Instructions For Use (IFU)

The device provides exercise therapy and guidance on musculoskeletal pain management to people with either a specific diagnosis or a generic need for musculoskeletal pain treatment or prevention. The device helps people address their injuries by providing them with an exercise plan that is updated and altered based on their feedback on each exercise. The device is intended to be used after consultation with an authorized healthcare professional.

1.1 Main Functions

The table below presents the main high-level functions of the system.

No	Feature
1	The device offers treatment/prevention exercise plans for musculoskeletal pain.
2	The device creates a customized initial musculoskeletal treatment/exercise plan.
3	The device adjusts the treatment/exercise plan based on the patient’s feedback.
4	The app screens for potential health concerns indicated by red and yellow flags during workouts, prompting the user with recommended next steps.
5	The device monitors people’s progress in the treatment/exercise plan execution.
6	The device keeps the user’s training journal.
7	The device provides guidance and information for pain management.
8	The device enables the user to communicate with a healthcare professional.
9	The device communicates with external third-party systems used in the healthcare environment.
10	A healthcare professional can monitor patient progress with the treatment/exercise plan and assign patients to programs.
11	The device uses algorithms to collect the treatment data and suggest/adjust the treatment plan for patients.

Table 1. Main functions

2. Medical Indications

This chapter presents medical indications for using this medical device.

Musculoskeletal pains related to:
1. Joints
2. Ligaments
3. Tendons
4. Muscles
5. Connective tissue
Prescribed treatment plans by healthcare professionals.
The product shall be used only after consulting a healthcare professional if any known health condition is present.
Conditions such as, but not limited to:
1. Back: Pain without radiation to legs, Lumbago, Non-Specific Low Back Pain, Osteoarthritis of the Back, Spondylosis of the Thoracic spine, Spondylosis of the Lumbar spine, Lower back spasms, Facet Joint Syndrome, Sacroilliac Joint syndrome, Sacroilliac Joint Dysfunction, Sciatica, Lumbago with Sciatica, Bulging Disc in the Back.
2. Elbow: Golf Elbow, Medial Elbow Epicondylitis, Tennis Elbow, Lateral Elbow Epicondylitis, Biceps Tendonitis of the elbow, Triceps Tendonitis of the elbow.
3. Neck: Non-specific Neck pain, Neck Distortion, Whiplash, Facet Joint Pain, Osteoarthritis of the neck, Spondylosis of the Cervical Spine, Uncovertebral arthrosis, Neck spasms.
4. Shoulder: Rotatorcuff Syndrome, Impingement syndrome of the shoulder, Shoulder Impingement syndrome, Subacromial Impingement syndrome, Postero-superior impingement of the shoulder, Internal Impingement of the shoulder, Supraspinatus tendonit, Acromioclavicular joint sprain, Acromioclavicular joint osteoarthritis, Biceps tendonitis of the shoulder, Shoulder Instability.
5. Ankle: Ankle Sprain, Ankle sprain consequences, Unstable Ankle Joint.
6. Hip: Hip Joint Pain, Hip Joint Osteoarthritis, Hip Joint Synovitis, Hip Joint Impingement, Femoroacetabular impingement, Hip joint dysplasia, Hip Labral Tear of low severity. Rectus femoris tendinopathy, Iliopsoas tendinopathy, Tensor fasciae latae Pain, Adductor Tendinopathy, Gluteal tendinopathy, Greater Trochanteric Pain Syndrome, Greater trochanteric Bursitis, Piriformis Syndrome.
7. Achilles tendon: Achilles Tendinopathy, Achilles Entesopathy, Retrocalcaneal Bursitis.
8. Heel/foot sole: Plantar fasciitis, Heel Spurs.
9. Knee: Knee Osteoarthritis, Knee synovitis, Meniscus tear (without locking), Bruised Knee, Knee distortion, Plica syndrome of the knee, Patellofemoral Pain Syndrome, Post Op Knee Arthroscopy Exercises, Jumpers knee, Patella tendinopathy, Quadriceps tendinopathy, Pes Anserine Bursitis, Iliotibial Band Friction Syndrome (ITBFS), Runner’s Knee, Long distance running runner’s knee, Hamstring syndrome.

3. Medical Contraindications

This chapter presents medical contraindications which should exclude using this medical device.

Pregnant women shall use the system only after a prescription from a healthcare professional.
If the following conditions are suspected :
1. fracture
2. infection
3. cancer
Local joint effusion of the body parts intended for training.
Intolerable pains.
Untreated mental illnesses.
Untreated severe osteoporosis.
Untreated hypertension.
Untreated heart conditions.
Myositis.
Untreated vasculitis.
Known medical conditions contraindicating exercise.
Ehlers-Danlos syndrome
Any medical or tissue complication/condition where physical exercise is harmful.

4. User Groups

This chapter presents different user groups which will be using the medical device.

