GE MUSE NX XML Developer Guide_SM_2102027-228_A Protector ClassMate Laboratory Fume Hoods User's Manual

GE Healthcare

MUSE NX

™

Cardiology Information System

XML Developer Guide

2102027-228A

MUSE NX
Cardiology Information System
English

©

2018 General Electric Company

All Rights Reserved.

™

Publication Information

The information in this manual applies only to the MUSE™ NX Cardiology Information System. It does not apply to earlier product versions.
Due to continuing product innovation, specifications in this manual are subject to change without notice.

12SL, CASE, CardioSoft, InSite ExC, MAC, MACCRA, MARS, MUSE, Marquette, MobileLink, and MULTI-LINK are trademarks owned by GE
Medical Systems Information Technologies, Inc., a General Electric Company going to market as GE Healthcare. All other trademarks
contained herein are the property of their respective owners.

For more information about compliance, refer to the Regulatory and Safety Guide for this product.

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

Table 1: Revision History

Revision Date Comments

A 30 September 2018 Internal release.

To access other GE Healthcare Diagnostic Cardiology documents, go to the Common Documentation Library (CDL), located at http://

apps.gehealthcare.com/servlet/ClientServlet, and select Cardiology.

To access Original Equipment Manufacturer (OEM) documents, go to the device manufacturer's website.

This document is an XML developer guide for the MUSE™ Cardiology Information System, also referred to as the "product,” “system,” or
“device.” This document is intended to be used by GE Healthcare service personnel.

Support

GE Healthcare maintains a trained staff of application and technical experts to answer questions and to respond to issues and problems
that may arise during the installation, maintenance, and use of this product.

If you require additional assistance, contact your GE Healthcare representative, or GE Healthcare support at one of the following numbers:

• North America: 1-800-558-7044

• Europe: [phone]

• Asia: [phone]

Training

This document is intended as a supplement to, not a substitute for, thorough product training. If you have not received training on the use
of the product, you should request training assistance from GE Healthcare.

To see available training, go to the GE Healthcare training website www.gehealthcare.com/training.

For more self-paced course offerings, tools, and reference guides you may find useful, visit the GE Healthcare Education Store at

www.gehealthcare.com/educationstore.

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Service Manual Language Information

WARNING
(EN)

ПРЕДУПРЕЖДЕНИЕ
(BG)

警告

ZH-CN

This service manual is available in English only.

• 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.

Това упътване за работа е налично само на английски език.

• Ако доставчикът на услугата на клиента изиска друг език, задължение на клиента
е да осигури превод.

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

• Неспазването на това предупреждение може да доведе до нараняване на
доставчика на услугата, оператора или пациент в резултат на токов удар или
механична или друга опасност.

本维修手册仅提供英文版本。

•

如果维修服务提供商需要非英文版本，客户需自行提供翻译服务。

•

未详细阅读和完全理解本维修手册之前，不得进行维修。

•

忽略本警告可能对维修人员，操作员或患者造成触电、机械伤害或其他形式的伤
害。

警告

(ZH-TW)

UPOZORENJE
(HR)

本維修手冊只提供英文版。

•

如果客戶的維修人員有英語以外的其他語言版本需求，則由該客戶負責 提供翻譯服
務。

•

除非您已詳閱本維修手冊並了解其內容，否則切勿嘗試對本設備進行維 修。

•

不

重視本警告可能導致維修人員、操作人員或病患因電擊、機械因素或 其他因素而

受到傷害。

Ove upute za servisiranje dostupne su samo na engleskom jeziku.

• Ukoliko korisnički servis zahtijeva neki drugi jezik, korisnikova je odgovornost osigurati
odgovarajući prijevod.

• Nemojte pokušavati servisirati opremu ukoliko niste konzultirali i razumjeli ove upute.

• Nepoštivanje ovog upozorenja može rezultirati ozljedama servisnog osoblja, korisnika
ili pacijenta prouzročenim električnim udarom te mehaničkim ili nekim drugim
opasnostima.

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VAROVÁNÍ
(CS)

Tento provozní návod existuje pouze vanglickém jazyce.

• Vpřípadě, že externí služba zákazníkům potřebuje návod vjiném jazyce, je zajištění
překladu doodpovídajícího jazyka úkolem zákazníka.

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

• Vpřípadě nedodržování této varování může dojít kporanění pracovníka prodejního
servisu, obslužného personálu nebo pacientů vlivem elektrického proudu, respektive
vlivem mechanických či jiných rizik.

ADVARSEL
(DA)

WAARSCHUWING
(NL)

HOIATUS
(ET)

Denne servicemanual findes kun på engelsk.

• Hvis en kundes tekniker har brug for et andet sprog end engelsk, er det kundens
ansvar at sørge for oversættelse.

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

• Manglende overholdelse af denne advarsel kan medføre skade på grund af elektrisk,
mekanisk eller anden fare for teknikeren, operatøren eller patienten.

Deze service manual is alleen in het Engels verkrijgbaar.

• Indien het onderhoudspersoneel een andere taal nodig heeft, dan is de klant
verantwoordelijk voor de vertaling ervan.

• Probeer de apparatuur niet te onderhouden voordat deze service manual
geraadpleegd en begrepen is.

• Indien deze waarschuwing niet wordt opgevolgd, zou het onderhoudspersoneel, de
gebruiker of een patiënt gewond kunnen raken als gevolg van een elektrische schok,
mechanische of andere gevaren.

Käesolev teenindusjuhend on saadaval ainult inglise keeles.

• 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
(FI)

Tämä huolto-ohje on saatavilla vain englanniksi.

• 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.

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ATTENTION
(FR)

Ce manuel technique n'est disponible qu'en anglais.

• Si un service technique client souhaite obtenir ce manuel dans une autre langue que
l'anglais, il devra prendre en charge la traduction et la responsabilité du contenu.

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

• Le non-respect de cet avertissement peut entraîner chez le technicien, l'opérateur ou
le patient des blessures dues à des dangers électriques, mécaniques ou autres.

WARNUNG
(DE)

FIGYELMEZTETÉS
(HU)

AÐVÖRUN
(IS)

Diese Serviceanleitung ist nur in englischer Sprache verfügbar.

• Falls der Kundendienst eine andere Sprache benötigt, muss er für eine entsprechende
Übersetzung sorgen.

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

• Bei Zuwiderhandlung kann es zu Verletzungen des Kundendiensttechnikers, des
Anwenders oder des Patienten durch Stromschläge, mechanische oder sonstige
Gefahren kommen.

Ez a szerviz kézikönyv kizárólag angol nyelven érhető el.

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

• Ne próbálja elkezdeni használni a berendezést, amíg a szerviz kézikönyvben leírtakat
nem értelmezték és értették meg.

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

Þessi þjónustuhandbók er eingöngu fáanleg á ensku.

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

• Reynið ekki að afgreiða tækið nema þessi þjónustuhandbók hefur verið skoðuð og
skilin.

• Brot á að sinna þessari aðvörun getur leitt til meiðsla á þjónustuveitanda, stjórnanda
eða sjúklingi frá raflosti, vélrænum eða öðrum áhættum.

PERINGATAN
(ID)

Manual servis ini hanya tersedia dalam bahasa Inggris.

• Jika penyedia jasa servis pelanggan memerlukan bahasa lain selain dari Bahasa
Inggris, merupakan tanggung jawab dari penyedia jasa servis tersebut untuk
menyediakan terjemahannya.

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

• Mengabaikan peringatan ini bisa mengakibatkan cedera pada penyedia servis,
operator, atau pasien, karena terkena kejut listrik, bahaya mekanis atau bahaya
lainnya.

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AVVERTENZA
(IT)

Il presente manuale di manutenzione è disponibile soltanto in Inglese.

• Se un addetto alla manutenzione richiede il manuale in una lingua diversa, il cliente è
tenuto a provvedere direttamente alla traduzione.

• Si proceda alla manutenzione dell'apparecchiatura solo dopo aver consultato il
presente manuale ed averne compreso il contenuto.

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

警告

(JA)

경고

(KO)

ЕСКЕРТУ
(KK)

このサービスマニュアルは英語版しかありません。

•

サービスを担当される業者が英語以外の言語を要求される場合、翻訳作業はその
業者の責任で行うものとさせていただきます。

•

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

•

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

본 서비스 지침서는 영어로만 이용하실 수 있습니다.

•

고객의 서비스 제공자가 영어 이외의 언어를 요구할 경우, 번역 서비스를 제공하는
것은 고객의 책임입니다.

•본

서비스 지침서를 참고했고 이해하지 않는 한은 해당 장비를 수리하려고 시도하지

마십시오.

•이

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

공자, 운영자 혹은 환자에게 위해를 가할 수 있습니다.

Бұл қызмет көрсету

Тұтынушының қызмет

•
етсе, аудару бойынша

бойынша

нұсқаулығы

провайдері

ағылшын

тек

ағылшын

тілінен

қызметтерімен қамтамасыз

тілінде

басқа

тұтынушы

ету

қолжетімді.

нұсқаны

тілдегі

жауапкершілігінде

талап

болуы тиіс.

Бұл қызмет көрсету

•

қызмет көрсетуден

Бұл

•

ескертуді елемеу

шогынан,

механикалық

бойынша

бас

қызмет

нұсқаулығын назарға

тартыңыз.

провайдері, оператор немесе

немесе

басқа қауіптер нəтижесінде жарақат

түсінбегенше, жабдыққа

алып,

емделушінің

электр

алуына

мүмкін.

əкелуі

BRĪDINĀJUMS
(LV)

Šī apkalpotāju rokasgrāmata ir pieejama tikai angļu valodā.

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

• Neveiciet aprīkojuma apkopi, neizlasot un nesaprotot apkalpotāju rokasgrāmatu.

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

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ĮSPĖJIMAS
(LT)

Šis eksploatavimo vadovas yra prieinamas tik anglų kalba.

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

• Nemėginkite atlikti įrangos techninės priežiūros, nebent atsižvelgėte į šį eksploatavimo
vadovą ir jį supratote.

• Jei neatkreipsite dėmesio į šį perspėjimą, galimi sužalojimai dėl elektros šoko,
mechaninių ar kitų paslaugų tiekėjui, operatoriui ar pacientui.

ADVARSEL
(NO)

OSTRZEŻENIE
(PL)

AVISO
(PT-BR)

Denne servicehåndboken finnes bare på engelsk.

• Hvis kundens serviceleverandør trenger et annet språk, er det kundens ansvar å sørge
for oversettelse.

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

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

Niniejszy podręcznik serwisowy dostępny jest jedynie w języku angielskim.

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

• Nie należy serwisować wyposażenia bez zapoznania się i zrozumienia niniejszego
podręcznika serwisowego.

• Niezastosowanie się do tego ostrzeżenia może spowodować urazy dostawcy usług,
operatora lub pacjenta w wyniku porażenia elektrycznego, zagrożenia mechanicznego
bądź innego.

Este manual de assistência técnica só se encontra disponível em inglês.

• Se o serviço de assistência técnica do cliente não for GE, e precisar de outro idioma,
será da responsabilidade do cliente fornecer os serviços de tradução.

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

• O não cumprimento deste aviso pode por em perigo a segurança do técnico, operador
ou paciente devido a choques elétricos, mecânicos ou outros.

AVISO
(PT-PT)

Este manual técnico só se encontra disponível em inglês.

• Se a assistência técnica do cliente solicitar estes manuais noutro idioma, é da
responsabilidade do cliente fornecer os serviços de tradução.

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

• O não cumprimento deste aviso pode provocar lesões ao técnico, ao utilizador ou ao
paciente devido a choques eléctricos, mecânicos ou outros.

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AVERTISMENT
(RO)

Acest manual de service este disponibil numai în limba engleză.

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

• Nu încercaţi să reparaţi echipamentul decât ulterior consultării şi înţelegerii acestui
manual de service.

• Ignorarea acestui avertisment ar putea duce la rănirea depanatorului, operatorului
sau pacientului în urma pericolelor de electrocutare, mecanice sau de altă natură.

ПРЕДУПРЕЖДЕНИЕ
(RU)

UPOZORENJE
(SR)

VAROVANIE
(SK)

Настоящее руководство по обслуживанию предлагается только на английском языке.

• Если сервисному персоналу клиента необходимо руководство не на английском, а
на каком-то другом языке, клиенту следует обеспечить перевод самостоятельно.

• Прежде чем приступать к обслуживанию оборудования, обязательно обратитесь к
настоящему руководству и внимательно изучите изложенные в нем сведения.

• Несоблюдение требований данного предупреждения может привести к тому,
что специалисты по обслуживанию, операторы или пациенты получат удар
электрическим током, механическую травму или другое повреждение.

Ovo servisno uputstvo je dostupno samo na engleskom jeziku.

• 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.

Tento návod na obsluhu je k dispozícii len v angličtine.

• Ak zákazníkov poskytovateľ služieb vyžaduje iný jazyk ako angličtinu, poskytnutie
prekladateľských služieb je zodpovednosťou zákazníka.

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

• Zanedbanie tohto varovania môže vyústiť do zranenia poskytovateľa služieb,
obsluhujúcej osoby alebo pacienta elektrickým prúdom, mechanickým alebo iným
nebezpečenstvom.

OPOZORILO
(SL)

Ta servisni priročnik je na voljo samo v angleškem jeziku.

• Če ponudnik storitve stranke potrebuje priročnik v drugem jeziku, mora stranka
zagotoviti prevod.

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

• Če tega opozorila ne upoštevate, se lahko zaradi električnega udara, mehanskih ali
drugih nevarnosti poškoduje ponudnik storitev, operater ali bolnik.

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ADVERTENCIA
(ES)

Este manual de servicio sólo existe en inglés.

• 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
(SV)

UYARI
(TR)

ЗАСТЕРЕЖЕННЯ
(UK)

Den här servicehandboken finns bara tillgänglig på engelska.

• 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.

Bu servis klavuzunun sadece İngilizcesi mevcuttur.

• Eğer müşteri teknisyeni bu klavuzu İngilizce dşnda bir başka lisandan talep ederse,
bunu tercüme ettirmek müşteriye düşer.

• Servis klavuzunu okuyup anlamadan ekipmanlara müdahale etmeyiniz.

• Bu uyarya uyulmamas, elektrik, mekanik veya diğer tehlikelerden dolay teknisyen,
operatör veya hastann yaralanmasna yol açabilir.

Дане керівництво з сервісного обслуговування постачається виключно англійською
мовою.

• Якщо сервісний інженер потребує керівництво іншою мовою, користувач
зобов'язаний забезпечити послуги перекладача.

• Не намагайтеся здійснювати технічне обслуговування даного обладнання, якщо
ви не читали, або не зрозуміли інформацію, надану в керівництві з сервісного
обслуговування.

• Недотримання цього застереження може призвести до травмування сервісного
інженера, користувача даного обладнання або пацієнта внаслідок електричного
шоку, механічного ушкодження або з інших причин невірного обслуговування
обладнання.

CẢNH

(VI)

BÁO

Liệu Hướng Dẫn Sửa Chữa chỉ

Tài

Nếu

•

các

đơn vị

cung

cấp dịch vụ

Anh, thì khách hàng sẽ có trách

• Không

• Không tuân

được sửa chữa thiết bị trừ

thủ những cảnh

sửa chữa, người vận

hành hay

bản tiếng

có

cho khách hàng yêu

nhiệm

khi đã tham

báo này có

bệnh

nhân, do

khác

2102027-228A MUSE NX

Anh.

cấp

cung

khảo

thể dẫn đến

sốc điện,

™

cầu một

dịch vụ dịch thuật.

các

hiểu

và

Tài

tổn thương

các

rủi

các

ngôn

ngữ

nào khác

tiếng

liệu Hướng dẫn Sửa chữa.

người thực hiện

cho

ro về cơ khí hay các

rủi

ro

9

Table of Contents

1:Overview.............................................................................................................. 12

Technology..............................................................................................................................................................12

Communication....................................................................................................................................................13

Functionality of Imported Test Data..........................................................................................................13

2:Rules and Restrictions.......................................................................................14

General XML Document File Structure......................................................................................................14

XML Element and Tag Requirements........................................................................................................ 15

Content.....................................................................................................................................................................15

DTD File.................................................................................................................................................................... 16

3:Data Section and Element Requirements......................................................17

Resting ECG Test Requirements...................................................................................................................17

Required Sections and Elements.................................................................................................................18

4:Optional Sections............................................................................................... 20

Waveforms..............................................................................................................................................................20

MUSE System Data Types...............................................................................................................................21

Interface Development and Verification..................................................................................................22

Development..............................................................................................................................................22

Verification..................................................................................................................................................22

5:MUSE XML Import Option................................................................................. 23

Theory of Operation...........................................................................................................................................23

Customer Requirements.................................................................................................................................. 23

Install and Configure the MUSE XML Import Option..........................................................................23

Install the XML Import Option and the MUSE XML Parser Service...................................24

Set up the XML Shared Folder..........................................................................................................25

Use XMLCONFIG.EXE to Add a New XML Device......................................................................25

Use XMLCONFIG.EXE to Update or Delete a Device...............................................................27

Known XML Device Configurations................................................................................................ 27

System Checkout.................................................................................................................................................29

Troubleshooting....................................................................................................................................................29

6:Transactional XML to FDA XML Converter.....................................................30

System Requirements....................................................................................................................................... 30

Installation Procedures.....................................................................................................................................31

Create Directories................................................................................................................................... 31

Copy Files to Computer....................................................................................................................... 31

Use the XML Conversion Tool....................................................................................................................... 32

Run the MUSE2FDA Conversion Program................................................................................... 32

XML Data Mapping.................................................................................................................................33

Object Identifier Mapping....................................................................................................................33

User-Defined Mapping..........................................................................................................................33

XML Data Mapping.............................................................................................................................................35

MUSE2FDACFG.XML Mappings......................................................................................................... 35

Waveform Mapping - Raw.................................................................................................................42

Waveform Mapping - Median...........................................................................................................43

Interval Annotation Mapping.............................................................................................................43

Diagnosis (Interpretation) Mapping................................................................................................ 43

MUSE XML to FDA XML Mapping.....................................................................................................43

A:Section and Element Definitions.....................................................................53

Overview.................................................................................................................................................................. 53

GE Healthcare Data Sections............................................................................................................53

Table Explanation....................................................................................................................................54

Patient Demographics Section (Required)...............................................................................................54

Test Demographics Section (Required).....................................................................................................55

Order Information Section (Optional).........................................................................................................58

QRS Times and Types (Optional, Export Only)......................................................................................60

Diagnosis Section (Optional).......................................................................................................................... 60

Waveforms Section (Optional).......................................................................................................................61

Pacemaker Spikes Section (Optional)........................................................................................................ 61

Lead Data Section.............................................................................................................................................. 62

Pharma Data (Optional)....................................................................................................................................63

Resting ECG Measurements Section (Optional).................................................................................... 64

Original Resting ECG Section (Optional)................................................................................................... 65

QRS Section (Optional, Export Only)........................................................................................................... 65

XML Data Export..................................................................................................................................................65

Measurement Matrix..........................................................................................................................................69

Global Measurements...........................................................................................................................69

Per-Lead Measurements......................................................................................................................69

B:Sample XML Documents................................................................................... 73

Sample Well-formed Document.................................................................................................................. 73

Sample Patient Demographics Section....................................................................................................79

Sample Test Demographics Section.......................................................................................................... 79

Sample Order Information Section.............................................................................................................80

Sample Diagnosis Section with Diagnosis Statement.......................................................................80

Sample Waveform Section.............................................................................................................................81

Overview

Overview

GE Healthcare’s Transactional XML Developer's module allows you to import
cardiology-related data from non-GE Healthcare devices into the system for storage,
printing, and distribution to the Hospital Information System (HIS). The system accepts
only resting ECG test data, both confirmed and unconfirmed.

