Definición de variables

Well connect 6C po,er cord and turn on the po,er s,itch at the *ac+ of the machine *ut the 6C po,er light is off and the machine cannot *oot *# pressing the *oot +e# or it displa#s the  *atter# ,or+ing status after *oot' )f #ou confirm that the po,er is supplied *# 6C outlet normall# then the po,er fuse might *e *urnt out' 6t this time #ou should consider replacing the fuse tu*e of 6C po,er'

1）emo$e the po,er cordA

2 ） nscre, the fuse *o; lid at the *ottom of the machine ,ith scre,dri$er and remo$e  *urnt fuse tu*eA

B）eplace the fuse tu*e per designated specification and put on the lid ' Specification of fuse tu*e3 =/ /2=2=F

 :ote3 )f the fuse tu*e is un*urnt or *urnt again after replacing a ne, one of the same specification there might *e other failures of the machine please po,er off and contact Zoncare after-sale ser$ice department'

 _{o,er cord must *e remo$ed *efore replacing the fuse tu*eA 5nl# use the fuse tu*e of} 

designated specification'

'apter 7 <fter-sale Service

1' When the users *egin to use the ECG machine the# should fill out each item in ,arrant# card and send it *ac+ to Zoncare in time Zoncare ,ill *uild the users. profiles and contact them to +no, a*out the usage ,hich ,ill help pro$ide targeted first-rate ser$ices constantl#' 2' During normal use per this manual and operation notes if the machine fails please contact

Zoncare after-sale ser$ice center immediatel#' sers can en0o# free ser$ice ,ithin the stipulated time in ,arrant# card since the purchase da#'

B' Zoncare ma# fulfill its ,arrant# promise *# ,a#s of $isiting #our place telephone guidance or deli$er# *ac+ to Zoncare' '

' E$en ,ithin ,arrant# period the follo,ing ser$ices ,ill *e charged3 ①8ault and damage caused *# users. improper operationA

②8ault or damage caused *# falling do,n ,hile mo$ing the machine after purchaseA

③8ault and damage caused *# repairing transforming or decomposing the machine out of  Zoncare

④8ault and damage caused *# fire or natural disaster after purchaseA ⑤8ault and damage caused *# Zoncare unspecified thermal paperA ⑥8ault and damage caused *# connection ,ith other de$icesA

⑦Warrant# seal is *ro+en' sers pri$atel# alter and replace the series num*ers of the machine and lead ,ire' '

=' Zoncare ,ill assume no responsi*ilit# for fault of other connected de$ices directl# or  indirectl# caused *# this product.s fault'

' )f ,arrant# la*el is damaged Zoncare has the right to e;empt free ser$ice ,ithin stipulated time on ,arrant# card'

4' 8or chargea*le ser$ices out of ,arrant# period please continue to follo, !Ser$ice Contract ules"' 8or details please consult the customer ser$ice center of Zoncare'

<ppendi; ?

?(1 /erformance ?nde;

ead Standard or Ca*rera 12-lead s#nchronous

ac<uisition

Sampling ac<uisition ?H@

6mplitude-fre<uenc# characteristic /a+e 1H@ as *enchmar+ '=H@ ～ 1=H@ (-B'd* - O'd*%

/ime constant B'2 秒

CM  ＞?d&

)nput circuit current T'1U6

 :oise le$el T1=UFp-p

olari@ation resistance $oltage LB mF

Cali*ration $oltage 1mF L= 8ilter 6C=H@2d&； Sensiti$it# 1'2=mm7mF 2'= mm7mF = mm7mF 1 mm7mF 2 mm7mF  mm7mF automaticA S,itching error is L= aper speed = mm7s '2= mm7s 1 mm7s 12'= mm7s 2= mm7s =mm7s error is L=

ecording mode thermal arra# printing

rinting resolution I a;is ? dot7mm

9 a;is  dot7 mm (paper speed 2=mm7s% 2 dot7 mm (paper speed =mm7s%

aper specification ?mm(W% or =mm(W% 2m(% fast thermal rolling paper 

)ndication for poorl#-contacted electrodes )ndi$idual indication for each electrode

?(2 Safet ?nde;

?(2 Safet ?nde;

S

Saaffeett## ffllooaatteed d aannd d ddeeffii**rriillllaattiioon n pprrooooff

atient lea+ current atient lea+ current

normal

normal status status d'c'T'1m6 d'c'T'1m6 a'c'T'1m6a'c'T'1m6 single

single failure failure status status d'c'T'=m6 d'c'T'=m6 a'c'T'=m6a'c'T'=m6 Safet#

