Whole You Sleep Appliances Product Guide

Whole You is a healthcare brand.

We want to help people with sensory and physical mobility challenges enjoy their life to the fullest through revolutionary healthcare solutions.

Together, we will redefine health as the ability to enjoy life to the fullest, revolutionizing what human health looks, sounds, and feels like.

w w w. w h o l e y o u . c o m

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INTRODUCING

Whole You Sleep Appliances Whole You offers sleep apnea patients an alternative to the CPAP machine.

Our sleep appliances provide a more personalized and less intrusive treatment to specifically fit each patient so that they can enjoy better sleep with more freedom.

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Sleep Appliances Product Line Recommended Appliances by Patient’s Condition

BLUE Patient’s Condition

Needs freedom to open/close mouth

Larger tongue

Bruxism/TMD sufferer

Larger tongue & bruxism/TMD sufferer

Suggested function for appliance

p.05

PINK

p.07

p.09

p.11

p.13

A dual-block device, allows mouth to open/close more freely

Increased tongue space

Accommodates clenching & grinding

Increased tongue space and accommodates clenching & grinding

Smaller mouth

Shorter adjustment arms for compatibility

Smaller mouth & bruxism/TMD sufferer

Shorter adjustment arms for compatibility and accommodates clenching & grinding

Medicare Approved Highly recommended: The appliance is specially made for this patient type.

Recommended: The appliance is appropriate for this patient type if a highly recommended device is not used.

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INTRODUCING the appliances that address the issues associated with tongue space of your patients Known Issues of OSA Patients 1. Many OSA patients have an enlarged tongue, which is an indicator in identifying potential signs of OSA. 2. Narrow arches are often found in OSA patients.

Intraoral Check-list for Obstructive Sleep Apnea (OSA)

Narrow arches are often found in OSA patients

Our Solutions Whole You Sleep Appliance Respire EF 1. The alloy framework creates a thinner appliance to reduce lingual coverage for maximum tongue space.

2. No acrylic in the anterior allows for an increased opening, which naturally moves the tongue forward.

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Respire Blue EF+

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Blue

Breakthrough Design for Increased Comfort

Reduced Lingual Coverage for Maximum Tongue Space

Reduced Coverage of Anterior Teeth

4-Wing Design for Additional Support

Respire Blue EF+ Details • • • •

6 mm maximum advancement Mesh support system for durability Option to add elastic hooks and/or anterior discluding ramp 1-year manufacturer’s warranty 8

Respire Blue+

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Blue

Ergonomically Designed: Allows Vertical Movement while Comfortable to Wear

4-Wing Design for Additional Support

Mesh Support System for Durability

Respire Blue+ Details • • • • •

6 mm maximum advancement Available in hard or hard/soft-fitting surface Option to add elastic hooks and/or anterior discluding ramp Option for reduced lingual coverage 1-year manufacturer’s warranty

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Respire Pink

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Pink

Suitable Design for Patients with Bruxism at Night

Telescopic Hardware for Increased Lateral Movement

Medicare Approved

Respire Pink Details • • • • • •

5 mm maximum advancement Available in hard and hard/soft-fitting surface Option to add elastic hooks and anterior discluding ramp Option for reduced lingual coverage 1-year manufacturer’s warranty 2-Day Rush Service Available 10

Respire Pink EF

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Extra Wearing Comfort for Patients with Bruxism or Larger Tongues

Pink

Telescopic Hardware for Increased Lateral Movement

Endurance Framework for Increased Tongue Space

Reduced Coverage For Anterior Teeth

Respire Pink EF Details • • • •

5 mm maximum advancement Option to add elastic hooks and anterior discluding ramp 1-year manufacturer’s warranty Medicare Approved

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Respire Pink Micro

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Compact Design Suitable for Patients with Smaller Mouths

Pink

Telescopic Hardware for Increased Lateral Movement

Shorter Adjustment Arm

Respire Pink Micro Details •

• • • • • •

6 mm maximum advancement with an extra anterior fixing element Available in hard and hard/soft-fitting surface Option to add elastic hooks and anterior discluding ramp Option for reduced lingual coverage 1-year manufacturer’s warranty Medicare Approved 2-Day Rush Service Available 14

Insertion and Titration Whole You Sleep Appliance Respire Blue+ / Respire Blue EF+ INSERTION It is recommended to insert the upper component first then the lower. To remove, take out the lower component then the upper. Some devices may have different paths of insertion, so some may be best inserted anterior first (front side) then posterior (back side).

