System Design Description (SyDD) — ISO/IEC/IEEE 15289 — Description | IEEE 29148 §6.5
Generated 2026-03-27 — UHT Journal / universalhex.org
flowchart TB n0["system<br>Hospital Patient Monitoring System"] n1["subsystem<br>Vital Signs Acquisition"] n2["subsystem<br>Central Monitoring Station"] n3["subsystem<br>Alarm Management"] n4["subsystem<br>Clinical Data Integration"] n5["subsystem<br>Network and Communication"] n0 -->|contains| n1 n0 -->|contains| n2 n0 -->|contains| n3 n0 -->|contains| n4 n0 -->|contains| n5 n1 -->|Raw vital sign data| n5 n5 -->|Aggregated waveforms| n2 n5 -->|Vital sign streams| n3 n3 -->|Alarm notifications| n2 n5 -->|Monitoring data| n4
Hospital Patient Monitoring System — Decomposition
| Ref | Requirement | V&V | Tags |
|---|---|---|---|
| SUB-SUBSYSTEMREQUIREMENTS-001 | The ECG Acquisition Module SHALL acquire continuous electrocardiogram signals using a minimum 3-lead electrode configuration with a common-mode rejection ratio of at least 90 dB. | — | subsystem, vital-signs-acquisition, ecg, session-170 |
| SUB-SUBSYSTEMREQUIREMENTS-002 | The ECG Acquisition Module SHALL digitise the analogue ECG signal with a bandwidth of 0.05 Hz to 150 Hz and a minimum sampling rate of 500 samples per second per channel. | — | subsystem, vital-signs-acquisition, ecg, session-170 |
| SUB-SUBSYSTEMREQUIREMENTS-003 | The Pulse Oximetry Module SHALL measure arterial oxygen saturation (SpO2) with an accuracy of +/- 2% over the range of 70% to 100% SpO2. | — | subsystem, vital-signs-acquisition, spo2, session-170 |
| SUB-SUBSYSTEMREQUIREMENTS-004 | The Pulse Oximetry Module SHALL derive pulse rate from the photoplethysmogram signal with an accuracy of +/- 3 beats per minute over the range 30 to 250 bpm. | — | subsystem, vital-signs-acquisition, spo2, session-170 |
| SUB-SUBSYSTEMREQUIREMENTS-005 | The NIBP Measurement Module SHALL perform oscillometric blood pressure determination with an accuracy of +/- 5 mmHg for systolic and diastolic pressures over the range 40 to 260 mmHg. | — | subsystem, vital-signs-acquisition, nibp, session-170 |
| SUB-SUBSYSTEMREQUIREMENTS-006 | The NIBP Measurement Module SHALL limit cuff pressure to a maximum of 300 mmHg and SHALL automatically deflate the cuff within 180 seconds of inflation initiation to prevent tissue ischaemia. | — | subsystem, vital-signs-acquisition, nibp, safety, session-170 |
| SUB-SUBSYSTEMREQUIREMENTS-007 | The Signal Conditioning Unit SHALL reject 50 Hz and 60 Hz mains interference from all sensor input channels by at least 40 dB without attenuating the physiological signal bandwidth. | — | subsystem, vital-signs-acquisition, signal-conditioning, session-170 |
| SUB-SUBSYSTEMREQUIREMENTS-008 | While operating on battery backup, the Vital Signs Acquisition Subsystem SHALL continue acquiring all vital sign parameters without data loss for a minimum of 30 minutes. | — | subsystem, vital-signs-acquisition, reliability, session-170 |
| SUB-SUBSYSTEMREQUIREMENTS-009 | The Alarm Detection Engine SHALL evaluate each incoming vital sign sample against the configured upper and lower alarm thresholds for that parameter within 500 milliseconds of receipt. | — | subsystem, alarm-management, session-171 |
| SUB-SUBSYSTEMREQUIREMENTS-010 | The Alarm Detection Engine SHALL support compound alarm rules that evaluate Boolean combinations of up to four vital sign parameters to detect multi-parameter clinical deterioration patterns. | — | subsystem, alarm-management, session-171 |
| SUB-SUBSYSTEMREQUIREMENTS-011 | The Alarm Prioritization Module SHALL classify each alarm condition into one of three priority levels — crisis, warning, or advisory — in accordance with IEC 60601-1-8 Clause 6.3. | — | subsystem, alarm-management, session-171 |
| SUB-SUBSYSTEMREQUIREMENTS-012 | When a patient record indicates a known pre-existing condition for a monitored parameter, the Alarm Prioritization Module SHALL adjust the alarm priority according to the clinician-configured exception rules for that condition. | — | subsystem, alarm-management, session-171 |
| SUB-SUBSYSTEMREQUIREMENTS-013 | The Alarm Fatigue Mitigation Unit SHALL apply a configurable alarm delay of 0 to 60 seconds per parameter before promoting a threshold crossing to an active alarm, suppressing transient artifact-induced violations. | — | subsystem, alarm-management, session-171 |
| SUB-SUBSYSTEMREQUIREMENTS-014 | The Alarm Fatigue Mitigation Unit SHALL never suppress or delay crisis-priority alarms regardless of delay configuration or suppression rules. | — | subsystem, alarm-management, session-171 |
