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WARNING This service manual is available in English only.

• If a customer's service provider requires a language other than
(EN) 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.
• Ако доставчикът на услугата на клиента изиска друг език,
(BG) 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
пациентa в резултат на токов удар, механична или друга
опасност.
VÝSTRAHA Tento provozní návod existuje pouze v anglickém jazyce.
• V případě, že externí služba zákazníkům potřebuje návod v
(CS) 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 výstrahy 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.
• Hvis en kundes tekniker har brug for et andet sprog end
(DA) engelsk, er det kundens ansvar at sørge for oversættelse.
• Forsøg ikke at servicere udstyret uden at læse og forstå
denne servicemanual.
• Manglende overholdelse af denne advarsel kan medføre
skade på grund af elektrisk stød, mekanisk eller anden fare for
teknikeren, operatøren eller patienten.
WARNUNG Diese Serviceanleitung existiert nur in englischer Sprache.
• Falls ein fremder Kundendienst eine andere Sprache benötigt,
(DE) ist es Aufgabe des Kunden für eine entsprechende
Übersetzung zu sorgen.
• Versuchen Sie nicht diese Anlage zu warten, ohne diese
Serviceanleitung gelesen und verstanden zu haben.
• Wird diese Warnung nicht beachtet, so kann es zu
Verletzungen des Kundendiensttechnikers, des Bedieners
oder des Patienten durch Stromschläge, mechanische oder
sonstige Gefahren kommen.
UPOZORENJE Ovaj servisni priručnik dostupan je na engleskom jeziku.
• Ako davatelj usluge klijenta treba neki drugi jezik, klijent je
(HR) dužan osigurati prijevod.
• Ne pokušavajte servisirati opremu ako niste u potpunosti
pročitali i razumjeli ovaj servisni priručnik.
• Zanemarite li ovo upozorenje, može doći do ozljede davatelja
usluge, operatera ili pacijenta uslijed strujnog udara,
mehaničkih ili drugih rizika.
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ΠΡΟΕΙΔΟΠΟΙΗΣΗ Το παρόν εγχειρίδιο σέρβις διατίθεται μόνο στα αγγλικά.

• Εάν ο τεχνικός σέρβις ενός πελάτη απαιτεί το παρόν εγχειρίδιο
(EL) σε γλώσσα εκτός των αγγλικών, αποτελεί ευθύνη του πελάτη
να παρέχει τις υπηρεσίες μετάφρασης.
• Μην επιχειρήσετε την εκτέλεση εργασιών σέρβις στον
εξοπλισμό αν δεν έχετε συμβουλευτεί και κατανοήσει το παρόν
εγχειρίδιο σέρβις.
• Αν δεν προσέξετε την προειδοποίηση αυτή, ενδέχεται να
προκληθεί τραυματισμός στον τεχνικό σέρβις, στο χειριστή ή
στον ασθενή από ηλεκτροπληξία, μηχανικούς ή άλλους
κινδύνους.
ATENCION Este manual de servicio sólo existe en inglés.
• Si el encargado de mantenimiento de un cliente necesita un
(ES) 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.
HOIATUS See teenindusjuhend on saadaval ainult inglise keeles
• Kui klienditeeninduse osutaja nõuab juhendit inglise keelest
(ET) 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.
• Jos asiakkaan huoltohenkilöstö vaatii muuta kuin
(FI) 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 d’installation et de maintenance est disponible
uniquement en anglais.
(FR) • Si le technicien d'un client a besoin de ce manuel dans une
langue autre que l'anglais, il incombe au client de le faire
traduire.
• Ne pas tenter d'intervenir sur les équipements tant que ce
manuel d’installation et de maintenance 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.
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FIGYELMEZTETÉS Ezen karbantartási kézikönyv kizárólag angol nyelven érhető el.

• Ha a vevő szolgáltatója angoltól eltérő nyelvre tart igényt,
(HU) akkor a vevő felelőssége a fordítás elkészíttetése.
• Ne próbálja elkezdeni használni a berendezést, amíg a
karbantartási kézikönyvben leírtakat nem értelmezték.
• Ezen figyelmeztetés figyelmen kívül hagyása a szolgáltató,
működtető vagy a beteg áramütés, mechanikai vagy egyéb
veszélyhelyzet miatti sérülését eredményezheti.
PERINGATAN Panduan Servis ini hanya tersedia dalam Bahasa Inggris.
• Jika penyedia layanan pelanggan memerlukan bahasa di luar
(ID) Bahasa Inggris, maka pelanggan bertanggung jawab untuk
memberikan layanan tersebut.
• Jangan mencoba menyervis peralatan ini, kecuali Panduan
Servis ini telah dijadikan rujukan dan dipahami dengan baik.
• Kelalaian memperhatikan Peringatan ini dapat menyebabkan
cedera terhadap penyedia layanan, operator, atau pasien
akibat bahaya kejutan listrik, mekanik, dan bahaya lainnya.
AÐVÖRUN Þessi þjónustuhandbók er aðeins fáanleg á ensku.
• Ef að þjónustuveitandi viðskiptamanns þarfnast annas
(IS) tungumáls en ensku, er það skylda viðskiptamanns að skaffa
tungumálaþjónustu.
• Reynið ekki að afgreiða tækið nema að þessi
þjónustuhandbók hefur verið skoðuð og skilin.
• Brot á sinna þessari aðvörun getur leitt til meiðsla á
þjónustuveitanda, stjórnanda eða sjúklings frá raflosti,
vélrænu eða öðrum áhættum.
AVVERTENZA Il presente manuale di manutenzione è disponibile soltanto in
lingua inglese.
(IT) • Se un addetto alla manutenzione richiede il manuale in una
lingua diversa, il cliente è tenuto a provvedere direttamente
alla traduzione.
• Procedere alla manutenzione dell'apparecchiatura solo dopo
aver consultato il presente manuale ed averne compreso il
contenuto.
• Il mancato rispetto della presente avvertenza potrebbe
causare lesioni all'addetto alla manutenzione, all'operatore o
ai pazienti provocate da scosse elettriche, urti meccanici o altri
rischi.

