Cara Plus Instructions for Use

1. Cara Plus Product Description

Manufacturer: Spectrum Wellness Limited, 38/39 Fitzwilliam Square West, Dublin 2, D02 NX53, Ireland.

1. Cara Plus is an AI-enabled digital mental health support application that provides text-based conversational support, evidence-based guided exercises and self-monitoring tools for adults experiencing mild to moderate symptoms of anxiety and/or depression.
2. The application is delivered via Apple and Android mobile devices (Android v8.0 or higher; iOS v16 or higher).
3. The device provides text-based conversational interaction with an AI companion, evidence-based guided exercises (breathing, mindfulness, visualisation), symptom self-tracking using validated measures (PHQ-9, GAD-7), and automated safety monitoring with escalation to crisis resources.
4. No human therapist is involved in real-time interaction with the user.

2. Intended conditions for use

1. Cara Plus is software intended to manage symptoms of anxiety and/or depression in adults who experience mild to moderate symptoms of anxiety and/or depression.
2. The device is intended for use in any environment where an adult can safely and comfortably use a mobile phone. This includes home settings, workplace settings, outpatient settings, and remote settings. The device should be used in situations where the user is able to focus on the interaction and is not engaged in activities that require full attention.
3. The device is intended to be used directly by adults (lay people).

3. Intended user

1. The device is intended for adults aged eighteen and older who experience mild to moderate symptoms of anxiety and/or mild to moderate symptoms of depression.
2. The device is intended for use by individuals who are able to read, write and interact in English fluently.
3. The user must be able to install and operate the Android or iOS application and read the in-app content.

4. Intended Purpose

Cara Plus is software intended for use in the management of symptoms of mild to moderate anxiety and/or depression in adults. Cara Plus is intended for adults aged 18 or over in any environment where an adult can safely and comfortably use a mobile phone. Contraindications are listed in Section below and are enforced by the software.

4.1. Software support window

Software support for Cara Plus 1.0 ends three years from first market placement. After this date, no further security patches or feature updates will be issued for v1.0. You will be notified 3 months before end-of-support and migrated to the supported successor version. Current support status is shown in the in-app About screen.

5. Contraindications

1. Individuals under 18 years of age.
2. Individuals with severe symptoms of depression (PHQ-9 ≥ 15) at the point of use.
3. Individuals with severe symptoms of anxiety (GAD-7 ≥ 15) at the point of use.
4. Individuals who currently experience suicidal thoughts, intent to self harm, or who have made a recent suicide attempt.
5. Individuals who have been diagnosed with, or who present symptoms of, psychotic disorders, including those currently experiencing hallucinations, delusions, or loss of contact with reality.
6. Individuals with active substance dependence, who are currently in withdrawal.
7. Individuals with any condition that prevents them from safely and comfortably using a mobile phone.

6. Warnings, limitations and precautions

1. ⚠ This device is not an emergency service. If you are in crisis or at immediate risk of harm to yourself or others, contact your local emergency services.
2. ⚠ Do not rely solely on this application if symptoms worsen, persist or become severe. Seek advice from a healthcare professional.
3. ⚠ The application operates in English only. Language provision confirmed against the European Commission's 'MDR – Language Requirements for Manufacturers' (Rev. 3, August 2025): Ireland's national implementing law (S.I. No. 547/2017) permits English (or English and Irish) across Label/Instructions for Use and Graphical User Interface (GUI) content, with no separate GUI-specific requirement. This is reassessed for any additional market (e.g. GB, under UK MDR) before launch there.
4. ⚠ A stable internet connection is required for the application to function.
5. ⚠ The AI may occasionally produce responses that are inaccurate, incomplete or inappropriate. The user should not rely on the AI for clinical advice, diagnosis or treatment decisions.
6. ⚠ The application may collect and process information you share. Refer to the Privacy Notice for how data is handled.
7. ⚠ The device is not intended to provide diagnosis.
8. ⚠ The device is not intended to provide medical treatment or replace professional clinical care.

