TASK FORCE MONITOR 3040

K014063 · Cnsystems Medizintechnik GmbH · DSB · Feb 7, 2002 · Cardiovascular

Device Facts

• Record ID: K014063
• Device Name: TASK FORCE MONITOR 3040
• Applicant: Cnsystems Medizintechnik GmbH
• Product Code: DSB · Cardiovascular
• Decision Date: Feb 7, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2770
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Task Force® Monitor 3040 (TFM) is intended to noninvasively measure and display a patient's hemodynamic parameters using Impedance Cardiography (ICG), Electrocardiography (ECG), oscillometric Blood Pressure (oscBP) and continuous blood pressure measurement. The TFM monitors continuously the subject's hemodynamic parameters without reporting any diagnosis. Every measurement must be supervised by a medical trained professional. The Task Force® Monitor 3040 is a diagnoses aiding device and therefore not designed for vital sign monitoring or self-monitoring of patients.

Device Story

TFM 3040 measures hemodynamic parameters noninvasively; inputs include ICG (8 electrodes), ECG (4 electrodes), oscillometric BP (upper arm cuff), and continuous BP (finger cuff). Device combines BioZ.pc ICG technology with Finapres continuous BP measurement; system automatically corrects continuous BP trend to absolute oscillometric values. Operated by trained medical professionals in hospitals/clinics; PC-based architecture separates patient instrumentation electronics (isolation/defib protection) from user interface. Software displays hemodynamic parameters (SV, CO, SVR, VI, TFC, LVET, PEP, LCWI, HR, BP) and enables data storage. Benefits include continuous monitoring without measurement interruptions common in predicate devices; aids clinical decision-making via hemodynamic analysis, including blood pressure variability spectra and Baroreceptor Reflex Sensitivity (BRRS).

Clinical Evidence

Bench testing only. Device performance validated against predicate methods for ICG and blood pressure. Clinical study cited to demonstrate that TFM follows arterial blood pressure trends similarly to the Finapres device, with the advantage of continuous signal acquisition without interruptions.

Technological Characteristics

PC-based system (Intel Pentium III, Windows 2000). ICG: 400µA, 40kHz. ECG: 1000-1200Hz sampling. BP: Oscillometric and photoplethysmographic (Penaz method). Materials: ISO 10993-1 compliant disposable electrodes (polyethylene, stainless steel, Ag/AgCl). Connectivity: Standalone PC. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-25, IEC 60601-2-30, EN 1060-1/3, ANSI/AAMI SP 10.

Indications for Use

Indicated for noninvasive hemodynamic monitoring in hospital, outpatient, and clinical settings. Patient population includes those requiring hemodynamic assessment; contraindications include patients with sepsis, severe heart insufficiency, aortic valve insufficiency, aortic valve stenosis, or those with movement artifacts.

Regulatory Classification

Identification

An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.

Special Controls

*Classification.* Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• CardioDynamics BioZ.pc (K001081)
• Ohmeda 2350 Finapres (K880572)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a symbol that resembles a stylized caduceus, with three parallel lines that curve and merge into a single line at the bottom.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## FEB 0 7 2002

CNSystems Medizintechnik GmbH c/o Mr. Mark Job TÜV Product Service 1775 Old Highway 8 New Brighton, MN 55112-1891

Re: K014063

Trade Name: Task Force® Monitor 3040 Regulation Number: 21 CFR 870.2770 Regulation Name: Impedance Plethysmograph Regulatory Class: Class II (two) Product Code: DSB Dated: January 31, 2002 Received: January 31, 2002

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section > IQ(x) premanted is substantially equivalent (for the indications
referenced above and have determined the devices marketed in interstate referenced above and nave delemined the devices marketed in interstate
for use stated in the enclosure) to legally marketed to a fevice. Device Amendments, for use stated in the enclosure) to regally inanced teched Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment of the Federal Food. Drue, commerce prior to May 28, 1976, the enactinence with the provisions of the Federal Food, Drug, devices that have been recuassified in accordance was areas approval application (PMA).
and Cosmetic Act (Act) that do not require approval assured a provisions of the Act. and Cosmetic Act (Act) that do not require approvate of the general controls provisions of the Act. The You may, therefore, market the device, subject to the gentlation annual registration, listing of
general controls provisions of the Act include requirements for annual misbr general controls provisions of the Act merate requirement.
devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) more in the endering your device can
may be subject to such additional controls. Birts 800 to 808 In addition FDA may may be subject to such additional controlist Existing major roganto 898 In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 In a be lound in the Code of Federal Regeralistian, and the Federal Register.

