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„ViViRA“- Instruction for use

Version 12.0, 1st of March, 2023

1. Purpose and General Information

1. Purpose and General Information

The DiGA ViViRA is a digital app for the treatment of back pain in non-specific back pain or arthrosis of the spine (osteochondrosis) that has been finally included in the DiGA directory by the BfArM. The app can be used according to a doctor's prescription and without a doctor's prescription. It offers, among other things, personalized and therapeutic training content that adapts based on user feedback, ways to monitor training activity and disease progression, ways to test movement ability, and knowledge articles on musculoskeletal health. These instructions for use describe how to use the ViViRA app as intended.
 
Before using the app, a doctor should confirm that ViViRA is suitable for you and your particular health situation.
 
ViViRA does not provide medical or therapeutic diagnosis or treatment.
 
Read these instructions carefully and completely before using ViViRA. Please pay particular attention to the following sections:
 
Section 2: Legal requirements for the use and processing of your data.
Section 3: Technical and medical conditions for use and contraindications
Section 4: Safety Instructions and Side Effects
 
Training with ViViRA can be done without supervision by a doctor or therapist.
 
Frequency of use
Unless otherwise instructed by a doctor, you should do one ViViRA training session of 4 exercises per day, at least 3 days per week.
 
Duration of use
The duration of use is limited to 90 days per prescription. If further therapy is needed, follow-up prescriptions may follow. There is no general duration of use to be observed. However, in case of complaints, a doctor should be consulted.
 
Note
Image excerpts from the app used in the instructions for use show the display on Apple devices. The display on devices using the Android operating system may differ slightly from this display.
Questions can be sent to service@diga.vivira.com at any time.
 

2. Legal requirements for the application, processing of your data

2. Legal requirements for the application, processing of your data

As a prerequisite for use, you confirm at the start of the introduction that you:

  • Are at least 18 years old
  • Have read and accepted the ViViRA General Terms and Conditions of Business
  • Have read and accepted the ViViRA Privacy Policy and consent to the processing of your personal health data by ViViRA.

You can find our currently valid privacy policy at: www.vivira.com/datenschutzerklaerung/. You can revoke your consent to the processing of your data at any time in the ViViRA app under Profile > Settings > Manage your data.

3. Requirements for use and contraindications

3. Requirements for use and contraindications

3.1. Technical requirements for the application

ViViRA is currently compatible with operating systems from Android 7.0 and iOS 14.0.
In order to be able to use the ViViRA service to its full extent, you should urgently keep both the ViViRA App and the operating system of your end device up to date ("Updates"). We recommend that you check both the operating system and the ViViRA for updates at least once a month. If older or not commonly used software is used, you may be limited or unable to use the services, or you may become a target of cyberattacks.

It is not possible to use the service without a stable broadband internet connection.
 

3.2. Medical condition for use

A prerequisite for using the programs is a stable general state of health.

If you experience pain, discomfort, or loss of function during or after using the app, you should stop the program and, if necessary – at your own discretion – consult a doctor.

Pause ViViRA if

  • severe pain
  • swollen or very warm joints
  • fever
  • general feelings of illness


3.3. Contra-indications

ICD-10Description
C41.2 Malignant neoplasm of bone and articular cartilage: Spine
C70.1 Malignant neoplasm: Spinal cord membranes
C79.4 Secondary malignant neoplasm of other and unspecified parts of the nervous system
C79.5 Secondary malignant neoplasm of bone and bone marrow
C79.88 Secondary malignant neoplasm of other localities not specified
G55.1 Compression of nerve roots and nerve plexus due to disc damage
G99.2 Myelopathy in diseases classified elsewhere
I80 Thrombosis, phlebitis and thrombophlebitis
M00 Purulent arthritis
M01 Direct joint infections in infectious and parasitic diseases classified elsewhere
M02 Reactive arthritis
M03 Post-infectious and reactive arthritides in diseases classified elsewhere
M23.4 Free joint body in knee joint
M24.05 Free joint body: pelvic region and thigh
M46 Other inflammatory spondylopathies
M50 Cervical disc damage
M50.1 Cervical disc damage with radiculopathy
M51.0 Lumbar and other disc damage with myelopathy
M51.1 Lumbar and other disc damage with radiculopathy
M87 Bone necrosis
M93.0 Epiphyseolysis capitis femoris (non-traumatic)
M93.2 Osteochondrosis dissecans
T84 Complications due to orthopaedic endoprostheses, implants or grafts
Z96.6 Presence of orthopaedic joint implants
Z96.64 Presence of a hip joint prosthesis
Z96.65 Presence of a knee joint prosthesis
Z96.68 Presence of other specified orthopaedic joint implants

