Dräger Medical Narkomed 6400 Assembly instructions

Air-Only Mode
for the Narkomed 6400 Anesthesia System
Date: 30 January 2004
© 2004 Draeger Medical, Inc.
Instruction
Manual
Operator’s
Part Number: 4118081-001
Rev: A
WARNING: For a full understanding of the performance characteristics of this product, the
user should carefully read this manual before operating.
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Part Number: 4118081-001 Rev: A
Air-Only Mode Operator’s Manual
Contents
Section 1. Introduction
Operator's Responsibility for Patient Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2
Limitation of Liability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2
Restriction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3
Copyright. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3
Trademark Notices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3
Disclaimer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3
Recommendations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3
Purpose of This Manual. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-4
How This Manual Is Organized . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-4
Conventions Used in This Manual. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-4
General Warnings and Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-5
Section 2. General Description
Air-Only Mode Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-2
Air-Only Mode Control Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-2
Air-Only Mode Status Message. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-3
Section 3. Preuse Checkout
Preuse Checkout for Air-Only Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-2
Section 4. Air-Only Mode Operation
Enabling Air-Only Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-2
Special Conditions in Air-Only Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-3
Enabling N2O/Air/O2 Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-8
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Part Number: 4118081-001 Rev: A Air-Only Mode Operator’s Manual
1Introduction
This section introduces you to the Air-Only Mode Operator’s Manual
and provides important safety information.
Operator's Responsibility for Patient Safety ....................... 1-2
Limitation of Liability .......................................................... 1-2
Restriction .......................................................................... 1-3
Copyright ........................................................................... 1-3
Trademark Notices ............................................................. 1-3
Disclaimer .......................................................................... 1-3
Recommendations ............................................................. 1-3
Purpose of This Manual ..................................................... 1-4
How This Manual Is Organized .......................................... 1-4
Conventions Used in This Manual ..................................... 1-4
General Warnings and Cautions ........................................ 1-5
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1-2
1Introduction
Part Number: 4118081-001 Rev: A
Air-Only Mode Operator’s Manual
Operator's Responsibility for Patient Safety
Draeger Medical anesthesia products are designed to provide the greatest
degree of patient safety that is practically and technologically feasible. The
design of the equipment, the accompanying literature, and the labeling on
the equipment take into consideration that the purchase and use of the
equipment are restricted to trained professionals, and that certain
inherent characteristics of the equipment are known to the trained
operator. Instructions, warnings, and caution statements are limited,
therefore, to the specifics of the Draeger Medical design. This publication
excludes references to hazards that are obvious to a medical professional,
to the consequences of product misuse, and to potentially adverse effects in
patients with abnormal conditions. Product modification or misuse can be
dangerous. Draeger Medical disclaims all liability for the consequences of
product alterations or modifications, as well as for the consequences that
might result from the combination of Draeger Medical products with
products supplied by other manufacturers if such a combination is not
endorsed by Draeger Medical.
The operator of the anesthesia system must recognize that the means of
monitoring and discovering hazardous conditions are specific to the
composition of the system and the various components of the system. It is
the operator, and not the various manufacturers or suppliers of
components, who has control over the final composition and arrangement
of the anesthesia system used in the clinical practice. Therefore, the
responsibility for choosing the appropriate safety monitoring devices rests
with the operator and user of the equipment.
Patient safety may be achieved through a variety of different means
depending on the institutional procedures, the preference of the operator,
and the application of the system. These means range from electronic
surveillance of equipment performance and patient condition to simple,
direct contact between operator and patient (direct observation of clinical
signs). The responsibility for the selection of the best level of patient
monitoring belongs solely to the equipment operator. To this extent, the
manufacturer, Draeger Medical, disclaims responsibility for the adequacy
of the monitoring package selected for use with the anesthesia system.
However, Draeger Medical is available for consultation to discuss
monitoring options for different applications.
Limitation of Liability
Draeger Medical's liability, whether arising from or related to the
manufacture and sale of the products, their installation, demonstration,
sales representation, use, performance, or otherwise, including any
liability based upon Draeger Medical's product warranty, is subject to and
limited to the exclusive terms of Draeger Medical's limited warranty,
whether based upon breach of warranty or any other cause of action
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1-3
Introduction 1
Part Number: 4118081-001 Rev: A Air-Only Mode Operator’s Manual
whatsoever, regardless of any fault attributable to Draeger Medical and
regardless of the form of action (including, without limitation, breach of
warranty, negligence, strict liability, or otherwise).