| SUB-SUBSYSTEMREQUIREMENTS-015 | When an alarm passes through fatigue mitigation filtering, the Alarm Notification Controller SHALL activate both an audible annunciator and a visual indicator at the bedside within 2 seconds of receiving the filtered alarm event. | — | subsystem, alarm-management, session-171 |
| SUB-SUBSYSTEMREQUIREMENTS-016 | The Alarm Notification Controller SHALL transmit crisis and warning alarms to the nurse call system and designated mobile devices within 5 seconds of alarm activation. | — | subsystem, alarm-management, session-171 |
| SUB-SUBSYSTEMREQUIREMENTS-017 | When a crisis alarm remains unacknowledged for a configurable escalation period (default 120 seconds), the Alarm Notification Controller SHALL escalate the notification to the charge nurse and unit supervisor. | — | subsystem, alarm-management, session-171 |
| SUB-SUBSYSTEMREQUIREMENTS-018 | The Alarm History and Audit Logger SHALL record every alarm event — including detection, prioritization, suppression, notification, acknowledgement, and silencing — with a UTC timestamp, patient identifier, and operator identity in a tamper-evident audit trail. | — | subsystem, alarm-management, session-171 |
| SUB-SUBSYSTEMREQUIREMENTS-019 | The Display Rendering Engine SHALL render continuous ECG waveforms at a minimum refresh rate of 25 frames per second with a sweep speed selectable between 12.5 mm/s and 50 mm/s. | — | subsystem, central-monitoring-station, display, session-172 |
| SUB-SUBSYSTEMREQUIREMENTS-020 | The Display Rendering Engine SHALL update numeric vital sign readouts within 1 second of receiving new parameter values from the Patient Tile Manager. | — | subsystem, central-monitoring-station, display, session-172 |
| SUB-SUBSYSTEMREQUIREMENTS-021 | The Patient Tile Manager SHALL support simultaneous display of at least 32 patient tiles, each showing the active vital sign parameters, alarm status, and patient identifier for one monitored bed. | — | subsystem, central-monitoring-station, tile-manager, session-172 |
| SUB-SUBSYSTEMREQUIREMENTS-022 | When a patient alarm state changes, the Patient Tile Manager SHALL reorder the tile display within 2 seconds so that patients with crisis-priority alarms appear in the most prominent screen positions. | — | subsystem, central-monitoring-station, tile-manager, session-172 |
| SUB-SUBSYSTEMREQUIREMENTS-023 | The Trend Analysis Engine SHALL maintain rolling trend buffers of at least 72 hours duration for each monitored vital sign parameter per patient. | — | subsystem, central-monitoring-station, trend, session-172 |
| SUB-SUBSYSTEMREQUIREMENTS-024 | The Trend Analysis Engine SHALL detect gradual vital sign deterioration by computing a weighted early warning score at 5-minute intervals and SHALL flag patients whose score increases by 2 or more points within any 60-minute window. | — | subsystem, central-monitoring-station, trend, session-172 |
| SUB-SUBSYSTEMREQUIREMENTS-025 | The Alert Dashboard Controller SHALL provide a one-touch alarm acknowledgement control that records the acknowledging clinician identity, timestamp, and alarm identifier in the audit trail. | — | subsystem, central-monitoring-station, alert-dashboard, session-172 |
| SUB-SUBSYSTEMREQUIREMENTS-026 | When a clinician activates the alarm silence function, the Alert Dashboard Controller SHALL suppress the audible annunciator for a maximum of 120 seconds while maintaining the visual alarm indicator. | — | subsystem, central-monitoring-station, alert-dashboard, session-172 |
| SUB-SUBSYSTEMREQUIREMENTS-027 | The Multi-bed Overview Processor SHALL generate a ward-level acuity summary screen that colour-codes each bed by the highest active alarm priority and updates within 3 seconds of any alarm state change. | — | subsystem, central-monitoring-station, multi-bed, session-172 |
| SUB-SUBSYSTEMREQUIREMENTS-028 | The Multi-bed Overview Processor SHALL compute and display per-bed alarm frequency statistics over configurable time windows of 1, 4, 8, and 24 hours to support alarm burden assessment by charge nurses. | — | subsystem, central-monitoring-station, multi-bed, session-172 |
| SUB-SUBSYSTEMREQUIREMENTS-029 | The HL7/FHIR Interface Engine SHALL support bidirectional communication using HL7 v2.x messaging (ADT, ORU, ORM message types) and FHIR R4 RESTful API operations for patient, observation, and device resources. | — | subsystem, clinical-data-integration, session-173 |
| SUB-SUBSYSTEMREQUIREMENTS-030 | The HL7/FHIR Interface Engine SHALL process inbound HL7 messages and FHIR resource requests within 500 milliseconds of receipt under normal operating load. | — | subsystem, clinical-data-integration, session-173 |
| SUB-SUBSYSTEMREQUIREMENTS-031 | When an ADT Admit event is received for a bed with an active bedside monitor, the Patient ADT Manager SHALL automatically associate the patient record with the monitor within 2 seconds of event receipt. | — | subsystem, clinical-data-integration, session-173 |
