mectron Piezosurgery - Page 45

Manualofuseandmaintenance
EN
95
Guidance and manufacturer’s declaration - Electromagnetic immunity
ThePiezosurgeryMedicaldeviceisdesignedtoworkintheelectromagneticenvironmentspeciedbelow.
TheclientoruserofthePiezosurgeryMedicaldeviceshouldalwaysmakesurethatitisusedonlyinsuch
environment.
Immunitytest IEC60601
Testlevel
Compliancelevel Electromagnetic
environment-Guidance
Electrostatic
discharge(ESD)
IEC61000-4-2
±6kVcontact
±8kVair
Thedevicecontinues
toworkregularlyandin
safety.
Floorsmustbewood,
concreteorceramic.Ifthe
oorislinedwithsynthetic
materials,therelative
humidityshouldbeat
least30%
Electricalfast
transient/burst
IEC61000-4-4
±2kVforpowersupply
lines
±1kVforinput/outputlines
Thedevicecontinues
toworkregularlyandin
safety.
Thequalityofthepower
supplyshouldbethatof
atypicalcommercialor
hospitalenvironment.
Surge
IEC61000-4-5
±1kVindifferentialmode
±2kVincommonmode
Thedevicecontinues
toworkregularlyandin
safety.
Thequalityofthepower
supplyshouldbethatof
atypicalcommercialor
hospitalenvironment
Voltagedips,short
interruptionsand
voltagevariations
onpowersupply
inputlines
IEC61000-4-11
<5%U
T
(>95%dipinU
T
)
for0,5cycles
40%U
T
(60%dipinU
T
)
for5cycles
70%U
T
(30%dipinU
T
)
for25cycles
<5%U
T
(>95%dipinU
T
)
for5s
Thedevicecanvaryfrom
therequiredlevelsof
immunitywithadurationof
<5%/>95%/5saslong
asthedeviceremainsin
safety,nomalfunctions
havebeendetectedand
canberestoredtopre-test
statuswiththeintervention
oftheoperator.
Thequalityofthepower
supplyshouldbethatof
atypicalcommercialor
hospitalenvironment.
Powerfrequency
(50/60Hz)
magneticeld
IEC61000-4-8

3A/m Thedevicecontinues
toworkregularlyandin
safety.
Gridfrequencymagnetic
eldsshouldhavelevels
characteristicofatypical
commercialorhospital
environment
NOTE:U
T
isthea.c.mainsvoltagepriortoapplicationofthetestlevel.