NORTH AMERICAN DRÄGER Drager Narkomed 2B User manual

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Field

Service

Procedure

Part Number: SP00152

Date: 1 March 2004

© 2004 Draeger Medical, Inc.

Rev: P

Narkomed 2B

PMC Procedure

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NM2B

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PMC PROCEDURE

6.0 PMC PROCEDURE, NARKOMED 2B

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

(9) require a response at the corresponding line on the

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.

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 8401892)

-- AC Receptacle Circuit Tester

Materials Required:

-- Spiromed Lubrication Kit (P/N 2218180)

-- 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)

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NM2B PMC PROCEDURE (continued)

Materials Required (continued):

-- Fresh Gas Leak Test Adapter (P/N 4115041 or equivalent)

-- Volumeter/Fresh Gas Adapter (P/N 4115042)

-- 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)

-- NIBP w/Luer Test Adapter (P/N 4116111-001)

-- Pressure Monitor Test Adapter (P/N 4115043 or equivalent)

Key test equipment and materials illustrations are shown on following pages.

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NM2B

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PMC PROCEDURE (continued)

4114807 PRESSURE TEST ASSEMBLY , WITH ADAPTERS

4114830-002 4114830-001

4114830-004 4114830-003

4114830-006 4114830-005

SP15001

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NM2B PMC PROCEDURE (continued)

15

900

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

8401892

SIEMENS TEST LUNG

TEST TERMINAL

SP15002

6-4

NM2B

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PMC PROCEDURE (continued)

TEST TERMINAL

S010158

FRESH GAS OUTLET VOLUME TEST DEVICE

4115041

FRESH GAS

LEAK TEST DEVICE

TEST TERMINAL

S010159

BREATHING SYSTEM LEAK TEST DEVICE

4115042

VOLUMETER/

FRESH GAS HOSE

ADAPTER

SP15003

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NM2B PMC PROCEDURE (continued)

4115038

PDM TO PATIENT SUCTION ADAPTER

AVENGER

4108114

SCAVENGER ADAPTER

4110709

LUER (F) 1/8 MPT

ADAPTER FOR TOP PORT

ON CAPNOMED FLOW METER

4116111-001

NIBP W/LUER

TEST ADAPTER

4115043
PDM TO

MONITOR ADAPTER

6-6

SP15004

NM2B

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PMC PROCEDURE (continued)

Periodic Manufacturer's Certification General Instructions

The purpose of this manual is to provide detailed instructions for performing a Periodic
Manufacturer’s Certification (PMC) inspection on a Narkomed 2B 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.

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

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NM2B PMC PROCEDURE (continued)

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.

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
“Vigilance Audit(r) Validation” labels have been removed.

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NM2B

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PMC PROCEDURE

PM Certification Procedure for Narkomed 2B Anesthesia System

1. Use the PM Certification form for Narkomed 2B/ 2C/ GS Anesthesia Systems (P/N
S010211).

2. Completely fill in the header information.

3. Determine if the ventilator has an MJV-2 square Clippard valve. If ventilator has an
MJV-2, perform the lubrication procedure every 12 months in accordance with
SP00062. Place a check mark and indicate the next lubrication due date in the “Vent
Valve Lube Due” line on the Periodic Manufacturer’s Certification form. If the
ventilator has a Humphrey valve (lubrication is not required), indicate so with a (H)
next to the “Vent Valve Lube Due” line on the Periodic Manufacturer’s Certification
form.

4. Replace the VENTILATOR RELIEF VALVE DIAPHRAGM every 12 months in
accordance with SP00075. Place a check mark and indicate the next replacement
date at “Relief Valve Diaphragm Due” 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.

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NM2B PMC PROCEDURE (continued)

7. 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.

8. Based on the “EQUIPMENT CONDITION” inspect the machine for any “DMI
RECOMMENDATIONS” that would apply. Use the Narkomed 2C section of the
“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.

9. 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, P/N 4114857. 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.

10. 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.

11. If applicable, remove the previous PM CERTIFICATION VALIDATION label and
attach the new label (P/N S010006 w/phone #, or S010007 w/o phone #) in a
prominent location on the rear of the anesthesia machine.

12. 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 near the flowmeter shield of the anesthesia machine.

