TRIOS BY 3SHAPE HOW TO PROVIDE 3SHAPE TRIOS INTRAORAL SCANS FOR THE PRODUCTION OF SOMNODENT DEVICE. KEY QUESTIONS: 1 How do I send my case?

HOW TO PROVIDE 3SHAPE TRIOS INTRAORAL SCANS FOR THE PRODUCTION OF SOMNODENT DEVICE. TRIOS BY 3SHAPE KEY QUESTIONS: 1 How do I send my case? Send TRIOS scan files to your local SomnoMed Laboratory via 3Shape Communicate TM Attach a.jpeg file of your fully completed SomnoDent Order Form within your TRIOS order via 3shape Communicate TM Note: Please refer to Section A. Step 4 - Sending a SomnoDent Order Form with your Scan on how to attach the form. 2 How do I connect to SomnoMed in US and Canada via 3Shape Communicate? Go to your Connections tab in 3Shape click Add Connection and search for SomnoMed North America for Canadian customers and SomnoMed for US customers via our email username: eordersusa@somnomed.com and in Canada, eorderscanada@somnomed.com Click Find and in Results click on our lab SomnoMed North America or SomnoMed and click Connect SomnoMed US or SomnoMed Canada will receive a request for connection and once confirmed we are ready to exchange files. Note: Any problems you may contact our Operations leaders, Eric Cole in the US at ecole@somnomed.com or Kevin Prevett in Canada at kprevett@somnomed.com 3 What file type do I send? Your 3Shape TRIOS system will generate scan files in a 3shape format that we accept.. SomnoMed IOS User Guide 903398RevA Copyright 2018 SomnoMed Inc. 1

KEY QUESTIONS CONTINUED: 4 How many shots are ideal when taking TRIOS scans? Single full arch scan is ideally around 1500 shots Upper and Lower scans combined ideally around 3000 shots. Note: You will experience slow transfer speeds when you scan images greater than above number of shots. 5 How do scan a protrusive bite record? Please see Section A: Step 1. SOMGauge Protrusive Bite Recording then Step 2. d) Protrusive Bite Scanning 6 What must my intra-oral scan include? Please refer to Section B - What must my scan include? and IOS Checklist for details 7 When do I calibrate 3Shape TRIOS? At least once a week and turn your TRIOS scanning system on 10 minutes prior to use. Colour calibration is not necessary for SomnoDent cases. SOMNODENT AIR SOMNODENT FUSION SOMNODENT HERBST ADVANCE Copyright 2018 SomnoMed Inc. 2

TABLE OF CONTENTS 04 SECTION A: SCANNING WORKFLOW FOR 3 SHAPE TRIOS 05 STEP 1: SOMGauge Protrusive Bite Recording 11 STEP 2: Taking TRIOS Digital Impressions 11 a Create Orders 13 b Lower Arch Scanning 16 c Upper Arch Scanning 18 d Protrusive Bite scanning 17 STEP 3: Check TRIOS scans 21 STEP 4: Sending a SomnoDent Order Form with your Scan 21 a Downloading & Converting file to JPEG 25 b Attaching JPEG to your scan 26 STEP 5: Send your scan file via 3shape Communicate 27 STEP 6: Communication with SomnoMed Lab 27 Tips for Obtaining a Good Scan 28 SECTION B: WHAT MUST MY SCAN INCLUDE? 29 SECTION C: EXAMPLES OF ACCEPTABLE & UNACCEPTABLE SCANS 44 SECTION D: IOS CHECKLIST FOR SOMNODENT ORDERS Copyright 2018 SomnoMed Inc. 3

SECTION A: SCANNING WORKFLOW FOR 3 SHAPE TRIOS STEP 1 SOMGauge Protrusive Bite Recording STEP 2 Taking TRIOS Digital Impressions a Create orders b Lower arch scanning c Upper arch scanning d Protrusive Bite scanning STEP 3 Check 3Shape TRIOS scans STEP 4 Sending a SomnoDent Order Form with your Scan a Converting file to JPEG b Attaching JPEG to your scan STEP 5 Send your scan file via 3shape Communicate STEP 6 Communication with SomnoMed Lab 3SHAPE TRIOS PREPARATION Turn on the cart or PC in advance to allow the system to heat up. Allow the system to warm up for about 10 minutes prior to use. Make sure the scanner tip is warm to avoid condensation on the mirror. Copyright 2018 SomnoMed Inc. 4