ViViRA may only be used if none of the following contraindications are present, unless you have received medical clearance from a doctor who considers physical exercise as used in the ViViRA App to be safe in your particular case:

Acute inflammation or fever 
Do not use the ViViRA app if you have an acute inflammation or fever. 

Herniated disc or sensorimotor disorders
Do not use the ViViRA app if you have or have had a slipped disc or sensorimotor complaints. In addition to a herniated disc, these include numbness or weakness in your legs, loss of sensation in your genital area, and bowel or bladder incontinence.

Under neurological treatment
Do not use the app if you are receiving medical treatment for a stroke, paralysis, MS or seizure disorder.

Previous spinal surgery
Do not use the ViViRA app if you have had spinal surgery.

Previous hip or knee surgery
Do not use the ViViRA App if you have had knee or hip surgery in the past, especially if you have had a new joint or your leg axis has been corrected.

Possible spine, spinal cord, knee or hip joint injuries.
Do not use the ViViRA app if your pain is due to a fall or other physical injury and has not been medically evaluated to rule out injury to the spine, spinal cord or affected joint.

Spinal or joint infection
Do not use the ViViRA App if you have been diagnosed with a spinal, hip or knee infection in the past.

Spinal tumour
Do not use the ViViRA App if you have a medical history of a spinal tumour, cancer or excessive night sweats, unexplained weight loss and/or unexplained fatigue.

Free joint bodies
Do not use the ViViRA App if you have a free joint body in your knee or hip joint or if you have known osteochondrosis dissecans or bone necrosis.

Advanced heart disease
Do not use the ViViRA App if you have or have had a history of heart disease, shortness of breath after climbing less than 2 flights of stairs, or other unexplained cardiovascular conditions (e.g. palpitations, unexplained swelling of the legs, cough).

Rheumatic disease
Do not use the ViViRA App if you have a known rheumatic disease.

Decreased bone density
Do not use the ViViRA App if you have known low bone density (age-related bone loss or other medical reasons).

Gait unsteadiness or frequent falls.
Do not use the ViViRA App if you have an unsteady gait, frequent falls, low blood pressure or dizziness caused by exercise.

Bleeding tendency, history of increased bleeding, or taking anticoagulant medications
Do not use the ViViRA App if you suffer from increased bleeding, if you have a hereditary bleeding disorder or if you are taking medication that inhibits your blood clotting.

Pregnancy
Do not use the ViViRA App if you are pregnant or think you may be pregnant.

Lung failure
Do not use the ViViRA App if you have respiratory failure.

Thrombosis
Do not use the ViViRA App if you are currently being treated for thrombosis.

Psychosis
Do not use the ViViRA App if you are currently being treated for psychosis.

Skin sensitivity disorder
Do not use the ViViRA App if you have a skin sensitivity disorder.

Large skin defects or severe burns
Do not use the ViViRA app if you are, or have recently been, hospitalized for large skin defects or severe burns.

3.4. Accessibility
The app is not accessible and not suitable for users with visual impairments.

4. Safety instructions and side effects

4. Safety instructions and side effects

4.1. Safety instructions

Caution.
Always follow your doctor's instructions regarding the exercises and movements you are allowed to perform in your particular health condition. Your doctor's instructions always take precedence over the instructions in the app and must always be followed exactly. Failure to follow your doctor's instructions when using ViViRA may result in pain and injury.

