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GE Healthcare

MAC™ i Resting ECG Analysis System


Service Manual
2065935-002 Revision D

English
© 2012, 2015 General Electric Company.
All Rights Reserved.
Publication Information
The information in this manual applies only to MAC™ i Resting ECG Analysis System version 2. It does not apply to earlier product versions.
Due to continuing product innovation, specifications in this manual are subject to change without notice.
MUSE, CASE, MAC, MARS, and 12SL are trademarks owned by GE Medical Systems Information Technologies, Inc., a General Electric Company
going to market as GE Healthcare. All other trademarks contained herein are the property of their respective owners.
This product complies with the requirements concerning medical devices from the following regulatory bodies:

The document part number and revision appear at the bottom of each page. The revision identifies the document’s update level. The
revision history of this document is summarized in the following table.

Revision Date Comments


A 11 July 2012 Internal release of this manual.
B 12 July 2012 Internal release of this manual.
C 19 October 2012 Initial release to customer.
D 17 March 2015 Updates for printers.

To access other GE Healthcare manuals, go to the Common Documentation Library (CDL), located at http://www.gehealthcare.com/usen/
service/biomed_tech_selfservice/services_user_doc/products/support.html and click Cardiology.
To access Original Equipment Manufacturer (OEM) manuals, go to the device manufacturer's Web site.
India Headquarters
Wipro GE Healthcare Pvt. Ltd., No.4, Kadugodi Industrial Area, Bangalore – 560 067, Karnataka India
Tel: +91 80 2845 2923/25/26
Fax: +90 80 28452924
Service Contact:
Tel: +91 80 32937750
Toll free number:
1 800 425 7255 (BSNL)
1 800 102 7750 (Airtel)

Service Manual Language Information


WARNING This service manual is available in English only.
(EN) • If a customer's service provider requires a language other than English, it is the customer's
responsibility to provide translation services.

• Do not attempt to service the equipment unless this service manual has been consulted
and is understood.

• Failure to heed this warning may result in injury to the service provider, operator, or patient,
from electric shock, mechanical or other hazards.
ПРЕДУПРЕЖДЕНИЕ Това упътване за работа е налично само на английски език.
(BG) • Ако доставчикът на услугата на клиента изиска друг език, задължение на клиента е
да осигури превод.

• Не използвайте оборудването, преди да сте се консултирали и разбрали упътването


за работа.

• Неспазването на това предупреждение може да доведе до нараняване на доставчика


на услугата, оператора или пациент в резултат на токов удар или механична или
друга опасност.

2 MAC™ i Resting ECG Analysis System 2065935-002D


17 March 2015
Service Manual Language Information (cont'd.)

警告 本维修手册仅提供英文版本。
ZH-CN • 如果维修服务提供商需要非英文版本,客户需自行提供翻译服务。
• 未详细阅读和完全理解本维修手册之前,不得进行维修。
• 忽略本警告可能对维修人员,操作员或患者造成触电、机械伤害或其他形式的伤害。
警告 本維修手冊只提供英文版。
(ZH-TW) • 如果客戶的維修人員有英語以外的其他語言版本需求,則由該客戶負責 提供翻
譯服務。

• 除非您已詳閱本維修手冊並了解其內容,否則切勿嘗試對本設備進行維 修。
• 不重視本警告可能導致維修人員、操作人員或病患因電擊、機械因素或 其他因素
而受到傷害。
UPOZORENJE Ove upute za servisiranje dostupne su samo na engleskom jeziku.
(HR) • Ukoliko korisnički servis zahtijeva neki drugi jezik, korisnikova je odgovornost osigurati
odgovarajući prijevod.

• Nemojte pokušavati servisirati opremu ukoliko niste konzultirali i razumjeli ove upute.
• Nepoštivanje ovog upozorenja može rezultirati ozljedama servisnog osoblja, korisnika ili
pacijenta prouzročenim električnim udarom te mehaničkim ili nekim drugim opasnostima.

VAROVÁNÍ Tento provozní návod existuje pouze v anglickém jazyce.


(CS) • V případě, že externí služba zákazníkům potřebuje návod v jiném jazyce, je zajištění
překladu do odpovídajícího jazyka úkolem zákazníka.

• Nesnažte se o údržbu tohoto zařízení, aniž byste si přečetli tento provozní návod a
pochopili jeho obsah.

• V případě nedodržování této varování může dojít k poranění pracovníka prodejního


servisu, obslužného personálu nebo pacientů vlivem elektrického proudu, respektive
vlivem mechanických či jiných rizik.
ADVARSEL Denne servicemanual findes kun på engelsk.
(DA) • Hvis en kundes tekniker har brug for et andet sprog end engelsk, er det kundens ansvar
at sørge for oversættelse.

• Forsøg ikke at servicere udstyret medmindre denne servicemanual har været konsulteret
og er forstået.

• Manglende overholdelse af denne advarsel kan medføre skade på grund af elektrisk,


mekanisk eller anden fare for teknikeren, operatøren eller patienten.
WAARSCHUWING Deze service manual is alleen in het Engels verkrijgbaar.
(NL) • Indien het onderhoudspersoneel een andere taal nodig heeft, dan is de klant
verantwoordelijk voor de vertaling ervan.

• Probeer de apparatuur niet te onderhouden voordat deze service manual geraadpleegd


en begrepen is.

• Indien deze waarschuwing niet wordt opgevolgd, zou het onderhoudspersoneel, de


gebruiker of een patiënt gewond kunnen raken als gevolg van een elektrische schok,
mechanische of andere gevaren.

2065935-002D MAC™ i Resting ECG Analysis System 3


Service Manual Language Information (cont'd.)

HOIATUS Käesolev teenindusjuhend on saadaval ainult inglise keeles.


(ET) • Kui klienditeeninduse osutaja nõuab juhendit inglise keelest erinevas keeles, vastutab
klient tõlketeenuse osutamise eest.

• Ärge üritage seadmeid teenindada enne eelnevalt käesoleva teenindusjuhendiga


tutvumist ja sellest aru saamist.

• Käesoleva hoiatuse eiramine võib põhjustada teenuseosutaja, operaatori või patsiendi


vigastamist elektrilöögi, mehaanilise või muu ohu tagajärjel.
VAROITUS Tämä huolto-ohje on saatavilla vain englanniksi.
(FI) • Jos asiakkaan huoltohenkilöstö vaatii muuta kuin englanninkielistä materiaalia, tarvittavan
käännöksen hankkiminen on asiakkaan vastuulla.

• Älä yritä korjata laitteistoa ennen kuin olet varmasti lukenut ja ymmärtänyt tämän
huolto-ohjeen.

• Mikäli tätä varoitusta ei noudateta, seurauksena voi olla huoltohenkilöstön, laitteiston


käyttäjän tai potilaan vahingoittuminen sähköiskun, mekaanisen vian tai muun
vaaratilanteen vuoksi.
ATTENTION Ce manuel technique n'est disponible qu'en anglais.
(FR) • Si un service technique client souhaite obtenir ce manuel dans une autre langue que
l'anglais, il devra prendre en charge la traduction et la responsabilité du contenu.

• Ne pas tenter d'intervenir sur les équipements tant que le manuel technique n'a pas été
consulté et compris.

• Le non-respect de cet avertissement peut entraîner chez le technicien, l'opérateur ou le


patient des blessures dues à des dangers électriques, mécaniques ou autres.
WARNUNG Diese Serviceanleitung ist nur in englischer Sprache verfügbar.
(DE) • Falls der Kundendienst eine andere Sprache benötigt, muss er für eine entsprechende
Übersetzung sorgen.

• Keine Wartung durchführen, ohne diese Serviceanleitung gelesen und verstanden zu


haben.

• Bei Zuwiderhandlung kann es zu Verletzungen des Kundendiensttechnikers, des


Anwenders oder des Patienten durch Stromschläge, mechanische oder sonstige Gefahren
kommen.
ΠΡΟΕΙΔΟΠΟΙΗΣΗ Το παρόν εγχειρίδιο σέρβις διατίθεται στα αγγλικά μόνο.
(GR) • Εάν το άτομο παροχής σέρβις ενός πελάτη απαιτεί το παρόν εγχειρίδιο σε γλώσσα εκτός
των αγγλικών, αποτελεί ευθύνη του πελάτη να παρέχει υπηρεσίες μετάφρασης.

• Μην επιχειρήσετε την εκτέλεση εργασιών σέρβις στον εξοπλισμό εκτός εάν έχετε
συμβουλευτεί και έχετε κατανοήσει το παρόν εγχειρίδιο σέρβις.

• Εάν δεν λάβετε υπόψη την προειδοποίηση αυτή, ενδέχεται να προκληθεί τραυματισμός
στο άτομο παροχής σέρβις, στο χειριστή ή στον ασθενή από ηλεκτροπληξία, μηχανικούς
ή άλλους κινδύνους.

4 MAC™ i Resting ECG Analysis System 2065935-002D


17 March 2015
Service Manual Language Information (cont'd.)

FIGYELMEZTETÉS Ez a szerviz kézikönyv kizárólag angol nyelven érhető el.


(HU) • Ha a vevő szerviz ellátója angoltól eltérő nyelvre tart igényt, akkor a vevő felelőssége
a fordítás elkészíttetése.

• Ne próbálja elkezdeni használni a berendezést, amíg a szerviz kézikönyvben leírtakat


nem értelmezték és értették meg.

• Ezen figyelmeztetés figyelmen kívül hagyása a szerviz ellátó, a működtető vagy a páciens
áramütés, mechanikai vagy egyéb veszélyhelyzet miatti sérülését eredményezheti.

AÐVÖRUN Þessi þjónustuhandbók er eingöngu fáanleg á ensku.


(IS) • Ef að þjónustuveitandi viðskiptamanns þarfnast annars tungumáls en ensku, er það skylda
viðskiptamanns að skaffa tungumálaþjónustu.

• Reynið ekki að afgreiða tækið nema þessi þjónustuhandbók hefur verið skoðuð og skilin.
• Brot á að sinna þessari aðvörun getur leitt til meiðsla á þjónustuveitanda, stjórnanda eða
sjúklingi frá raflosti, vélrænum eða öðrum áhættum.
PERINGATAN Manual servis ini hanya tersedia dalam bahasa Inggris.
(ID) • Jika penyedia jasa servis pelanggan memerlukan bahasa lain selain dari Bahasa Inggris,
merupakan tanggung jawab dari penyedia jasa servis tersebut untuk menyediakan
terjemahannya.

• Jangan mencoba melakukan servis terhadap perlengkapan kecuali telah membaca dan
memahami manual servis ini.

• Mengabaikan peringatan ini bisa mengakibatkan cedera pada penyedia servis, operator,
atau pasien, karena terkena kejut listrik, bahaya mekanis atau bahaya lainnya.
AVVERTENZA Il presente manuale di manutenzione è disponibile soltanto in Inglese.
(IT) • Se un addetto alla manutenzione richiede il manuale in una lingua diversa, il cliente è
tenuto a provvedere direttamente alla traduzione.

• Si proceda alla manutenzione dell'apparecchiatura solo dopo aver consultato il presente


manuale ed averne compreso il contenuto.

• Il non rispetto della presente avvertenza potrebbe far compiere operazioni da cui derivino
lesioni all'addetto, alla manutenzione, all'utilizzatore ed al paziente per folgorazione
elettrica, per urti meccanici od altri rischi.

警告 このサービスマニュアルは英語版しかありません。
(JA) • サービスを担当される業者が英語以外の言語を要求される場合、翻訳作業はその業
者の責任で行うものとさせていただきます。

• このサービスマニュアルを熟読し、十分に理解をした上で装置のサービスを
行ってください。

• この警告に従わない場合、サービスを担当される方、操作員あるいは患者が、感電
や機械的又はその他の危険により負傷する可能性があります。

경고 본 서비스 지침서는 영어로만 이용하실 수 있습니다.


(KO) • 고객의 서비스 제공자가 영어 이외의 언어를 요구할 경우, 번역 서비스를 제공하는 것
은 고객의 책임입니다.

• 본 서비스 지침서를 참고했고 이해하지 않는 한은 해당 장비를 수리하려고 시도하


지 마십시오.

• 이 경고에 유의하지 않으면 전기 쇼크, 기계상의 혹은 다른 위험으로부터 서비스 제


공자, 운영자 혹은 환자에게 위해를 가할 수 있습니다.

2065935-002D MAC™ i Resting ECG Analysis System 5


Service Manual Language Information (cont'd.)

BRĪDINĀJUMS Šī apkalpotāju rokasgrāmata ir pieejama tikai angļu valodā.


(LV) • Ja apkalpošanas sniedzējam nepieciešama informācija citā, nevis angļu, valodā, klienta
pienākums ir nodrošināt tās tulkošanu.

• Neveiciet aprīkojuma apkopi, neizlasot un nesaprotot apkalpotāju rokasgrāmatu.


• Šī brīdinājuma neievērošana var radīt elektriskās strāvas trieciena, mehānisku vai citu risku
izraisītu traumu apkopes sniedzējam, operatoram vai pacientam.

ĮSPĖJIMAS Šis eksploatavimo vadovas yra prieinamas tik anglų kalba.


(LT) • Jei kliento paslaugų tiekėjas reikalauja vadovo kita kalba - ne anglų, numatyti vertimo
paslaugas yra kliento atsakomybė.

• Nemėginkite atlikti įrangos techninės priežiūros, nebent atsižvelgėte į šį eksploatavimo


vadovą ir jį supratote.

• Jei neatkreipsite dėmesio į šį perspėjimą, galimi sužalojimai dėl elektros šoko, mechaninių
ar kitų paslaugų tiekėjui, operatoriui ar pacientui.
ADVARSEL Denne servicehåndboken finnes bare på engelsk.
(NO) • Hvis kundens serviceleverandør trenger et annet språk, er det kundens ansvar å sørge
for oversettelse.

• Ikke forsøk å reparere utstyret uten at denne servicehåndboken er lest og forstått.


• Manglende hensyn til denne advarselen kan føre til at serviceleverandøren, operatøren
eller pasienten skades på grunn av elektrisk støt, mekaniske eller andre farer.

OSTRZEŻENIE Niniejszy podręcznik serwisowy dostępny jest jedynie w języku angielskim.


(PL) • Jeśli dostawca usług klienta wymaga języka innego niż angielski, zapewnienie usługi
tłumaczenia jest obowiązkiem klienta.

• Nie należy serwisować wyposażenia bez zapoznania się i zrozumienia niniejszego


podręcznika serwisowego.

• Niezastosowanie się do tego ostrzeżenia może spowodować urazy dostawcy usług,


operatora lub pacjenta w wyniku porażenia elektrycznego, zagrożenia mechanicznego
bądź innego.
AVISO Este manual de assistência técnica só se encontra disponível em inglês.
(PT-BR) • Se o serviço de assistência técnica do cliente não for GE, e precisar de outro idioma, será
da responsabilidade do cliente fornecer os serviços de tradução.

• Não tente reparar o equipamento sem ter consultado e compreendido este manual de
assistência técnica.

• O não cumprimento deste aviso pode por em perigo a segurança do técnico, operador ou
paciente devido a choques elétricos, mecânicos ou outros.
AVISO Este manual técnico só se encontra disponível em inglês.
(PT-PT) • Se a assistência técnica do cliente solicitar estes manuais noutro idioma, é da
responsabilidade do cliente fornecer os serviços de tradução.

• Não tente reparar o equipamento sem ter consultado e compreendido este manual
técnico.

• O não cumprimento deste aviso pode provocar lesões ao técnico, ao utilizador ou ao


paciente devido a choques eléctricos, mecânicos ou outros.

6 MAC™ i Resting ECG Analysis System 2065935-002D


17 March 2015
Service Manual Language Information (cont'd.)

AVERTISMENT Acest manual de service este disponibil numai în limba engleză.


(RO) • Dacă un furnizor de servicii pentru clienţi necesită o altă limbă decât cea engleză, este de
datoria clientului să furnizeze o traducere.

• Nu încercaţi să reparaţi echipamentul decât ulterior consultării şi înţelegerii acestui


manual de service.

• Ignorarea acestui avertisment ar putea duce la rănirea depanatorului, operatorului sau


pacientului în urma pericolelor de electrocutare, mecanice sau de altă natură.
ПРЕДУПРЕЖДЕНИЕ Настоящее руководство по обслуживанию предлагается только на английском языке.
(RU) • Если сервисному персоналу клиента необходимо руководство не на английском, а на
каком-то другом языке, клиенту следует обеспечить перевод самостоятельно.

