Kaia Back Pain

Instructions for Use

If you want to get a paper version of the instructions for use, please contact our support at support@kaiahealth.de.

Table of Contents

Welcome to Kaia Back Pain

1. The Kaia Back Pain therapy concept
   1. How Kaia Back Pain works
   2. When can Kaia Back Pain be used (intended use and indications)?
   3. When should Kaia Back Pain not be used (contraindications)?
   4. Known side effects of Kaia Back Pain
2. Getting started
3. Your daily program
   1. Course overview
   2. Physical exercises
   3. Motion Coach
   4. Relaxation practices
   5. Learning modules
4. The Kaia Back Pain App
   1. The “Today” tab
   2. The “Progress” tab
   3. The “Browse” tab
   4. The “Support” tab
   5. The “Settings” tab
5. Building habits
   1. Make concrete plans
   2. Set realistic goals
   3. Give yourself a reward
6. Getting in touch
7. Technical information
   1. Install the app
   2. Uninstall the app
   3. Update the app

Appendix

1. Hardware and software compatibility
2. Label & symbols

Welcome to Kaia Back Pain!

Thank you for choosing Kaia Back Pain to be a part of your pain relief. Congratulations on taking the first step!

If you are reading this, then you are one of millions around the world suffering from lower back pain. The good news is, you’ve taken an important first step towards better back health. Together with thousands of other users you decided to get active against back pain. Kaia Back Pain training can be done in just minutes per day. Schedule a quick session before work, during your lunch break and even while you travel! It is easy to use in the comfort of your home, engaging and entertaining.

This document contains important information to help you get started with the Kaia Back Pain app. Keep in mind that your doctor is the best person to provide you with information about your diagnosis and answer any medical questions you might have. If you have questions about registering for Kaia Back Pain or reimbursement, please contact our Customer Support at support@kaiahealth.de.

So, what are you waiting for? Let’s get started!

1. The Kaia Back Pain therapy concept

WARNING: Read these instructions carefully before use. Before using Kaia Back Pain, consult a physician and schedule a medical check-up so you and your back pain can be approved for physical therapy.

1.1 How Kaia Back Pain works

Kaia Back Pain is a digital therapy app that is based on the evidence-based concept of multidisciplinary rehabilitation.

Kaia Back Pain delivers new course units daily in your Daily Program that show you how to get physically active and proactively manage your back pain. When you register for Kaia Back Pain, the app uses your information to tailor your Daily Program to your unique needs.

Your Daily Program combines 3 main approaches that are particularly effective when used together:

• Physical Exercises - Simple exercise routines tailored to your specific needs which can help you to manage back pain in the comfort of your home.
• Relaxation Practices - Using the latest findings from mindfulness and progressive muscle relaxation, Kaia Back Pain helps your brain and body to cope with pain in a gentle but effective way.
• Learning Modules - Understanding the cause of your back pain and the connections in your body helps you to manage it more efficiently.

We advise our users to adhere as closely as possible to the instructions to avoid potential harm and to gain maximum benefits.

WARNING: If you experience severe pain or loss of function in any body part during or after the use of Kaia Back Pain, stop the exercise immediately and consult a physician.

Kaia Back Pain should be used between 3 and 7 times a week, unless you have been instructed otherwise by a healthcare professional. Use of Kaia Back Pain can contribute to improving common complaints associated with low back pain like the intensity of pain or impaired movement.

1.2 When can Kaia Back Pain be used (intended use and indications)?

Kaia Back Pain is intended for multidisciplinary rehabilitation of non-specific back pain (M54.-) that has persisted for longer than 4 weeks and for multidisciplinary rehabilitation following previous episodes of non-specific back pain. Patients can use the app with or without current or past supervision from medical professionals but need to have undergone prior medical examination to exclude causes for back pain that would require specific treatment. The app is designed to be used directly by laypersons in a home setting without prior training.

WARNING: Kaia Back Pain cannot diagnose your conditions or injuries and cannot safely exclude potentially dangerous causes for your back pain. Do not use Kaia Back Pain in lieu of medical consultation. Please consult your physician if you have any questions related to diagnosis.

1.3 When should Kaia Back Pain not be used (contraindications)?

WARNING:You should only use Kaia Back Pain if you do not have any of the contraindications listed below.

