Copyright HEMO SAPIENS^®

Noninvasive Hemodynamic and O₂ Transport Monitoring & Management Systems - HOTMAN^®

HOTMAN^® SYSTEMS:

Product Specification

Overview

HOTMAN^® Systems are PC-based systems for automatic, noninvasive and hands-free acquisition of a patient’s blood flow and left-ventricular parameters by the Company’s Thoracic Electrical Bioimpedance (TEB) module EXT-TEBCO^®, and manual entry of arterial blood pressure, hemoglobin and saturation level of O₂ in arterial and mixed venous blood, via the systems’ keyboard.

The systems then process and display the digital values of measured and calculated hemodynamic and O₂ transport parameters and provides graphical information how the value of each parameter compares to its normal range - a function of gender, age and clinical state (the Monitoring mode). The digital values of measured and calculated hemodynamic and O₂ transport parameters are stored, automatically and periodically, on the system hard disk. Based upon the values of measured and calculated hemodynamic and O₂ transport parameters, and, if any and/or all are at abnormal level, the systems implement the hemodynamic management analysis and provide the clinician with a clear definition of the hemodynamic causes responsible for the observed abnormal hemodynamic state (the Hemodynamic Management mode). Since the relationship between the hemodynamic causes and the resulting hemodynamic state is bi-directional, the systems can model in advance the results of proposed therapy (the Hemodynamic Modeling mode).

The built-in network communication features enable HOTMAN^® Systems to become components of a network.

HOTMAN^® Systems’ intended purpose is noninvasive hemodynamic assessment and management of patients, ranging from neonatology through pediatrics and adults to geriatrics. Its utility is in physicians’ offices, medical centers and hospitals.

HOTMAN^® SYSTEMS’ HEMODYNAMIC & O₂ MEASUREMENTS

Blood Flow & L.V. Performance Measurements

The blood flow and left ventricular performance measurements are performed automatically by the System’s EXT-TEBCO^® Module (HOTMAN^® Communication Protocol).

Cardiac Index (CI) / Stroke Index (SI) Measurement Accuracy by EXT-TEBCO^®:

+20% (comparable with the accuracy of thermodilution method)

Heart Rate (HR) Range:

40 - 222 beats/min

Calculation:

CI = (SI x HR)/1000

Patient Interface:

TEB patient interface consists of special, TEB-approved and tested 8 solid gel electrodes (placed on a patient’s neck and lower thorax as four pairs) connected to the System via a patient cable.

TEB Measurement Current: 7 μA RMS @ 65 kHz

Blood Pressure Measurements and Calculations

A manual or automated occlusive cuff is used to measure a patient’s arterial blood pressure and the measured values are entered via the keyboard as Systolic/Diastolic (S/D).

Equation used:

MAP = [(S - D)/3] + D

HOTMAN^® System’s default mode is “All Noninvasive Measurement” mode and normal mean values of Central Venous Pressure, CVP = 4 torr, and Pulmonary Artery Occluded Pressure, PAOP = 9 torr, are used in calculations. If the patient is catheterized and the actual values of CVP and PAOP are known, they may be entered via the keyboard by switching the System to “Invasive Data Available.” The values of CVP and PAOP are used for calculations of afterload (SSVRI) and contractility (LSWI):

SSVRI = 80 (MAP – CVP) / SI

LSWI = 0.0144 [MAP – (PAOP – 2)] x SI

Oxygen Transport Dynamics Measurements and Calculations

HOTMAN^® Systems also have a capability to process and display complete Oxygen Transport Dynamics information. When the values of Hgb (Hemoglobin) and SpO₂ (saturation of O₂ in arterial blood measured by pulse oximetry) are known and entered via the keyboard, HOTMAN^® Systems calculate and display the real time value of DO₂I (O₂ Delivery Index). When the SvO₂ (saturation of O₂ in mixed venous blood) value is known, it may be entered via the keyboard and HOTMAN^® Systems display, in real time, the value of the highest hierarchy Oxygen Transport parameter - VO₂I (O₂ Consumption Index).

Equations used:

DO₂I = CI x 10 Hgb x SpO₂ x 1.34

VO₂I = CI x 10 Hgb x (SpO₂ - SvO₂) x 1.34

HOTMAN^® SYSTEMS’ HEMODYNAMIC AND O₂ TRANSPORT MONITORING PAGE

Note: All Data display pages contain in the top panel the patient’ name, gender age, height, weight and ID Number. In the Monitoring and Management Page a Footnote may be entered to document clinical or other condition or observation.

Parameters Displayed:

Analog Signals (digitized): ECG, dZ/dt, DZ, DZ/Dt_resp

Digital Parameters: “All Noninvasive Measurement” Mode selected

HEMODYNAMICS ONLY (Hgb or SpO₂ value not entered)

Respiratory Rate	RR	breaths/min
Cardiac Index (global blood flow)	CI	l/mim/m^2
Heart Rate	HR	beats/min
Stroke Index	SI	ml/ m^2
Mean Arterial Pressure	MAP	torr = mmHg
Systolic/Diastolic Blood Pressure		torr
End-Diastolic Index	EDI	ml/m^2
Ejection Phase Contractility Index	EPCI	sec^-1
Inotropic State Index	ISI	sec^-2
Left Stroke Work Index	LSWI	g.m/m^2
Ejection Fraction (estimate)	EF	%
Stroke Systemic Vascular Resistance Index	SSVRI	dyn.sec.cm^-5.m^2
Thoracic Fluids Conductivity (Content)	TFC	1/W

Digital Parameters: “Invasive Data Available” Mode selected

COMPLETE OXYGEN TRANSPORT DYNAMICS (Hgb, SpO₂, SvO₂, CVP and PAOP values entered)