6.1. Device Malfunction or Technical Failure

If the application:

• Fails to start
• Freezes or crashes
• Does not display messages correctly
• Does not respond to input

Users should:

• Close and restart the application
• Check their internet connection
• Restart their device if necessary
• Contact support if the issue persists. Contact details are available in the Preferences section under Contact us.

Do not rely on the application for urgent support in the event of technical failure.

6.1.1. Information about issues

6.1.1.1. No Internet Connection

6.1.1.2. Something went wrong

6.1.1.3. Sending failed

7. Notification symbols

1. The application may display notifications or prompts related to the user’s activity, including exercise completion and other relevant in app information.
2. A persistent Get Support button is available within the chat interface and provides access to external support and crisis resources.
3. If risk related content is detected during a conversation, the chat may be temporarily disabled for approximately 30 minutes and external support resources will be displayed.
4. External support resources remain accessible at any time through the Get Support button, regardless of whether risk related content has been detected.

8. Use

8.1. Installation

Cara Plus is downloaded and installed from Google Play Store and Apple App Store as part of the host application.

8.2. First-time setup

8.2.1. Consent

On the welcome screen, you will be provided with important information about Cara Plus, including links to the Instructions for Use, Privacy Policy, and Terms of Service. Please review this information, select I consent to the above, and tap Get Started to continue.

8.2.2. Brief Overview

8.2.3. Onboarding questionnaire

You will be asked a range of questions to help us understand whether Cara Plus is suitable and appropriate for you, and to provide you with the right support. Please answer all questions accurately.

The eligibility assessment consists of three parts:

1. An initial screening screen with a series of checkboxes:

2. A questionnaire containing 7 questions to assess the severity of anxiety symptoms:

3. A questionnaire containing 9 questions to assess the severity of depression symptoms:

Please answer all questions accurately. Your responses are used to determine whether Cara Plus is suitable for you.

If your answers suggest that Cara Plus is not suitable for you, you will not be able to continue with onboarding and will be signposted to external support resources instead. These services are external resources and are not provided by Cara Plus.

If your answers suggest that you match the intended use of Cara Plus, you will proceed to personalising your experience, including choosing your AI personality and your first wellbeing goal.

8.2.4. Disclaimers

Before starting your first chat, you will be shown important disclaimers about using Cara Plus. Please read and accept the information presented, then tap Get Started to continue to the chat.

8.2.5. Choosing an AI personality

There are three options available: Supportive, Structured and practical, and Empowering. This choice defines how Cara sounds and responds to you. You can change it at any time in settings.

8.3. Selecting a goal

Choose the area you would like to focus on for your first chat. Goals are organised into five groups:

1. Mood
   • Feeling Down
   • Persistent Low Mood
   • Negative Thoughts
2. Anxiety
   • Coping with Anxiety
   • Worry or Intrusive Thoughts
   • Moments of Panic
   • Social Anxiety
3. Stress & Burnout
   • Navigating Burnout
   • Reducing Stress
   • Balancing Emotions
4. Wellbeing
   • Happiness
   • Mindfulness
   • Improving Sleep Quality
5. Resilience
   • Self Esteem & Confidence
   • Develop Resilience
   • Build Self Connection
   • Understand Your Values

You can switch between the groups and select any goal to begin your first chat. The goal is simply a starting point for the conversation. You can discuss anything related to it, and you can choose a different goal for future chats.

