Pre-Installation Manual 186 Pages.pdf

Pre-Installation Manual Revolution Ascend Family

5987663-1EN

Revision 5

General Service Documentation © 2024 GE HealthCare. GE is a trademark of General Electric Company used under trademark license.

GE HealthCare proprietary. Reproduction and/or distribution is prohibited.

This manual covers the following products:

Product Name Configuration

Revolution Ascend • 40mm-collimation

• Performix 40 Plus X-ray Tube

• VT1700V/VT2000/VT2000x Table

• Revolution Ascend Black Covers

Revolution Ascend Elite • 40mm-collimation

• Performix 40 Plus X-ray Tube

• NG1700 Elite Standard Table / NG2000 Elite Heavy

Table

• Revolution Ascend Purple Covers

• True Enhance DL Option

Revolution Ascend Plus • 40mm-collimation

• Performix 40 Plus X-ray Tube

• NG1700 Elite Standard Table / NG2000 Elite Heavy

Table

• VT1700V/VT2000/VT2000x Table

• Revolution Ascend Purple Covers

Revolution Ascend Select • 20mm-collimation

• Performix Plus X-ray Tube

• NG1700 Elite Standard Table / NG2000 Elite Heavy

Table

• Revolution Ascend Purple Covers

Language Policy DOC0371395 - Global Language Procedure

ПРЕДУПРЕЖ

ДЕНИЕ

(BG)

Това ръководство е налично само на китайски (ZH-CN), английски, френски, немски, японски, корейски, полски, португалски (PT-BR), руски, испански и виетнамски. Ако доставчикът на услуги на даден клиент изисква език, който е различен от тези езици, отговорност на клиента е да предостави преводачески услуги.

警告

(ZH-CN)

本手册仅提供中文 (ZH-CN)、英文、法语、德语、意大利语、日语、韩语、波兰语、葡萄牙语

(PT-BR)、俄语、西班牙语和越南语版本。如果客户的服务提供商需要其他语言，则客户有责任

提供翻译服务。

警告

(ZH-HK)

本手冊僅提供中文 (ZH-CN)、英文、法文、德文、意大利文、日文、韓文、波蘭文、葡萄牙文

(PT-BR)、俄文、西班牙文及越南文版本。如客戶的服務供應商需要這些語言以外的版本，則相

關客戶有責任提供有關的翻譯服務。

警告

(ZH-TW)

此手冊僅提供中文 (ZH-CN)、英文、法文、德文、義大利文、日文、韓文、波蘭文、葡萄牙文

(PT-BR)、俄文、西班牙文和越南文版本。假如客戶的服務提供者所需語言版本不在所列語言之

中，客戶需自行負責提供翻譯服務。

UPOZORENJE

(HR)

Ovaj je priručnik dostupan samo na kineskom (ZH-CN), engleskom, francuskom, njemačkom, tali-janskom, japanskom, korejskom, poljskom, portugalskom (PT-BR), ruskom, španjolskom i vijetnams-kom jeziku. Ako klijentov serviser zahtijeva jezik koji nije jedan od tih jezika, odgovornost je klijenta pružiti uslugu prevođenja.

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VÝSTRAHA

(CS)

Tato příručka je k dispozici pouze v čínštině (ZH-CN), angličtině, francouzštině, němčině, italštině, japonštině, korejštině, polštině, portugalštině (PT-BR), ruštině, španělštině a vietnamštině. Pokud poskytovatel služeb zákazníka vyžaduje jiný jazyk než tyto jazyky, je odpovědností zákazníka posky-tovat překladatelské služby.

ADVARSEL

(DA)

Denne vejledning findes kun på kinesisk (ZH-CN), engelsk, fransk, tysk, italiensk, japansk, koreansk, polsk, portugisisk (PT-BR), russisk, spansk og vietnamesisk. Hvis en kundes tjenesteudbyder kræver et andet sprog end disse sprog, er det kundens ansvar at levere oversættelsestjenester.

WAARSCHUW-

ING

(NL)

Deze handleiding is alleen beschikbaar in het Chinees (ZH-CN), Engels, Frans, Duits, Italiaans, Japans, Koreaans, Pools, Portugees (PT-BR), Russisch, Spaans en Vietnamees. Als de serviceprovider van een klant een andere taal dan deze talen vereist, is het de verantwoordelijkheid van de klant om vertaalservices te leveren.

WARNING

(EN)

This manual is available in Chinese (ZH-CN), English, French, German, Italian, Japanese, Korean, Polish, Portuguese (PT-BR), Russian, Spanish, and Vietnamese only. If a customer's service provider requires a language other than these languages, it is the customer's responsibility to provide transla-tion services.

HOIATUS

(ET)

See juhend on saadaval ainult hiina (ZH-CN), inglise, prantsuse, saksa, itaalia, jaapani, korea, poola, portugali (PT-BR), vene, hispaania ja vietnami keeles. Kui kliendi teenusepakkujal on vaja juhendit mõnes muus keeles, on tõlketeenuste osutamine kliendi kohustus.

VAROITUS

(FI)

Tämä opas on saatavilla vain kiinaksi (ZH-CN), englanniksi, ranskaksi, saksaksi, italiaksi, japaniksi, koreaksi, puolaksi, portugaliksi (PT-BR), venäjäksi, espanjaksi ja vietnamiksi. Jos asiakkaan palvelun-tarjoaja edellyttää muuta kuin näitä kieliä, käännöspalveluiden tarjoaminen on asiakkaan vastuulla.

ATTENTION

(FR)

Ce manuel est disponible uniquement en allemand, anglais, chinois (ZH-CN), coréen, espagnol, français, italien, japonais, polonais, portugais (PT-BR), russe et vietnamien. Si le prestataire de servi-ces d'un client nécessite que le manuel soit rédigé dans une autre langue que celles mentionnées ci-dessus, il incombe au client de le faire traduire.

WARNUNG

(DE)

Dieses Handbuch ist nur auf Chinesisch (ZH-CN), Englisch, Französisch, Deutsch, Italienisch, Japa-nisch, Koreanisch, Polnisch, Portugiesisch (PT-BR), Russisch, Spanisch und Vietnamesisch verfügbar.