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Page 2 - Mr. Mark Job

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised allat I DA 3 issuation of a basevice with other requirements of the Act that I DA has made a decommanding administered by other Federal agencies. You must of ally receral statutes and regulations and limited to: registration and listing (21 comply with an the Act 3 requirements, not 801); good manufacturing practice requirements as set CI K I at 807), idocing (21 CFR Part 820); and if applicable, the electronic forul in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to oogin mains of substantial equivalence of your device to a legally premarked notineation: "The PDF interession for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific arrive tor your avitro diagnostic devices), please contact the Office of additionally 21 CF N Fat 007.10 101 11 12:11 Paally, for questions on the promotion and advertising of Compliance at [phone]. Finance at [phone]. Also, please note the your do roo, prease connect more to premarket notification" (21CFR Part 807.97). regulation entitied, "Misoranung of responsibilities under the Act may be obtained from the Other general information on your reportional and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Dork Tith

L Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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of T Page I

510(k) Number (if known): K014063

Task Force® Monitor 3040 Device Name:

### Indications For Use:

Indications For Use:
The Task Force® Monitor 3040 (TFM) is intended to noninvasively measure and display a patient's The Task Force® Mouitor 3040 (TFM) is intended to nominastry Incerverer diography (BCG),
hemodynamic parameters using Impedaace Cardiography (ICG), Electrocrapity (BCG), ( The Marce parameters using Impelane Cardingson (ICC), phocores (ontinental), The TFM (1), The TFM (1), The TFM (1), The TFM (10), The TFM (10), The TFM monitors oscillometric Blood Pressure (oscBP) and continuous silova I reporting any diagnosis.
continuously the subject's hemodynamic parameters without reporting any diagnosis. ostinuously the subject's hemodynamic parameters without reportung any the Castil Porce® Monito!
Every measure of the supervised by a medical trained professional. The Task F Every measurement must be supervised by a medical trained processor.
3040 is a diagnoses aiding device and therefore not designed for vital sign monitoring or self-monitoring of patients.

(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

(Optional Format 3-10-98)

Respiratory Devices Division of Cardiova 510(k) Number

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Image /page/3/Picture/0 description: The image shows the logo for CNSystems. The logo consists of a stylized human figure on the left, followed by the text "CNSystems" in a bold, sans-serif font. Below the company name, there is a tagline that reads "The Brain & Heart Company" in a smaller, regular font.

# 1. Summary and Certification

# 1. 1 Premarket Notification 510(k) Summary

# SUBSTANTIAL EQUIVALENCE

SUBSTANTIAL EQUI▼ALLENOE
Identification of predicate devices, model and manufacturer:

| Predicate device: | CardioDynamics BioZ.pc |
|--------------------------|------------------------------------------|
| Model: | BZ-500/BZ-501 |
| Manufacturer: | CardioDynamics International Corporation |
| Predicate Device 510(k): | K001081 |
| Reason for Submission: | New device |
| Predicate device: | Ohmeda Finapres |
| Model: | 2350 Finapres |

Manufacturer: Predicate Device 510(k): Reason for Submission:

Ohmeda Medical K880572 New device

The Task Force® Monitor 3040 is substantially equivalent to the BioZ.pc in terms of design, in-The Task Force® Monitor 3040 is substantally equivated to the Diozalia 1000 is substantially
tended use and principle of operation. Furthermore the Task Force® Monitor 3040 i tended use and principle of operation. Futurerinon interest and principle of operation.
equivalent to the Finapres 2350 in terms of intended use and principle of open

equivalent to the Finapres 2350 in tems of intended use openamic patient monitor-The Task Force® Monitor 3040 simply combines inc nomination of the measurement
ing principle of the BioZ.po system with the nominuous blood pressure measurement ing principle of the BioZ.pc system with the nomination electronics (which provides all data acof the Finapres 2350 device. The patient instrumentation electronics with the of the Finapres 2350 device. The patent instrumention the PC which interacts with the user.
quited isolation and defib protection) are separated from the PC which interacts w quisition, isolation and defib protection) are separated notes and the software is enclosed.
The software is pre-installed on the PC, a backup copy of the software is enclose

The software of the Task Force® Monitor 3040 controls the hardware, displays the hemodynamic
. The software of the supportunities atore the measurement data on the hard disk The software of the Task Force® Monitor 3040 ontrols the naturent data on the hard disk (like in
parameters and given the possibility to store the measurement data on the bir parameters and gives the possibility to store the measurent and on and and announce integrity
the BioZ.pc). Both devices (Task Force® Monitor 3040 and BioZ.pc) use a socured the BioZ.pc). Both devices (Tast Force" Niomie 10-0 and Divenove that no common has occurred of check when the monitoring software is first activated, to filsure mail and other will be the beginning of each measurement.