| SUB-SUBSYSTEMREQUIREMENTS-032 | When an ADT Discharge event is received, the Patient ADT Manager SHALL disassociate the patient record from all bound monitors and archive the monitoring session data within 5 seconds. | — | subsystem, clinical-data-integration, session-173 |
| SUB-SUBSYSTEMREQUIREMENTS-033 | The Clinical Data Repository SHALL refresh cached patient demographics and medication data from the EHR at a configurable interval not exceeding 15 minutes and upon receipt of any ADT update event for the patient. | — | subsystem, clinical-data-integration, session-173 |
| SUB-SUBSYSTEMREQUIREMENTS-034 | The Clinical Data Repository SHALL respond to patient context queries from the Alarm Management Subsystem and Central Monitoring Station within 50 milliseconds. | — | subsystem, clinical-data-integration, session-173 |
| SUB-SUBSYSTEMREQUIREMENTS-035 | The Data Export Controller SHALL export continuous vital sign observation data to the hospital EMR in HL7 ORU message format or FHIR Observation resources at a configurable interval of 1 to 60 minutes. | — | subsystem, clinical-data-integration, session-173 |
| SUB-SUBSYSTEMREQUIREMENTS-036 | The Terminology and Coding Service SHALL map all exported vital sign measurements to their corresponding LOINC observation codes with a mapping completeness of at least 99% for standard vital signs (heart rate, SpO2, NIBP, temperature, respiratory rate). | — | subsystem, clinical-data-integration, session-173 |
| SUB-SUBSYSTEMREQUIREMENTS-037 | The Medical-Grade Network Switch SHALL forward vital sign data frames between any two ports with a maximum latency of 500 microseconds under full traffic load. | — | subsystem, network, session-174 |
| SUB-SUBSYSTEMREQUIREMENTS-038 | The Medical-Grade Network Switch SHALL provide dual redundant uplink paths with automatic failover completing within 3 seconds upon detection of link loss. | — | subsystem, network, session-174 |
| SUB-SUBSYSTEMREQUIREMENTS-039 | The Wireless Access Controller SHALL complete roaming handoff for mobile patient monitors between access points within 100 milliseconds without loss of vital sign data packets. | — | subsystem, network, session-174 |
| SUB-SUBSYSTEMREQUIREMENTS-040 | The Wireless Access Controller SHALL authenticate all wireless client devices using WPA3-Enterprise with 802.1X certificate-based authentication before granting network access. | — | subsystem, network, session-174 |
| SUB-SUBSYSTEMREQUIREMENTS-041 | The Time Synchronization Service SHALL maintain clock alignment across all connected monitoring devices to within 1 millisecond of the network master clock using IEEE 1588 Precision Time Protocol. | — | subsystem, network, session-174 |
| SUB-SUBSYSTEMREQUIREMENTS-042 | The Clinical Network Firewall SHALL enforce TLS 1.2 or higher on all data flows carrying patient health information between the monitoring VLAN and the hospital enterprise network. | — | subsystem, network, session-174 |
| SUB-SUBSYSTEMREQUIREMENTS-043 | The Clinical Network Firewall SHALL isolate the clinical monitoring network into a dedicated VLAN with access control lists permitting only authorized protocols and endpoints per IEC 80001-1. | — | subsystem, network, session-174 |
| SUB-SUBSYSTEMREQUIREMENTS-044 | The Message Broker and Data Distribution Service SHALL deliver alarm event messages to all subscribed consumers within 50 milliseconds of publication with guaranteed at-least-once delivery semantics. | — | subsystem, network, session-174 |
| SUB-SUBSYSTEMREQUIREMENTS-045 | The Message Broker and Data Distribution Service SHALL support topic-based routing with per-patient and per-parameter granularity, enabling subsystems to subscribe to specific vital sign streams without receiving unrelated traffic. | — | subsystem, network, session-174 |
| SUB-SUBSYSTEMREQUIREMENTS-046 | When the primary PTP grandmaster clock becomes unavailable, the Time Synchronization Service SHALL promote a secondary clock source and re-synchronize all devices within 10 seconds while maintaining sub-5 millisecond accuracy during the transition. | — | subsystem, network, session-174 |
| Ref | Requirement | V&V | Tags |
|---|---|---|---|
| IFC-INTERFACEDEFINITIONS-001 | The interface between the ECG Acquisition Module and the Signal Conditioning Unit SHALL convey digitised ECG samples at 500 Hz per channel via a synchronous serial data bus with a maximum latency of 2 ms. | — | interface, vital-signs-acquisition, ecg, session-170 |
