FCC ID: 2BAUV-OCCLUSENSE WiFi Module

Regulatory Compliance Information Occlusense Regulatory Compliance Information Regulatory Compliance Information This document covers the Regulatory Compliance information which will be part of the Occlusense Module datasheet and related documents shared with customers. 1 Regulatory Compliance Information 2.1 United States The Occlusense module has received Federal Communications Commission (FCC) CFR47 Telecommunications, Part 15 Subpart C Intentional Radiators single-modular approval in accordance with Part 15.212 Modular Transmitter approval. Single modular transmitter approval is defined as a complete RF transmission sub-assembly, designed to be incorporated into another device, that must demonstrate compliance with FCC rules and policies independent of any host. A transmitter with a modular grant can be installed in different end-use products (referred to as a host, host product, or host device) by the grantee or other equipment manufacturer, then the host product may not require additional testing or equipment authorization for the transmitter function provided by that specific module or limited module device. The user must comply with all of the instructions provided by the Grantee, which indicate installation and/or operating conditions necessary for compliance. A host product itself is required to comply with all other applicable FCC equipment authorization regulations, requirements, and equipment functions that are not associated with the transmitter module portion. For example, compliance must be demonstrated: to regulations for other transmitter components within a host product; to requirements for unintentional radiators (Part 15 Subpart B), such as digital devices, computer peripherals, radio receivers, etc.; and to additional authorization requirements for the non-transmitter functions on the transmitter module (i.e., Verification or Declaration of Conformity) as appropriate (e.g., Bluetooth and Wi-Fi transmitter modules may also contain digital logic functions). 2.1.1 Labeling and User Information Requirements The Occlusense modules have been labeled with its FCC ID number. If the FCC ID is not visible when the module is installed inside another device, then the outside of the finished product into which the module is installed must display a label referring to the enclosed module. This exterior label can use wording as follows:

For the Occlusense:

Contains Transmitter Module FCC ID: 2BAUV-OCCLUSENSE or Contains FCC ID: 2BAUV-OCCLUSENSE This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. A user's manual for the finished product should include the following statement:

This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy, and if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try 2 Regulatory Compliance Information to correct the interference by one or more of the following measures:

Reorient or relocate the receiving antenna Increase the separation between the equipment and receiver Connect the equipment into an outlet on a circuit different from that to which the receiver is connected Consult the dealer or an experienced radio/TV technician for help Changes or modifications made to the device not expressly approved by Dr. Jean Bausch GmbH & Co. KG could void the user's authority to operate the equipment. Additional information on labeling and user information requirements for Part 15 devices can be found in KDB Publication 784748, which is available at the FCC Office of Engineering and Technology (OET) Laboratory Division Knowledge Database (KDB) https://apps.fcc.gov/oetcf/kdb/index.cfm 2.1.2 RF Exposure All transmitters regulated by FCC must comply with RF exposure requirements. KDB 447498 General RF Exposure Guidance provides guidance in determining whether proposed or existing transmitting facilities, operations or devices comply with limits for human exposure to Radio Frequency (RF) fields adopted by the Federal Communications Commission (FCC). From the FCC Grant: Output power listed is conducted. This transmitter is restricted for use with the specific antenna tested in this application for Certification. In the end product, the antenna used with this transmitter must be installed to provide a separation distance of at least 6.5 cm from all persons and must not be co-located or operation in conjunction with any other antenna or transmitter. User and installers must be provided with antenna installation instructions and transmitter operating conditions for satisfying the RF exposure compliance. 2.1.3 Approved Antenna Types To maintain modular approval in the United States, only the antenna types that have been tested shall be used. It is permissible to use a different antenna, provided the same antenna type and antenna gain

(equal to or less than) is used. An antenna type comprises antennas having similar in-band and out-of band radiation patterns. 2.1.4 Helpful Websites Federal Communications Commission (FCC): http://www.fcc.gov FCC Office of Engineering and Technology (OET) Laboratory Division Knowledge Database (KDB):

https://apps.fcc.gov/oetcf/kdb/index.cfm 3 Regulatory Compliance Information 3.1 Canada The Occlusense module has been certified for use in Canada under Innovation, Science and Economic Development Canada (ISED, formerly Industry Canada) Radio Standards Procedure (RSP) RSP-100, Radio Standards Specifi- cation (RSS) RSS-Gen and RSS-247. Modular approval permits the installation of a module in a host device without the need to recertify the device. 3.1.1 Labeling and User Information Requirements Label Requirements (from RSP-100 Issue 11, Section 3): The host device shall be properly labeled to identify the module within the host device. The Innovation, Science and Economic Development Canada certification label of a module shall be clearly visible at all times when installed in the host device, otherwise the host device must be labeled to display the Innovation, Science and Economic Development Canada certification number of the module, preceded by the words Contains, or similar wording expressing the same meaning, as follows:

For the Occlusense module:

Contains IC: 30548-OCCLUSENSE User Manual Notice for License-Exempt Radio Apparatus (from Section 8.4 RSS-Gen, Issue 4, November 2014): User manuals for license-exempt radio apparatus shall contain the following or equivalent notice in a conspicuous location in the user manual or alternatively on the device or both:

This device complies with Industry Canada license exempt RSS standard(s). Operation is subject to the following two conditions:

(1) This device may not cause interference, and

(2) This device must accept any interference, including interference that may cause undesired operation of the device. Le prsent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de licence. L'exploitation est autorise aux deux conditions suivantes:

(1) l'appareil ne doit pas produire de brouillage, et

(2) l'utilisateur de l'appareil doit accepter tout brouillage radiolectrique subi, mme si le brouillage est susceptible d'en compromettre le fonctionnement. Transmitter Antenna (From Section 8.3 RSS-GEN, Issue 4, November 2014): User manuals, for transmitters shall display the following notice in a conspicuous location:

Under Industry Canada regulations, this radio transmitter may only operate using an antenna of a type and maximum (or lesser) gain approved for the transmitter by Industry Canada. To reduce potential radio interference to other users, the antenna type and its gain should be so chosen that the equivalent isotropically radiated power (e.i.r.p.) is not more than that necessary for successful communication. Conformment la rglementation d'Industrie Canada, le prsent metteur radio peut 4 Regulatory Compliance Information fonctionner avec une antenne d'un type et d'un gain maximal (ou infrieur) approuv pour l'metteur par Industrie Canada. Dans le but de rduire les risques de brouillage radiolectrique l'intention des autres utilisateurs, il faut choisir le type d'antenne et son gain de sorte que la puissance isotrope rayonne quivalente (p.i.r.e.) ne dpasse pas l'intensit ncessaire l'tablisse-ment d'une communication satisfaisante. Immediately following the above notice, the manufacturer shall provide a list of all antenna types approved for use with the transmitter, indicating the maximum permissible antenna gain (in dBi) and required impedance for each. 3.1.2 RF Exposure All transmitters regulated by ISED must comply with RF exposure requirements listed in RSS-102 - Radio Frequency (RF) Exposure Compliance of Radio communication Apparatus (All Frequency Bands). This transmitter is restricted for use with a specific antenna tested in this application for certification, and must not be co-located or operating in conjunction with any other antenna or transmitters within a host device, except in accordance with Canada multi-transmitter product procedures. The installation of the transmitter must ensure compliance is demonstrated according to the ISED SAR procedures. 3.1.3 Helpful Web Sites Industry Canada: http://www.ic.gc.ca/

5

Instructions for Use Bausch and OccluSense are trademarks of Dr. Jean Bausch GmbH & Co. KG, registered in the EU and other countries. Apple, Mac, iPad, iPad Air, iPad mini, AirDrop, iTunes are trademarks of Apple Inc., registered in the U.S. and other countries. All other trademarks are the property of their respective owners. 2 3 INDEX Symbols..............................................................................................................................8 Terminology, Hardware requirements iPad................................................................9-10 GENERAL INFORMATION 1 Medical device manufacturer...................................................................................11 2 Medical device distributors......................................................................................11 3 Intended Use...........................................................................................................12 4 Device description (components, etc.)....................................................................12 4.1 Operating and functional elements of the OccluSense-System........................13 4.2 System features...............................................................................................14 5 Contraindications.........................................................................................................15 6 Expected clinical benet.........................................................................................15 7 Precautions / Safety Instructions............................................................................16 PREPARATION 8 Installation of the OccluSense-iPad-App ..................................................................17 8.1 Battery Charging......................................................................................18-21 OCCLUSENSE-iPAD-APP 9 Overview..................................................................................................................22 9.1 Intended use of the OccluSense-iPad-App......................................................22 9.2 Overview of the OccluSense-iPad-App.............................................................22 9.3 User manual.....................................................................................................23 INSTALLATION 10 First Use...............................................................................................................24 10.1 Demo Mode...................................................................................................24 10.2 Initial Setup.................................................................................................25 10.2.1 Switch on the handheld................................................................................25 10.2.2 Start the initial setup..............................................................................26-27 10.2.3 Integration into your own WLAN network.....................................................28 10.2.4 Registration of the system.......................................................................29-30 10.3 Administration of OccluSense handheld devices...........................................31 10.3.1 Rename handheld........................................................................................31 10.3.2 Disconnect handheld....................................................................................31 10.3.3 Pairing of the handheld with the OccluSense-iPad-App..........................32-33 SAFETY 4 11 Safety Check...........................................................................................................34 12 Function test......................................................................................................34-35 PATIENT MANAGEMENT 13 Manage patient data...............................................................................................36 13.1 Overview..........................................................................................................36 13.2 Create patient..............................................................................................37 13.3 Edit patient data..........................................................................................38 13.4 Delete a patients data.................................................................................38 RECORDINGS 14 Start a recording....................................................................................................39 14.1 General........................................................................................................39 14.1.1 Switch off handheld.....................................................................................40 14.1.2 Insert Sensor...........................................................................................40-41 14.1.3 Switch on the handheld....................................................................................42 14.1.4 Check WLAN connection...............................................................................42 14.1.5 Check if sensor is ready for recording.............................................................43 14.2 Set a patient active.........................................................................................43 14.2.1 Patient data..................................................................................................44 14.3 Recording modes.............................................................................................45 14.3.1 Recording and Live-Mode........................................................................46-47 14.4 Recording of the masticatory pressure distribution......................................48 14.4.1 Insert the sensor into the patients mouth.......................................................48 14.4.2 Recording.....................................................................................................49 14.4.3 Finish recording.......................................................................................50-51 EVALUATION OF RECORDINGS 15 Viewing recordings.......................................................................................................52 15.1 Overview..................................................................................................52-55 15.2 Resizing, turning and tilting the view...........................................................55 15.3 Playing recordings........................................................................................56 15.4 Filtering.......................................................................................................57 15.5 Viewing recorded data...................................................................................58 15.6 Additional visualization options........................................................................59 15.7 Renaming recordings and adding notes........................................................60 15.8 Fullscreen........................................................................................................61 MANAGE RECORDINGS 5 16 Manage and export recordings................................................................................62 16.1 Play back recordings...................................................................................63 16.2 Compare recordings.................................................................................63-64 16.3 Export recordings and snapshots.................................................................64 16.4 Export recordings as video..............................................................................65 16.5 Export data via iTunes PC/Mac software.......................................................66 16.6 Export patients data via AirDrop..................................................................67 16.7 Import.............................................................................................................67 SETTINGS 17 Menu Settings......................................................................................................68 17.1 Recording settings.......................................................................................68 17.2 Handheld rmware (and updates)................................................................68 17.3 Terms and conditions...................................................................................68 18 Menu Imprint.......................................................................................................68 TROUBLESHOOTING 19 Basic troubleshooting..................................................................................................69 19.1 Damages of the handheld............................................................................69 19.2 Reset to factory default....................................................................................69 19.3 Connection lost after Firmware Update........................................................69 19.4 Entering wrong WLAN credentials..................................................................69 19.5 Troubleshooting table..............................................................................70-73 CLEANING 20 Cleaning and disinfection..........................................................................................74 20.1 Handheld.........................................................................................................74 20.2 Charging Station..............................................................................................75 20.3 Test-Sensor....................................................................................................75 20.4 Reusability...................................................................................................75 MAINTENANCE 21 Batteries, electrical safety, software updates..........................................................76 21.1 General..........................................................................................................76 21.2 Replacing the batteries............................................................................76-77 21.3 Software-Updates..........................................................................................78 NOTICE 6 22 Transport & Storage................................................................................................79 23 Expected lifetime....................................................................................................79 24 Disposal Instructions................................................................................................79 25 Electromagnetic Compatibility.................................................................................79 26 Warrenty.................................................................................................................80 27 Customer Service....................................................................................................80 28 Spare parts...............................................................................................................81 29 Notication of incidents..........................................................................................81 30 Declaration of Conformity............................................................................................82 7 Symbols In compliance with relevant EU directives In compliance with relevant UK directives UK RP: OBELIS UK LTD, Sandford Gate, Oxford, OX4 6LB, UK Follow Instructions for Use!

