EDAN SE-12 Series User Manual
EDAN SE-12 Series is a portable electrocardiograph that is designed to provide accurate and reliable ECG recordings. It is lightweight and easy to use, making it ideal for use in a variety of settings, including hospitals, clinics, and home healthcare. The SE-12 Series features a large, high-resolution display that makes it easy to view ECG waveforms. It also has a built-in thermal printer that allows you to print out ECG recordings for later review. The SE-12 Series is a versatile device that can be used to perform a variety of ECG tests, including resting ECGs, exercise ECGs, and arrhythmia monitoring. It is also compatible with a variety of accessories, such as external defibrillators and pacemakers.
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Vedrørende denne brochure
P/N: 01.54.032423
MPN: 01.54.032423030
Udgivelsesdato: december 2018
© Alle EDAN INSTRUMENTS, INc. 2007-2018. Alle rettigheder forbeholdes.
ERKLÆRING
Denne vejledning hjælper dig med at få en bedre forståelse af produktets drift og vedligeholdelse.
I denne påmindelse skal brugen af produktet nøje overholde denne håndbog. Brugerens drift er ikke i overensstemmelse med denne vejledning kan forårsage fejl eller ulykker, Libang
Instrument Co., Ltd. (i det følgende benævnt Libang) er ikke juridisk ansvarlig.
Libang har ophavsret til denne håndbog. Intet materiale indeholdt i denne vejledning må fotokopieres, kopieres eller oversættes til andre sprog uden forudgående skriftligt samtykke fra lederen.
Materialer, der er beskyttet af loven om ophavsret, herunder men ikke begrænset til tekniske oplysninger, patentoplysninger og andre fortrolige oplysninger, er inkluderet i denne vejledning, og brugeren må ikke videregive sådanne oplysninger til nogen uafhængig tredjepart.
Brugere bør forstå, at der ikke er nogen udtrykkelig eller implicit ret eller tilladelse i denne vejledning til at give dem nogen intellektuel ejendomsret.
Libang har ret til at ændre, opdatere og i sidste ende forklare denne vejledning.
OPLYSNINGER OM PRODUKTER
Produktnavn: Elektrokardiograf
Model: SE-12, SE-12 Express, SE-1200, SE-1200 Express, SE-1201
Fabrikantens ansvar
Libang er kun ansvarlig for enhver indvirkning på enhedens sikkerhed, pålidelighed og ydeevne under følgende omstændigheder:
I
Monteringsoperation, forlængelse, omjustering, ændring eller reparation af personer, der er godkendt af Libang, og
Den elektriske installation af det relevante rum opfylder de nationale standarder, og måleren bruges i overensstemmelse med brugsanvisningen.
Vilkår anvendt i denne brochure
Denne vejledning har til formål at give nøglebegreber til sikkerhedsforanstaltninger.
Advarsel
Advarselsmærket anbefaler ikke at tage visse handlinger eller omstændigheder, der kan forårsage personskade
Skader eller død.
Forsigtighed
Advarselsetiketten anbefaler ikke handlinger eller situationer, der kan beskadige enheden, generere unøjagtige data eller ugyldiggøre programmet.
Bemærk
Kommentarer giver nyttige oplysninger om funktioner eller procedurer.
II
Indholdsfortegnelse
Kapitel 1 Sikkerhedsvejledning. . . . . . . . . . . . . . . . . . . . . . . 1
1.1 Vejledninger/brugsanvisninger. . . . . . . . . . . . . . . . . . . . . 1
Generelle forholdsregler. . . . . . . . . . . . . . . . . . . 6
Forberedelse og drift advarsler (for SE-12 Express motion elektrokardiogram). . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . 7
Kontraindikationer (for SE-12 hurtig øvelse elektrokardiogram). . . . . . . . . . . . . . . . . .
1.3 Symbolliste. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Kapitel II Introduktion. . . . . . . . . . . . . . . . . . . . . . 12
2.1 Øverste panel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
2.3 Front panel. . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
2.5 Højre panel. . . . . . . 18
2.6 Bundplade. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
2.7 Funktioner. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Det tredje kapitel er kirurgisk forberedelse. . . . . . . . . . . . . . . . . . 22
. . . . . . . . . . . . . . . 22
3.1.1 Tilslut patientkablet til elektrokardiografen. . . . . . . . . . . . . . . . . . 23
. . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
3.3 Vedhæft elektroderne til patienten. . . . . . . . . . . . . . . . . . . . . . . . 24
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
3.6 Optagelsespapiret indlæses. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Kapitel 4 Grundlæggende operationel vejledning. . . . . . . . . . . . . . . . . . . . . . 35
4.3 Beskrivelse af arbejdsmønstret. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Iii
10.10 Systemvedligeholdelsesindstillinger 56
Kapitel 11 Motion Electrocardiogram Operation Instruktioner (kan konfigureres til SE-12
Iv
V
SE-12 serie EKG manual sikkerhedsvejledning
Kapitel 1 Sikkerhedsvejledning
Dette kapitel indeholder vigtige sikkerhedsoplysninger relateret til brugen af SE-12-serien elektrokardiografer.
1.1 Anvendelses-/forventet brugsanvisning
Den tilsigtede anvendelse af SE-12-serien elektrokardiografen er at indsamle EKG-signaler fra voksne og børn (fra fødsel til 21 år) gennem overfladen EKG-elektroder. Elektrokardiografer anvendes kun på hospitaler eller sundhedsfaciliteter af læger og veluddannede sundhedspersonale. Elektrokardiogrammet optaget af elektrokardiografen kan hjælpe brugeren med at analysere og diagnosticere hjertesygdomme. Forklaring af EKG med måling og fortolkning
Erklæringen er kun tilgængelig for klinikere som rådgivning.
1. Advarsel
2. Denne enhed er ikke designet til intrakardial brug eller direkte hjerteapplikationer.
3. Denne enhed er ikke hjemme.
4. Dette udstyr anvendes ikke til behandling eller overvågning.
5. Denne enhed bruges kun til voksne og børn.
Resultaterne af instrumentet skal undersøges i overensstemmelse med patientens overordnede kliniske tilstand og kan ikke erstatte den rutinemæssige undersøgelse.
1.2 Advarsler og advarsler
For at kunne bruge elektrokardiografen sikkert og effektivt for at undgå de farer, der kan skyldes ukorrekt drift, skal du læse manualen og være fortrolig med enhedens funktioner og korrekte driftsprocedurer, inden du bruger den.
Vær opmærksom på følgende advarsler og forholdsregler.
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SE-12 serie EKG manual sikkerhedsvejledning
1.2.1 Advarsel om sikkerhed
1. Advarsel
2. Elektrokardiogrammet bruges af kvalificerede læger eller professionelt uddannet personale. De bør være bekendt med indholdet af denne manual inden operationen.
3. Kun kvalificerede serviceingeniører kan installere denne enhed, og kun serviceingeniører, der er autoriseret af producenten, kan åbne kabinettet.
Ellers kan der opstå sikkerhedsrisici.
4. Eksplosionsfare-Brug ikke en elektrokardiograf, hvis det brændbare bedøvelsesmiddel blandes med ilt eller andre brændbare stoffer.
5. Fare for elektrisk stød-stikkontakten skal være en jordforbindelse på hospitalet.
Forsøg ikke at justere trigeminalstikket til en to-slot stikkontakt. Denne enhed kan kun tilsluttes en strømforsyning med beskyttet jordforbindelse.
6. Før du tilslutter eller afbryder enheden, skal du sørge for, at strømmen er slukket, og at ledningen er afbrudt fra stikkontakten. Ellers kan elektrisk stød eller anden skade forekomme hos patienten eller operatøren.
7. Hvis integriteten af den eksterne beskyttelsesleder er i tvivl, skal enheden drives af et internt lithium-ion genopladeligt batteri.
8. Brug ikke denne enhed i tilfælde af højspændingsudstyr med høj statisk elektricitet eller gnister.
9. Kun patientkabler og andet tilbehør, der leveres af producenten, kan anvendes.
Ellers kan ydeevne og elektrisk stød ikke garanteres.
10. Brugen af patientkabler og andre tilbehør, der leveres af ikke-producenter, kan resultere i øget stråling eller nedsat immunitet.
11. Elektrokardiografen har bestået sikkerhedsdetektering af anbefalede tilbehør, perifere enheder og ledninger, og der er ikke fundet nogen fare, når elektrokardiografen arbejder med en pacemaker eller anden stimulator.
12. Sørg for, at alle elektroder er korrekt forbundet til patienten før operationen.
Sørg for, at den ledende del af elektroden og den tilhørende konnektor, herunder den neutrale elektrode, ikke er i kontakt med jorden eller andre ledende genstande.
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SE-12 serie EKG manual sikkerhedsvejledning
13. Advarsel
14. En engangselektrode skal anvendes til defibrillering.
15. Elektroder af heterogene metaller bør ikke anvendes; Ellers kan det forårsage høj polarisationsspænding.
16. Engangselektroden kan kun bruges en gang.
17. Rør ikke ved patienter, senge, borde eller enheder, når du bruger EKG og defibrillatorer.
18. Kontakt ikke det ikke-medicinske elektriske udstyr og de dele, der er tilgængelige for patienten på samme tid.
19. Tryk ikke på signalindgangen eller udgangskontakten og patienten på samme tid.
20. Udstyr, der anvender højfrekvent spænding til patienter (herunder elektrokirurgisk udstyr og nogle respiratoriske transducere), understøttes ikke og kan producere uønskede resultater. Afbryd patientens datakabel fra elektrokardiografen eller afbryd ledningen fra patienten, inden du udfører et program, der bruger højfrekvent kirurgisk udstyr.
21. Hvis der anvendes WIFI-teknologi, skal installationen og driften af WIFI være mindst
20 cm mellem radiatoren og menneskekroppen for at opretholde overholdelse af
FCC RF eksponeringsretningslinjer. Beskyttelsesdæksel bør ikke installeres i eller omkring et værelse, der bruger WIFI.
22. Fokus på inspektioner for at undgå udeladelse af vigtige hjertebølger.
23. Fare for elektrisk stød-Når ikke-medicinsk udstyr er beregnet til at blive drevet af flere bærbare stikkontakter med isolationstransformatorer, skal du ikke forbinde ikke-medicinsk elektrisk udstyr, der drives som en del af systemet, direkte til vægstikket.
24. Fare for elektrisk stød-Tilslut ikke elektrisk udstyr, der ikke leveres som en del af systemet til flere bærbare stikkontakter, der leverer strøm til systemet.
25. Tilslut ikke udstyr eller tilbehør, der ikke er godkendt af producenten eller ikke godkendt af IEC/EN 60601-1 til elektrokardiografen. Uautoriseret udstyr eller tilbehør betjenes eller anvendes med elektrokardiografen uden test eller support, og
EKG-drift og sikkerhed er ikke garanteret.
Intet ikke-medicinsk udstyr (såsom en ekstern printer) er tilladt at blive brugt i nærheden af patienten
(1,5m/6ft.).
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SE-12 serie EKG manual sikkerhedsvejledning
26. Advarsel
27. Når du bruger flere bærbare stikkontakter til at drive systemet, må du ikke overskride den maksimale tilladte belastning.
28. Flere bærbare stikkontakter må ikke placeres på gulvet.
29. Brug ikke flere ekstra bærbare stikkontakter eller forlængelsesledninger i et medicinsk elektrisk system, medmindre producenten udpeger det som en del af systemet. En flerhed af bærbare stikkontakter, der er tilvejebragt af systemet, kan kun bruges til at drive en enhed, der skal indgå i systemet.
30. Vedhæftningsenheder, der er tilsluttet analoge og digitale grænseflader, skal certificeres i overensstemmelse med deres respektive IEC/EN-standarder (f.eks.
IEC/EN 60950 for databehandlingsudstyr og IEC/EN 60601-1 for medicinsk udstyr).
Derudover skal alle konfigurationer være i overensstemmelse med en gyldig version af IEC/EN 6001-1-standarden. Derfor skal enhver, der forbinder den ekstra enhed med signalindgangs- eller udgangskontakten for at konfigurere det medicinske system, sikre, at det opfylder a) En gyldig version af systemstandarden IEC/EN 60601-1. Hvis du har spørgsmål, bedes du kontakte vores tekniske serviceafdeling eller din lokale forhandler. b) Tilslutning af en vedhæftet fil (f.eks. En ekstern printer) eller en anden enhed
(f.eks. En computer) til denne elektrokardiograf udgør et medicinsk system. I dette tilfælde skal der træffes yderligere sikkerhedsforanstaltninger under systeminstallationen, og systemet skal give:
31. I patientmiljøet svarer det til det sikkerhedsniveau, der leveres af medicinsk elektrisk udstyr, der opfylder IEC/EN 60601-1, og
32. Et passende sikkerhedsniveau for ikke-medicinsk elektrisk udstyr, der opfylder andre
IEC eller ISO sikkerhedsstandarder uden for patientmiljøet.
33. Hvis alle vedhæftede filer, der er tilsluttet systemet, ikke opfylder kravene i IEC/EN
60601-1, skal de installeres uden for patienten.
Du bør købe en computer, printer, tredemølle, effektmåler og blodtryksmonitor fra producenten. Ellers er producenten ikke ansvarlig for vedligeholdelsen af pc-hardware, operativsystem og andet tilbehør.
Hvis flere instrumenter er forbundet til en patient, kan summen af lækstrømmen overstige grænserne i IEC/EN 60601-1 og kan udgøre en sikkerhedsrisiko. Kontakt din servicepersonale.
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34. SE-12 serie EKG manual sikkerhedsvejledning
35. Advarsel
36. Den potentielle udligningslinje kan tilsluttes den potentielle udligningslinje for andre enheder, hvis det er nødvendigt. Sørg for, at alle enheder er forbundet til den potentielle udligningsterminal.
37. Elektrokardiogrammet må ikke repareres eller vedligeholdes, når det bruges sammen med patienten.
38. Den elektriske kobler eller stikkontakt bruges som en isolationsanordning fra strømforsyningen. Placer elektrokardiografen i en position, hvor operatøren nemt kan få adgang til den frakoblede enhed.
39. Medicinsk elektrisk udstyr skal installeres og tages i brug i overensstemmelse med bilag 2EMC-oplysninger.
40. Enheden bør ikke bruges ved siden af andre enheder eller stables med andre enheder. Se venligst den anbefalede intervalafstand, der er angivet i bilag 2 EMCoplysninger.
41. Bærbare og mobile RF-kommunikationsenheder kan påvirke medicinsk elektrisk udstyr, se den anbefalede intervalafstand, der er angivet i bilag 2 EMC-oplysninger.
42. Sammensætningen af elektrokardiografen og ændringerne i løbet af den faktiske levetid skal vurderes i overensstemmelse med kravene i IEC60601-1.
Denne enhed er ikke sikker. Det er ikke beregnet til brug i MRmiljøer.
Magnetiske felter og elektriske felter kan forstyrre enhedens normale ydeevne.
Sørg derfor for, at alle eksterne enheder, der arbejder i nærheden af enheden, opfylder de relevante EMC-krav. Røntgenapparater eller MR-enheder er en mulig kilde til interferens, fordi de kan udsende højere niveauer af elektromagnetisk stråling.
1. 1.2.2 Advarsel om vedligeholdelse af lithium-ion-batterier
Advarsel
Forkert drift kan resultere i opvarmning, tænding eller eksplosion af et internt lithium-ion-batteri (i det følgende benævnt et batteri) og kan resultere i et fald i batterikapaciteten. Det er nødvendigt at læse brugervejledningen omhyggeligt og være mere opmærksom på advarsler.
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2. SE-12 serie EKG manual sikkerhedsvejledning
3. Advarsel
4. Kun kvalificerede serviceingeniører, der er godkendt af producenten, kan åbne batterirummet og udskifte batteriet og skal bruge batterier af samme model og specifikationer som producenten.
5. Der er fare for eksplosion-vend ikke de positive og negative elektroder, når du installerer batteriet.
6. Opvarm ikke eller sprøjt batteriet eller kast det i ild eller vand.
7. Må ikke ødelægge batteriet; Brug ikke skarpe genstande som nåle til at gennembore batteriet; Brug ikke en hammer til at slå, træde eller kaste for at forårsage stærk vibration; Fjern ikke eller modificer batteriet.