A difference is the software installation kit: while CardioDynamics encloses a software installation
ics allows only and on the supported block on the PC . Furthermore Cardio A difference is the software installetion kit: While Cardiobynamics allows only
kit diskette, the TFM software is pre-installed on the PC. Furthermore CardioDynamics, kit diskette, the TFM software is pre-installed on the P. Futush by CardioDynamics,
particular models of notebook PC's which have been previously validated by Cardio the TFM particular models of notebook PC's which have been previously valuation of the first of the TFM
due to the short life cycle of state-of-the-art PC's, CNSystems ships a fully system.

The Task Force® Monitor 3040, the BioZ.pc system and the Finapres device are portable in design The Task Force® Monitor 3040, the BioZ.pc system and clinical see of the Task Force® and for use in the hospital, outpatient and climical secures. Inc. monthers using Impedance Monitor 3040 is to noninvasively measure a patient s lientodyname parament. Monitoring is accom-

Chapter 6: Page 1 (13)

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Image /page/4/Picture/0 description: The image shows the logo for CNSystems, which includes a stylized figure of a person next to the company name in bold, sans-serif font. Below the company name, in a smaller font, is the tagline "The Brain & Heart Company." The logo is simple and professional, conveying a sense of expertise in the fields of neuroscience and cardiology.

CNSystems Medizintechnik GmbH urope, Austria, 8020 Graz umkircherstrasse t +43/316/7 23456-0, Fax: -2 nail: [e-mail]

plished by attaching 3 double electrodes and a neutral electrode for ICG (1 in the neck and 2 on each side of the thorax), 4 electrodes for ECC, one finger cuff for continuous blood pressure mad 2 on
surement and one upper arm cuff for assillements blog pressure measurement and one upper arm cuff for oscillonetic blood pressure measurement. ICG is injecting a minimal current through the oscholietive blood pressurement. ICG is injecting
the inner electrodes. the inner electrodes.

The Task Force® Monitor 3040 uses the same methods and algorithms for calculating the patient's hemodynamic parameters as both predicate devices.

Blood pressure is measured in two ways: the absolute blood pressure values are measured with an oscillometric device and the continuous blood pressure values are measured with an
(same method as the Finances device). The TEM a (same method as the Finances device). The TFM system automatically corrects the continuous blood pressure trend to the absolute values of the oscillometric device. Due to the state-of-the-ar electronic components, the blood pressure is monitored contiguously without any internuptions while the Finances device has o interupt the measurement for resetting the set point from time to
time.

Both the Task Force® Monitor 3040 and the BioZ.pc are IBM PC-based products, which differ
only in the version of the operation system only in the version of the operation system.

The Task Force® Monitor 3040 (TFM) is substantially equivalent to its predicate devices, the BioZ.pc currently marketed by CardioDynamics International Corporation and the Finances, the The TFM has the same intended use and no technological differences which would rise new questions concerning safety and effectiveness.

The justification for this substantial equivalence determination is presented below.

Substantial equivalence is shown in the following table (on the next page).

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CNSystems
The Brain & Heart Company

CNSystems Medizintechnik GmbH
Europe, Austria, 8020 Graz
Baumkircherstria, 8020 Graz
Tel.: [phone] Fax: -2
Email: [e-mail]