1

• Confirmed tests - results were read and confirmed by a physician.

• Unconfirmed tests - results were not interpreted or read by a physician.
Multiple types of vendor data are accepted. The data can be all text, or a combination

of textual and waveform data. After the textual data reaches the system, you can
modify it. Once confirmed, both textual and waveform data are stored long-term in
the system databases. You cannot perform serial comparison on imported data, and
interpretation is stored as free text.

This chapter provides an overview of the Transactional XML Developer's module and
the requirements needed to run it. This document is intended for individuals who
develop Cardiology-related XML documents they want to store in the MUSE system.

Technology

The Transactional XML Developer's module uses the Extensible Markup Language
(XML) as the means of importing non-GE Healthcare cardiology data into the system.
The test data is packaged into an XML file called a document. This document is sent to
the system where the data is converted into the appropriate format and then stored
in the system databases.

The conversion of data from XML into the system's format is based on a fixed set of
data tags. The data tags are contained in XML Document Type Definition (DTD) files
defined by GE Healthcare. Each specific test type has its own DTD file.

To successfully transfer your data into the system, you must adhere to the
requirements of the DTD file as well as the rules and restrictions specified in this
guide.

The Transactional XML Developer's module is built on the Microsoft XML parser and
requires the installation of that software. Refer to MUSE Information System XML
Export Option Instruction.

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This manual assumes a working knowledge of XML. It is not intended as a guide to
XML nor its terminology. You are encouraged to take advantage of the abundance of
information about XML and the XML data specification available on the Internet.

Communication

The system expects to receive XML document files containing the vendor’s data
either through FTP communication (the system is designated to be the FTP server)
or through a mapped drive over a local area network. The local area network
connecting to the system must support Ethernet Layer 2 protocol and TCP/IP protocol
running layers 3 and 4. These simple communication techniques do not allow for any
type of communication acknowledgment other than the inherent acknowledgments
built into FTP and/or the network transfers.

You only need to set up a few communication parameters to establish this simple
communication. The system needs to know:

Overview

• The location of the XML document file(s).

• The extension of the XML document files containing data you are storing on the
system. The filename designation accepts wild cards.

NOTE:

The XML document file(s) must reside in a shared directory, that is, a directory to
which the system has access.

Once the system accepts an XML document, it begins to parse the data. Once the
system successfully acquires the data in the XML document, the XML document is
deleted from the communication directory. If the transfer of information fails and the
system is unable to obtain the XML document data, the XML document is not deleted
from the communication directory but instead is renamed with a .BAD extension.

Functionality of Imported Test Data

The MUSE System XML Parser accepts third-party vendor data. Because some of this
data is not analyzed with 12SL, there are limitations to what you can do with the data:

• You cannot run the data through serial comparison.

• You can send it to carts for printing (Reverse Transmission).

You can retrieve data from acquiring resting ECG devices using the Remote Query
feature.

You may have limitations in the printing and display of the data because some third­party data does not include all 10 seconds of all 12 leads.

If there is enough information, the system analyzes the data to produce median
complexes. The system generates a set of measurements called the Measurement
Matrix for the data.

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Rules and Restrictions

Rules and Restrictions

To successfully transfer non-GE Healthcare cardiology information to the system
through the Transactional XML Developer's module, you need to submit your data in
the form of a valid XML document. The XML document you submit must meet all the
standard XML requirements and must adhere to specific rules.

2

General XML Document File Structure

The following outlines the general document file structure for XML documents.

• Every XML document must be a well-formed XML document.

• XML documents must be valid to the DTD. The system does not process invalid
documents.

• Each XML document must begin with an XML document type declaration that
specifies:

• The version of XML you are using.

• The encoding of the XML document (for example, “windows-1252”)

• The name of the root element.

• The name of the GE Healthcare external DTD file.

• The root element identifies the information in the document and relates it to a

specific type of system data.

NOTE:

The XML document file(s) must be located in a shared directory, that is, a
directory to which the system has access.

• XML documents must contain only one root element.

• XML documents must contain one, and only one, test.

• Each XML document must contain displayable ASCII characters.

• Each data element must be on a separate line, and the line must terminate with a
carriage return and line feed (hex format of 0x0D0x0A).

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• Each non-empty element within the XML document must contain three
components:

• A start tag

• An end tag

• The element’s content or value, configured as: <StartTag> Content </EndTag>

• Every XML document must contain a Patient Demographics and Test
Demographics data section, and the required elements of each. See "Section and

Element Definitions" on page 53 for more information.

XML Element and Tag Requirements

This section defines the specific XML element and tag requirements to effectively use
the Transactional XML Developer's module.

• Every data section and element in the XML document must use the appropriate GE
Healthcare-defined tag. See "Section and Element Definitions" on page 53 for a
list of acceptable sections and elements and their corresponding GE Healthcare
tags.

Rules and Restrictions

Content

• Each XML tag (for example, PatientLastName) consists of a maximum of 127
characters.

• The acceptable values of certain elements are predefined by GE Healthcare. For
example, the value of the Gender element is limited to male or female. These
Predefined Values are specified in the tables in "Section and Element Definitions"

on page 53 .

The body (content) of the XML document is all the data contained between the root
element start and end tags. This includes multiple sections and elements within each
section. The data contained in the body of an XML document can be any combination
of text, predefined values, and waveform data.

Limits on the value of an element depend on the specific type of element. Refer to the
tables in "Section and Element Definitions" on page 53 for limitations on element
values.

You can omit elements that have no content, known as empty-elements, from the
document or note them as: <tag> </tag>

The shortcut method of <tag/> is not supported.

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Rules and Restrictions

DTD File

The GE Healthcare Transactional XML Developer's module uses a library of DTD files.
The DTD file is specific to the resting ECG test type. You must include the appropriate
DTD filename in the data declaration of your XML document.

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Data Section and Element Requirements

The system is capable of accepting large amounts of data pertaining to a resting
ECG test. To manage this data, the information is organized into logical groups called
sections. For example, data related to patient statistics (patient ID, patient name,
age, and so forth) is grouped into a section of the XML document called Patient
Demographics. Similarly, data associated with a particular test (acquisition date and
time, location, and so forth) is grouped into a data section called Test Demographics.

Data Section and Element Requirements

3

Within a section, certain elements are required while others are optional. If your XML
document includes a particular section, it also must include all required elements for
that section. Optional elements are included at your discretion.

Resting ECG Test Requirements

The following are required for resting ECG:

• 500 Hz test data only (250 allowed for export)

• For a 12 lead ECG: 10 seconds of 8 leads in order (I, II, V1-V6)

• For a 15 lead Pediatric ECG: 10 seconds of 11 leads in order (I, II, V1-V6) and V3r,
V4r, V7

• For a 15 lead Vector Loop ECG: 10 seconds of 11 leads in order (I, II, V1-V6) and X, Y,
Z

• For a 15 lead Aux ECG: 10 seconds of 11 leads in order (I, II, V1-V6) and any 3 lead
labels from the supported extra leads (V2R, V3R, V4R, V5R, V6R, V7R, X, Y, Z, V8, V9,
V8R, V9R, NEHB_D, NEHB_A, NEHB_J, ML, CH, A1, A2, A3, A4, VM, BP_X, BP_Y, BP_Z)

• Data sampled at 4.88uV/bit

• Waveform data Hex64 encoded

The Resting ECG file can contain the following sections, which must be in this order:

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Data Section and Element Requirements

NOTE:

The Waveform element includes an optional PaceSpikes element that can be
imported. The import of spikes will override the 12SL automatic spike detection. If
the pacemaker spikes are known, they should be included in the XML.

Section Tag Required Repeats Export

MUSE Information MuseInfo N N y

Patient Demographics PatientDemographics Y N N

Test Demographics TestDemographics y N N

Order Information Order N N N

Only

Resting ECG
Measurements

Original Resting ECG
Measurements

Diagnosis Diagnosis N N N

Original Diagnosis OriginalDiagnosis N N Y

Extra Questions ExtraQuestions N N N

ACI TIPI Anaylsis ACITIPIAnalysis N N N

Measurement Matrix MeasurementMatrix N N Y

Interval Editor Interval
Measurements

QRS Times and Types QRSTimesTypes N N Y

Interval Editor Amplitude
Measurements

Waveform Waveform N Y N

Image Image N Y N

RestingECGMeasurements N N N

originalRestingECGTMeasurements N N Y

IntervalMeasurements N N Y

AmplitudeMeasurements N N Y

Pharmaceutical Trial Data PharmaData N N N

Required Sections and Elements

Of all the possible data you can send to the system, you must include the following
two sections in every XML document the system receives. Within each of the required
sections there are required elements. The required sections and elements are:

• Patient Demographics section Required element: Patient ID

• Test Demographics section Required elements:

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Data Section and Element Requirements

• Data Type

• Site

• Acquisition Device

• Status

• Acquisition Time

• Acquisition Date

• Acquisition Software Version

All other sections and elements are optional. If you choose to include a particular
section, you must include the required elements for that section. A complete listing
of possible data sections and their associated elements is available in "Section and

Element Definitions" on page 53. Required elements for each section are in the

Field Status column of each table.
NOTE:

If your XML document contains elements other than those identified in "Section

and Element Definitions" on page 53, the file is considered invalid and does not

process.

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Optional Sections

Optional Sections

There are many optional sections that you can include. Optional sections include an
assortment of common elements.

One section requires special attention. Although the Diagnosis section is optional, if
you use a Diagnosis section, you must include the Diagnosis Statement section(s),
which requires a Statement Text element. XML samples of optional data sections are
provided in "Sample XML Documents" on page 73.

4

NOTE:

Optional sections include:

• Order Information

• Diagnosis with Diagnosis Statement

• Waveforms

Waveforms

You can include waveforms associated with a patient test in the body of XML
documents.

The required tag for including waveform information in the body of an XML document
is Waveform. Since waveforms are made up of lead data, the Waveform section
of the document must contain information about the leads, followed by the actual
Lead Data section with all its required elements. The data for each lead must be
uncompressed and hex64 encoded.

The required elements in the Lead Data section include a 32–bit Cyclic Redundancy
Check (CRC),, which is a number derived from the lead data. The system recalculates
this CRC from the data it receives and compares it to the CRC sent in the
LeadDataCRC32 element. Different CRC values indicate a transmission error.

For tests that were not analyzed by GE Healthcare's 12SL analysis program, the
diagnosis is input as free text.

Additional information on section and element requirements when including
waveform data in your XML document is located in "Section and Element Definitions"

on page 53.

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A sample waveform section from an XML document is located in "Sample XML

Documents" on page 73.

MUSE System Data Types

The MUSE system stores various types of information in an assortment of data types.
The acceptable data types are shown in the following table.

NOTE:

Although the system can accept many data types, each specific system data field
requires a particular type of data. The specific format required for each element
passing to the system is specified in the tables in "Section and Element Definitions"

on page 53.

Data Type Description

Date Contains the day, month, and year to store on the system. Format the date

as either MM/DD/YYYY or MM-DD-YYYY. Where:MM = Month 01-12DD =
Day = 01-31YYYY = Four digit year value

Optional Sections

Time Contains the hour, minutes, seconds, and milliseconds to store on the

system. The time must be formatted as HH:MM:SS:NN. Where:HH = Hour =
00-23MM = Minute = 00-59SS = Second = 00-59NN = Hundredths = 00-99
(optional)

Predefined Values You can pass many elements to the system for which the system expects

to receive one of a limited number of predefined responses. For example,
the Gender element is one of these Predefined Values. If your XML
document contains the Gender element, then the data passed to the
system through that element must be one of the following predefined
options for this data:

• Male

• Female

These Predefined Values and their acceptable options are specified in the
tables in "Section and Element Definitions" on page 53.

Diagnosis Statements Contains the textual interpretation, impressions, or conclusions regarding

a particular test. No statement or sentence of the diagnosis, referred to
as the Statement Text (StmtText), can exceed 127 characters. In addition
to the Statement Text, you can include one or more Statement Flags for
each Statement Text. The Statement Flag indicates one or more of the
following conditions about the statement itself:

• EndsLine - Statement ends the interpretative line

• Deleted - Statement was deleted from interpretation

• UserInsert - Statement was added to the interpretation by the user

User ID A unique numeric number assigned to every person in the system User’s

List.

Numeric A number within the element specified range.

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Optional Sections

Data Type Description

String A finite set of characters from the ASCII character set. A String type always

has a defined maximum length of characters.

8 Bit Unsigned Data types ranging from 0 to 253.

8 Bit Signed Data types ranging from –125 to +125. If the sign is not explicitly defined, it

is assumed to be a positive value.

16 Bit Unsigned Data types ranging from 0 to 65533.

16 Bit Signed Data types ranging from –32765 to +32765. If the sign is not explicitly

defined, it is assumed to be a positive value.

32 Bit Unsigned Data types ranging from 0 to 4,294,967,293.

32 Bit Signed Data types ranging from –2,147,483,645 to +2,147,483,645.

Float Data types cannot exceed three decimal points. Exponential notation is

not supported.

Interface Development and Verification

Each vendor must develop, test, verify, and validate their interface before connecting
to the MUSE system.

Development

Each vendor requesting the ability to interface their specific devices with the GE
Healthcare MUSE system is solely responsible for developing the software and/or
hardware needed to complete this interface.

Verification

Before submitting data to the system through the Transactional XML Developer's
module, the interface must undergo verification and validation, including clinical
testing, by a GE Healthcare-specified certification agent. This verification process is a
requirement of GE Healthcare as well as the Food and Drug Administration (FDA). Its
purpose is to ensure the overall safety and effectiveness of the interface.

Near or upon completion of the requesting vendor’s interface development, the
requesting vendor must contact GE Healthcare’s interface certification agent to
request and schedule an interface certification date and time.

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MUSE XML Import Option

This chapter describes how to configure the MUSE XML Import option to process
incoming XML files on the MUSE system.

MUSE XML Import Option

5

Theory of Operation

The XML Import option allows the MUSE system to acquire XML files that meet
the MUSE Transactional XML specification. Devices that are able to output the
appropriately structured XML files send their XML files into a shared folder on the
MUSE system. The MUSE XML Parser service searches this shared folder, acquires
the XML files from the shared folder, and moves them into the MUSE system for
processing. The test is normalized and stored in the MUSE database.

Figure 1: XML Acquisition Flow Chart

Customer Requirements

The customer is responsible for supplying the following:

• XML files that meet the MUSE Transactional XML specification. Refer to the MUSE
Cardiology Information System Transactional XML Developer’s Guide for details.

• Network connectivity between the device that can output XML files and the MUSE
application server.

Install and Configure the MUSE XML Import Option

Adding the XML Import option consists of the following tasks:

• "Install the XML Import Option and the MUSE XML Parser Service" on page 24

• "Set up the XML Shared Folder" on page 25

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MUSE XML Import Option

• "Use XMLCONFIG.EXE to Update or Delete a Device" on page 27

Install the XML Import Option and the MUSE XML Parser Service

Use the following procedure to install the XML Import option and MUSE XML Parser
service.

NOTE:

This procedure may only be performed by a qualified GE Healthcare service
representative.

1. Log on to the MUSE application server as the MUSE Administrator user.

2. Perform a full or partial shutdown of the MUSE system following the auto

shutdown procedures described in the System Administration chapter of the
MUSE Cardiology Information System Service Manual.

NOTE:

If you are just checking to see if the option is already enabled, a shutdown is
not required. If you have to enable or disable the option, the MUSE services
will be restarted and a shutdown is required.

