Achilles EXP: Service Manual

AchillesTM EXPII
Service Manual
0197
Part Number: LU44543 Rev 17
READ THIS FIRST
Using This Manual

The Achilles EXPII device must not be repaired by anyone who has not received manufacturer’s service
training. The contents of this manual and the Achilles EXPII Operator’s Manual can be used as a
reference to the service training and in repair of the Achilles EXPII device.
• Read the Achilles EXPII Operator’s Manual to familiarize yourself with the use and operation
of the Achilles EXPII device. The service manual is to be used in conjunction with the Achilles
EXPII Operator’s Manual.
• Read the Safety and Overview Chapters to familiarize yourself with the scanner as a whole
and with the general function of the circuit boards.
• The subsequent chapters and appendices contain common procedures and troubleshooting
information and can be read as needed but are good sources of information.
• When a problem arises, the Troubleshooting should be referenced.
• This manual commonly references other sections and pages of this manual and the Achilles
EXPII Operator’s Manual as needed.
• Contact Lunar Customer Support for the latest product information.
GE Healthcare Lunar makes no warranty of any kind with regard to this material and shall not be held
liable for errors contained herein or for incidental or consequential damages in connection with the
furnishings or use of this manual.
Read through this manual thoroughly before attempting to service any components. Unauthorized
service may void system warranties or service contracts. Consult the GE Healthcare Lunar Customer
Support Department prior to attempting any servicing.
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. “
General Product Information

The Achilles EXPII ultrasonometer is designed to measure ultrasound transmissions through the os
calcis of individuals when medically indicated by their physicians. The Achilles EXPII Operator’s Manual
provides instructions for operating and maintaining the Achilles EXPII ultrasonometer.
AchillesTM is a trademark of GE.
Copyright© 2010 General Electric Company. All rights reserved.
Information Requested by GE Healthcare Lunar

When requesting assistance from GE Healthcare Lunar, please provide the following information:
• System ID
• System Serial Number,
• Component Serial Number (Pump, SBC)
2
• Institution, Doctor, or Owner Name
• Location
• Complete list of symptoms and procedures conducted to diagnose the problem
• Descriptions and Part Numbers of parts needed for service
• QA History (last 4 QA reports, hopefully including the last passing QA in addition to any
failing QA reports)
• Other Error or System Messages
For problems with specific patient scans, it is recommended that you print the scan and email it, with
a description of the problem, to GE Healthcare Lunar Customer Support Department.
This document contains confidential or proprietary information of GE Healthcare Lunar. Neither the
document nor associated information is to be reproduced, distributed, used or disclosed, either in
whole or in part, except as specifically authorized by GE Healthcare Lunar.
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 пациентa в резултат на токов удар, механична или друга опасност.
警告本维修手册仅提供英文版本。
(ZH-CN) ▪ 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。
(ZH-HK) ▪ 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。
(ZH-TW) ▪ 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。
UPOZORENJE Ovaj servisni priručnik dostupan je na engleskom jeziku.
(HR) ▪ Ako davatelj usluge klijenta treba neki drugi jezik, klijent je 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.
VÝ STRAHA 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 výstrahy může dojít k poranění pracovníka prodejního servisu,
obslužného personálu nebo pacientů vlivem elektrického proudu, respektive vlivem mechanických či
jiných rizik.
Achilles EXPII Service Manual ii

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 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.
WAARSCHUWING Deze onderhoudshandleiding is enkel in het Engels verkrijgbaar.
(NL) • Als het onderhoudspersoneel een andere taal vereist, dan is 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.
HOIATUS See 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 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.
WARNUNG Diese Serviceanleitung existiert nur in englischer Sprache.
(DE) • Falls ein fremder Kundendienst eine andere Sprache benötigt, 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.
ΠΡΟΕΙΔΟΠΟΙΗΣΗ Το παρόν εγχειρίδιο σέρβις διατίθεται μόνο στα αγγλικά.
(EL) • Εάν ο τεχνικός σέρβις ενός πελάτη απαιτεί το παρόν εγχειρίδιο 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.
FIGYELMEZTETÉ S
Ezen karbantartási kézikönyv kizárólag angol nyelven érhető el.
(HU)
• Ha a vevő szolgáltatója angoltól eltérő nyelvre tart igényt, 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.
AÐ VÖ RUN Þessi þjónustuhandbók er aðeins fáanleg á ensku.
(IS) • Ef að þjónustuveitandi viðskiptamanns þarfnast annas 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.
Achilles EXPII Service Manual 3

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.
このサービスマニュアルに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。
경고 본 서비스 매뉴얼은 영어로만 이용하실 수 있습니다.
(KO)
▪ 고객의 서비스 제공자가 영어 이외의 언어를 요구할 경우, 번역 서비스를 제공하는 것은
고객의 책임입니다.
▪ 본 서비스 매뉴얼을 참조하여 숙지하지 않은 이상 해당 장비를 수리하려고 시도하지 마십시오.
▪ 본 경고 사항에 유의하지 않으면 전기 쇼크, 기계적 위험, 또는 기타 위험으로 인해 서비스
제공자, 사용자 또는 환자에게 부상을 입힐 수 있습니다.
RĪDINĀJUMS Šī apkopes rokasgrāmata ir pieejama tikai angļu valodā.
(LV) • Ja klienta apkopes sniedzējam nepieciešama informācija citā 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.
ĮSPĖJIMAS Šis eksploatavimo vadovas yra tik anglų kalba.
(LT) • Jei kliento paslaugų tiekėjas reikalauja vadovo kita kalba – ne 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.
ADVARSEL Denne servicehåndboken finnes bare på engelsk.
(NO) • Hvis kundens serviceleverandør har bruk for 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 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.
AVISO 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.
ATENÇ Ã O 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.
(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.
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.
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.
UPOZORNENIE 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, 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.
ATENCION 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.
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.
DİKKAT Bu servis kılavuzunun sadece ingilizcesi mevcuttur.
(TR) • Eğer müşteri teknisyeni bu kılavuzu ingilizce 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.

AchillesTM EXPII
Service Manual
Revision History
Rev. Date Comment Editor
1 2010/09 Initial Release Xu Gangming
2 2010/11 - update specifications Xu Gangming
- update illustrations of UI and system label
- update QA criteria and failure code
3 2010/11 - add EU Representative Xu Gangming
- refine the multi-language warning
4 2011/2 - update for CE mark Xu Gangming
5 2012/6 - Update EU rep Xu gangming
- Update contact information of GE France
- Add section 4.4 Revise Serial number
6 2013/08 - update section A.4 Firmware Revision History Xu Gangming
- update section A.5 Hardware Revision History
- add IPX description
- update parameter for dimension, weight, etc.
7 2015/06 - update section A.4 Firmware Revision History Rakesh Ravindra
with Firmware 2.10
- update section A.5 Hardware Revision History
with LU43933 REV8 - SBC

with Firmware 2.20
with Firmware 2.30
10 2016/05 - Update section 1.2 with UDI description Akhil Sreedharan
- Update Headquarters and Manufacturer
addresses.
- Replace ‘GE Medical systems Lunar’ and ‘GE
Lunar’ with ‘GE Healthcare Lunar’ in the entire
document.
11 2016/09 - Update section A.4 Firmware Revision History Rakesh Ravindra
with Firmware 2.40
- Update section 4.3.1 and 4.3.2 with a note to set
date and time after for software
upgrade/download to 2.40.
12 2016/10 - Updated section5.4 Tube Replacement with Sridhar Kumar
LU45532 for water leakage issues
- Updated section 5.6 Replace SBC with New SBC
board procedure.
- Updated Section 4.4 Revise Serial Number step 2
- Updated section 5.14 Replace Base Assembly with
a note and section Affix system label procedure.
- Updated section A.2 Spare part List with new FRU
LU45532

13 2017/09 - Updated CE Mark in the section 1.2.1 – Symbols Brijesh Soni
and Labels and
- Updated CE Mark in the cover page
14 2018/03 - Updated Table of Contents Rakesh Ravindra
- Updated section A.4: Firmware Revision History
with Release 2.50 and
- Updated section A.5: Hardware Revision History
with SBC Revisions.
15 2018/07 - Updated Table of Contents Rakesh Ravindra
- Updated section A.4: Firmware Revision History
with Release 2.60 and
- Added section 3.3.9: Export To CSV Feature
- Updated section A.2: Spare Parts list to include
Resource CD part number LU44021
16 2018/12 - Added section 4.5 for ID9001/ 9002/ChangEUI.exe Akhil Sreedharan

error fix & referred this section in Appendix A.1
Error List
- - Added Appendix D to add SBC battery
replacement procedure service note
(HCSDM00533244)

17 2020/03 ECR2278055: Rakesh Ravindra
- At "Using this Manual", Removed Lunar
distributor weblink- link not accessible, updated
to contact lunar customer support for
information.
- At contact information, Removed Lunar
distributor weblink- link not accessible
- At section 1.4.1, updated warning and added
appendix F for power cord selection guidelines
(PR# 17090490)
- At section 1.4.3 updated sub section ‘Immunity’ as
per IEC 60601-1-2 Ed 4 test report DOC1860975.
- At Section 3.3, added note about service
password requirement while accessing service
screen (hidden panel)
- At Section 3.3.1, updated path to access version
info and calibration info
- At Section 3.3.5, added export log button click
instruction.
- Updated Section 3.3.9 to PIN/CSV settings
- Added section 3.3.10 Security Features
- At section 3.4.2 included SI unit (m/s) for SOS
values
- Added section 3.4.3 and Appendix E for the
instructions to resolve QA failures with f+ error
code (HCSDM00567591): included note of system
temperature control during water calibration with
software version 2.70.
- Updated OM section number for file management
at section 4.1 and section 4.2 factory reset
- Updated GE box download link: at section 4.4 to
download Unit SN revise tool, at section 4.3 to
download USB driver software and latest EXPII
software release under note. Removed Lunar
distributor weblink- link not accessible.
- At Section 5.5, removed instruction to adjust
brightness as it is available for LCD assembly.
- At Appendix A.1, updated Table A-1 Error list for
export to csv and secure login feature
- At Appendix A-2, added water phantom in spare
part list (HCSDM00567591)
- At A-4 Updated Firmware Revision history for SW
v2.70
- Updated figures 3-1,3-2,3-16,3-17,3-18,3-21,4-1
relevant now.

Headquarters: USA GE Healthcare
GE Medical Systems Ultrasound & Primary Care Application Hotlines
Diagnostics, LLC.
Street address: Clinical & Software Support
3030 Ohmeda Dr. Tel: 1-800-437-1171
Madison, WI 53718 USA Fax: 1-608-826-7107
Mailing address:
P.O. Box 7550 Service Support & Repair
Madison, WI 53707-7550 USA Tel: 1-800-437-1171
Toll-free: +1-800-437-1171
Tel: +1-608-221-1551 Accessories & Parts
Fax: +1-608-826-7102 Tel: 1-800-558-2040
1-800-558-5102
Manufacturer:
GE MEDICAL SYSTEMS (CHINA) CO. LTD.
No 19, Changjiang Road,
Wuxi National Hi-Tech, Dev. Zone
214028 Jiangsu, China
Tel: +86–510–85225888
Fax: +86–510–85226688
GE Healthcare Europe GE Healthcare Ultrasound

