Philips iE33 - Safety and Regulatory Requirements

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Pressure Limits
• Operating: 525 mmHg to 795 mmHg (700 hPa to 1,060 hPa)
• Storage: 375 mmHg to 795 mmHg (500 hPa to 1,060 hPa)
Humidity Limits
• Operating: 30% to 85%
• Storage: 15% to 95%
Temperature Limits
• Ambient Operating Temperature: 16°C to 40°C (61°F to 104°F)
• Internal Operating Temperature: 16°C to 55°C (61°F to 131°F)
• Storage: -34°C to 65°C (-29°F to 149°F)
Safety and Regulatory Requirements
Classication
• Class I equipment with Type B, 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.
iE33 User Manual
348
4535 616 23901
Specifications
13