Wenn ein Dienstleister des Kunden dieses in einer anderen Sprache als die genannten benötigt, liegt es in der Verantwortung des Kunden, Übersetzungsdienstleistungen zu erbringen.

ΠΡΟΕΙΔΟΠΟΙ

ΗΣΗ

(EL)

Αυτό το εγχειρίδιο είναι διαθέσιμο μόνο σε Κινεζικά (ZH-CN), Αγγλικά, Γαλλικά, Γερμανικά, Ιταλικά, Ιαπωνικά, Κορεατικά, Πολωνικά, Πορτογαλικά (PT-BR), Ρωσικά, Ισπανικά και Βιετναμέζικα. Εάν ο πάροχος υπηρεσιών ενός πελάτη απαιτεί γλώσσα που δεν συμπεριλαμβάνεται σε αυτές τις γλώσσες, αποτελεί ευθύνη του πελάτη να παρέχει υπηρεσίες μετάφρασης.

FIGYELMEZ-

TETÉS

(HU)

Ez a kézikönyv az alábbi nyelveken érhető el: angol, francia, japán, kínai (ZH-CN), koreai, lengyel, német, olasz, orosz, portugál (PT-BR), spanyol és vietnámi. Ha az ügyfél szolgáltatója ezektől eltérő nyelvű kézikönyvet szeretne, akkor az ügyfél feladata, hogy gondoskodjon a megfelelő fordításról.

AÐVÖRUN

(IS)

Þessi handbók er aðeins fáanleg á kínversku (ZH-CN), ensku, frönsku, þýsku, ítölsku, japönsku, kóresku, pólsku, portúgölsku (PT-BR), rússnesku, spænsku og víetnömsku. Ef þjónustuaðili viðskipta-vinar þarfnast annars tungumáls en þessara tungumála er það á ábyrgð viðskiptavinarins að veita þýðingarþjónustu.

AVVERTENZA

(IT)

Questo manuale è disponibile solo in lingua cinese (ZH-CN), inglese, francese, tedesco, italiano, giap-ponese, coreano, polacco, portoghese (PT-BR), russo, spagnolo e vietnamita. Qualora un fornitore di servizi del cliente richieda una lingua diversa dall'inglese, sarà responsabilità del cliente fornire il servizio di traduzione corrispondente.

警告

(JA)

このマニュアルは、中国語 (ZH-CN)、英語、フランス語、ドイツ語、イタリア語、日本語、韓

国語、ポーランド語、ポルトガル語 (PT-BR)、ロシア語、スペイン語、およびベトナム語のみ

で提供されています。お客様のサービスプロバイダがこれらの言語以外の言語を必要とする 場合は、お客様の責任において翻訳サービスを提供してください。

경고

(KO)

이 설명서는 중국어(중국어-중국), 영어, 프랑스어, 독일어, 이탈리아어, 일본어, 한국어, 폴란드어, 포르 투갈어(포르투갈어-브라질), 러시아어, 스페인어, 베트남어로만 제공됩니다. 고객의 서비스 제공자가 이 언어를 제외한 다른 언어를 요구하는 경우, 번역 서비스를 제공하는 것은 고객의 책임입니다.

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BRĪDINĀJUMS

(LV)

Šī rokasgrāmata ir pieejama tikai ķīniešu (ZH-CN), angļu, franču, vācu, itāliešu, japāņu, korejiešu, poļu, portugāļu (PT-BR), krievu, spāņu un vjetnamiešu valodā. Ja klientu apkalpošanas speciālistam ir nepieciešama cita valoda, kas atšķiras no šeit norādītajām, klienta pienākums ir nodrošināt tulko-šanas pakalpojumus.

ĮSPĖJIMAS

(LT)

Šis vadovas pateikiamas tik kinų (ZH-CN), anglų, prancūzų, vokiečių, italų, japonų, korėjiečių, lenkų, portugalų (PT-BR), rusų, ispanų ir vietnamiečių kalbomis. Jei klientų paslaugų teikėjui reikalinga kita nei šios kalba, už vertimo paslaugų suteikimą atsako klientas.

ADVARSEL

(NO)

Denne håndboken er bare tilgjengelig på kinesisk (ZH-CN), engelsk, fransk, tysk, italiensk, japansk, koreansk, polsk, portugisisk (PT-BR), russisk, spansk og vietnamesisk. Hvis en kundes tjenesteleve-randør krever et annet språk, er det kundens ansvar å levere en oversettelsestjeneste.

OSTRZEŻENIE

(PL)

Niniejsza instrukcja jest dostępna wyłącznie w języku chińskim (ZH-CN), angielskim, francuskim, nie-mieckim, włoskim, japońskim, koreańskim, polskim, portugalskim (PT-BR), rosyjskim, hiszpańskim i wietnamskim. Jeśli usługodawca klienta wymaga języka, który nie został wymieniony powyżej, obowiązkiem klienta jest zapewnienie usług tłumaczeniowych.

ATENÇÃO

(PT-BR)

Este manual está disponível somente em chinês (ZH-CN), inglês, francês, alemão, italiano, japonês, coreano, polonês, português (PT-BR), russo, espanhol e vietnamita. Se o prestador de serviços de um cliente necessitar de um idioma diferente dos mencionados, o fornecimento dos serviços de tradução é de responsabilidade do cliente.

ATENÇÃO

(PT-PT)

Este manual está disponível apenas em alemão, chinês (ZH-CN), coreano, espanhol, francês, inglês, italiano, japonês, polaco, português (PT-BR), russo e vietnamita. Se o fornecedor de serviços de um cliente necessitar de um idioma diferente dos listados aqui, é da responsabilidade do cliente assegurar os serviços de tradução.

ATENŢIE

(RO)

Acest manual este disponibil numai în limbile chineză (ZH-CN), engleză, franceză, germană, italiană, japoneză, coreeană, poloneză, portugheză (PT-BR), rusă, spaniolă şi vietnameză. Dacă furnizorul de servicii al unui client solicită o limbă diferită faţă de aceste limbi, este responsabilitatea clientului să furnizeze servicii de traducere.

