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PMC PROCEDURE (continued)
The letters A, B, C, D and the Roman Numerals I, II are used as codes in the individual matrix for
each model of anesthesia machine. The letters A, B, C, and D are used in descending order to indicate
the certification level of the equipment. They are as follows:
A = Certified
B = Certified with Recommendations
C = Conditionally Certified
D = No Certification
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 recommendations apply to machine being inspected. (Only item number 33 - "No
Recommendations" shall apply for this certification level.)
Certified with Recommendations- A numbered recommendation with a code of B applies to the
machine being examined.
Conditionally Certified- A numbered recommendation with a code of BCI or BCII applies to the
machine being examined.
No Certification- A numbered recommendation 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 Compact could have recommendation numbers 8, 10, 11, and 18 apply.
# 8- Oxygen analyzer is not interfaced with the anesthesia machine. Code is BCII.
# 10- Pressure monitor is not interfaced with anesthesia ventilator. Code is B.
# 11- Ventilator is equipped with descending bellows. Code is BCI.
# 48.1- O2 analyzer is nonfunctional. Code is D.
The correct certification for this machine is D, which means "NO CERTIFICATION".
A Narkomed Standard could have recommendation numbers 2, 10, and 48.2 apply.
# 2- No oxygen pressure depletion warning. Code is BCII.
# 10- Pressure monitor is not interfaced with anesthesia ventilator. Code is B.
# 48.2 O2 analyzer is non functional. Code is D.
The correct certification for this machine is D, which means "NO CERTIFICATION".
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6-1C
NM3
Rev. V
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