Instructions for Use

1. Areas of application

1.1 Intended purpose

Balm Medical is a digital tool aimed at people who want to participate in a scientifically based program and exercises. It supports self-help and coping with the signs of illness listed in 3.2. (Indication). The aim is to halt the deterioration of health by providing access to systematic and scientifically based content and strategies. The program is designed to enable independent self-help. It contains recommendations, diary-like documentation of symptoms, follow-up care, and interactive exercises. These features are intended to increase the use of the program and support general 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:
1. Generalized anxiety disorder (GAD)
2. Insomnia
3. Chronic Pain
4. 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.

0800 111 0 111
0800 111 0 222
www.telefonseelsorge.de

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

Emergency numbers in United States of America:

988 Suicide and Crisis Lifeline
911 Emergency Services

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:

Device and platform
1. Balm Medical is accessible exclusively via a desktop web environment and via the Balm Dtx website
2. Compatible with common desktop web browsers (e.g., Chrome, Firefox, Safari, Edge)
3. Supports standard desktop operating systems (Windows, macOS, Linux)
Physical environment
1. Quiet, private room free from distractions
2. Well-lit area to ensure clear visibility of the screen
3. Comfortable seating that allows for extended periods of concentrated interaction
4. Not intended for use in noisy, chaotic environments such as public spaces
Internet connectivity
1. Stable broadband Internet connection required
2. Recommended minimum speed: 5 Mbit/s download, 1 Mbit/s upload
Hardware requirements
1. Desktop computer or laptop with a screen size of at least 13 inches
2. Keyboard and mouse or touchpad for navigation and input
3. Audio output (speakers or headphones) for potential audio content
Software requirements
1. Latest version of a supported web browser
2. JavaScript enabled
3. Cookies allowed for session management
4. No additional software installation required beyond the web browser
Privacy and security
1. Please ensure that you are in a private environment where your screen and any audio output cannot be observed or overheard by others
2. The use of personal, password-protected devices is recommended to maintain confidentiality
Time and environment
1. Please allow yourself sufficient time to use Balm Medical. The environment should allow for uninterrupted sessions of 30-60 minutes.
2. We recommend that you conduct a session 1-2 times per week.
3. Please minimize potential interruptions by, for example, muting your phone and notifications and closing all other applications.

Note: We recommend that you use Balm Medical on a desktop computer.

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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. Registration

9.1 Registering for Balm Medical

1. Use your laptop or computer to access the Balm Medical website using this link. You can use any web browser.

2. In the first step, we ask you to carefully read the agreements on the processing of health data, data protection, and the general terms and conditions and, if you agree, to accept them.

3. Next, please enter your email address and personal details. Please scroll down to see all the fields you need to fill in.

4. The “access code” is: BalmFree

5. After opening the email, please click on the “Complete registration” button.

6. You will then receive a confirmation email. Please navigate to your email program and open the email from the sender “ZITADEL.” Just to be safe, check your spam folder.

7. You will be redirected to the “Activate user” screen. Please do NOT delete or change the “Code” field.

8. Please choose a secure password of your choice and confirm it.

9. Click on “Continue.”

10. Your Balm user account is now activated. Click on “Continue” again.

11. You must now log in with your email and password.

9.2 Verifying successful registration

To verify successful installation and access to the Balm Medical platform

1. Navigate to the Balm platform URL (balm.significo.com) using a supported web browser.

2. Confirm that the login page loads without errors

3. Click on Log in

4. Enter your email address and password

5. Make sure that the page balm.significo.com/paths loads

6. Please click on the Explore Path button to see more information about the intervention.

7. Click Enroll to register for the intervention

8. You now have access to the first session and can start accessing the intervention content

10. Security and Maintenance

10.1 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.

10.2 Reporting Malfunctions

You can report malfunctions via:

Email: balmsupport@significo.com

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)

10.3 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.

11. Manufacturer and Product Information

Manufacturer:

Balm is a brand of Significo GmbH.
Produced by: Significo Digital GmbH
Heinrich-Mann-Allee 3 B, 14473 Potsdam, Germany
Email: balmsupport@significo.com
Website: balm.significo.com
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A free printed copy of the instructions for use is available on request.
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Information current as of:
06 January 2024
Version: 0.1.2
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Further Information:

Balm is a Class I medical device in accordance with Regulation (EU) 2017/745 (MDR).

42625015962616C6DBA

Symbol Legend:

CE Mark (Communauté Européenne): Indicates the product complies with Regulation (EU) 2017/745 or Directive 93/42/EEC on medical devices.

Instructions for Use (ISO 7000-1641): See the instructions for use or electronic instructions for use.

Manufacturer (ISO 7000-3082): 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).

Warnings and necessary precautions.

Instructions for use Balm Medical

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