Dräger Medical Fabius Tiro Technical & Service Manual page 254

Anesthesia system
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PMS 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 BC, 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, use the above list in descending order from bottom to
top. For example, "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 Standard or Compact could have recommendation numbers 10, 11 and 15 apply.
10 - Breathing pressure monitor is not interfaced with anesthesia machine system power switch
or ventilator. Code is B.
11 - Ventilator is equipped with descending bellows and lacks CO2 monitoring. Code is D1.
15 - Vaporizer mounting using a vaporizer selection valve. Code is B.
The correct certification for this machine is D, which means "NO CERTIFICATION", and
additional recommendation I applies.
A Narkomed AMIII or Narkomed II could have recommendations 6 apply, and failure code 46.2.
6 - Oxygen ratio monitor instead of oxygen ratio monitor controller. Code D II.
46.2 - O2 analyzer malfunction. Code D.
Correct certification for this machine is D, which means "NO CERTIFICATION".
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APPENDIX A
12
FABIUS TIRO

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