• Potential spinal injury or fracture (T09.- / M51.-)
  Do not use Kaia Back Pain if your back pain:
  • Is related to a fall or other serious injury, and
  • Has not been examined by your doctor to rule out spinal damage
• Decreased bone density (M80.- / M81.- )
  Do not use Kaia Back Pain if you have a history of low bone density (bone loss related to age or other medical reasons) unless your doctor has given you a medical exam and cleared you to do physical exercises such as those used in Kaia Back Pain.
• Spinal tumor (D48.- / C79.5)
  Do not use Kaia Back Pain if you have or have had any of the following unless your doctor has given you a medical exam and cleared you to do physical exercises such as those used in Kaia Back Pain:
  • Spinal tumor
  • History of cancer
  • Excessive night sweating, unexplained weight loss, and/or unexplained fatigue
• Spinal infection (M46.-)
  Do not use Kaia Back Pain if you have or have had any of the following unless your doctor has given you a medical exam and cleared you to do physical exercises such as those used in Kaia Back Pain:
  • History of unexplained fever
  • Recent bacterial infection
  • Unexplained potential symptoms of infection (feeling ill and/or tired)
  • Recent injection anywhere in the body
• Disc herniation (M51.-)
  Do not use Kaia Back Pain if you have or have had any of the following unless your doctor has given you a medical exam and cleared you to do physical exercises such as those used in Kaia Back Pain:
  • History of feeling numb or weak in your legs
  • Loss of feeling in the genital area
  • Bowel or bladder incontinence
• Previous spinal surgery (Z98.-)
  Do not use Kaia Back Pain if you have had previous spinal surgery unless your doctor has given you a medical exam and cleared you for physical exercises such as those in Kaia Back Pain.
• Advanced heart disease (I50.- / I51.-)
  Do not use Kaia Back Pain if you have or have had any of the following unless your doctor has given you a medical exam and cleared you to do physical exercises such as those used in Kaia Back Pain:
  • History of heart disease
  • Shortness of breath after climbing less than 2 flights of stairs
  • Other unexplained cardiovascular (related to the heart and blood vessels) complaints (such as heart palpitations, leg swelling, and cough)
• Conditions affecting your control over your lower body (from hips to toes) (G82.-)
  Do not use Kaia Back Pain if you have any conditions affecting your control over your lower body (such as a neurological condition) unless your doctor has given you a medical exam and cleared you to do physical exercises such as those used in Kaia Back Pain.
• Musculoskeletal problems affecting major joints in the lower body (M25.-)
  Do not use Kaia Back Pain if you have any conditions causing pain or reduced movement in the major joints of your lower limbs unless your doctor has given you a medical exam and cleared you for physical exercises such as those used in Kaia Back Pain.
• Pregnancy (O09.-)
  Do not use Kaia Back Pain if you are or think you may be pregnant.
• Gait imbalance (R26.-), history of falls (R29.6)
  Do not use Kaia Back Pain if you have or have had any of the following unless your doctor has given you a medical exam and cleared you to do physical exercises such as those used in Kaia Back Pain:
  • Walking imbalance
  • History of falling
  • Dizziness or low blood pressure brought on by exercise
• Coagulopathy (D68.-) or history of bleeding event
  Do not use Kaia Back Pain if you have or have had any of the following unless your doctor has given you a medical exam and cleared you to do physical exercises such as those used in Kaia Back Pain:
  • History of hemorrhage (excessive bleeding from a blood vessel)
  • Bleeding disorder

Relative contraindications

• Do not use Kaia Back Pain if you have trouble understanding any portion of the instructions in the app.
• Do not use Kaia Back Pain if you are under 18 years of age.

1.4 Known side effects of Kaia Back Pain

The following side effects have been reported for Kaia Back Pain in the past:

• Changes of back pain intensity and location (most often increased intensity of back pain during or after exercise, change in location of pain)
• Pain in neck muscles during or after exercise
• Pain in other parts of the body than the back during or after exercise
• Unpleasant sensations during exercise (like snapping sensations or temporary dizziness)
• Cramps in muscles during or after exercise

If these complaints are persistent for longer than a few days, please consult a physician.

2. Getting started

In order to get started with Kaia Back Pain, complete the following steps:

1. Register for the app on the Kaia Back Pain website at https://signup-msk.kaiahealth.de/ or directly through the app.
2. Complete your Kaia Back Pain Profile questionnaire. Your questionnaire answers are important, as we use them to create your Daily Program. To complete the questionnaire, tap the “Start” button and answer the questions. If you need help during any step, simply tap the blue info icon on the top-right side of the screen to receive additional information.
3. Once you’ve completed all of these steps, your account is ready and you’re able to start your first Kaia day!

3. Your daily program

As previously mentioned, multidisciplinary rehabilitation is particularly effective for treating back pain. Our approach at Kaia Back Pain includes physical exercises, relaxation practices, and learning modules. In order to provide the best therapy program for you, the app will provide new information every day.