8. Når lækage eller lugt er fundet, skal batteriet stoppes straks. Hvis din hud eller klud kommer i kontakt med den lækkede væske, skal du straks rense den med vand. Tør ikke af, hvis lækagen sprøjtes i øjnene. Vandet først med vand og gå til lægen med det samme.
9. Håndter eller genanvend udtømte batterier i overensstemmelse med lokale bestemmelser.
10. Batteriet kan kun installeres eller fjernes, når enheden er slukket.
Når elektrokardiogrammet ikke er i brug i lang tid, skal du fjerne batteriet fra elektrokardiografen.
Hvis batteriet opbevares separat og ikke bruges i lang tid, anbefaler vi, at batteriet oplades mindst en gang hver 6. måned for at forhindre overudladning.
1. 1.2.3 GENERELLE SPØRGSMÅL
2. Forsigtighed
3. Føderal (amerikansk) lov begrænser sådanne enheder fra kun at blive solgt af en læge eller i henhold til en læge ordre.
Undgå flydende stænk og høje temperaturer. Temperaturen under drift skal holdes mellem 5 ° C og 40 ° C, og bør opretholdes mellem -20 ° C og 55 ° C under transport og opbevaring.
Brug ikke denne enhed i et støvet, dårligt ventileret eller ætsende miljø.
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4. SE-12 serie EKG manual sikkerhedsvejledning
5. Forsigtighed
6. Sørg for, at der ikke er nogen stærk elektromagnetisk interferenskilde omkring enheden, såsom en radiosender eller mobiltelefon. Bemærk: Stort medicinsk elektrisk udstyr som elektrokirurgisk udstyr, strålingsudstyr og magnetisk resonansbilleddannelsesudstyr kan medføre elektromagnetisk interferens.
En brudt sikring kan kun udskiftes med en sikring af samme type og rating som den oprindelige sikring.
Udstyr og tilbehør skal bortskaffes i overensstemmelse med lokale bestemmelser efter udløbet af levetiden.
Derudover kan de returneres til forhandleren eller producenten til genbrug eller korrekt bortskaffelse.
Batteriet er farligt affald. Håndter dem ikke med husholdningsaffald. I slutningen af batteriets levetid overleveres batteriet til det relevante indsamlingssted for genbrug af affaldsbatteriet. For mere information om genbrug af produktet eller batteriet, bedes du venligst
Kontakt venligst dit lokale kommunale kontor eller den butik, hvor du køber produktet.
1. 1.2.4 Advarsel om forberedelse og drift (SE-12 Express
2. Motion elektrokardiogram)
3. Advarsel
4. Test løbebåndets sikre stop (svampetype) og sikkerhedsstop (rebtype), før du bruger systemet.
Under øvelsestesten sikres det, at sådanne prøver overvåges af en veluddannet tekniker, der opfylder kravene til træningstestovervågning, har tilstrækkelig kardiopulmonal genoplivningstræning og støttes af en læge, der er bekendt med øvelsestesten eller akutmedicinen, der foretager en eventuel forbedring af vurderingen eller overholdelsen af prøven i nærheden.
Træningstestrummet er udstyret med det nødvendige effektive førstehjælpsudstyr, såsom defibrillatorer, blodtryksmålere mv. Og har de nødvendige effektive lægemidler.
Sluk for systemets strøm og afbryd strømledningen fra stikkontakten efter brug af systemet.
5. -7-
6. SE-12 serie EKG manual sikkerhedsvejledning
7. Advarsel
8. Sørg for, at strømmen er slukket før defibrillering, og strømledningen er afbrudt fra stikkontakten.
9. Hold maskinens fire fødder på jorden for at sikre, at maskinen fungerer stabilt.
10. Løbebåndet skal drives af en bestemt stikkontakt.
11. Kontroller løbebåndet/effektmåleren omhyggeligt, inden du bruger løbebåndet/effektmåleren.
12. Patienter, der gennemgår træningsprøver, skal have passende tøj og sko.
13. Hold dine hænder, hår, smykker og løse tøj væk fra bevægelige dele.
14. Lad ikke patienten stå på løbebåndet, når du starter løbebåndet. Under opstartsprocessen skal patienten stå på fodsporet og holde armlænet. Vent, indtil det løbende bælte bevæger sig, og læg foden på bæltet.
For at undgå statisk elektricitet bør patienter ikke bære løse tøj eller tøj, der er tilbøjelige til statisk elektricitet (såsom nylon).
Stop med at udøve straks, når patienten føler sig ubehagelig eller unormal under operationen.
1. Tryk på sikkerhedsblokken (svampetype) eller træk sikkerhedsblokken
(rebtype) ud for at stoppe løbebåndet straks i tilfælde af en nødsituation.
2. 1.2.5 Kontraindikationer (SE-12 Express Motion Electrocardiogram)
3. Absolut kontraindikationer:
4. Akut myokardieinfarkt (inden for 2 dage)
5. Høj risiko ustabil angina
6. Hemodynamisk skade forårsaget af ukontrolleret arytmi
7. Symptomatisk alvorlig aortastensose
8. Klinisk ude af kontrol hjertesvigt
Akut lungeemboli eller lungeinfarkt
Indfør sel
Defibri llering type
CF applik ations kompo
Nej.
Vareb eskriv else
PROD
UKTI
ON
Akut myocarditis eller perikarditis
Patienten modsatte testen.
1. -8-
2. SE-12 serie EKG manual sikkerhedsvejledning
3. Relative kontraindikationer:
4. Venstre hovedkranspulsstensose
5. Moderat stenotisk ventrikulær hjertesygdom
6. Unormal serumelektrolyt
7. Alvorlig hypertension (systolisk blodtryk > 200 mm Hg eller diastolisk blodtryk >
110 mm Hg)
8. Rapid arytmi eller langsom arytmi
Hypertrofisk kardiomyopati
Patien ten kan ikke samar bejde på grund af psyki ske lidels er eller fysisk handi cap
Høj atrioventrikul
ær blok 1.3 Symbolliste
Symboler
1
2
3
4
nent
Forsig tighed
Betjen ingsve jlednin g
Lige potenti el jordfor bindel se
5
6
7
Patient kabel stikkontakt
8
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Sikker hedsv ejledni ng
SDkortsp or
Net port
AC
Batteri inspek tion
Batteri oplad ningsi ndikat or
Strøm forsyni ng/nø gle
Genbr ug/ge nanve ndeligt univer selt symbo l
Materi ale numm er
Løben umme r
Frems tillings dato
16
17
18
19
20
14
15
11
12
9
10
SE-12 serie EKG bruger manual
13
USB stikkontakt
Fremstillere
Godke ndt repræ senta nt
Fælle sskab et
Europæere
21
CE-mærkning
22
Advarsel: Føderal (amerikansk) lov begrænser denne enhed til kun at være Lægenes ordre.
-10-
Sikker hedsv ejledni ng
24
SE-12 serie EKG bruger manual
23
Bortskaffelsesmetode
Se brugervejledning
(Baggrund: blå; symbol: hvid)
25
(Bagg runde n: gul; symbo ler og kontur er: sort)
Feder al
Comm unicati ons
Comm ission:
26*
27*
Advarsel
Ikke-ioniseret elektromagnetisk stråling
Indeholder FCC ID:
YOPGS 2011MIZ
Indeholder FCC ID: YOPGS 2011 MIZ
MR er ikke sikkervæk fra magn etisk reson ansbill eddan nelse
(MRI)
28
Udstyr
Overholder AAMI standarder. 601-1, IECstandard. 60601-2-25
29
1. Certificeret af CSA-standarden. C22.2 nr. 60601-1, CSA-standard. C22.2 Nej
2. 60601-2-25
Bemærk:
26 */27 *: Velegnet til enheder med trådløse funktioner.
Håndbogen er trykt i sort/hvid.
-11-
Introduktion til SE-12-serien EKG-manualen
Kapitel 2 Indledning
SE-12-serien elektrokardiografen indsamler samtidigt 12 ledende EKG-signaler. Det viser operationsmenuen, EKG-parametrene og elektrokardiogrammet.
Ved at bruge en højkvalitets termisk optager kan du se 12-kanals hjertebølger på LCD-skærmen og udskrive dem. De indsamlede EKG-data kan gemmes, transmitteres og udføres.
Manuel, automatisk, rytmisk, R-R analyse eller VCG (kun SE-12 Express, SE-1200 Express og SE-1201) er frit tilgængelige.
For SE-12 Express er motion-EKG-funktionen konfigurerbar. Når patienter med koronar hjertesygdom kører, kan øget hjertebelastning forårsage hypotension i hjertemusklen, hvilket igen forårsager unormale ændringer i elektrokardiogrammet. Derfor kan SE-12 Express motorelektrokardiogramfunktion bruges til at diagnosticere okkult koronar hjertesygdom og atypisk angina pectoris og ordinere arbejdsbyrde for patienter med myokardieinfarkt før afladning for at evaluere den terapeutiske virkning.
1 SE-12-serien elektrokardiografer kan drives af elektricitet eller batterier.
2 Konfiguration: vært, netledning, patientkabel, brystelektrode, lemelektrode, engangselektrode, klip/kort/bananstikadapter, varmt optagepapir, sikring, batteri.
Bemærk:
Billederne og vinduerne i denne vejledning er kun til reference.
Denne vejledning tager billeder og grænseflader af SE-12 Express som et eksempel, og de kan se lidt anderledes ud end din model.
2.1 Taget Indikato rer
LCD-skærm
Optager
Tastatur
Figur 2-1 SE-12 skitse
-12-
Introduktion til SE-12-serien EKG-manualen
D
C
E
Q
G O H N M 1
J
K
Figur 2-2 SE-12 Express tastatur Navn
Forklaring
Bemærk:
I
Disse knapper er kun tilgængelige, når tryk-EKG-funktionen er
F
P e r o g r u st at
T a
2.
2 p e r a p k n
B
A
aktiveret.
Fast det.
Indtast prøvefasen. Længden af præ-testfasen er ikke
A
Når startskærmen for bevægelsestesten vises, og
Træningstesten afsluttes, og tryk på denne knap for at indtaste en testfri tilstand.
Øvelser
Tryk for at komme ind i øvelsesfasen. I praksisfasen skal du trykke på dette
-13-
INDLEDNING
Navn
key to restart the test.
NOTE: Pressing the Stop tmill key cannot add the timing of the current phase during the exercise test.
B Function Key Press to select menu functions on the screen.
Nøglen går ind i næste fase af
øvelsen.
- 14 -
C
D
E
F
SE-12 Series Electrocardiograph User Manual
Name
Gender Key
Delete Key
Age Group Key
Enter
Explanation
Introduction
Press to quickly select the gender for the patient when Gender is selected in the Patient Information Setup window.
Press to delete characters.
Press to quickly select the age group on the main screen when you set Age to Age Group in the Patient Information Setup window.
Press to confirm operation.
Press to move the cursor:
Pressing Tab can move the cursor forward, and pressing Shift + Tab can move the cursor backward.
Press to feed paper:
G Tab/Feed paper
If Paper Marker is set to Yes , pressing Tab can advance the recorder paper to the next black marker; if Paper Marker is set to No, pressing
Tab can advance the paper for 2.5cm. Pressing Tab again can stop advancing the paper.
H
I
Fn
Arrow Keys
For SE-1201, press FEED to feed paper.
Press Fn and a letter key to type special characters.
Pressing Fn + a can type è .
Press to move the cursor or switch between options.
Press to start or stop printing reports
J PRINT/STOP Pressing Shift + PRINT/STOP can quickly enable or disable the print out function in the auto or rhythm mode.
K 1mV/COPY
In the manual mode, pressing the 1mV/COPY key can insert a 1mV calibration mark during the printing course.
In the auto, rhythm or VCG mode, pressing the 1mV/COPY key can print the ECG report which was printed out last time.
L SLEEP/WAKE UP Press to rest/waken the electrocardiograph
Press to select a working mode among the auto, manual, rhythm, R-R analysis and VCG modes.
M MODE NOTE: Only if a working mode is selected in the Work Mode Setup window, can the working mode be selected by pressing the
MODE key when the main screen is displayed.
N Power On/Off Power-on/Power-off
- 15 -
A
B
SE-12 Series Electrocardiograph User Manual
Name
O Spacebar
Explanation
Introduction
Press to add a space between typed characters or select/deselect a checkbox
Press to cancel operation
P Esc/Reset
NOTE: A large polarization voltage may cause baseline drift. On the main screen, pressing Esc can decrease the polarization voltage and draw the baseline to zero quickly.
Press Shift + Tab to move the cursor backward.
Q Shift
Press Shift and a number key to input the special character in the top right corner of the key.
If Caps Lock is set to Off , pressing Shift + P can type a capital P .
If Caps Lock is set to On , pressing Shift + P can type a lowercase p .
2.3 Front Panel
A BC
Figure 2-3 SE-12 Express Front Panel
Symbol Name Explanation
Mains supply indicator
When the device is powered by the mains supply, this indicator is lit.
Battery indicator
When the device is powered by battery, this indicator is lit.
- 16 -
SE-12 Series Electrocardiograph User Manual
Symbol Name Explanation
Introduction
C
Battery recharging When the battery is being recharged, this indicator is indicator lit.
2.4 Rear Panel
A
B C D
Name
Figure 2-4 SE-12 Express Rear Panel
Explanation
A Mains Supply Socket AC SOURCE: alternating current supply socket
B
Potential equalization conductor provides a connection between
Potential Equalization the unit and the potential equalization bus bar of the electrical
Conductor installation.
C Handle Part for people to hold
D Heat Emission Hole Path for internal heat emission
- 17 -
SE-12 Series Electrocardiograph User ManualIntroduction
2.5 Right Panel
CD
A B E
G
F
Figure 2-5 SE-12 Express Right Panel
Name Explanation
A Patient Cable Socket Connecting to the patient cable
Connecting to a PC
B Serial Port 1
C USB Socket 1
D
E
In the exercise test, only the treadmill/ergometer recommended by the manufacturer can be connected.
Standard USB socket, connecting to a PC
USB Socket 2
Standard USB socket, connecting to a U disk, a bar code reader or a USB printer recommended by the manufacturer
External Input / Output Connecting to the external signal device
Socket
F Serial Port 2
G Net port
USB interface.
In the exercise test, only the BP Monitor recommended by the manufacturer can be connected.
Standard net port, connecting to a PC
CAUTION
Only the USB equipment recommended by the manufacturer can be connected to the
- 18 -
SE-12 Series Electrocardiograph User ManualIntroduction
2.6 Bottom Panel
D
C D
B
E
A
Figure 2-6 SE-12 Express Bottom Panel
Name Explanation
A Speaker Hole
B Battery Compartment
Path for sound from speaker
Compartment for battery
C Fuse
D Heat Emission Hole
T1AL250VP, Ø5×20mm (for UL device)
Path for internal heat emission
The specification is: T3.15AH250V, Ø5×20mm
E Label Position for product information label
1) Battery Compartment
NOTE: If the battery has not been used for two months or more, you should recharge it before using it again.
2) Fuse
There are two fuses of the same specification installed on the bottom of the main unit.
WARNING
Ruptured fuses must only be replaced with those of the same type and rating as the original.
