AMX-4+ Operating Documentation Rev 15

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AMX-4+ OPERATION (MODEL 2169360, 2236420 & 2275938 SERIES)

GE Healthcare REV 15

om 2166913-1EN FRONT MATTER

Direction 2166913-1EN Revision 15

AMX-4+ Operation (Model 2169360, 2236420 & 2275938 Series)

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 on Radiation Protection, and take adequate steps to protect against injury.

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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.

AMX-4+ OPERATION (MODEL 2169360, 2236420 & 2275938 SERIES)

GE Healthcare REV 15

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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 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.

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 ii

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.

AMX-4+ OPERATION (MODEL 2169360, 2236420 & 2275938 SERIES)

GE Healthcare REV 15

om 2166913-1EN 6/17/94

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:

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):

• • • •

Reorient or relocate the affected device(s). Increase the separating space between the equipment and the affected device. Power the equipment from a source different from that of the affected device. 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.

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AMX-4+ OPERATION (MODEL 2169360, 2236420 & 2275938 SERIES)

GE Healthcare REV 15

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Medical Device Directive This product complies with the following requirements: Council Directive 93/42/EEC concerning medical devices when it bears the following CE marking of conformity:

The location of the CE mark label on the equipment is in the service system manual. European registered place of business: GE Medical Systems SCS Quality Assurance Manager 283 rue de la Minière 78530 BUC France Green QSD 1990 Standard issued by MDD (Medical Devices Directorate, Department of Health, UK). Medical Device Good Manufacturing Practice Manual issued by the FDA (Food and Drug Administration, Department of Health, USA). Underwriters' Laboratories, Inc. (UL), an independent testing laboratory. Canadian Standards Association (CSA). International Electrotechnical Commission (IEC), international standards organization, when applicable.

GE Healthcare reserves the right to make changes in specifications and features shown herein, or discontinue the product described at any time without notice or obligation. The original language of this manual is English.

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AMX-4+ OPERATION (MODEL 2169360, 2236420 & 2275938 SERIES)

GE Healthcare REV 15

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Technical Manual Updates When operating or servicing GE Healthcare products, please contact your GE representative for the latest revision of product documentation. Product documentation may also be available on-line at the GE Healthcare support documentation library.

Contact Information Manufactured by: GE Medical Systems, LLC (GE Healthcare) United States address: GE Medical Systems, LLC (GE Healthcare) 3000 N Grandview Ave Waukesha WI 53188 USA Phone number: United States: 262-544-3011 International: +1-262-544-3011 Web address: www.gehealthcare.com

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AMX-4+ OPERATION (MODEL 2169360, 2236420 & 2275938 SERIES)

GE Healthcare REV 15

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REVISION HISTORY REV

DATE

REASON FOR CHANGE

0

Dec. 13, 1996

Initial release.

1

Aug. 22, 1997

Changed Periodic Maintenance Schedule to yearly for all checks.

2

Dec. 1, 1998

Added CE regulatory requirements.

3

Apr. 5, 1999

Added Warning in Section 4.

4

Apr. 12, 1999

Added AMX4+ model 2236420.

5

May 6, 1999

Added yoke mounting screws tighten and replace requirements to Table 7-1. Add model numbers to charging specs in section 6.

6

July 14, 1999

Removed “yoke mounting screws tighten and replace requirements” from Table7-1.

7

Feb. 29, 2000

Updated first periodic maintenance visit from 12 months to 13 months after installation to agree with Information Service Letter.

8

Mar. 27, 2002

Added section 10, Options.

9

Sept. 17, 2003

Added circuit breaker notes to section 7. Added new model numbers. Added caution to section 2.

10

June 24, 2005

Added WEEE symbol definition.

11

May 5, 2008

Created new part number to comply with new international standard. Incremented all operator manuals to the same revision.

12

May 5, 2008

Created new part number to comply with new international standard. Incremented all operator manuals to the same revision.

13

Sept. 7, 2010

Added Section 11, Environmental Conditions

14

Feb. 9, 2011

Added Manufactured By statement

15

Sept. 1, 2012

Revised cleaning instructions. Refer to CAPA 5970812. Revised Periodic Maintenance Schedule for hand switch replacement. Refer to CAPA 5970812. Added text to front matter on how to obtain most recent revisions of technical manuals. Related to resolution of CAPA 5970812.

