Manamed PlasmaFlow User Manual Download Page 10

8

GUIDANCE AND MANUFACTURER’S DECLARATION - ELECTROMAGNETIC EMISSIONS

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

RF Emissions CISPR11

Harmonic Emissions IEC
61000-3-2
Voltage Fluctuations IEC
61000-3-3

RF Emissions CISPR11

Class B

Class A

Complies

Group 1 

The PlasmaFlow is suitable for use in all establishments, including domestic establishments and those directly connected
to the public low-voltage power supply network that supplies buildings used for domestic purposes.

The PlasmaFlow uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely
to cause any interference in nearby electronic equipment.

Emissions Tests

Compliance

Electromagnetic Environment Guidance

GUIDANCE AND MANUFACTURER’S DECLARATION - ELECTROMAGNETIC IMMUNITY

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

Electrostatic
Discharge (ESD)
IEC 61000-4-2

Electrical Fast
Transient/Burst
IEC61000-4-4

Surge

IEC61000-4-5

±1kV differential
mode

±2kV common mode

±1kV differential
mode

±2kV common mode

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment.  If the user of the 
PlasmaFlow requires continued operation during power mains interruptions, it is recommended that the
PlasmaFlow be powered from an uninterrupted power supply or a battery.

Voltage
dips, short
interruptions
and voltage
variations on
power supply
input lines

IEC61000-4-11

Power Frequency
(50/60Hz)
Magnetic Fields
IEC61000-4-8

30 A/m at
50 or 60 Hz

30 A/m at
50 or 60 Hz

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical
commercial or hospital environment.

NOTE: UT is the a.c mains voltage prior to application of the test level.

<5%UT (>95% dip in UT)
for 0.5 cycle
40%UT (60% dip in UT)
for 5 cycles
70%UT (30% dip in UT)
for 25 cycles
<5%UT (>95% dip in UT)
for 5 seconds

<5%UT (>95% dip in UT)
for 0.5 cycle
40%UT (60% dip in UT)
for 5 cycles
70%UT (30% dip in UT)
for 25 cycles
<5%UT (>95% dip in UT)
for 5 seconds

±2kV for power
supply lines
±1kV for input/
output lines

±2kV for power
supply lines
±1kV for input/
output lines

Mains power quality should be that of a typical commercial or hospital environment.

Floors should be wood, concrete or ceramic tile.  If floors are covered with synthetic material, 
the relative humidity should be at least 30%.

±8kV contact

±15kV air

±8kV contact

±15kV air

Immunity

Test

IEC 60601 Test

Level

Compliance

Level

Electromagnetic Environment Guidance

Compliance Statements & Declarations Electromagnetic Compatibility (EMC) Tables

Summary of Contents for PlasmaFlow

Page 1: ...Vascular Therapy System USER GUIDE Compressible Limb Sleeve Device Scan QR Code to watch Instructions for Use...

Page 2: ...re Indicator 4 Quick Start Instructions for Wearing and Operating PlasmaFlow 4 Switching Modes 5 PlasmaFlow Use and Care 5 Operating Conditions 5 Storage 5 Cleaning and Disinfecting 6 Battery and Char...

Page 3: ...Consult local county requirements for proper disposal instructions This symbol designates the degree of protection against electrical shock from the wrap as being a type B applied part Consult instru...

Page 4: ...DIFY OR CHANGE THE DEVICE 6 2 ATTEMPT ANY SERVICE WHILE THE DEVICE IS IN USE 0LASMA LOW IS A EDICAL LECTRICAL EVICE 4HE FOLLOWING ARE PRECAUTIONS SPECIFIC TO EDICAL LECTRONIC EVICES s O NOT OPERATE IN...

Page 5: ...ss and lightweight cuffs Each cuff features a house control unit that contains a Power Button Charging Port and an LCD Screen to monitor patient usage and device air pressure The control units are not...

Page 6: ...f the device The RED Charging LED indicator located above the Power Button on the device will illuminate or flash depend ing on the state of the charge When the battery is charging the LED indicator w...

Page 7: ...charging cord cracked plastic housing unit torn cuffs etc Refer to image of PlasmaFlow for description of the system components Do not attempt to connect the wall supply if any damage is noticed Avoid...

Page 8: ...EANS Battery and Charging Safety Battery Do not attempt to replace the lithium ion battery Do not attempt to replace the battery with non approved batteries Incorrect replacement of batteries could re...

Page 9: ...device continues to alarm call ManaMed Customer Service at 888 508 0712 DO NOT ATTEMPT TO FIX THE DEVICE Limited Warranty ManaMed Inc warrants to the original purchaser of its PlasmaFlow Vascular The...

Page 10: ...should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the PlasmaFlow requires continued oper...

Page 11: ...uch as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast andTV broadcast cannot be predicted theoretically with accuracy To assess the...

Page 12: ...46 888 508 0712 toll free CustomerService manamed net www manamed com PlasmaFlow is a registered trademark of ManaMed Inc ManaMed and the ManaMed logo are trademarks of ManaMed Inc Manufactured By Sca...

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