Do not reuse!

Medical Device Manufacturer Order Number Serial Number IP Protection Class Class II Expiry date [yyyy-mm-dd]

Production date [yyyy-mm-dd]

Unique Device Identier LOT Number Waste electrical and electronic equipment (WEEE) must be disposed of separately. These must not be disposed of with normal household waste. Applied part of TYPE B, IEC 60601-1 Do not use if package is broken!

Do not expose to heat!

Some chapters describe usage procedures. In order to see which action of the OccluSense-System is required, the following symbols are used:

User interaction with the handheld User interaction with the iPad Interaction with the patient 8 WEEE-Reg-No.: DE 11349707 Terminology Recorded raw data:

Recorded data by the handheld device. OccluSense-iPad-App:

The software that manages, stores and visualizes the raw data recorded by the OccluSense handheld (Available for free in the Apple AppStore). Recording:

Raw data converted by the OccluSense-iPad-App. OccluSense-System:

Entire treatment unit according to chapter 4 "Device description". Handheld:

The central electronic device of the OccluSense-System, which executes the collection of raw data as well as its intermediate storage and transmission to the iPad (chapter 4.1). Hardware requirements iPad

(not included) Regarding the status of these operating instructions, an evaluation unit is an Apple iPad on which the app OccluSense from the Apple App Store must be installed. In order to use the app, you rst have to register the system within the app. The OccluSense-iPad-App has been developed for the following iPad models:

www.occlusense.com/ipad Installation on an iPad mini is not recommended. In order to use the app in full functionality, the system must be registered rst within the app. The instructions for the installation and registration can be found in chapter 10. 9 CAUTION Using the application on a not supported device is possible but at the users own risk. It is possible to run the app on an unsupported iOS version at the users own risk. NOTE A particular notication will pop up when the app is running on a not supported iOS or hardware. The usage out of the applications technical scope will be logged for safety rea-

sons. 10 GENERAL INFORMATION 1 Medical device manufacturer Dr. Jean Bausch GmbH & Co. KG Oskar-Schindler-Str. 4 D-50769 Kln - Germany Phone: +49-221-70936-0 Fax: ++49-221-70936-66 E-Mail: info@bauschdental.de Web: www.occlusense.com 2 Medical device distributors

(U.S. Initial importer) Bausch Articulating Papers, Inc. 12 Murphy Drive Nashua, NH 03062 - United States of America Tel: (603) 883-2155 | Tel: 1-888-6-BAUSCH | Fax: (603) 883-0606 E-Mail: info@bauschdental.com | Web: www.bauschdental.com Bausch Articulating Papers (Australasia) Pty. Ltd G.P.O. Box 3733, Sydney NSW 2001, Australia Tel: +61-2-9345-1945 | Fax: +61-2-9345-1955 E-Mail: info@bauschdental.com.au | Web: www.bauschdental.com.au Bausch Articulating Papers Japan K. K. 5F, 1-1-31, Nishimidorigaoka Toyonakashi, Osaka Japan 560-0005 Tel:+81 6-6845-0020 | Fax:+81 6-6845-0024 E-Mail: info@bauschdental.jp | Web: www.bauschdental.jp Bausch Importao de Materiais Odontolgicos Ltda. Rua Paulo Eduardo Xavier de Toledo, 379 salas 8 e 9 13304-240 Itu-SP, Brasil Tel: +55 11 3020-9263 E-Mail: vendas@bauschbrasil.com.br | Web: www.bauschbrasil.com.br Bausch Articulating Papers Co., Ltd.

#1004, The O Ville B/D, 344, Jong-Ro, Jongno-Gu, Seoul 03114, Korea info@bauschdental.kr | www.bauschdental.kr 11 3 Intended Use Analog and digital representation of antagonistic tooth contacts (occlusion) in the ave-

rage adult dentition on the patient's entire dental arch (for transient use). The application is intended exclusively for dentists and physicians/physiotherapists with specialized further training (CMD, craniomandibular dysfunction). 4 Device description (components, etc.) The OccluSense-System consists of the following components:

- Handheld BK 5001

- Charging station incl. Power supply BK 5002

- iPad App available in the Apple AppStore BK 5100

(requires an Apple iPad [no medical device], not included)

- 1 test sensor BK 5011

- 25 OccluSense-Sensors BK 5025

- Manual BK 5051

- 3 NiMH rechargable batteries BK 5013

- 1 Screwdriver IP 6 BK 5012

- 25 OccluSense-Sensors XL BK 5035 (not included) The medical device components do not contain any of the following substances:

- Pharmaceuticals

- Tissues or cells of human origin or their derivatives

- Tissues or cells of animal origin or their derivatives within the meaning of EU Regulation 722/2012 The touchable surfaces of medical device components consist of physiologically harmless plastics and colorants. Environmental conditions:

Temperature range 0 +35 Relative humidity 20% 90%. noncondensing Atmospheric pressure 650hPa 1060hPa max. height a.s.l. 3000m International Protection Rating: IP 40 Class: Class II 12 4.1 Operating and functional elements of the OccluSense-

System 1 3 4 5 6 7 8 9 10 11 2 1 3 4 5 6 7 8 9 Charging station incl. power supply 2 Sensor (Applied Part type B) Handheld (ME-Device) Control button 1 (pink) Control button 2 (green) Sensor lid Display Unlock button 10 Control button 3 (Reset) 11 Battery compartment 12 Test sensor

(not shown) 13 Screwdriver

(not shown) 14 3 pieces AAA NiMH rechargeble batteries (not shown) 13 4.2 System features The OccluSense system is used to record and display occlusal contacts and the mas-

ticatory force. It does not provide direct diagnoses or therapy recommendations. Furthermore, the system does not control treatment/therapy and there is no monitoring of or intervention in vital functions. The digital recording (and analog representation of the occlusion) is performed by the OccluSense sensor, when connected with the handheld. The recorded raw data, captured during the occlusion test, are buffered in the handheld. Subsequently the handheld trans-

mits this data via the wireless interface to the OccluSense-iPad-App. The OccluSense-iPad-App saves the recorded raw data and displays it 1:1 (i.e. without interpretation or highlighting) graphically on the iPad screen. Electrical connection OccluSense Sensor inductive power transmission

(galvanically isolated) OccluSense Handheld WLAN Charger iPad Electrical connection Power supply 14 5 Contraindications The OccluSense-System is for professional use only (see chapter 3) and is not suitable for:

Patients with edentulous jaw Patients with incomplete full-grown jaw 6 Expected clinical benefit The OccluSense system allows the examination of the patient's antagonistic tooth con-

tacts (occlusion) by means of the OccluSense sensor. Compared to conventional occlusion test materials (papers, foils), the system displays the occlusal contacts not only as a (nal) state on the occlusal surfaces of the teeth, but also the temporal progression from the initial contact to the nal intercuspal position as a graphical representation on the iPad. This allows to illustrate the masticatory force distribution on the entire dental arch. The dentist has the option to compare several recordings with one another, e.g. before and after dental treatment (not an automatic function of the OS-iPad-App) and to save these on the iPad for documentation purposes (forensics). The deduction of therapeutic measures must not be based solely on the information pro-

vided by the OccluSense system. Additional information must be obtained in order to make a comprehensive diagnosis. The graphical representation of the occlusal contacts must not be used to draw conclusions from the actually exerted bite forces (absolute values). These are relative value representations. 15 7 Precautions/ Safety Instructions OccluSense is a medical device meant for professional use only (see chapter 3). The OccluSense-System must be used with the supplied or prescribed accessories only. It is not allowed to connect any part of the OccluSense-System to an external DC power source. The power supply of the system has to be carried out exclusively with the supplied charging accessory. Before using the OccluSense-System, components have to be checked for external damages (visual inspection). Damaged components must not be used. The OccluSense-System must not be altered without the manufacturer's permission. The sensor must not be modied (e.g. cut to size). The handheld is designed for battery operation only. Mains operation is not intended and may result in serious injury of the patient or the practitioner. The use of non-rechargeable batteries is not permitted and may result in serious injury of the practitioner or destruction of the handheld when attempting to recharge it. The handheld must be disconnected from the charging station during use. The charging station has to be located outside the patients vicinity. The charging station must be positioned in such a way that the plug-in power supply unit is in easy reach and the separation from the mains can be accomplished without difculty. The charging station can be disconnected from the mains by pulling the plug-in power supply out of the socket. All parts of the OccluSense-System are not thermo-disinfectable or autoclavable and are not delivered sterile. Only cleaning agents and disinfectants as described in chapter 21 Cleaning and disinfection are allowed. The charger is maintenance-free. The treatment light should not be directed towards the handheld during treatment to ensure good readability of the display. The OccluSense-System is not intended to serve as the sole basis for diagnosis / the-

rapy decisions. 16 PREPARATION 8 Installation of the OccluSense-iPad-App Before using the OccluSense-System for the rst time, install the OccluSense-iPad-

App on the iPad (www.occlusense.com/install). Before initial operation of the OccluSense-System or after reset to factory default, a network conguration of the handheld and the associated pairing with an iPad is required. The procedure is described below. NOTE The handheld comes with uncharged batteries. The rechargeble batteries must be charged before rst use (see chapter 8.1). The OccluSense handheld is designed for use with three AAA NiMH batteries only (included). The handheld can also be used with other AAA NiMH batteries than those supplied. These AAA NiMH batteries must have a minimum capacity of 1000mAh. Perform a visual inspection for external damages. Only use the handheld unit and charging station if there are no external dama-

ges. 17 8.1 Battery Charging 1. Loosen the screws of the battery compartment lid with the screwdriver supplied, remove the battery compart-

ment cover and insert the supplied NiMH batteries into the battery compartment. 2. Insert the battery compartment cover and tighten the screws. 3. Connect the plug-in power supply unit to the supply voltage. (Rated Voltage:

100-240V, Rated Current: 160-80mA) 4. Insert the handheld into the charging station as shown. CAUTION Batteries inserted inversely can reach high temperatures and damage the de-

vice. 18 5. The charging process is indicated by a permanently lit LED located between the two operating buttons. All OccluSense devices with a serial number A000500 - A002499 have a red LED, devices from serial number B002500 have a blue LED. S/N A000500 - A002499 from S/N B002500 NOTE Both the permanently lit red or blue LED in the handheld unit and the ashing red or blue LED in the charger only indicate the battery charging process and do not represent a warning!