- 19 -
SE-12 Series Electrocardiograph User ManualIntroduction
2.7 Features
♦
Supporting AC and DC power supply modes, internal rechargeable li-ion battery with professional battery powered circuit, battery management and protection systems
♦ Supporting multi-language
♦
Full alphanumeric keyboard (For SE-12 Express/SE-1200 Express/SE-1201, touch screen is available)
♦
ECG signals of 12 leads are gathered and amplified simultaneously, 12-channel waves are displayed and recorded simultaneously
♦
Correct detection for failure electrodes
♦
Convenient operation of recording by pressing the PRINT/STOP key with high efficiency
♦ High resolution thermal recorder, recording frequency response ≤300Hz
♦
Supporting external USB printer
♦ Supporting accurate digital filter to decrease the polarization voltage and other interferences
♦
Despite that SE-1201 only supports folded paper, the other models can support both rolled and folded paper recorded with high resolution waveforms, calibration mark, gain, speed and filter
♦
The auto, manual, rhythm, R-R analysis and VCG (only configurable for SE-12
Express/SE-1200 Express/SE-1201) modes can be chosen freely
♦
Flexible printing formats
♦ Supporting ECG waves displaying with grid
♦
Automatic baseline adjustment for optimal printing
♦ Convenient operation of system setup and file management
♦
Multiple file formats: DAT, PDF and configurable formats (SCP/FDA-XML/DICOM)
♦
Measurement function and interpretation function
♦
Supporting bar code reader
♦
ECG data can be transmitted to the PC software through the serial cable, net cable, or
WIFI (configurable for SE-12 Express/SE-1200 Express/SE-1201)
♦
Real-time transmission to ECG data management software
♦
Supporting order function
♦
Ability to disable USB ports, which can enhance security of ECG data and lower the potential of distribution of computer viruses
♦
Supporting QTcFd and QTcFm formulae
- 20 -
SE-12 Series Electrocardiograph User ManualIntroduction
The following features are only for the exercise test function of SE-12 Express
(configurable)
♦ Real-time analysis, ST segment and trend are applied while sampling
♦
Real-time display and print of 12-lead simultaneous ECG waveforms with average template
♦
ST segment analysis while sampling; ST position is adjustable while sampling;
♦
Providing average templates of three rhythm leads in every stage to observe the change of ST segments between every two stages
♦
Automatically forming elaborate reports, including Summary Report, ST Scope Report,
Summary Average Template Report and Trend Graph Report
♦
Supporting magnifying or minifying the average templates
♦
Providing saving PDF files to U disk and transmitting PDF files to the server by implanting FTP protocol.
♦ Providing classical exercise protocols; exercise protocols can be edited and created
♦
Providing 30 exercise stages at most in a user-defined protocol
♦
Automatically controlling and adjusting the speed and grade of the treadmill or the power of the ergometer
♦
Supporting multi-types of treadmill or ergometer
- 21 -
SE-12 Series Electrocardiograph User ManualOperation Preparations
Chapter 3 Operation Preparations
WARNING
Before use, the equipment, patient cable and electrodes should be checked. Replace them if there is any evident defectiveness or aging which may impair the safety or the performance, and make sure that the equipment is in proper working condition.
3.1 Connecting the Patient Cable to the Electrocardiograph and Electrodes
WARNING
The performance and electric shock protection can be guaranteed only if the original patient cable and electrodes of the manufacturer are used.
The patient cable includes the main cable and lead wires which can be connected to electrodes.
Patient Cable for Resting ECG
Patient Cable for Exercise ECG
- 22 -
SE-12 Series Electrocardiograph User ManualOperation Preparations
3.1.1 Connecting the Patient Cable to the Electrocardiograph
Connect the patient cable to the patient cable socket on the right side of the main unit, and then secure them with two screws.
3.1.2 Connecting the Patient Cable to Electrodes
The identifiers and color codes of electrode connectors used comply with IEC/EN requirements.
In order to avoid incorrect connection, the identifiers and color codes are specified in Table 3-1.
Moreover the equivalent codes according to AHA requirements are given in Table 3-1 too.
Table 3-1 Electrode Connectors and Their Identifiers and Color Codes
Identifier
IEC
Color Code Color Code Identifier
AHA
R
L
N or RF
F
C1
C2
C3
C4
C5
Red
Yellow
Black
Green
White/Red
White/Yellow
White/Green
White/Brown
White/Black
RA
LA
RL
LL
V1
V2
V3
V4
V5
White
Black
Green
Red
Brown/Red
Brown/Yellow
Brown/Green
Brown/Blue
Brown/Orange
C6 White/Violet
3.2 Preparing the Patient
V6 Brown/Violet
3.2.1 Instructing the Patient
Before attaching the electrodes, greet the patient and explain the procedure. Explaining the procedure decreases the patient's anxiety. Reassure the patient that the procedure is painless.
Privacy is important for relaxation. When possible, prepare the patient in a quiet room or area where others can't see the patient. Make sure that the patient is comfortable. The ECG is affected by noise related to patient movement.
- 23 -
SE-12 Series Electrocardiograph User ManualOperation Preparations
3.2.2 Preparing the Skin
Thorough skin preparation is very important. The skin is a poor conductor of electricity and frequently creates artifacts that distort the ECG signals. By performing methodical skin preparation, you can greatly reduce the possibility of noise caused by muscle tremor and baseline drift, ensuring high-quality ECG waves. There is natural resistance on the skin surface due to dry, dead epidermal cells, oils and dirt.
To Prepare the Skin
Shave hair from electrode sites, if necessary. Excessive hair prevents a good connection.
Wash the area thoroughly with soap and water.
Dry the skin with a gauze pad to increase capillary blood flow to the tissues and to remove the dead, dry skin cells and oils.
3.3 Attaching Electrodes to the Patient
Two kinds of electrode can be used, one is the reusable electrode (including chest electrodes and limb electrodes), and the other is the disposable electrode.
WARNING
1. Make sure that all electrodes are connected to the patient correctly before operation.
2. Ensure that the conductive parts of electrodes and associated connectors, including neutral electrodes, do not come in contact with earth or any other conducting objects.
NOTE: The quality of ECG waveform will be affected by the contact resistance between the patient and the electrode. In order to get a high-quality ECG, the skin-electrode resistance must be minimized while connecting electrodes.
- 24 -
SE-12 Series Electrocardiograph User ManualOperation Preparations
3.3.1 Electrode Placement (for Resting ECG)
The electrodes' positions on the body surface are shown in the following tables and figures.
Standard 12-Lead Placement
IEC
C1
C2
C3
C4
C5
C6
L
R
F
N
AHA
V1
V2
V3
V4
V5
V6
LA
RA
LL
RL
Electrode Placement
Fourth intercostal space at the right border of the sternum
Fourth intercostal space at the left border of the sternum
Fifth rib between C2 and C4
Fifth intercostal space on the left midclavicular line
Left anterior axillary line at the horizontal level of C4
Left midaxillary line at the horizontal level of C4
Left arm
Right arm
Left leg
Right leg
- 25 -
SE-12 Series Electrocardiograph User ManualOperation Preparations
NEHB Placement
IEC
N st
N ax
AHA
A1
A2
Electrode Placement
Attachment point of the second rib to the right sternal edge
Fifth intercostal space on the left posterior axillary line
N ap
R
L
N or RF
V4
RA
LA
RL
Left mid-clavicular line in the fifth intercostal space
Right arm
Left arm
Right leg
F LL Left leg
Frank Lead Placement (for VCG)
IEC
C1
C2
C3
AHA
V1
V2
V3
Electrode Placement
Right mid-axillary line on the same horizontal level as C3 and C4
Sternum at the level of C3 and C4
Mid-clavicular line in the fifth intercostals space
- 26 -
SE-12 Series Electrocardiograph User Manual
C4
C5
V4
V5
C6
L
V6
LA
Left mid-axilary line on the same horizontal level as C3
Center of spine on the same horizontal level as C3 and C4
Neck, avoid carotid artery and jugular vein
Left deltoid
Operation Preparations
R RA
F
N
LL
RL
Right deltoid
Upper leg as close to torso as possible
Upper leg as close to torso as possible
3.3.2 Electrode Placement (for Exercise ECG)
The Precordial Electrodes' Positions on Body Surface:
IEC
C1
C2
C3
C4
C5
R / L
N / F
AHA
V1
V2
V3
V4
V5
Electrode Placement
Fourth intercostal space at the right border of the sternum
Fourth intercostal space at the left border of the sternum
Fifth rib between C2 and C4
Fifth intercostal space on the left midclavicular line
Left anterior axillary line at the horizontal level of C4
C6 V6 Left midaxillary line at the horizontal level of C4
The Extremity Electrodes' Positions on Body Surface:
IEC AHA Electrode Placement
RA / LA Below the right/left clavicle
RL / LL Below the right/left rib
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SE-12 Series Electrocardiograph User ManualOperation Preparations
3.3.3 Attaching the Reusable Electrodes (for Resting ECG)
Connecting to a Lead Wire
Reed
Clamp
Limb Electrode
Suction Bulb
Metal Cup Connecting to a Lead Wire
Chest Electrode
1) Ensure that the electrodes are clean;
2) Clean the electrode area which is a short distance above the ankle or the wrist with 75% alcohol;
3) Daub the electrode area on the limb with gel evenly;
4) Place a small amount of gel on the metal part of the limb electrode clamp or on the brim of the chest electrode's metal cup;
5) Attach the electrodes in place.
When connecting the chest electrodes, place the electrode on the chest electrode site and squeeze the suction bulb. Unclench it and the electrode is adsorbed on the chest;
NOTE: Long-time measurement with a strong negative pressure on the suction bulb may cause reddening of the skin. When using the electrode on kids or patients with delicate skin, squeeze the suction bulb lightly.
3.3.4 Attaching the Disposable Electrodes
CAUTION
The disposable electrodes can only be used for one time.
- 28 -
SE-12 Series Electrocardiograph User ManualOperation Preparations
Disposable Electrode (clip style):Clip/Snap/Banana Socket Adaptors
Disposable Electrode Connection (Clip Style)
1) Align all lead wires of the patient cable to avoid twisting, and connect the clip/snap/banana socket adaptors to the patient cable.
2) Clean the electrode areas on the body surface with 75% alcohol.
3) Attach the disposable electrodes to the electrode positions on the body surface.
4) Clip the disposable electrodes with the clip/snap/banana socket adaptors.
Snap/Banana Socket AdaptersDisposable Electrode (Snap Style)
Disposable Electrode Connection (Snap Style)
1) Align all lead wires of the patient cable to avoid twisting, and cnnect Snap/Banana Socket Adapters to connector of patient cable.
2) Clean the electrode areas on the body surface with 75% alcohol.
3) Attach the disposable electrodes to the electrode positions on the body surface.
4) Connect Snap/Banana Socket Adapters to the disposable electrodes.
3.4 Inspection Before Power-On
In order to avoid safety hazards and get good ECG records, the following inspection procedures are recommended before operation.
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SE-12 Series Electrocardiograph User ManualOperation Preparations
WARNING
The electrocardiograph is intended to be used by qualified physicians or personnel professionally trained, and they should be familiar with the contents of this user manual before operation.
1) Environment:
♦
Make sure that there is no electromagnetic interference source around the equipment, especially large medical electrical equipment such as electrosurgical equipment, radiological equipment, magnetic resonance imaging equipment etc. Turn off these devices when necessary.
♦
Keep the examination room warm to avoid muscle tremor voltages in ECG signals caused by cold.
2) Power Supply:
♦
If the mains supply is used, please check whether the power cord is connected to the unit well. The grounded three-slot outlet should be used.
♦
When the battery capacity is low, recharge the battery before use.
3) Patient Cable:
♦
Make sure that the patient cable is connected to the unit firmly, and keep it far away from the power cord.
4) Electrodes:
♦ Make sure that all electrodes are connected to lead wires of the patient cable correctly.
♦
Ensure that the chest electrodes do not contact with each other.
5) Patient:
♦
The patient should not come into contact with conducting objects such as earth, metal parts etc.
♦ Ensure that the patient is warm and relaxed, and breathes calmly.
3.5 Turning On/Off the Electrocardiograph
WARNING
1. If the integrity of the external protective conductor is in doubt, the equipment should be powered by the battery.
2. Potential equalization conductor of the unit should be connected to the potential equalization bus bar of the electrical installation when necessary.
- 30 -
SE-12 Series Electrocardiograph User ManualOperation Preparations
The electrocardiograph can be powered by either the mains supply or the battery.
To turn on the Electrocardiograph:
♦ When operating on AC power
Make sure that the mains supply meets the requirements (refer to A1.4 Power Supply
Specifications) before power-on, and then press on the keyboard to turn on the unit. The mains supply indicator () is lit, and the logo will be displayed on the LCD screen after self-test.
If the battery is weak when the mains supply is used, it will be recharged automatically at the same time. Both the mains supply indicator () and the battery recharging indicator () will be lit.
♦
When operating on battery power
Press on the keyboard to turn on the unit, and then the battery indicator () will be lit and the battery symbol will be displayed. The logo will be displayed on the LCD screen after self-test.
Because of the consumption during the storage and transport course, the battery capacity may not be full. If the symbol and the hint information Battery Weak are displayed, which means the battery capacity is low, please recharge the battery first.
CAUTION
1. If the electrocardiograph is turned off because of low battery capacity or unexpected power failure, the settings or the current ECG report may not be saved.
2. The electrocardiograph cannot print an ECG report when the battery is weak.
3. The use of electrocardiograph accessories (such as barcode reader) will deplete battery power at a faster rate. The battery will require more frequent charging if these accessories are used with the electrocardiograph.
To turn off the Electrocardiograph:
♦
When operating on AC power
Hold down the key to display the hint System is shutting down… on the screen.
Then the device will be off a few seconds later. Remove the plug from the outlet.
♦ When operating on battery power
Hold down the key to display the hint System is shutting down… on the screen.
Then the device will be off a few seconds later.
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SE-12 Series Electrocardiograph User ManualOperation Preparations
NOTE:
1. When turning off the device, follow the above sequence strictly, or else there may be something wrong on the screen.
2. Do not hold down the key when the device displays the hint information System is shutting down… on the screen.
3.6 Loading Recorder Paper
NOTE:
1. When the folded thermal paper is used, the paper roller is unnecessary and must be taken out.
2. When using the paper of 215mm in width, the two movable parts should be removed.
3. The exit edge can help you tear the recorder paper.
4. If the paper with black markers is used, make sure that the markers are on the bottom.
CAUTION
Make sure that the recorder paper, is installed in the center of the recorder, and the paper edge is parallel with the casing edge in the direction of advancing paper, in order to avoid paper deviation or damage to the paper edge.
When the recorder paper runs out or is not loaded, the hint message No Paper will appear on the screen. Then you should load or replace the recorder paper immediately.
Groove
Movable
Part 1
Movable
Part 2
Paper Tray
Casing Button
Exit Edge
(Edge for tearing paper)
Exit
Paper Roller
Casing
- 32 -
SE-12 Series Electrocardiograph User ManualOperation Preparations
SE-12/SE-12 Express/SE-1200/SE-1200 Express:
Step 1Step 2 Folded paper / Rolled paperStep 3
1) Press the casing button downwards and remove the casing to open the recorder.
2) Take off the wrapper of the new folded paper, and then put it in the paper tray.
3) Pull the paper out with the grid side facing the thermal print head, and replace the casing on the recorder.
If rolled paper is used, Place the paper and the roller gently in the recorder with the roller pin clicking into the groove. Pull the paper out with the grid side facing the thermal print head.
4) Press down the recorder casing firmly.
SE-1201 A5 paper ：
Step 1Step 2
1) Press the casing button downwards to open the recorder.
2) Take off the wrapper of the new folded paper, and then put it in the paper tray with the grid side facing the thermal print head.
3) Close the recorder casing firmly.
- 33 -
SE-12 Series Electrocardiograph User ManualOperation Preparations
SE-1201 A4 paper:
Step 1Step 3
1) Tilt the electrocardiograph and put the record paper to the paper tray through the opening on the bottom panel with the grid side facing the thermal print head.
2) Press the casing button downwards to open the recorder.
3) Pull the paper out with the grid side facing the thermal print head, and close the recorder casing firmly.
After loading paper,
1) Set Paper Marker to No in the Record Info Setup1 window.
2) Advance the recorder paper.
When the main screen is displayed, you can press to advance the paper for
2.5cm. Press again to stop advancing the paper.
- 34 -
SE-12 Series Electrocardiograph User ManualBasic Operation Guidance
Chapter 4 Basic Operation Guidance
The following sections provide an overview of the main operations and functions.
You can operate the electrocardiograph by using the touch screen (configurable).
CAUTION
Do not touch the LCD screen with sharp things such as pencils or pens; otherwise, it will be damaged.