3.1 Course overview

You can customize your Daily Program by joining and leaving courses. To leave or enroll in a course, select the “Settings” tab on the bottom of the screen. From the “Settings” screen, select “Course enrollment”. This will lead you to an overview of the available courses with the option to enroll in or leave each course. Click on a course to add it to your daily schedule. The courses you are enrolled in are marked with a dark blue check-mark icon.

Each course consists of several units. In your Daily Program, you’ll receive one unit or exercise each day for every course in which you are enrolled. If all units from the day are finished, the day will be marked as complete.

3.2 Physical exercises

Physical exercises are the cornerstone of your daily therapy. Based on the answers you provided when you signed up and the feedback you give after each exercise session, the app will select the best physical exercises for you every day. To start a physical exercise session, select “See exercises” and tap on the dark blue “Start” button at the bottom of the “Workout” screen.

Kaia Back Pain makes it easy for you to decide how long you want your Kaia Back Pain workout to be each day. To do this, go to the “Workout” in your Daily Program. There you can select the number of exercise rounds that suit you best.

Please note: We recommend connecting to WiFi each time you use Kaia Back Pain to ensure best performance. If you choose not to connect to WiFi, please check with your network service provider regarding data usage and overages.

Step 1: Instruction video

Before each physical exercise begins, Kaia Back Pain will show you a short intro video showing the proper way to do the exercise. Be sure to pay close attention to how the exercise is done and listen for hints on how to maintain the proper form. If you forget the instructions or need a reminder, you can always revisit the intro video during the exercise session. To do this, press the “Pause” button in the bottom left and then the white “Instructions” icon on the bottom right of the exercise video screen.

Step 2: Doing your Kaia Back Pain physical exercises

After the instructions, it’s your turn to exercise! For static exercises (exercises that feature a position that’s meant to be held for a certain period of time), Kaia Back Pain will show you the exact position to hold. In the case of dynamic (moving) exercises, you will be shown how to properly perform the movements.

Simply do the exercise for the duration indicated by the timer in the bottom-right corner of the exercise video screen. To pause your training, press the “Pause” button on the bottom left. To cancel your training, select the white “X” button in the top-right corner.

Please note: If you cancel your training, no progress will be saved and you will need to start the exercise from the beginning in order to complete that day’s Daily Program.

Pause screen

Once you’ve paused the exercise, you will be shown the “Pause” screen. From this screen, you can skip the exercise, cancel the training, or revisit the instructions by clicking each respective button. You can add exercises to “Favorites” by clicking the “Favorite” star button. These exercises can be found and revisited in the “Browse” tab under “Favorites” at the bottom of the screen.

To save your favorite exercises during exercising: First, tap the “Pause” button. From the “Pause” screen, click the “Favorite” star button to save the exercise to “Favorites”.

What makes training effective is very individual. So focus on finding a rhythm that works for you and your everyday life. Where you do the Kaia Back Pain workout is entirely up to you. For many of our users, it has proven helpful to always do the exercises in the same place. This makes it easier to develop a routine and to integrate the exercises regularly into your daily life. Just experiment with when and where the Kaia Back Pain exercises fit best into your daily routine until you find what works. The most important thing is that you stick to your Kaia Back Pain program regularly!

3.3 Motion Coach

Unsure if you’re doing the exercises correctly? We’ve got you covered. Kaia Motion Coach can help ensure that you’re doing the exercises correctly. Plus, it keeps track of your exercise repetitions.

Kaia Motion Coach captures your movements during your Kaia Back Pain physical exercises with your device’s camera. It gives you real-time feedback and suggestions on how to perform each exercise better and more precisely. Currently, Kaia Motion Coach is not yet available for all exercises in your Kaia Back Pain training program. However, it can be accessed for certain exercises in the “Browse” tab. We are working on offering more exercises that use Kaia Motion Coach.

You can click on the running-figure “Motion Coach” icon directly during Kaia Back Pain workouts to get real-time assistance with exercise correction. After you tap the “Motion Coach” button, the exercise will automatically resume where you left off, with Motion Coach now enabled. Please follow the instructions and adjust to the feedback given by Motion Coach for the best experience possible.

Alternatively, you can start the movement coach for specific exercises, independent of your daily program, from the “Library” area.

3.4 Relaxation practices

The second pillar of your Kaia Back Pain Daily Program is relaxation practices. Kaia Back Pain currently features two different relaxation techniques: breathing exercises and progressive muscle relaxation.

You can participate in both these techniques by enrolling in or leaving the respective courses in the course overview.

