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The Catheter Input Module - IC2 J-Box Bipolar Cable Assembly (3m) is an accessory to the PURE EP™ System.
The catheter input modules are used for connecting the IC catheters to the amplifier (aka MSU - Main System Unit).
The PURE EP™ is a system that consists of two main parts: the amplifier (aka MSU - Main System Unit),
and the personal computer (PC), which are connected over a highspeed
fiber optic cable. The patient is connected to the amplifier via
a set of supplied ECG cables and commercially available
intracardiac (IC) catheters. The amplifier includes hardware and
embedded software necessary for acquiring ECG and IC signals
from patients. The device is not intended for active patient
monitoring. It consists of one ECG and seven IC modules designed
to acquire 12-lead ECG and 56 IC signals and send the digitized
data to the PC. The PC has preinstalled PURE-EP software and is
connected to display monitors. The pre-installed software provides
visualization of received data from the amplifier on real-time and
review screens. It also includes a signal processing module that
provides various filter options for real-time and review screens.
BIOSIG TECHNOLOGIES, INC.
PE-002-007-000
In Commercial Distribution
- 00856750007048 ()
PE-002-007-000
- Cardiac electrophysiology analysis system
The Dual ECG Splitter Box is an accessory to the PURE EP™ System.
It allows splitting a single array of input ECG signals into two output signals to use in conjunction with the PURE EP™ system.
The PURE EP™ is a system that consists of two main parts: the amplifier (aka MSU - Main System Unit),
and the personal computer (PC), which are connected over a highspeed
fiber optic cable. The patient is connected to the amplifier via
a set of supplied ECG cables and commercially available
intracardiac (IC) catheters. The amplifier includes hardware and
embedded software necessary for acquiring ECG and IC signals
from patients. The device is not intended for active patient
monitoring. It consists of one ECG and seven IC modules designed
to acquire 12-lead ECG and 56 IC signals and send the digitized
data to the PC. The PC has preinstalled PURE-EP software and is
connected to display monitors. The pre-installed software provides
visualization of received data from the amplifier on real-time and
review screens. It also includes a signal processing module that
provides various filter options for real-time and review screens.
BIOSIG TECHNOLOGIES, INC.
PE-002-021-000
In Commercial Distribution
- 00856750007123 ()
PE-002-021-000
- Cardiac electrophysiology analysis system
The ECG Cable is an accessory to the PURE EP™ System.
The ECG cable Assembly (4.8m) connects to standard ECG patches on the patient’s skin.
The cable connects directly to the blue plug on the amplifier (aka MSU - Main System Unit).
The PURE EP™ is a system that consists of two main parts: the amplifier (aka MSU - Main System Unit),
and the personal computer (PC), which are connected over a highspeed
fiber optic cable. The patient is connected to the amplifier via
a set of supplied ECG cables and commercially available
intracardiac (IC) catheters. The amplifier includes hardware and
embedded software necessary for acquiring ECG and IC signals
from patients. The device is not intended for active patient
monitoring. It consists of one ECG and seven IC modules designed
to acquire 12-lead ECG and 56 IC signals and send the digitized
data to the PC. The PC has preinstalled PURE-EP software and is
connected to display monitors. The pre-installed software provides
visualization of received data from the amplifier on real-time and
review screens. It also includes a signal processing module that
provides various filter options for real-time and review screens.
BIOSIG TECHNOLOGIES, INC.
PE-002-008-000
In Commercial Distribution
- 00856750007055 ()
PE-002-008-000
- Cardiac electrophysiology analysis system
The Catheter Input Module - IC1 J-Box Unipolar/Bipolar Cable Assembly (3m) is an accessory to the PURE EP™ System.
The catheter input modules are used for connecting the IC catheters to the amplifier (aka MSU - Main System Unit).
The PURE EP™ is a system that consists of two main parts: the amplifier (aka MSU - Main System Unit),
and the personal computer (PC), which are connected over a highspeed
fiber optic cable. The patient is connected to the amplifier via
a set of supplied ECG cables and commercially available
intracardiac (IC) catheters. The amplifier includes hardware and
embedded software necessary for acquiring ECG and IC signals
from patients. The device is not intended for active patient
monitoring. It consists of one ECG and seven IC modules designed
to acquire 12-lead ECG and 56 IC signals and send the digitized
data to the PC. The PC has preinstalled PURE-EP software and is
connected to display monitors. The pre-installed software provides
visualization of received data from the amplifier on real-time and
review screens. It also includes a signal processing module that
provides various filter options for real-time and review screens.
