(204 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the software as including "algorithms" for basic physiological calculations, not advanced AI/ML techniques.
No
The device is described as a monitoring system that collects physiological data to aid in diagnosis and treatment, not to provide therapy itself.
Yes
Explanation: The "Intended Use / Indications for Use" section states, "Data from the Dyna-Vision™ system is intended to be used by healthcare professionals as an aid to diagnosis and treatment." This explicitly indicates its role in the diagnostic process.
No
The device description explicitly states the system consists of a "body-worn unit with sensor input modules" and a "telemetry server," which are hardware components. It also mentions working with 3rd party 510(k) cleared hardware like an SpO2 module and ECG patient lead.
Based on the provided information, the Dyna-Vision Telemontoring System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Dyna-Vision's Function: The Dyna-Vision system directly monitors physiological data from the patient's body (ECG, heart rate, SpO2, temperature, respiration effort) using external sensors. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "continuous collection of physiological data" and the data is used as an "aid to diagnosis and treatment" by healthcare professionals. This aligns with the function of a patient monitor, not an IVD.
Therefore, the Dyna-Vision Telemontoring System falls under the category of a patient monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Dyna-Vision Telemontoring System is a wreless monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings and for normal daily activities. Physiological data recorded include: Electrocardiography (EGG), Heart Rate variability (R-R interval), Peripheral capillary Oxygen saturation (SpO2), Skin Temperature and respiration effort Data is transmitted wirelessly in near real time to a central location where it is stored for analysis. The Dyna-Vision™ system can be configured by Authorized Persons to notify healthcare professionals when physiological data falls outside selected parameters. Data from the Dyna-Vision™ system is intended to be used by healthcare professionals as an aid to diagnosis and treatment.
The device is intended for use on general care patients aged 18 years or more, as a general patient monitor, to provide physiological information. It is not intended for use on critical care patients.
Product codes (comma separated list FDA assigned to the subject device)
MHX, MWI, DRG, DSI, DRT, FLL, DQA
Device Description
The Dyna-Vision system is a wireless multi-parameter data collection systems that monitors physiological data such as: Electrocardiography (EGG), Heart Rate, Heart Rate variability (R-R interval), Peripheral capillary Oxygen saturation (SpO2), Skin Temperature and Rate of respiratory effort.
The system consist of:
- A body-worn unit with sensor input modules for the near real time acquisition of the physiological data with built-in wireless
- communication for data transmission.
- A telemetry server to receive the physiological data and transmit the physiological data to
- A workstation installed on a central server (or PC) equipped with software with which the physician can process the physiological data and create reports regarding the transmitted data, and read and configure alerts/notifications when a threshold value is exceeded. The alert function is an adjunct to and not intended to replace vital sign monitoring.
The software includes algorithms for Heart Rate, Heart Rate variability (R-R interval) and rate of respiratory effort.
The device is intended to be used by clinicians and medically qualified personnel in healthcare facilities. The body-worn unit for data acquisition, is a transportable battery-operated unit to record Electrocardiograph (ECG), Heart Rate variability (R-R interval), Peripheral capillary Oxygen saturation (SpO2), Skin Temperature and Rate of respiratory effort to be also used by the patient in the home setting and anywhere where WIFI or cell communication is available.
The Dyna-Vision system works with 3rd party 510(k) cleared SpO2 module (Nonin OEM III, K092101), and ECG patient lead (Scottcare K092947).
The device is intended for use on general care patients aged 18 years or more.
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
18 years or more
Intended User / Care Setting
healthcare professionals for continuous collection of physiological data in home and healthcare settings
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)
No clinical studies were utilized for the purpose of obtaining safety and Clinical Performance effectiveness data. Usability validation is part of the Clinical Performance Data: data.
Bench testing was carried out on the following characteristics: Non-Clinical Tests:
- Electrocardiograph (EGG)
- Heart rate variability (R-R interval)
- . Heart rate
- SpO2
- Skin Temperature
- ECG impedance for Rate of respiratory effort
- . Notification
- . Measurement accuracy
- . Communication, data transmission and storage
- Reliability (QoS) Wireless Quality of Service
- Electromagnetic compatibility (EMC)
- . Electrical safety testing
- Wireless Coexistence Wi-Fi testing
- Software verification and validation testing
- . Biocompatibility verification
In addition to the above, usability testing was also conducted.