3. From the Windows Control Panel, go to Programs > Programs and Features.

4. Select MUSE NX R1, right-click and select Change.

The Welcome window opens.

5. Click Next.

The MUSE Server Details window opens.

6. Click Next.

The Select Database Server window opens.

7. Select the appropriate database server and click Next.

The Database Configuration window opens.

8. Make the appropriate selections and click Next.

The Select Options window opens.

9. Verify that XML Import option is selected. If it is not selected, select it now and go

to the next step. If XML Option is selected, click cancel.
This installs the MUSE XML Parser service.

10. Continue to click Next and follow the install wizard until you reach the MUSE

Serial Number window.

11. If you added the XML Import option in step 9, you need to enter the Options

Configuration Password.
NOTE:

Only qualified GE Healthcare service representatives have access to this
password. This password cannot be provided to customers.

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12. Click Next until your changes are applied and the Maintenance Complete

window opens.

13. Click Finish.

14. If you performed a full or partial shutdown of the MUSE system in step "2", cancel

the shutdown following the procedures described in the System Administration
chapter of the MUSE Cardiology Information System Service Manual.

Set up the XML Shared Folder

To transfer XML tests from an XML-capable device to the MUSE system, you need to
create a shared folder on the MUSE system.

The MUSE XML Parser service on the MUSE application server is only configured to
check the MUSE XML folder (default is d:\muse\xml) for incoming XML files to process.

This folder may need to be shared to allow XML-capable devices to transfer records
into it. If this folder is shared, the XML-capable device that will be writing data
to the share must have access to it. Customers are responsible for ensuring this
connectivity between the XML device and the MUSE system.

MUSE XML Import Option

NOTE:

There are nine DTD files in the MUSE XML folder. These .DTD files are required
for the MUSE system to acquire XML records. These files must not be altered or
deleted.

Use XMLCONFIG.EXE to Add a New XML Device

The XMLCONFIG utility inserts entries into the cfgXmlInput table in the MUSE_System
database.

1. Log on to the MUSE application server as the MUSE Administrator user.

2. Run the xmlconfig.exe utility located in the folder where the MUSE application is

installed (default is c:\Program Files(x86)\MUSE).

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MUSE XML Import Option

3. Click New Device.

The XML Input Devices window opens.

The Add a New XML Device window opens.

4. Enter the device configuration using the following table.

Field Value

Device Name Enter a unique name for each device. The value entered here

must match the <AcquisitionDevice> value in the incoming XML
file.

Device Type Select ECG. No other data types are supported at this time.

Manufacturer Select the appropriate manufacturer. Anyone other than Physio

Controls or Getemed is acceptable unless the device is actually
a Physio Controls (except for LP15-GL) or Getemed device. The
specific configurations for the Physio Control LP12 and Getemed
devices are documented in "Known XML Device Configurations"

on page 27. When in doubt, choose Other.

Image Type Always set this to Image as Waveform Data Points.

Analysis Function Always set this to XML_AnalyzeWaveform. This is case sensitive

and is auto-populated in the XMLCONFIG utility; do not change
this value.

5. Click OK.

6. Verify the Device Name has been added to the list of XML Devices in the

XMLCONFIG utility.

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7. Close the XMLCONFIG utility.

8. Restart the MUSE XML Parser service.

Use XMLCONFIG.EXE to Update or Delete a Device

1. Log in to the MUSE application server as the MUSE Administrator user.

MUSE XML Import Option

2. Run the xmlconfig.exe utility located in the folder where the MUSE application is

installed (default is c:\Program Files (x86)\MUSE).
The XML Input Devices window opens.

3. To update a device, select the device and click Update Device and use the

information in step "4" of the "Use XMLCONFIG.EXE to Add a New XML Device" on

page 25 .

NOTE:

When updating a device, the device name cannot be changed. To change
the name of a device, the device must first be deleted and then recreated
with a new name.

To delete a device, click Delete Device.

4. Click OK.

5. Close the XMLCONFIG utility.

6. Restart the MUSE XML Parser service.

Known XML Device Configurations

The following windows display the XML device configurations you must use to
configure the following specific devices:

• Physio Controls LifePak 12

• Physio Controls LifePak 15

• Getemed CM3012

• DataMed Format Translator

• Zoll RescueNet

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MUSE XML Import Option

Physio Controls LifePak 12 Getemed CM3012

Physio Controls LifePak 15 DataMed Format Translator

Zoll RescueNet

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MUSE XML Import Option

System Checkout

To make sure the MUSE XML Import option is properly set up, do the steps below.

1. Transfer an XML file to the XML folder on the MUSE system.

2. Log on to the MUSE system.

3. Verify the test displays in the Edit List.

4. Verify the test opens in Editor.

Troubleshooting

Use the following troubleshooting tips if something is not working correctly.

Symptom Condition Action

The XML file is not processed
from the XML folder.

XML is renamed to BAD in the
MUSE XML folder.

The MUSE XML Parser service is
not started.

The XMLCONFIG.EXE
configuration is incorrect.

MUSE XML Parser is unable to
process the XML file.

Start the MUSE XML Parser
service.

Ensure the XMLCONFIG.EXE
configuration is correct.

Check the MUSE application log
for details.

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Transactional XML to FDA XML Converter

Transactional XML to FDA XML
Converter

6

System Requirements

The following table lists the requirements to install and successfully convert resting
ECGs from transactional XML to FDA XML.

Item Requirements

MUSE system • Software version 9 or higher

Personal computer: • Must not be a MUSE file server or client

• Options activated:

• XML Export (ECG-only)

• Results Interface

• Interface Toolkit

• *HIS File Copy

• *HIS FTP

• *HIS Drive Mapping* At least one of these three options
needs to be activated.

• XML device set up in System Setup. Refer to the MUSE XML
Export Option Installation Instructions.

• Windows 7 or later

• Microsoft .NET Framework Version 4.5.1 Redistributable Package

• CD drive

• Internet access

Internet Access eDelivery Account

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Installation Procedures

Use the following instructions to install the muse2fda.exe conversion program.
NOTE:

During the installation of MUSE NX R1, Microsoft .NET Framework 4.6.2 is
automatically installed.

Create Directories

NOTE:

Installation of software requires administrative privileges on the computer.

Create the following directory structure on the computer hard drive running the XML
conversion program.

NOTE:

The following directory hierarchy is suggested as a way to help you organize your
files, but is not required to run the MUSE2FDA program. The procedures in this
document refer to these directories by the following names.

Transactional XML to FDA XML Converter

Copy Files to Computer

1. From the eDelivery portal, copy and mount the .iso file to the computer that will
run the XML conversion.

2. Copy the following files to the directories created earlier.
NOTE:

The four DTD files MUST be copied to the directory that contains the ECGs in
transactional XML format.

Name of File Copy to Directory

I2.dtd TransactionalXML

I2FIELD.DTD TransactionalXML

restecg.dtd TransactionalXML

restecgfield.dtd TransactionalXML

template.xml XMLConversionTool

templateutf8.xml XMLConversionTool

muse2fdacfg.xml XMLConversionTool

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Transactional XML to FDA XML Converter

Name of File Copy to Directory

muse2fda.exe XMLConversionTool

template_minimal.xml XMLConversionTool

Use the XML Conversion Tool

Copy the transactional XML files from the MUSE system to removable media, such as
a flash drive, and from the removable media to the XML Conversion directory. If the
computer is networked to the MUSE system, you can map the XML device to the XML
Conversion directory. Refer to the MUSE XML Export Option Installation Instructions for
details.

Run the MUSE2FDA Conversion Program

1. From the Windows desktop of the computer running the XML conversion utility,
open a Command Prompt window.

2. In the Command Prompt window change to the directory where the
muse2fda.exe file is located.

3. Type the following at the prompt and press Enter.

muse2fda.exe [MUSE XML path] [FDA XML path] [-t:template-filename] [-e:error-filename] [-v]
[-val] [-p:FDA_Prefix]

The following table summarizes the meaning and function of the parts of this
command line.

Portion of Command Line Meaning/Function

[MUSE XML path] Directory/file name of transactional XML file

(wildcards and ? masks supported).

[FDA XML path] Destination directory name for the FDA XML

files.

-t:template-filename Path to the template.xml file name. Defaults
to current directory’s template.xml.

-e:error-filename Path to error file. Default action writes an
error log to the console.

-v Enable verbose mode.

-val Validates MUSE XML file(s) against the MUSE

-p:FDA_Prefix Names FDA XML files with the template:

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DTD files.

[FDA_Prefix] PID_YYYYMMDD_HHMMSS.xml

Defaults to FDA_ [MUSE XML FILEname] .xml

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The following is an example using the directory structure suggested in "Create

Directories" on page 31. In the Command Prompt window, type:

muse2fda.exe [Space] ..\transactionalxml\*.xml [Space] ..\fdaxml

XML Data Mapping

This section covers the following mappings:

• "MUSE2FDACFG.XML Mappings" on page 35

• "Waveform Mapping - Median" on page 43

• "Waveform Mapping - Raw" on page 42

• "Interval Annotation Mapping" on page 43

• "Diagnosis (Interpretation) Mapping" on page 43

Object Identifier Mapping

Transactional XML to FDA XML Converter

Many FDA fields require the use of an Object Identifier (OID). These OIDs are not
typically entered on an electrocardiograph. It is difficult to see a real-world scenario
where they would be input at the ECG device. They can be populated by the use
of an external configuration file, MUSE2FDACFG.XML. The MUSE2FDACFG.XML
configuration file allows for the definition of OID values as well as controlling how
various other fields are mapped.

User-Defined Mapping

The <MUSE2FDA> configuration file allows for various tags that reference specific FDA
required or optional fields to be specified in a user-defined <Mapping> section of the
file. This section addresses the following cases:

• No equivalent field exists in the GE Healthcare XML definition.

• The definition exists, but only in the /RestingECG/PharmaData section; historical
data would not have these fields.

• The definition of the meaning under FDA XML versus GE Healthcare XML is
ambiguous.

• The user did not enter the value of a required field during the trial and now wishes
to define a valid default value.

This mechanism would be used for the following fields:

/MUSE2FDA/Mapping
Config File Tag

trialSubjectCode Qn || Pn || value || null /AnnotatedECG/componentOf/

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MUSE2FDA Config File
Valid Values

FDA XML Field

timepointEvent/componentOf/
subjectAssignment/subject/
trialSubject/code

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Transactional XML to FDA XML Converter

/MUSE2FDA/Mapping
Config File Tag

treatmentGroup

MUSE2FDA Config File
Valid Values

Qn || Pn || value || null /AnnotatedECG/componentOf/

AssignmentCode

clinicalTrialID “PPC” || Qn || Pn || value

|| null

timePointEventCode “PVN” || Qn || Pn || value

|| null

timePointEventCode_

DisplayName

“PVN” || Qn || Pn || value
|| null

trialInvestigatorID “RMDID” || “PHID” || Qn

|| Pn || value || null

FDA XML Field

timepointEvent/componentOf/
subjectAssignment/definition/
treatmentGroupAssignment/code

/AnnotatedECG/componentOf/
timepointEvent/componentOf/
subjectAssignment/componentOf/
clinicalTrial/id/@extension

/AnnotatedECG/componentOf/
timepointEvent/code/@code

/AnnotatedECG/componentOf/
timepointEvent/code/
displayName

/AnnotatedECG/componentOf/
timepointEvent/componentOf/
subjectAssignment/componentOf/
clinicalTrial/responsibleParty/
trialInvestigator/id/@extension

reasonCode Qn || Pn || value || null /AnnotatedECG/reasonCode/

@code

confidentialityCode Qn || Pn || value || null /AnnotatedECG/

confidentialityCode/@code

RTPCode Qn || Pn || value || null /AnnotatedECG/definition/

relativeTimepoint/componentOf/
protocolTimepointEvent/code/
@code

RTPTimePointEvent Qn || Pn || value || null /AnnotatedECG/definition/

relativeTimepoint/componentOf/
protocolTimepointEvent/code/
@code

RTPReferenceCode Qn || Pn || value || null /AnnotatedECG/definition/

relativeTimepoint/componentOf/
protocolTimepointEvent/
component/referenceEvent/code/
@code

Consider a MUSE2FDACFG.XML entry in the mapping section.

<Mapping>

<trialSubjectCode> Qn or Pn or Value || Null </trialSubjectCode>

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Qn or Pn are used to specify which extra question value, for example /
ExtraQuestions/Answer or /PharmaData/PharmaAnswerN, where N = 1..5, should

be used to populate the value in the FDA output. If no value is entered for this tag,
the field is not mapped from the GE Healthcare XML. If a value other than Qn || Pn is
present, that value is used to populate the field in all records being converted by the
program.

XML Data Mapping

This section covers the following mappings:

• "MUSE2FDACFG.XML Mappings" on page 35

• "Waveform Mapping - Median" on page 43

• "Waveform Mapping - Raw" on page 42

• "Interval Annotation Mapping" on page 43

Transactional XML to FDA XML Converter

• "Diagnosis (Interpretation) Mapping" on page 43

MUSE2FDACFG.XML Mappings

The following table describes the mappings controlled by muse2fdacfg.xml.
A field can be left blank by including a set of open/close tags, for example,
<trialSubjectCode></trialSubjectCode>.

MUSE2FDACFG.XML Field Notes FDA XML Field Mapping

SubjectID/OrganizationOID Should be an Organization

ID, for example,

1.2.3.4.5.6.100

SubjectID/ID The root value should be

unique for the trial; the
extension should hold the
traditional patient identifier.

/AnnotatedECG/
componentOf/
timepointEvent/
componentOf/
subjectAssignment/
subject/trialSubject/id/
@root

/AnnotatedECG/
componentOf/
timepointEvent/
componentOf/
subjectAssignment/
subject/trialSubject/id

Field is set to value from

MUSE2FDACFG.XML

If /MUSE2FDA/SubjectID/
UseSecondary is TRUE

root = /MUSE2FDA/
SubjectID/ OrganizationOID
+ “.” + /RestingECG/
PatientDemographics/
PatientID and extension
= /RestingECG/
PatientDemographics/
SecondaryID

or

if /MUSE2FDA/SubjectID/
UseSecondary is different
from TRUE, root = /
MUSE2FDA/SubjectID/
OrganizationOID and
extension = /RestingECG/
PatientDemographics/
PatientID

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Transactional XML to FDA XML Converter

MUSE2FDACFG.XML Field Notes FDA XML Field Mapping

SubjectID/UseSecondary TRUE See next column. root = /MUSE2FDA/

SubjectID/UseSecondary FALSE See next column. root = /MUSE2FDA/

trialSubject/
OrganizationOID

treatmentGroup
Assignment/
OrganizationOID

Should be an Organization
ID, for example,

1.2.3.4.5.6.100

Should be an Organization
ID, for example,

1.2.3.4.5.6.100

/AnnotatedECG/
componentOf/
timepointEvent/
componentOf/
subjectAssignment/
subject/ trialSubject/code/
@codeSystem

/AnnotatedECG/
componentOf/
timepointEvent/
componentOf/
subjectAssignment/
definition/ treatmentGroup
Assignment/code/
@codeSystem

SubjectID/ OrganizationOID
+ “.” + /RestingECG/
PatientDemographics/
PatientID and extension
= /RestingECG/
PatientDemographics/
SecondaryID

SubjectID/ OrganizationID
and extension
= /RestingECG/
PatientDemographics/
PatientID

Field is set to value from

MUSE2FDACFG.XML

Field is set to value from

MUSE2FDACFG.XML

ProtocolID/
OrganizationOID

SiteID/OrganizationOID Should be an Organization

StudyEventPerformer/
OrganizationOID

Should be an Organization
ID, for example,

1.2.3.4.5.6.100

ID, for example,

1.2.3.4.5.6.100

The MUSE definition of a
"location" matches the FDA
definition of a "site"

Should be an Organization
ID, for example,

1.2.3.4.5.6.100

/AnnotatedECG/
componentOf/
timepointEvent/
componentOf/
subjectAssignment/
componentOf/ clinicalTrial/
id/@root

/AnnotatedECG/
componentOf/
timepointEvent/
componentOf/
subjectAssignment/
componentOf/ clinicalTrial/
location/trialSite/id/@root

and

/AnnotatedECG/
componentOf/
timepointEvent/
componentOf/
subjectAssignment/
componentOf/ clinicalTrial/
location/trialSite/id/
@extension

/AnnotatedECG/
componentOf/
timepointEvent/ performer/
studyEventPerformer/id/
@root

Field is set to value from

MUSE2FDACFG.XML

Field is set to value from

MUSE2FDACFG.XML

and

extension = /Resting
ECG/TestDemographics/
Location

Field is set to value from

MUSE2FDACFG.XML

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Transactional XML to FDA XML Converter

MUSE2FDACFG.XML Field Notes FDA XML Field Mapping

VisitID/OrganizationOID Should be an Organization

reasonCode/
OrganizationOID

AnnotationAuthor/
OrganizationOID

ID, for example,

1.2.3.4.5.6.100

Should be an Organization
ID, for example,

1.2.3.4.5.6.100

Should be an Organization
ID, for example, 1. 2. 3. 4. 5.

