AMX-4 + Periodic Maintenance Rev 10

AMX−4+ PERIODIC MAINTENANCE MODELS: 2169360, 2236420 & 2275938

GE Healthcare REV 10

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AMX−4+ PERIODIC MAINTENANCE MODELS: 2169360, 2236420 & 2275938

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DIRECTION 2173227−100

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. 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.

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.

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DIRECTION 2173227−100

DAMAGE IN TRANSPORTATION 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. To file a report: −

Call 1−800−548−3366 and use option 8.

−

Fill out a report on http://egems.med.ge.com/edq/home.jsp

−

Contact your local service coordinator for more information on this process

Rev. June 13, 2006

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REVISION HISTORY REV

DATE

REASON FOR CHANGE

A 0 1

Oct. 30 1996 Dec. 13, 1996 Mar. 7, 1997

2 3 4 5 6 7

Aug. 14, 1997 Dec. 10, 1997 Apr. 12, 1999 Nov. 8, 2000 July 30, 2003 Feb. 15, 2008

8

21NOV2008

9

15JAN2013

10

21APR2015

Initial draft. Initial release. Deleted requirement for signature testing for new−from−factory installations (Section 4). High Impact Inspection. Added touchup paint to Section 1. Added AMX−4+ Model 2236420 Series. Added AMX−4+ Model 2275938 Series. Added note about installing local language label over English rating plate. Updated Table 1−2 to remove old labels and add new international labels. Updated flowchart in Table 2−1 to modify “Install Film Bin Label” to read “Install International Labels”. Updated all occurrences of Operator Manual part number 2166913−100 to new part number 2166913−1EN. Updated Section 1−3 and Section 2 to add hand switch cleaning/replacement instructions. Refer to CAPA 5970812. Updated Collimator Interface Tightness section in Illustration 2-1.

LIST OF EFFECTIVE PAGES PAGE NUMBER

REVISION NUMBER

All

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REVISION NUMBER

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PAGE NUMBER

REVISION NUMBER

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TABLE OF CONTENTS SECTION 1 − INTRODUCTION...

1

1-1 1-2 1-3 1-4 1-5 1-6

Identification... General... Cleaning... Inspection... HHS Testing... Tools and Materials...

1 1 2 2 2 3

SECTION 2 − PM SCHEDULES...

3

SECTION 3 − INSPECTION...

4

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SECTION 1 − INTRODUCTION 1-1

Identification See Illustration 1−1. The AMX−4+ is identified by Model Number on the rating plate located on the top cover. Model part and catalog numbers are identified in Table 1−1. TABLE 1−1 AMX−4+ MODELS

Description

Part number

catalog number

Part number

catalog number

domestic

2169360−7

A0659F

2236420−7 & 2275938−7

A0659JF

domestic, aec

2169360−8

A0659FA

2236420−8 & 2275938−8

A0659JG

domestic, tech switch

2169360−9

A0659FC

2236420−9 & 2275938−9

A0659JH

domestic, aec, tech switch

2169360−10

A0659FB

2236420−10 & 2275938−10

A0659JJ

iec, emc

2169360

A0659A

2236420 & 2275938

A0659J

iec, emc, aec

2169360−2

A0659AA

2236420−2 & 2275938−2

A0659JA

iec, emc, tech switch

2169360−3

A0659AB

2236420−3 & 2275938−3

A0659JB

iec, emc, aec, tech switch

2169360−4

A0659AC

2236420−4 & 2275938−4

A0659JC

japan

2169360−5

A0659C

2236420−5 & 2275938−5

A0659JD

japan short column

2169360−6

A0659D

2236420−6 & 2275938−6

A0659JE

ILLUSTRATION 1−1 AMX−4+ IDENTIFICATION

RATING PLATE

1-2

General The AMX−4+ contains operating safeguards to provide maximum safety. Before calling for service, be certain proper operating procedures are being used. Refer to Direction 2166913−1EN, AMX−4+ Operation, or Direction 2166911−100, AMX−4+ International Operation, for proper operating procedures.

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GE Healthcare REV 10

DIRECTION 2173227−100 Satisfactory equipment performance requires the use of service personnel specially trained on x−ray apparatus. GE Healthcare is responsible for the effects on safety, reliability, and performance only if the following conditions are met: −

The electrical wiring of the relevant rooms complies with all national and local codes.

−

All assembly operations, extensions, re−adjustments, modifications, or repairs are carried out by GE Healthcare authorized service representatives.

−

The equipment is used in accordance with the instructions for use. Refer to Direction 2166913−1EN, AMX−4+ Operating Manual, or Direction 2166911−100, AMX−4+ International Operation, for proper operating procedures. Only trained and qualified personnel should be permitted access to the internal parts of this equipment.

GE Healthcare, and its associates, maintain a worldwide organization of stations from which one may obtain skilled x−ray service. If desired, arrangements can usually be made to furnish preventive and/or emergency service on a contract basis. A GE Healthcare representative will be glad to discuss this plan.

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Cleaning The AMX−4+ should be cleaned frequently, particularly if corroding chemicals are present. Use a cloth slightly moistened in warm, soapy water to clean all surfaces. Wipe with a cloth slightly moistened in clean water. Do not use cleaners or solvents of any kind. They may remove markings and could damage the finish and plastic covers.