• Прежде чем приступать к обслуживанию оборудования, обязательно обратитесь к


настоящему руководству и внимательно изучите изложенные в нем сведения.

• Несоблюдение требований данного предупреждения может привести к тому, что


специалисты по обслуживанию, операторы или пациенты получат удар электрическим
током, механическую травму или другое повреждение.
UPOZORENJE Ovo servisno uputstvo je dostupno samo na engleskom jeziku.
(SR) • Ako klijentov serviser zahteva neki drugi jezik, klijent je dužan da obezbedi prevodilačke
usluge.

• Ne pokušavajte da opravite uređaj ako niste pročitali i razumeli ovo servisno uputstvo.
• Zanemarivanje ovog upozorenja može dovesti do povređivanja servisera, rukovaoca ili
pacijenta usled strujnog udara, ili mehaničkih i drugih opasnosti.
VAROVANIE Tento návod na obsluhu je k dispozícii len v angličtine.
(SK) • Ak zákazníkov poskytovateľ služieb vyžaduje iný jazyk ako angličtinu, poskytnutie
prekladateľských služieb je zodpovednosťou zákazníka.

• Nepokúšajte sa o obsluhu zariadenia skôr, ako si neprečítate návod na obsluhu a


neporozumiete mu.

• Zanedbanie tohto varovania môže vyústiť do zranenia poskytovateľa služieb, obsluhujúcej


osoby alebo pacienta elektrickým prúdom, mechanickým alebo iným nebezpečenstvom.
OPOZORILO Ta servisni priročnik je na voljo samo v angleškem jeziku.
(SL) • Če ponudnik storitve stranke potrebuje priročnik v drugem jeziku, mora stranka zagotoviti
prevod.

• Ne poskušajte servisirati opreme, če tega priročnika niste v celoti prebrali in razumeli.


• Če tega opozorila ne upoštevate, se lahko zaradi električnega udara, mehanskih ali drugih
nevarnosti poškoduje ponudnik storitev, operater ali bolnik.
ADVERTENCIA Este manual de servicio sólo existe en inglés.
(ES) • Si el encargado de mantenimiento de un cliente necesita un idioma que no sea el inglés, el
cliente deberá encargarse de la traducción del manual.

• No se deberá dar servicio técnico al equipo, sin haber consultado y comprendido este
manual de servicio.

• La no observancia del presente aviso puede dar lugar a que el proveedor de servicios, el
operador o el paciente sufran lesiones provocadas por causas eléctricas, mecánicas o
de otra naturaleza.

2065935-002D MAC™ i Resting ECG Analysis System 7


Service Manual Language Information (cont'd.)

VARNING Den här servicehandboken finns bara tillgänglig på engelska.


(SV) • Om en kunds servicetekniker har behov av ett annat språk än engelska ansvarar kunden
för att tillhandahålla översättningstjänster.

• Försök inte utföra service på utrustningen om du inte har läst och förstår den här
servicehandboken.

• Om du inte tar hänsyn till den här varningen kan det resultera i skador på serviceteknikern,
operatören eller patienten till följd av elektriska stötar, mekaniska faror eller andra faror.
UYARI Bu servis kılavuzunun sadece İngilizcesi mevcuttur.
(TR) • Eğer müşteri teknisyeni bu kılavuzu İngilizce dışında bir başka lisandan talep ederse, bunu
tercüme ettirmek müşteriye düşer.

• Servis kılavuzunu okuyup anlamadan ekipmanlara müdahale etmeyiniz.


• Bu uyarıya uyulmaması, elektrik, mekanik veya diğer tehlikelerden dolayı teknisyen,
operatör veya hastanın yaralanmasına yol açabilir.
ЗАСТЕРЕЖЕННЯ Дане керівництво з сервісного обслуговування постачається виключно англійською мовою.
(UK) • Якщо сервісний інженер потребує керівництво іншою мовою, користувач зобов'язаний
забезпечити послуги перекладача.

• Не намагайтеся здійснювати технічне обслуговування даного обладнання, якщо


ви не читали, або не зрозуміли інформацію, надану в керівництві з сервісного
обслуговування.

• Недотримання цього застереження може призвести до травмування сервісного


інженера, користувача даного обладнання або пацієнта внаслідок електричного шоку,
механічного ушкодження або з інших причин невірного обслуговування обладнання.

CẢNH BÁO Tài Liệu Hướng Dẫn Sửa Chữa chỉ có bản tiếng Anh.
(VI) • Nếu các đơn vị cung cấp dịch vụ cho khách hàng yêu cầu một ngôn ngữ nào khác tiếng
Anh, thì khách hàng sẽ có trách nhiệm cung cấp các dịch vụ dịch thuật.

• Không được sửa chữa thiết bị trừ khi đã tham khảo và hiểu Tài liệu Hướng dẫn Sửa chữa.
• Không tuân thủ những cảnh báo này có thể dẫn đến các tổn thương cho người thực
hiện sửa chữa, người vận hành hay bệnh nhân, do sốc điện, các rủi ro về cơ khí hay
các rủi ro khác.

8 MAC™ i Resting ECG Analysis System 2065935-002D


17 March 2015
Contents

1 Introduction
Intended User............................................................................................ 13

Indications for Use .................................................................................... 13

Contraindiations ....................................................................................... 13

Prescription Device Statement ................................................................. 13

Regulatory and Safety Information........................................................... 14


Safety Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Safety Hazards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Classification of Medical Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Certification Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Accuracy of Input Signal Reproduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Modulating Effects in Digital Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
EMI/EMC/RF Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Biocompatibility. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Legal Notice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Supplies and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Responsibility of the Manufacturer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Responsibility of the Purchaser/Customer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Product and Package Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Training ..................................................................................................... 28

Equipment Identification........................................................................... 28
Product Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Serial Number Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Device Address Label and Rating Plate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Product Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Service Information................................................................................... 31
Service Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Warranty Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Additional Assistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Manual Information .................................................................................. 31


Manual Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Document Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Related Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

2 Product Overview
Hardware Description ............................................................................... 36
Top View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Side View. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Rear View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Keypad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

2065935-002D MAC™ i Resting ECG Analysis System 9


System Overview ...................................................................................... 38
Mechanical Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Functionality. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
External Power Supply Module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
DC Power Inlet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Battery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Main PCB Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Voltage Supply and Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Thermal Printer and Motor Assembly Interface. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
ECG Recording and Pre-processing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

3 Installation and Setup


Printer Options.......................................................................................... 43
Setting the Printer Configurations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

Using the Service Menu............................................................................. 44


Navigating to the Service Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Entering the Serial Number. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Updating the Application Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Updating the Boot Software. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Storing the System Log. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Accessing the System Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

Programming the MAC i Device Without a User Interface........................ 47

4 Diagnostic and Safety Tests


Diagnostic Device Tests ............................................................................ 49
Display Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Keypad Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Writer Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Battery Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Acquisition Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
System Info . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

Electrical Safety Tests: Leakage Current Tests ......................................... 52


Enclosure (Chassis) Leakage Current Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Patient Leakage Current Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

5 Maintenance and FRU Replacement Procedures


Recommended Maintenance .................................................................... 59
Inspection and Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Battery Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Calibration Check. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

Replacing Field Replaceable Units (FRUs).................................................. 62


Safety Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Replacing the Battery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Removing and Replacing the Top Cover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Removing and Replacing the Bottom Cover. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Replacing the Thermal Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Replacing the Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Replacing the Main PCB Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
Replacing the Power Supply. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
Additional Functional Checkout Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Adjustment Instructions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

10 MAC™ i Resting ECG Analysis System 2065935-002D


6 Troubleshooting
Power Errors.............................................................................................. 79
The Device Does Not Turn On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
Battery Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82

Blank Display............................................................................................. 84

Printing Errors........................................................................................... 85
Printer Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
Data Printing Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88

7 Parts List for Field Replaceable Units (FRUs)


Printer Kit .................................................................................................. 91

Printer Door Kits ....................................................................................... 92

Hardware Kit ............................................................................................. 93

Display Module Kit .................................................................................... 94

PWA Kit ..................................................................................................... 94

Plastic Parts Kit ......................................................................................... 95

Cover Top Assembly Kit............................................................................. 96

Battery Kit ................................................................................................. 96

Battery Cover ............................................................................................ 97

Cover Bottom Kit....................................................................................... 97

Software Kit............................................................................................... 98

Power Supply Kit ....................................................................................... 98

A Technical Information
Specifications ............................................................................................ 99

B Electromagnetic Compatibility (EMC)


Guidance and Manufacturer’s Declaration—Electromagnetic
Emissions ................................................................................................ 105

Guidance and Manufacturer’s Declaration—Electromagnetic


Immunity................................................................................................. 106

Guidance and Manufacturer’s Declaration—Electromagnetic


Immunity................................................................................................. 107

Recommended Separation Distances ..................................................... 108

2065935-002D MAC™ i Resting ECG Analysis System 11


12 MAC™ i Resting ECG Analysis System 2065935-002D
Introduction
1
This document describes the MAC™ i Resting ECG Analysis System, also referred to as
the “product”, “system”, or “device”. The document is intended to be used by anyone
who maintains or troubleshoots this equipment.
This chapter provides general information required for the proper use of the system
and this manual. Familiarize yourself with this information before using the system.

Intended User
The MAC™ i Resting ECG Analysis System is intended to be used by qualified medical
personnel who have received proper medical and product training.

Indications for Use


The MAC i Resting ECG Analysis System is intended to acquire, analyze, and record
electrocardiographic information for adult and pediatric populations. The basic
system delivers 12–lead ECGs, and can be upgraded to provide software analysis
options, such as interpretive analysis of the electrocardiogram.
The MAC i is intended to be used by trained operators in a hospital or medical
professional’s facility as well as used in clinics, physician offices, outreach centers or
wherever ECG testing is performed to record ECG signals from surface electrodes.

Contraindiations
This system is not intended for use in the following manner:
• During patient transport
• With high-frequency surgical units
• As an intra-cardiac application
• As a vital signs physiological monitor

Prescription Device Statement


CAUTION:
United States federal law restricts this device to sale by or on the order of a
physician.
2065935-002D MAC™ i Resting ECG Analysis System 13
Introduction

Regulatory and Safety Information


This section provides information about the safe use and regulatory compliance of
this device. Familiarize yourself with this information and read and understand all
instructions before attempting to use this device. The system software is considered
medical software. As such, it was designed and manufactured to the appropriate
medical regulations and controls. Any exceptions are noted in the Compliance
Information - Exceptions section.
NOTE:
Disregarding the safety information provided is considered abnormal use of
this device and could result in injury, loss of data, and void any existing product
warranties.

Safety Conventions
A Hazard is a source of potential injury to a person, property, or the system.
This manual uses the terms DANGER, WARNING, CAUTION, and NOTICE to point out
hazards and to designate a degree or level of seriousness. Familiarize yourself with
the following definitions and their significance.

Definitions of Safety Conventions

Safety Definition
Convention
DANGER Indicates an imminent hazard, which, if not avoided, will result in death
or serious injury.
WARNING Indicates a potential hazard or unsafe practice, which, if not avoided,
could result in death or serious injury.
CAUTION Indicates a potential hazard or unsafe practice, which, if not avoided,
could result in moderate or minor injury.
NOTICE Indicates a potential hazard or unsafe practice, which, if not avoided,
could result in the loss or destruction of property or data.

Safety Hazards
The following messages apply to the system as a whole. Specific messages may also
be provided elsewhere in the manual.
DANGER:
EXPLOSION HAZARD – Use near flammables may cause explosion.
Do not use in the presence of flammable anesthetics, vapors, or liquids.

14 MAC™ i Resting ECG Analysis System 2065935-002D


Introduction

WARNING:
POSSIBLE ELECTRIC SHOCK – Failure to properly ground the device when
connected to an AC power source could result in an electric shock to the patient or
operator.
When using AC power, the mains plug must be connected to an appropriate
power supply.
Operate the device from its battery if the integrity of the protective earth
conductor is in doubt.

Classification of Medical Device


The device is classified as follows, according to IEC 60601-1:

Medical Device Classifications

Category Classification
Type of protection against electrical shock Class 1 internally powered equipment

Degree of protection against electrical shock Type CF defibrillation-proof applied part


Degree of protection against harmful ingress This system is not protected against the
of liquids ingress of liquids.
Degree of protection against harmful ingress This system is not protected against the
of solids and liquids ingress of solid materials.
Degree of safety of application in the Equipment is not suitable for use in the
presence of a flammable anesthetic mixture presence of a flammable anesthetic mixture
with air or with oxygen or with nitrous oxide with air or with oxygen or with nitrous oxide
Method(s) of sterilization or disinfection Not applicable
recommended by the manufacturer
Mode of operation Continuous operation

Take care to avoid accidental spills or ingress of materials into the system.

Certification Information
Medical Equipment
Classified with respect to electric shock, fire, mechanical, and other
specified hazards only in accordance with UL 60601-1, CAN/CSA
C22.2 No. 601.1, IEC 60601-2-25, IEC 60601-1, IEC 60601-1-2, IEC
60601-2-51

2065935-002D MAC™ i Resting ECG Analysis System 15


Introduction

This system bears CE mark 0459 indicating it conforms with the


provisions of Council Directive 93/42/EEC concerning medical
devices, and it fulfills the essential requirements of Annex I of this
directive.
The system is in radio-interference protection class A in accordance
with EN 55011. The country of manufacture is indicated on the
equipment labeling.
The product complies with the requirements of standard EN
60601–1–2 “Electromagnetic Compatibility – Medical Electrical
Equipment”.

Accuracy of Input Signal Reproduction


• Overall System Error meets AAMI EC11 3.2.7.1 requirements. Overall System Error is
between or within ±5%.
• Frequency Response meets AAMI EC11 3.2.7.2 requirements, using testing methods
A and D. Frequency response is between or within ±10% between 0.67 and 40 Hz
and between +0 and -10% for 20 ms, 1.5 mV triangular input.

Modulating Effects in Digital Systems


This device uses digital sampling techniques that may produce some variation in
amplitudes of Q, R, and/or S waves from one heart beat to the next, which may be
particularly noticeable in pediatric recordings. If you observe this phenomenon,
be aware that the origin of amplitude variations is not entirely physiological. For
measuring voltages of Q, R, and S waves, GE Healthcare advises using the QRS
complexes with the largest deflection of the particular waves.

EMI/EMC/RF Safety Information


This system is designed and tested to comply with applicable regulations regarding
EMC and must be installed and put into service according to the EMC information
stated in the Electromagnetic Compatibility appendix of the Service and/or Operator’s
manual. Changes or modifications to this system not expressly approved by GE
Healthcare could cause EMC issues with this or other equipment. Mains power should
be a standard commercial or hospital environment.
Before installing or using the device or system, be aware of the proximity of known RF
sources, such as the following:
• Radio and TV stations
• Portable and mobile RF communication devices (cell phones, two-way radios)
• X-ray, CT, or MRI devices

16 MAC™ i Resting ECG Analysis System 2065935-002D


Introduction

These devices are also possible sources of interference as they may emit higher
levels of electromagnetic radiation.
WARNING:
EQUIPMENT MALFUNCTION/INTERFERENCE — Use of portable phones or other
radio frequency (RF) emitting equipment near the system may cause unexpected
or adverse operation.
Do not use portable phones or other electronic equipment that may emit radio
frequency (RF) near this system.
WARNING:
EQUIPMENT MALFUNCTION/INTERFERENCE — Do not use the equipment or system
adjacent to, or stacked with, other equipment.
If adjacent or stacked use is necessary, test the equipment or system to verify
normal operation in the configuration in which you are using it.
WARNING:
ACCESSORIES/COMPONENTS — Adding accessories or components, or modifying
the medical device or system, may result in increased EMISSIONS or decreased
IMMUNITY of the device or system.
Use the following resources for more information on EMI/EMC and RF concerns:
• The Supplies and Accessories Reference Guide for your system
• Qualified GE Healthcare or approved third-party personnel
• The Electromagnetic Compatibility appendix in your system service or operator’s
manual
NOTE:
Compliance provides reasonable protection against radio-frequency interference.
However, there is no guarantee that interference will not occur in a particular
installation. You can tell whether this device or system is causing interference by
turning it off. If the interference stops, it was most likely caused by the device or
system.

Biocompatibility
The parts of the system described in this manual that come into contact with the
patient during the intended use, including all accessories, fulfill the biocompatibility
requirements of the applicable standards. If you have questions in this matter, contact
your GE Healthcare representative.

