Safety And Regulatory Requirements - Philips EPIQ 7 User Manual

Ultrasound system
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Specifications
Temperature Limits
• High operating temperature: 40°C (104°F) between 1060 hPa and 795 hPa (795 mmHg to
596 mmHg), linearly decreasing to 35°C (95°F) at 700 hPa (525 mmHg)
• Low operating temperature: 10°C (50°F) from 700 hPa to 1060 hPa (525 mmHg to
795 mmHg)
• Storage temperature range: -20°C to 60°C (-4°F to 140°F)

Safety and Regulatory Requirements

Classification
• Class I equipment with Type BF and Type CF applied parts
• Ordinary Equipment/Continuous Operation
• Non-AP/APG
Electromechanical Safety Standards Met
The system complies with the requirements of IEC 60601-1 Medical Electrical Equipment,
General Requirements for Safety, including all applicable collateral and particular standards, as
well as all applicable national deviations.
Compliance
Philips products comply with relevant international and national standards and laws.
Information on compliance will be supplied by your local Philips representative, or the
manufacturer, on request.
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Safety and Regulatory Requirements
EPIQ 7 User Manual 4535 617 25341

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