Draeger Medical shall in no event be liable for any special,
incidental, or consequential damages (including loss of profits)
whether or not foreseeable and even if Draeger Medical has been
advised of the possibility of such loss or damage. Draeger Medical
disclaims any liability arising from a combination of its product
with products from another manufacturer if the combination has
not been endorsed by Draeger Medical. Buyer understands that
the remedies noted in Draeger Medical's limited warranty are its
sole and exclusive remedies.
Furthermore, buyer acknowledges that the consideration for the
products, equipment, and parts sold reflects the allocation of risk
and the limitations of liability referenced herein.
Restriction
Federal law restricts this device to sale by, or on the order of, a physician.
Copyright
Copyright 2004 by Draeger Medical, Inc. All rights reserved. No part of this
publication may be reproduced, transmitted, transcribed, or stored in a
retrieval system in any form or by any means, electronic or mechanical,
including photocopying and recording, without written permission of
Draeger Medical, Inc.
Trademark Notices
Datagrip, DrägerService, Narkomed, Narkomed GS, ORM,
Quality Service For Life, Respitone, Vigilance Audit, Vitalert, and Vitalink
are registered trademarks of Draeger Medical, Inc. All other products or
name brands are trademarks of their respective owners.
Disclaimer
The content of this manual is furnished for informational use only and is
subject to change without notice. Draeger Medical, Inc. assumes no
responsibility or liability for any errors or inaccuracies that may appear in
this manual.
Recommendations
In the interest of patient safety, Draeger Medical strongly advocates the
use of an oxygen analyzer, pressure monitor, a volume monitor, and an
end-tidal CO2monitor in the breathing circuit at all times.
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1-4
1Introduction
Part Number: 4118081-001 Rev: A
Air-Only Mode Operator’s Manual
Purpose of This Manual
This manual provides operating instructions for Air-Only Mode. It is
intended for use by trained clinical professionals familiar with accepted
medical procedures, practices, and terminology used in delivery of
anesthesia and patient monitoring.
How This Manual Is Organized
All users of the Air-Only Mode must read this manual completely before
using the equipment. This manual is intended to be used in conjuction
with the Narkomed 6400 Anesthesia System Operator’s Instruction
Manual.
In addition to this introductory section, this manual contains three other
sections:
Section 2 - “General Description” provides a summary of Air-Only Mode
features and functions.
Section 3 - “Preuse Checkout” provides a checkout procedure for Air-Only
Mode.
Section 4 - “Air-Only Mode Operation” contains detailed operational
information for Air-Only Mode.
Conventions Used in This Manual
This manual has several conventions to help organize the information
presented. Please read about these conventions carefully to understand
their significance in the manual.
Typefaces Different typefaces are used throughout the manual to differentiate
between narrative information and machine messages and labels.
Warningsand
Cautions Parts of this manual may contain warning and caution statements about
Air-Only Mode.
•Warning statements give important information that, if ignored, could
lead directly to personal injury.
•Caution statements give important information that, if ignored, could
lead directly to equipment damage and indirectly to a personal injury.
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1-5
Introduction 1
Part Number: 4118081-001 Rev: A Air-Only Mode Operator’s Manual
General Warnings and Cautions
The following list of warnings and cautions apply to general operation of
the Air-Only Mode. Warnings and cautions about specific functions appear
with those topics.
WARNING: Any person involved with the operation of Air-Only Mode
must be thoroughly familiar with this instruction manual.
However, instructions in this manual in no way supersede
established medical procedures for patient care.
WARNING: The Air-Only Mode is designed to be operated under the
constant surveillance of a qualified operator.
WARNING: To ensure patient safety:
• This device should be used by, or on the order of, a
physician.
• Constant attention by a qualified professional is needed
whenever a patient is under anesthesia or connected to a
ventilator. Some equipment malfunctions may pass
unnoticed in spite of the monitor alarm.
• Always make sure that alarm limits are set and alarms
are active when monitoring a patient. Do not rely
exclusively on the audible alarm system for patient
monitoring. Adjusting the alarm volume to a low level
during patient monitoring can jeopardize the patient.
• If the accuracy of any value display is in doubt, first
determine the patient’s vital signs by alternate means
before verifying that the Air-Only Mode is working
correctly.
