CONFIDENTIAL 1 10/29/20 1:52:12 PM – IFU ETROG®Care PLATFORM INSTRUCTIONS FOR USE MULTIVS ES008 A Wireless Wearable Health monitor Patch and Chest Belt. This document may contain information that is confidential or attorney-client privileged and may constitute inside information. The contents of this document are intended only for the recipient(s) listed above. If you are not the intended recipient, you are directed not to read, disclose, distribute or otherwise use this document.
CONFIDENTIAL 2 10/29/20 1:52:12 PM – IFU Device Description The ETROG® Care Platform is a wireless physiological monitoring system. The Platform was developed with an Application Programming Interface intended to allow development of user interface applications enabling health care professionals to access collected vital information.
CONFIDENTIAL 3 10/29/20 1:52:12 PM – IFU Indications for Use MULTIVS ES008A is an integrated Bio-Sensors and wireless transceiver, rechargeable battery-operated device that can be worn on the body torso via adhesive patch or chest belt, Enabling recording of heart rate, electrocardiography (ECG), Photoplethysmogram (PPG), Pulse Wave Transit time (PWTT), Changes in Blood Pressure, heart rate variability (HRV) , R-R interval, respiratory rate, skin temperature, activity (including step count) and posture (
CONFIDENTIAL 4 10/29/20 1:52:12 PM – IFU Contraindications: The device is not intended for use on patients who have implanted defibrillator or pacemaker. The device is not intended as a stand-alone diagnostic monitor, but the data can be used to diagnose health status. Warnings: Depending on wireless connectivity, a temporary interruption of data transmission is possible, which may impact continuous or real-time monitoring.
CONFIDENTIAL 5 10/29/20 1:52:12 PM – IFU Precautions: • For data to be sent to a healthcare professional for review: The device battery must have adequate power for data transmission. Red flashing LED on device will indicate that the battery power is low. Low power device notification will be passed to gateway and server too. • The patch must be attached to the patient. Notification will indicate if the patch is off the body or not properly attached.
CONFIDENTIAL 6 10/29/20 1:52:12 PM – IFU Storage and Handling • Storage temperature range: 0 – 40o C • Storage relative humidity range: 10 – 95% RH • The patient hands must be clean and dry before handling MULTIVS ES008A. Gloves are recommended for healthcare professionals when handling the Device. System Interoperability The ETROG® Care Platform is a wireless physiological monitoring system.
CONFIDENTIAL 7 10/29/20 1:52:12 PM – IFU MULTIVS ES008A Operating Instructions MULTIVS ES008A Overview Top View - Device Bottom View - Device Top View - Device with Patch Bottom View - Device with Patch Charger Cabel Device Charging This document may contain information that is confidential or attorney-client privileged and may constitute inside information. The contents of this document are intended only for the recipient(s) listed above.
CONFIDENTIAL 8 10/29/20 1:52:12 PM – IFU Preparation and Application Note: Please fully charge the device before start of use. MULTIVS ES008 Patch 1. Take device and attach to patch via magnetic connectors. Retain the adhesive backing of patch. 2. Select the location for patch placement on body as per the diagram below. ensure it is free from hair and skin is intact. 3. Use isopropyl alcohol to clean the skin area where the patch is intended to be placed and allow site to fully dry. 4.
CONFIDENTIAL 9 10/29/20 1:52:12 PM – IFU ES-Chest Belt 1. Take device and attach to chest belt via magnetic connectors. 2. Use isopropyl alcohol to clean the skin area where the belt is intended to be placed and allow site to fully dry. 3. Strap the belt around chest as per the diagram below and adjust size. the feel should be firm yet comfortable.
CONFIDENTIAL 10 10/29/20 1:52:12 PM – IFU Connect to Gateway Please refer to the Gateway application’s user manual for more instructions on how to connect to the MULTIVS ES008A. During first time connection a calibration and data measurement control test will be done – to ensure proper placement and compatibility. Removal and Re-application ES-Patch Grip the Device and gently pull away from patch magnets. Place Device in original box or soft material.
CONFIDENTIAL 11 10/29/20 1:52:12 PM – IFU Charging Place device on provided cradle or connect to charging cable as per diagram. The charging connector is magnetic and will align automatically to the right position. Connect the USB plug to available charger. (not provided). Led indicator During charging the Device led indication will flash slowly RED and will be steady GREEN when device is fully charged.
CONFIDENTIAL 12 10/29/20 1:52:12 PM – IFU Disposal Disposal of a battery into fire or a hot oven, or mechanically crushing or cutting of a battery can result in an explosion. Leaving a battery in an extremely high temperature surrounding environment that can result in an explosion or the leakage of flammable liquid or gas. A battery subjected to extremely low air pressure may result in an explosion or leakage of flammable liquid or gas.
