51
Operating Instruction TNI soft Flow 50 homecare system
Guidance and manufacturer’s declaration - electromagnetic immunity
TheTNI soft Flow 50isintendedforuseintheelectromagneticenvironmentspeciedbelow.
ThecustomerortheuseroftheTNI soft Flow 50shouldassurethatitisusedinsuchanenvi-
ronment.
Immunitytest IEC60601
testlevel
Compliancelevel Electromagneticenviron-
ment-guidance
Electrostatic
discharge(ESD)
IEC61000-4-2
±8kVcontact
±15kVair
±8kVcontact
±15kVair
Floorsshouldbewood,con-
creteorceramictile.Ifoorsare
coveredwithsyntheticmaterial,
therelativehumidityshouldbe
atleast30%.
Electricalfast
transient/burst
IEC610004-4
±2kVforpower
supplylines
±1kVforinput/
outputlines
±2kVforpower
supplylines
[noinput/output
lineswith>3m
present]
Mainspowerqualityshouldbe
thatoftypicalcommercialor
hospitalenvironment.
Surge
IEC61000-4-5
±1kVline(s)to
line(s)
±2kVline(s)to
earth
±1kVline(s)to
line(s)
[noearthpresent]
Mainspowerqualityshouldbe
thatoftypicalcommercialor
hospitalenvironment.
Voltagedips,short
interruptionsandvoltage
variationsonpowersupply
inputlines
IEC61000-4-11
0%U
T
for0.5cycle
at0°,45°,90°,135°,
180°,225°,270°and
315°
0%U
T
1cycles
and
70%U
T
for30cycles
at0°
0%U
T
for300cycles
0%U
T
for0.5cycle
at0°,45°,90°,135°,
180°,225°,270°and
315°
0%U
T
1cycles
and
70%U
T
for30cycles
at0°
0%U
T
for300cycles
Mainspowerqualityshouldbe
thatoftypicalcommercialor
hospitalenvironment.Iftheuser
ofthe
TNI soft Flow 50re-
quirescontinuedoperationdur-
ingpowermainsinterruptions,it
isrecommendedthatthe
TNI soft Flow 50bepowered
fromanuninterruptiblepower
supplyorbattery.
Powerfrequency
(50/60Hz)
magneticeld
IEC61000-4-8
30A/m 30A/m Powerfrequencymagneticelds
shouldbeatlevelscharacter-
isticofatypicallocationina
typicalcommercialorhospital
environment
NOTEUTisthea.c.mainsvoltagepriortoapplicationofthetestlevel.
Table 7 - Guidance and manufacturer’s declaration - electromagnetic immunity 1