Kouterveldstraat 20 Beethovenstrasse 239
1831 Diegem D-42655 Solingen
Belgium Germany
Tel: +32-2-719-7311 Tel: +49-212-2802-0
Fax: +32-2-719-7223 Fax: +49-212-2802-390
:
GE Medical Systems SCS
283 rue de la Minière
78530 BUC, France
GE Healthcare France GE ヘルスケア・ジャパン株式会社
Lunar-3ème étage 191-8503
24 Avenue de l’Europe 東京都日野市旭が丘 4-7-127
CS 20 529 Tel: 0120-202-021
78 457 VELIZY Fax: 042-585-9371
France
Tel: +33-1.34.49.53.65
Fax: +33-1.34.49.54.06
http://www.gehealthcare.com/
http://supportcentral.ge.com/ProcessMaps/form_new_request.asp?prod_id=28049&form_id=238116&
node_id=413422&map_id=&reference_id=&reference_type=
http://supportcentral.ge.com/products/sup_products.asp?prod_id=28049
http://supportcentral.ge.com/dataforms/sup_dataform_display_beta.asp?dataform_id=134513
http://supportcentral.ge.com/products/sup_products.asp?prod_id=48030
Table of Contents
Chapter 1. Safety and Specification ...................................................................... 1
1.1. General Safety .................................................................................................................. 1
1.1.1. Biological .................................................................................................................. 1
1.1.2. Contraindications ..................................................................................................... 1
1.1.3. Electrical................................................................................................................... 1
1.1.4. Thermal .................................................................................................................... 1
1.1.5. Patient Information Privacy and Security (HIPAA) ................................................ 1
1.1.6. Environmental .......................................................................................................... 2
1.1.7. Warnings .................................................................................................................. 2
1.2. Symbols and Labels .......................................................................................................... 3
1.2.1. Symbols and Labels .................................................................................................. 3
1.2.2. Internal Symbols....................................................................................................... 6
1.2.3. Unique Device Identification ................................................................................... 6
1.3. Specification ..................................................................................................................... 7
1.4. Requirements .................................................................................................................... 8
1.4.1. Electrical Requirements ........................................................................................... 8
1.4.2. Peripheral Requirements .......................................................................................... 8
1.4.3. Environmental Requirements................................................................................. 10
Chapter 2. System Overview .............................................................................. 13
2.1. Instructions ..................................................................................................................... 13
2.1.1. How the device works ............................................................................................. 13
2.1.2. Indications for Use ................................................................................................. 13
2.1.3. Comparison of Techniques (QUS vs. DXA) ........................................................... 14
2.1.4. Comparison of Sites (Heel vs. Hip or Spine) ......................................................... 14
2.1.5. DEXA Referral criteria........................................................................................... 14
2.1.6. Fracture Risk .......................................................................................................... 15
2.2. Achilles EXPII Features ................................................................................................ 16
2.2.1. Outlook Features .................................................................................................... 16
2.2.2. Inside Features ....................................................................................................... 17
2.3. Control Block ................................................................................................................. 18
2.3.1. Power ...................................................................................................................... 19
2.3.2. SBC ......................................................................................................................... 21
2.3.3. Pump Assembly....................................................................................................... 21
2.3.4. LCD Assembly ........................................................................................................ 22
2.3.5. Printing ................................................................................................................... 22
2.3.6. Heater Control Board ............................................................................................. 22
2.3.7. USB Interface Board .............................................................................................. 22
Chapter 3. Diagnostics and Troubleshooting ....................................................... 23
3.1. Troubleshooting Guideline ............................................................................................ 23
3.1.1. Remote Troubleshooting ......................................................................................... 23
3.1.2. On Site/Off Site Troubleshooting ........................................................................... 23
3.2. Customer Diagnostics Function .................................................................................... 24
3.2.1. Find System Information ....................................................................................... 24
3.2.2. Perform QA procedure ........................................................................................... 24
3.2.3. Diagnostics Screen ................................................................................................. 27
3.3. Service Diagnostics Function ........................................................................................ 33
3.3.1. Detailed System Information .................................................................................. 33
3.3.2. QA Ignore ............................................................................................................... 34
3.3.3. Force Result ............................................................................................................ 34
3.3.4. Service Diagnostic .................................................................................................. 34
3.3.5. View Detailed Error Log ........................................................................................ 35
3.3.7. Sensors .................................................................................................................... 36
3.3.8. Rent Mode ............................................................................................................... 37
3.3.9. PIN/CSV Settings .................................................................................................... 37
3.3.10. Security Features ..................................................................................................... 38
3.4. QA Failures .................................................................................................................... 39
3.4.1. Operation Related QA Issues ................................................................................. 39
3.4.2. QA Failure Codes ................................................................................................... 40
3.4.3. Procedure to resolve QA failures with ‘f+’ error code .................................... 41
3.5. Measurement Failures ................................................................................................... 45
3.5.1. Operation Related Measurement Issues ................................................................. 45
3.5.2. Patient Measurement Error Messages ................................................................... 46
Chapter 4. Software Maintenance ...................................................................... 42
4.1. File Management – (Operator manual section 3.2.4) .................................................. 42
4.2. Factory Reset (Operator manual section 4.13) ............................................................. 43
4.3. Download/Upgrade Software ......................................................................................... 44
4.3.1. Download/Upgrade Software through USB cable ................................................. 44
4.3.2. Upgrade Software through USB Memory Stick ..................................................... 53
4.4. Revise Serial number ..................................................................................................... 55
4.5. ID9001/9002/ChangE UI.exe error fix .......................................................................... 57
Chapter 5. FRU Replacement ............................................................................. 59
5.1. Preparation for servicing ............................................................................................... 59
5.2. Replace Top Cover Assembly (LU43959) ...................................................................... 59
5.3. Replace Pump Assembly (LU43851).............................................................................. 61
5.4. Tube Replacement with LU45532 for water leakage issues ......................................... 63
5.5. Replace LCD Assembly (LU43945) ............................................................................... 65
5.6. Replace SBC (LU43933) ................................................................................................ 66
5.7. Replace Heater Control Board (LU43939).................................................................... 68
5.8. Replace Power Board (LU43932) .................................................................................. 70
5.9. Replace Printer Interface Board (LU43909) ................................................................. 71
5.10. Replace USB Interface Board (LU43911) ..................................................................... 72
5.11. Replace Printer Head (LU42996) .................................................................................. 73
5.12. Replace Power Entry (LU43898) ................................................................................... 74
5.13. Replace Power Filter Board (LU44047) ........................................................................ 75
5.14. Replace Base Assembly (LU43919) ............................................................................... 76
5.15. System Functional Test .................................................................................................. 78
5.16. Cleaning.......................................................................................................................... 78
Appendix A. Parts and Tools ........................................................................... 79
A.1. Error List ........................................................................................................................ 79
A.2. Spare Parts List .............................................................................................................. 82
A.3. Service Tools List............................................................................................................ 83
A.4. Firmware Revision History ............................................................................................ 84
A.5. Hardware Revision History ............................................................................................ 88
Appendix B. Circuit Schematics ...................................................................... 90
B.1. LU43933 rev2, SBC ........................................................................................................ 90
B.2. LU43939 rev1, Heater Control Board ........................................................................... 90
B.3. LU43909 rev1, Printer Interface Board ........................................................................ 91
B.4. LU43911 rev1, USB Interface Board ............................................................................. 91
B.5. LU44047 rev1, Power Filter Board ............................................................................... 91
Appendix C. Assembly Drawings .................................................................... 93
C.1. LU43850 rev2, Scanner.................................................................................................. 93
C.2. LU43885 rev2, Base and Main Support Assembly ........................................................ 93
Appendix D: SBC battery replacement procedure .............................................. 94
Appendix E: Service record template for procedure section 3.4.3 ...................... 96
Appendix F: Power Cord Selection Guidelines ................................................... 97
Chapter 1. Safety and Specification
1.1. General Safety
This chapter highlights safety procedures and features that should be carefully read before servicing
the Achilles EXPII Bone Ultrasonometer.
DO NOT attempt to service the Achilles EXPII without first reading this manual.
DO NOT attempt any repairs without prior instructions from authorized GE Healthcare LUNAR personnel.
1.1.1. Biological
The Achilles EXPII are Noncritical Patient Contact Devices.
The unit requires low-level disinfection before being serviced. This can help prevent transmission of
infection between patients and the service personnel.
1.1.2. Contraindications
There are no known contraindications associated with the use of Achilles EXPII and service of Achilles EXPII.
1.1.3. Electrical
The unit is designed to meet or exceed IEC-601 standards.
DO NOT attempts any repairs without using appropriate ESD grounding.
1.1.4. Thermal
Since the Achilles EXPII uses membranes filled with heated water, the design incorporates circuitry to
assure water temperatures do not exceed a maximum of 45°C. This prevents the possibility of injury.
DUAL Thermocouple:
There is thermocouple (two sensors) in the pump water reservoir. One monitor (TC1) the
temperature of the water so that the Single Board Controller (SBC) can regulate the heater to control
the temperature of the water to around 33±0.5°C, disable fill pump when TC1 exceed 35°C.
The other (TC2) monitors the temperature of the water for protection, so that the SBC can shutdown
heater when exceed 45°C, preventing excessively hot water from entering the membranes.
Thermostat:
There is also a thermostat that disables the heater enable relay at 45°C±3°C.
All thermocouple amplifiers are configured such that if either input wire is broken or if the input
connector is plugged in backwards, the corresponding temperature reading indicates a maximum
temperature. This will cause a Heater Error and prevent operation until the fault is corrected.
1.1.5. Patient Information Privacy and Security (HIPAA)

HIPAA (Health Insurance Portability and Accountability Act) is a set of US statutes and regulations
designed to provide standards for the use, disclosure, and transmission of patient data to ensure
Patient Information Privacy and Security.
Use of any patient data that exists on the Achilles EXPII Device to be serviced is strictly limited to the
servicing of the system. Any other use or distribution of this data is prohibited.

1.1.6. Environmental
It is required that the service and any waste generated from the service of all GE Healthcare Lunar
systems comply with all appropriate local environmental regulations as well as with GE policy.
DO NOT DISCARD:
The waste of electrical and electronic equipment must not be disposed of as unsorted
municipal waste and must be collected separately. Please contact an authorized
representative of the manufacturer for information concerning the decommissioning of
your equipment.
1.1.7. Warnings
This manual contains warning and caution statements wherever appropriate for your safety.
The warnings and cautions used throughout the manual are based on the safety standards
established by the International Electrotechnical Commission (IEC). In addition, the manual uses
notes to attract the reader’s attention to important information.
Safety Information:
The operator must obey the information related to this symbol for safe operation of the
Achilles EXPII.
WARNING: A warning statement reflects a potentially hazardous condition that, if not

avoided, could result in serious injury.
CAUTION: A caution statement reflects a condition that, if not avoided, could result in
equipment or property damage.

1.2. Symbols and Labels
1.2.1. Symbols and Labels
The Achilles EXPII labels show safety information. These labels are fixed to the Achilles System
ultrasonometer components. Actual labels on the device may vary.
OR
Figure 1-1 System Label
Figure 1-2 Fill Port Figure 1-3 USB Port

Symbols and Labels Description
Manufacturer:
(1) Indicates the manufacturer and its address
Fuse Rating:
(2) Indicates the device fuse rating and input voltage information.
ETL mark
Shows compliance to UL60601-1 and CAN/CSA C22.2 No.601.
(3)
DO NOT DISCARD:
The waste of electrical and electronic equipment must not be
disposed of as unsorted municipal waste and must be collected
separately. Please contact an authorized representative of the
manufacturer for information concerning the decommissioning of
your equipment.
GEHC is committed to compliance with environmental regulations
in all the markets we serve and have prepared this notice to inform
you of certain aspects of the EU Battery Directive.
The EU Battery Directive 2006/66/EC is intended to establish

improved methods to recycle and disposal of batteries once their
useful life is completed. One goal of the Directive is to educate
end users of batteries about the battery label, which is known as a
separate collection symbol or crossed out wheelie bin . Since
implementation of this directive, you may find batteries or
(4) packaging labeled with the following separate collection symbol:
The separate collection symbol is affixed to a battery, or packaging,

to advise you that the battery must be recycled or disposed of in
accordance with local or country laws. To minimize potential effects
on the environment and human health, it is important that all
marked batteries that you remove from the product are properly
recycled or disposed.
For information on how the battery may be safely removed from

the device, please consult the service manual or equipment
instructions. Information on the potential effects on the
environment and human health of the substances used in batteries
is available at this url: http://www.gehealthcare.com/euen/weee-
recycling/index.html
(5) Prescription Device Label for United States

Indicates requirements of input power
(6)
Safety Information:
(7) The operator must obey the information related to this symbol for safe
operation of the device. Refer to this manual for important safety
information.
Type B Equipment:
Shows the device has Type B protection against electrical shock. Refer to IEC-
(8)
60601-1 for more information about the Type B Equipment rating.
Product Name
Catalogue number
Part Number
(9)
Serial Number
Manufacture Date
Fill Port
(10) Indicates the location where water is added to the device.
USB
(11)
Refer to instruction manual, follow instructions for use.

(12)
CE Mark:
(13) Shows the Achilles EXPII system complies with the European Council
0197 directive (93/42/EEC, Medical Device Directive, Annex II).
(14) IPX7 Protected against the effects of immersion (Transducers)
UDI: Unique Device Identifier - A UDI is a unique numeric or alphanumeric

identification code assigned to medical devices by the manufacturer of the
(15) device. A unique device identification marking is applied to a Product
Model that is designated as a medical device as per USA FDA UDI
regulation.

1.2.2. Internal Symbols
Electrical connections that are grounded to ensure operator and individual
(1) safety.
Location: Beside heater board
Heater
Components that control the function of the system heater.
(2)
Location: On Pump Assembly
1.2.3. Unique Device Identification

Identifier Description
Each Achilles EXP II system has a unique identification marking. The Unique Device
UDI Identification (UDI) marking appears on the product label located above the USB
HOST.
The product contains the following Medical Devices. Product installation, service maintenance, repairs or field
replacement of these Medical Devices should follow the applicable reporting requirements of the regulation.
Component/Description USA FDA Medical Device Classification
Achilles EXPII Class 2

1.3. Specification
Buildup
The device was built up with LCD, Pump, Control Circuit, Footplate, and so on.
Parameter Specification
Dimensions ➢ 275mm x 305mm x 550mm (11” H x 12” W x 22” D)
Weight ➢ 11.5 kg (25.4 lbs.)
Display ➢ 6.5’’ Color LCD VGA (640 x 480) with graphical display
➢ Tilts and inverts for optimal viewing
➢ Brightness ≥ 400cd/m2
Printer ➢ Internal 58mm thermal printer with graphical output
➢ Print report 15 seconds
➢ Specific external printer support for A4 size paper
USB port ➢ USB2.0
➢ USB Host x 2, USB Slave x 1
Battery ➢ CR2032 +3V
➢ Inside device, customer dose not required to replace it
Power Consumption ➢  650VA without peripherals
Transducers ➢ Quarter wave-matched broadband elements
➢ Center frequency = 0.5 MHz
➢ Single element transmission and reception
Output power of ➢ p-< 1 MPa
Ultrasound ➢ Iob< 20 mW/cm2
➢ Ispta< 100 mW/cm2
Coupling System ➢ SmartDry™
➢ Fluid-coupled, through-transmission ultrasound
➢ Fully automated and self-contained
➢ Heated coupling fluid 33° C (92°F)
➢ 70% Isopropyl Alcohol or Ethanol
➢ Replaceable TPE (Thermoplastic elastomer) Membranes
➢ Pressure <3 psi
Analysis ➢ Real-time, point-by-point analog/digital conversion
➢ Smart detection algorithm, Discrete Fourier Transform
➢ Simultaneous Stiffness/SOS/BUA determination
Results ➢ Stiffness Index with WHO classification
➢ T-Score with % Young Adult
➢ Z-Score with % Age-Matched
In Vivo Precision and
Accuracy ➢ < 2.0% CV (ambient temperatures between 15℃ and 33℃)
Scan Throughput ➢ 10 seconds Signal Acquisition
Warm up ➢ 15 minutes from 4℃
Expected Service Life ➢ 6 years

Compliance to Standards
• EN 60601-1 (Class I, Type B, IPX0, (Transducer: IPX7)) Safety requirements for medical electrical
devices
• EN 60601-1-2 Electromagnetic compatibility – Requirements and tests
• EN60601-1-4 Programmable electrical medical devices
• EN60601-2-37 Particular requirements for the safety of ultrasonic medical diagnostic
• EN980 Graphical symbols for use in the labeling of medical devices
• EN1041 Information supplied by the manufacturer with medical devices
• ISO10993 standard Biological evaluation of medical devices Part 1: Evaluation and testing.
• EN60601-1-6 Collateral Standard for Usability Engineering
• UL 60601-1
• CSA C22.2 No. 601.1
• European Council Directive (93/42/EEC, Medical Device Directive, Annex II)
1.4. Requirements
Always comply with the requirements when installing, operating, transporting the device. GE is
responsible for the effects of safety, reliability, and performance only if:
➢ Assembly operations, extensions, readjustments, modifications, or repairs are carried out
by persons authorized by GE.
➢ The electrical installation of the relevant room complies with the requirements of the
appropriate regulations.
➢ The equipment is used in accordance with the instructions for use.
1.4.1. Electrical Requirements

Parameter Requirement
Voltage 100–240V AC @50/60 Hz
Power Capacity ≥ 650VA
THD (Total Harmonic < 5% per IEEE 519-1992 standard for power quality and total
Distortion) harmonic distortion
WARNING: To avoid the risk of electric shock, this equipment must only be connected to a supply main
with protective earth. Ensure the power cord used with the system is having proper protective earth pin
compatible with the hospital power socket. Refer Appendix F for power cord selection guidelines.
1.4.2. Peripheral Requirements

To maintain electrical safety, all computer equipment and accessories connected to the scanner
must meet all requirements for safety. U.S.A. and Canada require UL/CSA and FCC certification.
European countries require CE mark certification. Rest of world countries should follow their local
requirements for computer equipment and accessories certification. Declarations of conformity to
the required standards should meet or exceed the requirements of EN 60950 and CISPR 22, "Safety
of Information Technology Equipment" and EN 55024 "Information Technology Equipment -
Immunity Characteristics".
WARNING: The correct connection of the computer and all peripherals is necessary to maintain
electrical safety. The signal cable of the scanner is intended only for connection to an approved
computer. Call GE Healthcare Lunar Support or your GE Healthcare Lunar distributor before adding
peripherals. Operator shall not touch Person and computer or peripherals simultaneously.

