Instructions For Use Kaia Back Pain

Kaia Back Pain Relief

Instructions for Use

Revision: 7, 2021-03-12

Table of Contents

Welcome to Kaia

  1. The Kaia Therapy Concept
    1. How Kaia works
    2. Kaia can be used when (Intended use and Indications)
    3. Kaia should not be used when (Contraindications)
    4. Known side effects of Kaia: Back Pain
  2. Your Daily Therapy
    1. Course overview
    2. Physical Exercises
    3. Motion Coach
    4. Relaxation Practices
    5. Education Modules
  3. The Kaia App
    1. The “Today” tab
    2. The “You” tab
    3. Training Schedule
    4. Coach Chat
  4. Building Habits
    1. Make concrete Plans
    2. Set realistic goals
    3. Give yourself a reward
  5. Getting in Touch
  6. Technical Information
    1. Install the app
    2. Uninstall the app
    3. Update the app
    4. Settings

Appendix

  1. Hardware Requirements
  2. Label & Symbols

Welcome to Kaia!

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 toward 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 in 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.

In this document, we have collected important information to help you get started with Kaia Back Pain, henceforth called Kaia. If your questions have not been addressed here, please reach out to your in-app Coach or contact us at support@kaiahealth.com. So, what are you waiting for? Let’s get started!

1. The Kaia Therapy Concept

WARNING: Read these instructions carefully before use. Before using Kaia, 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 works

Kaia is a digital therapy app that is based on the evidence-based concept of multidisciplinary rehabilitation. This means that Kaia delivers content, renewed daily, that is intended to teach users to self-manage their pain. This content combines several approaches that are particularly effective when used together. After you have completed an initial Self Test during the signup process, you are presented with content from three different categories:

  • 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 helps your brain and body to cope with chronic 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, stop the exercise immediately and consult a physician.

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

1.2 Kaia can be used when (Intended use and Indications)

Kaia is intended for multidisciplinary rehabilitation of non-specific back pain that has persisted for longer than 4 weeks (subacute and chronic back pain), 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 cannot diagnose your conditions or injuries and cannot safely exclude potentially dangerous causes for your back pain. Do not use Kaia in lieu of medical consultation. Please consult your physician if you have any questions related to diagnosis.

1.3 Kaia should not be used when (Contraindications)

WARNING: You should only use the Kaia Back Pain app if you do not have any of the contraindications listed below and if you have already seen a doctor. Before you use the Kaia Back Pain app, your doctor should exclude any cause for back pain that would require specific treatment and clear you to do physical exercises such as those used in the Kaia Back Pain app.

  • Potential spinal injury or fracture
    Do not use the Kaia Back Pain app 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
    Do not use the Kaia Back Pain app 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 the Kaia Back Pain app.

  • Spinal tumor
    Do not use the Kaia Back Pain app 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 the Kaia Back Pain app:
    • Spinal tumor
    • History of cancer
    • Excessive night sweating, unexplained weight loss, and/or unexplained fatigue

  • Spinal infection
    Do not use the Kaia Back Pain app 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 the Kaia Back Pain app:
    • 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
    Do not use the Kaia Back Pain app 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 the Kaia Back Pain app:
    • History of feeling numb or weak in your legs
    • Loss of feeling in the genital area
    • Bowel or bladder incontinence

  • Previous spinal surgery
    Do not use the Kaia Back Pain app 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 the Kaia Back Pain app.

  • Advanced heart disease
    Do not use the Kaia Back Pain app 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 the Kaia Back Pain app:
    • 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)
    Do not use the Kaia Back Pain app 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 the Kaia Back Pain app.

  • Musculoskeletal problems affecting major joints in the lower body
    Do not use the Kaia Back Pain app 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 the Kaia Back Pain app.

  • Pregnancy
    Do not use the Kaia app if you are or think you may be pregnant.