6.100

/AnnotatedECG/
componentOf/
timepointEvent/ code/
@codeSystem

/AnnotatedECG/
componentOf/
timepointEvent/
reasonCode/@codeSystem

/AnnotatedECG/
component/series/
subjectOf/ annotationSet/
author/assignedEntity/id

Field is set to value from

MUSE2FDACFG.XML

Field is set to value from

MUSE2FDACFG.XML

If /MUSE2FDA/
AnnotationAuthor/OID
is not empty, and if
any of: /RestingECG/
TestDemographics/
OverreaderID
or /RestingECG/
TestDemographics/
OverreaderLastName
are not empty, then
the FDA XML field is
populated with the value
of /AnnotationAuthor/OID

If MUSE2FDA/
AnnotationAuthor/
OID is not empty
and /RestingECG/
TestDemographics/
OverreaderID is not empty,
then the /RestingECG/
TestDemographics/
OverreaderID is populated
into /AnnotatedECG/
component/series/
subjectOf/annotationSet/
author/assignedEntity/id/
@extension

If /MUSE2FDA/
AnnotationAuthor/
OID is not empty
and if /RestingECG/
TestDemographics/
OverreaderFirstName
or /RestingECG/
TestDemographics/
OverreaderLastName
are not empty, MUSE
Overreader Name
values are used to
populate: /AnnotatedECG/
component/series/
subjectOf/annotationSet/
author/assignedEntity/
assignedAuthorType/
assignedPerson/name
and /AnnotatedECG/
component/series/
derivation/derivedSeries/
subjectOf/annotationSet/
author/assignedEntity/
assignedAuthorType/
assignedPerson/name

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Transactional XML to FDA XML Converter

MUSE2FDACFG.XML Field Notes FDA XML Field Mapping

InvestigatorID/
OrganizationOID

relativeTimePoint/
OrganizationOID

sponsorOrganization/
OrganizationOID

ProtocolID/
ClinicalTrialProtocolTitle

VisitID/CodeSystemName String /AnnotatedECG/

Should be an Organization
ID, for example,

1.2.3.4.5.6.100

Should be an Organization
ID, for example,

1.2.3.4.5.6.100

Should be an Organization
ID, for example,

1.2.3.4.5.6.100

String /AnnotatedECG/

/AnnotatedECG/
componentOf/
timepointEvent/
componentOf/
subjectAssignment/
componentOf/ clinicalTrial/
responsibleParty/
trialInvestigator/id/@root

/AnnotatedECG/definition/
relativeTimepoint/code/
@codeSystem

/AnnotatedECG/
componentOf/
timepointEvent/
componentOf/
subjectAssignment/
componentOf/
clinicalTrial/author/
clinicalTrialSponsor/ID/root

componentOf/
timepointEvent/
componentOf/
subjectAssignment/
componentOf/clinicalTrial/
id/title

componentOf/
timepointEvent/code

Field is set to value from

MUSE2FDACFG.XML

Field is set to value from

MUSE2FDACFG.XML

Field is set to value from

MUSE2FDACFG.XML

Field is set to string

Field is set to string

sponsorOrganization/name String, for example, ABC Inc /AnnotatedECG/

componentOf/
timepointEvent/
componentOf/
subjectAssignment/
componentOf/ clinicalTrial/
author/clinicalTrialSponsor

trialSubjectCode Qn, where n=1..4 /AnnotatedECG/

componentOf/
timepointEvent/
componentOf/
subjectAssignment/
subject/trialSubject/code

trialSubjectCode Pn, where n=1..4 /AnnotatedECG/

componentOf/
timepointEvent/
componentOf/
subjectAssignment/
subject/trialSubject/code

trialSubjectCode String /AnnotatedECG/

componentOf/
timepointEvent/
componentOf/
subjectAssignment/
subject/trialSubject/code

Field is set to string

Field is set to the value of
ExtraQuestion N answer

Field is set to the value of
Pharma Question N

Field is set to the string

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Transactional XML to FDA XML Converter

MUSE2FDACFG.XML Field Notes FDA XML Field Mapping

treatmentGroup
AssignmentCode

treatmentGroup
AssignmentCode

treatmentGroup
AssignmentCode

clinicalTrialID PPC /AnnotatedECG/

Qn, where n=1..4 /AnnotatedECG/

componentOf/
timepointEvent/
componentOf/
subjectAssignment/
definition/ treatmentGroup
Assignment/code

Pn, where n=1..4 /AnnotatedECG/

componentOf/
timepointEvent/
componentOf/
subjectAssignment/
definition/ treatmentGroup
Assignment/code

String /AnnotatedECG/

componentOf/
timepointEvent/
componentOf/
subjectAssignment/
definition/ treatmentGroup
Assignment/code

componentOf/
timepointEvent/
componentOf/
subjectAssignment/
componentOf/clinicalTrial/
id/@extension

Field is set to the value of
ExtraQuestion N answer

Field is set to the value of
Pharma Question N

Field is set to the string

Field is set to the value of /
RestingECG/PharmaData/
PharmaProjectCode

clinicalTrialID Qn, where n=1..4 /AnnotatedECG/

componentOf/
timepointEvent/
componentOf/
subjectAssignment/
componentOf/clinicalTrial/
id/@extension

clinicalTrialID Pn, where n=1..4 /AnnotatedECG/

componentOf/
timepointEvent/
componentOf/
subjectAssignment/
componentOf/ clinicalTrial/
id/@extension

clinicalTrialID String /AnnotatedECG/

componentOf/
timepointEvent/
componentOf/
subjectAssignment/
componentOf/ clinicalTrial/
id/@extension

timePointEventCode PVN /AnnotatedECG/

componentOf/
timepointEvent/ code/
@code

timePointEventCode Qn, where n=1..4 /AnnotatedECG/

componentOf/
timepointEvent/ code/
@code

Field is set to the value of
ExtraQuestion N answer

Field is set to the value of
Pharma Question N

Field is set to the string

Field is set to the value of /
RestingECG/PharmaData/
PharmaVisitNumber

Field is set to the value of
ExtraQuestion N answer

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Transactional XML to FDA XML Converter

MUSE2FDACFG.XML Field Notes FDA XML Field Mapping

timePointEventCode Pn, where n=1..4 /AnnotatedECG/

timePointEventCode String /AnnotatedECG/

timePointEventCode_
DisplayName

timePointEventCode_
DisplayName

timePointEventCode_
DisplayName

timePointEventCode_
DisplayName

trialInvestigatorID RMDID /AnnotatedECG/

PVN /AnnotatedECG/

Qn, where n=1..4 /AnnotatedECG/

Pn, where n=1..4 /AnnotatedECG/

String /AnnotatedECG/

componentOf/
timepointEvent/ code/
@code

componentOf/
timepointEvent/ code/
@code

componentOf/
timepointEvent/ code/
displayName

componentOf/
timepointEvent/ code/
displayName

componentOf/
timepointEvent/ code/
displayName

componentOf/
timepointEvent/ code/
displayName

componentOf/
timepointEvent/
componentOf/
subjectAssignment/
componentOf/ clinicalTrial/
responsibleParty/
trialInvestigator/id/
@extension

Field is set to the value of
Pharma Question N

Field is set to the string

Field is set to the value of /
RestingECG/PharmaData/
PharmaVisitNumber

Field is set to the value of
ExtraQuestion N answer

Field is set to the value of
Pharma Question N

Field is set to the string

Field is set to Referring MD
ID Value

trialInvestigatorID PHID /AnnotatedECG/

trialInvestigatorID Qn, where n=1..4 /AnnotatedECG/

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componentOf/
timepointEvent/
componentOf/
subjectAssignment/
componentOf/ clinicalTrial/
responsibleParty/
trialInvestigator/id/
@extension

componentOf/
timepointEvent/
componentOf/
subjectAssignment/
componentOf/ clinicalTrial/
responsibleParty/
trialInvestigator/id/
@extension

™

Field is set to
Pharmaceutical
Investigator ID Value

Field is set to the value of
ExtraQuestion N answer

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Transactional XML to FDA XML Converter

MUSE2FDACFG.XML Field Notes FDA XML Field Mapping

trialInvestigatorID Pn, where n=1..4 /AnnotatedECG/

componentOf/
timepointEvent/
componentOf/
subjectAssignment/
componentOf/ clinicalTrial/
responsibleParty/
trialInvestigator/id/
@extension

trialInvestigatorID String /AnnotatedECG/

componentOf/
timepointEvent/
componentOf/
subjectAssignment/
componentOf/ clinicalTrial/
responsibleParty/
trialInvestigator/id/
@extension

reasonCode Qn, where n=1..4 /AnnotatedECG/

reasonCode/@code

reasonCode Pn, where n=1..4 /AnnotatedECG/

reasonCode/@code

reasonCode String /AnnotatedECG/

reasonCode/@code

confidentialityCode Qn, where n=1..4 /AnnotatedECG/

confidentialityCode/@code

Field is set to the value of
Pharma Question N

Field is set to the string

Field is set to the value of
ExtraQuestion N answer

Field is set to the value of
Pharma Question N

Field is set to the string

Field is set to the value of
ExtraQuestion N answer

confidentialityCode Pn, where n=1..4 /AnnotatedECG/

confidentialityCode String /AnnotatedECG/

timePointEventReason
Code

timePointEventReason
Code

timePointEventReason
Code

RTPCode Qn, where n=1..4 /AnnotatedECG/definition/

RTPCode Pn, where n=1..4 /AnnotatedECG/definition/

RTPCode String /AnnotatedECG/definition/

Qn, where n=1..4 /AnnotatedECG/

Pn, where n=1..4 /AnnotatedECG/

String /AnnotatedECG/

confidentialityCode/@code

confidentialityCode/@code

componentOf/
timepointEvent/
reasonCode/@code

componentOf/
timepointEvent/
reasonCode/@code

componentOf/
timepointEvent/
reasonCode/@code

relativeTimepoint/ code/
@code

relativeTimepoint/ code/
@code

relativeTimepoint/ code/
@code

Field is set to the value of
Pharma Question N

Field is set to the string

Field is set to the value of
ExtraQuestion N answer

Field is set to the value of
Pharma Question N

Field is set to the string

Field is set to the value of
ExtraQuestion N answer

Field is set to the value of
Pharma Question N

Field is set to the string

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Transactional XML to FDA XML Converter

MUSE2FDACFG.XML Field Notes FDA XML Field Mapping

RTPTimePointEvent Qn, where n=1..4 /AnnotatedECG/definition/

relativeTimepoint/
componentOf/
protocolTimepointEvent/
code/@code

RTPTimePointEvent Pn, where n=1..4 /AnnotatedECG/definition/

relativeTimepoint/
componentOf/
protocolTimepointEvent/
code/@code

RTPTimePointEvent String /AnnotatedECG/definition/

relativeTimepoint/
componentOf/
protocolTimepointEvent/
code/@code

RTPReferenceCode Qn, where n=1..4 /AnnotatedECG/definition/

relativeTimepoint/
componentOf/
protocolTimepointEvent/
component/
referenceEvent/code/
@code

RTPReferenceCode Pn, where n=1..4 /AnnotatedECG/definition/

relativeTimepoint/
componentOf/
protocolTimepointEvent/
component/
referenceEvent/code/
@code

Field is set to the value of
ExtraQuestion N answer

Field is set to the value of
Pharma Question N

Field is set to the string

Field is set to the value of
ExtraQuestion N answer

Field is set to the value of
Pharma Question N

RTPReferenceCode String /AnnotatedECG/definition/

Waveform Mapping - Raw

The primary difference in the encoding between the GE Healthcare format and the
FDA format is detailed in the following table:

Format Description

GE Healthcare format The GE Healthcare format stores the waveform as ASCII encoded

FDA format The FDA format stores each sample value in ASCII as a separate

relativeTimepoint/

Field is set to the string

componentOf/
protocolTimepointEvent/
component/
referenceEvent/code/
@code

binary data that is supported by the XML parser, which reduces
the size of the file.

The derived leads are not stored in the GE Healthcare file.

number.

On mapping to FDA format, all 10s of the raw waveforms are
converted. Derived leads, for example III, aVR, aVF, and aVL, are
also calculated and added to the FDA file .

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Transactional XML to FDA XML Converter

Sample GE Healthcare Waveform data (ASCII encoded binary):
<WaveFormData>
BAADAAMAAwADAAMAAgACAAIAAgACAAIAAgACAAIAAgACAAIAAQ

ABAAEAAQABAAEAAQAB
AAEAAQABAAEAAQABAAEAAQABAAEAAQABAAEAAQABAAAAAAAA

AAAAAAAAAAAAAQABAAEA

AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA.....etc.

Sample FDA Waveform data (Each sample is an individual point)
<digits>-13 -7 -2 0 3 3 3 3 3 0 -9 -11 -14 -14 -15 -16 -18 -22 -25 -26 -26 -24 -23 -23

-23 -23 -25 -30 -36 -39 -36 -17 17 71 139 231 329 414 469 495 482 418 316 195 107

50 17 -14 -31 -35 -34 -41 -41 -43 -45 -45 -47 -44 -42 -44 -46 -48 -46 -46 -46 -46 -47

-48 -48 -49 -49 -49 -50 -50 -48 -49 -50 -54 -58 -53 -48 -54 -58 -59 -60 -57 -53 -57

-62 -67 -71 -66 -60 -62 -67 -64 -64 -64 -62 ... etc.

Waveform Mapping - Median

Median waveforms are also mapped. Derived leads, for example III, aVR, aVF, and
aVL, are calculated and added to the FDA file. Like the raw waveforms, the derived
leads, III, aVR, aVF, and aVL are also calculated and included in the FDA output .

Interval Annotation Mapping

All annotations made using the MUSE Interval Editor are added to the FDA output.

Diagnosis (Interpretation) Mapping

In the FDA format, Diagnosis statements are treated as an annotation. They are
optionally mapped to the FDA file if the /MUSE2FDA/options/ MapDiagnosis is set to
TRUE.

MUSE XML to FDA XML Mapping

The following tables show the mapping of MUSE XML tags to FDA XML tags using
XPaths. For more information about XPath (XML Path Language), see http://

www.w3.org/TR/xpath.

Table 2: Patient Demographics

Patient Demographics

MUSE XML FDA XML

/RestingECG/
PatientDemographics/
DateofBirth

/RestingECG/
PatientDemographics/
Gender

2102027-228A MUSE NX

/AnnotatedECG/componentOf/timepointEvent/
componentOf/subjectAssignment/subject/trialSubject/
subjectDemographicPerson/birthTime

/AnnotatedECG/componentOf/timepointEvent/
componentOf/subjectAssignment/subject/trialSubject/
subjectDemographicPerson/administrativeGenderCode/@code

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Transactional XML to FDA XML Converter

MUSE XML FDA XML

Patient Demographics

codeSystem = 2.16.840.1.113883.5.1

codeSystemName = is not populated

displayName = is not populated

The value of this tag is properly converted from the MUSE using the
following mapping:

MALE = M

FEMALE = F

/RestingECG/
PatientDemographics/
Race

/AnnotatedECG/componentOf/timepointEvent/
componentOf/subjectAssignment/subject/trialSubject/
subjectDemographicPerson/raceCode/@displayName

codeSystemName = Race

displayName = /RestingECG/PatientDemographics/

Gender

The value of this tag is properly converted from the MUSE system
using the following mapping:

CAUCASIAN = 2106-3 White

WHITE = 2106-3 White

BLACK = 2054-4 Black or African American

ORIENTAL = 2028-9 Asian

MONGOLIAN = 2028-9 Asian

ASIAN = 2028-9 Asian

ASIAN INDIAN = 2029-7 Asian Indian

BANGLADESHI = 2030-5 Bangladeshi

BURMESE = 2032-1 Burmese

CAMBODIAN = 2033-9 Cambodian

CHINESE = 2034-7 Chinese

FILIPINO = 2036-2 Filipino

INDONESIAN = 2038-8 Indonesian

JAPANESE = 2039-6 Japanese

44 MUSE NX

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2102027-228A

MUSE XML FDA XML

KOREAN = 2040-4 Korean

MALAYSIAN = 2042-0 Malaysian

PAKISTANI = 2044-6 Pakistani

SRILANKAN = 2045-3 Srilankan

THAI = 2046-1 Thai

VIETNAMESE = 2047-9 Vietnamese

SINGAPOREAN = 2051-1 Singaporean

HISPANIC = 2131-1 Other Race

Transactional XML to FDA XML Converter

Patient Demographics

UNKNOWN = 2131-1 Other Race

OTHER = 2131-1 Other Race

MIXED RACE = 2131-1 Other Race

OTHER RACE = 2131-1 Other Race

HISPANIC OR

= 2131-1 Other Race

LATINO

INDIAN = 1002-5 Native American

ESKIMO = 1002-5 Native American

AMERICAN INDIAN = 1002-5 Native American

OTHER PACIFIC

= 2500-7 Other Pacific Islander

ISLANDER

POLYNESIAN = 2078-4 Polynesian

HAWAIIAN = 2076-8 Hawaiian or Pacific Island

PACIFICISLANDER = 2076-8 Hawaiian or Pacific Island

NATIVE HAWAIIAN

= 2076-8 Hawaiian or Pacific Island
OR OTHER PACIFIC
ISLANDER

PACIFIC ISLANDER = 2076-8 Hawaiian or Pacific Island

2102027-228A MUSE NX

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Transactional XML to FDA XML Converter

MUSE XML FDA XML

Patient Demographics

/RestingECG/
PatientDemographics/
PatientLastName/

/AnnotatedECG/componentOf/timepointEvent/
componentOf/subjectAssignment/subject/trialSubject/
subjectDemographicPerson/name

RestingECG/
PatientDemographics/
PatientFirstName

NOTE:

If the
PatientLastName
is longer than
three letters,
then the last
name initial and
first name initial
are combined,
otherwise only
the last name is
mapped.