With empty NiMH batteries, the handheld can be charged for a short time using a charging time of at least 15 minutes. If the handheld is left in storage for longer periods with batteries inserted, the batteries may discharge. If a prolonged storage without use is foreseeable, it is recommended to remove the batteries from the handheld. After a storage period of the handheld with inserted rechargeable batteries of more than 3 months, it is recommended to fully recharge the rechargeable batteries before reuse. If the batteries have discharged after a full charge and a too low battery voltage is displayed, the batteries have become unusable. In that case, replace the bat-

teries. During the charging process, elevated temperatures may occur in the handle area of the handheld and in the charging station, which, however, decay imme-

diately after the charging process has been completed and do not pose any risk to the user or patient. 19 Figure 1: Empty Battery Figure 2: Low Battery The rechargeable batteries must be charged at the latest when the battery icon shows only one bar in red (Figure 1). However, it is recommended to recharge them when two yellow bars of the battery symbol occur (Figure 2). The batteries can also be charged earlier if you want to ensure that they are ready for use. CAUTION To charge the rechargeable batteries, only use the supplied charging station incl. the permanently connected power supply in order to prevent damage to the handheld unit and the rechargeable batteries. The use of the charging station is not permitted in the direct patient environment

(directly at the treatment chair). Do not use a multiple socket to operate the AC adapter. The plug-in power supply must be connected directly to a mains socket. 20 The handheld can be charged both when it is switched on and when it is switched off. As soon as the handheld is placed in the charging station, the handheld switches to a charging state in which the operation is disabled and a battery charging icon (Figure 3) is displayed. Charging of the batteries is indicated by a permanently lit LED (No warning notice!) (Figure 4). After a full charge cycle, the LED turns off. The charging process takes about 3-4 hours with 1000mAh batteries. The charging time may vary depending on the type of battery used and its capacity. With one battery charge, at least 100 recordings in 150Hz and 10 seconds mode recording time (or 30 minutes of live mode) can be made. Figure 3: Initiating the charging process. Figure 4: The charging of the batteries is indicated by a permanently lit red or blue LED

(This is not a warning notice!). 21 OCCLUSENSE-iPAD-APP (BK 5100) 9 Overview 9.1 Intended use of the OccluSense-iPad-App The OccluSense-iPad-App allows to record and manage data from the OccluSense-

Handheld-Device. During a recording, all occlusion data is transferred to the app, which enables to display the data two-dimensionally, three-dimensionally or in a combined view. The recorded data can be viewed and ltered. Furthermore the app allows zooming, tilting and rotating within the visualization. Recorded data is automatically assigned to the respective patient and can be commented and compared with each other which makes an easy analysis of occlusion data possi-

ble. 9.2 Overview of the OccluSense-iPad-App The app consists of ve main menu items (Figure 5) presented on the navigation bar on top of the screen. The currently active menu item is highlighted in blue. The structure and the functionality of each single menu item will be described in detail in the following chapters. Figure 5: Main menu of the app 22 9.3 User manual The user manual can be accessed via the integrated PDF viewer (Figure 6). Figure 6: User manual If you tap "MANUAL", the corresponding chapter in the PDF manual will automatically open according to the current action.

(Example: You are in the patient management, tap on "MANUAL" and the PDF manual opens chapter 13.) At the bottom of the screen is the status bar (Figure 7). If the app is not connected to a handheld, the status bar is empty. If it is connected to a handheld, the rmware version of the handheld is displayed on the left and the status of the handheld is displayed on the right. Figure 7: Status bar at the bottom of the app Symbol of the handheld:

Colored dot:

- Green:

- Yellow:

- Red:

Battery symbol:

Handheld is connected to the app Quality of the WLAN connection good connection quality moderate connection quality poor connection quality Battery condition of the handheld. 23 INSTALLATION 10 First use 10.1 Demo Mode After installation the app starts in demo mode, indicated by UNREGISTERED in the top left corner (Figure 8). Figure 8: UNREGISTERED label in the top left corner of the app. In the demo mode predened patients and recordings are available to give a rst im-

pression of the app. It is not possible to create new patients and recordings. Please refer to chapter 13 for further information about the patient management. The functionality of the settings menu is restricted to the registration menu. For activating the full functionality of the app you have to leave the demo mode and connect the hand-

held device with the app (chapter 10). Please refer to chapter 10.2.4 for further infor-

mation about the registration. 24 10.2 Initial Setup At delivery, the handheld is not precongured for an existing WLAN. In the course of the initial setup your iPad will rst connect to the OccluSense handheld. Subsequently, it is possible to integrate the handheld into your existing WLAN. Check if your iPad is connected to your WLAN network. Have your WLAN password ready. NOTE TECHNICAL REQUIREMENTS FOR THE WIRELESS LOCAL AREA NETWORK (WLAN) 2.4 GHz WLAN-Standard IEEE802.11 b/g/n (5 GHz is NOT supported) No MAC lter activated (MAC = Medium Access Control) DHCP server with two free IP addresses available OccluSense is a network device - If you have any problems connecting the OccluSense to your network, please ask your system administrator. 10.2.1 Switch on the handheld To switch on the handheld, press button 1 (pink button, see chapter 4.1). The WLAN net-

work name and password (WEP) are shown on the handheld display (Figure 9). Figure 9: WLAN-SSID and password (WEP) provided 25 10.2.2 Starting the initial setup Select "Initial setup" in the settings and tap "Start". Figure 10: Initial setup Now enter the WEP password in the eld (Figure 11) which is shown on the display of your OccluSense handheld device (Figure 9). Figure 11: Input eld for the WEP password 26 Allow access to the WLAN "Occlusense" by tapping on "Join". Figure 12: Connection to the integrated WLAN of the OccluSense handheld When the handheld has been successfully connected, the display shows Figure 13. This symbolizes "successful connection with the OccluSense iPad app", "no sensor inserted"

and "no patient data available". Figure 13: Handheld is connected Figure 14: Successful setup NOTE If the horseshoe shaped symbol appears in yellow, a function test is required

(Chapter 12). 27 10.2.3 Integration into your own WLAN network In the next step, you will see the dialog message from gure 14. Conrm the dialog with

"Yes". The OccluSense-iPad-App now changes to the "Connection" settings. Tap on "Next" (Figure 15). In the following screen please enter the WLAN credentials of your network (Figure 16). The last WLAN network, the iPad has been connected to, will be suggested as the network SSID. Enter the password of your WLAN network and allow the OccluSense-iPad-App to access the network in order to write the data to the handheld. Figure 15: Instructions for the external Figure 16: Enter WLAN name and password WLAN-Setup A successful connection between the handheld and the WLAN is indicated by the green bars and the rst 6 characters of the WLAN in the upper left corner of the handheld screen. If the connection between the handheld and the WLAN has failed, the connection status is indicated on the handheld screen by transparent status bars. 28 10.2.4 Registration of the System After the initial pairing, please restart the app. To do this, press the home button twice

(iPad without home button: swipe up from the bottom of the screen) and swipe up the preview of the app to close it. Now the full functionality of the app is available. In case you have not yet registered the app you have access to all functions for 14 days. After this period the demo mode will be reactivated and you have to register the app for further use (Figure 17). Figure 17: The handheld registration form is located in the Settings menu NOTE The registration is mandatory for full functionality of the app in combination with the handheld device. For the registration an Internet connection is required. 29 Step 1: connect your handheld device to the app and to ll the registration form with your name, address and e-mail address. Step 2: tap the Register button to send your registration data. You will receive a con-

rmation e-mail. NOTE If you have not received a conrmation e-mail, check your junk mail folder or check the e-mail address you have entered. Step 3: press the Conrm button in the e-mail and switch back to the app. The app still needs Internet access to receive the conrmation of your registration data. If your registration was successful a green checkmark is being displayed:

After the registration process, the OccluSense-iPad-App has to be restarted to exit the DEMO mode. To do this, press the home button twice (iPad without home button: swipe up from the bottom of the screen) and swipe up the preview of the app to close it. Then reopen the OccluSense-iPad-App. NOTE When reactivating the demo mode none of your data will be deleted by the app although it is no more visible. After successful registration your data is available again. 30 10.3 Administration of OccluSense handheld devices Beside the initial setup, the OccluSense-iPad-App provides other functions for the administration of handheld devices. 10.3.1 Rename handheld If you intend to use several handhelds with one app, you should immediately assign a name to the handheld to make identication of each individual handheld easier. You can assign a name to a handheld within the registration settings section (Figure 18). Tap on the eld "Device name" to change the text. Figure 18: Screen for renaming the device, Disconnect, Switch device and Find device. 10.3.2 Disconnect handheld In order to use another handheld, the connection of the current handheld with the Occlu-

Sense-iPad-App must be disconnected. This process requires the handheld to be turned on and connected to the iPad-App. Then tap on Disconnect. The WLAN data and the name of the handheld remain stored in the device so that it can be reconnected at any time (see chapter 10.3.3). 31 10.3.3 Pairing the handheld with the OccluSense-iPad-App The app shows unpaired handhelds in the "Devices" list (OccluSense-iPad-App -> Set-

tings -> Handheld Registration -> Switch device) (Figure 18). To pair, select the handheld from the "Devices" list (Figure 19)

(default name is "DEFAULT"). Once the pairing has been completed successfully, the OccluSense-iPad-App will from now on connect automatically to this handheld. Figure 19: List of available devices after "switch device" button has been selected. NOTE Only previously disconnected handheld devices can be reconnected (Chapter 10.3.2). If your device is not shown in the list of available devices, please close the list, press Find device on the previous screen, and try again. 32 NOTE The purpose of integrating the handheld and the evaluation unit into the IT-network is to enable the live mode. Minimum IT network requirements are the following:

WPA/WPA2 WLAN encryption DHCP server in the IT network with at least two free IP addresses WLAN standards IEEE802.11 b/g/n (2.4 GHz) If these requirements of the IT network can not be met, there is a risk that the handheld can either not be used at all or in full functionality. If the entered WLAN data is incorrect, communication between the iPad and the handheld is not possible. In this case, a factory reset is required (Chapter 19.2). If no WLAN network is available in the dental ofce, the WLAN network provided by the handheld device can be used to a limited extent. However, an independent WLAN network is recommended in the dental ofce!

