Kaia COPD

Instructions for Use

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

• Revision: 11, 2022-12-23

Table of contents

Welcome to Kaia COPD: My Active COPD Therapy

1. The Kaia COPD therapy concept
   1. How Kaia COPD works
   2. When can Kaia COPD be used? (intended use and indications)
   3. When should Kaia COPD not be used? (contraindications)
   4. Known side effects of Kaia COPD
2. Your daily program
   1. Course overview
   2. Physical exercises
   3. Kaia motion analysis technology
   4. Relaxation and breathing practices
   5. Theory sessions
3. Kaia COPD
   1. The “Today” tab
   2. The “Progress” tab
   3. The “Browse” tab
   4. The “Support” tab
   5. The “Settings” tab
4. Building habits
   1. Make concrete plans
   2. Set realistic goals
   3. Don’t get discouraged
5. Getting in touch
6. 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 COPD: My Active COPD Therapy

Thank you for choosing Kaia COPD to improve the way you manage your chronic obstructive pulmonary disease (COPD). Congratulations on taking the first step.

The Kaia COPD program can be done in just a few minutes per day. All you need is enough space to move and relax, as well as a stable Internet connection for your smartphone or tablet. This document contains important information to help you get started with Kaia COPD. Keep in mind that your doctor is still the best person to provide you with information about your diagnosis and answer any medical questions you might have. If you have questions about signing up for Kaia COPD or reimbursement through your private or statutory health insurance, please contact our Customer Support via support@kaiahealth.de.

Let’s get started!

1. The Kaia COPD therapy concept

WARNING: Please read these instructions carefully before use. Before using Kaia COPD, consult a doctor to make sure you are cleared to be physically active with COPD.

1.1 How Kaia COPD works

Kaia COPD is a digital application based on pulmonary rehabilitation, a clinically validated lung-health program. This means through different therapy elements, Kaia COPD encourages you to be physically active every day and to more actively manage your COPD.

Kaia COPD combines several approaches that have proven to be particularly effective when used together.

• Workout — Physical exercises tailored to your specific capabilities and needs, with varying levels of difficulty.
• Theory — Interactive knowledge modules with tips and tricks for effectively managing your COPD
• Relaxation and breathing practices — Exercises that help you to control your breathing and better manage shortness of breath

Your therapy starts with a questionnaire to determine your exercise capacity. With this questionnaire, we can get an idea of how you're currently managing your COPD. Your answers allow us to tailor the workouts to your symptom severity and exercise ability.

We advise our users to follow the instructions as closely as possible. This way you can use Kaia COPD safely and get the most out of the program.

Kaia COPD should ideally be used between 3 and 7 times a week, unless you have been instructed otherwise by your doctor.

WARNING: If you experience any sudden discomfort such as chest pain or increased shortness of breath during or after using Kaia COPD, stop the exercise immediately and consult a doctor.

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

Kaia COPD is a medical product based on the concept of pulmonary rehabilitation for use by people with COPD. Each time the app is used, Kaia delivers new course units to promote physical activity and to help people proactively manage their COPD. Kaia COPD supports people aged 18 years or older with a diagnosis of COPD (J44.-) as long as contraindications and other causes for symptoms which require specific therapy are excluded. Kaia COPD cannot diagnose conditions or injuries and cannot replace a medical consultation.

1.3 When should Kaia COPD not be used (contraindications)?

WARNING: You should only use Kaia COPD if you do not have any of the contraindications listed below and if your doctor has cleared you for physical exercise.

Do not use Kaia COPD if you have trouble understanding any part of the instructions or if you do not speak English well enough to fully understand the instructions given in the app. Do not use Kaia COPD if you are under 18 years of age.