ОСТОРОЖНО

(RU)

Настоящее руководство доступно только на китайском (ZH-CN), английском, французском, немецком, итальянском, японском, корейском, польском, португальском (PT-BR), русском, испанском и вьетнамском языках. Если поставщику услуг заказчика требуется руководство на каком-либо другом языке, перевод руководства на необходимый язык осуществляется стороной заказчика.

UPOZORENJE

(SR)

Ovaj priručnik dostupan je samo na kineskom (ZH-CN), engleskom, francuskom, nemačkom, itali-janskom, japanskom, korejskom, poljskom, portugalskom (PT-BR), ruskom, španskom i vijetnams-kom jeziku. Ako korisnik kao pružalac usluge zahteva neki drugi jezik od navedenih, njegova je dužnost da obezbedi prevod.

UPOZORNE-

NIE

(SK)

Táto príručka je dostupná len v nasledovných jazykoch: čínština (ZH-CN), angličtina, francúzština, nemčina, taliančina, japončina, kórejčina, poľština, portugalčina (PT-BR), ruština, španielčina a viet-namčina. Ak poskytovateľ služieb daného zákazníka požaduje iný ako tieto jazyky, za poskytnutie prekladateľských služieb zodpovedá zákazník.

ATENCION

(ES)

Este manual está disponible solo en chino (ZH-CN), inglés, francés, alemán, italiano, japonés, co-reano, polaco, portugués (PT-BR), ruso, español y vietnamita. Si el proveedor de servicios de un cliente requiere un idioma distinto de estos idiomas, es responsabilidad del cliente proporcionar los servicios de traducción.

VARNING

(SV)

Den här manualen finns endast tillgänglig på kinesiska (ZH-CN), engelska, franska, tyska, italienska, japanska, koreanska, polska, portugisiska (PT-BR), ryska, spanska och vietnamesiska. Om en kunds tjänsteleverantör behöver ett annat språk än dessa är det kundens ansvar att ordna med översätt-ningstjänster.

OPOZORILO

(SL)

Ta priročnik je na voljo v kitajščini (ZH-CN), angleščini, francoščini, nemščini, italijanščini, japonščini, korejščini, poljščini, portugalščini (PT-BR), ruščini, španščini in vietnamščini. Če kupčev ponudnik storitev potrebuje drug jezik, mora za prevod poskrbeti kupec.

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DİKKAT

(TR)

Bu kılavuz yalnızca Çince (ZH-CN), İngilizce, Fransızca, Almanca, İtalyanca, Japonca, Korece, Lehçe, Portekizce (PT-BR), Rusça, İspanyolca ve Vietnamca dillerinde mevcuttur. Müşteri servis sağlayıcısı bu dillerden başka bir dil talep ederse çeviri hizmeti sağlamak müşterinin sorumluluğundadır.

ЗАСТЕРЕЖЕН

НЯ

(UK)

Цей посібник доступний лише китайською (ZH-CN), англійською, французькою, німецькою, італійською, японською, корейською, польською, португальською (PT-BR), російською, іспанською та в’єтнамською мовами. Якщо постачальник послуг замовника використовує мову, яку не вказано у цьому переліку, послуги з перекладу має забезпечити замовник.

Damage in Transportion All packages should be closely examined at time of delivery. If damage is apparent, have notation "damage in shipment" written on all copies of the freight or express bill before delivery is accepted or "signed for" by a GE HealthCare representative or a hospital receiving agent. Whether noted or concealed, damage MUST be reported to the carrier immediately upon discovery, or in any event, within 14 days after receipt, and the contents and containers held for inspection by the carrier. A transportation company will not pay a claim for damage if an inspection is not requested within this 14 day period.

To file a report:

• Call 1-800-548-3366 and use option 6.

• Fill out the GIQ workflow for any items missing, damaged, OBF/FOI for in process installs: https:// app.sc.ge.com

• Contact your local service coordinator for more information on this process.

Rev. Nov. 10, 2017

Certified Electrical Contractor Statement All electrical Installations that are preliminary to positioning of the equipment at the site prepared for the equipment shall be performed by licensed electrical contractors. In addition, electrical feeds into the Power Distribution Unit shall be performed by licensed electrical contractors. Other connections between pieces of electrical equipment, calibrations and testing shall be performed by qualified GE HealthCare personnel. The products involved (and the accompanying electrical installations) are highly sophisticated, and special engineering competence is required. In performing all electrical work on these products, GE will use its own specially trained field engineers. All of GE's electrical work on these products will comply with the requirements of the applicable electrical codes.

The purchaser of GE equipment shall only utilize qualified personnel (i.e., GE's field engineers, personnel of third-party service companies with equivalent training, or licensed electricians) to perform electrical servicing on the equipment.

IMPORTANT … X-Ray Protection X-ray equipment if not properly used may cause injury. Accordingly, the instructions herein contained should be thoroughly read and understood by everyone who will use the equipment before you attempt to place this equipment in operation. The GE HealthCare will be glad to assist and cooperate in placing this equipment in use.

Although this apparatus incorporates a high degree of protection against x-radiation other than the useful beam, no practical design of equipment can provide complete protection. Nor can any practical design compel the operator to take adequate precautions to prevent the possibility of any persons carelessly exposing themselves or others to radiation.

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It is important that anyone having anything to do with x-radiation be properly trained and fully acquainted with the recommendations of the National Council on Radiation Protection and Measurements as published in NCRP Reports available from NCRP Publications, 7910 Woodmont Avenue, Room 1016, Bethesda, Maryland 20814, and of the International Commission on Radiation Protection, and take adequate steps to protect against injury.

The equipment is sold with the understanding that the GE HealthCare, its agents, and representatives have no responsibility for injury or damage which may result from improper use of the equipment.

Various protective materials and devices are available. It is urged that such materials or devices be used.

Lithium Battery Cautionary Statements

CAUTION

RISK OF EXPLOSION.

Danger of explosion if battery is incorrectly replaced.

Replace only with the same or equivalent type recommended by the manufacturer.

Discard used batteries according to the manufacturer’s instructions.

WARNING

DANGER D’EXPLOSION

Il y a danger d’explosion s’il y a replacement incorrect de la batterie.