CAUTION Integrating the handheld into an IT-network that includes other devices can result in risks for patients, operators or third parties that the manufacturer can not evaluate. For this reason, practitioners must identify, analyze, assess and control these risks. Changes in IT networks can lead to new risks and therefore require additional analysis. 33 SAFETY 11 Safety check The function test described below ensures that the OccluSense-System works properly and that the masticatory pressure distribution is displayed correctly. It is therefore necessary that the function test is performed once a day. First of all, a visual inspection for external damages of the device must be made. If damages of the handheld, charging station or test sensor are detected, e.g. broken parts of the sensor lid, the device must not be used. In this case, see chapter 19 Troubleshooting. 12 Function test To initiate the sensor test of the handheld, the handheld has to be connected to the app rst. Then tap Next and follow the instructions on the screen (Figure 20-23). The function test is performed with the supplied test sensor, following these ve steps:

1. Place the test sensor in the correct position and close the sensor lid 2. Switch on the handheld and establish a connection with the iPad 3. Follow the instructions is performed automatically in the OccluSense-iPad-App. The function test NOTE A sensor test notication will pop up every day. However, you can proceed without conducting the sensor test. If a test has not been performed for the last 5 days the app will disable any live mode or recording functionality until the sensor test has been performed successfully (Figure 20-23). 34 Figure 20: First step of the sensor test, Figure 21: Second step, press the left (pink) insert the test sensor into the handheld button to start Figure 22: The sensor test was successful Figure 23: The sensor test failed 4. The result of the function test is displayed in the app. If this is repeatedly negative, the device must not be used. In this case, see chapter 19.5 "Troubleshooting". 5. Remove the test sensor from the handheld and place it in the storage box. NOTE If the sensor test fails permanently (Figure 23), please visit our support website:

help.occlusense.com 35 PATIENT MANAGEMENT 13 Manage patient data 13.1 Overview In the Patients section you can manage patients and their recordings (Figure 24). It is possible to create, edit, delete and export patient data as well as viewing and deleting old recordings of occlusion data and editing the attached notes. In this view you are also able to switch the active patient. Figure 24: Patient management of the app The view is split into two sections. On the left side, a list of all patients is located. At the top of this list, you nd the tools to search the list, create a new patient and to switch into edit mode, where patients can be deleted or exported. NOTE The search mechanism takes the ID and the last name of the patient into consideration. 36 13.2 Create patient Tap the Plus-symbol at the top left of the screen to create a new patient. After that you will be asked to enter the patient data (Figure 25). All elds are mandatory and have to be lled in. As soon as you have entered all the data, conrm by tapping on Done. If you do not want to create a new patient, tap on Cancel. Figure 25: Detailed view when creating a new patient in the patient management If you enter for instance asian, arabic or cyrillic characters in the rst or last name eld, new elds for the rst and last name will appear. The new name elds only accept ASCII characters and the names entered in these elds are used for the handheld device to display the active patient. ASCII characters are the latin alphabet. The patient number eld accepts only ASCII characters (Figure 26). Figure 26: Detailed view with additional name elds 37 13.3 Edit patient data In order to edit a patients data, the patients name has to be selected rst. Then tap on the Edit Patient-symbol at the top right of the screen. After that the data can be edited. The patient number can not be changed. If you want to save your changes, tap the Done button. If you want to discard your changes, tap the Cancel button. 13.4 Delete a patients data To delete a patients data, the patient has to be selected rst. Then tap on the Edit Pa-

tient-symbol at the top right of the screen. Finally tap on Delete. To delete several patients at once, tap on Edit at the top of the patient list. Now you can select the patients you want to delete. Then tap on Delete at the bottom of the list. 38 RECORDINGS 14 Start a recording 14.1 General Before starting the recording, the following preparations have to be made:

- Create / select patient

- Insert the sensor into the handheld

- Select capture mode An upright sitting position of the patient is recommended. NOTE If this has not yet been performed, the initial setup has to be made rst (see chapter 10). The recording will be started and stopped by the control buttons of the OccluSense handheld only. For recording, a permanent, wireless connection between the handheld and OccluSense-iPad-App is required. CAUTION The handheld may only be used with closed access covers (battery compartment and sensor lid) AND inserted sensor in the patient environment. Replacing the sensors or batteries which require to open the respective access covers must be done outside the patient environment. The practitioner must not touch the patient when the access covers are open. 39 14.1.1 Switch off handheld The handheld must be switched off to prevent unwanted operation. If the unit has been turned on after removing it from the charging station, press and hold button 1 (pink) for more than 2 seconds. The handheld then turns off (display off). 14.1.2 Insert sensor The OccluSense-Sensor is a horseshoe shaped pressure sensor. The sensor consists of a printed electronic circuit inside featuring a sensibility of 256 pressure levels. The red color coating on the outside enables the dentist to control the occlusion just like with regular occlusion test materials. The total thickness of the sensor is only 60 microns which allows testing the dynamic occlusion as well. The OccluSense-Sensor is a single-use product, limited to one patient in the same treatment only. CAUTION Only use sensors from undamaged original packagings!

Observe expiry date!

40 To insert the sensor:

1) Unlock the sensor lid of the handhed by simul-

taneously pressing the side release buttons. Open the sensor lid. 2) Remove the sensor from its packaging and insert it into the contact area. The insertion direction and position are deter-

mined by the marking on the sensor as well as by positioning pins, over which the sensor must be inserted. 3) Close: To do this, press the sensor lid downwards until the snap-in lugs of the release buttons snap in on both sides. 41 14.1.3 Switch on the handheld Figure 27: Display after switching on the handheld To switch on the handheld, briey press operating button 1 (pink). During initialization, the device displays the product logo including the version number of the rmware.

(Figure 27). 14.1.4 Check WLAN connection Figure 28: successful WLAN connection When the handheld is switched on, it automatically connects to the last congured WLAN network. The connection is indicated by the colored bar diagram in the top left of the display. If no network has been congured before, see chapter 10.3. The connection is to be checked after switching the handheld (Figure 28). 42 14.1.5 Check if sensor is ready for recording Figure 29: Sensor inserted properly Figure 30: Sensor inserted improperly The graphic on the left (Figure 29) shows that the OccluSense-iPad-App is connected to the handheld and the sensor is inserted properly. If the sensor is defective or inserted improperly, the graphic on the right appears on the display (Figure 30). The sensor or its position must be checked (chapter 14.1.2). 14.2 Set a patient active In order to start a recording, the patient must be activated rst. When you select a patient from the patient list, a message eld is being displayed in order to activate this patient (Figure 31). Figure 31: Set patient active 43 14.2.1 Patient data Figure 32: Patient set active (handheld) Figure 33: Patient set active (iPad) Create a new patient (chapter 13.2) and/or activate a patient (chapter 14.2). The patient's name is transferred to the handheld (Figure 32). Check if the patients data is correct. The currently active patient is always displayed in the upper left corner of the iPad screen (Figure 33). If no name is displayed, no patient is activated. The occlusion test can now be performed. NOTE The patient data is used to assign a recording to a patient and is stored together with the recorded data. Only after activating a patient, the handheld is ready to start a recording. 44 14.3 Recording modes A recording can be performed in different modes:

Live mode The handheld records raw recording data at a frequency of 20Hz (= 20 frames per second) and transmits it without intermediate storage to the OccluSense-iPad-App. The Occlu-

Sense-iPad-App displays this data graphically in realtime. The duration of the live mode is not limited. Recording mode The handheld records raw recording data at an adjustable frequency (50Hz, 100Hz, 150Hz, Hz = frames per second) over a recording time which has to be previously set. The data is buffered in the handheld. Only after a complete recording the data is being transferred to the OccluSense-iPad-App. Live + Recording mode The live mode is started rst (e.g. for setup). Pressing the button 1 (pink) terminates the live mode and starts a recording just like in recording mode, saves it and transmits it to the OccluSense-iPad-App. The currently selected recording mode and recording time are shown on the handheld display and in the OccluSense-iPad-App. NOTE The Live mode as well as the Live + Recording mode are only available if the OccluSense has been integrated in your WLAN network (Chapter 10.3) to ensure the best performance. 45 14.3.1 Recording and Live-Mode To start a recording, a handheld with an inserted sensor has to be connected to the app

(Chapter 14.1.2) and a patient has to be activated (Chapter 13). The currently active pa-

tient is always shown at the top left of the screen (Figure 34). By tapping on the top left patient information, the app will switch to the patient management screen, described in chapter 13. Figure 34: Active patient, including the full name, the birthdate, a gender icon and the patient ID To be able to start a recording, the handheld has to receive information about the ope-

ration mode and the duration of the recording (Figure 35). These values can be set in the recording view and are transmitted automatically to the handheld. Default values for the recording are set in the settings and are applied when a new patient is selected and activated or when the New recording button in the patient management is pres-

sed. Figure 35: Recording settings in the recording view 46 For the duration of the recording, a value between 1 and 99 seconds can be chosen. For the operation mode, one of the following options can be selected (Figure 36):

Live Realtime mode (no recording) Recording 50Hz Recording 50 pictures/sec. (no live view) Recording 100Hz Recording 100 pictures/sec. (no live view) Recording 150Hz Recording 150 pictures/sec. (no live view) Live + Recording 50Hz Recording 50 pictures/sec. (with live preview) Live + Recording 100Hz Recording 100 pictures/sec. (with live preview) Live + Recording 150Hz Recording 150 pictures/sec. (with live preview) Figure 36: Recording mode and duration The live mode can only be selected if the handheld is connected to the app via your local area network. After choosing both values for recording mode and duration, the recording can be started by pressing the left (pink) button of the handheld. If the recording view is not currently active, the app will automatically switch to this view. NOTE In live mode the data is only displayed but not recorded. However, it is possible to save a snapshot of the live data. A snapshot is like a recording with only one image. To save a snapshot, press the right, green button of the handheld. When the live mode is active, it is indicated by red dot and the text LIVE MODE at the bottom of the screen (Figure 37). Figure 37: Live mode icon in the recording view 47 14.4 Recording of the masticatory pressure distribution The practitioner must perform the following steps in order to record the masticatory pressure distribution of a patient:

14.4.1 Insert the sensor into the patient's mouth NOTE Slightly squeezing the cardboard frame makes it easier to insert the sensor into the patient's mouth. The printed red triangle on the sensor marks the centerline. Only touch the sensor on the cardboard frame. CAUTION Do not insert the sensor too deep into the mouth!