• If the display loses patient data, it is possible that active
monitoring is not being performed. Close patient
observation or alternate monitoring devices should be
used until monitor function is restored.
• The Air-Only Mode bypasses conventional minimum O2
controls, allowing the clinician to deliver only air with no
oxygen flow. Constant surveillance of the patient’s
inspired oxygen level while in Air-Only Mode should be
provided.
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Part Number: 4118081-001 Rev: A Air-Only Mode Operator’s Manual
2 General Description
This section describes Air-Only Mode Option features and general
functionality.
Air-Only Mode Overview .................................................... 2-2
Air-Only Mode Control Button ............................................ 2-2
Air-Only Mode Status Message ......................................... 2-3
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2-2
2General Description
Part Number: 4118081-001 Rev: A
Air-Only Mode Operator’s Manual
Air-Only Mode Overview
The Air-Only Mode allows the clinician to deliver 21% oxygen (air) as the
fresh gas. The clinician selects this mode using a control button located on
the standard Narkomed 6400 screen.
WARNING: Minimum oxygen flow is disabled in Air-Only Mode.
Air-Only Mode Control Button
The Air-Only Mode button is located on the secondary taskbar at the
bottom of the main Narkomed 6400 screen. This button allows the
clinician to toggle between Air-Only Mode and normal N2O/Air/O2
operating mode.
Note: This control button is displayed only if the Air-Only Mode option is
installed on the machine; if the option is not installed, the key is
not displayed.
Note: The label on the button always reflects the action that the clinician
can select if the button is touched, not the current status.
Figure 2-1. Secondary Taskbar Showing the Air-Only Mode Control Button
Figure 2-2. Secondary Taskbar Showing the N2O/Air/O2 Control Button
Template Air-Only
Mode
Respi-
toneTM
Vent Info
Notebook
Low Flow
Wizard
Limits
Autoset
Utilities
Notebook
Auto
Pressure
Thrshld
O2 Cal Alarm
Suspend
Main
Screen
To Primary
Keys
Template N2O/Air
O2
Respi-
toneTM
Vent Info
Notebook
Low Flow
Wizard
Limits
Autoset
Utilities
Notebook
Auto
Pressure
Thrshld
O2 Cal Alarm
Suspend
Main
Screen
To Primary
Keys
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2-3
General Description 2
Part Number: 4118081-001 Rev: A Air-Only Mode Operator’s Manual
Air-Only Mode Status Message
If the Air-Only Mode option is installed, a message indicating the status of
the option is displayed in the oxygen parameter box.
When Air-Only Mode is enabled, the message Air-Only Mode is displayed
below the oxygen concentration value (See Figure 2-3.) This indicates that
minimum oxygen flow has been turned off, allowing the clinician to use air
only to achieve 21% oxygen. Oxygen and nitrous oxide flows must be
turned off for proper operation.
Figure 2-3. Air-Only Mode Message in Oxygen Parameter Box
When Air-Only Mode is disabled, the message N2O/Air/O2 is displayed
below the oxygen concentration value (See Figure 2-4.) This indicates that
minimum oxygen flow is on and all three fresh gases will function
normally.
Figure 2-4. N2O/Air/O2 Message in Oxygen Parameter Box
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Part Number: 4118081-001 Rev: A Air-Only Mode Operator’s Manual
3Preuse Checkout
This section contains a preuse checkout procedure for Air-Only Mode.
Preuse Checkout for Air-Only Mode .................................. 3-2
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3-2
3Preuse Checkout
Part Number: 4118081-001 Rev: A
Air-Only Mode Operator’s Manual
Preuse Checkout for Air-Only Mode
Use this procedure daily and between successive cases to verify proper
operation of Air-Only Mode. This checkout procedure should be used as
part of the comprehensive checkout procedure provided in the Narkomed
6400 Operator’s Instruction Manual.
1. Enable Air-Only Mode by pressing the [Air-Only Mode] control button
and then pressing the [Continue] button in the dialog box.
2. Turn all flow control knobs completely off and verify that no fresh gas
(including oxygen) is flowing through any flow tube.
3. Verify that the message Air-Only Mode is displayed at the bottom of the
oxygen parameter box.
4. Turn up the air flow control and verify that flow of air is possible with
no oxygen flowing.