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AMX-4+ OPERATION (MODEL 2169360, 2236420 & 2275938 SERIES)

GE Healthcare REV 15

om 2166913-1EN TABLE OF CONTENTS

TABLE OF CONTENTS SECTION

TITLE

1

BEFORE YOU BEGIN...1-1 1-1 1-2

2

Available Options ...1-2 How to Use This Book ...1-2

SAFETY FIRST...2-1 2-1

3

PAGE

Good Operating Practices ...2-1

OPERATING CONTROLS ...3-1 3-1

Turning the AMX-4+ On ...3-3

4

DRIVING THE AMX-4+...4-1

5

X-RAY PROCEDURE...5-1 5-1 5-2 5-3 5-4 5-5 5-6 5-7

6

CHARGING THE BATTERIES/CAPACITY GAUGE OPERATION...6-1 6-1

7

Mechanical Setup ...5-1 Latch Lock Release ...5-1 Adjustment of Column and Telescoping Arm ...5-2 Tube Unit Rotation ...5-3 Adjustment of Collimator ...5-4 Technique Selection ...5-8 Taking Exposures ...5-10

Application Tip ...6-4

MAINTENANCE AND SERVICE ...7-1 7-1 7-2 7-3 7-4 7-5

Cleaning the Unit ...7-1 Hand Switch Cleaning and Disinfecting Instructions ...7-1 Main Power Circuit Breaker ...7-2 Periodic Maintenance by Service Personnel ...7-2 Qualified Service Available ...7-2

8

MESSAGES ON DISPLAY...8-1

9

SYMBOLS...9-1 9-1 9-2 9-3

IEC Classification ...9-1 Earth Leakage Current ...9-1 Applicable IEC Symbols ...9-1 vii

AMX-4+ OPERATION (MODEL 2169360, 2236420 & 2275938 SERIES)

GE Healthcare REV 15

SECTION 10

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TITLE PAGE OPTIONS ... 10-1 10-1 10-2 10-3

11

Dose Area Product (DAP) Meter ...10-1 Mobil-AIDTM Automatic Exposure Control (AEC) ...10-1 Remote Control Handswitch ...10-1

ENVIRONMENTAL CONDITIONS ... 11-1

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AMX-4+ OPERATION (MODEL 2169360, 2236420 & 2275938 SERIES)

GE Healthcare REV 15

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SECTION 1 BEFORE YOU BEGIN The instructions in this operation manual are for use with the AMX-4+ Mobile X-ray Unit, Models

2169360 2169360-5 2169360-9 2169360-13

2169360-2 2169360-6 2169360-10 2169360-14

2169360-3 2169360-7 2169360-11 2169360-15

2169360-4 2169360-8 2169360-12 2169360-16

Models

2236420 2236420-5 2236420-9

2236420-2 2236420-6 2236420-10

2236420-3 2236420-7

2236420-4 2236420-8

Models

2275938 2275938-5 2275938-9 2275938-14

2275938-2 2275938-6 2275938-10 2275938-15

2275938-3 2275938-7 2275938-12 2275938-16

2275938-4 2275938-8 2275938-13 2275938-17

Your AMX-4+ is designed for ease of operation and years of reliable service. Each time you push a button, you can depend on the same consistent radiographic quality - quality comparable to radiographs made in a full scale X-ray room. ILLUSTRATION 1-1

Since the AMX-4+ is battery operated, there's no need to plug in your mobile X-ray unit before taking exposures. Battery operation makes the AMX-4+ easily adapted to operating, intensive care, and emergency room applications. Because of a dual-motor drive, driving and positioning the AMX-4+ requires a minimum of effort. And the control panel's cut-away design permits optimum visibility for steering down crowded corridors. 1-1

AMX-4+ OPERATION (MODEL 2169360, 2236420 & 2275938 SERIES)

GE Healthcare REV 15

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The self-stopping bumper, one of many built-in safety devices, helps prevent unwanted mobility - the motors stop and the brakes activate upon impact with another object. Operator controls are microprocessor based, combining the latest technology with simplicity of design. The control panel includes three illuminated displays: a kVp and mAs display to reflect the technique selected, a battery display for at-a-glance battery status, and a message display to provide helpful information on the operating status of the AMX-4+ .

1-1

Available Options Mobil-Aid Automatic Exposure Control. For operating instructions, refer to Mobil-Aid Owner's Manual, Number 69198.

