Intended Use Statement

Albus Pro/HR/Lite is a stand-alone medical device software (MDSW) intended for the structured display and secure sharing of measurement data obtained from an external CE-marked device.

The software enables users and authorized stakeholders (such as healthcare professionals or employer representatives, subject to user consent) to access and review submitted measurement data over time.

 

The software:

• Displays unprocessed measurement values exactly as received

• Does not analyze, interpret, or transform data

• Does not provide alerts, recommendations, thresholds, or decision support

 

The output of the software is not intended to be used as the sole basis for diagnosis, treatment decisions, or clinical management. All interpretation of data remains the responsibility of the user or qualified professionals. This device is CE-marked in accordance with Regulation (EU) 2017/745.

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​Safety Information

General Safety

• The software provides display-only functionality and does not perform clinical analysis or decision-making.

• The system must not be used as a substitute for professional judgment.

• The software is not intended for emergency or critical care use.

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Limitations of Use

• Do not use the software as the sole basis for:

  • Diagnosis

  • Treatment decisions

  • Clinical monitoring

  • Legal or disciplinary actions

• The software does not provide real-time monitoring or alerts.

• Data accuracy depends on the correct functioning of the connected external CE-marked device.

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Data Interpretation

• All displayed data consists of raw measurement values received from an external device.

• The software does not modify or contextualize the data.

• Interpretation must always be performed by the user or qualified professionals.

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User and Access Safety

• Access to data is restricted to authorized users via secure authentication.

• Data sharing occurs only with user consent and role-based permissions.

• Users are responsible for maintaining device security (e.g., PIN, biometric lock).

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Cybersecurity and Data Protection

• All data is encrypted in transit and at rest.

• User access and system interactions are logged for traceability.

• The system is designed in accordance with GDPR and recognized cybersecurity standards.

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Residual Risk

All identified risks have been mitigated and assessed as acceptable in relation to the intended purpose of the device. No unacceptable residual risks remain.

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Summary

Albus Pro/HR/Lite is a low-risk, Class I medical device software designed for secure visualization and communication of measurement data. Its safety is ensured through clear limitations of use, secure system design, and the absence of clinical decision-making functionality.

 

​​Manufacturer: Albus Care System AB
Address: Varvsgatan 10, 824 55 Hudiksvall, Sweden
SRN: SE-MF-000053283

Product: Albus Pro/HR/Lite
Model: ALBUS-MDSW
Basic UDI-DI: 730000908373Pro/HR/LiteRU
UDI-DI: 07300009083732
Software version: 2.0.x
Risk Class: Class I (MDR Rule 11)​

 

Updates

This overview is reviewed and updated on a yearly basis.

IFU Version: 2.0
Date of issue: 2026-04-16