PMS PROCEDURE (continued) NM2C
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"CertifiedwithRecommendations"."ConditionallyCertified"wouldtakeprecedenceover
"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".
6-1G Rev. T
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