Dräger Medical SP00180 User manual

Service
Procedure
Field
Date: 23 February 2004
© 2004 Draeger Medical, Inc.
Part Number: SP00180
Rev: E
Narkomed MRI
PMC Procedure
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PMC PROCEDURE
NM MRI
6.0 PMC Procedure, Narkomed MRI
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
4114551, available from the Draeger Medical, Inc. Technical Service Department,
shall be completed by the Technical Service Representative each time a PMC is
performed. Space is also provided on the PMC checklist form to record the results of
a vapor concentration test.
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 with 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 EL number of all calibrated test equipment used. Also record the
calibration due dates.
Test Equipment Required:
*-- Multi-Meter (Fluke or Equivalent)
*-- Electrical Safety Analyzer (Biotek 501 Pro or Equivalent)
*-- Test Pressure Gauge, P/N S000063
-- Fresh Gas Outlet Volume Test Device, P/N S010158
-- Fresh Gas Leak Test Device, P/N 4113119
-- Adapter Assembly, Test Terminal, P/N 4104389
*-- Flowmeter Test Stand (Capnomed), P/N S000081
-- Breathing System Leak Test Device, P/N S010159
-- Dow Corning High Vacuum Grease, P/N S4105908
-- Tube, Corrugated, 22 mm x 12 in. long, P/N 9995112
-- Breathing Bag, 3 liter, P/N 9995330
-- Baromed Pressure Test Fixture
*-- Test Minute Volume Meter, P/N 2212300 (or Equivalent)
*-- Digital Pressure Manometer (SenSym PDM 200CD or Equivalent)
*-- Riken Gas Indicator, Model 18
-- Stop Watch
-- Test Lung (P/N 8401892)
Test equipment illustrations are shown on following pages.
6-1
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PMC PROCEDURE (continued) NM MRI
WARNING: Always lock the casters after this anesthesia machine has been
positioned in the MRI scanner room. Magnetic attractive forces
between the magnet and the anesthesia machine may cause
unintentional movement of the anesthesia machine if the casters are
unlocked.
WARNING: The power supply charger assembly must not be taken into the magnet
room. Damage to the equipment, MRI system, or personal injury could
result.
WARNING: The anesthesia machine must be removed from the MRI scanner room
before servicing the machine. Do not enter the MRI scanner room with
any tools or instruments. These items may be strongly attracted to the
magnet and may cause serious injury or death when brought into an
MRI scanning room.
6-2
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PMC PROCEDURE (continued)
NM MRI
SVOOO22
4113119
FRESH GAS LEAK TEST DEVICE
CONNECT TO
TEST PRESSURE GAUGE
6-2A
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PMC PROCEDURE (continued) NM MRI
SV00025
8401892
SIEMENS TEST LUNG
6-2B
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PMC PROCEDURE (continued)
NM MRI
SVOOO23
TESTTERMINAL
TESTTERMINAL
S010159
BREATHING SYSTEM LEAK TEST DEVICE
S010158
FRESH GAS OUTLET VOLUME TEST DEVICE
6-2C
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PMC PROCEDURE (continued) NM MRI
SVOOO27
0100
S000081
FLOW METER
TEST STAND
S000063
REGULATOR TEST
PRESSURE GAUGE
6-2D
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PMC PROCEDURE (continued)
NM MRI
SVOOO24
TESTTERMINAL
2212300
MINUTE
VOLUMETER
4104389
TEST TERMINAL
ADAPTER
D
510
100
ml
vol/min
15
Liter
200
300
400
500
600
700
800
900
6-2E
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PMC PROCEDURE (continued) NM MRI
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 the Narkomed MRI 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 insure proper product labeling.
Several additional documents have been created to ensure the success of this new program.
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 sample checklists with typical periodic maintenance items filled in,
including vapor concentrations 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 DMI'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 Recommendations 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 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 DMI 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.
6-2F
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PMC PROCEDURE (continued)
NM MRI
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".
6-2G
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PMC PROCEDURE (continued) NM MRI
For example:
A Narkomed 3 could have recommendation number 21 and failure code 61.1 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 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 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 NAD recommendations or failure codes apply. The correct
certification level for this machine is Code A, “CERTIFIED”.