Legal Notice
GE Healthcare software contains several fields that can be filled in before performing
an ECG. Some of these fields are required, while others are optional and left to the
user to assess whether they are needed to perform the exam. The field Race is one
of these optional fields. Race has been acknowledged by the medical profession as
useful to analyze some pathologies. You should be aware that, in some jurisdictions,
the processing of data revealing an individual's racial origin is subject to legal
requirements, such as obtaining the patient's prior consent. If you elect to collect this
type of data, it is your responsibility to ensure that you comply with all applicable
legal requirements.

2065935-002D MAC™ i Resting ECG Analysis System 17


Introduction

Supplies and Accessories


You should use only supplies and accessories that GE Healthcare recommends. For
a list of recommendations, refer to the supplies and accessories reference guide
for this system
Contact GE Healthcare before using anything that is not recommended for this system.

Responsibility of the Manufacturer


GE Healthcare is responsible for the safety, reliability, and performance of hardware
supplied by GE Healthcare only if the following conditions are met:
• Assembly operations, extensions, readjustments, modifications, or repairs are
performed by persons authorized by GE Healthcare.
• The electrical installation of the room where the device is used complies with the
requirements of the appropriate local, state, and other government regulations.
• The equipment is used in accordance with the instructions for use.

Responsibility of the Purchaser/Customer


The customer is responsible for providing appropriate desks, chairs, electrical wall
outlets, network connections, and analog phone lines, and for locating any of the
system components described in this manual in compliance with all local, state, and
national codes.

Product and Package Information


This section identifies the following:
Hardware Label Locations
This section identifies the product labels and their locations on the product and
packaging.
See “Symbol Descriptions” on page 21 for detailed descriptions of the symbols used on
these labels.

18 MAC™ i Resting ECG Analysis System 2065935-002D


Introduction

Device Labels, Front Device Labels, Side

Device Packaging

Accessory Kit Packaging

2065935-002D MAC™ i Resting ECG Analysis System 19


Introduction

Label Descriptions on Hardware and Packaging

Item Label Location Description


1 Front of the Device Address Label and
device Rating Plate
It provides regulatory and
cautionary information
2 Front of the The option code label
device

3 Side of device Product Label


Identifies this device.
See “Product Label” on
page 29 for detailed
information.
4 On the The shipping label
packaging contains the following
carton information:
• Name and address of
the manufacturer
• Product Name
• Part Number
• Model number

MACi with 58 mm Printer • Barcode (serial


number)
• Serial number
• Label Part number
• Software version

MACi with 80 mm Printer


5 On the Recycling symbol
packaging
carton

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Introduction

Label Descriptions on Hardware and Packaging (cont'd.)

Item Label Location Description


6 On the Environmental symbols
packaging for shipping
carton

7 On the Accessory kit label


Accessory Kit
carton

Option Codes Label

Option Code Label

Option Code Description


1 Measurement
2 Three-channel printing in 58 mm printer
3 Measurement and Interpretation

NOTE:
This system comes as a single-channel system by default. If you are using it as
a three-channel system, you must activate the three-channel option with the
three-channel option code. Refer to the operator’s manual for instruction on
entering option codes.

Symbol Descriptions
The following table describes symbols or icons that may be on the device or its
packaging. Not all of the symbols defined in the table apply to your device or its
packaging.
Symbols are used to convey warnings, cautions, prohibitions, mandatory actions,
or information. Any symbol on your device or packaging with markings in color
indicates there may be a danger, warning, or mandatory action. Any symbol on your
device or packaging that is in black and white provides additional information or may
indicate a caution. Familiarity with these symbols assists in the use and disposal
of the equipment.

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Introduction

For equipment symbols not shown, refer to the original equipment manufacturer
(OEM) manuals.

Symbol Descriptions

Symbol Description
Catalog or Orderable Part Number
Indicates the manufacturer's catalog or part number.

Serial Number
Indicates the manufacturer's serial number.

Batch Code or Lot Number


Indicates the manufacturer's batch code or lot number.

Date of Manufacture (Year-Month)


Indicates the original manufacture date for this device.

Manufacturer
Indicates the name and address for the manufacturer of this device. It
may also include the date it was manufactured.

Authorized Representative in the European Community


Indicates the name and address of the authorized representative in the
European Community for this device.
12SL
Indicates the device uses the Marquette™ 12SL ECG Analysis Program to
analyze and interpret ECG readings.

Consult Instructions for Use


Consult the operating instructions.

No User– or Field-serviceable Parts


Do not open or disassemble the device for any reason.

Class II Equipment
Identifies equipment that meets the safety requirements specified for
class II equipment by IEC 60601–1.
This device was designed so that it does not require a safety connection
to electrical earth (US ground). No single failure results in dangerous
voltage becoming exposed and causing an electric shock. This is
achieved without relying on an earthed metal casing.
Defibrillation-proof Type BF Applied Part
Identifies a defibrillation-proof type BF applied part on medical
equipment that complies with IEC 60601–1.
This device meets the requirements for protection against electric shock
for an earth-free (floating) applied part (one intended for contact with
patients).

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Introduction

Symbol Descriptions (cont'd.)

Symbol Description
Defibrillation-proof Type CF Applied Part
Identifies a defibrillation-proof type CF applied part on medical
equipment that complies with IEC 60601–1.
This device meets the requirements for protection against electric shock
for an earth-free (floating) applied part (one intended for contact with
patients) for cardiac application.
IPxy IP Code (Ingress Protection Rating)
Classifies and rates the degree of protection provided against the
intrusion of solid objects (such as body parts like hands and fingers,
dust, accidental contact), and liquids.
The first numeral (x) represents the degree of protection against the
ingress of solid objects.
The second numeral (y) represents the degree of protection against the
ingress of liquids.
For products with an IPxy rating, see the Classification of Medical Device
in this chapter for a description of that rating. Not all products have
an IPxy rating.

CAUTION:
SAFETY GROUND PRECAUTION
Pulling on the cable can cause the cord to deteriorate resulting in
electrical problems.
Remove the power cord from the mains source by grasping the
plug. DO NOT pull on the cable.

CAUTION:
CONSULT ACCOMPANYING DOCUMENTS
There may be specific warnings or precautions associated with the
device that are not otherwise found on the label.
Consult the accompanying documentation for more information
about safely using this device.

CAUTION:
ELECTRIC SHOCK
Indicates the presence of hazardous energy circuits or electric
shock hazards.
To reduce the risk of electric shock hazards, do not open this
enclosure. Refer servicing to qualified personnel.

CAUTION:
HOT SURFACE
Indicates that the marked item may be hot.
Take appropriate precautions before touching the item.
Non-ionizing Electromagnetic Radiation
Indicates that the equipment emits elevated, potentially hazardous,
levels of non-ionizing radiation (electromagnetic energy) for diagnosis or
treatment.

2065935-002D MAC™ i Resting ECG Analysis System 23


Introduction

Symbol Descriptions (cont'd.)

Symbol Description
Protective Earth (ground)
Identifies the terminal of a protective earth (ground) electrode or any
terminal that is intended for connection to an external conductor for
protection against electric shock in case of a fault.
Follow Instructions For Use
Read and understand the operator's manual before using the device
or product.
As a mandatory action sign, this symbol is identified by a blue background
and white symbol.

WARNING:
ENVIRONMENTAL OR HEALTH HAZARD
Incinerating the device or product could present a risk to the
environment or human health.
Do not incinerate this device or product.

As a general prohibition sign, this symbol is identified by a white


background, red circular band and slash, and a black symbol.

WARNING:
HAND CRUSHING HAZARD
This device contains moving parts that could crush the user's hand.
Keep hands clear of the device while it is in operation. Disconnect
power before reaching into or servicing the device.

As a warning sign, this symbol is identified by a yellow background, black


triangular band, and a black symbol.

WARNING:
PINCH POINT
This device contains moving parts that could pinch body parts.
Keep hands clear of the device while it is in operation. Disconnect
the power before reaching into or servicing the device.

As a general prohibition sign, this symbol is identified by a white


background, red circular band and slash, and a black symbol.

WARNING:
PERSONAL INJURY DO NOT REACH IN
Reaching into the equipment can cause personal injury.
Do not place hands into any openings.

As a general prohibition sign, this symbol is identified by a white


background, red circular band and slash, and a black symbol.

24 MAC™ i Resting ECG Analysis System 2065935-002D


Introduction

Symbol Descriptions (cont'd.)

Symbol Description

WARNING:
BODILY INJURY
Indicates the presence of mechanical parts that can result in
pinching, crushing, or other bodily injury.
To avoid risk of bodily injury, keep away from moving parts.
Disconnect power before reaching into area or servicing.

As a warning sign, this symbol is identified by a yellow background, black


triangular band, and a black symbol.

WARNING:
BODILY INJURY
Indicates the presence of a sharp edge or object that can cause
cuts or other bodily injury.
To prevent cuts or other bodily injury, do not contact sharp edge of
object.

As a warning sign, this symbol is identified by a yellow background, black


triangular band, and a black symbol.

WARNING:
BODILY INJURY
Indicates the presence of a potential tip-over hazard that can result
in bodily injury.
To avoid risk of bodily injury, follow all instructions for maintaining
the stability of the equipment during transport, installation, and
maintenance.

As a warning sign, this symbol is identified by a yellow background, black


triangular band, and a black symbol.
Upper Temperature Limit
Indicates the maximum temperature for transportation and handling of
this package. The limit is indicated next to the upper horizontal line.

Temperature Limits
Indicates the upper and lower temperature limits for the transportation
and handling of this package. They are indicated next to the upper and
lower horizontal lines.
Can Be Recycled
Indicates you may recycle this material or device. Recycle or dispose of
in accordance with local, state, or country laws.

Waste Electrical and Electronic Equipment (WEEE)


Indicates this equipment contains electrical or electronic components
that must not be disposed of as unsorted municipal waste but collected
separately. Contact an authorized representative of the manufacturer
for information concerning the decommissioning of your equipment.

2065935-002D MAC™ i Resting ECG Analysis System 25


Introduction

Symbol Descriptions (cont'd.)

Symbol Description
Contains <heavy metal chemical symbol>
Indicates this equipment contains heavy metal and must not be
disposed of as unsorted municipal waste but collected separately.
The example shows Lithium Ion.

Environmental Friendly Use Period (EFUP)


Per Chinese standard SJ/T11363–2006, indicates the number of years
from the date of manufacture during which you can use the product
before any restricted substances are likely to leak, causing a possible
environmental or health hazard.
NOTE:
• If the device contains less than the maximum concentration of
restricted substances, the symbol contains a lowercase e
• This is also referred to as China RoHS.
Japan RoHS
Indicates the device or product meets the regulations limit or ban for
specific substances in new electronic and electric equipment in Japan.
The Green Mark (with the G) indicates the product is within the tolerances
of hazardous chemicals.
The Content Mark (with the R and letters below) indicates which
hazardous substance(s) was used during the manufacturing of the
electrical or electronic equipment that exceeds maximum tolerances.
Fragile
Indicates the contents are fragile. Handle with care.

This Way Up
Indicates the correct upright position of the package.

Do Not Stack
Indicates that you should not stack the container or place a load on
the container.

Keep Dry
Indicates that you need to keep the container away from rain and other
sources of moisture.

Humidity Limits
Indicates upper and lower humidity limits for the transportation and
handling of this package. They are indicated next to the upper and
lower horizontal lines.

26 MAC™ i Resting ECG Analysis System 2065935-002D


Introduction

Symbol Descriptions (cont'd.)

Symbol Description
Atmospheric Limits
Indicates the upper and lower barometric pressure limitations for the
transportation and handling of this package. They are indicated next to
the upper and lower horizontal lines.
Rx Only
US Federal law restricts this device to sale by or on the order of a
physician.

The following table describes certification symbols that may be used on your device
or its packaging. The inclusion of a symbol in this table does not indicate that your
product was certified by that symbol’s governing body and is listed for reference
only. To identify which organizations have certified your device, refer to the labeling
on your device or its packaging.

Certification Symbols

Certification Description
Symbol
UL Mark
Indicates compliance with applicable Underwriters Laboratories
requirements.

UL Listed Mark
Indicates compliance with international or regional standards for
Underwriters Laboratories safety requirements.

UL Listed, Canada/US
Indicates compliance with international or regional standards for
Underwriters Laboratories safety requirements in Canada and the
United States.
UL Classification Mark
Indicates this medical equipment is UL Classified with respect to electric
shock, fire, and mechanical hazards only in accordance with UL 60601-1,
CAN/CSA C22.2 NO. 601.1, and IEC 60601-2-25.
UL Classification Mark, Canada/US
Indicates this medical equipment is UL Classified with respect to electric
shock, fire, and mechanical hazards only in accordance with UL 60601-1,
CAN/CSA C22.2 NO. 601.1, and IEC 60601-2-25 for the US and Canada.
CE Mark
Indicates the device or product conforms with applicable EU (European
Union) directives.
PCT (GOST-R) Mark
Indicates the device or product conforms with applicable Russian
Gosstandart technical and safety standards.

2065935-002D MAC™ i Resting ECG Analysis System 27


Introduction

Certification Symbols (cont'd.)

Certification Description
Symbol
NRTL Certification
Indicates the device or product has met the National Recognized Testing
Laboratories certification.
The NRTL certification attainted is added to the mark of the applicable
testing laboratory. The example displays the NRTL certification with
the MET Laboratories mark.
China Metrology Certification
Indicates the device or product complies with applicable China
Metrology Certification requirements.
FCC Approval (US only)
Indicates the device or product complies with Federal Communications
Commission Rule Part 18 Subpart B (Section 18.203) – General
information regarding applications and authorizations for industrial,
scientific, and medical (ISM) equipment.
TÜV Rheinland
Indicates the device or product complies with applicable technical
and safety requirements following testing by Technischer
Überwachungs-Verein, (Technical Inspections Organization).

CCC (China)
Indicates the device or product conforms with applicable China
requirements.

Training
This manual is intended as a supplement to, not a substitute for, thorough product
training. If you have not received training on the use of the system, you should request
training assistance from GE Healthcare.
To see available training, go to the GE Healthcare training Web
site (www.gehealthcare.com/training). Select Education>Product
Education-Technical>Diagnostic Cardiology.
For more self-paced course offerings, tools, and reference guides you
may find useful, please visit the GE Healthcare Education Store at
www.gehealthcare.com/educationstore.

Equipment Identification
Every GE Healthcare product has a product label that identifies the product name,
part number, manufacturing information, and unique serial number. This information
is required when contacting GE Healthcare for support.

28 MAC™ i Resting ECG Analysis System 2065935-002D


Introduction

Product Label
The product label is laid out in the following format. Depending on the product, the
label may vary slightly in format, but it contains the same information.

Product Label Format

Item Description
1 Product description
2 Product part number
3 Device serial number (See “Serial Number Format” on page 29 for more
information.)
4 Product bar code
5 Date of manufacture in YYYY-MM format

Serial Number Format


Each device has a serial number that uniquely identifies it and provides important
information. You need the product code and the entire serial number before servicing
or requesting support for your product. The serial number format is shown in the
following illustration:

Serial Number Format

Item Name Description


1 Product Code Three-letter code that uniquely identifies the product line.
See “Product Codes” on page 30 for more information.
2 Year Manufactured Two-digit code identifying the year the device was
manufactured. Values range from 00 to 99
For example: 00 = 2000, 04 = 2004, 05 = 2005 (and so on).
3 Fiscal Week Two-digit code identifying the week the device was
Manufactured manufactured.
Values range from 01 to 52. GE Healthcare's fiscal weeks
correspond to the calendar week. For example, 01 = first
week in January.
4 Product Sequence Four-digit number identifying the order in which this
device was manufactured. Values range from 0001 to
9999.

2065935-002D MAC™ i Resting ECG Analysis System 29


Introduction

Serial Number Format (cont'd.)

Item Name Description


5 Manufacturing Site One-letter code identifying the site where the device was
manufactured. For example, F = Milwaukee, N = Freiburg,
P = Bangalore
6 Miscellaneous For example, P = device is a prototype, R = device was
Characteristic refurbished, U = device was upgraded to meet the
specifications of another product code, A= device is in
production.

Device Address Label and Rating Plate


The Device Address label and Rating plate is laid out in the following format.
Depending on the product, the label may vary slightly in format.

Address Label and Rating Plate Format

Item Description
1 Manufacturer name and address
2 Electrical rating of the device
3 Symbols
See“Symbol Descriptions” on page 21 for a description of the symbols used on
this label.
4 Country of origin
5 Product description

Product Codes
The product code identifies specific system platforms.
You can identify the product code using the serial number listed on the product label
located in one of the following places:
• On the product label attached to the device.
• On the product label provided with the application CD.
For software application systems, you can view the serial number by launching the
system application and clicking Help > About.
For information on launching the application, refer to the service or operator's manual
for this system.