Remplacer uniquement avec une batterie du même type ou d’un type recommandé par le constructeur. Mettre au rébut les batteries usagées conformément aux instructions du fabricant.

Omissions & Errors Customers, please contact your GE Sales or Service representatives.

GE personnel, please use the Healthcare PQR Process to report all omissions, errors, and defects in this publication.

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Revision History Revision Date Reason for change

5 Oct 25, 2024 Chapter 1, Section 1.2: Update Pre-Installation Checklist.

Chapter 5, Section 5.2.1: Add rear cover door dimension Chapter 5, Section 5.2.5: Add Z8G5 information Chapter 7, Section 7.2.1: Update Figure 7-1 and following explanation Chapter 8, Section 8.2.2.2: Update Figure 8-3 according to site feedback Chapter 8, Section 8.4: Add Z8G5 information and add new lightweight dolly information in the Table 8-6 Chapter 12, Section 12.3.3: Update Feeder Wire Size per global team Chapter 13, Section 13.3.6: Update power cable size from 14 (2) to 14 (2.5) per global team Chapter 13, Section 13.3.3: Update Cardiac cable information on Table 13-4 Chapter 13, Section 13.6: Update A1 information, refer to DOC2058932 Chapter 14, Section 14.4.3: Update dolly weight in Table 14-2 Chapter 15, Section 15.2.4: Tilting not approved for Flat-bed Truck. feedback

4 Feb 05, 2024 Add Revolution Ascend Family configuration Table on Page 2 Chapter 1, Section 1.2: Update Pre-Installation Checklist per DOC1809666_r8 Chapter 5, Section 5.1.3: Add NG Elite Table information in Table 5-1 Chapter 6, Section 6.2.1: Add Figure 6-4 Tube Change Box Delivery Chapter 7, Section 7.1: Add NG Elite table room size information on Table 7-1 Chapter 8, Section 8.2.2.1: Add Figure 8-2 Boom-In-Room Routing without Junction Box.

Chapter 8, Section 8.2.2.4: Update Junction Mounting Plate Chapter 8, Section 8.4: Add NG Elite Table information in Table 8-6 Chapter 8, Section 8.5.1 and 8.5.2: Update Anchor information Chapter 8, Section 8.6.2: Add VT2000x information in Figure 8-41 to fix IB issue.

Chapter 9, Section 9.5.1: Add EMC 4.1 information Chapter 10, Add Section 10.2 Stray Radiation information Chapter 12, Section 12.3.1: Update power requirement per

SPRHCSDM00727629

Chapter 13, Add Section 13.6 Typical Customer Supplied Wiring Chapter 14, Section 14.2.1: Update lifting description per SPRHCSDM00720264 Chapter 14, Section 14.4: Add new gantry dolly information Chapter 14, Section 14.5: Update Table Delivery Considerations Appendix B: Add NG Elite Table cover removal information

3 April 18, 2022 Update contents according to HII Log (DOC2715511) Chapter 6: Update Figure 6-1 and 6-2 according to SPR HCSDM00671907 Chapter 14: Update tilt-bed truck to forklift

2 August 12, 2021 Chapter 10: Update Table 10-2 and 10-3 Update first NOTE of Figure 10-1 and 10-2

1 July 19, 2021 Initial Release

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Contents 1 Introduction

1.1 Introduction

1.1.1 Using the Pre-Installation Manual

1.1.2 Assigning a Site Project Coordinator

1.1.3 Customer Responsibility

1.1.4 Roles and Responsibilities

1.2 Pre-Installation Checklist

2 Installation Types

2.1 How to Determine the Best Installation Type for Your Site

2.2 Typical Installations

2.3 Construction Site Installations

2.3.1 Full Construction Site with Completed Radiology Area

2.3.2 Full Construction Site with Limited Delivery Access

2.4 Relocatable Building Installations

2.5 Upgrade Installations

2.6 Quick Installations

2.7 Two-Step (Temporary) Installations

3 System Siting Requirements

3.1 System Siting Requirements

3.1.1 Regulatory Requirements

3.1.2 Electrical

3.1.3 Structural

3.1.3.1 Dust and Air Quality

3.1.3.2 Environmental Influences

3.1.3.3 Finished Floor Requirements

3.1.3.4 Finished Walls Requirements

3.1.4 Radiation Protection

3.1.5 Environmental

3.1.6 Options

3.1.7 Clearances

3.1.8 Network

3.1.9 Chemical Contamination

3.1.10 Delivery

4 Regulatory Requirements

4.1 Regulatory Terms and Definitions

4.2 Regulatory Clearances for United State

5 System Component Dimensions

5.1 Minimum Operating Clearances

5.1.1 Ceiling Pedestal Mount Installation

Revolution Ascend Family Contents

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5.1.2 Injector Control Installation

5.1.3 System Operational Clearances

5.2 Component Dimensions

5.2.1 Gantry Dimensions

5.2.2 Table and Gantry Dimensions (with NG Elite 1700 Table / VT1700V)

5.2.3 Table and Gantry Dimensions (with NG Elite 2000 Table / VT2000 Table / VT2000x)

5.2.4 Power Distribution Unit Dimensions

5.2.5 Console Dimensions

6 Service Clearance Requirements

6.1 Service Clearance Requirements

6.1.1 Gantry Service Clearance

6.2 Service Clearances for Single Service Engineer

6.2.1 Cover Removal

6.2.2 Power Distribution Unit (PDU)

6.2.3 Console

6.2.4 Storage Cabinet

7 Room Sizes

7.1 Room Dimensions

7.1.1 Minimum Room Size

7.2 Short Footprint Considerations

7.2.1 Instruction of using Short Footprint function

7.3 Control Room Considerations

7.3.1 Typical Control Room Layout

7.3.1.1 Console Considerations

7.3.1.2 Console Long Cable Option

7.4 Patient Environment

8 Structural and Mounting Requirements

8.1 Importance of Meeting Structural Requirements

8.1.1 Levelness, Vibration, and Floor Loading

8.1.2 Seismic Loading

8.1.3 Anchoring

8.2 Ceiling Requirements

8.2.1 Regulatory Requirements

8.2.2 Ceiling Requirement for Boom-in-Room

8.2.2.1 Ceiling Mounted Devices

8.2.2.2 Pedestal Mounting Plate (Supplied by Customer)

8.2.2.3 Pedestal Height Requirement

8.2.2.4 Junction (Box) Mounting Plate

8.2.3 Ceiling Requirement for Auto Patient Positioning Depth Camera

8.2.3.1 Depth Camera Installation Typical Layout

8.2.3.2 Junction Plate Requirement

8.2.3.3 Junction Plate Position

8.2.4 Ceiling Requirement for AVIMOS Camera

Contents Revolution Ascend Family

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8.2.4.1 AVIMOS Camera Installation Typical Layout