警告 このサービスマニュアルには英語版しかありません。
• 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
(JA) 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理解せずに、装置のサービ
スを行わないでください。
• 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
あるいは患者さんが、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。
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ЕСКЕРТУ Осы қызмет көрсету нұсқаулығы тек ағылшын тілінде

қолжетімді.
(KK) • Егер тұтынушылардың қызметтер жеткізушісі ағылшын
тілінен басқа тілді талап етсе, аудару қызметтерімен
қамтамасыз ету тұтынушының жауапкершілігіне кіреді.
• Осы қызмет көрсету нұсқаулығын түсініп, ол туралы кеңес
алмайынша жабдыққа қызмет көрсетуге тырыспаңыз.
• Осы ескертуді орындамау электр тогының соғуы,
механикалық немесе басқа да қауіптер салдарынан
қызметтер жеткізушісінің, оператордың немесе
емделушінің жарақаттануына алып келуі мүмкін.

경고 본• 서비스
고객의 매뉴얼은 영어로만영어
서비스 제공자가 이용하실
이외의수언어를
있습니다 . 경우 , 번
요구할
• 역본 서비스
서비스를매뉴얼을
제공하는참조하여
것은 고객의 책임입니다
않은 이상. 해당 장비를
(KO)
숙지하지
수리하려고 시도하지 마십시오 .
• 는본 기타
경고 위험으로
사항에 유의하지 않으면제공자
인해 서비스 전기 ,쇼크 , 기계적
사용자 위험 , 또
또는 환자에게
부상을 입힐 수 있습니다 .
ĮSPĖJIMAS Šis eksploatavimo vadovas yra tik anglų kalba.
• Jei kliento paslaugų tiekėjas reikalauja vadovo kita kalba – ne
(LT) anglų, suteikti vertimo paslaugas privalo klientas.
• Nemėginkite atlikti įrangos techninės priežiūros, jei
neperskaitėte ar nesupratote šio eksploatavimo vadovo.
• Jei nepaisysite šio įspėjimo, galimi paslaugų tiekėjo,
operatoriaus ar paciento sužalojimai dėl elektros šoko,
mechaninių ar kitų pavojų.
BRĪDINĀJUMS Šī apkopes rokasgrāmata ir pieejama tikai angļu valodā.
• Ja klienta apkopes sniedzējam nepieciešama informācija citā
(LV) valodā, klienta pienākums ir nodrošināt tulkojumu.
• Neveiciet aprīkojuma apkopi bez apkopes rokasgrāmatas
izlasīšanas un saprašanas.
• Šī brīdinājuma neievērošanas rezultātā var rasties elektriskās
strāvas trieciena, mehānisku vai citu faktoru izraisītu traumu
risks apkopes sniedzējam, operatoram vai pacientam.
WAARSCHUWING Deze onderhoudshandleiding is enkel in het Engels verkrijgbaar.
• Als het onderhoudspersoneel een andere taal vereist, dan is
(NL) de klant verantwoordelijk voor de vertaling ervan.
• Probeer de apparatuur niet te onderhouden alvorens deze
onderhoudshandleiding werd geraadpleegd en begrepen is.
• Indien deze waarschuwing niet wordt opgevolgd, zou het
onderhoudspersoneel, de operator of een patiënt gewond
kunnen raken als gevolg van een elektrische schok,
mechanische of andere gevaren.
ADVARSEL Denne servicehåndboken finnes bare på engelsk.
• Hvis kundens serviceleverandør har bruk for et annet språk, er
(NO) 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.
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OSTRZEŻENIE Niniejszy podręcznik serwisowy dostępny jest jedynie w języku