1.4.3. Environmental Requirements
Parameter Requirement
Operating ambient Temperature: 15C ~ 35C,
Humidity: 30 – 90%RH (non-condense)
Storage/Transport ambient Temperature*: -20C ~ 70C, Humidity:
30 – 95%RH (non-condense)
Static Static-free environment
Dust, fumes, and debris Clean, well ventilated environment, free from dust, smoke, and
other airborne contaminants.
External cleaning agents 70% Isopropyl Alcohol or Ethanol
Temperature*: Pump shall be no more than half full of water when the temperature is below 0C
Electromagnetic interference
Although the scanner meets safety standards regarding electromagnetic interference (EN60601- 1-2),
you may still experience a loss of performance under extreme electromagnetic conditions. Maximize
the distance between the scanner and other equipment, and use a dedicated power line, to avoid
interference to and from the scanner.
Emissions
This device is suitable for use in the following environment. The user must assure that it is used
only in the electromagnetic environment as specified.
Emission Type Compliance Electromagnetic Environment
CISPR 11 RF Group 1 This device uses RF energy only for its internal
Emissions Class B function. Therefore, RF emissions are very low and
are not likely to cause any interference in nearby
electronic equipment. It is suitable for use in all
establishments, other than domestic establishments
and those directly connected to the public low-
voltage power supply network that supplies buildings
used for domestic purposes.
Recommended Separation Distance
Recommended Separation Distance between portable and mobile RF communications

equipment and the Achilles EXPII System
The Achilles EXPII is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the Achilles EXPII can help prevent
electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the Achilles EXPII as recommended
below, according to the maximum output power of the communications equipment
Rated maximum Separation distance according to frequency of transmitter in meters
output power of
transmitter W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz

0.01 0.1 0.1 0.2
0.1 0.4 0.4 0.8
1.0 1.2 1.2 2.4
10 3.9 3.9 7.9
100 11.7 11.7 23.3
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.
Immunity
This device is suitable for use in the following environment. The user must assure that the
device is used according to the specified guidance and only in the electromagnetic
environment listed.
Immunity IEC 60601-1-2 EMC Environment and

Compliance Level
Type Test Level Guidance
IEC 61000-4-2 ± 8 kV contact ± 8 kV contact Floors should be wood,
Static discharge concrete, or ceramic
(ESD) ± 2kV, ±4kV, ±8kV, ±15kV ± 2kV, ±4kV, ±8kV, tile. If floors are
air ±15kV air covered with synthetic
material, the relative
IEC 61000-4-4 ± 2 kV ± 2 kV
humidity should be at
Electrical fast 100 kHz repetition 100 kHz repetition least 30%.
transient/ frequency frequency
burst
Mains power quality
IEC 61000-4-5 ± 0,5 kV, ± 1 kV (Line to ± 0,5 kV, ± 1 kV (Line
should be that of a
Surge Line) to Line)
typical commercial
Immunity and/or hospital
± 0,5 kV, ± 1 kV, ± 0,5 kV, ± 1 kV, environment. If the
± 2 kV (Line to Earth) ± 2 kV (Line to Earth) user requires continued
operation during power
IEC 61000-4-11 0% UT for 0.5 cycle; 0% UT for 0.5 cycle;
mains interruptions, it
Voltage dips, Sync Angle (degrees): Sync Angle (degrees): is recommended that
short 0,45,90,135,180,225,270, 0,45,90,135,180,225,2 the device be powered
interruptions 315 70,315 from a UPS or a
and voltage
battery.
variations on
0% UT for 1 cycle; 0% UT for 1 cycle;
mains supply
NOTE: UT is the a.c.
70% UT for 25 cycles; 70% UT for 25 cycles; mains voltage prior to
application of the test
0% UT (interruption) for 0% UT (interruption) level.
250 cycles; for 250 cycles; Power frequency

IEC 61000-4-8 magnetic fields should
Power be at levels
frequency 30 A/m 30 A/m characteristic of a
(50/60 Hz) typical location in a
magnetic field typical commercial
and/or hospital
IEC 61000-4-6 3 VRMS 150 kHz – 80 MHz 3 VRMS environment.
Conducted RF
6 VRMS in ISM and
Separation distance to
amateur radio bands 6 VRMS radio communication
between 150 kHz and 80
equipment must be
MHz
maintained according
to the method below.
80% AM at 1kHz Interference may occur
IEC 61000-4-3 10 V/m 80 MHz – 2.7 GHz 10 V/m 80 MHz – 2.7 in the vicinity of
Radiated RF GHz equipment marked
with the symbol:
80% AM at 1kHz
NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects, and people.

Chapter 2. System Overview
2.1. Instructions
2.1.1. How the device works
The Achilles EXPII is bone ultrasonometer that use high frequency sound waves (ultrasound) to
evaluate bone status in the heel, the os calcis (see Figure 2-1). Achilles EXPII measurements are
performed with the person seated, with one foot placed on the Footplate. The heel is
surrounded by warm water encapsulated between inflated membranes. Water is the optimum
medium for the transmission of ultrasound. A transducer on one side of the heel converts an
electrical signal into a sound wave, which passes through the water and the person’s heel. A
transducer at a fixed distance on the opposite side of the heel receives the sound wave and
converts it to an electrical signal that is analyzed. The Achilles EXPII measure the speed of sound
(SOS) and the frequency-dependent attenuation of the sound waves (broadband ultrasound
attenuation or BUA), and combines them to form a clinical measure called the Stiffness Index.
Figure 2-1 Ultrasound Transmission
2.1.2. Indications for Use

The Achilles ultrasonometer measures ultrasound variables of the os calcis to provide a clinical
measure called Stiffness Index. The Stiffness Index indicates risk of osteoporotic fracture in
postmenopausal women comparable to bone mineral density (BMD) as measured by X-ray
absorptiometry at the spine or hip.
Stiffness index results expressed as t-scores are used to assist the physicians in the diagnosis
of osteoporosis in the same way as are t-scores or obtained by x-ray absorptiometry. Either the
stiffness index t-score or x-ray absorptiometry t-score can be utilized by a physician, in
conjunction with other clinical risk factors, to provide a comprehensive skeletal assessment.
The stiffness index has a precision error in older women comparable to that of x-ray
absorptiometry, which makes it suitable for monitoring bone changes.

2.1.3. Comparison of Techniques (QUS vs. DXA)
Spine and femur bone density measurements have gained acceptance as the clinical “gold
standard” by which to diagnose osteoporosis, evaluate fracture risk, and monitor skeletal changes.
The most commonly used clinical technique is dual-energy x-ray absorptiometry (DXA), which is
capable of measuring bone density at virtually any skeletal site.
The International Society for Clinical Densitometry (ISCD) has confirmed that peripheral bone
density measurements have value for assessing fracture risk and identifying individuals who
should be considered for a DXA measurement. Of the available techniques quantitative ultrasound
(QUS) is one of the best methods for assessing fracture risk in men and postmenopausal women.
The primary advantage of QUS is the absence of ionizing radiation. The heel is the measurement
site of choice for QUS, as it is easy to access, has very little soft overlying soft tissue, and has
a relatively uniform size and structure. Equally important, the heel is a highly trabecular, weight
bearing site.
Stiffness Index values are influenced primarily by the elastic properties of the os calcis, which in
turn is heavily dependent on the quantity and structure of bone mineral. Stiffness Index is not
the same as mechanical stiffness. Studies show that Stiffness Index correlates with heel BMD
and predicts risk of fracture almost as good as hip BMD. There is also some evidence that it
provides information about fracture risk different from that provided by BMD, as the two values
together have better predictive power than either alone.
Several hypotheses exist about what it is that QUS measures. Most agree that it is more than just
bone density. Generally, it is believed that BUA is related strongly to Bone Mineral Content (BMC)
and weakly to connective tissue and that SOS is related strongly to BMC and weakly to bone
micro architecture. Therefore, the linear combination (Stiffness Index) is a better indicator of bone
structure than either SOS or BUA alone (or DEXA). Both SOS and BUA tend to increase as BMD
increases. BUA and SOS have roughly equal numerical contributions to Stiffness Index over the
range of human values. The initial mean Caucasian female young normal reference was set to be
equal to a Stiffness Index of 100.
Stiffness Index converges more rapidly following the start of measurement than either BUA or SOS
which tend to converge in opposite directions. Stiffness Index, as a combination of BUA and SOS,
balances these differences and measurement time is reduced. Stiffness Index is also more robust
against some factors which can affect ultrasound results, such as variations in temperature. It has
proven itself again by being more resistant to changes in results due to coupling medium than BUA
or SOS.
Achilles EXPII use QUS (quantitative ultrasound) to measure Stiffness Index.
2.1.4. Comparison of Sites (Heel vs. Hip or Spine)

Osteoporosis is a systemic discordant disease i.e. the first indication of the disease can be in any
bone of the body (like vascular disease, you do not know where the first signs will appear), but if
not treated the disease will progress to all sites. Comparison among sites will be different unless
individual is very young (no disease anywhere) or very old (disease everywhere). For the Achilles
QUS Systems we assess the bone quality of the os calcis because it is highly trabecular and a
weight bearing bone with very high metabolic activity/bone turnover, like the hip and spine.
2.1.5. DEXA Referral criteria

An ISCD position statement on use of peripherals recommends using a referring cutpoint with 90%
sensitivity - i.e. when using the Achilles T-score cutpoint to refer women to DXA tables, you will
"catch" 90% of the women with a T-score below -2.5 at the spine or hip. These cutpoints are device-
specific - i.e. the Achilles cutpoint differs from other QUS devices or PIXI cutpoint. Several studies
have examined what this referral cutpoint should be. It becomes a matter of what sensitivity vs.
specificity you want. Typically, the cutpoint for 90% sensitivity is Achilles T-score ~ -1.0.

Another way to look at this: rather than divide the Achilles individuals into two (2) groups (refer to
DXA, do not refer to DXA), the physician could use 3 groups (treat, refer to DXA, do not refer to DXA).
Two (2) studies have looked at this method, wherein those with lowest Achilles T-scores are deemed
to be at very high risk for osteoporosis and are treated (not referred to DXA), those with very high
Achilles T are deemed at very low risk and not referred to DXA, and those in the middle gray area
are referred to DXA.
2.1.6. Fracture Risk

T-scores for Stiffness Index can be used in a manner similar to BMD from X-ray absorptiometry in
assessing a women’s risk of osteoporotic fracture. An expert group of the World Health Organization
has proposed operational levels at which physicians can recognize increased risk in postmenopausal
women. These are based on “T-scores.” A T-score from -1 to -2.5 is considered to reflect
“osteopenia,” while a T-score below -2.5 SD is considered to reflect “osteoporosis.”
There is no clear demarcation for increased risk of fracture at a specific given level of BMD or of
Stiffness Index, but rather there is a continuous gradient of risk (Figure 2-2). Stiffness Index values
should be considered together with other risk factors for women (BMD, low body weight, fracture
history, corticosteroid use, use of long-acting tranquilizers, history of falling). In particular,
individuals with a prior history of osteoporotic fracture should be considered to have double the risk
of future fracture at any density level. The National Osteoporosis Foundation (NOF) has developed
practice guidelines for physicians to help in such evaluation (National Osteoporosis Foundation:
Physician’s Guide to Prevention and Treatment of Osteoporosis. Washington, D.C., National
Osteoporosis Foundation, 2003.). As yet there are no consensus guidelines on how physicians should
combine the results of X-ray absorptiometry from different skeletal sites, or from X-ray
absorptiometry and ultrasonometry, in individual evaluation. The data from clinical studies suggest
that Stiffness Index is somewhat independent of X-ray absorptiometry and provides incremental
information on fracture risk.
High
Risk
M oderate
Risk
Low
Risk
+3 +2 +1 0 -1 -2 -3 -4
T-score
Figure 2-2 Risk Curve

2.2. Achilles EXPII Features
2.2.1. Outlook Features
Figure 2-3 Features of the Achilles EXPII (Part 1)
Figure 2-4 Features of the Achilles EXPII (Part 2)
(1) Calf Support (8) USB-Host (Thumb Drive, External Printer)

(2) Handle (9) USB-Slave (PC Software Option)
(3) (Inflated) Membrane (applied part) (10) Internal Printer Door with Thermal Paper Slot
(4) Membrane Retainer Ring (11) Fuse Box
(5) Footplate (applied part) (12) Power Switch
(6) LCD Display with Touch Panel (13) Power Cable Jack
(7) Stylus, for Touch Panel (14) Water Management Tray

2.2.2. Inside Features
Figure 2-5 Inside Features (part 1)
Figure 2-6 Inside Features (part 2)

2.3. Control Block
This diagram gives an overview of all control blocks.
Figure 2-7 Control Block

2.3.1. Power
Heater board
TPS54310 V3.3 I/O
TPS54310 V1.8 I/O
TPS54310 V1.2 DSP_CORE
TPS54310 V1.2 FPGA_CORE

5V
LP38961 VD/A_3.3
100~242V Power Power 12V
LP38961 VA/D_3.3
50/60Hz Filter Board
-12V
LP38961 V2.5 Ref
LP9076 VD/A_5
LP9076 +5V AMP
TPS54550 V8.3_Internal Printer
LM79L05 -5V AMP
Figure 2-8 power management diagram