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.
Vitalconnect platform, K 141167, TeleSentry Wireless Ambulatory ECO Arrhythmia Monitor, K092947, Model 7500 Digital Pulse Oximeter, K080255, Disposable Temperature Probes, K070339, Propaq CS, K012451
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.
Not Found
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
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads facing right, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 29, 2016
Techmedic Development International B.V. % Patsy Trisler Regulatory Consultant, Oserve Group, Inc Qserve Group Us Inc. P.O Box 940 Charlestown. New Hampshire 03603
Re: K152973
Trade/Device Name: Dyna-Vision Telemonitoring System Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector And Alarm (Including ST-Segment Measurement And Alarm) Regulatory Class: Class II Product Code: MHX, MWI, DRG, DSI, DRT, FLL, DQA Dated: March 22, 2016 Received: March 29, 2016
Dear Patsy Trisler:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mitchell Stein
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K152973
Device Name Dyna-Vision Telemonitoring System
Indications for Use (Describe)
The Dyna-Vision Telemontoring System is a wreless monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings and for normal daily activities. Physiological
data recorded include: Electrocardiography (EGG), Heart Rate variability (R-R interval), Peripheral capillary Oxygen saturation (SpO2), Skin Temperature and respiration effort Data is transmitted wirelessly in near real time to a central location where it is stored for analysis. The Dyna-Vision™
system can be configured by Authorized Persons to notify healthcare professionals when physiological data falls outside selected parameters. Data from the Dyna-Vision™ system is intended to be used by healthcare professionals as an aid to diagnosis and treatment.
The device is intended for use on general care patients aged 18 years or more, as a general patient monitor, to provide physiological information. It is not intended for use on critical care patients.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
| Submitter Name: | Techmedic Development International B.V. |
|---|---|
| Submitter Address: | Broeker Werf 6 |
| 1721 PC Broek op Langedijk | |
| Netherlands | |
| Phone Number: | +31(0)226 342044 |
| Fax Number: | +31(0)226 341446 |
| Contact Person: | Rutger Brest van Kempen |
| Date Prepared: | 22-08-2015 |
| Device Trade Name: | Dyna-Vision |
| Common Name | Patient Telemonitoring Sytem |
| Classification Name, | |
| Number & | |
| Product Code: | Monitor, physiological, patient (with arrhythmia detection or alarms) |
| 870.1025 (ΜΗΧ); | |
| Transmitters and Receivers, Physiological Signal, Radiofrequency | |
| 870.2910 (DRG) | |
| Monitor, Cardiac (including cardiotachometer and rate alarm, 870.2300 | |
| (DRT); | |
| Thermometer, electronic, clinical, 880.2910 (FLL); and | |
| Oximeter, 870.2700 (DQA) | |
| Classification Panel: | Cardiology |
| Predicate Devices: | Vitalconnect platform, K 141167 |
| TeleSentry Wireless Ambulatory ECO Arrhythmia Monitor, K092947 | |
| Model 7500 Digital Pulse Oximeter, K080255 | |
| Disposable Temperature Probes, K070339 | |
| Propaq CS, K012451 | |
| Device Description: | The Dyna-Vision system is a wireless multi-parameter data collection |
| systems that monitors physiological data such as: Electrocardiography | |
| (EGG), Heart Rate, Heart Rate variability (R-R interval), Peripheral | |
| capillary Oxygen saturation (SpO2), Skin Temperature and Rate of | |
| respiratory effort. | |
| The system consist of: | |
| • A body-worn unit with sensor input modules for the near real | |
| time acquisition of the physiological data with built-in wireless |
.