STEP 1 SOMGAUGE PROTRUSIVE BITE RECORDING! IMPORTANT TO NOTE! A desirable an protrusive bite record is the most important process to ensuring a successful scan and as such accurate SomnoDent device. An optimum bite record maximises patient comfort, increase compliance and reduce chair-time. SomnoMed recommends use of the SOMGauge for accurate and repeatable bite registration scanning within the digital workflow. The SOMGauge allows precise measurement of protrusion at the same time as providing stable control of occlusal vertical opening (OVD) during recording. This is particularly useful on a patient with a heavy curve of spee, over-erupted teeth and/or anterior bite opening. As such the SOMGauge has been designed to visually guide clinicians during bite recording to ensure a minimum 3.0mm of inter-occlusal space is maintained across the arch. This 3.0mm interocclusal space is the minimum dimension required at the two closest opposing teeth thereby ensuring SomnoMed can manufacture a SomnoDent appliance without needing any adjustment to OVD during manufacturing.! If you are not using SomGauge: Please be aware that SomnoMed technicians require 3mm clearance between the narrowest points of contact of the two closest opposing teeth across the occlusal scheme. If you are using another bite registration technique and there is less than 3mm clearance between two closest opposing teeth SomnoMed will contact you to open the bite. As we need to accommodate the manufacture of the SomnoDent. If we do open the vertical dimension we can use an Acculiner should you request this. Copyright 2018 SomnoMed Inc. 5

Taking a protrusive bite record Please refer to our educational video on using SOMGauge at youtu.be/t1yn0fvs5ee 3.0mm Ensure fork covers some portion of last tooth. Covering some portion of last tooth ensures adequate (3.0mm) inter-occlusal clearance maintained for SomnoDent fabrication. If a distal wrap of last tooth requested a complete coverage of last tooth by fork must be present. Complete coverage of last tooth by fork Copyright 2018 SomnoMed Inc. 6

Taking a protrusive bite record CONTINUED... Inadequate coverage of last tooth by fork for a distal wrap case. If distal wrap ordered and inadequate coverage of last tooth by fork present the result can be an undesirable opening on virtual articulator leading to posterior premature contacts between splints requiring chairside adjustments. Once bite record is complete trim excessive bite registration material from fork. The fork and material should be trimmed maximally as the role now of the registration is to support the lower jaw whilst occlusion scanning takes place. Trimming excess material facilitates unobstructed direct line of sight from TRIOS camera to teeth thereby achieving fast occlusion scanning and reduced reading errors. A Remove the bite fork from the SOMGauge Registration material BEFORE trimming B Separate front part of fork from adjustable ramp. By removing front part of fork the operator may now freely access both left and right hand side of arch for protrusive scanning. Copyright 2018 SomnoMed Inc. 7

Taking a protrusive bite record CONTINUED... C Maximally trim all unnecesary bite material using a sharp scalpel. Unnecessary bite material is any material obscuring the buccal surfaces of the patient s clinical crowns. Where possible, expose the clear fork which will assist faster TRIOS protrusion scanning as camera cannot see the clear material. D Place fork in patient s mouth to check all buccal aspects of teeth are unobscured. Registration material AFTER trimming SomnoMed IOS User Guide 903398RevA Copyright 2018 SomnoMed Inc. 9

Taking a protrusive bite record CONTINUED...! TIP! If you cannot see all buccal aspects TRIOS may not be able to automatically capture desired position. If this occurs you may need to perform a manual alignment of occlusion after scanning. Obscured dentition and undesirable. Unobscured dentition and fast automatic scanning Copyright 2018 SomnoMed Inc. 10

