These are the Instructions for Use for Safer Care 1.1. To access more general online help please click here.

Date of Issue: 26 November 2025 DRAFT

Table of Contents

Product Outline

Product Details

Intended Use

Safety Information

Safety Instructions

Cautions

General Precautions

Technical Information

Pre-Use Requirements and Dependencies

System Requirements

Intended Users

Software Installation, Upgrade and Configuration

Step by Step Instructions

Logging In

Initiating a Contact Trace for a Case

Interpreting an Encounter

Viewing Contacts

Reviewing Contact Exposure

Exporting Results

Assigning Tags to People and Assets

Managing Users and Permissions

Configuring Contact Tracing Policies

Logging Out

Troubleshooting

Storage and Handling

Disposal

Technical Specifications

Cybersecurity and Data Protection

Maintenance and Updates

Regulatory Information

 Manufacturer Information

Product Outline

Safer Care is a digital contact tracing software-based medical device designed to support infection prevention and control (IPC) measures within healthcare settings. It integrates with third-party Real-Time Location Systems (RTLS) that typically use wearable Ultra-Wide-Band (UWB) tags to provide real-time and historical location tracking of individuals (staff and patients) and assets within a healthcare facility.

Product Details

Product name: Safer Care

 Product catalogue number: 1.1

Intended Use

Read these instructions thoroughly before using Safer Care.

The intended purpose of Safer Care is to use RTLS tracking data on people and assets to:

1. Identify and record encounters; close contact events between individuals, facilities and assets to enable rapid contact tracing in the event of a suspected or confirmed infectious disease case (e.g., COVID-19, Norovirus, MRSA).
2. Provide accurate encounter data to assist infection control teams in assessing exposure and contamination risks and implementing targeted interventions.
3. Generate reports to facilitate evidence-based decision-making for quarantine measures, testing protocols and outbreak management.
4. Provide accurate location data to ensure compliance with infection control policies and adherence to restricted area protocols.

Safer Care is not intended to replace clinical decision-making, but serves as a support tool for healthcare professionals managing and planning for infection outbreaks.

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 Safer Care.

 Cautions

Caution:  Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate impact to the health of patients.

General Precautions

• The application provides decision-support data only. Final clinical or infection control decisions must be made by qualified healthcare professionals.

• Do not rely solely on the system for critical safety decisions.
• Ensure that all data inputs are accurate (e.g., patient and staff details, infection details).
• Users must not share login credentials or download identifiable data outside approved channels.
• The system should not be used without an active data processing agreement between the healthcare organisation (the Data Controller) and Proxximos (the Data Processor).

Technical Information

Pre-Use Requirements and Dependencies

System Requirements

Intended Users

Safer Care is intended for use by four types of roles within the deploying organisation:

1. Owner: Administrators who manage other users of the system and the organisation’s policies for contact tracing.
2. Clerk: Staff who allocate wearable tags to patients, staff and visitors for the organisation.
3. Viewer: Ward staff who are able to see a summary of current cases and infection status across the ward.
4. Clinician: Infection prevention and control (IPC), Occupational Health (OH) and Ward staff who use Safer Care to identify contacts and contaminated assets and fixtures across their organisation for a Case.

Users may be allocated more than one role according to their needs. Users must be authorised and have completed approved training provided by Proxximos or the deploying organisation prior to using the application.

Patients, visitors and general staff will not use Safer Care directly. By agreeing to wear the tag, they are participants, not users.

Software Installation, Upgrade and Configuration

No local installation is required for Safer Care.

To access the system:

1. Open a supported browser.
2. Navigate to the secure application URL: https://app.proxximos.com
3. Log in using your assigned credentials or NHS Identity.
4. Review and accept the privacy notice and terms of use at first login.

Users accessing Safer Care for the first time will be issued with an email invitation providing a personalised link through which they may be required to set their password details (according to the configuration in place for that organisation).

Note: Only users authorised under the deploying organisation’s information governance processes may access the application.

Configuration is required during deployment of Safer Care in the organisation. The key configurations are:

• Implementing the authentication setup required for the organisation,
• Connecting and validating the deployment of the RTLS, and
• Defining the contact tracing policies for each infection and pathogen

The authentication is implemented and tested by Proxximos working in conjunction with the organisation’s IT department.

