NM2C PMS PROCEDURE (continued)
Periodic Manufacturer’s Certification General Instructions
The purpose of this manual is to providedetailed instructions for performing a Periodic Manufacturer’s
Certification (PMC) inspection on all models of Narkomed anesthesia machines.
A PMC consists of a complete Periodic Manufacturer’s Service procedure and a new certification level
inspection based on Draeger Medical, Inc. Recommendations and equipment performance. Additional
inspections are also performed to insure proper product labeling.
Several additional documents have been created to ensure the success of this new program. Following
is a brief description of the purpose of each document.
Field Service Procedure:
Periodic Manufacturer’s Certification Forms - Part Number SP00175.
This procedure illustrates sample checklists with typical periodic maintenance items filled in,
including vapor concentrations verification tests, parts replaced, general comments and certification
levels. Also included are sample PMC labels marked toshow several levels of certifications. Anexcerpt
from Draeger Medical, Inc.’s Anesthesia System Risk Analysis and Risk Reduction is included, and also
a sample of an Executive Summary to be furnished to the hospital’s Risk Manager or Chief of
Anesthesia.
Field Service Procedure:
NAD Recommendations Guidelines Index Anesthesia Systems - Part Number S010250.
This Guideline was created to provide an assessment of each machine’s certification. It contains
various comprehensive overviews of possible equipment conditions and their associated certification
levels.
The first list in the Recommendation Guidelines is a reference chart for machine certification based
onequipment status. The secondis an abbreviated summaryof all NAD Recommendations and Failure
Codes including the Condition Number, Equipment Condition, Recommended Corrections, Certification
Code, and Tests Affected when applicable.
There is also a matrix classified as "Failure Codes" which identifies the correct manner in which to
document equipment tests that fail, or were unable to be performed due to circumstances beyond the
control of the service technician performing the inspection. (Ex: Air cylinder supply is unavailable to
perform Air High Pressure Leak test.) The Failure Codes section also indicates suggested resolution
of the situation. Failure Code numbers begin at 34 and use the same certification levels strategy, and
carry the same weight as NAD Recommendation equipment condition codes.
The next section of the guideline lists all NAD Recommendations identified at a machine’s major
assembly level. This section is divided into subsections titled: "Anesthesia System", "Vaporizers",
"Absorber System", "Ventilator" and "Scavenger System". The final matrix is the most comprehensive
index sorted by machine model and includes Equipment Condition, Certification Code, and NAD
Recommendations. It also specifies any suggested upgrade path including ordering information that
should be taken such as installing a Bellows with Pressure Limit Control 4109664-S01 Kit, after
market modification kit to a machine not equipped with pressure limit control.
Rev. T 6-1F
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