Do not bend the sensor!

48 14.4.2 Recording Start the recording on the handheld by pressing button 1 (pink). The patient opens and closes the mouth according to the instructions of the practi-

tioner. In recording mode, the recording does not begin until a minimum force is ex-

ceeded or by pressing button 1 (pink). The handheld indicates the start and end of the recording through an acoustic signal. Stopping the recording depends on the selected mode:

Live mode: In live mode, the start/end is not being indicated by an acoustic signal. The recording is ended by pressing button 1 (pink). Recording Mode / Combined Mode: The recording ends automatically after the specied recording time has elapsed. NOTE Static and dynamic occlusion recordings are possible. 49 14.4.3 Finish recording Remove the sensor from the patient's mouth. The evaluation of the recorded raw data as well as the visualization of the masticatory pressure conditions are processed by the OccluSense-iPad-App. Remove the sensor from the handheld and dispose of it properly after the desired recordings have been made. Perform the cleaning and disinfection procedure as described in chapter 20. NOTE Occlusal contact points are also marked on the occlusal surfaces of the patient's teeth. CAUTION The OccluSense-Sensors are medical devices for single use and must be disposed of immediately after use (chapter 24). 50 NOTE The interpretation in the OccluSense-iPad-App and storage of the data depends on the selected recording mode:

Live mode: the interpretation is shown in realtime. Live recordings are not being saved. However, it is possible to save individual snapshots by pressing button 2 (green). Recording mode / combined mode: After recording, the raw data is being stored in the patients le of the OccluSense-iPad-App and displayed automatically after the recording has been nished. 51 EVALUATION OF RECORDINGS 15 Viewing recordings 15.1 Overview In the section Recording, you can start a recording or the live mode (Figure 38). A gra-

phical representation of the data is arranged in the center of the screen. The recorded or live data can either be displayed two-dimensionally, three-dimensionally or in a com-

bined view. The following chapters describe, how it is possible to record data using this menu item and which features are available for data analysis and processing. Figure 38: Recording view of the app NOTE The color distribution and bar height of the images are always individually de-

pendent on the patient's teeth shape and occlusal behavior. Therefore, recor-

dings are not comparable with the recordings of other patients. 52 2D View The recorded data can be displayed in three ways. The rst view is called "2D" which shows the recorded data of the masticatory pressure by two dimensionally colored squares (Figure 39). Figure 39: 2D view of the occlusal pressure distribution 3D View The second option is the three dimensional view, called 3D (Figure 40) which shows the data by using a bar diagram. The bars have different heights which represent the occlusal pressure - the higher the bar the higher the pressure of the occlusal contact. When calculating the masticatory pressure distribution, the ratio of individual contact points with the surrounding areas as well as with all contact points of the entire dental arch is taken into consideration. This includes the number of contact points as well as the bite force. The bars show a color gradient from green to yellow to red and imply the masticatory pressure distribution in a certain area. A pin-point pressure is being displayed from red to orange while a pressure on a larger surface area is being displayed from yellow to green. 53 The relative pressure difference between these pressure points and surfaces is illustrated by the height of the bars in the 3D view. The bars show a color gradient from green to yellow to red and represent the relative difference of a contact point to its adjacent contacts. A green color implies a small re-

lative difference between the adjacent contacts. The color gradient will turn from yellow to red if the difference between the adjacent contacts will become higher. In addition to the markings on the occlusal surfaces, like with conventional occlusion test materials, OccluSense is able to record the temporal sequence of intercuspidation. During this dynamic process, the pressure points and surfaces change in their appea-

rance. Figure 40: 3D view of the occlusal pressure distribution 54 2D/3D View The third option is to combine the previous two views, called 2D/3D (Figure 41) in order to view both on one screen. Figure 41: Combined 2D/3D view 15.2 Resizing, turning and tilting the view The three dimensional view can be resized by a pinch gesture with two ngers. The view can also be rotated by swiping horizontally across the diagram and tilted by swiping vertically across the diagram. The position and direction of the two dimensional view can not be changed. 55 15.3 Playing recordings If the recording is not a snapshot, it is possible to view all occlusion pressure changes over time, just like a video. The operative elements for this purpose can be found on the bottom of the screen

(Figure 42). Figure 42: Controls of a recording (while the recording is paused) To play back the recording, press the Play button which is depicted as a simple arrow pointing to the right. If the recording is already running, the Play button is replaced with the Pause button, which is depicted as two vertical parallel bars (Figure 43). Figure 43: Controls of a recording (while the recording is playing) On the left and right of these buttons are two double-headed arrows which are pointing to the left or right. These buttons move the recording back or forward by one frame, allowing to nd the exact moment of the recording which is relevant for you. Above the described buttons, you will see a blue line with a white point. This line sym-

bolizes the total length of the recording, while the point shows where the current frame is located in relation to the total length. Both of these time units are shown in seconds and milliseconds (current time: left, total time: right). The button can be used to set the playback speed in three modes. It should be noted, that the selected frame rate of 50 Hz, 100 Hz, or 150 Hz during the recording has an inuence on the playback speed (see table on page 57). This feature enables a detailed temporal evaluation of the occlusal contacts. 56 1/4 Speed 1/2 Speed 1/1 Speed (Realtime) 40 sec. Playback 1/8 Speed 20 sec. Playback 1/4 Speed 10 sec. Playback 1/2 Speed 80 sec. Playback 1/12 Speed 40 sec. Playback 1/6 Speed 20 sec. Playback 1/3 Speed 120 sec. Playback 60 sec. Playback 30 sec. Playback Recording 50 Hz Example:

10 sec. Recording =

Recording 100 Hz Example:

10 sec. Recording =

Recording 150 Hz Example:

10 sec. Recording =

15.4 Filtering At the right edge of the screen you can nd a vertical line with a white dot (slider). The slider enables you to manually set the threshold of the graphical representation between

"0" (= upper end of the slider) and "256" (= lower end of the slider) to highlight relevant pressure points and areas. With the setting of the threshold you determine the type of representation, so that changes in color and height of the columns in the diagram may result (Figure 44). The set value is displayed in the lter icon. The preset lter value is set to 30 to omit electrical noise of the sensor. Figure 44: Slider to adjust the threshold 57 15.5 Viewing recorded data The recorded data is available in the section Recordings. It is also possible to load and view older recordings and snapshots. Tap on the Load recording button in the top left and select the recording that shall be viewed (Figure 45). Figure 45: List of available recordings of the activated patient 58 15.6 Additional visualization options At the top right edge of the screen are three buttons. A tap on the button in the middle, with the three dots opens a small menu with the options to activate or deactivate the vi-

sualization of the occlusal force distribution (Figure 46). It represents the occlusal pres-

sure distribution by the sensor zones. If one or both menu options are activated, the visualization is only displayed in the 2D view. The Show Force Distribution in Percent option shows twelve percentage numbers for the twelve zones of the sensor. These zones are indicated by the blue lines around the sensor. The Show quartered Force Distribution option shows a circle with four quarters in the background of the sensor diagram (Figure 46). The color of each quarter is a gradient ranging from green to yellow to red and shows the difference of the pressure between the quarters. The pressure of a quarter is calculated with the bar values of the quarter. Depending on the height of the difference, the quadrant color changes from green to yellow to red. Figure 46: Occlusal pressure with both options for the occlusal force distribution enabled 59 15.7 Renaming recordings and adding notes Renaming recordings By using this button, you can edit the name of a recording. This option is available in the section Recording as well as in the Patients section. The search eld in the list of recordings can be used to nd a recording by the name. Notes By using this button you can add a note to a recording or edit an existing one. At the top of the note view are two buttons:

the trash bin to delete the open note the button to save and close the note

The note is attached to the recording and is also shown within the patient management below the recording. The length of the note is not limited (Figure 47). Figure 47: Renamed recording including a note 60 15.8 Fullscreen At the top right, the fullscreen-button is located. By using this you can maximize the diagram view and all controls, not necessary to interact with the diagram, are hidden. The fullscreen view also permits the export of recordings as pictures, PDF or video

(chapter 16). To leave the full screen view, tap on the button again (Figure 48). Figure 48: Fullscreen view of a recording 61 MANAGE RECORDINGS 16 Manage and export recordings You can manage your recordings from within the patients folder (Figure 49). When a pa-

tient has been selected from the patients list, all recordings of this specic patient ap-

pear. Recordings will be collected in folders sorted by date. Renamed recordings (chapter 15.7) can easily be found by using the search eld. The note of a recording, if existent, is displayed below the recording entry and adapted to the rst two lines if the text is too long. To see the note in full length, tap on the more button and the full text will appear. Figure 49: Recordings of a patient If you want to delete a recording, swipe to the left to open the submenu NOTE/DELETE and tap on DELETE. The menu item NOTE enables editing of the note (chapter 15.7). To start a new recording for the selected patient, tap the New Recording button at the bottom right corner of the screen. The patient will be set active and the view will be switched to RECORDING. 62 16.1 Play back recordings To play back a recording a patient has to be selected from the patients list. After se-

lection, a list of recordings related to this patient will appear. Tapping on recording, all occlusion data will be displayed in a new diagram view, as described in chapter 13.3. When displaying a recording, you can easily switch between all recordings of the same patient using the list on the left. 16.2 Compare recordings The "Compare Recordings" button in the playback view enables you to select two recor-

dings of a patient and display them next to each other (Figure 50). To change the recordings to be compared, use the "Load Recording" button at the top right of the respective segment. The comparative view does not offer the functionality of the occlusal force distribution

(Chapter 16.2), full screen (Chapter 15.8) or the combined 2D / 3D view (Chapter 15). To return to the playback view, tap the "Back" button located at the top left of the screen. Figure 50: Comparison view of two recordings 63 NOTE This functionality only allows the comparison of recordings of the same patient. Hence, at least two recordings or snapshots need to be available. 16.3 Export recordings and snapshots Recordings can be exported as images in .png format, or as pdf les including the notes of the recording, or as videos. This export functionality is only available in the full screen mode of a recording, described in chapter 15.8. There is an export button at the top right corner, which opens a message box with the option to choose the format (Figure 51).