30 MAC™ i Resting ECG Analysis System 2065935-002D


Introduction

Service Information
This section provides information pertaining to the maintenance and servicing of the
system. Familiarize yourself with this information before requesting service from GE
Healthcare or its authorized representatives.

Service Requirements
For systems with hardware provided by GE Healthcare, failure on the part of the
responsible individual, hospital, or institution using this equipment to implement
a satisfactory maintenance schedule may result in equipment failure and possible
safety hazards.
For software only products, maintenance of the hardware and operating system on
which the software resides is the responsibility of the customer.
Regular maintenance, irrespective of usage, is essential to ensure that the components
of this system are always functional when required.

Warranty Information
This device is considered GE Healthcare-supplied hardware. Only authorized GE
Healthcare service personnel should service the device. Any unauthorized attempt to
repair equipment under warranty voids that warranty. It is the user's responsibility to
report the need for service to GE Healthcare or to one of their authorized agents.

Additional Assistance
GE Healthcare maintains a trained staff of application and technical experts to answer
questions and respond to issues and problems that may arise during the installation,
maintenance, and use of this system.
Contact your local GE Healthcare representative to request additional assistance.

Manual Information
This section provides information for the correct use of this manual.
Keep this manual with the equipment at all times and periodically review it. You
should request training assistance from GE Healthcare, if needed.

Manual Purpose
This manual provides technical information for service representatives and technical
personnel so they can maintain the equipment to the assembly level. It serves as a
guide for maintenance and electrical repairs that are considered field-repairable.
Where necessary, the manual identifies additional sources of relevant information
and technical assistance.
See the operator’s manual of this system for the instructions necessary to operate the
equipment safely in accordance with its function and intended use.

Document Conventions
This manual uses the following conventions.

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Introduction

Typographical Conventions
Convention Description
Bold Text Indicates keys on the keyboard, text to enter, or hardware items such as
buttons or switches on the equipment.
Italicized-Bold Indicates software terms that identify menu items, buttons or options in
Text various windows.
CTRL+ESC Indicates a keyboard operation. A plus (+) sign between the names of two
keys indicates that while holding the first key, you should press and release
the second key. For example, Press CTRL+ESC means to press and hold the
CTRL key and then press and release the ESC key.
<space> Indicates that you must press the spacebar. When instructions are given
for typing a precise text string with one or more spaces, the point where
you must press the spacebar is indicated as <space>. This ensures that
the correct number of spaces is inserted in the correct positions within
the literal text string. The purpose of the < > brackets is to distinguish the
command from the literal text within the string.
Enter Indicates that you must press the Enter or Return key on the keyboard. Do
not type Enter.
> The greater than symbol, or right angle bracket, is a concise method to
indicate a sequence of menu selections.
For example, the statement “From the main menu, select System > Setup >
Options to open the Option Activation window” replaces the following:
1. From the main menu, select System to open the System menu.
2. From the System menu, select Setup to open the Setup menu.
3. From the Setup menu, select Options to open the Option Activation
window.

Illustrations
All illustrations in the manual are provided as examples only. Depending on system
configuration, screens in the manual may differ from the screens on your system.
All patient names and data are fictitious. Any similarity to actual persons is
coincidental.
Notes
Notes provide application tips or additional information that, while useful, are not
essential to the correct operation of the system. They are called out from the body
text through a flag word and indentation, as follows:
NOTE:
The tip or additional information is indented below the NOTE flag word.

32 MAC™ i Resting ECG Analysis System 2065935-002D


Introduction

Related Documents
The following documents provide additional information that may be helpful in the
installation, configuration, maintenance, and use of this system.

Related Documents for the MAC™ i Resting ECG Analysis System

Part Number Title


2065935-001 MAC™ i Resting ECG Analysis System Operator’s Manual
2036070-006 12SL™ Physician’s Guide
2065935-007 MAC™ i Resting ECG Analysis System Supplies and Accessories
Reference Guide

2065935-002D MAC™ i Resting ECG Analysis System 33


Introduction

34 MAC™ i Resting ECG Analysis System 2065935-002D


Product Overview
2
The MAC i Resting ECG System is a portable electrocardiograph with an integrated
thermal printer and motor assembly. It is designed to acquire, process, and record
ECG signals.
The battery is integrated into the device. A table–top switching power supply (external
AC/DC power supply) connects the device to mains. The print function works only on
battery power. The battery is a lithium-ion rechargeable battery that is charged when
the device is connected to the mains through the external AC/DC power supply.
The available functions and operation of the MAC i system are described in the
operator’s manual.
The MAC i Resting ECG System is available in the following configurations:

MAC i Configurations

Part Number Description


2065804–001 MAC™ i v2 Resting ECG System single-channel
2065804–002 MAC™ i v2 Resting ECG System single-channel with measurement
2065804–003 MAC™ i v2 Resting ECG System single-channel with measurement and
interpretation
2065804–004 MAC™ i Resting ECG System three-channel with 80 mm printer
2065804–005 MAC™ i Resting ECG System three-channel with 80 mm printer and with
measurement
2065804–006 MAC™ i Resting ECG System three-channel with 80 mm printer with
measurement and interpretation
2065804-007 MACi Resting ECG System three-channel with 58 mm printer
2065804-008 MACi Resting ECG System three-channel with 58 mm printer and with
measurement
2065804-009 MACi Resting ECG System three-channel with 58 mm printer with
measurement and interpretation

2065935-002D MAC™ i Resting ECG Analysis System 35


Product Overview

Hardware Description
This section identifies the key components of the MAC i system hardware. Familiarize
yourself with these components, their location, and their use before attempting
to use the system.

Top View

Item Name Description


1 Display panel View the lead/lead group, heart rate, mode of
operation, speed, gain, and filter settings.
2 Keypad Press the keypad keys to power on the system,
change operating parameters, or control
operations.

Side View

Item Name Description


1 ECG signal input connector Connect the patient cable at this location.

36 MAC™ i Resting ECG Analysis System 2065935-002D


Product Overview

Rear View

Item Name Description


1 External power connector Connect the power cord of the external AC/DC
adaptor at this location to charge the battery.

Keypad

Keypad

Item Name Description


1 On/Off key Turns the device on and off.
2 External power LED A solid green LED indicates that the system
is connected to an active mains.
3 Battery charging LED A yellow LED indicates the battery voltage
status:
• A solid yellow light indicates the battery
is recharging.
• A flashing yellow light indicates a low
battery.
• No yellow light indicates the battery is
fully charged.

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Product Overview

Keypad (cont'd.)

Item Name Description


4 On/Off LED A solid green LED indicates the device is
turned on.
No LED indicates the device is turned off.
5 Mode Key Use to select the mode—ECG or RHY.
6 Lead Key Use to select a different lead configuration.
7 Arrowpad Use the up, down, right, and left cursor keys
to move the cursor on the display panel.
8 Enter key Located in the center of the arrowpad, use
the Enter key to select the current menu.
9 Start/Stop (ECG) key Use with the Enter key during diagnostic
tests and to start and stop the ECG
recording.

System Overview
The MAC i Resting ECG System is a 12-lead, 3-channel system with a 2-line x 16
character display and passive patient cable.

Mechanical Structure
The major mechanical components of the MAC i device are at the top and bottom
covers with the following sub assemblies:
• PCB assembly mounted over the bottom cover
The display connector, keypad connector, printer connector, and patient cable
connector are mounted to the PCB assembly.
• Battery pocket, battery cover, and battery
• Thermal printer, paper pocket, and printer door
• The display window and keypad are housed in the top cover and linked to the main
PCB assembly through flexible cables.

Functionality
The following block diagram details the main PCB assembly containing all of the
circuitry for the MAC i Resting ECG System. The AC/DC switching power supply, battery,

38 MAC™ i Resting ECG Analysis System 2065935-002D


Product Overview

thermal printer, keypad, and display are not on the main PCB assembly. The PCB
assembly is divided into two sections: isolated and non-isolated.

Main PCB Assembly

External Power Supply Module


The power supply module is a table-top switching power supply of 18 watts. It accepts
the universal input voltage of 100V to 240V ±10% AC and gives single output of 12V @
1.5A. The specifications of the power supply are outlined in the following table:

Power Supply Specifications

Item Description
Input voltage range 100-240V ±10% AC
Frequency 47-63 Hz
Full load output current 1.5A
Output voltage 12V
Line regulation ±1%
Load regulation ±5%

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Product Overview

DC Power Inlet
The power inlet to the device is through a miniature right angle power jack located
on the PCB assembly at the rear of the device. You can connect the output AC/DC
adaptor directly to the jack provided on the device. This jack is designed to fit the
AC/DC adaptor recommended by GE Healthcare. Other types of AC/DC adaptors may
cause permanent damage or inferior performance of the system.

Battery
A customized, rechargeable Lithium-Ion battery with built-in 2S protection is mounted
to the battery pocket on the bottom cover. Use the dedicated battery charger to
charge the battery. The battery specifications are listed in the following table:

Battery Specifications

Item Description
Rated voltage 7.2V
Battery voltage 5.4–8.4V

Main PCB Assembly


The system’s main PCB assembly contains all of the circuitry for the system except the
power supply line, battery, thermal printer, keypad, and display. The circuitry can be
grouped by functionality. The following figure shows the PWA connector details.

PWA Connector Details

Item Circuit Name


1 SW1 Switch
2 J5 Printer cable connector
3 J4 Display connector
4 J3 SD card connector
5 W1 Power jack connector

40 MAC™ i Resting ECG Analysis System 2065935-002D


Product Overview

PWA Connector Details (cont'd.)

Item Circuit Name


6 J10 Battery connector
7 J11 ECG cable connector
8 J7 Keypad connector

Voltage Supply and Monitoring


The system requires several regulated voltages for operation of its various
components. If the battery voltage is greater than the cutoff voltage of 6.5V ±2%, the
onboard DC-DC converter is enabled to generate +5V and +3.3V, causing the unit to
turn on.
The following signals indicate the device’s voltage status:
• A flashing yellow LED on the keypad indicates a low battery when its voltage falls
below 7V ±2%.
• A solid yellow LED indicates the battery is charging.
If the voltage falls below 6.4V ±2%, the system turns off automatically.
The output of the power supply is connected to a resettable fuse for overcurrent
protection.
A Lithium-Ion charge management IC charges the battery when the device is
connected to mains. The input to the battery charger is +12V.
The charging conditions of the DS2 and DS5 LEDs (shown in the following illustration)
are described in the following table.

MAC i PCB - Top Right Side View

DS2 and DS5 LED Charging Conditions

Charger Operation DS2 DS5

Charge in progress ON OFF


Charge complete OFF ON
Charge suspend, timer fault, over OFF OFF
voltage, sleep mode, battery absent

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Product Overview

Display
The alphanumeric interface displays on a 16 x 2 character liquid-crystal display
powered by a +5V power supply.

Thermal Printer and Motor Assembly Interface


The device is equipped with a thermal printer and motor assembly. The voltage supply
to the printhead and motor is cut off when the thermal printhead is overheated or in
case of error conditions. The motor is a bipolar stepper powered by an IC driver that
moves the paper at speeds of 5, 25, or 50 mm/s.

ECG Recording and Pre-processing


The ECG acquisition side is isolated by a distance of 4 mm from the non-isolated side.
There is no electrical conduction path between the isolated and non-isolated sections
except a 68 M-ohm resistor provided as a path for the leakage current.
Connector J11 connects the ECG leads to the MAC i system. The system supports 10
leadwire ECG cables. Refer to“Main PCB Assembly” on page 40 for more information
on the PWA Connector details.

42 MAC™ i Resting ECG Analysis System 2065935-002D


Installation and Setup
3
The MAC i Resting ECG System can be installed by the user. Refer to the MAC i Resting
ECG System Operator’s Manual for more information regarding the following:
• Setup menu
• Option codes
Your device serial number is required during the installation and setup.
NOTE:
If you need assistance locating the serial number of your device, refer to “Product
and Package Information” on page 18, or contact GE Healthcare Service.

Printer Options
The MAC i is available in two printer configurations:
• 58 mm (two–inch) printer
This configuration delivers the following:
• A single–channel recording and an optional three–channel recording in ECG
mode.
• A single–channel recording in rhythm mode.
• 80 mm (three–inch) printer
This configuration delivers the following:
• A three–channel recording in ECG mode.
• A single–channel recording in rhythm mode.
• A three-channel recording in rhythm mode.
The three–channel configuration has an option for both roll and z-fold paper. The
z-fold paper is included in the accessory kit. If you prefer to use roll paper, you
may order it separately. For ordering information, refer to the MAC i Supplies and
Accessories Reference Guide.

Setting the Printer Configurations


The MAC i PWA contains a switch (SW1) for selecting either a two–inch or three–inch
printer. Use the two–inch printer setting when you are using a single-channel

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Installation and Setup

configuration, and the three–inch printer setting when you are using a three-channel
configuration.
The switch setting for each configuration is described in the following tables.

Switch Settings for 58 mm Printer Configuration

Switch Number: 1 2 3
Switch Position: Away from the Toward the number Toward the number
number

58 mm Printer Switch Settings

Switch Settings for 80 mm Printer Configuration

Switch Number: 1 2 3
Switch Position: Toward the number Away from the Away from the
number number

80 mm Printer Switch Settings

Using the Service Menu


The Service Menu provides access to do the following:
• Enter the serial number (See “Product and Package Information” on page 18, or
contact GE Healthcare Service for this information)
• Update the application software
• Update the Boot software
• Store the system Log
• Access the system information

Navigating to the Service Menu


Use the following procedure to navigate to each item of the Service Menu.
44 MAC™ i Resting ECG Analysis System 2065935-002D
Installation and Setup

For keypad details, refer to “Keypad” on page 37.


1. Move the cursor to configuration C on the display and press Enter.
The Configuration Menu is displayed.
2. Press and hold Start/Stop + down cursor key to display the Service Menu.
3. Press the right or left cursor key to navigate between the Service Menu options.
4. Press Enter to open the selected menu.

Entering the Serial Number


Use the following procedure to enter the serial number.
1. Open the Service Menu and select Serial No.
2. Press Enter to enter the Serial Number.
3. Press Enter and use the Up and Down arrow keys with the Enter key to select
the Serial Number characters.
4. Once all 13 characters are entered, the system displays the following message
and then returns to the Serial No. menu: Ser. No. Stored.

Updating the Application Software


Use the following procedure to update the application software.
1. Open the top cover of the device without removing the key sheet cable from
the connector J7.
For information on removing the top cover, see “Removing the Top Cover” on
page 64. Keep the printer door closed.
2. Connect the external power supply and then turn on the device.
3. Insert the SD card formatted in FAT16 file system with the released MAC i
software.
NOTE:
The validated manufacturer SD card is a 2 GB SANDISK.
4. Open the Service Menu and select the Update ARM SW menu.
5. Press Enter to begin updating the Boot software.
The system displays the following messages and then turns off after a few
minutes:
Updating SW

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Installation and Setup

Programming complete
NOTE:
If Boot SW can also updated from the software currently in the device, the
system displays the following message on the screen: Update Boot SW.
1. Press Enter to program Boot.
Do not remove the SD card until programming is completed.
2. After programming is completed, remove the SD card and restart the
system for normal operation.
6. If any error messages are displayed, please correct the errors based on the
message displayed and press Enter to restart programming.
To exit programming during error conditions, press Start/Stop to return to the
Startup screen.
If you are not updating the boot software, reattach the top cover and complete the
“Software Functional Checkout Procedures” on page 76.
If you are updating the boot software at this time, proceed to “Updating the Boot
Software” on page 46.

Updating the Boot Software


Use the following procedure to update the boot software.
NOTE:
Boot SW update is applicable only if the Boot version has changed from the
previous version in the device and is not already programmed during application
sofware update.
1. If you do not already have the top cover removed for another procedure, use the
instructions in “Removing the Top Cover” on page 64 to remove the top cover.
If you already have the top cover removed, begin with the next step.
2. Open the Service Menu and navigate to the Update BOOT software menu.
3. Press Enter to display the Update Boot SW menu.
4. Press Enter to start updating the boot software.
The system displays the following messages and then returns to the Service
Menu:.
• Update Boot SW
• Programming Complete
When you have finished updating the boot software, reattach the top cover and
complete the “Software Functional Checkout Procedures” on page 76.