8.2.4.2 Junction Plate Requirement

8.2.4.3 Cable Requirement

8.3 Minimum Floor Requirements

8.3.1 Floor Levelness Specification

8.3.1.1 Critical Specifications

8.3.1.2 Floor Levelness Guidelines

8.3.1.3 Measuring Floor Levelness

8.3.2 Scan Window

8.3.3 Floor Vibration Specification

8.3.3.1 Requirements

8.3.3.2 Sources of Floor Vibration

8.3.4 Floor Strength

8.4 Floor Loading and Component Weights

8.4.1 Floor Loading and Anchoring Guidelines

8.4.2 Anchor Edge Distance Definition

8.5 GE-Supplied Anchoring

8.5.1 Specifications of GE-supplied Anchors

8.5.2 Requirements for Using GE-supplied Anchors

8.6 Seismic Mounting

8.6.1 Overview

8.6.2 Center-of-Gravity Information

9 Environmental Requirements

9.1 Temperature and Humidity Specifications

9.1.1 Temperature (Scan and Control Rooms)

9.1.2 Humidity (Scan Room & Control Room)

9.1.3 Other Guidelines

9.2 Cooling Requirements

9.3 Altitude

9.4 Electro-Magnetic Interference (EMI)

9.4.1 Gantry

9.4.2 Console / Computer Equipment

9.4.3 PDU

9.4.4 EMI Reduction

9.4.5 Equipment EMI "Envelopes"

9.5 Electro-Magnetic Compatibility (EMC)

9.5.1 Electromagnetic Interference (EMI) Consideration

9.6 System Component Noise Levels

10 Radiation Protection Requirements

10.1 Shielding Requirements

10.2 Stray Radiation (Scatter Radiation) (Reference: IEC60601-2-44:2009 Clause203.11, Clause203.13.2)

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11 Network Requirements

11.1 Network Connections

11.1.1 Network Type

11.1.2 Network Speed

11.1.3 Network Cable Routing

11.2 Customer Broadband Responsibilities

11.2.1 Contact GE to Find Zone Broadband Specialist

11.2.2 Provide GE with IT Contact Information for the Site

11.3 Digital Service and Connectivity Requirements

11.3.1 Background

11.3.2 InSite RSVP Connectivity Requirements

12 Power Requirements

12.1 Introduction

12.2 System Input Power

12.2.1 Power Source Configuration

12.2.2 Rating

12.2.3 Regulation

12.2.4 Phase Imbalance

12.2.5 Sags, Surges and Transients

12.2.6 Grounding

12.2.7 Potential Equalization Conductor (Reference IEC 60601-1-2 2007; 2014; 2020)

12.3 Recommended Power Distribution System

12.3.1 Using a Dedicated Distribution Transformer (Recommended)

12.3.2 Using an Existing Distribution Transformer

12.3.3 System Power Requirements

13 Interconnection Data

13.1 Introduction

13.2 Component Designators

13.3 Interconnect Runs, Wiring and Cables

13.3.1 GE Healthcare Supplied (Standard Length 5867933) (Reference IEC 60601-1-2 6.8.3.201(IEC

60601-1 Edition 2 Scheme) / 5.2.2(IEC60601-1 Edition 3 Scheme))

13.3.2 GE Healthcare-Supplied (Optional, Long Run Length 5867933-2) (Reference IEC 60601-1-2

6.8.3.201(IEC 60601-1 Edition 2 Scheme) / 5.2.2(IEC60601-1 Edition 3 Scheme))

13.3.3 GE Healthcare Supplied (Cables of Options) (Reference IEC 60601-1-2 6.8.3.201(IEC 60601-1

Edition 2 Scheme) / 5.2.2(IEC60601-1 Edition 3 Scheme))

13.3.4 UPS Wiring Cables (Reference IEC 60601-1-2 6.8.3.201(IEC 60601-1 Edition 2 Scheme) /

5.2.2(IEC60601-1 Edition 3 Scheme))

13.3.5 A1/MDP UPS

13.3.6 Contractor/Customer-Supplied

13.3.7 Fuse

13.4 Contractor Supplied Components

13.5 Scan Room Warning Light and Door Interlock

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13.6 Typical Customer Supplied Wiring

13.7 Gantry Power Connection

14 Delivery and Storage Requirements

14.1 Delivery Types and System Lifting and Rigging Restriction

14.1.1 Loading Dock Deliveries

14.1.2 Ground (Non-Loading Dock) Deliveries

14.1.2.1 Liftgate Truck

14.1.2.2 Tiltbed Truck - NOT Approved

14.1.2.3 Forklift Truck

14.2 Delivery to the Scan Suite

14.2.1 Lifting

14.2.1.1 Stairway Deliveries

14.2.1.2 Rigging

14.2.2 Floor Protection

14.2.3 Un-loading and un-packing the System

14.3 Dollies

14.3.1 Installations within the United States

14.3.2 Zero Clearance Dollies

14.3.3 Tilting Table Dollies (Not Applicable for NG Elite Table)

14.3.4 Installations Outside of the United States

14.4 Gantry Delivery Considerations

14.4.1 Gantry Shipping State

14.4.2 Door Openings

14.4.3 Elevator Requirements

14.5 Table Delivery Considerations

14.6 Standalone Console Delivery Consideration

14.7 Delivery Temperature and Humidity Tolerance

14.8 Storage Requirements

14.8.1 Storage

14.8.2 Construction Sites

15 Handling Requirements

15.1 Transportation

15.2 Handling Requirements

15.2.1 Avoid Dropping

15.2.2 Avoid Shocks and Vibrations

15.2.3 Avoid Tipping

15.2.4 Flat-bed Truck Removal (NOT Approved Tilting)

A Regulatory Clearances for US A.1 Regulatory Clearances

A.2 Minimum Regulatory Workspace Clearances by Major Subsystem

A.3 How to Measure

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B Alternate Cover Removal Options B.1 Overview

B.2 Front Cover Removal

B.3 Rear Cover Removal

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1 Introduction This document contains the physical and electrical data necessary for planning and preparing a site for system installation. The responsibility of arranging and paying for this work rests solely with the purchaser.

