(58 days)
No
The document describes standard signal processing and calculation of hemodynamic parameters based on established methods (ICG, ECG, photoplethysmography, oscillometric BP). There is no mention of AI, ML, or any learning algorithms. The device architecture and calculations are stated to be equivalent to the predicate device, which is a traditional medical device.
No.
The intended use explicitly states that the device is a "diagnosis aiding device" and "not designed for vital sign monitoring or self-monitoring of patients," which suggests it assists in diagnosis rather than directly treating or preventing a disease.
No
The device is described as a "diagnoses aiding device" that "continuously monitors the subject's hemodynamic parameters without reporting any diagnosis." It is explicitly stated that it is "not designed for vital sign monitoring or self-monitoring of patients."
No
The device description explicitly states the system consists of a Patient Biosignal Electronic System (PBES) and a PC, and mentions assessing ICG signals using electrodes, indicating hardware components beyond just software.
Based on the provided information, the Task Force® Monitor 3040 (TFM) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- TFM's Function: The TFM measures physiological parameters directly from the patient's body using non-invasive methods (ICG, ECG, photoplethysmography, oscillometric and continuous blood pressure). It does not analyze samples taken from the body.
- Intended Use: The intended use explicitly states it "noninvasively measure and display a patient's hemodynamic parameters." It also clarifies it's a "diagnoses aiding device" and "not designed for vital sign monitoring or self-monitoring of patients." This aligns with a device that provides physiological data for a medical professional to interpret, rather than performing a diagnostic test on a sample.
Therefore, the TFM falls under the category of a physiological monitoring device or a diagnostic aid that uses non-invasive methods, not an IVD.
N/A
Intended Use / Indications for Use
The Task Force® Monitor 3040 (TFM) is intended to noninvasively measure and display a patient's hemodynamic parameters using Impedaace Cardiography (ICG), Electrocaphy (BCG), (The Marce parameters using Impelane Cardingson (ICC), photocores (continental), 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.
Product codes (comma separated list FDA assigned to the subject device)
DSB
Device Description
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The device is for use in the hospital, out-patient and clinical setting.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.2770 Impedance plethysmograph.
(a)
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.(b)
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.
0
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.
1
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 (301) 591 1010. Finance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
2
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
3
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)
Image /page/3/Picture/15 description: The image contains a handwritten text that appears to be "UB". The letters are written in a simple, slightly slanted style. The "U" is on the left, and the "B" is on the right, with the two letters connected.
4
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: office@cnsystems.at
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).
5
CNSystems
The Brain & Heart Company
CNSystems Medizintechnik GmbH
Europe, Austria, 8020 Graz
Baumkircherstria, 8020 Graz
Tel.: +43/315/77 234566-0 Fax: -2
Email: office@cnsystems.at
ubstantial Equivalenc
| ು |
|---|
| I |
| रे |
| 6 |
| Attribute | Task Force Monitor 3040 (new) | BioZ.PC (Predicate) | Ohmeda 2350 Finapres (Predicate) | |
|---|---|---|---|---|
| Manufacturer | CNSystems Medizintechnik GmbH | |||
| Baumkircherstrasse 1 | ||||
| A - 8020 Graz, Austria | CardioDynamics International Corp. | |||
| 6175 Nancy Ridge Drive | ||||
| San Diego, CA 92121, USA | Ohmeda Medical | |||
| 355 Inverness Dr. South | ||||
| Englewood, CO 80112 5810, USA | ||||
| 510(k) number | none | K001081 | K880572 | |
| Indication for use | The TFM has the same intended use/indi- | |||
| cations for use as the BioZ.PC device. | ||||
| Additionally it combines the ICG method | ||||
| and the continuous blood pressure method | ||||
| of the Finapres device. | The device is for use in the hospital, out- | |||
| patient and clinical setting. The BioZ.PC | ||||
| is to noninvasively measure a patient's | ||||
| hemodynamic parameters using Imped- | ||||
| ance Cardiography (ICG). Monitoring is | ||||
| accomplished by attaching 8 electrodes to | ||||
| the patient, injecting a minimal current | ||||
| through the upper electrodes, and reading | ||||
| the returning voltage waveform from the | ||||
| inner electrodes. Each measurement has | ||||
| to be supervised by a medical profes- | ||||
| sional. | The Finapres device is to noninvasively | |||
| and continuously measure a patient's arte- | ||||
| rial blood pressure using the photopl- | ||||
| ethysmographic method first described by | ||||
| Penaz. The device uses a finger cuff for | ||||
| systolic and diastolic blood pressure mea- | ||||
| surement and calculates also mean arterial | ||||
| 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. |
6
/ CNSystems
The Brain & Heart Company
CNSystems Medizintechnik GmbH
Europe, Austria, 8020 Graz
Baumkircherstria, 8020 Graz
Tel.: +43/316/77 234566-0 Fax: -2
Email: +43//316/77 234566-07 2ystems.at
7
| | CNSystems Medizintechnik GmbH
Europe, Austria, 8020 Graz
Baumkircherstrasse 1
Tel.: +43/316/7 23456-0, Fax: -2
Email: office@cnsystems.at | | | | | |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| | Table | | | | | |
| CNSystems
The Brain & Heart Company | Attribute | Task Force Monitor 3040 (new) | A difference between the TFM and the
BioZ.pc is the blood pressure measure-
ment. The predicate device uses manual
user input of blood pressure values or
optional an oscillometric BP measure-
ment. The interval of measurement can be
set by the user. The TFM system includes
the continuous blood pressure method of
the Finapres device for assessing online
and real-time blood pressure values. | BioZ.PC (Predicate) | Monitoring is accomplished by attaching
8 electrodes to the patient, injecting a
minimal current through the upper elec-
trodes, and reading the return voltage
waveform from the inner electrodes.