Storing the System Log


Use the following procedure to store the system log.
1. If you do not already have the top cover removed for another procedure, use the
instructions in “Removing the Top Cover” on page 64 to remove the top cover.
If you already have the top cover removed, begin with the next step.
2. Open the Service Menu and navigate to the Store Sys Log menu.
46 MAC™ i Resting ECG Analysis System 2065935-002D
Installation and Setup

3. Insert the blank SD card without write protection enabled.


NOTE:
The SD card must be formatted in a FAT16 file system before use. If the SD
card is not formatted, the system displays the following message: Format
SD Card.
• Press Enter to format the card and store the system log.
• Press Start/Stop to exit without formatting the SD card.
4. Press Enter to store the Sys log or press Start/Stop to exit the screen.
When you have finished storing the system log, reattach the top cover and complete
the “Software Functional Checkout Procedures” on page 76.

Accessing the System Information


Use the following procedure to access System Info.
1. Open the Service Menu and navigate to the System Info menu.
2. Press Enter to check the system information.
The system displays the ARM and PSoC software version for 5 seconds and then
returns to the menu.
NOTE:
The ARM software version displayed is the MAC i system application
software version. The PSoC software version displayed is the version of the
programmed controller on the board.

Programming the MAC i Device Without a User


Interface
Use the following procedure to program the MAC i device without a user interface:
1. Using a Windows-based PC with an SD card reader, copy the released
manufacturing software to an empty SD card that is formatted in a FAT16 file
system.
2. In the root folder on the SD card, create a file named Update.com.
3. Open the top cover of the device without removing the key sheet cable from
the connector J7.
For information on removing the top cover, see “Removing the Top Cover” on
page 64. Keep the printer door closed.
4. Insert the SD card into the device.
NOTE:
The validated manufacturer SD card is a 2 GB SANDISK.

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Installation and Setup

5. Connect the external power supply and turn on the device.


The battery LED located on the keypad starts blinking to indicate the system is
updating. When it is complete, the unit turns of automatically.
6. Remove the SD card.
The device is programmed.
NOTE:
If the battery LED does not blink within 15 seconds, the system shuts down
and you cannot start the device. See “Troubleshooting” on page 79 to
determine and fix the problem.

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Diagnostic and Safety Tests
4
All messages displayed during self tests are in English. The system menu guides you
through the functions and testing.

Diagnostic Device Tests


The device test function tests various modules of the system and is conducted through
the keypad interface. Use the following steps to initiate device tests:
1. Navigate to the Configuration menu.
2. Press Start/Stop + Enter until the Device test is displayed.
3. Press the right or left cursor key to display the next or previous test.
The following tests are available:
• Display Test
• Keypad Test
• Writer Test
• Battery Test
• Acquisition Tests
• System Information

Display Test
Use the following procedure to complete the Display test.
1. Select the Display test and press Enter to start the test.
2. Press the right or up cursor key.
Two rows of 16 black squares are displayed on the screen.
3. Press the left or down cursor key to clear the display.
4. Press Enter to exit and move to the next test
If the display test does not pass, see “Troubleshooting” on page 79 to diagnose and fix
the problem.

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Diagnostic and Safety Tests

Keypad Test
Use the following procedure to complete the Keypad test.
1. Select the Keypad test and press Enter to start the test.
2. Press each key on the keypad in sequence.
The corresponding name for the key is displayed on the screen. Refer to the
following table for the corresponding name of the key.

Key Message on Display


Left cursor KEY_LEFT
Up cursor KEY_UP
Right cursor KEY_RIGHT
Down cursor KEY_DOWN
Enter KEY_ENTER
Lead KEY_LEAD
Mode KEY_MODE
Start/Stop Exits the key test, displays Device Test, and moves
to next test.
NOTE:
Do not press the Start/Stop key until you are
finished testing the other keys.

If the keypad test does not pass, see “Troubleshooting” on page 79 to diagnose and fix
the problem.

Writer Tests
Use the following procedure to complete the writer tests.
1. Select the Writer test and press Enter to start the test.
2. Press the up or down cursor key to select the speeds: 5, 25 or 50 mm/s.
3. Press Enter to begin printing a scale of 1 mm and another scale of 25 mm on
the bottom edge of the paper, as seen in the following example:
The same pattern is printed at all speeds: 5, 25, and 50 mm/sec.

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Diagnostic and Safety Tests

Writer Test at 50 mm/s


4. Press the up or down cursor key to select the roller test.
5. Press Enter to begin printing slanted parallel lines.
An ideal printout for the roller test is shown in the following illustration:

Roller Test
The printout should have uniformly placed slanted parallel lines. If white spots
are observed in the printout, repeat this step three times. We recommend
replacing the printer if you continue to observe the white spots.
6. Press the up or down cursor key to select Exit.
7. Press Enter to exit and return to the Device Test menu.
If the writer test does not pass, see “Troubleshooting” on page 79 to diagnose and fix
the problem.

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Diagnostic and Safety Tests

Battery Test
Use the following procedure to complete the battery test.
1. Select the Battery test and press Enter to start the test.
The battery voltage is displayed.
2. Press Enter to exit the battery test and proceed to the Acq. Test.
If the battery test does not pass, see “Troubleshooting” on page 79 to diagnose and fix
the problem.

Acquisition Test
Use the following procedure to test the acquisition cable connectivity:
1. Connect the patient cable with all of the leads shorted to the lead RL.
2. Load the printer with paper.
3. Press Enter to start the Acq. Test.
The following message is displayed: Connect all leads to RL.
4. Press Enter to start acquiring the data.
The following message is displayed: Acq. Test Acquiring Data.
The result of the test is printed. Leads I, II, and V1 to V6 are printed. This confirms
the acquisition cable connectivity of all 10 leads except RL.
If the acquisition test does not pass, see “Troubleshooting” on page 79 to diagnose
and fix the problem.

System Info
Use the following procedure to access and review the system information.
1. Select System Info and press Enter.
The system prints the following information:
• Serial Number of the device
• ARM software version
• PSoC software version
When System info is displayed, press Enter.
NOTE:
The ARM software version displayed is the MAC i system application software
version. The PSoC software version displayed is the version of the programmed
controller on the board.

Electrical Safety Tests: Leakage Current Tests


The suggested safety analysis tests comply with the international standard IEC
60601-1. Perform the tests with safety testing instruments with measuring circuits
calibrated according to IEC 60601-1. To ensure personal safety, refer to the user
documentation that came with the testing instrument.

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Diagnostic and Safety Tests

Perform the tests under normal, ambient conditions of temperature, humidity, and
pressure with line voltage.
The leakage currents correspond to 110% of the rated voltage for the tested unit. If
this is not taken into account when performing the leakage tests, you must calculate
the measured values.
Confirm that the current leakage test results meet the requirements. All indicated
electrical safety checks require a pass/fail indication for the steps performed. Record
the measurement values in your debrief.
You need to conduct the following safety tests:
• “Enclosure (Chassis) Leakage Current Test” on page 53
• “Patient Leakage Current Tests” on page 54
Complete the electrical safety tests according to the following recommended
schedule:
• After initial setup
• Once every 12 months after setup as part of a regular maintenance plan
• Whenever power sources are affected by servicing
The following electrical diagram shows the Measuring Circuit [M], required for leakage
current. The reading in mV corresponds to mA (leakage current). The safety tester
instruments generally work with this Measuring Circuit [M] and the displayed values
are converted to leakage current.

Measuring Instrument/Calibrator (R,≥1 MΩ)

Enclosure (Chassis) Leakage Current Test


This test measures leakage current from the chassis to ground during normal
conditions (NC) and single fault conditions (SFC).
In all cases, the leakage current is measured from any exposed conductive parts to
ground; you need to turn the device on and off while connected to your safety-testing
instrument.

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Diagnostic and Safety Tests

Enclosure Leakage Current

Step Polarity Condition1 UUT-ON2 Result Leakage


Current Limits
1 Forward Polarity NC µA Pass/Fail 100 µA
2 Neutral Open, SFC µA Pass/Fail 500 µA
Forward Polarity
3 Neutral Open, Reverse SFC µA Pass/Fail 500 µA
polarity
4 Reverse Polarity NC µA Pass/Fail 100 µA
1 NC = Normal Condition; SF = Single Fault Condition
2 UUT = Unit Under Test

During NC, take measurements under the following conditions (refer to the safety
tester diagram):
• Device in “ON” state
• Polarity switch at NORM and RVS
• GND switch GND closed
• S1 (neutral) closed
During SFC, take measurements under the following conditions (refer to the following
safety tester diagram):
• Device in “ON” state
• Polarity switch NORM and RVS
• GND switch closed, S1 (neutral) open
• GND switch closed, S1 (neutral) closed
The test has failed if the measured values are greater than those in the following table:

Enclosure Leakage Current Test Failure Conditions

NC SFC
Polarity: NORM & RVS Polarity: NORM & RVS
S1 (neutral): closed S1 (neutral): closed I open
GND: closed GND: open I closed
Total tests/combinations: 2 Total tests/combinations: 2
100 µA (IEC & UL) 500 µA (IEC)
300 µA (UL)

Patient Leakage Current Tests


These tests measure leakage current of the device’s floating inputs (patient
connections) to ground.

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Diagnostic and Safety Tests

Patient Leakage Current-to-Ground Test


This test measures leakage current from the floating input (patient connection) to
ground during normal condition (NC and single fault condition (SFC). In all cases,
measure the leakage current from the floating input to ground. You need to turn the
device on and off while connected to your safety testing instrument.

Patient Leakage Current-to-Ground

Step Polarity Condition1 UUT-ONv2 Result Leakage


Current Limits
1 Forward Polarity NC µA Pass/Fail 10 µA
2 Neutral Open, SFC µA Pass/Fail 50 µA
Forward Polarity
3 Ground Open, SFC µA Pass/Fail 50 µA
Forward Polarity
4 Ground Open, SFC µA Pass/Fail 50 µA
Reverse Polarity
5 Neutral Open, SFC µA Pass/Fail 50 µA
Reverse Polarity
6 Reverse Polarity NC µA Pass/Fail 10 µA
1 NC = Normal Condition; SF = Single Fault Condition
2 UUT = Unit Under Test

During NC, take measurements under the following conditions (refer to the safety
tester diagram):
• Device in “ON” state
• GND switch GND closed
• Polarity switch NORM and RVS
• S1 (neutral) closed
During SFC, take measurements under the following conditions (refer to the safety
tester diagram):
• Device in “ON” state
• Polarity switch NORM and RVS

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Diagnostic and Safety Tests

• GND switch closed, S1 (neutral) open


• DND switch open, S1 (neutral) closed
The test has failed if the measured values are greater than those in the following table:

Patient Leakage Current to Ground Test Failure Conditions


NC SFC
Polarity: NORM & RVS Polarity: NORM & RVS
S1 (neutral): closed S1 (neutral): closed I open
GND: closed GND: open I closed
Total tests/combinations: 2 Total tests/combinations: 4
10 µA (IEC & UL) 50 µA (EC & UL)

Patient Leakage Current, Mains on Applied Part Test


WARNING:
ELECTRIC SHOCK/PERSONAL INJURY — Mains voltage is applied to floating input
(patient connection), patient cables/test plug conductors, and the safety tester
patient jack.
Avoid contact with these parts.
For the protection of the person performing these tests, use the following values of
resistor R: Type CF — 100 kOhm (220 to 240 V).
Disconnect the safety tester from the line voltage before connecting the patient
cable/test plug to the device. After disconnecting the line voltage, connect the patient
cable/test plug to the device.
This test performs leakage current tests during single fault conditions (SFC) with line
voltage applied to the floating (patient connection) inputs.
In all cases, measure the leakage current from the floating (patient) inputs jack of the
device to ground.
Use the following steps to set up this leakage current test:
1. Disconnect the safety tester from the line voltage.
2. Ground all signal input and output connections (all SIPs and SOPs connected to
ground).
3. Connect the patient cable or test plug to the device.
4. Connect the patient cable or test plug to the safety tester.
5. Ensure that the person completing the test is not touching the patient cable or
test plug, the floating (patient) input, or the device conductive surfaces.
6. Connect the safety tester to the line voltage. (See the previous warning.)
During SFC, take measurements under the following conditions (refer to safety tester
diagram):
• Device in “ON” state
• Polarity switch NORM and RVS
• S1 (neutral) open
• GND switch closed
56 MAC™ i Resting ECG Analysis System 2065935-002D
Diagnostic and Safety Tests

The test has failed if the measured values are greater than those in the following table:

Patient Leakage Current Mains on Applied Part Test Failure Conditions

NC SFC
N/A Polarity: NORM & RVS
S1 (neutral): open
GND: Closed
Total tests/combinations: 0 Total tests/combinations: 2
N/A 50 µA (IEC & UL)

After completing this test, disconnect the safety tester from line voltage before
disconnecting the patient cable or test plug and the device.

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Diagnostic and Safety Tests

58 MAC™ i Resting ECG Analysis System 2065935-002D


Maintenance and FRU Replacement
5
Procedures

GE Healthcare does not recommend any Preventive Maintenance for this system.
Preventive Maintenance may be performed by the user.
The user may perform the following on their system:
• Recommended Maintenance
• Diagnostic Tests
• Electrical Safety Tests
If further technical assistance is required, contact the nearest GE Healthcare Service
Center.
WARNING:
EQUIPMENT FAILURE/HEALTH RISK — Failure to implement the recommended
maintenance schedule may cause equipment failure and possible health hazards.
All individuals who use this device assume the responsibility for performing the
recommended maintenance, unless an Equipment Maintenance Agreement exists.

Recommended Maintenance
This section contains instructions for the following recommended maintenance:
• Inspection and cleaning
• Visual inspection
• Exterior cleaning
• Interior cleaning
• Printhead cleaning
• Battery Maintenance
• Calibration Check

Inspection and Cleaning


Check the device and accessories for mechanical defects that can impair proper
performance.
2065935-002D MAC™ i Resting ECG Analysis System 59
Maintenance and FRU Replacement Procedures

Visual Inspection
• Check that the patient cable and lead wires are not defective or broken.
• Check that the electrodes are not out of date.
• Inspect the cords and cables for fraying or other damage.
• Ensure the display is mounted correctly, and check for any cracks or damage on
the display.
• Inspect the keys and keypad to make sure they have correct markings on them
and to ensure proper operation.
• Confirm the green LED is a steady light when the device is connected to an external
power adaptor plugged into an AC line and the AC switch is on.
• Check that the printer cable is properly inserted in connector J5. See “Main PCB
Assembly” on page 40 for details on the PCB.
• Check for loose or missing screws on the entire system assembly.

Exterior Cleaning
Clean and disinfect exterior surfaces monthly, or more often as needed. Use the
following procedure to clean exterior surfaces:
1. Use a clean, soft cloth and an agent or disinfectant that contains alcohol and is
commonly used in hospitals.
NOTE:
Do not use disinfectants with a phenol base or peroxide compounds.
2. Wring excess water/solution from the cloth. Do NOT drip water or any liquid on
the system, and avoid open vents, plugs, or connectors.
3. Dry surfaces with a clean cloth or paper towel.

Interior Cleaning
Check for dust on the interior components and clean as needed with commercially
available compressed air.
Printhead Cleaning
Clean the thermal printhead periodically to ensure good print quality and long printer
life.
Observe the following precautions when cleaning the printhead:
• Do not hit the thermal printhead with anything hard.
• Do not use sand paper on the thermal printhead.
• Do not use unnecessary force on the thermal printhead.
NOTE:
Use a disposable wrist strap to avoid static electricity.

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Maintenance and FRU Replacement Procedures

Use the following procedure to clean the thermal printhead:


1. Open the printer door.
2. Gently wipe off the heating element part of the surface with cotton swabs and
ethyl alcohol.
Be sure to wring the cotton before cleaning.
3. Close the printer door when the printhead is completely dry.

Battery Maintenance
The battery has a shelf life of six months. Recharge the battery once every six
months if it is stored for a long period of time. The system can print only when
the battery is connected to the device. With a fully charged battery (8.3–8.4V) you
can print approximately 250 ECG reports continuously in sequential single-lead or
simultaneous three–lead format at a speed of 25 mm/sec and gain of 10 mm/mV
without measurement enabled.
NOTE:
If the device cannot produce at least 100 ten-second ECG reports in simultaneous
format on a fully charged battery, replace the battery. For instructions on
replacing the battery, see “Replacing the Battery” on page 62.
For maximum battery life, and to avoid low battery shutdown, charge the battery
when the low battery condition is indicated. For details, refer to System LEDs in
the MAC™ i Resting ECG System Operator’s Manual).
Keeping the battery idle for more than six months may reduce the battery
life. System specification and performance is guaranteed only with a battery
recommended by GE Healthcare.