STEP 2 TAKING TRIOS DIGITAL IMPRESSIONS A Create Orders Enter Patient Details. Please enter ALL fields to ensure your case integrity throughout manufacturing. Note: First and Last name mandatory for SomnoDent orders. Choose Lab: SomnoMed US SomnoMed North America Canada Note: You must have connected to SomnoMed or SomnoMed North America via 3Shape Communicate previously using your Connections tab; please see front page of this document. Copyright 2018 SomnoMed Inc. 11

Select Study model and attach JPEG file of Order Form in Images Note: Please refer to Section A: Step 4 - Sending SomnoDent Order Form with your Scan. Now you are ready to scan. Press TRIOS icon circled below to begin scanning SomnoMed IOS User Guide 903398RevA Copyright 2018 SomnoMed Inc. 12

B Lower Arch Scanning Place scanner tip (mirror) facing down in order to scan lower arch. Keep patient s mouth dry (saliva control). Locate scanner tip adjacent to patient s first molar (e.g. tooth 36 or 46). Turn scanner on camera by pressing scanner switch. Once scanning, maintain a steady speed following the scanning strategy below. 4... and go through buccal/labial side. Lower 1 Scanning start point: Lower 2 When anterior region reached, wave scanner throughout anterior region. Copyright 2018 SomnoMed Inc. 13

Inspect your scans checking they meet SomnoMed s most current requirements. See Section B What must my scan include? Section C: Acceptable and Unacceptable Scans! TIP! Saliva control is important to achieving an accurate scan. Excess saliva may cause undesirable reflections. The mouth should be dried using air before scanning. It may be necessary to redry themouth throughout scanning. Rescan the area after trimming off and drying teeth. Undesirable saliva reflection visible at 46 and 47. Rescan area to resolve. Copyright 2018 SomnoMed Inc. 14

Check your scan. Remove any unnecessary noise from scan (e.g. lips, tongue, cheeks) using Trim tool Undesirable noise in scan images can reduce scan accuracy and undesirably increase file sizes. Remove noise in images using Trim tool within TRIOS prior to sending cases to SomnoMed. Before using Trim tool After using Trim tool Copyright 2018 SomnoMed Inc. 15

C Lower Arch Scanning Place scanner tip (mirror) facing up. Keep patient s mouth dry (saliva control). Locate scanner tip adjacent to patient s first molar (e.g. tooth 16 or 26). Turn scanner on camera by pressing scanner switch. Once scanning, maintain a steady speed following the scanning strategy below. 1 Scanning start point : Upper 2 Having reached anterior region, wave scanner palatal to labial throughout anterior region. 3 For Edentulous cases, scan all palatal areas. Refer to Appendix D 4 and go through palatal side for upper Copyright 2018 SomnoMed Inc. 16

Inspect your scans against SomnoMed s most current requirements! Note: See Section B: What must my scan include? & Section C: Acceptable and Unacceptable Scans! Important note for clinicians using AccuLiner mounting: Your Scan must include incisive papilla and hamular notches in order to digitally mount upper model to HIP plane. Must include incisive papilla and hamular notches Copyright 2018 SomnoMed Inc. 17

D Lower Arch Scanning Place prepared bite record in patient s mouth. Ask patient to gently bite and steadily hold fork between teeth to limit movement whilst scanning. Place scanner tip (mirror) facing down for scanning protrusive bite. Insert scanner tip to patient s upper right buccal posterior region. Follow below recommended scan strategy for occlusion scan. Copyright 2018 SomnoMed Inc. 18

STEP 3 CHECK TRIOS SCANS Check your protrusive scan meets SomnoMed s minumum occlusal Vertical Dimension (OVD) requirement.! TIP! The minimun OVD check ensures an accurate first time fit minimising posterior premature contacts at issue and mazinmising patient comfort. You can check distance between upper and lower teeth using Clearance Tool in color map. 3.0 mm minimum is required between two closest opposing teeth in arch. Copyright 2018 SomnoMed Inc. 20