# ubstantial Equivalenc

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| |

| Attribute | Task Force Monitor 3040 (new) | BioZ.PC (Predicate) | Ohmeda 2350 Finapres (Predicate) | |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | CNSystems Medizintechnik GmbH<br>Baumkircherstrasse 1<br>A - 8020 Graz, Austria | CardioDynamics International Corp.<br>6175 Nancy Ridge Drive<br>San Diego, CA 92121, USA | Ohmeda Medical<br>355 Inverness Dr. South<br>Englewood, CO 80112 5810, USA | |
| 510(k) number | none | K001081 | K880572 | |
| Indication for use | The TFM has the same intended use/indi-<br>cations for use as the BioZ.PC device.<br>Additionally it combines the ICG method<br>and the continuous blood pressure method<br>of the Finapres device. | The device is for use in the hospital, out-<br>patient and clinical setting. The BioZ.PC<br>is to noninvasively measure a patient's<br>hemodynamic parameters using Imped-<br>ance Cardiography (ICG). Monitoring is<br>accomplished by attaching 8 electrodes to<br>the patient, injecting a minimal current<br>through the upper electrodes, and reading<br>the returning voltage waveform from the<br>inner electrodes. Each measurement has<br>to be supervised by a medical profes-<br>sional. | The Finapres device is to noninvasively<br>and continuously measure a patient's arte-<br>rial blood pressure using the photopl-<br>ethysmographic method first described by<br>Penaz. The device uses a finger cuff for<br>systolic and diastolic blood pressure mea-<br>surement and calculates also mean arterial<br>blood pressure. | |
| | Attribute | Task Force Monitor 3040 (new) | BioZ.PC (Predicate) | Ohmeda 2350 Finapres (Predicate) |
| | Physical description / functioning | The device architecture of the TFM is equivalent to the BioZ.pc. The TFM system consists of a Patient Biosignal Electronic System (PBES) and a PC for calculating and displaying the hemodynamic parameters. ICG signals from a patient are assessed using the same method as the predicate device (8 electrodes, injecting a minimal current). The user inputs the patient's data into the TFM software on the PC including gender, age, height, weight, hematocrit and the distance between the inner ICG electrodes. The PC runs Windows 2000 operating system. The parameters are displayed on a full color screen and measurement data can be stored on the PC's hard disk. The TFM calculates and displays the same hemodynamic parameters as the predicate device. | The device consists of a Patient Interface Module and a separate PC. The PC software provides the user interface for the BioZ.pc system and checks the hardware when the software is activated. The user inputs patient parameters into the user software, including patient gender, height, body frame size, weight, age and blood pressure. The Monitor then utilizes these parameters and measures the ICG signals to determine the hemodynamic properties of that particular patient. The PC runs Windows 98 operating system. The parameters are displayed on a full color screen and measurement data can be stored on the PC's hard disk. | This device measures noninvasively arterial blood pressure in the finger using a method originally devised ba Dr. Jan PENAZ. The monitor displays the pressure wave form, digital values of systolic, diastolic and mean pressure as well as pulse rate and a time annotated trend display. The device uses a cathode ray tube (CRT) for displaying the signals and values. To follow the arterial blood pressure the Finapres has a servo valve to control the cuff pressure, the pressure transducer are located in the patient interface module. The finger cuff contains the photo electronic components for measuring a blood Plethysmograph and a bladder for applying pressure to the finger. The bladder is wrapped around the patient's finger and connected to the patient interface module. A pump in the monitor unit provides the finger cuff with required air pressure. |

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/ CNSystems
The Brain & Heart Company

CNSystems Medizintechnik GmbH
Europe, Austria, 8020 Graz
Baumkircherstria, 8020 Graz
Tel.: [phone] Fax: -2
Email: +43//316/77 234566-07 2ystems.at

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| | CNSystems Medizintechnik GmbH<br>Europe, Austria, 8020 Graz<br>Baumkircherstrasse 1<br>Tel.: [phone], Fax: -2<br>Email: [e-mail] | | | | | |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| | Table | | | | | |
| CNSystems<br>The Brain & Heart Company | Attribute | Task Force Monitor 3040 (new) | A difference between the TFM and the<br>BioZ.pc is the blood pressure measure-<br>ment. The predicate device uses manual<br>user input of blood pressure values or<br>optional an oscillometric BP measure-<br>ment. The interval of measurement can be<br>set by the user. The TFM system includes<br>the continuous blood pressure method of<br>the Finapres device for assessing online<br>and real-time blood pressure values. | BioZ.PC (Predicate) | Monitoring is accomplished by attaching<br>8 electrodes to the patient, injecting a<br>minimal current through the upper elec-<br>trodes, and reading the return voltage<br>waveform from the inner electrodes.<br>The device calculates and displays 12<br>hemodynamic parameters including<br>Stroke Volume (SV), Cardiac Output<br>(CO), System Vascular resistance, Veloc-<br>ity Index (VI), Thoracic Fluid Content<br>(TFC), Systolic Time Ratio, Left Ventric-<br>ular Ejection Time (LVET), Pre-Ejection<br>Period (PEP), Left Cardiac Work/Index<br>(LCWI), Heart rate (HR), Systolic and<br>Diastolic Blood Pressure (SBP, DBP).<br>Each PC provided will be fully tested<br>with its BioZ.pc device prior to shipment. | Ohmeda 2350 Finapres<br>(Predicate) |