BIOSIG TECHNOLOGIES, INC.
PE-002-006-000
In Commercial Distribution
- 00856750007031 ()
PE-002-006-000
- Cardiac electrophysiology analysis system
Dri-Scope Aid-Cabinet; Pump Ceiling; Series 1840; DSAC-PC2-MOB; TRICOR Label;
Dri-Scope Aid - Cabinet system is intended to aid in drying and venting internal channels of cleaned and disinfected endoscopes. The system is designed to cost-effectively convert existing passive cabinets (or closets) to active drying cabinets (or closets). The system can process as many as 16 endoscopes that are waiting in the queue. It provides pressure sensitive continuous flow of clean HEPA filtered air. Simply attach the endoscope, press the button to place the endoscope in the processing queue and the system will take care of the rest. After the drying cycle is complete, the system will periodically cycle dry air through the endoscope internal channels on a timed basis indefinitely until the endoscope is removed from the system. This (TRICOR Systems Inc - built / TRICOR Systems Inc - labeled) ceiling-mounted pump version is one component of the Dri-Scope Aid – Cabinet system that contains an internal pump used to provide HEPA filtered air to other parts of the system. Note: this system has been programmed to accept external software commands and/or remote monitoring via Mobile Aspects proprietary hardware and software.
TRICOR SYSTEMS, INC.
DCPC-MOB
In Commercial Distribution
- 00810053600375 ()
DCPC-MOB
- Endoscope dryer
Dri-Scope Aid-Cabinet; Pump Wall; Series 1840; DSAC-PW2-MOB; TRICOR Label;
Dri-Scope Aid - Cabinet system is intended to aid in drying and venting internal channels of cleaned and disinfected endoscopes. The system is designed to cost-effectively convert existing passive cabinets (or closets) to active drying cabinets (or closets). The system can process as many as 16 endoscopes that are waiting in the queue. It provides pressure sensitive continuous flow of clean HEPA filtered air. Simply attach the endoscope, press the button to place the endoscope in the processing queue and the system will take care of the rest. After the drying cycle is complete, the system will periodically cycle dry air through the endoscope internal channels on a timed basis indefinitely until the endoscope is removed from the system. This (TRICOR Systems Inc - built / TRICOR Systems Inc - labeled) wall-mounted pump version is one component of the Dri-Scope Aid – Cabinet system that contains an internal pump used to provide HEPA filtered air to other parts of the system. Note: this system has been programmed to accept external software commands and/or remote monitoring via Mobile Aspects proprietary hardware and software.
TRICOR SYSTEMS, INC.
DCPW-MOB
In Commercial Distribution
- 00810053600368 ()
DCPW-MOB
- Endoscope dryer
Merge Cardio is a software medical device that is an integrated multi-modality image cardiovascular information management system. The Merge Cardio system is intended to allow authorized health care professionals the ability to import, export, review, analyze, quantify, report and manage digital cardiovascular images, documents, and data related to cardiology. The study list supports workflow management by providing a robust study list with configurable informational columns supporting navigation, current study and reporting status, and prior study availability and relevancy. The system offers standard image controls such as brightness, contrast, zoom, and cine playback controls; as well modality specific tools such as R-wave sync and frame rate sync. The system allows users to review images, annotate images, perform digital subtraction on XA images, perform quantitative measurements on images (based on modality and anatomy including quantitative coronary analysis, left ventricular analysis, distance, angle, velocity, slope, area, velocity time integral, and volume), derive US measurements, and generate clinical reports. The system provides the ability to create clinical reports for Adult Echo, Pediatric Echo, Vascular US, Nuclear Medicine, Cath/Peripheral Invasive, Electrophysiology, Cardiac CT, and Cardiac MR. Merge Cardio runs on standard information technology hardware and software, using standard technology operating systems and user interfaces. Communication and data exchange are done using standard protocols.