4
| communication for data transmission.A telemetry server to receive the physiological data and transmit the physiological data toA workstation installed on a central server (or PC) equipped with software with which the physician can process the physiological data and create reports regarding the transmitted data, and read and configure alerts/notifications when a threshold value is exceeded. The alert function is an adjunct to and not intended to replace vital sign monitoring. | |
|---|---|
| The software includes algorithms for Heart Rate, Heart Rate variability (R-R interval) and rate of respiratory effort. | |
| The device is intended to be used by clinicians and medically qualified personnel in healthcare facilities. The body-worn unit for data acquisition, is a transportable battery-operated unit to record Electrocardiograph (ECG), Heart Rate variability (R-R interval), Peripheral capillary Oxygen saturation (SpO2), Skin Temperature and Rate of respiratory effort to be also used by the patient in the home setting and anywhere where WIFI or cell communication is available. | |
| The Dyna-Vision system works with 3rd party 510(k) cleared SpO2 module (Nonin OEM III, K092101), and ECG patient lead (Scottcare K092947). | |
| The device is intended for use on general care patients aged 18 years or more. | |
| Physical Description: | Dyna-Vision Unit dimensions: 118 x 65 x 33 mm, Weight +/- 260 gram, Power Internal battery 3.7 V |
| Statement of Indication for Use: | The Dyna-Vision Telemonitoring System is a wireless monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings and for normal daily activities. Physiological data recorded include: Electrocardiography (EGG), Heart Rate, Heart Rate variability (R-R interval), Peripheral capillary Oxygen saturation (SpO2), Skin Temperature and respiration effort. |
| Data is transmitted wirelessly in near real time to a central location where it is stored for analysis. The Dyna-Vision™ system can be configured by Authorized Persons to notify healthcare professionals when physiological data falls outside selected parameters. Data from the Dyna-Vision™ system is intended to be used by healthcare professionals as an aid to diagnosis and treatment. | |
| The device is intended for use on general care patients aged 18 years or more, as a general patient monitor, to provide physiological information. It is not intended for use on critical care patients. | |
| Summary of Technological Characteristics | The Dyna-Vision system offers near real time full-disclosure streaming ECG/SpO2/temperature from anywhere using the cellular network and a telemetry service offering tele-monitoring solutions to remote locations. The Dyna-Vision unit is connected to a patient and switched on. The device automatically connects to the local cellular network to send the |
II
5
data in near real time to the Dyna-Vision Server from where it can be retrieved using the Dyna-Vision software on a workstation. The collected data can be reviewed and reports can be created for sending to a cardiologist or family physician.
Bench testing was carried out on the following characteristics: Non-Clinical Tests:
- Electrocardiograph (EGG) ●
- Heart rate variability (R-R interval)
- . Heart rate
- SpO2 ●
- Skin Temperature ●
- ECG impedance for Rate of respiratory effort ●
- . Notification
- . Measurement accuracy
- . Communication, data transmission and storage
- Reliability (QoS) Wireless Quality of Service
- Electromagnetic compatibility (EMC)
- . Electrical safety testing
- Wireless Coexistence Wi-Fi testing
- Software verification and validation testing ●
- . Biocompatibility verification
In addition to the above, usability testing was also conducted.
Referenced Standards and Performance Testing:
The Dyna-Vision device was tested and meets the requirements of following performance Standards and is in accordance with FDA Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm.
- IEC 60601-1- Medical Electrical Equipment Part 1: Basic safety ● and essential performance Ed3.1 2005+A1:2012
- . IEC 60601-1-2 - Medical electrical equipment-basic safety and essential performance-EMC-Edition 3: 2007-03
- . IEC 60601-1-11 - Medical electrical equipment-basic safety and essential performance-used in the home healthcare-Ed. 1: 2010-04
- IEC 60601-2-47 - Basic safety and essential performance of ambulatory electrocardiographic systems 2012
- . AAM1/ANSI EC38
- . AAMI I ANSI EC57 - Testing and reporting performance results of cardiac rhythm and st-segment measurement algorithms 2012
- . ISO 80601-2-61 - Basic safety and essential performance of pulse oximeter equipment 2011
- IEC 80601-2-59 Basic safety and essential performance of screening thermographs for human febrile temperature screening 2008
No clinical studies were utilized for the purpose of obtaining safety and Clinical Performance effectiveness data. Usability validation is part of the Clinical Performance Data: data.
6
The comparison tabulated below demonstrates that the Dyna-Vision Conclusion device is substantially equivalent to the predicate devices. The nonclinical data support the safety of the device and the hardware and software verification and validation demonstrate that the Dyna-Vision device should perform as intended in the specified use conditions.
