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The CardioQ-EDM series fluid management and cardiac output monitoring systems are designed to provide clinicians with real-time information about patients left ventricular blood flow and key hemodynamic parameters. The CardioQ-EDM series beat to beat data on cardiovascular status can be used by the managing clinician to evaluate and optimize hemodynamic performance in anesthetized, sedated or conscious patients in the operating room, intensive care unit, emergency room or ward. The CardioQ-EDM series monitors when used in Flow Monitoring Mode (esophageal Doppler) or Pressure Monitoring Mode (EDM+ only) are intended for use with adult and pediatric patients. When the CardioQ-EDM series monitors are used for High-Definition Impedance CardioGraphy with a PhysioFlow Q-Link module the intended use is for adult patients only.

The CardioQ-EDM series are medical instruments designed to monitor cardiac function and fluid status. The CardioQ-EDM & EDM+ achieve this by combining Doppler measurements of the blood flow (4MHz continuous wave ultrasound) to monitor and quantify the blood flow in the descending thoracic aorta. In addition to this the CardioQ-EDM+ previously introduced as an upgrade to the EDM under (K132139) allows additional Pulse Pressure Waveform Analysis (PPWA) through arterial blood pressure based parameters slaved from a high-end monitor. The CardioQ-EDM (K111542) & Cardio EDM+ (K132139) have now been introduced with the addition of a USB Hub accessory and software modifications that allow the CardioQ-EDM series monitors to display hemodynamic parameters from the coupled together hemodynamic impedance cardiography device. The addition of USB Hub accessory and software modifications allow the CardioQ-EDM series monitors to become a non-invasive cardiac output measurement system which displays hemodynamic parameters, allowing analysis of a trans-thoracic impedance cardiography signal & cardiac output monitoring. The only addition to the CardioQ-EDM & CardioQ-EDM+ is the enabling of HD-ICG functionality through the USB Hub accessory introduction and software modifications to display the hemodynamic parameters from the coupled hemodynamic impedance cardiography device.

The Deltex Medical CardioQ-EDM+ / Deltex Medical CardioQ-EDM cardiac function and fluid status monitoring system is designed to provide clinicians with real-time information about a patient's left ventricular blood flow and key hemodynamic parameters. The Deltex Medical CardioQ-EDM+ / Deltex Medical CardioQ-EDM beat-to-beat data on cardiovascular status can be used by the managing clinician to evaluate and optimize hemodynamic performance in anesthetized, sedated or conscious patients in the operating room, intensive care unit, emergency room or ward.

The Deltex Medical CardioQ-EDM series are medical instruments designed to monitor cardiac function and fluid status. The CardioQ-EDM series combine Doppler measurement of the blood flow (4MHz continuous wave ultrasound) with Pulse Pressure Waveform Analysis (PPWA) to monitor and quantify the blood flow in the descending thoracic aorta and hence calculate other clinically significant information.

The probe is for use with the Deltex Medical CardioQ-EDM and CardioQ-EDM+ for Monitoring of cardiac output and fluid status. The probe is only approved for oral placement into the esophagus of a single anesthetized patient 15 years of age or younger, 50cm (20") to 170cm (67") in height.

The Deltex Medical Ltd KDP72 Pediatric Doppler Probe is an oral extravascular blood flow probe designed to work with the CardioQ-EDM and CardioQ-EDM+ Systems (K111542 and K132139 respectively). It consists of a shaft, which is a spring reinforced silicone tube, with an electrical connector on the machine end and an ultrasonic transmitting and receiving tip on the patient end. The tip is fully covered and sealed to the shaft with a silicone rubber boot and by wires running through the shaft to the connector. Visual product identification is provided at the machine end and the device is provided single packed sterile for single patient use.

The CardioQ-EDM+ cardiac function and fluid status monitoring system is designed to provide clinicians with real-time information about a patient's left ventricular blood flow and key hemodynamic parameters. The CardioQ-EDM+ beat-to-beat data on cardiovascular status can be used by the managing clinician to evaluate and optimize hemodynamic performance in anesthetized, sedated or conscious patients in the operating room, intensive care unit, emergency room or ward.