| IFC-INTERFACEDEFINITIONS-002 | The interface between the Pulse Oximetry Module and the Signal Conditioning Unit SHALL transmit red and infrared photoplethysmogram samples at a minimum rate of 100 Hz with time-stamped synchronisation to the system clock. | — | interface, vital-signs-acquisition, spo2, session-170 |
| IFC-INTERFACEDEFINITIONS-003 | The interface between the NIBP Measurement Module and the Signal Conditioning Unit SHALL report cuff pressure readings at 200 Hz during inflation and deflation, and SHALL signal measurement completion with systolic, diastolic, and MAP values. | — | interface, vital-signs-acquisition, nibp, session-170 |
| IFC-INTERFACEDEFINITIONS-004 | The interface between the Signal Conditioning Unit and the Network and Communication Subsystem SHALL output calibrated vital sign parameter packets at 1 Hz containing heart rate, SpO2, NIBP, and temperature values conforming to IEEE 11073 encoding. | — | interface, vital-signs-acquisition, network, session-170 |
| IFC-INTERFACEDEFINITIONS-005 | The interface between the Vital Signs Acquisition Subsystem and the Alarm Detection Engine SHALL deliver calibrated vital sign samples as time-stamped parameter-value pairs at the acquisition sampling rate, with parameter identity, unit of measure, and signal quality indicator. | — | interface, alarm-management, session-171 |
| IFC-INTERFACEDEFINITIONS-006 | The interface between the Alarm Detection Engine and the Alarm Prioritization Module SHALL convey alarm condition events containing the violated parameter identity, threshold value, measured value, direction of violation, and detection timestamp. | — | interface, alarm-management, session-171 |
| IFC-INTERFACEDEFINITIONS-007 | The interface between the Alarm Notification Controller and the Central Monitoring Station SHALL transmit alarm notification messages containing patient identifier, bed location, alarm priority, parameter identity, and current value using a reliable transport with delivery confirmation. | — | interface, alarm-management, session-171 |
| IFC-INTERFACEDEFINITIONS-008 | The interface between the Alarm Notification Controller and the nurse call system SHALL conform to the facility nurse call protocol and transmit crisis and warning alarms with bed location and alarm type within 3 seconds of alarm activation. | — | interface, alarm-management, session-171 |
| IFC-INTERFACEDEFINITIONS-009 | The interface between the Alarm Management Subsystem and the Alert Dashboard Controller SHALL deliver alarm events via an asynchronous message queue with guaranteed delivery, conveying alarm identifier, priority level, parameter name, threshold value, measured value, and patient identifier within 500 milliseconds of alarm activation. | — | interface, central-monitoring-station, session-172 |
| IFC-INTERFACEDEFINITIONS-010 | The interface between the Vital Signs Acquisition Subsystem and the Patient Tile Manager SHALL stream digitised vital sign samples via a publish-subscribe transport, with each message containing the patient identifier, parameter type, sample value, and acquisition timestamp, at a rate matching the source sampling frequency. | — | interface, central-monitoring-station, session-172 |
| IFC-INTERFACEDEFINITIONS-011 | The interface between the Alert Dashboard Controller and the Alarm Management Subsystem SHALL convey clinician alarm acknowledgement and silence commands, including the operator identity, action type, and alarm identifier, with a round-trip confirmation latency of no more than 1 second. | — | interface, central-monitoring-station, session-172 |
| IFC-INTERFACEDEFINITIONS-012 | The interface between the HL7/FHIR Interface Engine and the Clinical Data Repository SHALL transfer patient demographic, medication, and allergy data using an internal normalized patient context schema, with each update carrying a timestamp and source EHR system identifier. | — | interface, clinical-data-integration, session-173 |
| IFC-INTERFACEDEFINITIONS-013 | The interface between the Clinical Data Repository and the Alarm Prioritization Module SHALL provide patient clinical context (active medications, known conditions) within 50 milliseconds upon query to support context-aware alarm priority adjustment. | — | interface, clinical-data-integration, session-173 |
| IFC-INTERFACEDEFINITIONS-014 | The interface between the Data Export Controller and the Network and Communication Subsystem SHALL support TLS 1.2 or higher encrypted transport for all outbound clinical data exports, with mutual certificate authentication to the receiving EMR endpoint. | — | interface, clinical-data-integration, session-173 |
| IFC-INTERFACEDEFINITIONS-015 | The interface between the Medical-Grade Network Switch and Wireless Access Controller SHALL use IEEE 802.1Q tagged VLAN trunks with dedicated VLAN IDs for clinical monitoring traffic and management traffic. | — | interface, network, session-174 |
