General Terms of Use of the
OccluSense® iPad app of Dr. Jean Bausch GmbH & Co. KG, Cologne
1. Subject matter of the contract; scope of application
1.1 Dr. Jean Bausch GmbH & Co KG (for provider details see website: http://www.occlusense.com/imprint) is the provider (hereinafter referred to as the Provider) of the mobile application "OccluSense® iPad App". The OccluSense® iPad app (hereinafter also referred to as the app) is part of the OccluSense® system, which consists of the OccluSense® handheld device (incl. charging station and power supply unit) and the OccluSense® sensor.
1.2 These General Terms of Use (hereinafter referred to as GTU) apply to all users of the App upon first access to the functions of the OccluSense® iPad App. These GTU are supplemented by the instructions for use (www.occlusense.com/downloads) and the data protection notice (www.occlusense.com/dataprotection-en) in their respective current versions.
1.3 User’s acknowledgements of deviating terms of use are hereby rejected. Individual agreements remain unaffected by this.
1.4 Users are entitled to use the app in accordance with the following provisions.
2. Services; costs of using the basic model; costs of using the paid model
2.1 The OccluSense® system allows users to visualize masticatory pressure distribution and to locate relevant contact points of the entire dental arch of the respective patient with full dentition (for temporary use). Initially, the OccluSense® iPad app has the following functions:
* Demo mode during first use to give a first insight of the range of functions;
2.2 After a one-time registration of the OccluSense® System, the user is granted access to all functions of the OccluSense® System, in particular
* Checking the masticatory pressure distribution of the patient's occlusion;
* Display of single premature contacts and graphical representation of occlusal pressure conditions on the iPad;
* Visualization of the masticatory pressure distribution within the entire dental arch;
* Possibility to compare several recordings, e.g. before and after a dental treatment incl. storage options on the iPad for documentation purposes;
* General patient management (create, edit, delete and export patient data).
2.3 The use of the OccluSense® iPad app is free of charge for users of the basic model, but requires the purchase of the other components of the OccluSense® system.
2.4 The use of the payment model (OccluSense® Connect) of the OccluSense® iPad app offers the professional user access to an extended range of functions of the OccluSense-iPad-app which means that it is possible for him to automatically synchronise stored occlusion data locally on the end device used within a provided cloud in order to ensure a consistent database on other end devices used by the professional user. Furthermore, when using the payment model of our OccluSense-iPad-app, it is possible for the professional user to receive and edit the personal data stored in the cloud and by using the OccluSense PC software on corresponding PC systems, import it into his patient management system.
2.5 Insofar as the digital services of the OccluSense® iPad app are not provided free of charge by the Provider, the costs and billing modalities, e.g. for the payment model, can be found in the current price information on the Provider's website or by contacting the Provider's sales department. The current price information at the time the contract is concluded with the provider (order) is decisive for determining the price of the individual service. In the event of a contract extension, the price information current at the time of the contract extension shall be decisive, provided that the user was informed separately of the changed prices by the provider at least 14 days before the corresponding contract extension and the user continues to use the services without objection. The user shall be informed separately of the right of objection and the legal consequences of remaining silent in the event of a price change.
3. Approval and usage requirements; registration; mobile applications and app store; system requirements
3.1 Using the functionalities of the app requires the free download of our OccluSense® iPad app from the Apple App Store. The terms and conditions of the Apple App Store must be complied with for downloading our app.
3.2 In general, this licence contract is concluded with the download of this app when the user clicks on the install field in the app-store and enters their password for the app-store, if prompted.
3.3 Only doctors/physiotherapists with specialist training (CMD, craniomandibular dysfunction) and their specialist staff are entitled to purchase the OccluSense® system and use the OccluSense® iPad app.
3.4 In order to obtain the functions of the basic model, the user must register the app by providing his full name, postal and email address and if applicable further data requested during the registration process, otherwise the access to full functionality ends after 14 days. Subsequently, the app goes back into demo mode and the user must register the app for further usage. The user must indicate their full name, a valid email address and a postal address during registration; all statements must be true.
3.5 To obtain the functions of the payment model, the user submits an offer via the app or the order form on the provider's website. The contract is concluded with the order confirmation from the provider.
3.6 Both the download and the registration of the app require an existing internet connection. This iPad app has been developed and tested for the following devices: http://www.occlusense.com/ipad
The app is optimized for iPads with a minimum screen size of 9.7”. Installation on an iPad mini is not recommended for this application. The user can find all other system requirements in the instructions for use (www.occlusense.com/downloads), which can be accessed within the app under the menu item "Instructions".
