Periodic Manufacturer’s Certification General Instructions; Field Service Procedure - Dräger Narkomed 2B Service Manual

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NM2B PMC PROCEDURE (continued)
Periodic Manufacturer's Certification General Instructions
The purpose of these procedures is to provide detailed instructions for performing a Periodic
Manufacturer's Certification (PMC) inspection on the Narkomed 2B anesthesia machine.
A PMC consists of a complete Periodic Manufacturer's Service procedure and a certification level
inspection based on DMI 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 to show several levels of certifications. An excerpt
from DMI'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:
DMI 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
on equipment status. The second is an abbreviated summary of all DMI 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 DMI Recommendation equipment condition codes.
The final matrix is the most comprehensive index sorted by machine model and includes Equipment
Condition, Certification Code, and DMI 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.
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