Contraindications with ICD-10 code

• Advanced heart failure (I50.-), heart disease, or other unexplained cardiovascular complaints (I51.-)
  Do not use Kaia COPD if you have or have had any history of heart disease, shortness of breath while at rest, or any other unexplained cardiovascular complaints (eg, heart palpitations, unexplained swelling for the legs, cough) unless your doctor has given you a medical exam and cleared you to do physical exercises such as those used in Kaia COPD.
• Pulmonary embolism, pulmonary infarction (I26.-), or deep vein thrombosis (DVT) (I80.2-)
  Do not use Kaia COPD if you have had a DVT or embolism. Ask your doctor if you are able to use Kaia COPD and be physically active if you have had a pulmonary embolism, pulmonary infarction, or DVT.
• Current exacerbation or respiratory infection (both with shortness of breath) (J44.1-)
  Do not use Kaia COPD during a flare-up (exacerbation) of your COPD or during any respiratory infections. After a COPD exacerbation, ask your doctor if you are able to use Kaia COPD and be physically active.
• Pregnancy (O09.-)
  Do not use Kaia COPD if you are pregnant.

Relative contraindications with ICD-10 code

Only use Kaia COPD after a thorough consultation with your doctor if you have any of the conditions mentioned below (relative contraindications):

• Musculoskeletal conditions such as herniated discs (M51.-),decreased bone density (M80.- / M81.-), or previous spinal surgery (Z98.-)
• Neurological conditions such as a recent cerebrovascular accident (CVA) (stroke) (I63.-)
• Gait imbalance (R26.-), tendency to fall (R29.6-)
• Unexplained chest pain (I51.9) or previous myocardial infarction (I21.-)

1.4 Known side effects

The following side effects have been reported with regular physical activity and with the use of Kaia COPD:

• Pain in neck muscles during or after exercise
• Unpleasant sensations during or after exercise (like popping sensations in the back or temporary dizziness)
• Cramps in muscles during or after exercise

If these complaints persist for longer than a few days, please consult your doctor.

2. Your daily program

Kaia COPD offers an extensive training program that includes education, workouts, and relaxation courses. Kaia COPD is unique because it provides a new, personalized mix of your therapy program every day.

From the “Today” tab, you can start your sessions of your selected courses. To begin an exercise, tap on a course and then select “Start.”

2.1 Course overview

You can customize your daily program by joining and leaving courses. To enroll in a course, select the “Settings” tab on the bottom of the screen. From the “Settings” screen, select “Course enrollment” to see an overview of your courses.

Tap 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. You can leave courses at any time—the only course that is a fixed part of your therapy program is the workout course. Each course consists of several modules. In your daily program, you’ll receive one module or exercise each day for every course in which you are enrolled. If all daily units are finished, the day will be marked as complete.

2.2 Physical exercises

Physical exercises are the cornerstone of your daily therapy program. Kaia COPD will select the best physical exercises for you every day based on the answers you provided when you completed your questionnaire and the feedback you give after each exercise session. To start your daily physical exercise session, select “Workout” in the “Today” tab and tap on “Start” button.

You can adjust the length of the workout by selecting the desired length of training lengths or number of exercise rounds before beginning your workout. Once you start your Daily Program, the exercise videos will be loaded into Kaia COPD.

Therefore, we recommend connecting to WiFi each time you use Kaia COPD 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, Kaia COPD will show you a short introduction video explaining the exercise. Be sure to pay close attention to how the exercise is done and how to maintain proper form. If you forget the instructions or need a reminder, you can always revisit the introduction video during the exercise session. To do this, press the “Pause” button in the bottom left and then the “Instructions” icon on the bottom right.

Step 2: Doing your Kaia COPD physical exercises

After the instructions, it’s your turn to exercise! For static exercises (without fluid movements), Kaia COPD will show you the exact position to hold. For dynamic (with fluid movements) 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 stop your exercise, select the white “X” button in the top-right corner.

Please note: If you stop the exercise, progress will not be saved.

Pausing exercises

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 tapping on the respective buttons. You can add exercises to your “Favorites” by tapping the “Favorite” star button. These exercises can be found and revisited in the “Browse” tab under “Favorites” at the bottom of the screen.

You can also add exercises to your “Favorites” at the beginning of a physical exercise in “Exercise Overview” by tapping on the “Favorite” star button.

What makes training effective is different for everyone, so focus on finding a rhythm that works for you and your everyday life. Where you do the Kaia COPD workout is entirely up to you. Many of our users find it 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. Experiment with when and where the Kaia COPD exercises fit best into your daily routine until you find what works for you. The most important thing is that you stick to your Kaia COPD program regularly!