Table 3: Test Demographics

Test Demographics

MUSE XML FDA XML

/RestingECG/TestDemographics/
AcquisitionTechLastName

/RestingECG/TestDemographics/
AcquisitionTechFirstName

/RestingECG/TestDemographics/
AcquisitionTechID

46 MUSE NX

The conversion program generates a
GUID (Globally Unique Identifier) which is
stored in this XPath.
/AnnotatedECG/componentOf/
timepointEvent/performer/
studyEventPerformer/id/@root

/AnnotatedECG/componentOf/
timepointEvent/performer/
studyEventPerformer/ assignedPerson/
name/family

/AnnotatedECG/componentOf/
timepointEvent/performer/
studyEventPerformer/ assignedPerson/
name/given

/AnnotatedECG/componentOf/
timepointEvent/performer/
studyEventPerformer/ assignedPerson/id

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2102027-228A

Test Demographics

MUSE XML FDA XML

Transactional XML to FDA XML Converter

/RestingECG/TestDemographics/
AcquisitionTime and /RestingECG/
TestDemographics/AcquisitionDate

NOTE:

StartTime = AcquisitionDate +
AcquisitionTime; EndTime = StartTime + 10
seconds

StartTime:

1. /AnnotatedECG/componentOf/
timepointEvent/effectiveTime/low/
@value

2. /AnnotatedECG/effectiveTime/low/
@value

3. /AnnotatedECG/component/series/
effectiveTime/low/@value

4. /AnnotatedECG/component/series/
derivation/Series/effectiveTime/low/
@value

EndTime:

1. /AnnotatedECG/componentOf/
timepointEvent/effectiveTime/high/
@value

2. /AnnotatedECG/effectiveTime/high/
@value

3. /AnnotatedECG/component/series/
effectiveTime/high/@value

4. /AnnotatedECG/component/series/
derivation/Series/effectiveTime/
high/@value

/RestingECG/TestDemographics/LocationName

NOTE:

The MUSE system definition of allocation
matches the FDA definition of a site.

/RestingECG/TestDemographics/
AcquisitionSoftware Version

NOTE:

This value is stored in two places.

2102027-228A MUSE NX

/AnnotatedECG/componentOf/
timepointEvent/componentOf/
subjectAssignment/ componentOf/
clinicalTrial/location/trialSite/location/
name

/AnnotatedECG/component/
series/author/seriesAuthor/
manufacturedSeriesDevice/
softwareName
/AnnotatedECG/component/
series/derivation/derivedSeries/
author/seriesAuthor/
manufacturedSeriesDevice/
softwareName

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Transactional XML to FDA XML Converter

MUSE XML FDA XML

Test Demographics

/RestingECG/TestDemographics/
AcquisitionDevice

NOTE:

This value is stored in two places.

/AnnotatedECG/component/
series/author/seriesAuthor/
manufacturedSeriesDevice/
softwareName/
manufacturerModelName
/AnnotatedECG/component/
series/author/seriesAuthor/
manufacturedSeriesDevice/
softwareName/
manufacturerModelName

Table 4: Diagnosis

Diagnosis

MUSE XML FDA XML

/RestingECG/Diagnosis/DiagnosisStatement [index]/
StmtText

/AnnotatedECG/controlVariable1[ index ]/
relatedObservation/value/@value

Table 5: Rhythm Wave

Rhythm Wave

MUSE XML FDA XML

/RestingECG/Waveform/LowPassFilter /AnnotatedECG/component/series/

/RestingECG/Waveform/HighPassFilter /AnnotatedECG/component/series/

/RestingECG/Waveform[2]/SampleBase

NOTE:

The samplebase is converted from samples/
second to seconds/sample.

/RestingECG/ Waveform[2]/Lead Data[i]/
WaveFormData

NOTE:

Here "i" varies from 1 to 8. (Leads I, II, V1 – V6)

48 MUSE NX

The conversion program generates a GUID
which is stored in this XPath./AnnotatedECG/
component/series/id/@root

component/sequenceSet/controlVariable[1]/
controlVariable/value/@value

component/sequenceSet/controlVariable[2]/
controlVariable/value/@value

/AnnotatedECG/component/series/
component/sequenceSet/component[1]/
sequence/value/increment/@value

/AnnotatedECG/component/series/
component/sequenceSet/component[i+1]/
sequence/value/digits.
Here "i" varies from 0 to 12. Leads I, II, and V1
– V6 come directly from the MUSE XML data.
Leads III, aVR, aVL, and aVF are derived from
Leads I and II.

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Rhythm Wave

MUSE XML FDA XML

Transactional XML to FDA XML Converter

/RestingECG/Waveform[2]/LeadData[i]/
LeadAmplitudeUnitsPerBit

/AnnotatedECG/component/series/
component/sequenceSet/component[ i + 1]/
sequence/value/scale/@value

Table 6: Median Wave

Median Wave

MUSE XML FDA XML

The conversion program generates a GUID
which is stored in this XPath./AnnotatedECG/
component/series/derivation/Series/id/@root

/RestingECG/Waveform[1]/SampleBase /AnnotatedECG/component/series/

derivation/Series/component/sequenceSet/
component[1]/sequence/value/increment/
@value

/RestingECG/ Waveform[1]/Lead Data[i]/
WaveFormData

NOTE:

Here "i" varies from 1 to 8. (Leads I, II, and V1 –
V6)

/AnnotatedECG/component/series/
derivation/Series/component/sequenceSet/
component[ i+1]/sequence/value/digits
Here "i" varies from 0 to 12. Leads I, II, and V1
– V6 come directly from the MUSE XML data.
Leads III, aVR, aVL, and aVF are derived from
Leads I and II.

/RestingECG/ Waveform[1]/ LeadData[i]/
LeadAmplitudeUnitsPerBit

/AnnotatedECG/component/series/
derivation/Series/component/sequenceSet/
component[ i+1 ]/sequence/value/scale/
@value

Table 7: Interval Measurements

Interval Measurements

MUSE XML FDA XML

The conversion program generates a GUID
which is stored in this XPath./AnnotatedECG/
componentOf/timepointEvent/componentOf/
subjectAssignment/subject/trialSubject/id/
@root

/RestingECG/IntervalMeasurements/
MeasuredInterval

/RestingECG/IntervalMeasurements/
IntervalMeasurement Mode

This value is not mapped but used to loop
through all leads.

This value is not mapped but used for
comparison of mode.

2102027-228A MUSE NX

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Transactional XML to FDA XML Converter

Table 8: Interval Measurements - Raw Mode

BeatOffset is read from this XPath.
RestingECG/IntervalMeasurements/
MeasuredInterval [ index ]/Interval
MeasurementBeatOffset

Interval Measurements — Raw Mode

/RestingECG/IntervalMeasurements/
MeasuredInterval [ index ]/Interval
MeasurementPOnset

NOTE:

The sum of POnset + BeatOffset is converted
from milliseconds to seconds and then mapped.

/RestingECG/IntervalMeasurements/
MeasuredInterval [ index ]/Interval
MeasurementPOffset

NOTE:

The sum of POffset + BeatOffset is converted
from milliseconds to seconds and then mapped.

/RestingECG/IntervalMeasurements/
MeasuredInterval [ index ]/Interval
MeasurementLeadID

/RestingECG/IntervalMeasurements/
MeasuredInterval [ index ]/Interval
MeasurementQOnset

NOTE:

The sum of QOnset + BeatOffset is converted
from milliseconds to seconds and then mapped.

/AnnotatedECG/component/series/
subjectOf[ index ] /annotation[1]/
component/ Annotation/support/
supportingROI/component/boundary/value/
low/@value

/AnnotatedECG/component/series/
subjectOf[ index ] /annotation[1]/
component/ Annotation/support/
supportingROI/component/boundary/value/
high/@value

/AnnotatedECG/component/series/
subjectOf[ index ]/annotation[1]/
component[1]/ Annotation/support/
supportingROI/component[2]/boundary/
code/@code

/AnnotatedECG/component/series/
subjectOf[ index ]/annotation[1]/
component[2]/ Annotation/support/
supportingROI/component/boundary/value/
low/@value

/RestingECG/IntervalMeasurements/
MeasuredInterval [ index ]/Interval
MeasurementQOffset

NOTE:

The sum of QOffset + BeatOffset is converted
from milliseconds to seconds and then mapped.

/RestingECG/IntervalMeasurements/
MeasuredInterval [ index ]/Interval
MeasurementLeadID

/RestingECG/IntervalMeasurements/
MeasuredInterval [ index ]/Interval
MeasurementTOffset

NOTE:

The sum of TOffset + BeatOffset is converted
from milliseconds to seconds and then mapped.

50 MUSE NX

/AnnotatedECG/component/series/
subjectOf[ index ] /annotation[1]/
component[2]/ Annotation/support/
supportingROI/component/boundary/value/
high/@value

/AnnotatedECG/component/series/
subjectOf[ index ] /annotation[1]/
component[2]/ Annotation/support/
supportingROI/component[2]/boundary/
code/@code

/AnnotatedECG/component/series/
subjectOf[ index ] /annotation[1]/
component[3]/ Annotation/support/
supportingROI/component/boundary/value/
high/@value

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Interval Measurements — Raw Mode

Transactional XML to FDA XML Converter

/RestingECG/IntervalMeasurements/
MeasuredInterval [ index ]/Interval
MeasurementLeadID

/AnnotatedECG/component/series/
subjectOf[ index ] /annotation[1]/
component[3]/ Annotation/support/
supportingROI/component[2]/boundary/
code/@code

Table 9: Interval Measurement - Median Mode

Interval Measurements — Median Mode

/RestingECG/IntervalMeasurements/
MeasuredInterval [ index ]/Interval
MeasurementPOnset

NOTE:

POnset is converted from milliseconds to
seconds.

/RestingECG/IntervalMeasurements/
MeasuredInterval [ index ]/Interval
MeasurementPOffset

NOTE:

POffset is converted from milliseconds to
seconds.

/RestingECG/IntervalMeasurements/
MeasuredInterval [ index ]/Interval
MeasurementLeadID

/AnnotatedECG/component/series/
derivation/Series/subjectOf[ index ] /
annotation[1]/ component/Annotation/
support/supportingROI/component/
boundary/value/low/@value

/AnnotatedECG/component/series/
derivation/Series/subjectOf[ index ] /
annotation[1]/ component/Annotation/
support/supportingROI/component/
boundary/value/high/@value

/AnnotatedECG/component/series/
derivation/Series/subjectOf[ index ] /
annotation[1]/component[1]/Annotation/
support/supportingROI/component[2]/
boundary/code/@code

/RestingECG/IntervalMeasurements/
MeasuredInterval [ index ]/Interval
MeasurementQOnset

NOTE:

QOnset is converted from milliseconds to
seconds.

/RestingECG/IntervalMeasurements/
MeasuredInterval [ index ]/Interval
MeasurementQOffset

NOTE:

QOffset is converted from milliseconds to
seconds.

/RestingECG/IntervalMeasurements/
MeasuredInterval [ index ]/Interval
MeasurementLeadID

2102027-228A MUSE NX

/AnnotatedECG/component/series/
derivation/Series/subjectOf[ index ] /
annotation[1]/component[2]/Annotation/
support/supportingROI/component/
boundary/value/low/@value

/AnnotatedECG/component/series/
derivation/Series/subjectOf[ index ] /
annotation[1]/component[2]/Annotation/
support/supportingROI/component/
boundary/value/high/@value

/AnnotatedECG/component/series/
derivation/Series/subjectOf[ index ] /
annotation[1]/component[2]/Annotation/
support/supportingROI/component[2]/
boundary/code/@code

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Transactional XML to FDA XML Converter

Interval Measurements — Median Mode

/RestingECG/IntervalMeasurements/
MeasuredInterval [ index ]/Interval
MeasurementTOffset

NOTE:

TOffset is converted from milliseconds to
seconds.

/RestingECG/IntervalMeasurements/
MeasuredInterval [ index ]/Interval
MeasurementLeadID

/AnnotatedECG/component/series/
derivation/Series/subjectOf[ index ] /
annotation[1]/component[3]/Annotation/
support/supportingROI/component/
boundary/value/high/@value

/AnnotatedECG/component/series/
derivation/Series/subjectOf[ index ] /
annotation[1]/component[3]/Annotation/
support/supportingROI/component[2]/
boundary/code/@code

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Section and Element Definitions

Section and Element Definitions

This section describes the data sections and definitions needed for transactional XML
interchanges.

A

Overview

GE Healthcare’s Transactional XML Developer's module allows you to import
cardiology-related data from non-GE Healthcare devices into the system for storage,
printing, and distribution to the Hospital Information System (HIS). The system accepts
only resting ECG test data, both confirmed and unconfirmed.

• Confirmed tests - results were read and confirmed by a physician.

• Unconfirmed tests - results were not interpreted or read by a physician.
Multiple types of vendor data are accepted. The data can be all text, or a combination

of textual and waveform data. After the textual data reaches the system, you can
modify it. Once confirmed, both textual and waveform data are stored long-term in
the system databases. You cannot perform serial comparison on imported data, and
interpretation is stored as free text.

This chapter provides an overview of the Transactional XML Developer's module and
the requirements needed to run it. This document is intended for individuals who
develop Cardiology-related XML documents they want to store in the MUSE system.

GE Healthcare Data Sections

GE Healthcare has defined data sections, each containing a unique combination of
data fields:

• Required sections:

• Patient Demographics

• Test Demographics

• Optional sections:

• Additional Patient Demographics

• Additional Test Demographics

• Order Information

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Section and Element Definitions

• Diagnosis with Diagnosis Statement

• Waveforms

If you include any of the optional sections, you must include the required data fields
specific to that section. Required data fields are indicated in the tables provided on
the following pages.

Table Explanation

Each of the common sections are described in one of the tables provided on the
following pages. In addition to identifying the elements, each table also provides the
following information:

Column Description

XML Tag Indicates the GE Healthcare XML tag you must use if you are including the

MUSE Length Identifies the maximum field text length allowed for each data element.

specified element in your XML document.

Type Specifies the type of data being passed for a particular element. You may

further clarify the information in this field with information in the Value/
Range column or the "MUSE System Data Types" on page 21.

Value/Range Provides additional detail or specifies the limits for the element’s content. In

the case of Predefined Values, the acceptable values for the element are
listed in this column.

Field Status Identifies whether or not this element is required in your XML document.

If Required is in this column, you must include the element in your XML
document for the associated section.

If this column is blank, the element is optional for the associated section.

Export Only Only used in XML data exported from MUSE.

Description Provides a description for every element in the associated section of data.

Each of these elements should occur only once unless otherwise noted.

Patient Demographics Section (Required)

The Patient Demographics section contains information about the patient. The
following table lists the required and optional elements for this section. Certain
elements are required only if another element is included. For example, the AgeUnits
element is required only when the PatientAge element is used. These types of
dependencies are noted in the Field Status column.

XML Tag MUSE

PatientID 16 String Required - No Truncation

54 MUSE NX

Type Value/Range Field

Length

Must Match MUSE ID
scheme

Export

Status

Required The Patient ID must be assigned

™

Description

Only

for the life of the patient and must
be unique for this patient.

2102027-228A

Section and Element Definitions

XML Tag MUSE

PatientAge Numeric 0 - 127 Patient age

AgeUnits See Value/Range YEARS, MONTHS, WEEKS,

DateofBirth 10 DATE MM/DD/YYYY or MM-DD-

Gender See Value/Range MALE, FEMALE CE6 Patient gender

Race See Value/Range lo CAUCASIANBLACK

Type Value/Range Field

Length

DAYS, HOURS

YYYY

ORIENTALHISPANIC
INDIANESKIMO
HAWAIIANPACIFIC
ISLANDERMONGOLIAN
ASIANUNKNOWN
WHITEASIAN
INDIANBANGLADESHI
BURMESECAMBODIAN
CHINESEFILIPINO
INDONESIAN
JAPANESEKOREAN
MALAYSIAN
PAKISTANISRILANKAN
THAIVIETNAMESE
SINGAPORE
ANOTHERMIXED
RACEOTHER
RACEHISPANIC OR
LATINOAMERICAN
INDIANOTHER PACIFIC
ISLANDER
POLYNESIAN
NATIVE HAWAIIAN
OR OTHER ISLANDER

Status

Required if
PatientAge
is
provided.