7
Substantial Equivalence Comparison Table
| Feature | Dyna-Vision | Predicate #1
(Indications for
Use/Technology) | Predicate #2
(Technology) | Predicate #3
(Add on) | Predicate #4
(Add on) | Predicate #5
(Add on) | |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K # | K 141167 | K092947 | K080255 | K070339 | K012451 | |
| Trade name | Dyna-Vision
Telemonitoring
System | VitalConnect Platform, | TeleSentry Wireless
Ambulatory ECO
Arrhythmia Monitor, | Model 7500 Digital
Pulse Oximeter | Disposable
Temperature Probes
& Skin Temperature
Sensor | Propaq 200 Series
Monitors | |
| Manufacturer | Techmedic
Development
International BV | VitalConnect Inc | Scottcare Inc | Nonin Medical Inc | Cincinnati Sub-Zero
Products Inc | Welch Allyn protocol,
inc. | |
| Device
description
summary | Dyna-Vision
Telemonitoring
System relies on an
ambulant, wireless
device, which uses
sensors to collect,
transmit and
remotely assess
ECG and
physiological
parameters in near
real time. The
system includes
alerts triggered by
parameters
exceeding preset
limits. | The VitalConnect
Platform is a wireless
data collection system
that monitors
physiological data.
The VitalConnect
Platform and the
predicate device
contains small
ambulatory monitoring
sensors that measure
ECG, heart rate,
respiration rate,
activity, body
orientation, body/skin
temperature. | TeleSentry is a
battery powered
ambulatory ECG
monitor, which
analyzes an
electrocardiographic
signal. | The Nonin® Model
7500 Digital Pulse
Oximeter is a
portable, table top
device indicated for
use in measuring,
displaying, and
recording functional
oxygen saturation of
arterial hemoglobin
(SPO2) and pulse
rate of adult,
pediatric, infant, and
neonatal patients. | To detect
hypo/hyperthermia,
the body temperature
is continuously
monitored using
disposable
temperature sensors
or probes. The basic
component of these
sensors is a
resistance chip,
which is sensitive to
changes in
temperature. The
chip is in the form of
"400" series
thermistor connected
to a lead wire and
encapsulated in a
PVC cup. At the end
of the lead wires an
insert molded
connector or
standard phone
connector provides
for the | The Propaq 200 Series
monitors are small,
lightweight, portable,
multi-parameter patient
monitors equipped with
either a monochrome
or color display. The
monitors provide real
time monitoring and
display of ECG,
respiration, invasive
blood pressure, non-
invasive blood
pressure, temperature,
CO2 and SpO2. | |
| | Regulation &
Product Code | 21 CFR 870.2910,
DRG
Transmitters and
Receivers,
Physiological Signal,
Radiofrequency | 21 CFR 870.1025,
DSI
Arrhythmia detector
and alarm (including
ST-segment
measurement and
alarm).
DRG
Transmitters and
Receivers,
Physiological Signal,
Radiofrequency | 21 CFR 870.2700,
DQA
Oximeter | interconnection with
the instrument cable. | 21 CFR 880.2910,
FLL
Clinical electronic
thermometer | 21 CFR 870.2300,
DRT
Monitor, cardiac (incl.
cardiotachometer &
rate alarm) |
| Intended Use | The Dyna-Vision
Telemonitoring
System is a wireless
monitoring system
intended for use by
healthcare
professionals for
continuous collection
of physiological data
in home and
healthcare settings
and for normal daily
activities.
Physiological data
recorded include:
Electrocardiography
(EGG), Heart Rate,
Heart Rate variability
(R-R interval) | 21 CFR 870.2910,
DRG
21 CFR 880.2910,
FLL
21 CFR 870.1025,
MHX
21 CFR 870.2300,
DRT
21 CFR 870.2700,
DQA | 21 CFR 870.1025,
DSI
Arrhythmia detection
and alarm (including
ST-segment
measurement and
alarm)
MHX
Monitor, physiological,
patient (with
arrhythmia detection
or alarm) | The TeleSentry
device is intended for
diagnostic evaluation
of patients who
experience transient
symptoms or
asymptomatic events
that may suggest
non-lethal cardiac
arrhythmia. The
device continuously
monitors and records
the data,
automatically records
alarm events
triggered by an
arrhythmia detection
algorithm or manually
by the patient and | The Nonin® Model
7500 Digital Pulse
Oximeter is a
portable,
for Use tabletop
device indicated for
use in measuring,
displaying, and
recording functional
oxygen saturation of
arterial hemoglobin
(SpO2) and pulse
rate of adult,
pediatric, infant, and
neonatal
patients. It is
indicated for spot-
checking and / or
continuous | Skin Temperature
Sensor (487M and
499B): The CSZ skin
temperature sensor is
intended for
use in routine
continuous
monitoring skin
temperature when
the other sensors
which might better
reflect core body
temperature are not
indicated clinically.