The connection is implemented and tested by Proxximos on behalf of the organisation and typically working closely with the provider of the RTLS.

The tracing policies are defined by the Administrators in the organisation, with support from Proxximos, using the Safer Care management portal.

Step by Step Instructions

Logging In

• Enter user ID and password or authenticate via NHS Identity (according to the configuration in place for the organisation).
• Upon successful login, the application will display a dashboard tailored to .
  • Viewers and Clinicians will be presented with a list of the current and recent Cases in their area of interest.
  • Clerks will be presented with a list of current participants in their organisation (those who might wear tags).
  • Owners will be presented with a dedicated management interface.

Initiating a Contact Trace for a Case

This can be done only by users with a Clinician role.

1. Select “Add new case” button on the dashboard.
2. Enter or select the index case (e.g., patient or staff that the system has been tracking).
3. Enter the date and time that symptoms first appeared – the ‘onset’ time.
4. Enter the nature of the Infection and, if known, the Pathogen (e.g., Respiratory, Covid19).
5. Click ‘Save and search consequences’ button.
6. Review the generated list of contacts showing level of exposure (Intensity) and number of exposure events (Encounters) according to the methods of transmission appropriate for the nature of the infection (e.g., Droplet, Airborne or Direct).

Interpreting an Encounter

The Clinician determines the risk that the Contact has been infected by the Case by reviewing the data for the Encounters between the two people (or person with an asset or place).

An Encounter is an event where Case and Contact are in close proximity or within a closed environment that matches the policy for an infection. Safer Care applies a slightly wider search envelope to account for accuracy of the RTLS system to generate a set of candidate encounters for consideration.

Filters can be applied to remove outlying candidate encounters as appropriate.

Intensity is a measure of how close and how long a Case and a Contact have been during an encounter – relative to the policy for that infection. A relative intensity of 1 represents encounters that meet the policy threshold (e.g., 2m for 15 minutes typically used for Covid19 would result in an intensity = 1). The longer and closer the encounter the greater the intensity score.

Intensity is calculated in two discrete steps.

• Firstly, the raw physics of the encounter are measured through;
  • Encounter Duration / Policy Duration, multiplied by
  • The square of Policy Proximity / Encounter Proximity*

• Secondly, the aggregate intensity for one or more encounters for a Contact is calculated by;
  • The sum of the above for each encounter, which is then
  • Reduced to provide a workable comparison using the function:  Log(2)+1
• Alternative calculations for airborne intensity where the nature of the room matters, uses room-size rather than proximity to support the same calculation.

*A minimum proximity threshold of 50cm is imposed for droplet and airborne based transmissions.

Viewing Contacts

This can be done by users with either a Viewer or a Clinician role.

• Identify an existing Case of interest and open the Case consequences page.
• Apply filters as appropriate to view the higher-intensity Encounters.
• View the summary of Contacts, Assets and Locations visited across the methods of transmission presented for the Case.

Reviewing Contact Exposure

This can be done only by users with a Clinician role.

• Select Contacts listed for the Case to view their Encounter details.
• Use the controls to replay the movement details for the Case and Contact, Place or Asset to understand the nature of the encounter and its context.
• Enter the level of risk that is appropriate for the contact to have been infected, or the asset or place to be contaminated. This is saved by Safer Care for subsequent reporting and analysis.

Exporting Results

This can be done only by users with a Clinician role.

• Export contact details as a PDF or CSV for inclusion in IPC reports.

Assigning Tags to People and Assets

This can be done only by users with a Clerk role.

• Select the person or asset of interest
• Assign a tag using its serial number with the date and time that the tag was started to be worn or carried.
• Identify existing assignments to end or change the period of assignment as appropriate.

Managing Users and Permissions

This can be done only by users with an Owner role.

Administration of users is done through a dedicated web-based interface – the Safer Care Management Portal.

• Navigate to Organisation Users.
• Add or remove users, assign appropriate roles (Clerk, Viewer, Clinician, Admin).
• Users may have more than one role if this is appropriate to their job function. Ensure users’ access rights correspond to their job function and organisation policy.

New users will receive an email with an invitation to access Safer Care and set up their password details as appropriate.

Configuring Contact Tracing Policies

This can be done only by users with an Owner role.

