6-8
NMGS
PMC PROCEDURE (continued)
Roman Numerals I and II do not affect the certification level but rather are provided to give
further instructions to the end user as follows:
I = The system in its present configuration shall only be used with a CO2 monitor incorporating
an apnea warning. The operator of the system is advised to frequently scan the CO2 readings and
alarm thresholds.
II =The present configuration of equipment requires that the unit operate at all times with an
oxygen analyzer that includes a low oxygen warning. The operator of the system is advised to
frequently scan the oxygen readings and alarm limits.
Following is an explanation of machine certification levels:
Certified-
No DMI Recommendations or Failure Codes apply to machine being inspected. (Only
item number 33 - “No Recommendations” shall apply for this certification level.)
Certified with Recommendations-
A numbered DMI Recommendation or Failure Code with a
code of B applies to the machine being examined.
Conditionally Certified-
A numbered DMI Recommendation or Failure Code with a code of BCI
or BCII applies to the machine being examined.
No Certification-
A numbered DMI Recommendation or Failure Code with a code of D applies to
the machine being examined.
When multiple recommendations apply, “No Certification” would take precedence over
“Conditionally Certified” and “Certified with Recommendations”. “Conditionally Certified” would
take precedence over “Certified with Recommendations”.
For example:
A
Narkomed 2B
could have DMI Recommendation number 21 and Failure Code 61.1 that apply.
21 - No ventilator pressure limit control. Code is B. 61.1 - Enflurane agent is unavailable to test.
Code is BC. Correct certification for this machine is BC, which means CONDITIONALLY
CERTIFIED WITH RECOMMENDATIONS.
A
Narkomed 4
could have DMI Recommendation numbers 14 and 21 apply.
14 - CO2/Agent monitor exhaust port is not properly connected to the waste gas scavenger. Code
B. 21 - No ventilator pressure limit control. Code B.
The correct certification for this machine is B, which means “CERTIFIED WITH
RECOMMENDATIONS”.
A
Narkomed 2B, 2C or GS
could have DMI Recommendation 30 apply. 30 - Anesthesia machine
is equipped with inhalation anesthesia vaporizers without an agent analyzer in the breathing
system. Code B.
The correct certification for this machine is B, which means “CERTIFIED WITH
RECOMMENDATIONS”.
A
Narkomed 6000
could have no DMI Recommendations or Failure Codes apply. The correct
certification level for this machine is Code A, “CERTIFIED”. The correct certification for this
machine is A, which means “CERTIFIED”.
Code, D also means “NO CERTIFICATION”, also means the machine shall not receive a
Periodic Manufacturer’s Certification label. The machine shall receive a “WARNING -
This System Is Not Certified” label, P/N 4114857. This label shall be placed at a
prominent location on the right side of the machine after all other previous PM and
“Vigilance Audit(r) Validation” labels have been removed.
Summary of Contents for Narkomed GS
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