Relaxation practices are included in your Daily Program. To start a relaxation practice, go to the “Today” tab and select a relaxation unit by tapping on it. Then, click the dark blue “Start” button at the bottom. The app will then play an audio recording that will guide you through the entire exercise.

3.5 Learning modules

The third pillar of the daily Kaia therapy is learning modules. These concise and easy to digest sections offer additional information about the nature and background of your back pain and help you understand how to achieve long-lasting pain relief. To start a learning module, select a “Theory” unit by tapping on it and then tap the dark blue “Start” button at the bottom.

4. The Kaia Back Pain App

In the Kaia Back Pain App, you will find five different areas in the bottom bar - also called tabs. The five areas are as follows:

1. “Today“
2. “Progress”
3. “Browse”
4. “Help”
5. “Settings”

4.1 Tab “Today“

At the core of the Kaia Back Pain app is the “Today” tab. This is where you will find your daily program with the units of the courses in which you are currently enrolled and that are suggested to you. Tap the “See exercises” button to start your daily physical exercises, or select any other content on the screen to get active against back pain.

4.2 The “Progress” tab

After your first Kaia Back Pain day, you’ll be asked to briefly rate your pain intensity and sleep quality before starting your Daily Program. In the “Progress” tab, you’ll find an overview of these self-reported daily stats.

4.3 The “Browse” tab

In the “Browse” tab, you’ll find an overview of the different physical exercises in Kaia Back Pain. Here, you can review the video instructions for exercises, activate Motion Coach for a particular exercise, or see an overview of your last exercises as well as a list of your favorites.

4.4 The “Support” tab

For further information about the app, you can always chat with Kaia Back Pain Customer Support. Chat is easily accessible from the “Support” tab on the bottom right of the screen. The Chat works similarly to other messaging apps. Just type your message and your question or comment will be answered soon. Please keep in mind that this is not a live chat. Your message will be answered within 24 hours. If you haven’t received a reply within a few hours, please reach out to the Kaia Back Pain Customer Support at support@kaiahealth.de.

IMPORTANT INSTRUCTIONS

1. Kaia is not a replacement for medical advice. Please consult your physician if you have any medical questions.
2. Always adhere to the instructions given in Kaia Back Pain. Be sure to give honest answers to the questions asked in the app.
3. Your Kaia Back Pain account contains personal information and allows us to customize your program for you. Therefore, never share your Kaia account with other people. Please note that the use of Kaia is limited to private, non-shared devices.
4. Be on the lookout for Kaia Back Pain update notifications. Always update your app to the most current version when you receive an update notification from Kaia Back Pain. This is because updates may contain content relevant to your safety.

4.5 The “Settings” tab

In the “Settings” tab, you can update your personal information, view legal documents and adjust other app settings.

Once in the “Settings” screen, you’ll see the following sections:

• Training Schedule: Enables you to set your desired weekly training schedule as well as reminders for your training days.
• Course enrollment enables you to access your Kaia Back Pain course overview. Here, you can subscribe and unsubscribe from learning and relaxation courses.
  • Please note that you are always subscribed to the Workout course.
  • Your course enrollment selections in this section affect which course units are included in your Daily Program. A unit from every course you’re enrolled in will be added to your Daily Program.
  • Once you’ve completed all course units on a given day, that day will be marked as complete in the app.
• Subscription: Here, you can access details about your current Kaia Back Pain subscription length.
• Manage your data: Here, you can export your data as a PDF or in a machine-readable format. If you want, you can also show a printout or a digital version of your training history to your doctor to discuss your progress with Kaia Back Pain. You can also view, revoke and grant consent for data processing, as well as delete your user account and all associated data.
• General & Legal: Here, you can adjust other settings such as notification and contact settings. In this section, you can also adjust the language used in Kaia Back Pain or update your login credentials. Furthermore, you can view legal information, such as terms and conditions and privacy policy as well as used software licenses.
• Help Center: Here, you can access detailed instructions on how to access the sections and their corresponding features in the “Settings” screen, as well as information on many other topics related to how to use Kaia Back Pain. You can also contact our support here.

5. Building habits

We all have different ways of approaching change in our lives. While some can instantly add a new habit, others need some more time to adjust. Whatever your situation, the key to implementing change is to form habits. Below is some advice that has helped Kaia Back Pain users make the most of their therapy.

5.1 Make concrete plans

Getting started with Kaia Back Pain is easier when you set a fixed time in your schedule to do your training: the more concrete, the better. For example, set your training schedule to do your physical exercises every Monday, Wednesday, Friday, and Saturday after waking up but before breakfast. Make sure you have your workout clothes and exercise mat set up and ready to go.