| IFC-INTERFACEDEFINITIONS-016 | The interface between the Medical-Grade Network Switch and Clinical Network Firewall SHALL carry all inter-VLAN traffic through a trunk port supporting IEEE 802.1Q at a minimum bandwidth of 10 Gbps. | — | interface, network, session-174 |
| IFC-INTERFACEDEFINITIONS-017 | The interface between the Message Broker and Data Distribution Service and subscribing subsystems SHALL use a publish-subscribe protocol with topic hierarchies structured as patient/parameter/event-type, with message payloads conforming to a common JSON schema. | — | interface, network, session-174 |
| IFC-INTERFACEDEFINITIONS-018 | The interface between the Time Synchronization Service and bedside monitoring devices SHALL use IEEE 1588 PTPv2 messages over multicast UDP, with the grandmaster announcing at a minimum rate of 1 message per second. | — | interface, network, session-174 |
flowchart TB n0["component<br>ECG Acquisition Module"] n1["component<br>Pulse Oximetry Module"] n2["component<br>NIBP Measurement Module"] n3["component<br>Temperature Measurement Module"] n4["component<br>Signal Conditioning Unit"] n0 -->|Raw ECG waveform| n4 n1 -->|PPG signal| n4 n2 -->|Cuff pressure data| n4 n3 -->|Thermistor resistance| n4
Vital Signs Acquisition Subsystem — Internal
flowchart TB n0["component<br>Alarm Detection Engine"] n1["component<br>Alarm Prioritization Module"] n2["component<br>Alarm Fatigue Mitigation Unit"] n3["component<br>Alarm Notification Controller"] n4["component<br>Alarm History and Audit Logger"] n5["component<br>Alarm Detection Engine"] n6["component<br>Alarm Prioritization Module"] n7["component<br>Alarm Fatigue Mitigation Unit"] n8["component<br>Alarm Notification Controller"] n9["component<br>Alarm History and Audit Logger"] n10["external<br>Vital Signs Acquisition"] n11["external<br>Central Monitoring Station"] n10 -->|vital sign data streams| n5 n5 -->|alarm condition events| n6 n6 -->|prioritized alarms| n7 n7 -->|filtered alarm stream| n8 n8 -->|alarm notifications| n11 n5 -->|raw alarm events| n9 n8 -->|notification delivery status| n9
Alarm Management Subsystem — Internal
flowchart TB n0["component<br>Display Rendering Engine"] n1["component<br>Patient Tile Manager"] n2["component<br>Trend Analysis Engine"] n3["component<br>Alert Dashboard Controller"] n4["component<br>Multi-bed Overview Processor"] n1 -->|tile content| n0 n2 -->|trend graphs| n0 n3 -->|alarm status overlay| n1 n4 -->|bed priority ranking| n1 n2 -->|deterioration signals| n4
Central Monitoring Station — Internal
flowchart TB n0["component<br>HL7/FHIR Interface Engine"] n1["component<br>Patient ADT Manager"] n2["component<br>Clinical Data Repository"] n3["component<br>Data Export Controller"] n4["component<br>Terminology and Coding Service"] n0 -->|Patient context from EHR| n2 n0 -->|ADT events| n1 n1 -->|Patient-device bindings| n2 n2 -->|Clinical data for export| n3 n4 -->|Standardized codes| n3 n4 -->|Terminology mappings| n0
Clinical Data Integration Subsystem — Internal
flowchart TB n0["component<br>Medical-Grade Network Switch"] n1["component<br>Wireless Access Controller"] n2["component<br>Time Synchronization Service"] n3["component<br>Clinical Network Firewall"] n4["component<br>Message Broker and Data Distribution Service"] n0 -->|VLAN trunks| n1 n0 -->|Ingress/egress traffic| n3 n2 -->|PTP sync| n0 n4 -->|Pub/sub streams| n0 n3 -->|Security policies| n1
Network and Communication Subsystem — Internal
| Entity | Hex Code | Description |
|---|---|---|
| Alarm Detection Engine | 41F77B19 | Software component within a hospital patient monitoring alarm management subsystem that continuously evaluates incoming vital sign data streams against configurable clinical thresholds and rule-based alarm conditions to detect clinically significant deviations |
| Alarm Fatigue Mitigation Unit | 41B77B19 | Software component within a hospital alarm management subsystem that implements intelligent alarm delay, suppression of non-actionable alarms, and escalation logic to reduce clinician alarm fatigue while preserving patient safety |
| Alarm History and Audit Logger | 40853359 | Software component within a hospital alarm management subsystem that records all alarm events, clinician responses, silencing actions, and escalation steps into a tamper-evident audit log for clinical review, regulatory compliance, and alarm system performance analysis |
| Alarm Management Subsystem | 51F77B19 | Intelligent alarm processing engine that applies clinical decision rules to vital sign data streams, manages alarm thresholds, suppresses nuisance alarms through delay and correlation logic, prioritizes alarm severity, and routes notifications to appropriate clinical staff via bedside annunciators, central station, and mobile devices. |