Administration of contact tracing policies is done through a dedicated web-based interface – the Safer Care Management Portal.

• Navigate to Organisation Policies.
• Identify the methods of transmission appropriate to each Infection Site – Pathogen pairing.
• Set the policies for contact duration, proximity and location appropriate for each transmission method for the Infection Site – Pathogen pair.

These policies will be enacted for all new Cases in the deploying organisation. They will affect both the transmission methods selected for analysis and the search parameters used to retrieve encounters from the location data.

Note: Any Cases run prior to the change in policies will not be updated to the new policy settings.

Logging Out

• Always log out at the end of each session by selecting Logout from the main menu.
• Do not leave the browser session unattended.

Troubleshooting

Storage and Handling

• No physical components are stored locally.
• Ensure access devices are secured in accordance with NHS IT and Information Governance policies.

Disposal

• If the service is discontinued or contract terminated, all personal data will be securely deleted from the system in line with NHS and company data retention policies.

Technical Specifications

The Safer Care device is provided  as a Software as a Service (SaaS) product delivered via a secure web browser. It operates in conjunction with an RTLS or equivalent tracking system used within the healthcare setting.

Safer Care comprises the following components:

• An interface to third-party RTLS providing accurate tracking of location of people and assets in near real time.
• A database system where people, places and assets can be associated with the RTLS location feed so that the location of each can be defined in near real time.
• A platform where algorithms can operate on the location feeds to identify encounters between people, assets and fixtures where a risk of infection transmission occurs.
• A web-based application where trained healthcare professionals are able to use the algorithms to interrogate the tracking data to identify contacts for a known infection case.
• A web-based management application where trained administrators are able to define policies for contact tracing and manage users of the system.
• Role-based access control (RBAC) ensures that only authorised users can view sensitive and identifiable data.
• An audit module captures user actions, queries and configurational changes.
• The platform provides APIs (Application Programming Interfaces) that support the FHIR (Fast Healthcare Interoperability Resources) data exchange protocols for integrating with third party patient records and laboratory test systems.

Safer Care has no hardware. It does, however, rely on the supply of near real-time location information from third party RTLS systems installed within the customer’s environment. Such systems typically have the following hardware:

• Wearable tags – battery powered electronic devices for assets, patients, staff and others.
• Base stations – mains to 12v DC electronic devices that receive radio signals from the tags installed across the areas of interest, typically every 10m to 20m.
• The following requirements are in place for Safer Care to integrate with a RTLS:
  • The location data is accurate to +/- 30cm for 90% of the time
  • A location for each tag is provided every 5 seconds where the tag is moving, and 5 minutes where motionless for 90% of the time.
  • The tags and the base station are CE marked.
  • The service provides a near real-time feed of data (e.g., MQTT service).

Proxximos has the following manufacturers of hardware for use by Safer Care version 1:

Please note: Where Safer Care is deployed with an alternative RTLS, Proxximos is not held responsible for the accuracy or performance of the contact tracing results or infection control services provided.

Cybersecurity and Data Protection

• All data transmitted and stored are encrypted in transit (TLS 1.2+) and at rest (AES-256).
• Access is controlled via role-based permissions.
• Login methods are according to the policies of the deploying organisation.
• System level audit logs record all access, data queries, and exports.
• The system complies with UK GDPR, Data Protection Act 2018, and NHS DSPT standards.
• In the event of a data breach or suspected incident, users must follow their local NHS data breach policy and notify their organisation’s DPO immediately.

Maintenance and Updates

• Software updates are deployed automatically through the managed Azure environment.
• Administrator Users will be notified in advance of planned maintenance or version upgrades.
• Each software update undergoes validation testing before deployment to ensure continued conformity to the intended purpose.

Regulatory Information

The Safer Device complies with the Medical Devices Regulations 2002 (SI 618) as subsequently amended by the EU Exit Regulations of 2019 (SI 791), 2020 (SI 1478) and 2023 (SI 627) and 2024 (SI 1368) (UK MDR 2002, as amended).

Device Classification: Class I (UK MDR 2002)

 Manufacturer Information

Product Name: Safer Care

Manufacturer: Proxximos Limited

Address: 7 Bligh’s Walk, Sevenoaks. TN13 1DB, UK

Website: proxximos.com

Support Contact: support@proxximos.com or +44 333 577 8875