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This device has been tested to meet the electrical and safety requirements 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 80601-2-30, ANSI/AAMI/ISO 81060-2, NIBP requirements
Blood pressure measurement performance
Heart rate range:
30 - 199 beat per minute
Measurement unit:
mmHg
Systolic Measurement Range:
60 mmHg - 250 mmHg
Diastolic Measurement Range:
30 mmHg - 180 mmHg
Accuracy of Pressure:
±3 mmHg
Accuracy of Pulse rate:
±4% of reading
Blood glucose measurement performance
Measurement unit:
mg/dL or mmol/L
Linear range:
20 to 600 mg/dL (1.1 to 33.3mmol/L)
Precision:
±5 % (CV)
Accuracy:
±15 mg/dL (0.83 mmol/L) when glucose < 100 mg/
dL (5.5 mmol/L)
±15% when glucose ≥ 100 mg/dL (5.5 mmol/L)
Ketone warning:
glucose value is above 240 mg/dL (13.3 mmol/L)
Summary of Contents for TD-3261G
Page 1: ...Owner s Manual FORA TD 3261G Blood Glucose Plus Blood Pressure Monitoring System...
Page 2: ...2...
Page 10: ...10 Monitor Overview Front Side Back Pressure Cuff 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18...
Page 20: ...20 Step 2 Press to switch between General AC PC and QC mode...
Page 70: ......