Power Entry
AC power enters the unit at the back of the Achilles EXPII System through an AC Entrance module.
This module contains a Power Cord Receptacle, an Off/On Switch, and a Fuse Holder. The fuse is
rated at 5.0 Amps and 250 Volts (F5.0AH 250V). AC is used to power the Heater and the Power Board.
Power Filter Board

The Power Filter Board is used to restrain EMI.
Power Board
The Power Board provides +5 and +/-12 volts to the SBC. +5 Volts DC is used to power the logic
circuitry on the SBC. The +/-12 VDC is used for Transmit/Receive functions, Pump control, Stepper
Motor controls and Heater control.
2.3.2. SBC
The Control Board (SBC) controls all devices in the Achilles EXPII unit. It consists of three basic
sections, OS platform, FPGA and Front End. Those sections and their functions are outlined below.
• OS platform,
DaVinci chip TMS320DM6446, runs the WinCE6.0 and application.
NAND Flash, 2 pieces of 256M bytes NAND Flash are used to storage system OS, firmware, FPGA
configuration data, measurement data and QA data.
EEPROM is to storage DaVinci System configuration parameters.
DDR is the major memory for program and temporary data storage.
• FPGA section,
Altera Cyclone II FPGA EP2C15F484C8N, controls the circuits (transducer, pressure sensor,
temperature sensor, stepper motor, internal printer and power detection), and communicates with
DM6446 through EMIF port.
The transmit pulse trigger comes from FPGA and be controlled its amplitude via a DAC (digital to
analog converter). The receive signal is sampled and digitized via ADC and acquired by FPGA.
• SBC Analog Section

The transmit pulse is formed and shaped here. The received signal is amplified and the sample and
hold is performed in the analog section.
2.3.3. Pump Assembly

• Detect Board
The Detect Board is embedded inside Pump Assembly, and its main function is for Pump/SBC split
relative to current Express. The pump assembly calibration data is stored in EEPROM on Detect
Board.
• Stepper Motor
The unit has a stepper motor that is connected to a piston/diaphragm configuration. This pump is
used to fill and drain the membranes with water. It is controlled by dedicated chip L6208 on SBC.
• Thermocouples
There are two thermocouples (PT100) installed in the pump mount reservoir. One sends a signal to
the Detect Board (then to SBC) to monitor and control water temperature at 33°C. The other
thermocouple (maximum temperature) sends the signal to Detect Board (then to SBC) to disable the

pump if the temperature has reached 35-45°C, preventing excessively hot water from entering the
heel membranes.
• Thermostat
This is an additional safety device that operates under a normally closed configuration and it opens
up when the heater element in the reservoir is ~45°C, disabling the heater enable relay in the Heater
Control Board.
• Pressure Sensor
This switch is installed inside pump mount reservoirs. It is to detect the pressure of pump water, and
send the data to Detect Board. The pump filling stops when the pressure reaches a pre-determined
pressure (3.0 PSI)
• Home Position Switch

This switch determines when the piston/diaphragm configuration is fully retracted. At this stage
there is no water in the membranes.
• Transducers
The transducers used in the Achilles EXPII are unfocused ultrasonic transducers.
They are set up to transmit and receive sound waves at opposite sides of tissue at a variety of
frequencies.
2.3.4. LCD Assembly

The LCD assembly displays system status and provides the input interface.
LCD and Touch panel

Touch panel is affixed on the LCD panel. Gasket between Touch panel and cover is used to prevent
water.
LCD is controlled by DaVinci LCD controller. Touch Panel is controlled by dedicated control chip,
TSC2046 on LCD Interface Board.
LCD Interface Board

The LCD Interface Board provides power for LCD, and enables standby mode and reverse display
function, and responses from physical press on Touch Panel.
2.3.5. Printing
Printer Interface Board
The printer interface board connect printer with SBC, provides 8.3 V power for print header.
Printer Head
58mm embedded thermal printer
2.3.6. Heater Control Board

The heater control board receives an ON/OFF switching signal from the SBC to maintain the water
temperature at 33 ± 0.5℃ by controlling the input voltage to the heater element.
The Heater Control Board will switch off heater when the water temperature is over 45℃ ± 3℃.
2.3.7. USB Interface Board

The Achilles EXPII is compatible with USB2.0. It extends two USB master ports from DaVinci USB port,
to connect with slave device (external printer, USB Flash Memory Stick). And it interfaces a USB slave
port, which extended from DaVinci EMIF port.

Chapter 3. Diagnostics and Troubleshooting
3.1. Troubleshooting Guideline
3.1.1. Remote Troubleshooting
➢ The person troubleshooting this unit must have a clear understanding how to operate it. Refer to
the operator's manual.
➢ Write down the Customer Name, Customer ID, Location, System Serial Number, Firmware Version,
PC Software Version, and Hardware Revision. The System Serial Number and Hardware Revision
information can be found on the bottom of the unit.
➢ A clear description of the problem.
➢ When did the problem first occur and what was the customer attempting to do at that time?
➢ Does it appear to be an intermittent problem, or does it happen all the time?
➢ Any possibility of power surges to the facility during use of the device?
➢ Any possibility of temperature issues at the facility during use of the device?
➢ If you are troubleshooting with a customer, it is important that they send you a “failed” QA
printout when dealing with QA or Patient Measurement problems.
➢ After troubleshooting the unit over the phone, write a Field Service call log report.
➢ If you encounter a problem that has not been described in this troubleshooting chapter, contact
GE Healthcare Lunar Customer Support to assure prompt action. Be sure to have the problem
information indicated above.
3.1.2. On Site/Off Site Troubleshooting

This section is written from the most likely to least likely cause/reason for each issue. Read the
Software History, Unit revision, and Operator errors sections below. The solution to the problem may
be in these sections. Reading these sections may resolve the problem without going into further
troubleshooting.
Contact GE Healthcare Lunar Customer Support for the latest information on software releases.
Assumptions:
➢ The person troubleshooting this unit must have a clear understanding how to operate it. Refer to
the operator's manual.
➢ The incoming voltage and AC fuses have been verified.
➢ The Environmental specifications are being observed.
➢ Electrostatic Discharge (ESD) prevention is a must. Make sure the Achilles EXPII and any other
devices that are attached to the unit are isolated from power when wearing a wristband-
grounding strap while servicing any internal components of the unit.
➢ If you are servicing the unit, write up a service report and send it to GE Healthcare Lunar Customer
Support, Attn: Achilles Team, via mail, e-mail, or fax. We use these reports to track field
inquiries and failures so we can improve our informational sources as well as the reliability of the
unit.
➢ If you encounter a problem that has not been described in this troubleshooting chapter, contact
GE Healthcare Lunar Customer Support to assure prompt action. Be sure to have the problem
information indicated above.

3.2. Customer Diagnostics Function
The following diagnostics functions are also interpreted in the Operator’s manual, and they could be
conducted by the end-customer. Ask customer about the results or guide customer to do that if the
information will help on troubleshooting.
3.2.1. Find System Information

By menu , you can find Software Version, Serial Number, Reference Population, Printer Setting,
Auto Print Quantity, and so on.
Figure 3-1 Unit Information
3.2.2. Perform QA procedure

The device requires completing quality assurance procedure before the first-time use.
Take out the QA Cylinder from Ship Kit. Prepare the Spray Bottle filled with 70% Isopropyl Alcohol or
Ethanol.
Click QA button from home page (see Figure 3-2), or go to -> Maintenance -> Quality Assurance
Follow the instruction as the device prompt.

Figure 3-2 Home Page
1) Spray both membranes with alcohol
Figure 3-3 Spray both membranes

2) Spray both sides of QA cylinder
Figure 3-4 Spray QA cylinder
3) Place QA cylinder between deflated membranes. See Figure 3-5

Figure 3-5 Place QA cylinder
4) Click button. The membranes will be filled and be forced into the QA test cylinder. The
membranes should continue to fill until they press firmly against each other.
5) QA Measuring begins, two waveforms display on the screen. The waveforms should be well-
defined and symmetrical with two peaks, see Figure 3-6
Figure 3-6 QA Measuring

6) Membranes retract when QA Measuring complete, result displays on the screen, see Figure 3-7

Figure 3-7 QA results
7) Remove the cylinder from the System.
3.2.3. Diagnostics Screen

A user diagnostic screen is available to assist the user in troubleshooting and correcting common
problems.
Go to -> Maintenance -> Diagnostics, see Figure 3-8.
Figure 3-8 Diagnostics Options
Touch Panel Key Test

Go to -> Maintenance -> Diagnostics -> Touch Panel -> Key Test
1) Click Key Test, use the Stylus to click on the blank area of the screen, asterisks will display after

each clicking, check the asterisks are right at the position of where you clicked. See Figure 3-9.
2) Click to return
Figure 3-9 Key Test
Touch Panel Calibration

This option helps to adjust the performance of Touch Panel when it doesn’t work well.
1) Go to -> Maintenance -> Diagnostics -> Touch Panel -> Calibration
2) Click the center of target by stylus
3) Repeat as the target moves
4) As the screen prompts, tap the Touch Panel again to save the new calibration setting. Or wait 30
seconds to let the device cancel save, and keep current setting
Figure 3-10 Touch Panel Calibration
LCD Character Test

Go to -> Maintenance -> Diagnostics -> LCD -> Character

1) Verify that the entire screen displays alpha characters properly and across the entire screen. See
Figure 3-11.
2) Click to return
Figure 3-11 LCD Character Test
LCD Grey Test

Go to -> Maintenance -> Diagnostics -> LCD -> Grey
1) Verify that the entire screen displays Gary column properly and across the entire screen. See
Figure 3-12.
2) Click to return
Figure 3-12 LCD Gary Test
LCD Color Test

Go to -> Maintenance -> Diagnostics -> LCD -> Color
1) Verify that the entire screen displays Color column properly and across the entire screen. See

Figure 3-13.
2) Click to return
Figure 3-13 LCD Color Test
Internal Printer Test

Go to -> Maintenance -> Diagnostics -> Printer -> Internal Printer Test
1) Verify the printer will continuously printing out with alpha characters on the paper
2) Click anywhere on the screen to stop
3)
Figure 3-14 printout from Internal Printer Test
Internal Printer Feed Paper

Go to -> Maintenance -> Diagnostics -> Printer -> Internal Feed Paper
1) Verify the internal printer will continuously advance paper.
2) Click anywhere on the screen to stop

External Printer Test
Go to -> Maintenance -> Diagnostics -> Printer -> External Printer Test
1) Verify a Test Page is printing from External Printer
2) Click to return
Figure 3-15 Test Page from External Printer
Pump Test
Go to -> Maintenance -> Diagnostics -> Pump
1) Verify the membranes are continuously being filled and drained and the cycle times are
displayed on screen.
2) Click Cancel to stop. If you stop the process but the membrane is not fully drained, go to
Maintenance -> Water Management -> Drain Membrane to drain completely.

3.3. Service Diagnostics Function
There are several special diagnostics built into the system for use by service personnel only.
These options are available from a hidden screen. This screen can be accessed from the Main Menu
by first pressing the lower left corner of the Main Menu and then by pressing the lower right corner
immediately afterward. The hidden Diagnostics menu will then appear.
Figure 3-16 Service Options
Note: With Achilles EXPII software version 2.70, 10-digit service password shall be required to access the
above service screen. Contact GE Healthcare Lunar Customer Support for the service password
information.
3.3.1. Detailed System Information

Go to Service menu → Information → Version Info
Figure 3-17 Detailed Unit Information

Go to service menu → Information → Calibration Info

Figure 3-18 Calibration Information example
3.3.2. QA Ignore
Go to Service -> Service Tools -> QA Ignore
This option enables (“On”) system to measure without a pass QA. Click to switch between ON/Off.
The default is “Off”. When complete debug, remember to turn it “Off”.
3.3.3. Force Result

Go to Service -> Service Tools -> Force Result
This option enables (“On”) system to directly display results from Reference Population without
measurement. Click to switch between ON/Off. The default is “Off”. When complete debug,
remember to turn it “Off”.
3.3.4. Service Diagnostic

This function allows service personnel to conduct a test on several sub-systems. Firmware will
automatically diagnostic them one by one and display the result on the screen after action has
finished, the result will point out the status of each sub-systems or function modules and it can be
printed out from internal printer.

Figure 3-19 Service Diagnostic
Go to Service -> Service Tools -> Service Diagnostic

1) Select the items to test
2) Click on Start.
3) The screen may prompt that:
4) USB test need insert a USB memory stick
5) Transducer test need place QA cylinder and spray Isopropyl Alcohol.
6) Click Print to printer out the result if necessary
7) Click to return
Figure 3-20 Diagnostic Status
3.3.5. View Detailed Error Log

By this option, service personnel can review the detailed historical Error Log. Each record includes

Date, Time, Error ID, Error content and Suggestions.
Go to Service -> Service Tools -> Log
Figure 3-21 Error Log

1) Click Previous/Next to see the earlier/later record
2) Click and hold the scroll bar with styles to move down the content
3) Click on Print if necessary
4) Click Cancel to return
5) Click Export Log to export log to USB drive
3.3.6. Auto Test (Lab use only)

Lab use only, this option will be moved to R&D menu.
Go to Service -> Service Tools -> Auto Test
Measure Test
This procedure enables the system to automatically perform measurements. Place a QA Cylinder
into the foot well before start. Note: This procedure cannot be stopped once start, except the device
is powered off.
Database Test
Not exist.
3.3.7. Sensors
Go to Service -> Sensor
Heater Sensor
This option (“Off”) is to disable the heater control function, and allows perform Measure or QA
without check water temperature.
Click to switch between ON/Off. The default is “On”. When complete debug, remember to turn it
“On”.
Fill Sensor
This option is to enable pressure control for pump filling.