- PDF: A preview including the respective notes opens and subsequently can be exported or printed

- PNG: The export will take a screenshot of the current scene and save it in the Photos App on the iPad. Additionally, the images or PDFs are being copied to a shared folder of the app, acces-

sible via iTunes on your PC or Mac (chapter 16.5). Figure 51: Exporting a screenshot is possible as either PDF or as PNG 64 16.4 Export recordings as videos Recordings can also be exported as MP4 videos by recording the playback. The videos include your interactions with the recording like the rotation, tilting, zooming, adapting the threshold or using the default controls to display the desired frame. Exporting a re-

cording as video is also only available in the full screen mode. Use the timeline slider to select the frame you want to start the video export. Then tap the red recording button. Accept the capture of the screen to start the recording. Now tap on the play button to start the playback and interact with the recording in the way you want it to be seen in the video. When nished, tap on the grey Stop symbol. Now a preview of the recorded video will be shown (Figure 52). The video can be trimmed via the controls at the bottom. After trimming the video, this has to be conrmed by tapping the Done Button at the top right corner. Then use the Save button in the same position to save the video to the iOS Photos app. Figure 52: The preview of the video recording mode. CAUTION iOS offers the storage of photos/videos in the iCloud photo library. We recom-

mend to disable this feature in the iCloud settings. We expressly point out that the storage of personal data in cloud services is under the sole responsibility of the user. 65 16.5 Export data via iTunes PC/Mac software To export data to a PC or Mac, you have to connect the iPad to the PC/Mac. The cable is included with the iPad. The software "iTunes" has to be installed on the PC/Mac.

(www.apple.com/itunes/download/). The data of a selected patient can be exported by tapping on the Export button at the right side, below the Edit Patient button. In the context menu, select "iTunes" and the export will be conrmed. To export one or more patients data, tap on Edit at the top of the patient list. Now you can select any number of patients. The button selects all patient records at once. As soon as all patients are selected, tap on Export at the bottom of the list. In the context menu, select "iTunes" and the export will be conrmed. Exported recordings are saved as raw binary data. You can access and copy the exported data via iTunes to any PC or Mac by navigating to the specic application folder (Figure 53). This is necessary for a data backup. Exported images and PDFs as well as video recordings of a patient can be transmitted to a PC or Mac in the same way. NOTE: as of macOS Catalina (10.15), the file manager is located in the Finder. Figure 53: Location in iTunes to access exported les from the app 66 16.6 Export patients data via AirDrop The data of a selected patient can be exported to another iPad or Mac by tapping the

"Export Data" button on the right side below the "Edit Patient" button. In the context menu, select the other device in the section AirDrop. To export several patient data simultaneously, tap "Edit"at the top of the patient list. Select all patients recordings that you want to export. The button selects all patient records at once. In the context menu, select the other device in the section AirDrop. The data received on a Mac is used for data backup. If data is sent to another iPad with an installed OccluSense-iPad-App, it can be imported and used there. CAUTION In addition to the AirDrop and iTunes export functions, iOS may also offer cloud-

based services. We do NOT recommend the use of these services and expressly point out that the storage of personal data in cloud services is under the sole responsibility of the user. 16.7 Import To import previously exported data to another iPad running the OccluSense-iPad-App, connect the iPad to a PC or Mac, open the iTunes software and navigate to the specic application folder (Figure 53) as described in chapter 16.5. Click the Add button in iTunes to add the previously exported data (Figure 53). Start the OccluSense-iPad-App and go to the patient management screen. Tap the Edit but-

ton on top of the patients list and use the Import button to start the import process

(Figure 54). Figure 54: Import button If the data has been sent via AirDrop to an iPad, the OccluSense-iPad-App will launch automatically. You will be asked if the received le should be saved for immediate or later import. If you decide to import the data later, the le can be imported by using the Import button in the edit mode of the patients list (Figure 54). To avoid duplicates, the ID of the patient is being considered. If the patient already exists, the recordings are being synchronized. If the same ID is being used for a different patient you have to choose between the existing or imported patient. New imported recordings will be added to the respective list of recordings, sorted by date. Updated notes of synchronized recordings are automatically being added. 67 SETTINGS 17 Menu Settings 17.1 Recording settings The default settings for duration and frequency can be selected here. These settings will be applied whenever you set a new patient active, described in chapter 14.2, or when the New recording button in the patient management has been pressed. 17.2 Handheld firmware (and updates) This view shows the rmware version of the connected handheld device as well as the latest available rmware version. If a new rmware version is available you can start the update. The handheld device will receive and install the update automatically. This might take a few minutes. During the update process the connection to the handheld will be lost and the WLAN data might be lost as well. To reconnect the handheld device, refer to chapter 10.2. NOTE The update for the OccluSense-iPad-App is provided by the Apple AppStore in the standard update process. 17.3 Terms and conditions The terms and conditions of the app are listed here. You will be asked to accept these terms and conditions to register your handheld device, which is needed to use all functio-

nalities of the app. 18 Menu Imprint (HELP -> Imprint) The imprint contains all the important information about the legal manufacturer, further contact details and software license agreements. When tapping on the e-mail address, the default mail app on the iPad will open. 68 TROUBLESHOOTING 19 Basic troubleshooting 19.1 Damages of the handheld CAUTION In case of a mechanical damage, the device must be returned or disposed of properly. 19.2 Reset to factory default To reset the handheld to factory default, you have to press and hold the reset button that can be accessed through a small hole inside the battery compartment (chapter 4.1). You will hear a sound when the reset has been initiated. To access the button a very thin object (i.e. paperclip) is required. After resetting, the handheld is in factory conguration. No data in the OccluSense-iPad-App is being de-

leted or changed. 19.3 Connection lost after Firmware Update Updating the rmware of the handheld may cause a disconnection to the wireless net-

work. If the handheld device has lost information about the local wireless network, indicated by the missing name of the local wireless network at the handheld device connection indicator, switch the iPads wireless network to the network of the OccluSense handheld device. Then reconnect the handheld device to the local wireless network, for details refer to chapter 10.2. If the handheld device does not reconnect automatically to the app when using the wireless network of the handheld device, establish the connection manually. 19.4 Entering wrong WLAN credentials As described in chapter 10 the WLAN credentials have to be correct, otherwise the hand-

held will be out of reach for further connectivity attempts. If you have accidentally en-

tered incorrect WLAN connection credentials, please reset the handheld as described in chapter 19.2 and try again. 69 19.5 Troubleshooting table General (all components) Error (symptom) Cause Handheld, charging station, test sensor, screwdriver or Occlu-

Sense-Sensors are missing. Handheld, charging station, test sensor, screwdriver or Occlu-

Sense-Sensors are damaged. OccluSense-Sensor Seal pack is damaged. OccluSense-iPad-App Error (symptom) Cause The OccluSense-iPad-App is not The users iPad is not compatible with the OccluSense-iPad-App installed properly on the iPad. Action Consult Bausch

(support@occlusense.com) Consult Bausch

(support@occlusense.com) Action See operating instructions,

"Hardware Requirements"

The iOS-version of the user is not compatible with the Occlu-

Sense-iPad-App Update the iOS The OccluSense-iPad-App has not been downloaded correctly or completely from the appstore Try to download the App again Check internet access The connection between Occlu-

Sense -iPad-App and handheld is not possible. Another handheld is already connected to the app Disconnect the current inter-

connection, see instructions for use (chapter 10.3.2) The WLAN connection between Check (or let check) WLAN iPad and handheld is insufcient or not available connection The rechargeable batteries of the iPad or the handheld are not properly charged Make sure that batteries are properly charged (chapter 8.1 and iPad user manual) No connection can be established between iPad and handheld. Only sample/demo data is visible. The registration process has not been performed Make sure that iPad and handheld are in the same WLAN and connected (Settings ->

Handheld registration) Perform registration process, see chapter 10.2.4 70 Error (symptom) A recording of the bite force distri-

bution can not be started. Cause Patient le has not been created or activated in the OccluSense -

iPad-App Action Create patient le in the Occlu-

Sense-iPad App (chapter 13.2) Activate patient in the Occlu Sense-iPad-App (chapter 14.2) The regularly requested function test (with the test sensor) has not been performed Perform function test with test sensor (chapter 12) The function test has failed Ensure correct position of the test sensor in the handheld!

Perform function test again In case of further function test failures consult Bausch

(support@occlusense.com) A required update of the Occlu-

Sense -iPad-App or the hand-

held rmware was not installed Ensure connection to the Apple AppStore Perform update (chapter 17.2, 21.3) OccluSense-Handheld Error (symptom) Cause Handheld can not be switched on. There are no batteries in the battery compartment The batteries have been inserted incorrectly Action Insert batteries into the battery compartment (chapter 8.1) Remove the batteries from the battery compartment and insert them according to the identi-

cation marks inside the battery compartment (section 8.1) Ensure the rm contact of the the battery poles with the battery probes The batteries are insufciently charged Charge the batteries (chapter 8.1) Batteries cannot be inserted into the handheld. Battery compartment cover can not be opened see manual (chapter 8.1) There are no (suitable) batteries available Use of 3 x AAA NiMH recharge-

able batteries, 1000 mAh

(chapter 8) 71 Error (symptom) Battery compartment cannot be closed The connection between Occlu-

Sense iPad-App and handheld is not possible. Cause Battery compartment cover is defective or missing Screwdriver is damaged or missing Action Consult Bausch

(support@occlusense.com) Connect handheld with iPad App

(chapters 10) Reset the handheld to factory default (chapter 19.2) No connection can be established between iPad and handheld. The WLAN conguration has been Reset the handheld to factory set up incorrectly default (chapter 19.2) Connect iPad App to the handheld

(chapter 10) and re-enter WLAN credentials

(chapter 10) The recording of the bite force distribution cannot be started The registration process has not been performed Perform registration process, see chapter 10.2.4 The regularly requested function test (with the test sensor) has not been performed or it has failed Perform or repeat function test with test sensor (chapter 12) Consult Bausch

(support@occlusense.com) OccluSense-Charging station Error (symptom) The charging station cannot be connected to the (local) power supply. Cause The matching power supply plug is defective or missing Action Consult Bausch

(support@occlusense.com) The handheld batteries are not

(correctly) charged. There are no batteries in the battery compartment The batteries were inserted incorrectly Insert batteries into the battery compartment (chapter 8.1) The handheld is not correctly positioned in the charging station Insert handheld into the charging station (chapter 8.1) The charging station does not recognize the inserted handheld Make sure that the handhelds position in the charging station is correct and without any inter-

mediate layer 72 OccluSense-Test-Sensor Error (symptom) Handheld does not recognize the OccluSense-Test-Sensor Cause OccluSense-Test-Sensor is not properly inserted Action Check position of the test sensor in the handheld (chapter 12) OccluSense-Sensor Error (symptom) The handheld does not recognize the OccluSense-Sensor. Cause OccluSense-Sensor is not properly inserted The used OccluSense-Sensor is defective or manipulated Action Check position of the test sensor in the handheld and, if neces-

sary, reposition the sensor

(chapter 14.1.2) Treatment Error (symptom) The handheld turns off after a few recordings Cause There are no suitable recharge-

able batteries inserted in the battery compartment The batteries are defective The recordings are assigned to another patient A patient other than the patient being treated is set active in the OccluSense-iPad-App Replace unrecognized Occlu-