  • Gait imbalance or history of falls
    Do not use the Kaia Back Pain app 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 the Kaia Back Pain app:
    • Walking imbalance
    • History of falling
    • Dizziness or low blood pressure brought on by exercise

  • Coagulopathy or history of bleeding event
    Do not use the Kaia Back Pain app 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 the Kaia Back Pain app:
    • History of hemorrhage (excessive bleeding from a blood vessel)
    • Bleeding disorder

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

  • Do not use the Kaia Back Pain app if you are under 16 years of age.

WARNING: Use the Kaia Back Pain app responsibly. Only use the app if you understand the language used in the app very well.

The user completes the sign-up process by logging into the app and actively confirming that he/she does not suffer from any of the contraindications indicated in the list on the screen, so that the user is aware of the eligibility for using the app.

contraindications

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. Your Daily Therapy

As previously mentioned, multidisciplinary rehabilitation is particularly effective for treating back pain. Our approach at Kaia includes physical exercises, relaxation practices, and learning modules. In order to provide the optimal therapy program for you, the app will select one exercise from each category every day. These exercises can be found under the “Today” tab.

daily_courses

From this screen, you can begin any of the exercises selected for your daily program:

  • To begin an exercise, tap on the card and then click the “Start” button
  • To switch between exercises, swipe left or right with your finger

While completing one exercise daily from each category (physical exercises, relaxation practice, learning module) is recommended, you can also choose to complete only certain exercises or add more exercises from additional courses category (see below).

2.1 Course overview

You can change your daily program by joining and leaving courses. To leave or enroll in a course, tap the button “Edit Courses” located on the top right corner of the “Today” tab. This will lead you to an overview of the available courses with the option to “Subscribe” or “Leave” each course.

course_overview_v2

Each course consists of several units. In your daily program, you will be presented with one unit or exercise for every course you are enrolled in. If all units from the day are finished, the day will be marked as completed. Please note, it is not possible to leave the Physical Exercises course.

2.2 Physical Exercises

Physical exercises are the cornerstone of your daily therapy. Based on the Self Test answers you provided when you signed up, the feedback you give after each exercise session, and the data of thousands of other Kaia users, the app will select the best exercises for you every day. To start a physical exercise session, select a “Movement” card and click “Start”.

Hint: To see which exercises are included in your session for that day, just scroll down from the card graphic for a preview.

Once you begin your daily program, the app will start to download the exercise videos. Please note: We recommend connecting to WiFi prior to starting your program as the downloads can be sizeable. If you choose not to connect to WiFi, please check with your service provider regarding data usage and overages.


Step 1: Instruction Video

instructions_video

Before your training begins, the Kaia app will show you a short introduction with the proper way to perform the exercise. Pay close attention to how the exercise is being executed and listen for hints on how to maintain the proper form. If you forget or need a reminder, you can always revisit the instructions during the exercise session. To do so, press “Pause” then the “Instructions” button.


Step 2: Exercise execution

physical_exercise

After the instructions, it will be your turn to exercise. For static exercises, Kaia will show you the position to hold. In the case of dynamic exercises, you will be shown the proper execution. Simply perform the movement for the duration indicated by the timer in the bottom right corner of the screen. To pause your training, press the “Pause” button on the bottom left. To cancel your training, select the “x” in the top right corner. Please note: If you cancel your training, no progress will be saved.


Pause Screen

pause_exercise

Once you have 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 “star” button. These exercises can be found and revisited in the “You” tab, under your “Favorite” list.

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

2.3 Motion Coach*

For some exercises, Kaia offers additional support to ensure proper execution. Motion Coach helps keep track of your repetitions, as well as offers guidance as you perform the exercise. Motion Coach uses your phone’s camera to pinpoint your movements and give you real-time feedback. To use Motion Coach, click on the “Motion Coach” icon or go to the “You” tab and look for Motion Coach enabled exercises there. Please note: Motion Coach is not currently available on all exercises.

motion_coach_exercise

Once you click on the “Motion Coach” button, the exercise will automatically continue from where you paused with Motion Coach enabled. Please follow the instructions and adjust to the feedback given by Motion Coach.