SENDING A SOMNODENT ORDER FORM WITH YOUR SCAN STEP 4 A Downloading SomnoDent Order Form and converting to a JPEG format 1 Download an Electronic SomnoDent Order Form from our website https://somnomed.com/en/orderform/! TIP! Completing SomnoDent Order Forms online ensures most current instructions are received and reduces errors understanding handwritten notes. 2 Save your SomnoDent Lab (will be a.pdf file) to your Desktop for now and future orders Copyright 2018 SomnoMed Inc. 21

7 Click and Drag to perimeter of Order Form 8 Order Form will open within Snipping Tool application. 9 Select Save As and rename file to the Patient s name. Note the location where your file is saved. Copyright 2018 SomnoMed Inc. 23

B Attaching JPEG file of SomnoDent Order form to TRIOS scan 1 Select Images tab 2 Select Add Image - A Windows Explorer window will open 3 Locate SomnoDent Order Form.JPEG file select it and click Open in window 4 Your Image SomnoDent Order form.jpeg file will appear 5 Return to scan and you are ready to send your files to SomnoMed Copyright 2018 SomnoMed Inc. 25

STEP 5 SEND YOUR SCAN FILE VIA 3SHAPE COMMUNICATE Step 1 Press the Send button (1) Step 2 Press the Send order button (2) 1 Note: Please attach a JPEG file of SomnoMed Order Form* including all fabrication instructions and Return Date within your scan order. PLEASE REFER TO: SECTION A : Step 4 - Sending a Order Form with 2 your Scan.! TIP! It is recommended to perform post-processing within the analyzing step and check result is acceptable.! TIP! You can always return to the order and send it later. You can also re-send a changed order. ATTENTION: SomnoMed cannot process your order without a fully completed SomnoDent Order Form even if you get an approved message of the scan via 3shape Communicate TM. Copyright 2018 SomnoMed Inc. 26

STEP 6 COMMUNICATION WITH SOMNOMED Please do not hesitate to contact your local SomnoMed customer service regarding your order. System messages are automatically generated by TRIOS to inform you about the order status. For example, you are notified if the order has not been accepted by SomnoMed Lab within 18 hours. You also receive a message when SomnoMed approves your order.! Tips to Obtaining a Good Scan 1 Dry teeth lightly using compressed air. Be sure to reach the narrow regions between teeth. Consider using a saliva ejector and/or gauze pads. 2 Get a good start: Start at patient s right 1st molar. Wait for about 5 scanner clicks before proceeding (helps build up a good starting point). Complete preparation including preparation line. Scan neighbouring teeth: Occlusion, lingual/palatial side, buccal/labial side. 3 Keep scanner head at 0-5mm from teeth, it is OK to touch the teeth occasionally. 4 Move scanner slowly and smoothly, you should hear a more rapid clicking sound Copyright 2018 SomnoMed Inc. 27

5 Keep lips, cheeks, and tongue out of the scanner s view: Use your finger or a dental mirror to create space between the teeth, lips and cheeks. Use a lip-and-cheek-retractor to keep lips and cheeks away. Be careful not to scan your own or assistant s fingers. If you get lips, cheeks or tongue in the scan, make sure to delete it all, especially where they have contact with the teeth (no surfaces should stick out from the teeth). 6 Keep focus on: Option 1 - Look at the teeth while scanning and listen to the clicks. If it stops clicking/capturing, carefully move back to the area marked on the screen. Option 2 - Look at the 2D image at the lower right corner. What you see here is what you scan. Avoid lips, cheeks and the tongue to get an easy scan. 7 When scanning is complete, inspect the result by rotating the scan. 8 The important areas are: Occlusal surfaces. Contact points. Soft tissue near gingiva margins (avoid interference from gingiva, saliva, blood). If an important area is missing, simply touch or click the area on the model on screen, and re-start scanning from this point. 9 Bite Scan: Start from the upper second molar. While centring the 2D image on occlusion plane, slowly move the scanner tip in straight mesial direction with equal coverage of the upper and lower teeth. Scan at least 4 teeth for optimal alignment. This should take no more than 5 seconds. 9 Important to achieving good colours: Avoid the light from the dentist chair lamp pointing directly into the patient s mouth. Copyright 2018 SomnoMed Inc. 28