Calibration Check
Complete a regular calibration check of the system once a year.
Use the following procedure to check calibration of the system:
1. Turn on the system.
2. Connect the patient cable to the system.
3. Take a rhythm printout in default settings for each lead:
a. Start a Rhythm recording.
b. Wait for 2 to 3 seconds.
c. Stop the recording.
4. Ensure that the calibration pulse for all leads is 5 mm ±5% in width and 10 mm
±5% in height.

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Maintenance and FRU Replacement Procedures

Replacing Field Replaceable Units (FRUs)


When it is determined that a FRU is faulty, refer to the following instructions to replace
it. Follow the safety instructions when replacing components.
WARNING:
OPERATOR INJURY – Repairing the system when it is powered on may cause injury.
Turn off the system before replacing components.

Safety Instructions
The following considerations apply when repairing the system:
• Only authorized, trained personnel may conduct repairs.
• Before opening the device, turn off the power and disconnect the external power
supply from the unit.
• Before opening the device or completing any servicing, remove the battery.
• Use only the original GE Healthcare FRUs identified in the FRU list.
• When replacing electronic components, implement ESD protection.
• Dispose of defective or empty Li-ion batteries in accordance with the applicable
legal regulations in your country or return them to the factory.
NOTE:
Use necessary personal protective equipment (PPE) while performing maintenance
on the device.
After completing any FRU replacement, conduct a thorough visual inspection of the
system. For more information, see “Visual Inspection” on page 60.

Replacing the Battery


No matter how well you maintain your battery, you eventually need to replace it.

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Maintenance and FRU Replacement Procedures

Replacing the Battery Component

Use the following procedure to replace the battery:


1. Lift the snap region in the battery cover (1) and slide it out of the bottom cover.
The arrows indicate the direction in which the snap region moves (2).
2. Remove the battery from its compartment.
3. Place the new battery into the battery compartment with the battery label
facing down and the battery terminals facing the battery contacts on the PCB.
Reverse voltage protection is implemented mechanically.
4. Slide the snap region of the battery cover back into the bottom cover.
Functional Checkout Procedures (Battery)

No special tools are needed to perform the following functional checkout procedures.
1. Perform a Calibration Check.
See “Calibration Check” on page 61 for more information.
2. Verify ECG printing in default ECG mode and in Rhythm mode by connecting the
device to a 12–lead simulator.
Refer to the MAC™ i Resting ECG System Operator’s Manual for details on
printing ECGs.
3. Verify that the Battery Test was successful.
Refer to “Battery Test” on page 52.

Removing and Replacing the Top Cover


It is often necessary to remove the top cover in order to service other components
in the device.
The following sections explain how to remove the top cover, replace the top cover, and
complete the functional checkout after replacing this FRU.

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Maintenance and FRU Replacement Procedures

Removing the Top Cover

Use the following procedure to remove the top cover of the device:

1. Remove the battery.


See “Replacing the Battery Component” on page 63 for more information.
2. Turn the device upside down and remove the fastening screws on the bottom (1).
There are four screws, one at each corner of the device.
3. Return the device to the upright position with the keypad facing up.
4. Open the printer door along with the roller.
5. Raise the top cover of the housing and disconnect the key sheet flex cable from
the J7 connector on the PWA (2).

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Maintenance and FRU Replacement Procedures

Replacing the Top Cover Kit

Use the following procedure to replace the top cover:

Item Description
1 Key sheet flex cable
2 Fastening screws (4)

1. Remove the top cover.


See “Removing the Top Cover” on page 64 for instructions.
2. Remove the faulty top cover assembly and replace it with the new one.
3. Reconnect the flex cable to the J7 connector on the PWA.
For more information, see “Main PCB Assembly” on page 40.
4. Ensure that the key sheet flex cable is routed as shown in the previous diagram
while closing the top cover assembly.
Functional Checkout Procedures (Top Cover)

The following tools are needed to complete the checkout procedures:


• Phillips screwdriver
• Anti-static wrist strap
• ECG simulator
Use the following procedure to complete the functional checkout for this FRU
replacement:
1. Perform a visual inspection on the following:
• Fasteners
• Internal cables
• Keypad
• Power (green) LED

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Maintenance and FRU Replacement Procedures

See “Visual Inspection” on page 60 for details.


2. Perform a Calibration Check.
See “Calibration Check” on page 61 for more information.
3. Verify ECG printing in default ECG mode and in Rhythm mode by connecting the
device to a 12–lead simulator.
Refer to the MAC™ i Resting ECG System Operator’s Manual for details on
printing ECGs.
4. Perform a Keypad Test and verify it is successful.
See “Keypad Test” on page 50 for more information.

Removing and Replacing the Bottom Cover


It is often necessary to remove the bottom cover in order to service other components
in the device.
The following procedures explain how to remove bottom cover, replace the bottom
cover, and complete the functional checkout after replacing this FRU.
Removing the Bottom Cover

Use the following procedure to remove the bottom cover of the device:

1. Remove the battery.


See “Replacing the Battery Component” on page 63 for more information.
2. Turn the device upside down and remove the fastening screws on the bottom (1).
There are four screws, one at each corner of the device.

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Maintenance and FRU Replacement Procedures

Replacing the Bottom Cover Kit

Use the following procedure to replace the bottom cover kit:

1. Turn the device over so the bottom is facing up.


2. Align the bottom cover to the device.
3. Replace the screws in the bottom cover (1).
There are four screws, one at each corner of the device.
Ensure that the screws are fastened securely.

Functional Checkout Procedures (Bottom Cover)

The following tools are needed to complete the checkout procedures:


• Phillips screwdriver
• Anti-static wrist strap
• ECG simulator
• Safety tester for measurements according to 60601–1
• Multimeter
• Mac™ i Resting ECG System Operator’s Manual (for reference)
Use the following procedure to complete the functional checkout for this FRU
replacement:
1. Perform a visual inspection on the following:
• Fasteners
• Internal cables
See “Visual Inspection” on page 60 for details.
2. Confirm that the label with the correct serial number is on the new bottom cover.
If you do not know the serial number, contact GE Healthcare Service.
3. Perform a Calibration Check.
See “Calibration Check” on page 61 for more information.
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Maintenance and FRU Replacement Procedures

4. Verify ECG printing in default ECG mode and in Rhythm mode by connecting the
device to a 12–lead simulator.
Refer to the MAC™ i Resting ECG System Operator’s Manual for details on
printing ECGs.
5. Verify that all options are restored successfully. Use the following procedure
to check the options:
Option Task
MEAS (measurement option) Take a 10–second ECG in any report format and
ensure that the measurement page is printed at the
end of the report.
3LRF (3–Lead Report Format Ensure that four report formats (SIM3, SEQ3, SEQR,
option) and SIML) are available in the ECG mode.
DIAG (interpretation option) Take a 10–second ECG in any report format and
ensure that the interpretation page is printed at the
end of the report.

6. Verify that the external power LED on the keypad is a steady green when the
external power supply is connected to the unit.
This LED must be a steady green whether the device is in the Off or On condition.
Refer to “Keypad” on page 37 for the location of the LED.
7. Verify the battery charging progress by checking the status of LED DS2 and
DS5 on the PWA.
See “Voltage Supply and Monitoring” on page 41 for more information.
8. Conduct the following tests and verify they are successful:
• Display Test (see “Display Test” on page 49).
• Keypad test (see “Keypad Test” on page 50).
• Writer tests (see “Writer Tests” on page 50).
• Battery tests (see “Battery Test” on page 52).
• Acquisition Module tests (see “Acquisition Test” on page 52).
• System Info (see “System Info” on page 52).
• Enclosure Leakage Current Test (see “Enclosure (Chassis) Leakage Current
Test” on page 53).
• Patient Leakage Current-to-Ground Test (see “Patient Leakage
Current-to-Ground Test” on page 55).

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Maintenance and FRU Replacement Procedures

Replacing the Thermal Printer


The following illustration and table identify the key components involved when
replacing the thermal printer.

Item Description
1 Printer door with Printer Roller
2 Printer
3 Screws fastening the base of the printer to the printer mounting base
4 Connector J5 and the flat ribbon printer cable

The following procedures explain how to replace the printer and complete the
functional checkout after replacing this FRU.
Replacing the Printer Kit

Use the following procedure to replace the printer kit:


1. Open the device and printer door as described in “Removing the Top Cover”
on page 64.
2. Open the J5 connector and disconnect the flat ribbon printer cable.
See “Main PCB Assembly” on page 40.
3. Remove the two screws fastening the base of the printer to the printer mounting
base to remove the earthing cable.
4. Detach the roller from the new printer module and align the mounting holes of
the new printer to those of the printer module base.
5. Use the screws and washers to fasten the printer and earthing cable onto the
printer mounting base.
6. Connect the flat ribbon cable to the J5 connector on the PCB.

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Maintenance and FRU Replacement Procedures

Functional Checkout Procedures (Thermal Printer)

The following tools are needed to complete the checkout procedures:


• Phillips screwdriver
• Anti-static wrist strap
• ECG simulator
Use the following procedure to complete the functional checkout for this FRU
replacement:
1. Perform a visual inspection on the following:
• Fasteners
• Internal cables
See “Visual Inspection” on page 60 for details.
2. Perform a Calibration Check.
See “Calibration Check” on page 61 for more information.
3. Verify ECG printing in default ECG mode and in Rhythm mode by connecting the
device to a 12–lead simulator.
Refer to the MAC™ i Resting ECG System Operator’s Manual for details on
printing ECGs.
4. Perform the Writer Tests and verify they are successful.
See “Writer Tests” on page 50 for more information.

Replacing the Display


The following procedures explain how to replace the display and complete the
functional checkout after replacing this FRU.

Item Description
1 Fastening screws (2)
2 Display module

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Maintenance and FRU Replacement Procedures

Replacing the Display Module

Use the following procedure to replace the display.


For information on the location of the J4 connector, see “Main PCB Assembly” on
page 40.
1. Open the device as described in “Removing the Top Cover” on page 64.
2. Remove the top cover assembly from the bottom cover.
3. Remove the two fastening screws from the display and detach the display
module from the PWA connector J4.
4. Insert the new display module into the PWA connector J4.
5. Position the standoff in line with the mounting hole between the display module
and the PWA, and fasten it with the two fastening screws.
6. After completing the assembly, ensure there is a uniform gap between the
display connector and PWA connector J4.
Functional Checkout Procedures (Display)

The following tools are needed to complete the checkout procedures:


• Phillips screwdriver
• Anti-static wrist strap
• ECG simulator
Use the following procedure to complete the functional checkout for this FRU
replacement:
1. Perform a visual inspection on the following:
• Fasteners
• Display
2. Perform a Calibration Check.
See “Calibration Check” on page 61 for more information.
3. Verify ECG printing in default ECG mode and in Rhythm mode by connecting the
device to a 12–lead simulator.
Refer to the MAC™ i Resting ECG System Operator’s Manual for details on
printing ECGs.
4. Perform a Display Test and verify it is successful.
See “Display Test” on page 49 for more information.

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Maintenance and FRU Replacement Procedures

Replacing the Main PCB Assembly


The following procedures explain how to replace the main PCB assembly and
complete the functional checkout after replacing this FRU.

Item Description
1 Fastening screws (4)
2 Printer cable

Replacing the PWA Kit

Use the following procedure to replace the Main PCB Assembly:


1. Open the device as described in “Removing the Top Cover” on page 64.
2. Disconnect the keypad cable from J7 and the printer cable from J5.
See “Main PCB Assembly” on page 40 for the locations of the J7 and J5
connectors.
3. Remove the two screws fastening the display module to the PWA.
4. Remove the display from the connector J4.
See “Replacing the Display ” on page 70.
5. Remove the four screws fastening the PCB assembly to the bottom cover.
6. Return the PCB assembly to the factory in ESD packaging.
7. Orient the new main PCB assembly, align the mounting holes with those in the
bottom cover, and fasten the new PCB assembly to the bottom cover with the
screws.
8. Refasten the display assembly to the PWA.
9. Reconnect the keypad cable to J7 and printer cable to J5.
Refer to “Main PCB Assembly” on page 40 the locations of the J7 and J5
connectors.
10. Reattach the upper section of the device to the lower section with the four
screws.

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Maintenance and FRU Replacement Procedures

11. Replace the battery in the battery pocket and slide on the battery cover.
12. Turn on the device and enter the settings.
For more information on entering settings, refer to the MAC™i Resting ECG
Analysis Operator’s Manual.
13. Enter the serial number and option codes (optional) as necessary.
This should restore the previous user settings.
• If you do not know the serial number, contact GE Healthcare Service.
• If you do not know the option code, refer to “Setting up the System for
Operation” in the MAC™i Resting ECG System Operator’s Manual.
• If the previous user settings are not restored, select the default settings.
Functional Checkout Procedures (Main PCB Assembly)

The following tools are needed to complete the checkout procedures:


• Phillips screwdriver
• Anti-static wrist strap
• ECG simulator
• Safety tester for measurements according to 60601–1
• Multimeter
• Mac™ i Resting ECG System Operator’s Manual (for reference)
Use the following procedure to complete the functional checkout for this FRU
replacement:
1. Perform a visual inspection on the following:
• Fasteners
• Internal cables
• Display
• Keypad
• Power (green) LED
2. Verify the serial number restored successfully.
If you do not know the serial number, contact GE Healthcare Service.
3. Perform a Calibration Check.
See “Calibration Check” on page 61 for more information.
4. Verify ECG printing in default ECG mode and in Rhythm mode by connecting the
device to a 12–lead simulator.
Refer to the MAC™ i Resting ECG System Operator’s Manual for details on
printing ECGs.

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Maintenance and FRU Replacement Procedures

5. Verify that all options are restored successfully. Use the following procedure
to check the options:
Option Task
MEAS (measurement option) Take a 10–second ECG in any report format and
enabled ensure that the measurement page is printed at the
end of the report.
3LRF (3–Lead Report Format Ensure that four report formats (SIM3, SEQ3, SEQR,
option) and SIML) are available in the ECG mode.
DIAG (interpretation option) Take a 10–second ECG in any report format and
enabled ensure that the interpretation page is printed at the
end of the report.

6. Verify that the external power LED on the keypad is a steady green when the
external power supply is connected to the unit.
This LED must be a steady green whether the unit is in the Off or On condition.
Refer to “Keypad” on page 37 for the location of the LED.
7. Verify the battery charging progress by checking the status of LED DS2 and
DS5 on the PWA.
See “Voltage Supply and Monitoring” on page 41 for more information.
8. Perform the following tests and verify they are successful:
• Display Test (see “Display Test” on page 49).
• Keypad test (see “Keypad Test” on page 50).
• Writer tests (see “Writer Tests” on page 50).
• Battery tests (see “Battery Test” on page 52).
• Acquisition Module tests (see “Acquisition Test” on page 52).
• System Info (see “System Info” on page 52)
• Enclosure Leakage Current Test (see “Enclosure (Chassis) Leakage Current
Test” on page 53).
• Patient Leakage Current to Ground Test (see “Patient Leakage
Current-to-Ground Test” on page 55).

Replacing the Power Supply


The following procedures explain how to replace the power supply and complete the
functional checkout after replacing this FRU.
Replacing the Power Supply Kit

Use the following procedure to replace the Power Supply kit:


1. Unplug the old power supply from the power source and then from the device.
2. Plug the new power supply kit into the device and then into the power source.
Functional Checkout Procedures (Power Supply)

You need a Safety Tester for measurements (that complies with 60601–1) to complete
the checkout procedures.
74 MAC™ i Resting ECG Analysis System 2065935-002D
Maintenance and FRU Replacement Procedures

Use the following procedure to complete the functional checkout for this FRU
replacement:
1. Verify that the external power LED on the keypad is a steady green when the
external power supply is connected to the unit.
This LED must be a steady green whether the unit is in the Off or On condition.
Refer to “Keypad” on page 37 for the location of the LED.
2. Verify the battery charging progress by checking the status of LED DS2 and
DS5 on the PWA.
See “Voltage Supply and Monitoring” on page 41 for more information.
3. Perform the following tests and verify they are successful:
• Enclosure Leakage Current Test (see “Enclosure (Chassis) Leakage Current
Test” on page 53).
• Patient Leakage Current to Ground Test (see “Patient Leakage
Current-to-Ground Test” on page 55).

