CareCompass Instructions for Use

Product Outline

Product Details

CareCompass is a tool designed to provide a digital solution to enable caregivers of individuals living with Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS) to seamlessly build personalized care guides, enabling the entire care team to provide personalized care according to the latest information and best practices. CareCompass is a responsive web application accessed through a browser-based dashboard which requires registration. All data entered is stored and encrypted in a database hosted in the United States.

	CareCompass
	Phase 2

Intended Use

Read this instruction manual thoroughly before using CareCompass. Please keep these instructions for future reference.

CareCompass is intended for caregivers of individuals with DS and LGS in the United States. It supports building personalized care guides that detail the care conditions and needs of those with DS and LGS, helping caregivers navigate complex care needs to provide personalized care according to the latest information and best practices. CareCompass is not intended to represent a call to action or duty of care, diagnose or detect any medical conditions, nor replace healthcare professionals. It provides a platform for sharing care-related information under the control of the main caregiver who maintains responsibility for the accuracy of the content within and control of access to said content.

Safety Information

Safety instructions

Warning: Indicates a potentially hazardous situation which, if not avoided, could result in patient death or serious impact to the health of patients. Please follow the mandatory safety information supplied with the CareCompass. CareCompass is not intended to diagnose, treat or manage disease or medical conditions and should not be used for such purposes. CareCompass is not intended to detect and report any emergency or therapeutic adverse events related to DS, LGS or any comorbidity. The clinical decision-making process and duty of care to patients with DS and LGS is the responsibility of the designated healthcare professionals. CareCompass is not intended to replace the services of a healthcare professional. The content contained within CareCompass is sharable at the discretion of permitted primary caregivers who maintain the responsibility for the accuracy of the content within and control of access to said content within CareCompass. Ensure you read the instruction manual thoroughly before using CareCompass. Keep these instructions for future reference. CareCompass enables the addition of your loved one’s allergies and medications schedule and record of administration, including epilepsy specific medication, rescue medication, vitamins, supplements and over the counter medications. This is so there is a complete overview which is readily accessible to provide to healthcare professionals involved in your loved one’s care. However, it is the primary caregiver’s responsibility to ensure that the correct medications (including the schedule, dosage and route) and allergies information is entered into the Medication & Allergies module and matches their legal prescription. Any changes in medication or allergy status should be made in CareCompass in a timely way. Caregivers should be aware of the risk when logging the record of medicines that have been administered by the caregiver to the patient into CareCompass, that if this record is not kept accurate and up to date and logged every time medicine is adminstered (thus leaving gaps), then there is a chance for user misinterpretation around this important feature. This could lead to medicines adminstration errors if, for example, the caregiver could not recall whether a particular dose had been given or not. It is not intended that CareCompass is to be used as a medications management or medicines administration system, in place of health organisation systems and processes for managing medication for patients with DS or LGS. Healthcare professionals who are provided with medications information from CareCompass should always verify the patient’s medication through a medicines reconcilliation process and not solely rely on information logged in CareCompass by the primary caregiver. This includes allergies and medicines contraindications. Although CareCompass permits the logging of these by the primary caregiver, this record of allergies and ADRs should not be considered by healthcare professionals as the de facto complete record and must refer to healthcare organisation systems and processes and clinical assessment to determine medicines reconcilliation and full list of allergies. Primary caregivers must ensure that any instructions for use for medications administrations, eg. rescue medicines instructions for use, or any other part of the patient’s care plan, intended to be provided to other people involved in their loved one’s care, are correct and up to date. Any changes to any aspect of the patient’s care plan or health or allergy status, particularly when sharing via CareCompass with third parties involved in the patient’s care, must be made in a timely way. Primary caregivers are responsible for ensuring the correct medical devices and equipment information is entered into CareCompass, including the schedule for renewal/maintenance and all instructions for use. Any changes to the medical device and equipment plan must be made in a timely way, particularly when sharing the careplan with other caregivers. The content of the Seizure Action Plan in CareCompass is the responsibility of the primary caregiver to ensure is correct and up to date and any changes to the plan made in a timely way. Content uploaded into CareCompass such as videos are the responsibility of the primary caregiver.