4.1 Basic Operation
Operation
To select options on the bottom panel of the screen
To move the cursor
To erase the typed information
Keys
Corresponding functional keys
Tab or Shift + Tab
Bksp
To input special characters
To switch between upper case and lower case
To select or deselect an item
Switch between options
To confirm and entering a screen
Shift + numeric key
Shift +letter key
Space
Up and down arrow keys
Enter
To cancel operation; return to the upper level refresh all patient information except for the Gender ,
ESC
Age Group , Exam.Room
, Physician and Technician Shift + Bksp information after you print an ECG report
- 35 -
SE-12 Series Electrocardiograph User ManualBasic Operation Guidance
4.2 About the Main Screen
After the electrocardiograph is turned on, the main screen appears.
Figure 4-1 SE-12 Express Main Screen1
Figure 4-2 SE-12 Express Main Screen2
NOTE:
1. The modification of filter, gain, or speed on the main screen is only effective for the current patient.
2. When the leads are off, the lead names will be highlighted.
3. Work mode can be selected by pressing the MODE key when the main screen is displayed.
- 36 -
.
SE-12 Series Electrocardiograph User ManualBasic Operation Guidance
4.3 Work Mode Description
There are five work modes in SE-12 series electrocardiograph.
AUTO:In the auto mode, the ECG data can be analyzed, saved, printed and transmitted.
The lead groups are switched automatically according to the lead sequence during the printing course. After the ECG waves of one lead group are printed within a certain time, the system switches to print ECG waves of another lead group automatically. 1mV calibration marks will be printed at the beginning of an ECG report.
MANU:In the manual mode, you can determine the lead group to be displayed and printed.
Pressing the Left or Right arrow can switch among the lead groups.
RHYT:In the rhythm mode, the ECG data can be saved and transmitted. You can print 60s rhythm-lead ECG waveform of one lead in the Single Lead style or 20s rhythm-lead ECG waveform of three leads in the Three Leads style.
R-R:In the R-R analysis mode, you can select a lead to print its R-R histogram, R-R trend chart, 180s compressed ECG waveform and all the R-R interval values.
VCGOnly configurable for SE-12 Express/SE-1200 Express/SE-1201
In the VCG mode, X, Y, Z waves and frontal, horizontal, sagittal planes can be displayed. 10s sampled ECG data can be analyzed, and vector waves, vector loops, measure information, diagnosis information can be printed.
- 37 -
SE-12 Series Electrocardiograph User ManualEntering Patient Information
Chapter 5 Entering Patient Information
5.1 Entering Patient Information Manually
1.
Configure the Patient Information Setup window. (Configurable)
For details, please refer to Section 10.4 "Patient Information Setup".
2.
Select Patient on the main screen1 to open the Patient Information window.
5.2 Entering Patient Information by Using a Reader (Configurable)
1.
Configure the bar code
For more detailed information about configuring the bar code, please contact the manufacturer or the local distributor.
2.
Connect the bar code/social security card/ID card reader to USB socket 2 on the right panel of the electrocardiograph.
3.
When the main screen is displayed, scan the patient's bar code with the bar code/social security card/ID card reader, and then the patient information will appear in the corresponding region.
NOTE: Recommended social security card reader: T6-ULD-I, USB socket;
Recommended ID card reader: GTICR100-02, USB socket.
5.3 Entering Patient Information by Acquiring Orders
NOTE: To use the order function, the ECG data management software (DMS) of the manufacturer must be installed in the PC.
1.
Connect the electrocardiograph to the PC with Ethernet cable recommended by the manufacturer.
2.
Log into the DMS.
3.
Set Server IP, Local IP, Gateway and Subnet Mask in the Transmission Setup window.
4.
Select Order Acquired function in Setup-> Patient Info
5.
Open the Patient Information window.
6.
Enter the patient ID manually in the ID textbox or connect a bar code reader, press Order, and then the matched order will be loaded from the DMS and the order information will be displayed in the corresponding textboxes.
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SE-12 Series Electrocardiograph User ManualPrinting ECG Reports
Chapter 6 Printing ECG Reports
The operation procedure is as follows:
Select a work mode
Configure printing and system parameters if necessary
Press PRINT/STOP to start sampling
MANU mode
Press PRINT/STOP to stop sampling
Manually switch lead group
NOTE:
1. The working mode cannot be changed during the printing course. Stop printing reports before changing the working mode.
2. Within three seconds after returning to the main screen, if you press the
PRINT/STOP key to print an ECG report in the auto quick mode or the manual mode, the recorder will not respond.
3. If Print Out is set to Off in the Record Info Setup1 window, the ECG report can be saved and transmitted, but cannot be printed out by pressing the PRINT/STOP key in the auto and rhythm modes.
4. Please consult with physician or medical professional regarding diagnosis produced by VCG test if you have any questions or concerns about your results.
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SE-12 Series Electrocardiograph User ManualTransmitting ECG Data
Chapter 7 Transmitting ECG Data
WARNING
1. This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: a) this device may not cause harmful interference, and b) this device must accept any interference received, including interference that may cause undesired operation.
2. If the FTP user name and password are compromised, then transmitted data may be compromised.
3. The patients' basic and health information embedded in SCP, FDA-XML and DICOM files is not encrypted to allow for portability, therefore the user is responsible for ensuring security of these files, otherwise PHI(Projected Health information)may be compromised when transmitting SCP, FDA-XML or DICOM files.
4. Data that is transmitted to a web browser is not encrypted, therefore it is the user needs to ensure network security to ensure that patients' basic and health information is not compromised when using a web browser.
5. Data transmitted between the device and order server is not encrypted, therefore the user needs to ensure network security to ensure that patient information is not compromised when querying orders from the server.
6. Beware that the SE-12 series do not have built in anti-malware protection. Any USB devices connected to the SE-12 series should be verified as not being infected before being connected to the SE-12 series.
Note that the system can be used without USB by utilizing alternative methods, namely:
7. As a cyber security precaution, the SE-12 series will only read and download files that follow a specific EDAN format. These files are encoded in a manner for the SE-
12 to conduct checks to ensure file integrity, but note that to allow for portability, the files are not encrypted.
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SE-12 Series Electrocardiograph User ManualTransmitting ECG Data
NOTE:
1. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
Reorient or relocate the receiving antenna.
Increase the separation between the equipment and receiver.
Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
Consult the dealer or an experienced radio/TV technician for help.
2. Any changes or modifications to this unit not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment.
7.1 Transmitting ECG Data to the PC
ECG data in DAT/PDF/SCP/FDA-XML/DICOM format can be transmitted to the PC. To transmit ECG data in DAT format, the DMS of the manufacturer must be installed in the PC. To transmit ECG data in PDF/SCP/FDA-XML/DICOM format, the FTP receiving software must be installed in the PC.
CAUTION
It is forbidden to connect or disconnect a U disk or a USB printer during the transmission course.
NOTE: The SCP/FDA-XML/DICOM function can be activated on the Advanced
Setup screen. Password is required to enter the Advanced Setup screen.
For details, please contact the manufacturer or the local distributor.
1.
Log into the FTP receiving software.
2.
Configure the Transmission Setup window.
1) Press Shift+F1 in the Transmission Setup window to open the Basic Setup window.
2) Set Auto Transmission to On and Transmission Mode to Net Port or Wireless.
3) Set the Server IP item to the IP of the PC.
For details, please refer to Section 10.5.1 "Basic Setup".
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SE-12 Series Electrocardiograph User ManualTransmitting ECG Data
4) Set the FTP User Name, FTP Password and FTP Path items. a) The user name and the password you input in the FTP User Name and FTP
Password items must be available for FTP server. b) The path you input in the FTP Path item must be the subdirectory of the path you input in the FTP receiving software.
NOTE: For more information about FTP server, consult your Network
Administrator.
3.
Set File Format in the File Setup window.
4.
In the auto or rhythm mode, ECG data will be transmitted through the network automatically after an ECG report is printed out.
NOTE: If the message Transmitting Fails appears on the system screen, then there has been an error in network communication of the data. Please check the network connection, move the device where the wireless signal is stronger or directly use a U disk to transfer data.
7.2 Real-time Transmission to the DMS
In real-time transmission, the electrocardiograph functions as an ECG sampling box to the DMS software.
NOTE: To use the real-time transmission function, the ECG data management software (DMS) of EDAN must be installed in the PC.
1.
Start the DMS.
2.
In the Sampling Setting window, set Device Model to SE12.
3.
Connect USB socket 1 of the electrocardiograph to the USB socket of the PC by using the high-speed USB cable.
For details, please contact the manufacturer or the local distributor.
4.
Start real-time transmission
The sampling box transmits to the PC the ECG signals acquired from the patient. Acquisition and transmission are simultaneous. The ECG signals are displayed on the PC monitor and eventually analyzed. For more details, refer to the user manual of the DMS software.
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SE-12 Series Electrocardiograph User ManualManaging Orders
Chapter 8 Managing Orders
NOTE: To use the order function, the ECG data management software (DMS) of
EDAN must be installed in the PC.
Operation procedures are as follows:
1.
On the electrocardiograph, configure the Order Setup screen.
2.
Connect the electrocardiograph to the PC installed with the DMS by using an Ethernet cable recommended by the manufacturer.
3.
Set Server IP, Local IP, Gateway and Subnet Mask in the Transmission Setup window. For details, please refer to Section 10.5 "Transmission Setup".
4.
Select Load on the Order Manager screen to load orders from the DMS, and then a hint will be displayed as follows.
NOTE: If orders are modified on the DMS, the corresponding orders displayed on the Order Manager screen will be refreshed after you load orders from the software.
A
B
IHGFEDC
Figure 8-1 Order Manager Screen
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SE-12 Series Electrocardiograph User Manual
Name
For example, 2/200
A
Explanation
Order Count
200 is the total number of orders that can be electrocardiograph.
Managing Orders stored in the
2 is the current number of orders stored in the electrocardiograph.
Orders will be loaded and displayed in the order list.
B Order List
The order information includes ID, Name, Request No., Order Date,
Exam.Room and State.
State includes: √ indicates an order with examination
No mark indicates an order without examination.
C Return Press to return to the main screen1.
D Del All Press to delete all the orders from the electrocardiograph.
E Delete Press to delete the selected order from the electrocardiograph.
F Search Press to search for orders on the Order Manager screen.
G Setup Press to make the related settings.
H Load Press to load orders to the electrocardiograph.
I Examine
Press to return to main screen1 for starting examination of the selected order.
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SE-12 Series Electrocardiograph User ManualManaging Files
Chapter 9 Managing Files
IHGFEDC
PONMLKJ
Figure 9-1 File Manager Screen1
Figure 9-2 File Manager Screen2
- 45 -
A
B
SE-12 Series Electrocardiograph User Manual
Name
For example, 0% (1)
A File Count
0% is space occupancy of the files stored in the electrocardiograph.
1 is the current number of files stored in the electrocardiograph.
Explanation
For 10s AUTO data, the upper storage limit is 800.
Files will be loaded and displayed in the file list.
Managing Files
The file information includes ID, Name, Time, Mode and State.
B File List
State includes: No mark
T indicates the file is transferred successfully.
E indicates the file is exported successfully.
C indicates the file has been edited.
NOTE : A file can be displayed in more than one state at the same time.
C Return Press to return to the main screen.
D Import Press to import files from the U disk to the electrocardiograph.
E Search Press to open the SearchInfo Setup window.
F Select
Press to highlight a file on the File Manager screen1, and then press Select to select the file and display the File Manager screen2.
G Del All Press to delete all the files from the electrocardiograph.
H Export All Press to export all the files from the electrocardiograph to the U disk.
I Trans All Press to transmit all the files to the PC.
J Return Press to return to the File Manager screen1.
K Preview Press to open the file preview screen.
L Delete Press to delete the selected file from the electrocardiograph.
M Export Press to export the selected file from the electrocardiograph to the U disk.
N Trans Press to transmit the selected file to the PC.
O Record Press to print the selected file.
P Edit
Press to open the Patient Information window. Then you can edit the patient information.
Export file path: ECGDATA\ECG-Device No.\Export\ Export Date and Time
Import file path: ECGDATA
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SE-12 Series Electrocardiograph User ManualManaging Files
CAUTION
1. When files are being printed, transmitted, deleted or exported, you cannot turn off the electrocardiograph.
2. Do not cut off the mains supply directly when no battery is installed in the device, or else, the stored data may be lost.
3. It is forbidden to connect or disconnect a U disk or a USB printer during the transmission course.
NOTE:
1. Please insert the U disk recommended by the manufacturer. Please set the format to
FAT or FAT32 when formatting the U disk.
2. If you select Delete After Trans. Or Export in the File Setup window, the files will be deleted from the File Manager screen after they are exported.
3.
For SE-12 and SE-1200, Rhythm data cannot be previewed.
4.
Only the ECG files in DAT format produced by the electrocardiograph of the manufacturer can be imported.
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SE-12 Series Electrocardiograph User ManualSystem Setup
Chapter 10 System Setup
Select Setup on the main screen1 to display the System Setup screen.
10.1 Work Mode Setup
Items
Mode Options
Display Style
Rhythm Style
Sampling Mode
Duration
(Periodic Sample)
Interval
(Periodic Sample)
Preview
Auto Arrhythmia Detection
Default
Auto, Manual, Rhythm
6×2
Three Leads
Real-time Sample
60 min
1 min
Off
Off
Default (Only in the U.S.)
Auto, Manual, Rhythm, R-R
3×4+1R
Three Leads
Real-time Sample
60 min
1 min
Off
Off
10.2 Filter Setup
Items Default Default (Only in the U.S.)
AC filter On On
EMG filter Off Off
DFT filter 0.67Hz
0.67Hz
Lowpass filter 100Hz 100Hz
NOTE:
1. AC frequency can be set to 50Hz or 60Hz on the Advanced Setup screen according to local mains supply specifications.
2. Only when EMG Filter is set to Off, can the setting of Lowpass Filter be effective.
3. To pass the distortion test, the electrocardiograph has to be configured with the highest bandwidth in filter settings. Otherwise, ECG signal may be distorted.
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SE-12 Series Electrocardiograph User Manual
10.3 Record Info Setup
System Setup
10.3.1 Setup 1
Items
Auto Record Style
Default
6×2
Default (Only in the U.S.)
3×4+1R
Manual REC Style
Record Mode
Record Sequence
Gain
6 channels
Save Paper
Sequential
10mm/mV
6 channels
Save Paper
Sequential
10mm/mV
AGC
Print Out
Off
On
Off
On
Paper Marker
Record Device
Yes
Thermal
Yes
Thermal
Speed 25mm/s 25mm/s
Sample Time 10s 10s
NOTE:
1. If the time period is longer than 10s, the ECG data sampled will be stored, and the last 10s of data will be analyzed.
2. Record sequence of lead groups include Sequential and Simultaneous which can be set by user according to different kinds of clinic situation.
Item Description
Record Device Choose from: Thermal, HP1010/1510 , HP M401 , HP 1020/1020PLUS/1106
HP 2010/1050/2000, HP 2015/2035, and HP 1525 are also compatible.
You should connect the corresponding USB printer to the electrocardiograph.
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SE-12 Series Electrocardiograph User ManualSystem Setup
WARNING
If the printer used is not the type listed above, additional safety measures (such as applying an isolation transformer to supply the medical system) should be taken when the safety of the medical system has not been evaluated. If in doubt, consult our technical service department or your local distributor.
CAUTION
It is forbidden to connect or disconnect a U disk or a USB printer during the transmission course.
NOTE:
1. During the USB printing course, pressing the PRINT/STOP key again cannot stop printing ECG reports.
2. USB printing is ineffective in the auto periodic sampling mode, manual mode, VCG mode, and R-R analysis mode.
10.3.2 Setup 2
Items
Measure / Analysis / Diagnosis
Conclusion / Report Confirm
Template / Position Marker /
Time Scale / Minnesota Code /
Device No.
Baseline Adjustment
RR Interval List
Grid of Thermal Report
Grid of USB Report
Default
On
Off
Horizontal
Off
Off
On
Default (Only in the U.S.)
