Device identification
Product: Balm Medical
Product type: SaMD
Product classification: Class I
UDI-DI: 04262501590008
UDI-PI: 1.1.0
1. Areas of application
1.1 Intended purpose
Balm Medical is intended to be used as a digital tool for individuals seeking to engage in an evidence-based psycho-educational program and exercises helping to self-manage and cope with signs of condition as Generalized Anxiety Disorder (GAD), Insomnia, Chronic Pain, Mild Depression. The device aims to maintain and counteract the worsening of health conditions by providing access to psycho-educational content and strategies with features such as instructions, diary-like symptom tracking, including follow-up, and interactive exercises. These features are designed to enhance user engagement with the educational material and support overall well-being.
1.2 Who is Balm Medical suitable for?
Balm Medical offers appropriate prevention strategies and supportive care for people who:
- are at least 18 years old
- have mild to moderate symptoms of the following conditions: Generalized anxiety disorder (GAD), Insomnia, Chronic pain, Mild depression
- want to maintain or improve their health through evidence-based psychoeducational interventions.
- are at risk of developing problems without preventive intervention.
- need ongoing support to help themselves cope with the above conditions.
The tool allows users to monitor their symptoms in a diary-like manner, enabling them to observe the progression of their frequent (mild/moderate) health problems and counteract any deterioration in their condition through standardized psychoeducational programs and exercises. The online program does not provide information or individualized therapy based on the information entered by the user, but rather offers general information about cognitive behavioral therapy techniques and how they work.
2. People who should not use Balm Medical (exclusion criteria)
Balm Medical is not suitable for people who
- have been diagnosed with severe mental disorders, including but not limited to: Severe depression with suicidal thoughts, Bipolar disorder, Schizophrenia or other psychotic disorders, Personality disorders
- are in acute mental crises that require immediate professional intervention.
- with a history of self-harm or active suicidal thoughts.
- who are currently undergoing intensive inpatient or outpatient psychiatric treatment.
- who are experiencing an acute mental health crisis requiring immediate professional intervention
- who are unable to give informed consent due to cognitive impairment or other factors.
- with visual impairment
- with hearing impairment
- who cannot read, write, or understand German or English
- who cannot operate a desktop computer
This software tool is not intended to replace professional medical care, medication, or other forms of primary treatment for diagnosed health disorders; nor is it intended to diagnose any disease or condition. Users who experience severe symptoms or are unsure about their suitability for this application should consult a qualified healthcare provider before use.
3. Contraindications
Balm Medical should not be used
- as a substitute for professional healthcare.
- by individuals experiencing severe psychological symptoms or suicidal thoughts.
- in psychological emergency situations.
- as a diagnostic tool. All results from Balm Medical symptom assessments must be independently and thoroughly reviewed by a qualified medical professional.
4. Warnings and remaining risks
Warnings
- Balm Medical is not a substitute for professional healthcare
- If symptoms worsen, consult a healthcare provider immediately
- Do not rely solely on Balm Medical to manage serious medical conditions
Remaining risks
- Possible misinterpretation of self-monitoring data
- Possible delay in seeking professional help if you rely too much on the platform
- Risk of data breaches or unauthorized access to personal information
5. Emergency information
In case of suicidal tendencies or an acute crisis, emergency services should be notified.
Emergency numbers in Germany:
- Emergency services: 112
- Police: 110
The telephone counseling service offers a listening ear in life crises, around the clock, free of charge, and anonymously.
The telephone counseling team knows the appropriate facilities and contact points in the event of acute crises and suicidal tendencies. Clinics and other crisis services in your area can also be found in the address list of the German Depression Aid Foundation: www.deutsche-depressionshilfe.de
6. General technical requirements
For proper use, the following technical requirements should be met:
- Access to a compatible device (smartphone, tablet, or computer)
- Stable internet connection
- Ability to update the software tool as needed
- Basic troubleshooting skills for technical problems
7. Environment in which Balm Medical should be used
Balm Medical is designed for use in a controlled, private environment that promotes concentration and engagement. The typical usage environment and requirements are:
1. Device and platform
- It is recommended to use Balm on a desktop computer.