The device calculates and displays 12
hemodynamic parameters including
Stroke Volume (SV), Cardiac Output
(CO), System Vascular resistance, Veloc-
ity Index (VI), Thoracic Fluid Content
(TFC), Systolic Time Ratio, Left Ventric-
ular Ejection Time (LVET), Pre-Ejection
Period (PEP), Left Cardiac Work/Index
(LCWI), Heart rate (HR), Systolic and
Diastolic Blood Pressure (SBP, DBP).
Each PC provided will be fully tested
with its BioZ.pc device prior to shipment. | Ohmeda 2350 Finapres
(Predicate) |
ન્ડ 7
8
| 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. | ||||
| 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 | ||||
| Europe, Austria, 8020 Graz | ||||
| Baumkircherstrasse 1 | ||||
| Tel.: +43/316/7 23456-0, Fax: -2 | ||||
| Email: office@cnsystems.at | ||||
| Table | ||||
| CNSystems | ||||
| 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 | |||
| ECG measuring range ±5mV, indication range 30 - 150 beats/min, sampling frequency: 1000Hz (Europe), 1200Hz (USA) | ||||
| oscillometric BP measuring accuracy: ±5mmHg, measuring range: 50 to 250mmHg | ||||
| continuous BP measuring accuracy: ±5mmHg (due to oscBP), measuring range: 50 to 250mmHg | ||||
| The inaccurateness of the ICG signal can raise under following conditions: |
- sepsis
- severe heart insufficiency
- aortic valve insufficiency
- aortic valve stenosis
*patient movement artefacts | ICG measuring current: 2.5mA rms, 70kHz, no further information available; ECG sampling frequency: 1000Hz (in Europe)
The device does not accommodate patients who: - weight more than 340 lb. (164 kg)
- weight less than 60 lb. (27.3 kg)
- have mean arterial pressure greater than 130mmHg
- have late sepsis (e.g., stage 3 and 4)
- have aortic insufficiency | BP measuring range: 20 to 260mmHg, measuring accuracy: pressure transducer Linearity: + 2mmHg to -4.5mmHg (+ 0.25kPa to - 0.55kPa
Heart rate measuring range: 12 to 175bpm, measuring accuracy: ± 5bpm or ± 5% of reading, whichever is higher |
| Table | | | | |
| | Task Force Monitor 3040 (new) | BioZ.PC (Predicate) | Ohmeda 2350 Finapres (Predicate) | |
| Attribute | The inaccurateness of the oscillometric
blood pressure signal can raise under fol-
lowing conditions: - weak pulses
- irregular pulses
- patient movement artefacts
- tremor artefacts
- respiratory artefacts
- gravel road artefacts
The device does accommodate patients
within the following limits:
- weight: 66.14 - 440.9 lbs (30 - 200 kg)
- height: 1.64 - 8.20 feet (50 - 250 cm) | | | |
| Power Consumption | 115V version
nominal voltage: 115V / 60Hz
power consumption: 240mA, 25W
230V version
nominal voltage: 230V / 50Hz
power consumption: 120mA, 25W | 115V / 60Hz
230V / 50Hz | 115V version
nominal voltage: 115V / 60Hz
power consumption: 1,5A
230V version
nominal voltage: 230V / 50Hz
power consumption: 0,75A | |
.