4. Contract duration; cancellation
4.1 The contract of use, based on these GTU, is concluded for an indefinite period of time with regard to the basic model and starts with the installation of the OccluSense® iPad app on the user's mobile device and/or with the completed registration of the app by providing the user data.
4.2 The user has the right to cancel his contract with regard to the basic model in writing (e.g. by e-mail to info@occlusense.com) without stating reasons with a notice period of 14 calendar days. The provider will then cancel the registration of the user within the term of cancellation, which ends the licence agreement between the parties.
4.3 Any additional contract concluded for the payment model has a minimum duration of one calendar month and will automatically be extended by a further calendar month unless it is terminated in due time via the Apple AppStore's cancellation function.
4.4 Each party has the right to terminate this contract in text form (e.g. by email to info@occlusense.com) for good cause without observing a notice period. An important reason for the provider is in particular:
• the significant breach of the clauses of these GTU by a user;
• the criminal action of a user/users or the attempt of such an action.
5. Rights and obligations of the users
5.1 The user is authorized to use the OccluSense®-iPad-App in the framework of the usage option granted to it by the provider as intended. The user is obligated to refrain from illegal actions and misuse of the access options to the system.
5.2 The user will continuously review and update its user data for accuracy.
5.3 The user is obligated to familiarize itself with the correct, technical and secure usage of the OccluSense®-system and to pay particular attention to the instructions. The instruction manual (www.occlusense.com/downloads) can be called up within the app under the menu item “Instruction”.
6 Rights and obligations of the provider; obligation of the user to run an update
6.1 The provider agrees to review the OccluSense®-iPad-App for functionality and security to the best extent possible.
6.2 The provider shall investigate complaints of users and third parties concerning malfunctions and decides which measures shall be taken in this case.
6.3 The design of content and technology, in particular in form and content of the OccluSense®-iPad-App lie solely at the discretion of the provider. The provider reserves the right to adapt, extend or improve services with updates at any time.
6.4 Users are obligated to run an update or a version change of the app, as soon as the download of an update or a new version is announced in the App Store.
7 System failure: Availability of the services; warranty
7.1 Due to the nature of the internet and mobile end devices, the provider does not assume any guarantee for the uninterrupted availability of the OccluSense®-iPad-App.
7.2 Regarding liable service offers, in case of unavailability of the service to a considerable extent (> 2 % unavailability), a pro rata refund of the consideration shall be made if the service cannot be made up for in a manner that is reasonable for the user. Availability is calculated on the basis of the time allotted to the respective calendar month during the contract term minus scheduled maintenance and downtimes that are beyond the control of the provider (force majeure, fault of third parties, etc.). Scheduled maintenance work shall preferably take place outside core working time (Monday to Friday 08:00 to 18:00 CET).
7.3 During maintenance work, it may occur that the aforementioned services may not be available on short call. Corresponding services will be made up by the provider in accordance with the user at the next possible time, provided this is acceptable for the user.
7.4 The OccluSense® iPad app distributed by the provider essentially corresponds to the product description in the instructions for use.
7.5 The product descriptions do not pose to be guarantees without separate written agreement.
7.6 Claims for defects do not exist for insignificant deviation of the agreed or assumed condition nor for an insignificant impairment of the serviceability of the OccluSense® iPad app.
7.7 The Provider shall remedy any defects in usability, excluding further claims for defects, by delivering a new version or an update. In the case of updates and new version deliveries, claims for defects are limited to the new features of the update or new version delivery compared to the previous version status.
7.8 In all other respects, the statutory provisions apply.
8. Risk distribution; specific exclusion of liability; contraindications; expected clinical benefit; precautions / safety notices
8.1 The OccluSense® iPad app is a medical device within the meaning of the Medical Devices Act. Use of the OccluSense® iPad app is at the user's own risk.
8.2 The OccluSense® system serves only as a diagnostic aid for recording and presentation of the occlusion conditions by visualization of the pressure conditions of the contact points, respectively the masticatory pressure distribution.
8.3 The OccluSense® system does not generate automatic therapy recommendations. Furthermore, the system does not control the treatment/therapy and there is no intervention in vital functions. The user is aware of the fact that the use of the OccluSense® iPad app is not a substitute for further (dental) medical advice, examination or treatment. The OccluSense® system is not intended to serve as the sole basis for diagnoses/therapy decisions. The provider is therefore not liable for damages suffered by the user (and indirectly for damages suffered by the patient) due to the user's own actions and conclusions based solely on the information and documentation displayed or retrieved from the OccluSense® iPad app.