angielskim.
(PL) • Jeśli serwisant klienta wymaga języka innego niż angielski,
zapewnienie usługi tłumaczenia jest obowiązkiem klienta.
• Nie próbować serwisować urządzenia bez zapoznania się z
niniejszym podręcznikiem serwisowym i zrozumienia go.
• Niezastosowanie się do tego ostrzeżenia może doprowadzić
do obrażeń serwisanta, operatora lub pacjenta w wyniku
porażenia prądem elektrycznym, zagrożenia mechanicznego
bądź innego.
ATENÇÃO Este manual de assistência técnica encontra-se disponível
unicamente em inglês.
(PT-BR) • Se outro serviço de assistência técnica solicitar a tradução
deste manual, caberá ao cliente fornecer os serviços de
tradução.
• Não tente reparar o equipamento sem ter consultado e
compreendido este manual de assistência técnica.
• A não observância deste aviso pode ocasionar ferimentos no
técnico, operador ou paciente decorrentes de choques
elétricos, mecânicos ou outros.
ATENÇÃO Este manual de assistência técnica só se encontra disponível em
inglês.
(PT-PT) • Se qualquer outro serviço de assistência técnica solicitar este
manual noutro idioma, é 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 colocar em perigo a
segurança do técnico, do operador ou do paciente devido a
choques eléctricos, mecânicos ou outros.
ATENŢIE Acest manual de service este disponibil doar în limba engleză.
• Dacă un furnizor de servicii pentru clienţi necesită o altă limbă
(RO) 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.
ОСТОРОЖНО! Данное руководство по техническому обслуживанию
представлено только на английском языке.
(RU) • Если сервисному персоналу клиента необходимо
руководство не на английском, а на каком-то другом
языке, клиенту следует самостоятельно обеспечить
перевод.
• Перед техническим обслуживанием оборудования
обязательно обратитесь к данному руководству и поймите
изложенные в нем сведения.
• Несоблюдение требований данного предупреждения
может привести к тому, что специалист по
техобслуживанию, оператор или пациент получит удар
электрическим током, механическую травму или другое
повреждение.
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UPOZORNENIE Tento návod na obsluhu je k dispozícii len v angličtine.

• Ak zákazníkov poskytovateľ služieb vyžaduje iný jazyk ako
(SK) angličtinu, poskytnutie prekladateľských služieb je
zodpovednosťou zákazníka.
• Nepokúšajte sa o obsluhu zariadenia, kým si neprečítate
návod na obluhu a neporozumiete mu.
• Zanedbanie tohto upozornenia môže spôsobiť zranenie
poskytovateľa služieb, obsluhujúcej osoby alebo pacienta
elektrickým prúdom, mechanické alebo iné ohrozenie.
OPOZORILO Ta servisni priročnik je na voljo samo v angleščini.
• Če ponudnik servisnih storitev za stranko potrebuje navodila v
(SL) drugem jeziku, mora stranka sama poskrbeti za prevajanje.
• Ne poskušajte servisirati opreme, ne da bi prej prebrali in
razumeli servisni priročnik.
• Če tega opozorila ne upoštevate, obstaja nevarnost
električnega udara, mehanskih ali drugih nevarnosti in
posledičnih poškodb ponudnika servisnih storitev, uporabnika
opreme ali pacienta.
UPOZORENJE Ovo servisno uputstvo je dostupno samo na engleskom jeziku.
• Ako klijentov serviser zahteva neki drugi jezik, klijent je dužan
(SR) 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.
VARNING Den här servicehandboken finns bara tillgänglig på engelska. .
• Om en kunds servicetekniker har behov av ett annat språk än
(SV) 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.
 Bu servis kılavuzunun sadece ingilizcesi mevcuttur.
• Eğer müşteri teknisyeni bu kılavuzu ingilizce dışında bir başka
(TR) 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.
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ПОПЕРЕДЖЕННЯ Цей посібник із технічного обслуговування доступний лише

англійською мовою.
(UK) • Якщо постачальнику послуг із технічного обслуговування
потрібна інформація мовою, відмінною від англійської,
відповідальність за надання послуг перекладу несе
користувач.
• Технічне обслуговування обладнання можна виконувати
лише після ознайомлення з посібником із технічного
обслуговування та усвідомлення його змісту.
• Недотримання цього попередження може призвести до
травм постачальника послуг, оператора або пацієнта,
спричинених дією електричного струму, механічних або
інших пошкоджень.
CẢNH BÁO Hướng dẫn sử dụng dịch vụ này chỉ sẵn dùng bằng tiếng Anh.
• Nếu nhà cung cấp dịch vụ của khách hàng yêu cầu ngôn ngữ
(VI) khác ngoài tiếng Anh, thì khách hàng phải có trách nhiệm
cung cấp các dịch vụ dịch thuật.
• Không được tìm cách sửa chữa thiết bị trừ khi đã tham khảo
và hiểu rõ Hướng dẫn sử dụng dịch vụ này.
• Bỏ qua lời cảnh báo này có thể gây thương tích cho nhà cung
cấp dịch vụ, nhân viên vận hành hoặc bệnh nhân do sốc điện,
những nguy hiểm về máy móc hoặc yếu tố khác.

