Instructions for Use

Version 4.0 · 20 August 2025 · © 2023 Digitineers GmbH & Co. KG, Tübingen

Instructions for Use – Vertidisan^®

1. Application Notes

Intended Purpose

Vertidisan^® serves to improve vertigo in peripheral balance disorders. It also serves to document manually entered health data and to forward that documentation. Vertidisan does not serve to produce or provide information for use in diagnostic or therapeutic decisions.

Medical Purpose

Vertidisan^® ("App") is an online-based, CE-marked medical device for therapeutic support of patients with vertigo as a result of a peripheral balance disorder. It contains digital, interactive, multimodal, diagnosis-adapted therapeutic training programmes consisting of 90 therapy sessions with vertigo exercises, cognitive behavioural therapy units, vertigo counselling, and guidance on muscle relaxation and muscle building. Relaxation phases and health education are also included.

Vertidisan^® is suitable for patients with so-called peripheral vertigo, vestibular neuronopathy, otogenic vertigo, ear vertigo, other disorders of vestibular function, and vertigo syndrome NOS. A detailed list of indications and contraindications is provided in Appendix 1.

Training can be carried out without supervision by a physician or therapist. Before use, however, a physician should have confirmed that Vertidisan^® is appropriate for you and your health situation. Unless otherwise instructed by a physician, one Vertidisan^® training session should be completed per day. The duration of use depends on the type and duration of the complaint and is therefore determined solely by your physician.

The therapy programme of this app is published by Prof. Dr. med. Hans-Peter Zenner, University Professor of ENT Medicine, Tübingen. The efficacy of the app has been scientifically verified; nonetheless, it does not offer the best therapy in every case. Vertigo may also indicate serious illness. Some patients may not be able to follow the exercise programme.

Minimum age: 18 years.

Please read the instructions for use carefully before using the app. A physician should also have confirmed that Vertidisan^® is suitable for you and your specific health situation before use. Questions beyond these instructions may be directed to support@digitineers.com at any time.

Safety Notes

• Vertigo can in individual cases be attributable to serious illness. We therefore recommend seeking medical advice before using Vertidisan.
• Individual exercises are not suitable for every patient. We therefore recommend seeking medical advice before using Vertidisan.
• Clarify with your physician whether independent performance of physical exercises is appropriate for you.
• Do not perform exercises under the influence of alcohol or narcotics.
• Choose an appropriate location with sufficient space. Avoid trip hazards or inappropriate clothing. Have something to hold on to (e.g. a chair) within reach.

Supplementary Notes

• During the exercises, please put your smartphone down (e.g. on a stand).
• During all exercises you are accompanied by audio guidance from the app so you do not constantly need to look at the screen.
• During and after the first exercises, temporary vertigo and/or muscle soreness may occur — this is normal at first and will diminish later.
• Exercises frequently last approximately 10–15 minutes per day, sometimes a little longer.
• Medical cognitive behavioural therapy and medical counselling can last up to 30 minutes. Plan your training days accordingly, e.g. at the weekend.
• You can replay the instructional videos from earlier exercises as often as you wish by reopening the tiles for days whose programme you have already completed.
• In most cases you should do the exercises for 3 months. If you become free of vertigo earlier, you can click the "End Therapy" button (in the library) at any time and then stop.
• Particularly from the age of 60, more than 3 months of therapy may be required.
• If you have consented to the use of your health data, the app synchronises usage data with the server. You can revoke this consent at any time — all your personal health data will then be irreversibly deleted, although the app will continue to function.
• The app is not designed for simultaneous use by multiple users or devices.

2. Technical Requirements

Vertidisan^® can be accessed as an interactive online programme via any internet connection. The patient receives an access key which entitles use of Vertidisan^® for 90 usage days after initial registration.

You need a smartphone or tablet with an Android operating system (version 12 and above) or Apple iOS (version 18 and above), as well as an e-mail address. No special computer skills are required, as Vertidisan^® guides you through the programme.

3. How Vertidisan Works

3.1 Content

The medical content of Vertidisan^® has been compiled by experienced physicians. All content and treatment principles on which the Vertidisan^® therapy is based come from science, from treatment guidelines for psychotherapists and physicians, or from recommendations of specialist societies for the treatment of vertigo. In the treatment units, most therapy sessions are prepared as audio or video recordings by a physician or therapist.