| Alarm Notification Controller | 55FD7A18 | Hardware/software controller within a hospital alarm management subsystem that manages the distribution of alarm signals through audible annunciators, visual indicators at bedside, and remote notification to nurse call systems and mobile devices |
| Alarm Prioritization Module | 41B77959 | Software module within a hospital alarm management subsystem that classifies detected alarm conditions into severity levels (crisis, warning, advisory) according to IEC 60601-1-8 priority categories and clinical context |
| Alert Dashboard Controller | 50BD7B18 | User-interface controller within a hospital central monitoring station that manages alarm status displays and clinician interaction. Provides alarm acknowledgement controls, alarm silence functions, escalation timers, and alarm history views. Interfaces with the Alarm Management Subsystem to receive alarm events and relay clinician responses. |
| Central Monitoring Station | 54ED5218 | Nursing station workstation that aggregates and displays real-time vital signs from all bedside monitors in a ward or unit. Provides multi-patient overview, waveform display, trend charting, and alarm summary dashboard for clinical staff. |
| Clinical Data Integration Subsystem | 40B57359 | Middleware and data services layer that stores patient monitoring data, performs trend analysis and clinical analytics, and integrates with hospital information systems via HL7 FHIR and ADT interfaces. Manages patient context (admit/discharge/transfer), maps bedside monitors to patient records, and exports data to the Electronic Health Record. |
| Clinical Data Repository | 40851119 | Local data store within a hospital patient monitoring system that caches patient demographics, active medication lists, allergy information, and clinical context received from the EHR. Provides low-latency access to patient context for alarm management and display subsystems. |
| Clinical Network Firewall | 50A53859 | Network security appliance enforcing segmentation between the clinical monitoring VLAN, hospital enterprise network, and external interfaces. Implements deep packet inspection, intrusion detection, and access control lists to protect patient monitoring data flows per IEC 80001-1 medical network risk management requirements. |
| Data Export Controller | 40F77B19 | Software component within a hospital patient monitoring system that manages outbound data flows to external systems including EMR archival, clinical analytics platforms, and regulatory reporting. Handles batch and streaming export modes with configurable data retention policies. |
| Display Rendering Engine | 54F57319 | Real-time waveform and numeric vital sign rendering engine within a hospital central monitoring station. Processes streaming ECG, SpO2, and NIBP data to render continuous waveforms, numeric readouts, and colour-coded alarm states on large-format displays at the nursing station. |
| ECG Acquisition Module | D4E55019 | Bedside patient monitoring component that acquires cardiac electrical activity via surface electrodes, amplifies the biopotential signal, and digitises it for waveform display and arrhythmia analysis |
| HL7/FHIR Interface Engine | 51F77959 | Protocol translation engine within a hospital patient monitoring system that handles bidirectional HL7 v2 messaging and FHIR R4 REST API calls for interoperability with Electronic Health Record systems. Converts internal monitoring data formats to standard healthcare interoperability formats and vice versa. |
| Hospital Patient Monitoring System | 55FF7319 | An integrated clinical monitoring system deployed in hospital wards to continuously track patient vital signs including heart rate, blood pressure, SpO2, respiration rate, and temperature, providing real-time alarming, trend analysis, and integration with electronic health records |
| Medical-Grade Network Switch | D2A51018 | Layer 2/3 managed Ethernet switch providing deterministic low-latency connectivity between bedside monitors, central stations, and clinical data systems within the hospital patient monitoring network. Supports VLAN segmentation and Quality of Service prioritization for real-time vital sign traffic. |
| Message Broker and Data Distribution Service | 40F57319 | Publish-subscribe middleware layer distributing real-time vital sign streams, alarm events, and patient context updates between bedside monitors, central monitoring stations, alarm management, and clinical data integration subsystems. Provides guaranteed message delivery, topic-based routing, and configurable quality-of-service levels for different data criticality tiers. |