*Note: The Motion Coach feature is currently only available with iOS and select Android devices.

2.4 Relaxation Practices

The second pillar of your daily Kaia therapy is relaxation practices. It has been shown in scientific studies that pain-specific relaxation techniques can help sustainably and effectively reduce pain levels, particularly for persisting back pain. Kaia currently features two different techniques to assist in relaxation: 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.

course_overview breathing

Relaxation practices are included in your daily program. To start a session, select a card by tapping on it on the “Today” tab and then click “Start”. The app will play an audio recording which will guide you through the entire exercise. You will have the option to give feedback once the exercise is completed.

2.5 Education 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, please select a card by tapping on it and then click “Start”.

daily_courses knowledge

The information is presented in an interactive chat format. You will be presented with information, followed by different options you can select to proceed or continue.

3. The Kaia App

3.1 Tab „Today“

At the core of the Kaia therapy 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. Once you finish all courses for which you are enrolled, your daily program will be counted as completed. However, the Kaia app experience does not stop here. There are other features and functions designed to enhance and enrich your experience.

daily_courses

WARNINGS:

  1. Always adhere to instructions given by Kaia and give honest answers upon self-assessment to ensure your safety.
  2. Never share your Kaia account with other people.
  3. Always update your app when offered as updates may contain content relevant to your safety.

3.2 Tab “You”

The “You” tab in the app serves two purposes. First, it shows you where you are in your Kaia therapy journey. Second, it enables you to revisit past exercises. This is also where you can access Motion Coach directly and improve your exercise form.

The basic function of the progress screen is showing you how far you’ve come with your Kaia therapy, but also to let you access past exercises and Motion Coach exercises (if these are applicable). Click on one of the images below the “Recent” or “Favorite” sections to start an exercise. By tapping “Show More” you can access all your “Favorite” and most recent exercises. You can check how your pain and sleep levels have developed over the past 30 days, as well as the day of your Kaia therapy you are in currently.

Hint: You can change which days you’d like to be reminded to use Kaia by clicking on the calendar at the top of this tab.

progress you_area

3.3 Training Schedule

Kaia is intended to be used regularly to achieve long-lasting improvement In fact, studies have shown that the more frequently Kaia is used, the more quickly results are seen. If you want to be reminded on a specific day of the week about your Kaia exercises, you can enable this with a function called “Training Schedule”. If a day is enabled, you will receive a notification on your phone in the morning of the selected day.

The training schedule can be accessed in the “You” tab, by tapping the calendar shown on the top of the page, or by going to “Settings”, which are located in the top right corner of the “You” tab.

3.4 Coach Chat

For further information about the app or motivational support, you can always chat with your Kaia Coach. The chat is easily accessible in the tab in the bottom right of the screen. The Coach chat works similarly to other messaging apps. Just type your message and your question or comment will be answered by your Kaia Coach. Please keep in mind that this is not a live chat. Your message will be answered as soon as possible. If you don’t receive any reply within 48 hours please reach out to the Kaia Customer Support (support@kaiahealth.com).

4. 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. Here’s some advice that has helped Kaia users make the most of their therapy:

4.1 Make Concrete Plans

Getting startedwith Kaia 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 equipment set up and ready to go.

For some of our users, it helps to always do Kaia 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!

4.2 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, are 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 your frequency and duration later. The most important thing is to get started!

4.3 Give Yourself a Reward

Kaia can increase your quality of life significantly over time but getting there can be difficult. 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.

