Classification: | Physiological Functions of Diagnosis and Monitoring Equipment |
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Type: | Patient Monitor |
Certification: | ISO13485 |
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Audited by an independent third-party inspection agency
Model:CCG-FM21K
Features:
1 Folded 10.4 inches TFT LCD high-brightness screen
2 12-crystal waterproof pulse Doppler transducer (optional), providing wider beam area and more homogeneous signal, thus realizing better
performance for beside monitors than conventional transducers.
3 Event Marker makes it easy to annotate perceived fetal movements (FM), or other events on the strip chart.
4 Fetal Movement Profile(FMP) detects and automatically records gross fetal body movements.
5 Heart rate offset mode makes it easy to visually distinguish between the heart rates of twins by allowing you to offset the secondary FHR + 30BPM.
6 Heartbeat Coincidence recognition provides visual and audible indication when it detects synchronous fetal or maternal heart-rate signals, indicating
that you may be monitoring a duplicate signal.
7 Fetal heart rate alarm provides both audible and visual alerts if the heart rate is outside of the user-defined high/low range.
8 Easy-to-load Z-fold paper stacks itself neatly upon exiting the recorder, facilitating easy storage.
9 Internal Li-on battery power or AC power from external power supply.
10 Supporting TCP/IP or wireless connection to the central monitoring station
11 NST Report (Fetus health report)
Fetal Acoustic Stimulator(FASt)
The optional Fetal Acoustic Stimulator uses low frequency vibro-acoustic stimuli(VAS) to "wake" the fetus, increasing the efficiency of antepartum testing and improving retest consistency.
VAS indicated with a musical note on the strip
Physical Specifications |
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Dimension and Weight |
Dimension |
32cm (W)*26cm (D)*8cm (H) |
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Weight |
standard configuration: 2.8 kg |
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Operation Environment |
Power requirements |
AC100-240V , 50/60Hz |
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Power |
50VA |
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Temperature |
0-40ºC |
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Humidity |
0-93% non-condensing |
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Fetal/Maternal Performance Specifications |
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Performance Specifications |
Display |
10.4 inches (1024×768 pixel) color TFT -LCD |
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Indicator |
Visual on-display and integrated, alarm light, audible alarm |
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Battery |
Internal rechargeable Li-ion battery power |
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Alarm |
Visual on-display and integrated, alarm light, audible alarm |
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Memory |
24-hours memory for fetal traces 150 groups patient data |
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Printer |
America standard/international standard Built-in thermal printer (paper width:110mm) 1/2/3cm/min real-time printing speed, fast print speed (stored traces) |
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Paper |
Z-fold, thermosensitive |
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Record Message |
ID, name, age, date, time, print speed etc |
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CMS |
Support connecting to central monitoring station through LAN (TCP/IP) or wireless connection |
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Fetal/Maternal Technical Specifications |
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Ultrasound (FHR) |
Measurement range |
US |
30 to 240 bpm |
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Resolution |
Display |
1bpm |
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Printer |
1bpm |
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jitter@200 bpm |
≤3bpm |
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Display update rate |
0.25second |
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Beat to bea change(max.) for ultrasound |
28bpm |
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US frequency |
1MHz±5%Hz |
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TOCO |
Measurement method |
Strain gauge sensor element |
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Sensitivity |
1 unit =2.5g |
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Resolution |
1 unit |
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Measurement range |
500 units |
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Baseline setting |
0, 5,10, 15, 20 can be selective |
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Update rate |
0.25 second |
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Auto offset correction |
3 second after connecting the transducer |
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Auto zero adjust |
TOCO value is set to zero negative following a negative Measure value for 5 seconds |
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Auto Fetal Movement (AFM) |
Technique |
Pulsed doppler ultrasound |
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Range |
0-100% |
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Resolution |
1% |
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Automatic fetal movement actograph |
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Manual fetal movement marker |
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Maternal NIBP(MNIBP) |
Operation mode |
Manual/automatic/ STAT |
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Measurement unit |
mmHg / kPa selectable |
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Test interval |
0-480 minutes |
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Accuracy |
Max.Std.deviation:8 mmHg(1.1kPa) |
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Max. mean Error: ±5mmHg(±0.7kPa) |
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Measurement range |
Systolic |
30 to 270 mmHg(4 to 36 kPa) |
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Diastolic |
10 to 245 mmHg(1.5 to 32kPa) |
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Mean |
20 to 255 mmHg(2.5 to 34kPa) |
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Pulse rate range |
20-250bpm |
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Over-pressure protection |
Yes |
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Maternal SpO2 (MSpO2) |
Measurement range |
0%-100% |
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Resolution |
1% |
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Accuracy |
±2% |
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Pulse rate range accuracy |
±3bpm |
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