The CardioQ-EDM+, is a medical instrument designed to monitor cardiac function and fluid status, providing clinicians with real-time information about a patient's left ventricular blood flow and key hemodynamic parameters in anesthetized, sedated or conscious patients in the operating room, intensive care unit, emergency room or ward. In addition, the CardioQ-EDM+ includes a function to calculate arterial blood pressure based parameters from an output slaved from a vital signs monitor. The CardioQ-EDM+ combines Doppler measurement of blood flow with Pulse Pressure Waveform Analysis (PPWA). In "Flow Monitoring Mode" the system employs esophageal Doppler monitoring (EDM) techniques using 4 MHz continuous wave ultrasound to monitor and quantify the blood flow in the descending thoracic aorta. displaying this data as a maximum velocity curve, a velocity spectrum and derived measurements. Real-time information about cardiac function, in particular left ventricular flow, is displayed continuously. For the CardioQ-EDM+, the newly added "Pressure Monitoring Mode" the system slaves the arterial blood pressure signal supplied by the hospital patient monitoring system to provide systolic and diastolic pressures and derived parameters. The CardioQ-EDM+ uses these classical blood pressure measurements to calculate Stroke Volume (SV), Cardiac Output (CO), Stroke Volume Variation (SVV). Pulse Pressure Variation (PPV) and a small number of derived parameters. The pressure derived stroke volume is calibrated from the CardioQ-EDM+'s Doppler ultrasound measurement of stroke volume ensuring consistency and allowing frequent recalibration.

The CardioQ-EDM cardiac function and fluid status monitoring system is designed to provide clinicians with real-time information about a patient's left ventricular blood flow and key hemodynamic parameters. The CardioQ-EDM's beat-to-beat data on cardiovascular status can be used by the managing clinician to evaluate and optimize hemodynamic performance in anesthetized, sedated or conscious sedated patients in the operating room, intensive care unit, emergency room or ward.

The CardioQ-EDM system employs esophageal Doppler techniques using 4 MHz continuous thoracic aorta, displaying this data as a maximum velocity curve, a descriting there is derived measurements. Thus, real-time information about verouty opesant in particular left ventricular flow, is displayed continuously. This is the same as for the predicate CardioQ K031706. CardioQ-EDM is an enhancement of the CardioQ K031706; obsolete The components have been replaced and an improved/modernized user interface created, by utilizing the full capabilities of the new components.

The I2 probe is for use with the Deltex Medical CardioQ for the monitoring of cardiac output and fluid status. The I₂ is only approved for oral or nasal placement into the esophagus of a single patient 16 years of age or older. The probe may be placed orally or nasally in sedated or anesthetized patients. The probe must be placed nasally in awake patients.

Esophageal probe for measuring blood flow in the descending aorta. Sterile. For single use only. Overall length 89 cm (35"). Shaft construction Spring enclosed in silicone rubber. Shaft color Clear (non-pigmented) shaft. Shaft flexibility (N) 0.095. Main shaft diameter 14 FG (~4.8 mm). Distal tip diameter 19FG (~6.3 mm). Maximum Usage time (hours) 6, 24 or 72. Main shaft wall thickness 0.03" (~0.7mm). Marks in the shaft The probe shaft has three depth markers at 35, 40 and 45 cm. Color of transducer head "clear" (non-pigmented). Color of the molded connector "white" (pigmented). Color of the shaft "clear" (non-pigmented). Connection to the monitor non-reversible connector with ROM to identify probe type. Doppler transducer / Central frequency 4MHz. Doppler transducer / Global maximum output 195 mW/cm². Doppler transducer / Mechanical index 0.039. Spring wire 0.030" (0.76 mm) diameter to BS5216 HS3, Pre-galvanized. Spring length 550mm (+/- 25 mm). Spring internal diameter 1.80/2.00 mm. Spring external diameter 3.30/3.50 mm. Spring pitch The spring has fewer turns per unit of length (it has a larger pitch than DP 240). ROM memory This ROM memory is characteristic for the particular probe. Mode of operation Esophageal probe transmits and receives 4 MHz Continuous Wave Doppler (CWD) ultrasound from the probe tip at a fixed angle to the descending aorta, by excitation of a piezo-electric transducer. The ultrasound is reflected by the red blood cells and is received by a separate transducer in the probe tip. Signals are returned via the Patient Interface Cable (PIC) to CardioQ Monitor. This permits to measure blood flow velocities in the descending thoracic aorta. Compatible Monitor CardioQ monitor. Rx Status Rx. Physicians Caution included in labeling Yes.

When used in conjunction with the CardioQ cardiac output and fluid status monitoring system, the DP240 is designed to provide clinicians with real-time information about left-ventricular blood flow. The DP240 is designed to operate in a clinical setting in which the patients are under general anesthesia or are sedated in the intensive care unit. The DP240 can be placed into the esophagus via oral or nasal insertion in adults.