On
Off
Horizontal
Off
Off
On
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SE-12 Series Electrocardiograph User ManualSystem Setup
10.3.3 Setup 3
Items Default Default (Only in the U.S.)
XYZ Wave / Measure / Analysis Off Off
QRS Gain 20mm/mV 20mm/mV
NOTE:
1. Only if the VCG function is activated, can the Record Info Setup3 window appear.
For details on activating the VCG function, please contact the manufacturer or the local distributor.
2. Pressing F2 twice in the Record Info Setup window can display the Setup3 window.
10.4 Patient Information Setup
Items
Gender / Pacemaker
First\Last Name / BP / Race / Height /
Weight / Medication / Room No. /
Department / Physician / Technician /
Ref-Physician / Exam. Room
ID Mode
ID Hint
Age Mode
H/W Unit
BP Unit
Prompt
Patient Information Refreshed
Order Acquired
User-defined
Default
On
Off
Auto
On
Age cm/kg mmHg
Confirmed By
On
Off
Cleared
Default (Only in the U.S.)
On
Off
Manual
On
D.O.B
inch/lb.
mmHg
Confirmed By
On
Off
Cleared
- 51 -
SE-12 Series Electrocardiograph User Manual
Item Description
Patient Options Select the item displayed in the Patient Information window.
Child Mode is available only when Glasgow algorithm is used. In the Child
Mode, lead V3 is used to sample ECG signals of V4R.
System Setup
The lead sequence of the Child Mode is: I, II, III, aVR, aVL, aVF, V4R, V1, V2,
V4, V5, V6.
NOTE:
1. Pacemaker appears in the Patient Information window after it is selected in the Patient Information Setup window. Set Pacemaker to
Yes in the Patient Information window, and the Pacemaker information will be displayed on the report printed out.
2. Pacemaker is recommended to be set to No unless it is known that the majority of the electrocardiograph usage will be on patients with pacemakers.
3. Glasgow algorithm is a configurable advanced function. Password is required to enter the Advanced Setup screen. To activate it, please contact the local distributor.
10.5 Transmission Setup
Items
Auto Transmission
Transmission Mode
FTP User Name / FTP Password
FTP Path
Enable WIFI
Auto Get IP
Default
Off
Net Port
EDANDAT
Cleared
Disabled
Off
Default (Only in the U.S.)
Off
Net Port
EDANDAT
Cleared
Disabled
Off
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SE-12 Series Electrocardiograph User ManualSystem Setup
10.5.1 Basic Setup
Item
IP Addresses
Description
Set Server IP, Local IP, Gateway, Subnet Mask
For the cross-network transmission, a) Set the first two sections of the Local IP item to the first two sections of the IP of the PC.
b) Set the third section of the Local IP item to the network segment of the electrocardiograph which depends on the configuration of Router.
c) The last section of the Local IP item can be set at random.
For the same network transmission, a) Set the first three sections of the Local IP item to the first three sections of the IP of the PC.
b) The last section of the Local IP item can be set at random, but it can't be the same as the last section of the IP of the PC.
NOTE: If WIFI is enabled and Auto Get IP is selected in the WIFI
Setup window, IP addresses excluding server IP can be acquired automatically.
10.5.2 WIFI Setup (Configurable)
NOTE:
1. The WIFI transmission function is only available for the machine configured with the
WIFI module.
2. Data transmission through Wi-Fi is not supported during ECG sampling.
Item
Auto Get IP
Description
Select this item, addresses of Local IP, Gateway and Subnet Mask will be acquired automatically after the wireless network is connected successfully.
View MAC
Address
NOTE :
1.
Only if WIFI is disabled, can Auto Get IP option be available.
2.
To use Auto Get IP , DHCP function needs to be enabled on the router.
View the MAC address of the WIFI module.
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SE-12 Series Electrocardiograph User Manual
Item
SECURITY
Description
The encryption type for the connected wireless network.
System Setup
NOTE : While SE-12 Express supports WEP encryption, we do not recommend the usage of WEP given the known security issues with the WEP protocol. The recommended WIFI encryption modes are
WPA or WPA2.
10.6 Lead Setup
Items
Lead Sequence
Nehb
Rhythm Lead 1
Rhythm Lead 2
Rhythm Lead 3
Lead Off Hint
Description
Default
Standard
Off
II
V1
V5
Off
Default (Only in the U.S.)
Standard
Off
II
V1
V5
Off
Item
Lead Sequence Choose from: Standard or Cabrera
Lead
Sequence
Lead group 1 Lead group 2 Lead group 3 Lead group 4
Standard
І, II, III aVR, aVL, aVF V1, V2, V3 V4, V5, V6
Cabrera aVL, І, -aVR
II, aVF, III V1, V2, V3 V4, V5, V6
Nehb Choose from: On or Off .
Lead Sequence: I, II, III, ND, NA, NI
NOTE: If you set Nehb to On, the working mode is fixed to be manual.
10.7 Display&Sound Setup
Items
Brightness
Default
10
Default (Only in the U.S.)
10
Key Volume Medium Medium
Hint Volume Medium Medium
- 54 -
SE-12 Series Electrocardiograph User Manual System Setup
Items
QRS Volume
Notify Volume
Display Colors
Default
Off
Medium
Option 1
Default (Only in the U.S.)
Off
Medium
Option 1
On Grid
10.8 Date&Time Setup
On
Please set DATE&TIME correctly when it ' s the first time you use the electrocardiograph.
Items
Date Mode
Time Mode
Power Off/ LCD Off
Default
DD-MM-YYYY
24 Hours
Cleared
Default (Only in the U.S.)
DD-MM-YYYY
24 Hours
Cleared
10.9 File Setup
File Format
Delete After Trans. Or Export
Replace When Memory Full
Item
Auto Save
Items
Auto Save
Description
Default
To ECG
DAT
Off
Off
Choose from: Off, To ECG or To External Memory
Default (Only in the U.S.)
To ECG
Off
Off
Select Off , ECG data will not be saved.
Select To ECG , ECG data in the auto or rhythm mode will be saved in the
ECG automatically.
Select To External Memory , ECG data in the auto or rhythm mode will be automatically saved to the directory of ECGDATA\ECG-
X\Store\Examination Date of the external memory after an ECG report is printed out.
NOTE: X in the directory of ECGDATA\ECG-X\Store\Examination Date can be set in the Device No.
textbox in the Transmission Setup window.
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SE-12 Series Electrocardiograph User Manual
10.10 System Maintenance Setup
System Setup
Item
Items
System Password
System Password
Default
Cleared
Default (Only in the U.S.)
Cleared
Description
If you set the system password in the System Maintenance window, you need enter the password before opening the System Setup screen.
10.11 Other Setup
Items
External Input
External Output
Caps Lock
Item
External Output
Default
Off
Off
Off
Default (Only in the U.S.)
Off
Off
Off
Description
The external output socket is equipped in the electrocardiograph, through which the electrocardiograph can send rhythm lead signals to the external equipment.
Choose from: Off, Standard or Triggered
Select Standard , the electrocardiograph sends ECG signals of rhythm lead 1.
Select Triggered , the electrocardiograph sends pulses with the height of 5V and the width of 45ms, based on the data of rhythm lead 1.
- 56 -
SE-12 Series Electrocardiograph User Manual Operation Instructions for Exercise ECG
Chapter 11 Operation Instructions for Exercise ECG
(Configurable for SE-12 Express)
Exercise ECG test contributes to discover myocardial ischemia, including the treadmill test and the ergometer test. The patients with stable chest pain or unstable chest pain but drug controlled, the heart blood reserve function and myocardial ischemia existence to be estimated after myocardial infarction or cononary artery reconstruction surgery need to do exercise test. Please consult with physician or medical professional regarding diagnosis produced by Exercise ECG test if you have any questions or concerns about your results.
Diagnosis of exercise test contributes to:
1.
Diagnose the coronary artery ischemic disease
2.
Estimate the severity, fatalness and prognosis of the known or suspicious coronary heart disease
3.
Provide early fatalness evaluation of the acute myocardial infarction before discharge
4.
Evaluate the heart status of patients in different age groups and genders with other heart diseases or coronary artery reconstruction.
11.1 About the Main Screen of Exercise ECG
NOTE: Some keys are used in operating SE-12 Express, please refer to Section 2.2
"Keyboard and Keys" for details.
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SE-12 Series Electrocardiograph User Manual Operation Instructions for Exercise ECG
W
C
B
A
D E F G H
N
I J K
L
M
O
V U T S R Q P
Figure 11-1 Main Screen of ST Trend
Figure 11-2 Main Screen of Template
Y
X
- 58 -
SE-12 Series Electrocardiograph User Manual Operation Instructions for Exercise ECG
Z
C
A
B
A1
ID
Name
Figure 11-3 Closeup View of Template
When ID Mode is set to Manual , the length of the patient ID plus the length of the default ID is within 30 ASCII characters.
When ID Mode is set to Auto , the patient ID is 0~1999, 999, 999.
When ID Mode is set to Time , the patient ID can be automatically generated according to the time when you press the Pretest key to start an exercise test. Entering the patient ID manually is not supported.
Patient Name: within 60 ASCII characters or the equivalent number of other characters that can be supported by equivalent memory used by 60 ASCII characters
HR Overrange!
, Sys. Overrange!
, Dia. Overrange!
, Saving, No
Paper , Paper Error, U disk, USB Scanner, Security Reader, ID
Card Reader.
NOTE:
Hint Information1 1. The above hint information is listed in a priority-ranked sequence. HR Overrange!
, Sys. Overrange!
and Dia.
Overrange! have the same priority to be displayed.
2. If more than one fault occurs, the hint information which has the same priority will be displayed in a circulative mode.
- 59 -
SE-12 Series Electrocardiograph User Manual Operation Instructions for Exercise ECG
3. If more than one fault occurs, only the hint information with a higher priority will be displayed.
Lead X Off, DEMO, Module Error, Overload, TM-400 Treadmill hint information (including Lanyard Off, Transmission
Communication Error, Transducer Error, Incline Error, Great
Interference, No Speed Signal, Abnormal Speed, UART Error )
D Hint Information2
NOTE:
1.
Lead X Off has a high priority to be displayed. The other hint information of Hint Information2 has a normal priority to be displayed.
2. If more than one fault occurs, the hint information which has the same priority will be displayed in a circulative mode.
E
F
G
Current Protocol
Total Time
3. If more than one fault occurs, the hint information which has a high priority will be displayed.
The selected protocol name
The total time counted from the beginning of the pretest phase to the end of the exercise test.
Current Phase and The current phase and stage of the exercise test
Stage NOTE: Before or after the exercise test, state name is displayed.
The left number is the total exercise phase time, which is counted
H
Total Exercise Phase from the beginning to the end of the exercise phase.
Time and Stage Time The right number is the stage time, which shows the running time
Current Speed or
J
K
I Rotation Speed, Grade or Power, Workload
Current Time
Battery Symbol of the current stage.
When the treadmill is used, the current speed, grade and workload of the treadmill will be displayed on the main screen; When the ergometer is used, the current rotation speed and power of the ergometer will be displayed on the main screen.
Current examination time.
Identify the current capacity of the battery
L
Systolic Blood Pressure and Diastolic Blood
Pressure
The left number is the systolic blood pressure, and the right number is the diastolic blood pressure.
If a wireless network is connected successfully, an icon appears on
M WIFI the main screen.
: Poor signal (-85dBm ＜ transmit power ≤-70dBm);
- 60 -
SE-12 Series Electrocardiograph User Manual Operation Instructions for Exercise ECG
: Good signal (-70dBm ＜ transmit power ≤-50dBm);
: Great signal (-50dBm ＜ transmit power)
T
U
R
S
NOTE : For successful data transmission, please transmit data when the WIFI signal is good or great.
The left number is the current heart rate, and the right number is
N
O
Current Heart Rate and the target heart rate.
Target Heart Rate
ST Trend
75% is the percentage of the current heart rate to the target heart rate.
Display 3-lead ST trends.
During the exercise test or when the test is terminated:
P Template Button / Exit
Q Lead / Setup
This button changes into Template on the ST Trend screen, press it to display the 3-lead average templates;
No testing:
This button changes into Exit , press it to exit the main screen of the exercise test.
During the exercise test or test is terminated:
This button changes into Lead , press it to open the Lead Setup window.
No testing:
Filter
Gain
This button changes into Setup , press it to open the System
Setup screen.
EMG Filter: Off, 25Hz, 35Hz or 45Hz
Lowpass Filter: 75Hz, 100Hz, 150Hz, 270Hz or 300Hz
2.5 mm/mV, 5 mm/mV, 10 mm/mV, 20 mm/mV, 10/5 mm/mV
Post J is the length after J point of ST segment.
Press to set Post J to 0, 20ms, 40ms, 60ms or 80ms.
Post J: 80ms
Hold / Trans
NOTE : J point is the connection point between the end of QRS complex and the start of ST segment. It is the standard point to fix the position of ST segment. Please select a proper option based on the patient's actual ECG waves.
During the exercise test:
This button changes into Hold , press it to keep the current speed and grade until it is pressed again.
NOTE: The test cannot enter the next stage automatically in Hold state.
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V
W
X
SE-12 Series Electrocardiograph User Manual
No testing: operations.
Operation Instructions for Exercise ECG
This button changes into Hold , and it does not respond to any
Test is terminated:
Patient
ECG waveforms
Average Template
This button changes into Trans , press it to transmit the file to the
PC.
Press to open the Patient Information window. It is invalid in the exercise test.
Display real-time ECG waveforms.
Press to display the 3-lead average template waves which are updated every 10 seconds and the positions of the calibration lines. The Template button will change into the ST Trend button.
The 3 leads can be selected in the Lead Setup window of the exercise test.
Y ST Trend Button / Exit
Press average wave.
or to magnify or minify the selected lead
During the exercise test:
This button changes into ST Trend on the Average Template screen, press it to display the 3-lead ST trends.
No testing or test is terminated:
Z
Closeup View of
Waveforms
This button changes into Exit , press it to exit the main screen of the exercise test.
Closeup view of the selected lead.
A1 Gain and Speed
Press to set the gain to 20mm/mV or 40mm/mV .
Press to set the speed to 50mm/s or 100mm/s .
11.2 Operation Preparations
1.
Turn on the electrocardiograph
NOTE: Turn on the electrocardiograph before connecting the treadmill or the ergometer; or else, the start-up of the electrocardiograph may be abnormal.
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SE-12 Series Electrocardiograph User Manual Operation Instructions for Exercise ECG
2.
Connect the electrocardiograph to the treadmill or the ergometer.
CAUTION
Only the treadmill/ergometer recommended by the manufacturer can be connected to
Serial Port 1 and Serial Port 2.
1) Connect the electrocardiograph to the treadmill
RS232 port
RS232
NOTE: The position of the RS232 port may be different on different treadmills.
2) Connect the RS232 port of the ergometer to the RS232 port of the electrocardiograph with an RS232 cable.
NOTE: The position of the RS232 port may be different on different ergometers.
3) Connect the electrocardiograph to the ergometer
RS232 port
4) Connect the RS232 port of the ergometer to the RS232 port of the electrocardiograph with an RS232 cable.
NOTE: The position of the RS232 in port may be different on different ergometers.
3.
Connect the electrocardiograph to the stress BP monitor
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SE-12 Series Electrocardiograph User Manual Operation Instructions for Exercise ECG
4.
Connect the power cords, and connect the earth wire (when necessary)
5.
Load the recorder paper
6.
Turn on the stress BP monitor and treadmill/ergometer
7.
Set the electrocardiograph
1) Activate the stress ECG function.
For details, please contact the manufacturer or the local distributor.
2) After turning on the electrocardiograph, press Pretest on the keyboard to open the main screen of the exercise test.
3) Select Setup on the main screen1 to open the System Setup screen.
4) Configure the System Setup screen.
For details, please refer to Chapter 10 "System Setup".
8.
Set the treadmill or the ergometer for external control
1) For TM-400 treadmill
It is ready for external control and needn't be set.
2) For Lode Treadmill Valiant
Hold down the following two keys for 10 seconds, and then you will enter the service menu of the Valiant.
