GENERAL DESCRIPTION
Cardiotocography (CTG) system for antepartum foetal and maternal monitoring.
Product Description
Capable of external monitoring of foetal heart rate (FHR) and maternal uterine activity (UA).
Alphanumeric display shows FHR1, FHR2 and UCs and alarms.
Automatically detects transducers when they are plugged in.
Includes remote switch for event marking.
Automatic self-test on power up.
System reports with status and alarms.
Unit includes a battery allowing for > 2 hours continuous operation.
Power requirements: 100 - 240 Volts - 50/60 Hz.
FETAL HEART RATE MONITORING
Foetal heart rate detected by ultrasonic transducer/probe.
Capable of measuring FHR in the 50-240 beats per minute (bpm) range with 1 bpm resolution and 2 bpm accuracy.
Can monitor twins (i.e., has two transducers).
Includes high/low audible and visual alarms.
Includes signal quality/loss indicators and alarm(s).
Provides audible feedback on signal quality.
MATERNAL UTERINE ACTIVITY MONITORING
Uterine contractions measured though a pressure sensitive transducer.
Capable of measuring relative uterine contractions (UCs) in the range of 0-100 units with at least 1 unit resolution and 1 unit accuracy.
Includes signal loss due to unplugged transducer.
Intended Purpose
Cardiotocography (CTG) is a continuous recording of the fetal heart rate obtained via an ultrasound transducer placed on the mother’s abdomen. CTG is widely used in pregnancy as a method of assessing fetal well‐being, predominantly in pregnancies with increased risk of complications.
PRINTER/RECORDER
Integrated thermal printer with automatic and manual print-out modes.
Prints FHR1, FHR2, UCs, marked events and parameters and relevant alarms.
Print speeds include 1, 2 and 3 cm/min.
Compatible with z-folded thermal paper.
Two different model are supplied: One model allows for adjusting paper scale between 20 and 30 bmp/cm, the other model has a fixed paper scale of 30 bmp/cm
Includes alarms of another indicator for end of paper.
SUPPLIED WITH
Instructions for assembly, use and maintenance in English, French and Spanish.
1 x Plastic protective dust cover.
1 x UC transducer.
2 x FHR ultrasound transducers.
1 x Remote switch event marker with cable.
3 x Adjustable transducer belts for ultrasound (2 FHRs) and toco (UC).
2 x Box of thermal recording paper, total 100 z-folded sheets.
2 x Bottle of ultrasound gel, approximately 250ml.
Instruction for Use
The QVCAD System is indicated for use as an aid to the reader during
screening procedures in searching images of female breasts produced by
the some've Automated Breast Ultrasound System (screening mammography
BI-RADS® Assessment Category 1 of 2, and BI-RADS Composition/Density
c of d) to detect mammography-occult lesions in regions not known to have
suspicious findings. The indicators produced by the QVCAD System are not intended to be used for diagnostic characterization of suspicious findings.
Accessories /Spares/ Consumables
At extra costs additional optional features can be requested:
- An optional cart can be included.
- An optional back up battery can be included.
Regulatory & Conformity Requirements
CE mark Comply to EU Council Directive 93/42/EEC (MDD) of EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
US FDA 510(K) clearance
CE certificate available for Class IIa and above devices
Manufacturer’s Quality Management System is certified to ISO 13485 : 2016
Classification:
Classified under EU MDR 2017/745 as Class IIb device
Environmental requirements
Context-dependent requirements Handling environment temperature:
–20 to 60 °C"
Cardiotocography (CTG) system for antepartum foetal and maternal monitoring.
Product Description
Capable of external monitoring of foetal heart rate (FHR) and maternal uterine activity (UA).
Alphanumeric display shows FHR1, FHR2 and UCs and alarms.
Automatically detects transducers when they are plugged in.
Includes remote switch for event marking.
Automatic self-test on power up.
System reports with status and alarms.
Unit includes a battery allowing for > 2 hours continuous operation.
Power requirements: 100 - 240 Volts - 50/60 Hz.
FETAL HEART RATE MONITORING
Foetal heart rate detected by ultrasonic transducer/probe.
Capable of measuring FHR in the 50-240 beats per minute (bpm) range with 1 bpm resolution and 2 bpm accuracy.
Can monitor twins (i.e., has two transducers).
Includes high/low audible and visual alarms.
Includes signal quality/loss indicators and alarm(s).
Provides audible feedback on signal quality.
MATERNAL UTERINE ACTIVITY MONITORING
Uterine contractions measured though a pressure sensitive transducer.
Capable of measuring relative uterine contractions (UCs) in the range of 0-100 units with at least 1 unit resolution and 1 unit accuracy.
Includes signal loss due to unplugged transducer.
Intended Purpose
Cardiotocography (CTG) is a continuous recording of the fetal heart rate obtained via an ultrasound transducer placed on the mother’s abdomen. CTG is widely used in pregnancy as a method of assessing fetal well‐being, predominantly in pregnancies with increased risk of complications.
PRINTER/RECORDER
Integrated thermal printer with automatic and manual print-out modes.
Prints FHR1, FHR2, UCs, marked events and parameters and relevant alarms.
Print speeds include 1, 2 and 3 cm/min.
Compatible with z-folded thermal paper.
Two different model are supplied: One model allows for adjusting paper scale between 20 and 30 bmp/cm, the other model has a fixed paper scale of 30 bmp/cm
Includes alarms of another indicator for end of paper.
SUPPLIED WITH
Instructions for assembly, use and maintenance in English, French and Spanish.
1 x Plastic protective dust cover.
1 x UC transducer.
2 x FHR ultrasound transducers.
1 x Remote switch event marker with cable.
3 x Adjustable transducer belts for ultrasound (2 FHRs) and toco (UC).
2 x Box of thermal recording paper, total 100 z-folded sheets.
2 x Bottle of ultrasound gel, approximately 250ml.
Instruction for Use
The QVCAD System is indicated for use as an aid to the reader during
screening procedures in searching images of female breasts produced by
the some've Automated Breast Ultrasound System (screening mammography
BI-RADS® Assessment Category 1 of 2, and BI-RADS Composition/Density
c of d) to detect mammography-occult lesions in regions not known to have
suspicious findings. The indicators produced by the QVCAD System are not intended to be used for diagnostic characterization of suspicious findings.
Accessories /Spares/ Consumables
At extra costs additional optional features can be requested:
- An optional cart can be included.
- An optional back up battery can be included.
Regulatory & Conformity Requirements
CE mark Comply to EU Council Directive 93/42/EEC (MDD) of EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
US FDA 510(K) clearance
CE certificate available for Class IIa and above devices
Manufacturer’s Quality Management System is certified to ISO 13485 : 2016
Classification:
Classified under EU MDR 2017/745 as Class IIb device
Environmental requirements
Context-dependent requirements Handling environment temperature:
–20 to 60 °C"
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $1,657.81 |
