Fora D40 - Page 75

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This device has been tested to meet the electrical and safety require-
ments of: IEC/EN 60601-1, IEC/EN 60601-1-2, IEC/EN 61010-1, IEC/
EN 61010-2-101, IEC/EN 61326-2-6, EN 301 489-17, EN 300 328.
Reference to Standards:
• EN 1060-1 / EN 1060-3, NIBP-requirements
• IEC 60601-1 General requirement for safety
• IEC 60601-1-2 Requirements for EMC
• EN 1060-4, NIBP clinical investigation
• AAMI/ANSI /IEC 80
601-2-30, ANSI/AAMI/ISO 81060-2, NIBP
requirements
Blood pressure measurement performance
Pressure range: 0 - 300 mmHg
Heart rate range: 40 -199 beat per minute
Measurement unit: mmHg
Systolic Measurement Range: 55 mmHg -255 mmHg
Diastolic Measurement Range: 25 mmHg -195 mmHg
Pulse Rate Measurement Range: 40 -199 beats / minute
Maximum ination pressure: 280 mmHg
Accuracy of Pressure: ±3 mmHg or ±2% of reading
Accuracy of Pulse rate: ±4% of reading