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| Attribute | Table | BioZ.PC (Predicate) | Ohmeda 2350 Finapres (Predicate) | |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Task Force Monitor 3040 (new) | | | |
| | The Penaz-method for beat-to-beat blood pressure measurement (same as the Finapres device) follows very good the arterial blood pressure trend but the absolute values of BP are not accurate due the physiology of finger arteries. Therefore TFM uses a oscillometric blood pressure device for assessing absolute BP values and continuos BP for trend recording. A difference between the TFM and the Finapres device is the interruption of measurement. While the Finapres interrupts from time to time for re-setting the pressure set point, the TFM has no interruptions because of state-of.the-art electronic components. A clinical study shows, that both devices follow the arterial blood pressure very well with the difference, that the TFM has no interruptions in the signal.<br>Because of the combination of ICG and continuous BP further analysis can be made: spectra of blood pressure variability and Baroreceptor Reflex Sensitivity (BRRS). Both methods have been published many times. | | | |
| Attribute | Task Force Monitor 3040 (new) | BioZ.PC (Predicate) | Ohmeda 2350 Finapres (Predicate) | |
| Patient Circuitry Package | Internal to TFM instrument | Internal to BioZ.PC instrument | Internal to Finapres instrument | |
| CPU | Intel Pentium III of higher | Intel 586 or equivalent | none | |
| CPU Packaging | External PC | External PC | none | |
| PC Operating System | Windows® 2000 | DOS within Windows®98 | none | |
| PC Software | Pre-installed and fully tested on every TFM prior to shipment. | Provided on a CD-ROM | none | |
| User Interface Software | TFM program V1.1 Revision 3 | BioZ ver 1.52 | not known | |
| User Display | External PC VGA Screen | External PV VGA Screen | Internal cathode ray tube (CRT) | |
| Blood Pressure Electronics | Internal to TFM instrument | Internal to BioZ.PC instrument | Internal to Finapres instrument | |
| | | | | |
| | CNSystems Medizintechnik GmbH<br>Europe, Austria, 8020 Graz<br>Baumkircherstrasse 1<br>Tel.: [phone], Fax: -2<br>Email: [e-mail] | | | |
| | | Table | | |
| CNSystems<br>The Brain & Heart Company | Attribute | Task Force Monitor 3040 (new) | BioZ.PC (Predicate) | Ohmeda 2350 Finapres (Predicate) |
| | Performance specification | ICG measuring current: 400µA eff., 40 kHz, temporal derivative of impedance dZ/dt: ±10 Ohm/s<br>ECG measuring range ±5mV, indication range 30 - 150 beats/min, sampling frequency: 1000Hz (Europe), 1200Hz (USA)<br>oscillometric BP measuring accuracy: ±5mmHg, measuring range: 50 to 250mmHg<br>continuous BP measuring accuracy: ±5mmHg (due to oscBP), measuring range: 50 to 250mmHg<br>The inaccurateness of the ICG signal can raise under following conditions:<br>* sepsis<br>* severe heart insufficiency<br>* aortic valve insufficiency<br>* aortic valve stenosis<br>*patient movement artefacts | ICG measuring current: 2.5mA rms, 70kHz, no further information available; ECG sampling frequency: 1000Hz (in Europe)<br>The device does not accommodate patients who:<br>* weight more than 340 lb. (164 kg)<br>* weight less than 60 lb. (27.3 kg)<br>* have mean arterial pressure greater than 130mmHg<br>* have late sepsis (e.g., stage 3 and 4)<br>* have aortic insufficiency | BP measuring range: 20 to 260mmHg, measuring accuracy: pressure transducer Linearity: + 2mmHg to -4.5mmHg (+ 0.25kPa to - 0.55kPa<br>Heart rate measuring range: 12 to 175bpm, measuring accuracy: ± 5bpm or ± 5% of reading, whichever is higher |
| Table | | | | |
| | Task Force Monitor 3040 (new)…