When be “On”, Membrane filling will stop by either 1) the water pressure reaches 3.0 psi, or 2) the
motor reaches stepper position 11500.
When be “Off”, Membrane filling will stop only by the motor reaches stepper position 12000.
Drain Sensor
This option is to enable Home Switch control for pump draining.
When be “On”, Membrane draining will stop by either 1) Home Switch is triggered, or 2) the motor
reaches position 0.
When be “Off”, Membrane draining will stop only by the motor reaches 12000 steps (not position).
3.3.8. Rent Mode

Lunar Achilles EXPII support Rent Mode for specific customer use. There are two limitation 500 or
1000 measurements according to customer’s purchase. The system will be locked and notice user
when measurements meets the limitation. Download/update SW without impact rent mode.
Go to Service -> Rent Mode, click on the button to switch between On and Off, this function will be
enabled after cycle power.
Note: once it is turned on, you need input the key code to access the system.
3.3.9. PIN/CSV Settings

Go to Service (hidden panel, enter service password) -> Service Tools -> PIN/CSV settings, click on
this button, password input screen is displayed. Enter the service PIN.
Figure 3-22 Service Tools

Service personnel will see the following options within it as shown below in Figure 3-23.
Figure 3-23 PIN/CSV settings

1. Export to CSV after every Measurement: This feature can be enabled/disabled by selecting/
unselecting the checkbox (highlights in blue/left Blank) and clicking on “Set” button. This
enabled/disabled configuration will be saved into a system configuration file.
With this feature enabled, system generates a .CSV (comma separated value) report of patient
measurement data after every measurement is completed in external USB Drive when connected
to the system.
2. Reset User PIN: This feature is used to reset User PIN (4-digit numeric password). This feature is
used to enable the EXPII user in any of the following situation:
A. User forgot PIN
B. User PIN is locked due to 25 continuous failed login attempts.
After the PIN reset, user must immediately create new PIN by clicking on Login button at home
screen.
Figure 3-24 User PIN Reset
3.3.10. Security Features

With Achilles EXPII Software version 2.70, following service screens will be secured with numeric
password. password input screen shall be displayed to enter service password/PIN (secure numeric
password):
UI screens Service Password/PIN

1. Service screen (hidden panel) 10-digit Service Password
2. PIN/CSV settings 4-digit Service PIN
3. R & D Tools
4. Rent Mode 4-digit Service RM PIN
Note:
Contact GE Healthcare Lunar Customer Support for the service password/PIN information.
For User Security features and User PIN related information with software version 2.70, refer to the latest
operator manual.

3.4. QA Failures
3.4.1. Operation Related QA Issues
Qualify the following conditions when assessing Quality Assurance concerns:
Did you place the QA Cylinder correctly?

You must always use the QA Cylinder to assure membranes contact each other. The QA Cylinder
should be placed with open ends toward both membranes, so that when the membranes inflate,
they fill the inside of the QA Cylinder.
Did you use the enough coupling medium and in the correct place?
It only takes a small amount, but it must be where the membranes touch together. The ultrasound
transmission will be very poor if there is insufficient 70% Isopropyl Alcohol or Ethanol. The entire
surface of both membranes and the insides of both sides of the QA Cylinder should be coated for
transmission of the ultrasound signal through the QA Cylinder Coating, these surfaces also help
reduce wear on the membranes while they inflate into the QA Cylinder.
Do the membranes touch together in the center of the QA Cylinder?

The membranes must touch firmly together in the center of the QA Cylinder. If this is not the case,
possible problems include:
➢ System water level is low. Is there an adequate water level in the system? Use ADD WATER
procedure to fill the pump.
➢ Gas has accumulated in the membranes. Ultrasound transmission requires a continuous water
path. This means no air pockets inside the membranes. Burp any accumulated air out of the
membranes and use ADD WATER procedure to fill the pump.
➢ One or both membranes may be too stiff or too loose. If this is the case, the membranes may be
imbalanced and not touch in a large enough area. Replace both membranes.
➢ One or both membranes may have a leak. If this is the case, the membranes may be imbalanced
and not touch in a large enough area. Replace both membranes and use the ADD WATER
procedure to fill the pump.

Do the membranes have much air in the top when inflated?
Gas has accumulated in the membranes. Ultrasound transmission requires a continuous water path.
This means no air pockets inside the membranes. Burp any accumulated air out of the membranes
and use ADD WATER procedure to fill the pump.
Do you notice water collecting in the footwell, in the Water Management Tray, or on the floor
under the Achilles EXPII unit?
One or both membranes may have a leak. If this is the case, the membranes may be imbalanced and
not touch in a large enough area. Replace both membranes and use the ADD WATER procedure to
fill the pump.
Does the unit stay a long time?

In some case, if you perform QA with the unit stayed a long time, the transducers surface may cling
some small air bubble (may not visible by naked eye), which will block ultrasound transmission.
Remove both membranes, clear both transducers’ surface.
3.4.2. QA Failure Codes

If the Achilles EXPII unit fails the QA test, the printed QA report includes error codes indicating the
cause for failure.
Table 3-1 QA Failure Codes and Internal Criteria

Failure Code Measurement Internal Criteria
“g+” QA Gain Expected Value +/- 100

“f+” QA BUA 54 +/- 5 (dB/MHz)
Range depends on Water Temperature
“s+” QA SOS 1511 +/- 20 m/s (@ 31.0 ͦC) to
1520 +/- 20 m/s (@ 35.0 ͦC)
Heater Over
“o” 41.0 ͦC - 45.0 C
ͦ
Temperature
“g+” (lowercase) - Gain value out of range

Some possible causes are:
➢ No or insufficient coupling medium. You must use 70% Isopropyl Alcohol or Ethanol. It only takes
a small amount, but it must be applied over the entire surface of both membranes and inside
both sides of the QA Cylinder.
➢ Burp any accumulated air out of the membranes and use ADD WATER procedure to fill the pump.
➢ Foreign object between membranes. Remove foreign object.
➢ Inoperative transducer cables/loose connections. Tighten the connections and replace cables as
necessary.
➢ Bad Water. Drain and refill the reservoir with new distilled water.
Bad Transducer and /or the gain circuitry on the SBC. Replace SBC or pump kit.
“f+” (lowercase) - BUA value out of range

This error is related mainly to the quality of coupling between transducer surfaces (through the
water, membrane, and coupling medium on one side, through the QA cylinder membrane, and then
through the coupling medium, membrane, and water on the other side).
Some probable causes are:

➢ QA cylinder not inserted or inserted incorrectly. Insert QA cylinder.

➢ No or insufficient coupling medium. You must use 70% Isopropyl Alcohol or Ethanol. It only takes
a small amount, but it must be applied over the entire surface of both membranes and inside
both sides of the QA Cylinder.
➢ Air bubbles in the membranes. Burp any accumulated air out of the membranes and use ADD
WATER procedure to fill the pump.
➢ Foreign object between membranes. Remove or clean foreign material.
➢ Inoperative transducer cables/loose connections. Tighten the connections and replace cables as
necessary. See maintenance sections for procedure.
➢ Bad Water. Drain and refill the reservoir with new distilled water.
➢ Bad Transducer and/or gain circuitry on the SBC. Replace SBC or pump kit.
➢ Refer section 3.4.3.
“s+” (lowercase) –SOS value out of range

The speed of sound (SOS) through water is out of tolerance. SOS can be affected by the ability of the
unit to monitor and control the temperature of the water in the pump and membranes. It can also
be affected by any pressure, force or deflection that might change the distance between the
transducer surfaces and thus effect the calculation of SOS given the expected time of flight of the
ultrasound signal. It can also be affected by the proportion properties of all materials in the
ultrasound signal path including water, membranes, coupling medium, and QA Cylinder.
Some probable causes are:

➢ QA cylinder not inserted or inserted incorrectly. Insert QA cylinder.
➢ Foreign object between membranes. Remove or clean foreign material.
➢ Water Temperature out of specifications.
➢ Bad Water mixture. Completely drain and refill the reservoir with new steamed distilled water.
➢ Bad calibration or a transducer has moved out of position. Confirm results using GENERAL
DEBUG. Replace SBC or pump kit.
➢ Water has been contaminated with Alcohol. Completely drain and refill the reservoir with new
steamed distilled water.
“o+” (lowercase) - Over temperature threshold check failed

The over-temperature threshold was not detected during test or the over temperature reference
voltage is incorrect.
3.4.3. Procedure to resolve QA failures with ‘f+’ error code

PURPOSE:
This service procedure provides the required instructions for field engineers to resolve QA failures with ‘f+’
error code by recalibrating the transducers.
SUPPLY:
Achilles EXPII water phantom - LU45788 (FRU)
INITIAL CONDITION:
Achilles EXPII system fails QA procedure with ‘f+’ error code.
IMPORTANT NOTE:
This procedure is applicable only for Achilles EXPII systems which fails QA due to BUA out of
range (f+ error) and with software version 2.10 or above.
Ensure the water temperature during calibration is as recommended in the procedure below.

PROCEDURE
➢ Turn the Achilles unit “ON”, perform a QA measurement. QA should fail with ‘f+’ error code.
➢ Follow the troubleshooting instructions for this error, provided in this manual. Perform a QA measurement.
If QA fails again, continue the below steps.
➢ Turn OFF the system. Remove the footplate & membranes. Ensure the top cover is present and the pump
is filled with clean distilled water.
➢ Assemble the water phantom to the pump. Ensure the phantom is locked to the pump with the membrane
retaining rings & the O-rings. The air hole should be facing up as shown below.
Caution: Improper fitment of water phantom will result in water leak and calibration failure.
Air Hole
Membrane retaining ring
Water Phantom
➢ Turn ON the system and wait for the water to heat up. Check the water temperature under
Maintenance→Diagnostics→Temperature (TC1).
Wait for temperature to stabilize between 32.9 ͦC to 33.1 C ͦ . Ensure the difference between TC1 & TC2 is
not more than 1 ͦ C. If the system is not heating up to the desired temperature, diagnose for any systemic
issues.

Caution: Perform the water calibration as soon as the temperature is between 32.9 Cͦ to 33.1 ͦC.
Note: With software version 2.70, system will allow water calibration only at temperature range 32.9 ͦC to 33.1 ͦC.
➢ Go to hidden service menu (Hidden screen can be accessed from the Main Menu by first pressing the
lower left corner of the Main Menu and then by pressing the lower right corner immediately afterward).
➢ Go to R&D Tools→Enter Service PIN→Calibration→Water.
Wait till water calibration is completed successfully.

Note: There will be a slight overflow of water through the air hole till the water inside the phantom
reaches the optimum level. This is normal. Clean the water spill on the device surface.
➢ Go to hidden service menu → Information → Calibration Info
➢ Check the ‘Gain’ value in the calibration information screen. Ensure this value is between 47-102. If not,
clean the transducer surfaces and repeat the water calibration procedure. If still the gain value is not in
the range of 47-102, this calibration process is not valid. Replace the pump assembly.
➢ If water calibration is successful and the gain value is in the acceptable range, remove the water phantom
and assemble the membranes & footplate. Inspect the membranes for any damage.
➢ Perform QA measurement. System shall pass the QA.
➢ If QA fails, replace the pump assembly.
COMPLETION
Record the water calibration temperature, gain value from calibration info screen and final SOS & BUA
values of QA test in the comments section of service dispatch. Also record any other additional comments.
Fill in the appendix E sheet of this service manual and send the file (as an attachment) to the email id:
Achille.4x6kxpapu136vv8l@u.box.com. This sheet will be added in the GE Box folder ‘Achilles EXPII - Field
Water Calibration Records’ for future reference. A confirmation email saying “Your email attachment
was successfully uploaded” will be received.

3.5. Measurement Failures
3.5.1. Operation Related Measurement Issues
Qualify the following conditions when assessing Measurement concerns:
Was the System full of Water?

The pump must always have an appropriate volume of water in it. The membranes need to be able
to inflate on both sides so that they can contact the patient’s skin on both sides of the heel. For
optimal coupling, the membranes need to wrap around below and around the back of the heel on
both sides. If this does not occur, measurements are likely to fail because the ultrasound signal will
be unstable and weak. The signal will be insufficient to move through the water, coupling medium,
and heel.
Did you use an appropriate coupling medium?

70% Isopropyl Alcohol or Ethanol.
Alcohol evaporates and runs off rapidly. Perform measurements within 10-15 seconds.
Is the Patient Positioned Correctly?

Positioning of the patient’ Body relative to the machine, the Leg relative to the calf support, and the
Heel relative to the footplate, heel support, and transducers is critical to proper results. See the
Operator’s Manual for more detail.
Is the Patient and System prepared Correctly?
Coupling medium must be applied to both membranes and to both sides of the patient’s heel. See
the Operator’s Manual for more detail.
Is the Patient stable during measurement?

Movement of the heel during measurement will impact the ability of the system to determine a
consistent result. This may lead to measurement failures. The patient should remain still and relaxed
during the measurement. See the Operator’s Manual for more detail.
Are the Membranes leaking or imbalanced?

Replace membranes and perform ADD WATER procedure to ensure good coupling.
Has the water in the pump been changed recently?

Replace membranes and perform ADD WATER procedure to ensure good coupling. With rapid and
extended patient measurements using alcohol as the coupling medium, alcohol can slowly permeate
the membranes and corrupt the water solution in the pump reservoir. If this happens, completely
replace the water solution.
Has the Patient been measured several times?

Sometimes patients with very dry or calloused skin can display difficulties with patient measurements.
Reapply coupling medium and retry (several times if needed). Skin is conditioned by the coupling
medium.
Has the Patient’s other foot been measured?

Sometimes patients can have interesting anatomy that displays difficulties for patient measurements.
Measuring the other foot can help discover this and provide an idea of the true stiffness of the
original foot.
Has a different patient been measured?

Sometimes patients can have interesting anatomy that displays difficulties for patient measurements.
Measuring another patient can help discover this.

Has there been any recent problem or trend with QA Report values?
Monitor QA details to note any trend or shift in any of the QA Report values.
3.5.2. Patient Measurement Error Messages
Measurement errors are often related to patient preparation. Make sure the operator is familiar and in
compliance with the patient measurement procedure outlined in the Operator’s Manual.
Error Message What’s up?

Perform a QA You may have not performed a Quality Assurance (QA) procedure
recently. You must perform this procedure at least once every 7
days. Always verify the time and date are correct.
Measurement Error, This indicates a patient preparation, positioning or movement issue.
Reposition and Re- Reapply coupling medium. Reposition the patient and repeat the
measure measurement. Or, choose to measure the other foot. See the
Operator’s Manual for more detail.