8.4 Contraindications
The OccluSense® system is intended for use by professional users only and is not suitable for:
• Patients with edentulous jaw
• Patients with incomplete full-grown jaw
8.5 Expected clinical benefit
• The OccluSense® system allows to check the masticatory pressure distribution of the patient.
• Compared to conventional occlusion test materials (papers, foils), the system displays the occlusal contacts not only as a (final) state on the occlusal surfaces of the teeth, but also the temporal progression from the initial contact to the final 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 tomake a comprehensive diagnosis. The graphical representation of the occlusal contactsmust not be used to draw conclusions from the actually exerted bite forces (absolute
values). These are relative value representations.
8.6 Precautions / Safety Instructions
• OccluSense® is a medical device for professional use only.
• 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 may not be altered without the manufacturer's permission.
• The sensor must not be modified (e.g. cut to size).
• The hand-held device is designed for battery operation only. Mains operation (100-240 VAC) is not intended and may result in serious injury to 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 patient’s 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 difficulty.
• 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 20 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/therapy decisions.
9. Liability; exclusions of liability, limitation of liability
9.1 General liability, limitation of liability and exclusions
9.1.1 The provider has unlimited liability for intention and gross negligence.
9.1.2 The provider is only liable for minor negligence – except in the case of injury to life, limb or health – if significant contractual obligations were violated. Significant contractual obligations are those whose fulfilment is necessary to achieve the objective of the contract. The liability is limited to the contractually typical and foreseeable damage, however, up to a maximum of EUR 50,000.00.
9.1.3 Liability for indirect and unpredictable damage, loss of production and use, lost profits, lost savings and financial losses due to third-party claims is excluded in the case of ordinary negligence – except in the case of injury to life, limb or health.
9.1.4 The liability for financial losses is excluded, as far as liability is mandatory in cases of damage to privately used property under the Product Liability Act or in cases of intent or gross negligence or the breach of essential contractual obligations for contractually typical foreseeable damage.
9.1.5 As far as the liability according to sections 9.1.2 to 9.1.4 is excluded or limited, this also applies to the personal liability of the employees, staff, representatives, organs and vicarious agents of the provider.
9.2 Delays
9.2.1 In the event of delays, the statutory provisions shall apply in compliance with the general limitation of liability in accordance with Section 9.1.1-9.1.5 of these GTC.
9.2.2 Delays in performance due to force majeure and events that not only temporarily make the service considerably more difficult or impossible for the provider – in particular this includes strikes, lockouts, official orders, etc., even if they occur at suppliers or third party service providers of the provider – are not the responsibility of the provider even in case of bindingly agreed terms and dates. In this case, the deadlines and dates extend and shift appropriately.
9.3 Liability for data loss
The user is aware that, in the context of its duty to mitigate damage, the user must ensure the regular backup of its data in particular. The provider is only liable for the loss of data to the extent that the user has fulfilled its obligations to backup to an appropriate extent and the lost data can be mechanically reproduced with reasonable technical effort.
9.4 No change of burden of proof
A change of the burden of proof to the disadvantage of the customer is not connected with the above regulations.
9.5 Exclusion of further liability
Any liability beyond these GTC is excluded - regardless of the legal nature of the asserted claim. However, the above limitations or exclusions of liability do not apply to legally binding strict no-fault liability (e.g. in accordance with the Product Liability Act) or liability arising from a no-fault guarantee.
10. Data protection
10.1 The provider has taken extensive technical and organizational precautions to ensure the confidential and exclusively targeted treatment of data. However, the misuse by unlawful acts of third parties cannot be completely ruled out.
10.2 The provider undertakes to pass on the data stored during the registration only for its own purposes and not to outside third parties, provided there is no official obligation or the user has not expressly given its consent. This regulation concerning the handling of data is specified and supplemented by the Data protection notice (www.occlusense.com/dataprotection-en).
10.3 The provider undertakes to obligate its employees, who are entrusted with the administration and/or operation of the OccluSense®-iPad-App to strict compliance with data protection regulations.
10.4 Provider may record error reports (such as crash reports) of users to ensure quality of operation of the OccluSense®-iPad-App. The user sends the error report to the provider with separate consents. Section 10.2 is accordingly applicable for such data.