Saturation of O2 in Mixed Venous Blood	SvO2	%
O2 Consumption Index	VO2I	ml/min/m^2
O2 Delivery Index	DO2I	ml/min/m^2
Hemoglobin	Hgb	g/dl
O2 Saturation in Arterial Blood	SvO2	%
Respiratory Rate	RR	breaths/min
Cardiac Index (global blood flow)	CI	l/mim/m^2
Heart Rate	HR	beats/min
Stroke Index	SI	ml/ m^2
Mean Arterial Pressure	MAP	torr = mmHg
Systolic/Diastolic Blood Pressure	Sys/Dia	torr
End-Diastolic Index	EDI	ml/m^2
Temperature	TEMP	^OC or ^OF
Ejection Phase Contractility Index	EPCI	sec^-1
Inotropic State Index	ISI	sec^-2
Left Stroke Work Index	LSWI	g.m/m^2
Ejection Fraction (estimate)	EF	%
Stroke Systemic Vascular Resistance Index	SSVRI	dyn.sec.cm^-5.m^2
Central Venous Pressure	CVP	torr
Thoracic Fluids Conductivity (Content)	TFC	1/W
Pulmonary Artery Occluded Pressure (Wedge)	PAOP	torr

HOTMAN^® SYSTEMS’ Hemodynamic Management Page

Parameters Displayed

Analog Signals (digitized): ECG, dZ/dt, DZ, DZ/Dt_resp

Digital Values:

Hemodynamic State:

Percentage deviation in MAP from Normotension
Percentage deviation in SI from Normodynamic Circulation

Hemodynamic Modulators (causes):

Percentage deviation in Intravascular Volume from Normovolemia

Percentage deviation in Inotropic State from Normoinotropy

Percentage deviation in Vasoactive State from Normovasoactivity

Percentage deviation in Chronotropic State from Normochronotropy

Hemodynamic Management Modeling

A unique feature of HOTMAN^® Systems Hemodynamic Management Page is that it can be switched from its identification of hemodynamic causes of an abnormal hemodynamic state to hemodynamic modeling. In this mode, the user/clinician can model hemodynamic effects of any cardioactive and vasoactive drug and see its hemodynamic effect on patient’ existing hemodynamic state, without exposing the patient to potentially undesirable effects of an incorrectly selected therapy.

Hardware Configurations

• Modular HOTMAN^® System, consisting of a PC or notebook (Windows XP OS and HOTMAN^® software installed) with EXT-TEBCO^® Module (HOTMAN^® communication protocol) connected via a serial communication cable to PC/notebook’s COM1 serial port. Any display page can be printed in color on attached printer. For notebooks with USB ports only, an RS232-to-USB Converter is available.
  
  
• Stand-Alone HOTMAN^® System, consisting of an All-in-One PC (Windows XP, HOTMAN^® software installed) and EXT-TEBCO^® Module attached. Any display page can be printed in color on attached printer.

HOTMAN^® Softwares Available

• N/P for assessing and managing hemodynamics and O₂ transport dynamics in neonatal and pediatric patients through an approximate age of 15
• PRG for assessing and managing hemodynamics and O₂ transport dynamics in young women of childbearing age (nongravidas) and during pregnancy (gravidas).
• BAS for assessing and managing hemodynamics and O₂ transport dynamics of adult males and postmenopausal females
  
  

SIDE EFFECTS

There are no known side effects to the exposure of the TEB measurement current. In some patients, there may be some sensitivity to the electrode gel, resulting in minor skin irritation.

INTENDED USE

Since adequacy of O₂ delivery is a pre-requisite of cardiovascular health, the utility of HOTMAN^® Systems bridges many disciplines of medicine:

• For patients of all ages, HOTMAN^® Systems enable rapid assessment of hemodynamics and define a straight-line therapy to correct any observed hemodynamic abnormality. These features are important in emergency care and in critical care medicine.
• HOTMAN^® BAS System is an invaluable tool in correct treatment of hypertension and congestive heart failure in older adults. Reports document improvements of outcome in treatment of hypertension from current 21-25% to 65-85%. Since the straight-line therapy leads to minimization of cardiodynamic and vasoactive drugs needed for correct therapy, it leads to major savings when compared to current trial-and-error management methodology.
• Male impotence and women infertility can often be traced to inadequate O₂ delivery. HOTMAN^® BAS System and HOTMAN^® PRG System can be used to identify and treat these dysfunctions.
• In surgical patients, HOTMAN^® Systems are used for preoperative assessment and correction of hemodynamics (especially volemia). Normohemodynamic and normoperfusion state at the onset of the surgery leads to less complications and shorter duration of hospitalization.
• HOTMAN^® BAS and PRG Systems provide a valuable input in improvement of training methods of athletes in sports medicine.
• HOTMAN^® Systems’ Hemodynamic Modeling feature is an important teaching tool of hemodynamics in medical schools.
• The noninvasive features of HOTMAN^® Systems reduce mortalities and morbidities associated with invasive procedures currently used for hemodynamic measurements.

HOTMAN^â Systems Accessories

Every HOTMAN^® System has the following components:

• EXT-TEBCO^® Module (detached or attached)
• Patient cable
• PC or notebook
• A corresponding HOTMAN^® System software (BAS, PRG or N/P) on a CD-ROM
• Operator’s Manual on a CD-ROM
• EXT-TEBCO^® and PC/notebook power sources
• Color Printer
• Textbook - Sramek BB: Systemic Hemodynamics and Hemodynamic Management

User must provide:

• A device for noninvasive measurement of blood pressure
• Pulse Oximeter (to process O₂ Transport Dynamics)
• 8 single TEB disposable electrodes (or 4 TEB disposable electrode pairs) for each application. The electrodes may remain in place for up to 48 hours.
• Paper and color cartridges for the printer