SECTION B: WHAT MUST MY SCAN INCLUDE? (SEE PICTURE EXAMPLES IN SECTION C AND IOS CHECKLIST) ORDER FORM A Fully Completed SomnoDent Order Form with Patient and Product Details SCAN QUALITY B No large holes (>0.5mm diameter) within scanned file mesh Note: Some small holes (<0.5mm diameter) are normal and acceptable C Fully Completed SomnoDent Order Form with Patient and Product Details Note: that scans which include unnecessary details may have reduced accuracy in these areas EXTENSIONS D Coverage of all teeth including some portion of last teeth E Soft tissue to 5.0mm beyond gingival margin at all lingual and palatal surfaces F Teeth and soft tissue to 2.0mm beyond gingival margin at facial surfaces of anteriors and premolars OCCLUSION G Protrusive registration we recommend using a SOMGauge set at 60-80% of maximum protrusion Note: Should dentist require otherwise please indicate on Order Form H Minimum of 3.0mm clearance between two closest teeth in opposing arches Note: Using SOMGauge will ensure accuracy with clearance. Include distal of last molars if Distal Wrap is requested EXTENSIONS I Distal Wrap - soft tissue to 5mm beyond gingival margin for buccal of molars J Breathing Hole - Minimum of 5mm clearance between two closest opening anteriors K Dentitrac Compliance Recorder - Extension of 7mm in lower posterior regions on left side L Edentulous - Coverage of entirety of palate M AccuLiner Articulator - Coverage of hamular notches and incisive papilla Copyright 2018 SomnoMed Inc. 28

SECTION C: EXAMPLES OF ACCEPTABLE SCANS SCAN QUALITY ACCEPTABLE: Maxilla Perfect Very few small data holes (<0.5mm diameter) Enough soft tissue all around No noise in scan data Copyright 2018 SomnoMed Inc. 29

Scan Quality ACCEPTABLE: Mandible Good No data holes Enough soft tissue all around Little noise in anterior might be limited powder Little noise at terminal molar might be moving tongue Cheek or cotton roll in anterior should be avoided if possible Overall, quality is good but not perfect. A SomnoDent can be manufactured successfully using this scan. Not ideal Not ideal Not ideal Copyright 2018 SomnoMed Inc. 30

Scan Quality ACCEPTABLE B No large holes (>0.5 mm diameter) within scanned file mesh. Some small holes (<0.5 mm diameter) are normal and acceptable C No unnecessary details (e.g. lips, tongue, cheeks) may have reduced accuracy in these areas. Copyright 2018 SomnoMed Inc. 31

Scan Quality UNACCEPTABLE Holes on posterior teeth and soft tissue B No large holes (>0.5 mm diameter) within scanned file mesh. Some small holes (<0.5 mm diameter) are normal and acceptable C No unnecessary details (e.g. lips, tongue, cheeks) may have reduced accuracy in these areas. Unacceptably large hole UNACCEPTABLE All areas on scan must be white no red or black (3M only) Copyright 2018 SomnoMed Inc. 32

Scan Quality NOT IDEAL Rough regions due to repaired holes in mesh may lead to poor fits and appliance rocking. B No large holes (>0.5 mm diameter) within scanned file mesh. Some small holes (<0.5 mm diameter) are normal and acceptable C No unnecessary details (e.g. lips, tongue, cheeks) may have reduced accuracy in these areas. NOT IDEAL Cheeks included in scan reduced overall accuracy in those areas Copyright 2018 SomnoMed Inc. 33

EXTENSIONS SUFFICIENT SOFT TISSUE EXTENSION AN EXAMPLE OF SOMNODENT FLEX IN-SITU Sufficient soft tissue extension ensures SomnoDent design can maximize patient comfort. ACCEPTABLE E Teeth and soft tissue to 5.0mm beyond gingival margin at all lingual surfaces and buccal of molars 5.0mm 5.0mm 2.0mm F Teeth and soft tissue to 2.0mm beyond gingival margin at facial surfaces of anteriors and premolars 5.0mm Include hamular notches if models need to be mounted on AccuLiner Copyright 2018 SomnoMed Inc. 34