Signal Too Small The measurement signal was too small for the Achilles EXPII to detect
and process. This can be caused by:
➢ An abnormally small foot,
➢ Very high bone density of the patient's heel
➢ Low of pump water, or bad water
➢ Improper patient preparation
➢ Improper patient positioning
➢ Air in membranes or the transducers’ surfaces
➢ System parameter drifted
NOT AN ERROR - Very high bone density

The “Signal too small” message is not always related to an error.
It may be an indication of a patient with a very high bone density. To
confirm the results:
Determine if there is a reason for the high value, e.g., patient is a
runner or does high impact weight bearing exercise.
Make sure the foot/ankle being measured didn't have a previous
injury/surgery (pin).
Measure the opposite foot. If both feet have comparable values, it is
likely the patient has very high bone density.
NOT AN ERROR – Foot too small

A "Signal Too Small" message may occur when measuring feet at the
smallest size limit. The anklebone of a small foot may be in the
ultrasound beam causing abnormally high attenuation. Try re-
positioning and re-measuring. Also try the opposite foot.
This error is often related to an operator issue as well. Always verify

the following:
➢ Make sure the system is not low on water. Perform
MAINTENANCE/ADD WATER procedure.
➢ Change the water in the system periodically.
➢ Good Patient Positioning. Always use the Toe Peg, the Calf
Support with calf lightly touching, and a proper "upright sitting"
position.
➢ Good Patient Preparation. Sometimes it helps to apply a liberal
amount of alcohol and let it absorb into the skin for 10-15
seconds.
➢ Replace membranes if needed.
➢ Gently clean transducer surfaces.
➢ If there are still problems, first check the QA history to
determine if the system has become less sensitive. The operator
should fax the QA history for review before visiting the site. If
there is a drift in values, then the system should be repaired.

Chapter 4. Software Maintenance
4.1. File Management – (Operator manual section 3.2.4)
Go to Maintenance -> Tools -> File Management. See Figure 4-1
Figure 4-1 File Management
Export File
1) Insert an USB memory stick into the USB-hose slot (see Figure 4-2). The device will take seconds
to automatically install for the new hardware.
Figure 4-2 Insert a USB memory stick

2) Click on the buttons to Export Database
➢ The Patient Database will be exported to Patient.sdf
➢ The Configure File will be exported to SettingData.xml
➢ And QA Database will be exported to QACylinder.sdf
3) Check the device has prompt successful.
The device will prompt on the screen if the files already exist in the USB memory stick. Click Yes

to overwrite the previous one. If you would like to keep the previous file, either rename it or
move it into another folder.
Figure 4-3 Exported Files
Import File
1) Insert an USB memory stick into the USB-hose slot.
2) Click on the buttons to Import Database
3) The device will prompt successful
4.2. Factory Reset (Operator manual section 4.13)

This option allows user to reset several items, like Patient Database, QA Database and Configurations
to factory default value.
Warning: Performing this procedure will reset (erase) all QA data and all patient data and
configurations like printer setting, report setting and so on.
Follow the screen instructions to back up the database or configurations into a memory stick as need.
Figure 4-4 Factory Reset Option

4.3. Download/Upgrade Software
4.3.1. Download/Upgrade Software through USB cable
Requirement: PC/Laptop with windows XP/Vista or higher
Lunar Achilles EXPII Device
USB cable
Install Lunar Achilles USB Driver onto PC/Laptop

1) Double click “Lunar Achilles USB Driver 1.0.exe”, display as following. Click “Next”.
Lunar Achilles Driver exe file is available in SW-Tools folder of the Achilles EXPII software resource
CD (LU44021) or download from location: https://ge.box.com/s/tjt82yc4xuf510zxd2zk2cxsqp2fpjuk
2) Change installation directory or select default directory, then click “Next” button.

3) Click “Install” button, the ChangE USB Driver will be installed.
4) When installation is finish, as show following. Click “Finish” button to exit installation.

5) Connect PC/Laptop to unit through USB cable. Unit USB port’s position as show blew:
6) Press and hold touch panel meanwhile power on unit. Release touch panel until the unit as
show blew:
7) In PC/Laptop “Device Manager”, when “Lunar Achilles” is in the list of “Universal Serial Bus
controller” that indicates windows enumerate successful and Power off unit.

Download Software Package through USB cable
1) Press and hold touch panel meanwhile power on unit. Release touch panel until the unit as
show blew:
2) Double click “Lunar Achilles Upgrading Tool.exe”, display as following:
3) Click “Open” button to choose the software package (e.g. ChangE_Image.bin), the version
information will display on screen:

4) Click “Download” button to start downloading software package into unit. The downloading
process as following:
5) Checking process will begin when Downloading is completed.

6) When downloading and checking are all completed, success will be displayed:
Note: Always verify the system date and time are correct after firmware upgrade from software
version below 2.40 to 2.40 or higher and set the Date & Time appropriately.

4.3.2. Upgrade Software through USB Memory Stick
Requirement: Lunar Achilles Device
USB Memory Stick (with 30MB free space)
• Copy software package (ChangE_Image.bin) into USB memory stick root directory.
• Power on unit and insert USB memory stick into unit.
• Enter “Maintenance” → ” Tools”→ ” Firmware upgrade”, then click button NEXT, Unit
display as following:
• When the process is finish, display is below:

• Re-cycle unit, Boot loader will refresh software package, the LCD display as following for a
few minutes:
• When complete to refresh software package, software will run automatically, LCD display
the main page.
Note:
1. Always verify the system date and time are correct after firmware upgrade from software version
below 2.40 to 2.40 or higher and set the Date & Time appropriately.
2. For the latest Achilles EXPII software version, Contact GE Healthcare Lunar Customer Support or
download from this link: https://ge.box.com/s/o5wnbt1jxhyscj1t4dv88it5tyqf7hew

4.4. Revise Serial number
The Serial number may need to update when the SBC is replaced. Serial number is required for
generating OsteoReportN (PC software) software Key
Requirement: PC/Laptop with windows XP/Vista or higher

Lunar Achilles EXPII Device
USB cable
EXPII SN Revise Tool
Procedures:
1) Download “EXPII Unit SN Revise Tool (.zip)”, follow its “readme.doc” to install from below link:
https://ge.box.com/s/i34mu0h5v0wmtxvdo95qvsdkdg5rip80
2) Identify the system serial number from the system label pasted either at the bottom or sides of the
base cover assembly. (e.g.: 60123)
3) Run Serial Number Revise Tool on Laptop, follow the prompted instructions to update Serial
Number.
4) Turn on the unit

5) Connect Laptop PC to units by USB slave cable shipped with units.
6) Click left bottom and then right bottom to access the service menu. Switch Manufacture Mode
“On”.

7) From PC desktop, enter the correct Serial Number in blank box.
Note: Serial number is 5 digits numeric character only.
8) Press “Set” to start revise serial number automatically. Confirm the Unit Serial Number is
changed to desired serial number.
9) Click “Close” when the progress completed.
10) Restart the unit, click from the home screen to check if serial number was updated
correctly.
11) Switch Manufacture Mode “off”.

4.5. ID9001/9002/ChangE UI.exe error fix
Warning:
Performing this procedure will reset (erase) all patient & QA data.
1. Turn the Achilles unit “ON”. The UI displays the error message (ID9001/9002/ChangE UI.exe).
2. Power “OFF” the unit and follow below instructions for programming " Achilles FCT Software Test
Image 2.20 "
C. Connect the PC/Laptop with the Achilles unit through USB cable.
D. Press & hold touch panel, meanwhile power on the unit. Release touch panel when the unit
displays the below screen:
E. Download ‘Recovery_Image.zip’ to the PC/Laptop from the below link. (GE reference: LU45666)
https://ge.box.com/v/Lunar-FCT-2-20
F. Extract the downloaded zipped folder to the PC/Laptop. Open the extracted folder → Double
click on “Lunar Achilles Upgrading Tool”. A pop-up window will be displayed, as below.

G. Click ‘Download’ button to start downloading the recovery software package. On download
completion, below message shall be displayed.
H. Remove the USB connection and restart the system. System UI shall be displayed as below.
3. Power “OFF” the unit and follow service manual section ‘4.3. Download/Upgrade Software’ to install
the system software.
4. Remove USB cable connection and restart the unit.
5. Click ON button, LCD displays the home UI.

6. Perform Service Diagnostic (Refer section 3.3.4). System should pass the diagnosis.
7. Perform a QA measurement. System should pass the QA.
If issue persists even after following this procedure, replace the SBC board.

Chapter 5. FRU Replacement
Warning:
Always turn off the Achilles EXPII device and isolated from power before open the Top
Cover. Disconnect any device (laptop computer, printer, etc.) from the Achilles EXPII device.
Warning:
Electrostatic Discharge (ESD) prevention is a must when replace the inside parts. Make
sure the Achilles EXPII unit is isolated from power when wearing a wrist-band grounding
strap.
5.1. Preparation for servicing

Get a clear and adequate space for servicing:
➢ Adequate space for removing, placing and testing parts
➢ Sufficient power supply and minimum 3 feet to all electrical panels
➢ ESD prevention for electrical parts
➢ Sufficient tools (see appendix A.3)
➢ Alcohol and soft tissue for cleaning
5.2. Replace Top Cover Assembly (LU43959)
Figure 5-1 Top Cover Assembly
1) Remove the Calf Guide and Footplate

2) Remove screws (1) and (2) from back end of Top Cover. Completely loosen the screws (3), (4)
and (5) shown below.
3) Tilt the display unit forward as shown below.
4) Pull the Handle, raise the Top Cover and remove it by sliding over the display.

5) Replace Top Cover with a new one and assemble in reverse order.
5.3. Replace Pump Assembly (LU43851)
Caution:
Always Drain the Pump Water before attempting any repairs on the Pump Assembly.
Figure 5-2 Pump Assembly
Follow section 5.1 to remove Top Cover Assembly

Loosen Cable Clip (1), unplug connectors (2) from SBC. Remove SBC Shield (3), remove AC Shield (4).
Remove Grounding Cable (1) from Metal Support. Unplug 3 connectors (2) from Heater Control
Board. Remove Cables from Cable Clip (3).

Remove 3 Connectors (1) from SBC. Remove Cables from Cable Clip (2).
Remove 2 Screws (1) (2) from bottom of device. Loosen 2 Screws (3) (4) from beside Pump Motor.
Carefully lift the Pump Assembly off/out of the base.

Replace Pump Assembly with a new one, ensure Water Drain Tubes line up with and inside of the
Drain Funnels in the base of the unit.
(Insert picture)
Mount the Pump Assembly by against steps.

5.4. Tube Replacement with LU45532 for water leakage issues
If there is any water leakage near the accumulator caps or tube. Follow the below procedure to replace
the silicone tube along with orifice connector.
Remove the pump assembly using the Chapter 5.3 Replace Pump Assembly Procedure Figure 5-3.
Figure 5-3
Cut the leakage portion of Silicone tube above the leakage area using cutter as shown below
Remove the cut portion of the Silicone tube from the accumulator cap as shown below .

Take the orifice connector from LU45532 and connect to existing silicone tube tightly.
Take new Silicone tube from LU45532 and connect tightly between orfice and pump accumulator cap.
Reassemble the pump assembly by following the section 5.3 and perform PUMP TEST from Diagnostic
screen 3.2.3 for 10 times and ensure that there is no leakage at tube joints.

5.5. Replace LCD Assembly (LU43945)
Figure 5-4 LCD Assembly

1) Follow section 5.1 to remove Top Cover Assembly
2) Remove 2 screws (1) from LCD bracket
3) Remove LCD Interface ribbon cable from 3 clips (2), (3) and (4). Unplug the connector (5) from
SBC.
4) Take off the LCD Assembly from the bracket.

5) Replace LCD Assembly with a new one and mount it by against steps.
6) Adjust Brightness if necessary.
5.6. Replace SBC (LU43933)
Figure 5-5 SBC

2) Loosen Cable Clip (1), unplug the five connectors (2) from SBC. Remove SBC Water Shield (3).
3) Remove 3 Connectors (1) from SBC. Remove Cables from Cable Clip (2).

4) Remove screws from SBC.
5) Take off the SBC from Metal Chassis.
6) Replace SBC with a new one, and mount it by against steps. Make sure the bottom edge of SBC
is in groove, shown below.
7) Mandatorily update the serial number of the system using the below steps.
8) Identify the serial number of the system from the System label pasted on the base assembly cover.
9) Disconnect below connection (1) between SBC and Pump as shown in figure below.
Notice: Missing of the step 9 before updating the serial number may remove the Pump calibration
data and could lead to QA not pass.

10) Follow the procedure mentioned in the section 4.4 to update the serial number using Unit SN revise
tool.
11) Turn off the system.
12) Re-Connect the Pump -SBC connector (1) shown in above figure.
13) Turn ON the system and ensure the QA procedure.
5.7. Replace Heater Control Board (LU43939)
Figure 5-6 Heater Control Board

2) Remove AC Shield
3) Remove 3 connectors from Heater Control Board
4) Remove 4 screws (1), (2), (3) and (4) from Heater Control Board

5) Replace Heater Control Board with a new one, and mount it by against steps.

5.8. Replace Power Board (LU43932)
Figure 5-7 Power Board

2) Remove AC Shield
3) Remove 2 connectors (1) and (2) from Power Board. Remove 4 screws (3), (4), (5) and (6).
4) Replace Power Board with a new one, and mount it by against steps.

5.9. Replace Printer Interface Board (LU43909)
Figure 5-8 Printer Interface Board

2) Remove the all connectors from SBC and Heater Control Board. Remove Grounding Cable from
Chassis.
3) Loosen the 4 screws that hold the Chassis to Base Assembly. Take Chassis out of Base.
4) Remove the 4 screws (1), (2), (3) and (4) from Printer Interface Board. Pull Printer Interface
Board a little out, and remove cable (5) and (6) from Printer Interface Board.
5) Replace Printer Interface Board with a new one, and mount it by contrary steps

5.10. Replace USB Interface Board (LU43911)

Chassis.
4) Remove buckle of USB Cover from Chassis.
5) Remove the 4 screws that mount the USB Bracket, take it away from Chassis.

6) Open the USB Shield, Remove the 4 screws from the USB Board. Pull the USB Board out of the
Shield, and then unplug the connected cable.
7) Replace USB Interface Board with a new one, and mount it by contrary steps.
5.11. Replace Printer Head (LU42996)

Chassis.
4) Remove the cable (1) from Printer Interface Board.
5) Rotate the Printer Head Knob to revert printer paper, Remove the 2 screws (1) and (2) from
Printer Head.

