Dräger NAD Assembly instructions

NAD Omicron Monitor
Date: 16 February 2000
© 2000 Draeger Medical, Inc.
Instruction
Manual
Operator’s
Part Number: 4114448-001
Rev: D
RETURN TO CD-ROM TABLE OF CONTENTS

RETURN TO CD-ROM TABLE OF CONTENTS

Preliminary i
Contents
Section 1. Introduction
Operator’s Responsibility for Patient Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2
General Warnings, Cautions, and Notes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3
Section 2. Flow Head Installation
Flow Head Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-2
Section 3. Operating Instructions
Real Time Pressure Bar Graph. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-2
Breathing Pressure Low Limit Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-2
User Input Keys. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-2
Section 4. Cleaning and Sterilizing
User Responsibilities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-2
Pre-Processing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-2
Omicron Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-2
Flow Head . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-3
Triple Lumen Tubing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-3
Section 5. Troubleshooting
Faults and Actions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-2
Section 6. Specifications
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-3
Pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-3
FI02 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-3
Flow. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-4
Displayed Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-4
Environmental . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-5
User Adjustable Alarm Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-6
Other Functions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-7
RETURN TO CD-ROM TABLE OF CONTENTS

RETURN TO CD-ROM TABLE OF CONTENTS

1-1
1Introduction
This section introduces you to the North American Dräger (NAD)
Omicron Monitor and describes how to use this manual.
Operator’s Responsibility for Patient Safety ....................... 1-2
General Warnings, Cautions, and Notes ........................... 1-3
RETURN TO CD-ROM TABLE OF CONTENTS

1-2
1Introduction
Operator’s Responsibility for Patient Safety
The NAD Omicron Monitor will perform as detailed in this manual, and on
its accompanying label, when assembled, operated, maintained, and
repaired according to the following instructions.
If your NAD Omicron Monitor needs to be repaired, contact your NAD
service representative or contact NAD directly at the following address:
3122 Commerce Drive
Telford, PA 18969
Tel: [phone]
WARNING: The NAD Omicron Monitor should not be repaired or
modified by any individual or entity other than NAD
personnel or repair services authorized by NAD.
Malfunctions resulting from damage due to improper use or
alteration of the NAD Omicron Monitor are the sole
responsibility of the user.
RETURN TO CD-ROM TABLE OF CONTENTS

1-3
Introduction 1
General Warnings, Cautions, and Notes
WARNING: Upon power up, the monitor will load the last saved alarm
settings. These parameters may not be appropriate for the
current patient’s ventilatory status. The user must review
these alarm parameters to determine their appropriateness
for the current patient and adjust those settings as clinically
necessary.
WARNING: If the NAD Omicron Monitor shows a reading of 127 cm H2O
or -127 cm H2O, DO NOT CONTINUE TO USE THE UNIT
IN CLINICAL SETTINGS. Remove the unit from use for
servicing.
CAUTION: United States Federal Law restricts this device to sale by or
on the order of the physician.
CAUTION: The NAD Omicron monitor has been designed to work only
with the Narkomed MRI anesthesia machine. Use only NAD
supplied oxygen and flow sensors with this monitor to ensure
accuracy and compatibility with MRI systems.
NOTE: Due to the sensitivity of the monitor, and while monitoring
within the Respiratory Volume display, a “00” may be
occasionally observed on the Respiratory Volume display. The
presence of the “00” does not influence the accuracy of data or
alarms management, and the display will be updated with
real-time Respiratory Volume data at the completion of the
next expiratory phase.
RETURN TO CD-ROM TABLE OF CONTENTS

RETURN TO CD-ROM TABLE OF CONTENTS

2-1
2Flow Head Installation
This section instructs you on installing the flow head.
Flow Head Installation ....................................................... 2-2
RETURN TO CD-ROM TABLE OF CONTENTS

2-2
2Flow Head Installation
Flow Head Installation
Connect the flow head sensor to the monitor through the flexible triple
lumen tubing. The flexible tubing mates with the monitor only one way,
ensuring that each pressure port is connected correctly. The flexible tubing
is labled “Toward Flow Head.” Ensure that the arrows on the tubing are
pointing in the direction of the flow sensor. See Figure 2-1.
CAUTION: The NAD Omicron Monitor has been designed to work only
with the Narkomed MRI anesthesia machine. Use only NAD-
supplied oxygen and flow sensors with this monitor to ensure
accuracy and compatibility with MRI systems.
Fi
g
ure 2-1. Rear Panel
The flow sensor is intended for use on patients with tidal volumes from 50
to 1500 milliliters. The flexible tubing transfers pressures within the
sensor housing to ports on the monitor. The monitor uses these pressures
to compute displayed values. The flexible tubing transfers two flow
parameters (+ flow and - flow) and the pressure within the patient
breathing circuit.
9 VDC Proz
FiO2
PORT B
Ambient
Pressure
FLOW/PORT A
Breathin
g
Circuit
Prox
RETURN TO CD-ROM TABLE OF CONTENTS