MERGE HEALTHCARE SOLUTIONS INC.
12.4
In Commercial Distribution
- 00842000101123 ()
- Radiology picture archiving and communication system workstation
Merge Cardio is a software medical device that is an integrated multi-modality image cardiovascular information management system. The Merge Cardio system is intended to allow authorized health care professionals the ability to import, export, review, analyze, quantify, report and manage digital cardiovascular images, documents, and data related to cardiology. The study list supports workflow management by providing a robust study list with configurable informational columns supporting navigation, current study and reporting status, and prior study availability and relevancy. The system offers standard image controls such as brightness, contrast, zoom, and cine playback controls; as well modality specific tools such as R-wave sync and frame rate sync. The system allows users to review images, annotate images, perform digital subtraction on XA images, perform quantitative measurements on images (based on modality and anatomy including quantitative coronary analysis, left ventricular analysis, distance, angle, velocity, slope, area, velocity time integral, and volume), derive US measurements, and generate clinical reports. The system provides the ability to create clinical reports for Adult Echo, Pediatric Echo, Vascular US, Nuclear Medicine, Cath/Peripheral Invasive, Electrophysiology, Cardiac CT, and Cardiac MR. Merge Cardio runs on standard information technology hardware and software, using standard technology operating systems and user interfaces. Communication and data exchange are done using standard protocols.
MERGE HEALTHCARE SOLUTIONS INC.
12.3
In Commercial Distribution
- 00842000101109 ()
- Radiology picture archiving and communication system workstation
Dri-Scope Aid-Cabinet; Pump Wall BL1; Series 1840; DSAC-PW3-MOB; TRICOR Label;
Dri-Scope Aid - Cabinet system is intended to aid in drying and venting internal channels of cleaned and disinfected endoscopes. The system is designed to cost-effectively convert existing passive cabinets (or closets) to active drying cabinets (or closets). The system can process as many as 16 endoscopes that are waiting in the queue. It provides pressure sensitive continuous flow of clean HEPA filtered air. Simply attach the endoscope, press the button to place the endoscope in the processing queue and the system will take care of the rest. After the drying cycle is complete, the system will periodically cycle dry air through the endoscope internal channels on a timed basis indefinitely until the endoscope is removed from the system. This (TRICOR Systems Inc - built / TRICOR Systems Inc - labeled) wall-mounted pump version is one component of the Dri-Scope Aid – Cabinet system that contains an internal pump used to provide HEPA filtered air to other parts of the system. This pump component is used along with 2 (or 1) of the Dri-Scope Aid - Manifolds which together works as a drying system. Note: this system has been programmed to accept external software commands and/or remote monitoring via Mobile Aspects proprietary hardware and software.
TRICOR SYSTEMS, INC.
DCPW-BL1-MOB
In Commercial Distribution
- 00810053600474 ()
DCPW-BL1-MOB
- Endoscope dryer
The Universal SmartECG is an ECG amplifier that connects to electrodes on a patient and a PC with Windows operating systems via a USB connection. The ECG amplifier detects electrical impulses from the patient and coverts them into a digital signal that can be displayed and recorded on the computer.
The ECG system consists of a 12-lead ECG, multi-language Office Medic Software and VectraplexECG, a UL 60950 compliant host computer and accessories. The 12-lead ECG includes an analog front end designed to detect, amplify, filter, and output biopotential measurements in real time, a microprocessor to communicate and control the analog front end and system, short circuit protection, ESD protection, defibrillation isolation and protection, a green indication LED, 10 leadwires, lead off detection, USB communication to PC and Office Medic or VectraplexECG, and bootloader. The device is powered by the USB connector and is regulated to two separate supplies, a
3.3V digital supply and a 3.3V analog supply to respectively power the digital and analog circuitry.
The 12-lead ECG outputs ECG waveform information via USB to the Office Medic or VectraplexECG Software that translates, filters, analyzes, and displays the ECG waveform in real time. The hardware contains an FTDI USB UART translator chip to install required USB drivers to the PC and allow appropriate data conversion to the PC during ECG measurement.
VECTRACOR INC
AHA
In Commercial Distribution
- 00857175006173 ()
Z-7000-0500
- Electrocardiograph, professional, multichannel