Export
Only

Description

Age Units

Patient date of birth

Patient race

HeightIN Numeric 0-127 Patient height in inches

HeightCM Numeric 0-323 Patient height in centimeters

WeightLBS Numeric 0-1,000 Patient weight in pounds

WeighKG Numeric 0-455 Patient weight in kilograms

PatientLastName 40 String Patient last name

PatientFirstName 20 String Patient first name

AnalysisAge 16 Bit Unsigned Patient age used to run analysis

AnalysisAgeUnits See Value/Range YEARSMONTHS

WEEKSDAYS
HOURS

Test Demographics Section (Required)

The Test Demographics section contains information about the particular test. It
includes such elements as the type of test performed and the date and time of
the test. Any element included in this section should only be included once in the
document.

program

Analysis age units

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Section and Element Definitions

XML Tag MUSE Length Type Value/Range Field

DataType See Value/

Site Numeric 1-254 Required No MUSE site number -

SiteName String Optional Yes MUSE site name - export

AcquisitionDevice 5 String Required No Name or acronym for the

Status See Value/

EditListStatus See Value/

Priority See Value/

Location Numeric 0 - 599 Optional No Location number

LocationName String Optional Yes Location name - export

RoomID 5 String Optional No Patient room number

AcquisitionTime 11 TIME HH:MM:SS:NN Required No Time test was per formed

AcquisitionDate 10 DATE MM/DD/YYYY or MM-DD-YYYY Required No Date test was performed

CartNumber Numeric No Number corresponding to

Range

Range

Range

Range

RESTING, STRESS, HOLTER, HIRES Required No Identifies the specific type

CONFIRMED, UNCONFIRMED, FELLOW Required No Status of test

• Unknown

• Newly Acquired

• Confirmed at cart, unconfirmed
during acquisition

• Updated

• Updated after fellow confirmed

• Updated after confirmed

• Updated after fellow confirmed,
confirmed

• Demographics complete

• Demographics complete after
fellow confirmed

• Demographics complete after
confirmed

• Demographics complete after
fellow confirmed, confirmed

• Diagnosis complete

• Diagnosis complete after fellow
confirmed

• Diagnosis complete after
confirmed

• Diagnosis complete after fellow
confirmed

• Diagnosis and Demographics
complete

• Fellow confirmed

• Confirmed

• Confirmed after fellow
confirmed

• Confirmed at cart

NORMAL, PREOP, STAT Optional No Priority of test

Status

Optional Yes Workflow status of the test

Export Only Description

of test

associated to Hospital
Name (import and export)

only

device on which the test
was performed

corresponding to MUSE list
of locations

only

a device

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Section and Element Definitions

XML Tag MUSE Length Type Value/Range Field

AcquisitionSoftware
Version

AnalysisSoftware
Version

UserDefined 10 String Optional Yes User-defined data

EditDate DATE MM/DD/YYYY or MM-DD-YYYY Optional Yes Date of the last edit

EditTime TIME HH:MM:SS:NN Optional Yes Time of the last edit

OrderingMDID UserID 1-10000 No Ordering MD MUSE ID

ReferringMDID UserID 1-10000 No MUSE referring MD MUSE ID

OverreaderID UserID 1-10000 No MUSE interpreting MD ID

FellowID UserID 1-10000 No MUSE fellow ID number

AcquisitionTechID UserID 1-10000 No Technician performing test

EditorID User ID 1-10000 No MUSE transcriptionist ID

TestType 24 String No Description of test

TestReason 32 String No Reason for test

OrderingMDLastName 16 String No Ordering MD last name

OrderingMDFirstName 10 String No Ordering MD first name

ReferringMDLastName 16 String No Referring MD last name

ReferringMDFirstName 10 String No Referring MD first name

OverreaderLastName 16 String No Interpreting MD last name

OverreaderFirstName 10 String No Interpreting MD first name

OptionNumber Numeric 0–65535 Optional No Legacy user defined

FellowLastName 16 String No Fellow last name

FellowFirstName 10 String No Fellow first name

AcquisitionTechLastName 16 String No Performing technician last

AcquisitionTechFirstName 10 String No Performing technician first

EditorLastName 16 String No Transciptionist last name

EditorFirstName 10 String No Transciptionist first name

SecondaryID 16 String No Patient secondary ID

HISStatus Numeric Bit flags:Bit 0 – A

9 String Required No Version of software used to

9 String Optional Yes Version of software used to

billing transaction was
sentBit 1 – A result
transaction was
sentBit 2 –
Never bill this
recordBit 3 –
Test has order
extra questions
Bit 4 – Test has
been edited

Status

Optional Yes Status of record in the

Export Only Description

acquire test

analyze test

number

number

number

MUSE ID number

number used by older ECG
carts

name

name

Hospital Information
System

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Section and Element Definitions

XML Tag MUSE Length Type Value/Range Field

XMLSourceVersion 127 String Yes Vendor version of software

Order Information Section (Optional)

The Order Information section contains information provided through the HIS link
to the MUSE system about an order or account that was assigned to the test. Any
element included in this section should only be included once in the document.

XML Tag MUSE Length Type Value/Range Field Status Export Only Description

RequisitionNumber 9 String No Requisition number for a test

HISOrderNumber 9 String No Order number for a test

HISAccountNumber 19 String No Patient account number

HISSytemID 17 String No HIS system identifier

Episode 5 String No Episode or occurrence of the order

HISTestType 32 String No HIS description of test.

OrderingMDID 2 UserID 1–10000 Optional No Ordering MD ID

OrderingMDHISID 32 String No Ordering MD HIS ID

HISOrderingMDLastName 16 String No HIS ordering MD last name

HISOrderingMDFirstName 10 String No HIS ordering MD first name

ScheduleTime 32 String No Priority of test

OrderTime DATE TIME MM/DD/YYYY

OrderExpirationTime 4 DATE TIME MM/DD/YYYY

AdmitTime 4 TIME HH:MM:SS:NN No Patient Admit Time

AdmitDate 4 DATE MM/DD/YYYY

AdmitDiagnosis 80 String No Admitting Diagnosis

HISLocation 20 String No Patient HIS location

Bed 12 String No Patient bed number

Comments 80 String No Ordering comments

ExtraADTData1 32 String No Additional ADT data field 1

ExtraADTData2 32 String No Additional ADT data field 2

ExtraADTData3 32 String No Additional ADT data field 3

ExtraADTData4 32 String No Additional ADT data field 4

ExtraOrderData1 32 String No Additional order data field 1

ExtraOrderData2 32 String No Additional order data field 2

ExtraOrderData3 32 String No Additional order data field 3

ExtraOrderData4 32 String No Additional order data field 4

58 MUSE NX

HH:MM:SS

HH:MM:SS

HH:MM:SS

™

Status

Export Only Description

used to create XML
document

No Time test should be performed

No Time order should expire and not be

No Patient Admit Date

available

2102027-228A

Section and Element Definitions

XML Tag MUSE Length Type Value/Range Field Status Export Only Description

ExtraAccountData1 32 String No Additional account data field 1

ExtraAccountData2 32 String No Additional account data field 2

ExtraAccountData3 32 String No Additional account data field 3

ExtraAccountData4 32 String No Additional account data field 4

AttendingMDID 2 UserID 1–10000 No Attending MD ID

AttendingMDHISID 32 String No Attending MD HIS ID

AttendingMDLastName 16 String No Attending MD last name

AttendingMDFirstName 10 String No Attending MD first name

PriorHISAccountNumber 19 String No Prior patient account number

AlternateVisitID 19 String No Alternate visit or account number

HISDisposition 19 String No Text description of patient class

PatientDischargeDate 4 DATE MM/DD/YYYY or

PatientDischargeTime 4 TIME HH:MM:SS:NN No Patient's discharge time

AdmitSource 32 String No Place patient was admitted from

DischargeDisposition 32 String No Disposition of patient at discharge

PrimaryDiagnosticCode 15 String No Primary diagnosis code

SecondaryDiagnosticCode 15 String No Secondary diagnosis code

TertiaryDiagnosticCode 15 String No Third diagnosis code

OtherDiagnosticCode 15 String No Fourth diagnosis code

CurrentDiagnosis 80 String No Text of current diagnosis

ServicingFacility 17 String No Servicing facility

AdmittingMDID 2 UserID 1-10000 No Admitting MD ID number on the MUSE

AdmittingMDHISID 32 String No Admitting MD HIS ID

AdmittingMDLastName 16 String No Admitting MD last name

AdmittingMDFirstName 10 String No Admitting MD first name

ConsultingMDID 2 UserID 1-10000 No Consulting MD MUSE ID

ConsultingMDHISID 32 String No Consulting MD HIS ID

ConsultingMDLastName 16 String No Consulting MD last name

ConsultingMDFirstName 10 String No Consulting MD first name

ReferringMDHISID 32 String No Referring MD HIS ID

HospitalService 19 String No Hospital service

AmbulatoryStatus 15 String No Ambulatory status

AdmissionType 19 String No Admission type

DangerCode 16 String No Danger code

AltRequisitionNumber 32 String No Alternate requisition number

PlacersHISID 32 String No Order placer's HIS ID

MM-DD-YYYY

No Patient's discharge date

time

system

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Section and Element Definitions

XML Tag MUSE Length Type Value/Range Field Status Export Only Description

PlacersLastName 16 String No Order placer' s last name

PlacersFirstName 10 String No Order placer's first name

OrderPlacementDate 10 DATE MM/DD/YYYY or

OrderPlacementTime 11 TIME HH:MM:SS:NN No Order placement time

ReasonForTest 80 String No Reason for test

MM-DD-YYYY

No Order placement date

QRS Times and Types (Optional, Export Only)

The QRS Times and Types section is supported on export only.

XML Tag MUSE

Type Value/

Length

QRS See "QRS

Section
(Optional,
Export Only)"
on page
65

GlobalRR Numeric Optional Yes The global mean R-R

QTRGGR Numeric Optional Yes Sample index of the QRS

Diagnosis Section (Optional)

The Diagnosis section contains the physician’s textual comments and interpretation
of the test. If you include this section, you must include the Diagnostic Statement
section.

Range

Field
Status

Optional
Repeats

Export

Description

Only

Yes The QRS times and

types, see "QRS Section

(Optional, Export Only)"
on page 65.

measurement

trigger from the start of
the median

124 for 250 sps248 for
500 sps

XML Tag MUSE

Type Value/Range Field

Length

Modality See Value/

Range

StatementCount Numeric 0-254 Total number

60 MUSE NX

Export

Description

RESTING,
STRESS,
HOLTER, CATH,
HIRES

Status

Required Type of test

Only

to which this
diagnosis
corresponds

of diagnosis
statements

™

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Section and Element Definitions

XML Tag MUSE

Type Value/Range Field

Length

LabelText 32 String String

DiagnosisStatement Variable Repeats All diagnosis

Waveforms Section (Optional)

If you include the Waveforms section, you must include all required elements and all
Lead Data sections.

XML Tag MUSE Length Type Value/Range Field Status Description

WaveformType See Value/Range MEDIANRHY THM Required

WaveformStartTime Numeric 32 Bit Unsigned Required Offset in buffer to beginning of

NumberofLeads Numeric 8 or 11 Required Total number channels in the

SampleType See Value/Range DISCRETE_

SAMPLESCONTINUOUS_
SAMPLESMULTIPLEX_
SAMPLESSIMPLEX_
SAMPLES

Export

Description

Status

Only

describing
diagnosis

statements

waveform

waveform excluding derived leads.
For 12 lead, use 8.For 15 lead, use

11.

Required One of the four types of samples

listed in the Comments section

SampleBase Numeric 16 Bit Unsigned Required Sample Rate Base

SampleExponent Numeric 8 Bit Unsigned Required Exponent value used in conjunction

HighPassFilter Numeric 16 Bit Unsigned High pass filter applied to data

LowPassFilter Numeric 16 Bit Unsigned Low pass filter applied to data

ACFilter See Value/Range NONE, 50, 60 Required

LeadData Variable See "Lead Data Section"

PaceSpikes See "Pacemaker Spikes

on page 62

Section (Optional)" on
page 61

Pacemaker Spikes Section (Optional)

The Pacemaker Spikes section is supported on import and is not produced on export.

with the Sample Base value

before it was received by MUSE (in
hundredths of Hertz)

before it was received by MUSE (in
Hertz, usually 150 Hz)

Repeats

Required
Repeats

Optional See "Pacemaker Spikes Section

AC filter applied to data before it
was received by MUSE (in Hertz)

Base64 encoded uncompressed
raw signal data for the current
lead, each data sample must
be in low byte/high byte format
(little endian format). Samples
the size of LeadSampleSize
and can be multiplied by
LeadAmplitudeUnitsPerBit to get
the actual value. Missing samples
should be represented as zeros.

(Optional)" on page 61

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Section and Element Definitions

XML Tag MUSE

PaceType See Value/Range ExternalInternalRequired No Defines if pacing was

PaceCharacteristicsFromDevice True/False TRUEFALSE Optional group of

PaceWidth Numeric Optional group of

PaceWidthUnits See Value/Range milliseconds Optional group of

PaceAmplitude Numeric Optional group of

PaceAmplitudeUnits See Value/Range microvolts Optional group of

IndexOffsets Required No Locations of the

Length

Type Value/

Range

Field Status Export

(PaceCharacteristicd
FromDevice,
PaceWidth,
PaceWidthUnits)

(PaceCharacteristicd
FromDevice,
PaceWidth,
PaceWidthUnits)

(PaceCharacteristicd
FromDevice,
PaceWidth,
PaceWidthUnits)

(PaceAmplitude,
PaceAmplitudeUnits)

(PaceAmplitude,
PaceAmplitudeUnits)

Only

No Indicates if the pacer

No Width of the pacemaker

No Units for PaceWidthThis

No Amplitude of all pace

No Units for

Description

done external to the body
or internally

characteristics are taken
from the device recording
them. This tag is ignored
by MUSE.

spikesThis tag is ignored
by MUSE.

tag is ignored by MUSE.

spikesThis tag is ignored
by MUSE.

PaceAmplitudeThis tag is
ignored by MUSE.

beginning of spikes in
sample offsets from the
beginning of the ECG
(zero based).(Convert a
time in milliseconds to a
sample offset by dividing
by 2 when sample rate is
500 and 4 when sample
rate is 250.) Offsets
are zero-based, so the
first sample is zero, the
second is one, and so
forth. The spike offsets
are comma delimited.

Lead Data Section

Required if you include a Waveform section.

XML Tag MUSE

Length

LeadByteCountTotal Numeric 16 Bit Unsigned Required Total uncompressed lead buffer

LeadTimeOffset Numeric 16 Bit Unsigned Required Offset of lead in reference to the

LeadSampleCountTotal Numeric 16 Bit Unsigned Required Total number of samples in the

LeadAmplitudeUnitsPerBit Numeric Float Required A/D scaling factor (for ECG this

LeadAmplitudeUnits See Value/

LeadHighLimit Numeric 16 Bit Signed Required High limit value for a single lead

62 MUSE NX

Type Value/Range Field

Range

™

VOLTSMILLIVOLTS
MICROVOLTS

Status

Description

size in bytes

waveform (in milliseconds)

lead buffer

value is the number of volts per A/
D bit)

Required A/D scaling factor units (for ECG,

this is usually microvolts)

measurement

2102027-228A

Section and Element Definitions

XML Tag MUSE

LeadLowLimit Numeric 16 Bit Signed Required Low limit value for a single lead

LeadID See Value/

LeadOffsetFirstSample Numeric 16 Bit Unsigned Required Offset within lead buffer of first

FirstSampleBaseline Numeric 32 Bit Unsigned Required Value indicating amount of

LeadSampleSize Numeric 8 Bit Unsigned Required Size of individual data sample (in

LeadOff BOOL TRUE, FALSE Required Boolean value indicating the Lead

BaselineSway BOOL TRUE, FALSE Required Boolean value indicating that

ExcessiveACNoise BOOL TRUE, FALSE Boolean value indicating that

MuscleNoise BOOL TRUE, FALSE Boolean value indicating the

LeadDataCRC32 Numeric 32 Bit Unsigned Required 32 bit CRC of unencoded and

Length

Type Value/Range Field

Range

I,II, V1,V2,V3,
V4,V5,V6 VCG - add
X,Y, Z Ped - add
V3R,V4R,V7

Status

Required Specific lead Identifier

Description

measurement

valid lead data (in samples)

baseline shift

bytes)

is off

baseline sway is present in the data

excessive AC noise is present in
data

muscle noise is present in the data

uncompressed raw signal data for
the current lead

WaveFormData Variable Base64 Encoded

Pharma Data (Optional)

The optional Pharma Data section is both import and export.

XML Tag MUSE

Length

PharmaDoseType 32 String 16 Bit Unsigned

PharmaRRinterval Numeric 16 Bit Unsigned RR Interval

PharmaVisitNumber 6 String Visit Number

PharmaVisitType 17 String Visit Type defined by trial

PharmaUniqueECGID 32 String Value assigned by cart to ECG

PharmaPPinterval Numeric 16 Bit Unsigned PP Interval

Data

Required Base64 encoded uncompressed

raw signal data for the current
lead. Each data sample must be
in low byte/high byte format (little
endian format).

Type Value/Range Description

Administrator

PharmaExtendedCartID 10 String Value assigned to cart by trial

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Section and Element Definitions

XML Tag MUSE

Type Value/Range Description

Length

PharmaCartID 16 String Value assigned by cart to ECG

PharmaProjectCode 32 String Project Code assigned by trial

administrator

PharmaQuestion1 10 String First user defined question

PharmaAnswer1 17 String First user defined answer

PharmaQuestion2 10 String Second user defined question

PharmaAnswer2 17 String Second user defined answer

PharmaQuestion3 10 String Third user defined question

PharmaAnswer3 17 String Third user defined answer

PharmaQuestion4 10 String Fourth user defined question

PharmaAnswer4 17 String Fourth user defined answer

PharmaQuestion5 10 String Fifth user defined question

PharmaAnswer5 17 String Fifth user defined answer

Resting ECG Measurements Section (Optional)

The Resting ECG Measurements section is not required in the XML document.

XML Tag Type Value/Range Field Status Description

SystolicBP Numeric 0-999 Systolic blood pressure (mm Hg)

DiastolicBP Numeric 0-999 Diastolic blood pressure (mm Hg)

VentricularRate Numeric 0-999 Ventricular rate in BPM

AtrialRate Numeric 0-999 Atrial rate (in BPM)

PRInterval Numeric 0-999 P-R inter val (in msec)

QRSDuration Numeric 0-999 QRS duration (in msec)

QTInterval Numeric 0-999 QT interval (in msec)

QTCorrected Numeric 16 Bit unsigned Bazett' s Algorithm

PAxis Numeric -89 to 270 P axis

RAxis Numeric -89 to 270 R axis

TAxis Numeric -89 to 270 T axis

QRSCount Numeric 0–254 QRS count

QOnset Numeric 16 Bit unsigned Q onset (median complex sample point)

QOffset Numeric 16 Bit unsigned Q offset (median complex sample point)

POnset Numeric 16 Bit unsigned P onset (median complex sample point)

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XML Tag Type Value/Range Field Status Description

POffset Numeric 16 Bit unsigned P offset (median complex sample point)

TOffset Numeric 16 Bit unsigned T offset (median complex sample point)

ECGSampleBase Numeric 16 Bit unsigned Required ECG sample rate base

ECGSampleExponent Numeric 8 Bit signed Required ECG sample rate base exponent

QTcFrederica Numeric 16 Bit unsigned QT calculated with the Frederica Algorithm

Original Resting ECG Section (Optional)

This Original Resting ECG section includes the original resting ECG measurements
for 12SL before they were edited. The tags for this section are identical to the tags
in the Resting ECG Measurements section. See "Resting ECG Measurements Section

(Optional)" on page 64.