TITRATION

Adjustment Screw

Insert the adjustment key into the hole of screw. Turn in the direction of the arrow.

One (1/4) turn is equal to 0.2 mm.

Two (2) types of fitting surfaces of Blue+ 1. Hard/Soft Device - Dual laminate layer that provides a soft layer on the tooth surface.

Note: If device needs trimming, please use heat resistant bur (green strip) or blue rubber wheel bur.

Chrome Framework

2. Hard Device - All acrylic and retained with ball clasps; allows device to be tightened if it becomes loose. Note: If device needs trimming, regular acrylic burs work fine.

One (1) type of fitting surfaces of Blue EF+ Hard EF Device - The EF is retained with “C” clasps. The tip of the clasp can be curved towards the tooth for extra relief.

Adjustment Screw

Adjusting the chrome framework When adjusting the chrome material it is recommended that a heat resistant bur is used for minor adjustments. For major adjustment thedevice may have to be remade. Please contact Respire for more details.

Adjustment (mm) 0.2 0.4 0.6 0.8 1.0 1.2 1.4 1.6 1.8 2.0 2.2 2.4 2.6 2.8 3.0 3.2 3.4 3.6 3.8 4.0 4.2 4.4 4.6 4.8 5.0 5.2 5.4 5.6 5.8 6.0 Turns (90 degree) 1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

29

30

Whole You Sleep Appliance Respire Pink+ / Respire Pink EF+ INSERTION

Adjustment Key

It is recommended that you hold the upper and lower components together Place the upper component over the teeth, have patient press over the lower teeth. Do not bite into place. Some devices may have different paths of insertion, so some may be best inserted anterior first (front side) then posterior (back side).

TITRATION Insert the adjustment key into the rear of the hinge attached to the appliance to adjust the mandibular advancement. Turning counterclockwise once extends the length by 1/4 mm. Turning 4 times extends by 1mm. The maximum advancement is 7 mm. *Do not exceed the length of 7mm

Two (2) types of fitting surfaces of Pink+ 1. Hard/Soft Device - Dual laminate layer that provides a soft layer on the tooth surface. Note: If device needs trimming, please use heat resistant bur (green strip) or blue rubber wheel bur.

Adjustment Key

2. Hard Device - All acrylic and retained with ball clasps; allows device to be tightened if it becomes loose. Note: If device needs trimming, regular acrylic burs work fine.

One (1) type of fitting surfaces of Pink EF+ Hard EF Device - The EF is retained with “C” clasps. The tip of the clasp can be curved towards the tooth for extra relief.

Chrome Framework

Adjusting the chrome framework When adjusting the chrome material it is recommended that a heat resistant bur is used for minor adjustments. For major adjustment thedevice may have to be remade. Please contact Respire for more details.

Adjustment (mm) 0.25 Turns

1

1

1.5

2

2.5

3

3.5

4

4.5

5

5.5

6

6.5

7

4

6

8

10

12

14

16

18

20

22

24

26

28

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Whole You Sleep Appliance Respire Pink Micro Respire Pink EF Micro (Herbst)

Respire Pink Micro

INSERTION It is recommended to insert the upper component firs then the lower. To remove, take out the lower component then the upper. Some devices may have different paths of insertion, so some may be best inserted anterior first (Front side) then posterior (Back side).

TITRATION To titrate the device, place wrench into hole. Turn in the direction of the plus (+) sign. A 90 degree (quarter) turn is equal to 0.0625mm. One full circle turn is equal to 0.25mm, and 4 full circle turns is equal to 1mm.

Anterior Fixinf Element

Maximum protrusion is 5mm = 20 full circle turns around.Do not titrate over 5mm.

Respire Pink EF Micro

Fitting surfaces for the Respire Pink EF Micro The EF is retained with “C” clasps. The tip of the clasp can be curved toward the tooth for extra relief.

When adjusting the chrome material it is recommended that a heat resistant bur is used for minor adjustments. For major adjustment the device may have to be remade. Please contact Respire for more details.

MICRO TITRATION The micro arm will advance up to 3mm. For further titration once fully advanced, unscrew the fixing element on the upper device using the allen wrench.

Then turn the adjustable component on the herbst arm back to the starting point (zero turns). Then, using the allen wrench, connect the herbst arm to the anterior fixing element on the upper device. A further 3mm of advancement can be made from this point. *After adjusting, lock with locking nut.

