Dyna-Vision Telemonitoring System

{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) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(k) Summary | Submitter Name: | Techmedic Development International B.V. | |---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter Address: | Broeker Werf 6<br>1721 PC Broek op Langedijk<br>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,<br>Number &<br>Product Code: | Monitor, physiological, patient (with arrhythmia detection or alarms)<br>870.1025 (ΜΗΧ);<br>Transmitters and Receivers, Physiological Signal, Radiofrequency<br>870.2910 (DRG)<br>Monitor, Cardiac (including cardiotachometer and rate alarm, 870.2300<br>(DRT);<br>Thermometer, electronic, clinical, 880.2910 (FLL); and<br>Oximeter, 870.2700 (DQA) | | Classification Panel: | Cardiology | | Predicate Devices: | Vitalconnect platform, K 141167<br>TeleSentry Wireless Ambulatory ECO Arrhythmia Monitor, K092947<br>Model 7500 Digital Pulse Oximeter, K080255<br>Disposable Temperature Probes, K070339<br>Propaq CS, K012451 | | Device Description: | The Dyna-Vision system is a wireless multi-parameter data collection<br>systems that monitors physiological data such as: Electrocardiography<br>(EGG), Heart Rate, Heart Rate variability (R-R interval), Peripheral<br>capillary Oxygen saturation (SpO2), Skin Temperature and Rate of<br>respiratory effort.<br>The system consist of: | | | • A body-worn unit with sensor input modules for the near real<br>time acquisition of the physiological data with built-in wireless | . {4}------------------------------------------------ | | <ul><li>communication for data transmission.</li><li>A telemetry server to receive the physiological data and transmit the physiological data to</li><li>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.</li></ul> | |------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | 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<br>(Indications for<br>Use/Technology) | Predicate #2<br>(Technology) | Predicate #3<br>(Add on) | Predicate #4<br>(Add on) | Predicate #5<br>(Add on) | | |----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K # | K 141167 | K092947 | K080255 | K070339 | K012451 | | | Trade name | Dyna-Vision<br>Telemonitoring<br>System | VitalConnect Platform, | TeleSentry Wireless<br>Ambulatory ECO<br>Arrhythmia Monitor, | Model 7500 Digital<br>Pulse Oximeter | Disposable<br>Temperature Probes<br>& Skin Temperature<br>Sensor | Propaq 200 Series<br>Monitors | | | Manufacturer | Techmedic<br>Development<br>International BV | VitalConnect Inc | Scottcare Inc | Nonin Medical Inc | Cincinnati Sub-Zero<br>Products Inc | Welch Allyn protocol,<br>inc. | | | Device<br>description<br>summary | Dyna-Vision<br>Telemonitoring<br>System relies on an<br>ambulant, wireless<br>device, which uses<br>sensors to collect,<br>transmit and<br>remotely assess<br>ECG and<br>physiological<br>parameters in near<br>real time. The<br>system includes<br>alerts triggered by<br>parameters<br>exceeding preset<br>limits. | The VitalConnect<br>Platform is a wireless<br>data collection system<br>that monitors<br>physiological data.<br>The VitalConnect<br>Platform and the<br>predicate device<br>contains small<br>ambulatory monitoring<br>sensors that measure<br>ECG, heart rate,<br>respiration rate,<br>activity, body<br>orientation, body/skin<br>temperature. | TeleSentry is a<br>battery powered<br>ambulatory ECG<br>monitor, which<br>analyzes an<br>electrocardiographic<br>signal. | The Nonin® Model<br>7500 Digital Pulse<br>Oximeter is a<br>portable, table top<br>device indicated for<br>use in measuring,<br>displaying, and<br>recording functional<br>oxygen saturation of<br>arterial hemoglobin<br>(SPO2) and pulse<br>rate of adult,<br>pediatric, infant, and<br>neonatal patients. | To detect<br>hypo/hyperthermia,<br>the body temperature<br>is continuously<br>monitored using<br>disposable<br>temperature sensors<br>or probes. The basic<br>component of these<br>sensors is a<br>resistance chip,<br>which is sensitive to<br>changes in<br>temperature. The<br>chip is in the form of<br>"400" series<br>thermistor connected<br>to a lead wire and<br>encapsulated in a<br>PVC cup. At the end<br>of the lead wires an<br>insert molded<br>connector or<br>standard phone<br>connector provides<br>for the | The Propaq 200 Series<br>monitors are small,<br>lightweight, portable,<br>multi-parameter patient<br>monitors equipped with<br>either a monochrome<br>or color display. The<br>monitors provide real<br>time monitoring and<br>display of ECG,<br>respiration, invasive<br>blood pressure, non-<br>invasive blood<br>pressure, temperature,<br>CO2 and SpO2. | | | | Regulation &<br>Product Code | 21 CFR 870.2910,<br>DRG<br>Transmitters and<br>Receivers,<br>Physiological Signal,<br>Radiofrequency | 21 CFR 870.1025,<br>DSI<br>Arrhythmia detector<br>and alarm (including<br>ST-segment<br>measurement and<br>alarm).