Additional Functional Checkout Procedures


The following components have checkout procedures you need to perform after
replacing the associated FRUs.
Hardware Functional Checkout Procedures
The following tools are needed to complete the checkout procedures:
• Phillips screwdriver
• Anti-static wrist strap
• ECG simulator
Use the following procedure to complete the functional checkout for this FRU
replacement:
1. Perform a visual inspection on the following:
• Fasteners
• Display
See “Visual Inspection” on page 60 for details.
2. Perform a Calibration Check.
See “Calibration Check” on page 61 for more information.
3. Verify ECG printing in default ECG mode and in Rhythm mode by connecting the
device to a 12–lead simulator.
Refer to the MAC™ i Resting ECG System Operator’s Manual for details on
printing ECGs.

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Maintenance and FRU Replacement Procedures

Plastic Parts Functional Checkout Procedures


The following tools are needed to complete the checkout procedures:
• Phillips screwdriver
• Anti-static wrist strap
• ECG simulator
Use the following procedure to complete the functional checkout for this FRU
replacement:
1. Perform a visual inspection on the following:
• Fasteners
• Internal cables
• Keypad
• Power (green) LED
2. Perform a Calibration Check.
See “Calibration Check” on page 61 for more information.
3. Verify ECG printing in default ECG mode and in Rhythm mode by connecting the
device to a 12–lead simulator.
Refer to the MAC™ i Resting ECG System Operator’s Manual for details on
printing ECGs.
4. Perform the Writer Tests and verify they are successful.
See “Writer Tests” on page 50 for more information.
Software Functional Checkout Procedures
The following tools are needed to complete the checkout procedures:
• Phillips screwdriver
• Anti-static wrist strap
• ECG simulator
Use the following procedure to complete the functional checkout for this FRU
replacement:
1. Verify the serial number restored successfully.
If you do not know the serial number, see “Product and Package Information” on
page 18 for the location of the serial number on your device. If you still cannot
find the serial number, contact GE Healthcare Service.
2. Perform a Calibration Check.
See “Calibration Check” on page 61 for more information.
3. Verify ECG printing in default ECG mode and in Rhythm mode by connecting the
device to a 12–lead simulator.
Refer to the MAC™ i Resting ECG System Operator’s Manual for details on
printing ECGs.

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Maintenance and FRU Replacement Procedures

4. Verify that all options are restored successfully. Use the following procedure
to check the options:
If the following option is Do the following…
enabled…
MEAS (measurement option) Take a 10–second ECG in any report format and
ensure that the measurement page is printed at the
end of the report.
3LRF (3–Lead Report Format Ensure that four report formats (SIM3, SEQ3, SEQR,
option) SIML) are available in the ECG mode.
DIAG (interpretation option) Take a 10–second ECG in any report format and
ensure that the interpretation page is printed at the
end of the report.

5. Verify that the external power LED on the keypad is a steady green when the
external power supply is connected to the unit.
This LED must be a steady green whether the unit is in the Off or On condition.
Refer to “Keypad” on page 37 for the location of the LED.
6. Verify the battery charging progress by checking the status of LED DS2 and
DS5 on the PWA.
See “Voltage Supply and Monitoring” on page 41 for more information.
7. Perform the following tests and verify they are successful:
• Display Test (see “Display Test” on page 49).
• Keypad test (see “Keypad Test” on page 50).
• Writer tests (see “Writer Tests” on page 50).
• Battery tests (see “Battery Test” on page 52).
• Acquisition Module tests (see “Acquisition Test” on page 52).
• System Info (see “System Info” on page 52)

Adjustment Instructions
This system does not require any component adjustments.

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Maintenance and FRU Replacement Procedures

78 MAC™ i Resting ECG Analysis System 2065935-002D


Troubleshooting
6
This section contains troubleshooting instructions for specific problems. When a
particular problem is observed, the service personnel should follow the sequence
described to pinpoint the area of failure.
Only approved personnel may conduct repairs. For safety information, refer to “Safety
Instructions” on page 62.
NOTE:
It is recommended that you update the unit software with the same software
version before replacing the PWA Kit. To update the software without the user
interface, refer to “Programming the MAC i Device Without a User Interface” on
page 47. To update the software through the user interface of the device refer
to “Updating the Application Software” on page 45.

Power Errors
Errors may occur concerning the external and battery power.
In the following list, identify the error that best describes the conditions you have
observed. Follow the steps outlined in the flowchart to pinpoint the faulty component.
• The Device Does Not Turn On
• “The External Power LED is On” on page 80
• “The External Power LED is Not On” on page 81
• Battery Errors
• “Device Does Not Turn On in Battery Only Connection” on page 82
• “Battery Error Message is Displayed” on page 83

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Troubleshooting

The Device Does Not Turn On


Identify the error that best describes the conditions you have observed and use the
flowchart to locate the problem.
The External Power LED is On
When the device is connected to an external power supply, the green LED on the
keypad lights up. If the green LED lights up but the device does not turn on, use the
following flowchart to pinpoint the defective component. For information on how to
replace components, see “Replacing Field Replaceable Units (FRUs)” on page 62.

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Troubleshooting

The External Power LED is Not On


When the external power supply is connected to the device, the green external power
LED on the keypad lights up. When the device is connected to mains and it does not
turn on, use the steps outlined in the following flowchart to pinpoint the defective
component. For information on how to replace components, see “Replacing Field
Replaceable Units (FRUs)” on page 62.

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Troubleshooting

Battery Errors
Identify the error that best describes the conditions you have observed and use the
flowchart to locate the problem.
Device Does Not Turn On in Battery Only Connection
This system prints and records ECGs only in battery mode operation with the external
power supply cord disconnected from the device. If the device does not turn on, use
the following flowchart to diagnose the problem. For information on how to replace
components, see “Replacing Field Replaceable Units (FRUs)” on page 62.

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Troubleshooting

Battery Error Message is Displayed


This device can only print when it is powered by the battery. If there is a problem with
the battery, you receive the following message: Battery Error. Use the following
flowchart to diagnose the problem. For information on how to replace components,
see “Replacing Field Replaceable Units (FRUs)” on page 62.

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Troubleshooting

Blank Display
If the device is on and the ON/OFF LED is steady green on the keypad but the display is
blank, use the following flowchart to pinpoint the faulty component. For information
on how to replace components, see “Replacing Field Replaceable Units (FRUs)” on
page 62.

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Troubleshooting

Printing Errors
The following list is several printing-related errors that can occur:
• Printer Error Messages
• “Door Open” on page 86
• “Paper Error” on page 87
• Data Printing Errors
• “Paper is Moving but Not Printing” on page 88
• “Data Does Not Print on the Upper or Lower Edges of the Paper” on page 89
• “Printing Only Baselines” on page 89

Printer Error Messages


Locate the topic that matches the error message you received and use the flowchart
to determine the reason for the error message.

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Troubleshooting

Door Open
The thermal printer has a micro-switch that detects when the printer door is closed. If
the door is open, you receive the following message: Door Open. Use the following
flowchart to diagnose the problem. For information on how to replace components,
see “Replacing Field Replaceable Units (FRUs)” on page 62.

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Troubleshooting

Paper Error
When a problem occurs with the thermal paper, the following error message is
displayed: Paper Error. Use the following flowchart to diagnose the problem. For
information on how to replace components, see “Replacing Field Replaceable Units
(FRUs)” on page 62.

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Troubleshooting

Data Printing Errors


If the data does not print correctly on the paper, locate the topic that matches
the error you are experiencing and use the flowchart to determine the reason for
the problem. For information on how to replace components, see “Replacing Field
Replaceable Units (FRUs)” on page 62.
• “Paper is Moving but Not Printing” on page 88
• “Data Does Not Print on the Upper or Lower Edges of the Paper” on page 89
• “Printing Only Baselines” on page 89

Paper is Moving but Not Printing


If the paper is moving but no data is printed on it, use the following flowchart to
diagnose the problem. For information on how to replace components, see “Replacing
Field Replaceable Units (FRUs)” on page 62.

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Troubleshooting

Data Does Not Print on the Upper or Lower Edges of the Paper
If the printer is not printing on one or more edges of the paper, use the following
flowchart to determine why the printing is incomplete. For information on how to
replace components, see “Replacing Field Replaceable Units (FRUs)” on page 62.

Printing Only Baselines


If the printer is printing only baselines, use the following flowchart to diagnose
the problem. For information on how to replace components, see “Replacing Field
Replaceable Units (FRUs)” on page 62.

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Troubleshooting

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Parts List for Field Replaceable Units
7
(FRUs)

This chapter identifies the available Field Replaceable Units (FRU) using illustrations
and part numbers. FRUs fall into three categories: stand-alone FRUs, FRU kits, and
assemblies. You can order any stand-alone FRU, FRU kit, or assembly using the part
numbers provided in this chapter. To order FRUs, contact GE Healthcare Service or an
approved GE Healthcare vendor.

Printer Kit

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Parts List for Field Replaceable Units (FRUs)

Printer Kit 58 mm 2047366–001


Printer Kit 80 mm 2047339–001

Item Item Description


1 Printer Roller
2 Printer Module

Printer Door Kits

Printer Door Kit MAC i 58 mm Printer Configuration (PN 2066518- 001)

Item Description

1 PRINTER DOOR MACI


2 PRINTER DOOR–HINGE COMPONENT

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Parts List for Field Replaceable Units (FRUs)

Printer Door Kit–MAC i 80 mm (PN 2047335–001)

Item Item Description


1 PRINTER DOOR
2 PRINTER DOOR–HINGE COMPONENT

Hardware Kit
Hardware Kit MAC i (PN 2047367-001)

Item Description QTY


M2 X 10 PHILIPS HEAD M/C SCREW 2
SCR FH #4-40X1/4" ZINC AHNL.DIN965 2
ST SCR DIN7981 M2.2 X 16 -A2 2
WSHR DIN 6796 M2-A2 1
SCR DIN7985-M3X10-4.8-Z-A2F (ISO7045) 12
EARTHING CABLE 1
BUMPON SJ-6125, 15.9MM DIA, 6.35MM THK 4

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Parts List for Field Replaceable Units (FRUs)

Display Module Kit

Display Module Kit MAC i v2 (PN 2066356-001)

Item Item Description


1 ST SCR DIN7981 M2.2 X 16 -A2
2 LCD MODULE COMPLETE MAC i
3 STANDOFF MAC i

PWA Kit

PWA Kit MAC i v2 (PN 2066447-001)

Item Item Description


1 PCB MAC I CPU Board

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Parts List for Field Replaceable Units (FRUs)

Plastic Parts Kit

Plastic Parts Kit MAC i 58 mm Printer Configuration (PN 2066448–001)

Item Item Description

1 PRINTER MOUNTING BASE - MAC i


2 PATIENT CABLE CONNECTOR HOLDER

Plastic Parts Kit MAC i 80 mm Printer Configuration (PN 2068724-001)

Item Item Description


1 PRINTER MOUNTING BASE - MAC i
2 PATIENT CABLE CONNECTOR HOLDER

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Parts List for Field Replaceable Units (FRUs)

Cover Top Assembly Kit

Cover Top Assembly Kit MAC i (PN 2066450-001)

Item Item Description


1 Cover Top Assembly — MAC I

Battery Kit

Battery (PN 2047357–001)

Item Description
1 Battery (Lithium Ion)

96 MAC™ i Resting ECG Analysis System 2065935-002D


Parts List for Field Replaceable Units (FRUs)

Battery Cover

Battery Cover (PN 2047333-001)

Item Item Description


1 Battery Cover
2 BUMPON SJ-6125, 15.9MM DIA, 6.35MM THK

Cover Bottom Kit

Cover Bottom Kit MAC i (PN 2066519-001)

Item Item Description


1 BUMPON SJ-6125, 15.9MM DIA, 6.35MM THK
2 COVER BOTTOM

2065935-002D MAC™ i Resting ECG Analysis System 97


Parts List for Field Replaceable Units (FRUs)

Software Kit
Software Kit MACi v2.00 SP1 (PN 2066452-001)

Item Description
CARD SECURE DIGITAL - 2GB
SW CODE MAC i v2.0
LABEL SD CARD FOR MAC i Software Kit

Software Kit MACi v2.00 SP2 (PN 2066452-002)

Item Description
CARD SECURE DIGITAL - 2GB
SW CODE MAC i v2.00 SP2
LABEL SD CARD FOR MAC i Software Kit

Power Supply Kit


Power Supply Kit MAC i (PN 2066456–001)

Item Description
PWR SPLY MEDICAL CLASS I

98 MAC™ i Resting ECG Analysis System 2065935-002D


Technical Information
A
The MAC i system is a microprocessor augmented automatic electrocardiograph
with 10 leadwires and 12–lead simultaneous acquisition with programmable lead
configuration.

Specifications
Processing

Element Specifications
Acquisitions 12–lead simultaneous ECG acquisition
Digital sampling rate 2000 samples/second/channel
Acquisition mode 10 seconds of simultaneous and sequential ECG recording
Computerized Supports Measurement with Marquette™ 12SL™ ECG Analysis
measurements Program (optional feature)
Interpretation Supports Interpretation with Marquette™ 12SL™ ECG Analysis
Program (optional feature)
ECG analysis frequency 500 samples/second/channel
Dynamic range AC differential ±5 mV,
DC offset ±300 mV
Resolution 4.88 µV/LSB @ 500 sps
Frequency response –3 dB @ 0.01 to 150 Hz
Low cutoff frequency 0.01 Hz
0.02 Hz
0.16 Hz
0.32 Hz
High cutoff frequency 150 Hz
40 Hz
20 Hz (if the muscle filter is enabled)
Operating modes Automatic ECG (12–lead data)
Rhythm/Manual (real-time data)
Common mode rejection >100 dB (with AC filter enabled)
Input impedance >10M Ohm @ 10 Hz (defibrillator protected)

2065935-002D MAC™ i Resting ECG Analysis System 99


Technical Information

Processing (cont'd.)

Element Specifications
Patient leakage <10 µA in normal condition
<50 µA in single fault condition
Lead-fail indication Disconnected lead detection. Each single electrode is
monitored except N/right leg.
Heart rate meter 30 to 300 BPM ±10% or ±5 BPM, whichever is greater
Heart rates outside 30 to 300 BPM are not displayed.
Startup time 7 seconds

Display

Element Specifications
Display type 2 x 16 alphanumeric display with adjustable contrast
Display data Operating Mode
Heart rate
Print formats/Lead display
Speed
Gain
Muscle filter
AC filter
Configuration menu

Report Format

Element Specifications
Lead sequence Standard
Cabrera

Writer

Element Specifications
Writer technology Thermal dot array printhead
Writer speed 5 mm/s
25 mm/s
50 mm/s
Number of traces Available in single-channel and three-channel
Writer sensitivity/gain 2.5 mm/mV
5 mm/mV
10 mm/mV
20 mm/mV
Writer speed accuracy ±5%
Writer amplitude accuracy ±5%
Paper size 58 mm roll paper (for single-channel configuration)
80 mm roll paper (for three–channel configuration)
80 mm Z-fold (for three–channel configuration)
Writer speeds accuracy ±5%

100 MAC™ i Resting ECG Analysis System 2065935-002D


Technical Information

Writer (cont'd.)

Element Specifications
Writer amplitude accuracy ±5%
Writer resolution Horizontal 40 dots/mm @ 25 mm/s
vertical 8 dots/mm

Paper type 80 mm roll and Z-fold for three-channel configuration


58 mm roll for single-channel configuration

Keypad

Element Specifications
Type Membrane keyboard with tactile feedback

Software Standard

Element Specifications

Resting ECG mode Records and prints 12-lead resting ECGs with 10 seconds
duration as a standard feature
Language support English

Software Options

Element Specifications
Measurement Supports measurement with Marquette™ 12SL™ ECG analysis
program:
• Vent. Rate
• P duration
• PR interval
• RR Interval
• QRS duration
• QT/QTc
• P-R-T axes
Three–channel printing Supports three-channel printing in Automatic ECG mode:
• three-lead Simultaneous
• three-lead Sequential
Interpretation Supports interpretation with Marquette™ 12SL™ ECG analysis
program

Power Supply/Electrical

Element Specifications
Power supply External AC/DC adaptor
Ratings/Input voltage 100V to 240V ±10%

2065935-002D MAC™ i Resting ECG Analysis System 101


Technical Information

Power Supply/Electrical (cont'd.)