:
9
CNSystems
The Brain & Heart Company 3
CNSystems Medizintechnik GmbH
Europe, Austria, 8020 Graz
Baumkircherstria, 8020 Graz
Tel.: +43/315/77 234565-0 Frax: -2
Email: +43/315/77 234565-0 Frax: -22
Email: office@cns
10
U60
11
u (a t
12
| Attribute | Task Force Monitor 3040 (new) | BioZ.PC (Predicate) | Ohmeda 2350 Finapres (Predicate) |
|---|---|---|---|
| Dimensions / weight | Main monitor | ||
| (height x width x depth) | |||
| 4.13in x 18.31in x 11.42in | |||
| (10.5cm x 46.5 cm x 29cm) |
Continuous device
(height x width x depth)
1.38in x 3.31in x 6.46in
(3.5cm x 8.4cm x 16.4cm)
Oscillometric device
(height x width x depth)
1.38in x 3.15in x 5.12in
(3.5cm x 8cm x 13cm)
Weight (including all TFM devices and
cables without PC and screen:
15.4 lbs (7 kg) | Dimensions
(width x height x depth)
14.0in x 12.1in x 7.0in
(35.6cm x 30.8cm x 17.8cm)
weight: 12 lbs (5.5kg) | Monitor unit
(height x width x depth)
6.1in x 11.8in x 16.7in
(15.5cm x 30cm x 42.5cm)
Patient Interface Module
1.63in x 2.75in x 3.9in
(4.14vm x 6.98cm x 9.9cm)
Weight: 26.2 lbs (11.9 kg) |
| | | | |
| Attribute | Task Force Monitor 3040 (new) | BioZ.PC (Predicate) | Ohmeda 2350 Finapres (Predicate) |
| Materials / Accessory | Patient cables: 8.2 ft. (2.5 m)
Electrodes: all disposable electrodes are for single use, tested and certified according to ISO 10993-1
ICG: 4 electrodes
- Polyethylene foam plastic with a medical adhesive made of polyacrylate
- composite film made of 38µm polyester film and 12µm aluminium film
- the electro conductive adhesive consists of polyacrylate, polyole, water and electrolyte
*the electrodes are latex free and PVC free
ECG: 4 electrodes
(510(k) number: K853939)
*polyethylene foam plastic, 1mm with a medical adhesive made of polyacrylate - sensor system: the stud (upper part) is made of stainless steel, the eyelet (lower part) is made of ABC plastics with 0,0025mm Ag/AgCl-coating
- a quick-recovery conductive gel containing 3% KCl
- a little sponge drenched in gel | Patient cable: 10ft (3m)
Electrodes: Four Pre-Gelled, Disposable Dual Sensors | Patient cable: 16ft (5m)
Finger cuff: plastic material |
| | Task Force Monitor 3040 (new) | BioZ.PC (Predicate) | Ohmeda 2350 Finapres (Predicate) |
| Attribute | * a label made of polyethylene - the cover foil is made of polyethylene, 40 - 70µm
- the cover for the sponge is made of polyethylene
The ECG electrodes are latex free. | | |
| | Finger cuff and fixing cuffs:
The fabric is tested according to ISO 10993 and is used by Borch Textile Group for their Surgical Gowns (FDA 510(k): K954674).
Oscillometric cuff: The TFM uses BP cuffs from Rudolf Riester GmbH & Co. KG, Jungingen, Germany. These cuffs are generally used by Riester BP devices (for example K002954) | | |
| | Table | | |
| Attribute | Task Force Monitor 3040 (new) | BioZ.PC (Predicate) | Ohmeda 2350 Finapres (Predicate) |
| Standards | * IEC 60601-1, Medical electrical equipment, General requirements for safety
- IEC 60601-1-1, 1. Collateral Standard: Safety requirements
- IEC 60601-1-2, 2. Collateral Standard: Electromagnetic compatibility - Requirements and tests
- IEC 60601-1-4, 4. Collateral Standard: Programmable electrical medical systems
- IEC60601-2-25, Part 2: Particular requirements for the safety of electrocardiographs
- IEC 60601-2-30, Part 2: Particular requirements for the safety of automatic cycling indirect blood pressure monitoring equipment.
- EN 1060-1, Non-invasive sphygmomanometers - Part 1: General requirements
- EN 1060-3, Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems
- ANSI/AAMI SP 10, Electronic or automated sphygmomanometers
- ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and | * IEC 601-1
- UL2601
- CSA 622.2 | |
Chapter 6: Page 10 (13)
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Chapter 6: Page 13 (13)