| Multi-bed Overview Processor | 50F77319 | Aggregation processor within a hospital central monitoring station that synthesises ward-level situational awareness from individual patient data streams. Generates multi-bed overview screens showing the acuity status of all monitored beds, highlights deteriorating patients, and computes ward-level statistics such as alarm frequency and staff response times. |
| Network and Communication Subsystem | 50A57019 | Hospital-grade wired and wireless network infrastructure connecting bedside monitors to central stations and clinical data servers. Includes medical-grade Wi-Fi access points, Ethernet switches with VLAN isolation for clinical traffic, network redundancy with automatic failover, and secure communication protocols ensuring data integrity and low-latency transmission of waveform and alarm data. |
| NIBP Measurement Module | D6DD3018 | Non-invasive blood pressure measurement component using an inflatable cuff, motorised pump, bleed valve, and pressure transducer to perform oscillometric blood pressure determination |
| Patient ADT Manager | 41B73B18 | Software component within a hospital patient monitoring system that processes Admit, Discharge, and Transfer events from the hospital information system. Automatically binds bedside monitors to patient records upon admission and unbinds on discharge or transfer. |
| Patient Tile Manager | 40B53118 | Software component within a hospital central monitoring station that manages per-patient display tiles. Each tile aggregates the vital signs, alarm status, and patient demographics for one bed. Handles tile layout, assignment of beds to screen positions, and tile priority based on alarm severity. |
| Pulse Oximetry Module | D4CC3018 | Non-invasive optical sensor module using red and infrared LEDs with a photodetector to measure arterial blood oxygen saturation (SpO2) and pulse rate via photoplethysmography |
| Signal Conditioning Unit | 50F53018 | Embedded processing unit within the bedside monitor that receives raw analog and digital signals from all sensor modules, applies filtering, noise rejection, and digital signal processing to produce calibrated vital sign parameters |
| Temperature Measurement Module | D48D1218 | Patient body temperature measurement component using a thermistor probe to acquire continuous or spot-check temperature readings for clinical monitoring |
| Terminology and Coding Service | 50A5F158 | Software component within a hospital patient monitoring system that maps internal measurement identifiers and alarm codes to standard medical terminologies including LOINC observation codes, SNOMED CT clinical terms, and ICD-10 diagnostic codes for semantic interoperability. |
| Time Synchronization Service | 40A57B58 | Precision time protocol (PTP/IEEE 1588) and NTP service providing sub-millisecond time alignment across all bedside monitors, central stations, and data repositories in the hospital patient monitoring system. Ensures temporal coherence of vital sign samples, alarm timestamps, and audit records. |
| Trend Analysis Engine | 50F73319 | Data processing engine within a hospital central monitoring station that computes, stores, and displays historical vital sign trends. Maintains rolling 72-hour trend buffers per patient parameter, calculates statistical summaries, and detects gradual clinical deterioration patterns that may not trigger threshold alarms. |
| Vital Signs Acquisition Subsystem | D4E55219 | Bedside sensor array and signal conditioning hardware that captures patient vital signs including ECG waveforms, pulse oximetry (SpO2), non-invasive blood pressure (NIBP), respiration rate via impedance pneumography, and core body temperature. Includes analog front-ends, ADCs, and local signal preprocessing. |
| Wireless Access Controller | 51B77018 | Centralized wireless LAN controller managing clinical-grade Wi-Fi access points throughout the patient care area. Provides seamless roaming for mobile patient monitors and handheld devices, enforcing WPA3-Enterprise authentication and maintaining sub-100ms handoff latency for continuous vital sign telemetry. |
| Component | Belongs To |
|---|---|
| Vital Signs Acquisition Subsystem | Hospital Patient Monitoring System |
| Central Monitoring Station | Hospital Patient Monitoring System |
| Alarm Management Subsystem | Hospital Patient Monitoring System |
| Clinical Data Integration Subsystem | Hospital Patient Monitoring System |
| Network and Communication Subsystem | Hospital Patient Monitoring System |
| ECG Acquisition Module | Vital Signs Acquisition Subsystem |