Caution. 
Before performing an exercise, always pay close attention to the exercise instructions in the instruction video and always read the explanatory texts below the instruction videos. They contain important information on how to perform the exercises correctly. If you are not sure how to perform an exercise, stop it and ask your doctor or therapist. Although the exercises have been selected to be suitable for self-training at home without a doctor or therapist present, incorrect execution of the exercises can lead to pain and injury.

Caution. 
Always answer carefully and truthfully the questions you are asked in the app, especially about your complaint area, medical findings, movement restrictions, pain and the ability to perform all repetitions of an exercise. Inaccurate or incorrect information in the ViViRA app may result in you being given exercises that are not suitable for you. Performing such exercises can lead to pain or injury.

Caution. 
Some exercises require you to assume a quadrupedal position and a supine or prone position. If you have difficulty getting up after assuming these positions, you should not perform these exercises.

Caution. 
Some exercises require you to assume toe-up positions. If you have any insecurities about standing on your toes, e.g. balance problems and/or risk of falling, you should not perform these exercises.

4.2. Specific advice and warnings

Non-specific back pain

  • Note: Back pain in particular is often associated with stress, exercise and lack of sleep. This is called non-specific back pain. Only select "Non-specific back pain" from the list of medical indications in the app if you ...
    • do not feel any radiation in the legs
    • do not have a slipped disc
    • do not have scoliosis
  • Warnung: Wenn du starke Rückenschmerzen hast, solltest du dein Training unterbrechen und einen Arzt aufsuchen.

Osteoarthritis of the back (osteochondrosis)

Note: Osteoarthritis is a degenerative change in the cartilage that covers the joint surfaces. Colloquially, it is also referred to as "joint wear and tear". Osteoarthritis is characterised by pain and restricted movement in the joint and is often accompanied by morning stiffness that improves with movement.

Warning: Exercise often helps with osteoarthritis pain, which can sometimes be weaker and sometimes stronger. Start exercising slowly so you don't overexert yourself. Reduce the intensity of exercise or skip painful exercises if your pain persists.
 
4.3. Side effects
Side effects are undesirable effects that may occur when using the app as intended. What are the possible side effects?

  • Temporary, mild pain due to overuse of joints, muscles or tendons.

For the information at this point, reported side effects that occurred in at least one in 50,000 ViViRA installations were considered. We are not aware of any other side effects at the time of writing this leaflet.

Other possible side effects, although none have been reported to us by users:

  • Pain in the legs, knees, back of the hands
  • Ischialgiform pain in the area of the lumbar spine due to irritation of the nerve exit points from the spine
  • Irritation of joints with impaired function
  • Swelling
  • Itching

4.4. Reporting adverse effects or events
If you notice an adverse effect (e.g. a discomfort or change) while using ViViRA, send us a message directly from the app (Profile > Settings > Send us a message) or email us at service@diga.vivira.com. You can also contact a doctor to report an adverse effect.
 

5. Therapy concept

5. Therapy concept

ViViRA is based on movement therapy.

"Exercise therapy is a physiotherapy procedure to increase resilience and restore normal body functions through systematic and individually adapted physical exercises." (Pschyrembel Clinical Dictionary)

Exercise therapy is part of the guidelines for the treatment of non-specific and degenerative back pain and is thus a recognised professional standard. In addition, the positive effect of exercise therapy on pain reduction has been scientifically proven.

Within the framework of movement therapy, ViViRA specifically addresses mobility (mobility), stability (strength) and coordination through regular self-exercises. "Mobility is the combination of muscle flexibility and range of motion of the joint, both together form the mobility of a body part.(...) Stability describes the maintenance of posture and the control of fundamental movements. It therefore requires strength in different joint positions, at different speeds of movement and in combinations of these. (...) Coordination, or the correct neuromuscular control, is the third essential pillar of a movement. What is meant by this is the ability of our brain to control a movement and to control its course." (Klingenberg 2019)

The ViViRA exercises were selected according to a functional training approach. They usually affect several joints and muscle groups, i.e. they follow the principle of supra-regional dependencies and related muscle chains. ViViRA training thus follows a holistic therapy approach to support the strengthening of the body in its entire range of motion.

