Periodic Manufacturer's Certification General Instructions - Dräger Medical Fabius Tiro Technical & Service Manual

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FABIUS TIRO
PMS PROCEDURE (continued)
APPENDIX A

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 Fabius Tiro anesthesia machine.
A PMC consists of a complete Periodic Manufacturer's Service procedure and a certification
level inspection based on Draeger Medical, Inc. Recommendations and equipment
performance. Additional inspections are also performed to ensure proper product labeling.
Several additional documents have been created to assist the technician through the process.
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 the sample checklists with typical periodic maintenance items filled in,
including vapor concentration 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 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 Recommendation 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 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.
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