Code D, which means “NO CERTIFICATION”, also means the machine shall not
receive a Periodic Manufacturer’s Certification label. The machine shall also
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® Validation” labels have been removed.
6-2H
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PMC PROCEDURE (continued)
NM MRI
PM Certification Procedure for Narkomed MRI Anesthesia System
1. Use the PM Certification form for Narkomed MRI Anesthesia Systems (P/N 4114551).
2. Completely fill in the header information.
3. Replace the VENTILATOR RELIEF VALVE DIAPHRAGM in accordance with SP
00075. Place a check mark and the replacement date at “VENT VALVE REPLACEMENT”
line on the Periodic Manufacturer’s Certification form.
4. Check all vapor 19 and 19.1 vaporizers for correct labeling. All vaporizers must have a label
stating "THE CONCENTRATION OUTPUT OF THIS VAPORIZER SHALL BE VERIFIED
AFTER IT HAS BEEN ATTACHED TO THE ANESTHESIA MACHINE" (part # S010015).
This label shall be attached to the rear of the vaporizer directly below the mount.
5. All Key Index Safety Systems vaporizers, (K.I.S.S.) must have a label stating "CAUTION:
AFTER FILLING HAS BEEN COMPLETED, REINSERT PLUG INTO UPPER FILLER
PORT AND TIGHTEN LOCKING SCREW" (part # 4112520-001). This label shall be attached
to the vaporizer directly above the keyed filler. Place a check mark at "K.I.S.S. LABEL" on the
PM Certification form.
6. 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” writen 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.
7. Perform the vapor concentration test on all Dräger vapor vaporizers in accordance with
SP00073. 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, test results @ 1%, 2.5%, 4%, and a PASS or FAIL indication. This label
shall be attached to the upper right side of the vaporizer. If vaporizer fails the concentration
test, 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 equipment operator to
remove the failed vaporizer from the machine and install a replacement vaporizer or an
adapter block onto the mount. All nonfunctional Dräger vapor vaporizers must be removed
from service for machine to receive certification.
6-2J
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PMC PROCEDURE (continued) NM MRI
PM Certification Procedure for Narkomed MRI Anesthesia System
8. Proceed with PM Certification procedure. If any tests fail refer to the "Failure Codes"
listing in DMI Recommendations Guidelines Index (P/N S010250) to determine
correct certification level starting point. Failure codes shall be documented on the
"RECOMMENDATIONS / GENERAL COMMENTS" section of the PM Certification
form and on the Executive Summary. If a test fails that has not been identified by the
"Failure Codes" list, consult with Draeger Medical, Inc. to assess the proper
certification level.
9. Based on the "EQUIPMENT CONDITION" inspect the machine for any "DMI
RECOMMENDATIONS" that would apply. Use the Narkomed MRI section of the
"DMI RECOMMENDATION GUIDELINES INDEX" (P/N S010250). Note all
applicable DMI recommendations on the Executive Summary. NOTE: If using a
carbon form, indicate the Equipment Condition number and to see reverse side under
the "RECOMMENDATIONS / GENERAL COMMENTS" section of the form.
10. Determine the correct certification level of the machine based on the combined lowest
common denominator of "Equipment Conditions" and "Failure Codes". If the machine
is at least conditionally certified fill out the "PM CERTIFICATION" label. Check the
box(s) on the validation label where appropriate. Write the month and year, (three
months from date of PM Certification) next to "NEXT VISIT DUE:" If certification
level is "D", machine shall not receive a "PM CERTIFICATION" label. Any machine
not receiving a PM Certification label shall receive a "WARNING NOT CERTIFIED"
label. This label shall be placed at a prominent location on the left side of the
machine after all other previous PMC and Vigilance Audit Validation labels have
been removed.
11. In the "CERTIFICATION LEVEL" section of the PM Certification form, record the
last visit certification level, the current certification level and the next visit due
month and year, (three months from date of PM Certification) in the spaces provided.
12. If applicable, remove the previous PM CERTIFICATION VALIDATION label and
attach the new label (P/N S010006 w/phone #, or P/N S010007 w/o phone #) in a
prominent location on the rear of the anesthesia machine.