Safet#

clas

class s ) ) t#pe C8t#pe C8  ,ith protect,ith protecti$e circuit for i$e circuit for defidefi*rilla*rillation and tion and pacepace-- ma+ing

ma+ing Co

Contntininuouous us ,o,or+r+ining g titimeme momore re ththan an 1 1 hohoururss

?($ /ower Specifications

?($ /ower Specifications

6 6C C oo,,eerr 2222FFLL2222FF  ==HH@@LL11HH@@  44==FF66 &atter# &atter# recharge

rechargea*le li-ion a*le li-ion *atter# (12F71=m6h%*atter# (12F71=m6h% continuousl# ,or+ing for more than B hours continuousl# ,or+ing for more than B hours

?(8

?(8 <ppearance /arameters<ppearance /arameters

S Sii@@ee ((  > > W W > > HH% % 22mmm m >>22mmm m >>====mmmm W Weeiigghhtt aa**oouut t 22''22++gg

?(7 Environmental 'onditions

?(7 Environmental 'onditions

44 44

Operation Operation 6

6mm**iieennt t //eemmppeerraattuurree ==℃～℃～

6

6mm**iieennt t HHuummiiddiitt## 22??==

6

6ttmmoosspphheerriic c rreessssuurree 44++ppaa～～1+pa1+pa

=ransport and Storage =ransport and Storage 6m*ient /emperature

6m*ient /emperature －－22℃～℃～O==O==℃℃ 6

6mm**iieennt t HHuummiiddiitt## 11～～== 6

6ttmmoosspphheerriic c rreessssuurree ==++ppaa～～1+pa1+pa

?(3 <der

?(3 <derence to ence to StandardsStandards

G&7/ 11-2?

G&7/ 11-2? ac+aging-icac+aging-ictorial mar+ing for handling torial mar+ing for handling of goodsof goods

G&7/ -2?

G&7/ -2? General principles for preparation of instructions for use General principles for preparation of instructions for use ofof industrial producets

industrial producets

G&7/ 141-2 G&7/ 141-2

En$ironmental re<uirement and test methods for m En$ironmental re<uirement and test methods for m edicaledical electrical e<uipment

electrical e<uipment

)EC 1-2-2=3 211

)EC 1-2-2=3 211 Medical electrical e<uipment Medical electrical e<uipment art2-2=3articart2-2=3articular re<uirementsular re<uirements for the safet# of

for the safet# of electrocardioelectrocardiographsgraphs )EC 2=-132B

)EC 2=-132B u**er insulated ca*les of reted $oltages up to and includingu**er insulated ca*les of reted $oltages up to and including =74=F-art 13General re<uirements

=74=F-art 13General re<uirements )EC 224-1324

)EC 224-1324 ol#$in#l chloride insulated ca*les of rated $oltages up to andol#$in#l chloride insulated ca*les of rated $oltages up to and including =74=F- art 13General re<uirements

including =74=F- art 13General re<uirements )EC 1-132

)EC 1-132 Medical electrical e<uipment art Medical electrical e<uipment art 13General re<uirments for13General re<uirments for  *asic safet# and

 *asic safet# and essential performaessential performancence I

II I 1111BB--22  SSiinngglle e aannd d mmuullttii--cchhaannnneel l EECCG G mmaacchhiinnee II ==-212

II ==-212 ElecElectromatromagnetignetic c compcompati*ilati*ilit# it# (EMC% (EMC% stanstandarddards s for for medicmedicalal electrical e<uipment'

electrical e<uipment'

<ppendi; ??

<ppendi; ?? ElectromElectromagneticagnetic 'ompati.ilit 4EM'6'ompati.ilit 4EM'6

/he product meets the

/he product meets the re<uirements of EMC-Medical Electrical E<uipment in EMC re<uirements of EMC-Medical Electrical E<uipment in EMC standard3 )ECstandard3 )EC

4? 4?