User Group*	Description
Patients/users	Patient – a group of users using the device for exercise therapy and musculoskeletal pain treatment. Users – a group of users using the device for musculoskeletal pain prevention.
Physiotherapists	A group of users using the device for delivering exercise therapy to patients/users groups.
Healthcare professionals	A group of users using the system to refer patients for exercise therapy. A group of users using the device to supervise and adapt the user/patient exercises when needed.

Table 2. User groups

5. User Profile and Population

This chapter provides a more thorough analysis of the User Groups from the previous chapter from a profile and population perspective. A user profile should contain a summary of the mental, physical and demographic traits of an intended user group, as well as any special characteristics, such as occupational skills, job requirements, and working conditions, which can have a bearing on medical device design decisions.

User Group*	Summary of mental, physical, and demographic traits*	Special characteristics*
Patients/Users	1. Age: the product is available for and used by people of all ages above 18, genders, weights, and heights after diagnosis from a medical professional. 2. Conditions: as specified in medical indications and contraindications.	1. A smartphone-literate person. 2. Direct access to the internet is required.
Physiotherapists	1. Age: the product is available for and used by people of all ages above 18, genders, weights, and heights. 2. Mentally healthy.	1. A computer and smartphone-literate person. 2. A valid certificate for practicing physiotherapy.
Health care professionals	1. Age: the product is available for and used by people of all ages above 18, genders, weights, and heights. 2. Mentally healthy.	1. A computer and smartphone-literate person. 2. A valid certificate in a practiced area.

6. Intended Usage Environment / Usage Environment

The device is to be used in safe, user/patient-selected environments. This is usually the home environment. The mobile application operates on an end-user mobile device. It only requires internet access.

7. Information regarding the Use of the Medical Device

This chapter provides a detailed description of how to use the Injurymap application and gives logically ordered steps for all main functions.

7.1 Visiting the App Store

For iOS Users: Open the Apple App Store.

For Android Users: Open the Google Play Store.

7.2 Search for the App

In the search bar, type Injurymap and press search. Find the Injurymap app in the search results and tap on it. Tap the install/download button. The app will begin downloading.

7.3 Open the App

Once installed, tap the Injurymap icon to open the app.

7.4 Sign up + log In:

If you’re a new user, tap on the “Get started” option and select your preferred sign up method:

If you already have an account, tap “Sign In” and select the sign-in option relevant to your existing user account.

7.5 Injury screening process:

During the initial sign up process, you will be prompted to select which body part you wish to treat with the Injurymap app. After making your selection, the app will guide you through a short screening process to ensure your condition is apt for physiotherapeutic treatment with the device.

Select a body part and carefully follow the screening prompts on screen and answer as accurately as possible.
During the screening process, you will be prompted to answer whether or not a medical professional has already determined that you can start exercising.
If this is the case, answer “yes” to skip the rest of the screening process.
In rare cases, depending on your answers during the screening process, we may advise you to seek the opinion of a medical professional before you begin using the exercises in the Injurymap app.

Note #1: depending on your method of accessing the Injurymap app (e.g.if your doctor has referred you to the app via a direct download link), you may not encounter the screening process during the initial sign up.

Note #2: If you add additional body parts after the initial sign up process, you will need to complete the screening process once more.

7.6 Personalize Your Experience:

During the initial sign up process, you will be asked a series of questions about your health, injury history, goals, and your exercise and notification preferences.

Follow the prompts and answer as accurately as possible to help the app tailor your rehabilitation to your needs.

7.7 Subscription and payment details:

During the initial sign up process, we will ask you to pick a subscription model and enter your payment details.
Press continue
Select your preferred subscription model
Press Subscribe, select a payment method and press subscribe to start your subscription.

If you already have an active subscription, press Restore subscription to link it to your new Injurymap user account.

7.8 Today Screen:

The Today Screen gives you an overview of your currently active training programs and your overall progression.

Press “Today’s workout” to see an overview of your next workout.
Press the downwards-facing arrow next to your injury type to select between your active training programs or add a new training program.
Start a workout by pressing the “Let’s go!” button to start a workout.
Access your profile page by pressing the heart icon in the bottom center of the screen.
Access the Tips section by pressing the Tips icon on the bottom right of the screen.
You can return to the Today screen from other screens in the app by pressing the Today icon on the lower left of the screens.

7.9. Exercising with the Injurymap app:

Start a workout by navigating to the Today screen and pressing the “Let’s go!” button.

When starting a workout, you will see an overview of the equipment you will need to complete the workout.
If your training program requires the use of resistance rubber bands, you will be prompted with an option to purchase these.
Press “Take me to the first exercise” to start the workout.