3.2 Functions

Vertidisan^® encompasses recognised treatment elements of physiotherapy, cognitive behavioural therapy, counselling, and muscle relaxation and building. The app conveys information about diseases involving vertigo, presents exercises, methods and techniques, and supports you with additional written information to deepen the content of Vertidisan^® exercises and integrate them into everyday life.

The primary functions include: video demonstrations of vertigo exercises; cognitive behavioural therapy video sequences; medical vertigo counselling; and muscle relaxation via Progressive Muscle Relaxation (Jacobson), Autogenic Training, or brief relaxation. Additional functions include audios for relaxation guidance, a health knowledge library, therapy progress recording, and a progress report for self-review or digital forwarding to your physician or electronic patient record (ePA).

3.3 Product Description

Vertidisan^® offers structured therapy for patients with peripheral balance disorders. The app has no measurement or diagnostic functions and is therefore a Class I medical device under the Medical Device Regulation (MDR). In accordance with German scientific guidelines, the therapy programme contains units from five main areas:

• Vertigo exercises: Video demonstrations of scientifically founded vertigo exercises as an almost daily therapy item, accompanied by written instructions.
• Cognitive behavioural therapy (CBT): A structured, manualised CBT programme.
• Vertigo counselling: Medical video sequences and short articles providing information about vertigo and current treatment and diagnostic options.
• Muscle relaxation: Audio with medical guidance for Progressive Muscle Relaxation (Jacobson) and Autogenic Training.
• Otago Exercise Programme (OEP): For patients with a tendency to fall, the OEP carefully strengthens the muscles, particularly the legs, to further reduce fall risk.

In addition: a Knowledge Library covering many questions about vertigo.

3.4 Setup and Programme Configuration

During setup you can answer questions about yourself, your symptoms and any existing medical findings. Answering the health-related questions is not mandatory — you can use the app without providing this information.

3.5 Daily Therapy

After setting up your Vertidisan^® therapy account you will regularly receive instructions for your daily therapy. Stop an exercise if it triggers or worsens vertigo or pain, or if you notice other side effects. Consult a physician if these symptoms persist.

3.6 Progress Log and Sharing Progress Data

If you wish, you can keep a therapy outcome log. You can enter details about your vertigo at any time and generate a progress report in PDF format, which you can then provide to your physician or therapist.

3.7 Scientific Data Analysis

You can provide the therapy report data to us in anonymised format — without any reference to your person — to enable scientific analysis for improving the app. Anonymous means the data contains neither your name, date of birth, address, nor any code linked to you.

4. Legal Requirements for Use and Data Processing

As a prerequisite for use, at the start of setup you confirm that you are at least 18 years old, that you have read and accept the Vertidisan^® Terms and Conditions, and that you have read and accepted the Vertidisan^® Privacy Policy.

Consent to the processing of your personal health data by Vertidisan^® is not a prerequisite. We as the manufacturer do not have access to your personal health data. If you wish the app to record and evaluate your health-related data, you must first give your consent. You can revoke this consent at any time.

5. Medical Requirements

5.1 Medical Prerequisites for Use

Pause using Vertidisan^® in the event of fever or a general feeling of illness. If you experience pain, increased vertigo, malaise or vomiting during or after use, stop the programme and consult a physician if necessary.

5.2 Contraindications, Warnings, Interactions

Contraindications — Vertidisan^® must not be used in the presence of:

• Cervical spine and neck disorders
• Acute inflammatory diseases
• Febrile condition
• Heart failure (cardiovascular decompensation)
• Respiratory failure (pulmonary insufficiency)
• Motor disorders
• Seizure disorders (e.g. epilepsy)
• Spinal cord injury
• Psychoses
• Cutaneous sensory disorders with impaired mobility
• Pregnancy
• Thrombosis
• Coagulation disorders including anticoagulant therapy
• Large skin defects
• Burns requiring hospitalisation
• Metastases from malignant tumours
• Significant visual impairment
• Frailty / frailty syndrome

Pregnancy: Vertidisan^® must not be used during pregnancy.

Driving and operating machinery: As long as Vertidisan^® does not trigger vertigo, the app does not restrict participation in road traffic or the operation of machinery. Vertigo may lead to such restrictions.

Warnings: Please observe the warnings in these instructions. They relate to complaints or conditions for which it is important that you have discussed them with your treating physician, as special attention is required in these cases.

Interactions: No interactions between Vertidisan^® and additionally used medicines, food or dietary supplements are known. Nevertheless, Vertidisan^® should not be used together with medicines whose intake is associated with a risk of falling. Ask your doctor or pharmacist.