1.1 Introduction

The information in this manual applies to the following GE Healthcare CT Scanners:

• Revolution Ascend

• Revolution Ascend Elite

• Revolution Ascend Plus

• Revolution Ascend Select

The information in this manual does NOT apply to non-fixed (mobile) installations.

1.1.1 Using the Pre-Installation Manual

This manual is the official source of prerequisites to installing a General Electric (GE) Computed Tomography (CT) system. Topics covered are site planning, site preparation, and the system requirements. This manual is divided into requirements for the customer, the system, the environment and on-site construction. It also includes the importance of addressing the local and national regulatory requirements, which may be specific to your location.

A GE Project Manager (PM) will be available for specific questions or concerns. The PM’s primary responsibility is to assist the buyer with the siting requirements. This manual is a guide toward the actual installation of your GE CT system. Prior to any construction or installation, GE Headquarters Architectural Planning must approve the completeness of all preliminary concepts, site plans, and final working drawings.

Pre-installation includes the procurement and installation of ALL requirements, materials, and services necessary for the installation and startup of a CT system.

1.1.2 Assigning a Site Project Coordinator

It is the customers (purchaser) responsibility to assign a site project coordinator. The site project coordinator is the primary contact and liaison between with the construction planners, architects, contractors, and any other site administrative personnel for all site related functions; reporting to the purchaser.

The primary responsibility of the site project coordinator, working closely with GE , is to ensure the purchaser upholds all requirements outlined in this manual. To ensure a successful installation, it is recommended that the site project coordinator manage the entire project from pre-install to final startup, be familiar with all phases of pre-installation and installation of similar medical device construction projects. The site project coordinator should read and understand the contents of this manual and be familiar with the installation procedures.

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1.1.3 Customer Responsibility

It is the responsibility of the customer to prepare the site in accordance with all the specifications provided in this manual and in conjunction with site-specific drawings and applicable regulations.

Consideration should be taken for future expansion during the design phase of the site. It is essential to verify all aspects of the site configuration before construction has begun, as subsequent changes can be costly or impractical.

Pre-Install Checklist A detailed pre-installation checklist is provided in this manual, see Customer Pre-Installation Checklist. It is the responsibility of the customer to ensure all requirements on the checklist are fulfilled and that the site conforms to all specifications and requirements detailed in this manual.

Planning and Design Work The customer will select the location of the site. All architectural, mechanical, and electrical drawings associated with the design and planning of the site are the responsibility of the customer. Any alterations or modifications to the drawings or to products not specifically included in the sales contract are the customers responsibility. The customer shall provide the site project coordinator, a clean and safe work environment including proper lighting, and a level suitably supported structured floor. All floors, walls and ceiling should be in a finished state prior to installation, and all site-construction renovation completed.

Regulatory Compliance The customer shall be solely responsible for all regulatory compliance. All work shall comply with national, state and local regulatory and building codes for the location in which the installation occurs. This includes but is not limited to: permits, inspections, radiation licensing, fire control devices, earthquake regulations, international building codes.

Electrical RequirementsThe customer shall be solely responsible for providing all electrical material and service required as outlined and illustrated in this publication. This includes but is not limited to: Installation of all properly-sized junction boxes, outlets with covers, line safety switches, and fittings installed at the locations specified in the site design. Supplying electrical power of the required voltage, all necessary power supply cables and grounds, all necessary power cables and grounds to the PDU, and an Emergency-Off switch in the scan room.

NOTE

GE does not provide or install the wires, conduits, junction boxes, or ducting illustrated in this publication .

1.1.4 Roles and Responsibilities

• Customer : Also known as Buyer or Purchaser or End User. This is the entity that has enteredinto contract with GE to buy the product.

• GE Salesperson : Responsible for completing the customer order process. They coordinate the completion of customer order as desired by the customer, for the customer. They are responsible for correcting incorrect orders. Changing orders, coordinating any replacement of damage in shipment items and for resolving missing in shipment issues.

• GE Project Manager (PM) : Responsibilities include the overall project coordination and site planning of GE products; manages activities cross-functionally with sales, customer, customer contractors, and local field teams to ensure customer site is designed and prepared to accept and install product in the facility.

• GE Field Engineer : GE field personnel responsible for the actual assembly, installation, calibration of the product and verification of the proper operation and configuration of the GE

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• Zone Broadband Specialist : GE personnel responsible for providing IT expertise and maintaining records of specific network IT connectivity parameters that are required to properly configure the products’ connection to the broadband connection provided by the customer.

• Network IT Personnel : Dedicated on site personnel affiliated with or contracted by the customer.

Responsible for providing IT expertise necessary to ensure successful network IT connectivity between the GE product and the facility.

• Qualified Electrician : Also known as Electrical Contractor. Qualified (Certified by a regulatory agency), In-House individual or entity contracted by the customer. Responsible for electrical connections between customer power source and up to and including the final connection to the GE product.

• Architectural Engineer : Dedicated on site personnel affiliated with the customer or contracted by the customer to manage the details of the construction parameters defined by regulatory agencies and as defined by parameters in the GE Pre-installation manual for the proper installation of the GE product.

• Structural Engineer : Dedicated on site personnel affiliated with the customer or contracted by the customer to manage the details of the structural parameters defined by regulatory agencies and as defined by the structural parameters provided in the GE Pre-installation manual for the proper installation of the GE product.

• HVAC Design Engineer : Dedicated on site personnel affiliated with the customer or contracted by the customer to manage the details of the air conditioning and air handling parameters defined by regulatory agencies and as defined by parameters in the GE Pre-installation manual for the proper installation of the GE product.