You can find more literature on the therapy concept in the ViViRA app in the "Knowledge" section under "ViViRA therapy concept".
 

6. Introduction and set-up of your Vivira account

6. Introduction and set-up of your Vivira account

In the introduction to the app, you answer questions about yourself, your area of complaint, any medical findings and movement restrictions. Your training program is configured from this information.
 
Shortly before the end of the introduction, the app will ask you to enter your email address and a password of your choice to set up your ViViRA account. To verify your identity, we will send you an email that you must confirm.

We also need your email address so that we can contact you with important product safety notifications. ViViRA will never share your email address with third parties or use it for promotional purposes. Please use a secure password that only you know and that consists of at least 8 characters, including at least one upper and lower case letter and at least one number.

If you have received an activation code for ViViRA from your health insurance company, you can enter it on the code activation screen. For iOS users (iOS version 16.0 and above), you may also scan the code on your insurance letter.

As soon as you have completed the introduction and set up your ViViRA account, you can use the ViViRA app for therapeutic training!

7. Daily exercises

7. Daily exercises

7.1. Basic information

In the app, after setting up your ViViRA account, you will receive 4 exercises per day. After each exercise, you give feedback on whether the exercise triggered or intensified pain and whether you were able to perform all repetitions. The exercises in your training plan change in intensity and complexity according to your input.

Stop an exercise if it causes or worsens pain or if you notice a loss of function. See a doctor if these symptoms persist.

7.2. Entry via the Today page

You can access the exercises from the Today page in the app by tapping the exercise card.

Entry via the Today page

Swipe up and down to see the four daily exercises. Tap the orange triangle to start the respective exercise preview.

Exercises
7.3. Exercise Preview

Follow carefully the explanations on how to do the exercise in the video of the exercise preview. In addition, read the explanation below the video. As soon as you are familiar with the correct execution of the exercise, tap on "Start exercise".

Exercise Preview
7.4. Exercise execution

Perform the exercise with the number of runs and repetitions or seconds indicated here. Once you have finished, tap “Done”.

Exercise execution
7.5. Feedback after the exercise

After performing the exercise, answer questions about pain and your ability to complete the exercise.

Stop an exercise if it triggers or worsens pain or if you notice a loss of function. Seek medical attention if these symptoms persist.

If you report pain, you will have the option to remove the exercise from your programme.

The information you provide will determine whether you increase the intensity and complexity of the exercise next time.

Caution!
Once feedback has been entered, it cannot be taken back or undone. Therefore, take special care to enter your feedback correctly.

Caution!
Removing an exercise from the program cannot be undone. The exercise will be removed permanently. Therefore, pay special attention if you want to try the exercise again in the future or remove it from the program.

7.6. Exercise history

You can view your exercise history on the activity page of the app.

Exercise history
8. Weekly progress report

8. Weekly progress report

8.1. Basic information

The app asks you to answer a weekly progress log with seven questions about pain, limitations and your therapeutic treatment.

8.2. Entry via the Today page

You can access the History Log from the Today page in the app by tapping the History Log card.

Entry via the Today page
8.3. Entry via the outcomes page

You can also access the progress log via the outcomes page in the app by tapping on "Track now".

Entry via the outcomes page
8.4. Answering the questions

The questions are asked in the form of a written dialogue. You make statements by pressing a slider and by yes/no statements.

Answering the questions
9. Monthly movement test

9. Monthly movement test

9.1. Basic information

Every month, the app asks you to perform a movement test with 15 movements. A movement score is calculated using the information you provide after each movement.

9.2. Entry via the Today page

You can access the movement test via the Today page in the app by tapping the movement test card.

Entry via the Today page
9.3. Entry via the outcomes page 

You can also access the movement test via the outcomes page in the app by tapping on "Test now".