13. Check the appropriate boxes on the "PM CERTIFICATION NOTICE" label, (part #
S010011). If the machine is not certified, the last box of this notice label shall be
marked. Attach this notice to the flow shield of the anesthesia machine.
14. Have the customer sign each PM Certification form or the Executive Summary, and
review the equipment conditions and the recommendations with the customer.
15. Return top copy to Draeger Medical, Inc. Service Department, keep middle copy for
service organization records, give bottom copy to customer.
6-2K
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PMC PROCEDURE (continued)
NM MRI
6.1 Safety Testing
6.1.1 Circuit Isolation Test
6.1.1.1 Turn the System Power switch to STANDBY, remove the AC power cord
from the outlet.
6.1.1.2 Set a multimeter to its highest resistance range, and carefully check for
continuity between Pin 1 of the machine power connector located at the
rear of the machine and any exposed unpainted surface of the machine
chassis. There shall be no continuity between these points.
6.1.1.3 Reconnect the power cable to the machine power connector.
6.1.2 Protective Ground Continuity Test
NOTE: Do not plug the safety analyzer into a line isolation monitor as
inaccurate readings may occur.
6.1.2.1 Plug the Biotec 501 Pro power cord into a live receptacle; place the power
switch of the Biotek 501 Pro to the “1” or ON position and ensure that
the keys marked GROUND, NEUTRAL and POLARITY are in the
NORMAL position.
NOTE: If the corresponding red LEDs for GND, NEU and POL are not lighted,
they are in the normal position.
6.1.2.2 Attach the ground lead from the red Test Lead input to the ground hole
of the AC test receptacle on the Biotec 501 Pro. Select the Single Lead
condition by ensuring that the SINGLE/DUAL key is not illuminated.
Press the gray key marked RESIST, then press the blue key marked
CAL. When the word CAL is no longer shown in the display window of
the Biotec 501 Pro, you may proceed.
6.1.2.3 Remove the red lead from the ground hole of the AC test receptacle and
attach the alligator clip to the free end, leaving the other end plugged
into the red Test Lead input of the Biotec 501 Pro with the Single Lead
and Resistance conditions still selected. Attach the alligator clip to any
exposed unpainted surface of the machine chassis.
6.1.2.4 Plug the charger cord into the test receptacle of the 501 Pro. The
resistance reading then shown on the Biotec 501 Pro display is the
Chassis Resistance. Bend and exercise the power cord to check for
intermittent readings. Record the reading on the PMC form. (≤0.1 ohm)
6-3
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PMC PROCEDURE (continued) NM MRI
6.1.3 Chassis Leakage Current Test
6.1.3.1 Press the gray Leakage key. Leave all other selections from the previous
test the same.
6.1.3.2 Set the white keys on the Biotec 501 Pro labeled GROUND, NEUTRAL
and POLARITY for normal polarity. Record the reading on the PMC
form. (0 µA)
6.1.3.3 Set the white keys for NORMAL ground, OPEN neutral and NORMAL
polarity. Verify reading is zero. (0 µA)
6.1.3.4 Set the white keys for OPEN ground, NORMAL neutral and NORMAL
polarity. Record the reading on the PMC form. Note: Old power supply:
≤150 µA but not zero. New power supply: ≤120 µA but not zero.
6.1.3.5 Set the white keys for NORMAL ground, NORMAL neutral and
REVERSE polarity. Record the reading on the PMC form. (0 µA)
6.1.3.6 Set the white keys for NORMAL ground, OPEN neutral and REVERSE
polarity. Verify reading is zero. (0 µA)
6.1.3.7 Set the white keys for OPEN ground, NORMAL neutral and REVERSE
polarity. Record the reading on the PMC form. Note: Old power supply:
≤150 µA but not zero. New power supply: ≤120 µA but not zero.
6.1.3.8 Return the white keys on the Biotec 501 Pro to their Normal positions.
6.2 Self-Diagnostics: Core-M Monitor
6.2.1 Connect the pipeline supply or open the cylinders.
6.2.2 Turn the System Power switch to ON.
6.2.3 Verify that the Omicron monitor LCD display and LED lamps performs a
self-diagnostic test.
6.2.4 Verify that the green "Power" LED activates.
6-4
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PMC PROCEDURE (continued)
NM MRI
6.2A Self-Diagnostics: VPO Monitor
6.2.A.1 Connect the pipeline supply or open the cylinders.
