Copyright BoMed

OEM Noninvasive Cardiac Output Module

Model TEBCO®

Marketing Product Specification

Overview

This document describes and defines specifications for BoMed’s TEBCO® OEM Noninvasive Cardiac Output Module. TEBCO® connects to the patient via four pairs of special TEB, dual, pre-gelled, disposable electrodes. TEBCO® employs all-digital signal processing. It provides cardiac index, stroke index, heart rate, respiratory rate and 6 other cardiodynamic parameters, together with ECG and three Thoracic Electrical Bioimpedance (TEB) digitized analog signals. The data are transmitted to the host system via a serial, optoisolated, RS-232 interface or a USB Port. The TEBCO® Module’s patient circuitry is isolated from the host system’s main power and ground.

TEBCO® DESCRIPTION

TEBCO® (Thoracic Electrical Bioimpedance Cardiac Output) is a printed circuit board (PCB), containing insulated electronic circuitry for ECG detection, the circuitry for TEB detection, measurement and digital processing, and the optoisolated, serial RS-232 communication circuitry. On the input side, TEBCO® is connected to the patient via a special, 10 ft (3 m) long patient cable and four pairs of HSI® proprietary, disposable solid gel TEB electrodes, placed along the frontal plane on the patient’s neck and lower thorax. The output of TEBCO® is a standard serial RS-232 or USB port, communicating the data at 9600 baud to the host system. The data consist of four digitized analog signals, sent out continuously, and of the digital values of ten cardiodynamic and respiratory parameters, transmitted once for every 16 accepted heart beats and/or for every heart beat (software selectable).

TEBCO® OEM Module kit consists of:

·         TEBCO® printed circuit board (PCB) assembly

·         TEB/ECG Patient Cable

·         Operator's Manual

·         Windows software on a CD-ROM, to capture and display the TEBCO®-generated digital data and digitized analog signals and to calculate a patient's actual cardiac index and stroke index values

The following items must be supplied by the host system and/or the user:

·         Eight HSI® solid gel TEB electrodes (four pairs) for each patient application

·         A host system with a RS-232 or USB Port

  • 5VDC @ 450 mA power from the host system

Some tools and components are available from BoMed:

·         Windows software for data capture, decompression and display is provided on a CD-ROM with each TEBCO® OEM Module

·         Digital data communication format and protocol are described in the Operator's Manual

TEBCO® SPECIFICATIONS

Dimensions:

5.5 x 9.1 x 0.6 inch (140 x 231 x 15 mm). Four-layer PCB with surface mounted components on one side.

Weight: 6 oz (170 g)

Cardiac Output& Accuracy:

20% (comparable with the accuracy of thermodilution method)

Heart Rate Range:

40 - 222 beats/min

TEB Range:

12 - 48 ohm

Electrodes:

Each electrode pair consists of one measurement current electrode and one ECG/TEB sensing electrode. The preferable location of the four sensing electrodes is at the following thoracic landmarks: Two at the intersection of frontal plane and the line of the root of the neck, two at the intersection of frontal plane (midaxillary line) and the xiphoid process level. The measurement current electrodes are placed as follows: Each neck electrode is 5 cm (2 inches) above its corresponding sensing electrode, each upper abdominal electrode is 5 cm below the corresponding xiphoid process level sensing electrodes.

Output Data:

Analog Signals (digitized):

1) ECG @ 20 msec/sample

2) dZ/dt @ 20 msec/sample

3) DeltaZ @ 20 msec/sample

4) dZ/dt resp @ 20 msec/sample

Cardiodynamic and respiratory parameters:

Heart Rate (HR) [beats/min] +1 beat/min

Ventricular Ejection Time (VET) [sec] +10 msec

Pre-ejection Period (PEP) [sec] + 10 msec

 Thoracic Fluid Conductivity (TFC) [1/ohm] +5%

Ejection Phase Contractility Index (EPCI) [1/sec] +10%

Inotropic State Index (ISI) [1/sec/sec] +10%

Ejection Fraction (EF) estimate [%]

*Stroke Index (SI) [ml/beat/mSuperscript2] + 20%

*Cardiac Index (CI) [liters/min/mSuperscript2] + 20%

Respiratory Rate (RR) [breaths/min] + 0.2 breath/min

* Transmitted SI and CI values are standardized for a 180 cm @ 80 kg male and must be recalculated by the host system for actual gender and body habitus.

Self-test:

Upon software initiation by the host system, TEBCO® produces simulated ECG and TEB signals @ HR = 100 beats/min, RR = 25 breaths/min, TFC = 0.033/ohm , (dZ/dt)max = 1.5 ohm/sec and VET = 260 msec.

TEB Measurement Current:

7 µA RMS @ 65 kHz

DC Power Supplies Requirements:

Host System: + 5 V @ 450 mA for RS232 communication or +5V @ 500 mA for USB communication

Power Consumption:

2.2 W (RS232) / 2.5 W (USB Communication)

Humidity:

Any relative humidity without condensation

Elevation:

Any

Operating Temperature:

0 - 50oC

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The following are the trademarks of HEMO SAPIENS INC.:

HEMO SAPIENS, HSI, TEBCO, HOTMAN.

TEBCO® is covered by the US Patent No. 5,503,157 and 5,529,072. Other patents pending.

TEBCO® is FDA listed as a Class II Device