6) Take the Printer Head away from Chassis. Replace the Printer Head with a new one and mount it
by contrary steps.
5.12. Replace Power Entry (LU43898)
Figure 5-9 Power Entry

Chassis.
4) Remove Grounding Cable (1) from Chassis, remove cable (2) from Power Choke.

5) Remove screws (1), (2) from Power Entry.
6) Take off the Power Entry from Chassis, replace with a new one and mount it by contrary steps.
5.13. Replace Power Filter Board (LU44047)
Figure 5-10 Power Choke

Chassis.

4) Remove cables (1) (2) and 2 screws (3) (4) from the Power Filter Board.
5) Replace the Power Filter Board with a new one, and mount it by contrary steps.
5.14. Replace Base Assembly (LU43919)
Figure 5-11 Base Assembly

Chassis.
4) Remove 2 Screws from bottom of device. Loosen 2 Screws beside Pump Motor. Take Pump
Assembly out of Base.
5) Replace the Base Assembly with a new one, mount Pump Assembly, Chassis, Top Cover and so
on by contrary steps.
Note: Mandatorily update the System label by following the below procedure.
Affix System Label
6) Identify the Serial Number, Manufacturing Year and month from the system label of Defective base
assembly.

7) Refer to the system label Language/Part number pasted on the defective base cover assembly and
take the appropriate System label part number from FRU Kit content(LU43919)
Figure 5-12
8) Affix the new System label in the location as shown below (Fig 5-13).
Figure 5-13
Note: Only in Japan region, it requires 2 labels to be pasted (English System Label, LU44034 and
Japan information Label, LU45541) to affix as per Japan regulation.These 2 labels are to be pasted
on opposite sides of Base cover. Fig 5-14 shown below.
Figure 5-14
9) Peel of the individual numbers as required by the serial number from LU45538-Number Sticker in FRU
kit and paste it in the system label as shown below (Figure5-15)
Figure 5-15
10) Based on the Manufacturing Month and Year of the system identified before,Peel of the Month and
year numbers as required from LU45538-Number Sticker and paste it in the system label in YYYY-MM
format as shown below (Figure5-16)
Figure 5-16
11) Verify the System label, Serial Number and manufacturing month and year was affixed properly in the
system label.(Figure5-17)
Figure 5-17
5.15. System Functional Test
CAUTION:
Perform following tests after each troubleshooting or repair to verify system functionality.
1) Verify that any originally reported or diagnosed problem has been resolved.
2) Perform 4 QAs and record the results. Verify that all QAs pass.
3) Configure the System so that the Reference Graph will print out on the internal printer.
4) Perform a Measurement with a QA cylinder, entering a Sex of Female and an age of 45.
5) Print the results. Verify that the Reference Graph is displayed.
5.16. Cleaning
After all troubleshooting and servicing are complete, clean the device (Top Cover, LCD, Footplate,
Calf support, Membranes, Water Tray) by alcohol and soft tissue.

Appendix A. Parts and Tools
A.1. Error List
Reference: ABSF0010. This Error List is embedded in the firmware, the content of Error ID,
Error Content, and Pop up message will be displayed on screen, that is customer seeable.
Service representative could find its Possible Cause and Suggested Actions by each Error ID.
Table A-1 Error List

Pop up message (customer
Error_Type Error_ID Error_Content Possible Cause Suggested Action
seeable)
SBC_ERR 1.EEPROM cold
EEPROM_SBC soldering Contact your Service
1001 read error 2. EEPROM broken Change SBC Board Representative
1.EEPROM cold Contact your Service
EEPROM_SBC soldering Representative
1002 write error 2. EEPROM broken Change SBC Board
1.NAND Flash for data Contact your Service
storage broken Representative
NAND Flash 2. NAND Flash for data
1003 read error storage cold soldering Change SBC Board
1.NAND Flash for data
storage broken Contact your Service
NAND Flash 2. NAND Flash for data Representative
1004 write error storage cold soldering Change SBC Board
1.Battery failure or No
Battery 1. Check the battery Contact your Service
2. RTC chip cold volume, check the battery Representative
soldering and RTC chip 2. Change the SBC Board
1005 RTC error broken
PUMP_ERR Check water level add water Check water level add water if
2001 Low water error Water low if low low
1.Pump does not 1.Check the SBC/Detect Contact your Service

EEPROM_PUMP connect to SBC board connection Representative
2002 read error 2. EEPROM broken 2. Check Detect board
1.Pump does not 1.Check the SBC/Detect
EEPROM_PUMP connect Board connection
2003 write error 2. EEPROM broken 2.Check Detect board NA
Pressure Value High

error (Exceed 1.7psi 1.Pressure sensor Contact your Service
2004 during broken 1. Check the pressure Representative
measurement or 2.EEPROM broken sensor
exceed 3.0 psi 3. Detect Board broken 2. Check Detect board
during QA)
HEATER_ERR 1.Connection between 1. Check the connection Temperature exceeds

thermistor and detect between thermistor and maximum of 45C - Cycle
3001 board not well detect board power.
2.SBC broken 2. Replace SBC If problem persists,
Temperature over contact your Service
45 error Representative.
1. AC Control Board 1. Check AC control board
3002 Heating time too broken 2. Replace detect board Contact your Service
long error (cannot 2. PUMP_EEPROM Representative
reach 33±0.5 °C broken
within 15 min) 3 Detect board broken

ACQUISITION_ERR 1.People have Abnormal Stiffness Index
abnormal Stiffness - reposition foot and
Index remeasure.
2. Tx/Rx circuit broken If problem persists,
4001 Value out of 3. Transducer broken 1. Check Tx/Rx circuit Contact your Service
range error 4. Foot not 2. Check transducer Representative.
positions well
Unable to converge -
reposition foot and remeasure.
4002 Unable to If problem persists, contact
converge error Foot not still your Service Representative.
INT_PRINTER_ERR 1.Check the connection

1. Printer interface between printer interface
board not connect well board and SBC 2. Replace Cannot find internal printer -
Internal printer 2. Printer interface printer interface board contact your Service
5001 not connected board broken Representative.
error
5002 Internal printer

Printer lever up - check
levers up error Lever up
position of lever.
Internal printer Out of paper - add paper.

5003 no paper error No paper
Printer temperature too high -
wait a few minutes and try again.
Internal printer 1.Printing time too If problem persists, contact your
5004 Temperature high long Service Representative.
error 2. Printer broken
1.Replace the printer
EXT_PRINTER_ERR External printer External printer not
6001 not connected 1.Not connected well connected - check connection
error 2. Not supported type and verify if printer is
of printer compatible.
External printer 1. Out of paper
6002 abnormal status 2. Paper block Check external printer status.
error
Recalibrate Touch Panel using
TOUCH_PANEL_ Touch panel 1. Touch panel not 1.Replace TP stylus.
ERR 7001 calibration error connect well 2. Check connection of If problem persists,
2. Touch panel broken TP interface board and SBC contact your Service
Representative.
USB_MEMORY_ 1. USB memory stick Check USB memory
STICK_ERR not connected well stick connection and
Detect USB 2. Not support certain 1. Check USB interface verify USB memory stick is
8001 memory stick error type of USB memory board connection with SBC compatible. If problem persists,
3.USB interface board 2. Submit to engineering contact your Service
not connected well team Representative.
4. SW Bugs
Export USB failure - check write

1. USB memory stick
protect switch and USB memory
8002 Write protect Submit to engineering team
Export USB file space availability. If problem
2. USB memory full
error persists, contact your Service
3. SW Bugs
Representative.
Import USB failure - retry.

8003 Import USB file Submit to engineering team If problem persists, contact your
error SW Bugs Service Representative.

DATA_MANAGER_ Patient Database error
ERR Patient Database SW Bugs (load, add, delete,
9001 error (load, add, Refer to section 4.5 search) -retry.
delete, search) If problem persists, contact your
Service Representative
QA Database error
QA Database (load, add, delete, search) -
error (load, add, Refer to section 4.5 retry.
9002 delete, search) SW Bugs If problem persists, contact your
Service Representative.
SOFTWARE_ Software error – cycle power.

GENERIC_ERR Software If problem persists, contact
10001 Exception error SW Bugs your Service Representative.
Submit to engineering team
Out of memory – cycle power.

If problem persists, contact
10002 Out of memory Memory leakage your Service Representative.
error Submit to engineering team
SECURE_USER_PIN 11001 User PIN Not Unable to read User PIN 1. Reset User PIN, Refer User PIN not Enabled.
_ERR Enabled stored in the system. section 3.3.9.
2. If problem persists,
Submit to engineering team.
11002 Secure Login Not Secure Login Not Check secure login is Secure Login is not enabled in
Enabled Enabled. enabled in Privacy Settings. Privacy Settings.
11003 Maximum invalid User PIN is locked due Reset User PIN, Refer User PIN is Locked, Contact
PIN attempts (25) to maximum (25) invalid section 3.3.9. Service Representative.
reached, User Pin login attempts by the
Locked. user.
EXPORT_TO_CSV_ 12001 User exported User exported patient No service action required, Export *.CSV successful.
LOG CSV file with total measurement data from indicates relevant activity
data of ‘xx’ User Tools. log. (* is the file name:
EXPIIPatientResults_ (Serial
(where ‘xx’ is the number of Device) _
number of (YYYYMMDDhhmmss).CSV)
patient
measurement
record in
exported CSV file)
USER_PWD_ 12101 User PIN Created User created User PIN No service action required, User PIN Creation Successful.
CREATION_LOG successfully from Home screen using indicates relevant activity Note: This User PIN is
Create User PIN. log. mandatory for system usage.
If you forget this PIN, contact
Service Representative for PIN
reset.
USER_PIN_ 12102 User Changed PIN User changed PIN at No service action required, User PIN Change Successful.
CHANGED_ LOG successfully User Tools using indicates relevant activity Note: This User PIN is
“Change PIN” log. mandatory for system usage.
If you forget this PIN, contact
Service Representative for PIN
reset.
SERVICE_USER_ 12111 User PIN was Service reset User PIN No service action required, User PIN Reset successfully.
PWD_ RESET_LOG reset by Service using “Reset User PIN” indicates relevant activity Create new PIN immediately at
successfully at PIN/CSV settings log. Home screen by clicking
"Login".

A.2. Spare Parts List
This list includes CRU, FRU, and Optional parts. Both CRU and FRU are orderable from GPRS, and
Optional parts could be ordered locally or from GE Accessories Business.
No. Part Number Description Notes

1 LU44547 Pump Assy
2 LU43945 LCD Assy
3 LU43933 Board, SBC
4 LU43909 Board, Printer interface
5 LU43911 Board, USB interface
6 LU43939 Board, Heater Control
7 LU43932 Board, Power Supply
8 LU44047 Board, Power Filter
9 LU42996 Printer Head, Thermal
10 LU43898 Power Entry
11 LU43919 Base Assy
12 LU43959 Top Cover Assy
13 LU44545 Screws Kit for FRUs (47 comp)
14 LU44257 CABLE, AC SUPPLY
15 LU43914 CABLE, DC-SUPPLY
16 LU43992 CABLE, PRINTER INTERFACE
17 LU43897 CABLE, USB INTERFACE
18 LU43988 Calf Support
19 LU43975 Footplate
20 LU43965 Water Tray
21 LU43862 Plug, Fill Port
22 LU44588 QA Cylinder
23 LU43859 Membrane Retaining Ring
24 LU43999 Bottle, Cleaning
25 LU44002 Bottle, Water fill
26 LU44005 Fill Cap, Water Bottle
27 LU44014 Screwdriver, Fill Port
28 LU44283 Foot Shim
29 LU44024 Thermal Paper
30 LU43996 MEMBRANE PACK

31 LU43922 Printer Cover
32 LU44121 Spring, Printer Cover
33 LU45532 Silicone Hose w /orifice
34 LU44021 EXPII ASSY, RESOURCE CD
35 LU45788 Water phantom
A.3. Service Tools List

Lunar Achilles EXPII requires few Tools for field service. See recommended specification in below list,
the red/bold number indicates its mandatory requirement.
Tool Name Specification Where used Reference
Crossed #1 x 75mm x 183mm The screws to fix Circuit Boards. STANLEY 61-
Screwdriver (Total Length < 210mm) The screws to fix Printer Head. 292-23
Crossed #2 x 200mm x 315mm The screws to fix Top Cover. STANLEY 61-
Screwdriver The screws to fix Chassis onto 304-23
Base Assembly.
The screws mount Pump
Assembly onto Base Assembly.
Flatted 6.5 x 100mm x 215mm The screws to adjust LCD torque. STANLEY 61-
Screwdriver 327-23
Hex Nut 7mm The nuts to fix grounding cables 7mm Nut
Driver (Total Length < 210mm) onto chassis. Driver from kit:
STANLEY 94-
184-22
PC/Laptop PC or Laptop with: Download Firmware
Win XP or Vista
USB port

A.4. Firmware Revision History
The following is a summary of firmware developed for the Achilles EXPII, including release type,
features, and intended distribution. Not all versions are released to the field. It is recommended that
the summary of previous versions be read and understood so that the full feature set of given
firmware version can be known.
Firmware 2.70
• Release date: March 2020
• Compatibility:
Always set the system date and time after firmware upgrade from software version below
2.40 to version 2.40 or higher.
No other Compatibility Issue.
• Changes:
ECR 2278055 - To release Achilles EXPII Software release version 2.70 with below software
updates:
A. Secure Login Feature for user authentication.
B. Export to CSV Report Feature for Users
C. SPR: HCSDM00542936: Measurement Report Printing of selected saved record (1/3, 2/3 or
3/3) issue fix
D. SPR: HCSDM00548460: Exported CSV file contain Gender and Foot column with "?" mark,
when EXPII language set to Japanese fix
E. SPR HCSDM00571946: Abnormal characters in Japanese keypad in SW v2.60 issue fix
F. CAPA: PR# 17089221: Patient Info not saved in patient DB record after updating it during re-
measurement with same patient ID.
G. UI Improvement for Gender and Foot selection during measurement based on PR#
17087890 investigation.
H. UI improvement to display gender in Patient Measurement Record Review Screen based on
PR# 17087890 investigation and SPR: HCSDM00542936.
I. UI Improvement to display Pump Maintenance instructions in QA screen
J. Improvement to display measurement units for Temperature, SOS, BUA in report printouts
as per IEC 60601-1, Units of Measurement: Numeric indications of parameters on ME
Equipment expressed in SI units, according to ISO 80000-1 as an improvement.
K. UI improvement during Water Calibration Process in Service screen