- Compatible with common desktop web browsers (e.g., Chrome, Firefox, Safari, Edge)
- Supports standard desktop operating systems (Windows, macOS, Linux)
2. Physical environment
- Quiet, private room free from distractions
- Well-lit area to ensure clear visibility of the screen
- Comfortable seating that allows for extended periods of concentrated interaction
- Not intended for use in noisy, chaotic environments such as public spaces
3. Internet connectivity
- Stable broadband Internet connection required
- Recommended minimum speed: 5 Mbit/s download, 1 Mbit/s upload
4. Hardware requirements
- Desktop computer or laptop with a screen size of at least 13 inches
- Keyboard and mouse or touchpad for navigation and input
- Audio output (speakers or headphones) for potential audio content
5. Software requirements
- Latest version of a supported web browser
- JavaScript enabled
- Cookies allowed for session management
- No additional software installation required beyond the web browser
6. Privacy and security
- Please ensure that you are in a private environment where your screen and any audio output cannot be observed or overheard by others
- The use of personal, password-protected devices is recommended to maintain confidentiality
7. Time and environment
- Please allow yourself sufficient time to use Balm Medical. The environment should allow for uninterrupted sessions of 30–60 minutes.
- We recommend that you conduct a session as recommended in the respective application.
- Please minimize potential interruptions by, for example, muting your phone and notifications and closing all other applications.
Note: Balm Medical is not designed for mobile or tablet use. We recommend using Balm Medical on a desktop computer.
8. System requirements
To ensure smooth and trouble-free operation, we recommend the following components:
8.1 Hardware
- Computer with internet connection
- Processor: 1 GHz or faster
- RAM: 2 GB or more
- Storage: 500 MB free space
- Display: 1366 x 768 resolution or higher
8.2 Software
- Google Chrome: Version 129/101 or higher
- Safari: Version 17.4 or higher
- Microsoft Edge: Version 130 or higher
- Firefox: Version 125 or higher
- Opera: Version 109 or higher
9. Security and maintenance
9.1 Provision of updates
- Updates are supplied during regular maintenance windows outside peak usage times.
- Updates are rigorously tested before release.
- After every update, thorough tests are performed to ensure system stability and functionality.
9.2 Reporting malfunctions
You can report malfunctions via:
When reporting, please provide:
- A detailed description of the problem
- Date and time of occurrence
- Any error messages received
- Steps to reproduce the issue (if applicable)
- Screenshots (if applicable)
9.3 Password recovery
To reset a lost password:
- Click the “Log In” link on the homepage.
- Enter the registered email address.
- Click “Continue.”
- On the login page, click “Reset Password.”
- Follow the instructions in the password-reset email.
- Create a new, strong password.
9.4 Reporting of serious incidents
If a serious incident has occurred in relation to the product, please report it:
- to the manufacturer: see contact details in chapter 10. Manufacturer and Product Information, and
- to the competent authority of the EU Member State in which the user or patient is established. The list of national competent authorities for medical devices is available on the European Commission's website: https://health.ec.europa.eu/medical-devices-sector/contacts_en. Please go to “Vigilance contact points” (PDF).
10. Manufacturer and product information
10.1 Product name
Balm Medical
10.3 IFU in paper
These instructions for use are provided in electronic form. A printed copy is sent out free of charge on request within 5 working days – email balmsupport@significo.com or write to the manufacturer address. Please include the product name, your preferred language and a postal address.
10.4 Instructions for use information current as of
IFU_BALM_MEDICAL_EN.v3
10.5 CE mark and risk class
Balm Medical is a Class I medical device in accordance with Regulation (EU) 2017/745 (MDR).
10.6 Unique Device Identifier (UDI)
UDI-DI: 04262501590008
10.7 Symbol legend acc. EN ISO 15223-1:2021
CE Mark (Communauté Européenne):
Indicates the product complies with Regulation (EU) 2017/745.
Instructions for Use:
See the instructions for use or electronic instructions for use.
Manufacturer:
Name and address of the medical-device manufacturer.
Unique Device Identification (UDI): Information on the device’s unique identifier.
Indicates that the item is a medical device (MD).
Caution: To indicate that caution is necessary when operating the device or that the current situation needs operator awareness.