By default, the Valiant is shipped with the Lode RS232 communication protocol. It should be set to the Trackmaster RS232 protocol. You can change the communication protocol by following the procedures below: a) Select Prot id and select the second RS232 protocol which is the Trackmaster communication protocol b) Select Baudrate and set this to 4800 Baud c) Press the red button to leave the service menu d) Turn off the Valiant
3) For Lode ergometer
By default, the Corival ergometer is shipped with the LODE RS232 communication protocol. It should be set to the ERGOLINE P4 protocol. You can change the RS232 protocol by following the procedures below: a) Turn on the ergometer and press Enter b) You will be in MAINMENU
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SE-12 Series Electrocardiograph User Manual Operation Instructions for Exercise ECG c) Select, by using the Up/Down keys, the menu SYSTEM PARAMETER and press
Enter d) Select, by using the Up/Down keys, the menu SETTINGS and press Enter e) Select, by using the Up/Down keys, the menu RS232 PROTOCOL and press
Enter f) Select, by using the Up/Down keys, ERGOLINE P4 and press Enter g) Save the selected RS232 protocol or restore the default RS232 protocol, which is also the LODE PROTOCOL. h) Turn off the ergometer
4) For controlling the Lode ergometer by SE-12 Express
The ergometer should be set in the ANALOG mode. The ANALOG mode should be selected as follows. a) Turn on the ergometer and press Enter b) You will be in MAINMENU c) Select, by using the Up/Down keys, the menu SYSTEM PARAMETER and press
Enter d) Select, by using the Up/Down keys, the menu SETTINGS and press Enter e) Press Enter to confirm the menu DEFAULTSTARTMENU and press Enter f) The Lode ergometer is now ready for external control
NOTE: You can also let the ergometer start up in the ANALOG mode every time you turn on the ergometer, by using the default start menu.
If you turn off the ergometer, it will start up in the ANALOG mode every time the ergometer is turned on again. For details on setting other models for external control, please refer to the connection instruction of the models.
9.
Select Patient on the main screen1 to open the Patient Information window, and then enter the patient information. For details on entering patient information, please refer to Chapter 5,
"Entering Patient Information".
NOTE: If you do not enter the patient age or the birthday before pressing the Pretest key to begin the exercise test, a hint will pop up to remind you to input the patient age.
11.3 Exercise Test
The following method is recommended when operating SE-12 Express electrocardiograph connected with a treadmill.
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SE-12 Series Electrocardiograph User Manual Operation Instructions for Exercise ECG
Operation Method:
1.
Instruct the patient, attach the disposable electrodes to the patient, and then apply the stress
BP monitor to the patient. For details, please refer to Chapter 3 Operation Preparations.
2.
Instruct the patient to lay on the bed, oberserve the ECG waveforms and the supine blood pressure.
3.
Select a protocol for the patient and configure the System Setup screen.
NOTE: You cannot change the settings of the System Setup screen after staring an exercise test.
4.
Press the Pretest key to begin the pretest phase.
5.
Press the Exercise key to enter the exercise phase, and then observe the ECG waveforms, heart rate, blood pressure, the patient's state and ST trend during the exercise test. If the stress
BP monitor is connected, the patient's blood pressure is measured once at a phase, and you should print or save an ECG report after the main screen displays the BP value.
6.
When the target value is reached, such as the target heart rate, press the Recovery key to enter the recovery phase, and then instruct the patient to walk on the treadmill for 1 minute.
Observe the ECG waveforms, heart rate, blood pressure and the patient's state during the recovery stage.
7.
Instruct the patient to sit on the bed, and then observe the ECG waveforms and the blood pressure for 6 ～ 8 minutes.
8.
When the patient's heart rate resumes the normal value, press the Test end key to terminate the exercise test. Press the PRINT/STOP key to print the final report. Select Trans on the main screen of excersice screen to tranmist the report to the PC.
9.
Take off the patient cable and electrodes, press the Pretest key to exit the test, and then prepare for the next patient.
WARNING
1. During the exercise test, ensure that such tests are supervised by properly trained technician who meets competency requirements for exercise test supervision, fully trained in cardiopulmonary resuscitation, and is supported by a physician skilled in exercise testing or emergency medicine who is in close proximity for pretest assessment or compliance that may raise.
2. Remind patients to take care not to fall down from the treadmill.
3. Press down the emergency stop switch of the treadmill before defibrillating to avoid the hazard to the patient and the operator.
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SE-12 Series Electrocardiograph User Manual Operation Instructions for Exercise ECG
11.4 Factory Defaults of Exercise ECG
General Information Setup
Items Default Default (Only in the U.S.)
Display Style 6×2 3×4+1R
Speed Unit
Post J
Device Style
Treadmill Model
Ergometer Model
BP Monitor
Normal BP Range (Sys./Dia.) mph
60ms
Treadmill
TMX425
Ergoline
Tango mph
60ms
Treadmill
TMX425
Ergoline
Tango
Maximum 220/90 mmHg
Minimum 110/60 mmHg
Max Predicted HR=220-Age
Target HR= Max Predicted HR*85%
Filter Setup
Items
AC filter
EMG filter
Default
On
Off
DFT filter
Lowpass filter
Items
0.67Hz
100Hz
Recorder Setup
Default
Gain 10mm/mV
Paper Marker Yes
Items
12-Lead Report: Record Style
12-Lead Report: ST Info
Record Info Setup
Default
6×2+1
On
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Default (Only in the U.S.)
On
Off
0.67Hz
100Hz
Default (Only in the U.S.)
10mm/mV
Yes
Default (Only in the U.S.)
3×4+1R
On
SE-12 Series Electrocardiograph User Manual
Manual Report
Pretest Report
Exercise Report: Auto Report
Exercise Report: Print Time
Recovery Report: Auto Report
Recovery Report: Start Time
Recovery Report: Interval
Final Report: Summary / ST
Scope / Trend Graph / Summary
Template Report
Final Report: Edit Conclusion
Late Stage
20s
2min
Off
Items
Transmit After Saving
FTP User Name/FTP Password
FTP Path
Operation Instructions for Exercise ECG
Transmission Setup
Default
Off
EDANDAT
Cleared
Late Stage
20s
2min
Off
Default (Only in the U.S.)
Off
EDANDAT
Cleared
Transmission - WIFI Setup
Items
Enable WIFI
Auto Get IP
(with WIFI configured)
Default
Disabled
Off
Lead Setup
Default (Only in the U.S.)
Disabled
Off
Items
Lead Sequence
Rhythm Lead 1
Rhythm Lead 2
Default
Standard
II
V1
Default (Only in the U.S.)
Standard
II
V1
Rhythm Lead 3 V5 V5
NOTE:
1. Pressing the Up or Down arrow can switch the display style during the exercise test.
When the display style is 3×1, pressing the Left or Right arrow can switch the lead group.
2. Except for the General Information Setup window, the Record Information Setup window and the Protocol Manager screen, the changes of the System Setup screen are synchronous in both Resting and Exercise ECG tests.
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SE-12 Series Electrocardiograph User Manual Operation Instructions for Exercise ECG
3. You should test whether the treadmill is controlled by SE-12 Express well when SE-
12 Express is connected to the treadmill for the first time.
4. Do not stand on the treadmill when testing it for the first time.
5. Before the exercise test, be sure to be familiar with the user manual of the treadmill or the ergometer.
6. If you have any questions about the operation, please contact us or your local distributor.
11.5 Managing Protocols
Select Protocol on the System Setup screen, and press Enter to open the Protocol Manager
(treadmill or ergometer) screen.
NOTE: The Protocol Manager (treadmill or ergometer) screen can be displayed according to the Device Type setting you configure in the General Information
Setup window. Managing treadmill protocols is taken for an example in this manual; therefore there is no further description for managing ergometer protocols.
1.
Adding Protocols
Select Add on the Protocol Manager screen to display the Adit Protocol dialog box.
Enter the new protocol name in the Protocol Name textbox, and then enter the stage information of every stage, including the time, speed and grade. After that, press Enter to confirm.
NOTE:
1) When Time of a stage in the exercise phase is set to 00, this stage and its following stages in the exercise phase will not be carried out.
2) "1/3" in the Add Protocol window stands for "the current page/ the total pages".
3) Pressing Shift + Left/Right can turn pages in the on the Add Protocol window .
2.
Editing Protocols
Select a protocol on the Protocol Manager screen by pressing the Up or Down arrow, and select
Edit to display the Edit Protocol dialog box.
Edit the protocol name or the stage information of every stage, including the time, speed and grade. After that, press Enter to confirm.
NOTE: For the Bruce or Modified Bruce protocol, only the stage information of the pretest and recovery phases can be edited.
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SE-12 Series Electrocardiograph User Manual Operation Instructions for Exercise ECG
3.
Setting Default Protocols
Select a protocol on the Protocol Manager screen by pressing the Up or Down arrow, and press
Select to set the selected protocol as the default protocol.
4.
Deleting Protocols
Pressing Del All on the Protocol Manager screen can delete all the protocols from the electrocardiograph.
Or, you select a protocol on the Protocol Manager screen, select Delete , and then press Enter to delete the selected protocol from the electrocardiograph.
NOTE: Only the customized treadmill protocol can be deleted.
5.
Restoring Protocols
Pressing Restore on the Protocol Manager screen can restore the factory settings.
6.
Return
Pressing Return on the Protocol Manager screen can return to the System Setup screen for the exercise test.
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SE-12 Series Electrocardiograph User Manual
Chapter 12 Error Messages
Hint Information
Hint information and the corresponding causes provided by the electrocardiograph are listed in
Table 12-1.
Message
Lead off
Battery Weak
Table 12-1 Error Messages and Causes for Resting ECG
Cause
Electrodes fall off the patient or the patient cable falls off the unit, or a high polarization voltage occurs.
The battery is weak.
No Paper Recorder paper runs out or is not loaded.
Testing
Paper Error
The ECG data is being sampled periodically.
When Paper Marker is set to Yes , the electrocardiograph advances the recorder paper to the next black marker. If it advances the paper for 300mm and cannot find the next black marker, the hint Paper
Error is displayed.
Testing The ECG data is being sampled periodically.
Sampling/Analyzing/Recor
ECG signals are being sampled / analyzed / recorded.
ding
Learning
Detecting
Transmitting
The self-study process of arrhythmia arithmetic in the Trigger
Sample mode
The examining process of arrhythmia data in the Trigger Sample mode
ECG data is being transmitted from the electrocardiograph to the
PC through the net or serial cable in the auto or rhythm mode.
Transmitting fails
Loading Order…
Memory Full
Data fails to be transmitted through Ethernet or WIFI.
Orders are being loaded to the electrocardiograph.
There is no space for saving more records.
Module Error
DEMO
There is something wrong with the signal sample module.
The system is in the demonstration mode.
The direct current offset voltage on an electrode is too high.
Overload
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SE-12 Series Electrocardiograph User Manual card reader is connected to the USB interface.
Hint Information
Message Cause
U Disk / USB Printer / USB A U disk, a USB printer or a bar code reader / security reader / ID
Scanner / Reader
Message
Battery Weak
No Paper
Paper Error
Module Error
DEMO
Overload
HR Overrange!
Sys. Overrange!
Dia. Overrange!
Lanyard Off
Trans.Comm Err
Transducer Err
Lead X off
Incline Err
Great Interference
No Speed Signal
Table 12-2 Hint Information and Causes for Exercise ECG
Cause
The battery is weak.
Recorder paper runs out or is not loaded.
When Paper Marker is set to Yes , the electrocardiograph advances the recorder paper to the next black marker. If it advances the paper for 300mm and cannot find the next black marker, the hint Paper Error is displayed.
There is something wrong with the signal sample module.
The system is in the demonstration mode.
Electrodes fall off the patient or the patient cable falls off the unit.
The direct current offset voltage on an electrode is too high.
Heart rate exceeds the normal range.
Systolic blood pressure exceeds the normal range.
Diastolic blood pressure exceeds the normal range.
The safety stop (mushroom type) is revolved and the safety stop
(cord type) is pulled out.
The transducer and the main control board lines are not connected well.
The transducer doesn't work well or is not connected well.
The incline motor doesn't work well or is not connected well.
There is great magnetic interference around the transducer.
The speed sensor doesn't work well or is not connected well.
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SE-12 Series Electrocardiograph User Manual
Message Cause
Hint Information
The speed set in the electrocardiograph is different from the actual
Abnormal Speed speed of the running belt; the signal cable is not connected well, parts, the speed sensor are loose, or great magnetic field exists.
UART Error The serial cable is not connected well.
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SE-12 Series Electrocardiograph User Manual
Chapter 13 FAQ
FAQ
1. Operating Problems
Q1: I was trying to select a file from the file list on the File Manager screen, but the file was in the middle of the long list. Is there any way to make the selection faster?
A1: Actually, the system provides a method for fast moving: pressing Shift + Up or Down arrow can move the cursor up or down in the file list very fast.
Q2: I was just about to input the age when I suddenly realized that I had entered the Name textbox unintentionally, can I just go back without pressing Tab for a whole circle?
A2: As a matter of fact, the system does take such unintentionalities into consideration by providing Shift + Tab as the way back, as the Microsoft Windows operating system does.
Q3: I want to save the ECG data without printing, could it be possible?
A3: Yes, you can set Print Out to Off in the Record Info Setup1 window. Or, in the auto or rhythm mode, you can directly press Shift + PRINT/STOP to enable or disable the print out function. The ECG data will be collected and saved without printing. In the same way, if the transmission settings are configured, the ECG data could be transmitted to the PC without printing.
Q4: The screen of SE-12 series electrocardiograph is too shiny. Could it be possible to weaken the brightness of the screen?
A4: There is a setup item named brightness in the Display & Sound Setup window, you can press the Left or Right arrow to change the value, which would lead to the change of the brightness of the screen.
Q5: I want to input the patients' phone number in the Patient Information window, but there is no such item. Can I add it manually?
A5: Yes, there is a user-defined item for entering patient information. It works in this way: first input the name of the item in the User-defined textbox in the Patient Information Setup window, e.g. Tel. Then return to the main screen1, and open the Patient Information window, the Tel item will be displayed in this window. Now it's possible to input the phone number of the patient in the Tel textbox.
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SE-12 Series Electrocardiograph User Manual FAQ
Q6: Memory Full is displayed on the main screen; Or, the hint Memory full! Replace the earliest file? pops up every time when I save an ECG report to the electrocardiograph. What am I supposed to do?
A6: Memory Full is used to remind you that the amount of stored file reaches the upper limit.
The display of the pop-up hint Memory full! Replace the earliest file?
is related to the settings of the File Setup window.
Select Off from the Replace When Memory Full list box, when the amount of stored files reaches the upper limit and you save an ECG report to the electrocardiograph, the hint
Memory full! Replace the earliest file? pops up.
Select On from the Replace When Memory Full list box, when the amount of stored files reaches the upper limit and you save an ECG report to the electrocardiograph, the hint
Memory full! Replace the earliest file? does not pop up.
You can deal with the hint as follows:
1) You can just delete several stored files from the electrocardiograph to ensure the amount of stored file not to reach the upper limit.
2) When Memory Full is displayed on the main screen, you can set Auto Save to To U
Disk to save the added ECG reports. However, the amount of stored files in the electrocardiograph still reaches the upper limit.
2.
Printing Problems
Q1: I was encountered with paper-jam, what was I supposed to do?
A1: If it happened for the first time, it might be the result of an inappropriate placement of the paper. In this case, please open the recorder casing, pull the paper out of the paper tray, tear the pages with rumples, and then put the paper in the paper tray again, adjust the position of the paper carefully and close the casing.
Q2: The hint Paper Error is displayed on the screen, what should I do?
A2: It might be the result of unsuccessful detection of the black markers, first open the recorder casing so as to clear the error information, and then check whether the black marker is on the bottom of the paper. Reload the paper in the paper tray. If it doesn't work, change the paper.
If the problem still exists, please contact the manufacturer or the local distributor for further disposal.
Q3: The hint No Paper is displayed on the screen, what should I do?
A3: Check whether the paper runs out, or the black marker is just facing the black marker detection window on the thermal printing head, as the following figure shows.