Section and Element Definitions

QRS Section (Optional, Export Only)

The QRS section is supported on export only.

XML Tag MUSE

Length

Number Numeric Required Yes Number of this QRS

Type Numeric Required Yes The beat type number for

Time Numeric Required Yes The sample index (zero

Type Value/

Range

Field
Status

XML Data Export

The MUSE system supports an XML Export option that provides an XML
representation of Resting ECG data based on the existing Transactional XML
Developer's specifications. You can include Waveform and measurements
matrix data in the output if the test is a 12– or 15–lead ECG. The waveform and
measurement matrix data are not available for reduced ECGs and ECGs that were
created manually on the MUSE system. The XML Export includes the following
additional sections:

Export
Only

Description

this QRS as determined by
analysis

based) of the beginning of
this QRS complex, from the
beginning of the waveform.

• PharmaData

• ACITIPIAnalysis

• IntervalMeasurements

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Section and Element Definitions

• AmplitudeMeasurements

• MeasurementMatrix
The resting ECG measurements section is different from the one used in XML import.
For the individual data fields within these sections, refer to the following tables:

XML Tag MUSE

MuseVersion 16 String Required Yes The version of MUSE system

RegisteredName 50 String Optional Yes Registered customer name for

XML Tag MUSE

ACITIPI Analysis <ACITIPIAnalysis>

TIPIStatement ACI TIPI statements

ACITIPIAlgorithmVersion 9 String Version of the ACI TIPI algorithm

TwelveSLVersion 9 String Version of the 12SL algorithm

TIPIScore Numeric 8 Bit Unsigned ACI TIPI Score

TIPIChestPain NonePrimary

TIPIGender Male, Female ACI TIPI Gender

TIPIAgeRange Pediatric (<16)16-40

Length

Type Value/

Length

Range

Type Value/Range Description

Field Status Export

ComplaintSecondary
Complaint

years41-50
yearsOver 50 years

Only

ACI TIPI Chest Pain Rating

ACI TIPI Age Range

Description

producing the XML

this MUSE

Interval Measurements <IntervalMeasurements>

IntervalMeasurement
TimeResolution

IntervalMeasurement
AmplitudeResolution

Interval
MeasurementFilter

Interval
MeasurementMode

IntervalMeasurement
MethodType

LeadInterval
CalculationMethod

LeadPOnset
CalculationMethod

Numeric 25, 50, 100 The resolution for time (x) (in mm/ms)

Numeric 10, 20, 40 The resolution for amplitude (y) (in mv/

String None, 40, 80 The type of low pass filter used to smooth

String medians, raw The mode used to measure the data

String OnsetOffset

String MeanMedian

String Mean

66 MUSE NX

mm)

the waveform display (in Hz0

(median or consecutive raw beats)

IntervalGlobal

MinimumMaximum

MedianEarliestLatest

™

The measurement method to determine
the global measurements

Method to determine global intervals
from each lead; present when
IntervalMeasurementMethodType is set
to Interval.

Method to determine global P Onset
from each lead; present when
IntervalMeasurementMethodType is set
to OnsetOffset.

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Section and Element Definitions

XML Tag MUSE

LeadPOffset
CalculationMethod

LeadQOnset
CalculationMethod

LeadQOffset
CalculationMethod

LeadTOffset
CalculationMethod

BeatPOnset
CalculationMethod

BeatPOffset
CalculationMethod

Length

Type Value/Range Description

String Mean

String Mean

String Mean

String Mean

String Mean

String Mean

MedianEarliestLatest

MedianEarliestLatest

MedianEarliestLatest

MedianEarliestLatest

MedianEarliestLatest

MedianEarliestLatest

Method to determine global P Offset
from each lead; present when
IntervalMeasurementMethodType is set
to OnsetOffset.

Method to determine global Q

Onset from each lead; present when
IntervalMeasurementMethodType is set

to OnsetOffset.

Method to determine global Q

Offset from each lead; present when
IntervalMeasurementMethodType is set

to OnsetOffset.

Method to determine global T Offset
from each lead, present when
IntervalMeasurementMethodType is set
to OnsetOffset.

Method to determine global P Onset
from each beat; present when

IntervalMeasurementMethodType
is set to OnsetOffset and the
IntervalMeasurementMode is set to
Raw.

Method to determine global P Offset
from each beat; only present when

IntervalMeasurementMethodType
is set to OnsetOffset and the
IntervalMeasurementMode is set to
Raw.

BeatQOnset
CalculationMethod

BeatQOffset
CalculationMethod

Interval
Measurement
LeadID

Interval
Measurement
BeatNumber

Interval
Measurement
BeatOffset

Interval
Measurement
POnset

Interval
Measurement
POffset

String Mean

String Mean

String I, II, III, AVR, AVL, AVF,

Numeric 16 Bit Unsigned The beat index of the beat in the ECG.

Numeric 16 Bit Unsigned The offset in number of samples to the

Numeric 16 Bit Unsigned The P Onset measurement for this beat

Numeric 16 Bit Unsigned The P Offset measurement for this beat

MedianEarliestLatest

MedianEarliestLatest

V1, V2, V3, V4, V5, V6

Method to determine global Q Onset
from each beat; present when

IntervalMeasurementMethodType
is set to OnsetOffset and the
IntervalMeasurementMode is set to
Raw.

Method to determine global Q Offset
from each beat; present when

IntervalMeasurementMethodType
is set to OnsetOffset and the
IntervalMeasurementMode is set to
Raw.

Lead ID

The first beat is zero; present when

IntervalMeasurementMode is set to
Raw.

beginning of this beat, present when

IntervalMeasurementMode is set to
Raw.

and lead

and lead.

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Section and Element Definitions

XML Tag MUSE

Interval
Measurement
QOnset

IntervalMeasurementQOffset Numeric 16 Bit Unsigned The Q Offset measurement for this beat

IntervalMeasurementTOffset Numeric 16 Bit Unsigned The T Offset measurement for this beat

IntervalMeasurementRRInterval

Amplitude Measurements <AmplitudeMeasurements>

AmplitudeMeasurementMode String Raw, Median Modes used to measure amplitude in the

AmplitudeMeasurementLeadID String I, II, III, AVR, AVL, AVF,

AmplitudeMeasurementWaveID String IE_P, IE_PPM,

Length

Type Value/Range Description

Numeric 16 Bit Unsigned The Q Onset measurement for this beat

V1, V2, V3, V4, V5, V6

IE_QIE_QS, IE_R,
IE_RPMIE_S, IE_SPM,
IE_STJIE_STJ40,
IE_STJ60IE_STJ80,
IE_T, IE_TPMIE_U,
IE_SPPMIE_RPPM,
IE_PPPMIE_DELTA,
IE_TNCHIE_TDNCH,
IE_QRSNCH

and lead

and lead

and lead

Interval Editor

Lead ID

Name of the Wavelet you are measuring

AmplitudeMeasurementBeatID Numeric Beat ID

AmplitudeMeasurementPeak Numeric Peak of the wavelet (in uV)

AmplitudeMeasurementStart Numeric Start of wavelet in samples

AmplitudeMeasurementDuration Numeric Wavelet duration (in msec)

AmplitudeMeasurementArea Numeric Wavelet area (in uv*msec)

Extra Questions <ExtraQuestions>

ExtraQuestion Variable See Extra Question

Extra Question <ExtraQuestion>

Question 10 String Generic question prompt

Answer 17 String This can be an String,

QRSTimesTypes <QRSTimesTypes>

GlobalRR Numeric 16 Bit unsigned Average RR Interval

QTRGGR Numeric 124, 248 Constant, for premacvu and monitor EEC

QRS <QRS>

<ExtraQuestion>

numeric (32 bit
unsigned), or Yes, No,
or Unknown

Repeating section (see Extra Question
<ExtraQuestion>)

Answer to the question

124; for macvu ECG 248

Number Byte 0-254 QRS Number

Type Byte QRS Type

Time Numeric 0-999 QRS Duration

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Measurement Matrix

<MeasurementMatrix> is the XML tag for the Measurement Matrix. The

measurement matrix exported in the XML file contains the global measurements and
per-lead measurements. This document details the contents of both sections. The
data in the XML file is Base64 encoded and should be decoded before interpreting as
described in the following sections.

Global Measurements

An array of 18 words (2–byte values) follows the data header:
[0] =36// always 36 (decimal), (the array size in bytes)
[1] =pon// P-wave onset in median beat (in samples)
[2] =poff// P-wave offset in median beat
[3] =qon// Q-Onset in median beat

Section and Element Definitions

[4] =qoff// Q-Offset in median beat
[5] =ton// T-Onset in median beat
[6] =toff// T-Offset in median beat
[7] =nqrs// Number of QRS Complexes
[8] =qrsdur// QRS Duration
[9] =qt// QT Interval
[10]=qtc// QT Corrected
[11]=print // PR Interval
[12]=vrate// Ventricular Rate
[13]=avgrr// Average R-R Interval
[14]=0xFFFFh// Pad- Always 0xFFFFh
[15]=0xFFFFh// Pad- Always 0xFFFFh
[16]=0xFFFFh// Pad- Always 0xFFFFh
[17]=636;//(53*12) Decimal Number of Columns*Number of Leads

Per-Lead Measurements

The per-lead measurements section follows the global measurements. These
measurements consist of an array 12 leads by 53 four-byte values. The four bytes are
further subdivided into three parts. The first byte is the lead ID, the second byte is the
measurement ID, and the remaining two bytes are the actual measurement value.

For each lead of the 12 leads in the order [I, II, V1, V2, V3, V4, V5, V6, III, AVR, AVL, AVF],
the following values are present:

[1]PONA \\ P Wave amplitude at P-onset

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Section and Element Definitions

[2]PAMP \\ P wave amplitude

[3]PDUR \\ P wave duration

[4]bmPAR \\ P wave area

[5]bmPI \\ P wave intrinsicoid (time from P onset to peak

of P)

[6]P'AMP \\ P Prime amplitude

[7]P'DUR \\ P Prime duration

[8]bmPPAR \\ P Prime area

[9]bmPPI \\ P Prime intrinsicoid (time from P onset to peak

of P')

[10]QAMP \\ Q wave amplitude

[11]QDUR \\ Q wave duration

[12]bmQAR \\ Q wave area

[13]bmQI \\ Q intrinsicoid (time from Q onset to peak of Q)

[14]RAMP \\ R amplitude

[15]RDUR \\ R duration

[16]bmRAR \\ R wave area

[17]bmRI \\ R intrinsicoid (time from R onset to peak of R)

[18]SAMP \\ S amplitude

[19]SDUR \\ S duration

[20]bmSAR \\ S wave area

[21]bmSI \\ S intrinsicoid (time from Q onset to peak of S)

[22]R'AMP \\ R Prime amplitude

[23]R'DUR \\ R Prime duration

[24]bmRPAR \\ R Prime wave area

[25]bmRPI \\ R Prime intrinsicoid (time from Q onset to peak

[26]S'AMP \\ S Prime Amplitude

[27]S'DUR e\\ S Prime Duration

[28]bmSPAR \\ S Prime wave area

70 MUSE NX

of R Prime)

™

2102027-228A

Section and Element Definitions

[29]bmSPI \\ S intriniscoid (time from Q onset to peak of S

prime)

[30]STJ \\ STJ point, End of QRS Point Amplitude

[31]STM \\ STM point, Middle of the ST Segment

Amplitude

[32]STE \\ STE point, End of ST Segment Amplitude

[33]MXSTA \\ Maximum of STJ, STM, STE Amplitudes

[34]MNSTA \\ Minimum of STJ and STM Amplitudes

[35]SPTA \\ Special T-Wave amplitude

[36]QRSA \\ Total QRS area

[37]QRSDEF \\ QRS Deflection

[38]MAXRA \\ Maximum R Amplitude (R or R Prime)

[39]MAXSA \\ Maximum S Amplitude (S or S Prime)

[40]TAMP \\ T amplitude

[41]TDUR \\ T duration

[42]bmTAR \\ T wave area

[43]bmTI \\ T intriniscoid (time from STE to peak of T)

[44]T'AMP \\ T Prime amplitude

[45]TPDUR \\ T Prime duration

[46]bmTPAR \\ T Prime area

[47]bmTPI \\ T Prime intriniscoid (time from STE to peak of T)

[48]TEND \\ T Amplitude at T offset

[49]PAREA \\ P wave area, includes P and P Prime

[50]QRSAR \\ QRS area

[51]TAREA \\ T wave area, include T and T Prime

[52]QRSINT \\ QRS intriniscoid (see following)

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Section and Element Definitions

[53]BITFLG \\ Bitmask sum of (values) decoded as follows:

Bit 1 (2) :TTAL- Peak of T > ST measurement

Bit 2 (4) :STDOWN- ST Segment Depressed

Bit 3 (8) :STELEV- ST Segment Elevated

Bit 4 (16) :JELEV- J point Elevated by 100uV

Bit 5 (32) :DLTWV- Delta-Wave Detected

Bit 6 (64) :STINJ- ST Segment Elevated

Bit 7 (128):PPDEEP- P Prime Area was 1000uV*ms

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Sample XML Documents

To successfully transfer your test data to the MUSE system, you must submit your
data in the form of XML documents. These documents must be valid to the DTD files.
Following are samples of XML files.

Sample XML Documents

B

Sample Well-formed Document

<?xml version="1.0"? encoding="windows-1252”?><!DOCTYPE RestingECG SYSTEM "restecg.DTD">

<RestingECG>

<PatientDemographics>

<PatientID>041399090751</PatientID> <Race>Unknown</Race><Gender>Unknown</
Gender><PatientLastName></PatientLastName> <PatientFirstName></PatientFirstName> <AnalysisAge>47</
AnalysisAge> <AnalysisAgeUnits>Years</AnalysisAgeUnits>

</PatientDemographics>

<TestDemographics>

<DataType>RESTING</DataType> <Site>1</Site><AcquisitionDevice>ABC123</AcquisitionDevice>
<Status>UNCONFIRMED</Status> <Priority>STAT</Priority> <Location>0</Location> <AcquisitionTime>09:08:38</
AcquisitionTime> <AcquisitionDate>04/13/1999</AcquisitionDate> <CartNumber>000</CartNumber>
<AcquisitionSoftwareVersion>Version 2.31< /AcquisitionSoftwareVersion>

</TestDemographics>

<AddPatientDemographics>

<PatientSSN>990-90-9090</PatientSSN> <PatientAddress1>300 N. Main Street</
PatientAddress1><PatientAddress2>Apt. 2C</PatientAddress2><PatientCity>Newtown</PatientCity>
<PatientState>OH</PatientState> <PatientCountry>USA</PatientCountry>

</AddPatientDemographics>

<OrderInformation>

<HISTestType>12-Lead Electrocardiograph
</HISTestType><HISAccountNumber>10100
</HISAccountNumber> <AdmitDiagnosis>
Chest Pain</AdmitDiagnosis> <HISOrderingMDLastName>
Gannon<HISOrderingMDLastName>
<HISOrderingMDFirstName>Joe
<HISOrderingMDFirstName> <ServicingFacility>
St.Mary's Hospital</ServicingFacility>

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Sample XML Documents

</OrderInformation>

<Diagnosis>

<Modality>RESTING</Modality>

<DiagnosisStatement>

</DiagnosisStatement>

<DiagnosisStatement>

</DiagnosisStatement>

<DiagnosisStatement>

<StmtFlag>EndsLine</StmtFlag>

<StmtText>*** ACUTE MI SUSPECTED ***</StmtText>

<StmtFlag>EndsLine</StmtFlag>

<StmtText>Abnormal ECG **Unconfirmed**</StmtText>

<StmtFlag>EndsLine</StmtFlag>

<StmtText>Normal sinus rhythm</StmtText>

</DiagnosisStatement>

<DiagnosisStatement>

<StmtFlag>EndsLine</StmtFlag>

<StmtText>ST elevation consider inferior injury or acute infarct</StmtText>

</DiagnosisStatement>

</Diagnosis>

<Waveform>

<WaveformType>Rhythm</WaveformType><WaveformStartTime>0</WaveformStartTime>
<NumberofLeads>8</NumberofLeads> <SampleType>CONTINUOUS_SAMPLES</SampleType>
<SampleBase>500</SampleBase><SampleExponent>0</SampleExponent>

<LeadData>

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<LeadByteCountTotal>10000</LeadByteCountTotal>

<LeadTimeOffset>0</LeadTimeOffset>

<LeadSampleCountTotal>5000</LeadSampleCountTotal>

<LeadAmplitudeUnitsPerBitt>4.88</LeadAmplitudeperUnit>

<LeadAmplitudeUnits>microvolts</LeadAmplitudeUnits>

<LeadHighLimit>32767</LeadHighLimit>

<LeadLowLimit>-32768</LeadLowLimit>

<LeadID>I</LeadID>

<LeadOffsetFirstSample>0</LeadOffsetFirstSample>

<FirstSampleBaseline>0</FirstSampleBaseline>

<LeadSampleSize>2</LeadSampleSize>

<LeadOff>FALSE</LeadOff>

<BaselineSway>FALSE</BaselineSway>

<LeadDataCRC32>3082779520</LeadDataCRC32>

Sample XML Documents

<WaveFormData>

+f/8/wAAAQAAAAAAAgAFAAgACgALAAwADwAPAA8ADgAPABAAEQARABMAFAA
UABMAEwATABEAEQARAA8ADgARABIAEQAQABEAEQAOAAoACQAIAAoADwARABAADwAL
AAoACQAIAAkACgALAAoACgAKAAoACQAJAAoACgAKAAoACgAKAAoACgAKAAoACQAJAAoACg
AKAAsACgAKAAoACgALAAoACgAJAAkACgALAAoACQAKAAsACgAJAAoACwALAAsACwAL
AAoACgAMAAoACgALAA0ADwAQABAA3v/e/97/3//f/9z/2//a/9n/1//U/9P/1f/V/9X/1f/V/9X/1 v/V/9P/0f/R/9H/z//
P/9D/ z//Q/9H/0f/S/w==