Sense-Sensor Consult Bausch

(support@occlusense.com) Action see manual (chapter 8.1) Replace batteries use of 3 x AAA NiMH recharge-

able batteries, 1000 mAh

(chapter 8) Create patient le in the Occlu-

Sense-iPad-App (chapter 13.2) Activate patient in the Occlu-

Sense-iPad-App (chapter 14.2) 73 CLEANING 20 Cleaning and disinfection The components of the OccluSense-System (handheld, charging station and test sensor) must be cleaned and disinfected regularly after each treatment as part of general practice hygiene. In principle, the following must be observed: "Requirements for hygiene in reprocessing medical devices Recommendation of the Commission for Hospital Hygiene and Infection Prevention (KRINKO) at the Robert Koch Institute (RKI) and the Federal Institute for Drugs and Medical Devices (BfArM)", Bundesgesundheitsblatt 2012 - 55:1244-1310. Damaged system components may not be reused and must be disposed of properly if the warranty has expired. The following system components must be stored dust-free after cleaning and disinfection. Storage conditions:

Temperature range Relative humidity Atmospheric pressure 0C ... +80C 20% ... 90%

500hPa ... 1060hPa 20.1 Handheld Clean and disinfect the handheld within max. 2 hours after treatment:

1. Switch off the handheld. To do this, press and hold button 1 (pink) for more than 2 seconds. Alternatively, the handheld switches itself off automatically after appro-

ximately 4 minutes. 2. Remove the sensor from the device and dispose it in accordance with ofcial disposal regulations. (see also: Chapter 24 "Disposal instructions") 3. In case of any contamination, such as saliva, wipe off the surfaces with a damp cloth and dry the surfaces. 4. Visual inspection of the handheld for any damages 5. Disinfect the surfaces (also in the area of the sensor lid below the sensor) with disinfection tissues.

- Recommended disinfectant tissues: e. g. Kanizid Microspray-AF quick disinfectant tissues from Kaniedenta or appropriate disinfectants.

- Note: Cleaning agents and disinfectants containing formaldehyde may only be used after cleaning and disinfection in order to prevent a protein xation. 74 20.2 Charging Station 1. Disconnect the charging station from the electric supply system. 2. Proceed as described in chapter 20.1, steps 3 to 5. 20.3 Test-Sensor Cleaning and disinfection as described in chapter 20.1, steps 3 to 5. 20.4 Reusability Frequent reprocessing has no effect or limitation on the system components of the Occlu-

Sense-System, as the end of the product's life is determined by wear and tear and da-

mage caused by use. The use of damaged and dirty components is the responsibility of the user. In case of disregard any liability is excluded. NOTE The instructions of the manufacturer of the detergent and disinfectant must be followed strictly. In particular, the concentrations to be used and the ap-

plication times must be observed!

CAUTION The components of the OccluSense-System are not suitable for mechanical cleaning and thermal disinfection processes. The battery compartment cover must be closed during cleaning and disinfection. Switch off the handheld before cleaning/disinfection!

It is mandatory that the contact time of the disinfectant product is being obser-

ved and that the unit is NOT switched on during this time. The OccluSense-Sensors are disposable medical devices and must not be reu-

sed. 75 MAINTENANCE 21 Batteries, electrical safety, software updates 21.1 General The OccluSense-System is basically maintenance-free. However, the system must be calibrated once a day (if used) in the form of a function test. If the function test runs successfully as described in chapters 11 and 12 "Safety test & function test with test sensor", no maintenance is required. However, if errors occur during the function test of the device, then there is probably a defect in the Occlu-

Sense-System. In this case see chapter 19. CAUTION Do not make any repairs or other changes to the system. The use of damaged and altered components is under the responsibility of the user. In case of disregard any liability is excluded. 21.2 Replacing the batteries 1. Loosen the screws of the battery compartment cover using a Torx IP 6 screwdriver (included) and remove the battery compartment cover. The screws of the battery compartment cover are

"captive", i. e. they remain on the battery compart-

ment cover after opening. 76 2. Remove the batteries to be replaced and dispose of in accordance with the ofcial disposal regulati-

ons (see chapter 24). 3. Insert new suitable AAA NiMh rechargeable batteries (with a capacity of at least 1000mAh each) in the correct arrangement (see markings in the battery compartment). 4. Insert the battery compartment cover and tighten the screws by hand. CAUTION Batteries inserted inversely can reach high temperatures and damage the device. Pay attention to the marking in the battery compartment!

77 21.3 Software-Updates For troubleshooting purposes, the OccluSense-System supports updating the handheld rmware and the OccluSense-iPad-App. As soon as an update of the handheld rmware or the OccluSense-iPad-App is available, a reminder for the update is automatically displayed and can be downloaded and installed by selecting:

"Settings" -> "Handheld Firmware"

78 NOTICE 22 Transport & Storage In case of a longer storage of the OccluSense-System, it is recommended to remove the batteries from the handheld and store them together with the other system compo-

nents in the system case (included). The same applies to the transport of the system. Transport and storage conditions:

Temperature range 0C ... +80C Relative humidity 20% ... 90%

Atmospheric pressure 500hPa ... 1060hPa 23 Expected lifetime The expected lifetime of the handheld is 5 years. Expiry date of sensor: See label on the packaging. 24 Disposal Instructions The components of the OccluSense-System (handheld unit, charging station, test sen-

sor) as well as the OccluSense-Sensors must be disposed of in accordance with the applicable ofcial disposal regulations. This means in detail:

Rechargeable Batteries: EU Directive 2006/66/EC; Law on the placing on the market, ta-

king back and environmentally friendly disposal of batteries and accumulators (Battery Act - BattG) Handheld equipment (without batteries), charging station and test sensor: EU Directive 2012/19/EU on waste electrical and electronic equipment (WEEE); Act on the marketing, take-back and environmentally sound disposal of electrical and electronic equipment

(ElektroG) OccluSense-Sensor ("general"): Disposal in normal waste OccluSense-Sensor ("contaminated", e. g. HIV or hepatitis): disposal according to TRBA 250 25 Electromagnetic Compatibility Changes or modications of this system which are not expressively approved by the ma-

nufacturer may result in increased emissions or increased susceptibility to the equipment or system. The system has been designed and tested to comply with applicable EMC regulations. It has to be operated only as described in chapters 8,10,12 and 15. 79 26 Warranty From the date of purchase, a legal warranty of 24 months applies to all product com-

ponents. The warranty for the battery functionality is 12 months. This warranty covers repairs due to material and/or processing defects. Damage caused by improper use and/or cleaning & disinfection or caused by unauthorized service and repair providers or by the user himself during service or repair attempts will void the warranty. Otherwise, the General Terms and Conditions of Dr. Jean Bausch GmbH & Co. KG apply. 27 Customer Service Please use our support system and our knowledge database under the menu item "Help". You can contact our support team via the request form. An internet connection is required. Alternatively, you can reach our support system at help.occlusense.com. Phone support:

Germany & Europe The Americas:

Japan:

+49-221-982 59010 (multilingual)

+1 (844) 633-4002

+81-50-3101-4161 Dr. Jean Bausch GmbH & Co. KG Oskar-Schindler-Strae 4 D 50769 Kln GERMANY www.occlusense.com help@occlusense.com 80 28 Spare parts

- Charging Station BK 5002

- Battery compartment cover BK 5001-3

- Test Sensor BK 5011

- Screwdriver BK 5012

- Power supply adapter Europe BK 5003

- Power supply adapter USA/Japan BK 5004

- Power supply adapter UK BK 5005

- Power supply adapter Australia BK 5006

- Power supply adapter China BK 5007 29 Notification of incidents NOTE Serious incidents in connection with the application of the OccluSense-System have to be reported to Dr. Jean Bausch GmbH & Co. KG [info@occlusense.com]

and the respective authority of the EU member state!

NOTE The OccluSense-System is an intensively tested product. Nevertheless, a mal-

function may result in the incorrect display of the masticatory forces. The de-

cision of therapeutic treatments must not be based solely on the data recorded by the OccluSense-System. For this purpose, further information must be ob-

tained in order to provide a comprehensive diagnosis. From the values of the recorded masticatory forces shown, no conclusions can be drawn about the ab-

solute forces (absolute values). The recordings of the masticatory forces are relative value representations. 81 30 Declaration of Conformity Please download the Declaration of Conformity for OccluSense here:

www.occlusense.com/downloads 82 U.S.A. U.S.A. & CANADA FCC ID: 2BAUV-OCCLUSENSE Contains Microchip ATWINC1500-MR210PB - FCC ID: 2ADHKATWINC1500 The frequency band in which the appliance operates is 2.4 GHz. Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful inter-

ference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. Changes or modications made to the Device Name device not expressly approved by Dr. Jean Bausch GmbH

& Co. KG could void the user's authority to operate the equipment. This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. CANADA IC 30548-OCCLUSENSE Contains transmitter module Microchip ATWINC1500-MR210PB - IC: 20266-WINC1500PB This device contains licence-exempt transmitter(s)/receiver(s) that comply with Innovation, Science and Eco-

nomic Development Canadas licence-exempt RSS(s). Operation is subject to the following conditions:

This device may not cause interference. This device must accept any interference, including interference that may cause undesired operation of the device. Cet appareil contient un ou des metteurs/rcepteurs exempts de licence conformes aux RSS exempts de licence d'Innovation, Sciences et Dveloppement conomique Canada. Le fonctionnement est soumis aux con-

ditions suivantes :

Cet appareil ne doit pas provoquer d'interfrences. Cet appareil doit accepter toutes les interfrences, y compris les interfrences susceptibles de pro-

voquer un fonctionnement indsirable de l'appareil. EUROPE The ATWINC1500-MR210PB module is an R&TTE Directive assessed radio module that is CE marked and has been manufactured and tested with the intention of being integrated into a nal product. JAPAN KOREA TAIWAN 007 AD0199 R-CRM-mcp-WINC1510MR210P CCAN18LP0321T2 INDIA CHINA ETA Certicate No: NR-ETA/5411-RLO(NR) CMIIT ID: 2018DJI1305 BRAZIL Segurana Compulsrio 02560-19-12141 83 Dr. Jean Bausch GmbH & Co. KG Oskar-Schindler-Strae 4 D-50769 Kln - Germany Tel: +49-221-70936-0 Fax: +49-221-70936-66 info@bauschdental.de www.bauschdental.de Bausch Articulating Papers, Inc. 12 Murphy Drive Nashua, NH 03062, U.S.A. Tel: +1-603-883-2155 Tel: 888-6-BAUSCH Fax: +1-603-883-0606 info@bauschdental.com www.bauschdental.com Bausch Articulating Papers (Australasia) Pty. Ltd ABN 73093760402 G.P.O. Box 3733, Sydney NSW 2001, Australia Tel: +61-2-9345-1945 Fax: +61-2-9345-1955 info@bauschdental.com.au www.bauschdental.com.au Bausch Articulating Papers Japan K. K. 5F, 1-1-31, Nishimidorigaoka Toyonakashi, Osaka 560-0005, Japan Tel: +81 6-6845-0020 Fax: +81 6-6845-0024 info@bauschdental.jp www.bauschdental.jp Bausch Importaco de Materiais Odontolgicos Ltda. Rua Paulo Eduardo Xavier de Toledo, 379 salas 8 e 9 13304-240 Itu-SP, Brasil Tel: +55 11 3020-9263 vendas@bauschbrasil.com.br www.bauschbrasil.com.br Bausch Articulating Papers Co., Ltd.