5. Getting in touch

legal_manufacturer Legal Manufacturer

kaia health software GmbH (abbreviated as Kaia in the text)
Siegfriedstr. 8
80803 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 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.

ce_registration_mark

6. Technical Information

6.1 Install the app

Installation - Android

Steps for Installation:

  1. Open The Google 'Play Store' (make sure you have an active internet connection)
  2. Click on the search bar
  3. Type 'Kaia Backpain Relief' or similar Keywords
  4. Spot the Kaia Icon with Blue Circle and Title as seen.
  5. Click on Install and watch the progress
  6. Once app is installed 'Install' button changes to 'Open'
  7. Click on Open to Launch the app
Installation - iOS

Steps for Installation:

  1. Open The 'Apple Store' (make sure you have an active internet connection)
  2. Click on the search tab
  3. Type 'Kaia Backpain Relief' or similar Keywords in the search bar
  4. Spot the Kaia Icon with Blue Circle and Title as seen.
  5. Click on Download Icon and watch the progress
  6. You can stop the installation by clicking on Stop Button
  7. Once the app is installed the 'Download' button changes to 'Open' , Click on Open to Launch the app.

6.2 Uninstall the app

Uninstallation - Android

Steps for uninstallation:

  1. Open Settings
  2. Go to Apps section
  3. Search for 'Kaia' & Click
  4. Click on 'Uninstall' button, the app will be uninstalled.
Uninstallation - iOS

Steps for uninstallation:

  1. Long Press the screen or default way to 'wobble' icons on iOS device and Click on the Cross
  2. Click Delete to Uninstall the application

6.3 Update the app

Update - Android

Steps for Update:

  1. Open The Google 'Play Store' (make sure you have an active internet connection)
  2. Click on the search bar
  3. Type 'Kaia Backpain Relief' or similar Keywords
  4. Click on 'Update' button
  5. Wait for download to complete.
  6. Click on Open to access the update
Update - iOS

Steps for Update:

  1. Open The ‘Apple Store' (make sure you have an active internet connection)
  2. Click on the search bar
  3. Type 'Kaia Backpain Relief' or similar Keywords
  4. Click on 'Update' button
  5. Wait for download to complete.
  6. Click on Open to access the update

6.4 Settings

The settings screen can be accessed from the ‘You’ Tab and it allows the user to change the personal data and access the general account information.

The information that can be altered are as follows

  1. First and Last Name
  2. Training Schedule
  3. Age
  4. Gender

settings general_settings

When the user selects the ‘General’ tab, the user is able to make changes to the following,

  1. Notifications section
  2. Change email address
  3. Change password
  4. Language settings

In this screen the user is also able to access the Instructions for Use which provides a detailed guide on how to use Kaia Back Pain Relief app. The Contact screen allows the user to access information about the manufacturer and other regulatory requirements.

Appendix

i. Hardware Requirements

iOS

General

In order to be able to download from App Store and use Kaia Back Pain iOS app your device needs to satisfy the following conditions:

Operating system version iOS 12.0 or newer
Device hardware no restrictions

Motion Coach Support

General

Operating system version iOS 13.0 or newer
Device hardware All supported except ones below

Devices that do NOT support Motion Coach regardless iOS version

iPhone iPod iPad
iPhone iPod touch 1st gen iPad 1st gen
iPhone 3G iPod touch 2nd gen iPad 2
iPhone 3GS iPod touch 3rd gen iPad 3rd gen
iPhone 4 iPod touch 4th gen iPad 4th gen
iPhone 4S iPod touch 5th gen iPad Air 1
iPhone 5 iPod touch 6th gen iPad Air 2
iPhone 5C iPad mini 1
iPhone 5s iPad mini 2
iPhone 6 iPad mini 3
iPhone 6 Plus iPad mini 4
Android

General

In order to be able to download from App Store and use Kaia Back Android app the user’s device needs to meet these conditions:

Operating system version Android 5.1 (Lollipop) or newer
Device hardware no restrictions*

* The android devices must satisfy hardware specifications required by Google for running Android 5.1

