Question 1

What is Spirit X and what does it do?

Accepted Answer

Spirit X is a Class IIa medical device software that provides digitalized validated questionnaires and their automated analysis. It's designed to aid in the detection (screening), diagnosis, and monitoring of mental health conditions. The platform digitalizes what has traditionally been done on paper, making mental health screening more accessible and efficient.

Question 2

Who can use Spirit X?

Accepted Answer

Spirit X is designed for multiple user groups: • Clients (lay persons): Answer questionnaires and receive appointments • Assessors: Healthcare professionals who view client profiles and create availability events • Helpers: Trained healthcare professionals who manage resource planning • Administrative roles: Field coordinators, tenant admins, and super admins for system management

Question 3

What are the main contraindications and limitations?

Accepted Answer

Spirit X should NOT be used in: • Intensive care settings • Emergency situations or life-threatening conditions • With users/patients who cannot understand the software system or questionnaires • As the sole basis for diagnostic and therapeutic decision making

Question 4

How long can Spirit X be used in a single session?

Accepted Answer

Spirit X is intended for continuous use for less than 60 minutes (transient use). The frequency and duration of sessions should be defined by qualified healthcare experts based on individual needs.

Question 5

What are the key benefits of using Spirit X?

Accepted Answer

• Early identification of people at risk for mental health issues • Improved access to mental health care • Automatic calculation of questionnaire scores • Reduced healthcare resources and turnaround times • Prevention of errors from manual score calculation • Longitudinal monitoring of patients for treatment effectiveness

Question 6

What technical requirements are needed to use Spirit X?

Accepted Answer

Spirit X is a Progressive Web App (PWA) that requires: • A desktop computer or mobile device with internet access • Chromium-based web browsers or Mozilla Firefox • An environment that guarantees privacy (ideally)

Question 7

Is there a specific patient population for Spirit X?

Accepted Answer

The platform is designed for people with unknown mental health status (referred to as "clients" rather than "patients"). There are no general limitations regarding health, age, gender, ethnicity, or nationality. Clients must be able to read or have a helper/caregiver assist them.

Question 8

How is Spirit X maintained and updated?

Accepted Answer

Maintenance is processed through regular updates provided directly in the software. As a progressive web app, manual or local updates are not required. Updates are automatic and seamless.

Question 9

What should I do if I encounter a serious incident?

Accepted Answer

If a serious incident occurs (deterioration in a patient's health associated with the product), immediately suspend use and contact Spirit X customer support at https://spirit-x.ch/contact/ or at info [at] spirit-x [dot] ch.

Question 10

Are there any reported side effects?

Accepted Answer

According to the current documentation, there are no reported side effects associated with Spirit X usage.

Question 11

How does Spirit X handle data security and privacy?

Accepted Answer

Spirit X is designed to meet high standards of data protection, aligned with the Swiss Federal Act on Data Protection (FADP), GDPR, and the Medical Device Regulation (MDR). For any data security or privacy concerns, contact support at https://spirit-x.ch/contact/.

Question 12

What clinical claims does Spirit X make?

Accepted Answer

The software claims to: • Enable mental health screening of populations that might otherwise not be screened • Determine severity of mental health symptoms • Check for signs of suicidal tendencies • Automatically triage patients by severity, urgency, and syndromal classification • Allow longitudinal monitoring for treatment effectiveness

Question 13

Where can I get user guides and additional documentation?

Accepted Answer

Individual user guides are available for different user groups through https://spirit-x.ch/contact/. Guides are available for assessors, helpers, field coordinators, researchers, admins, and other roles.

Question 14

What is the current software version and regulatory status?

Accepted Answer

The current software version is 2.21. Spirit X is classified as a Class IIa medical device according to EU Regulation 2017/745 (MDR) and carries the CE marking.

Question 15

How can I get support or report issues?

Accepted Answer

For malfunctions, problems, questions, or to request printed instructions, contact Spirit X support through https://spirit-x.ch/contact/. You can also reach Spirit X Solutions AG, the manufacturer, at info [at] spirit-x [dot] ch.

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