1-3-1

Hand switch Cleaning and Disinfecting Instructions SAFETY PRECAUTIONS − Before you Begin ·

Disconnect the hand switch cord from the body of the hand switch before performing the maintenance / cleaning procedures

·

Never use solvents or flammable solutions to clean the hand switch

·

Never use a dripping cloth (or) immerse hand switch in water or cleaning solutions

INSTRUCTIONS Use a cloth moistened in warm soapy water (use mild soap) to clean the hand switch. APPROVED CLEANERS The cleaners listed below are approved for cleaning the hand switch: ·

Bleach − 50% mix with water (5−8% household Bleach)

·

Glutaraldehyde <5%

·

Polyethylene Glycol <20% (tested as Cidex Plus 28)

·

Isopropyl Alcohol 70% concentration

·

Hydrogen Peroxide 15−40% concentration Never use cleaners or solvents of any kind if you are uncertain of the nature of the cleaning agent. The hand switch should be cleaned using EPA cleared and EPA registered high−level disinfecting agents.

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DIRECTION 2173227−100

Inspection In order to assure continued performance of this x−ray equipment, a periodic inspection program must be established. It is the owner’s responsibility to supply or arrange for this service. Periodic Maintenance can locate potential problems before they occur. Since maintenance checks involve cost, it is not practical to attempt to assure zero failures. The following inspection requirements, with suggested inspection intervals, are GE Healthcare recommendation for the most cost effective maintenance schedule. Inspection intervals are based on average daily use of one eight hour shift. More frequent inspection is appropriate where equipment use is above average. Equipment that regularly exhibits out of tolerance conditions should also be inspected more frequently.

1-5

HHS Testing The United States Department of Health and Human Services (HHS) has established performance requirements for diagnostic x−ray equipment. These requirements are defined in Title 21 of the Code of federal regulations (21 CFR), and apply only to certain specified components identified as “certified equipment.” The manufacturer of specified diagnostic x−ray components must certify that the components:

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1.

Perform as required by the HHS standard when installed, adjusted, and tested as specified in the manufacturer ’s instructions to the assembler. Refer to Direction 2173222−100 AMX−4+ Installation for HHS compliance testing as it pertains to the AMX−4+ during installation.

2.

Will continue to comply when maintained in accordance with the manufacturer’s instructions. The importance of HHS compliance testing cannot be over emphasized. Before starting Periodic Maintenance procedures, review Direction 46−013894 System Field Test for HHS. Pay particular attention to “Introduction” (Tab 1 of Direction 46−013894).

Tools and Materials In addition to the standard service representatives tool kit, the following items are required: −

Direction 2173221−100, AMX−4+ Ratings & Specifications and associated tools and materials.

−

Direction 2173224−100, AMX−4+ Functional Check and associated tools and materials.

−

Direction 2173225−100, AMX−4+ Service and associated tools and materials.

−

Direction 2190775−100, Stranded Steel Cable Inspection, and associated tools and materials

SECTION 2 − PM SCHEDULES Your AMX 4+ does not require any planned maintenance to be performed for a 13 month period following installation. PM should begin in the 13th month that follows your system’s installation anniversary date. Following the 13th month, PMs should be performed at the frequency indicated in Section 3 that follows. Note: The hand switch MUST be replaced at least once in every 3 years.

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AMX−4+ PERIODIC MAINTENANCE MODELS: 2169360, 2236420 & 2275938

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DIRECTION 2173227−100

SECTION 3 − INSPECTION The recommended interval between maintenance checks is 12 months. The following flowchart shows the recommended sequence for performing an annual periodic maintenance check on the AMX−4+. ILLUSTRATION 2−1 INSPECTION STEERING FUNCTIONAL CHECK Refer to ”Functional Check” in Direction 2173224−100, AMX−4+ Functional Check, and perform all defined checks. POWER CORD CHECK Refer to ”Power Cord Check” in Direction 2173224−100, AMX−4+ Functional Check, and perform all defined checks.

COUNTERWEIGHT CABLE Refer to Direction 2190775−100, Stranded Steel Cable Inspection, and perform all applicable checks to the main, safety, and follower counterweight cables. Exception is that this is a 12 month interval for the AMX−4+.

COLLIMATOR INTERFACE TIGHTNESS Verify that there is no movement between the collimator and X−ray tube. If there is no movement, verify mounting screws tightness for torque specs per Direction 2173225-100. If any movement is detected, you MUST remove the collimator and inspect all related fasteners. Refer to ”Servicing the Collimator” in Direction 2173225−100, AMX−4+ Service, for more information.

DRIVE BELT TENSION Refer to Illustration 2−2. Adjust the tension of drive belts on both wheels: Loosen the bolt and nut P62 (about one turn) to allow the spring P56 to apply the tension to the drive belts. Then tighten the nut and torque to 50−60 ft.−lbs to maintain the position of the motor assembly. Finally, apply Loctite 242 P99 on the nut to keep the fastening from loosening.

HHS TESTS (Excluding AEC) Refer to ”HHS Tests (Excluding AEC)” in Section 3 of Direction 2173221−100, AMX−4+ Ratings & Specifications, and perform all defined procedures.

NO

Mobil−AID AEC Present? YES AEC HHS TESTS

Refer to ”AEC HHS Tests” in Section 3 of Direction 2173221−100, AMX−4+ Ratings & Specifications, and perform all defined procedures.

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ILLUSTRATION 2−2 DRIVE BELT

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General Electric Company. GE Medical Systems, a General Electric Company, going to market as GE Healthcare. 3000 N. Grandview Boulevard Waukesha, Wisconsin 53188, USA www.gehealthcare.com