The following Android devices are compatible to run Motion Coach

Manufacturer Model Device ID
HMD Global Nokia 8 Sirocco HMD Global - Nokia 8 Sirocco
HMD Global Nokia 8 HMD Global - TA-1012
HTC 10 HTC - HTC 10
HTC One M9 HTC - HTC One M9
HTC U Ultra HTC - HTC U Ultra
HTC U11 HTC - HTC U11
HUAWEI Mate 10 Pro HUAWEI - BLA-L09
HUAWEI Mate 10 Pro HUAWEI - BLA-L29
HUAWEI P20 Pro HUAWEI - CLT-L09
HUAWEI P20 Pro HUAWEI - CLT-L29
HUAWEI HUAWEI MediaPad M5 10.8 HUAWEI - CMR-AL09
HUAWEI HUAWEI MediaPad M5 10.8 HUAWEI - CMR-W09
HUAWEI Honor 10 HUAWEI - COL-L29
HUAWEI Honor Play HUAWEI - COR-L29
HUAWEI HUAWEI P30 HUAWEI - ELE-L29
HUAWEI P20 HUAWEI - EML-L09
HUAWEI Mate 20 HUAWEI - HMA-L29
HUAWEI Mate 20 Pro HUAWEI - LYA-L09
HUAWEI Mate 20 Pro HUAWEI - LYA-L29
HUAWEI Mate 9 HUAWEI - MHA-L29
HUAWEI HUAWEI MediaPad M5 8.4 HUAWEI - SHT-W09
HUAWEI Honor 9 HUAWEI - STF-L09
HUAWEI P30 Pro HUAWEI - VOG-L29
HUAWEI P10 HUAWEI - VTR-L09
LGE LG G7 ThinQ LGE - LM-G710
OnePlus OnePlus7 Pro OnePlus - GM1913
OnePlus OnePlus3 OnePlus - ONEPLUS A3000
OnePlus OnePlus3 OnePlus - ONEPLUS A3003
OnePlus OnePlus3T OnePlus - ONEPLUS A3010
OnePlus OnePlus5 OnePlus - ONEPLUS A5000
OnePlus OnePlus5T OnePlus - ONEPLUS A5010
OnePlus OnePlus 6 OnePlus - ONEPLUS A6003
OnePlus OnePlus6T OnePlus - ONEPLUS A6013
Sony Xperia Z5 Compact Sony - E5823
Sony Xperia Z3+ Dual Sony - E6533
Sony Xperia Z3+ Sony - E6553
Sony Xperia Z5 dual Sony - E6633
Sony Xperia Z5 Premium Sony - E6853
Sony Xperia XZ Sony - F8331
Sony Xperia XZ Premium Sony - G8141
Sony Xperia XZs Sony - G8232
Sony Xperia XZ1 Sony - G8341
Sony Xperia XZ1 Compact Sony - G8441
Sony Xperia XZ2 Sony - H8266
Sony Xperia XZ2 Compact Sony - H8324
Sony Xperia XZ3 Sony - H8416
Xiaomi Mi 5 Xiaomi - MI 5
Xiaomi MI 8 Xiaomi - MI 8
Xiaomi MI 9 Xiaomi - MI 9
Xiaomi Mi 9T Xiaomi - Mi 9T
Xiaomi POCO F1 Xiaomi - POCOPHONE F1
ZTE A2017G ZTE - ZTE A2017G
Asus ZenFone Ares (ZS572KL) asus - ASUS_A002
Motorola Moto Z (2) motorola - Moto Z (2)
Samsung Galaxy S7 samsung - SM-G930U
Samsung Galaxy S8+ samsung - SM-G955U
Samsung Galaxy S9 samsung - SM-G960F
Samsung Galaxy S9 samsung - SM-G960U
Samsung Galaxy S9+ samsung - SM-G965F
Samsung Galaxy S9+ samsung - SM-G965U
Samsung Galaxy Note8 samsung - SM-N950U
Samsung Galaxy Note9 samsung - SM-N960F
Samsung Galaxy Tab S3 samsung - SM-T820
Samsung Galaxy Tab S3 samsung - SM-T825
Samsung Galaxy Tab S4 samsung - SM-T830

ii. Label* & Symbols

contact

ce_registration_mark CE registration mark with notified body number. Indicates compliance with the requirements of the EU 2017/745 Medical Device Regulations
legal_manufacturer Manufacturer
consult_operation_instructions 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