Revision 1.0
Release Date: 2024-06-28
Injurymap, ApS
Danneskiold-Samsøes Allé 41, st, c/o Health Tech Hub Copenhagen,
1434 København K, Denmark
E-mail: [email protected]
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.
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
This chapter presents medical indications for using this medical device.
This chapter presents medical contraindications which should exclude using this medical device.
This chapter presents different user groups which will be using the medical device.
User Group* | Description |
Patients/users |
|
Physiotherapists |
|
Healthcare professionals |
|
Table 2. User groups
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. |
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.
This chapter provides a detailed description of how to use the Injurymap application and gives logically ordered steps for all main functions.
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.
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.
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.
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.
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.
The Today Screen gives you an overview of your currently active training programs and your overall progression.
Start a workout by navigating to the Today screen and pressing the “Let’s go!” button.
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.
On the settings screen, you have the option to:
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.
This chapter presents the conditions and situations for which the device is not intended to be used.
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.
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
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
Injurymap, ApS recommends installing all recent Injurymap application updates to keep it up to date.
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.
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