Flosonics Medical FloPatch FP120 Скачать руководство пользователя страница 27

User Manual 

 FloPatch FP120 

Rev 1.0

 

 

 

 

 

CONFIDENTIAL  

UNCONTROLLED UNLESS OTHERWISE SIGNED AND/OR STAMPED. 

Page 27 / 33 

 

 

The FloPatch FP120 is intended for use in the electromagnetic environment specified 
below. The customer or the user of the FloPatch FP120 should assure that it is used in 

such an environment. 

Immunity Test 

IEC 60601 Test 

Level 

Compliance Level  Electromagnetic Environment 

 

Guidance 

Conducted RF IEC 

61000-4-6

 

3 Vrms 

150 kHz to 80 MHz 

6 Vrms 

ISM bands inside 

150 kHz to 80 MHz

 

 

N/A

 

 

Portable and mobile RF communications 
equipment should be used no closer to any 

part of the FloPatch FP120 including cables, 
than the recommended separation 

distance calculated from the equation 

applicable to the frequency of the 

transmitter. 

 

Recommended separation distance 

= 1.2√

P

 

Radiated RF IEC 

61000-4-3 

 

3 V/m 

80 MHz to 2,7 GHz 

 

RF communication 

equipment inside 

80 MHz to 6 GHz 

3 V/m 

80 MHz to 2,7 GHz 

 

RF communication 

equipment inside 

80 MHz to 6 GHz 

= 1.2

80 MHz to 800 MHz 

= 2.3

800 MHz to 2.7 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 survey

should be less than the compliance level in each 

frequency range

b

 

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. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site 
survey should be considered. If the measured field strength in the location in which the FloPatch FP120 is used 

exceeds the applicable RF compliance level above, the FloPatch FP120 should be observed to verify normal 
operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or 

relocating the FloPatch FP120 

 

b) 

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. 

 

 
 

 
 
 

Содержание FloPatch FP120

Страница 1: ...NCONTROLLED UNLESS OTHERWISE SIGNED AND OR STAMPED Page 1 33 USER MANUAL FP120 Ultrasonic Blood Flow Monitor 4 MHz 204 73 Elm St Unit Sudbury Ontario P3C 1R7 Canada info flosonicsmedical com flosonics...

Страница 2: ...Classification 6 3 2 Warnings 6 3 3 Cautions 7 3 4 Symbols 7 4 FLOPATCH OVERVIEW 8 4 1 Main Unit Diagram 9 5 BASIC OPERATION 10 6 USER INTERFACE 13 6 1 Welcome Screen 13 6 2 Home Screen 14 6 3 FloPat...

Страница 3: ...NED AND OR STAMPED Page 3 33 9 7 1 Mechanical Index MI 29 9 7 2 TI Thermal Index 29 9 7 3 Measurement Uncertainties 30 9 7 4 Prudent Use Statement 31 9 7 5 References for Acoustic Output Safety 31 9 7...

Страница 4: ...to comply with the limits for a Class B digital device pursuant to part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference in a residential ins...

Страница 5: ...romettre le fonctionnement CAN ICES 3 B NMB 3 B RF Exposure Statement This equipment complies with ISED RSS 102 radiation exposure limits set forth for an uncontrolled environment Cet quipement est co...

Страница 6: ...be used in oxygen rich and in the presence of flammable anesthetics WARNING The device is intended for intact skin only Do not use the device on or near open wounds WARNING The device is not intended...

Страница 7: ...ne 3 4 Symbols Labelling Presentation Reference Title of Symbol Notes ISO 7010 M002 Consult Instructions for Use IFU This indicates that the Instructions for use must be consulted before using this de...

Страница 8: ...20 is a non invasive blood flow evaluation device to be used in a medical hospital setting for use by a trained medical professional The FloPatch FP120 is a hands free wearable ultrasound device that...

Страница 9: ...IDENTIAL UNCONTROLLED UNLESS OTHERWISE SIGNED AND OR STAMPED Page 9 33 4 1 Main Unit Diagram Ultrasound gel to be applied liberally on wide face of probe geometry Ultrasound probe face On Off Button S...

Страница 10: ...tion with the mobile app 2 Open the mobile app and navigate to the Assess Bloodflow screen Press the button in the bottom left corner to open a list of devices available to connect Select the desired...