 ℃℃

1-1-2' 1-1-2'

@O=E

@O=E

Asing te accessories" transducers" and ca.les out of stipulated range ma increase EM' Asing te accessories" transducers" and ca.les out of stipulated range ma increase EM' emission and9or decrease EM' immunit of tis device(

emission and9or decrease EM' immunit of tis device( =is device sould not .e

=is device sould not .e used adKacent to or staced wit used adKacent to or staced wit oter devices( 'losel o.serve teoter devices( 'losel o.serve te device if necessar to mae sure tat it

device if necessar to mae sure tat it runs normall in its configuration(runs normall in its configuration( =e device needs

=e device needs specspecial ial preprecautcautions regardions regarding its ing its EM'EM'" " and sould .e and sould .e instinstalled andalled and repaired in te environment were te following EM' information is satisfied(

repaired in te environment were te following EM' information is satisfied(

Even if tose oter devices meet te emission reuirements of '?S/0" still te ma cause Even if tose oter devices meet te emission reuirements of '?S/0" still te ma cause interference to tis device(

interference to tis device( %

%en en ininpuput t sisigngnal al amamplplititudude e is is lolowewer r ttan an tte e ststipipululatated ed mimininimumum m in in teteccninicacall specifications" it ma lead to inaccurate measurement(

specifications" it ma lead to inaccurate measurement(

/orta.le and mo.ile communication euipment will affect te

/orta.le and mo.ile communication euipment will affect te performperformance of ance of tis device(tis device(

#uidance and manufacturer’s declaration-- electromagnetic emissions #uidance and manufacturer’s declaration-- electromagnetic emissions /his machine is intended for

/his machine is intended for use in electromagnetic en$ironment specified *elo,'use in electromagnetic en$ironment specified *elo,' /he customer or the user of this machine should assure that it

/he customer or the user of this machine should assure that it is used in such en$ironment'is used in such en$ironment' E

Emmiissssiioonns s tteesstt ''oommpplliiaannccee EEMM' ' eennvviirroonnmmeennt t N N gguuiiddeelliinnee

8 emissions 8 emissions

C)S 11

C)S 11 Group 1Group 1

/h

/he e e<e<uiuipmpmenent t ususes es 8 8 enenererg# g# ononl# l# fofor r ititss internal function' /herefore its 8 emissions are internal function' /herefore its 8 emissions are $e

$er# r# llo, o, aand nd aarre e nonot t lili++elel# # to to ccaaususe e aan#n# interference to near*# electronic e<uipment'

interference to near*# electronic e<uipment' 8 emissions

8 emissions C)S

C)S Class 6Class 6

/

/hhe e ee<<uuiippmmeennt t iis s iinntteennddeed d ffoor r uusse e iin n aallll esta*lishments including domestic esta*lishments esta*lishments including domestic esta*lishments and

and thothose se dirdirecectl# tl# conconnecnected ted to to the the pu*pu*lic lic lo,lo,-- $o

$oltltagage e popo,e,er r susuppppl# l# nenet,t,oror+ + ththat at susupplpplieiess  *uildings used for dome

 *uildings used for domestic purposes'stic purposes' Harmonic Harmonic Emissions Emissions )EC 1-1-2 )EC 1-1-2 Class 6 Class 6 Foltage Foltage 8luctuation78lic+er  8luctuation78lic+er  emissions emissions )EC 1-1-2 )EC 1-1-2 Compliance Compliance %<0@?@# %<0@?@# 4 4

B =is macine can .e used . professional medical staff onl( =e device9sstem migt cause interference or distur.ance to te operation of near. euipment( =ere migt .e a need to tae alleviating measures" suc as adKusting te direction" placing te macine again or sielding relevant fields(

#uidance and manufacturer’s declaration-- electromagnetic emissions

/his machine is intended for use in electromagnetic en$ironment specified *elo,'

/he customer or the user of this machine should assure that it is used in such en$ironment'

?mmunit test ?E' 3!3!1 =est level 'ompliance level

EM' environment- guidance Electrostatic discharge (ESD% )EC 1--2 L +F contact L? +F air  L +F contact L? +F air 

8loors must *e ,ood concrete or ceramic tile' )f floors are co$ered ,ith s#nthetic material the relati$e humidit# should *e at least B' Electrical fast transient (E8/%7*urst )EC 1-- L2 +F po,er cord L1 +F )75 ca*les (ength VBm%' L2 +F po,er cord L1 +F input7output ca*les (VBm%

Mains po,er <ualit# should  *e that of t#pical commercial or hospital en$ironment' Surge )EC 1--= L1 +F differential mode L2 +F common mode L1 +F differential mode L2 +F common mode

Mains po,er <ualit# should  *e that of t#pical commercial or hospital en$ironment'

Foltage dips Short interruptions and $oltage $ariation on po,er suppl# input lines )EC 1--11 = / (V= dip in /% for '= c#cle  / ( dip in /% for = c#cles 4 / (B dip in /% for 2= c#cles = / (V= dip in /% for = s = / (V= dip in /% for '= c#cle  / ( dip in /% for = c#cle 4 / (B dip in /% for 2= c#cle = / (V= dip in /% for = s

