical.us on the Resources tab

Patients with Medicare CoverageWhether you have Original or Traditional Medicare coverage, Atos Medical will submit a claim on your behalf to the provider (some restrictions may apply). For assigned items you will be required to pay 20% of the Medicare allowed amount (provided you have satisfied your Medicare Part B deductible for the year). Medicare will pay the remaining 80%. In order to take advantage of the Medicare rates, Medicare requires that we have a completed written physician order form prior to the shipment of your order. For non-assigned items, you will be responsible for payment in full at the time of order. Atos will file your claim, and Medicare will reimburse you based on their portion of the allowed amount.

Patients without Insurance or DME Coverage• Order online at www.shopatosmedical.com• Call 800.217.0025, option 2, to place an order• Pay by VISA, MasterCard, American Express, Discover, bank

draft, check or money order

Prescription ProductsProducts with Rx next to the name need a prescription from a physician or a non-physician eligible provider. The Rx must be on file with Atos Medical and have product specifically listed. Caution: USA Federal law restricts these products to sale by or on the order of a physician or a licensed SLP.

Payment - Terms of SaleNet 30 days, FOB. New Berlin, WI. Check, Money Order, bank draft from your account, Visa, MC, American Express and Discover are accepted. Products can be shipped COD (Cash on Delivery) for an additional fee + shipping charges. Insurance coverage, payment, co-payments, deductibles and some restrictions apply depending on the individual’s policy and medical need.

Returned Goods AuthorizationProduct must be returned in saleable condition, original packaging and contents may not be tampered with to receive credit and/or exchange. Atos Medical reserves the right to reject or refuse any returns/exchanges if we feel the packaging has been tampered with in any way. Any product in client’s possession longer than 90 days will not be considered for a return. Returns will not be accepted without prior authorization and an Atos Medical Inc return merchandise authorization (RMA) number. To obtain an RMA number, please call 800.217.0025. There is a 25% restocking fee on all returned merchandise. Shipping charges are nonrefundable. RMA numbers issued by Atos Medical Inc are good for 30 days only. The product must be received by Atos Medical Inc within that time. RMA numbers cannot be extended or re-issued. Atos Medical Inc highly recommends using a reputable shipping carrier capable of providing proof of delivery, as well as properly packaging and fully insuring my return shipment. Shipping charges and risk of loss on all return shipments are the responsibility of the client.

PrivacyAtos Medical has always respected the privacy of our clients. Like most health care providers, Atos Medical is subject to federal laws that protect the privacy of personal information related to medical services and products. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) requires that we provide a PSA/Notice of HIPAA Privacy Policy to you. This notice describes our legal duties and privacy practices related to your protected information. We are required to have a completed Patient Service Agreement (PSA) and HIPAA Signature Form on file.

Order Information (US only*)Orders may be placed online at www.shopatosmedical.comor contact a Customer Service Representative at 1.800.217.0025Contact UsOffice Hours: 8:00am-5:00pm Central Time (CT)Extended Customer Service Hours: 7:00am-5:30pm CT Mon-Thu and 7:00am-5:00pm CT Fri.

Address:Atos Medical Inc.2801 South Moorland RoadNew Berlin, WI 53151-3743

All Payments to:Atos Medical Inc.Dept CH 17589Palatine, IL 60055-7589

Telephone/Fax:1.800.217.0025, Option 11.800.217.0025, Option 9 (Spanish) 1.844.389.4918 (Fax)

Email:[email protected]

Please refer to atosmedical.ca for approved products.

*Order information herein applies to US clients only. For information on placing an order in Canada, please contact Atos Medical Canada Inc, Tel. +1 833 514 2867 or [email protected]

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Speaking hands-free means that I am able to hug my wife and say ‘I love you’ without having to use my hands. —Henry

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US Office: Atos Medical Inc., 2801 South Moorland Road, New Berlin, WI 53151-3743Tel. +1 800 217 0025, Fax. +1 844 389 4918Email: [email protected], Web: www.atosmedical.us, Online Ordering: www.shopatosmedical.com

Canadian Office:Atos Medical Canada Inc., 20 Simona Drive, Unit #5, Bolton, ON L7E 4K1Tel. +1 833 514 2867, Fax. +1 905 857 2868 Email: [email protected], Web: www.atosmedical.ca

At Atos Medical, we are committed to giving a voice to people who breathe through a stoma, with design solutions and technologies built on decades of experience and deep understanding of our users.

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Product Catalog 2019 - Atos Medical · 2019-04-10 · Atos Medical - Who we are At Atos Medical, we are committed to giving a voice to people who breathe through a stoma, with design