AMX-4+ International Operation Manual

GE MEDICAL SYSTEMS

AMX–4+ INTERNATIONAL OPERATION MANUAL

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Direction 2166911–100 Revision 5

AMX–4+ International Operation Manual

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 General Electric Company, Medical Systems Group, 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. It is important that everyone 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

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on Radiation Protection, and take adequate steps to protect against injury. The equipment is sold with the understanding that the General Electric Company, Medical Systems Group, its agents, and representatives have no responsibility for injury or damage which may result from improper use of the equipment. Various protective material and devices are available. It is urged that such materials or devices be used. CAUTION: United States Federal law restricts this device to use by or on the order of a physician.

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If you have any comments, suggestions or corrections to the information in this document, please write them down, include the document title and document number, and send them to: GENERAL ELECTRIC COMPANY MEDICAL SYSTEMS MANAGER – INFORMATION INTEGRATION, AMERICAS W–622 P.O. BOX 414 MILWAUKEE, WI 53201–0414

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 Medical 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 electrical codes.

the

applicable

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

DAMAGE IN TRANSPORTATION 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 General Electric 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. Call Traffic and Transportation, Milwaukee, WI (414) 827–3449 / 8*285–3449 immediately after

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damage is found. At this time be ready to supply name of carrier, delivery date, consignee name, freight or express bill number, item damaged and extent of damage. Complete instructions regarding claim procedure are found in Section “S” of the Policy & Procedure Bulletins. 6/17/94

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REGULATORY REQUIREMENTS This product conforms with the requirements of Council Directive 93/42/EEC concerning medical devices when it bears the following CE marking of conformity:

0459 Note:

This equipment generates, uses, and can radiate radio frequency energy. The equipment may cause radio frequency interference to other medical and non-medical devices and radio communications. To provide reasonable protection against such interference, the AMX4+ Mobile X–Ray Unit complies with emissions limits for a Group 1, Class A Medical Devices as stated in EN 60601–1–2. However, there is no guarantee that interference will not occur in a particular installation. If this equipment is found to cause interference (which may be determined by switching the equipment on and off), the user (or qualified service personnel) should attempt to correct the problem by one or more of the following measure(s): D

Reorient or relocate the affected device(s).

D

Increase the separating space between the equipment and the affected device.

D

Power the equipment from a source different from that of the affected device.

D

Consult the point of purchase or service representative for further suggestions.

The manufacturer is not responsible for any interference caused either by the use of interconnect cables other than those recommended, or by unauthorized changes or modifications to this equipment. Unauthorized changes or modifications could void the user’s authority to operate the equipment. To comply with the regulations applicable to an electromagnetic interface for a Group 1, Class A Medical Device, all interconnect cables to peripheral devices must be shielded and properly grounded. Use of cables not properly shielded and grounded may result in the equipment causing radio frequency interference in violation of the European Union Medical Device directive and FCC regulations. Setting for Mobile AID Under certain Electro Static Discharge (ESD) conditions, the optional Automatic Exposure Control for the AMX 4+ may self–modify its settings. The operator will need to adjust the settings to their original condition. If the problem cannot be corrected, please call service. iii

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Disposal of Waste of Electrical and Electronic Equipment

This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment FRA Ce symbole indique que les déchets relatifs à l’équipement électrique et électronique ne doivent pas être jetés comme les ordures ménagères non–triées et doivent être collectés séparément. Contactez un représentant agréé du fabricant pour obtenir des informations sur la mise au rebut de votre équipement. POB Este símbolo indica que os resíduos do equipamento elétrico e eletrônico não devem ser descartados no sistema de coleta de lixo municipal, e sim coletados separadamente. Favor entrar em contato com um representante autorizado do fabricante para obter informações sobre como descartar seu equipamento. SPA Este símbolo indica que el equipo eléctrico y electrónico no debe tirarse con los desechos domésticos y debe tratarse por separado. Contacte con el representante local del fabricante para obtener más información sobre la forma de desechar el equipo. GER Dieses Symbol kennzeichnet elektrische und elektronische Geräte, die nicht mit dem gewöhnlichen, unsortierten Hausmüll entsorgt werden dürfen, sondern separat behandelt werden müssen. Bitte nehmen Sie Kontakt mit einem autorisierten Beauftragten des Herstellers auf, um Informationen hinsichtlich der Entsorgung Ihres Gerätes zu erhalten. ITA Questo simbolo indica che i rifiuti derivanti da apparecchiature elettriche ed elettroniche non devono essere smaltiti come rifiuti municipali indifferenziati e devono invece essere raccolti separatamente. Per informazioni relative alle modalità di smantellamento delle apparecchiature fuori uso, contattare un rappresentante autorizzato del fabbricante.

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GE MEDICAL SYSTEMS

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REVISION HISTORY REV

DATE

REASON FOR CHANGE

0 1 2 3 4 5

Dec. 13, 1996 Feb. 5, 1997 Aug. 22, 1997 Dec. 1, 1998 Oct. 21, 2004 June 29, 2005

Initial release. Added Portuguese translation (2166913–127). Added Japanese translation (2166913–140). Added CE regulatory requirements. Added Chinese translation (2166913–141). Corrected Table of Contents: Changed Chinese translation document number from 2166911–141 to 2166913–141 and Japanese translation document from 2166911–140 to 2166913–140. Added WEEE symbol and definition.