Anterior Fixinf Element

Micro Screw Change

Adjustment (mm) 0.0625

0.25

0.5

1.0

1.5

2.0

2.5

3.0

3.5

4.0

4.5

5.0

5.5

6.0

Turns (90 degree) 1

4

8

16

24

32

40

48

8

16

24

32

40

48

DENTITRAC® COMPLIANCE CHIP Compliance Chip Option with DentiTrac Micro-Recorder available to be embedded into the Whole You Sleep Appliance* to measure patient compliance to oral appliance therapy Easy data extraction: Patient compliance data is easily extracted with DentiTrac Base Station from the micro-recorder and uploaded to the cloud for tracking and reporting.

Accessible from anywhere: Patient improvement can be watched over time using cloud services where you can access to patient compliance data records from anywhere.

Accuracy without compromise: Accurate wearing times can be determined measuring a wide range of metrics, from temperature to three dimensional rotation. *Available in Respire Pink Series

The Base Station must be purchased separately and clinicians should contact Braebon to activate the micro-recorder.

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2-DAY Rush Service

   

2-DAY RUSH SERVICE

Express service now available for those must-have cases* Send a case to us and we will have it back to your office just in 48 hours** Contact us to discuss pricing Now available in 2 models

Respire Pink

Respire Pink Micro

How It Works...

(Example) SUNDAY MONDAY

1. Take your patient’s impressions and overnight the case to us.

TUESDAY

2. We fabricate the appliance.

WEDNESDAY

3. You receive the completed device by 10:30am!

THURSDAY FRIDAY SATURDAY

* This service applies to US domestic shipping only. **Confirmation by Respire Medical is required before placing any Rush Service order.

To reduce manufacturing time, we ask that only PVS style impressions be sent.

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INTRODUCING

Whole You Daytime Appliance Daytime Appliances help treat sleep apnea patients who experience Temporomandibular Joint Disorder (TMD) symptoms during the day.

The devices work by repositioning the jaw throughout the day to decrease clicking and decompress painful nerves.

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Daytime Appliance Product Line

Gelb Splint Design A popular design, the Gelb splint covers the posterior teeth, creating more space for the tongue to rest in the mouth.

Lingual Coverage Design Similar to the Gelb Splint, the Lingual Coverage Design protects the lingual anterior teeth to avoid super eruption.

Full Coverage Design The Full Coverage Design covers all of the occlusal surface of the teeth to give a more balanced bite.

Designs can be customized.

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Manufacturer of Whole You Appliances

Respire was formed in March 2010 with a business model of providing a range of top quality, functional devices to make sleep apnea treatment available to more people than ever before.

Following the initial years of growth the company has never been in a better position to capitalize on the opportunities in the market. Respire has built a solid operational foundation and has a strong management team to create products and services that drive growth in the marketplace.

Respire was acquired by Whole You, Inc., a Mitsui Chemicals Company in 2015. Whole You brings a wealth of resources and knowledge to help drive us forward in the next phase of our growth.

This new partnership will help provide you with industry leading products and services over the coming years as we continue to build our relationship with you.

David Walton CEO & Co-founder of Respire Medical

18 Bridge Street, Suite 4J Brooklyn, NY 11201 Phone 718-643-7326 Fax 718-643-7322 25

FDA 510(k) Number Respire Blue+*: K111207 Respire Blue EF+*: K152292 Respire Pink+ / Pink Micro**: K131138 Respire Pink EF+ / Pink EF Micro**: K150572 Respire Pink Series with DentiTrac®: K170692 *Respire Blue+ and Respire Blue EF+ are design changes of Respire Blue and Respire Blue EF, which do not require a separate 510(k) submission. **Respire Pink+, Respire Pink Micro, Respire Pink EF+, and Pink EF Micro are design changes of Respire Pink and Respire Pink EF, which do not require a separate 510(k) submission.

“Respire Blue+”, “Respire Blue EF+”, “Respire Pink+”, “Respire Pink EF+”, “Respire Pink Micro”, and “Respire Pink EF Micro” are the trademarks of Respire Medical.

www.wholeyou.com Toll free 1-844-548-3385 Manufactured by Respire Medical 18 Bridge Street, Suite 4J Brooklyn, NY 11201 Phone 718-643-7326 Fax 718-643-7322 WYR-021-1 Rev. 1 10/2017