For some of our users, it helps to always do Kaia Back Pain in the same room. However, the app allows you to train anytime and anywhere, so feel free to try different locations and times to see what works for you.

The relaxation exercises are ideal for cooling down after the physical exercises or before going to bed to help you fall asleep. Try out different times and see what works so you can be consistent with your training!

5.2 Set realistic goals

Trying to achieve goals by relying on implementing impossible changes will just result in frustration. There is a reason that New Year’s resolutions rarely work; we are just not made to completely change behavior in a short amount of time. What works, however, is making small changes.

If it’s been a while since you’ve played a sport or exercised, start with one or two physical exercises per week. If you’re new to relaxation, plan short sessions so you aren’t overwhelmed. You can always increase the frequency and duration of your training later. The most important thing is to get started! Make sure to follow your doctor's instructions as well.

5.3 Give yourself a reward

Kaia Back Pain can increase your quality of life significantly over time but getting there can be challenging. Setting up a routine isn’t easy, so don’t be too hard on yourself if you miss a training session or two. Don’t get discouraged; just go back to where you left off. Plus, there’s nothing wrong with a little reward when you achieve your goals!

6. Getting in touch

Legal Manufacturer

kaia health software GmbH (abbreviated as Kaia in the text)
Herzog-Wilhelm-Strasse 26
80331 Munich
Germany
info@kaiahealth.com

If you notice any deterioration in your health that you as a user or your healthcare provider feel may be linked to use of the Kaia Back Pain app, please reach out to us under the contact information provided above.

Please reach out to us if you require a paper copy of the Instructions for Use.

Kaia Back Pain is a medical device of class IIa.

7. Technical information

7.1 Install the app

How to install Kaia Back Pain in Android

1. Go to the Google Play Store on your computer, smartphone, or tablet (make sure you have an active Internet connection).
2. Click on the search bar.
3. Type “Kaia Back Pain”
4. Look for the blue-circle Kaia logo and confirm that you have the correct Kaia app for Back Pain, as Kaia has more than 1 app.
5. Click on “Install” and monitor the installation progress.
6. Once the app is installed, the “Install” button will change to “Open.”
7. Click on “Open” to launch the app.

How to install Kaia Back Pain in iOS

1. Go to the Apple App Store on your computer, smartphone, or tablet (make sure you have an active Internet connection).
2. Click on the search tab.
3. Type “Kaia Back Pain” in the search bar.
4. Look for the blue-circle Kaia logo and confirm that you have the correct Kaia app for Back Pain, as Kaia has more than 1 app.
5. Click on the Download icon and monitor the installation progress.
6. You can stop the installation by clicking on the Stop button.
7. Once the app is installed, the Download button will change to Open. Click on Open to launch the app.

7.2 Uninstall the app

How to uninstall Kaia Back Pain in Android

1. Open Android settings.
2. Go to the Apps section.
3. Search for Kaia Back Pain and click on it.
4. Click on the Uninstall button to uninstall the app.

How to uninstall Kaia Back Pain in iOS

1. Press the screen for 2 seconds until the app icons “wobble.” Then, click on the minus sign on the top-left side of the Kaia Back Pain icon.
2. Click Delete to uninstall Kaia Back Pain.

7.3 Update the app

How to update Kaia Back Pain in Android

1. Open the Google Play Store (make sure you have an active Internet connection).
2. Click on the search bar.
3. Type “Kaia Back Pain” in the search bar.
4. Click on the Update button.
5. Wait for the download to complete.
6. Click on Open to access the update.

How to update Kaia Back Pain in iOS

1. Open the Apple App Store (make sure you have an active Internet connection).
2. Click on the search bar.
3. Type “Kaia Back Pain” in the search bar.
4. Click on the Update button.
5. Wait for the download to complete.
6. Click on Open to access the update.

Appendix

i. Hardware and software compatibility

iOS

On iOS, all Apple smartphone and tablet models running iOS 13.0 or later are supported, except for the following devices, which do NOT support Motion Coach: iPad Mini 4, iPad Air 2.

Android

On Android, Kaia Back Pain can be installed and run on all smartphone and tablet models running the Android 5.1 (Lollipop) operating system or later, if they meet Google's requirements for Android version 5.1 or later.

Kaia ensures the correct functionality of Kaia Back Pain on the following Android devices through periodic reviews:

ii. Label* & symbols

	CE registration mark with notified body number. Indicates compliance with the requirements of the EU 2017/745 Medical Device Regulations
	Manufacturer
	Consult the operating instructions

*Please check the Contact page in the Settings screen of the app for the latest version, release date and UDI information