6.2.A.2 Turn the System Power switch to ON.
6.2.A.3 Verify that the following is displayed:
(9) 6.2.A.4 Record the machine software version on the header of the checklist form.
6.2B CONFIGURATION: VPO Monitor
6.2B.1 Press the CONFIG key.
6.2B.2 The CONFIGURE screen is displayed.
6.2B.3 Verify the correct Time and Date.
NARKOMED MRI
COPYRIGHT 2000 DRAEGER MEDICAL, INC.
VERSION: 1.00 NM MRI
SOFTWARE ID: 3B31
DIAGNOSTIC TESTS
FIRMWARE PASS
RAM PASS
VIDEO PASS
A/D CONVERTER PASS
AUDIO PASS
CLOCK PASS
NON-VOLATILE MEMORY PASS
PERIODIC CERTIFICATION DUE
FUNCTIONAL
6-4A
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PMC PROCEDURE (continued) NM MRI
6.2C SERVICE DATA: VPO Monitor
6.2C.1 Press and hold the Oxygen High Limit key and the Volume Low Limit key,
and then press the key.
6.2C.2 The Main Service Screen appears.
(9) 6.2C.3 Record the Last Service Date on the PMC form.
(9) 6.2C.4 Record the Hours Run Since Last Service on the PMC form.
(9) 6.2C.5 Record the Total Hours Run on the PMC form.
6.2C.6 Select and enter the Service Log.
6.2C.7 Verify any pertinent information from the Service Log. Contact the
Draeger Medical, Inc. Technical Service Department if necessary.
6.2C.8 Press EXIT to return to the Main Service screen.
6.2C.9 Select the SRVC Service Code.
6.2C.10 Select and enter your Technical Service Rep. I.D. number.
(9) 6.2C.11 Press the RESET key. This resets the last service date to the current date
and resets the hours run since last service to zero.
6.2C.12 Press the PMS SCHED key.
(9) 6.2C.13 Select and enter the month of the next service due date. The internal clock
of the machine limits the amount of date advance to a maximum of six
months from the current service date.
5
6-4B
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PMC PROCEDURE (continued)
NM MRI
6.3 Battery Circuit Test
6.3.1 Deleted
6.3.2 If needed, replace the battery as outlined in the Battery Replacement
Procedure in Section 4 of this manual/
6.3.3 Is "ON" LED lighted? __ (Y)
6.3.4 With the System Power switch ON, unplug the AC power cord.
6.3.5 Is yellow "AC PWR FAIL" LED lighted as long as the power cord is
unplugged? __ (Y)
6.3.6 Press and hold the "BATTERY TEST" button.
6.3.7 Is green Battery Test LED lighted as long as "BATTERY TEST" button is
depressed? __ (Y)
6.3.8 Release the "BATTERY TEST" button.
6.3.9 Restore AC power to the machine.
6.3.10 Does the "AC PWR FAIL" LED extinguish? __ (Y)
6-5
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PMC PROCEDURE (continued) NM MRI
6.4 High Pressure Leak Test
6.4.1 Yoke Assemblies
6.4.1.1 Turn the ventilator off.
6.4.1.2 Turn the System Power switch to STANDBY.
6.4.1.3 Disconnect the pipeline supply or close the cylinders.
6.4.1.4 Remove cylinder or yoke plug from each yoke assembly.
6.4.1.5 Do all the yoke handles adjust smoothly? ___ (Y)
6.4.1.6 Are the two (2) yoke pins installed securely in each yoke? ___ (Y)
6.4.1.7 Is there only one (1) cylinder washer on each yoke assembly? ___ (Y)
6.4.1.8 Is there a yoke plug attached to each yoke assembly? ___ (Y)
6.4.1.9 Is the proper gas I.D. label affixed to each yoke assembly? ___ (Y)
6.4.1.10 Attach a cylinder to each yoke assembly, open the cylinder valve, let the
pressure stabilize, close the cylinder valve, and remove the cylinder from
the yoke assembly.
6.4.1.11 Does the yoke check valve assembly prevent the escape of excessive
pressure? ___ (Y)
6.4.1.12 Attach the cylinders to the yokes.
6-6
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