警告 本维修手册仅提供英文版本。
• 如果客户的维修服务人员需要非英文版本，则客户需自行提供
(ZH-CN) 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服务人员、操作人员或患者造成电击、
机械伤害或其他形式的伤害。
警告 本服務手冊僅提供英文版本。
• 倘若客戶的服務供應商需要英文以外之服務手冊，客戶有責任
(ZH-HK)
提供翻譯服務。
• 除非已參閱本服務手冊及明白其內容，否則切勿嘗試維修設
備。
• 不遵從本警告或會令服務供應商、網絡供應商或病人受到觸
電、機械性或其他的危險。
警告 本維修手冊僅有英文版。
• 若客戶的維修廠商需要英文版以外的語言，應由客戶自行提供
(ZH-TW)
翻譯服務。
• 請勿試圖維修本設備，除非 您已查閱並瞭解本維修手冊。
• 若未留意本警告，可能導致維修廠商、操作員或病患因觸電、
機械或其他危險而受傷。
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M1192872 A 08 2015 7
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Service Disclaimer Addendum

Multi-Language
M1192872
A 08 2015
Printed in USA
© Datex-Ohmeda, Inc. – All rights reserved.
Released

Class: Minor
GE and GE Monogram are trademarks of 8 1/2 x 11”
General Electric Company. 24#, White
2-Sided
8 Datex-Ohmeda, Inc., a General Electric Company, 7-Hole Punch
doing business as GE Healthcare. When used in manuals, insert after front cover.
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Field Action Bulletin

Technical Bulletin Unique FM LCS 17 005_ DOC2079929

Identifier
Title FMI 34089 - 9100c/Aelite Anesthesia Systems – Potential Display
Failure
Subject Mandatory Field upgrade the system and software of 9100c/Aelite
Anesthesia Systems
Applicability (affected product, 9100c/Aelite
process)
Date (DD-MMM-YYYY) 4-Jan-2018
Originating Business Healthcare Systems (HCS)
Originating Modality Clinical Care Solutions (CCS) / Anesthesia & Respiratory Care (ARC)
Details

FMI34089 Instruction Revision History

Date Revision Author Reason for Change – Define Section Updated

Initial FMI instruction document.
See My 1 Li Yuan
Workshop
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FMI FIELD MODIFICATION INSTRUCTION FMI

FMI FIELD MODIFICATION INSTRUCTION FMI No: 34089

FMI Title: 9100c/Aelite Anesthesia Systems – Potential Display Failure

Purpose: The purpose of this Bulletin is to communicate the launch of FMI34089 on GE Healthcare 9100c / Aelite
Anesthesia systems.

FMI TYPE
☒Recall/Reportable
☐Business – Mandatory/Not -Reportable
☐Business – On Request/Not -Reportable
Section 1: RESOURCES:
One qualified Field Service Engineer for 1hr. labor. The Field Engineer will need to be GEHC Service trained on the
9100c/Aelite systems. No additional Service training is required.

Section 2: TOOLS, TEST EQUIPMENT, and FIELD SUPPLIED MATERIALS:

Standard Service tools are needed to execute this Field action. One laptop computer with Windows 7 or 10
operating system is also needed for this Field action. Other tools will be included in the FMI kit. This mandatory
upgrade will be performed at no cost to the end user customers. GE Healthcare CCS will provide the parts required
for this FMI at no charge to GE affiliates and distributors
WARNING：Do not perform testing or maintenance on the machine while it is being used on a patient. Possible
injury can result. Electrostatic discharge through circuit boards may damage the components on them. Wear a
static control wrist strap before touching the circuit boards. Handle all circuit boards by their non-conductive
edges. Use antistatic containers when transporting them. Connections should not be made to the electrostatic
sensitive parts unless ESD precautionary procedures are followed.
Section 3: SPECIAL INSTRUCTIONS:
FMI 34089 requires a customer communication letter. The pole/region FMI Regulatory Manager or Service
equivalent is responsible for providing proof of the delivery of the letter to the customer, per the individual
country/region requirement. The Service Record Dispatch should document the letter delivery including the
recipient name, title and date of review as well as the FMI completion.
The FMI Service Record should include 4 elements of documentation: 1) the machine SN and the DMB SN for the
applied 9100c/Aelite unit, 2) the FMI Kit numbers installed, 3) evidence the system check-out has passed or a copy
of the checklist attached in this FMI Instruction, and 4) evidence stating device is ready for clinical use. As a best-
practice the attached checklist should be provided as an attachment into the Service Record.
Section 4: TECHNICAL SUPPORT
APAC CHINA EGM/SHS EUROPE
Park, Jung Heum (Korea) He, Fei Shahwan, Rabah Pytlik, Stas
Jang, Jong Moon Li, Spring Darwish, Haitham Morton, Richard
Rukiye, Cengiz Esther Ech Chad
Chew, Boon-Lai
INDIA LATAM USCAN
Bera, Santanu Villafuerte, Israel N/A
Sunny, Vipin Pozzo, Ramiro
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Section 5: EFFECTIVITY
The affected 9100c / Aelite Anesthesia devices have been listed in FMI 34089 Customer Communication Letter.