</WaveFormData>

</LeadData>

<LeadData>

<LeadByteCountTotal>10000</LeadByteCountTotal>

<LeadTimeOffset>0</LeadTimeOffset>

<LeadSampleCountTotal>5000</LeadSampleCountTotal>

<LeadAmplitudeperUnit>4.88</LeadAmplitudeperUnit>

<LeadAmplitudeUnits>microvolts</LeadAmplitudeUnits>

<LeadHighLimit>32767</LeadHighLimit>

<LeadLowLimit>-32768</LeadLowLimit>

<LeadID>II</LeadID>

<LeadOffsetFirstSample>0</LeadOffsetFirstSample>

<FirstSampleBaseline>0</FirstSampleBaseline>

<LeadSampleSize>2</LeadSampleSize>

<LeadOff>FALSE</LeadOff>

<BaselineSway>FALSE</BaselineSway>

<LeadDataCRC32>2009428550</LeadDataCRC32>

<WaveFormData>

VgBRAEkAQgA9ADgAMAAqACQAHwAZABQADwAKAAUAAAD8//f/8//v/+z/5 v/k/+H/3//
d/9r/1//U/9H/z//N/8v/y//K/8n/xf/E/8X/x//G/8b/xv/E/8L/wf/A/8D/wP/A/8D/wP/B /8H/
NgA2ADQANQA4ADkAOQA7AD0APgBAAEIARgBKAE0ATwBRAFQAVQBXAFsAXgBgAGM AZgBsAG8A
cAB0AHUAeQB8AA==

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Sample XML Documents

</WaveFormData>

</LeadData>

<LeadData>

<LeadByteCountTotal>10000</LeadByteCountTotal>

<LeadTimeOffset>0</LeadTimeOffset>

<LeadSampleCountTotal>5000</LeadSampleCountTotal>

<LeadAmplitudeperUnit>4.88</LeadAmplitudeperUnit>

<LeadAmplitudeUnits>microvolts</LeadAmplitudeUnits>

<LeadHighLimit>32767</LeadHighLimit>

<LeadLowLimit>-32768</LeadLowLimit>

<LeadID>V1</LeadID>

<LeadOffsetFirstSample>0</LeadOffsetFirstSample>

<FirstSampleBaseline>0</FirstSampleBaseline>

<LeadSampleSize>2</LeadSampleSize>

<LeadOff>FALSE</LeadOff>

<BaselineSway>FALSE</BaselineSway>

<LeadDataCRC32>2158029626</LeadDataCRC32>

<WaveFormData>

//8AAP////8AAAMABgAHAAgACAAIAAkACwANAA8ADgAOAA8ADgAMAAsADQ
AOAA8AEAARABIAEQAPABAAEgARABAAEAARABMAEwAUABIAEQARABAADwAPABIAFQA
YABgAFgATABIAEgASABIABQAEAAQABQAGAAUABAADAAIAAwAEAAQAAwAEAAcACAAGAAY
ABgAGAAYABgAFAAQAAgACAAEAAAAAAAAAAAD//wAAAQABAP//AQAEAAQABAABA P7//P/9/////v/9//3//f/8//z/
+v/4//f/ 9f/0//P/9P/z/w==

</WaveFormData>

</LeadData>

<LeadData>

<LeadByteCountTotal>10000</LeadByteCountTotal>

<LeadTimeOffset>0</LeadTimeOffset>

<LeadSampleCountTotal>5000</LeadSampleCountTotal>

<LeadAmplitudeperUnit>4.88</LeadAmplitudeperUnit>

<LeadAmplitudeUnits>microvolts</LeadAmplitudeUnits>

<LeadHighLimit>32767</LeadHighLimit>

<LeadLowLimit>-32768</LeadLowLimit>

<LeadID>V2</LeadID>

<LeadOffsetFirstSample>0</LeadOffsetFirstSample>

<FirstSampleBaseline>0</FirstSampleBaseline>

<LeadSampleSize>2</LeadSampleSize>

<LeadOff>FALSE</LeadOff>

<BaselineSway>FALSE</BaselineSway>

<LeadDataCRC32>1964450664</LeadDataCRC32>

<WaveFormData>

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Sample XML Documents

IQAnAC0AMgA5AEAAQwBGAEkATQBRAFYAWQBbAFsAXABcAFsAWwBbAF kAWABUAFAASwBLAE0ATgBNAEoARAA/
ADsAOwA9AD8APQA9ADoANwA1ADQAMwA2 ADcAOAA2ADMAMgAxADEAMwA0ADQA5f/l/+P/5P/l/+L/4v/h/
+H/5P/k/+X/5P/k/+P/4v/h/ +H /4v/i/9//3P/a/9r/2f/Y/9j/1v/V/9P/0f/R/9L/0P/O/8z/y//M/8v/yv/J/8b/w//C/8L/v/
+7 /7r/uv+6/7j/uP+1/7T/sf+u/63/rf+s/w==

</WaveFormData>

</LeadData>

<LeadData>

<LeadByteCountTotal>10000</LeadByteCountTotal>

<LeadTimeOffset>0</LeadTimeOffset>

<LeadSampleCountTotal>5000</LeadSampleCountTotal>

<LeadAmplitudeperUnit>4.88</LeadAmplitudeperUnit>

<LeadAmplitudeUnits>microvolts</LeadAmplitudeUnits>

<LeadHighLimit>32767</LeadHighLimit>

<LeadLowLimit>-32768</LeadLowLimit>

<LeadID>V3</LeadID>

<LeadOffsetFirstSample>0</LeadOffsetFirstSample>

<FirstSampleBaseline>0</FirstSampleBaseline>

<LeadSampleSize>2</LeadSampleSize>

<LeadOff>FALSE</LeadOff>

<BaselineSway>FALSE</BaselineSway>

<LeadDataCRC32>2092541187</LeadDataCRC32>

<WaveFormData>

RQBIAEwAUABTAFgAXQBhAGQAZABkAGYAZgBlAGUAYgBeAF0AWgBXAFM
ATgBKAEcAQwBCAD8APQA7ADgANQAyAC8ALgArACgAJQAlACMAIgAgAB0AGwAaABkAF
wAXABkAGgAaABgAFgAUABMA3f/b/9v/3f/f/9//3f/d/97/4P/h/+H/3//e/+H/4v/i/+P/4f/f/97/ 3f/b/9r/2P/Y/9j/ 2P/
Z/9j/1//W/9f/1v/U/9L/0//V/9X/1f/T/9L/0P/P/9H/0f/P/8//zv/O/8//zv/L/8r/yf/I/8n/y//L/w==

</WaveFormData>

</LeadData>

<LeadData>

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<LeadByteCountTotal>10000</LeadByteCountTotal>

<LeadTimeOffset>0</LeadTimeOffset>

<LeadSampleCountTotal>5000</LeadSampleCountTotal>

<LeadAmplitudeperUnit>4.88</LeadAmplitudeperUnit>

<LeadAmplitudeUnits>microvolts</LeadAmplitudeUnits>

<LeadHighLimit>32767</LeadHighLimit>

<LeadLowLimit>-32768</LeadLowLimit>

<LeadID>V4</LeadID>

<LeadOffsetFirstSample>0</LeadOffsetFirstSample>

<FirstSampleBaseline>0</FirstSampleBaseline>

<LeadSampleSize>2</LeadSampleSize>

<LeadOff>FALSE</LeadOff>

<BaselineSway>FALSE</BaselineSway>

<LeadDataCRC32>2115653667</LeadDataCRC32>

<WaveFormData>

UQBSAFEATgBMAEoASQBHAEcARQBEAEMAQQA9ADoANwA0ADEALAA
oACQAIAAaABcAEwASABAADgAKAAUAAwAAAP7//v/8//r/+P/2//X/8//w/+3/6//r/+v/6 f/o/+j/ 6f/p/+n/6f/p/+f/3//
b/9n/2//e/+D/4v/k/+L/4f/i/+X/5f/k/+b/6P/p/+n/6P/p/+n/6P/o/+f/5 //p/+r/6//s/+3/7v/u/+7/7//u/+3/8P/y//X/9//5//
r/+f/4//n/+//9/wAABAAFAAUAAgACAAQ ABwAMAA8AEQATAA==

</WaveFormData>

</LeadData>

<LeadData>

<LeadByteCountTotal>10000</LeadByteCountTotal>

<LeadTimeOffset>0</LeadTimeOffset>

<LeadSampleCountTotal>5000</LeadSampleCountTotal>

<LeadAmplitudeperUnit>4.88</LeadAmplitudeperUnit>

<LeadAmplitudeUnits>microvolts</LeadAmplitudeUnits>

<LeadHighLimit>32767</LeadHighLimit>

<LeadLowLimit>-32768</LeadLowLimit>

<LeadID>V5</LeadID>

<LeadOffsetFirstSample>0</LeadOffsetFirstSample>

<FirstSampleBaseline>0</FirstSampleBaseline>

<LeadSampleSize>2</LeadSampleSize>

<LeadOff>FALSE</LeadOff>

<BaselineSway>FALSE</BaselineSway>

<LeadDataCRC32>1318632558</LeadDataCRC32>

<WaveFormData>

GQAXABcAFgAVABYAFgAVABUAFAATABIAEAAOAA0ADQALAAsACgAKAAoACg
AHAAUABAAFAAcABwAGAAMAAQD///7/AAABAAEAAAD///3//P/7//r/+f/4//f/9v/1//b/9// 3//b/9v/2//X/5v/j/+H/4v/j/
+T/5P/k/+X/5//n/+f/5v/k/+b/5//o/+n/6f/q/+n/6P/n/+f/5v/l/+X/ 5f/n/+j/5//o/+n/6//r/+n/6P/o/+n/6//t/+//8P/v//H/8f/
w//D/8v/0//T/9P/0//X/9v/3//j/9//4/w==

</WaveFormData>

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</LeadData>

<LeadData>

<LeadByteCountTotal>10000</LeadByteCountTotal>

<LeadTimeOffset>0</LeadTimeOffset>

<LeadSampleCountTotal>5000</LeadSampleCountTotal>

<LeadAmplitudeperUnit>4.88</LeadAmplitudeperUnit>

<LeadAmplitudeUnits>microvolts</LeadAmplitudeUnits>

<LeadHighLimit>32767</LeadHighLimit>

<LeadLowLimit>-32768</LeadLowLimit>

<LeadID>V6</LeadID>

<LeadOffsetFirstSample>0</LeadOffsetFirstSample>

<FirstSampleBaseline>0</FirstSampleBaseline>

<LeadSampleSize>2</LeadSampleSize>

<LeadOff>FALSE</LeadOff>

<BaselineSway>FALSE</BaselineSway>

<LeadDataCRC32>4053461019</LeadDataCRC32>

Sample XML Documents

<WaveFormData>

9v/3//r//f///wEAAgACAAMABAAFAAgACgALAAwADAAKAAoACwAOAA8ADwA
PABAADwAOAA8AEAASABEAEQAOAA0ADgAPABAADgANAAwACgAIAAoACwALAAsADAANA
A8AEAAOAAsACgAJAAgA7f/r/+r/6f/o/+f/5f/k/+b/6P/p/+n/5//j/+L/4//k/+X/5f/l/+X/4//g/97/ 3P/c/9v/ 2v/d/9//3//
e/93/3f/c/9r/2f/a/9j/2P/Z/9z/3P/b/9r/2f/Y/9j/2f/X/9b/1f/U/9b/1//X/9X/0v/Q/w==

</WaveFormData> </LeadData></Waveform>

</RestingECG>

Sample Patient Demographics Section

<?xml version="1.0"? encoding="windows-1252”?><!DOCTYPE RestingECG SYSTEM
"restecg.DTD"><RestingECG>

<PatientDemographics>

<PatientID>041399090751</PatientID> <Gender>Male</Gender> <Race>Unknown</Race>

<PatientLastName></PatientLastName><PatientFirstName></PatientFirstName>
<AnalysisAge>47</AnalysisAge> <AnalysisAgeUnits>Years</AnalysisAgeUnits>

</PatientDemographics>

</RestingECG>

Sample Test Demographics Section

<?xml version="1.0"? encoding="windows-1252”?> <!DOCTYPE RestingECG SYSTEM "restecg.DTD">
<RestingECG>

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<TestDemographics>

<DataType>RESTING</DataType> <Site>1</Site> <AcquisitionDevice>ABC123</
AcquisitionDevice> <Status>UNCONFIRMED</Status>

<Priority>STAT</Priority><Location>0</Location> <AcquisitionTime>09:08:38</AcquisitionTime>

<AcquisitionDate>04/13/1999</AcquisitionDate> <CartNumber>000</CartNumber>
<AcquisitionSoftwareVersion>Version 2.31</AcquisitionSoftwareVersion>

</TestDemographics>

</RestingECG>

Sample Order Information Section

<?xml version="1.0"? encoding="windows-1252”?> <!DOCTYPE RestingECG SYSTEM "restecg.DTD">
<RestingECG>

<OrderInformation>

<HISTestType>12-Lead Electrocardiograph</HISTestType> <HISAccountNumber>10100</
HISAccountNumber> <AdmitDiagnosis>Chest Pain</AdmitDiagnosis>

<HISOrderingMDLastName>Gannon<HISOrderingMDLastName>
<HISOrderingMDFirstName>Joe<HISOrderingMDFirstName> <ServicingFacility>St.Mary's
Hospital</ServicingFacility>

</OrderInformation>

</RestingECG>

Sample Diagnosis Section with Diagnosis Statement

<?xml version="1.0"? encoding="windows-1252”?> <!DOCTYPE RestingECG SYSTEM "restecg.DTD">
<RestingECG>

<Diagnosis>

<Modality>RESTING</Modality> <DiagnosisStatement>

<StmtFlag>EndsLine</StmtFlag>

<StmtText>*** ACUTE MI SUSPECTED ***</StmtText>

</DiagnosisStatement> <DiagnosisStatement>

<StmtFlag>EndsLine</StmtFlag>

<StmtFlag>UserInsert</StmtFlag>

<StmtText>Abnormal ECG **Unconfirmed**</StmtText>

</DiagnosisStatement><DiagnosisStatement>

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<StmtFlag>EndsLine</StmtFlag>

<StmtText>Normal sinus rhythm</StmtText>

</DiagnosisStatement>

</Diagnosis>

</RestingECG>

Sample Waveform Section

<Waveform>

<WaveformType>Rhythm</WaveformType>

<WaveformStartTime>0</WaveformStartTime>

<NumberofLeads>8</NumberofLeads>

Sample XML Documents

<SampleType>CONTINUOUS_SAMPLES</SampleType>

<SampleBase>500</SampleBase>

<SampleExponent>0</SampleExponent> <LeadData>

<LeadByteCountTotal>10000</LeadByteCountTotal>

<LeadTimeOffset>0</LeadTimeOffset>

<LeadSampleCountTotal>5000</LeadSampleCountTotal>

<LeadAmplitudeperUnit>204918.0</LeadAmplitudeperUnit>

<LeadAmplitudeUnits>volts</LeadAmplitudeUnits>

<LeadHighLimit>4294967295</LeadHighLimit>

<LeadLowLimit>4294967295</LeadLowLimit>

<LeadID>I</LeadID>

<LeadOffsetFirstSample>0</LeadOffsetFirstSample>

<FirstSampleBaseline>0</FirstSampleBaseline>

<LeadSampleSize>2</LeadSampleSize>

<LeadOff>FALSE</LeadOff>

<BaselineSway>FALSE</BaselineSway>

<LeadDataCRC32>3790641214</LeadDataCRC32>

<WaveFormData>

</WaveFormData>

</LeadData>

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<LeadData>

<LeadByteCountTotal>10000</LeadByteCountTotal>

<LeadTimeOffset>0</LeadTimeOffset>

<LeadSampleCountTotal>5000</LeadSampleCountTotal>

<LeadAmplitudeperUnit>204918.0</LeadAmplitudeperUnit>

<LeadAmplitudeUnits>volts</LeadAmplitudeUnits>

<LeadLowLimit>4294967295</LeadLowLimit>

<LeadHighLimit>4294967295</LeadHighLimit>

<LeadID>II</LeadID>

<LeadOffsetFirstSample>0</LeadOffsetFirstSample>

<FirstSampleBaseline>0</FirstSampleBaseline>

<LeadSampleSize>2</LeadSampleSize>

<LeadOff>FALSE</LeadOff>

<LeadDataCRC32>269312671</LeadDataCRC32>

<BaselineSway>FALSE</BaselineSway>

<WaveFormData>

</WaveFormData>

</LeadData>

</Waveform>

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GE Medical Systems

Information Technologies, Inc.

8200 West Tower Avenue
Milwaukee, WI 53223 USA
Tel:
Tel:

GE Medical Systems

Information Technologies GmbH

Munzinger Straße 5
79111 Freiburg Germany
Tel:

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

www.gehealthcare.com