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Software Architecture DVT Pump

This document outlines the software architecture for the firmware of the DVT Compression Pump, detailing its structure, key components, and data flow to ensure safety and compliance with IEC 62304. It includes descriptions of various software components such as the user interface, control logic, safety monitoring, and communication interfaces, all classified as low risk. The architecture also emphasizes data logging and compliance with medical device software standards.

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bhardwaj.sumit04
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18 views2 pages

Software Architecture DVT Pump

This document outlines the software architecture for the firmware of the DVT Compression Pump, detailing its structure, key components, and data flow to ensure safety and compliance with IEC 62304. It includes descriptions of various software components such as the user interface, control logic, safety monitoring, and communication interfaces, all classified as low risk. The architecture also emphasizes data logging and compliance with medical device software standards.

Uploaded by

bhardwaj.sumit04
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Swell Cure

Document No.: Swellcure/F/DES/036


Software architecture description
Revision No.: 00

Page 1 of 2 Issue Date: 18.12.24

Software Architecture Description for DVT Compression Pump

1. Introduction
This document describes the software architecture for the firmware of the DVT
Compression Pump. It defines the structure, key components, data flow, and interactions
between different subsystems. The architecture is designed to ensure safety, reliability, and
compliance with IEC 62304.

2. Regulatory References
The software architecture complies with the following regulatory standards:
- IEC 62304: Medical device software – Software life cycle processes
- ISO 14971: Risk management for medical devices
- IEC 60601-1: General requirements for medical electrical equipment

3. Software System Overview


The firmware of the DVT Compression Pump is designed as an embedded system with real-
time control over pressure regulation and safety functions. It consists of multiple
interconnected components, including user interfaces, control logic, and monitoring
subsystems.

4. Software Components

4.1 User Interface (UI)


- **Function**: Provides an interface for users to set compression parameters and monitor
status.
- **Software Safety Classification**: Class A (Low Risk)
- **Deployment**: Runs on an embedded microcontroller with an LCD touchscreen or
button interface.
- **User Groups**: Healthcare professionals and technicians.

4.2 Control Logic


- **Function**: Manages real-time pressure regulation based on user settings and sensor
feedback.
- **Software Safety Classification**: Class A (Low Risk)
- **Deployment**: Embedded firmware running on a microcontroller.
- **User Groups**: Internal system process.

RM Swell cure Therapies Pvt. Ltd.


Controlled Copy. Print outs are uncontrolled copies.
Swell Cure
Document No.: Swellcure/F/DES/036
Software architecture description
Revision No.: 00

Page 2 of 2 Issue Date: 18.12.24

4.3 Safety Monitoring


- **Function**: Monitors device status, detects faults, and triggers alarms when necessary.
- **Software Safety Classification**: Class A (Low Risk)
- **Deployment**: Runs as an independent module within the firmware.
- **User Groups**: Healthcare professionals and service technicians.

4.4 Communication Interfaces


- **Function**: Interfaces with external systems such as hospital data management systems.
- **Software Safety Classification**: Class A (Low Risk)
- **Deployment**: May include wired/wireless communication protocols.
- **User Groups**: IT staff for system integration.

5. Data Storage and Logging


The firmware logs operational data, including pressure cycles, alerts, and system
performance. Data is stored in onboard memory and can be exported for compliance
tracking.

6. Compliance with IEC 62304


The software architecture follows IEC 62304 guidelines for medical device software. All
critical functions have been designed with redundancy and fail-safe mechanisms to ensure
patient safety.

7.. Approval

Prepared by:

Approved by:

RM Swell cure Therapies Pvt. Ltd.


Controlled Copy. Print outs are uncontrolled copies.

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