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80-0067-00-MO-RevJ 2019-01-30 SunTech CT40 User Manual | 49
c) As an alternative to FM modulation, 50% pulse modulation at 18 Hz may be used because while it does
not represent actual modulation, it would be worst case.
Specifications, General
Conditions for
Use:
Operating: 10°C (50°F) to 40°C (104°F) 15 90% RH non-condensing - 700 kPa - 1060 kPa.
Operating the monitor in an environment at maximum temperature can produce temperatures
exceeding 41°C (41.6°C highest recorded) on a patient applied part. It is up to the operator to
determine if this temperature is too high based upon the condition of a patient and, if so, to
ensure the ambient temperature of the environment is 38°C or below.
Storage:
-20°C (-4°F) to 55°C (131°F) 15 90% RH non-condensing - 500 kPa - 1060 kPa. Performance
can be affected if, used or stored outside the specified temperature, humidity, or altitude listed
in the ranges above.
Power: Internal power supply. Input: 100-240 VAC @ 1.5A max, 50-60 Hz. Output +9VDC @ 5A IEC 320
type input connector.
Calibration: The accuracy of cuff - pressure transducers/indicators should be verified bi-annually.
Safety
Systems:
Independent hardware over-pressure circuit and redundant software overpressure algorithm to
limit cuff pressure to less than 300 mmHg (+20/-10mmHg). Independent hardware timing
circuit and redundant software timer algorithm to limit the duration of a blood pressure cycle
to less than 180 seconds.
Dimensions: Size (without thermometer option): 8” x 6.75’’ x 5.2’’)
Standards:
ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012,
EN 60601-1:2006/A1:2013, IEC 60601-1-2: 2014, IEC 80601-2-30: 2013, ISO 80601-2-61: 2011,
ISO 15223-1:2016 ISO 10993-1, 2009, ISO 10993-5, 2009, EN ISO 10993-10, 2010, ISO 81060-
2:2013, EN 50419: 2006, EN ISO 14971:2012CSA C22.2 No. 60601-1, EN ISO 81060-1: 2012,
IEC 60601-1-6: 2013
Classifications: Equipment Classification: Class IIa per MDD, Class II (Electrical Shock), Continuous mode of
operation, CE (413)
Ingress of
liquid
Ingress Protection: IPX1 for BP and SpO2 modules.
IPX0 for temperature modules (no protection of ingress to liquids).
Weight 0.6 lbs. (284) gm
Specifications, Blood Pressure Measurement
Measurement: Oscillometric with step deflation
Range:
Pressure: Diastolic: 20-200 mmHg (adult), 20-160
mmHg (pediatric). Systolic: 40-260 mmHg (adult), 40-
230 mmHg (pediatric)
Heart Rate: 30-220 BPM (beats per
minute)
Accuracy (BP): Meets or exceeds ANSI/AAMI/ISO 81060-2:2013 standard for noninvasive accuracy (±5mmHg
mean error with 8mmHg standard deviation).
49


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