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SE-12 Series Electrocardiograph User Manual FAQ
Reload the paper in the paper tray, close the recorder casing firmly. If the problem still exists, please contact the manufacturer or the local distributor for further disposal.
Q4: I want to print the hospital name in the report, but I can't find the place to enter it, where is it?
A4: Please open the Other Setup window, and move the cursor to the Institution textbox, and then input the hospital name. The content you input in this textbox will be printed in the report.
Q5: I pressed the PRINT/STOP key, but the ECG didn't start printing, what's wrong with it?
A5: The system will not respond to the PRINT/STOP key during the first 3s after you return to the main screen. Therefore, you have to wait for a few seconds, and then you are able to start the printing by pressing the PRINT/STOP key.
If you wait for a few seconds, but you still unable to start the printing by pressing the
PRINT/STOP key, please check whether there is any error information displayed on the screen.
If the hint No Paper or Paper Error is displayed on the screen, please deal with it according to the above-mentioned measures.
If the hint
Transmitting…
is displayed on the screen, which means that the ECG is transmitting the data to the PC, please wait a few seconds. You can start the printing after the data is transmitted.
If the problem still exists, please contact the manufacturer or the local distributor for further disposal.
Q6: I set the filter, speed and gain on the main screen1, but these settings were changed after printing.
A6: The filter, speed and gain which are set on the main screen1 will not be saved, and they are changed when you exit the main screen1 or after printing. If you want to save these settings, please set them in the Record Info Setup window and the Filter Setup window.
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SE-12 Series Electrocardiograph User Manual FAQ
3. Transmitting Problems
Q1: The ECG doesn't respond to any keys after a long time of transmission. It transmits nothing for there is no new data appearing on the screen of the PC software. What should I do?
A1: Some error may occur during the transmission course, for example, the connection between the ECG and the net cable may loosen. In this case, please connect the net cable well. If it doesn't work, please restart the ECG.
If the problem still exists, please contact the manufacturer or the local distributor for further disposal.
4. Main Unit Problems
Q1: After power-on, the ECG stays on the logo screen and doesn't open the main screen. I have restarted the machine several times, but there is no better change.
A1: The reason for this problem might be: there is a key pressed down, without springing up.
Find that key, and make it spring up, the problem should be solved.
Q2: I was doing the examination when the machine suddenly gave out a sound and displayed the hint Lead Off . What should I do?
A2: The corresponding electrodes are not connected well. Please find out which lead is off by checking the Lead Name area on the main screen (please refer to Section 4.3.1, "About the
Main Screen"). The lead whose name is highlighted is off. Please check whether the corresponding electrode of the lead is connected to the patient skin well, and then make sure that the patient cable socket is connected to the patient cable firmly.
If none of the above-mentioned measures takes effect, please contact the manufacturer or the local distributor for further disposal.
5. Exercise Test Problems
Q1: Before the exercise test, the treadmill cannot be started after I press the Start tmill key to test the connection. What should I do?
A1: Set Device Type to Treadmill and select a model from the Device Model list in the General
Information Setup window. Then make sure the RS232 cable between the electrocardiograph and the treadmill is connected well, the treadmill is powered on and the power switch is switched to On .
If the problem still exists, please contact the manufacturer or the local distributor for further disposal.
Q2: I press the Stop tmill key to stop the test temporarily during the exercise test, but in a while, the treadmill cannot be started after I press the Start tmill key. What should I do?
A2: Press the Stop tmill key, 1 minute later press the Start tmill key to start the treadmill.
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SE-12 Series Electrocardiograph User Manual Cleaning, Care and Maintenance
Chapter 14 Cleaning, Care and Maintenance
Use only the EDAN-approved substances and methods listed in this chapter to clean or disinfect your equipment. Warranty does not cover damage caused by using unapproved substances or methods.
Edan Instruments has validated the cleaning and disinfection instructions provided in this User
Manual. It is the responsibility of the healthcare professional to ensure that the instructions are followed so as to ensure adequate cleaning and disinfection.
14.1 General Points
Keep your electrocardiograph and accessories free of dust and dirt. To prevent the device from damage, please follow the instructions:
Use only the recommended cleaning agents and disinfectants listed in this manual. Others
hazards.
Always dilute according to the manufacturer's instructions.
Unless otherwise specified, do not immerse any part of the equipment or any accessories in liquid.
Do not pour liquid onto the equipment.
Do not allow liquid to enter the case.
Never use abrasive material (such as steel wool or silver polish).
Inspect the electrocardiograph and reusable accessories after they are cleaned and disinfected.
CAUTION
1. If you spill liquid on the equipment or accessories, or they are accidentally immersed in liquid, contact your service personnel or EDAN service engineer.
2. The equipment is chemically resistant to most cleaning agents, disinfectants and non-caustic detergents used in hospital, but cleaning agents or disinfectants that are not listed in this manual are not recommended. For example, didecyl dimethyl ammonium bromide, which contains quaternary ammonium salt, may corrode the equipment and accessories.
14.2 Cleaning
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SE-12 Series Electrocardiograph User Manual Cleaning, Care and Maintenance
If the equipment or accessory has been in contact with the patient, then cleaning and disinfection is required after each use.
The validated cleaning agents for cleaning the electrocardiograph and reusable accessories are:
Mild near neutral detergent
Ethanol (75%)
Isopropanol (70%)
Cleaning agents should be applied or removed using a clean, soft, non-abrasive cloth or paper towel.
WARNING
Turn off the power before cleaning. The mains supply must be switched off if it is used.
1.
Switch off the main unit and disconnect it from the power cord.
2.
Wipe the exterior surface of the electrocardiograph, patient cable, and reusable electrodes
(suction bulbs of chest electrodes and the clamps of limb electrodes) using a soft cloth dampened with the cleaning solution until no visible contaminants remain.
3.
Wipe off the cleaning solution with a fresh cloth or towel dampened with tap water after cleaning until no visible cleaning agent remains.
4.
Dry the electrocardiograph, patient cable, and reusable electrodes in a ventilated and cool place.
CAUTION
Any remainder of cleaning solution should be removed from the main unit and the patient cable after cleaning.
14.3 Disinfection
To avoid permanent damage to the equipment, it is recommended that disinfection is performed only when it is considered as necessary according to your hospital' regulations.
Clean the equipment and reusable accessories before they are disinfected. The validated disinfectants for disinfecting the electrocardiograph and reusable accessories are:
Ethanol (75%)
Isopropanol (70%)
If Ethanol or Isopropanol is used for both cleaning and disinfecting, then a new cloth is required to be used for the disinfection step.
CAUTION
1. Do not use high-temperature, high-pressure
ionizing radiation as vapour or
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SE-12 Series Electrocardiograph User Manual Cleaning, Care and Maintenance disinfection methods.
2. Do not use chloric disinfectant such as chloride, sodium hypochlorite etc.
3. Clean and disinfect reusable electrodes after each use.
WARNING
Turn off the power before disinfection. The mains supply must be switched off if it is used.
1.
Switch off the main unit and disconnect it from the power cord.
2.
Wipe the exterior surface of the electrocardiograph, patient cable, and reusable electrodes
(suction bulbs of chest electrodes and the clamps of limb electrodes) using a soft cloth dampened with the disinfectant solution.
3.
Wipe off the disinfectant solution with a dry cloth after disinfection if necessary.
4.
Dry the electrocardiograph, patient cable, and reusable electrodes for at least 30 minutes in a ventilated and cool place.
14.4 Care and Maintenance
CAUTION
Operate the cardiograph, charge the battery, and store the battery at a temperature of
40 ℃ (104ºF) or lower. Exposure to higher temperature may reduce battery life, damage the battery, and degrade overall cardiograph performance.
14.4.1 Recharge and Replacement of Battery
1) Capacity Identification
The battery capacity can be identified according to the battery symbol in the top right corner of the LCD screen.
-> -> ->
Capacity is from full to empty.
2) Recharge
SE-12 series electrocardiograph is equipped with the recharge control circuit together with the battery. When the unit is connected to the mains supply, the battery will be recharged automatically. Then the battery recharging indicator ( ) and the mains supply indicator
( ) will be lit at the same time. During the recharging course, the symbol flashes in the top right corner of the LCD screen. After the battery is fully recharged, the symbol stops flashing, and the battery recharging indicator ( ) is black.
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SE-12 Series Electrocardiograph User Manual Cleaning, Care and Maintenance
Because of the capacity consumption during the storage and transport course, the battery capacity is not full when it is used for the first time. Battery recharge should be considered before the first use.
NOTE: The battery will automatically stop charging if you print an ECG report.
CAUTION
Repeated undercharging of the battery will damage the battery and reduce battery life.
3) Replacement
When the useful life of the battery is over, or foul smell and leakage are found, please contact the manufacturer or the local distributor for replacement.
WARNING
1. Only qualified service engineers authorized by the manufacturer can open the battery compartment and replace the battery, and the battery of the same model and specification provided by the manufacturer must be used.
2. Danger of explosion -- Do not reverse the anode and the cathode when installing the battery.
3. When the battery's useful life is over, contact the manufacturer or the local distributor for disposal or dispose of the battery according to local regulations.
4. Remove the battery from the electrocardiograph when the electrocardiograph isn't used for a long time.
5. If the battery is stored alone and not used for a long time, we recommend that the battery be charged at least once every 6 months to prevent overdischarge.
CAUTION
If the battery has been fully charged and requires recharging after printing only a few
ECGs, consider replacement.
14.4.2 Recorder Paper
NOTE : Recorder paper provided by the manufacturer should be used. Other paper may shorten the life of the thermal print head. The deteriorated print head may lead to illegible ECG reports and block the advance of the paper.
Storage Requirements:
Recorder paper should be stored in a dry, dark and cool area, avoiding excessive temperature, humidity and sunshine.
♦
Do not put the recorder paper under fluorescence for a long time.
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SE-12 Series Electrocardiograph User Manual Cleaning, Care and Maintenance
♦
Make sure that there is no polyvinyl chloride or other chemicals in the storage environment, which will lead to color change of the paper.
♦ Do not overlap the recorder paper for a long time, or else the ECG reports may transprint each other.
14.4.3 Visual inspection
Perform a visual inspection of all equipment and peripheral devices daily. If you notice any items
that need repair, contact a qualified service engineer to make the repairs.
Check the case and display screen for cracks or other damage.
Regularly inspect all plugs, cords, cables, and connectors for fraying or other damage.
Verify that all cords and connectors are securely seated.
Inspect keys and controls for proper operation.
14.4.4 Maintenance of the Main Unit and the Patient Cable
CAUTION
Besides the maintenance requirements recommended in this manual, comply with local regulations on maintenance and measurement.
The following safety checks should be performed at least every 12 months by a qualified person who has adequate training, knowledge, and practical experience to perform these tests.
a) Inspect the equipment and accessories for mechanical and functional damage. b) Inspect the safety related labels for legibility. c) Inspect the fuse to verify compliance with the rated current and circuit-breaking characteristics. d) Verify that the device functions properly as described in the instructions for use. e) Test the protection earth resistance according to IEC/EN 60601-1: Limit: 0.1 ohm. f) Test the earth leakage current according to IEC/EN 60601-1: Limit: NC 500μA, SFC
1000μA. g) Test the enclosure leakage current according to IEC/EN 60601-1: Limit: NC 100μA,
SFC 500μA. h) Test the patient leakage current according to IEC/EN 60601-1: Limit: NC a.c. 10μA, d.c.
10μA; SFC a.c. 50μA, d.c. 50μA. i) Test the patient auxiliary current according to IEC/EN 60601-1: Limit: NC a.c. 10μA, d.c. 10μA; SFC a.c. 50μA, d.c. 50μA.
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SE-12 Series Electrocardiograph User Manual Cleaning, Care and Maintenance j) Test the patient leakage current under single fault condition with mains voltage on the applied part according to IEC/EN 60601-1: Limit: 50μA (CF). k) Test the essential performance according to IEC/EN 60601-2-25, or methods recommended by the hospital or local distributor.
The leakage current should never exceed the limit. The data should be recorded in an equipment log. If the device is not functioning properly or fails any of the above tests, the device has to be repaired.
WARNING
Failure on the part of the responsible individual hospital or institution employing this equipment to implement a satisfactory maintenance schedule may cause undue equipment failures and possible health hazards.
1) Main Unit
♦
Avoid excessive temperature, sunshine, humidity and dirt.
♦
Put the dustproof coat on the main unit after use and prevent shaking it violently when moving it to another place.
♦ Prevent any liquid from seeping into the equipment; otherwise the safety and the performance of the electrocardiograph cannot be guaranteed.
2) Patient Cable
♦
Integrity of the patient cable, including the main cable and lead wires, should be checked regularly. Make sure that it is conductible.
♦ Do not drag or twist the patient cable with excessive stress while using it. Hold the connector plug instead of the cable when connecting or disconnecting the patient cable.
♦
Align the patient cable to avoid twisting, knotting or crooking in a closed angle while using it.
♦ Store the lead wires in a big wheel to prevent any people from stumbling.
♦ Once damage or aging of the patient cable is found, replace it with a new one immediately.
3) Reusable Electrodes
♦
Electrodes must be cleansed after use and make sure there is no remainder gel on them.
♦
Keep suction bulbs of chest electrodes away from sunshine and excessive temperature.
♦
After long-term use, the surfaces of electrodes will be oxidized because of erosion and other causes. By this time, electrodes should be replaced to achieve high-quality ECG records.
CAUTION
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SE-12 Series Electrocardiograph User Manual Cleaning, Care and Maintenance
The device and accessories are to be disposed of according to local regulations after their useful lives. Alternatively, they can be returned to the dealer or the manufacturer for recycling or proper disposal.
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SE-12 Series Electrocardiograph User Manual Accessories
Chapter 15 Accessories
WARNING
Only the patient cable and other accessories supplied by the manufacturer can be used.
Or else, the performance and electric shock protection cannot be guaranteed.
15.1 Standard Accessories
Accessory
Power cord (European)
Power cord(American)
Patient Cable (European)
Patient Cable (American)
Adult Chest electrodes
Adult Limb electrodes
Table 15-1 Standard Accessories List
Thermal Recorder Paper
Rechargeable Li-ion Battery (SE-12)
Rechargeable Li-ion Battery (SE-12 Express)
Fuse
Part Number
01.13.036638
01.13.037122
01.57.471500*
01.57.471499*
01.57.040163
01.57.040162
01.57.107371
21.21.064149
21.21.064146
21.21.64073
21.21.064172
15.2 Configurable Accessories
Table 15-2 Configurable Accessories List
Accessory Part Number
01.57.107581
(Snap Style)
Patient Cable (European)
01.57.107583
(Grabber Style)
Patient Cable (American)
Patient Cable for Exercise ECG / European Standard
Patient Cable for Exercise ECG / American Standard
Grounding Wire
01.57.107582
(Snap Style)
01.57.107584
(Grabber Style)
01.57.109850
01.57.109851
01.13.114214
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SE-12 Series Electrocardiograph User Manual
Accessory
Pediatric Chest Electrodes
Pediatric Limb Electrodes
Adult Disposable Adhesive Electrodes
Pediatric Disposable Adhesive Electrodes
Part Number
01.57.040168
01.57.040169
01.57.471858
01.57.471862
01.57.471859
Accessories
Disposable Resting electrodes
Disposable Exercise electrodes
Snap/Banana Socket Adapters
Clip/Snap/Banana Socket Adapter
Thermal Recorder Paper (Rolled, 210mm×30m)
01.57.471863
01.57.471860
01.57.471864
01.57.040172
01.57.32461
Thermal Recorder Paper (Folded, 215mm×280mm×100P) 01.57.107451
BP Monitor 83.61.328019
ECG Bag
MT-201 Trolley
01.56.465625
83.61.111847
MT-801 Trolley
Belt for Exercise Test
U Disk
83.63.5600232
01.57.106750
01.18.052245
02.04.111902
CA-100 Lead wire bracket
Bar Code Reader (One-Dimension)
02.04.242639*
02.04.242640*
01.23.068023
Bar Code Reader (Two-Dimension) 21.18.052311
SE-12 series electrocardiograph and accessories are available by contacting the manufacturer or your local distributor.