<br>DRG<br>Transmitters and<br>Receivers,<br>Physiological Signal,<br>Radiofrequency | 21 CFR 870.2700,<br>DQA<br>Oximeter | interconnection with<br>the instrument cable. | 21 CFR 880.2910,<br>FLL<br>Clinical electronic<br>thermometer | 21 CFR 870.2300,<br>DRT<br>Monitor, cardiac (incl.<br>cardiotachometer &<br>rate alarm) | | Intended Use | The Dyna-Vision<br>Telemonitoring<br>System is a wireless<br>monitoring system<br>intended for use by<br>healthcare<br>professionals for<br>continuous collection<br>of physiological data<br>in home and<br>healthcare settings<br>and for normal daily<br>activities.<br>Physiological data<br>recorded include:<br>Electrocardiography<br>(EGG), Heart Rate,<br>Heart Rate variability<br>(R-R interval) | 21 CFR 870.2910,<br>DRG<br>21 CFR 880.2910,<br>FLL<br>21 CFR 870.1025,<br>MHX<br>21 CFR 870.2300,<br>DRT<br>21 CFR 870.2700,<br>DQA | 21 CFR 870.1025,<br>DSI<br>Arrhythmia detection<br>and alarm (including<br>ST-segment<br>measurement and<br>alarm)<br>MHX<br>Monitor, physiological,<br>patient (with<br>arrhythmia detection<br>or alarm) | The TeleSentry<br>device is intended for<br>diagnostic evaluation<br>of patients who<br>experience transient<br>symptoms or<br>asymptomatic events<br>that may suggest<br>non-lethal cardiac<br>arrhythmia. The<br>device continuously<br>monitors and records<br>the data,<br>automatically records<br>alarm events<br>triggered by an<br>arrhythmia detection<br>algorithm or manually<br>by the patient and | The Nonin® Model<br>7500 Digital Pulse<br>Oximeter is a<br>portable,<br>for Use tabletop<br>device indicated for<br>use in measuring,<br>displaying, and<br>recording functional<br>oxygen saturation of<br>arterial hemoglobin<br>(SpO2) and pulse<br>rate of adult,<br>pediatric, infant, and<br>neonatal<br>patients. It is<br>indicated for spot-<br>checking and / or<br>continuous | Skin Temperature<br>Sensor (487M and<br>499B): The CSZ skin<br>temperature sensor is<br>intended for<br>use in routine<br>continuous<br>monitoring skin<br>temperature when<br>the other sensors<br>which might better<br>reflect core body<br>temperature are not<br>indicated clinically.<br>The sensor is<br>designed for<br>placement on the<br>surface of the skin. | The Propaq monitor is<br>intended to be used by<br>skilled clinicians for<br>multiparameter vital<br>signs monitoring of<br>neonatal, pediatric, and<br>adult patients in health<br>care facility bedside<br>applications. It is also<br>intended for intra-<br>facility transport.<br>The ECG channel is<br>intended for five-lead<br>or three-lead ECG<br>monitoring.<br>The Respiration<br>(RESP) channel is | {8}------------------------------------------------ {9}------------------------------------------------ | Peripheral capillary<br>Oxygen saturation<br>(SpO2), Skin<br>Temperature and<br>respiration effort. | to gravity including<br>fall). | automatically<br>transmits the<br>recorded event<br>activity associated<br>with these symptoms<br>for review by a<br>licensed physician. | monitoring of patients<br>during both motion<br>and non-motion<br>conditions, and for<br>patients who are well<br>or poorly perfused. | Instrument Cables<br>(4872MS and<br>4900B): The intended<br>use of the instrument<br>cable is to<br>interconnect the<br>disposable<br>temperature<br>sensor/probe with the<br>temperature<br>monitoring<br>instrument. | intended to detect the<br>rate or absence of<br>respiratory effort,<br>deriving the signal by<br>measuring the ac<br>impedance between<br>selected terminals of<br>ECG electrodes. | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Data is transmitted<br>wirelessly in near<br>real time to a central<br>location where it is<br>stored for analysis.<br>The Dyna-Vision™<br>system can be<br>configured by<br>Authorized Persons<br>to notify healthcare<br>professionals when<br>physiological data<br>falls outside selected<br>parameters. Data<br>from the Dyna-<br>Vision™ system is<br>intended to be used<br>by healthcare<br>professionals as an<br>aid to diagnosis and<br>treatment.<br>The device is<br>intended for use on<br>general care patients<br>aged 18 years or<br>more, as a general<br>patient monitor, to<br>provide physiological<br>information. It is not<br>intended for use on<br>critical care patients. | Data is transmitted<br>wirelessly to a central<br>location where it is<br>stored for analysis.