Cautions

Caution: Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate impact to the health of patients. Ensure all data entered into CareCompass is accurate and updated regularly to reflect the latest care information. Ensure sharing of your CareCompass account is reviewed regularly to avoid potential misuse or misunderstanding of the information provided. Avoid sharing sensitive information through unsecured channels.

General Precautions and Assumptions

• Regularly review and update the data entered into CareCompass to ensure it remains relevant and accurate.
• Be aware of the data privacy policies and ensure you are comfortable with the data being shared within CareCompass.
• Monitor access to the care guide and manage permissions appropriately.

Technical Information

Pre-Use Requirements and Dependencies

• CareCompass requires an internet connection and a compatible web browser.
• Users must complete a self-registration process to access the platform.
• Ensure your device meets the minimum technical specifications for optimal performance.

Software Installation, Upgrade and Configuration

• CareCompass is a web-based application; no installation is required.
• Always use the latest version of your web browser to ensure compatibility.
• CareCompass can be configured by users choosing which parts of the platform they enter data into to tailor a care guide for the individual with DS or LGS.

Step by Step Instructions

1. Registration and onboarding

   • You will be invited to CareCompass via email.
   • Open the CareCompass website via the link in the email and complete the self-registration form.
   • Follow the onboarding process to enter initial information about yourself and your loved one.

2. Building the care guide

   • Once your account is created, you can access the various modules of CareCompass from the home page or side menu to start building your care guide.
   • o Populate the care guide with information about your loved one’s health, medications, seizure action plans, daily routines, and journal entries. o You can find out more about each of these modules in the ‘Help & FAQs’ module of the platform. o

3. Sharing the care guide

   • Use the 'Share' button to configure a view of your care guide you would like to share.
   • You can share your care guide by inviting Care Team Members who will need to create an account to access the content you have chosen to share, or by generating an Open2All link which makes the content you have chosen to share accessible to anyone who has the link.
   • You can manage sharing permissions and deactivate Open2All links on the ‘Sharing’ module, you should regularly review that you are comfortable with the sharing settings shown on the ‘Sharing’ module.

4. Updating and managing data

   • Regularly update your care guide with the latest information.
   • Upload media such as images and videos to enhance content in the care guide.
   • Keep your account information up to date in the account settings area.

Troubleshooting

• Login Issues: Ensure your internet connection is stable and your credentials are correct. Use the 'Forgot Password' feature if needed.
• Data Syncing Problems: Refresh your browser and check your internet connection. Reach out to your contact person at UCB for support if the issue persists.
• Media Upload Errors: Ensure your internet connection is stable, check the file format meet the platform’s requirements, try a smaller sized media item.

For more comprehensive troubleshooting tips, please visit the 'Help & FAQs’ module of the platform.

Technical Specifications

• CareCompass supports the latest versions of popular web browsers (Chrome, Firefox, Safari, Edge).
• Data is encrypted at rest and during transit to ensure security and privacy.
• The platform is hosted on secure servers located in the United States.

Regulatory Information

CareCompass complies with all applicable institutional policies and regulatory requirements related to data privacy and cybersecurity. It is not classified as a software medical device and should not be used for diagnostic or therapeutic purposes. Users are informed of the intended use and terms and conditions during the registration and onboarding process.

Manufacturer Information

Partizan International Limited Address: 31 Charlotte Road, First Floor, London, EC2A 3PB Contact: UCB sponsors this product and provides first-line support for any user questions or issues, reach out to your contact person at UCB for support.

Label

	CareCompass
	V2.2.5991
	Partizan International Limited 31 Charlotte Road, First Floor, London, EC2A 3PB
	Refer to instructions before using CareCompass
This software product has been designed according to ISO 13485:2016 and DCB0219