• Independent Contractor : Person or entity who contracts to do work for another person according to his or her own processes and methods; the contractor is not subject to another's control except for what is specified in a mutually binding agreement for a specific job. Can be contracted by GE personnel or by the customer for a unique or special task as part of the GE product installation process.

• Customer provided Project Coordinator : Dedicated contact person that works with GE Project Manager (PM). Acts as the single point of contact for the customer. Coordinates with all persons or entities contracted by the customer for the successful installation of a GE product.

• Rigger : Person, persons or entity hired as an Independent Contractor to perform a specific task related to the movement of GE product from the point of delivery to the scan suit where it will be installed.

1.2 Pre-Installation Checklist

To ensure the latest revision is used, locate DOC2949059 on SIMS Content Viewer.

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2 Installation Types

2.1 How to Determine the Best Installation Type for Your

Site

Discuss installation options with your PMI to determine which of the installation types listed below best fits your site and schedule.

• 2.2 Typical Installations on page 19 Typical Installations

• 2.3 Construction Site Installations on page 19 Construction Site Installations

• 2.4 Relocatable Building Installations on page 20 Re-locatable Installations

• 2.5 Upgrade Installations on page 21 Upgrade Installations

• 2.6 Quick Installations on page 21 Quick Installations

• 2.7 Two-Step (Temporary) Installations on page 22 Two-Step (Temporary) Installations

2.2 Typical Installations

Typical installations occur at established sites with finished, dust-free, occupancy-ready scan suites.

The rooms range from suggested to minimum room sizes, and have NO ongoing construction on-site. A typical installation allows customers flexibility for room upgrades and site improvements.

Upgrades and improvements may require additional planning prior to system delivery, especially when involving:

• Seismic approval

• Floor structural improvements

• HVAC improvements

• Electrical improvements

• Review of scan room shielding requirements by a qualified radiological health physicist.

As with any installation, the final site design for a typical installation must meet all service and regulatory requirements detailed in this manual.

2.3 Construction Site Installations

A construction installation describes installation at sites without an occupancy permit, often with ongoing construction. In general, construction sites fail to meet the recommended specifications for delivery of the system. GE does not recommend construction installations, as they can result in delays, increased costs, and possible damage to the system. When construction-site delivery proves unavoidable, the installation falls into one of two categories.

• Full construction site with completed radiology area.

• Full constructions site with limited delivery access.

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Review the following categories to determine which most closely matches the condition of the planned installation site.

2.3.1 Full Construction Site with Completed Radiology Area

This type of site consists of a finished, dust-free, occupancy-ready radiology suite. While there is no remaining construction in or around the scan suite area, there may be ongoing construction in other areas. At the time of delivery such sites feature:

• Dust control measures deployed in the radiology suite area.

• Scan suite access limited to a single entrance (see Figure 2-1 Full construction site with completed radiology area on page 20).

• Radiology suite sealed off from the remaining construction area.

• Operational HVAC, with a positive air pressure within the radiology suite.

In addition the radiology suite at such a site REMAINS in a dust-free, occupancy-ready state after delivery and throughout the remaining construction phase.

Figure 2-1 Full construction site with completed radiology area

2.3.2 Full Construction Site with Limited Delivery Access

This type of site allows delivery during ongoing construction of the radiology suite area. At such sites, delivery occurs prior to site completion, but the product remains stored until a finished, dustfree, occupancy-ready radiology suite area is ready. This type of site requires the system scanner to be delivered in a sealed package with dollies. Delivery to the storage area may require a lift truck or riggers. Installation work begins only when the site reaches the completed, dust-free, occupancy-ready radiology suite requirement.

NOTE

If delivery requires vertical or horizontal lifting, the PMI adds the necessary identifier to the order.

2.4 Relocatable Building Installations

A re-locatable building is made in a factory and delivered to the site of its permanent location.

Relocatable buildings qualify as fixed sites and must satisfy all of the requirements of a fixed site. The gantry and table must be mounted on a solid concrete floor. Any other floor type installations must designed by the customer’s structural engineer and meet all GE Healthcare’s specifications listed in this manual.

Refer to the 8 Structural and Mounting Requirements on page 61 of this manual for further information.

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2.5 Upgrade Installations

Upgrade installations occur after the installation of another system. A change in the customer’s needs requires the installation of additional equipment at the same site. For example, adding a PET system to an existing CT system.

To proceed with an upgrade installation, the customer’s room size must be large enough to accommodate the new product without violating the regulatory and service requirements of the new product. When planning for an upgrade installation, siting requirements of the new equipment may exceed those of your existing system. Requirements needing additional consideration include:

• Floor thickness

• Room shielding

• Additional electrical capacity

• Increased cooling capacity

• Scan room shielding requirements

The final site design must include a room layout showing the equipment room with the recommended room size dimensions. All upgrade installations must meet all service and regulatory requirements detailed in the manual.

2.6 Quick Installations

Quick Installations involve sites requiring minimum room improvements. These installations typically consist of a weekend de-installation and room preparation completion, with a next business day delivery and installation.

Requirements A site must meet a number of requirements to qualify for a Quick Installation, including:

electrical, structural, and HVAC requirements outlined in this manual. Also, the suite must meet all regulatory and minimum size requirements, as well as, the scan room shielding requirements. The facility must accommodate delivery and meet all delivery requirements. Consult this manual for details of the requirements and your PMI for information about any additional requirements your installation must meet.

Consult your Project Manager of Installation (PMI) for information about any additional requirements.

Restrictions The following restrictions govern Quick Installations: check with your PMI regarding floor anchor re-use.

• Quick Installations require a new room print that accurately reflects the rooms targeted for upgrade.

• You CANNOT re-use existing floor anchors for a new CT system.

• New floor anchors must be a minimum of 102 mm (4 in) from any existing floor penetrations.

• Rooms not meeting the minimum requirements for the final product must undergo an upgrade/ enlargement prior to the installation.

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2.7 Two-Step (Temporary) Installations

The two-step installation is a temporary installation of one system in a site, with the intention of upgrading the site to another system in a near future date. All two-step installations must comply with ALL siting requirements necessary for the upgraded or final system. This includes the recommended room size and all electrical, structural, and HVAC requirements. All System Siting Requirements apply to these types of installations. The customer is responsible for verifying compliance with all requirements. Rooms not meeting minimum requirements for the final product must undergo sufficient upgrading/enlargement.