Firmware 2.60
• Release date: July 2018
• Compatibility:
• Changes:
ECR 2251367 - To release Achilles EXPII Software release version 2.60
1. UI support for New languages (Norwegian, Finnish, Turkish and Swedish). As part of this release,
system labels for Sweden, Finland and Norway and Operator manuals for Sweden, Finland,
Norway and Turkey released.
2. Export to CSV feature addition in service screen: Export to CSV file onto external USB drive after
every Measurement and Export all Measurement records to CSV Now onto external USB drive.
3. CSO 00309381 issue (PR #17084285 INV) fix: In Clinical Risk Factor selection UI screen: Different
Clinical Risk Factor printed on external printer report other than one selected during
measurement and When Japanese language is set, Japanese strings in UI needed correction.
Firmware 2.50
• Compatibility:
Refer to compatibility statement of LU43933, REV12 in Hardware Revision History section
• Changes:
ECR 2237068- To release Achilles EXPII Software release version 2.50
1. To Qualify Micron NAND Flash on SBC board due to Samsung NAND Flash
Obsolescence (SCR-0034733)
2. To Fix the Internal Printer Lever issue as Improvement Opportunity
Firmware 2.40
• Release date: September 2016
• Compatibility:
2.40 to version 2.40 or higher
No other Compatibility Issue
• Changes:
To fix Leap Year Date Issue (29th Feb date issue)
Other Improvement fixes:
1. QA procedure not mandate when system date is less than last QA date
2. Risk assessment comment string not automatically printed on reports for
certain range of T-score value.
Firmware 2.30
• Release date: April 2016
• Compatibility:
No Compatibility Issue
• Changes:
to undo the FPGA code modification for printer lever issue fix in software version 2.20

Firmware 2.20
• Compatibility:
• Changes:
ECR 2195715 - To release Achilles EXPII Software release 2.20 with fix to below issues
a. Internal Printer lever issue
b. Few Japanese display messages improvement
Firmware 2.10
• Release date: June 2015
• Compatibility:
• Changes:
ECR 2188758 - To solve System standby/Sleep mode issue
Firmware 2.00
• Release date: Aug 2013
• Compatibility:
Please refer to compatibility statement of LU43933, REV7 below in section of Hardware
Revision History.
• Changes:
Support SBC rev7 (Internal printer driver update)
Improve Japanese font in external report
Fix dot bug in internal printer test report
Firmware 1.51
• Release date: May 2013
• Compatibility:
None compatibility issue.
• Changes:
ECR 2146685 - EXPII Date Time Reset Issue and add Dutch UI
Firmware 1.50
• Compatibility:
• Changes:
ECR 4787 – EXPII internal printer issue
Firmware 1.41
• Release date: Nov 2011
• Compatibility:
• Changes:
ECR 4766 - Achilles EXPII Reporting Tool Maintenance Project
ECR 4776 - EXPII Unit cannot bootup correctly
ECR 4779 - Achilles EXPII Firmware upgrade from 1.40 to 1.41 (Bug fix)
Firmware 1.30
• Compatibility:
• Changes:
ECR 4738 - Japanese UI translation and IME Improvement (Bug fix)
ECR 4744 – Improvement raised by Marketing (Bug fix)

Firmware 1.20
• Compatibility:
• Changes:
ECR 4699 - Achilles EXPII Software Improvement found during workout with commercial
team in PVCS Tracker (Bug fix)
ECR 4700 - Achilles EXPII Improvement 2 found during workout with Commercial team (Bug
fix)
ECR 4708 - Achilles EXPII Support external USB Color printer (Bug fix)
ECR 4720 - Achilles EXPII External Report missing Patient Name print from database (Bug
fix)
ECR 4726 - Achilles EXPII Bug found during cycle test (Bug fix)
ECR 4728 - Achilles EXPII Japanese IME dull sound character (Bug fix) ECR 4729 - Achilles
EXPII feedback from Japanese Team (Bug fix)
Firmware 1.10
• Release date: Mar 2011
• Compatibility:
• Changes:
ECR 4698 - Achilles EXPII Software Bugs found during workout with commercial
team (Bug
fix)
ECR 4701 - Achilles EXPII Translation Correction for Japanese, Korean,
Chinese (Bug fix) ECR 4702 - Achilles EXPII External Report Improvement
(Bug fix)
ECR 4703 - Achilles EXPII Japanese IME Improvement (Bug fix)

A.5. Hardware Revision History
The following is the list of changes in SBC revisions.
LU43933 REV12 - SBC

• Compatibility: SBC board Rev12 should be used with firmware version 2.50 onwards only.
• Changes: Added Micron NAND Flash memory as a substitute for LU00132-825 in the BOM
• Note:
The SBC version for LU43933 Rev12 will still show as “7” in the Detailed Information Screen
(section 3.3.1) since it is not a major change from Rev7.
The exact Hardware Revision can be identified from the Barcode label present in the SBC.
LU43933 REV11 - SBC

• Release date: August 2017
• Compatibility: Backward Compatible to previous revision

• Changes: Added substitutes for LU00002-825, LU00003-825, LU00005-825, LU00007-825,
LU00020-825, LU00021-825 in the BOM.
• Note:
LU43933 REV10 - SBC


• Changes: Added substitutes for Capacitors (LU00008-825, LU00163-825, LU00164-825 &
LU00166-825) in the BOM.
• Note:
LU43933 REV9 - SBC

• Release date: April 2017

• Changes: Updated the SBC board TST document
• Note:

LU43933 REV8 - SBC
• Release date: Nov 2014

• Changes: Removed Capacitors C409 and C410.
• Note:
“08” in the highlighted place represent Rev8 and “07” represents Rev7.
LU43933 REV7 - SBC

• Release date: Aug 2013
• Compatibility:
FRU-SBC LU43933 rev7 will be produced with the firmware 2.00 start from ECO implementation.
No change to existing Field FRU-SBC.
GPO stocked FRU (SBC rev <7 with Firmware <2.00) will be used up.
The new FRU (SBC rev7) is compatible to field units.
Capability of SBC vs. Firmware

Firmware <2.00 Firmware 2.00
SBC rev <7 Compatible. Work on Filed units. Compatible. Work on Filed units.
SBC rev7 Incompatible. Compatible. Work on Filed units.
Don’t degrade the firmware to previous version

on SBC rev7, that won’t work.
Capability of SBC + Firmware vs. ORN (PC software)
ORN 1.00 ORN 1.00 (SP001)
SBC rev<7 + Firmware <2.00 Compatible Compatible
SBC rev7 + Firmware 2.00 Incompatible Compatible
Note: If Rev 7 SBC replaced old one in

a repair activity please upgrade the
ORN to ORN (SP001) for customer
SBC rev<7 + Firmware 2.00 Compatible Compatible
Changes:
Remove components from position: U8, J2, U13, U14, Y3, U32, J6, and U31.
Update FPGA for internal printer driver

Appendix B. Circuit Schematics
B.1. LU43933 rev2, SBC
Double click the illustration to view the full file in pdf reader.
B.2. LU43939 rev1, Heater Control Board


B.3. LU43909 rev1, Printer Interface Board
B.4. LU43911 rev1, USB Interface Board

B.5. LU44047 rev1, Power Filter Board

Double click the illustration to view the full file in pdf eader.

Appendix C. Assembly Drawings
C.1. LU43850 rev2, Scanner
C.2. LU43885 rev2, Base and Main Support Assembly


Appendix D: SBC battery replacement procedure
1.0 PARTS, TOOLS AND TEST EQUIPMENT:
1.1 TOOLS AND TEST EQUIPMENT:
1.1.1 Standard Toolbox
REQUIRED EFFORT:
Personnel: 1 Field Engineer,
Time: 30 min
2.0 SERVICE INSTRUCTIONS:

Due to IATA/DOT shipping regulations GE cannot ship lithium batteries by air anymore. FEs need to purchase
the manufacturing equivalent batteries locally.
Regulations:
- IATA DGR Regulations 58th edition.
- DOT 49 CFR 173.185.
Operator Variations:
- FX-05: FedEx Express will not accept UN 3090 or UN 3480 offered as Section II
- 5X-03: UPS Air Cargo Service, Shipments containing UN 3090 or UN 3480 prepared per Section II are not
accepted
3.0 PRECAUTIONS:
3.1 Warning:
Turn the Achilles unit “OFF” and unplug it from the wall. Make sure to disconnect any device (laptop computer,
printer, etc.) from the Achilles unit.
Electrostatic Discharge (ESD) prevention is a must. Make sure the Achilles unit and any other devices (printer,
computer, etc.) attached to the Achilles unit are isolated from power when wearing a wrist-band
grounding strap.
3.2 Proper battery storage:

Keep batteries in a cool, dry place at normal room temperature. Keep battery in original sealed packaging until
use. If battery packaging is opened/damaged do not use.
3.3 Proper battery disposal:

Leave old battery with the customer to be processed as part of their waste stream. If not applicable, follow all
appropriate EHS & local government regulations to dispose.
NOTE: This procedure assumes that you have removed the Top Cover, Pump Assembly, Chassis, and SBC
Assembly before performing this procedure and will install the SBC Assembly, Chassis, Pump Assembly, and Top
Cover after performing this and other required procedures.
4.0 BATTERY REPLACEMENT PROCEDURE:

4.1 Prior to installation in the device, wipe the batteries and equipment terminals clean using a dry cloth.
4.2 Carefully remove the existing battery from the battery holder of SBC.
4.3 Push the new battery back into the holder.
4.4 Be sure to observe the proper positive/negative placement to prevent installation in reverse.
4.5 Plug in the Achilles unit and turn it "on" to test.
4.6 Set the Date, Time, and Configuration Options as described below:
4.6.1 Go to Maintenance and then Setup wizard, click continue as shown in Fig.2
4.6.2 Set date and time as shown in Fig.3.
4.6.3 Click to continue.
4.7 Power Cycle the system and verify that the Date and Time have been retained.

Lithium battery to be
replaced with the new
on the SBC Board
Figure 1: Lithium Battery on SBC board
Figure 2: Setup Wizard Figure 3: Set date and time
5.0 Equivalent battery type:
Battery P/N Battery contained in Equivalent part
LU00322-825 SBC-Board, Sony 3V-CR2032

3V-CR2032, 3V-CR2032L/BE (Panasonic)

Appendix E: Service record template for procedure section 3.4.3
Record the observations in the below table.
Sr. No. Description Observations
System ID: ____________________
Record the system ID, pump serial number

1. Pump SN: _____________________
& system software version
Software Version: _________________
BUA ________
2. Record the failed QA parameters SOS ________
Gain ________
Record the temperature at which water

3.
calibration was performed.
TC1____________ͦC
Record the gain value from the calibration

4. info screen, after performing water
Gain ________
calibration.
BUA ________
SOS ________
Record the QA parameters (after
5.
calibration)
Gain ________
QA Result _______
Field Engineer Details
Name:
Designation:
Date:

Appendix F: Power Cord Selection Guidelines
Ensure Achilles EXPII unit is connected to the mains supply with proper grounded power cord.
Below table shows the global plug standards and the corresponding socket and plug images. For
additional information, refer DOC2315407 -Achilles EXPII power cord selection guidelines matrix. This
document identifies appropriate power cords for the Achilles EXPII target countries.

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General Product Information

Information Requested by GE Healthcare Lunar

WARNING This service manual is available in English only.

Achilles EXPII Service Manual ii

Achilles EXPII Service Manual 3

Achilles EXPII Service Manual 4

Achilles EXPII Service Manual 5

8 2015/07 - update section A.4 Firmware Revision History Rakesh Ravindra

Achilles EXPII Service Manual 6

16 2018/12 - Added section 4.5 for ID9001/ 9002/ChangEUI.exe Akhil Sreedharan

Achilles EXPII Service Manual 7

Achilles EXPII Service Manual 8

GE Healthcare Europe GE Healthcare Ultrasound

1.1.5. Patient Information Privacy and Security (HIPAA)

Achilles EXPII Service Manual 1

WARNING: A warning statement reflects a potentially hazardous condition that, if not

Achilles EXPII Service Manual 2

Figure 1-1 System Label

Figure 1-2 Fill Port Figure 1-3 USB Port

Achilles EXPII Service Manual 3

The EU Battery Directive 2006/66/EC is intended to establish

The separate collection symbol is affixed to a battery, or packaging,

For information on how the battery may be safely removed from

(5) Prescription Device Label for United States

Achilles EXPII Service Manual 4

Refer to instruction manual, follow instructions for use.

UDI: Unique Device Identifier - A UDI is a unique numeric or alphanumeric

Achilles EXPII Service Manual 5

1.2.3. Unique Device Identification

Component/Description USA FDA Medical Device Classification

Achilles EXPII Class 2

Achilles EXPII Service Manual 6

Achilles EXPII Service Manual 7

• EN 60601-1-2 Electromagnetic compatibility – Requirements and tests

• EN60601-1-4 Programmable electrical medical devices

• EN60601-2-37 Particular requirements for the safety of ultrasonic medical diagnostic

• EN980 Graphical symbols for use in the labeling of medical devices

• EN1041 Information supplied by the manufacturer with medical devices

• EN60601-1-6 Collateral Standard for Usability Engineering

• CSA C22.2 No. 601.1

• European Council Directive (93/42/EEC, Medical Device Directive, Annex II)

1.4.1. Electrical Requirements

1.4.2. Peripheral Requirements

Achilles EXPII Service Manual 9

Recommended Separation Distance

Recommended Separation Distance between portable and mobile RF communications

Achilles EXPII Service Manual 10

Immunity IEC 60601-1-2 EMC Environment and

Achilles EXPII Service Manual 11

Achilles EXPII Service Manual 12

Figure 2-1 Ultrasound Transmission

2.1.2. Indications for Use

Achilles EXPII Service Manual 13

2.1.4. Comparison of Sites (Heel vs. Hip or Spine)

2.1.5. DEXA Referral criteria

Achilles EXPII Service Manual 14

2.1.6. Fracture Risk

Figure 2-2 Risk Curve

Achilles EXPII Service Manual 15

Figure 2-3 Features of the Achilles EXPII (Part 1)

Figure 2-4 Features of the Achilles EXPII (Part 2)