2.3 Kaia motion analysis technology

Unsure if you’re doing the exercises correctly? We’ve got you covered. Our digital trainer can help ensure that you’re using proper form when performing exercises. Our motion analysis technology analyzes your movements during your physical exercises using your device’s camera. It gives you real-time feedback and suggestions on how to perform each exercise better and more accurately. We already support many exercises and are constantly adding more.

If motion analysis technology is enabled for an exercise, you will see the “Motion Coach” icon. Tap the “Motion Coach”icon during a physical exercise to get real-time assistance with exercise correction. After you tap the button, the exercise will automatically resume where you left off with the Kaia motion analysis technology now enabled. Follow the instructions and adjust your movement based on the feedback given by the digital trainer for the best experience possible.

Alternatively, you can find motion analysis–enabled exercises, independent of your Daily Program from the “Browse” tab.

2.4 Relaxation and breathing practices

Relaxation and breathing exercises are another vital component of your Kaia COPD daily program. The relaxation and breathing exercise program offered in Kaia COPD is based on the principles of progressive muscle relaxation according to Edmund Jacobsen as well as on targeted breathing exercises.

Relaxation practices are included in your Daily Program. To start a relaxation practice, select a relaxation unit from the “Today” tab and tap “Start.” Kaia COPD will then play an audio recording that will guide you through the entire exercise. After completing the exercise, you can continue directly with the next course of your Daily Program.

2.5 Theory sessions

In the theory sessions, Kaia COPD provides you with comprehensive knowledge about the COPD. These short lessons offer helpful information about COPD and how it affects the body. You’ll also learn special breathing techniques and other practical tips for dealing with COPD in everyday life.

The lessons consist of interactive texts as well as short videos on important COPD topics (such as how to use different types of inhalers correctly).

The information is presented to you in an interactive chat format. You can choose how you want to continue in each unit from a variety of options, allowing you to select which topics you want to learn more about.

3. Kaia COPD

In Kaia COPD, you will find five different areas accessible via the bottom bar, also called tabs. These five areas are:

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

3.1 The “Today” tab

The “Today” tab is the hub of Kaia COPD. This is where you’ll find your Daily Program, which includes the units of the courses you are enrolled in or that are recommended to you. Here, you can also see the progress you made towards completing your Daily Program. Tap the “Workout” button to start your daily physical exercises, or select any other content on the screen to get active. If you have turned on the step tracker, you can also view your daily step goal and the progress you have made in the “Today” tab.

3.2 The “Progress” tab

After your first day with Kaia COPD, you’ll be asked to briefly rate your shortness of breath and general wel-lbeing before continuing with the program the next day. In the “Progress” tab, you’ll find an overview of these self-reported daily stats. Regularly asking about your shortness of breath and physical well-being will help you and your doctor continue to improve your COPD management. Your answers to these questions will be displayed in the "Progress" section.

In addition, you can allow Kaia COPD to access information about your steps on your smartphone and set a weekly step goal. Your steps are then displayed in the “Today” tab and in the “Progress” tab. This way, you can easily see if you have already reached your step goal for the day. You can adjust your step goal every Sunday.

3.3 The “Browse” tab

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

3.4 The “Support” tab

For further information about Kaia COPD, you can chat with the Kaia COPD Customer Support. You can always contact us from the “Support” tab. Please keep in mind that this is not a live chat. Your message will be answered within 24 hours. Alternatively, you can contact us via email at support@kaiahealth.de or via phone at +49 89 904226740 between 9.30am and 5.00pm (from Monday to Friday).

IMPORTANT INSTRUCTIONS

1. Always adhere to the instructions given in Kaia COPD, and be sure to give honest answers to the questions asked during sign-up and after the physical exercises.
2. Your Kaia COPD 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.
3. Update your app as soon as we notify you about an update, as it may contain important security-related content.