1-2

How to Use This Book Most sections of your operator manual (see Contents) are organized using two headings: 1. Overview, and 2

Steps

Overview Overview, as the name implies, presents general information on a particular operation. Introductory in nature, the overview is intended to help give you an overall understanding of a procedure or capability, quickly and easily. The word overview is flagged in bold text, like this ... Overview and appears in the left margin of the page. Steps For specific, detailed information in step-by-step sequence, you'll refer to the actual procedure. In this manual, we refer to procedures as steps. The word steps is flagged in bold text, like this ... Steps and also appears in the left margin of the page. Steps are listed numerically. Any supplemental information (that is, additional information you should know, but information that isn't really necessary to perform the procedure) is listed under the step in a bulleted  format. •

supplemental information is placed next to a bullet 1-2

AMX-4+ OPERATION (MODEL 2169360, 2236420 & 2275938 SERIES)

GE Healthcare REV 15

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We think you'll find the AMX-4+ portable design performs so easily that it seems to nearly run itself. To promote optimum operation of this or any radiographic equipment, however, be sure to read your operator's manual carefully. And, when not in use, store your manual in the cassette tray so that all new users can easily refer to it when needed.

1-3

AMX-4+ OPERATION (MODEL 2169360, 2236420 & 2275938 SERIES)

GE Healthcare REV 15

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SECTION 2 SAFETY FIRST This equipment is to be used by authorized medical personnel only. Your AMX-4+ is engineered for years of reliable service. To promote optimum safety, be sure to read this manual carefully, before operating the unit. Keep the manual with the equipment at all times. When not in use, store it in the AMX-4+ cassette tray. Always be alert to safety when you operate this equipment. You must be familiar enough with the equipment to recognize any malfunctions that can be a hazard. If a malfunction occurs or a safety problem is known to exist, isolate the unit to avoid unauthorized operation, and do not use this equipment until qualified personnel correct the problem.

CAUTION

2-1

WARNING

THIS X-RAY UNIT MAY BE DANGEROUS TO PATIENT AND OPERATOR UNLESS CORRECT EXPOSURE FACTORS AND OPERATING INSTRUCTIONS ARE OBSERVED.

WARNING

ALWAYS PROVIDE NECESSARY RADIATION PROTECTION FOR YOUR PATIENT AND YOURSELF WHEN OPERATING ANY X-RAY SYSTEM.

Good Operating Practices •

Wear a lead apron while performing an X-ray exam.

•

Step back at least 6 feet (1.8 meters) from the tube or to the full extension of the handswitch cord before making an exposure.

•

Always use the proper field sizes and technic factors for each procedure to minimize X-ray exposure and produce the best diagnostic results.

•

Check the digital display carefully before making an exposure: verify that the selected technique is the intended technique. Pay particular attention to the placement of the decimal point in the mAs setting to insure that whole numbers are not mistaken for an intended mAs fractional number.

•

When X-raying bed patients, move them as far as possible from nearby patients.

•

Ask visitors to step outside the room during an exposure.

•

Use gonadal shields for patients whenever possible.

•

Be sure to read and follow the maintenance schedule outlined in the Maintenance and Service section of this manual.

•

Under most conditions, cumulative radiation dose to the operator will not exceed recommended maximum permissible levels. However, as with all radiation-producing devices, a qualified radiation expert should evaluate situations involving frequent exposures using high kVp and mAs technics to determine if extra protective devices are necessary.

2-1

AMX-4+ OPERATION (MODEL 2169360, 2236420 & 2275938 SERIES)

GE Healthcare REV 15

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CAUTION

While driving the AMX-4+, keep the film bin closed. A loaded bin may close without warning possibly causing injury.

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AMX-4+ OPERATION (MODEL 2169360, 2236420 & 2275938 SERIES)

GE Healthcare REV 15

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SECTION 3 OPERATING CONTROLS ILLUSTRATION 3-1 AMX-4+ MOBILE X-RAY UNIT (RIGHT REAR VIEW)

TELESCOPING ARM Retractable arm supports collimator and X-ray tube.

TAPE MEASURE

VERTICAL COLUMN Supports telescoping arm.

CONTROL PANEL Contains most operator controls and all displays.

SKIN SPACER BARS

DRIVE HANDLE Grip to activate drive motors.