Section 6: PURPOSE DETAILED

There is a potential for an unexpected device malfunction involving loss of communication between the Control
Sample Board and Display Monitor Board during use. The purpose of this Field Modification Instruction is to
communicate to the Service organization a mandatory upgrade of the Display Monitor Board “OS” system and
install the new system software. A GE Healthcare Field Engineer or equivalent will be responsible for completing
the field action as well as documenting its completion.
Section 7: RELATED FMIs:
N/A

Section 8: KIT ITEM NUMBER & FURNISHED MATERIALS IN FMI KITS:

I. FMI Kit Part Number: 2107811-120 FMI 34089, 9100C, USB DISK WITH SOFTWARE V1.20.
II. FMI Kit Part Number: 2107811-130 FMI 34089, 9100C, USB DISK WITH SOFTWARE V1.30.
FMI Kit Number Description Quantity Note
2107811-120 USB DISK WITH SOFTWARE V1.20 1 Will be used in China and Korea only.
AND OS UPGRADE SOFTWRE
MINI USB CABLE, 1000MM 1
CONN, male, jumper 1
2107811-130 USB DISK WITH SOFTWARE V1.30 1 Will be used in other affected countries
AND OS UPGRADE SOFTWRE other than China and Korea.
MINI USB CABLE, 1000MM 1
CONN, male, jumper 1

Section 9: PROCEDURE
Installation procedure for FMI34089:

Part 1 Get the original System Key Code and Control Board ID number of the machine.
1. Turn on the machine, enter the Service Mode.
2. Enter the “Function Upgrade” to record the Current Option Key (Key Code) and Control Board ID (Fig 1, Fig 2).
Note: The original Control Board ID and Key Code is a mandatory requirement in order to apply for the new
Key Code in the next process.

Fig 1 Fig 2 Fig 3

Part 2 Install the “OS” Update Application to the laptop

1. Insert the USB disk to the laptop (Fig 3).
2. Double click the “9100c_OS_Update_setup.exe” inside the USB disk (Fig 4).
3. Click “Next” button when it appears (Fig 5).
4. Click “Next” button when it appears (Fig 6), wait for about 5 minutes until the windows change to the next
step.
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FMI FIELD MODIFICATION INSTRUCTION FMI

of this driver software”, click “Install this driver software anyway” to continue the installation (Fig 7).

Fig 4 Fig 5 Fig 6

Fig 7 Fig 8 Fig 9

5. Click the “Finish” button when it appears, and you will find the shortcut icon in the desktop of your laptop
after the software installed successfully (Fig 8 and Fig 9).

Part 3 Disassemble the Display Module (Refer to 9100c TRM 9.15)

1. Turn off the system and unplug the main power cord.
2. Loosen the thumbscrew that secures the display mounting bracket to the manifold.
3. Move the Display Module slightly right to disengage the mounting pins.
4. Lower the Display Module face down on a supporting pad, disconnect the cable (Fig 10).
Note: Put the Display Module on a proper supporting pad, at least 20cm high, to allow for the cable to
connect with the Display Module.

5. Remove the back cover of the Display Module. Record the DMB serial number in the FMI34089 Field Action
Checklist (Fig 11).

Fig 10 Fig 11

Part 4 Upgrade the “OS” for the Display Monitor Board (DMB)
1. Reconnect the cable of the Display Module.
2. Install the Jumper cap and connect the USB cable to the Mini-USB connector in the DMB (Fig 12).
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the speaker to make room for the USB cable to connect with the Mini-USB connector (Fig 13).

Fig 12 Fig 13

3. Reconnect the Main power cord, and then turn on the system.
Note: The display screen will be white after you turn on the system, if it is not white, please verify the Jumper
cap is installed correctly.

4. Connect the other side of the USB cable to your laptop USB port.
Note: It will take about 1 minutes to install the USB port driver. If your laptop can not recognize the board,
please unplug USB cable and re-insert for several times and you can also change another USB port for test.

5. Double click the “9100C OS Update Kit” shortcut icon in your laptop desktop to open the “OS” upgrade
Application.
Note：If the window shows “Serial port can not be found” (Fig 14), refer to step 4 for test.

Fig 14 Fig 15
6. Click “Start” to start the upgrading process (Fig 15).
Note: Do not remove the main power unless the upgrading is completed. If any error happened during the
upgrading, recycle the power and reselect the “Start”.

7. Click “Close” after the system is 100% installed (Fig 16).

Fig 16
8. Turn off the system and disconnect the main power cord.
9. Disconnect the USB cable.
10. Remove the Jumper cap.

Part 5 Install the System Software

1. Reconnect the main power cord, and then turn on the system.
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2. Wait for several minutes (less than 15 minutes) when display shows “Wait 3 Mins for Flash Scan” (Fig 17).
3. Insert the USB disk when the display shows “Please Insert APP Udisk” (Fig 18). After the USB disk is plugged,
the software will be installed automatically.
4. Wait for about 3minutes, the display will show “Normal View” after the software installed successfully. (Fig
19).
5. Turn off the machine and remove the USB disk.

Fig 17 Fig 18 Fig 19

Part 6 Re-config the Machine System

1. Turn on the machine. Enter the “Service Mode” and select the option of “Software Upgrade”.
2. Insert USB disk
3. Select the “Start Upgrade” (Fig 20).
4. Turn off the machine and remove the USB disk after the window shows “Upgrade Successful. Please Restart
the Machine” (Fig 21).
5. Turn on the machine. Enter the Service Mode, verify the software version is the same per the FMI Kit number.

