Gastrolyzer Gastro CH4ECK - Environment

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5!
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GastroCH
4
ECK
TM
Gastrolyzer®
'
'
Environment''
The!GastroCH
4
ECK™!complies!with!the!directive!EN!60601-1-2!electromagnetic!compatibility!but!can!
be!affected!by!cellular!phones!and!by!electromagnetic!interference!exceeding!the!levels!specified!in!
EN!50082:1!
Guidance!and!manufacturer’s!declaration:!Electromagnetic!Immunity!(IEC!60601-1-2)!
The!GastroCH
4
ECK™!is!intended!fo r!the!use!in!the!electromagnetic!environment!specified!below.!The!
customer!or!the!user!of!the!GastroCH
4
ECK™!should!assure!that!it!is!used!in!such!an!environment.!
Immu n ity !te st !!
!
IEC!606 0 1 !Te s t!le ve l!!
!
Compliance!level!!
!
Electromagnetic!environment!–!
guidance!!
!
Conducted!RF!IEC!
61000-4-6!!
Radiated!RF!IEC!
61000-4-3!!
3!V!rms!150!kHz!~!
80MHz!outside!ISM!
bands*!!
10!V!rms!150!kHz!~!
80MHz!in!ISM!
bands*!!
10!V!rms!80!kHz!~!
2.5!GHz!!
3!V!rms!!
3!V/m!!
80MHz!to!2.5GHz!!
!
Portable!and!mobile!RF!
communications!equipm ent!should!
be!used!no!closer!to!any!part!of!the!
GastroCH4ECK!including!cables,!
than!the!recom m e nd ed !sep ara tion!
distance!calculated!from!the!
equation!appropriate!to!the!
frequency!of!th e!tran sm itte r.!!
Interfere n ce !may!occur!in!th e !
vicinity!of!equipment!marked!with!
the!following!sym b ol:!!
!
!
Note!1:!At!80!M Hz!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.!
The!ISM!(industrial,!scientific,!and!medical)!bands!between!150!kHz!and!80!MHz!are!6.765!MHz!to!
6.795!MHz;!13.553!MHz!to!13.567!MHz;!26.957!MHz!to!27.283!MHz;!and!40.66!MHz!to!40.70!MHz.!!
The!compliance!levels!in!the!ISM!frequency!bands!between!150!kHz!and!80!MHz!and!in!the!
frequency!ran ge !80!M H z !to!2.5!G H z!are !inten d ed !to!de crea se!th e!likelih oo d!th at!m o bile /po rtab le!
communications!equipm ent!could!cause!interference!if!it!is!inadvertently!brought!into!patient!areas.!
For!this!reason,!an!additional!factor!of!10/3!is!used!in!calculating!the!recommended!separation!
distance!for!transmitters!in!these!frequency!ranges.!!
Field!strengths!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!elec trom a gne tic!site!surv ey!sh ou ld!be !con side red .!If!the!m easu red !field!stren gth !in!
the!location!in !w h ic h!t h e! GastroCH
4
ECK™!!is!used!e x ce ed s !th e !a pp lic a ble !R F !co mpliance!level!ab o v e,!
the!GastroCH
4
ECK™!should!be!observed!to!verify!normal!operation.!If!abnorm al!performan ce!is!
observed,!additional!measures!may!be!necessary,!such!as!reorienting!or!relocating!the!
GastroCH
4
ECK™.!!
Over!the!frequency!ranges!150!kHz!to!80!MHz!field!strength!should!be!less!than!3!V/m.!
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