| Pulse Oximetry Module | Vital Signs Acquisition Subsystem |
| NIBP Measurement Module | Vital Signs Acquisition Subsystem |
| Temperature Measurement Module | Vital Signs Acquisition Subsystem |
| Signal Conditioning Unit | Vital Signs Acquisition Subsystem |
| Alarm Detection Engine | Alarm Management Subsystem |
| Alarm Prioritization Module | Alarm Management Subsystem |
| Alarm Notification Controller | Alarm Management Subsystem |
| Alarm Fatigue Mitigation Unit | Alarm Management Subsystem |
| Alarm History and Audit Logger | Alarm Management Subsystem |
| Display Rendering Engine | Central Monitoring Station |
| Patient Tile Manager | Central Monitoring Station |
| Trend Analysis Engine | Central Monitoring Station |
| Alert Dashboard Controller | Central Monitoring Station |
| Multi-bed Overview Processor | Central Monitoring Station |
| HL7/FHIR Interface Engine | Clinical Data Integration Subsystem |
| Patient ADT Manager | Clinical Data Integration Subsystem |
| Clinical Data Repository | Clinical Data Integration Subsystem |
| Data Export Controller | Clinical Data Integration Subsystem |
| Terminology and Coding Service | Clinical Data Integration Subsystem |
| Medical-Grade Network Switch | Network and Communication Subsystem |
| Wireless Access Controller | Network and Communication Subsystem |
| Time Synchronization Service | Network and Communication Subsystem |
| Clinical Network Firewall | Network and Communication Subsystem |
| Message Broker and Data Distribution Service | Network and Communication Subsystem |
| From | To |
|---|---|
| ECG Acquisition Module | Signal Conditioning Unit |
| Pulse Oximetry Module | Signal Conditioning Unit |
| NIBP Measurement Module | Signal Conditioning Unit |
| Temperature Measurement Module | Signal Conditioning Unit |
| Alarm Detection Engine | Alarm Prioritization Module |
| Alarm Prioritization Module | Alarm Fatigue Mitigation Unit |
| Alarm Fatigue Mitigation Unit | Alarm Notification Controller |
| Alarm Notification Controller | Alarm History and Audit Logger |
| Alarm Detection Engine | Alarm History and Audit Logger |
| Patient Tile Manager | Display Rendering Engine |
| Trend Analysis Engine | Display Rendering Engine |
| Alert Dashboard Controller | Patient Tile Manager |
| Multi-bed Overview Processor | Patient Tile Manager |
| HL7/FHIR Interface Engine | Clinical Data Repository |
| Clinical Data Repository | Alarm Prioritization Module |
| Data Export Controller | Network and Communication Subsystem |
| Medical-Grade Network Switch | Wireless Access Controller |
| Medical-Grade Network Switch | Clinical Network Firewall |
| Message Broker and Data Distribution Service | Medical-Grade Network Switch |
| Time Synchronization Service | Medical-Grade Network Switch |
| Component | Output |
|---|---|
| ECG Acquisition Module | raw ECG waveform data |
| Pulse Oximetry Module | photoplethysmogram and SpO2 values |
| NIBP Measurement Module | systolic, diastolic, and mean arterial pressure |
| Temperature Measurement Module | calibrated body temperature readings |
| Signal Conditioning Unit | calibrated vital sign parameters |
| Alarm Detection Engine | alarm condition events with parameter identity and threshold delta |
| Alarm Prioritization Module | priority-classified alarm records with severity level and clinical context |
| Alarm Notification Controller | audible, visual, and remote alarm notifications |
| Alarm Fatigue Mitigation Unit | filtered alarm stream with suppressed non-actionable alarms |
| Alarm History and Audit Logger | tamper-evident alarm audit trail and performance analytics |
| Display Rendering Engine | rendered waveform and numeric vital sign displays |
| Patient Tile Manager | per-patient display tiles with aggregated vital signs and alarm status |
| Trend Analysis Engine | 72-hour vital sign trend graphs and deterioration alerts |
| Alert Dashboard Controller | alarm acknowledgement commands and alarm status views |
| Multi-bed Overview Processor | ward-level acuity overview and patient prioritisation displays |
| HL7/FHIR Interface Engine | HL7 v2 messages and FHIR R4 resources |
| Patient ADT Manager | patient-device association records |
| Clinical Data Repository | cached patient clinical context |
| Data Export Controller | formatted clinical data exports |
| Terminology and Coding Service | standardized medical terminology codes |
| Medical-Grade Network Switch | deterministic Ethernet frames |
| Wireless Access Controller | authenticated wireless sessions |
| Time Synchronization Service | synchronized clock references |
| Clinical Network Firewall | filtered and inspected traffic |
| Message Broker and Data Distribution Service | routed vital sign and alarm streams |