5.3 Accessibility

Current information on accessibility can be found in the Knowledge Library under "Accessibility". The app is not fully accessible — it is not suitable for users with severe visual impairments or severe motor disorders. For hearing-impaired users, all spoken texts are also available in written form and can be transmitted to compatible hearing aids, middle-ear implants or cochlear implants. For users with visual impairments, operating buttons have been made large and all therapy unit texts can also be listened to. For users with motor disorders of the hand, buttons are sized sufficiently large.

6. Risks and Side Effects

6.1 Risks

6.2 Side Effects

Known side effects:

• Temporary vertigo, increase in vertigo or balance disturbance (may occur at first and will soon subside)
• Temporary nausea, loss of appetite
• Temporary fatigue
• Temporary headaches
• Temporary neck pain
• Temporary blurred or tunnel vision
• Temporary musculoskeletal pain
• Muscle or back tension
• Temporary knee pain
• Temporary tinnitus
• Occasionally prolonged, temporary increase in vertigo

Caution! If the app triggers rotational vertigo or unsteadiness of gait that does not subside, please consult your physician.

Expected but not yet observed side effects: cardiovascular syncope, rise in blood pressure, connective tissue or muscle injuries, oedema, nasal mucosa inflammation, aversion to psychotherapy.

Reporting a Risk or Side Effect

You can report side effects to the manufacturer:

• By phone: 07071–704 3011
• By e-mail: meldung@digitineers.com (not data-secure)
• By post (also anonymously): Digitineers GmbH & Co. KG, August-Bebel-Str. 9, 72072 Tübingen, Germany

Serious side effects caused by Vertidisan must be reported to the German Federal Institute for Drugs and Medical Devices at mp-vigilanz@bfarm.de using the report form at www2.bfarm.de/medprod/mpsv/.

7. Installing the Vertidisan App

An internet connection is required for installation and use. Before installing the app, make sure you are either connected to Wi-Fi or have a large data volume with your network provider.

Apple devices (iPhone / iPad — iOS):

1. Open the App Store and tap the Search icon.
2. Enter "Vertidisan" in the search field.
3. Tap the download icon.
4. Wait until the blue circle next to Vertidisan^® has loaded, then tap "Open".

Android smartphones/tablets:

1. Open the Google Play Store.
2. Enter "Vertidisan" in the search field.
3. Tap "Vertidisan" next to the Vertidisan symbol.
4. Tap "Install".
5. Confirm access by tapping "Accept" and open the app.

You can now open the Vertidisan app at any time by tapping the Vertidisan icon in your menu.

8. Operating Vertidisan

8.1 First Steps: From Opening the App to Starting Therapy (Onboarding)

Open the app via the Vertidisan icon on your smartphone/tablet. Register and enter your access code.

• Access code: Where the requirements are met, statutory health insurance patients receive the code free of charge. Private patients can purchase the code and submit the invoice to their insurer for reimbursement. Details at www.vertidisan.com.
• Terms and Conditions: Read and accept the Terms and Conditions.
• Privacy: Read and accept the privacy information.
• Consent to data processing: Read and provide consent to the processing of personal data (without health data) in accordance with DiGAV §4.
• Voluntary consent to processing of health data: With your consent, we can provide you with individual therapy progress reports that you can read yourself or share with your physician or transmit to your electronic patient record (ePA). This consent is voluntary — the app works without it and can be revoked at any time in the Menu under "Consents".
• Progress questionnaires: Select and complete one or more scientific questionnaires to enable a progress report. The more questionnaires you complete, the more detailed the report. From Day 2 onwards, tap "Reports" in the footer, then "Answer questionnaire".
• Diagnosis selection: Vertidisan asks for your diagnosis (select "unknown" if unsure). The app then assembles appropriate exercises for your therapeutic training.
• Daily reminders: You can opt to receive a push notification reminder on your smartphone/tablet if you have not yet completed your daily therapy. Adjust notification type under your device's Settings.

8.2 Starting Therapy

The app guides you automatically to the therapy start page. Tap the "Day 1" tile. On Day 1 only, you first receive a series of information. Therapy follows afterwards. Open the respective video (or audio) and follow it. After the therapy, tap "Next" to reach an overview of all completed and upcoming therapy day tiles. Previous tiles can generally be reopened at any time; new ones are unlocked from midnight of the following day.

8.3 Continuing Therapy

The app's content builds on itself. After completing all content of a daily unit, the next daily unit is automatically unlocked from midnight. Tap the "Today" icon in the footer to access it.