Fig 20 Fig 21 Fig 22

6. Rotate the knob to select option of “Function Upgrade” to input the new optional features Key Code, then
click “Save New Key” button, (Fig 22).
Note: Log in the website of http://www.docodes.com to apply for the new optional features Key Code (refer
to TRM 8.1.1). The old Key Code and Board ID are needed to apply for the new Key Code (Part 1 step 2). If you
have difficulty to get the access of the website, please connect the region GE FE technical supporter for help.

7. Turn off the system and disconnect the main power cord.
8. Reassemble the speaker if you have disconnected in the previous step.
9. Reassemble the back cover of the Display Module.
10. Re-install the Display Module to the machine.

Part 7 Checkout Procedure

Please do the Alarm test per 9100c TRM section 3.10. No need to do the other Checkout Procedures listed in
9100c TRM section 3.
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FMI FIELD MODIFICATION INSTRUCTION FMI

Section 10: DISPOSITION OF MATERIALS

 Dispose of contaminated gloves after use in accordance with applicable laws and good laboratory
practices. Wash and dry hands.

Section 11: SERVICE RECORD COMPLETION & DOCUMENTATION REQUIREMENT(S):

FMI 34089 Field Action Checklist

Customer Name:
System ID / Serial
Number:
DMB M1187892 9100c DMB_ _ _ _ _
Serial Number:
Service Record #:
Date:

Install Field Action Kit

Field Action Kit – Installation FMI Kit 2107811-120 (For China and Korea only)
Procedure Expected Results Actual Result (Pass/Fail) Comments
Install FMI kit 2107811-120 according to the FMI kit 2107811- ☐ FMI Kit 2107811-120 is
FMI 34089 instruction DOC2079929 Rev.1 120 can be installed successfully.
section 9 part 1 to part 6 with reference to successfully
9100c TRM M1207026. installed. ☐ FMI Kit 2107811-120 is
NOT installed successfully.

Field Action Kit – Installation FMI Kit 2107811-130 (For other affected countries other than China
and Korea.)
Procedure Expected Results Actual Result (Pass/Fail) Comments
Install FMI kit 2107811-130 according to the FMI kit 2107811- ☐ FMI Kit 2107811-130 is
FMI 34089 instruction DOC2079929 Rev.1 130 can be installed successfully.
section 9 part 1 to part 6 with reference to successfully
9100c TRM M1207026. installed. ☐ FMI Kit 2107811-130 is
NOT installed successfully.

Final Tests / System Checkout

Procedure Expected Results Outcome / Pass-Fail Comments
Perform Checkout Procedure Checkout pass ☐ Checkout Pass.
according to FMI34089 following with the ☐ Checkout Fail.
instruction DOC2079929 TRM guidance. ☐ NA
Rev.1 section 9 part 7 with
reference to 9100c Series
TRM M1207026.
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FMI FIELD MODIFICATION INSTRUCTION
FMI COMPLETION GUIDE:
Use this table to determine completion status and if additional objective evidence is required.
FMI Completion Definition
Code Status
Open Initial Code - Work has not yet been
0 performed.
N/A
The Field Action has been
completed on given serial number
1 Completed
per instructions.
The Field Action is not required
because:
a) Consignee List was Incorrect
b) Later Version SW
c) FMI previously installed
d) Other Hardware changes
2 Not Required
invalidating FMI
e) Customer altered equipment
f) Equipment was scrapped
destroyed (Do NOT use the term
retired for scrapped/destroyed
equipment)
The Field Action is not executed
because:
a) System is in a storage location
and field action kit has been placed
with device
b) For consignees (distributors),
confirmed receipt of kit by
3 Not Executed consignee
c) The device is not reachable due to
War, Natural Disasters, Embargo,
Quarantine, political unrest, and a
field action kit has been reserved
d) Customer postponement with no
date when field action can be
executed.
Consignee/Customer refuses
delivery or installation of field action
kit and one of the following criteria
applies:
a) Consignee refuses delivery of the
field action kit.
4 Refused b) Customer refuses to have field
action kit installed.
c) Consignee/Customer has not
responded after 3 attempts
(separate days) to contact.
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Doc# DOC2079929 Rev. 1
Debrief (PAT) Best Practice
Implemented fix/modifications per FMI
instructions; include testing performed (if
required per the FMI Instructions) Attach
and/or provide test & inspection
document objective evidence as required
to your Service Record *or submit to
Service Admin /OP’s team.
Document details of why field action is
not required in the Service Record or
submit objective evidence to Service
Admin/ OP’s team.
a) Consignee List was Incorrect
b) Later Version SW
c) FMI previously installed
d) Other Hardware changes
invalidating FMI
e) Customer altered equipment
f) Equipment was scrapped destroyed
(Do NOT use the term retired for
scrapped/destroyed equipment)
a, b, c; Document details of why field
action was not executed and what was
done with the kit (left with system or
returned to warehouse); in the Service
Record or FMI Completion Certificate
Report (Distributor) and submit objective
evidence to Service Admin/ OP’s team.
d; attach postponement letter to Service
Record or submit to Service admin. or
Service Manager/OP’s team. If customer
refuses to sign postponement letter: note
that on the letter, sign, date and include
your SSO.
Document details of why field action was
not executed; attach customer signed
refusal letter to Service Record or send
document to your Service admin/OP’s
team before closure.
If customer refuses to sign, document that
attempt in detail on the Refusal and/or
Location Unknown Form or in the Service
Record. Escalate to Director of Service
(DOS) or Service Manager. They will
complete second attempt by contacting
higher authority at site.
The second attempt should be
documented by the DOS or Service
Manager in the Service Record, e-mail or
Page 8 of 15
DOC2079929, Rev:1
FMI
When / When Not to Use this
Code
N/A
This code should ONLY be used when
the service work is completed per the
FMI instructions.
This code should NOT be used to
describe that the initial
contact/inspection is complete when
the FMI was not executed.
This code should ONLY be used when
criteria a-f applies
This code should NOT be used when the
field action cannot be executed due to:
• Being unable to schedule the
unit (storage, war,
postponement) – See Code 3
• Customer refuses the Recall –
See Code 4
• Cannot Locate the unit -See
Code 5
This code should ONLY be used when
criteria a-d applies
This code should NOT be used when:
• The customer has provided a
specific future date to execute
on the field action – this is not a
Postponement
• Customer refuses the Field
Action – See Code 4
• Cannot Locate the unit - See
Code 5
This code should ONLY be used when
criteria a-c applies
This code should NOT be used when:
• Field action was not required –
See Code 2
• Field action was not executed -
See Code 3
• Cannot Locate the unit - See
Code 5
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FMI FIELD MODIFICATION INSTRUCTION FMI