NOTE

Temporary installations include all systems installed at a site for a period ranging from two weeks to six months.

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3 System Siting Requirements

3.1 System Siting Requirements

The requirements listed in this manual apply to all fixed-site customer installations, including installation within re-locatable buildings. The following requirements represent the MINIMUM that a site must meet before beginning ANY new or replacement system installation. All parties should review these requirements to ensure that the site meets all of the following:

• Service requirements

• Regulatory requirements

• Minimum structural, flooring, and vibration requirements

• Minimum HVAC requirements

• Minimum Electrical requirements

• All network requirements

• All radiation protection requirements

• All operational clearances

• All finished doors, floors, windows, ceilings, walls, and all plumbing and cabinets are installed.

• Does not have ANY continuing construction in the scan room OR neighboring suite areas.

• Conforms to the final GE Healthcare site print, which must be kept ON-SITE and must show all items intended for the finished room.

NOTE

Each site should receive a CT scanner quick start kit from the PMI. Use the Pre-Installation Checklist in this manual to confirm that the site meets all of the requirements listed above. GE Healthcare recommends completing all work to meet these requirements PRIOR to starting installation.

GE HEALTHCARE RESPONSIBILITY: The Project Manager (herein referred to as PM or PMI) assists the purchaser in meeting all system siting requirements.

The PMI also performs the following pre-installation delivery tasks:

• Determines the delivery type: ground, dock.

• Determines if the delivery requires tilt dollies or riggers; orders dollies and lifting crates, as needed.

• Determines if the delivery requires the use of floor protection.

• Determines if the ground delivery requires the use of a forklift, and informs GE Transportation of the need for a forklift.

Site Review with Customer: A site-ready visit should occur prior to the delivery date. This visit verifies that the site meets all system siting requirements and confirms that installation can proceed. During the site-ready visit, a GE representative confirms that the site meets all of the required site-ready conditions including floor levelness, and delivery route readiness. Lifting options and construction site packaging must be ordered prior to delivery and cannot be added on-site.

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CUSTOMER RESPONSIBILITY: Listed below is the breakdown of the customer tasks crucial for ensuring proper site preparation, regardless of whether planning for a replacement system at an existing site, or designing a new scan room for a first time.

Installation cannot proceed until verification of site-readiness occurs. A site is ready ONLY when it meets ALL delivery, regulatory, system, network, radiation protection, and operational requirements, as well as, requirements for any options. The purchaser is responsible for completing all work necessary to install the system, and includes:

• Completion of all structural items (recommended before installation begins.)

• PMI verification that ALL items on the Pre-Installation Checklist are completed.

• Review and preparation of all site-ready items.

To ensure timely delivery and installation, GE Healthcare recommends that the customer complete all necessary work and schedule a site-ready visit prior to the delivery date. To confirm that the site meets all requirements, you may need to employ these and other contractors: Structural Engineer and/or Architect, HVAC Contractor, Electrical Contractor, Qualified Radiological Health Physicist, Cleaning Services.

NOTICE

An improperly prepared site—one that is in a state of construction—can result in a delayed installation date and/or damage to the system.

3.1.1 Regulatory Requirements

Verify that the site conforms to all of the following:

• The room must meet all regulatory clearance requirements.

• The room must meet all minimum size requirements.

• The site print is on-site, reflects actual room size and layout, and has received final approval.

• No grounded walls are found in regulatory clearance areas.

• The room meets all local codes.

3.1.2 Electrical

• Install the correct size junction boxes with covers at locations shown in the installation plan.

• Install appropriate conduits and duct work for system cables. If the suite houses additional components, determine the necessary considerations and complete the connections.

• Install a power supply of correct voltage output and adequate kVA rating.

• Install local disconnects, including proper over-current protection. This includes the A1/MDP main disconnect with Lock-out and Tag-out (LOTO) installation.

3.1.3 Structural

• Install “steelwork” or other suitable support work for mounting equipment from walls or ceilings.

• Review structural requirements including:

◦ floor vibration

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◦ floor levelness

◦ floor thickness

◦ any seismic considerations, if applicable.

• Complete all suite and room renovations and modifications prior to delivery.

3.1.3.1 Dust and Air Quality

Ensure that the scan suite area is free of all dust, and not subject to ANY ongoing construction, including the installation of cabinets, hanging doors, and ceiling tiles.

CAUTION

POTENTIAL EARLY SYSTEM FAILURE.

Fine dust can deposit on the internal electronic components in Gantry, DAS, Tube, Table, PDU, and Operator Console.

It results in potential damage to the electronic components and lead to an early system failure.

Before installing scanner systems, ensure that the scan suite area is free of all dust and not subject to any ongoing construction.

TYPES OF DUST TO AVOID Ensure that NO construction occurs in or immediately around the scan suite area that results in:

• concrete dust

• drywall dust

• ceiling tile dust

• wood sawdust or shavings

• dust tracked into the CT suite from adjoining rooms

Failure to take appropriate precautions to protect the system against these types of dust may result in DAMAGE to the system and early SYSTEM FAILURE.

3.1.3.2 Environmental Influences

CT systems are designed with commercial components that are sensitive to air contaminants like sulfide, chloride and nitrates. It is the responsibility of the purchaser to ensure that the levels of these contaminates are low (Class1). See IEC60654-4 for air quality guidelines.

3.1.3.3 Finished Floor Requirements

Installation requires a finish floor in the scan and control rooms. The floor surface in the scan room directly under the gantry and table must be level. The floor flatness tolerance of the floor surface that the gantry and table will rest on is 6 mm (1/4 in) over a 3000 mm (118.0) distance. Shims should not be used to compensate for a floor that does not meet this requirement. Eight or more floor covering openings that are 101.6 mm (4 in) in diameter are made to ensure the table and gantry rest on a solid surface. These floor penetrations can be sealed if required. These requirements apply to all installation types.

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Finished Floor Exception 1 For sites replacing their scan room floor covering after the table and gantry are installed, the floor can…