CONFIDENTIAL 13 10/29/20 1:52:12 PM – IFU Troubleshooting Device Not Charging No led light Connectivity Make sure all magnets contacts are connected Belt – clean electrode area For additional information regarding the proper use of the MULTIVS ES008A Platform please contact the prescribing physician, caregiver, or healthcare provider. This document may contain information that is confidential or attorney-client privileged and may constitute inside information.
CONFIDENTIAL 14 10/29/20 1:52:12 PM – IFU ETROG SYSTEMS Contact Information: HQ ETROG SYSTEMS LTD. 7/9 Derech HaDarom Road, Kiryat Gat , ISRAEL Phone: +972 86665042 eMail: info@etrogsystems.com Web: www.etrogsystems.com USA ETROG Systems Ltd. 750 Chestnut Ridge Rd. Chestnut Ridge, NY 10977 Phone: +1 347 434 9204 This document may contain information that is confidential or attorney-client privileged and may constitute inside information.
CONFIDENTIAL 15 10/29/20 1:52:12 PM – IFU Product Specifications: Measurements ECG Dynamic Range Heart Rate (at rest and or physical activity) Photoplethysmogram (PPG) Respiration Rate (RR) Skin Temperature Specifications -10mV to +10mV 30 – 200 Beats per Minute (<±5 or 10% Beats per Minute, whichever is greater) RED, Infra RED, Green 6 – 30 BPM 150C – 470C (≤± 0.300C ) Step Count Re-set after upload to server / every 24 HRs.
CONFIDENTIAL 16 10/29/20 1:52:12 PM – IFU System Specifications Communications Bluetooth (BT4.2) Radio Modulation Radio Frequency Transmit power Max. 10 Meters (30 Feet Line of Sight) GFSK Security 2.402 – 2.48 GHz ≤0dBm AES-CCM 128 Bit Encryption (Advanced Encryption Standard-CCM mode) Battery Battery Type Battery Voltage Battery Life Polymer Li-Ion DC 3.7 V (0.
CONFIDENTIAL 17 10/29/20 1:52:12 PM – IFU Electromagnetic Emission Declaration MULTIVS ES008A is intended for use in the electromagnetic environment specified below. The end user of ES008A should assure that it is used in such an environment. Emission test Compliance Electromagnetic environment ES008A uses RF energy only for its internal RF emissions CISPR Group 1 function. Therefore, its RF emissions are very 11 low and are not likely to cause any interference in nearby electronic equipment.
CONFIDENTIAL 18 10/29/20 1:52:12 PM – IFU FCC Compliance •FCC ID: 2ATHK-ES008A • The MULTIVS ES008A Platform complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) This device must accept any interference received, including interference that may cause undesired operation (FCC Title 47, Subpart A, Part 15.19(3)).
CONFIDENTIAL 19 10/29/20 1:52:12 PM – IFU Canada License-exempt •IC ID: • This device complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device. • Le present appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de licence.
CONFIDENTIAL 20 10/29/20 1:52:12 PM – IFU Guidance and declaration – electromagnetic immunity (For ME equipment ME system that are not life-supporting) MULTIVS ES008A is intended for use in the electromagnetic environment specified below. The end user of the MULTIVS ES008A Platform should assure that it is used in such an environment.
CONFIDENTIAL 21 10/29/20 1:52:12 PM – IFU NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
CONFIDENTIAL 22 10/29/20 1:52:12 PM – IFU Recommended separation distance between portable and mobile RF communications equipment and MULTIVS ES008A Platform (For ME equipment ME system that are not life-supporting) MULTIVS ES008A is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled.
CONFIDENTIAL 23 10/29/20 1:52:12 PM – IFU General symbols Symbol IP24 IP67 Title Protected against splashing water Protected against submerging in water (up to 1 meter for 30 minutes) Re-use is not allowed This document may contain information that is confidential or attorney-client privileged and may constitute inside information. The contents of this document are intended only for the recipient(s) listed above.
CONFIDENTIAL 24 10/29/20 1:52:12 PM – IFU Symbol Title Read usage instructions Properly dispose of EEE (Electrical and Electronic Equipment) Non-ionizing radiation Defibrillation proof type CF applied part MR Unsafe Underwriters Laboratories MEDICAL — PATIENT MONITORING EQUIPMENT AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI ES60601-1 (2005), "Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance; CAN/CSA-C22.2 No.
CONFIDENTIAL 25 10/29/20 1:52:12 PM – IFU Not to be used in case package is damaged Prescription only Authorized Representative in the European Community Symbol Title Catalogue number Batch code Use by date Temperature limits (Storage) Humidity limits (Storage) Contents (Numeral represents quantity of units inside) This document may contain information that is confidential or attorney-client privileged and may constitute inside information.
