NORTH AMERICAN DRÄGER Narkomed Mobile Military User manual
Field
Service
Procedure
Part Number: SP00182
Date: 28 February 2003
© 2003 Draeger Medical, Inc.
Rev: E
Narkomed Mobile/Military
PMC Procedure
NM MOBILE/MILITARY
PMC PROCEDURE
6.0 PMC PROCEDURE, NARKOMED MOBILE/MILITARY
The procedures in this section shall be performed in their entirety each time a
component is removed, replaced, calibrated, adjusted and during all scheduled
Periodic Manufacturer's Certification (PMC) visits. A PMC Checklist form, P/N
S010211 is available from Draeger Medical, Inc. and shall be completed by the
Technical Service Representative each time a PMC is performed. Steps in the
procedure marked with (
checklist form.
Space is also provided on the PMC checklist form to record the results of a vapor
concentration test. Refer to the current Anesthesia Equipment & Monitoring System
Service Information CD-ROM Service Procedures section for vapor concentration
verification procedures.
NOTE:Test equipment listed below with an asterisk (*) requires calibration at a
maximum interval of one year. Verify the dates on test equipment calibration
labels. DO NOT USE any test equipment having an expired calibration date.
Notify your supervisor immediately if any equipment is found to be out of
calibration. In the space provided at the bottom of the PMC checklist form,
record the Model and ID number of all calibrated test equipment used.
In the space provided at the bottom of the PMC checklist form, record the Model and
ID number of all calibrated test equipment used. Also record the calibration due
dates. Examples are: multimeter, digital pressure meter, Riken gas analyzer, safety
analyzer, volumeter, trace gas analyzer, simulators.
ü) require a response at the corresponding line on the
Test Equipment Required:
• *Electrical Safety Analyzer (Biotek 501 Pro or equivalent)
• *Pressure Gauge with DISS Adapters (P/N 4114807 or equivalent)
• *Flowmeter 0-250 ml min. (P/N S000081 or equivalent)
• *Volume Meter (P/N 2212300 or equivalent)
• *Digital Pressure Manometer (SenSym PDM 200CD or Equivalent)
• *Riken Gas Indicator (Model 18H, or 1802D or equivalent)
•Stop Watch
• Test Lung (P/N 4115128)
Materials Required:
• Breathing Bag 3 liter (P/N 9995330 or equivalent)
• Patient Circuit: Y-piece, elbow, 2x 32” x 22mm hoses
• Hose 22 mm x 32” (P/N 9995132)
• Fresh Gas Outlet Volume Test Device (P/N S010158 or equivalent)
• Fresh Gas Leak Test Adapter (P/N 4115041 or equivalent)
• Volumeter/Fresh Gas Adapter (P/N 4115042)
6-1
PMC PROCEDURE (continued)
Materials Required (continued):
• Test Terminal 2x (P/N 4104389 or equivalent)
• Breathing System Leak Test Device (P/N S010159 or equivalent)
• PDM/Suction Adapter (P/N 4115038)
• Scavenger Adapter (P/N 4108114)
• Pressure Monitor Test Adapter (P/N 4115043 or equivalent)
Key test equipment and materials illustrations are shown on following pages.
NM MOBILE/MILITARY
6-2
NM MOBILE/MILITARY
TEST EQUIPMENT AND FIXTURE ILLUSTRATIONS
4115041
FRESH GAS
LEAK TEST DEVICE
PMC PROCEDURE (continued)
TEST TERMINAL
S010158
FRESH GAS OUTLET VOLUME TEST DEVICE
TEST TERMINAL
S010159
BREATHING SYSTEM LEAK TEST DEVICE
4115042
VOLUMETER/
FRESH GAS HOSE
ADAPTER
SP18201
6-3
PMC PROCEDURE (continued)
TEST EQUIPMENT AND FIXTURE ILLUSTRATIONS - Continued
4114807 PRESSURE TEST ASSEMBLY , WITH ADAPTERS
NM MOBILE/MILITARY
SP18202
4114830-002 4114830-001
4114830-004 4114830-003
4114830-006 4114830-005
6-4
NM MOBILE/MILITARY
TEST EQUIPMENT AND FIXTURE ILLUSTRATIONS - Continued
PMC PROCEDURE (continued)
SP18203
TEST
VOLUME
METER
4115087 33mm x 22mm ADAPTER
6-5
PMC PROCEDURE (continued)
TEST EQUIPMENT AND FIXTURE ILLUSTRATIONS - Continued
PDM TO PATIENT SUCTION ADAPTER
NM MOBILE/MILITARY
4115038
AVENGER
4108114
SCAVENGER ADAPTER
4115043
PDM TO
MONITOR ADAPTER
SP18204
6-6
NM MOBILE/MILITARY
TEST EQUIPMENT AND FIXTURE ILLUSTRATIONS - Continued
900
PMC PROCEDURE (continued)
15
Liter
100
S000081
FLOW METER
TEST STAND
800
700
vol/min
600
10
500
5
200
ml
300
400
4104389
TEST TERMINAL
ADAPTER
2212300
MINUTE
VOLUMETER
4115128
SIEMENS TEST LUNG
Rev. D
TEST TERMINAL
SP18205
6-7
PMC PROCEDURE (continued)
NM MOBILE/MILITARY
Periodic Manufacturer’s Certification General Instructions
The purpose of these procedures is to provide detailed instructions for performing a Periodic
Manufacturer’s Certification (PMC) inspection on the Narkomed Mobile/Military anesthesia
machine.
