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1200-000002 r04                                                                                                        16                                                                    UPDATED   10/25/2022 

 

 

 APPENDIX C – Electromagnetic Immunity  

Table 3. Guidance and manufacturer’s declaration – electromagnetic immunity For ME EQUIPMENT 

 

and ME SYSTEMS that are not LIFE-SUPPORTING (see 5.2.2.2).

 

Guidance and Manufacturer’s Declaration - Electromagnetic Immunity

 

The REVIAN RED 101 is intended for use in the electromagnetic environment specified below. The customer or the user 
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 

 

 

 

Radiated RF 

 

 

IEC 61000-4-3 

 

 

 

 

 

 

 

3 Vrms 

 

150 kHz to 80 MHz 

 

 

 

3 V/m 

 

 

80 MHz to 2700 MHz 

 

 

 

 

 

 

 

 

 

3 V 

 

 

 

 

 

 

10 V/m 

Portable and mobile RF communications equipment 

should be used no closer to any part of the REVIAN RED 

101, including cables, than the recommended 

separation distance calculated from the equation 

applicable to the frequency of the transmitter. 

 

Recommended separation distance 

d = [3.5/V

1

 

 

d = [3.5/E

1

P  80 MHz to 800 MHz 

d = [7/E

1

P  800 MHz 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 survey

a

 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: 

 

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 strength 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 REVIAN RED 101 is used exceeds the applicable RF compliance level above, the REVIAN 

RED 101 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be 

necessary, such as reorienting or relocating the REVIAN RED 101. 

b   

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

Summary of Contents for RED 101

Page 1: ...he counter medical device operated via mobile app to promote hair growth REVIAN RED is intended for a daily 10 minute treatment A treatment can be paused after it is initiated the remaining treatment...

Page 2: ...tandard and back 10mm headliners installed as illustrated below The Cap should not be loose enough that it falls off the head with ease nor should it fit too tightly A proper fitting Cap is an importa...

Page 3: ...s when the Cap is properly placed on your head Place the Cap on your head to activate the sensor or put your finger over the sensor located in the forehead area of the cap Press the CONNECT YOUR CAP b...

Page 4: ...again on your head and it will automatically pick up where it left off Only a single 10 minute treatment can be initiated daily Time remaining will be displayed on the mobile app screen Another treatm...

Page 5: ...ht will softly flash every 4 seconds When the cap is charging the app is not connected and will not provide a battery level To determine the battery level disconnect the charging cable from the cap an...

Page 6: ...during support tickets to help troubleshoot any issues you may be having with the app SUPPORT In the Troubleshooting section you can find answers to commonly asked questions and troubleshoot issues If...

Page 7: ...Messages and sound signals during use The mobile app will display messages on occasion These will appear as direct messages or icons in the mobile app App Messages Check Bluetooth This message appear...

Page 8: ...ice and not the Cap Check mobile device settings and ensure device isn t already paired with another device The mobile app is not scanning for the Cap Force the mobile app to scan for the Cap by tappi...

Page 9: ...revian com or on the website at revian com support PROBLEM POSSIBLE CAUSE SOLUTION The mobile app will not download firmware or software updates The cloud server is unavailable The device software is...

Page 10: ...te blue The charging cable connector will illuminate blue always when connected to AC power The battery should be charged from a depleted state to a full charge within 4 hours The battery will have en...

Page 11: ...of cleaning agents or solvents are not recommended and may damage the REVIAN RED Cap The battery is rechargeable but not intended as a user replaceable part Use the Cap only as intended and described...

Page 12: ...everse hair loss The approximate size of the Cap is Height 15 87 cm 6 25 in x Width 20 cm 7 87 in x Length 22 86 cm 9 in Weight 155 g 0 34lbs How is the REVIAN RED Cap shipped After order completion t...

Page 13: ...d I attach headliners The recommended headliners not only ensure proper fit of the Cap but they also provide additional comfort and help maintain cleanliness Is this a use it or lose it treatment plan...

Page 14: ...Compliance Electromagnetic Environment Guidance RF emissions CISPR 11 Group 1 REVIAN RED uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cau...

Page 15: ...quality should be that of a typical commercial hospital or home healthcare environment Surge IEC 61000 4 5 1 kV line s to line s 2 kV line s to earth PASS Mains power quality should be that of a typic...

Page 16: ...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 lev...

Page 17: ...as recommended below according to the maximum output power of the communications equipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 k...

Page 18: ...een the REVIAN mobile application running on an iOS or Android operating system and REVIAN cloud services as well as between the REVIAN app and the REVIAN RED Cap Figure E1 Communications of treatment...

Page 19: ...energy and if not used in accordance with the instructions may cause harmful interference to radio communications However there is no guarantee that interference will not occur in a particular instal...

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