on the Refusal Form and attach to the
Service Record or send to your Service
admin/ OP’s team before closure.

Document attempts using the 3 Attempts This code should ONLY be used when
in the “Refusal and/or Location Unknown the device cannot be located.
Form or record the required attempt This code should NOT be used when:
documentation in the Service Record. • The Field Action is not required
Documentation” included in the FMI – See Code 2
instructions. • The Field Action could not be
• First attempt must always be a executed due to getting access
two-way interaction between GE to the system – See Code 3
and the consignee (Distributor or • Customer refusal – See Code 4
End user).
• The person contacted by GE must
be a credible individual with
accurate knowledge of medical
device locations.
• This may also include physical
searches on site. Note: The
responsibility to track device
locations does ultimately belong
to the consignee.
• If the unit is not found at this site
but customer states that it has
moved to another site, document
where it has moved to, close as a
code 5 and the FMI Admin will
alert the appropriate FE.
MOST COMMON CODE 5 SCENARIOS
Consignee/Customer or Field
Location SCENARIOS: it is not possible cover all
5 Unknown
Engineer cannot find the device.
scenarios but below are a few examples:
Consignee has donated the device to
business “X”. OR
Consignee has sold the device to “X” OR
Customer says, “I don’t know where it is”
OR “I never had it” OR “It isn’t in my
inventory”
FE closes dispatch as “Location Unknown”
or “Equipment cannot be Located”, with
the first attempt completed either in the
“Service Record with all required
information or the “Three Attempts Form”
and either attach to the Service Record or
send to your Service Admin/OP’s team
before closure.
Customer says, “I don’t know where it is,
but I had it” OR “it is in my inventory but
we don’t know where it is”.
• FE should ask customer to
continue looking for it, Service
Manager/DOS/FE will then call
customer back in 1-2 weeks.
Customer may call FE sooner if
they get any new information.
• If customer still cannot find the
device, FE closes dispatch as
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“Equipment cannot be Located”,
with the first and second attempt
completed on “Three Attempts
Form” and either attach to the
Service Record or send to your
Service Admin/OP’s team before
closure.
**Remaining attempt(s) will be completed
by Service Admin or Program Manager
1. 2nd FE should refer to the primary
A Service Record has been closed out on a
FE Service Record for FMI
Customer given serial number by any of the
completion information.
Field Modification Service Record following:
Installed 2. State reasoning for closing as
6 has been closed according to
Administrative choices in code scenario column.
1. 2nd FE
administrative or other.
2. Administrative/Other
/Other 3. In detail, state FMI was installed in
3. Customer Installed
accordance with FMI Instructions.
(LCS business ONLY)
NOTE: Reference the Field Actions Recall Development Site: http://supportcentral.ge.com/@Recall
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GE Healthcare
Enter required data (For each attempt) into Service System and/or attach documentation into Service System, if feasible or send to local FMI Administrator

FMI Completion Certification Report

NOTE: Distributors, Dealers or Third-Party Service Providers ONLY. FMI #: _34089_______
Consignee/Customer Name:
__________________________________________________________
Street Address:
_____________________________________________________________________
City/State/Country:
__________________________________________________________________
Country Code: _____________ Phone Number: __________________________________________

Completion Date
System ID Model Number Serial Number Completion Status*
(dd-mmm-yyyy)
☐1-Completed
☐2-Not Required
☐3-Not Executed
☐4 – Refused
☐5 – Location Unknown
☐1-Completed
☐2-Not Required
☐3-Not Executed
☐4 – Refused
☐5 – Location Unknown
☐1-Completed
☐2-Not Required
☐3-Not Executed
☐4 – Refused
☐5 – Location Unknown
☐1-Completed
☐2-Not Required
☐3-Not Executed
☐4 – Refused
☐5 – Location Unknown
*Refer to FMI Completion Guide
______________________________________________
Comments:
_____________________________________________________
_____________________________________________________
Please provide the signature of the individual submitting this report with responsibility.