3.5 The “Settings” tab

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

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

• Training Schedule: Here, you can set your desired weekly training schedule as well as reminders for your training days
• Gender: In this section,you can specify your gender (female, male, or other)
• Course enrollment: This section enables you to access your Kaia COPD course overview. Here, you’ll find course suggestions. You can subscribe or unsubscribe to these courses and thus influence which courses are displayed in your current Kaia Daily Program. Each course you are enrolled in will be added to your daily therapy program with Kaia. Once you’ve completed all course units on a given day, your daily Kaia program is considered complete.
• Subscription: Here, you can access details about your current Kaia COPD access. Once your prescribed access expires, it won’t renew automatically and you do not need to cancel.
• Manage your data: Here, you can export your data as a PDF or in a machine-readable format. You can also show a printout or a digital version of your training history to your doctor to discuss your progress with Kaia COPD. 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 your notifications, your email address, or your password. In this section, you can also adjust the language used in Kaia COPD and view legal information, such as terms and conditions, our privacy policy, and software licenses.
• Help Center: Here, you can access detailed instructions on how to access the sections and their corresponding features on the “Settings” screen, as well as information on how to contact the Kaia Customer Support team.
• Log out: You can log out of Kaia COPD by tapping the "Log out" button. You have the option to log in again at any time. Your account will not be deleted.

4. Building habits

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

4.1 Make concrete plans

Getting started with Kaia COPD is easier when you set a fixed time in your schedule to do your Daily Program: the more concrete, the better. For example, set your training schedule to do your physical exercises every Monday, Wednesday, Friday, and Saturday. 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 the physical exercises in the same room. However, Kaia COPD allows you to be active anytime and anywhere, so feel free to try different locations and times to see what works best for you. This makes it easier for you to make your workouts a habit.

The relaxation exercises are ideal for cooling down after the physical exercises or before going to bed to help you fall asleep.

4.2 Set realistic goals

Trying to achieve goals by relying on implementing radical changes will often result in failure. There is a reason that New Year’s resolutions rarely work; we are just not made to completely change deeply rooted behaviors in a short amount of time. What works, however, is making small changes that are easier to stick to.

If it’s been a while since you’ve played a sport or exercised, start with one or two exercise days 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.

4.3 Don’t get discouraged

Kaia COPD can help improve 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. For extra motivation, try giving yourself a little reward when you achieve your goals!

5. 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

Note: If you or your doctor notice any deterioration in your health that may be linked to use of Kaia COPD, please reach out to us using the contact information provided above.

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

Kaia COPD is a medical device of class IIa.

6. Technical information

6.1 Install the app

How to install Kaia COPD on Android

1. Go to the Google PlayTM store on your computer, smartphone, or tablet (make sure you have an active Internet connection).
2. Tap on the search bar.
3. Type “Kaia COPD.”
4. Look for the yellow-circle Kaia logo.
5. Tap “Install” and monitor the installation progress.
6. Once the app is installed, the “Install” button will change to “Open.”
7. Tap “Open” to launch the app.

How to install Kaia COPD on iOS

1. Go to the Apple App Store on your computer, smartphone, or tablet (make sure you have an active Internet connection).
2. Tap on the search tab.
3. Type “Kaia COPD” in the search bar.
4. Look for the Kaia logo with a yellow outline.
5. Tap the “Download” icon and monitor the installation progress.
6. You can stop the installation by tapping the “Stop” button.
7. Once the app is installed, the “Download” button will change to “Open.” Tap “Open” to launch the app.

6.2 Uninstall the app

How to uninstall Kaia COPD on Android

1. Open Android settings.
2. Go to the Apps section.
3. Search for Kaia COPD and tap on it.
4. Tap the “Uninstall” button to uninstall the app.

How to uninstall Kaia COPD on iOS

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

6.3 Update the app

How to update Kaia COPD on Android

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

How to update Kaia COPD on iOS

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

Appendix

i. Hardware and software compatibility

iOS

On iOS, all Apple smartphone and tablet models running iOS 15.4 or later are supported, except for the following devices, which do not support Motion Coach: iPad Mini 4, iPad Air 2.

Kaia COPD is compatible with the Apple HealthKit interface.

Android

On Android, Kaia COPD can be installed and run on all smartphone and tablet models running the Android 7 (Nougat) operating system or later, if they meet Google's requirements for Android version 7 or later.

Kaia COPD is compatible with the Google Fit interface.

A list of Android devices for which Kaia ensures the correct functionality of Kaia COPD through periodic reviews can be found at https://kaiahealth.de/copd/.

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