Somnilink SPAP

JSON twin: https://www.healthaidb.com/software/somnilink-spap.json

Company Name

Compumedics

Product URL

https://www.compumedics.com.au/en/products/somnilink-spap/

Company URL

https://www.compumedics.com.au

Categories

• clinical Care
• diagnostic Support
• patient Facing
• Clinical
• Diagnostic

Summary

Somnilink SPAP is an auto-titrating CPAP device designed for the treatment of Obstructive Sleep Apnea (OSA) in adults, featuring integrated humidification and detailed data storage for enhanced patient management.

Description

Somnilink SPAP is an auto-titrating CPAP device designed for the treatment of Obstructive Sleep Apnea (OSA) in adults, featuring integrated humidification and detailed data storage for enhanced patient management. It utilizes a unique algorithm that responds to subtle changes in airway resistance and adjusts pressure accordingly, providing customized therapy for each breath. The device offers full disclosure physician monitoring through secure digital card technology, allowing clinicians to track patient response and compliance. Additionally, it includes an anti-spill water bottle and can be placed on a bedside table or mounted on the wall to save space.

Api Available

no

Certifications

• FDA 510(k)
• CE Mark
• TGA
• IEC 60601-1
• ISO 27001
• ISO 13485
• MDSAP
• GMP

Company Founding

1987

Company Offices

• Australia
• Italy
• United States
• Germany
• France

Compliance

• FDA
• CE Mark
• TGA
• IEC 60601-1
• ISO 27001
• ISO 13485
• MDSAP
• GMP

Customers

Data Residency

US/EU regions

Data Standards

• HL7
• DICOM

Deployment Model

• on_prem

Features

• Auto-titrating CPAP device
• Integrated humidification
• Detailed data storage for patient management
• Unique Somnilink algorithm responding to apneas, hypopneas, snoring, and flow limitations
• Differentiates between open and closed airways during reduced airflow episodes
• Subtle pressure adjustments based on airway changes
• Bedside table or wall-mounted placement
• LCD screen for humidification control and pressure response viewing
• Full disclosure physician monitoring via SD card technology
• Stores up to 3 years of data including nasal airflow, mask pressure, leak, set pressure, flow limitation index, events (apneas, hypopneas, snoring, flow limitation), AHI, pressure statistics
• Anti-spill water bottle design
• Five user-controlled humidification settings
• Intuitive graphical user interface with menu display, timed backlight, time/date display, user-definable alarm function, pressure readout, humidification control, secured clinical control mode
• Operating pressure range: 4-20 cm H2O
• Environmental conditions: Operating temperature +5°C to +35°C, operating humidity 10-95% non-condensing, storage and transport humidity 10-95% non-condensing
• IEC 60601-1 classification: Class 1, Type CF

Id

SW0649

Integration Partners

Integrations

• SD card for data storage and physician monitoring

Languages Supported

• English
• French
• German

Last Updated

2025-10-11

License

Commercial

Market Segment

• Enterprise
• SMB

Optional Modules

• ECG analysis package for advanced automatic processing of recorded data

Os Platforms

• Web

Pricing Details

Contact vendor for pricing information.

Pricing Model

Contact Vendor

Privacy Features

• Data anonymization
• Data minimization

Product Code

SW0649

Product Name

Somnilink SPAP

Ratings

Regions Available

• Australia
• Italy
• Europe
• Asia

Related Urls

• https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices

Release Year

Security Features

• Data encryption
• Audit logs
• User authentication

Specialties

• Sleep Medicine

Support Channels

System Requirements

Target Users

• Clinicians
• Patients

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "Somnilink SPAP",
  "company_name": "Compumedics",
  "product_url": "https://www.compumedics.com.au/en/products/somnilink-spap/",
  "company_url": "https://www.compumedics.com.au",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0649",
  "summary": "Somnilink SPAP is an auto-titrating CPAP device designed for the treatment of Obstructive Sleep Apnea (OSA) in adults, featuring integrated humidification and detailed data storage for enhanced patient management.",
  "description": "Somnilink SPAP is an auto-titrating CPAP device designed for the treatment of Obstructive Sleep Apnea (OSA) in adults, featuring integrated humidification and detailed data storage for enhanced patient management. It utilizes a unique algorithm that responds to subtle changes in airway resistance and adjusts pressure accordingly, providing customized therapy for each breath. The device offers full disclosure physician monitoring through secure digital card technology, allowing clinicians to track patient response and compliance. Additionally, it includes an anti-spill water bottle and can be placed on a bedside table or mounted on the wall to save space.",
  "categories": [
    "clinical Care",
    "diagnostic Support",
    "patient Facing",
    "Clinical",
    "Diagnostic",
    "Patient-facing"
  ],
  "market_segment": [
    "Enterprise",
    "SMB"
  ],
  "target_users": [
    "Clinicians",
    "Patients"
  ],
  "specialties": [
    "Sleep Medicine"
  ],
  "regions_available": [
    "Australia",
    "Italy",
    "Europe",
    "Asia"
  ],
  "languages_supported": [
    "English",
    "French",
    "German"
  ],
  "pricing_model": "Contact Vendor",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "Commercial",
  "company_offices": [
    "Australia",
    "Italy",
    "United States",
    "Germany",
    "France"
  ],
  "company_founding": "1987",
  "deployment_model": [
    "on_prem"
  ],
  "os_platforms": [
    "Web"
  ],
  "features": [
    "Auto-titrating CPAP device",
    "Integrated humidification",
    "Detailed data storage for patient management",
    "Unique Somnilink algorithm responding to apneas, hypopneas, snoring, and flow limitations",
    "Differentiates between open and closed airways during reduced airflow episodes",
    "Subtle pressure adjustments based on airway changes",
    "Bedside table or wall-mounted placement",
    "LCD screen for humidification control and pressure response viewing",
    "Full disclosure physician monitoring via SD card technology",
    "Stores up to 3 years of data including nasal airflow, mask pressure, leak, set pressure, flow limitation index, events (apneas, hypopneas, snoring, flow limitation), AHI, pressure statistics",
    "Anti-spill water bottle design",
    "Five user-controlled humidification settings",
    "Intuitive graphical user interface with menu display, timed backlight, time/date display, user-definable alarm function, pressure readout, humidification control, secured clinical control mode",
    "Operating pressure range: 4-20 cm H2O",
    "Environmental conditions: Operating temperature +5°C to +35°C, operating humidity 10-95% non-condensing, storage and transport humidity 10-95% non-condensing",
    "IEC 60601-1 classification: Class 1, Type CF"
  ],
  "optional_modules": [
    "ECG analysis package for advanced automatic processing of recorded data"
  ],
  "integrations": [
    "SD card for data storage and physician monitoring"
  ],
  "data_standards": [
    "HL7",
    "DICOM"
  ],
  "api_available": "no",
  "system_requirements": "",
  "compliance": [
    "FDA",
    "CE Mark",
    "TGA",
    "IEC 60601-1",
    "ISO 27001",
    "ISO 13485",
    "MDSAP",
    "GMP"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE Mark",
    "TGA",
    "IEC 60601-1",
    "ISO 27001",
    "ISO 13485",
    "MDSAP",
    "GMP"
  ],
  "security_features": [
    "Data encryption",
    "Audit logs",
    "User authentication"
  ],
  "privacy_features": [
    "Data anonymization",
    "Data minimization"
  ],
  "data_residency": "US/EU regions",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0649",
  "slug": "somnilink-spap",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/somnilink-spap.json"
  }
}