Inspection; Hhs Testing; Tools And Materials; Section 2 − Pm Schedules - GE AMX 4+ Manual

GE Healthcare
REV 10
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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.
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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:
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).
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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.
AMX−4+ PERIODIC MAINTENANCE
MODELS: 2169360, 2236420 & 2275938
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DIRECTION 2173227−100