Страница 11: ...identified carotid artery Ensure the logos images are right side up When the device is placed the Doppler sound will begin to be heard from the mobile app 6 Ensure a satisfactory Doppler sound and wa...

Страница 12: ...e screen and press the disconnect button on the screen that appears The FloPatch may remain secured to the patient to allow for reassessment 11 To perform subsequent assessments repeat Steps 1 2 to re...

Страница 13: ...application is opened from being closed It prompts the user to select one of four options 1 Start navigates the user to the Home Screen of the FloPatch iOS application 2 Frequently Asked Questions ope...

Страница 14: ...ess blood flow window if a FloPatch is already connected to the iOS device If no FloPatch is connected the FloPatch connection screen will appear see section 7 3 More information about the Assess Bloo...

Страница 15: ...oPatch is currently connected 2 A FloPatch is manually disconnected from the Assess Blood Flow screen and connect is selected The FloPatch connections screen allows you to connect a FloPatch by select...

Страница 16: ...eral parts In the above image the parts of the screen are labeled 1 14 and information about each component can be found below 1 The Return Button returns the iOS application back to the Home Screen o...

Страница 17: ...sment State button group controls the assessment state 3 of the iOS application There are three buttons in the assessment state button group 7a Collect Baseline 7b Begin Assessment 7c End Assessment T...

Страница 18: ...eft side of this component as a value from 1 to 4 Selecting this button opens a pop up containing the ID and device information for the connected FloPatch as well as an option to disconnect the curren...

Страница 19: ...creen The individual assessments can be identified by three features 1 The unique assessment ID 2 The duration of the assessment 3 The date and time of the recording A session may be deleted or loaded...

Страница 20: ...Total VTI and Corrected Flow Time 3 The Pre and Post Assessment Sliders 3a and 3b allow you to calculate the percent change between areas in the saved assessment 4 The Percent Change Area displays th...

Страница 21: ...device is displayed on the disconnect screen 7 TROUBLESHOOTING THE FLOPATCH Issue Solution Device is damaged Contact the manufacturer or return the device to manufacturer and stop all usage of the dev...

Страница 22: ...e any calibration Ensure the device has no visible damage before using it If any damage is evident stop all usage of the device and contact the manufacturer Do not reuse devices They are intended for...

Страница 23: ...Equipment Applied Part Type B Degree of Protection Against Harmful Ingress of Fluid IPx7 Degree of Safety in Presence of Flammable Anaesthetics Equipment not suitable for use in presence of flammable...

Страница 24: ...FloPatch FP120 Rev 1 0 CONFIDENTIAL UNCONTROLLED UNLESS OTHERWISE SIGNED AND OR STAMPED Page 24 33 Appendix B Compatible Mobile Devices iPad Pro Models A1980 A1876 iPad Air Gen 3 Models A2152 iOS Ver...

Страница 25: ...for use in all establishments other than domestic and may be used in domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used fo...

Страница 26: ...uptions and voltage variations on power supply input lines IEC 61000 4 11 0 UT 100 dip in UT for 1 cycle s 70 UT 30 dip in UT for 30 cycles 0 UT 100 dip in UT for 5 sec Not Applicable Not Applicable P...

Страница 27: ...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 surve...

Страница 28: ...73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation app...

Страница 29: ...inciple 9 7 Explanation of MI TI 9 7 1 Mechanical Index MI Scientific evidence suggests that mechanical or nonthermal bioeffects such as cavitation are threshold phenomena occurring only when a certai...

Страница 30: ...ned with the statistically derived Type A measurements on a root sum squared basis 1 Voltage V oscilloscope 2 9 The two contributing sources were the stated DC gain accuracy and digitization error of...

Страница 31: ...Document issued on October 2 2017 by the FDA 4 IEC 60601 2 37 Medical electrical equipment Part 2 37 Particular requirements for the basic safety and essential performance of ultrasonic medical diagno...

Страница 32: ...quirements of 201 12 4 2a are met it is not required to enter any data in the columns related to TIS TIB or TIC NOTE 5 If the requirements of 201 12 4 2b are met it is not required to enter any data i...

Страница 33: ...MPED Page 33 33 Ipa Attenuated pulse average intensity Ispta Spatial peak temporal average intensity spatial peak temporal average intensity srr Scan repetition rate pr Peak acoustic pressure npps Num...

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