User goals	Examples of topics to discuss with Cara Plus	How it looks in the app
Mood Feeling Down Persistent Low Mood Negative Thoughts	"I feel sad but don't know why." "How can I find joy in life?” "How can I avoid being overwhelmed by negative thoughts?"
Anxiety Coping with Anxiety Worry or Intrusive Thoughts Moments of Panic Social Anxiety	"I am anxious at work due to layoffs." "I feel stressed very often, how can I manage that?"
Stress & Burnout Navigating Burnout Reducing Stress Balancing Emotions	"How can I better balance my personal and professional life?" "What can I do to avoid feeling exhausted all the time after work?”
Well-being Happiness Mindfulness Improving Sleep Quality	"How can I improve my overall quality of life?” “I am having difficulties with falling asleep and always go to bed extremely late, how do I break the cycle?”
Resilience Self Esteem & Confidence Develop Resilience Build Self Connection Understand Your Values	"Why can’t I trust myself and believe I can succeed?" "What can I do to stay positive despite challenges?" "How can I give more meaning to my daily life?" "How can I better understand my emotions?"

8.4. Chat interaction

1. Type your message in the chat field.
2. Press send.
3. The AI will respond with guidance or exercises.
4. Optional: Tap the microphone icon to dictate your message
5. Confirm with tick icon

You may be offered an exercise directly during your conversation. To start it, tap the exercise card in the chat and follow the instructions on the screen.

You can interact with the exercise, close it at any time, and return to your chat to continue the conversation.

8.5. Ending a session

8.5.1. Closing the session

To end a session, tap the cross in the top left corner of the chat screen. You will be asked to confirm that you want to end the session. Tap End session to continue.

Once the session has ended, you will see a summary with key insights from your conversation.

You can then choose to:

• Download a copy: Enable the Download a copy toggle to save a copy of the session to your device.
• Share with the clinical team: Enable the Share with Spectrum.Life’s clinical team toggle if you would like to share your session summary with the clinical team.
• Finish: Tap Done to complete the session. If the sharing toggle is disabled, your session summary will not be shared with the clinical team.

Cara Plus is designed so that only you can access your personally identifiable interaction data within the app. Your data is encrypted, and access is restricted so that Spectrum Wellness Limited staff cannot view your personal conversation content. When you share a session summary with Spectrum.Life's clinical team, identifying details such as names, phone numbers, and email addresses are removed or masked first.

8.5.2. Session time-out

If you do not interact with Cara Plus for three hours, your session will be marked as inactive.

The next time you open the app, you can choose to:

• Continue the previous session with the same wellbeing goal, or
• Start a new session with a different wellbeing goal.

8.6. Continuing a previous chat

To continue your chat after ending a session, exiting the chat, or after a session timeout, you can tap the relevant goal in the Working on section, select the same goal again from the Goals menu, or tap the round Chat button in the centre of the bottom navigation bar.

8.7. Starting a new chat

To start a new chat, select a different goal from the Explore section. Your previous session history will remain available.

8.8. View session history

To view your previous conversations, scroll down on the Goals screen. Your previous sessions will remain visible.

8.9. Exercises Screen

From the home screen, navigate to Exercises to access interactive exercises.

To start an exercise, tap the exercise tile. You will be guided through the next steps. Tap the play button or follow the instructions shown on the screen.

To close an exercise, tap the cross in the upper right corner of the screen.

8.10. Safety Escalation

If a potential risk is detected during your conversation, Cara Plus may direct you to external support resources and temporarily disable the chat for approximately 30 minutes. Please use the support options shown on the screen if you need immediate or additional help.

These services are external resources and are not provided by Cara Plus.

8.11. External Support

External support resources are available at any time, even when no risk has been detected. Tap Get Support from the chat screen to view the available resources.

Please contact one of the listed support services whenever you feel you need external support.

These services are external resources and are not provided by Cara Plus.

8.12. Ongoing eligibility screening

To help make sure Cara Plus remains suitable for you, you will be asked to complete a short screening questionnaire every 14 days. This is the same type of check completed during onboarding.

When 14 days have passed since your last screening, you will see a screening prompt before you can continue using the app. You will need to complete the questionnaire to keep accessing Cara Plus.

If your answers suggest that you still match the intended use of Cara Plus, you will continue using the app as normal.

If your answers suggest that Cara Plus is no longer suitable for you, you will not be able to continue and will be signposted to external support resources instead.