3-1
3Operating Instructions
This section instructs you in how to use the NAD Omicron Monitor.
Real Time Pressure Bar Graph ......................................... 3-2
Breathing Pressure Low Limit ............................................ 3-2
User Input Keys ................................................................. 3-2
Display Function Keys ................................................. 3-3
Alarm Function Keys .................................................... 3-4
Calibration Function Keys ............................................ 3-8
RETURN TO CD-ROM TABLE OF CONTENTS

3-2
3Operating Instructions
Real Time Pressure Bar Graph
A common feature of all data screens is the real time pressure bar graph.
The bar graph represents the instantaneous pressure within the breathing
circuit. If the pressure exceeds the limits of the display (more than 120 cm
H2O or less than -10 cm H2O), the bottom or top segments will blink. The
unit displays two stationary segments; one that corresponds to the high
pressure alarm limit, and the other that corresponds to the low pressure
limit.
Breathing Pressure Low Limit
The breathing pressure low limit setting serves two purposes. First, when
the peak breathing pressure stays below the low limit for fifteen (15)
seconds, the Pressure and Respiratory Rate displays will display dashes
(---). Second, when the PEEP pressure stays above the low limit for fifteen
(15) seconds, the continuous pressure alarm is annunciated.
User Input Keys
User input keys are grouped into three categories: display function keys,
alarm function keys, and calibration function keys. See Figure 3-1.
Fi
g
ure 3-1. Front Panel
OP00067
cm/H2O
50
40
30
20
10
0
-10
120
110
100
90
80
70
60
450
VOLUME
Hi Alert
Mid Alert
Low Alert
Power
RETURN TO CD-ROM TABLE OF CONTENTS

3-3
Operating Instructions 3
Display
Function
Keys
Use the following display function keys to operate the NAD Omicron
Monitor.
O2 The O2 key is used to display the Inspiratory Oxygen screen. This is the
first screen to appear on the monitor when you turn on the system.
You must calibrate the oxygen sensor before oxygen data is displayed. For
greatest accuracy, you should complete the two-part calibration (first using
21% oxygen, then using 100% oxygen). After completing the first part (21%
calibration), the monitor will display oxygen concentration, and it will also
display LO O2 CAL to indicate that you have not performed the 100%
oxygen calibration.
CAUTION: The characteristics of the oxygen sensor change gradually
with time. To ensure accuracy, the oxygen sensor must be
recalibrated before each day’s use. If the oxygen sensor fails to
calibrate, refer to “Troubleshooting” on page 5-1.
PRES The Pres key is used to display the Breathing Pressure screen. The unit
displays three digital values. The largest value represents the peak
pressure recorded during the last breath. The other two values are smaller
and are located below the peak pressure. The value to the left of the peak
pressure represents the minimum, while the value to the right of the peak
pressure represents the mean pressure during the last breath.
WARNING: If the NAD Omicron Monitor shows a reading of 127 cm H20
or -127 cm H20, DO NOT CONTINUE TO USE THE UNIT
IN CLINICAL SETTINGS. Remove the unit from use for
servicing.
MIN VOL The Min Vol key is used to display the Minute Volume screen. The monitor
computes this parameter from a running average of tidal volumes from the
last four breaths, or 15 seconds, whichever is greater. It refreshes the
display after each breath.
TIDAL VOL The Tidal Vol key is used to display the Tidal Volume screen. Tidal volume
is computed from expiratory flow and is updated after each breath.
RR The RR key is used to display the Respiratory Rate screen. When
computing respiratory rate, the monitor counts both machine breaths and
the patient’s spontaneous breaths.
NEONATE/
ADULT The Neonate/Adult key will not invoke the neonatal mode of operation; the
monitor is always in the adult mode of operation. Depressing this key will
cause the high and low alarm limits for Tidal Volume and Minute Volume
to revert back to the last user-saved or factory-preset alarm parameters
(see Table 3-4 on page 3-7 for more information).
RETURN TO CD-ROM TABLE OF CONTENTS