When used in conjunction with the Cardiac output and fluid status monitoring system (K031706), the DP240 is designed to provide clinicians with real-time information about leftventricular function by measuring blood flow in the descending thoracic aorta. The probe is designed to operate in a clinical setting in which patients are under general anesthesia or sedated in the intensive care unit. The DP240 transmits a 4 MHz continuous wave ultrasonic 'carrier' signal from the probe tip at a fixed angle to the descending aorta, by excitation of a piezo-electric transducer. The ultrasound is reflected by the red blood cells and is received by a separate transducer in the probe tip. The DP240 is placed orally or nasally and inserted into the esophagus to a depth of 35 – 45 cm, (approx. 14" - 18") for insonation of the descending thoracic aorta at the 6" thoracic vertebra (approximately). The shaft and tip of the DP240 is the only component in contact with the patient and is manufactured with an outer insulating cover of medical grade silicone rubber. The probe is flexible and has a shaft diameter of 14 French (~4.8 mm, approx. 0.18"). The probe is supplied sterile and is for single-use only in adults.

The CardioQ cardiac output and fluid status monitoring system is designed to provide clinicians with real-time information about left-ventricular blood flow. The CardioQ is designed to operate in a clinical setting in which the patients are under general anesthesia or are sedated in the intensive care unit. The CardioQ offers the anesthetist and intensive care physician with beat-to-beat data on cardiovascular status and circulating blood volume, providing immediate feedback on the effect of any therapeutic intervention.

The CardioQ cardiac output and fluid status monitoring system is designed to provide clinicians with real-time information about left-ventricular blood flow. The CardioQ is designed to operate in a clinical setting in which the patients are under general anesthesia or are sedated in the intensive care unit. The CardioQ offers the anesthetist and intensive care physician with beat-to-beat data on cardiovascular status and circulating blood volume, providing immediate feedback on the effect of any therapeutic intervention. The CardioQ system employs esophageal Doppler using 4 MHz continuous wave ultrasound to monitor and quantify the blood flow in the descending thoracic aorta, displaying this data as a maximum velocity curve, a velocity spectrum and derived measurements. Thus, real-time information about cardiac function and haemodynamic status, in particular flow, is displayed continuously. The CardioQ system transmits the 4 MHz ultrasonic 'carrier' signal from the probe tip at a fixed angle to the descending aorta, by excitation of a piezo-electric transducer. The ultrasound is reflected by the red blood cells and is received by a separate transducer in the probe tip. Blood flow away from the probe results in frequencies less than 4 MHz being present in the received signal. Conversely, any reverse flow will produce frequencies higher than the carrier. The received signal is first demodulated, such that those frequencies corresponding to the blood flow are extracted and displayed as a real-time velocity spectrum. The spectrum displays the distribution of red blood cell velocities at a given point in time, i.e. a histogram of velocities over time. Thus, the brightness at any point in the spectrum is directly proportional to the number of red blood cells traveling at a given velocity at a given time in the cardiac cycle. The CardioQ automatically traces the maximum velocity of the spectrum at each time point. By calculating the area under this maximum-velocity curve during systole, a beat-to-beat value for Stroke Distance (SD) is given, being the distance a column of blood moves in the aorta during systole. Using a proprietary algorithm called the nomogram, the CardioQ estimates Stroke Volume (SV) using the measured SD and the size and age of the patient. The Stroke Volume is the volume of blood output by the heart during systole. Since the machine automatically calculates the patient's heart rate (HR) from the spectrum, it can also provide a beat-to-beat measurement of Cardiac Output (SV*HR). Other parameters calculated include: - . Peak Velocity (PV) - highest blood velocity recorded during systole - Mean Acceleration (MA) acceleration of the blood at the beginning of systole ● - Corrected Flow Time (FTc) systolic flow time (normalized to 60 bpm) . - Cardiac Index (CI) cardiac output normalized to body surface area o - Minute Distance (MD) a linear surrogate for cardiac output, being the distance a . column of blood moves in the aorta in one minute The CardioQ Cardiac Output and Fluid Status Monitoring System is comprised of the following components: CardioQ monitor Esophageal Doppler monitor (including power cord) which generates and processes the transmitted and received ultrasound signals, displays the resulting velocity spectrum and calculates the associated cardiac parameters. It is connected to the probe via the patient interface cable. The monitor displays the waveform and numerical data on a 10.4" color TFT LCD screen, which also provides the user interface and 'help' text. The monitor is operated by a large rotary 'encoder' knob and six 'soft' buttons whose function depends on the current screen mode. The monitor operates from a 100 – 240V A.C. supply. Patient Interface Cable 6' 3" long interconnect cable between the CardioQ monitor and probe, providing signal amplification and electrical isolation. CardioQ probe Esophageal Doppler monitor probe is placed orally and inserted to a depth of 35 – 40 cm. (approx. 14" - 16") for insonation of the descending thoracic aorta at the 60 thoracic vertebra (approximately). The CardioQ probe is the only component in contact with the patient and is manufactured with an outer insulating cover of medical grade silicone rubber. The probe is flexible and has a shaft diameter of 17 French (~5.5 mm, approx. 0.22"). The probe is supplied sterile and is for single-use only.