A PMC consists of a complete Periodic Manufacturer ’s Service procedure and a certification level
inspection based on Draeger Medical, Inc. Recommendations and equipment performance.
Additional inspections are also performed to ensure proper product labeling.
Several additional documents have been created to assist the technician through the process.
Following is a brief description of the purpose of each document.
Field Service Procedure:
Periodic Manufacturer’s Certification Forms - Part Number SP00175.This procedure illustrates
the sample checklists with typical periodic maintenance items filled in, including vapor
concentration verification tests, parts replaced, general comments and certification levels. Also
included are sample PMC labels marked to show several levels of certifications. An excerpt from
Draeger Medical, Inc.’s Anesthesia System Risk Analysis and Risk Reduction is included, and also
a sample of an Executive Summary to be furnished to the hospital’s Risk Manager or Chief of
Anesthesia.
Field Service Procedure:
DMI Recommendation Guidelines Index Anesthesia Systems - Part Number S010250.This
Guideline was created to provide an assessment of each machine’s certification. It contains
various comprehensive overviews of possible equipment conditions and their associated
certification levels.
The first list in the Recommendation Guidelines is a reference chart for machine certification
based on equipment status. The second is an abbreviated summary of all DMI Recommendations
and Failure Codes including the Condition Number, Equipment Condition, Recommended
Corrections, Certification Code, and Tests Affected when applicable.
There is also a matrix classified as “Failure Codes” which identifies the correct manner in which
to document equipment tests that fail, or were unable to be performed due to circumstances
beyond the control of the service technician performing the inspection. (Ex: Air cylinder supply is
unavailable to perform an Air High Pressure Leak test.) The Failure Codes section also indicates
suggested resolution of the situation. Failure Code numbers begin at 34 and use the same
certification levels strategy, and carry the same weight as NAD Recommendation equipment
condition codes.
The final matrix is the most comprehensive index sorted by machine model and includes
Equipment Condition, Certification Code, and DMI Recommendations. It also specifies any
suggested upgrade path including ordering information that should be taken such as installing a
Bellows with Pressure Limit Control 4109664-S01 Kit, after market modification kit to a machine
not equipped with pressure limit control.
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
6-8
NM MOBILE/MILITARY
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.
PMC PROCEDURE (continued)
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 "Vigi-
®
lance Audit
Validation" labels have been removed.
6-9
PMC PROCEDURE (continued)
NM MOBILE/MILITARY
PM Certification Procedure for Narkomed Mobile/Military Anesthesia System
1. Use the PM Certification form for Narkomed Mobile/Military Anesthesia Systems (P/
N 4115597).
2. Completely fill in the header information.
3. All Narkomed Mobile/Military machines are equipped with Humphrey valves. No
“MJV-2 LUBRICATION” is needed to be performed for this type of anesthesia
machine.
4. Replace the VENTILATOR RELIEF VALVE DIAPHRAGM every 12 months in
accordance with SP00075. Place a check mark and the replacement date at “VENT
VALVE REPLACEMENT” line on the Periodic Manufacturer’s Certification form.
5. If machine is equipped with a HALOTHANE Dräger Vapor 19 or 19.1 vaporizer,
determine if vaporizer must be inspected for soil condition one. Check the serial
number plate located on the rear of the vaporizer for a plus (+) preceding the serial
number. A HALOTHANE vaporizer serial number not preceded with a (+) must be
tested for soil in accordance with SP00073. If vaporizer does not need to be inspected,
indicate so with a plus (+) next to the “Vapor Inspection (H)” line on the Vigilance
Audit form. If vaporizer is soil condition 0, indicate so with “SOIL 0” written next to
the “Vapor Inspection (H)” line on the Vigilance Audit form. If vaporizer is soil
condition one, indicate so with “SOIL 1” written next to the “Vapor Inspection (H)” line
on the Vigilance Audit form. Place a “CAUTION DO NOT USE” label (part # 4114327)
on the vaporizer, and issue a departmental alert. The TSR shall also seek permission
from the equipment operator to remove the failed vaporizer from the machine and
apply a replacement vaporizer or an adapter block onto the mount. All “SOIL 1”
vaporizers must be removed from service for machine to receive certification.
6. Perform the vapor concentration test on all Dräger vapor vaporizers in accordance
with SP00073 at a six month maximum interval. Perform the vaporizer concentration
test on all Desflurane vaporizers in accordance with SP00091 for fixed mount
vaporizers and SP00189 for user removable D-tec vaporizers at a six month maximum
interval. For every vaporizer tested, fill out a "VAPOR VAPORIZER CALIBRATION
CHECK" label (part # S010016). Information on this label shall include your
signature, type of agent, date tested, a No Agent To Test or the test results @ 1%, 2.5%,
4% for H, E, I, or S vaporizers, or @ 4%, 10%, 12%, 16% for Desflurane vaporizers, and
a PASS or FAIL indication. This label shall be attached to the upper right side of the
vaporizer. If vaporizer fails the concentration verification, internal leak, or exclusion
system tests, check "NO" in the "RECOMMENDED FOR USE" section on the PM
Certification form. Place a "CAUTION DO NOT USE" label (part # 4114327) on the
vaporizer, and issue a departmental alert. The TSR shall also seek permission from
the customer to remove the failed vaporizer from the machine and install a
replacement vaporizer or an adapter block onto the mount. All nonfunctional
vaporizers must be removed from service for machine to receive certification.
6-10
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