10.5 Note to basic model: The provider of the OccluSense®-iPad-App does not store any patient data within the basic model. Depending on the hardware setting, this data is either stored exclusively locally on the user's iPad or stored in Apple's iCloud when the cloud function is activated. The user can prevent storage (with limitations) in the cloud by deactivating or restricting the cloud function of the iPad. The user is therefore solely responsible for collecting, processing and possibly transmitting patient data according to the basic principles of data protection.
10.6 Notes on OccluSense® Connect:
10.6.1 In the context of the provision and use of these cloud functions in OccluSense Connect, the user (e.g. dentist) is the controller of the processing activity within the meaning of the GDPR. The provider acts as the controller's processor in the context of the provision of OccluSense Connect, the OccluSense®-iPad-App and the associated functionalities. This means that the provider processes the personal data collected and entered by the user only on the express instructions of the user (dentist) as the controller. The user and provider are obliged to conclude an order processing contract in accordance with Art. 28 GDPR.
10.6.2 Insofar as the user posts personal data of a third party (e.g. patient), the user assures that he is entitled to do so. If applicable, the user is obliged to obtain consent from the third party before transmitting the personal data and to inform about this. Within the framework of the OccluSense Connect, the user is solely responsible for data capture, processing and if applicable transmitting patient data in accordance with the basic standards of data protection.
10.6.3 In order to ensure the use of the (cloud) functions of the OccluSense Connect of the OccluSense®-iPad-App in the event of instructions, the Provider uses the Open Telekom Cloud of the provider T-Systems International GmbH (Hahnstraße 43d, 60528 Frankfurt am Main, Germany). Accordingly, the provider has concluded a (sub)processing contract with T-Systems International GmbH in accordance with Art. 28 GDPR in order to ensure the security and integrity of personal data in the context of processing. For further information on how T-Systems International GmbH handles data protection, please refer to the related privacy policy: https://www.open-telekom-cloud.com/de/datenschutz. The provider bases the processing of personal data (e.g. user data and patient data) , at the instruction of the responsible on the data processing contract pursuant to Art. 28 GDPR. The provider stores the user's personal data only as long as it is necessary to fulfil the purpose of processing. If the processing purpose no longer applies (e.g. completion of the processing activity, cancellation of the contract), we delete the personal data, unless we are obliged to continue storing your personal data due to statutory retention periods.
11. Copyright and property rights; rights of use
11.1 The Provider is the owner of all property rights, intellectual property rights and copyrights relating to the OccluSense® iPad app.
11.2 The provider grants the user a non-exclusive and non-transferable or sub-licensable right to use the app and documentation to the extent and solely for its own purposes for the duration of this license agreement, as is equivalent to the purpose of the provider's provision and transfer.
11.3 The information, the app and the documentation are protected by copyright laws, international copyright treaties and other intellectual property laws and agreements. The user will respect these rights, in particular not remove alphanumeric identifiers, trademarks and copyright notices from the information, nor from the software, nor from the documentation, nor from any copies thereof.
11.4 Otherwise, §§ 69a ff. of the Copyright Act remains unaffected.
12. General Information
12.1 The law of the Federal Republic of Germany is exclusively applicable excluding the reference standards of international private law (IPR) and the United Nations Convention on Contracts for the International Sale of Goods (CISG). The application takes the legal requirements of the Federal Republic of Germany into account. The provider assumes no responsibility for the fact that the OccluSense®-iPad-App or its information or documentation may also be retrieved or downloaded from locations outside the Federal Republic of Germany. If users outside of the Federal Republic of Germany access the OccluSense®-iPad-App, they are solely responsible for compliance with the relevant provisions of the respective state law. Access to the OccluSense®-iPad-App, its information and/or documentation from countries where this access may be unlawful, is not permitted.
12.2 In case of doubt, the German contract text of these GTU and its components has priority over translations into other languages.
12.3 The invalidity of one or more provisions of this contract shall not affect the remaining validity of this contract.
12.4 The supplementary parts of these GTU can all be found in the OccluSense®-iPad-App.
12.5 These GTUs replace all previous GTUs. Further changes to these GTC will be communicated to the user in text form by the provider. If the user does not object to such changes within 14 days after receipt of the notification, the changes shall be deemed agreed if the user continues to make use of the services provided by the provider. The right of objection and the legal consequences of the silence shall be separately indicated to the user in case of amendment of these GTUs.
Status: June 2024
Version: R.2
Dr. Jean Bausch GmbH & Co. KG, Cologne