8.13. Preferences

To access Preferences, tap the gear icon in the top right corner of the Exercises screen.

In Preferences, you can:

• Adjust the AI personality
• View the Cara Plus Privacy Policy
• View the Cara Plus Terms of Service
• Read more About Cara Plus
• Access the Instructions for Use
• View our contact information to contact us for support, feedback, or other enquiries
• Withdraw your consent and delete your data

8.14. Withdrawing consent and deleting your account

At the bottom of Preferences, tap Withdraw consent and Delete data to begin the consent withdrawal and account deletion process.

You will be asked to confirm that you understand this action is permanent and that your account cannot be recovered. Select the confirmation checkbox, then tap Proceed.

Your consent will be withdrawn and your account and associated data will be deleted. This action is irreversible.

After deletion, you will be redirected to the initial Cara Plus screen and will not be able to continue using Cara Plus unless you provide consent again and complete the required onboarding steps.

Cara Plus does not store your interaction data in a form that identifies you personally.

When you delete your account, your account and any data linked to your identity are permanently and irreversibly removed. De-identified interaction data may be retained separately for up to 15 years, in accordance with Spectrum Wellness Limited's data retention policy, for regulatory, safety, and audit purposes. This retained data cannot be used to identify you.

9. Clinical Benefits

The expected clinical benefits of Cara Plus are based on clinical evaluation in the intended user population (adults with mild-to-moderate symptoms of anxiety and/or depression).

• For adults with mild-to-moderate anxiety symptoms (GAD-7 score 5–14) who use Cara Plus regularly for at least four weeks, the expected clinical benefit is the maintenance of anxiety symptoms without clinically meaningful worsening. Clinical evaluation showed that at least 75% of users did not experience a clinically meaningful worsening of anxiety symptoms over four weeks.
• For adults with mild-to-moderate depressive symptoms (PHQ-9 score 5–14) who use Cara Plus regularly for at least four weeks, the expected clinical benefit is the maintenance of depressive symptoms without clinically meaningful worsening. Clinical evaluation showed that at least 75% of users did not experience a clinically meaningful worsening of depressive symptoms over four weeks.

The current clinical evidence supports the benefit of maintaining symptom stability during regular use. A benefit of symptom reduction has not yet been established for this version of Cara Plus.

10. Minimum system specification

11. Compatibility with other devices

• Cara Plus has been validated for use on Apple and Android mobile phone devices (Android v8.0 or higher; iOS v16 or higher).
• Cara Plus interfaces directly with the host mobile device and does not require additional hardware.
• Cara Plus has not been validated for use on tablets, foldable devices, or desktop systems.
• Cara Plus does not interface with other medical devices.

12. IT security measures for the user environment

12.1. User-side controls:

1. Cara Plus doesn't have its own separate login. You access it through your host application, so keep those credentials secure and do not share your access details.
2. Use biometric or device-level screen lock on your phone.
3. Keep your phone operating system and Cara Plus application up to date.
4. Don't use Cara Plus on compromised/jailbroken or rooted devices.
5. Log out at the end of each session if your phone is shared with others.
6. Report any suspected unauthorised access to your account immediately to Spectrum support.
7. Protect your host-app credentials

12.2. Manufacturer-side controls:

1. All communications between the application and Spectrum servers are encrypted using TLS 1.2 or higher.
2. Sensitive data stored on the device is encrypted at rest.
3. Personal identifiable information is masked prior to cloud storage where appropriate.
4. Role-based access controls limit who can access user data within Spectrum.
5. Security audit logs are maintained for all sensitive system events.
6. The application's Software Bill of Materials is monitored continuously for vulnerabilities.

13. Performance Characteristics and Expected Outcomes

Cara Plus provides AI-generated conversational guidance to support your mental wellbeing. Responses are based on a clinically curated knowledge library and are designed to provide evidence-informed information and self-management support that is appropriate for the intended use of the device.

