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23

Electromagnetic Capability

IMMUNITY TEST

IEC 60601 Test Level

Compliance Level

Electromagnetic 

Environment - Guidance

ELECTROSTATIC DISCHARGE 

(ESD)

RF emissions

CISPR 11

Group 1

The medi pcs uses RF energy 

only for its internal function.  

Therefore, its RF emissions 

are very low and are no likely 

to cause any interference in 

nearby electronic equipment.

ELECTRICAL FAST 

TRANSIENT/BURST

IEC 610004-4

+2kV for power supply lines

+2kV for power supply lines

Mains power quality 

should be that of a typical 

commercial or hospital 

environment

Surge

IEC 61000-4-5

+1kV line(s) to line(2)

+2kV  line(s) to earth

1kV line(s) to line(2)

+2kV  line(s) to earth

Mains power quality 

should be that of a typical 

commercial or hospital 

environment.

Voltage dips, short interrup-

tions and voltage variations 

on power supply input lines

IEC 61000-4-11

0 % UT; 0,5 cycle 

At 0°, 45°, 90°, 135°, 180°, 225°, 

270° and 315°

0 % UT; 1 cycle

and

70 % UT; 25/30 cycles h)

Single phase: at 0°

0 % UT; 250/300 cycle

0 % UT; 0,5 cycle 

At 0°, 45°, 90°, 135°, 180°, 225°, 

270° and 315°

0 % UT; 1 cycle

and

70 % UT; 25/30 cycles h)

Single phase: at 0°

0 % UT; 250/300 cycle

Mains power quality 

should be that of a typical 

commercial or hospital 

environment.  If the user 

of the medi pcs requires 

continued operation during 

power mains interruptions, 

it is recommended that the 

medi pcs be powered from an 

uninterruptible power supply 

or a battery.

Power frequency (50/60 Hz) 

magnetic field

IEC 61000-4-8

30 A/m

30 A/m

Power frequency magnetic 

fields should be a levels char-

acteristic of a typical location 

in a typical commercial or 

hospital environment.

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

NOTE:  UT is the A.C. mains voltage prior to application of the test level.

The medi pcs is intended for use in the electromagnetic environment specified below.  

The customer or the user of the medi pcs should assure that it is used in such an environment.

Summary of Contents for Pcs brio

Page 1: ...medi pcsbrio medi pcs brio pneumatic compression system Operator s Manual...

Page 2: ...2...

Page 3: ...session 6 4 Turning off the PCU 6 5 Error screen 7 1 Storing the medi pcs brio 7 2 Cleaning the medi pcs brio 8 1 Troubleshooting 8 2 Warranty return policy 8 3 Safety warnings precautions 8 4 Labels...

Page 4: ...stingpulmonary edema existingpulmonaryembolism inflammatoryphlebitis severecongestivecardiacfailure severeatherosclerosisor otherischemicvasculardiseases anycircumstancewhere increasedvenousandlymphat...

Page 5: ...ression garment sizing and application information 4 Power Supply The power supply 2 1 4 connects the PCU to an electrical outlet Step 1 When your medi pcs brio arrives carefully unpack the contents a...

Page 6: ...he garment going up the garment from distal to proximal The step value setting can be changed in 1 mmHg increments ranging from 1 60 mmHg However the step value range is limited such that no chamber w...

Page 7: ...distal pressure is set to 50 mmHg with a step value of 3 mmHg Chamber 1 2 3 4 5 6 mmHg 50 47 44 41 38 35 Example 2 An 8 chamber garment whole leg or arm where the distal pressure is set to 80 mmHg wit...

Page 8: ...e medi pcs brio is now ready to operate Please review the settings displayed in the Treatment Summary screen to ensure that all settings have been entered correctly If you must unlock or change the tr...

Page 9: ..._____________________________ Language ______________________________ Treatment time ____________________________ Distal pressure ______________________________ Access level __________________________...

Page 10: ...cm Lower Leg Sizing Measurements T i p o f M i d d l e F i n g e r t o A x i l l a C G Floor to Knee Crease B C Floor to Gluteal Fold C G B Arm Garment Sizing Measurements Size Item Leg Length Circumf...

Page 11: ...before applying If desired apply a liner over the limb before applying the garment This will help keep the garment clean during use Loose unrestrictive clothing such as sweatpants or cotton t shirts m...

Page 12: ...arment either slide your limb out of the garment or undo the hook and loop material and remove your limb It is recommended to keep the hook and loop material fastened even when the compression garment...

Page 13: ...e latch mechanism and pulling the connector out The blocking port can remain in place for future treatment sessions Step 1 Locate the garment connectors at the end of the hoses attached to the garment...

Page 14: ...appear 6 4 The PCU will begin the fill to fit process after which the programmed treatment cycle will begin The Treatment Running screen will show treatment time remaining current active chamber in us...

Page 15: ...t Summary Screen Press the power switch on the back of the PCU to turn off the medi pcs brio Please note that the PCU inflation deflation valves close while the PCU is turned off If a garment is conne...

Page 16: ...sure that the power supply is unplugged before cleaning the PCU Gently wipe the PCU with a slightly damp cloth Do not allow any moisture or liquid to enter the device If additional cleaning is require...

Page 17: ...d any rapid movements or drastic posture changes during the first 5 10 minutes of treatment 2 Verify that the correct treatment settings have been selected by referring to the Treatment Summary screen...

Page 18: ...e or service the device while in use To completely eliminate power disconnect the power supply from the Pressure Control Unit or from the wall outlet Warning Electric Shock Hazard Unplug power supply...

Page 19: ...nce pain or notice your condition worsening contact your physician Do not change your treatment settings without consulting your physician Warning Parental Supervision Children under the age of 18 sho...

Page 20: ...ing the safety requirements specified for Class II equipment according to IEC 61140 Non ionizing electro magnetic radiation ISO 7000 IEC 60417 Graphical symbols for use on equipment 5140 To indicate o...

Page 21: ...47 Part15 Subpart B ICES 001 ISSUE 4 AS NZS CISPR 11 JIS T 0601 1 2 ABNT NBR IEC 60601 1 2 LEGAL MANUFACTURER medi USA LP 6481 Franz Warner Parkway Whitsett NC 27377 www mediusa com Made in USA Tempe...

Page 22: ...perating normally WARNING Use of accessories transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or...

Page 23: ...cle At 0 45 90 135 180 225 270 and 315 0 UT 1 cycle and 70 UT 25 30 cycles h Single phase at 0 0 UT 250 300 cycle 0 UT 0 5 cycle At 0 45 90 135 180 225 270 and 315 0 UT 1 cycle and 70 UT 25 30 cycles...

Page 24: ...ncy range b Interference may occur in the vicinity of equipment marked with the following symbol Guidance and Manufacturer s Declaration Electromagnetic Immunity NOTE 1 At 80 MHz and 800 MHz the highe...

Page 25: ...o any part of the medi pcs including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance E 6 d P...

Page 26: ...nd mobile RF communications equipment transmitters and the medi pcs as recommended below according to the maximum output power of the communications equipment For transmitters rated at a maximum outpu...

Page 27: ...27 For other language translations please visit www mediusa com...

Page 28: ...medi USA 6481 Franz Warner Parkway Whitsett NC 27377 info mediusa com T 800 633 6334 F 888 570 4554 mediusa com PBO157 Rev A...

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