Signature: _____________________________________________

Printed Name: __________________________________________

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FMI FIELD MODIFICATION INSTRUCTION FMI

GE Healthcare
Enter required data (For each attempt) into Service System and/or attach documentation into Service System, if feasible or send to local FMI Administrator

Dated and signed this _________day of __________, <YY>

Postponement of Medical Device Correction

FMI# _______34089_________

System ID or Device Serial Number and description of Medical Device(s) transferred or sold to
Consignee/Customer:

We, <Consignee/Customer Name>, have elected to postpone the updates required by the Medical Device
Correction referenced above because one of the following conditions exist (Check that which applies).

Device has been un-installed and a return to service date is unknown at this time
Device cannot be taken out of service at this time, future availability is not known
Device has been damaged or modified, such that the updates cannot be made. The schedule for
repairs to the device is not known.
Device believed to be in Consignee/Customer inventory, but cannot be located at this time

OTHER: _________________________________________________________________

______________________________________________________________________and the schedule for

repairs to the device or for device availability is not known at this time.

Disposition of associated Medical Device Correction Kit. (Check that which applies).

Kit(s) have been left with the Consignee/Customer

Kit(s) have been left with Device
Kit(s) material will be made available by GEHC at the time of device update

We, < Consignee/Customer Name >, understand the purpose of the correction and associated risk, and will
notify GEHC when the device has been located and is available for updates, or when the updates have been
completed.

Dated and signed this _________day of __________, <YY>

Please provide the signature of an individual with responsibility for risk and compliance.

Signature: _____________________________________________
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GE Healthcare
Enter required data (For each attempt) into Service System and/or attach documentation into Service System, if feasible or send to local FMI Administrator

Printed Name: __________________________________________

Title: __________________________________________________
NOTE: Translated versions available at http://supportcentral.ge.com/products/sup_products.asp?prod_id=144130
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GE Healthcare
Enter required data (For each attempt) into Service System and/or attach documentation into Service System, if feasible or send to local FMI Administrator

Rejection of Medical Device Correction

FMI# ______34089_______________
System ID or Device Serial Number and description of Medical Device(s) transferred or sold to
Consignee/Customer:

We, <Consignee/Customer Name>, have elected not to accept the updates required by the
Medical Device Correction referenced above.

Dated and signed this _________day of __________, <YY>

Please provide the signature of an individual with responsibility for risk and compliance.

Signature: ________________________________________________________________
Printed Name: _____________________________________________________________
Title: _____________________________________________________________________
Facility Name (i.e. Clinic or Site Name): ________________________________________
Address: __________________________________________________________________
City/State/Country: ________________________________________________________

NOTE: Translated versions available at http://supportcentral.ge.com/products/sup_products.asp?prod_id=144130

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FMI FIELD MODIFICATION INSTRUCTION FMI

GE Healthcare
Enter required data (For each attempt) into Service System and/or attach documentation into Service System, if feasible or send to local FMI Administrator

Refusal and/or Location Unknown Documentation

Check One:
Refusal Location Unknown
Attempt 1
Device Name and Serial/ID Number: ______________________________________________________________
Name of the person making the contact (SSO# if applicable): _________________________________________
Date of the Contact (dd/mmm/yyyy): ______________________________________________________________
Contact’s Name: ________________________________________________________________________________
Contact’s Title/Position: __________________________________________________________________________
Contact's Facility Name: _________________________________________________________________________
Response: _______________________ ______________________________________________________________
Contact Method (i.e.; email address, phone) ________________________________________________________

***NOTE: 2nd and 3rd attempts may be more appropriately made by the FMI program team. ***

Attempt 2
Device Name and Serial/ID Number: ______________________________________________________________
Name of the person making the contact (SSO# if applicable): _________________________________________
Date of the Contact (dd/mmm/yyyy): ______________________________________________________________
Contact’s Name: ________________________________________________________________________________
Contact’s Title/Position: __________________________________________________________________________
Contact's Facility Name: _________________________________________________________________________
Response: _______________________ ______________________________________________________________
Contact Method (i.e.; email address, phone) ________________________________________________________

Attempt 3
Device Name and Serial/ID Number: ______________________________________________________________
Name of the person making the contact (SSO# if applicable): _________________________________________
Date of the Contact (dd/mmm/yyyy): ______________________________________________________________
Contact’s Name: ________________________________________________________________________________
Contact’s Title/Position: __________________________________________________________________________
Contact's Facility Name: _________________________________________________________________________
Response: _______________________ ______________________________________________________________
Contact Method (i.e.; email address, phone): ________________________________________________________

CONTACT" may include

o The appropriate imaging department, biomedical engineer, and/or asset manager at the last "ship to" address.
o A person with knowledge of medical device locations at the last "billing address.”
o The local Field engineer or Manager that covers "ship to" address or "billing address" area. GEHC employee name if owned by GEHC.
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