ETROG SYSTEMS MULTIVS ES008 A Скачать руководство пользователя страница 20

  

 

CONFIDENTIAL 

10/29/20 1:52:12 PM – IFU 

 

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. If you have received this document in error, please notify the sender immediately and delete the 
document. Delivery of this document is not intended to waive any applicable privileges                                                   

©2020 ETROG SYSTEMS LTD. 

20 

 

 

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.  

Immunity test  

IEC 60601 
test level  

Compliance 
level  

Electromagnetic environment- guidance  

Radiated RF  
IEC 61000-4- 3  

 

10 V/m  
80 MHz to 
2.5 GHz  

 

10 V/m  

 

Portable and mobile RF communications 

equipment should be used no closer to any part of 

the MULTIVS ES008A Platform than the 

recommended separation distance calculated from 

the equation applicable to the frequency of the 

transmitter.  

Recommended separation distance  

𝑑

 = 1.17√

𝑃

 80 MHz to 800 MHz 

𝑑

 = 2.33√

𝑃

 800MHz 

to 2.5 GHz  

where P is the maximum output power rating of 

the transmitter in watts (W) according to the 

transmitter manufacturer and d is the 

recommended separation distance in meters (m).  

Field strengths from fixed RF transmitters, as 
determined by an electromagnetic site surveya 

should be less than the compliance level in each 

frequency range b.  

Interference may occur in the vicinity of equipment 

marked with the following symbol:  

 

 

 

Содержание MULTIVS ES008 A

Страница 1: ...bove If you are not the intended recipient you are directed not to read disclose distribute or otherwise use this document If you have received this document in error please notify the sender immediat...

Страница 2: ...s measurements mode to gather physiological data from the person being monitored and transmit the data via encrypted bi directional communication to the gateway smart phone mobile device when in range...

Страница 3: ...lectrocardiography 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 c...

Страница 4: ...nnectivity a temporary interruption of data transmission is possible which may impact continuous or real time monitoring Data will be stored on sensor device or gateway for transfer once connectivity...

Страница 5: ...ropriate care Data collected by MULTIVS ES008A for patients experiencing cardiac arrhythmia may indicate slightly elevated respiratory rate values compared to visual observation for the duration of th...

Страница 6: ...ent is not intended to waive any applicable privileges 2020 ETROG SYSTEMS LTD 6 Storage and Handling Storage temperature range 0 40o C Storage relative humidity range 10 95 RH The patient hands must b...

Страница 7: ...pient you are directed not to read disclose distribute or otherwise use this document If you have received this document in error please notify the sender immediately and delete the document Delivery...

Страница 8: ...2020 ETROG SYSTEMS LTD 8 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 ad...

Страница 9: ...document If you have received this document in error please notify the sender immediately and delete the document Delivery of this document is not intended to waive any applicable privileges 2020 ETR...

Страница 10: ...ons 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 applic...

Страница 11: ...f you have received this document in error please notify the sender immediately and delete the document Delivery of this document is not intended to waive any applicable privileges 2020 ETROG SYSTEMS...

Страница 12: ...e any applicable privileges 2020 ETROG SYSTEMS LTD 12 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 batte...

Страница 13: ...e or otherwise use this document If you have received this document in error please notify the sender immediately and delete the document Delivery of this document is not intended to waive any applica...

Страница 14: ...sclose distribute or otherwise use this document If you have received this document in error please notify the sender immediately and delete the document Delivery of this document is not intended to w...

Страница 15: ...the sender immediately and delete the document Delivery of this document is not intended to waive any applicable privileges 2020 ETROG SYSTEMS LTD 15 Product Specifications Measurements Specification...

Страница 16: ...notify the sender immediately and delete the document Delivery of this document is not intended to waive any applicable privileges 2020 ETROG SYSTEMS LTD 16 System Specifications Communications Bluet...

Страница 17: ...le privileges 2020 ETROG SYSTEMS LTD 17 Electromagnetic Emission Declaration MULTIVS ES008A is intended for use in the electromagnetic environment specified below The end user of ES008A should assure...

Страница 18: ...compliance could void the user s authority to operate the equipment FCC Title 47 Subpart A Part 15 21 Note This equipment has been tested and found to comply with the limits for a Class B digital dev...

Страница 19: ...ble privileges 2020 ETROG SYSTEMS LTD 19 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...

Страница 20: ...end user of the MULTIVS ES008A Platform should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Radiated RF IEC 61...

Страница 21: ...uld be considered If the measured field strength in the location in which MULTIVS ES008A Platform is used exceeds the applicable RF compliance level above the MULTIVS ES008A Platform should be observe...

Страница 22: ...ic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and MULTIVS ES008A as recommended below according to the maximum output power of...

Страница 23: ...tended recipient you are directed not to read disclose distribute or otherwise use this document If you have received this document in error please notify the sender immediately and delete the documen...

Страница 24: ...privileges 2020 ETROG SYSTEMS LTD 24 Symbol Title Read usage instructions Properly dispose of EEE Electrical and Electronic Equipment Non ionizing radiation Defibrillation proof type CF applied part...

Страница 25: ...distribute or otherwise use this document If you have received this document in error please notify the sender immediately and delete the document Delivery of this document is not intended to waive a...

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