COLLIMATOR Adjusts easily. Calibrated in inches or cm.

BRAKE RELEASE Releases brakes if drive motors fail.

SELF-STOPPING BUMPER Stops drive motors and activates brakes on impact.

FILM BIN Provides convenient storage for ten 14" x 17" cassettes.

3-1

HANDSWITCH Controls exposures and automatically timed field light.

AMX-4+ OPERATION (MODEL 2169360, 2236420 & 2275938 SERIES)

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ILLUSTRATION 3-2 AMX-4+ OPERATOR CONSOLE

KEY SWITCH Turn ON to drive the unit or take exposures. Turn OFF to remove key. Recharge in ON or OFF positions. NOTE: Top of cap key when in OFF position.

PENCIL TRAY

X-RAY EXPOSURE INDICATORS Light up when exposure is made. BATTERY STATUS DISPLAY Shows relative state of charge. At or near full charge, all segments are illuminated.

3-2

LATCH Secure the vertical column in the park / transport position. KVP AND MAS DISPLAY Displays kVp and mAs selections.

MESSAGE DISPLAY Displays status and error messages. KVP AND MAS CONTROLS Press the up or down kVp/mAs triangle to select the correct exposure setting.

AMX-4+ OPERATION (MODEL 2169360, 2236420 & 2275938 SERIES)

GE Healthcare REV 15

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Turning the AMX-4+ On Steps Be sure to refer to Maintenance and Service in this manual for important information on the circuit breaker. 1. Turn the keyswitch to the ON position.

ILLUSTRATION 3-3 KEYSWITCH

Keyswitch in ON position.

•

The unit performs diagnostics (self-tests to make sure everything is working correctly). This process takes a few seconds.

TESTING COMPLETE

2

When the technique and battery status displays light up, the unit is ready for operation. TESTING COMPLETE will also briefly appear on the message display.

3

If TEST -- XX FAILED is displayed, turn the unit OFF then ON again. If TEST -- XX FAILED displays again, write down the alphanumeric code (XX represents the code) and contact your service representative. 3-3

AMX-4+ OPERATION (MODEL 2169360, 2236420 & 2275938 SERIES)

GE Healthcare REV 15

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SECTION 4 DRIVING THE AMX-4+ Overview A compact design and dual motor assembly makes driving and maneuvering the AMX-4+ an easy process. If moving down hallways or just traveling from one room to another, you'll first make sure the telescoping arm is properly positioned and securely latched so maximum speed can be reached. Then simply grip the drive handle and steer the unit to your destination. (See Illustration 4-1.)

WARNING

WARNING

MOVEMENT OF THE AMX-4+ X-RAY UNIT COULD CAUSE THE HORIZONTAL ARM TO SLIDE AND STRIKE AN OPERATOR OR PATIENT IF NOT LATCHED PROPERLY. LATCH TELESCOPING ARM PROPERLY BEFORE MOVING THE UNIT. DO NOT DRIVE OR POSITION THE AMX-4+ UNIT UNLESS STANDING DIRECTLY BEHIND IT (SEE ILLUSTRATION 4-1). FAILURE TO DO THIS MAY RESULT IN LOSS OF CONTROL CAUSING SERIOUS INJURY AND EQUIPMENT DAMAGE.

ILLUSTRATION 4-1 DRIVE HANDLE

GRIP THE DRIVE HANDLE TO ACTIVATE THE MOTORS... RELEASE YOUR GRIP TO STOP THE UNIT.

4-1

AMX-4+ OPERATION (MODEL 2169360, 2236420 & 2275938 SERIES)

GE Healthcare REV 15

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The drive automatically adjusts to your pace, and can be pushed forward, turned or pulled in reverse at speeds of up to 3 mph (4.8 km per hour). A self-stopping bumper at the front of the unit automatically activates the brakes and turns off the drive motors upon impact, to help prevent accidents. If the bumper is engaged, simply grip the drive handle and pull the unit in reverse. (As with any mobile equipment, however, when driving the unit be sure to exercise reasonable care.) With the telescoping arm extended for a patient exam, the AMX-4+ pivots on the spot, rotating and maneuvering easily for exact positioning. Again, grip the drive handle and turn the unit to the desired position. AMX-4+ maneuvering speed is automatically reduced by 50 percent when the telescoping arm is extended. ILLUSTRATION 4-2 ARM EXTENDED

4-2