5. Turn off the air flow control.
6. If Air-Only Mode will not be used in the next case, return to N2O/Air/
O2operation by pressing the [N2O/Air/O2] control button and then
pressing the [Continue] button in the dialog box.
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Part Number: 4118081-001 Rev: A Air-Only Mode Operator’s Manual
4Air-Only Mode Operation
This section contains operational information for Air-Only Mode.
Enabling Air-Only Mode ..................................................... 4-2
Special Conditions in Air-Only Mode ................................. 4-3
Loss of O2 Numeric Data in Air-Only Mode ................. 4-3
Significant N2O/O2 Levels Detected in Air-Only Mode 4-5
New Case in Air-Only Mode ........................................ 4-6
VPO Hardware Fault in Air-Only Mode ........................ 4-7
Enabling N2O/Air/O2 Operation ........................................ 4-8
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4-2
4Air-Only Mode Operation
Part Number: 4118081-001 Rev: A
Air-Only Mode Operator’s Manual
Enabling Air-Only Mode
Air-Only Mode can be enabled only when there is valid oxygen data and
when the oxygen sensor is properly calibrated.
If the [Air-Only Mode] button is touched when there is no valid oxygen
reading, the hint message “A valid oxygen concentration must be
displayed to select Air-Only Mode” is displayed above the control button.
If the [Air-Only Mode] button is touched while there is an O2 CAL DUE
alarm posted, the hint message “O2 must be calibrated to select Air-Only
Mode” is displayed above the control button.
To enable Air-Only Mode:
1. Press [To Secondary Keys] on the main screen taskbar.
Several control buttons change to choose additional tasks.
2. Press [Air-Only Mode] on the secondary taskbar. If there is valid
oxygen data and no O2 CAL DUE alarm is posted, the following dialog
box is displayed:
Figure 4-1. Enable Air-Only Mode Confirmation Dialog Box
WARNING: If the N2O flow control valve is open while in Air-Only Mode,
it is possible that N2O will be delivered. Close the N2O flow
control valve to avoid inadvertent delivery of N2O to the
patient. Also adjust the oxygen flow control valve to an
appropriate level.
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4-3
Air-Only Mode Operation 4
Part Number: 4118081-001 Rev: A Air-Only Mode Operator’s Manual
• to cancel the request, touch [Cancel].
• to enable Air-Only Mode, adjust N2O flow to zero, appropriately adjust
oxygen flow, and touch [Continue]. The following actions occur:
– the minimum oxygen flow is disabled
– the label of the control button on the secondary taskbar changes to
N2O/Air/O2
–themessageAir-Only Mode is displayed under the oxygen
concentration value in the oxygen parameter box
– the oxygen low alarm limit is set to 18%
– the oxygen high alarm limit is set to 100%
3. Set air flow to the desired level.
Special Conditions in Air-Only Mode
The following paragraphs describe the dialog boxes that are displayed
during specific conditions that can occur in Air-Only Mode.
Loss of O2
NumericData
in Air-Only
Mode
Dialog boxes informing the clinician of loss of numeric data may appear on
the screen while in Air-Only Mode.
If the loss of numeric data is due to an oxygen sensor disconnect alarm (O2
SENSOR DISC), the following dialog box appears on the screen:
Figure 4-2. Loss of Numeric Data in Air-Only Mode (Sensor Disconnect)
• Ensure that the oxygen sensor cable at the breathing system interface
panel is properly connected.
•Touch
[Continue] to remove this dialog box. The system remains in Air-
Only Mode.
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4-4
4Air-Only Mode Operation
Part Number: 4118081-001 Rev: A
Air-Only Mode Operator’s Manual
If the loss of numeric data is due to a CAL O2 SENSOR or an O2 CAL
ERROR alarm, the following dialog box appears on the screen:
Figure 4-3. Loss of Numeric Data in Air-Only Mode (Calibration Problem)
• Calibrate the oxygen sensor or replace the oxygen sensor capsule.
Refer to the Narkomed 6400 Anesthesia System Operator’s Instruction
Manual for specific instructions.
•Touch
[Continue] to remove this dialog box. The system remains in Air-
Only Mode.
Adult Tidal
Volumes
Detected in
Air-Only
Mode
The following dialog box appears on the screen if a tidal volume greater
than 200 ml is detected for three consecutive breaths while in Air-Only
Mode and while in an automatic ventilation mode:
Figure 4-4. Adult Tidal Volumes Detected
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