The sensor is
designed for
placement on the
surface of the skin. | The Propaq monitor is
intended to be used by
skilled clinicians for
multiparameter vital
signs monitoring of
neonatal, pediatric, and
adult patients in health
care facility bedside
applications. It is also
intended for intra-
facility transport.
The ECG channel is
intended for five-lead
or three-lead ECG
monitoring.
The Respiration
(RESP) channel is |
8
9
| Peripheral capillary
Oxygen saturation
(SpO2), Skin
Temperature and
respiration effort. | to gravity including
fall). | automatically
transmits the
recorded event
activity associated
with these symptoms
for review by a
licensed physician. | monitoring of patients
during both motion
and non-motion
conditions, and for
patients who are well
or poorly perfused. | Instrument Cables
(4872MS and
4900B): The intended
use of the instrument
cable is to
interconnect the
disposable
temperature
sensor/probe with the
temperature
monitoring
instrument. | intended to detect the
rate or absence of
respiratory effort,
deriving the signal by
measuring the ac
impedance between
selected terminals of
ECG electrodes. |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Data is transmitted
wirelessly in near
real time to a central
location where it is
stored for analysis.
The Dyna-Vision™
system can be
configured by
Authorized Persons
to notify healthcare
professionals when
physiological data
falls outside selected
parameters. Data
from the Dyna-
Vision™ system is
intended to be used
by healthcare
professionals as an
aid to diagnosis and
treatment.
The device is
intended for use on
general care patients
aged 18 years or
more, as a general
patient monitor, to
provide physiological
information. It is not
intended for use on
critical care patients. | Data is transmitted
wirelessly to a central
location where it is
stored for analysis.
The Vital Connect
Platform can be
configured by
Authorized Persons
to notify healthcare
professionals when
physiological data falls
outside selected
parameters.
The device is intended
for use on general
care patients who are
18 years of age or
older as a general
patient monitor, to
provide physiological
information.
The data from the
VitalConnect Platform
is intended for use by
healthcare
professionals as an
aid to diagnosis and
treatment. It is not
intended for use on
critical care patients. | Contraindications:
a. Patients with
potentially life-
threatening
arrhythmias who
require inpatient
monitoring.
b. Patients who the
attending physician
thinks should be
hospitalized. | | | |
| General specifications | | | | | |
10
| Dimensions | 118 x 65 x 33 mm | 115 x 40 x 7 mm
(sensor + patch
without transmitter) | 110 x 6 x 2.6 | Approximately 219
mm x 92 x 142 mm | N/A | N/A |
|---------------------------------------------------------------------|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------|--------------------------------------------------------|--------------------------------------------------------------------|
| Weight | 260 gram with
battery | --- | 280 gram with battery | Approximately
900grams (2 lbs) with
battery | N/A | N/A |
| Interface | Foil with buttons and
LCD display | --- | Foil with buttons, no
display | --- | N/A | Foil with buttons and
LCD display |
| Energy source | Battery | Battery | Battery | N/A | N/A | Battery/Mains |
| Type | 3.7V lithium polymer
rechargeable | Disposable zinc air