Press the play button in the center of the screen to view the exercise video and follow along with the provided instructions.
In exercises that require performing repetitions or movement for certain periods of time, press the “Use timer” button to use the timer function.
Press “Exercise completed” after completing the exercise.
Provide feedback by rating the pain and difficulty levels you experienced while performing the exercise.
Your feedback will help the app automatically adjust your training program going forward. Press “I was unable to complete the exercise” if you are unable to complete the exercise.
Upon completing the workout, you will be presented with an overview screen displaying your results and overall progress. Press “Go to profile” to go to your profile page or “Read about phase 1/2/3” to find out more about your current training phase progression.

In rare cases, depending on your feedback, the app may prompt you to stop exercising and consult a medical professional before you resume use of the app. See Figure 11.

7.10. Profile/You screen:

The profile/You screen lets you review your weekly objective, your overall goals, your workout and pain level history, and your overall training phase progression.

From the profile/You page, you can access the settings page by tapping the gear icon in the upper right corner of the screen.

7.11. Settings screen:

On the settings screen, you have the option to:

Visit Injurymap on social media.
Add new training programs and adjust the workout duration.
Edit notification settings, or turn them on/off.
Switch the interface language (Danish or English are the currently supported options).
Access the terms and privacy information related to using the Injurymap app.
Access to our support page and the option to send us feedback.
Log out of your current user session.

7.12. Tips screen

The Tips screen allows you to browse information about your currently selected training program and general information about physiotherapeutic rehab training and the Injurymap app.

7.13. Changing or canceling your subscription

From the profile/You page, access the settings page by tapping the gear icon in the upper right corner of the screen.

Tap the “Support” button under SUPPORT. A new page will open in your browser.

Under “Cancel or change subscription”, tap ‘iTunes / App Store Guide’ if you are using an Apple device, or tap ‘Google Play Guide’ if you are using an Android device.

Follow the respective guides to change or cancel your Injurymap subscription.

8. Safety Information

This chapter presents the conditions and situations for which the device is not intended to be used.

The device shall not be used if it indicates, based on the provided user feedback, that a user shall consult a healthcare professional.
A training program within the device shall not be used if a healthcare professional has excluded the user/patient from using that training program.

9. Software Information

This section presents system requirements and explains important information about data security.

IT Network Characteristics:

Connection: A stable internet connection is essential, preferably 4G/LTE or Wi-Fi with a minimum speed of 5 Mbps for optimal performance.

Data Usage: Please ensure you have an adequate data plan if using mobile data, as the app can consume up to 100MB/hour during active use.

On-Device Security:

Encryption: Ensure that your device is set up with encryption (often default on newer devices) to protect stored data.

Lock Screen: Enable a secure lock screen (PIN, pattern, fingerprint, or facial recognition) on your device to prevent unauthorized access.

Software Updates: Regularly update your device’s OS and the app to benefit from the latest security patches.

General Recommendations:

Avoid Rooting/Jailbreaking: Rooting (for Android) or Jailbreaking (for iOS) your device can compromise its security. It’s recommended to avoid such practices for the app to function securely.

Public Wi-Fi: Avoid accessing the app on open public Wi-Fi networks. If necessary, use a trusted VPN service to encrypt your data traffic.

By ensuring compliance with the above requirements and recommendations, you will be well-prepared to run the software as intended and maintain a secure environment.

9a. Minimum & Recommended OS requirements:

Platform	OS
iOS	iPhone Requires iOS 13.0 or later iPad Requires iPadOS 13.0 or later iPod touch Requires iOS 13.0 or later Mac Requires macOS 11.0 or later and a Mac with Apple M1 chip or later.
Android	5.1 and up

Table 4. Minimum & Recommended OS requirements

9b. Recommended Devices

Platform	Model
iOS	Apple iPhones with iOS 13.0 or later installed.
Android	Android phones with Android OS 5.1 and up installed.

Table 5. Recommended Devices

9c. Software update

Injurymap, ApS recommends installing all recent Injurymap application updates to keep it up to date.

10. Safety Information

If you have questions or concerns about Injurymap application, please provide your feedback through [email protected].

Please report a serious incident occurring in relation to the device to Injurymap, ApS, and the local competent authority (EU) or local regulatory authority.

11. Symbol Glossary

Symbol title

Symbol

Description

Manufacturer

Indicates the medical device manufacturer

EN ISO 15223-1:2021, 5.1.1

Consult instructions for use

Indicates the need for the user to consult the instruction for use

EN ISO 15223-1:2021, 5.4.3

Medical device

Indicates the item is a medical device

EN ISO 15223-1:2021, 5.7.7

Unique device identifier

Indicates carrier that contains the unique device identifier information

EN ISO 15223-1:2021, 5.7.10

Manufacturer

Indicates the medical device manufacturer

EN ISO 15223-1:2021, 5.1.1

Consult instructions for use

Indicates the need for the user to consult the instruction for use

EN ISO 15223-1:2021, 5.4.3

Medical device

Indicates the item is a medical device

EN ISO 15223-1:2021, 5.7.7

Unique device identifier

Indicates carrier that contains the unique device identifier information

EN ISO 15223-1:2021, 5.7.10

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