LIST OF EFFECTIVE PAGES

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Title Page

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Back Page

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REVISION NUMBER

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CHAPTER 1 – USING THE MANUAL SECTION 1 INTRODUCTION

This AMX–4+ International Operation Manual consists of two components. 1. AMX–4+ International Operation Manual 2. AMX–4+ Operation The first component, this manual, the AMX–4+ International Operation Manual provides: D

How to use information for the AMX–4+ manual in 8 languages.

D

International reference information in the same 8 languages.

The second component, the AMX–4+ Operation, provides instructions for the proper operation of the AMX–4+ Mobile X–Ray unit in eight languages.

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D D D D D D D

English French Spanish German Italian Portuguese Japanese

2166913 –100 2166913 –101 2166913 –106 2166913 –108 2166913 –111 2166913 –127 2166913 –140

D

Chinese (Simplified)

2166913 –141

Customizing the Manual This manual can be customized or adapted to fit your needs. D

Examine the second component, the AMX–4+ Operation which contains versions in English, German, French, Italian, Spanish, Portuguese, Japaneses, and Chinese (Simplified).

D

Depending on your individual requirements, you have the option of removing the language versions you may not need, or if you prefer, retain all the versions. 1–1

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CHAPTER 2 – INTERNATIONAL REFERENCE

SECTION 1 ENGLISH 1–1

Introduction The instructions in following sections provide important international information for operators of the AMX–4+ Mobile X–Ray Units. Provided are: D

Specific information for each country for the safe operation of the AMX–4+ Mobile X–Ray Unit,

D

Telephone numbers of local offices maintained by General Electric Medical Systems – Europe for customer support.

This Chapter is separated into 8 sections by language. D

Section 1 – English

D

Section 2 – French

D

Section 3 – Spanish

D

Section 4 – German

D

Section 5 – Italian

D

Section 6 – Portuguese

D

Section 7 – Japanese

D

Section 8 – Chinese (Simplified)

The instructions in this manual will supersede any instructions in the AMX–4+ Operation Manual. 2–1

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X–Ray Protection

IMPORTANT! . . . X-RAY PROTECTION X–RAY EQUIPMENT IS DANGEROUS TO BOTH PATIENT AND OPERATOR UNLESS MEASURES OF PROTECTION ARE STRICTLY OBSERVED. Though this equipment is built to the highest standards of electrical and mechanical safety, the useful x–ray beam becomes a source of danger in the hands of the unauthorized or unqualified operator. Excessive exposure to x–radiation causes damage to human tissue. Therefore, adequate precautions must be taken to prevent unauthorized or unqualified persons to operate this equipment or to expose themselves or others to its radiation. Before operation, persons qualified and authorized to operate this equipment should be familiar with the Recommendations of the International Commission on Radiological Protection, contained in the Annals Number 26 of the ICRP, and with applicable national standards.

1–3

Telephone Number in USA In the United States of America, GE Medical Systems maintains a Customer Service Center were an Application Support Specialist is available to answer customer questions regarding the operation and application of the AMX–4+ Mobile X–Ray Unit. You can call the Customer Service Center on a 800 Support telephone line. The number is 1–800–682–5327

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SPAIN

GE Medical Systems España

Avda. de Europa 22 Parque Empresarial la Moraleja E–28100 ALCOBENDAS

RUSSIA

GE Medical Systems

Kosmodamianskaya nab. 52, TEL: +7 095 935 72 41 Bldg 1, 6th Floor FAX: +7 095 935 73 46 and 48 113054 MOSCOW TEL (satellite): +7 502 220 30 39 FAX (satellite): +7 502 220 32 59 TLX: 613020 GEMED SU

SWEDEN

GE Medical Systems

Box 6768 St. Eriksgatan 117 S–113 85 STOCKHOLM

TEL: +46 8 457 95 20 FAX: +46 8 457 95 47 TLX: 12228 CGRSWES

SWITZERLAND

GE Medical Systems (Schweiz) AG

Sternmattweg 1 CH–6010 KRIENS

TEL: 155 6958 (gebührenfrei) FAX: +41 41 421859

TURKEY

GE Medical Systems Turkiye A.S.

Mevluk Pehliran Sodak Yilmaz Han, No 24 Kat 1 Gayretteppe ISTANBUL

TEL: +90 212 75 5552 FAX: +90 212 211 2571

UNITED KINGDOM

IGE Medical Systems

Coolidge House 352 Buckingham Avenue SLOUGH Berkshire SL1 4ER

TEL: +44 753 874000 FAX: +44 753 696067

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TEL: +34 1 663 25 00 FAX: +34 1 663 25 01

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GE Medical Systems GE Medical Systems: Telex 3797371 P.O. Box 414, Milwaukee, Wisconsin 53201 U.S.A. (Asia, Pacific, Latin America, North America) GE Medical Systems Ċ Europe: Telex 698626 283, rue de la Minière, B.P. 34, 78533 Buc Cedex France