6-10
NMGS
PMC PROCEDURE (continued)
7.
Proceed with PM Certification procedure. If any tests fail refer to the “Failure
Codes” listing in DMI Recommendations Guidelines Index (P/N S010250) to
determine correct certification level starting point. Failure codes shall be
documented on the “RECOMMENDATIONS / GENERAL COMMENTS” section of
the PM Certification form and on the Executive Summary. If a test fails that has
not been identified by the “Failure Codes” list, consult with Draeger Medical, Inc. to
assess the proper certification level.
8.
Based on the “EQUIPMENT CONDITION” inspect the machine for any “DMI
RECOMMENDATIONS” that would apply. Use the Narkomed GS section of the
“RECOMMENDATION GUIDELINES INDEX” (P/N S010250). Note all applicable
DMI recommendations on the Executive Summary.
NOTE:
If using a carbon form, indicate the Equipment Condition number and to see
reverse side under the “RECOMMENDATIONS / GENERAL COMMENTS”
section of the form.
9.
Determine the correct certification level of the machine based on the combined
lowest common denominator of “Equipment Conditions” and “Failure Codes”. If the
machine is at least conditionally certified fill out the “PM CERTIFICATION” label.
Check the box(s) on the validation label where appropriate. Write the month and
year, (three months from date of PM Certification) next to “NEXT VISIT DUE:”. If
certification level is “D”, machine shall not receive a “PM CERTIFICATION” label.
Any machine not receiving a PM Certification label shall receive a “WARNING
NOT CERTIFIED” label, P/N
4114857
. This label shall be placed at a prominent
location on the left side of the machine after all other previous PMC and Vigilance
Audit Validation labels have been removed.
10.
In the “CERTIFICATION LEVEL” section of the PM Certification form, record the
last visit certification level, the current certification level and the next visit due
month and year, (three months from date of PM Certification) in the spaces
provided.
11.
If applicable, remove the previous PM CERTIFICATION VALIDATION label and
attach the new label (P/N S010006 w/phone #, or S010007 w/o phone #) in a
prominent location on the rear of the anesthesia machine.
12.
Check the appropriate boxes on the “PM CERTIFICATION NOTICE” label, (part #
S010011). If the machine is not certified, the last box of this notice label shall be
marked. Attach this notice near the flowmeter shield of the anesthesia machine.
13.
Have the customer sign each PM Certification form or the Executive Summary, and
review any Failure Codes equipment conditions and DMI Recommendations with
the customer.
14.
Return top copy to Draeger Medical, Inc. Service Department, keep middle copy for
service organization records, give bottom copy to customer.
Summary of Contents for Narkomed GS
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