battery | 3.7V lithium polymer
rechargeable | 7.2 volt NiMH battery
pack | N/A | N/A |
| Autonomy on
single charge | 22 hrs 3G streaming
36 hrs Wi-Fi
streaming | 3 days with ECG and
4 days without ECG
for the patch. No
information about the
transmitter autonomy | 2-3 days without
streaming. 6 hours
with streaming | 16 hours minimum | N/A | N/A |
| Communication | | | | | | |
| Wi-Fi | Yes
2,4 GHz | Bluetooth | No | N/A | N/A | N/A |
| Cellular | Yes
3G module | N/A | Yes
2G module | N/A | N/A | N/A |
| USB | Yes
2.0 | No | Yes | N/A | N/A | N/A |
| Memory | Yes
4 GB SD card | --- | Yes
4 GB SD card | N/A | N/A | N/A |
| Recording period | 60 days | --- | 60 days | N/A | N/A | N/A |
| Central
monitoring of
remotely
transmitted
patient data | Yes | Yes | Yes | N/A | N/A | Yes |
| Data sent to
central server | Yes | Yes | Yes | N/A | N/A | Yes |
| Physiological parameters | | | | | | |
| PROGRAMMAB
LE ALERT
SETTINGS AND
LIMITS | Yes | Yes | Yes | N/A | N/A | Yes |
| MONITORS
ECG | Yes | Yes | Yes | N/A | N/A | Yes |
| Method | ECG lead wires
attached to
disposable
electrodes to the skin | Patch on the skin to
measure single lead
ECG. | ECG lead wires
attached to
disposable electrodes
to the skin | N/A | N/A | ECG lead wires
attached to disposable
electrodes to the skin |
| Resolution | 24 bit | --- | 12 bit | N/A | N/A | N/A |
| Input impedance | > 20 Mohm | --- | > 20 Mohm | N/A | N/A | N/A |
| Common mode
rejection | -80dB - 100dB | --- | 92 dB | N/A | N/A | N/A |
| Sampling
frequency | 1,000, 800, 400 and
200 Hz | --- | 1,000, 200, 100 | N/A | N/A | N/A |
| Channels | 3, 5 and 12 channels | 1 channel | 3, 5 and 12 channels | N/A | N/A | N/A |
| QRS detection
AF detection | Yes - 99.8% | --- | Yes > 99% | N/A | N/A | N/A |
| MONITORS
HEART RATE | Yes | Yes | Yes | N/A | N/A | Yes |
| Method | QRS detection | QRS detection | QRS detection | N/A | N/A | QRS detection |
| Range | 25-300 bpm | Not specified | Not specified | N/A | N/A | 25-300 bpm |
| Accuracy | ± 2 bpm | ± 2 bpm | ± 2 bpm | N/A | N/A | ± 2 bpm |
| MONITORS
RESPIRATION | Yes | Yes | No | N/A | N/A | Yes |
| Method | Impedancy
Pneumography | … | N/A | N/A | N/A | Impedance
Pneumography |
| Impedance
dynamic range | >20 ohms | … | N/A | N/A | N/A | 20 ohms |
| Resolution | 5 seconds | … | N/A | N/A | N/A | 5 seconds |
| Range | 2 - 150 breaths/min | … | N/A | N/A | N/A | 2 to 150 breaths/min |
| MONITORS
SKIN
TEMPERATUR
E | Yes | Yes | No | N/A | Yes | Yes |
| Method | Skin thermistor | … | N/A | N/A | Skin thermistor | NA |
| Range | 0° to +50 | … | N/A | N/A | 0° to +50 | NA |
| Accuracy | >10°C to +50°C:
±0.1°C
50° to +122°F:
±0.2°F | … | N/A | N/A | >10°C to +50°C:
±0.1°C
50° to +122°F:
±0.2°F | NA |
| MONITORS
OXYGEN
SATURATION | Yes | No | No | Yes | N/A | Yes |
| Method | Photoplethysmogram
on finger.
Infrared: 910
nanometers @ 1.2
mW maximum
average | N/A | N/A | Photoplethysmogram
on finger.
Infrared: 910
nanometers @ 1.2
mW maximum
average | N/A | NA |
| | | | | | | |
| | Red: 660
nanometers @ 0.8
mW maximum
average | | | Red: 660 nanometers
@ 0.8 mW maximum
average | | |
| Range | 0-100% | N/A | N/A | 0-100% | N/A | NA |
| Accuracy | $\pm$ 2 digits
(from 70-100%) | N/A | N/A | $\pm$ 2 digits
(from 70-100%) | N/A | NA |
| USE IN HOME
AND
HEALTHCARE
SETTINGS | Yes | Yes | Yes/No (not exactly
specified) | Yes | N/A | Healthcare settings |
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