3-4
3Operating Instructions
Alarm
Function
Keys
Clearing
Alarms None of the monitor’s alarms is a latching type alarm. When an alarm
condition exists, the monitor clears the alarm at the end of the next breath
if the respiratory parameter falls within alarm limits during that breath.
SILENCE Press this key to silence alarms for 120 seconds. During this interval,
– if the alarm condition continues,
• the audible alarm remains off,
• one of the color-coded LED visual alarm indicators (lower right-
hand corner of the front panel) remains on, and
• the red alarm status indicator (upper left-hand corner of the
fnont panel) remains on.
– If the alarm condition exists longer than 120 seconds, the monitor
turns the audible alarm back on.
APNEA STBY Pressing the Apnea Stby key disables the pressure and volume apnea
alarms. The volume apnea alarms are automatically enabled again as soon
as the next breath is detected.
Setting Alarm Limits
Four Alarm Function Keys (High Limit, Low Limit, UP ARROW, DOWN
ARROW) are used to change alarm limits for the five displayed respiratory
parameters (Oxygen, Pressure, Minute Volume, Tidal Volume, or
Respiratory Rate).
NOTE: All alarms are suspended while the monitor is in alarm limit
setting screens.
Execute the following steps to view or change the alarm limit setting(s) for
a specific respiratory parameter:
1. Press the parameter’s display function key.
2. Use one of the following four keys:
–HIGHLIMIT
With the monitor set to a parameter’s display screen or to the Low
Limit Set screen, pressing the High Limit key opens the Set High
Limit Alarm screen for that parameter.
–LOWLIMIT
With the monitor set to a parameter’s display screen or to the High
Limit Set screen, pressing the Low Limit key opens the Set Low
Limit Alarm screen for that parameter. Unlike the High Limit Set
screens, there are only four Low Limit Set screens.
RETURN TO CD-ROM TABLE OF CONTENTS

3-5
Operating Instructions 3
NOTE: The Respiratory Rate parameter does not have a low limit
set point.
–UP ARROW
With the monitor set to either the High Limit or Low Limit Set
screen, press or press and hold this key to increase the alarm limit.
– DOWN ARROW
With the monitor set to either the High Limit or Low Limit Set
screen, press or press and hold this key to decrease the alarm limit.
The monitor keeps track of how long it displays a parameter’s High
or Low Limit Alarm Set screen. After 15 seconds without additional
user input, it automatically returns to the parameter’s display
screen.
Alarm Priority
Depending on the alarm urgency, the monitor issues three different
priority alarms: high, middle, and low priority. The visual alarm indicator
is color coded. If more than one alarm condition exists, the monitor shows
the highest alarm priority.
The following tables list the alarm alert priorities:
Table 3-1. Hi
g
h Alert Priorit
y
Alarms
Display Desi
g
nation Description
HI LIMIT Pressure Hi
g
h Limit Peak Pressure Value is above the
Hi
g
h Limit Set Value.
APNEA VOL Apnea Volume > 30 Sec Tidal Volume is less than 30 mL for
more than 30 seconds.
RATE ALRM Respiratory Rate Hi
g
h Limit Respiratory Rate is above the Hi
g
h
Limit Set Value.
O2 LO LMT O2Low Limit O2Concentration is below the Low
Limit Set Value.
CONT PR Continuous Pressure PEEP Pressure Value is above the
Low Limit Set Value for more than 15
seconds.
TIDAL HI Tidal Volume Hi
g
h Limit Tidal Volume Value is above the Hi
g
h
Limit Set Value.
RETURN TO CD-ROM TABLE OF CONTENTS

3-6
3Operating Instructions
Saving Alarm Limits
When the monitor leaves the manufacturer’s production facility, each
alarm limit is set to the values listed in Table 3-4 (factory presets).
Each time the NAD Omicron Monitor is energized, the alarm limits are set
to the last saved default values. Use this procedure to set the default
values to the current alarm limit settings:
1. Select the parameter to be changed and depress the parameter keys.
2. Change the setting by pressing the high or low limit button and the up
or down arrow keys.
3. Depress the parameter keys again (this will cause the numbers on the
monitor to disappear).
4. Simultaneously press the up and down arrow keys until the monitor
displays the message SAVE DATA; the alarm limit settings are saved.
Even when powered off, the monitor retains stored alarm limits.
NOTE: If the alarm limit settings for Tidal Volume and Minute Volume
are not saved as described above, depressing the Neonate/Adult
key will restore those alarm limits to the last user-saved or
factory-saved preset alarm parameters (see Table 3-4 on page 3-7
for more information).
Table 3-2. Middle Alert Priorit
y
Alarms
Display Desi
g
nation Description
APNEA VOL Apnea Volume > 15 sec Tidal Volume is less than 30 mL for
more than 15 seconds.
MINUT HI Minute Volume Hi
g
h Limit Minute Volume Value is above the
Hi
g
h Limit Set Value.
TIDAL LOW Tidal Volume Low Limit Tidal Volume Value is below the Low
Limit Set Value.
MINUT LOW Minute Volume Low Limit Minute Volume Value is below the
Low Limit Set Value.
Table 3-3. Low Alert Priorit
y
Alarms
Display Desi
g
nation Description
O2 HI LMT O2 Hi
g
h Limit O2concentration is above the Hi
g
h
Limit Set Value.
O2 SENSOR O2Sensor Failure O2Sensor failed or disconnected.
RETURN TO CD-ROM TABLE OF CONTENTS