Mains po,er <ualit# should  *e that of t#pical commercial or hospital en$ironment' )f the user of  this e<uipment re<uires continued operation during  po,er mains interruptions

)t is recommended that our   product *e po,ered from an

uninterrupti*le po,er  suppl# or a *atter#' o,er fre<uenc# (=7 HZ% magnetic field )EC 1--? B67m B67m

e$el characteristics of   po,er fre<uenc# magnetic

field should *e that of a t#pical location in a t#pical commercial or hospital en$ironment'

 :ote13 / is the 6'C' mains $oltage prior to application of the test le$el'

?2

#uidance and manufacturer’s declaration-- electromagnetic emissions

/he e<uipment is intended for use in the electromagnetic en$ironment specified *elo,' /he customer or the user of this machine should assure that it is used in such en$ironment

?mmunit test ?E' 3!3!1 =est level

'ompliance

level Electromagnetic environment Xguidance

Conduced 8 )EC 1-- B Frms 1=+H@ to ?MH@

BFrms _{orta*le and mo*ile 8 communications} E<uipment should *e used no closer to an#  part of the machine including ca*les than the

recommended separation distance calculated from the e<uation applica*le to the fre<uenc# of the transmitter'

ecommended separation distance d P 1'2 ;

√ 

 P adiated 8 )EC 1--B BF7m ?MH@ to 2'=GH@ B F7m d P 1'2 ;

√ 

 P  ? MH@ to ? MH@ d P 2'B ;

√ 

 P  ? MH@ to 2'=GH@

,here  is the ma;imum output po,er rating of the transmitter in ,atts (W% according to the transmitter manufacturer and d  _{is the}

recommended separation distance in meters (m%'

8ield strengths from fi;ed 8 transmitters as determined *# an electromagnetic site sur$e#

a

should *e less than the compliance le$el in each

fre<uenc# range

 :ote 1X 6t ? MH@ and ? MH@ the higher fre<uenc# range applies'

 :ote 2X /hese guidelines ma# not appl# in all situations' Electromagnetic propagation is affected *# a*sorption and reflection from structures o*0ects and people'

 8ield strengths from fi;ed transmitters such as *ase stations for radio (cellular7cordless% telephones and land mo*ile radios amateur radio 6M and 8M radio *roadcast and /F *roadcast cannot *e predicted theoreticall# ,ith accurac#' /o assess the electromagnetic en$ironment due to fi;ed 8 transmitters an electromagnetic site sur$e# should *e considered'

)f the measured field strength in the location in ,hich the e<uipment is used e;ceeds the applica*le 8 compliance le$el a*o$e the e<uipment should *e o*ser$ed to $erif# normal operation' )f a*normal  performance is o*ser$ed additional measures ma# *e necessar# such as reorienting or relocating the

0ecommended separation distances .etween porta.le and mo.ile 0C communication and te euipment

/he e<uipment is intended for use in an electromagnetic en$ironment in ,hich radiated 8 distur*ance are controlled' /he customer or the user of the e<uipment can help pre$ent electromagnetic interference  *# maintaining a minimum distance *et,een porta*le and mo*ile 8 communication e<uipment

(transmitters% and the e<uipment as recommended *elo, 0ated Output power of 

=ransmitter 4%atts6

Separation Distance <ccording to Creuenc of =ransmitter M 4Meters6

0ated Ma;imum

Output power of （%）

1= +H@～ ? MH@ d _{P 1'2} ? MH@～ ? MH@ d  _{P 1'2} ? MH@～ 2'= GH@ '1 '12 '12 '2B '1 'B? 'B? '4B 1 1'2 1'2 2'B 1 B'? B'? 4'B 1 12' 12' 2B'

8or transmitters at a ma;imum output po,er not listed a*o$e the recommended separation distanced in meters (m% can *e determined using the e<uation applica*le to the fre<uenc# of the transmitter ,here  is the ma;imum output po,er rating of the transmitter in ,atts (W% according to the transmitter  manufacturer'

 :ote3 6t ? MH@ and ? MH@ the separation distance for the higher fre<uenc# range applies'  :ote3 /hese guidelines ma# not appl# in all situations' Electromagnetic propagation is affected *# a*sorption and reflection from structures o*0ects and people'

<ppendi; ??? Environmental /rotection Declaration

@ames and contents of to;ic or aardous su.stances or elements in products  :ame

/o;ic or ha@ardous su*stances or elements

* Hg Cd Cr（F)）  && &DE

In document UNIVERSIDAD MIGUEL HERNÁNDEZ DE ELCHE FACULTAD DE MEDICINA TESIS DOCTORAL (página 87-182)