<br>The Vital Connect<br>Platform can be<br>configured by<br>Authorized Persons<br>to notify healthcare<br>professionals when<br>physiological data falls<br>outside selected<br>parameters.<br>The device is intended<br>for use on general<br>care patients who are<br>18 years of age or<br>older as a general<br>patient monitor, to<br>provide physiological<br>information.<br>The data from the<br>VitalConnect Platform<br>is intended for use by<br>healthcare<br>professionals as an<br>aid to diagnosis and<br>treatment. It is not<br>intended for use on<br>critical care patients. | Contraindications:<br>a. Patients with<br>potentially life-<br>threatening<br>arrhythmias who<br>require inpatient<br>monitoring.<br>b. Patients who the<br>attending physician<br>thinks should be<br>hospitalized. | | | | | General specifications | | | | | | {10}------------------------------------------------ | Dimensions | 118 x 65 x 33 mm | 115 x 40 x 7 mm<br>(sensor + patch<br>without transmitter) | 110 x 6 x 2.6 | Approximately 219<br>mm x 92 x 142 mm | N/A | N/A | |---------------------------------------------------------------------|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------|--------------------------------------------------------|--------------------------------------------------------------------| | Weight | 260 gram with<br>battery | --- | 280 gram with battery | Approximately<br>900grams (2 lbs) with<br>battery | N/A | N/A | | Interface | Foil with buttons and<br>LCD display | --- | Foil with buttons, no<br>display | --- | N/A | Foil with buttons and<br>LCD display | | Energy source | Battery | Battery | Battery | N/A | N/A | Battery/Mains | | Type | 3.7V lithium polymer<br>rechargeable | Disposable zinc air<br>battery | 3.7V lithium polymer<br>rechargeable | 7.2 volt NiMH battery<br>pack | N/A | N/A | | Autonomy on<br>single charge | 22 hrs 3G streaming<br>36 hrs Wi-Fi<br>streaming | 3 days with ECG and<br>4 days without ECG<br>for the patch. No<br>information about the<br>transmitter autonomy | 2-3 days without<br>streaming. 6 hours<br>with streaming | 16 hours minimum | N/A | N/A | | Communication | | | | | | | | Wi-Fi | Yes<br>2,4 GHz | Bluetooth | No | N/A | N/A | N/A | | Cellular | Yes<br>3G module | N/A | Yes<br>2G module | N/A | N/A | N/A | | USB | Yes<br>2.0 | No | Yes | N/A | N/A | N/A | | Memory | Yes<br>4 GB SD card | --- | Yes<br>4 GB SD card | N/A | N/A | N/A | | Recording period | 60 days | --- | 60 days | N/A | N/A | N/A | | Central<br>monitoring of<br>remotely<br>transmitted<br>patient data | Yes | Yes | Yes | N/A | N/A | Yes | | Data sent to<br>central server | Yes | Yes | Yes | N/A | N/A | Yes | | Physiological parameters | | | | | | | | PROGRAMMAB<br>LE ALERT<br>SETTINGS AND<br>LIMITS | Yes | Yes | Yes | N/A | N/A | Yes | | MONITORS<br>ECG | Yes | Yes | Yes | N/A | N/A | Yes | | Method | ECG lead wires<br>attached to<br>disposable<br>electrodes to the skin | Patch on the skin to<br>measure single lead<br>ECG. | ECG lead wires<br>attached to<br>disposable electrodes<br>to the skin | N/A | N/A | ECG lead wires<br>attached to disposable<br>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<br>rejection | -80dB - 100dB | --- | 92 dB | N/A | N/A | N/A | | Sampling<br>frequency | 1,000, 800, 400 and<br>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<br>AF detection | Yes - 99.8% | --- | Yes > 99% | N/A | N/A | N/A | | MONITORS<br>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<br>RESPIRATION | Yes | Yes | No | N/A | N/A | Yes | | Method | Impedancy<br>Pneumography | … | N/A | N/A | N/A | Impedance<br>Pneumography | | Impedance<br>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<br>SKIN<br>TEMPERATUR<br>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:<br>±0.1°C<br>>50° to +122°F:<br>±0.2°F | … | N/A | N/A | >10°C to +50°C:<br>±0.1°C<br>>50° to +122°F:<br>±0.2°F | NA | | MONITORS<br>OXYGEN<br>SATURATION | Yes | No | No | Yes | N/A | Yes | | Method | Photoplethysmogram<br>on finger.<br>Infrared: 910<br>nanometers @ 1.2<br>mW maximum<br>average | N/A | N/A | Photoplethysmogram<br>on finger.<br>Infrared: 910<br>nanometers @ 1.2<br>mW maximum<br>average | N/A | NA | | | | | | | | | | | Red: 660<br>nanometers @ 0.8<br>mW maximum<br>average | | | Red: 660 nanometers<br>@ 0.8 mW maximum<br>average | | | | Range | 0-100% | N/A | N/A | 0-100% | N/A | NA | | Accuracy | $\pm$ 2 digits<br>(from 70-100%) | N/A | N/A | $\pm$ 2 digits<br>(from 70-100%) | N/A | NA | | USE IN HOME<br>AND<br>HEALTHCARE<br>SETTINGS | Yes | Yes | Yes/No (not exactly<br>specified) | Yes | N/A | Healthcare settings | {11}------------------------------------------------ {12}------------------------------------------------ {13}------------------------------------------------