8.4 Completing Therapy

The "End Therapy" unit is accessible via the "Knowledge" icon (book icon). If you wish to end therapy early, please complete the "End Therapy" unit first.

8.5 App Controls

Within all therapy units, navigate using the "Next" button or the forward/back arrows. At the end of a daily programme, a footer with four icons appears:

• Today icon: Access today's programme, all completed days, and — from midnight — the next new daily programme via the respective tile. Tiles with a downward arrow provide downloadable PDF documents.
• Reports icon: Access your current therapy progress report. Tap the downward arrow (top right) to generate a PDF. The report can also be securely exported to your ePA or your registered physician's practice system. Tap "Answer questionnaire" to fill in your selected questionnaires (ideally once per week).
• Knowledge icon: Access the Knowledge Library with specialist medical articles on vertigo, literature references, quiz questions, therapy report analysis guidance, Otago exercises, and the "End Therapy" unit.
• Menu icon: Access Account settings (change e-mail/password, export data, end therapy, delete data); Consents/Revocations (notifications, terms, privacy, data processing); Legal (privacy policy, T&Cs, imprint, physician information, side effect reports, about us); Product Information (overview, indications, side effects, package leaflet, instructions for use); Medical Device information (name, version, UDI, manufacturer, intended purpose); and Actions (contact support, log out).

8.6 Intended Use

The app may only be used for its intended purpose: improving vertigo in peripheral balance disorders and documenting manually entered health data. It does not serve to produce or provide information for diagnostic or therapeutic decisions.

9. Classification and Operating System Requirements

Vertidisan^® is a standalone software mobile application with no measurement function and takes no therapeutic decisions. It is therefore a Class I medical device under MDR (2017). Required: a smartphone or tablet with Android (version 12 and above) or Apple iOS (version 18 and above) and a functioning internet connection.

10. Performance Features

Digitineers GmbH & Co. KG guarantees an average online availability of Vertidisan^® of 99.5% per year. Vertidisan^® has no additional functions that can be purchased.

11. Compatibility Statement

Vertidisan^® runs on an internet-capable device (smartphone or tablet with Android version 12 and above, or iPhone/iPad with iOS version 18 and above) with an internet connection sufficient for video streaming.

12. CE Marking

Vertidisan^® is a CE-marked Class I medical device under EU MDR (Medical Device Regulation 2017) and fulfils the requirements of the German Medical Devices Implementation Act (MPDG).

13. Data Protection

Vertidisan^® is compliant with the General Data Protection Regulation (GDPR) and sets high standards for technical data protection. Your medical data remains exclusively on secure servers in Germany. Further information can be found in the Privacy Policy via the Menu.

14. Product Labelling

Pursuant to DIN EN ISO 15223-1:2017-04, the CE mark, manufacturer details and file identification are located on www.vertidisan.com and in the app.

15. Contact

For content or technical questions, please e-mail us at any time: support@digitineers.com

16. Manufacturer

Vertidisan^® is manufactured and placed on the market by Digitineers GmbH & Co. KG in Germany.

Digitineers GmbH & Co. KG
August-Bebel-Str. 9
72072 Tübingen, Germany
www.digitineers.com

Appendix 1: Indications and Contraindications

Indications — Vertigo due to Disorders of Vestibular Function (ICD-10)

• H81.0 — Ménière's disease
• H81.1 — Benign paroxysmal vertigo
• H81.2 — Vestibular neuronitis
• H81.3 — Other peripheral vertigo (incl. vertigo: ear / otogenic / peripheral NOS)
• H81.8 — Other disorders of vestibular function
• H81.9 — Disorder of vestibular function, unspecified (incl. vertigo syndrome NOS)
• R29.6 — Tendency to fall, not elsewhere classified (incl. tendency to fall due to other unclear conditions; tendency to fall in elderly persons)

Contraindications — Vertidisan^® must not be used in the presence of:

• Cervical spine disorders / cervical syndrome
• Acute inflammatory diseases
• Febrile condition
• Heart failure (cardiovascular decompensation)
• Respiratory failure (pulmonary insufficiency)
• Motor disorders
• Seizure disorders (e.g. epilepsy)
• Spinal cord injury
• Psychoses
• Cutaneous sensory disorders with impaired mobility
• Thrombosis
• Coagulation disorders including anticoagulant therapy
• Large skin defects
• Burns requiring hospitalisation
• Metastases from malignant tumours
• Severe visual impairment
• Frailty / frailty syndrome
• Pregnancy

Version 4.0 · 20 August 2025