NOTE:
1 * Currently not available in the U.S.
2 The chest electrodes, limb electrodes, pediatric chest electrodes and pediatric limb electrodes are not available in the U.S.
3 The part name may vary depending on context, but the part number is constant .
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SE-12 Series Electrocardiograph User Manual Warranty & Service
Chapter 16 Warranty & Service
16.1 Warranty
EDAN warrants that EDAN's products meet the labeled specifications of the products and will be free from defects in materials and workmanship that occur within warranty period.
The warranty is void in cases of: a) Damage caused by mishandling during shipping. b) Subsequent damage caused by improper use or maintenance. c) Damage caused by alteration or repair by anyone not authorized by EDAN. d) Damage caused by accidents. e) Replacement or removal of serial number label and manufacture label.
If a product covered by this warranty is determined to be defective because of defective materials, components, or workmanship, and the warranty claim is made within the warranty period, EDAN will, at its discretion, repair or replace the defective part(s) free of charge. EDAN will not provide a substitute product for use when the defective product is being repaired.
16.2 Contact information
If you have any question about maintenance, technical specifications or malfunctions of devices, contact your local distributor.
Alternatively, you can send an email to EDAN service department at: [email protected].
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SE-12 Series Electrocardiograph User Manual
Appendix 1 Technical Specifications
A1.1 Safety Specifications
IEC 60601-1:2005/A1:2012
Technical Specifications
Comply with:
EN 60601-1:2006/A1:2013
IEC 60601-1-2:2014
EN 60601-1-2:2015
IEC/EN 60601-2-25
Anti-electric-shock type: Class І with internal power supply
Anti-electric-shock degree: CF type with defibrillation-proof
Degree of protection against harmful ingress of water:
Ordinary equipment (Sealed equipment without liquid proof)
Disinfection/sterilization Refer to the user manual for details method:
Degree of safety of application in the presence of Equipment not suitable for use in the presence of flammable gas flammable gas:
Working mode: Continuous operation
EMC:
Patient
Leakage
Current:
Patient
Auxiliary
Current:
CISPR 11, Group 1, Class A
NC <10μA (AC) / <10μA (DC)
SFC <50μA (AC) / <50μA (DC)
NC <10μA (AC) / <10μA (DC)
SFC <50μA (AC) / <50μA (DC)
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SE-12 Series Electrocardiograph User Manual
A1.2 Environment Specifications
Temperature:
Relative Humidity:
Atmospheric Pressure:
Transport & Storage
-20ºC (-4ºF) ~ +55ºC (+131ºF)
25% RH~93% RH
Non-Condensing
70 kPa ~106 kPa
Technical Specifications
Working
+5ºC (+41ºF) ~ +40ºC (+104ºF)
25% RH~80% RH
Non-Condensing
86 kPa ~106 kPa
A1.3 Physical Specifications
SE-12 420mm×330mm×105mm, ±2mm
420mm×330mm×120mm, ±2mm
Dimensions
SE-12 Express
SE-1200 420mm×330mm×120mm, ±2mm
SE-1200 Express
SE-1201
SE-12
SE-12 Express
420mm×330mm×120mm, ±2mm
361mm×262mm×135mm, ±2mm
≤ 5.0kg (Excluding recorder paper and battery)
≤ 6.5kg (Excluding recorder paper and battery)
Weight SE-1200
SE-1200 Express
SE-1201
SE-12
≤ 5.0kg (Excluding recorder paper and battery)
≤ 5.0kg (Excluding recorder paper and battery)
≤ 4.2kg (Excluding recorder paper and battery)
5.7", 320×240 LCD screen
Display
SE-12 Express
SE-1200
12.1", 800×600 LCD screen
5.7", 320×240 LCD screen
SE-1200 Express 8.0", 800×600 LCD screen
SE-1201 7", 800×480 LCD screen
A1.4 Power Supply Specifications
Operating Voltage = 100V-240V~
Mains Supply: Operating Frequency = 50Hz/60Hz
Input Current = 0.9-0.4A
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SE-12 Series Electrocardiograph User Manual
Rated Voltage = 14.8V
Rated Capacity = 5000mAh or 2500mAh
SE-1201 only supports 2500mAh
Technical Specifications
Rated Capacity 100% Charge Time 90% Charge Time
Internal Li-ion
Battery Pack:
2500mAh
5000mAh
3 hours
6 hours
Rated Capacity
2500mAh
5000mAh
Normal Work
Hours
≥ 4h
≥ 8h
2 hours
3.5 hours
Print Number and Duration
Auto Mode
（ 3×4+1R ）
Manual Mode
(Continual)
≥ 300 ≥ 2h
≥ 500 ≥ 4h
Fuse: T3.15AH250V, Ø5×20mm;
A1.5 Performance Specifications
Recording
Recorder: Thermal dot-matrix recorder
8 dots per mm / 200 dots per inch (amplitude axes)
Printing Density
40 dots per mm / 1000 dots per inch (time axes, @ 25 mm/s)
- 90 -
Effective Width:
Paper Speed:
Accuracy of data:
HR Recognition
Technique:
HR Range:
Accuracy:
ECG Unit
Leads:
Acquisition Mode:
A/D:
Resolution:
Time Constant:
Frequency Response:
Gain:
Input Impedance:
SE-12 Series Electrocardiograph User Manual Technical Specifications
SE-12, SE-12Express, SE-1200, SE-1200 Express:
Folded thermal paper: 210mm×295mm×100pages
Folded thermal
(Configurable) paper: 215mm×280mm×100pages
Recorder Paper:
Rolled thermal paper: 210mm×30m (Configurable)
SE-1201:
Folded thermal paper: 210mm×140mm×144 pages
Folded thermal paper: 210mm×295mm×100
(Configurable) pages
Folded thermal paper: 215mm×280mm×100
(Configurable)
±5% (x-axis), ±5%(y-axis) pages
210mm
5mm/s, 6.25mm/s, 10mm/s, 12.5mm/s, 25mm/s, 50mm/s (±3%)
Peak-peak detection
30 bpm ~300 bpm
±1 bpm
12 standard leads simultaneously 12 leads
24 bits
2.52uV/LSB
≥3.2s
0.01Hz
～ 300Hz
1.25mm/mV, 2.5mm/mV, 5mm/mV, 10mm/mV, 20mm/mV,
10/5mm/mV, AGC
≥100MΩ (10Hz)
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SE-12 Series Electrocardiograph User Manual
Input Circuit Current:
Input Voltage Range
≤0.01μA
≤±5 mVpp
Calibration Voltage:
DC Offset Voltage:
1mV±2%
Noise:
Minimum Amplitude:
±600mV
20 μVp-p
≤12.5 μVp-p
≤0.5mm
Multichannel crosstalk
AC Filter: On/Off
DFT Filter:
Filter
CMRR
Sampling Frequency
Pacemaker Detection
Amplitude
Width
Sampling Frequency
External Input/Output
Input
Output
WIFI (Configurable)
Transmitting Frequency
Frequency Band
0.01Hz/0.05Hz/0.15Hz/0.25Hz/0.32Hz/0.5Hz/0.67Hz
EMG Filter: Off/25Hz/35Hz/45Hz
LOWPASS Filter: 300Hz/270Hz/150Hz/100Hz/75Hz
≥140dB (AC ON)
≥123dB (AC OFF)
16,000/sec/channel
±750uV to ±700 mV
50μs to 2.0 ms
16,000/sec/channel
≥100kΩ; Sensitivity 10mm/V±5%;
Single ended
≤100Ω; Sensitivity 1V/mV±5%;
Single ended
2400-2497MHz
2400-2497MHz
Technical Specifications
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SE-12 Series Electrocardiograph User Manual Technical Specifications
Wireless protocol
Modulation Type
Transmitting Power
IEEE 802.11b/g/n
DSSS, CCK, OFDM
6~17dBm
Effective Radiated Power 6~17dBm
NOTE: Operation of the equipment below the minimum amplitude may cause inaccurate results.
- 93 -
Emission test
RF emissions
CISPR 11
RF emission
CISPR 11
Harmonic emissions
IEC/EN 61000-3-2
Voltage fluctuations/ flicker emissions
IEC/EN 61000-3-3
SE-12 Series Electrocardiograph User Manual EMC Information
Appendix 2 EMC Information
Electromagnetic emissions
Guidance and manufacture's declaration – electromagnetic emission
The 12-channel electrocardiograph is intended for use in the electromagnetic environment specified below. The customer or the user of the 12-channel electrocardiograph should assure that it is used in such an environment.
Compliance
Group 1
Class A
Class A
Complies
Electromagnetic environment – guidance
The 12-channel electrocardiograph uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
The 12-channel electrocardiograph is suitable for use in all establishments, other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
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SE-12 Series Electrocardiograph User Manual
Electromagnetic immunity
EMC Information
Guidance and manufacture's declaration – electromagnetic immunity
The 12-channel electrocardiograph is intended for use in the electromagnetic environment specified below. The customer or the user of 12-channel electrocardiograph should assure that it is used in such an environment.
IEC/EN 60601
Immunity test test level
Electrostatic
8 kV contact discharge (ESD)
IEC/EN 61000-4-2
15 kV air
Compliance level
8 kV contact
15 kV air
Electromagnetic environment - guidance
Floors should be wood, concrete or ceramic tile. If floor are covered with synthetic material, the relative humidity should be at least 30%.
Electrical fast transient/burst
IEC/EN 61000-4-4
2 kV for power
2 kV for power supply lines supply lines
Surge
IEC/EN 61000-4-5
Mains power quality should be that of a typical commercial or hospital environment.
1 kV line to line
1 kV line to line
2 kV line to
2 kV line to ground ground
Mains power quality should be that of a typical commercial or hospital environment.
Power frequency
(50Hz/60Hz) magnetic field
30 A/m 30 A/m
Power frequency magnetic fields should be at levels characteristic of a typical
IEC/EN 61000-4-8 location in a typical commercial or hospital environment.
Voltage dips, short
0 % U
T;
0.5 cycle 0 % U
T;
0.5 cycle interruptions and At 0°, 45°, 90°, At 0°, 45°,
Mains power quality should be
90°, that of a typical commercial or voltage variations on 135°, 180°, 225°, 135°, 180°, 225°, hospital environment. If the power supply input 270°and 315° lines
270°and 315° user of the 12-channel electrocardiograph requires
IEC/EN 61000-4-11
0 % U
T
; 1 cycle 0 % U
T
; 1 cycle continued operation during
- 95 -
SE-12 Series Electrocardiograph User Manual and and
EMC Information power mains interruptions, it is
70 % U
T
; 25/30 70 % U
T
; 25/30 recommended cycles ) cycles )
Single phase: at Single phase: at 0°
0° that the
12-channel electrocardiograph be powered from an uninterruptible power supply or
0 % U
T
; 250/300 cycle cycle
0 % U
T
; 250/300 a battery.
NOTE U
T
is the a.c. mains voltage prior to application of the test level.
Electromagnetic immunity
Guidance and manufacture's declaration – electromagnetic immunity
The 12-channel electrocardiograph is intended for use in the electromagnetic environment specified below. The customer or the user of the 12-channel electrocardiograph should assure that it is used in such an environment.
Immunity test
Conducted
RF
IEC/EN
61000-4-6
Radiated RF
IEC/EN
IEC/EN 60601 test Compliance level
Electromagnetic environment level guidance
Portable and mobile RF communications equipment should be used no closer to any part of the 12-channel electrocardiograph, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance
3 V rms between
3V rms d
1.2
P
6Vrms c)
150 kHz to 80 MHz
6Vrms c)
in ISM bands
150 kHz to
80 MHz in
0.15 MHz and 80 ISM bands
MHz
3 V/m between 0.15
MHz and 80
MHz
3 V/m d
1.2
P 80 MHz to 800 MHz
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SE-12 Series Electrocardiograph User Manual
61000-4-3 80 MHz to 2.7 GHz 80 MHz to
2.7 GHz
EMC Information d
2.3
P 800 MHz to 2.7 GHz d
6 P / E at RF wireless communications equipment bands
(Portable RF communications equipment
(including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the PADECG, including cables specified by the manufacturer).
Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a
should be less than the compliance level in each frequency range.
b
Interference may occur in the vicinity of equipment marked with the following symbol:
NOTE 1 At 80 MHz 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.
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SE-12 Series Electrocardiograph User Manual a
EMC Information
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 electromagnetic site survey should be considered. If the measured field strength in the location in which the 12-channel electrocardiograph is used exceeds the applicable RF compliance level above, the 12channel electrocardiograph should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the 12-channel electrocardiograph.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
c
The ISM (industrial, scientific and medical) bands between 0.15 MHz 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 amateur radio bands between 0.15 MHz and 80 MHz are
1.8 MHz to 2.0 MHz, 3.5 MHz to 4.0 MHz, 5.3 MHz to 5.4 MHz, 7 MHz to 7.3 MHz, 10.1
MHz to 10.15 MHz, 14 MHz to 14.2 MHz, 18.07 MHz to 18.17 MHz, 21.0 MHz to 21.4
MHz, 24.89 MHz to 24.99 MHz, 28.0 MHz to 29.7 MHz and 50.0 MHz to 54.0 MHz.
Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment
Test
Frequency
(MHz)
Brand a)
(MHz)
Service a)
Modulation Maximum Distance b)
Power(W) (m)
Pulse
IMMUNITY
TEST
LEVEL
(V/m)
385 380-390 TETRA 400 modulation b)
18Hz
1.8
0.3
27
450
710
745
780
810
GMRS 460,
FM
C)
±5 kHz
430-470
704-787
800-960
FRS 460 deviation
LTE Brand 13,
17
GSM
1kHz sine
Pulse modulation b)
217 Hz
Pulse
2
0.2
2
0.3
0.3
0.3
28
9
28
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SE-12 Series Electrocardiograph User Manual
870 800/900,TETRA modulation b)
800, iDEN 820, 18 Hz
930 CDMA 850, LTE
1720
Band 5
GSM 1800;
1845
1970
1700-1990
CDMA 1900;
GSM 1900;
DECT; LTE
Band 1, 3, 4,25;
Pulse modulation b)
217 Hz
2
2450
UMTS
Bluetooth,
Pulse WLAN,802.11
2400-2570 b/g/n, RFID modulation b)
2450, LTE 217 Hz
2
0.3
0.3
28
Brand 7
5240
5500
5785
5100-5800
WLAN 802.11
a/n
Pulse modulation b)
217 Hz
0.2
0.3
9
Note: If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM maybe reduce to 1m. The 1 m test distance is permitted by IEC 61000-4-3.
a) For some services, only the uplink frequencies are included.
b) The carrier shall be modulated using a 50% duty cycle square wave signal.
c) As an alternative FM modulation, 50% pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case.
- 99 -
EMC Information
28
SE-12 Series Electrocardiograph User Manual EMC Information
Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM
Recommended separation distances between portable and mobile RF communications equipment and the 12-channel Electrocardiograph
The 12-channel electrocardiograph is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the 12-channel electrocardiograph can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the 12channel electrocardiograph as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output
Separation distance according to frequency of transmitter(m) power of transmitter
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.7 GHz
(W) d
1.2
P d
1.2
P d
2.3
P
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1 1.2
1.2
2.3
10 3.8
3.8
7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for 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.
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SE-12 Series Electrocardiograph User Manual
Appendix 3 Abbreviations
Abbreviation
LCD
BP
ECG
HR
Full Description
Liquid Crystal Display
Blood Pressure
Electrocardiogram/Electrocardiograph
Heart Rate aVF aVL aVR
Left Foot Augmented Lead
Left Arm Augmented Lead
Right Arm Augmented Lead
LA
LL
Left Arm
Left Leg
RA
RL
ID
AC
USB
AGC
NC
SFC
Right Arm
Right Leg
Identification
Alternating Current
Universal Serial Bus
Auto Gain Control
Normal Condition
Single Fault Condition
- 101 -
Abbreviations
- 102 -
Advertisement
Key features
- Lightweight and portable
- Easy to use
- Large, high-resolution display
- Built-in thermal printer
- Versatile - can be used to perform a variety of ECG tests
- Compatible with a variety of accessories