3-7
Operating Instructions 3
.
Table 3-4. Factor
y
Pre-set Alarm Limits
Alarm Alarm Limit
O2 Hi
g
h Limit 100%
O2 Low Limit 30%
Pressure Hi
g
h Limit 50 cm H2O
Pressure Low Limit 12 cm H2O
Minute Volume Hi
g
h Limit 10 L
Minute Volume Low Limit 1 L
Tidal Volume Hi
g
h Limit 1200 mL
Tidal Volume Low Limit 200 mL
Respiratory Rate Hi
g
h Limit 60 BPM
RETURN TO CD-ROM TABLE OF CONTENTS

3-8
3Operating Instructions
Calibration
Function
Keys
An NAD Omicron monitor has three separate calibration operations; “21%
O2Calibration Operation” on page 3-8, “100% O2Calibration Operation”
on page 3-8, and “Pressure and Flow Calibration Operation” on page 3-8.
To prevent accidental or unexpected interruption of respiratory monitoring
that occurs during calibration, you must confirm that you intend to
calibrate the instrument. To do this, you must press and hold any of the
calibration keys for at least 3 seconds. This starts the calibration sequence
for that key’s function. To initiate another calibration sequence, you must
release all calibration keys for at least two seconds before pressing another
calibration key.
21% O2
Calibration
Operation
Follow these steps to execute the 21% Calibration Operation:
1. Expose the oxygen sensor to room air for at least 30 seconds.
2. Press the 21% O2 Cal key for three seconds to begin the oxygen
calibration.
After three seconds, the monitor will display CALIBRATE, which
indicates that it has completed room oxygen calibration.
100% O2
Calibration
Operation
Follow these steps to execute the 100% Calibration Operation:
1. Expose the oxygen sensor to a gas environment of 100% oxygen for at
least 60 seconds.
2. Press the 100% 02 Cal key for three seconds to begin the second part of
the oxygen calibraton.
After three seconds, the monitor will display CALIBRATE, which
indicates it has completed the 100% oxygen calibration.
Pressure and
Flow
Calibration
Operation
When the monitor is first energized, it will display pressure and volume
parameters even though you have not initiated a zero calibration. Without
performing a flow calibration, the monitor may not achieve its specified
accuracy. After 15 minutes, the monitor will display FLOW CAL to remind
you to perform a zero calibration.
The following steps describe the Pressure and Flow Calibration Operation:
1. Pressing the Flow Cal key for three seconds starts a calibration process
that sets zero values for both the pressure and flow channels. It is used
to reduce measurement inaccuracies due to temperature drift or other
external environmental variations.
2. To ensure flow accuracy, reduce the air flow to a minimum and remove
the patient hose at the exhalation valve. Turn the ventilator off and
minimize any movement of the patient or the monitor hoses.
3. When the calibration process starts, the monitor will display
CALIBRATE while it establishes the zero set point for the pressure
channel.
RETURN TO CD-ROM TABLE OF CONTENTS

3-9
Operating Instructions 3
4. After the pressure calibration is complete, the monitor will display
PRESS OK and 0000.
5. Within three seconds, the monitor will display FLOW OK and 0000,
indicating that it is establishing the zero set points for the two flow
channels (Plus and Minus Flow).
6. After the tidal volume calibration is complete, the monitor will display
TIDAL VOL and ----.
7. Finishing this sequence indicates that the monitor has successfully
completed both pressure and tidal volume zero calibrations and will
achieve pressure and volume accuracy specifications.
RETURN TO CD-ROM TABLE OF CONTENTS

RETURN TO CD-ROM TABLE OF CONTENTS