General instructions for use

The complete MS sherpa operating instructions are provided in electronic form and can be accessed through the MS sherpa Knowledge Base. Please read the operating instructions below carefully to ensure safe use of MS sherpa.

Hardware and Software Requirements

The minimum hardware and software requirements are as follows:

MS sherpa App for persons with MS, smartphone requirements:
- version 9 or higher for Android
- version 14.0 or higher for iOS

MS sherpa dashboard for caregivers, accessible via web browsers (Windows and Mac), no restrictions.

Available languages

The instruction manual is available in the following languages:
- English
- Dutch
- German

Current version of the instruction manual

The most recent version of the user manual can be found on the MS sherpa Knowledge Base.

Paper version

Paper versions of these Instructions for Use are available upon request. To obtain a paper version, send a request to support@mssherpa.nl and your request will be processed within 5 business days.

Medical emergencies / Side effects and contraindications

There are no foreseeable medical emergencies that may arise from the use of MS sherpa.

There are no contraindications for the use of MS sherpa.

There are no known side effects of MS sherpa.

Reporting of adverse events/incidents

Users must report any serious incident/event that occurred in connection with MS sherpa to Sherpa BV and/or the competent authority of the country where the user resides: Contact support@mssherpa..nl, they will process all incidents appropriately.

Target

The intended audiences for these instructions for use are MS caregivers and persons with MS using MS sherpa.

Intended purpose (product claim)

MS sherpa is designed to support the monitoring of individuals with MS, in order to provide individuals with MS and their professional care team(s) with personal insight into the presence and progression of symptoms associated with MS.

This intended purpose ("claim") is supported by clinical data identified, reviewed and analyzed during the clinical evaluation of the device, resulting in a positive benefit-risk ratio. Any remaining risks are part of the "Limitations of Use" and "Warnings & Precautions.

Use restrictions

Since the intended use of MS sherpa is to support monitoring in the normal clinical MS care setting, through the use of digital tests via a smartphone in the home setting , and using data analysis and algorithms to visualize insights, restrictions apply to its use.

MS sherpa is not intended:
-for diagnostic or therapeutic purposes or in any other way for routine medical practice
-To monitor persons with MS in an emergency situation
-to monitor persons with MS who are clinically unfit to monitor at home, e.g., patients at risk of being unable to summon emergency care.
-to use in an unsafe environment and/or when participating in traffic.

Based on the clinical evaluation, MS sherpa can be used safely and effectively by persons with MS and MS caregivers.

To ensure clinical suitability, health care providers and persons with MS should consider the intended use and limitations of the device. The final decision on clinical suitability for the person with MS is the responsibility of the physician.

Warnings and Precautions

Abnormal/unintended use of MS sherpa (e.g., for diagnostic purposes) by a healthcare provider or pmMS may result in clinical errors. MS sherpa should be used within the limitations of use at all times. Specific warnings and precautions can be found in the latest version of the manual on the MS sherpa Knowledge Base

MS sherpa and CE certification

Sherpa BV has been an independent Dutch healthcare innovation company since 2016.

MS sherpa has been available on the market as a CE-marked Class I device under the MDD since December 20, 2019, and currently in transition to CE Class IIa under the MDR.

MS sherpa is considered a medical device under Directive 93/42/EEC (MDD) as well as under Regulation (EU) 2017/745 (MDR).

Privacy and information security

All personal information in MS sherpa is handled in accordance with the General Data Protection Regulation (AVG) and our privacy and security guidelines, in accordance with ISO27001 and NEN7510 standards.

Information about Privacy, Information Security and User Agreements are provided in the Privacy Statements available in the MS sherpa app, MS sherpa caregiver dashboard and the MS sherpa knowledge base.