9.4. Carrying out the test

For each movement, you get an illustration with an explanation text. You try to perform the movement as instructed.

Afterward, you answer the questions for each exercise whether you were able to perform the movement and whether you had pain during the movement.

ViViRA calculates a score for the overall movement ability and a score for mobility, strength and coordination.

Send report
10. Steps

10. Steps

10.1. Basic information

The app allows you to record the steps you take every day.

10.2. Entry via the Today page

You access the entry area via the Today page in the app by tapping the "Enter steps" field under the exercise card.

10.3. Entry via the Today page

You access the entry area via the Today page in the app by tapping the "Log steps" field under the exercise card.

Entry via the Today page
10.4. Entering the steps

You can enter the steps manually or, on Apple devices, have the steps automatically transferred to the Vivira app via an integration with Apple Health.

Entering the steps
11. Visualisation of activity and progress

11. Visualisation of activity and progress

11.1. Basic information

Your daily training activity, your progress log, your exercise test scores and your daily steps are visually displayed in the app so that you can follow their progress over time at any time.

11.2. Activity

The activity page in the app shows you the history of your activities in the form of a timeline with your exercises, progress logs, movement tests and steps.

Activity
11.3. Outcomes

The outcomes page in the app shows you progress curves of the values you have entered for movement abilities, pain, and limitations. 

Outcomes
12. Sharing programme and history data

12. Sharing programme and history data

12.1. Basic information

If you want to share important program and progress data with a doctor or therapist, you can generate a PDF file with this data from the app. You can then print out the PDF file and present it to your doctor.

12.2. Entry via the profile page

On the profile page, tap on "Export your data" at the bottom.

Entry via the profile page
12.3. Create report

Tapping on "Create PDF report" opens a written dialogue in which you are asked questions about pain and your therapeutic treatment. After answering the questions, the app automatically creates a PDF file with your most important program and progress data. 

Create report
12.4. Send report

ViViRA explicitly does not recommend that you share your personal health data, e.g., in social media. Only share your personal health data in applications that guarantee the legally required level of data protection and data security, in which you know the group of recipients and in which you can determine exactly who the recipient(s) of your data are.

Send report
13. Knowledge article

13. Knowledge article

13.1. Basic information

In addition to the training, you can read knowledge articles on musculoskeletal health topics in the app to support the training effect.

13.2. Entry via the Today page

You can access the knowledge articles from the Today page by tapping the “Read insights” box under the Exercises card.

Entry via the Today page
13.3. Reading the articles

Swipe up and down as well as left and right to get an overview of the available articles. These cover topics such as "About ViViRA", "Pain", "Rest and Relaxation" and "Posture and Movement".

Reading the articles
14. Settings

14. Settings

14.1. Basic information

You can change your program settings at any time on the profile page and under Settings.

14.2. Entry via the profile page

You can find the settings by tapping on "Settings" at the top right of the profile page.

Anleitung: Einstieg über die Profil-Seite
14.3. Change of settings

In Settings, you can make a variety of changes to optimize your ViViRA experience, send us a service request or recommend ViViRA. You can set your notifications here, turn your Apple Health integration on and off, and change your password. You can also manage your data here or log out of the app so that it is only accessible again when you log in again. 

15. Tips for training with Vivira

15. Tips for training with Vivira

To start your training with ViViRA, read in particular the knowledge articles “About ViViRA” in the top row of knowledge articles. These will give you a basic understanding of the ViViRA training philosophy and a suitable weekly routine. They also give tips on what can be done if exercises are either too difficult for you or not challenging enough. 

16. Further information


16. Further information
 

Address:
ViViRA Health Lab GmbH
c/o Mindspace
Krausenstr. 9-10
10117 Berlin, Germany

Instruction for use
Please read the instructions for use before using the Vivira app


Vivira is a CE marked medical device

Further information
You can find more information about the manufacturer and news about the product on our website www.vivira.com.

Vivira Health Lab GmbH
c/o Mindspace
Krausenstr. 9-10
10117 Berlin, Deutschland
Kontakt: service@diga.vivira.com