Element Specifications
Input current Maximum 0.5A @ 100–240 VAC
Operating frequency 50 Hz to 60 Hz ±3 Hz
Output voltage 12V ±5%

Battery
Element Specifications
Battery type Replaceable and rechargeable Lithium-Ion 7.2V
Battery charge time Approximately 3 hours
Battery charging Automatic battery charging through a built-in charger during
line-power operation
Battery capacity* 7.2V typical, 2.25 AH ±10%
250 continuous ECGs in Sequential single–lead report format
at 25 mm/s and 10 mm/mV
250 continuous ECGs in Simultaneous three–lead report format
at 25 mm/s and 10 mm/mV
Minimum 120 minutes of continuous rhythm print at 25 mm/s
and 10 mm/mV
*These are for a fully-charged battery.

Physical
Element Specifications
Width Approximately 85 mm
Height Approximately 275 mm
Depth Approximately 215 mm
Weight Approximately 1.2 Kg (including battery and paper roll)

Environmental
Element Specifications
Operating Transport/Storage
Temperature 5° to 40°C (41° to 104°F) -15°C to +50°C (5° to 122°F)
Humidity 25% to 95% RH non-condensing 25% to 95% RH non-condensing
Pressure 710 hPA to 1060 hPA 500 hPA to 1060 hPA

Accessories
• Value reusable IEC/AHA limb clamps and bulb electrodes (user selectable)
• Value-fixed, 10-lead patient cable IEC/AHA (user selectable)
• External medical-grade power supply
• 58 mm standard roll paper
102 MAC™ i Resting ECG Analysis System 2065935-002D
Technical Information

• 80 mm standard roll paper


• 80 mm standard z-fold paper
• Electrode cream 250 ml tube
• Pediatric electrodes and universal clip (optional)
Safety and Regulatory

Code Description
MDD Class IIa Medical Device Classification for CE marking
IEC 60601-1 General requirements for safety
IEC 60601-1-2 General requirements for safety – electromagnetic
compatibility
IEC 60601-1-4 General requirements for safety – programmable electrical
medical systems
IEC 60601-2-25 Particular requirements for the safety of electrocardiographs
IEC 60601-2-51 Particular requirements for safety, including essential
performance, of recording and analyzing single-channel and
multi-channel electrocardiographs
IEC 60601-1-6 General requirements for basic safety and essential
performance – Collateral Standard: Usability-Edition 2.0
UL 60601–1 Medical electrical equipment, part 1: General Requirements
for Safety
CAN/CSA C22.2 No. General requirements for safety
601.1–M90
ANSI/AAMI EC-11 American National Standard Diagnostic Electrocardiography
Devices
ANSI/AAMI EC-13 American National Standard for cardiac monitors, heart rate
meters, and alarms (Section 4.2.7 Range and accuracy of heart
rate meter)

2065935-002D MAC™ i Resting ECG Analysis System 103


Technical Information

104 MAC™ i Resting ECG Analysis System 2065935-002D


Electromagnetic Compatibility (EMC)
B
This section describes the EMC information relevant to your product.
Changes or modifications to this system not expressly approved by GE Healthcare
could cause EMC issues with this or other equipment. This system is designed and
tested to comply with applicable regulations regarding EMC, and must be installed
and put into service according to the EMC information stated in this section.
WARNING:
EQUIPMENT MALFUNCTION Use of portable phones or other radio frequency (RF)
emitting equipment near the system may cause unexpected or adverse operation.
Do not use portable phones or other electronic equipment that may emit radio
frequency (RF) near this system.
WARNING:
EQUIPMENT MALFUNCTION Do not use the equipment or system adjacent to, or
stacked with, other equipment.
If adjacent or stacked use is necessary, test the equipment or system to verify
normal operation in the configuration in which you are using it.

Guidance and Manufacturer’s


Declaration—Electromagnetic Emissions
The system described in this manual is intended for use in the following specified
electromagnetic environment. It is the responsibility of the customer or user to ensure
that this system is used in such an environment.
EMC Emissions Test

Emissions Test Compliance Electromagnetic


Environment–Guidance
RF emissions (Radiated) Group 1 This device uses RF energy
EN55011 only for its internal function.
Therefore, its RF emissions
RF emissions (Conducted) Class B are very low and are not likely
EN55011 to cause any interference in
nearby electronic equipment.

2065935-002D MAC™ i Resting ECG Analysis System 105


Electromagnetic Compatibility (EMC)

EMC Emissions Test (cont'd.)

Emissions Test Compliance Electromagnetic


Environment–Guidance
Harmonic emissions Class B Class B equipment is
suitable for use in all
Voltage fluctuations/ Complies establishments, including
Flicker emissions domestic establishments
EN61000–3–3 and those directly connected
to the public low-voltage
power supply network that
supplies buildings used for
domestic purposes.

Guidance and Manufacturer’s


Declaration—Electromagnetic Immunity
The system described in this manual is intended for use in the following specified
electromagnetic environment. It is the responsibility of the customer or user to ensure
that this system is used in such an environment.
EMC Immunity Test

Immunity Test Compliance Electromagnetic


Environment–Guidance
Electrostatic discharge (ESD) 6 kV contact Floors should be wood,
IEC61000–4–2 8 kV air concrete, or ceramic tile.
If the floors are covered
with synthetic material, the
relative humidity should be
at least 30%.
Electrical Fast 2 kV for lines Mains power should be that
Transient/burst (EFT) of a typical commercial or
IEC 61000–4–4 hospital environment.

Fast Transient Surge (FTS) 1 kV line(s) to line(s) Mains power should be that
IEC61000–4–5 of a typical commercial or
hospital environment.
Voltage dips, short <5% Ut (>95% dip in Ut) for Mains power should be that
interruptions, and voltage 0.5 cycles of a typical commercial or
variations on power supply 40% Ut (60% dip in Ut) for 5 hospital environment.
input lines cycles If the user requires continued
IEC 61000–4–11 70% Ut (30% dip in Ut) for 25 system operation during
cycles power mains interruptions,
<5% Ut (>95% dip in Ut) for 5 it is recommended that
sec. the system is powered
from an applicably rated
uninterruptible power supply
or a battery.

106 MAC™ i Resting ECG Analysis System 2065935-002D


Electromagnetic Compatibility (EMC)

EMC Immunity Test (cont'd.)

Immunity Test Compliance Electromagnetic


Environment–Guidance
Power frequency (50/60 Hz) 3 A/m Power frequency magnetic
magnetic field fields should be at levels
IEC61000–4–8 characteristic of a typical
location in a typical
commercial or hospital
environment.
NOTE Ut is the AC mains voltage prior to application of the test level.

Guidance and Manufacturer’s


Declaration—Electromagnetic Immunity
The system described in this manual is intended for use in the following specified
electromagnetic environment. It is the responsibility of the customer or user to ensure
that this system is used in such an environment.
EMC Immunity Test

Immunity Test Compliance Compliance Electromagnetic


Test Level Level Environment–Guidance
Do not use portable or mobile
RF communications equipment
closer to any part of the system,
including the cables, than
the recommended separation
distance calculated for the
equation applicable to the
frequency of the transmitter.
Conducted RF 3 Vrms Recommended separation
EN 61000–4–6 150 KHz to 80 distance:
MHz d= 12√P
Radiated RF 3 V/m Recommended separation
EN 61000–4–3 80 MHz to 2.5 distance:
GHz 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 meters (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey:
ashould be less than the
compliance level in each
frequency range
bInterference may occur in the
vicinity of equipment marked with
the following symbol:

2065935-002D MAC™ i Resting ECG Analysis System 107


Electromagnetic Compatibility (EMC)

NOTE:
• At 80 MHz and 800 MHz, the higher frequency range applies.
• These guidelines may not apply in all situations. Electromagnetic propagation is
affected by the reflection from structures, objects, and people.
• aField strengths from fixed transmitters, such as base stations for radio
(cellular/cordless) telephones and land mobile 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,
consider conducting an electromagnetic site survey. If the measured field
strength in the location in which the system is used exceeds the applicable
RF compliance level listed in this table, observe the system to verify normal
operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating the system.
• bOver the frequency range 150 KHz to 80 MHz, field strengths should be less
than 3 V/m.

Recommended Separation Distances


The following table provides the recommended separation distances (in meters)
between portable and mobile RF communication equipment and the system described
in this manual, for equipment and systems that are not life-supporting.
The system is intended for use in the electromagnetic environment in which radiated
RF disturbances are controlled. The customer or the user of the system can help
prevent electromagnetic interference by maintaining the following recommended
minimum distance between portable and mobile RF communications equipment
(transmitters) and the system, according to the maximum output power of the
communications equipment.
Recommended Separation Distances

Rated Separation distance (meters) according to frequency of transmitter


maximum
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
output
d (meters) = 3.5/V1 x √P d = 3.5/E1 x √P d = 7/E1 x √P
power of
transmitter d (meters) for V1 = d for E1 = 3 V/m d for E1 = 3 V/m
in watts 3 Vrms
W
meters feet meters feet meters feet
0.01 0.117 0.383 0.117 0.383 0.233 0.766
0.1 0.369 1.210 0.369 1.210 0.738 2.421
1 1.167 3.828 1.167 3.828 2.333 7.655
10 3.689 12.104 3.689 12.104 7.379 24.208

108 MAC™ i Resting ECG Analysis System 2065935-002D


Electromagnetic Compatibility (EMC)

Recommended Separation Distances (cont'd.)

Rated Separation distance (meters) according to frequency of transmitter


maximum
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
output
d (meters) = 3.5/V1 x √P d = 3.5/E1 x √P d = 7/E1 x √P
power of
transmitter d (meters) for V1 = d for E1 = 3 V/m d for E1 = 3 V/m
in watts 3 Vrms
W
meters feet meters feet meters feet
100 11.667 38.276 11.667 38.276 23.333 76.552
For transmitters rated at a maximum output power not listed above, estimate the
recommended separation distance d in meters (m) using the equitation 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.

2065935-002D MAC™ i Resting ECG Analysis System 109


Index

A typographical 32
Cover Bottom Kit FRU 97
accessing System Info 47
Cover Top Assembly Kit FRU 96
accessories specifications 102
acquisition test 52
application software D
updating 45 DC power inlet 40
Assistance 31 device
symbols 21
B diagnostic tests 49
display connector location 40
battery Display Module Kit FRU 94
charging conditions 41 display panel 36
specifications 40 display specifications 100
battery connector 41 display test 49
battery specifications 102 document
battery test 52 part number 2
biocompatibility statement 17 revision 2
block diagram 38 document conventions 31
boot software documents
updating 46 related 33

C E
class B equipment 106 ECG
classification signal input connector 36
medical device 15 ECG cable connector location 41
Common Documentation Electrical Fast Transient/
Library (CDL) 2 burst (EFT)
compatibility EMC immunity test 106
electromagnetic 105 electrical specifications 101
EMC 105 electromagnetic
compliance 2 emissions
conducted RF guidance and
EMC immunity test 107 manufacturer’s
connector declaration 105
display 40 immunity
Keypad 41 guidance and
printer cable 40 manufacturer’s
SD card 40 declaration 106107
contraindications 13 separation distances 108
conventions electromagnetic
document 31 compatibility 105
illustrations 32 electrostatic discharge (ESD)
Notes 32 EMC immunity test 106
safety 14 EMC 16
110 MAC™ i Resting ECG Analysis System 2065935-002D
floor composition 106 G
mains power 106 GE Healthcare
separation distances 108 Common Documentation
EMC compatibility 105 Library (CDL) 2
EMC emissions test manuals 2
flicker emissions 106 guidance and
harmonic emissions 106 manufacturer’s
RF emissions declaration
conducted 105 electromagnetic
radiated 105 emissions 105
voltage fluctuation 106 guidance and
EMC immunity test manufacturer’s
conducted RF 107 declaration
Electrical Fast Transient/ electromagnetic
burst (EFT) 106 immunity 106
electrostatic discharge guidance and
(ESD) 106 manufacturer’s
Fast Transient Surge (FTS) 106 declaration
Power frequency (50/ electromagnetic
60 Hz) magnetic field 107 immunity 107
radiated RF 107
short interruptions on
power supply input lines 106 H
voltage dips on power Hardware Kit FRU 93
supply input lines 106 harmonic emissions test 106
voltage variations on
power supply input lines 106
EMI 16 I
environmental identification
specifications 102 equipment 28
equipment illustration conventions 32
identification 28 indications for use 13
external power connector 37 ingress protection 15
external power supply 39 instrument type 99
intended user 13
interface
F printer and motor
Fast Transient Surge (FTS) assembly 42
EMC immunity test 106
flicker emissions test 106 K
FRUs
Cover Battery 97 keypad 36
Cover Bottom Kit 97 arrowpad 38
Cover Top Assembly Kit 96 battery charging LED 37
Display Module Kit 94 ECG key 38
Hardware Kit 93 enter key 38
Plastic Parts Kit 95 external power LED 37
Power Supply Kit 98 lead key 38
Printer Door Kit 93 mode key 38
Printer Kit 92 on/off key 37
PWA Kit 94 on/off LED 38
Software Kit 98 start/stop key 38
keypad connector location 41
keypad specifications 101
2065935-002D MAC™ i Resting ECG Analysis System 111
keypad test 50 printer and motor assembly
interface 42
printer cable connector
L location 40
labeling Printer Door Kit FRU 93
package 18 Printer Kit FRU 92
product 18 processing specifications 99
product
codes 30
M labeling 18
manufacturer programming the device 47
responsibilities 18 protection
mechanical components ingress 15
location 38 purchaser/customer
medical device responsibilities 18
classification 15 PWA connector details 40
PWA Kit FRU 94
N
navigating R
Service Menu 44 radiated RF
Notes conventions 32 EMC immunity test 107
Radio Frequency (RF)
cautions 16
O devices 16
OEM 2 related documents 33
Original Equipment report format specifications 100
Manufacturer (OEM) 2 requirements
service 31
responsibilities
P manufacturer 18
package purchaser/customer 18
labeling 18 revision history 2
packaging RF emissions test
symbols 21 conducted 105
part number radiated 105
document 2
PCB assembly 38
PWA connector details 40 S
physical specifications 102 safety
Plastic Parts Kit FRU 95 conventions
Power frequency (50/ definitions 14
60 Hz) magnetic field hazards 14
EMC immunity test 107 safety and regulatory
power inlet specifications 103
DC 40 SD card connector location 40
power jack connector 40 separation distances
power supply electromagnetic 108
external 39 EMC 108
specifications 39 service
Power Supply Kit FRU 98 information 31
power supply specifications 101 requirements 31
prescription device service menu 44
statement 13 Service Menu
112 MAC™ i Resting ECG Analysis System 2065935-002D
navigating 44 V
short interruptions on
voltage
power supply input lines
supply and monitoring 41
EMC immunity test 106
voltage dips on power
Software Kit FRU 98
supply input lines
software options
EMC immunity test 106
specifications 101
voltage fluctuation
software standard
emissions test 106
specifications 101
voltage variations on power
specifications
supply input lines
accessories 102
EMC immunity test 106
battery 40, 102
display 100
electrical 101 W
environmental 102
keypad 101 warranty information 31
physical 102 writer specifications 100
power supply 39, 101 writer tests 50
processing 99
report format 100
safety and regulatory 103
software options 101
software standard 101
writer 100
storing
system log 46
symbols
device 21
packaging 21
system info 52
System Info
accessing 47
system log
storing 46

T
tests
acquisition 52
battery 52
diagnostic 49
display 49
keypad 50
writer 50
training 28
typographical conventions 32

U
updating
application software 45
boot software 46

2065935-002D MAC™ i Resting ECG Analysis System 113


114 MAC™ i Resting ECG Analysis System 2065935-002D
Asia Headquarters
GE Medical Systems GE Medical Systems GE Medical Systems
Information Technologies, Inc. Information Technologies GmbH Information Technologies, Inc.
8200 West Tower Avenue Munzinger Straße 5 Asia; GE (China) Co., Ltd.
Milwaukee, WI 53223 USA 79111 Freiburg Germany 1 Huatuo Road
Tel: +1 414 355 5000 Tel: +49 761 45 43 -0 Zhangjiang Hi-tech Park Pudong
+1 800 558 7044 (US Only) Fax: +49 761 45 43 -233 Shanghai, People's Republic of China 201203
Fax: +1 414 355 3790 Tel: +86 21 3877 7888
Fax: +86 21 3877 7451

GE Medical Systems Information Technologies, Inc., a General Electric Company, going to market as
GE Healthcare.

www.gehealthcare.com

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