OEC 9900 Elite Supplement and Update Rev 1

Medical device directive (EN)

Medical device directive (EN) This product conforms with the Medical Device Directive, Council Directive 93/42/EEC: June 14, 1993, as amended by 2007/47/07 (as applicable) following the provisions of Annex II, when it bears the CE Mark of Conformity shown at left. This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. Contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment. The separate collection symbol is affixed to a battery, or its packaging, to advise you that the battery must be recycled or disposed of in accordance with local or country laws. The letters below the separate collection symbol indicate whether certain elements (Pb=Lead, Cd=Cadmium, Hg=Mercury) are contained in the battery. To minimize potential effects on the environment and human health, it is important that all marked batteries that you remove from the product are properly recycled or disposed. For information on how the battery may be safely removed from the device, please consult the service manual or equipment instructions. Information on the potential effects on the environment and human health of the substances used in batteries is available at this url: http://www.gehealthcare.com/euen/weee-recycling/index.html.

CAUTION:

US Federal law restricts this device to sale by, or on the order of, a physician.

IMPORTANT: SAVE THESE INSTRUCTIONS. PLEASE READ THIS MANUAL BEFORE USING EQUIPMENT. This manual may not be reproduced, in whole or in part, without the written permission of GE Healthcare. Other product and company names mentioned herein are the property of their respective owners. The contents of this document are accurate at the time of publication. However, changes in design and additional features can, at any time, be incorporated in the hardware and software and may not be reflected in this version of the document. Contact GE Healthcare Technical Support for clarification, if discrepancies arise. This document was originally written and verified in English, part number 5370275-199DEV. GE OEC Medical Systems, a General Electric company, going to market as GE Healthcare.

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Supplement and update (EN)

Supplement and update (EN) Compliance information Dose Area Product The DAP specification for accuracy ± 50% is based on the IEC 60601-2-43. This is for reference only and does not imply compliance with the entire IEC 60601-2-43 standard but only the accuracy specification of the standard.

Workstation fails to start normally The 9900 Workstation rear panel contains four circuit breakers (three on 220 VAC systems), designed to protect the system in the event of a power surge. On 220 VAC systems, the single main power circuit breaker located on the left in Figure 1 may be a push button type breaker or a toggle handle circuit breaker. If the Workstation or C-Arm does not start up when the power switch is turned on, turn off the power switch and visually inspect the circuit breakers on the Workstation rear panel (see Figure 1). If any of the circuit breaker buttons extends approximately ¼" (6 mm) as shown in Figure 2, or if the toggle handle is positioned on "O" as shown in Figure 3, reset it by either pushing the button back in or setting the toggle handle to "I", and then turn the power switch on.

Figure 1: Circuit breaker locations, Workstation rear panel

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Supplement and update (EN)

Figure 2: Workstation circuit breaker detail

Figure 3: Workstation 220 VAC circuit breaker detail

If one or more breakers continue to trip, discontinue use, unplug the system from power, and call for service.

"Precharge Error" message at start up The underside of the 9900 Mainframe contains a large circuit breaker, CB1, shown in Figure 4, that disconnects the mainframe batteries from the circuit. The circuit breaker is intended for use when the system is shipped or transported, or during rough handling. A "Precharge Error" message displays on the X-ray Control Panel display screen if CB1 is switched off when the system is started up. Turn off system power and allow the Workstation to shut down. Reach under the Mainframe at the location indicated in Figure 4 and push the circuit breaker switch forward. Turn on system power.

Figure 4: C-Arm CB1, Mainframe Battery Disconnect

If the "Precharge Error" message recurs, call for service.

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Supplement and update (EN)

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