Every response is checked using built-in safety measures before it is shown. These measures are designed to reduce the likelihood of inappropriate or unsafe responses and to encourage users to seek additional support when needed.

Cara Plus can:

• Provide evidence-informed guidance and self-management strategies for mild-to-moderate symptoms of anxiety and depression.

• Answer questions related to mental wellbeing using information from its clinically curated knowledge library.

• Encourage healthy coping strategies and appropriate help-seeking when indicated.

Cara Plus does not:

• Diagnose mental health or other medical conditions.

• Replace assessment, diagnosis, or treatment by a qualified healthcare professional.

• Prescribe, recommend, or adjust medications.

• Provide crisis intervention, emergency support, or real-time monitoring.

• Make decisions on your behalf or guarantee that every response will be complete or suitable for your individual circumstances.

AI-generated responses may occasionally be incomplete or not fully applicable to your situation. You should use your own judgement and consult a healthcare professional if you are unsure about any information provided or if your symptoms worsen, do not improve, or cause significant distress. If you believe you are experiencing a medical or mental health emergency, contact your local emergency services or crisis support service immediately.

14. Basic UDI-DI, UDI-DI, product code, catalogue number or other unambiguous reference allowing traceability

15. Contact Information

For questions, information or Customer Support, please contact Spectrum Wellness Limited in any of the following ways:

• Email (security vulnerabilities): cara-security@spectrum.life
• Email (all other enquiries, including data access and portability requests): caraplus@spectrum.life
• Call: +44 74 1836 0046
• Postal: Spectrum Wellness Limited, 38/39 Fitzwilliam Square West, Dublin 2, D02 NX53
• CE marking per MDR Article 20; Notified Body Scarlet NB B.V. (3022).

Any serious incident that has occurred in relation to the device should be reported to the manufacturer (Spectrum Wellness Limited) and the competent authority of the member state in which the user is established, without delay.

A paper copy of this IFU can be requested at the email address above free of charge within 7 calendar days

eIFU can be found at https://www.spectrum.life/cara/eifu

16. Glossary of medical device symbols

Symbol	Symbol Title	Meaning of Symbol/Description	Standard/Regulation Title	Standard/ Regulation Reference
	Consult instructions for use or consult electronic instructions for use	Indicates the need for the user to consult electronic instructions for use.	Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements.	ISO 15223‐1, clause 5.4.3
			Graphical symbols for use on equipment.	ISO 7000-1641
	Manufacturer	Indicates the medical device manufacturer.	Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements.	ISO 15223‐1, clause 5.1.1
			Graphical symbols for use on equipment.	ISO 7000-3082
	Date of manufacture	Indicates the date when the medical device was manufactured. For software, the date when the specific software version was released.	Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements. Graphical symbols for use on equipment.	ISO 15223-1, clause 5.1.3 / ISO 7000-2497
	Medical device	Indicates the item is a medical device.	Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements.	ISO 15223‐1, clause 5.7.7
	Unique device identifier	Indicates a carrier that contains unique device identified information.	Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements.	ISO 15223‐1, clause 5.7.10
Vx.y.z	Software version	Indicates the software version of the medical device.	No dedicated ISO 15223-1 symbol; conventionally rendered as "VERSION" or "Vx.y.z" text on the label and within the application.	MDR Article 27 (UDI); IEC 82304-1 §5.4
	Warnings, Cautions	Indicates that caution is necessary when operating the device or control close to where the symbol is placed, or that the current situation needs operator awareness or operator action in order to avoid undesirable consequences.	Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements.	ISO 15223‐1, clause 5.4.4.
			Graphical symbols for use on equipment.	ISO 7000-0434A or ISO 7000-0434B
	Regulatory Approval	Indicates that the device complies with the applicable EU regulations, including Regulation (EU) 2017/745 on Medical Devices. The CE mark is accompanied by the identification number of the Notified Body.	EU Medical Device Regulation (EU MDR) 2017/745	EU Medical Device Regulation 2017/745