Extensions UNACCEPTABLE Missing screw/lug housing region E Teeth and soft tissue to 5.0mm beyond gingival margin at all lingual surfaces and buccal of molars F Teeth and soft tissue to 2.0mm beyond gingival margin at facial surfaces of anteriors and premolars UNACCEPTABLE Missing soft tissue Inadequate extension beyond gingival margin Copyright 2018 SomnoMed Inc. 35

Extensions UNACCEPTABLE Missing upper left posterior region E Teeth and soft tissue to 5.0mm beyond gingival margin at all lingual surfaces and buccal of molars F Teeth and soft tissue to 2.0mm beyond gingival margin at facial surfaces of anteriors and premolars 5.0mm Copyright 2018 SomnoMed Inc. 36

OCCLUSION To ensure future scans are also successful: Lateral scans ideally should scan more soft tissue Lateral scans ideally should not include canines (due to curvature of jaw) ACCEPTABLE: Alignment Successful Not ideal Copyright 2018 SomnoMed Inc. 37

Occlusion ACCEPTABLE H Minimum of 3.0mm clearance between two closest teeth in opposing arches. (include distal of last molars if Distal Wrap requested) 3.0mm UNACCEPTABLE Too closed (teeth in contact) Copyright 2018 SomnoMed Inc. 38

Occlusion NOT IDEAL Too open (unless specifically requested) H Minimum of 3.0mm clearance between two closest teeth in opposing arches. (include distal of last molars if Distal Wrap requested) 10.1mm ACCEPTABLE G Protrusive registration set at 60-80% of maximum protrusion 60 80% Copyright 2018 SomnoMed Inc. 39

DENTITRAC REQUIREMENTS Note: If requesting Compliance Recorder we require >7mm soft tissue extension beyond gingival margin at lower buccal. 7.0mm ANTERIOR OPENING REQUIREMENTS Note: If requesting Anterior Opening we require a minimum 5.0mm opening between anterior teeth. 5.0mm Copyright 2018 SomnoMed Inc. 41

SUFFICIENT SOFT TISSUE EXTENSION Sufficient palatal soft tissue extension ensures SomnoMed can fabricate an appliance that is minimal in dimension and as comfortable as possible Note: If requesting Compliance Recorder we require >7mm soft tissue extension beyond gingival margin at lower buccal. Copyright 2018 SomnoMed Inc. 42

IOS CHECKLIST FOR SOMNODENT 1 ORDER FORM A Fully completed order form with Patient and Product Details 2 SCAN QUALITY B No large holes (>0.5mm diameter) within scanned file mesh C No unnecessary details (e.g. lips, tongue, cheeks) 3 EXTENSIONS D Coverage of all teeth including some portion of last teeth E Soft tissue to 5.0mm beyond gingival margin for all lingual and palatal surfaces F Soft tissue to 2.0mm beyond gingival margin for all facial surfaces of anteriors and premolars G IMAGE UPPER LOWER IMAGE UPPER LOWER IMAGE UPPER LOWER 2.0mm Teeth and soft tissue extensions required to accommodate coupling mechanism of appliance ordered Copyright 2018 SomnoMed Inc. 44

4 OCCLUSION IMAGE UPPER LOWER H Protrusive registration set at 60-80% of maximum protrusion OR Order form states reason for protrusion 60-80% protrusion I Minimum of 3.0mm clearance between two closest teeth in opposing arches (excluding distal of last present teeth) 3.0mm 5 OPTIONAL FEATURES IMAGE UPPER LOWER J Distal Wrap Soft tissue to 5.0mm beyond gingival margin for buccal of molars K Distal Wrap Minimum of 3.0mm clearance between two closest teeth in opposing arches (including distal of last present teeth) 3.0mm 3.0mm L Anterior Opening Minimum of 5.0mm clearance between two closest opposing anteriors 5.0mm M Compliance Recorder Extension of 7.0mm in lower posterior regions on left side N/A N Edentulous Coverage of entirety of palette N/A O AccuLiner Articulator Coverage of hamular notches and incisive papilla Copyright 2018 SomnoMed Inc. 45