#1004, The O Ville B/D 344, Jong-Ro, Jongno-Gu Seoul 03114, Korea info@bauschdental.kr www.bauschdental.kr 1 2 6 0 2 2 _ 2 1 0 _ N E _ 1 5 0 5 K B _ e s n e S u l c c O _ U F I _ R P I

Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 USA Date: 05/24/2023 Ref: Attestation Statement Part 2.911(d)(7) Filing FCC ID:OccluSense FCC FRN: 0033654922 Dr. Jean Bausch GmbH & Co. KG certifies that, as of the dates of this application, Americas Compliance Consulting LLC dba iCertifi iCertifi is our designated U.S. agent for service of process for the above referenced FCC ID. Dr. Jean Bausch GmbH & Co. KG accepts to maintain an agent for no less than one year after the grantee has terminated all marketing and importation or the conclusion of any commission-related proceeding involving the equipment. iCertifi accepts, as of the date of the filing of the application, the obligation of the designated U.S. agent for service process for the above referenced FCC ID. Designated U.S. Agent Information:

Name: Americas Compliance consulting, LLC dba iCertifi FCC FRN: 0033399411 Address: 1001 SW Disk Drive, Suite 250, Bend, Oregon 97702 Contact Person: Paul Preston Tel: 866-885-4575 Email: fccagent@icertifi.com Sincerely, Dr. Jean Bausch GmbH & Co. KG FRN:

Andre Bausch GC442825 Americas Compliance Consulting LLC dba iCertifi Paul Preston Signature V02072023 Dr. Jean Bausch GmbH & Co. KG Oskar-Schindler-Str. 4 D-50769 Kln - Germany Tel: +49 (221) - 70 93 6-0 Fax: +49 (221) - 70 93 6-66 www.bauschdental.com BB_4c.indd 2 22.02.20 18:23

Dr. Jean Bausch GmbH & Co. KG Oskar-Schindler-Str. 4 D-50769 Kln - Germany Tel: +49 (221) - 70 93 6-0 Fax: +49 (221) - 70 93 6-66 www.bauschdental.com

Dr. Jean Bausch GmbH & Co.KG Oskar-Schindler-Str. 4 D-50769 Kln Germany Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 USA Ref: Attestation Statements Part 2.911(d)(5)(ii) Filing FCC ID: 2BAUV-OCCLUSENSE Date: August 15, 2023 Dr. Jean Bausch GmbH & Co. KG (the applicant) certifies that, as of the date of the filing of the application, the applicant is not identified on the Covered List as a specifically named entity or any of its subsidiaries or affiliates producing covered equipment. Sincerely, Andre Bausch Andre Bausch Dr. Jean Bausch GmbH & Co. KG Dr. Jean Bausch GmbH & Co. KG Oskar-Schindler-Str. 4 D-50769 Kln - Germany Tel: +49 (221) - 70 93 6-0 Fax: +49 (221) - 70 93 6-66 www.bauschdental.com Dr. Jean Bausch GmbH & Co. KG Oskar-Schindler-Strae 4 50769 Kln | GERMANY Phone: +49 (0) 221 70936-0 Fax: +49 (0) 221 70936-66 info@bauschdental.de www.bauschdental.com Persnlich haftende Gesellschafterin

(General Partner):

Dr. Jean Bausch Verwaltungs GmbH, Kln Handelsregister (Commercial Register):

Amtsgericht Kln HRA 1640 | HRB 72027 VAT-Id.-No.: DE122812032 Kommanditisten (Limited Partners):

Evelyn Bausch, Peter Bausch, Andr Bausch Geschftsfhrer (Executive Directors):

Andr Bausch, Peter Bausch Deutsche Bank Kln IBAN: DE76 3707 0024 0346 8881 00 BIC: DEUTDEDBKOE Sparkasse KlnBonn IBAN: DE08 3705 0198 0005 6625 49 BIC: COLSDE33 Postbank Kln IBAN: DE73 3701 0050 0056 1715 05 BIC: PBNKDEFF

WARNING:pdfminer.pdfpage:The PDF <_io.BufferedReader name='/Volumes/Scratch/Incoming/eg-scratch/6756378.pdf'> contains a metadata field indicating that it should not allow text extraction. Ignoring this field and proceeding. Use the check_extractable if you want to raise an error in this case 802 N. Twin Oaks Valley Rd., Suite 105 San Marcos, CA 92069 Phone: (760) 471-2100 FAX: (760) 471-2121 www.rfexposurelab.com Federal Communications Commission 7435 Oakland Mills Road Columbia, Maryland 21046 USA Date: 07/25/2023 Ref: FCC Class II Permissive change for FCC ID: 2BAUV-OCCLUSENSE

(Original Grant date: 07/10/2023) Dear Examiner, This is to request a Class II permissive change for FCC ID: 2BAUV-OCCLUSENSE, originally granted on 07/10/2023. The major change filed under this application is:

Change #1: This change is to request approval for portable category specific host model number: OCCLUSENSE, with integral antenna on WiFi module. Antenna is of same type and gain from original approval. SAR testing was conducted for RF compliance. Sincerely, By:

Jay Moulton Title:

Vice President, RF Exposure Lab On behalf of: Dr. Jean Bausch GmbH & Co. KG Telephone:

Fax:

e-mail:

760-471-2100 760-471-2121 jmmoulton@refexposurelab.com

(Signature)

Dr. Jean Bausch GmbH & Co.KG Oskar-Schindler-Str. 4 D-50769 Kln Germany RF Exposure Lab 802 N. Twin Oaks Valley Road, Suite 105 San Marcos, CA 92069 Authority to Act as Agent August 15, 2023 To Whom It May Concern:

RF Exposure Lab (Jay Moulton) is authorized to act on our behalf, until otherwise notified, for applications to iCertifi. We certify that we are not subject to denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 862. Further, no party, as defined in 47 CFR 1.2002 (b), to the application is subject to denial of federal benefits, that includes FCC benefits. We attest that all information provided is true and accurate subject to 2015, 47 CFR 2.911(d). We attest we are the responsible party subject to 2015, 47 CFR 2.909(a). This authorization is applicable to the product:

FCC ID: 2BAUV-OCCLUSENSE Agency Agreement Expiration Date: August 15, 2024 Best Regards, Dr. Jean Bausch GmbH & Co. KG Oskar-Schindler-Str. 4 D-50769 Kln - Germany Tel: +49 (221) - 70 93 6-0 Fax: +49 (221) - 70 93 6-66 www.bauschdental.com Andre Bausch By:

h B A d B Title: Managing Director On Behalf of:

Telephone:

Dr. Jean Bausch GmbH & Co. KG

+49-221-70936-0 Dr. Jean Bausch GmbH & Co. KG Oskar-Schindler-Strae 4 50769 Kln | GERMANY Phone: +49 (0) 221 70936-0 Fax: +49 (0) 221 70936-66 info@bauschdental.de www.bauschdental.com Persnlich haftende Gesellschafterin

(General Partner):

Dr. Jean Bausch Verwaltungs GmbH, Kln Handelsregister (Commercial Register):

Amtsgericht Kln HRA 1640 | HRB 72027 VAT-Id.-No.: DE122812032 Kommanditisten (Limited Partners):

Evelyn Bausch, Peter Bausch, Andr Bausch Geschftsfhrer (Executive Directors):

Andr Bausch, Peter Bausch Deutsche Bank Kln IBAN: DE76 3707 0024 0346 8881 00 BIC: DEUTDEDBKOE Sparkasse KlnBonn IBAN: DE08 3705 0198 0005 6625 49 BIC: COLSDE33 Postbank Kln IBAN: DE73 3701 0050 0056 1715 05 BIC: PBNKDEFF

Dr. Jean Bausch GmbH & Co. KG Oskar-Schindler-Str. 4 D-50769 Kln - Germany Tel: +49 (221) - 70 93 6-0 Fax: +49 (221) - 70 93 6-66 www.bauschdental.com

Federal Communications Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD-21046 Date : 2023.06.27 Re: Change of Identification Authorization, FCC ID: 2ADHKATWINC1500 To Whom It May Concern:

This letter grants authorization for representatives of Dr. Jean Bausch GmbH &

Co. KG to apply to the FCC for a change in identification as specified under 47CFR2.933 of the FCC rules. This authorization applies to Microchip Technology Inc., Model ATWINC1500-

MR210PB FCC ID: 2ADHKATWINC1500. The original grant date is: 15/10/2015 We are aware that Dr. Jean Bausch GmbH & Co. KG intends to market the above referenced product under their own FCC ID: 2BAUV-OCCLUSENSE. Microchip Technology Inc. will continue to sell their device under their existing FCC ID. The Model with a change in ID is identical in design and construction with our original model. The original test results continue to be representative of and applicable to the module with a change in ID. Sincerely, Signature:

HRUSHIKESH VASUKI Director, Business Unit General Manager, Wireless Solutions Group rishi.vasuki@microchip.com

WARNING:pdfminer.pdfpage:The PDF <_io.BufferedReader name='/Volumes/Scratch/Incoming/eg-scratch/6654220.pdf'> contains a metadata field indicating that it should not allow text extraction. Ignoring this field and proceeding. Use the check_extractable if you want to raise an error in this case 802 N. Twin Oaks Valley Rd., Suite 105 San Marcos, CA 92069 Phone: (760) 471-2100 FAX: (760) 471-2121 www.rfexposurelab.com May 22, 2023 Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 Re: Request Change in Identification Dear Examiner, This change of identification request applies for FCC ID: 2ADHKATWINC1500 as established in 47CFR 2.933(b) for a currently approved device. This application by Dr. Jean Bausch GmbH & Co. KG will establish a new FCC ID: 2BAUV-OCCLUSENSE for purpose of marketing. The original grant to Microchip Technology Inc. will remain in effect per 2.933(b). 1. The original identification is FCC ID: 2ADHKATWINC1500 2. The original grant date is 10/15/2015 3. The equipment is electrically identical, only applicant and FCC ID are different 4. The original test results continue to be applicable and representative of the equipment and there are no changes in the design, circuitry, or construction 5. Exterior photographs are included in this application and the label/location was provided. Best regards, Jay Moulton Vice President By:

Title:

On Behalf of: Dr. Jean Bausch GmbH & Co. KG Telephone: +49-221-70936-0