13. Have the customer sign each PM Certification form or the Executive Summary, and
review any Failure Codes equipment conditions and DMI Recommendations with
the customer.

14. Return top copy to Draeger Medical, Inc. Service Department, keep middle copy for
service organization records, give bottom copy to customer.

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NM2B

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PMC PROCEDURE (continued)

6.1 SELF-DIAGNOSTICS

6.1.1 Turn the System Power switch to ON and verify the “ON” LED is lighted?

6.1.2 Verify all LED’s on the keypad and ventilator displays are lit if applicable.
Verify the flowmeter lights operate properly.

6.1.3 Verify that the following is displayed on the alarm CRT:

VIDEO TEST PASS NARKOMED 2B

FIRMWARE TEST PASS VERSION x.xx DIAGNOSTICS
MEMORY TEST PASS COPYRIGHT, NAD INC. 1987-94
TIMERS TEST PASS
ANALOG TEST PASS
AUDIO TEST - PRIMARY PASS

- BACKUP PASS
SERIAL I/O TEST PASS
CLOCK TEST PASS
BACKUP MEMORY TEST PASS
AC POWER TEST PASS
RESERVE POWER TEST PASS

FUNCTIONAL

6.1.4 Record the machine software version on the header of the checklist form.

6.2 ELECTRICAL SAFETY- One Year Service Interval; Due Date _____

6.2.1 Ground Continuity

6.2.1.1 Unplug the AC power cord for all devices mounted to the
machine that may provide an alternate path to earth ground,
such as a Desflurane vaporizer.

6.2.1.2 Unplug the machine’s AC power cord and plug the power cord
of the safety analyzer into this AC receptacle.

NOTE: Do not plug the safety analyzer power cord into a line

isolation monitor circuit, as inaccurate readings may
occur.

NOTE: The BIOTECH 501 PRO will automatically test the

source outlet for open ground (or ground resistance of
31 Ohms or higher), reverse polarity, open neutral and
open line. (The latter two conditions will prevent the
analyzer from powering up.)

6.2.1.3 Turn on the safety analyzer and set it’s function switch to the
GROUND WIRE RESISTANCE position. Attach the test lead
to the red SINGLE LEAD connector of the analyzer. Connect
the other end of the red test lead to the AC receptacle ground
socket on the safety analyzer. Verify a displayed resistance of

0.00 ohms or, if necessary, press the CALIBRATE key on the
front panel of the analyzer to zero the device.

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SPIROMED

T

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NM2B PMC PROCEDURE (continued)

6.2.1.4 Set the safety analyzer GROUND switch to NORMAL. Set
the POLARITY switch to OFF.

6.2.1.5 Plug the machine’s AC power cord into the safety analyzer.

6.2.1.6 Apply the analyzer’s test lead to a cylinder yoke bolt.

6.2.1.7 What is the value displayed on the safety analyzer? ___ ohm
(0-0.1)

6.2.2 Circuit Isolation

6.2.2.1 Disconnect the respiratory volume sensor cord from the
interface panel.

6.2.2.2 Using a multimeter set to its highest
resistance range apply the test leads
between the yoke bolt and circuit
common at the volume interface test
pin. Refer to the corresponding
illustrations for the proper test pin
locations. There shall be no
continuity between these points.

6.2.2.3 Reconnect the respiratory volume
sensor cord to the interface panel.

6.2.3 Chassis Leakage Current

6.2.3.1 Apply the analyzer test lead to a
cylinder yoke bolt.

6.2.3.2 Set the safety analyzer to the
CHASSIS LEAKAGE CURRENT
position.

6.2.3.3 Record the total leakage current with the Polarity and
Ground switches set as follows:

Ground
Normal Normal
Open Normal
Open Reversed
Normal Reversed

Polarity

KEY

SP15005

EY

P15005A

ULTRASONIC

TEST

PIN

TES

PIN

6.2.3.4 Verify that the leakage current is 100* microamps or less in
each of the switch positions (110 microamps or less for the
220/240 volt power supply option).

6.2.3.5 300 microamps if external monitors are plugged into
convenience receptacles.

6.2.3.6 Shut off and unplug the safety analyzer. Remove the
anesthesia machine plug from the analyzer and plug it back
into the original AC receptacle.

6-12